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As filed with the Securities and Exchange Commission on August 29, 2007

Registration No. 333-142905



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

AMENDMENT NO. 3
TO
FORM S-1

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

MonoSol Rx, Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)
  2834
(Primary Standard Industrial
Classification Code Number)
  20-8623253
(I.R.S. Employer
Identification Number)

30 Technology Drive
Warren, New Jersey 07059
(732) 564-5000

(Address, including zip code, and telephone number, including area code,
of registrant's principal executive offices)

A. Mark Schobel
MonoSol Rx, Inc.
30 Technology Drive
Warren, New Jersey 07059
Telephone: (732) 564-5000

(Name, address, including zip code, and telephone
number, including area code, of agent for service)
With copies to:
Harva R. Dockery
Fulbright & Jaworski L.L.P.
2200 Ross Avenue, Suite 2800
Dallas, Texas 75201-2784
Telephone: (214) 855-8000
  William J. Grant, Jr.
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York, New York 10019-6099
Telephone: (212) 728-8000

Approximate date of commencement of proposed sale of securities to the public:    As soon as practicable after the effective date of this registration statement.

        If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, check the following box. o

        If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

        If this Form is a post-effective amendment filed pursuant to 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

        If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o


Calculation of Registration Fee


Title of each class of securities
to be Registered

  Amount to be Registered(1)
  Proposed maximum
offering price per share(2)

  Proposed maximum
aggregate offering price(2)

  Amount of
registration fee


Common Stock, par value $.01 per share   4,600,000 shares   $18.00   $82,800,000   $2,541.96

(1)
Including shares of common stock which may be purchased by the underwriters to cover overallotments, if any.

(2)
Estimated solely for purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.

        The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.




The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

PROSPECTUS (Subject to Completion)   Dated August 29, 2007

4,000,000 Shares

LOGO

Common Stock

This is the initial public offering of shares of our common stock. We are offering 4,000,000 shares of our common stock. Prior to this offering, there has been no public market for our common stock. We have applied for quotation of our common stock on The Nasdaq Global Market, Inc. under the symbol "MSRX." We expect that the public offering price will be between $16.00 and $18.00 per share.

Our business and an investment in our common stock involve significant risks. These risks are described under the caption "Risk Factors" beginning on page 8 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.


 
  Per Share
  Total
Public offering price   $     $  
Underwriting discount   $     $  
Proceeds, before expenses, to MonoSol Rx   $     $  

The underwriters may also purchase up to an additional 600,000 shares from us at the public offering price, less the underwriting discount, within 30 days from the date of this prospectus to cover overallotments.

The underwriters expect to deliver the shares against payment in New York, New York on            , 2007.


  Cowen and Company  
  CIBC World Markets  
  Susquehanna Financial Group, LLLP  

                        , 2007


TABLE OF CONTENTS

 
  Page
Prospectus Summary   1
Risk Factors   8
Special Notes Regarding Forward-Looking Statements   26
Use of Proceeds   28
Dividend Policy   28
Capitalization   29
Dilution   30
Selected Financial Data   31
Unaudited Pro Forma Financial Statements   33
Management's Discussion and Analysis of Financial Condition and Results of Operations   37
Business   53
Management   75
Compensation Discussion and Analysis   79
Principal Stockholders   105
Certain Relationships and Related Party Transactions   106
Description of Capital Stock   108
Material U.S. Federal Tax Considerations for Non-U.S. Holders of Our Common Stock   113
Shares Eligible for Future Sale   116
Underwriting   118
Legal Matters   123
Experts   123
Where You Can Find Additional Information   123
Index to Financial Statements   F-1

        You should rely only on the information contained in this prospectus. We have not, and the underwriters have not, authorized anyone to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. We are not, and the underwriters are not, making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.

        Information contained on our website is not part of this prospectus.

i



PROSPECTUS SUMMARY

        This summary provides an overview of selected information contained elsewhere in this prospectus and does not contain all of the information you should consider before investing in our common stock. You should carefully read the prospectus and the registration statement of which this prospectus is a part in their entirety before investing in our common stock, including the information discussed under "Risk Factors" beginning on page 8 and the financial statements and notes thereto that appear elsewhere in this prospectus. Unless otherwise indicated, all information in this prospectus assumes the underwriters do not exercise their option to purchase up to 600,000 shares of our common stock to cover overallotments.

Overview of Our Business

        We are a drug delivery company specializing in proprietary dissolving thin film pharmaceutical products. Our thin film, which is similar in size, shape and thickness to a postage stamp, dissolves rapidly and utilizes a novel process and proprietary encapsulation compositions to mask the taste of the drug contained within the film. We believe these qualities render our thin film easy to use and consequently will improve patient compliance, providing a significant benefit to patients and their prescribing physicians and healthcare institutions. Our thin film drug delivery technology has been commercialized in the over-the-counter, or OTC, marketplace and we are currently developing thin film containing prescription drugs. By incorporating approved drugs with soon-to-expire or expired patents into our thin film, we believe we can protect drug revenues important to our existing and future pharmaceutical partners. Furthermore, we are building the infrastructure required to produce our thin film rapidly and at scale.

        We believe our thin film drug delivery technology has several material benefits over existing drug delivery forms and should enjoy strong physician, patient and consumer acceptance. Our thin film improves convenience and ease of use through discretion and portability and precludes the need for water or liquids. Our thin film may also improve dosing accuracy relative to liquid formulations thereby ensuring proper dosing for the pediatric, geriatric and mentally ill patients where proper administration is often difficult. In addition, our thin film provides ease of dosing for patients with conditions that make it difficult to swallow other solid dosage forms such as tablets or capsules.

        Our proprietary thin film drug delivery technology is supported by a significant portfolio of intellectual property, which we believe differentiates us from our competitors. We believe this technology will enable pharmaceutical companies to better manage the life cycle of their products. By combining our thin film drug delivery technology with existing drugs, we believe our thin film can strategically differentiate existing or soon-to-be genericized drugs from potential generic competitors and can help protect branded prescription products against existing or new generic entries by providing additional patent protection or exclusivity in the marketplace. Additionally, we believe our thin film drug delivery technology can also be used to create new drug products with improved efficacy.

        We believe we are the only company completely dedicated to thin film as a drug delivery dosage form and have created a vertically integrated infrastructure to ensure leadership capabilities in the critical activities of drug tastemasking, analytical development, global formulation development, manufacturing and packaging. We have invested significantly in our model of vertical integration to develop an operational infrastructure that we believe will position us to seamlessly commercialize products in concert with our partners' respective sales forces.

Our Product Development

        We plan to develop and market our innovative thin film strip products in the prescription drug and OTC markets by pursuing four distinct revenue-generating strategies: (i) self-funded initiatives, or SFIs; (ii) partnered existing prescription products; (iii) partnered new prescription products; and (iv) partnered OTC pharmaceuticals and other products. We have identified and undertaken a number

1



of SFIs to develop thin film versions of existing products, which we ultimately intend to bring to market with a partner. We have also been engaged by pharmaceutical partners to develop thin film versions of existing prescription products. In the future, we expect to partner with pharmaceutical companies to deliver new prescription products with improved efficacy. We also expect to continue to develop and commercialize thin film products in the OTC and consumer marketplace.

Self-Funded Initiatives

        We are developing thin film versions of a series of existing blockbuster prescription drugs. We believe that these products can be approved by the Food and Drug Administration, or FDA, utilizing a 505(j) or NDA 505(b)(2) regulatory pathway, on the basis of limited clinical data and on a development to approval timeline of 24 to 30 months. To date, we have not filed with the FDA for approval of any products. We plan to advance development of these initiatives until we realize certain product-specific development milestones, at which point we expect to attract partners with whom we will commercialize these thin film products. We will be seeking partners at various stages of development and anticipate partnership opportunities upon attainment of milestones such as successful prototype development and stability, clinical bioequivalence, Chemistry, Manufacturing and Controls completion, post-filing with regulatory authorities or post-approval. We prefer to wait until we have reached more advanced milestones because we believe that the more complete an SFI project becomes, the more favorable the deal structure and terms we can secure from a potential partner. We have a large pool of drugs to choose from for thin film development due to our ability to carry a broad range of prescribed doses, up to 80 mgs of active ingredient, in our thin film compositions. We estimate there to be over 400 drug candidates suitable for development utilizing our thin film drug delivery technology and we intend to carefully evaluate those candidates to determine their suitability for internal development.

        We are currently self-funding the development of the following pharmaceutical products:


Self-Funded Initiatives

Brand Name

  Drug
  Patent
Expiration

  Category
  U.S. Sales
(Billions)*

  Status

Ambien®

 

Zolpidem Tartrate

 

Expired

 

Sleep

 

$

2.3

 

In Pilot Bioavailability/Bioequivalence Clinical Trial

Zofran®

 

Ondansetron HCl

 

Expired

 

Nausea/Vomiting

 

$

1.3

 

Pre-Clinical Work Complete; Pilot Bioavailability/Bioequivalence Clinical Trials Expected Third Quarter 2007

Aricept®

 

Donepezil HCl

 

11/2010

 

Alzheimer's Disease

 

$

1.1

 

In Pre-Clinical Development; Pilot Bioavailability/Bioequivalence Clinical Trials Expected First Half 2008

Lexapro®

 

Escitalopram Oxalate

 

3/2012

 

Anti-Depressant

 

$

2.0

 

In Pre-Clinical Development; Pilot Bioavailability/Bioequivalence Clinical Trials Expected First Half 2008

*
The numbers presented represent the U.S. sales of the existing prescription drugs listed in the table for fiscal year 2006 and are only intended to represent the current size of the market for these prescription drugs for that year. Additionally, these numbers are not meant to be representative of our future thin film product revenues as we, as a potential thin film drug delivery partner, may only receive a portion of the available revenue at any point in time. The drug targets that we have identified may change in revenue opportunity over time and could decline or increase based upon competing products and relative thin film acceptance within the market.

2


Our Partnered Products

        We are currently engaged with pharmaceutical partners to develop thin film versions of their existing prescription products. The following is a chart summarizing our disclosed partnered prescription products:


Disclosed Partnered Prescription Products

Product

  Category
  Partner
  Status

Ketorolac

 

Menstrual Pain

 

UMD Inc.

 

Pre-Clinical Work Complete

Multiple Products

 

Respiratory

 

Adams Respiratory Therapeutics, Inc.

 

In Product Development(1)

(1)
Our products are in various stages of the product development process including drug sourcing, tastemasking (if appropriate), film composition development and preliminary stability to support clinical investigation and potency requirements.

Our OTC Pharmaceuticals and Other Products

        We are developing and expect to market a number of OTC and other products with our partners. The following is a chart summarizing our partnered OTC and other products:


Partnered OTC Pharmaceuticals and Other Products

Product
    Brand Name

  Category
  Partner
  Status
Dextromethorphan   Cough   Vita Health Products, Inc.   Commercialized(1)
Diphenhydramine HCl   Cough   L. Perrigo Company   Prototypes Complete
Benzocaine
Chloraseptic®
  Sore Throat   Medtech Products Inc.   Commercialized(1)
Benzydamine   Sore Throat   Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.   Prototypes Complete
Undisclosed   Undisclosed   C.B. Fleet Company, Inc.   Prototypes Complete
Pectin and Menthol
Breathe Right®
  Snore Relief   GlaxoSmithKline plc   Commercialized(1)
Specialty Application
Marlboro®
  Tobacco   Philip Morris USA Inc.   Commercialized(1)
Chlorine Dioxide
TheraBreath®
  Halitosis   Dr. Harold Katz LLC   Commercialized(1)

(1)
Commercialized products are being manufactured when ordered by the partner and sold for revenue in accordance with a supply agreement or other arrangement with that partner.

3


Our Business Strategy

        Our strategy is to develop and partner to commercialize innovative thin film strip products in the prescription and OTC pharmaceutical markets. We seek to establish and maintain a leadership position in thin film drug delivery technology through continued development of our technology and our intellectual property portfolio. We believe that pharmaceutical companies will want to partner with us to extend the life cycle of their products, defend against patent expiration, protect against generic encroachment and differentiate their products in competitive categories. To achieve these goals, our strategy includes the following key elements:

Our Risks

        We are subject to a number of risks which could adversely affect our business, offset or eliminate any advantages of our approach or prevent us from successfully implementing our business strategy.

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        These and other risks of which you should be aware before you decide to buy our common stock are discussed more fully in the section of this prospectus entitled "Risk Factors."

Our Corporate Information

        We were incorporated in Delaware in March 2007. Our principal executive offices are located at 30 Technology Drive, Warren, New Jersey, and our telephone number is (732) 564-5000. We maintain a website at www.MonoSolRx.com. We have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a part of this prospectus.

        Unless the context indicates otherwise, the terms "MonoSol Rx," "we," "our," "us" or "the Company" refer to MonoSol Rx, Inc., a Delaware corporation, and the business of our predecessor company, Monosol Rx LLC, a Delaware limited liability company. Immediately prior to this offering, Monosol Rx LLC will merge with and into MonoSol Rx, Inc., a newly formed Delaware corporation, the shares of which are being sold in this offering. At the time of the merger, existing membership interest holders of Monosol Rx LLC will convert 157,198,704 membership interests into 11,029,412 shares of common stock in MonoSol Rx, Inc. The one existing share of MonoSol Rx, Inc.'s common stock, which is currently held by Monosol Rx LLC, will be cancelled upon the effectiveness of the merger. Additionally, all holders of performance units issued under Monosol Rx LLC's Performance Units Plans A and B will convert those units into stock appreciation rights, or SARs, of MonoSol Rx, Inc. on an economically equivalent basis. In this regard, 32,622,044 performance units will convert into 2,288,835 SARs. After completion of this offering, the existing equity owners of Monosol Rx LLC will own 11,029,412 shares of our common stock representing approximately 73.4% of the voting power of our outstanding capital stock. Approximately 2,288,835 of these shares will be available for the settlement of stock appreciation rights that were granted prior to this offering. See "Principal Stockholders" for more information regarding the ownership of our common stock.

5



The Offering


Common stock offered

 

4,000,000 Shares

Common stock to be outstanding after this offering

 

15,029,412 Shares

Use of proceeds

 

Proceeds from this offering will be used for product development including

 

 


 

clinical trials,

 

 


 

capital expenditures,

 

 


 

working capital, and

 

 


 

other general corporate purposes such as acquisitions of related technologies or products.

 

 

For additional information, see "Use of Proceeds."

Risk factors

 

See "Risk Factors" beginning on page 8 of this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our common stock.

Proposed Nasdaq Global Market symbol

 

MSRX

        The number of shares of our common stock outstanding after this offering is based on 11,029,412 shares outstanding on a pro forma basis as of June 30, 2007 and excludes, as of that date 1,502,941 shares of our common stock available for future grant under our 2007 Stock Incentive Plan.

        Unless otherwise indicated, all information in this prospectus assumes:

6



Summary Financial Data

        The table below sets forth summary financial data as of the dates and for the periods indicated. The data for the years ended December 31, 2006, 2005 and 2004 is derived from the audited financial statements of our predecessor Monosol Rx LLC, included elsewhere in this prospectus. The data for the six months ended June 30, 2007 and 2006 is derived from the unaudited financial statements of our predecessor Monosol Rx LLC, included elsewhere in this prospectus. The historical results presented below are not necessarily indicative of the results to be expected in any future periods. This information is only a summary, and you should read this data together with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and with the financial statements, the related notes and other financial information included in this prospectus.

 
  Year Ended December 31,
  Six Months Ended
June 30,

 
 
  2006
  2005
  2004
  2007
  2006
 
 
  (in thousands, except per interest and per share data)

 
Statement of Operations Data:                                
Revenues:                                
Manufacture and supply revenue   $ 1,765   $ 1,458   $ 1,947   $ 1,243   $ 1,145  
Co-development and research fees     950     665     100     917     350  
   
 
 
 
 
 
  Total revenues     2,715     2,123     2,047     2,160     1,495  

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Manufacture and supply     1,623     1,282     1,388     1,101     867  
General and administrative     11,296     7,372     3,168     7,557     4,441  
Research and development     1,993     1,258     1,010     1,365     845  
   
 
 
 
 
 
  Total costs and expenses     14,912     9,912     5,566     10,023     6,153  
   
 
 
 
 
 
  Operating loss     (12,197 )   (7,789 )   (3,519 )   (7,863 )   (4,658 )
Other income, principally related-party     64     41             27  
Interest income     226     46         291     53  
Interest expense     (845 )   (581 )   (41 )       (461 )
   
 
 
 
 
 
  Net loss   $ (12,752 ) $ (8,283 ) $ (3,560 ) $ (7,572 ) $ (5,039 )
   
 
 
 
 
 

Net loss applicable to membership interest holders

 

$

(12,752

)

$

(8,283

)

$

(3,560

)

$

(7,572

)

$

(5,039

)
Net loss per membership interest(3):                                
  Basic and diluted   $ (0.10 ) $ (0.07 ) $ (0.03 ) $ (0.05 ) $ (0.04 )
Weighted average number of membership interests outstanding:                                
  Basic and diluted     123,626     118,785     118,785     157,199     118,785  
 
  As of December 31, 2006
  As of June 30, 2007
 
 
   
   
  Pro Forma
As adjusted(2)

 
 
  Actual
  Actual
  Pro Forma(1)
 
 
  (in thousands)

 
Balance Sheet Data:                          
Cash and cash equivalents   $ 15,256   $ 7,781   $ 7,781   $ 68,398  
Working capital     14,830     6,175     6,175     67,607  
Total assets     27,179     22,713     22,713     82,238  
Total debt                  
Accumulated deficit     (24,595 )   (32,167 )   (59,204 )   (59,204 )
Members'/stockholders' equity     25,263     17,846     17,846     78,186  

(1)
On a pro forma basis to give effect to the merger of Monosol Rx LLC into MonoSol Rx, Inc.

(2)
On a pro forma as adjusted basis to give effect to (1) the merger of Monosol Rx LLC into MonoSol Rx, Inc. and (2) the sale of all of the shares of common stock in this offering at an initial public offering price of $17.00 per share, after deducting underwriting discounts and commissions and our estimated offering expenses. See "Unaudited Pro Forma Financial Statements."

(3)
Data per membership interest is based on the historical weighted average number of membership interests outstanding during the periods presented. Warrants issued in 2005 and 2006 have been included for the full term of each period presented pursuant to FAS 128, Earnings per Share. In 2006, preferred membership interests have also been reflected based on the issuance of these securities in November 2006, and based on their having rights as to voting and sharing of earnings and losses substantially equivalent to those of common membership interests.

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RISK FACTORS

        Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below and all of the other information set forth in this prospectus and the registration statement before deciding to invest in shares of our common stock. If any of the events or developments described below occur, our business, financial condition or results of operations could be negatively affected. In that case, the trading price of our common stock could decline, and you could lose all or part of your investment in our common stock.

Risks Related to Our Business and Industry

        We were recently organized and have a limited history of operations and earnings. Since our inception in January 2004, we have experienced significant net losses. We had a net loss of approximately $3.6 million for the year ended December 31, 2004, $8.3 million for the year ended December 31, 2005, $12.8 million for the year ended December 31, 2006 and $7.6 million for the six months ended June 30, 2007. As of June 30, 2007, we had an accumulated deficit of approximately $32.2 million and total members' equity of $17.8 million. On a pro forma basis giving account to the merger of Monosol Rx LLC into MonoSol Rx, Inc. our net loss and our accumulated deficit for the six months ended June 30, 2007 would have been $34.6 million and $59.2 million, respectively, and our net loss would have been $40.7 million for the year ended December 31, 2006. Our losses have resulted principally from expenses incurred in developing and administering our business and infrastructure, and costs associated with research and development of our technologies. Our losses may increase in the future as we expand our manufacturing capabilities, incur additional costs related to our research and development activities, and seek additional regulatory approvals. These losses, among other things, have had and will continue to have an adverse effect on our working capital, total assets and owners' equity. We have historically experienced considerable quarter-to-quarter variation in our results of operations and may not generate sufficient revenues from product sales to achieve or maintain profitable operations in the future. If we are unable to reduce our annual losses and achieve profitability, the value of our common stock will decline.

        Our future growth will depend in large part on our ability to successfully develop, obtain regulatory approval for, and commercialize our product candidates and those products developed in collaboration with other companies. In many instances, we will have to conduct significant additional pre-clinical and/or clinical studies with respect to these product candidates, and may need to obtain regulatory approval before we can commercialize them. Unexpected results or delays in our clinical trials may result in increased development costs. In addition, if one or more of our clinical trials are delayed, our competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could be significantly impaired.

        Product development is a long, expensive and uncertain process and, in some cases, entails both pre-clinical testing, which consists of laboratory testing using biological, chemical and animal models, and human clinical testing.

        We may suffer significant setbacks any time during the drug development process, even in advanced clinical trials, after obtaining promising results in earlier studies. At any point during clinical trials, undesirable side effects could be detected or the products may not exhibit the anticipated efficacy profile. These side effects and/or efficacy profiles could interrupt, delay or halt clinical trials of the product candidate being tested as well as related product candidates, and could result in the Food and Drug Administration, or FDA, or other regulatory authorities denying approval of such product candidates for any or all targeted indications.

8



        We may be required to conduct clinical studies in pediatric patient populations as a requirement for approval or as a post-market condition of approval. Pediatric studies can be difficult to conduct and can be quite costly and may not yield the anticipated results. According to the Code of Federal Regulations, pediatric trials with greater than minimal risk must confine research to children who have a condition or disorder, and the trial cannot pose any additional risks than would be normally encountered in the child's clinical care. For pediatric studies involving healthy subjects, the studies are generally more difficult to recruit because there are usually no direct benefits associated with this type of study. Serial blood samplings, blood drawing access, and trial design add to the cost of pediatric trials. Blood drawing volumes can also be a concern in clinical trials utilizing children less than two years of age thereby adding complexity and cost. In addition, many sites are largely ill equipped to entertain pediatric subjects for eight to 12 hours in the interest of adherence to a pharmacokinetic blood sampling schedule, this in turn limits site availability therein driving cost. The FDA's requests for more and longer trials are the main factors in boosting research expenditures year on year apart from the difficulties associated with recruiting child volunteers.

        Based on results at any stage of product development, we may decide to repeat or redesign pre-clinical studies or clinical trials, conduct entirely new studies or discontinue development of one or more of our product candidates. In addition, our product candidates may not demonstrate sufficient safety and efficacy in pending or any future pre-clinical testing or clinical trials to meet regulatory standards or obtain the requisite regulatory approvals, and even if such approvals are obtained for a product candidate, it may never become a viable commercial product.

        The commercial success of our products will depend primarily on achieving market acceptance among consumers and the medical community. To accomplish this, we, together with our collaborators, will have to convince physicians, patients, third party payors and other healthcare professionals that our products consistently offer benefits that are comparable to or superior to existing products and have acceptable safety profiles and costs. If we are not successful in these efforts, market acceptance of our products could be limited, if at all. Additionally, we do not have long-term safety data for many of our products. If long-term patient studies suggest that the use of our products or similar products produced by others are associated with adverse side effects, our products may not achieve market acceptance. Even if we demonstrate the safety and effectiveness of our products, the medical community and consumers may prefer already accepted products based upon established delivery technologies or competing new technologies. Additional factors that may influence market acceptance of our products include:


        If, due to any of these factors, our products do not achieve broad market acceptance, we will be unable to generate significant revenues from them, which would have a material adverse effect on our business, cash flows and results of operations.

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        We will, from time to time, after a quality review and assessment of their capabilities, engage and rely on third parties, contract research organizations and outside consultants to assist us in managing and monitoring our pre-clinical studies, clinical trials, obtaining regulatory approval, commercialization efforts, and marketing strategies.

        These third parties may not successfully carry out their contractual obligations, meet expected deadlines or follow regulatory requirements, including clinical, laboratory and manufacturing guidelines. We may also develop conflicting priorities or other conflicts of interest with our strategic partners. Our reliance on these third parties may result in increased costs and delays in completing, or in failing to complete, the testing, obtaining regulatory approval when required, and commercialization of our products. If clinical testing of our product candidates is compromised for any of the above-mentioned reasons, we will be unable to meet our anticipated development or commercialization timelines, which would have a material adverse effect on our business.

        We depend on third parties for the supply of certain ingredients we use to produce our products. While many of these ingredients are available from multiple suppliers, some may be available from only one supplier or a limited number of suppliers. For example, we currently have an agreement with Tate & Lyle Sucralose, Inc. where we agreed to buy a particular raw material exclusively from it as long as they supply that raw material at the quantity forecasted. If Tate & Lyle does not meet its obligations we are free to purchase that raw material from other sources.

        Our reliance on these suppliers exposes us to significant risks. These third parties may:

        If our suppliers are unwilling or unable to supply us with materials meeting our specifications, we may not be able to locate any alternative suppliers or enter into commercially reasonable agreements with suppliers in a timely manner or at all. Even if we are able to locate, qualify and enter into an agreement with new suppliers, it could take several months or longer to obtain regulatory clearance before a new supplier could begin supplying the relevant product to us. If we are delayed in establishing a secondary supply source for any raw material or component that we purchase from a single source, or cannot do so at an acceptable cost, we may suffer a shortage of commercial supply of that product or a higher cost of procuring the product, either of which would have a material adverse effect on our revenues, business and financial prospects.

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        We currently manufacture all of our products at our sole commercial manufacturing facility, which is located in Portage, Indiana. Accordingly, we face risks inherent in operating a single manufacturing facility since any disruption, such as a fire, natural disaster, terrorist attack or military action, could significantly interrupt our manufacturing capability. If an inspection by the FDA or other regulatory body identifies significant regulatory issues with respect to our compliance with cGMP, this also could have a material adverse impact on our ability to manufacture products for commercial distribution. Should this occur, we may not be able to timely respond to such inspectional observations and the time it would take the FDA or other regulatory body to re-inspect our facility. This could adversely affect the time to approval and our ability to produce products for the commercial market. We currently do not have alternative production plans in place or disaster-recovery facilities available. In case of a disruption, we will have to establish alternative manufacturing sources. This would require substantial capital on our part, which we may not be able to obtain on commercially acceptable terms or at all. Additionally, we would likely experience months or years of production delays as we build or locate replacement facilities and seek and obtain necessary regulatory approvals. If this occurs, we will be unable to satisfy customer orders on a timely basis, if at all. In addition, a disruption at our sole manufacturing site may impair or delay our ability to meet product demands from our customers. Also, operating any new facilities may be more expensive than operating our current facility. Furthermore, our business interruption insurance may not adequately compensate us for losses that may occur and we would have to bear the additional cost of any disruption. For these reasons, a significant disruptive event at our manufacturing facility could have drastic consequences on us, including threatening our financial viability.

        We need to expand our manufacturing capacity to meet anticipated demand for our products. In October 2006, we entered into an agreement to lease a 73,000 square foot facility in Portage, Indiana, the Ameriplex facility. We took possession of this facility in April 2007. The Ameriplex facility will become our primary research, development and manufacturing facility once it is retrofitted and occupied. We anticipate relocating our production and packaging equipment to the Ameriplex facility while we continue to make products for our existing customer base using such equipment. This relocation, if prolonged, could cause interruptions in our ability to make products, and our business could be adversely affected as a result. We may not be able to obtain the requisite regulatory approvals for the Ameriplex facility on a timely basis, or at all, and while we believe that the Ameriplex facility will be completed in phases through 2007 and the first half of 2008, we may not be able to complete the expansion of this facility within our anticipated time frame or budget. Even if we complete the construction in a timely manner, we may not be able to obtain the requisite regulatory approvals for the facility on a timely basis, or at all. If we cannot obtain necessary approvals for these contemplated expansions, or complete the planned construction in a timely manner, our ability to meet demand for our products would be adversely affected.

        We set goals for and make public statements regarding expected timing for the accomplishment of objectives material to our success, such as the commencement and completion of clinical trials. The actual timing of these events can vary dramatically due to factors such as delays or failures in our clinical trials, the uncertainties inherent in the regulatory approval process and delays in achieving manufacturing or marketing arrangements sufficient to commercialize our products. Our product development may not be completed, we may not make regulatory submissions or receive regulatory

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approvals as planned, and we may not be able to adhere to our current schedule for the launch of any of our products. If we fail to achieve one or more of these milestones as planned, the market price of our common stock could decline.

        The core of our strategy involves the development of our thin film drug delivery technology to targeted prescription pharmaceuticals. This area of product development is a multi-year process that requires formulation, stability, validation and analytical testing, clinical studies and necessary regulatory approvals prior to realizing any product revenue. We may need to raise additional funds through public or private debt or equity financings in order to develop or acquire new products or new product candidates, expand our manufacturing capacity, establish and expand our sales and marketing capabilities, obtain FDA approval for our product candidates and continue our commercial growth. Any additional equity financings may be on terms that are dilutive to our stockholders. Any debt financings we enter into may involve incurring significant interest expense and include covenants that restrict our operations. If we raise additional funds through collaborations or licensing arrangements, it may be necessary to relinquish some rights to our technologies, product candidates or products, or grant licenses on terms that are not favorable to us. Our ability to raise additional funds will depend on financial, economic, and market conditions and other factors, many of which are beyond our control. We may not be able to obtain financing on terms acceptable to us or at all. If financing is insufficient or unavailable, we will have to modify our growth and marketing strategies and scale back operations by delaying, reducing the scope of, or eliminating one or more of our planned developments, commercialization, or expansion activities. This may negatively affect the commercial expansion of our existing products and our ability to bring new over-the-counter, or OTC, and prescription pharmaceutical products to market, which could have a material adverse effect on our business, financial condition and results of operations.

        Our future need for additional funds may be significantly greater than we expect, and will depend on many factors, including:

        We anticipate the proceeds from this offering together with our existing cash balance will provide us with sufficient capital for approximately 24 months. During that time, any need we may have for additional capital will be in response to an unexpected opportunity to acquire technology, products or businesses that at this point are unknown to us or unexpected delays in the development of our product candidates.

        Our contracts for the development of thin film drug candidates generally allow our customers to terminate development or elect to not commercialize a candidate that is developed for thin film. Our partners could terminate development or not commercialize due to technical difficulties, issues with

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commercial acceptance, costs, regulatory barriers and other concerns. Such outcomes could have a material adverse effect on our business, financial condition and results of operations.

        In April 2006, we had a partner who terminated its project with us under a proof of principle agreement entered into in August 2005. At the time of termination, all contracted deliverables from us had been met in a satisfactory manner. The partner cited market forces and a need to redirect resources as its reasons for terminating the project. The termination of our project with the partner did not represent or cause any material harm to our operations or financial condition.

        Additionally, our relationship with some of our partners is on a purchase order basis and it is possible for these partners to discontinue placing product orders with us and thus terminate the relationship. This may impact our results of operations and future revenues.

        In connection with the growth of our business, we may experience rapid and significant growth in the number of our employees and the scope of our operations. Our future financial performance and our ability to commercialize our products and to compete effectively will depend, in part, on our ability to manage any future growth effectively. This growth and expansion is expected to place a significant demand on our financial, managerial and operational resources, and will require rapid analysis of new technologies, new markets, and new business relationships with a variety of industry players. Rapid growth, or mismanagement of such growth, could cause our operating costs to rise at a faster pace than is currently anticipated and could have a material adverse effect on our business, financial condition and results of operations.

        Disputes may arise between us and our partners and may involve the issue of the obligation to continue to purchase our products and pay royalties on the sale of our products. Such a dispute could result in expensive arbitration or litigation, which may not be resolved in our favor, or the termination of our relationship with the partner.

        The drug delivery, biotechnology, and pharmaceutical industries are characterized by intense competition and rapidly evolving technology. Our competitors have longer operating histories than we do, greater name recognition, and significantly greater resources and expertise in product development, regulatory matters, finance, marketing and sales. These organizations also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials and acquiring and licensing technologies. As a result, these competitors may be able to adapt more quickly to new or emerging technologies and changes in customer requirements. Competitors may use their extensive resources to develop products that are more effective, safer, more convenient or less costly than any that we are developing.

        While there are several competitors in the thin film drug delivery market, we believe our two primary competitors are Adhesives Research and Lohmann Therapie Systems. Since both Adhesives Research and Lohmann Therapie Systems are privately owned companies, information is not readily available regarding the status of their operations, the stage of development of their products, the identity of their partners or their historical or current revenues.

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        The success of our business is highly dependent on our management as well as our senior manufacturing and scientific personnel. In addition, we require additional skilled personnel in areas such as business and clinical development. Generally, we do not maintain key-person life insurance on any of our officers, employees or consultants. However, we do expect to maintain key-person insurance on A. Mark Schobel, our Chief Executive Officer. While we do have employment agreements and other retention inducements with certain key employees and consultants, those agreements do not prevent employees from leaving us to pursue other non-competing interests. The pool of individuals with relevant experience in the thin film drug delivery technology industry is very limited, and retaining and training personnel with the skills necessary to operate our business effectively is challenging, costly and time consuming. If we lose the services of any key personnel, our business, financial condition and results of operations could be materially and adversely affected.

        The principal members of management include the following individuals: A. Mark Schobel, our Chief Executive Officer; Keith Kendall, our Chief Financial Officer; Joseph Fuisz, our Senior Vice President, Business Development; Larry Kranking, our Senior Vice President, Manufacturing and Operations; and Dr. Pradeep Sanghvi, our Vice President, Pharmaceutical Development. Additionally, key members of our scientific staff include Garry Myers, our Senior Director of Pharmaceutical Development, and Dr. Richard Fuisz, a Consultant.

        With the exception of Larry Kranking and Garry Myers, all of the individuals named have employment or consulting agreements with us that extend at least through 2008. A further discussion of the terms and conditions of the employment agreements of certain key executives can be found in the Compensation Discussion and Analysis section of this prospectus. A further discussion of the terms and conditions of the consulting agreement with Dr. Fuisz can be found in the Certain Relationships and Related Party Transactions section of this prospectus.

        We are exposed to the risk of product liability claims inherent in businesses that test, manufacture, market and sell pharmaceutical products. We may be subject to claims against us even if the injury is due to the actions of others. We currently have several insurance policies to help protect against product liability claims. One policy covers product recall costs and liability dangers. This policy provides coverage of $2.5 million for each covered incident. Additionally, we have up to $50 million of product liability coverage.

        If we are involved in any product liability litigation, such litigation would consume substantial amounts of our financial and managerial resources and may result in adverse publicity regardless of the ultimate outcome of the litigation, decreased demand for our product candidates, withdrawal of clinical trial participants, significant litigation costs and substantial monetary awards to, or costs of settlement with, patients, product recalls and loss of revenues, and the inability to commercialize our product candidates. Although we believe we have appropriate insurance coverage, we may not be able to maintain our clinical trial insurance or product liability insurance at an acceptable cost or at all. In any event, liability insurance is subject to deductibles and coverage limitations and may not provide adequate coverage against potential claims or losses. A successful product liability claim brought against us could cause us to incur substantial liabilities.

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        If we or others identify serious, adverse events after any of our products are on the market:

Any of these events could harm or prevent sales of the affected products or could substantially increase the costs and expenses of commercializing or marketing these products.

        Our manufacturing and research and development activities sometimes involve the controlled use and disposal of potentially hazardous materials or controlled substances and chemicals. As such, we are subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous, radioactive and biological materials and wastes, and the cleanup of contaminated sites. The cost of compliance with these laws and regulations could be significant and accidental contamination or injury may occur. Although we believe that our safety and control procedures for handling, storing and disposing of such materials comply with the standards prescribed by applicable regulations, we cannot completely eliminate the risk of contamination or injury from use or mishandling of these materials. We also occasionally contract with third parties for the disposal of some of these materials. In addition, our collaborators and service providers may be working with these types of materials in connection with our collaborations. In the event of an accident or contamination, we could be held responsible for any injury caused to persons or property by exposure to, or release of, these materials and could be held liable for significant damages, civil penalties or fines, which may not be covered by or may exceed our insurance coverage.

        Additionally, we are subject on an ongoing basis to a variety of laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of continued compliance with current or new laws and regulations may be significant and could negatively affect our profitability, and current or future environmental regulation may impair our ongoing research, development or manufacturing efforts.

Risks Related to Our Intellectual Property

        Our success is dependent in part on obtaining, maintaining and enforcing patent and other intellectual property rights. We seek to obtain and maintain patents and other intellectual property rights to restrict the ability of others to market products that compete with our products. We currently have 29 patent applications pending in the U.S. of which seven are currently undergoing active examination. Each of these seven applications has received substantive actions from the United States Patent and Trademark Office, or USPTO, meaning we have received communications from the patent examiner relating to the substance of the claims as they are currently written and that appropriate

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responses have been or will be filed. In all cases, the examiner has initially rejected the claims of our applications as they are currently worded on the basis of prior art. One of these applications, directed to our proprietary drying process, is on appeal to the USPTO Board of Appeals and Interferences, or Board of Appeals, an administrative appeal body within the USPTO, requesting that the Board of Appeals reverse the examiner and grant the patent claims as they are currently worded in an attempt to obtain broad coverage. Broad claims, as opposed to narrower claims, mean that a wider range of competitive activities and processes may be prevented from impacting our business. Should the claims issue with such broad scope, they will limit the available ways in which others may achieve uniformity of drug content in oral dosage forms, or ODFs. Uniformity of content is a critical factor in obtaining FDA approval for ODFs. If the decision on appeal is favorable, then we will obtain the broad patent protection to which we believe we are entitled. We believe such a patent would represent a significant advantage in the field of ODFs. In the event the appeal is unfavorably or partially unfavorably decided, we have the opportunity to appeal further to the courts, or may elect to continue the case further at the USPTO by filing a continuation case, with claims more limited in scope. We have already filed continuation cases on the proprietary drying process with claims having a more narrow scope and with emphasis on new aspects of the process not previously claimed. These applications are being prosecuted before the USPTO contemporaneously with, but independent from the case on appeal.

        Because of the many complex legal and technical issues involved, the patent position of pharmaceutical firms is highly uncertain. The process for obtaining a patent in the U.S. involves a number of varying factors, including the subjectivity inherent in the normal examination process. Such factors may make it difficult to obtain the issuance of a patent or a patent with scope that is competetively meaningful. Patent applications we file or license from others may not result in the issuance of a patent. Moreover, although issued patents in the U.S. enjoy the pressumption of validity, this may be challenged and potentially overturned as the result of litigation. Patents, if issued, may be challenged and invalidated altogether, substantially narrowed as to scope or determined to be unenforceable. Consequently, it is not entirely certain how much protection, if any, patents will provide to us if we attempt to enforce them.

        The recent U.S. Supreme Court decision in KSR International v. Teleflex Inc., or the KSR decision, may have far reaching effects on the patent system in general. One of the established tenets of U.S. patent law is that the patent examiner cannot rightfully reject a patent claim as being obvious, and therefore unpatentable, on the basis of a combination of prior art references, unless there was some teaching, suggestion or motivation, or TSM, to suggest that the invention would be apparent to one of ordinary skill in the art. In the KSR decision, the court stated that the TSM need not be explicitly recited in the prior art, but could be derived from a common sense reason to combine prior art references in making a rejection based on obviousness. In essence, combinations of old elements to produce a predictable result may be considered obvious. The court, in the KSR decision, thus adopted a more flexible approach to finding the presence of TSM from the prior art.

        Although the KSR decision did not do away with the requirement for the examiner to show TSM in order to combine references in rejecting claims, many in the patent profession believe that this decision may make it easier for the examiner to find that TSM is present, thereby making it more difficult to obtain a patent. Additionally, as a result of the KSR decision, some patent practitioners also believe that many patents which are combination patents, meaning a combination of old elements, may be easier to attack on the basis of obviousness.

        In response to the KSR decision, the USPTO has circulated an internal memo instructing examiners to be explicit with their reasoning for combining references in rejecting claims. The memo also reiterates that the requirement for demonstrating proper TSM still stands and the examiners must demonstrate that there is proper teaching, suggestion or motivations to combine references.

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        Patent rights are territorial. Thus, the patent protection we do have will only extend to those countries in which we have issued patents. Even so, the laws of certain countries do not protect our intellectual property rights to the same extent as do the laws of the United States and various European countries. Competitors may successfully challenge our patents, produce similar drugs or products that do not infringe our patents, or produce drugs in countries where we have not applied for patent protection or that do not respect our patents. Additionally, the nature of claims contained in unpublished patent filings around the world is unknown to us and it is not possible to know which countries patent holders may choose for the extension of their filings under the Patent Cooperation Treaty, or other mechanisms. Furthermore, it is not possible to know the scope of claims that will be allowed in published applications and it is also not possible to know which claims of granted patents, if any, will be deemed enforceable in a court of law.

        Our patents, if issued, may not contain claims that are sufficiently broad to prevent others from practicing our technologies or developing competing products. Our competitors may create or use methods that reduce or eliminate any competitive advantage we may have based on our thin film development intellectual property portfolio. Additionally, technologies may exist that perform substantially the same as our technologies and avoid infringing our patent claims. Under such circumstances, our patents would be of little commercial value to us.

        We may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States. Thus, any patents that we own or license from third parties may not provide commercially meaningful protection from competition.

        We have concluded that certain competitively sensitive information is either not patentable or, for competitive reasons, it is not commercially advantageous to seek patent protection. In these circumstances, we seek to protect this know how and other proprietary information by maintaining it in confidence as a trade secret. Trade secret information is closely guarded and areas involving trade secrets have restricted access. To further maintain the confidentiality of our trade secrets, we generally enter into confidentiality agreements with our employees, consultants and collaborators upon the commencement of their relationships with us. These agreements require that all confidential information developed by the individual or made known to the individual by us during the course of the individual's relationship with us be kept confidential and not disclosed to third parties. Our agreements with employees also provide that inventions conceived by the individual in the course of rendering services to us shall be our exclusive property. However, we may not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with the terms of these agreements. The disclosure of our trade secrets would impair our competitive position. Adequate remedies may not exist in the event of unauthorized use or disclosure of our confidential information. Further, to the extent that our employees, consultants or contractors use trade secret technology or know how owned by others in their work for us, disputes may arise as to the ownership of related inventions.

        In the event that our technologies infringe or violate the patent or other proprietary rights of third parties, we may be prevented from pursuing product development, manufacturing or commercialization of our products that utilize such technologies. There may be patents held by others of which we are unaware that contain claims that our products or operations infringe. In addition, given the complexities and uncertainties of patent laws, there may be patents of which we know that we may

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ultimately be held to infringe, particularly if the claims of the patent are determined to be broader than we believe them to be. Adding to this uncertainty, in the United States, patent applications filed in recent years are confidential for 18 months, while older applications are not publicly available until the patent issues. As a result, avoiding patent infringement may be difficult.

        If a third party claims that we infringe its patents, any of the following may occur:

        In addition, employees, consultants, contractors and others may use the trade secret information of others in their work for us or disclose our trade secret information to others. Either of these events could lead to disputes over the ownership of inventions derived from that information or expose us to potential damages or other penalties. If any of these events occurs, our business will suffer and the market price of our common stock will likely decline.

        There has been substantial litigation and other proceedings regarding patent and intellectual property rights in the pharmaceutical industry. We may be forced to defend claims of infringement brought by our competitors and others, and we may institute litigation against others who we believe are infringing our intellectual property rights. The outcome of intellectual property litigation is subject to substantial uncertainties and may, for example, turn on the interpretation of claim language by the court, which may not be to our advantage, or on the testimony of experts as to technical facts upon which experts may reasonably disagree. Our involvement in intellectual property litigation could result in significant expense to us. Some of our competitors have considerable resources available to them and a strong economic incentive to undertake substantial efforts to stop or delay us from commercializing products. We, on the other hand, are a relatively small company with comparatively few resources available to us to engage in costly and protracted litigation. Moreover, regardless of the outcome, intellectual property litigation against or by us could significantly disrupt our development and commercialization efforts, divert our management's attention and quickly consume our financial resources.

        Furthermore, the validity and scope of our patents may also be challenged by third parties in re-examination proceedings at the U.S. Patent and Trademark Office, which may either strengthen a patent, or result in a reduced claim scope or a loss of all rights to a patent.

        In addition, if third parties file patent applications or issue patents claiming technology that is also claimed by us in pending applications, we may be required to participate in interference proceedings with the U.S. Patent and Trademark Office or in other proceedings outside the United States, including oppositions, to determine priority of invention or patentability. Even if we are successful in these proceedings, we may incur substantial costs, and the time and attention of our management and scientific personnel will be diverted in pursuit of these proceedings.

        As a result of patent infringement claims, or to avoid potential claims, we may choose or be required to seek a license from a third party and would most likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we were

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able to obtain a license, the rights may be non-exclusive, which could potentially limit our competitive advantage. Ultimately, we could be prevented from commercializing a product or be forced to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms. This inability to enter into licenses could harm our business significantly. At present, we have not received any threats of infringement or written demands from third parties that we take a license under their patents.

Risks Related to Government Regulation

        Many of our products are still under development, and we or our collaborating partners may not be able to commercialize these products until we comply with the requirements of federal, state and local regulatory authorities including the FDA, the Federal Trade Commission, or FTC, the Consumer Product Safety Commission, the U.S. Environmental Protection Agency, and various state and local agencies. In particular, the process of obtaining FDA approval for new drug products (including new dosage forms of previously approved drug products) can be costly and time-consuming, and the time required for obtaining such approval is uncertain. In addition, while the FDA has not made any definitive rulings on the regulatory status of film-based drug delivery systems, the FDA and state and local agencies could impose significant regulatory requirements on our products. Additionally, our customers may require that we obtain such approvals prior to licensing or purchasing our products. If the FDA or our customers require that we obtain regulatory approval of our products, we or our collaboration partners must demonstrate to the satisfaction of the applicable regulatory agency that such product candidate is safe and effective for its intended uses. In addition, we must show that the product can be consistently manufactured in compliance with cGMP. In general, these requirements mandate that manufacturers follow detailed design, testing, control, documentation and other quality assurance procedures throughout the entire manufacturing process. Despite the time, expense, and resources invested by us in the approval process, we may not be able to demonstrate that our product candidates are safe and effective. Therefore, we may not receive the regulatory approvals required to market them. Our current or future product candidates may not be approved by the FDA or any other governmental body, and FDA or other governmental reviews could be delayed by requests for further testing or other information that could adversely affect the time to market for our products. We currently have no prescription products filed with any regulatory authorities.

        Moreover, we cannot predict the impact of new government regulations that may adversely affect the discovery, development and production of our product candidates and the manufacturing and marketing of our products. We may be required to incur significant costs to comply with future laws or regulations.

        After receipt of initial regulatory approval, each of our products remains subject to extensive regulatory requirements, including requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, distribution and record-keeping. Furthermore, if we receive regulatory approval to market a particular product candidate, the product will also remain subject to the same extensive regulatory requirements. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the uses for which the product may be marketed or other conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product, which could reduce our revenues, increase our expenses or render the approved product candidate not commercially viable.

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        If we or our partners fail to comply with the regulatory requirements of the FDA or other applicable regulatory authorities, or if previously unknown problems with any approved commercial products, manufacturers or manufacturing process are discovered, we could be subject to administrative or judicially imposed sanctions or other setbacks, including:

        We and any third-party suppliers on which we may in the future rely will be required to comply with cGMP. In complying with these regulations, we and our third-party suppliers may be required to expend significant time, money and effort in the areas of design and development, testing, production, record-keeping and quality control to assure that our products meet applicable specifications and other regulatory requirements. Failure to comply with these or other regulatory requirements could result in an enforcement action against us, including the seizure of products and shutting down of production. Any of these third-party suppliers and we also may be subject to periodic inspections by the FDA and other regulatory agencies. If any of our third-party suppliers or we fail to comply with cGMP or other applicable manufacturing regulations, our ability to develop and commercialize our products could suffer significant interruptions.

        We are or will be, directly or indirectly through our customers, subject to extensive regulation by the various jurisdictions in which we may conduct our business. The laws that directly or indirectly affect our ability to operate our business include the following:

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        If our operations are found to be in violation of any of the laws, regulations, rules or policies described above or any other law or governmental regulation to which we or our customers are or will be subject, or if the interpretation of such laws, regulations, rules or policies change, we may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and curtailment or restructuring of our operations. Similarly, if our customers are found noncompliant with applicable laws, they may be subject to sanctions, which could negatively impact us. Any penalties, damages, fines, curtailment or restructuring of our operations would harm our ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that many such laws have not been fully interpreted by the regulatory authorities or the courts, and their provisions may be open to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert management resources from the operation of our business and damage our reputation.

Risks Related to this Offering and Our Common Stock

        Prior to this offering, there has been no public market for our common stock. We cannot predict the extent to which a trading market for our common stock will develop or be sustained after this offering. The initial public offering price will be determined by negotiations between us and the representatives of the underwriters, based on factors that may not be indicative of future performance, and may not bear any relationship to the price at which our common stock will trade upon completion of this offering. You may be unable to sell your shares of common stock at or above the initial public offering price.

        The initial public offering price was determined based on several factors which are summarized in the "Underwriting" section of this prospectus. This price may vary from the market price of our common stock after this offering. You may be unable to sell your shares of common stock at or above the initial offering price. The stock market, particularly in recent years, has experienced significant volatility particularly with respect to pharmaceutical and biotechnology stocks, or, collectively, biopharmaceutical stocks. The volatility of biopharmaceutical stocks often does not relate to the operating performance of the companies represented by the shares.

        The trading price of our common stock could be highly volatile in response to various factors, many of which are beyond our control, including:

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        In addition, equity markets in general, and the market for small pharmaceutical companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of companies traded in those markets. Changes in economic conditions in the United States or globally could also impact our ability to grow profitably. These broad market and industry factors may materially affect the market price of our common stock, regardless of our business or operating performance. In the past, following periods of volatility in the market price of a company's securities, securities class-action litigation has often been instituted against that company. Such litigation, if instituted against us, could cause us to incur substantial costs and divert management's attention and resources, which could have a material adverse effect on our business, financial condition and results of operations.

        Following the completion of this offering, our directors, executive officers and holders of 5% or more of our outstanding common stock will beneficially own approximately 68.8% of our common stock (inclusive of shares that will be set aside for the settlement of SARs outstanding at the time of this offering). In particular, MRX Partners, LLC, MonoLine RX, L.P., MonoLine RX II, L.P. and Monosol RX Genpar, L.P., all of which are under common control and managed by Bratton Capital Management L.P., will own 15.0%, 14.8%, 26.9% and 0.6%, respectively, for a total of 57.3%. Douglas Bratton, the President of Bratton Capital Management L.P., makes decisions on behalf of Bratton Capital Management L.P. and also serves on our board of directors. Additionally, Halifax Monosol Investors, L.P. will own 11.5% of our common stock. As a result, our directors, executive officers and holders of 5% or more of our outstanding common stock, acting together, or MRX Partners, LLC, MonoLine RX, L.P., MonoLine RX II, L.P. and Halifax Monosol Investors, L.P., may be able to significantly influence all matters requiring approval by our stockholders, including the election of directors and approval of mergers or other significant corporate transactions. The interests of this group of stockholders may not always coincide with our interests or the interests of other stockholders.

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This concentration of ownership could also have the effect of delaying, deferring or preventing a change in our control or impeding a merger or consolidation, takeover or other business combination that could be favorable to you.

        We expect to use proceeds from this offering for the development of prescription drug targets on thin film and other self-funded initiatives, including product development, clinical trials and submissions for new drug applications, or NDAs, 505(b)(2) applications, or 505(b)(2), supplemental new drug applications, or sNDAs, and abbreviated new drug applications, or ANDAs, operating expenditures and infrastructure, capital expenditures, and other general corporate purposes. However, our management has broad discretion over how these proceeds are used and could spend the proceeds in ways with which you may not agree. We may not invest the proceeds of this offering effectively or in a manner that yields a favorable or any return, and consequently, this could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline or delay the development of our product candidates.

        We have paid no dividends to date, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. As a result, we do not expect to pay any dividends in the foreseeable future. Any future payment of dividends, if any, will also depend on our financial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors. Furthermore, we may in the future become subject to contractual restrictions on, or prohibitions against, the payment of dividends. Accordingly, the success of your investment in our common stock will likely depend entirely upon any future appreciation. Our common stock may not appreciate in value after the offering or even maintain the price at which you purchased your shares, and you may not realize a return on your investment in our common stock.

        If you purchase common stock in this offering, you will pay more for your shares than the amounts paid by existing stockholders for their shares. The price per share you will pay will also substantially exceed the book value of our assets represented by your shares of common stock after subtracting related liabilities. You will incur immediate and substantial dilution of $11.90 per share, representing the difference between our pro forma net tangible book value per share after giving effect to this offering and the initial public offering price of $17.00 per share. Upon completion of this initial public offering, the new public investors will have contributed 57.6% of the total amount of capital used to fund us to date, and will own 26.6% of the common stock outstanding after this offering.

        Prior to this offering, you could not buy or sell our common stock publicly. An active trading market for our common stock may not develop or be sustained after this offering. You may not be able to sell your shares quickly or at the market price if trading in our stock is not active.

23


        Certain provisions of our certificate of incorporation and bylaws and applicable provisions of Delaware corporate law may make it more difficult for or prevent a third party from acquiring control of us or changing our board of directors and management. These provisions:

        In addition, Section 203 of the Delaware General Corporation Law, or DGCL, generally prohibits us from engaging in any business combination with certain persons who own 15% or more of our outstanding voting stock without the approval of our board of directors. These provisions could make it difficult for a third party to acquire us, or for members of our board of directors to be replaced, even if doing so would be beneficial to our stockholders. Any delay or prevention of a change in control transaction or changes in our board of directors or management could deter potential acquirers or prevent the completion of a transaction in which our stockholders could receive a substantial premium over the then-current market price for their shares.

        Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell their shares, could reduce the market price of our common stock. After this offering, we will have outstanding 15,029,412 shares of common stock. This includes the shares that we are selling in this offering, which may be resold in the public market immediately. The remaining approximately 11,029,412 shares are currently restricted as a result of securities laws or lock-up agreements but will be able to be sold in the near future. Moreover, after the expiration of the lock-up period described in the section of this prospectus entitled "Shares Eligible for Future Sale — Lock-up Agreements" approximately 15,029,412 shares of our common stock will be eligible for resale. We intend to register all shares of common stock that we may issue under our 2007 Stock Incentive Plan. See "Shares eligible for future sale" contained elsewhere in this prospectus.

        As a private company with limited resources, we have maintained a small finance and accounting staff. As a public company, the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the U.S. Securities and Exchange Commission, or SEC, as well as the rules of The Nasdaq Global Market, Inc. will require us to implement additional corporate governance practices and adhere to a variety of reporting requirements and complex accounting rules. Compliance with these public company

24


obligations will increase our legal and financial compliance costs and place significant additional demands on our finance and accounting staff and on our financial, accounting and information systems.

        In particular, as a public company, our management will be required to conduct an annual evaluation of our internal control over financial reporting and include a report of management on our internal control in our annual reports on Form 10-K. In addition, we will be required to have our independent registered public accounting firm attest to and report on management's assessment of the effectiveness of our internal control over financial reporting. Under current rules, we will be subject to these requirements beginning with our annual report on Form 10-K for our fiscal year ending December 31, 2008. If we are unable to conclude that we have effective internal control over financial reporting or, if our independent registered public accounting firm is unable to provide us with an attestation and an unqualified report as to the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements, which could result in a decrease in the value of our common stock.

        Effective internal control over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. If we cannot provide reliable financial reports or prevent fraud, our operating results could be harmed. We continue to evaluate our internal control over financial reporting. Given the status of our efforts, coupled with the fact that guidance from regulatory authorities in the area of internal control continues to evolve, uncertainty exists regarding our ability to comply by applicable deadlines. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could harm our operating results or cause us to fail to meet our reporting obligations. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock.

25



SPECIAL NOTES REGARDING FORWARD-LOOKING STATEMENTS

        This prospectus contains forward-looking statements. The forward-looking statements are contained principally in, but not limited to, the sections entitled "Summary," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business." Forward-looking statements provide our current expectations or forecasts of future events. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "will," "should," "could," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward looking.

        Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" and elsewhere in this prospectus. Accordingly, you should not unduly rely on these forward-looking statements.

        Factors that could cause our actual results to differ materially from those expressed or implied in our forward-looking statements include, but are not limited to:

26


        Forward-looking statements speak only as of the date on which they are made and, except as required by law, we undertake no obligation to update or publicly revise any forward-looking statement to reflect circumstances or events after the date on which the statement is made or to reflect the occurrence of unanticipated events. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC after the date of this prospectus.

27



USE OF PROCEEDS

        We will receive approximately $60.3 million in net proceeds from the sale of our common stock in this offering, after deducting underwriting discounts and commissions and estimated offering expenses. If the underwriters exercise their overallotment option in full, we estimate that our net proceeds will be approximately $69.8 million.

        Each $1.00 increase (decrease) in the assumed initial public offering price of $17.00 per share would increase (decrease) the net proceeds to us from this offering by $3.7 million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

        We currently expect to use the net proceeds of this offering as follows:

        We believe that the net proceeds from this offering, together with our existing cash and cash equivalents, as supplemented by our research and co-development fees, will be sufficient to complete the development and commercialization of our currently identified self funded initiatives, as listed on pages 2, 59 and 60, disclosed partnered prescription products, as listed on pages 3 and 61, as well as all the partnered OTC pharmaceutical and other products listed on pages 3 and 62. We or our partners may determine after further consideration to cease development of any of these products. If this were to occur, we expect that the proceeds would be adequate to support the development of a substitute product. Additionally, we believe the net proceeds will support all planned capital expenditures related to our Ameriplex facility, new equipment acquisitions as well as to meet our projected operating requirements for approximately the next 24 months. The amounts and timing of our use of proceeds will vary depending on a number of factors, including the amount of cash used by our operations, and the rate of growth, if any, of our business. The allocation of the net proceeds of this offering described above represents our best current estimate of our projected operating requirements. Our management will have broad discretion in the application of the net proceeds and we reserve the right to change the use of these proceeds in response to certain contingencies such as the results of our commercialization activities, competitive developments, opportunities to acquire or license products to others, technologies or businesses and other factors.


DIVIDEND POLICY

        We have not declared or paid any dividends to date. We currently intend to retain future earnings, if any, to fund the development and expansion of our business and do not anticipate paying dividends on our common stock in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors and will depend on a number of factors, including our financial condition, results of operations, capital requirements, restrictions contained in future financing instruments and other factors that our board of directors may deem relevant.

28



CAPITALIZATION

        The following table sets forth our cash and cash equivalents, and capitalization as of June 30, 2007:


 
  As of June 30, 2007
 
 
  Actual
  Pro Forma
  Pro Forma
As Adjusted

 
 
  (in thousands, except per share data)

 
Cash and cash equivalents   $ 7,781   $ 7,781   $ 68,398  
   
 
 
 

Members' equity/stockholders' equity:

 

 

 

 

 

 

 

 

 

 
 
Members' equity — Preferred A membership interests

 

 

16,887

 

 


 

 


 
 
Members' equity — Preferred A-1 membership interests

 

 

21,883

 

 


 

 


 
 
Members' equity — Common membership interests

 

 

11,243

 

 


 

 


 
 
Common stock, par value $.01 per share, 100,000,000 shares authorized, no shares issued and outstanding, actual; 11,029,412 shares issued and outstanding, pro forma; 15,029,412 shares issued and outstanding, pro forma as adjusted

 

 


 

 

110

 

 

150

 
 
Preferred stock, par value $.01 per share, 20,000,000 shares authorized, no shares issued and outstanding

 

 


 

 


 

 


 

Additional paid-in capital

 

 


 

 

76,940

 

 

137,240

 

Accumulated deficit

 

 

(32,167

)

 

(59,204

)

 

(59,204

)
   
 
 
 
 
Total members' equity/stockholders' equity

 

 

17,846

 

 

17,846

 

 

78,186

 
   
 
 
 
   
Total capitalization

 

$

17,846

 

$

17,846

 

$

78,186

 
   
 
 
 

        The table above should be read in conjunction with the "Use of Proceeds," "Selected Financial Data," "Unaudited Pro Forma Financial Statements," "Management's Discussion and Analysis of Financial Condition and Results of Operations," and our financial statements and related notes included elsewhere in this prospectus. This table is based on 157,198,704 membership interests in Monosol Rx LLC outstanding, 11,029,412 shares of our common stock outstanding on a pro forma basis, and 15,029,412 shares of our common stock outstanding on a pro forma basis as adjusted as of June 30, 2007 and excludes, as of that date 1,502,941 shares of our common stock available for future grant under our 2007 Stock Incentive Plan. See "Unaudited Pro Forma Financial Statements."

29



DILUTION

        If you invest in our common stock, your interest will be diluted immediately to the extent of the difference between the initial public offering price per share you pay in this offering and the as adjusted net tangible book value per share of our common stock immediately after this offering.

        Our pro forma net tangible book value as of June 30, 2007 was approximately $16.3 million, or approximately $1.48 per share of our common stock. Net tangible book value per share is equal to our total tangible assets minus total liabilities, divided by the number of shares of common stock outstanding.

        After giving effect to the sale of the 4,000,000 shares of our common stock in this offering and after deducting underwriting discounts and commissions and our estimated offering expenses, our pro forma as adjusted net tangible book value would have been approximately $76.6 million, or approximately $5.10 per share of common stock. This represents an immediate increase in pro forma as adjusted net tangible book value of approximately $3.62 per share to existing stockholders and an immediate dilution of approximately $11.90 per share to new investors. The following table illustrates this calculation on a per share basis:

Assumed initial public offering price per share         $ 17.00
Pro forma net tangible book value per share of common stock as of June 30, 2007   $ 1.48      
Pro forma as adjusted increase per share attributable to the offering   $ 3.62      
   
     
Pro forma as adjusted net tangible book value per share of common stock after this offering         $ 5.10
         
Pro forma as adjusted dilution per share to new investors         $ 11.90
         

        If the underwriters exercise their overallotment option in full, the pro forma as adjusted net tangible book value as of June 30, 2007 will increase to approximately $5.51 per share, representing an increase to existing stockholders of approximately $4.03 per share, and there will be an immediate dilution of approximately $11.49 per share to new investors.

        The following table summarizes, as of June 30, 2007 on a pro forma as adjusted basis, the total number of shares of our common stock purchased from us and the total consideration and average price per share paid by existing stockholders and by new investors:

 
  Total shares
  Total consideration
   
 
  Average price
per share

 
  Number
  %
  Amount
  %
Existing stockholders   11,029,412   73.4 % $ 50,013,000   42.4 % $ 4.53
New investors   4,000,000   26.6 % $ 68,000,000   57.6 % $ 17.00
  Total   15,029,412   100.0 % $ 118,013,000   100.0 % $ 7.85

        If the underwriters exercise their overallotment option in full, the following will occur:

        The tables and calculations above are based on 11,029,412 shares outstanding as of June 30, 2007 on a pro forma basis and exclude 1,502,941 shares of our common stock available for future grant under our 2007 Stock Incentive Plan.

30



SELECTED FINANCIAL DATA

        Prior to this offering, we conducted our business through Monosol Rx LLC. Immediately prior to this offering, Monosol Rx LLC will merge with and into MonoSol Rx, Inc., a newly formed Delaware corporation, the shares of which are being sold in this offering.

        The following table sets forth certain historical financial data for Monosol Rx LLC as of the dates and for the periods indicated. We have derived the selected historical statement of operations data for the years ended December 31, 2006, 2005 and 2004, and the balance sheet data as of December 31, 2006 and 2005, from the audited financial statements of Monosol Rx LLC included elsewhere in this prospectus. Prior to the formation of Monosol Rx LLC, our activities were carried out as part of the research and development efforts of Monosol, LLC, a manufacturer of commercial soluble films (the Predecessor). We have derived the historical financial data as of December 31, 2004 and 2003 (Predecessor), and for the year ended December 31, 2003 (Predecessor), from audited financial statements of Monosol Rx LLC that are not included in this prospectus. We have derived the selected historical statement of operations data for the six months ended June 30, 2007 and 2006, and the balance sheet data as of June 30, 2007 and 2006 from the unaudited financial statements of Monosol Rx LLC, included elsewhere in this prospectus. Since neither we nor our Predecessor were operating prior to 2003, no financial data has been presented for fiscal years prior to December 31, 2003. The historical results set forth below do not necessarily indicate results expected for any future period. The selected historical financial data should be read in conjunction with the discussion under the heading "Managements's Discussion and Analysis of Financial Condition and Results of Operations," and the historical financial statements and related notes included elsewhere in this prospectus.

 
  Year Ended December 31,
  Six Months
Ended June 30,

 
 
  2006
  2005
  2004
  Predecessor
2003

  2007
  2006
 
 
  (in thousands, except per interest and per share data)

   
 
Statement of Operations Data:                                      
Revenues:                                      
Manufacture and supply revenue   $ 1,765   $ 1,458   $ 1,947   $ 81   $ 1,243   $ 1,145  
Co-development and research fees     950     665     100         917     350  
   
 
 
 
 
 
 
  Total revenues     2,715     2,123     2,047     81     2,160     1,495  

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Manufacture and supply     1,623     1,282     1,388     52     1,101     867  
General and administrative     11,296     7,372     3,168     454     7,557     4,441  
Research and development     1,993     1,258     1,010     794     1,365     845  
   
 
 
 
 
 
 
  Total costs and expenses     14,912     9,912     5,566     1,300     10,023     6,153  
   
 
 
 
 
 
 
  Operating loss     (12,197 )   (7,789 )   (3,519 )   (1,219 )   (7,863 )   (4,658 )
Other income, principally related-party     64     41                 27  
Interest income     226     46             291     53  
Income expense     (845 )   (581 )   (41 )           (461 )
   
 
 
 
 
 
 

Net loss

 

$

(12,752

)

$

(8,283

)

$

(3,560

)

$

(1,219

)

$

(7,572

)

$

(5,039

)
   
 
 
 
 
 
 

Net loss applicable to membership interest holders

 

$

(12,752

)

$

(8,283

)

$

(3,560

)

$

(1,219

)

$

(7,572

)

$

(5,039

)
   
 
 
 
 
 
 

Net loss per membership interest:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  Basic and Diluted(1)   $ (0.10 ) $ (0.07 ) $ (0.03 ) $ (0.01 ) $ (0.05 ) $ (0.04 )
Weighted average number of membership interests outstanding:                                      
  Basic and Diluted     123,626     118,785     118,785     118,785     157,199     118,785  

31


 
  As of December 31,
  As of June 30,
 
 
  2006
  2005
  2004
  Predecessor
2003

  2007
  2006
 
 
  (in thousands)

   
 
Balance Sheet Data:                                      
Cash and cash equivalents   $ 15,256   $ 1,332   $ 266   $   $ 7,781   $ 5,507  
Working capital     14,830     580     127     69     6,175     4,579  
Total assets     27,179     12,306     10,114     1,862     22,713     17,385  
Total debt         6,203     626             11,577  
Accumulated deficit     (24,595 )   (11,843 )   (3,560 )   (1,219 )   (32,167 )   (16,882 )
Members' equity     25,263     4,665     7,744     1,862     17,846     4,061  

(1)
Data per membership interest is based on the weighted average number of membership interests outstanding during the periods presented. Warrants issued in 2005 and 2006 have been included for the full term of each period presented pursuant to FAS 128, Earnings per Share. In 2006, preferred membership interests have also been reflected based on the issuance of these securities in November 2006, and based on their having rights as to voting and sharing of earnings and losses substantially equivalent to those of common membership interests.

32



UNAUDITED PRO FORMA FINANCIAL STATEMENTS

        The following unaudited pro forma financial statements have been derived from the application of certain pro forma adjustments to the historical financial statements of Monosol Rx LLC included elsewhere in this prospectus, and give effect to (1) the merger of Monosol Rx LLC into MonoSol Rx, Inc. and (2) the sale of all of the shares of common stock in this offering at an initial public offering price of $17.00 per share after deducting underwriting discounts and commissions and estimated offering expenses.

        The unaudited pro forma financial statements presented below are based on the assumptions and adjustments described in the accompanying notes. The unaudited pro forma adjustments are based on available information and assumptions that management believes are reasonable under the circumstances. Such unaudited pro forma financial statements are presented for illustrative purposes only and are not necessarily indicative of what our financial position or results of operations would have been had this offering or other transactions described in this prospectus been consummated, nor are they necessarily indicative of what our financial position or results of operations will be in future periods. The unaudited pro forma financial statements, and the accompanying notes, should be read in conjunction with "Selected Financial Data," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the audited and unaudited financial statements and related notes of Monosol Rx LLC, included elsewhere in this prospectus.

33


        The following table sets forth our unaudited pro forma balance sheet as of June 30, 2007:


 
  As of June 30, 2007
 
 
  Actual
  Corporate
Formation
Adjustments

  Pro Forma
  Offering
Adjustments

  Pro Forma,
as Adjusted

 
 
  (in thousands)

 
Balance Sheet Data:                              
Assets:                              
Current assets:                              
Cash and cash equivalents   $ 7,781     $ 7,781   $ 60,617 (1) $ 68,398  
Trade receivables     1,392       1,392         1,392  
Other receivables     36       36         36  
Inventories     800       800         800  
Prepaid expenses and other current assets     269       269         269  
   
 
 
 
 
 
  Total current assets     10,278       10,278     60,617     70,895  
Property and equipment, net     9,796       9,796         9,796  
Other assets     1       1         1  
Deferred offering costs     1,092       1,092     (1,092 )    
Intangible assets, net     1,546       1,546         1,546  
   
 
 
 
 
 
    $ 22,713     $ 22,713   $ 59,525   $ 82,238  
   
 
 
 
 
 

Liabilities and Members Equity/Stockholders' Equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Current liabilities:                              
Accounts payable   $ 2,364     $ 2,364     (815 ) $ 1,549  
Accrued expenses     872         872         872  
Deferred revenue     867       867         867  
   
 
 
 
 
 
  Total current liabilities     4,103       4,103     (815 )   3,288  
   
 
 
 
 
 
Deferred revenue     689       689         689  
Asset retirement obligations     75       75         75  
   
 
 
 
 
 
Total non-current liabilities     764       764         764  
   
 
 
 
 
 
Members' equity/stockholders' equity:                              
Preferred A interests, no par value, 100,000,000 units authorized; 16,886,750 issued and outstanding     16,887   (16,887 )(2)            
Preferred A-1 interests, no par value, 100,000,000 units authorized; 21,526,850 issued and outstanding     21,883   (21,883 )(2)            
Common interests, no par value, 500,000,000 units authorized; 118,785,104 issued and outstanding     11,243   (11,243 )(2)            
Common stock, par value $.01 per share, 100,000,000 shares authorized, no shares issued and outstanding, actual; shares issued and outstanding, pro-forma; 11,029,412 issued and outstanding, pro forma as adjusted 15,029,412       110 (2)   110     40 (1)   150  
Additional paid-in capital       76,940 (2)(3)   76,940     60,300 (1)   137,240  
Accumulated deficit     (32,167 ) (27,037 )(3)   (59,204 )       (59,204 )
   
 
 
 
 
 
Total Members' equity     17,846       17,846     60,340     78,186  
   
 
 
 
 
 
    $ 22,713     $ 22,713   $ 59,525   $ 82,238  
   
 
 
 
 
 

(1)
Represents an increase from the receipt of the estimated net proceeds of this offering of $60.3 million, plus an adjustment for expenses paid prior to this offering.
(2)
Reflects the exchange of Monosol Rx LLC membership interests (common and preferred) for shares of MonoSol Rx, Inc. common stock.
(3)
Reflects $27.0 million of compensation expense related to the stock appreciation rights under the Monosol Rx LLC Amended and Restated Performance Unit Appreciation Plan, as amended at the time of the merger of Monosol Rx LLC into MonoSol Rx, Inc.

34


        The following table sets forth our unaudited pro forma statement of operations for the year ended December 31, 2006:


 
  Year-ended December 31, 2006
 
 
  Actual
  Corporate
Formation
Adjustments

  Pro Forma
  Offering
Adjustments

  Pro Forma,
as Adjusted

 
 
  (in thousands, except per interest and per share data)

 
Statement of Operations Data:                                
Revenues:                                
Manufacture and supply revenue   $ 1,765   $   $ 1,765   $   $ 1,765  
Co-development and research fees     950         950         950  
   
 
 
 
 
 
    Total revenues     2,715         2,715         2,715  

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Manufacture and supply     1,623         1,623         1,623  
General and administrative     11,296     27,037 (1)   38,333         38,333  
Research and development     1,993         1,993         1,993  
   
 
 
 
 
 
    Total costs and expenses     14,912     27,037     41,949         41,949  
   
 
 
 
 
 
    Operating loss     (12,197 )   (27,037 )   (39,234 )       (39,234 )
Other income, principally related-party     64         64         64  
Interest income     226         226         226  
Interest expense     (845 )       (845 )       (845 )
   
 
 
 
 
 
    Net loss before income taxes     (12,752 )   (27,037 )   (39,789 )       (39,789 )
Income taxes         900 (2)   900         900  
   
 
 
 
 
 
    Net loss   $ (12,752 ) $ (27,937 ) $ (40,689 ) $   $ (40,689 )
   
 
 
 
 
 
Pro forma net loss applicable to common stockholders                           $ (40,689 )
Pro forma net loss per common share:                                
  Basic and Diluted(3)                           $ (2.71 )
Pro forma weighted average number of common shares outstanding:                                
  Basic and Diluted(3)                             15,029  

(1)
Represents the compensation expense to be recorded in connection with the stock appreciation rights under the Monosol Rx LLC Amended and Restated Performance Unit Appreciation Plan, as amended at the time of the merger of Monosol Rx LLC into MonoSol Rx, Inc.

(2)
Represents the estimated deferred tax liability (long-term) to be recorded on the opening balance sheet of MonoSol Rx, Inc. in connection with the merger of Monosol Rx LLC into MonoSol Rx, Inc.

(3)
Pro forma net loss per common share is based on the conversion of all currently outstanding equity interests of the existing Monosol Rx LLC members into shares of common stock of MonoSol Rx, Inc. at a conversion ratio of one share per 14.253 membership interests, and the sale of all 4,000,000 shares of common stock being offered pursuant to this offering. All such shares of common stock are treated as outstanding for the entire period presented for purposes of this presentation.

        The following table sets forth our unaudited pro forma statement of operations for the six months ended June 30, 2007:

35



 
  Six months ended June 30, 2007
 
 
  Actual
  Corporate
Formation
Adjustments

  Pro Forma
  Offering
Adjustments

  Pro Forma,
as Adjusted

 
 
  (in thousands, except per interest and per share data)

 
Statement of Operations Data:                                
Revenues:                                
Manufacture and supply revenue   $ 1,243   $   $ 1,243   $   $ 1,243  
Co-development and research fees     917         917         917  
   
 
 
 
 
 
    Total revenues     2,160         2,160         2,160  

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Manufacture and supply     1,101         1,101         1,101  
General and administrative     7,557     27,037 (1)   34,594         34,594  
Research and development     1,365         1,365         1,365  
   
 
 
 
 
 
    Total costs and expenses     10,023     27,037     37,060         37,060  
   
 
 
 
 
 
    Operating loss     (7,863 )   (27,037 )   (34,900 )       (34,900 )
Other income, principally related-party                      
Interest income     291         291         291  
Interest expense                      
   
 
 
 
 
 
    Net loss before income taxes     (7,572 )   (27,037 )   (34,609 )       (34,609 )
Income taxes         (3)                
   
 
 
 
 
 
    Net loss   $ (7,572 ) $ (27,037 ) $ (34,609 ) $   $ (34,609 )
   
 
 
 
 
 
Pro forma net loss applicable to common stockholders                           $ (34,609 )
Pro forma net loss per common share:                                
  Basic and Diluted(2)                           $ (2.30 )
Pro forma weighted average number of common shares outstanding:                                
  Basic and Diluted(2)                             15,029  

(1)
Represents the compensation expense to be recorded in connection with the stock appreciation rights under the Monosol Rx LLC Amended and Restated Performance Unit Appreciation Plan, as amended at the time of the merger of Monosol Rx LLC into MonoSol Rx, Inc.

(2)
Pro forma net loss per common share is based on the conversion of all currently outstanding equity interests of the existing Monosol Rx LLC members into shares of common stock of MonoSol Rx, Inc. at a conversion ratio of one share per 14.253 membership interests, and the sale of all 4,000,000 shares of common stock being offered pursuant to this offering. All such shares of common stock are treated as outstanding for the entire period presented for purposes of this presentation.

(3)
As a result of the loss experienced during the six months ended June 30, 2007, the losses of our predecessor, and the uncertainties related to our ability to generate future profits, we have recorded no provision for, nor any benefit from, income taxes. In general, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the carrying amounts of existing assets and liabilities for book and tax purposes, and for net operating loss and tax credit carry forwards.

36



MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

        You should read the following discussion and analysis of financial condition and results of operations in conjunction with the "Selected Financial Information" and the financial statements and the related notes included elsewhere in this prospectus. In addition to historical information, the following discussion and analysis includes forward-looking information that involves risks, uncertainties and assumptions. Our actual results and the timing of events could differ materially from those anticipated by these forward-looking statements as a result of many factors, including those discussed under "Risk Factors" and elsewhere in this prospectus. See "Special Note Regarding Forward-Looking Statements" included elsewhere in this prospectus.

Overview

        We are a drug delivery company specializing in proprietary dissolving thin film pharmaceutical products. Since our inception in 2004, we have developed a significant portfolio of intellectual property and know how in thin film drug delivery, including formulation manufacturing, encapsulation and packaging. We are working with partners to develop thin film versions of their products for use in the prescription pharmaceutical, over-the-counter, or OTC, and consumer markets. Additionally, we began our self-funded initiatives by selecting prescription pharmaceutical products for development in our thin film technology based upon factors such as technical suitability, market opportunity, approved indications, patent expiration and other factors. We intend to further develop these products on our own before seeking a partner with the goal of maximizing our potential revenue.

        Both with partners and through our self-funded initiatives we are currently developing a number of prescription products. This is a multi-phase process which includes regulatory filings for approval of our formulations prior to them being sold in the marketplace. We are vertically integrated in all critical phases of development and manufacture of our thin film.

        We have incurred significant net losses since our inception in January 2004. As of December 31, 2006, we had accumulated net losses of $24.6 million, and our annual net loss has grown in size each year. Our losses have resulted principally from general and administrative expenses associated with developing our business and costs incurred in the research and development of our technologies. We expect to continue to incur net losses for the next several years as we pursue the development and commercialization of our product candidates.

        We have financed our early stage operations with revenue from co-development arrangements and manufacturing and supply arrangements, the proceeds of capital contributions from our members and various debt offerings to affiliates of our members. In addition to proceeds from this offering, we may require additional financing to execute our business strategy.

        Since the beginning of January 2006, we have added 60 employees, including contract employees and temporary employees. The growth in the size of our workforce included the hiring of our Chief Executive Officer and our Chief Financial Officer, as well as our Senior Vice Presidents of Business Development and Operations. We also added and plan to continue to add analytical scientists, packaging engineers and other manufacturing specialists necessary to attract and fulfill key customer contracts. These additional employees have increased dramatically, and will continue to increase our expenses in the short term but will enable the continued improvement of our thin film technology and development of products that we expect will produce revenue in the future.

        In October 2006, we leased the Ameriplex facility which will become our primary development and analytical laboratories and manufacturing facility when retrofitting is complete in 2008. This facility will give us a state of the art cGMP manufacturing facility with enough capacity to hold all of our operations and room to grow in the future. We expect to invest nearly $14 million in improvements to the facility over the next two years. This amount excludes investments in any additional equipment

37



necessary to ensure we have the appropriate capabilities and capacity to support ongoing customers' needs.

        In November 2006, we completed a private placement of equity and issued preferred membership interests in exchange for $16.9 million in cash and the settlement of $20.5 million principal amount of Tranche A and B notes, together with related accrued interest. This transaction allowed us to retire all of our outstanding debt and provided cash proceeds for product development and general corporate purposes, including capital expenditures and working capital.

        Since January 2007, we have entered into a number of new customer agreements for the development and supply of various products in the prescription pharmaceutical, OTC pharmaceutical and non-pharmaceutical categories. Each of these contracts and the products they represent have different development timelines and, in some cases, regulatory requirements that will determine when the products will be commercially available and begin to produce revenue. In each case, we expect the development effort to generate milestone-based development revenue for us in the near term and ultimately supply and, potentially, royalty revenue in the long term.

Financial Operations Overview

    Revenues

        We derive our revenues from two sources: manufacture and supply agreements and co-development and research fees. We currently generate manufacture and supply revenue from the production of thin film under commercial supply agreements with our customers for OTC products and a specialty application film. Co-development and research fees result from arrangements with third parties to test the applicability of and to develop products in thin film. These arrangements are usually for a finite period of time and are directed at a certain defined result. The fees may be related to completion of defined milestones. These arrangements may or may not lead to future research and development arrangements or manufacture and supply agreements. The acceptance of thin film as a drug delivery technology by medical practitioners and consumers along with increased direct-to-consumer marketing featuring nationally recognized brand names has helped create increased interest in our technology among potential partners as evidenced by recently signed agreements to develop and supply products to Philip Morris USA Inc., or Philip Morris USA, Adams Respiratory Therapeutics and Prestige Brands Holdings, Inc., or Prestige. These are examples of companies who are interested in our technology and our company.

        Additionally, we are also in substantive negotiations with several other potential drug customers for contractual development and supply agreements. We believe that these potential new relationships demonstrate the customer acceptance of our technology and will contribute to the revenue growth we expect to realize.

        With respect to our self-funded initiatives, we have continued to make progress with respect to the products we have identified and selected for development. We are in pilot bioavailability/bioequivalence clinical studies for the first product, Zolpidem Tartrate, and are preparing our second product, Ondansetron HCL, for clinical evaluation in the third quarter of 2007. We have also filed suitability petitions with the Food and Drug Administration, or FDA, for several other products in conjunction with the start of research and development activities.

        In the future, we expect to generate revenues from milestone payments for research and development activities and manufacture and supply agreements, which may include royalty payments.

        Our development, supply and licensing agreements with Adams Respiratory Therapeutics, Inc., or Adams, provides for revenues for product development through commercial launch of a total of $1.5 million. In addition, Adams agrees to pay $167,000 on each of the second, third and fourth anniversaries of commercial launch. The development agreement is for a seven-year term, covers the United States, Canada and Mexico and may be extended at Adams' election for up to three three-year

38



extension terms. In certain circumstances both we and Adams may cancel the development agreement before the term expires. We have agreed to develop the respiratory film product exclusively for Adams.

        Our supply agreement with Adams contains standard terms and conditions, and is also for a seven-year term, which may be extended by Adams for up to three three-year extension terms. Our license agreement with Adams has the same term as the supply agreement, including the same right to extend by Adams, but will remain in effect for an additional seven years in the event Adams terminates the agreement for our breach. The license agreement only applies to the respiratory thin film product. Under the license agreement, Adams agrees to pay royalties for the respiratory product on annual net sales within the territory of 5% for the first $15 million in net sales; 6% on net sales from $15 to $25 million; 7% on net sales from $25 to $35 million, and 7.5% on all net sales over $35 million. In the event that a competitor obtains an approval for a competing, "AB"-rated product, our royalty rates are subject to reduction in accordance with a formula based upon the percentage decline in net sales of the product we make. Such a reduction could be material. Adams may terminate the license agreement upon 30 days' notice.

        Our current manufacture and supply agreements for non-pharmaceutical products with Philip Morris USA and Dr. Katz provide revenue on a per strip or per case basis. The Philip Morris USA and Dr. Katz contracts are both exclusive arrangements and have five and four year terms, respectively. Our arrangements for the supply of OTC pharmaceuticals to Medtech Products Inc., or Medtech, a subsidiary of Prestige, GlaxoSmithKline plc, or GSK, Vita Health Products Inc., or Vita, and L. Perrigo Company, or Perrigo, whether via our contractual arrangements or on a purchase order basis, are all on a per strip, per packaged dose or per case basis and do not contemplate royalty payments based on sales. The agreement with Perrigo is a four year, nine month exclusive arrangement, and our agreement with Vita is a five year arrangement. Our relationships with Prestige and GSK are both purchase order supply arrangements until the formal manufacture and supply agreements are finalized.

        Our current partner agreements with Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A., or Angelini, and UMD Inc., or UMD, generate revenue for pharmaceutical development work. Through June 30, 2007, UMD has paid us $166,664 for formulation development and the manufacture of clinical supplies, contracted for on a purchase order basis. Angelini's initial work order is for $40,000 in development work, of which $20,000 has been billed and collected.

        In December 2006, we entered into a development agreement with a mid-sized global pharmaceutical manufacturer for a thin film that will buccally deliver certain controlled prescription actives. Under this agreement, we will receive payments upon meeting four different development milestones during the term of the agreement. This agreement has a term of nine months, which may be extended by the customer upon four weeks' notice. The customer is under no obligation to authorize all four development milestones, and may cancel the agreement at any time. Through May 2007, we have billed this customer $448,360 under this agreement.

        In August 2006, we entered into an agreement to develop a thin film that will sublingually deliver certain prescription actives. We have successfully completed preliminary formulation work and demonstrated our ability to achieve acceptable organoleptic performance and content uniformity at a very low drug loading level (i.e., micrograms). This product, should development continue, would entail the submission of a new drug application and will ultimately require dedicated manufacturing. This agreement may be terminated by either us or the customer upon 30 days' notice.

    Costs and Expenses

        Manufacture and Supply Costs and Expenses.    Manufacture and supply costs and expenses are comprised of costs and expenses related to manufacturing our thin film products, including raw materials, direct labor and fixed overhead. Our material costs include the costs of raw materials used in the production of our thin film drug delivery products and related packaging supplies. Direct labor costs consist of payroll costs (including benefits) of employees engaged in production activities. Fixed

39


overhead principally consists of indirect payroll, facilities rent and depreciation for production machinery and equipment. As we commercialize more products and are able to manufacture larger, contiguous batches of products while incorporating proprietary, patent pending, manufacturing processes utilizing our production facility, we expect our raw material, direct labor and overhead costs per strip to be reduced and our operating margins to increase. As we develop and commercialize more products and establish predictive reorder programs with our customers, we expect a greater utilization of annual strip production capacity and continued improvement of our costs and expenses on a per strip basis.

        Our manufacture and supply costs and expenses are impacted by the following factors:

    General and Administrative Expenses

        Our general and administrative expenses consist of salaries and benefits for executive and support personnel, professional fees for legal, accounting and other services, travel costs, facility-related costs such as rent, utilities for non-production activities and other general office expenses. These expenses include the following functions: corporate management, business development and licensing, finance, human resources, information systems and other administrative functions and unabsorbed manufacturing overhead costs. We expect our general and administrative expenses to increase as we continue to hire new employees, expand our infrastructure and incur additional costs related to the growth of our business and our operations as a public company.

    Research and Development Expenses

        Our research and development expenses reflect costs incurred in developing our thin film drug delivery technology, the development of our self-funded initiatives and external arrangements with third party partners. We expense research and development costs as incurred. Our partnered products generate co-development and research fees. Our research and development expenses consist primarily of:

        Our business is largely to identify presently marketed prescription pharmaceutical products that are suitable for thin film development. Our research and development cycle is shorter and less costly than the development of the pharmaceutical product itself. For each prescription thin film product we develop, we estimate that the research and development cycle will range between 24 to 30 months and total costs will be less than $5 million. The time frame and cost can be affected by the regulatory path we select or are required to follow and the extent to which regulatory authorities require follow-on clinical studies.

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        Research and development costs incurred by us during the last three fiscal years for internal proprietary projects and arrangements with third parties are as follows:

Fiscal Year

  Internal
Proprietary Projects

  Arrangements With
Third Parties

  Total
2006   $ 1,194,000   $ 799,000   $ 1,993,000
2005     899,000     359,000     1,258,000
2004     941,000     69,000     1,010,000

        We expect to incur increasing research and development expenses in future periods as we expand our internal research capabilities and increase the number of self-funded initiatives, or SFIs, we expect to enroll in pre-clinical studies and clinical trials. The process of conducting pre-clinical studies and clinical trials necessary to obtain FDA approval is costly and time consuming. We consider the development of our product candidates to be crucial to our long-term success. If we do not complete development of our product candidates and obtain regulatory approval to market one or more of these product candidates, we may not be successful. The probability of success for each product candidate may be impacted by numerous factors, including the timing and results of our pre-clinical research programs, the scope, rate of progress and cost of our clinical trials, future clinical trial results, the cost and timing of regulatory approvals, and the effects of competing technologies and market developments. We will make ongoing evaluations of our product candidates and determine which product candidates to advance and how much funding to direct to each based on an ongoing basis in response to their scientific and clinical success and market potential.

        The total cost and length of the product development program largely depends on a number of factors:

        In general, we believe the process from development to FDA approval should be up to 30 months based on the regulatory pathways, 505(j) or 505(b)(2), that we expect to undertake. For projects where we perform the development program prior to entering into a relationship with a partner, a self-funded initiative program, we believe development costs will be approximately $2.5 to $3.0 million. Given the uncertainty surrounding each stage of the development process, including regulatory approvals and the fact that we have not yet completed successful development of a prescription pharmaceutical product, we cannot be sure our estimates of the development costs of such products are accurate.

        Research and development expense consists of expenses incurred in connection with developing and advancing our thin film technology and developing our product candidates. These expenses consist primarily of salaries and related expenses, facility costs and costs for pre-clinical and clinical trials including research, formulation and manufacturing, as well as estimated potential third party payments for materials and services such as APIs and other raw materials, testing, legal and consulting fees. We charge all research and development expenses to operations as incurred.

        Clinical development timelines, likelihood of success and total costs vary widely. We do not currently track our research and development costs or our personnel and related costs on an individual product basis. The aggregate costs incurred during each period presented were calculated by combining costs directly associated with our operations as well as a costs allocation for shared resources supplied by Monosol, LLC. Furthermore, we use our research and development resources, including employees

41



and our thin film technology, across multiple drug development and OTC and other programs. As a result, we cannot state precisely the costs incurred for each of our research and development programs or our product candidates. Our total research and development expenses for the years ended December 31, 2006, 2005 and 2004 and the six months ended June 30, 2007 were $1,993, $1,258, $1,010 and $1,365, respectively.

        We expect our research and development expense to be substantial and to increase as we advance our portfolio of thin film product candidates through to commercialization as well as costs related with new partnered agreements. Due to the fact that our product candidates are still in various stages of development, we cannot estimate anticipated completion dates and when we might receive material net cash inflows from our research and development projects.

        There are many suitable candidates for development on thin film and the development time and cost for those opportunities is modest compared to that of developing a new API or demonstrating efficacy for a new indication. As such, the strength and viability of the company is not dependent upon any one project. If there is a failure to achieve the desired results in any one of the projects under development or the API is subject to adverse regulatory action prior to completion of our project, we believe there are enough alternate API candidates for development utilizing our thin film drug delivery technology to complete our business plan. In addition, this allows us the ability to continue a program of partnered and self-funded development initiatives to achieve the business growth and results that we seek.

Results of Operations

        The following discussion of our results of operations includes amounts presented in thousands, unless otherwise specifically stated.

    Three and Six Month Periods Ended June 30, 2007 and 2006

Revenues:

        Total revenue for the three and six months ended June 30, 2007 increased to $1,651 and $2,160, respectively, from those of the prior year comparable periods of $342 and $1,495, respectively.

        Manufacture and supply revenue increased during the three months ended June 30, 2007 by $632, or 347%, to $814 from $182 recognized during the corresponding three months ended in 2006. During the six months ended June 30, 2007, an increase of 9%, or $98, was realized as manufacture and supply revenue for 2007 reached $1,243 from $1,145 earned during the first half of 2006. During the comparative three month periods, we recognized revenues in 2007 from a first-time customer and significantly increased orders from an existing customer from whom no revenues were generated during the quarter ended June 30, 2006. During the comparative six month periods, manufacture and supply revenues from the aforementioned new customer combined with increased revenues from two major existing customers offset the loss of revenue from a major 2006 customer that placed no orders with us during the six months ended June 30, 2007.

        Co-development and research fees were $837 and $917 during the three and six month periods ended June 30, 2007, compared to $160 and $350 during the corresponding periods of the prior year, representing increases of $677 or 423% during the three month period and $567 or 162% during the six month period. The increases in co-development and research fees for the two periods were attributable to milestones completed for a new major customer and several smaller new customers that joined our customer base during 2007.

Customer Concentration:

        Customers are considered major customers when sales exceed 10% of total net sales for the period or outstanding receivable balances exceed 10% of total receivables and if the loss of that customer

42



would have a material adverse impact on us. During each of the three and six month periods ended June 30, 2007, we had two customers meeting these criteria. Sales during 2007 to these two customers, GlaxoSmithKline and Philip Morris USA accounted for revenues of $558 and $195, respectively, during the three month period, or 46% of total revenue for that quarter, and $602 and $633, respectively, during the six month period, or 57% of our year to date revenues. Outstanding receivable balances from these two customers at June 30, 2007 totaled $720, or 50% of total receivables at that date. During each of the three and six month periods ended June 30, 2006, we had three customers meeting these criteria. Sales during 2006 to these three customers, Leiner, Philip Morris USA, and Dr. Katz accounted for revenues of $4, $240 and $98, respectively, during the three month period, or 100% of total revenue for that quarter, and $896, $433 and $128, respectively, during the six month period, or 98% of our year to date revenues. Outstanding receivable balances from these three customers at June 30, 2006 totaled $218, or 100% of total receivables balance at that date.

Manufacture and Supply Costs and Expenses:

        Our manufacture and supply costs and expenses are influenced by a number of factors including product volume, mix, pricing, materials and manufacturing costs and excess and obsolete inventory. As a start up company we have very few commercialized products and are subject to wide variances in our manufacture and supply costs and expenses based on the timing of orders and the type of product produced for the limited number of customers we have.

        Manufacture and supply costs and expenses were $1,101 and $867 during the six month periods ended June 30, 2007 and 2006, respectively, an increase of $234 or 27%. For the respective three month periods of 2007 and 2006, these expenses totaled $850 and $223, representing an increase of $627 or 281%. Cost and expense levels increased over prior year amounts during both current periods as product volumes increased with the expansion of our customer base, as discussed above, and we incurred higher product finishing and packaging expenses in the second quarter of 2007 for certain new products and customer requirements.

        These costs and expenses as a percentage of manufacture and supply revenue were 104% and 123% for the three month periods ended June 30, 2007 and 2006, respectively, and 89% and 76% for the six month periods ended June 30, 2007 and 2006, respectively. During the three month period in 2006, lower sales order volume caused lower capacity utilization and resulted in production inefficiencies, compared to significantly increased sales unit volume, improved capacity utilization and related production efficiencies, along with a more favorable product mix during 2007. During the six month periods, the aforementioned increased product finishing and packaging expenses, combined with costs related to excess inventory and obsolescence contributed to the higher cost percentage for 2007.

General and Administrative Expenses:

        General and administrative expenses totaled $4,112 and $7,557 during the three and six month periods ended June 30, 2007, compared to $2,518 and $4,441 during the corresponding periods of the prior year, representing increases of $1,594 or 63% during the three month period and $3,116 or 70% during the six month period. The increases in 2007 for both periods were attributable to increased staffing levels across the business, higher legal and accounting fees and increased costs for facilities and related depreciation.

Research and Development Expenses:

        Research and development expenses totaled $680 and $1,365 during the three and six month periods ended June 30, 2007, and increased from $466 and $845 during the corresponding periods of the prior year. These increases were $214 or 46% during the three month period and $520 or 62% during the six month period. The increases during both periods were attributable to increased

43



employment expenses for staffing and infrastructure to support our internal research efforts and to greater expenses associated with commencement and development of various self-funded initiatives.

    Years Ended December 31, 2006, 2005 and 2004

        Revenue.    Manufacture and supply revenue increased $307, or 20% to $1,765 in 2006 from $1,458 in 2005. This increase is attributable to additional supply agreements we entered into with new customers and the initial demand generated by those contracts. Co-development and research fees increased $285, or 43% to $950 in 2006 from $665 in 2005. The increase was attributable to additional development arrangements with new customers. Manufacture and supply revenue decreased $489, or 25% to $1,458 in 2005 from $1,947 in 2004. This decrease is attributable to the discontinuation of business of one of our customers and the resulting termination of our relationship with that customer. Co-development and research fees increased $565, or 565% to $665 in 2005 from $100 in 2004. The increase was attributable to us commencing operations in 2004 and the expansion of our customer base in 2005.

        Customer Concentration.    Customers are considered major customers when sales exceed 10% of total net sales for the year or outstanding receivable balances exceed 10% of total receivables and if the loss of that customer would have a material adverse effect on our business. For 2006, we had four major customers with sales totaling $2,508, or 92% of net sales, and outstanding receivables of $563, or 97% of total receivables. For 2006, our major customers were Philip Morris USA, Leiner, King Pharmaceuticals, Inc. and Warner Chilcott UK Limited. These customers accounted for revenues of $1,233, $896, $280 and $100, respectively. For 2005, we had three major customers with sales totaling $1,802, or 85% of net sales and 100% of outstanding receivables. For 2005, our major customers, Momentus Solutions, LLC, Leiner and Philip Morris USA, accounted for revenues of $904, $550 and $348, respectively. For 2004, we had one major customer, Momentus Solutions, LLC, with sales totaling $1,774, or 90% of net sales, and outstanding receivables of $1,015, or 91% of total receivables.

    Costs and Expenses

        Manufacture and Supply Costs and Expenses.    Manufacture and supply costs and expenses increased by $341, or 27% to $1,623 in 2006 from $1,282 in 2005. This increase is attributable to the growth of revenue resulting from additional products sold as well as higher allocated overhead costs due to our adoption of Statement of Financial Accounting Standards, or SFAS, No. 151, Inventory Costs — an Amendment of Accounting Research Bulletin, or ARB, No. 43 effective January 1, 2006. Since our adoption of SFAS No. 151 was on a prospective basis, the higher levels of allocated overhead costs only affected our manufacture and supply costs and expenses in 2006. In the future, as we utilize a greater percentage of our manufacturing capacity, we expect that the amount of our allocated overhead will decrease in relation to our revenue. These increases were partially offset by lower levels of excess and obsolete inventory in 2006. Manufacture and supply costs and expenses decreased by $106, or 8% to $1,282 in 2005 from $1,388 in 2004. This decrease was attributable to a decrease in manufacture and supply revenue resulting from the terminated relationship with a significant customer as described above, offset by increased costs for excess and obsolete inventory in 2005. Our manufacture and supply cost and expenses as a percentage of manufacture and supply revenue were 92%, 88% and 71% for the years ended December 31, 2006, 2005 and 2004, respectively. The higher costs in 2006 and 2005 as compared to 2004 are principally attributable to higher excess and obsolete inventory costs for both periods as compared to 2004 and the adoption of SFAS No. 151 in 2006. In addition to the above, manufacture and supply costs and expenses are influenced by other factors such as product volume, mix and pricing, and based on our limited number of commercialized products, and associated customer base can lead to wide fluctuations in revenues and costs and expenses.

        General and Administrative Expenses.    General and administrative expenses increased by $3,924, or 53% to $11,296 in 2006 from $7,372 in 2005. General and administrative expenses increased by $4,204,

44



or 133% in 2005 from $3,168 in 2004. The increase of general and administrative expenses in 2006 and 2005 was attributable to the increase in the number of employees at our company from 11 full-time employees (inclusive of consultants and temporary workers) in 2004 to 36 and 63 full-time employees (inclusive of consultants and temporary workers) at the end of 2005 and 2006, respectively. In addition to increased staffing, we have incurred increased costs related to building our infrastructure and developing our business, including costs related to the recruitment of the current management team and other professionals, costs for additional facilities and related depreciation, as well as costs for outsourced formulation, and analytical and design work to support our development efforts.

        Research and Development Expenses.    Research and development expenses increased by $735, or 58% to $1,993 in 2006 from $1,258 in 2005. Research and development expenses increased by $248, or 25% to $1,258 in 2005 from $1,010 in 2004. The increased expenses in 2006 and 2005 were attributable to increased staffing and infrastructure to support our internal research efforts along with costs associated with the increase in partnered research and development arrangements for which we generate co-development and research fees.

Liquidity and Capital Resources

        The following discussion of our liquidity and capital resources includes amounts presented in thousands, unless otherwise specifically stated.

    Sources of Liquidity

        Since our inception in January 2004, we have never been profitable and as of June 30, 2007 we had an accumulated deficit of approximately $32,167. Through June 30, 2007, we received net proceeds from debt and equity issuances of approximately $42,574 as follows:


        We had $7,781 in cash and cash equivalents as of June 30, 2007. Currently, our cash equivalents have a maturity of three months or less. The core of our strategy involves the development of our thin film drug delivery technology to targeted prescription pharmaceuticals. This area of product development is a multi-year process that requires significant expenditures prior to realizing any product revenue. We may need to raise additional funds through public or private debt or equity financings in order to develop or acquire new products or new product candidates, expand our manufacturing capacity, obtain FDA approval for our product candidates and continue our commercial growth. The proceeds from this offering will enable us to continue to execute our strategy, attract partners for co-development arrangements and ultimately develop products for commercial supply.

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        We have received a letter of commitment from certain of our current equity owners to fund a $10,000,000 revolving credit facility, subject to standard conditions, including the completion of a definitive agreement. Any borrowings under this facility, together with interest, will be due on the earlier of the fifth business day after the completion of this offering, or August 19, 2008. Any loans under this credit facility will be used for our general corporate purposes and to pay our fees and expenses related to the facility. This facility will be secured by a pledge of all of our assets. The term of the commitment expires on the earlier of (1) our entering into definitive agreements regarding the Facility and (2) August 19, 2008. Interest due under this facility will be calculated at LIBOR plus 400 basis points and is payable at maturity.

    Cash Flows

        Six Months ended June 30, 2007 and 2006.    Cash used in operating activities totaled $5,629 for the six months ended June 30, 2007 and was primarily attributable to our $7,572 net loss, offset by $1,394 in non-cash charges, principally depreciation, and further offset by $549 from changes in operating assets and liabilities, principally an increase in deferred revenue reduced by increases in receivables and inventories. Cash used in operating activities was $3,215 for the six months ended June 30, 2006, the net result of our $5,039 net loss offset by $1,579 in non-cash charges, principally depreciation and interest expenses, and $245 from changes in operating assets and liabilities.

        Years ended December 31, 2006, 2005 and 2004.    Cash used in operating activities was $9,255 for the year ended December 31, 2006 and was primarily attributed to our $12,752 net loss, offset by $3,497 in non-cash charges such as depreciation, amortization and non-cash interest expense, and changes in operating assets and liabilities. Cash used by operating activities was $6,395 for the year ended December 31, 2005 and was primarily attributed to our $8,283 net loss, offset by $1,888 in non-cash charges such as depreciation, amortization, non-cash interest expense and the write-off of accounts receivable, and changes in operating assets and liabilities. Cash used by operating activities was $3,443 for the year ended December 31, 2004 and was primarily attributed to our $3,560 net loss, offset by $117 in non-cash charges such as depreciation and amortization and changes in operating assets and liabilities.

        Six Months ended June 30, 2007 and 2006.    Cash used in investing activities was $1,924 and $1,971 for the six months ended June 30, 2007 and 2006, respectively, and was attributable to capital expenditures for property, plant and equipment.

        Years ended December 31, 2006, 2005 and 2004.    Cash used in investing activities was $3,360, $2,761 and $1,194 for the years ended December 31, 2006, 2005 and 2004, respectively, and was attributable to capital expenditures for property, plant and equipment.

        Six Months ended June 30, 2007 and 2006.    Cash provided by financing activities was $78 for the six months ended June 30, 2007 representing the proceeds from an asset transfer to the predecessor of Monosol Rx LLC and from the aforementioned conversion of warrants, and offset by costs paid in connection with the planned offering described in this prospectus. For the six months ended June 30, 2006 cash provided by financing activities was $9,361 resulting from $9,500 of proceeds from the issuance of debt and warrants offset by debt payments.

        Years ended December 31, 2006, 2005 and 2004.    Cash provided by financing activities was $26,589 for the year ended December 31, 2006 and was primarily attributable to the $16,887 in net proceeds from the issuance of Series A Preferred Interests and $10,000 in net proceeds from the issuance of

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notes payable with warrants. Cash provided by financing activities was $10,222 for the year ended December 31, 2005 and was primarily attributable to $10,500 in net proceeds from the issuance of notes payable with warrants. Cash provided by financing activities was $4,903 for the year ended December 31, 2004 and was primarily attributable to $5,181 in capital contributions from members.

    Funding Requirements

        Upon completion of this offering, we believe that the net proceeds from this offering, together with our existing cash and cash equivalents, as supplemented by our revenue, will be sufficient to meet our projected operating requirements for approximately the next 24 months. We have based this estimate on assumptions that could change, and we could utilize our available financial resources sooner than we currently expect. The key assumptions underlying this estimate include:


        We believe that research and development through FDA approval could take up to 30 months for each of the product candidates we choose to develop. In certain cases, depending on the partner and the regulatory path, that timeframe may be shorter. We expect the entire approval process, including clinical trials, to cost between $2.5 and $3.0 million for each product developed as a self-funded initiative. Generally, when we enter into a thin film drug development agreement with a partner, the partner will agree to pay for the development costs through development and/or milestone payments. We assume in our plans regarding funding requirements that we will undertake the development of a minimum of six product candidates as self-funded initiatives which, commence at different times over the next two years. We seek to develop as many partnered or self-funded product candidates as our resources will allow.

        We currently expect the three non-pharmaceutical products we have developed with Philip Morris USA, GSK and Dr. Katz to contribute to our revenues during the next 24 months. Additionally, we expect that the OTC drug product we have developed with MedTech, a subsidiary of Prestige, will contribute to our revenues during the same timeframe. Due to the fact that our prescription product candidates are in various stages of development we cannot estimate anticipated completion dates, approval dates from the FDA or when we might receive material net cash inflows from these products. We also expect revenues from our co-development and research contracts to contribute revenues over the same timeframe.

        With respect to capital expenditures, we expect to invest $14 million through 2008 to retrofit the Ameriplex facility to a cGMP thin film manufacturing facility. Additionally, over the next 24 months we expect to invest an additional $10 to $12 million in laboratory facilities, manufacturing capacity and information technology assets.

        We expect to incur significant additional costs to support the obligations of a public company to various regulatory agencies, to investors and in order to comply with certain legislation and regulations, such as the Sarbanes-Oxley Act of 2002. These expenditures will include the costs of additional employees with specific skills and experiences such as SEC reporting or internal controls, as well as, additional costs to outside service providers such as audit, tax and legal fees. We expect those additional costs to be in excess of $1.5 million per year over the next two years.

        We may raise additional capital through public or private equity offerings, debt financings, corporate collaborations or other means. We may attempt to raise additional capital due to favorable

47



market conditions or other strategic considerations even if we have sufficient funds for planned operations. To the extent that we raise additional funds by issuance of equity securities, our stockholders may experience dilution, and debt financings, if available, may involve restrictive covenants or may otherwise constrain our financial flexibility. To the extent that we raise additional funds through collaborative arrangements, it may be necessary to relinquish some rights to our intellectual property or grant licenses on terms that are not favorable to us. In addition, payments made by potential collaborators or licensors generally will depend upon our achievement of negotiated development and regulatory milestones. Failure to achieve these milestones may harm our future capital position. If at any time sufficient capital is not available, either through existing capital resources or through raising additional funds, we may be required to delay, reduce the scope of, eliminate or divest one or more of our research, pre-clinical or clinical programs.

    Seasonality

        To the extent we are producing OTC cough, cold and allergy pharmaceutical products, which by nature are seasonal, we could experience some seasonality in revenues in the third quarter of 2007 and the second and third quarters of 2008. In the long term, our strategy is to target selected prescription pharmaceuticals on thin film that are not cough, cold and allergy pharmaceutical products. As those products are brought to the market and they begin to represent a larger share of our product portfolio, the effects of seasonality caused by any cough, cold and allergy products will be diminished.

    Contractual Obligations

        Our contractual obligations relate to operating leases for our facilities and purchases of production equipment.

        The following table sets forth a summary of our contractual obligations as of December 31, 2006:

Contractual Obligations

  Total
  Less Than
One Year

  One to
Three Years

  Four to
Five Years

  After
Five Years

Operating lease obligations   $ 2,879   $ 588   $ 1,075   $ 1,088   $ 128
Equipment purchase obligations     3,690     3,690            
   
 
 
 
 
  Total   $ 6,569   $ 4,278   $ 1,075   $ 1,088   $ 128
   
 
 
 
 

        Operating Lease Obligations.    We have various lease agreements for our production and research facilities and offices. Most leases contain renewal options, some contain purchase options and some require us to pay for taxes, maintenance and operating expenses. In October 2006, we entered into a lease for the Ameriplex facility. The lease expires in March 2012 with options to extend through March 2021, and a right of first refusal to purchase the facility. In July 2006, we entered into a lease for our headquarters located in Warren, New Jersey. The lease expires in 2011. We lease our current production facility in Portage, Indiana which houses our research and development, offices and manufacturing operations. This lease was set to expire in March 2008, with an option to extend for two additional years. In June 2007, we exercised our option and extended this lease through March 31, 2010. This lease also contains a purchase option at a fixed price. We also lease a small technology development laboratory in Kingsport, Tennessee. The lease related to the Kingsport, Tennessee laboratory expires in December 2009.

        Equipment Purchase Obligations.    In 2007, we entered into an agreement for the cash purchase of a new film casting line to fulfill production requirements under a commercial supply agreement. As of June 30, 2007, we have made $1,297 in progress payments for this casting line, and the customer that is a party to the supply agreement is obligated to make capacity commitment payments over two years that equal the cost of the equipment and any other capital expenditures related to its installation.

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    Off-Balance Sheet Arrangements

        We have no off-balance sheet arrangements.

Taxation

        Our predecessor, Monosol Rx LLC, operated as a limited liability company which, for federal, state and local income tax purposes was treated as a partnership. As such, in lieu of company-level income taxes, its members were subject to tax on their respective pro rata shares of Monosol Rx LLC's income, deductions, gains, losses and credits, as allocated in accordance with the members' operating agreement. Because Monosol Rx LLC was treated as a partnership for federal, state and local income tax purposes, no income taxes have been recognized in the accompanying financial statements, except for certain state non-income taxes, which are immaterial and included in general and administrative expenses. Effective on the merger of Monosol Rx LLC into MonoSol Rx, Inc., we will be subject to corporate-level income tax under subchapter C of the Internal Revenue Code for federal income tax purposes, as well as under state and local income tax laws. In accordance with U.S. generally accepted accounting principles, or GAAP, we are required to estimate the future tax consequences attributed to temporary differences between the financial statement and income tax bases of our assets and liabilities and record a deferred tax asset or liability. In the unaudited pro forma financial statements contained elsewhere in this prospectus, we recorded a $900,000 one-time non-cash charge on the statement of operations to recognize the deferred tax liability related to existing taxable temporary differences that will reverse in future periods. The temporary differences resulted principally from depreciation of property and equipment, and amortization of intangibles.

Performance Unit Plans

        Our predecessor, Monosol Rx LLC, maintained performance unit plans under which eligible employees and consultants received an opportunity to participate in future company appreciation in the event of a change in control transaction. In conjunction with this offering, all outstanding performance units will be converted on an economically equivalent basis into fully vested stock appreciation rights with respect to the shares of our common stock. See "Compensation Discussion and Analysis—Performance Unit Plans." We will recognize compensation expense of approximately $27.0 million upon completion of this offering, which has been reflected in the unaudited pro forma financial statements included elsewhere in this prospectus.

        We have not in the past nor do we intend in the future to redeem these equity appreciation rights for cash and as such, unless we elect to make a cash settlement, the vesting of units, their conversion to SARs and any subsequent exercise of those SARs will not create a liquidity event for us or a reduction of cash resources.

Critical Accounting Policies and Estimates

        The discussion and analysis of our financial condition and results of operations is based on the financial statements, which have been prepared in accordance with GAAP. The preparation of the financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

        Our significant accounting policies are more fully described in Note 1 to the financial statements appearing elsewhere in this prospectus. We believe that the following accounting policies relating to revenue recognition, research and development expenses, inventory valuation, intangibles and

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impairment of long-lived assets are most critical to aid you in fully understanding and evaluating our reported financial results.

    Revenue Recognition

        Our research and development agreements contain development milestones that we must meet in order to earn fees. In addition, these agreements often require that we achieve certain results in order to have the opportunity to earn additional fees and revenues. Product sales are generally a result of previous research and development efforts.

        We recognize revenue in accordance with Staff Accounting Bulletin, or SAB, No. 101 Revenue Recognition in Financial Statements, as amended by SAB No. 104. For manufacture and supply arrangements, we recognize revenue when products are shipped and the customer takes ownership and assumes risk of loss, collection of the relevant receivable is probable, pervasive evidence of an arrangement exists and the sales price is fixed or determinable. In instances where we utilize a third-party to complete the packaging process, revenue is recognized when the completed product is shipped from the third-party. Our products are made to order and manufactured only when a film order is received from a particular partner. Once delivered to the partner, that partner takes and assumes all risk of inventory levels, returns from retailers, changes in the market, as well as risk from new product introductions by their competitors. Since our partners are selling to the consumer or retailer they bear the burden of rebates, return allowances and other revenue offsets. Our contracts with our partners do not anticipate nor make provision for returns of any type other than product defects or recalls. Accordingly, our financial statements do not depict any past or potential dilution of revenues for these items.

        In the case of co-development and research fees, revenue is recognized when appropriate contractual milestones are realized, contractual amounts for those services are billed and collection of related receivables is probable. Absent significant historical data, the determination regarding the collectibility of revenues is based on management's judgments and are reviewed periodically. We currently reserve 2% of revenues for uncollectibility. We believe that given the customers we sell to and the nature of our agreements with them that this is a reasonable estimate. We believe it very unlikely that significant adjustments to revenue will be necessary due to the collectibility of our receivables. However, if our estimates of collectibility do not reflect our ability to collect revenues, our results of operations could be materially affected.

    Inventory Valuation

        Due to our continual change in customer mix, we evaluate the utility of our inventory frequently. Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Our inventories are evaluated for recoverability on a periodic basis and any non-usable inventory is written-off to expense. In addition, we establish a reserve for any inventory that may be stated in excess of its recoverable amount or potentially non-usable. Charges for such write-off and reserves are recorded as a component of manufacture and supply costs and expenses. Absent significant historical data, estimates regarding customer re-order cycles and inventory obsolescence are based on management's judgment and reviewed periodically. We manufacture to specific orders and do not generally manufacture for inventory or take inventory risk for finished goods and therefore believe it unlikely that significant adjustments for inventory obsolescence will take place. However, the FDA and other regulatory authorities may take action regarding certain active pharmaceutical ingredients that may cause raw material or packaging inventories to become non-usable. If our estimates for excess or obsolete inventory and its potential utility are less favorable than those projected, additional inventory reserves may be required.

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    Impairment of Long-Lived Assets

        Our property, plant and equipment are exposed to technological obsolescence. Management reviews the utility of these long-lived assets annually. In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long Lived Assets, long-lived assets such as property, plant and equipment, and purchased intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount. Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset exceeds its fair value. In 2006, as a result of management's evaluation of our property, plant and equipment, we recorded an impairment charge of $132,000. If these estimates or their related assumptions change the fair value of these assets in the future, we may be required to record additional impairment charges.

    Intangible Asset

        Management evaluates the utility of our intellectual property underlying our principal production capabilities annually. Our intangible asset relates to composition and process technology used in thin film technology acquired as part of the Kosmos Pharma Limited, or Kosmos, acquisition in 2004 (see Note 2 in accompanying financial statements). We amortize these intangible assets on a straight-line basis over 10 years which is the expected useful life of the associated technology. The estimates are based on assumptions that we believe to be reasonable, but which are inherently uncertain. Changes in the assumptions regarding utility and useful life or the emergence of newer, more advantageous technologies could materially affect our estimates and could result in additional amortization or impairment.

    Research and Development Costs

        We expense costs associated with research and development activities as incurred. Research and development costs include costs incurred for our internal proprietary research and development projects as well as costs incurred under arrangements with third parties for which we generate co-development and research fees.

Quantitative and Qualitative Disclosures about Market Risk

        Our exposure to market risk due to changes in interest rates relates primarily to the increase or decrease in the amount of interest income we can earn on our investment portfolio. We attempt to increase the safety and preservation of our invested funds by limiting default risk, market risk and reinvestment risk. We mitigate default risk by investing in short-term investment grade debt instruments. Due to the short-term nature of our investments, we do not believe that we have any material exposure to interest rate risk arising from our investments. We do not purchase, sell or hold derivatives or other market risk sensitive instruments to hedge interest rate risk or for trading purposes. All of our investment choices are consistent with and driven by good cash management practices.

Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

        In April 2006, our manager's general partner approved the engagement of KPMG LLP, or KPMG, to audit our financial statements for the fiscal years ended December 31, 2006, 2005, 2004 and 2003. Prior to our retention of KPMG, McGladrey & Pullen, LLP, or McGladrey, served as our certified independent accountants and reported on our financial statements for the fiscal year ended December 31, 2004. McGladrey was dismissed as our principal accountant on April 3, 2006.

        McGladrey's report on our financial statements did not contain an adverse opinion or a disclaimer of opinion and the financial statements were not qualified or modified as to uncertainty, audit scope or

51



accounting principles. During the fiscal years ended December 31, 2005 and 2004, and during the subsequent interim period between December 31, 2005 and McGladrey's dismissal, there were no disagreements with McGladrey on any matter of accounting principle or practice, financial statement disclosure or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of McGladrey, would have caused it to make reference to the subject matter of the disagreement in connection with its report on our financial statements. In addition, during the fiscal years ended December 31, 2005 and 2004, and during the subsequent interim period between December 31, 2005 and McGladrey's dismissal, there were no reportable events pursuant to Item 304(a)(1)(v) of Regulation S-K.

        During the fiscal years ended December 31, 2005 and 2004, and during the subsequent interim period between December 31, 2005 and McGladrey's dismissal, we did not consult with KPMG regarding either (i) the application of accounting principles to a specified transaction, either completed or proposed; or the type of audit opinion that might be rendered on our financial statements, or (ii) any matter that was either the subject of a disagreement or a reportable event with McGladrey.

Recent Accounting Pronouncements

        In July 2006, the Financial Accounting Standards Board issued FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement 109, or FIN 48. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise's financial statements and prescribes a threshold of more-likely-than-not for recognition of tax benefits of uncertain tax positions taken or expected to be taken in a tax return. FIN 48 also provides related guidance on measurement, derecognition, classification, interest and penalties, and disclosure. The provisions of FIN 48 were effective for us on January 1, 2007, with any cumulative effect of the change in accounting principle recorded as an adjustment to opening retained earnings. The adoption of FIN 48 did not have a material impact on our results of operations and financial condition.

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BUSINESS

Overview

        We are a drug delivery company specializing in proprietary dissolving thin film pharmaceutical products. Our thin film, which is similar in size, shape and thickness to a postage stamp, dissolves rapidly and utilizes a novel process and proprietary encapsulation compositions to mask the taste of the drug contained within the film. We believe these qualities render our thin film easy to use and consequently will improve patient compliance, providing a significant benefit to patients, their prescribing physicians and healthcare institutions. Our thin film drug delivery technology is currently used in the over-the-counter, or OTC, marketplace and we are developing thin film containing prescription drugs. By incorporating approved drugs with soon-to-expire or expired patents into our thin film, we believe we can extend their patent lives and protect the drug revenues important to our existing and future pharmaceutical partners. Furthermore, we are building the infrastructure required to produce our thin film rapidly and at scale.

        We believe our thin film drug delivery technology has several material benefits over existing drug delivery forms and should enjoy strong physician, patient and consumer acceptance. Our thin film improves convenience and ease of use through discretion and portability and precludes the need for water or liquids. Our thin film may also improve dosing accuracy relative to liquid formulations thereby ensuring proper dosing for the pediatric, geriatric and mentally ill patients where proper administration is often difficult. In addition, our thin film provides ease of dosing for patients with conditions that make it difficult to swallow other solid dosage forms such as tablets or capsules.

        Our proprietary thin film drug delivery technology is supported by a significant portfolio of intellectual property, which we believe differentiates us from our competitors. We believe this technology will enable pharmaceutical companies to better manage the life cycle of their products. By combining our thin film drug delivery technology with existing drugs, we believe our thin film can strategically differentiate existing or soon-to-be genericized drugs from potential generic competitors and can help protect branded prescription products against existing or new generic entries by providing additional patent protection or exclusivity in the marketplace. Additionally, we believe our thin film drug delivery technology can also be used to create new drug products with improved efficacy.

        We believe we are the only company completely dedicated to thin film as a drug delivery dosage form and have created a vertically integrated infrastructure to ensure leadership capabilities in the critical activities of drug tastemasking, analytical development, global formulation development, manufacturing and packaging. We have invested significantly in this model of vertical integration to develop an operational infrastructure that we believe will position us to seamlessly commercialize products in concert with our partners' respective sales forces.

        We have pursued and plan to continue to pursue four different strategic revenue paths to profitability. We plan to develop thin film versions of existing prescription products under partner-funded agreements. We also expect to self-fund the development of versions of existing prescription products which we intend to ultimately partner. We also plan to partner with pharmaceutical companies to develop and deliver new prescription products with improved efficacy and to continue to commercialize products in the OTC marketplace.

Our Business Strategy

        Our strategy is to develop and partner innovative thin film strip products in the prescription, generic and OTC pharmaceutical markets and to establish a leadership position in thin film drug delivery technology through continued development of our drug delivery technology and our intellectual property portfolio. We believe that pharmaceutical companies will want to partner with us to extend the life cycle of their products, defend against patent expiration, protect against generic encroachment and

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differentiate their products in competitive categories. To achieve these goals, our strategy includes the following key elements:

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Industry Overview

    Drug Delivery Methods

        Drug delivery companies apply proprietary technologies to create pharmaceutical products that improve the administration, absorption, efficacy, differentiation or cost of marketed pharmaceutical products. Drug delivery and related technologies have facilitated the improved delivery of drugs through a variety of means including oral (through controlled release, quick dissolve and liquids), injection, transdermal (through the skin), transmucosal (through the mucous membranes of the nose and mouth), intranasal and pulmonary methods. According to Front Line Strategic Consulting, U.S. sales of advanced drug delivery systems was $64.1 billion in 2005 and is projected to increase to approximately $153.5 billion by 2011. Thin film drug delivery was first introduced into the market in late 2004, and sales as a percentage of the aggregate market for advanced drug delivery systems in 2005 were less than .02%. Based on this information, we believe the thin film drug delivery opportunity is substantial and untapped.

        Drugs incorporating rapid-dissolve technology, like thin film, are particularly suitable for use by children, geriatric patients, and individuals with certain physiological conditions that create a difficulty in swallowing, or dysphagia. In addition, according to industry data, forty percent of people report problems swallowing tablets. Since rapid-dissolving dosage forms containing drugs are easier to swallow and often incorporate tastemasking technology, they have the potential to enhance patient compliance relative to conventional tablets. Furthermore, when compared to liquid formulations, rapid-dissolve technology may also improve dosing accuracy resulting in improved patient outcomes.

        Thin film strips were first introduced in 2001 by Warner-Lambert Consumer Healthcare in the form of the Listerine PocketPak®. We believe the global success of the product demonstrates consumer acceptance of thin strips. Novartis Consumer Health was the first major pharmaceutical company to launch several thin strip OTC pharmaceutical drug products under its Triaminic® and TheraFlu® brands. As demonstrated in the chart below based on IRI Infoscan data, Triaminic® Thin Strips have significantly outsold Triaminic® Softchews, its rapid dissolve alternative, since its introduction into the market.


Triaminic® Thin Strips and Triaminic® Softchews Sales Trends

GRAPHIC

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        Other thin film products on the market today include Prestige's subsidiary's, Medtech Products Inc., or Medtech, Chloraseptic® strips for sore throat, Pfizer's Sudafed PE® phenylephrine strips, and Novartis' Gas-X® simethicone strips. Of these products, only Chloraseptic® employs our technology.

    Trends in the Pharmaceutical Industry

        Growth in the drug delivery industry is being driven by several significant trends in the healthcare industry. We believe pharmaceutical companies are becoming increasingly focused on life cycle product management. Life cycle product management is an issue due to expiring patents, generic encroachment and declining new drug pipelines. In addition to life cycle management, other trends in the pharmaceutical industry include an increase in direct-to-consumer marketing and the continued influence of managed care on reducing costs of treatment. The following is a more detailed discussion of these trends:

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Our Solution

        We have developed a thin film drug delivery technology that we believe will be embraced by patients, prescribing physicians, healthcare providers, and pharmaceutical drug marketers. Our thin film, which is similar in size, shape and thickness to a postage stamp, dissolves quickly in the mouth and effectively hides the taste of the drug it contains. We believe these qualities render our thin film easy to use and consequently will improve patient compliance, providing a significant benefit to patients, their prescribing physicians and healthcare institutions. By incorporating approved drugs with soon to expire or expired patents into our thin film, we believe we can extend their patent lives and help protect the billions of dollars of drug revenues important to our existing and future pharmaceutical partners. Furthermore, we are building the infrastructure required to produce our thin film rapidly and at scale. We believe this combination creates a compelling partnering proposition for pharmaceutical companies who are in need of significant differentiation from branded competitors and generic drug manufacturers.

        We believe that our thin film drug delivery technology will have strong physician, patient and consumer acceptance. Evidence of this acceptance can be seen in the OTC pharmaceutical market where thin film pharmaceutical products have increased brand share and provided consumers with a preferred alternative to conventional tablets, orally dissolving tablets and other dosage forms. We believe our thin film drug delivery technology possesses several key advantages over existing drug delivery forms such as convenience, ease of dosing, portability and absence of the need for water or liquids; improved dosing accuracy relative to liquid formulations; accurate administration of drugs for the pediatric, geriatric and mentally ill patients where proper dosing can be difficult; and provides an easy alternative to patients with swallowing disorders and those who dislike taking other solid dosage forms such as tablets or capsules.

        For many of the same reasons we think our thin film delivery technology will appeal to physicians, patients, and consumers, we also believe our thin film drug delivery technology will appeal to healthcare providers. Compared to quick-dissolve tablet technologies, our strips disintegrate faster, are more durable, have excellent stability and are cost effective. In addition, our thin film accommodates unit dose packaging, is highly portable and is discreet. Because our thin film is easy to use, we believe our thin film technology may be a more effective means of drug delivery and may reduce the burden of repetitive daily dosing. Consequently, we believe our thin film will improve patient compliance with prescribed drug regimens reducing the need for repeat treatments.

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        We also believe our thin film drug delivery technology offers prescription pharmaceutical companies a compelling value proposition by enabling them to better manage the revenue life cycles of their products. Not only does our thin film drug delivery technology offer a unique ability to extend pharmaceutical product life through a non-"AB" rating but we also believe that our thin film drug delivery technology provides the essential characteristics necessary for product differentiation, performance and compliance with global drug standards. These characteristics include (i) limited clinical data requirements (505)(b)(2) application, abbreviated new drug application, or ANDA, or European Union Mutual Recognition Procedure regulatory pathways), (ii) speed of dissolution, (iii) load capacity or ability to carry the drug, (iv) compatibility with tastemasking techniques, (v) manufacturing scalability, (vi) content uniformity, (vii) stability, (viii) an extensive and protective intellectual property portfolio and (ix) a highly differentiated patient friendly delivery form. Furthermore, we are dedicated to thin film as a drug delivery dosage form and have created a vertically integrated infrastructure to ensure leadership capabilities in drug tastemasking, analytical development, global formulation development, manufacturing and packaging.

        We believe that our thin film technology is superior in its intellectual property portfolio position, ability to carry higher drug loads, better tastemasking performance, superior physical characteristics (reduced brittleness, increased pliability and resistance to tear), the ability to resist picking up water or moisture resulting in a more stable drug, shorter disintegration times at higher drug loads, excellent film casting efficiency, ease of packaging and greater final product yields.

Our Product Development

        We plan to develop and market our innovative thin film strip products in the prescription drug and OTC markets by pursuing four distinct revenue-generating strategies: (i) self-funded initiatives, or SFIs; (ii) partnered existing prescription products; (iii) partnered new prescription products; and (iv) partnered OTC pharmaceuticals and other products. We have identified and undertaken a number of self-funded initiatives, or SFIs, to develop thin film versions of existing products, which we ultimately intend to bring to market with a partner. We have also been engaged by pharmaceutical partners to develop thin film versions of existing prescription products. In the future, we expect to partner with pharmaceutical companies to deliver new prescription products with improved efficacy. We also expect to continue to develop and commercialize thin film products in the OTC and consumer marketplace.

        We do not currently have any thin film versions of existing prescription products in commercial production; however, we expect to have thin film versions of existing prescription products available for commercialization in 2009, pending regulatory approval. The thin film OTC drug and other products that we currently have in commercial production are Dextromethorphan Hydrobromide; Benzocaine (Chloraseptic®), Pectin and Menthol (Breathe Right®), Specialty Flavor Application (Marlboro®) and Chlorine Dioxide (TheraBreath®).

        We are developing thin film versions of a series of major revenue producing prescription drugs. We believe that these products can be approved on the basis of limited clinical data and on a development to approval timeline of 24 to 30 months. We plan to advance development of these initiatives until we realize certain product-specific development milestones, at which point we expect to attract partners with whom we will commercialize these film products. We have a large pool of drugs to choose from for thin film development because we believe our technology can be applied to over 400 drugs due to its load capacity. As a result, there are many candidates suitable for development utilizing our thin film drug delivery technology and we intend to carefully evaluate those candidates to determine their suitability for internal development.

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        The following chart summarizes potential SFI candidates by therapeutic category, number of candidates within each category and market opportunity based on 2005 worldwide sales:


Potential Self-Funded Initiative Candidates

Category                                                                       

  Number of Candidates
  2005 Global Category Market
Value in U.S. $
(Billions)

Anti-Psychotics   5+   $ 11.0+
Pain   15+     6.0+
Neurodegenerative Disease Treatments   12+     4.5+
Urinary Incontinence   7        3.0+
Anxiety/Depression   20+     15.0+
Erectile Dysfunction   3        2.5+

        We believe that these products can be approved on the basis of limited clinical data through the 505(b)(2) or ANDA regulatory pathways. For additional information, see the section of this prospectus entitled "Government Regulation." As thin film versions, these prescription drugs can strategically enter the global marketplace to minimize generic encroachment and in some cases allow sufficient marketing time to effectively replace the current dosage form with our non-generically substitutable film. In doing so, the drug's innovator can preempt generic introductions and retain the brand's sales and market share beyond ordinary patent expiration.

        We are currently self-funding the development of the following pharmaceutical products:


Self-Funded Initiatives

Brand Name

  Drug
  Patent
Expiration

  Category
  U.S. Sales
(Billion)*

  Status

Ambien®

 

Zolpidem Tartrate

 

Expired

 

Sleep

 

$

2.3

 

In Pilot Bioavailability/Bioequivalence Clinical Trial; Suitability Petition Filed with FDA

Zofran®

 

Ondansetron HCl

 

Expired

 

Nausea/Vomiting

 

$

1.3

 

Pre-Clinical Work Complete; Pilot Bioavailability/Bioequivalence Clinical Trials Expected Third Quarter 2007; Suitability Petition Filed with FDA

Aricept®

 

Donepezil HCl

 

11/10

 

Alzheimer's Disease

 

$

1.1

 

In Pre-Clinical Development; Pilot Bioavailability/Bioequivalence Clinical Trials Expected First Half 2008; Suitability Petition Filed with FDA

Lexapro®

 

Escitalopram Oxalate

 

3/12

 

Anti-Depressant

 

$

2.0

 

In Pre-Clinical Development; Pilot Bioavailability/Bioequivalence Clinical Trials Expected First Half 2008; Suitability Petition Filed with FDA

*
The numbers presented represent the U.S. sales of the existing prescription drugs listed in the table for fiscal year 2006 and are only intended to represent the current size of the market for these prescription drugs. Additionally, these numbers are not meant to be representative of our future thin film product revenues, as we, as a potential thin film drug delivery partner, may only receive a portion of the available revenue at any point in time. The drug targets that we have identified may

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    Our Partnered Products

        We are currently engaged with pharmaceutical partners to develop thin film versions of existing prescription products. The following is a chart summarizing our disclosed partnered prescription products:


Disclosed Partnered Prescription Products

Product

  Category
  Partner
  Status

Ketorolac

 

Menstrual Pain

 

UMD Inc.

 

Pre-Clinical Work Complete

Multiple Products

 

Respiratory

 

Adams Respiratory Therapeutics, Inc.

 

In Product Development(1)


(1)
Our products are in various stages of the product development process including drug sourcing, tastemasking (if appropriate), film composition development and preliminary stability to support clinical investigation and potency requirements.

        We have entered into pharmaceutical partner-funded agreements with companies to develop bioequivalent, thin film versions of existing drugs. We anticipate pursuing these products through either the 505(b)(2) or ANDA regulatory pathways. Under partnership agreements, our pharmaceutical partners fund the development program, regulatory submission and ultimately advertise, promote and market the new thin film product. One of the companies we have partnered with is Adams Respiratory Therapeutics, or Adams, for a thin film product for certain respiratory indications.

        We also currently, and in the future, expect to partner with pharmaceutical companies to deliver new prescription products with improved efficacy. Such improved results may be achieved through, for example, sublingual delivery (under the tongue) for those drugs suitable for absorption in that manner. Over the life of our relationship with a partner we could potentially enter into separate agreements for development fees, milestone payments, manufacturing fees and royalties as a percentage of sales. We believe these products have the potential to offer maximum value but also involve longer development timelines and more rigorous clinical requirements compared to our bioequivalent thin film versions of existing pharmaceutical products. We anticipate pursuing approval of these products with our partners through the new drug application, or NDA 505(b)(1), or 505(b)(2) regulatory pathways. One of the improved products we are developing, in conjunction with UMD Inc., is a vaginal film to treat menstrual pain. To date, this thin film product has achieved successful proof of principle bioavailability studies.

        We have had no proof of principle prototype development failures to date. We have also demonstrated the bioavailability of our initial zolpidem tartrate prototype in fasted patients and plan to perform additional pilot studies in the third quarter of 2007 to provide guidance as to bioequivalence.

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        We are currently developing and marketing a number of OTC and other products with our partners. The following is a chart summarizing our partnered OTC and other products:


Partnered OTC Pharmaceuticals and Other Products

Product
    
Brand Name

  Category
  Partner
  Status

Dextromethorphan

 

Cough

 

Vita Health Products, Inc.

 

Commercialized(1)

Diphenhydramine HCl

 

Cough

 

L. Perrigo Company

 

Prototypes Complete

Benzocaine
    
Chloraseptic®

 

Sore Throat

 

Medtech Products Inc.

 

Commercialized(1)

Benzydamine

 

Sore Throat

 

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

 

Prototypes Complete

Undisclosed

 

Undisclosed

 

CB Fleet Company, Inc.

 

Prototypes Complete

Pectin and Menthol
    
Breathe Right®

 

Snore Relief

 

GlaxoSmithKline plc

 

Commercialized(1)

Specialty Application
    
Marlboro®

 

Tobacco

 

Philip Morris USA Inc.

 

Commercialized(1)

Chlorine Dioxide
    
TheraBreath®

 

Halitosis

 

Dr. Harold Katz LLC

 

Commercialized(1)

(1)
Commercialized products are being manufactured when ordered by the partner and sold for revenue in accordance with a supply agreement or other arrangement with that partner.

        We have entered into an agreement with Prestige's subsidiary, Medtech, to develop and supply thin film containing benzocaine for the Chloraseptic® brand. We have also entered into agreements with L. Perrigo Company, or Perrigo, (for a store brand, diphenhydramine product), and CNS, Inc. (now owned by GSK) to develop and commercialize an anti-snore strip for the Breathe Right® franchise. In addition, we have partnered with Philip Morris USA Inc., or Philip Morris USA, to supply a long lasting specialty application film. We also have a development program in place with Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A., or Angelini, for an anti-inflammatory thin film product. The appropriate regulatory pathways will be followed to commercialize these products.

Competition

        We compete with drug delivery companies utilizing advanced technologies involving oral, injectable, patch-based, pulmonary and intranasal administration of pharmaceutical products. We also may compete with pharmaceutical companies seeking to develop and produce their own thin film products. However, some pharmaceutical companies have opted to partner with third-party technology providers rather than develop and manufacture their own delivery technologies in-house. However, such a trend may not continue in the future.

        While there are several competitors in the thin film drug delivery market, we believe there are two primary competitors, Adhesives Research and Lohmann Therapie Systems. We compete against these companies to attract and retain partner relationships for the development and manufacture of thin film pharmaceuticals.

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        We differentiate ourselves through our vertically integrated business model which we believe increases our speed to market, reduces third-party performance risk and increases control from a regulatory perspective. We believe our proprietary composition, tastemasking and manufacturing process provides us with a competitive advantage in thin film.

Our Inventors

        We believe our proprietary thin film drug delivery technology is supported by our portfolio of intellectual property. Our senior management and consultants are named inventors on many of our pending patent applications. We believe that we have a strong team of inventors with particular experience in drug delivery and medical sciences. We believe that our portfolio of intellectual property is a source of competitive strength for us.

        Our primary inventor to date is Richard C. Fuisz, M.D., one of our consultants. Dr. Fuisz founded Kosmos, the assets of which we substantially acquired in 2004. Dr. Fuisz is a named inventor for our issued Irish patent and on 69 of our pending worldwide patent applications.

        Garry Myers, is our senior director of product development. Mr. Myers is a named inventor on 56 of our pending worldwide patent applications.

        Dr. Pradeep Sanghvi, is our vice president for pharmaceutical development. Dr. Sanghvi is a named inventor on ten of our pending worldwide patent applications.

        A. Mark Schobel is our chief executive officer. Prior to joining us, he was a named inventor on 12 issued patents ranging from controlled release methods to diagnostic devices.

        Joseph Fuisz, the son of Dr. Fuisz, is a named inventor on 41 of our pending worldwide patent applications.

Intellectual Property

        Developing and protecting our global thin film intellectual property portfolio is a key component of our business strategy. Through our intellectual property we seek to attract partners for our products, deter new entrants from developing competing thin film drug delivery technologies and protect our products from competition. As of August 17, 2007, we had 17 published pending U.S. patent applications, 12 unpublished pending U.S. patent applications, five published pending Patent Cooperation Treaty, or PCT, applications, two unpublished pending PCT Applications, 40 published pending foreign applications, ten unpublished pending foreign applications and one issued Irish patent covering our thin film drug delivery technology. Our total number of patents and pending patent applications, including unpublished applications from all categories, exceeds 86.

        Prior to partnering with us, our pharmaceutical company partners perform due diligence on our intellectual property portfolio. This due diligence typically consists of establishing our "freedom to operate." The process of establishing "freedom to operate" consists of determining whether a product using our thin film drug delivery technology can be marketed without infringing the valid rights of third parties, and a qualitative assessment of our future ability to create intellectual property-based barriers to competition from third parties.

        A "freedom to operate" analysis generally includes a review of all known issued patents, as well as a review of known published pending art in the field. We believe our partners have reached favorable conclusions with respect to our "freedom to operate." We do not believe that our existing products and product candidates infringe upon the valid thin film intellectual property rights of others.

        We believe our global portfolio of patent applications is a significant source of competitive advantage. Our applications seek to cover our product compositions, our use of encapsulation for tastemasking, our manufacturing process, and certain novel packaging embodiments. We believe our most critical patent applications are those that relate to our ability to effectively mask the taste of the drug formulations incorporated into our thin film and to manufacture film in which the drug is uniformly dispersed.

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        Adoption of our thin film technology depends on our ability to successfully mask the often bitter and poor taste of drug formulations. To achieve this end, we are seeking certain patent claims covering the use of drug encapsulation for tastemasking in thin film products. Encapsulation refers to the coating of drug particles with a polymeric covering sufficient to help mask the taste of the drug particle while maintaining the ability to release the drug for absorption in the stomach. Encapsulation is an efficient method for combining a high ratio of drug to non-drug elements in the tastemasked particle. In fact, we have been able to incorporate as much as 60% drug by mass in our encapsulations. This allows us to deliver high drug loads in a single film. We believe we are the first and only company to commercially apply encapsulation technology in thin film.

        We believe the only commercially available alternative to encapsulation for tastemasking is the use of an ion exchange resin to bind the drug, forming a resinate that is less bitter than the drug alone, which then releases the drug in the stomach. The use of ion exchange resins for tastemasking has four significant challenges for its application to thin film. First, ion exchange resins are limited in their application to tastemask drugs due to the specificity of their chemistry. Second, the percentage of drug to non-drug elements in an ion exchange resinate tends to be fairly low, approximately 15-40% and is highly dependent on the drug. This means that the thin film needs to deliver a fairly large amount of resinate relative to the amount of drug that is delivered, thereby reducing the amount of drug which can be delivered by a single thin film dose. Third, ion exchange drug resinates form a new ionic drug complex which may necessitate more extensive safety and clinical investigations to obtain marketing approval from global regulatory authorities. Fourth, a patent covering the use of certain ranges of ion exchange resins for tastemasking in thin film was issued in June 2006 to Pfizer Consumer Health (US Patent 7,067,116). Unless Pfizer Consumer Health is willing to license its technology, it will be difficult for parties other than Pfizer Consumer Health to use ion exchange technology for thin film.

        We are also seeking patent protection for our "mother daughter" mixing system technology. In this system, a main batch of water-based coating solution is prepared in the "mother" tank. This solution is then pumped into a "daughter" tank where the tastemasked (encapsulated) active drug is mixed in, and then applied onto a backing paper on which it is dried into film. While one fully mixed daughter tank is being used to feed the coating system, the second daughter tank is charged with drug and polymer and fully mixed. The system is designed to provide a continuous batch coating process of a uniform dispersion thereby minimizing the residence time of the drug active (or encapsulated drug active where encapsulation is used) in the water-based coating solution prior to making film thus maintaining the integrity of the encapsulation. We believe this mixing technology is critically important to enable the use of tastemasked drug encapsulations in thin film, the capability to process some sensitive drugs that may tend to degrade over time in an aqueous environment and the ability to maintain uniform film performance at large batch scales. This translates into film with better and more consistent tastemasking. It also allows us to be more efficient in our manufacturing process and ensures consistent drug release as compared to films containing encapsulated drug manufactured without this system.

        Content uniformity is a requirement for all solid dosage forms. We need to maintain uniform dispersion of drug in our coating solution, during the application of the coating solution to the substrate, and during the ensuing drying process. We also have certain patent applications relating to our controlled film drying process, and the use of bottom drying in the initial stages of the film drying process. We believe that our process of controlled drying is critical to maintaining content uniformity of the drug during the drying process.

        Collectively, we believe our extensive global portfolio of patent applications covering our compositions, methods of manufacture, particularly as they relate to tastemasking and uniformity, and other critical aspects of our thin film drug delivery technology have the potential to create significant barriers to entry for potential competitors.

        We own, through assignment to us by our inventors, all of our pending thin film patent applications as well as our issued thin film patent in Ireland. We have not licensed any thin film patents from third parties. Our rights to practice and enforce our patent, and patents resulting from our

64



portfolio of pending applications, are thus unrestricted except to the extent we have agreed to license these applications to third parties.

        We have entered into license obligations with our customers in two contexts: funded development agreements whereby customers pay us to develop new thin film products, and commercial supply agreements whereby we have agreed to supply customers with thin film products. Because our agreements are individually negotiated, the terms of each agreement may vary.

        Development Agreements.    As a general matter, we seek to retain intellectual property rights as much as possible at the development agreement stage, in part because our development partners are typically not contractually bound to move from successful development into commercial distribution. In our OTC development agreements, we have not licensed intellectual property rights in connection with such development. It is however possible that we may do so in the future, particularly for high value OTC targets.

        In our development agreements for prescription drugs, we have entered into certain contingent licenses with our partners. In certain instances, we have agreed that, with respect to new intellectual property that we create, if any, in connection with the funded development work, we will license such new intellectual property exclusively to our customer for a defined field of use (which can be active pharmaceutical ingredient and/or based on a therapeutic category). If no new intellectual property arises, then we do not license anything. Additionally, we have retained exclusive intellectual property rights outside of the field. We have also entered into a funded development agreement for prescription candidates under which we have no license obligation at the development stage, like our OTC development agreements.

        Commercial Supply Agreements.    In our commercial supply agreements, we have licensed our intellectual property in a number of different ways. In a number of our OTC supply agreements, we have created an implied license to our thin film intellectual property by agreeing to supply a product, and by agreeing to exclusively sell certain products to such customers for a defined territory. However, we do not charge a royalty or grant explicit license rights. In other agreements, we charge a royalty based on level of sales. This royalty does not expire so long as we are supplying the product but does terminate on a country-by-country basis upon the market introduction of a competing thin film strip with the same active ingredient.

        To date, we have entered into one commercial supply agreement for prescription drugs. Under the license terms of this agreement, our partner must pay a royalty on net sales of the product for so long as the agreement is in effect. The royalty rate is tiered based on the level of sales, and is subject to reduction solely in the event that an "AB" ratable competing thin film is approved, in which case the royalty will be reduced by the annual sales decrease in our partner's sales, if any.

        A practice in the pharmaceutical industry is to refrain from investing resources where the potential for intellectual property obstacles is high. Since we have a number of patent applications pending this may serve as a deterrent to potential entrants. The uncertainty of the type and breadth of coverage that we may obtain may deter companies from making a substantial investment.

        In addition, our ability to avoid infringing the patents of third parties is also a source of competitive strength in intellectual property.

        Of course, when additional patents issue, such patents may be enforced where third parties infringe such patents. We have several very important patent applications relating to certain polyethelene oxide based compositions which are unique to the industry and provide significant advantages over conventional film-forming compositions. These advantages include relatively high drug loading, and a very flexible film which can be reliably packaged and does not require the use of a plasticizer (which may be important for freedom to operate in certain markets).

        In addition to our patent strategy, we use trade secrets, know how and continuing technological innovation to develop and maintain our competitive position. The development of our technology and many of our processes are dependent upon the knowledge, experience and skills of key scientific and

65



technical personnel. We have employment and/or consulting agreements in place with all of our principal inventors. We require all employees, consultants and advisors to enter into confidentiality agreements that prohibit the disclosure to or use of confidential information by any third party and which assign any invention rights to us. Further, as a matter of company policy, all scientific and technical employees have executed agreements that generally require disclosure and assignment to us of discoveries and inventions made by these individuals while devoted to our activities.

Manufacturing and Production

        We currently manufacture film strip products in our current good manufacturing practices, or cGMP, manufacturing facility in Portage, Indiana. Our Portage facility has a bulk film production capacity of approximately 750 million strips per year. Our Portage facility has successfully passed pharmaceutical and governmental audits, including a food inspection by the FDA and a pharmaceutical inspection by the Australian Therapeutic Goods Administration, or the Australian TGA. Our Portage facility is registered with the Drug Enforcement Administration, or DEA, for Class III-V drugs. We also have a research and development laboratory in Kingsport, Tennessee. The Kingsport facility is registered with the DEA for Class II-V drugs. We believe that our current production capacity is sufficient to meet our present output requirements.

        In October 2006, we entered into an agreement to lease the Ameriplex facility, a cGMP facility also in Portage, Indiana. Once retrofitted and approved, the Ameriplex facility will become our primary research, development, manufacturing and warehouse location. The Ameriplex facility provides us with the needed space for additional coating lines to meet future expected demand. The new facility and equipment give us greater control and operating efficiency for the products we produce.

        In January 2007, we engineered and placed an order for a new second film manufacturing line to fulfill a long term customer supply agreement. The new line will have a maximum capacity of nearly 2.2 billion strips per year. Additionally, we own another smaller film manufacturing line that we intend to upgrade and validate for pharmaceutical products in 2008. We expect that the existing facility, the Ameriplex facility, the additional production capacity and the outsourcing relationships we presently have will allow us to meet our supply requirements for at least the next three years.

        The various regulatory requirements to which we are subject, such as the regulations of the FDA, the DEA and the TGA, require us to adhere to cGMP. This standard requires manufacturers to follow elaborate design, testing, control, documentation and other quality assurance procedures throughout the entire manufacturing process. Our facility has undergone a food inspection by the FDA, a DEA inspection, a TGA drug inspection, and a number of quality and assurance inspections by pharmaceutical companies for cGMP compliance. In each case, our facility has passed inspection. At some point in the future, we will undergo a pharmaceutical inspection by the FDA as well. We are also subject to periodic re-inspection of our facilities.

        We purchase our raw materials from qualified, approved vendors both domestically and internationally. We only have one "sole supplier" agreement and typically source raw materials from the lowest cost provider whenever possible. We expect that we will enter into more formal and predictive supply agreements in the future as production volumes increase and are more predictive. Additionally, we purchase active pharmaceutical ingredients, or APIs, from various suppliers in cases where such ingredients are not supplied by our pharmaceutical company partners.

Government Regulation

        Our operations are subject to regulation by the federal government, state governments, and certain foreign governments. The Federal Food, Drug, and Cosmetic Act, or FDCA, other federal statutes and regulations, various state statutes and regulations, and laws and regulations of foreign governments govern to varying degrees the testing, approval, production, labeling, distribution, post-market surveillance, advertising, dissemination of information, and promotion of our products. The lengthy process of laboratory, animal and clinical testing, data analysis, manufacturing development, and

66



regulatory review necessary for required governmental approvals is costly and uncertain, and can delay or prevent product introductions in a given market. Promotion, marketing, manufacturing, and distribution of pharmaceutical products are regulated in all major world markets.

        The FDA's regulatory control of product approval directly affects our ability to launch our products in the United States market even though some OTC pharmaceutical products can be launched without the need for FDA product approval. These products are a subset of OTC products, which may be marketed without a specific FDA approval if they conform to a special published regulation of the FDA referred to as an OTC monograph.

        OTC products are those that are available to consumers without a prescription. They are available to consumers without a prescription because they can be labeled for safe and effective use without the supervision of a physician or other professional healthcare provider. In the United States, the FDA establishes OTC drug monographs for particular product classes, such as cough and cold products. The monographs specify permissible active ingredients, labeling and indications. Products that conform to a monograph may be marketed without a specific FDA approval. OTC products that do not conform to an OTC monograph generally require review and approval through a new drug application, or NDA, abbreviated new drug application, or ANDA, or 505(b)(2) application.

        Most prescription drugs marketed in the United States must be approved by the FDA before they can be lawfully marketed. In the case of an existing prescription drug that has already been approved by the FDA, the FDA will likely need to grant a separate and additional approval if the drug is to be marketed in a new film dosage form. Comparable requirements exist in other countries.

        For innovative, or non-generic, new drugs, an FDA approved NDA is generally required before the drugs may be marketed in the United States. The NDA must contain data to demonstrate that the drug is safe and effective for its labeled uses, and that it will be manufactured to appropriate quality standards. In order to demonstrate safety and effectiveness, an NDA typically must include or reference pre-clinical data from animal and laboratory testing and clinical data from controlled trials in humans. For a new chemical entity, this generally means that lengthy, uncertain and rigorous pre-clinical and clinical testing must be conducted. For compounds that have a record of prior or current use, it may be possible to utilize existing data or medical literature and limited new testing to support an NDA.

        Any pre-clinical laboratory and animal testing must comply with the FDA's good laboratory practice and other requirements. In order to initiate a clinical trial, the sponsor must submit an investigational new drug application, or IND, to the FDA or meet one of the narrow exemptions that exist from the IND requirement. Clinical testing in human subjects must be conducted in accordance with the FDA's good clinical practice and other requirements.

        The process leading up to the filing of the NDA presents a number of challenges. The FDA may refuse to accept the IND for review if applicable regulatory requirements are not met. Moreover, the FDA may delay or prevent the start of clinical trials if the manufacturing of the test drugs fails to meet cGMP requirements or the clinical trials are not adequately designed. Such government regulation may delay or prevent the study and marketing of potential products for a considerable period of time and may impose costly procedures upon a manufacturer's activities. In addition, the FDA may, at any time, impose a clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot continue without FDA authorization and then only under terms authorized by the FDA.

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        Success in early-stage clinical trials does not assure success in later-stage clinical trials. Results obtained from clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval, later discovery of previously unknown problems with a product may result in restrictions on the product or even withdrawal of the marketing approval for the product.

        Clinical trials involve the administration of the investigational drug to people under the supervision of qualified investigators. Clinical trials must be conducted under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. These protocols are submitted to the FDA as part of the IND.

        An independent institutional review board, or IRB, must review and approve each trial before it can begin, and these trials must be deemed adequate and well controlled to determine the safety and efficacy of the drug for each indication. Clinical trials are typically conducted in three sequential phases, but the phases may overlap or be combined. Phase I includes the initial introduction of an IND into a small number of humans. These trials are closely monitored and may be conducted in patients, but are usually conducted in healthy volunteer subjects. These trials are designed to determine the metabolic and pharmacologic actions of the drug in humans and the side effects associated with increasing doses as well as, if possible, to gain early evidence on effectiveness. Phase II usually involves trials in a limited patient population to evaluate dosage tolerance and appropriate dosage, identify possible adverse effects and safety risks and preliminarily evaluate the efficacy of the drug for specific indications. Phase III trials are large trials used to further evaluate clinical efficacy and test further for safety by using the drug in its final form in an expanded patient population. There can be no assurance that we will successfully complete Phase I, Phase II or Phase III testing within any specified period of time, if at all. Furthermore, clinical trials may be suspended at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

        The FDA can, and does, reject new drug applications, require additional clinical trials, or grant approvals on only a restricted basis even when product candidates performed well in clinical trials. The FDA regulates and typically inspects manufacturing facilities, equipment and processes used in the manufacturing of pharmaceutical products before granting approval to market any drug. Each NDA submission requires a substantial user fee payment, unless a waiver or exemption applies. The FDA has committed generally to review and make a decision concerning approval on an NDA within 10 months, and on a new priority drug within six months. However, final FDA action on the NDA can take substantially longer, and where novel issues are presented there may be review and recommendation by an independent FDA advisory committee. The FDA can also refuse to file and review an NDA it deems incomplete or not properly reviewable.

        In the United States, generic drugs are approved through an abbreviated process based on the submission to the FDA of an ANDA. The ANDA must seek approval of a drug product that has the same active ingredient(s), dosage form, strength, route of administration, and labeling as a so-called "reference listed drug" approved under an NDA, although some limited exceptions may be permitted. For example, an applicant may file a suitability petition with the FDA seeking the agency's approval to file an ANDA for a different dosage form of a drug than the dosage form in the existing reference listed drug. Under the FDA's regulations, the agency will not grant a suitability petition for a change in dosage form if clinical testing would be needed to establish the safety and efficacy of the change. The FDA has previously determined that an applicant could submit an ANDA for famotidine 10 mg (marketed under the brand name Pepcid AC®) in an orally dissolving strip formulation where the reference listed drug is a chewable tablet. In the case of a prescription drug that is currently marketed in a quick dissolve dosage form, management believes, based upon informal discussions with the FDA's Office of Generic Drugs, that it will be able to file an ANDA for approval of a film dosage form. We can give no assurance, however, that the FDA will make similar determination for our products.

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        An ANDA generally must contain limited clinical data to demonstrate that the product covered by the ANDA is absorbed in the body at the same rate and to the same extent as the reference listed drug. This is known as bioequivalence. In addition, the ANDA must contain information regarding the manufacturing processes and facilities that will be used to ensure product quality, and must contain certifications to patents listed with the FDA for the reference listed drug. An ANDA may not be approved if the reference listed product is subject to applicable periods of market exclusivity, or if there are valid patents other than manufacturing (process) patents covering the reference listed drug for the ANDA. Special procedures apply when an ANDA contains certifications stating that a listed patent is invalid or not infringed, known as a Paragraph IV certification. If the owner of the patent or the NDA for the reference listed drug brings a patent infringement suit within a specified time after receiving notice of a paragraph IV certification, an automatic stay bars FDA approval of the ANDA for a specified period of time pending resolution of the suit or other action by the court.

        The amount of testing and effort that is required to prepare and submit an ANDA is generally substantially less than that required for an NDA. ANDAs typically go through two review cycles at the FDA. The median time to approval can vary, but is likely to approximate 15-18 months.

        The first applicant to have an ANDA accepted for filing by the FDA that includes a Paragraph IV certification is awarded a 180-day period of marketing exclusivity. This means that the FDA may not approve another ANDA for that product until the first developer's 180-day period of marketing exclusivity has expired or has been waived. Under current law, the 180-day marketing exclusivity period generally begins with the first commercial marketing of the product, although the exclusivity can be forfeited by failure to market within specified timelines and certain other events, and some products are subject to prior rules under which the 180-day period is triggered by a court determination that the relevant patents are invalid, unenforceable or not infringed.

        We currently intend to seek approval of our film versions of drugs that are currently approved in non-rapid dissolve dosage forms by using a type of an NDA referred to as a "505(b)(2) application." Under section 505(b)(2) of the FDCA, 505(b)(2) applications may rely, in whole or in part, on safety or efficacy data that the applicant does not have a right to reference. For example, the applicant can cite published medical literature without a right to reference the underlying study data involved. Under current FDA regulations and policies, 505(b)(2) applications can also be used where the applicant is relying on prior FDA findings of safety or effectiveness regarding another company's NDA but does not qualify for the ANDA process because of some change being made for the new product relative to the existing products. For example, an applicant may seek FDA approval under section 505(b)(2) of a controlled-release formulation of an approved immediate-release formulation of another company. The 505(b)(2) applicant would reference in its application the immediate-release formulation, and submit new data to support the change to a controlled-release formulation. The 505(b)(2) application process may significantly reduce the time and expense of new drug development by eliminating the need for certain duplicative testing.

        505(b)(2) applicants must make patent certifications with respect to any reference listed drug in the same manner as ANDA applicants, and the 505(b)(2) applications are also subject to any market exclusivity periods covering a reference listed drug. These patent and market exclusivity protections on products referenced in a 505(b)(2) application may result in the lengthy and uncertain delays of approvals similar to those described above for ANDAs. In addition, there is ongoing debate around the legality of the FDA's interpretation of section 505(b)(2) to permit an applicant to rely upon prior FDA findings with respect to another company's application. If there is a legal challenge to the FDA's interpretation and the agency's view is invalidated, there would be new limitations on an applicant's ability to use the 505(b)(2) application process rather than conducting its own substantial clinical testing.

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        The FDA continues to review marketed products after approval or issuance of an OTC monograph. If previously unknown problems are discovered or if there is a failure to comply with applicable regulatory requirements, the FDA may restrict the marketing of a product, cause the withdrawal of the product from the market, or under certain circumstances seek recalls, seizures, injunctions or criminal sanctions. For example, the FDA may require labeling changes or additional studies for any marketed pharmaceutical product if new information reveals questions about a drug's safety or effectiveness. In addition, in the case of a product subject to an NDA, ANDA, or 505(b)(2) application, changes to the product, the manufacturing methods or locations, or labeling are subject to additional FDA approval, which may or may not be received, and which may be subject to a lengthy FDA review process.

        Whether marketed under an approved application or an OTC monograph, all drugs must be manufactured in conformity with cGMP and other FDA regulations and requirements, and pharmaceutical products subject to an approved application must be manufactured, processed, packaged, labeled and promoted in accordance with the approved application. Certain products must also be packaged with child-resistant and senior friendly packaging under the Poison Prevention Packaging Act and Consumer Product Safety Commission regulations. Products that do not comply with these requirements can be considered misbranded and subject to seizure, recall, monetary fines, and other penalties. We must comply with cGMP and product specific regulations enforced by the FDA, and are continually subject to inspection by the FDA and other governmental agencies. Manufacturing operations could be interrupted or halted in any of those facilities if a government or regulatory authority determines that our contract manufacturers do not comply with applicable regulations or as a result of an unsatisfactory inspection.

        The distribution of prescription pharmaceutical products is also subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. States require the registration of manufacturers and distributors who provide pharmaceuticals, including in certain states even if these manufacturers or distributors have no place of business within the state but satisfy other nexus requirements, for example, the shipment of products into such state. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples to licensed practitioners and impose other requirements to ensure accountability in the distribution of samples.

        Other reporting and recordkeeping requirements also apply for marketed drugs, including for most products requirements to review and report cases of adverse events. Product advertising and promotion are subject to FDA and state regulation, including requirements that promotional claims conform to any applicable FDA approval, and be appropriately balanced and substantiated. OTC drug advertising is also regulated by the Federal Trade Commission. Sales, marketing and scientific/educational programs must comply with applicable requirements of the anti-kickback provisions of the Social Security Act, the False Claims Act, the Veterans Healthcare Act, and the implementing regulations and policies of the United States Health and Human Services Office of Inspector General and United States Department of Justice, as well as similar state laws. Pricing and rebate programs must comply with applicable pricing and reimbursement rules, including the Medicaid drug rebate requirements of the Omnibus Budget Reconciliation Act of 1990. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

        In addition to the statutes and regulations described above, we are also subject to regulation under the Occupational Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation

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and Recovery Act and other federal, state and local regulations. We believe that we have complied with these laws and regulations in all material respects, and we have not been required to take any action to correct any material noncompliance. We are unable to predict, however, the impact on our business of any changes that may be made in these laws or of any new laws or regulations that may be imposed in the future. We cannot be sure that we will not be required to incur significant compliance costs or be held liable for damages resulting from any violation of these laws and regulations.

Sales And Marketing

        We market directly to leading pharmaceutical companies for products that we believe would benefit from our thin film drug delivery technology. Our strategy has been to leverage the brand equity, clinical, regulatory, marketing and sales capabilities of these pharmaceutical companies to maximize the value of our thin film drug delivery technologies. We will continue to build our credibility with major pharmaceutical companies by speaking at technical seminars, publishing in technical journals and exhibiting at pharmaceutical and drug delivery conferences.

        We pursue feasibility or pilot agreements with leading pharmaceutical companies who fund the development of new products incorporating our drug delivery technologies. If the new product development is successful, we generally enter into licensing and supply agreements.

Partner Agreements

        We have a number of partner agreements for the development of prescription and OTC thin film drug targets and the commercial supply of products including certain specialty non-pharmaceutical thin film applications. We have generally structured our partner agreements in the framework that is common to the rapid dissolve drug delivery market. Typically, a partner engages us to develop a particular product using specific active ingredients and, where appropriate, apply tastemasking and incorporate flavors. These arrangements are milestone-based and require payment by the partner as each particular milestone is achieved. Once development is underway, we negotiate a long-term commercial supply and licensing agreement with the partner. Revenue is realized under those agreements through the amount paid to us for product supply as well as through royalties. The royalties are calculated as a percentage of product sales. For the years ended December 31, 2006, 2005 and 2004 most of our partners were principally located in the Northeastern and Southeastern parts of the United States.

        We believe that the financial terms we have agreed upon with partners are in line with comparable transactions in the rapid dissolve drug delivery market. We believe we are able to attract certain higher value partnerships than traditional rapid dissolve transactions in certain cases because some of our partnerships involve new therapeutic products or total product replacements (i.e. moving an entire product into thin film). In contrast, rapid dissolve technologies have traditionally been limited to line extensions where a company sells a rapid dissolve tablet at the same time it offers a traditional tablet version (e.g. Schering Plough's Claritin® is sold as both a conventional tablet and as a rapidly dissolving Reditab). In 2006, Philip Morris USA, King Pharmaceuticals, Leiner Health Products and Warner Chilcott each accounted for more than 10% of our revenues or total receivables at December 31, 2006.

        Adams Respiratory Therapeutics, Inc.    In March 2007, we entered into development, supply and licensing agreements with Adams Respiratory Therapeutics, Inc., or Adams, for a prescription respiratory product. The development agreement includes a work plan for the initial product, which is a thin film containing a respiratory product, and contemplates that the parties may agree on additional products to be developed under the terms of the development agreement. The development milestones for the respiratory product from development through commercial launch total $1.5 million. In addition, Adams has agreed to pay $167,000 on each of the second, third and forth anniversaries of commercial launch. The development agreement also contains rights of first refusal for certain drugs

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that we or Adams may develop in the future. Pursuant to this right of first refusal, if we develop one of these pharmaceutical products, Adams will have the first right to exclusively market them in the United States. Likewise, if Adams desires to develop one of these drug products, we will have a right of first refusal to develop and manufacture them in the United States. These rights of first refusal are conditioned upon the development of a second thin film product, on terms to be negotiated, within 180 days following the proof of concept bio-study for the respiratory product, but in any case not before the calendar year 2008. In addition to other representations and warranties, we represent in the development agreement that our performance will not, to the best of our knowledge, infringe or otherwise conflict with the intellectual property rights of third parties. The development agreement is for a seven-year term, covers the United States, Canada and Mexico and may be extended at Adams' election for up to three three-year extension terms. In certain circumstances both we and Adams may cancel the development agreement before the term expires. We have agreed to develop the respiratory film product exclusively for Adams.

        Our supply agreement with Adams contains standard terms and conditions, and is also for a seven-year term, which may be extended by Adams for up to three three-year extension terms.

        Our license agreement with Adams has the same term as the supply agreement, including the same right to extend by Adams, but will remain in effect for an additional seven years in the event Adams terminates the agreement for our breach. The license agreement only applies to the respiratory thin film product. Adams agrees to pay royalties for the respiratory product on annual net sales within the territory of: 5% for the first $15 million in net sales; 6% on net sales from $15 to $25 million; 7% on net sales from $25 to $35 million, and 7.5% on all net sales over $35 million. In the event that a competitor obtains an approval for a competing, "AB"-rated product, our royalty rates are subject to reduction in accordance with a formula based upon the percentage decline in net sales of the product we make. Such a reduction could be material. Adams may terminate the license agreement upon 30 days' notice. Through June 30, 2007, we have not received any revenues from our agreements with Adams.

        UMD Inc.    UMD Inc., or UMD, has engaged us on a purchase order basis to develop a dual film system to vaginally deliver an active ingredient. Through June 30, 2007, UMD has paid us $166,664 for formulation development and the manufacture of clinical supplies, contracted for on a purchase order basis. This product has undergone in vivo testing with favorable results. We are currently negotiating follow-on development work with UMD.

        Philip Morris USA Inc.    In February 2007, we entered into a five-year strategic exclusive supply agreement with Philip Morris USA for the supply of specialty application film strips for use in certain tobacco products. Subject to the agreement terms, Philip Morris USA has agreed to purchase all of its requirements for specialty application film strips for those tobacco products from us. In return, we agree to supply all of Philip Morris USA's requirements up to the amount of the capacity for our new production line which we have agreed to deploy in connection with our entry into this agreement. Philip Morris USA can terminate the agreement if we fail to meet certain service levels. Philip Morris USA may also terminate our strategic supply agreement without penalty if a change in control, including certain changes in the composition of our board of directors occurs as well as under certain conditions. We have made certain representations and warranties to Philip Morris USA, including that the specialty application film strips we provide will not infringe upon the intellectual property rights of third parties. Through June 30, 2007, we have recognized $633,355 of revenue from this customer and its affiliates under our agreement. We have also recognized $1,580,721 from Philip Morris USA and its affiliates under previous agreements in prior years.

        Medtech Products Inc.    In October 2006, we entered into a development agreement with Medtech Products Inc., or Medtech, a subsidiary of Prestige. Pursuant to this agreement, we will develop three thin film product prototypes. During this development phase the agreement requires Medtech and us to negotiate a five-year commercial supply agreement, pursuant to which we will agree to supply all of

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Medtech's requirements for a benzocaine sore throat product, which Medtech will agree to exclusively purchase from us. Our development agreement with Medtech terminates if Medtech does not accept product validation and stability data within 180 days of the end of the development phase. This acceptance may not be unreasonably withheld by Medtech. Through June 30, 2007, we have recognized revenues from Medtech and its affiliates totaling $111,014.

        L. Perrigo Company.    In March 2007, we entered into a development and supply agreement with Perrigo. Under this agreement, we are to develop and supply a thin film product containing Diphenhydramine HCI, a cough medication, and in the future will receive payments upon reaching preformulation, pilot stability ($95,320), and scale-up ($247,520) milestones. This product will be a national brand equivalent to an existing, branded thin film product, and will be exclusive to Perrigo for store brand marketing in the United States and Canada. The initial term of the agreement extends through December 31, 2011. Through June 30, 2007, we have recognized revenues of $158,000 from our agreement with Perrigo.

        CNS, Inc.—GlaxoSmithKline plc.    We developed a snore relief thin film product for CNS, Inc. prior to its acquisition by GlaxoSmithKline plc, on a purchase order basis, and have recognized revenue of $601,465 through June 30, 2007 for such development. We have received a purchase order for product launch quantities and are currently negotiating a global supply agreement for the product.

        Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.    In April 2006, we entered into a development agreement with Angelini to develop a thin film product containing benzydamine, a sore throat medication. The initial work order is for $40,000 in development work, of which $20,000 has been paid to us.

        Dr. Harold Katz LLC.    In June 2004, we entered into a four-year exclusive agreement with Dr. Harold Katz LLC to supply breath strips to Dr. Harold Katz LLC and its affiliates, together, TheraBreath. This agreement has an initial term of four years, with automatic one year extensions unless one party notifies the other of its intent to cancel within three months of the extension. We also supply TheraBreath with a vitamin product on a purchase order basis. Through June 30, 2007, we have recognized revenues of $284,500 from this agreement.

        Vita Health Products, Inc.    In June 2006, we entered into a development and supply agreement with Vita Health Products, Inc. of Canada, or Vita. Under this agreement, we have agreed to supply two OTC thin film products to Vita for sale in the Canadian market. Vita is responsible for registering the products in Canada. In 2007, we received initial purchase orders from Vita for the two products. The initial term of the agreement is five years.

        C.B. Fleet Company, Inc.    We are developing a thin film OTC product for C.B. Fleet Company, Inc., or Fleet, on a purchase order basis. We also entered into a non-binding term sheet with Fleet in April 2007 which includes terms for the supply and license of this thin film product. Under these terms, we will receive a royalty of 3% to 6% of net sales, our royalty percentage increasing as certain sales volumes are reached, and we will sell the product exclusively to Fleet on a global basis, except for the Middle East and North Africa. Under the non-binding term sheet, Fleet also has the exclusive right to develop a second thin film product for a limited time period. We are working with Fleet on a definitive agreement based upon the non-binding term sheet. The initial work order is for $153,170 for formulation development and the manufacture of a pilot stability batch. Through June 30, 2007, revenue recognized under this contract totaled $75,650, and there are no contractual agreements for any further work.

        We have entered into two other agreements with global pharmaceutical companies to research and develop prescription drug targets for administration using our thin film drug delivery technology and intend to continue to enter into new agreements with other global pharmaceutical companies in the future. One of the agreements we have entered into entails a drug target to be delivered at a very low

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dose intra-orally in a highly content uniform way, and the other agreement entails the delivery of a controlled substance sublingually. We have successfully completed preliminary formulation work under both of these agreements and are progressing to the next stage of development. If completed successfully, the products will necessitate NDA submissions and approval prior to commercialization. Neither of these customers has agreed to extend the development of these products beyond work which has in one case been performed to date and in the other case we expect will be completed by September 2007.

Employees

        As of August 17, 2007, we had 70 employees (not including contract and temporary workers). Of these employees, four hold Ph.D. degrees. All of our employees are full-time; 21 of these are directly involved in research and development, and approximately 37 are involved in manufacturing operations, including regulatory affairs.

        We are subject to local labor laws and regulations with respect to our employees in those jurisdictions. These laws principally concern matters such as paid annual vacation, paid sick days, length of the workday and work week, minimum wages, pay for overtime, and insurance for workers' compensation.

        Our employees are not represented by a labor union. We do not have written employment contracts with most of our employees, and we believe that our relations with our employees are satisfactory.

Facilities

        We currently lease an approximately 10,000 square foot facility, including offices, in Portage, Indiana, which houses our research and development, analytical labs and cGMP manufacturing operations. This facility currently has the capacity to produce approximately 750 million thin film strips per year. Our lease on the Portage facility was entered into in February 2002 and expires (including renewals) in 2010, at which time we have the right to purchase the facility for approximately $1.3 million. Our current monthly rent for this facility is $14,304.

        We also lease a 400 square foot technology development laboratory in a multi-tenant facility in Kingsport, Tennessee, which is registered with the DEA for Class II-V drugs. The lease was entered into in January 2003 and expires December 31, 2009. Our monthly rent for this facility is currently $1,300.

        We currently lease our 4,140 square-foot headquarters office in Warren, New Jersey. The office is located in a large, multi-tenant technology center. The lease for this facility commenced in July 2006 and expires in 2011. Our monthly rent for this facility is currently $7,859.

        We also are guarantor of a lease for approximately 1,000 square feet of office space in Washington, D.C. The underlying lease was entered into by one of our consultants and expired in May 2007. This space is used as our business development office. We have extended the lease on a month to month basis.

        We also entered into an agreement to lease the 73,000 square foot Ameriplex facility. The lease and renewal options expire in 2021 and also contain a "right of first refusal" option on any potential sale of the property. The rent for the first 18 months of the lease is approximately $33,500 per month.

Legal Proceedings

        We are not currently a party to any material legal proceedings. We may, from time to time, become involved in litigation or other adversarial proceedings based on commercial claims, product liability or other claims.

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MANAGEMENT

Executive Officers And Directors

        Set forth below is the name, age, position and a brief account of the business experience of each of our executive officers and directors as of August 29, 2007:

Name

  Age
  Position(s)

A. Mark Schobel

 

51

 

President, Chief Executive Officer and Director

Keith J. Kendall

 

50

 

Executive Vice President, Chief Financial Officer, Treasurer and Secretary

Joseph Fuisz

 

36

 

Senior Vice President, Business Development and Licensing

Larry Kranking

 

60

 

Senior Vice President, Manufacturing and Operations

Dr. Pradeep Sanghvi

 

42

 

Vice President of Pharmaceutical Development

Douglas Bratton

 

48

 

Chairman of the Board and Director

Dr. Gregory Brown

 

54

 

Director

John Cochran

 

42

 

Director

Robert Flanagan

 

51

 

Director

Frank Tanki

 

67

 

Director

        A. Mark Schobel has served as our President, Chief Executive Officer and a member of our Board of Directors since November 2005. From March 2001 to November 2005, Mr. Schobel was the Global Head of New Technology and Product Innovation for the Consumer Health Business Unit at Novartis. Prior to Novartis, Mr. Schobel held various general management positions with Reed & Carnrick Pharmaceuticals, Warner-Lambert, and Pharmaceutical Formulations Inc.

        Keith J. Kendall has served as our Senior Vice President and Chief Financial Officer since July 2006. From February 1999 to June 2006, Mr. Kendall was the Vice President and Managing Director of the Americas for Hewlett Packard Financial Services. Mr. Kendall held a number of positions with AT&T Capital Corporation including President of AT&T Credit Corporation and NCR Credit Corporation from 1985 to 1998.

        Joseph Fuisz has served as Senior Vice President of Business Development and Licensing since September 2006. From January 2004 to September 2006, Mr. Fuisz served as a business development consultant for Monosol Rx LLC. Mr. Fuisz was a member of the board of Monosol Rx LLC from January 2004 to May 2007. From February 2000 to January 2004, Mr. Fuisz, who co-founded Kosmos Pharma, the assets of which were acquired in January 2004, served as Vice President and General Counsel of Kosmos Pharma. Mr. Fuisz practiced corporate law with the firm of Sullivan & Cromwell LLP from 1996 to 1999.

        Larry Kranking has served as our Senior Vice President of Manufacturing and Operations since March 2007. Prior to joining us, Mr. Kranking was President of Lang Medikaments, Inc. from January 2005 to May 2006, a contract manufacturing company focused on the production of sterile ophthalmic and parenteral products. From 1996 through 2004, Mr. Kranking was Vice President and General Manager of Eisai Inc., RTP, NC where he managed the design, construction, qualification and FDA approval of its parenteral and solid dose drug development and commercial operations facility.

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Mr. Kranking was a board member of the International Society of Pharmaceutical Engineering, or ISPE, from 1989 to 1998 and held the position of President from 1996 to 1997.

        Dr. Pradeep Sanghvi has served as our Vice President of Pharmaceutical Development since 2004, and is responsible for the technical and regulatory aspects of pharmaceutical formulation. Dr. Sanghvi was previously Director of Pharmaceutical Development at Penwest Pharmaceuticals, an oral drug development company, from October 2000 to February 2004. He also served as Director of Formulations and Process Development at Fuisz Technologies, a fast dissolve company that was acquired by Biovail Technologies, from December 1994 to September 2000.

        Douglas Bratton has served on our board of directors since 2004. He manages the investment operations of the Edward P. Bass Group of Fort Worth, Texas, or the Bass Group. Since 1983, Mr. Bratton has served as an investment professional with various organizations utilizing alternative asset strategies. Since 1997, Mr. Bratton has been President of Bratton Capital Management L.P., a firm that provides investment management services to the Bass Group.

        Dr. Gregory Brown joined our board in March 2007. He is currently an independent consultant with over 20 years of combined clinical, operating and healthcare investment experience. From 2003 through 2006, Dr. Brown was a partner at Paul Capital Partners, a global private equity firm. From 1997 through 2002, Dr. Brown was a healthcare investment banker and co-head of investment banking at Adams, Harkness & Hill, Inc. (now Canaccord Adams). Dr. Brown is a member of the board of directors of Oscient Pharmaceuticals Corporation. Dr. Brown was a practicing thoracic and vascular surgeon.

        John Cochran has served on our board of directors since 2004. He has been a partner of Bratton Capital Management L.P. since October 1998, and is responsible for directing its day-to-day operations. Mr. Cochran is also responsible for the operations of the Crestline Fund of Funds products. Prior to joining Bratton Capital Management L.P., from December 1989 to October 1998 he was employed with KPMG Peat Marwick, L.L.P.

        Robert Flanagan joined our board in January 2007. Since September 1989, Mr. Flanagan has been Executive Vice President of Clark Enterprises, Inc., a Bethesda, Maryland-based holding company that is the ownership, investment and asset management arm of the various Clark entities. Mr. Flanagan is a member of the board of directors of The Clark Construction Group, Inc., ILD Telecommunications, Martek BioSciences, Eagle Oil & Gas and Castle Brands, Inc.

        Frank Tanki joined our board in January 2007. He is a certified public accountant and retired in 1998 as a Senior Partner of Coopers & Lybrand, the predecessor of PricewaterhouseCoopers. Mr. Tanki was a member of the Coopers & Lybrand Executive Management Committee from 1994 to 1995 and the Firm Council from 1982 to 1994. He served as the Director of Accounting and SEC Technical Services as well as the Business Assurance Partner In Charge of the New York Practice. He served on the Auditing Standards Board of the American Institute of Certified Public Accountants. Mr. Tanki has been a member of the board of directors of Computer Horizons Inc. since November 2005 and the Nasdaq company, Media Sciences International, Inc. since December 2006.

Board Composition

        We have a board of directors comprised of six (6) members, which we believe will be compliant with the independence criteria for boards of directors under applicable law. We will continue to evaluate our compliance with these criteria over time. To the extent we deem necessary, we will seek to appoint additional independent directors.

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Board Committees

        Our audit committee is comprised of Frank Tanki (chairman), Robert Flanagan and Dr. Gregory Brown. All three members of the audit committee are independent as defined under the applicable listing standards of The Nasdaq Global Market. The board of directors has determined that Mr. Tanki is an "audit committee financial expert" as defined under SEC rules and regulations by virtue of his business background and experience described under "Executive Officers and Directors" above.

        Our audit committee is responsible for, among other things:


        Our compensation committee is comprised of John Cochran (chairman), Douglas Bratton and Robert Flanagan. Our compensation committee is responsible for, among other things:

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    Governance and Nominating Committee

        Our governance and nominating committee is comprised of Douglas Bratton (chairman), John Cochran and Dr. Gregory Brown. Our governance and nominating committee is responsible for, among other things:

Compensation Committee Interlocks And Insider Participation

        None of the members of our compensation committee was at any time during 2006 one of our officers or employees. No member of our compensation committee and none of our executive officers serve as a member of the board of directors or compensation committee of any entity that has one or more executive officers serving as a member of our board of directors or compensation committee.

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COMPENSATION DISCUSSION AND ANALYSIS

    Compensation Objectives

        The primary objective of the compensation committee of our board of directors with respect to executive compensation is to attract, motivate and retain the best possible executive talent. Further, we believe that compensation should support our business goals and encourage increased stockholder value. We expect to implement and maintain, compensation plans that link executive compensation to the achievement of key strategic goals such as the level of earnings and new product commercialization. The compensation program is designed to reward the attainment of both company goals and individual goals.

    Compensation Setting Process

        Total compensation levels for each of our named executive officers are evaluated on an annual basis. In the past, our predecessor company, Monosol Rx LLC and its manager's general partner set compensation levels for each of our named executive officers. In the future, our compensation committee will set compensation with input from our chief executive officer.

        During 2006, our manager's general partner relied on publicly available compensation data to establish compensation for our executive officers. As a startup company with significant operating losses, in order for us to attract highly skilled and experienced executive officers and managers, we aggressively bid for candidates in certain situations. In these cases, compensation was determined by industry norms, an individual's current compensation and a compensation premium that would be sufficient enough to attract that individual to work for us. In each of these cases, the manager's general partner and members of our advisory board were an integral part of setting each individual's executive compensation.

        Each of our named executive officers is a party to an employment agreement with us that sets forth certain elements of their respective compensation, including base salary. Please see the narrative discussion following the Grants of Plan-Based Awards table for additional information on the employment agreements with our named executive officers.

        During 2006, our manager's general partner took into account company performance and individual performance when determining annual bonuses. In setting and assessing company and individual performance, we have not used a predetermined formula or weighted factors. Our company achievement objectives generally relate to the growth of our business and the development of a company infrastructure to support the activities related to that growth. In 2006, our corporate focus was on revenues, customer development, product development and employee skill development. In 2006, the individual objectives generally related to either financial factors such as cash management and capital raising or strategic factors such as pre-clinical and clinical development, regulatory approval of our product candidates and management of our manufacturing operations in meeting cost targets and demand levels for our product and product candidates. The amount of emphasis put on each individual achievement depends on the individual's role within our company. Our manager's general partner also took into account an individual's tenure, position, performance and responsibilities in approving the 2006 bonuses. For the chief executive officer, overall company performance is used to evaluate his individual performance. Please refer to "Annual Bonus Opportunity" below for additional information.

        Following the completion of our initial public offering, our compensation committee expects to establish a benchmark group of companies in the life sciences and pharmaceutical industries that are similar to us in terms of stage of development, size, locations and/or job type. The benchmark group would also be representative of the types of companies we would compete with for executives and other employees.

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    Compensation Components

        Our executive compensation program includes the following five components:

        We do not have any formal policies for allocating compensation among these components. We consider market pay practices in determining the amounts to be paid, what components should be paid in cash versus equity and what portion of compensation should be short-term versus long-term.

    Base Salary

        Base salaries for each of our named executive officers, including our chief executive officer, are determined pursuant to the terms of their individual employment agreements. Base salaries are based on the scope of their responsibilities, taking into account competitive market compensation paid by other companies for similar positions to ensure that we are able to attract and retain quality candidates. The general partner of our manager has in the past had the discretion to increase the base salary of the chief executive officer from time to time, based upon such factors that include, but are not limited to, performance and market levels. Generally, the chief executive officer may increase base salaries of the other named executive officers from time to time in his discretion, based upon such factors that include, but are not limited to, performance and market levels. Following the completion of our initial public offering, our compensation committee will have the discretion to increase the base salary of both the chief executive officer as well as the chief financial officer. Please see the narrative discussion following the Grants of Plan-Based Awards Table for additional information on the employment agreements.

    Annual Bonus Opportunity

        Our executive officers are eligible for annual bonuses designed to reward the achievement of corporate financial and operational goals, as well as individual performance objectives. Bonus targets are expressed as a percentage of the executive's base salary, as provided in our named executive officers' respective employment agreements. Like our base salaries, the bonus targets set forth in the employment agreements were based on the scope of a named executive officer's responsibilities, taking into account competitive market compensation paid by other companies for similar positions to ensure that we are able to attract and retain quality candidates. Our manager's general partner has in the past and our compensation committee may in the future have the discretion to increase or decrease the bonus above the target percentage of an executive officer's bonus based on the performance of the individual against company and individual goals.

        The manager's general partner has in the past approved the annual bonus award for the chief executive officer. For each named executive officer other than the chief executive officer, the bonus award is based on the chief executive officer's performance assessment of each officer. Following the completion of our initial public offering, the compensation committee will determine the bonus award for both the chief executive officer as well as the chief financial officer. Typically, the bonus is paid in a single installment in the first quarter following the completion of a given fiscal year.

        In the past, in setting and assessing company and individual performance, we have not used a predetermined formula or weighted factors. Our company achievement objectives generally relate to the growth of our business and the development of a company infrastructure to support the activities related to that growth. In 2006, our corporate focus was on revenues, customer development, product development and employee skill development. In 2006, the individual objectives generally related to

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either financial factors such as cash management and capital raising or strategic factors such as pre-clinical and clinical development, regulatory approval of our product candidates and management of our manufacturing operations in meeting cost targets and demand levels for our product and product candidates. The amount of emphasis put on individual achievement depends on the individual's role within our company. The manager's general partner of our predecessor also took into account an individual's tenure, position, performance and responsibilities in approving the 2006 bonuses. For the chief executive officer, overall company performance is used to evaluate his individual performance.

        The level of company and individual executive achievement is monitored on an ongoing basis throughout the year. At the end of the year, as part of each executive officer's evaluation and compensation review, each executive officer's achievement, as well as the executive's contribution to corporate performance, is assessed. The manager's general partner has in the past and our compensation committee will in the future assess the performance of the chief executive officer.

        From time to time, special bonuses may be granted in order to attract highly qualified and talented executives. In 2006, Mr. Kendall received a one-time signing bonus when he joined us.

        In 2006, the following bonuses were earned by our named executive officers.

Executive Officer

  Position

  Actual Bonus
Amount Paid

  Target Bonus
(% of Base Salary)

 
A. Mark Schobel   President, Chief Executive Officer   $ 227,500   50 %
Keith Kendall*   Executive Vice President, Chief Financial Officer   $ 158,438   75 %
Joseph Fuisz*   Senior Vice President, Business Development and Licensing   $ 44,660   50 %
Dr. Pradeep Sanghvi**   Vice President of Pharmaceutical Development   $ 64,064   50 %
Carl Fischer***   former Chief Financial Officer and former Senior Director, Finance   $ 32,813   25 %

*
These officers joined us during 2006 and their bonus amounts are pro rated based upon their date of hire.
**
Dr. Sanghvi received a pro-rated bonus based upon his eligibility and base salary change under the terms of his employment agreement.
***
Mr. Fischer's employment with us terminated on July 31, 2007.

Please refer to the Summary Compensation Table and the narrative discussion following the Grants of Plan-Based Awards tables for additional information.

        For 2007, the manager's general partner of our predecessor determined that annual bonus awards for each executive officer should be contingent upon the achievement of company and individual performance targets and established our 2007 goals. We intend to rely more heavily on such company and individual goals and objectives and the measurement of achievement against those goals. We have established a performance management system that outlines the process for setting performance objectives and assessing performance against those objectives. As in the past, these goals continue to generally relate to our growth and continue to emphasize revenues, customer development, product development and employee skill development. Individual goals for each executive have been developed by the chief executive officer and the individual executive, with the oversight and approval of our board of directors. For the chief executive officer, the overall company goals are his individual goals. The individual goals will continue to generally relate to either financial factors such as cash management and capital raising or strategic factors such as pre-clinical and clinical development, regulatory approval of our product candidates and management of our manufacturing operations in meeting cost targets and demand levels for our product and product candidates.

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    Long-Term Incentives

        We believe that long-term performance is achieved through an ownership culture that encourages participation by our executive officers in equity-based awards. Our incentive plans have been established to provide our current and future directors, officers, consultants and advisors, including our executive officers, with incentives to help align their interests with the interests of our stockholders. We believe that the use of equity-based awards offers the best approach to achieve our compensation goals.

        In 2006, equity awards were granted under our performance units plan either upon the commencement of employment or due to antidilution measures with respect to previously granted awards. Equity awards have been negotiated on an individual basis with our named executive officers as part of their overall compensation packages. Equity awards have been made to support our compensation objectives of attracting, motivating and retaining executive talent and have been based upon the scope of a named executive officer's responsibilities, taking into account competitive market compensation paid by other companies for similar positions to ensure that we are able to attract and retain quality candidates.

    Performance Unit Plans

        Our predecessor, Monosol Rx LLC, maintained two substantially similar performance unit plans, which provide eligible employees and other service providers an opportunity to participate in our growth. Each performance unit represents the right to receive an amount equal to the increase in the fair market value of a unit of membership interest in Monosol Rx LLC between the date the performance unit is granted and the date it is settled. In general, performance units vest over time, subject to continuing employment or other service with us. Vesting accelerates upon a change in control or initial public offering. We have the right to redeem vested performance units within 12 months following a termination of the unit holder's employment or other service; however, the holder is not entitled to settlement of his or her vested performance units unless and until there is a change in control. The amount payable to a participant upon settlement of a performance unit is equal to the difference between the fair market value of a unit of membership interest in Monosol Rx LLC on the settlement date and the fair market value of a unit of membership interest in Monosol Rx LLC on the date the performance unit was granted.

        In April 2007, the holders of the stock purchase warrants issued in 2005 and 2006 in connection with our Tranche A and B Notes, exercised their rights to purchase common membership interests in Monosol Rx LLC. As a result of the exercise of warrants, an additional 55,785 membership interests were issued. In order to avoid the dilutive effect of the warrant redemption on the performance units, we increased the number of outstanding performance units held by our named executive officers by 55% to hold their respective equity interests stable. No other adjustments or awards have been made in 2007 with respect to our named executive officers and we do not expect to make further grants pending the completion of our initial public offering.

        We have amended and restated our performance unit plans into a single plan that will be effective upon the completion of the merger of Monosol Rx LLC into MonoSol Rx, Inc. At that time, all outstanding performance unit awards will be converted into economically equivalent stock appreciation rights, or SARs, in MonoSol Rx, Inc., at the same conversion ratio (14.253) that will be used to convert membership interests in Monosol Rx LLC into shares of MonoSol Rx, Inc. As of July 31, 2007, the number of outstanding performance units was approximately 32,622,044, with a weighted average base value per unit of approximately $0.364. Upon the merger of Monosol Rx LLC into MonoSol Rx, Inc., these outstanding performance units will be converted into SARs that may be exchanged for approximately 2,288,835 shares of our common stock with a weighted average base value of $5.19 as of the time of the conversion.

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        Upon exercise by a holder, SARs will be settled in the form of cash or shares of our common stock having a fair market value on the date of settlement equal to the aggregate difference between (a) the then fair market value of the shares covered by the exercise, and (b) the base value of those shares. We intend to settle all exercises of SARs using shares of our common stock. Under the amended and restated plan, SARs may not be exercised until the expiration of a lock-up period that will expire 180 days from the date of this prospectus (unless extended in certain circumstances). The responsibility for funding the settlement of those SARs will be borne by the persons who own membership interests in our predecessor, Monosol Rx LLC, immediately before its merger into MonoSol Rx, Inc. Therefore, at the time of the merger, the owners of MonoSol Rx LLC will cause approximately 2,288,835 shares of our common stock they would otherwise receive in the merger to be deposited with an independent trustee to be held and used upon exercise of the SARs. The trustee will transfer shares to the holders of the SARs (or to us for transfer to holders of the SARs) as and when the SARs are exercised and settled. Unless exercised sooner, each SAR will expire no later than the tenth anniversary of its corresponding performance unit's grant date. When all SARs have been exercised, or when all unexercised SARs have expired, the trustee will be instructed to return any shares then still held in trust (that is, shares that were not transferred pursuant to any exercise of the SARs) to the persons who were owners of Monosol Rx LLC immediately before the merger, pro rata according to their respective ownership percentages of Monosol Rx LLC immediately before the merger.

        The table below illustrates (a) the total number of outstanding performance units granted, net of forfeiture, by year from the inception of the plan in 2004, and (b) the as-converted SARs associated with the performance units. All years have been normalized based on the number of authorized performance units as of July 31, 2007.

Year Ending

  Performance
Units (Net of
Awards/
Forfeitures)

  Weighted
Average Base
Value
Per Unit(2)

  As Converted
into SARs(1)

  Weighted
Average Base
Value per
SAR(1)

2004   7,456,995   $ 0.08   523,199   $ 1.14
2005   5,271,554     0.12   369,864     1.71
2006   20,156,489     0.53   1,414,224     7.55
2007 (through July 31)   (262,994 )   0.12   (18,452 )   1.65
   
 
 
 
TOTAL (as of July 31, 2007)   32,622,044   $ 0.36   2,288,835   $ 5.19

(1)
Performance Units are converted into SARs, and their respective weighted average base values per unit are converted into weighted average base values per SAR, at the same conversion ratio that membership interests of Monosol Rx LLC are converted into common stock of MonoSol Rx, Inc., or 14.253 units per SAR.

(2)
The base value per unit is equal to the estimated fair market value of a unit of membership interest in Monosol Rx LLC on the date the performance units are deemed granted.

        The following table shows, with respect to each of our named executive officers, the number of performance units held by each officer immediately before those units are converted into SARs, the corresponding total number of shares of common stock covered by the SARs, and the aggregate value

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of the SARs at the time this offering is completed, based upon an assumed offering price of $17.00 per share:

Executive Officer

  Performance Units
to be converted

  No. of SARs
  Aggregate
Value

A. Mark Schobel   6,287,948   441,176   $ 5,208,749
Keith Kendall   4,715,961   330,882   $ 3,000,000
Joseph Fuisz   7,073,943   496,324   $ 6,067,231
Dr. Pradeep Sanghvi   1,571,987   110,294   $ 1,333,656
Carl Fischer   264,094   18,529   $ 234,845

    2007 Stock Incentive Plan

        In August 2007, the board of directors of MonoSol Rx, Inc. adopted and its sole stockholder approved a new stock incentive plan that will be effective upon the completion of our initial public offering.

        The plan is intended to help us (1) optimize our profitability and growth through long-term incentives that are consistent with our goals and that link the interests of participants to those of our stockholders, (2) provide participants with an incentive for excellence in individual and organizational performance, and (3) provide flexibility to help us attract, motivate and retain the services of participants who make significant contributions to our success.

        In general, the plan will be administered by our compensation committee. The compensation committee may delegate its authority to persons other than its members, subject to such limitations as may be imposed by the plan or applicable law or stock exchange rules. In general, our compensation committee will decide who will receive awards under the plan and the terms and conditions of those awards, and will have broad discretion regarding the administration and interpretation of the plan and individual awards made under the plan. Our board of directors has the authority to grant awards and to make other determinations under the plan with respect to non-employee directors.

        Our compensation committee or the board of directors, as the case may be, will have the authority to grant various types of awards to employees under the plan, including:

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        Our compensation committee will determine the date on which awards are payable and may permit or require a participant to defer payment of all or a portion of an award subject to conditions established by our compensation committee. If awards are paid in shares of our common stock, our compensation committee will determine whether the shares will be subject to transfer restrictions and/or vesting conditions.

        We will be authorized to issue up to 1,502,941 shares of our common stock (determined immediately following the completion of the initial public offering and adjusted for certain capital changes that may occur in the future) under the plan. In applying this limitation, we do not count as issued (and thus add back to the plan's share pool): (a) shares covered by awards that expire or are canceled, forfeited, settled in cash or otherwise terminated, and (b) shares delivered to us and shares withheld by us for the payment or satisfaction of purchase price or tax withholding obligations associated with the exercise or settlement of an award. Also, shares covered by stock-based awards assumed by us in connection with the acquisition of another company or business are not taken into account in determining the number of shares that are or may be issued under the plan.

        The exact number of future stock options and other awards that may be allocated to any one individual or group of individuals under the plan is not presently determinable. However, pursuant to new employment agreements that will be effective upon the completion of the initial public offering, Messrs. Schobel and Kendall will receive SARs covering 160,000 shares and 120,000 shares, respectively, and 77,702 and 39,678 shares of restricted stock, respectively. Please see the narrative discussion following the Grants of Plan Based Awards table for additional information. Our compensation committee has also approved a grant of 35,000 stock options to Larry Kranking, our Senior Vice President of Manufacturing and Operations, which will be effective as of the closing of this offering. These options will vest in three equal annual installments beginning on the first anniversary of this offering, and will have an exercise price per share equal to the offering price per share of the common stock in this offering.

        Unless it is terminated earlier, the plan will remain in effect until all shares subject to the plan have been purchased, acquired, or forfeited, and all cash awards have been paid or forfeited, pursuant to the plan's provisions. However, in no event may an award be granted after 10 years from the effective date of the plan. During the term of the plan, our board of directors may amend or terminate the plan. Any amendment that would cause the plan to fail to comply with any requirement of applicable law, regulation, or rule if it were not approved by stockholders will not be effective unless our stockholders approve the amendment.

    Employee Benefits and Perquisites

        Consistent with our compensation philosophy to attract and retain talent, we intend to continue to maintain competitive employee benefits and perquisites for all employees, including executive officers.

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        We currently offer the following employee benefits and perquisites to our named executive officers to remain competitive in the marketplace:

        For a further description of these benefits, please refer to the Summary Compensation Table set forth herein.

        In the future, the compensation committee, in its discretion, may revise, amend or add to the officers' executive benefits and perquisites as it deems advisable. We believe these benefits and perquisites are currently at competitive levels for comparable companies.

    Severance and Change in Control Protections

        The employment agreements with our named executive officers as well as our stock incentive plan will require us to provide compensation or other benefits to our named executive officers in connection with certain events related to a termination of employment or change in control. For a description of the terms of these arrangements see "Termination of Employment and Change-in-Control Arrangements."

        We have established these arrangements because we believe providing executive officers compensation and benefits arrangements upon a change in control is necessary in order for us to be competitive with compensation packages of other similarly situated companies and assists us in recruiting and retaining talented executives. In addition, formalizing our termination and change in control benefits provides us with certainty in terms of our obligations to an eligible executive in the event that our relationship with any such executive is terminated.

    Impact of Tax Treatment on Compensation

        In general, a federal income tax deduction is not allowed for annual compensation in excess of $1,000,000 paid to the chief executive officer or any of the four other most highly compensated officers of a public company. However, qualifying "performance-based" compensation is not counted against this limit. We anticipate that stock options and SARs awarded under our stock incentive plan will be deemed to be "performance-based" compensation that is not subject to the deduction limit. In addition, certain other awards that may be conditioned by our compensation committee on the attainment of prescribed performance goals may also qualify as "performance-based" compensation that is not subject to the deduction limit. To satisfy the requirements that apply to "performance-based" compensation, the performance measures must be approved by our stockholders, subject to transition relief that would apply generally to grants made before the 2011 annual stockholder meeting. It is expected that the performance measures to be used under the plan will be submitted for stockholder approval at the 2011 annual stockholder meeting (if not sooner).

        While we seek to take advantage of favorable tax treatment for executive compensation where appropriate, the primary drivers for determining the amount and form of executive compensation must be the retention and motivation of superior executive talent rather than tax-based considerations.

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Summary Compensation Table

        The following table sets forth the compensation for our chief executive officer, our chief financial officer, our former chief financial officer and our two other most highly compensated executive officers for the fiscal year ended December 31, 2006. We have no other executive officers. We refer to these officers collectively herein as our named executive officers.

Name and
Principal Position

  Salary
($)

  Bonus
($)

  Option
Awards(8)
($)

  All Other
Compensation
($)

  Total
($)

A. Mark Schobel
President and Chief Executive Officer
  $ 350,000   $ 227,500     $ 20,983 (9) $ 598,483

Keith Kendall
Executive Vice President, Chief Financial Officer

 

$

156,250

(1)

$

358,438

(5)


 

$

1,136

(9)

$

515,824

Joseph Fuisz
Senior Vice President—Business Development and Licensing

 

$

204,889

(2)

$

44,660

(6)


 

$

3,900

(9)

$

253,449

Dr. Pradeep Sanghvi
Vice President of Pharmaceutical Development

 

$

242,885

(3)

$

64,064

(7)


 

$

12,434

(9)

$

319,383

Carl Fischer
(former Chief Financial Officer)(4)

 

$

172,408

 

$

32,813

 


 

$

14,443

(9)

$

219,664

(1)
Mr. Kendall joined the company on June 16, 2006. Information presented is from June 16, 2006 through December 31, 2006.

(2)
Mr. Fuisz worked as a consultant for the period of January 1, 2006 through September 13, 2006 and $127,500 of his base salary listed above reflects his compensation earned as a consultant. Mr. Fuisz was hired as an employee on September 14, 2006 and $77,389 of his base salary listed above reflects his compensation earned as an employee.

(3)
Under the terms of his employment arrangement in effect during the initial part of 2006, Dr. Sanghvi received an annual base salary ranging from $176,775 to $187,500. Effective upon entry into his employment agreement on August 1, 2006, Dr. Sanghvi's annual base salary was increased to $280,000.

(4)
Mr. Fischer ceased his duties as our chief financial officer on June 16, 2006. He remained an employee and during 2007 served as our senior director, finance, which we did not consider to be an executive officer position. The compensation amounts reflected in the table were based upon his 2006 employment agreement. His employment agreement reflecting his role as our senior director, finance was entered into as of January 1, 2007 and expired on June 29, 2007. Mr. Fischer's employment with us terminated on July 31, 2007 pursuant to the terms of his separation agreement.

(5)
Consists of a signing bonus in the amount of $200,000 that Mr. Kendall received upon the commencement of his employment and an annual bonus in the amount of $158,438, pro-rated to his date of hire.

(6)
Mr. Fuisz received a pro-rated bonus in the amount of $44,660, based on his date of hire.

(7)
Dr. Sanghvi received a pro-rated bonus in the amount of $64,064, based on the date of his employment agreement.

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(8)
In 2006, awards of performance units were made under our performance unit plan to each of our named executive officers as follows:

(9)
Includes (i) matching contributions to our 401(k) plan in the following amounts with respect to each named executive officer: for Mr. Schobel: $17,577, Mr. Fuisz: $3,237, Dr. Sanghvi; $9,657 and Mr. Fischer: $11,631, (ii) premiums paid by us with respect to the medical insurance premiums (health, vision and dental) in the following amounts with respect to each named executive officer: for Mr. Schobel: $1,408, Mr. Kendall: $632, Mr. Fuisz: $210, Dr. Sanghvi: $1,408, and Mr. Fischer: $1,408, and (iii) premiums paid by us with respect to the life insurance policies in the following amounts with respect to each named executive officer: for Mr. Schobel: $1,998, Mr. Kendall: $504, Mr. Fuisz: $453, Dr. Sanghvi; $1,369 and Mr. Fischer: $1,404.

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Grants of Plan-Based Awards

        The following table provides information regarding the performance unit awards granted during fiscal year 2006 to our named executive officers.

Name

  Grant Date(1)
  Units
Underlying
Awards(1)
(#)

  Base Value
per unit(2)
($)

  As Converted into
SARS(3)
(#)

  Base
Value per
resulting SAR(3)
($)

A. Mark Schobel   2/13/2006
3/22/2006
6/16/2006
9/21/2006
  1,468,235
91,175
114,755
2,453,872
  0.251
0.251
0.557
0.636
  103,015
6,397
8,051
172,169
  3.58
3.58
7.93
9.07

Keith Kendall

 

6/16/2006

 

4,715,961

 

0.557

 

330,882

 

7.93

Joseph Fuisz

 

3/22/2006
6/16/2006
9/21/2006

 

1,166,572
130,003
2,739,816

 

0.251
0.557
0.636

 

81,849
9,121
192,232

 

3.58
7.93
9.07

Dr. Pradeep Sanghvi

 

3/22/2006
6/16/2006
9/21/2006

 

300,721
28,925
608,831

 

0.251
0.557
0.636

 

21,099
2,029
42,717

 

3.58
7.93
9.07

Carl Fischer

 

2/13/2006
3/22/2006
6/16/2006
9/21/2006

 

183,923
11,004
14,148
306,538

 

0.251
0.251
0.557
0.636

 

12,904
772
993
21,507

 

3.58
3.58
7.93
9.07

(1)
Each performance unit represents the right to receive an amount equal to the increase in the fair market value of a unit of membership interest in Monosol Rx LLC between the date the performance unit is granted and the date it is settled. We have the right to redeem vested performance units within 12 months following a termination of the unit holder's employment or other service; however, the holder is not entitled to settlement of his or her vested performance units unless and until there is a change in control.

(2)
The base value per unit is equal to the estimated fair market value of a unit of membership interest in Monosol Rx LLC on the date the performance units are deemed granted.

(3)
Upon the merger of Monosol Rx LLC into MonoSol Rx, Inc., all outstanding performance units will be converted into economically equivalent stock appreciation rights based upon the same conversion ratio (14.253:1) used to convert membership interests in Monosol Rx LLC into shares of MonoSol Rx, Inc.

    Annual Base Salary and Bonus Overview

        Base salary paid to the named executive officers in 2006 constituted approximately the following percentages of their total compensation as set forth in the Summary Compensation Table: Mr. Schobel: 58.5%; Mr. Kendall: 30.3%; Mr. Fuisz: 80.8%; Dr. Sanghvi: 76.0%; and Mr. Fischer: 78.5%. Discretionary annual bonuses paid to named executive officers in 2006 constituted approximately the following percentages of their total compensation as set forth in the Summary Compensation Table: Mr. Schobel: 38%; Mr. Kendall: 69.5%; Mr. Fuisz: 17.6%; Dr. Sanghvi: 20%; and Mr. Fischer: 14.9%. The base salary and bonus amounts are pro rata based upon the dates of hire of Mr. Kendall and Mr. Fuisz and, for Dr. Sanghvi, reflect the change in his salary and bonus eligibility under his employment agreement.

    Employment Agreements

        We have entered into employment agreements with each of our named executive officers. Please see the discussion under "Termination of Employment and Change-in-Control Arrangements" for additional information on our employment agreements.

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        A. Mark Schobel.    Mr. Schobel's employment agreement was entered into as of November 17, 2005. Mr. Schobel's employment agreement has a three-year term which automatically renews for additional one-year periods until terminated by us or Mr. Schobel. Pursuant to his employment agreement, Mr. Schobel received an annual base salary of $350,000 for 2006, which is subject to increase according to our policies and practices. In addition to receiving an annual base salary and standard employee benefits, Mr. Schobel is eligible for an annual bonus of 50% of his base salary, based on our achievement of established performance targets. If we exceed our performance targets, we may increase the amount of Mr. Schobel's annual bonus. The bonus is to be paid 50% in cash and 50% in cash or in performance units, under the managing partner's discretion. The employment agreement also provides for a grant of performance units under the performance units plan that entitle him to 4% of the growth in the fair market value of the Company over and above the base value assigned to the units at the time they were granted. Mr. Schobel is also entitled to certain anti-dilution rights in connection with his performance units under this agreement. The performance units vest ratably over the term of the employment agreement on the anniversary of his employment.

        On August 24, 2007, we entered into a new executive employment agreement with Mr. Schobel that will be effective upon the completion of this offering and continue through December 31, 2010. This agreement is automatically renewable for additional one-year periods until terminated by us or Mr. Schobel. Mr. Schobel's initial base salary will be $350,000 per year and may be increased at the discretion of our compensation committee. Mr. Schobel's annual bonus for fiscal year 2007 will be no less than the bonus he would otherwise have been entitled to receive under the terms of his previous employment agreement, determined at the discretion of our compensation committee. For each fiscal year after 2007, Mr. Schobel will be eligible for an annual target bonus opportunity equal to at least 75% of his base salary, based on our achievement of established performance targets. If we exceed our performance targets, our compensation committee may increase the amount of Mr. Schobel's annual bonus. Upon the completion of this offering and under our stock incentive plan, Mr. Schobel will receive SARs covering 160,000 shares, with a base price per share equal to the initial public offering price per share and 77,702 shares of restricted stock. The SARs will vest in 36 equal monthly installments beginning on the last day of the month next following the month in which this offering is completed and the restricted stock will vest on the third anniversary of the completion of this offering. In addition, in the event that payments to which Mr. Schobel is entitled pursuant to his new employment agreement constitute "excess parachute payments" under Section 280G of the Internal Revenue Code, he will be entitled to a gross-up payment to cover any excise taxes imposed on such payments.

        Keith Kendall.    Mr. Kendall's employment agreement was entered into as of June 16, 2006. Mr. Kendall's employment agreement has a three-year term which automatically renews for additional one-year periods until terminated by us or Mr. Kendall. Mr. Kendall's annual base salary is set at $325,000, which is subject to increase based upon performance and other considerations as appropriately determined by our chief executive officer. In addition to receiving an annual base salary and standard employee benefits, Mr. Kendall is eligible for an annual bonus of a target of 75% of his base salary, based on our achievement of established performance targets. If we exceed our performance targets, we may increase the amount of Mr. Kendall's annual bonus. The bonus is to be paid 66% in cash and 34% in cash or performance units in the chief executive officer's discretion. The employment agreement also provides for a grant of performance units under the performance unit plan that entitle him to 3% of the growth in the fair market value of the company over and above the base value assigned to the units at the time they were granted. These performance units vest ratably in six month periods over the term of the employment agreement. Mr. Kendall is also entitled to certain anti-dilution rights in connection with his performance units under this agreement.

        On August 24, 2007, we entered into a new executive employment agreement with Mr. Kendall that will be effective upon the completion of this offering and continue through December 31, 2010.

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This agreement is automatically renewable for additional one-year periods until terminated by us or Mr. Kendall. Mr. Kendall's initial base salary will be $325,000 per year and may be increased at the discretion of our compensation committee. The remainder of the terms of Mr. Kendall's new employment agreement are the same as those contained in Mr. Schobel's agreement, except that upon the completion of this offering and under our stock incentive plan, Mr. Kendall will receive SARs covering 120,000 shares, with a base price per share equal to the initial public offering price per share and 39,678 shares of restricted stock.

        Joseph Fuisz.    Mr. Fuisz's previous employment agreement was entered into on September 14, 2006 and provided for a term of two years and four months, concluding on December 31, 2008. Under the agreement, Mr. Fuisz's base salary was set at $280,000, which was subject to increase based upon performance and other considerations as appropriately determined by our chief executive officer. In addition to receiving an annual base salary and standard employee benefits, Mr. Fuisz was eligible for an annual bonus of a target of 50% of his base salary, based on our achievement of established performance targets. If we exceeded our performance targets, we had the option to increase the amount of this annual bonus. The bonus was payable in cash or performance units as determined by the company. Prior to entering into this employment agreement, Mr. Fuisz served as a consultant for business development and legal matters.

        On May 12, 2007, we entered into an amended and restated employment agreement with Mr. Fuisz on terms similar to his previous employment agreement. His base salary and bonus structure remain the same. The amended and restated employment agreement, however, provides for a term of 8 months and will conclude on December 31, 2007. There is no automatic renewal provision. Upon the conclusion of the term of the amended and restated employment agreement, and assuming that Mr. Fuisz neither resigns voluntarily nor is terminated for "cause" (as defined in his amended and restated employment agreement), Mr. Fuisz shall return to providing services to us as a consultant on the terms set forth in the form of consulting agreement attached as an exhibit to the amended and restated employment agreement.

        Dr. Pradeep Sanghvi.    Dr. Sanghvi's employment agreement was entered into on August 1, 2006 for a period of three years and automatically extends for additional one year periods unless terminated by us or Dr. Sanghvi. Under the agreement, Dr. Sanghvi's annual salary is set at $280,000, which is subject to increase based upon performance and other considerations as appropriately determined by our chief executive officer. In addition to receiving an annual base salary and standard employee benefits, Dr. Sanghvi is eligible for an annual bonus of a target of 50% of his base salary, based upon achievement by us and Dr. Sanghvi of established performance goals. The actual bonus amount may increase if such performance targets are exceeded. Prior to entering his employment agreement with us, Dr. Sanghvi was an at-will employee.

        Carl Fischer.    Mr. Fischer's employment agreement in his capacity of chief financial officer was in effect during 2006. The employment agreement was entered into on December 13, 2005 for a one-year term. Mr. Fischer received an annual base salary of $175,000 for 2006. In addition to receiving an annual base salary and employee benefits, Mr. Fischer was eligible for an annual bonus of 25% of his base salary, based on our achievement of established performance targets. The employment agreement also provides for a grant of performance units under the performance unit plan that entitle him to 0.5% of the growth in the fair market value of the company over and above the base value assigned to the units at the time they were granted. Mr. Fischer was entitled to certain anti-dilution rights in connection with his performance units.

        Mr. Fischer's employment agreement, reflecting his capacity as senior director, finance, was entered into on January 1, 2007 and expired on June 29, 2007. Under the agreement, Mr. Fischer received an annual base salary of $135,000. In addition to receiving an annual base salary and standard employee benefits, Mr. Fischer was eligible for a bonus of 30% of his base salary, pro-rated to reflect

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the six-month employment term, based upon achievement by us and Mr. Fischer of established performance goals.

        Upon the expiration of Mr. Fischer's employment agreement with us, he became an at-will employee and under the terms of Mr. Fischer's separation agreement, Mr. Fischer's employment with us terminated on July 31, 2007.

        During the respective terms of their employment agreements and following the termination of their agreements for any reason as long as the information remains confidential, Messrs. Schobel, Kendall, Fuisz and Fischer and Dr. Sanghvi shall not make use, for his own benefit or for the benefit of a business or entity other than us, of any verbal or written secret or confidential information, so long as the information is confidential.

        In addition, Messrs. Schobel, Kendall, Fuisz, Fischer and Dr. Sanghvi may not engage in competitive activities in the area of film based drug delivery systems during the terms of their respective employment agreements and for terms ranging from 12 to 24 months post-employment.

        Each of Messrs. Schobel, Kendall, Fuisz and Fischer and Dr. Sanghvi may not solicit any of our employees or customers for terms ranging from 12 to 24 months post-employment.

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Outstanding Equity Awards at December 31, 2006

        The following table provides information about the number of outstanding equity awards held by our named executive officers at December 31, 2006.

 
  Performance Unit Awards
Name

  Stock Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Awards (#)(1)
  Base Value
per Unit($)(2)

  As Converted into
SARS(3)(#)

  Base
Value per resulting
SAR(3)($)

  Expiration Date(4)
A. Mark Schobel   2,159,910   0.127   151,544   1.81   11/17/2015
    1,468,235   0.251   103,015   3.58   2/13/2016
    91,175   0.251   6,397   3.58   3/22/2016
    114,755   0.557   8,051   7.93   6/16/2016
    2,453,872   0.636   172,169   9.07   9/21/2016

Keith Kendall

 

4,715,961

 

0.557

 

330,882

 

7.93

 

6/16/2016

Joseph Fuisz

 

2,434,851

 

0.080

 

170,835

 

1.13

 

1/22/2014
    129,533   0.114   9,088   1.62   4/13/2015
    473,168   0.114   33,199   1.62   7/31/2015
    1,166,572   0.251   81,849   3.58   3/22/2016
    130,003   0.557   9,121   7.93   6/16/2016
    2,739,816   0.636   192,232   9.07   9/21/2016

Dr. Pradeep Sanghvi

 

364,858

 

0.088

 

25,599

 

1.25

 

2/23/2014
    268,653   0.114   18,849   1.62   4/13/2015
    300,721   0.251   21,099   3.58   3/22/2016
    28,925   0.557   2,029   7.93   6/16/2016
    608,831   0.636   42,717   9.07   9/21/2016

Carl Fischer

 

270,382

 

0.127

 

18,971

 

1.81

 

12/13/2015
    183,923   0.251   12,904   3.58   2/13/2016
    11,004   0.251   772   3.58   3/22/2016
    14,148   0.557   993   7.93   6/16/2016
    306,538   0.636   21,507   9.07   9/21/2016

(1)
Each performance unit represents the right to receive an amount equal to the increase in the fair market value of a unit of membership interest in Monosol Rx LLC between the date the performance unit is granted and the date it is settled. We have the right to redeem vested performance units within 12 months following a termination of the unit holder's employment or other service; however, the holder is not entitled to settlement of his or her vested performance units unless and until there is a change in control.
 
  Vesting
Percentage

  Cumulative
Vested
Percentage

 
After Year 1   25 % 25 %
After Year 2   25 % 50 %
After Year 3   50 % 100 %

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(2)
The base value per unit is equal to the estimated fair market value of a unit of membership interest in Monosol Rx LLC on the date the performance units are deemed granted.

(3)
Upon the merger of Monosol Rx LLC into MonoSol Rx, Inc., all outstanding performance units will convert into economically equivalent stock appreciation rights at the same conversion ratio (14.253:1) used to convert membership interests in Monosol Rx LLC into shares of MonoSol Rx, Inc.

(4)
Performance units do not expire; they continue until the time of termination or other triggering event. However, upon conversion of the performance units into SARs as part of our reorganization as a corporation, the units/SARs will expire on the tenth anniversary of the original grant date.

Director Compensation

        None of the members of our predecessor Monosol Rx LLC board of directors received any compensation from us during 2006 or any preceding periods.

        Upon the closing of this offering, we intend to provide stock options in addition to the current cash compensation to non-employee members of our board of directors for serving on our board of directors. We pay each of our non-employee directors $25,000 per year for serving on our board of directors. In addition to compensation for board services, we pay the members of our committees $10,000 per year to each member of our audit committee and $5,000 per year to each member of our compensation committee and governance and nominating committee. In addition to any payments for being a member of the various committees of our board of directors, we also pay the chair of the audit committee $10,000 and the chairs of each of the compensation committee and the governance and nominating committee $5,000. We also pay each member of the board of directors $1,500 per meeting of the board of directors. Members of our board of directors are reimbursed for some expenses in connection with attendance of board and committee meetings.

        In August 2007, the board of directors of MonoSol Rx, Inc. adopted and its sole stockholder approved a new stock incentive plan that will be effective upon the completion of an initial public offering. Upon the completion of this offering, each of our directors will receive an option to acquire 15,000 shares of our common stock. These options will vest quarterly over three years. On the date a new director is first elected or appointed to the board of directors, we intend that he or she will automatically be granted an option to acquire 15,000 shares of our common stock on the date of the grant. In addition, upon election of directors each year, we intend that each director will receive an automatic grant of options to acquire 5,000 shares of common stock on a fully diluted basis on the date of the grant. We expect that these options will also vest quarterly over three years.

Termination of Employment and Change-in-Control Arrangements

        The types of arrangements that would trigger payments to our named executive officers upon a change in control of the company include employment agreements, our stock incentive plan and our performance unit plans. We have established these arrangements because we believe providing executive officers compensation and benefits arrangements upon a change in control is necessary in order for us to be competitive with compensation packages of other similarly-situated companies and assists us in recruiting and retaining talented executives.

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    Employment Agreements

        Please see the narrative discussion following the grants of plan-based awards table for additional information on the employment agreements.

        A. Mark Schobel.    Pursuant to the terms of Mr. Schobel's employment agreement, if Mr. Schobel's employment is terminated due to his disability or death, Mr. Schobel will be entitled to receive:

        If we terminate Mr. Schobel's employment for "cause" (as defined in his employment agreement), Mr. Schobel will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans. Likewise, if Mr. Schobel voluntarily resigns, he will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans (with the exception of any bonus and/or incentive compensation).

        If we terminate Mr. Schobel's employment without "cause" or Mr. Schobel terminates such employment for "good reason," Mr. Schobel will be entitled to receive:

        In addition to the foregoing benefits, if Mr. Schobel terminates his employment for "good reason":

        If at any time during the initial two year period of Mr. Schobel's employment agreement, we are unable to fulfill our obligations as set forth therein, the managing general partner is required to guarantee payment of Mr. Schobel's base salary for a period of one year, payable in 12 equal monthly installments, less applicable deductions and withholdings.

        Pursuant to the terms of Mr. Schobel's new executive employment agreement that will become effective upon the completion of our initial public offering, if Mr. Schobel's employment is terminated due to his disability or death, Mr. Schobel will be entitled to receive:

95


        If we terminate Mr. Schobel's employment for "cause" (as defined in his new employment agreement), Mr. Schobel will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans. If Mr. Schobel voluntarily resigns, he will be entitled to receive his unpaid but earned base salary through the date of termination, any unpaid bonus earned for the year preceding the year in which employment terminates and any benefits to which he is entitled under any of our plans.

        If we terminate Mr. Schobel's employment without "cause" or if Mr. Schobel terminates his employment for "good reason" unrelated to a change in control, Mr. Schobel will be entitled to receive:

        In addition, if Mr. Schobel continues to comply with his non-compete, confidentiality and other obligations set forth in the new employment agreement and if he provides us with a general release, upon our termination of his employment without "cause" or his termination for "good reason" unrelated to a change in control, he will be entitled to receive:

        In the event that, during the period beginning 180 days before the effective date of a change in control (as defined in the new employment agreement) and ending 24 months following the effective date of a change in control, Mr. Schobel's employment is terminated by us without cause or by Mr. Schobel for good reason, Mr. Schobel will be entitled to the payments and benefits described above except (1) in lieu of the severance payments, Mr. Schobel will be entitled to receive an immediate cash payment of an amount equal to 3.0 times the sum of his base salary and target bonus (in each case determined without regard to any reduction prior to termination); and (2) the continuation period for continuing coverage under our group health and life insurance plans will be three years from the date of termination. The payments and benefits described in the preceding sentence will be conditioned upon Mr. Schobel's continuing compliance with his non-compete, confidentiality and other obligations set forth in the new employment agreement and upon his execution and delivery of a general release.

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        Keith Kendall.    Pursuant to the terms of Mr. Kendall's employment agreement, if Mr. Kendall's employment is terminated due to his disability or death, Mr. Kendall will be entitled to receive:

        If we terminate Mr. Kendall's employment for "cause" (as defined in his employment agreement), Mr. Kendall will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans. Likewise, if Mr. Kendall voluntarily resigns, he will be entitled to receive his unpaid but earned base salary through the date of termination, any benefits to which he is entitled under any of our plans (with the exception of any bonus and/or incentive compensation) and a pro rata bonus in cash calculated based upon Mr. Kendall's bonus amount from the previous year.

        If we terminate Mr. Kendall's employment without "cause" or Mr. Kendall terminates such employment for "good reason," Mr. Kendall will be entitled to receive:

        Regardless of the reason for Mr. Kendall's termination, within five days of his last day of employment with us, he shall receive a lump sum amount equal to the unvested portion of his 401(k) account.

        The severance terms of Mr. Kendall's new executive employment agreement that will become effective upon the completion of our initial public offering are the same as those contained in Mr. Schobel's agreement, with the exception of those provisions pertaining to a termination of employment in connection with a change in control.

        In the event that, during the period beginning 180 days before the effective date of a change in control (as defined in the new employment agreement) and ending 24 months following the effective date of a change in control, Mr. Kendall's employment is terminated by us without cause or by Mr. Kendall for good reason, Mr. Kendall will be entitled to the payments and benefits described above except (1) in lieu of the severance payments, Mr. Kendall will be entitled to receive an immediate cash payment of an amount equal to 2.75 times the sum of his base salary and target bonus (in each case determined without regard to any reduction prior to termination); and (2) the continuation period for continuing coverage under our group health and life insurance plans will be 33 months from the date of termination. The payments and benefits described in the preceding sentence will be conditioned upon Mr. Kendall's continuing compliance with his non-compete, confidentiality and other obligations set forth in the new employment agreement and upon his execution and delivery of a general release.

        Joseph Fuisz.    Pursuant to the terms of the employment agreement that was in effect on December 29, 2006, if Mr. Fuisz's employment is terminated due to his disability or death, Mr. Fuisz will be entitled to receive:

97


        If we terminate Mr. Fuisz's employment for "cause" (as defined in his employment agreement), Mr. Fuisz will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans. Likewise, if Mr. Fuisz voluntarily resigns, he will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans (with the exception of any bonus and/or incentive compensation).

        If we terminate Mr. Fuisz's employment without "cause" or Mr. Fuisz terminates such employment for "good reason," Mr. Fuisz will be entitled to receive:

        Pursuant to the terms of Mr. Fuisz's amended and restated employment agreement, which became effective on May 12, 2007, if Mr. Fuisz's employment is terminated due to his disability or death, Mr. Fuisz will be entitled to receive:

        If we terminate Mr. Fuisz's employment for "cause" (as defined in his amended and restated employment agreement), Mr. Fuisz will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans. Likewise, if Mr. Fuisz voluntarily resigns, he will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans (with the exception of any bonus and/or incentive compensation).

        If we terminate Mr. Fuisz's employment without "cause" or Mr. Fuisz terminates such employment for "good reason," Mr. Fuisz will be entitled to receive:

        In addition to the foregoing benefits, if Mr. Fuisz's amended and restated employment agreement is terminated for a reason other than his voluntary resignation or his termination for "cause" (as defined in his amended and restated employment agreement), then the vesting schedule of his remaining units will not be affected and will bridge any such break in service. We have entered into a letter agreement with Mr. Fuisz which provides for similar continued vesting in the event his employment with, or his engagement as a consultant by us is terminated for a reason other than his voluntary resignation or his termination for "cause" (as defined in his performance unit plan).

        Upon the automatic termination of Mr. Fuisz's amended and restated employment agreement on December 31, 2007, we will enter into a one-year consulting agreement with Mr. Fuisz.

        Further, if Mr. Fuisz resigns voluntarily or is terminated for "cause," Mr. Fuisz will lose all rights to and interests in the consulting agreement that is to become effective following the term of the amended and restated employment agreement.

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        Dr. Pradeep Sanghvi.    Pursuant to the terms of his employment agreement, if Dr. Sanghvi's employment is terminated due to his disability or death, Dr. Sanghvi will be entitled to receive:

        If we terminate Dr. Sanghvi's employment for "cause" (as defined in his employment agreement), Dr. Sanghvi will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans (with the exception of any bonus and/or incentive compensation). Likewise, if Dr. Sanghvi voluntarily resigns, he will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans (with the exception of any bonus and/or incentive compensation).

        If we terminate Dr. Sanghvi's employment without "cause," Dr. Sanghvi will be entitled to receive:

        Carl Fischer.    Pursuant to the terms of Mr. Fischer's employment agreement that was in effect on December 29, 2006, if we terminated Mr. Fischer's employment due to his disability or death, Mr. Fischer was entitled to receive:

        If we terminated Mr. Fischer's employment for "cause" (as defined in his employment agreement), Mr. Fischer will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he is entitled under any of our plans. Likewise, if Mr. Fischer voluntarily resigns, he will be entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he was entitled under any of our plans (with the exception of any bonus and/or incentive compensation).

        If we terminated Mr. Fischer's employment without "cause" (as defined in the employment agreement) or Mr. Fischer terminates such employment for "good reason," Mr. Fischer was entitled to receive:

99


        Under his employment agreement that was in effect for January 1, 2007 to June 29, 2007, if Mr. Fischer's employment was terminated due to his disability or death, Mr. Fischer was entitled to receive:

        If we terminated Mr. Fischer's employment for "cause" (as defined in his employment agreement), Mr. Fischer was entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he was entitled under any of our plans. Likewise, if Mr. Fischer voluntarily resigned, he was entitled to receive his unpaid but earned base salary through the date of termination and any benefits to which he was entitled under any of our plans.

        If we terminated Mr. Fischer's employment without "cause," Mr. Fischer was entitled to receive:

        Upon the expiration of Mr. Fischer's employment agreement with us, he became an at-will employee and under the terms of Mr. Fischer's separation agreement, Mr. Fischer's employment with us terminated on July 31, 2007. Under the separation agreement, Mr. Fischer received:

        The credited service is for the sole and exclusive purpose of vesting of the existing performance units. The credited service shall have no effect on any terms or conditions of Mr. Fischer's employment, nor does it create any right to additional grants of performance units or grants of stock in the event of our initial public offering. The credited service accelerated the vesting of Mr. Fischer's existing performance units, effective as of July 31, 2007, as shown below:

Date issued

  Number of performance units
  As converted
into SARS

  Percent vested
as of 6/29/07

  Percent vested
as of 12/31/07

 
12/31/05   270,382   18,971   25 % 50 %
2/13/06   183,923   12,904   25 % 25 %
3/22/06   11,004   772   25 % 25 %
6/16/06   14,148   993   25 % 25 %
9/21/06   306,538   21,507   0 % 25 %

        In addition to the benefits described above, Mr. Fischer received a pro rata bonus of 15% of his base salary ($20,250), payable in a lump sum. In consideration of these separation benefits, Mr. Fischer

100



agreed to release us from any and all claims or causes of action against us, including all claims that may arise out of or relate to his employment with us. Mr. Fischer has also agreed to a non-disparagement provision, whereby he agrees not to make any derogatory statements about us, our directors, officers, employees or agents. The non-compete, non-solicitation and confidentiality provisions set forth in Mr. Fischer's employment agreement remain in effect. See the narrative discussion following the Summary Compensation Table.

    Performance Unit Plans

        Within the context of the performance unit plans in effect as of December 29, 2006, a change in control is generally defined as an event or series of events (such as a merger, acquisition or reorganization) that result in our beneficial owners immediately preceding the change in control owning less than 20% of the company following the change in control event or an initial public offering as contemplated herein.

        Upon a change in control each participant's unvested units immediately vest and we are obligated to make a payment, either in cash or in the same consideration received by us upon the change in control.

        Each participant's distribution under the plans would be based upon the difference between the fair market value of a unit of membership interest in Monosol Rx LLC on the date the performance unit was deemed granted, and the fair market value of a unit of membership interest in Monosol Rx LLC at the time of a change in control.

        Under our amended and restated performance unit appreciation plan, which will be effective upon the completion of the merger of Monosol Rx LLC and MonoSol Rx, Inc., upon a change in control (as defined in the plan), unless the SARs are converted into equivalent stock appreciation rights or stock options with respect to stock of the acquiring or successor company, we will cause all then outstanding SARs to be redeemed immediately before the change in control based upon the difference between the transaction value and the base value of the underlying shares at the time of the change in control.

    2007 Stock Incentive Plan

        In August 2007, the board of directors of MonoSol Rx, Inc. adopted and its sole stockholder approved a new stock incentive plan that will be effective upon the completion of our initial public offering. In order to protect the rights of participants, we expect that our stock incentive plan will provide that, in the event of a change in control, as defined in the plan, outstanding awards made under the plan will either (1) be converted into equivalent awards with respect to shares of stock of the acquiring or successor company, or (2) be fully vested and settled in cash or shares. In general, we expect that if an award is converted into an equivalent award, the award will continue to be subject to the vesting and other terms and conditions applicable to the original award; however, vesting may accelerate in the event of an involuntary termination of employment within two years after the date of the change in control. Our board of directors will be responsible for determining the disposition of awards in the event of a change in control. No awards have been made under the plan at this time; however, Messrs. Schobel and Kendall will receive SARs and restricted stock, and Mr. Kranking and our non-employee directors will receive stock options, at the time of the initial public offering. See "Compensation Discussion and Analysis" and the narrative discussion following the Grants of Plan-Based Awards table.

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Potential Payments Upon Termination Without a Change in Control

        The following table provides quantitative disclosure of the estimated payments and benefits that would be provided to our named executive officers assuming that each named executive officer's employment with us was terminated on December 29, 2006, the last business day of our fiscal 2006, and was not in connection with an event that constituted a "Change in Control" under any agreement or plan described above. We have also assumed that the base salary earned by each named executive officer for his services to us through December 29, 2006 was fully paid.

Name

  Cash Severance Payment($)
  Cash
Payment for
Performance Units($)

  Other Benefits
Under Any of Our
Plans (present value)($)

  Total Termination Benefits($)
A. Mark Schobel(4)                        
Termination by us due to Mr. Schobel's disability or death   $ 0   $ 366,400 (1)(2) $ 0   $ 366,400
Termination by us for "cause"     0     0     0     0
Mr. Schobel's voluntary resignation     0     0     0     0
Termination by us without "cause" or by Mr. Schobel for "good reason"     656,250     366,400 (1)(2)   21,600     1,044,250

Keith Kendall(4)

 

 

 

 

 

 

 

 

 

 

 

 
Termination by us due to Mr. Kendall's disability or death     25,000     62,500 (1)   0 (3)   87,500
Termination by us for "cause"     0     0     0 (3)   0
Mr. Kendall's voluntary resignation     0     0     0 (3)   0
Termination by us without "cause" or by Mr. Kendall for "good reason"     798,958     62,500 (1)   0 (3)   861,458

Joseph Fuisz(4)

 

 

 

 

 

 

 

 

 

 

 

 
Termination by us due to Mr. Fuisz's disability or death     21,500     1,434,021 (1)   0     1,455,521
Termination by us for "cause"     0     0     0     0
Mr. Fuisz's voluntary resignation     0     0     0     0
Termination by us without "cause" or by Mr. Fuisz for "good reason"     560,000     1,434,021 (1)   0     1,994,021

Dr. Pradeep Sanghvi

 

 

 

 

 

 

 

 

 

 

 

 
Termination by us due to Dr. Sanghvi's disability or death     24,308     135,189 (1)   0     159,497
Termination by us for "cause"     0     0     0     0
Dr. Sanghvi's voluntary resignation     0     0     0     0
Termination by us without "cause"     723,333     0     0     723,333

Carl Fischer(4)

 

 

 

 

 

 

 

 

 

 

 

 
Termination by us due to Mr. Fischer's disability or death     2,692     34,400 (1)   0     37,092
Termination by us for "cause"     0     0     0     0
Mr. Fischer's voluntary resignation     0     0     0     0
Termination by us without "cause" or for "good reason"   $ 0   $ 34,400 (1) $ 21,600   $ 56,000

(1)
Under the terms of our performance unit plan, our advisory board may, in its sole discretion, elect to provide a participant in the plan with a cash payment for each vested performance unit in an amount equal to the difference between the fair market value of a unit of membership interest in Monosol Rx LLC on the date the performance unit was deemed granted and the fair market value

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(2)
If we elect not to exercise our discretion with respect to a cash payment, Mr. Schobel's employment agreement provides for the pro rata vesting of Mr. Schobel's performance units up to the date of termination, and at his option, not subject to repurchase. This consists of the vesting of 719,970 performance units granted at a base value per unit of $0.127.

(3)
Mr. Kendall is entitled to an amount equal to the unvested portion of his 401(k) account, which as of December 29, 2006 was $0.

(4)
Amounts are determined in accordance with the respective employment agreements that were in effect as of December 29, 2006 for Messrs. Schobel, Kendall, Fuisz and Fischer. Please refer to the description of these individuals' employment agreements set forth under "—Employment Agreements" above.


Potential Payments Upon a Change in Control Without Termination

        The following table provides quantitative disclosure of the estimated payments and benefits that would be provided to our named executive officers assuming an event which constituted a "change in control" under any agreement or plan described above on December 29, 2006, the last business day of our fiscal year 2006, in connection with which none of the named executive officers' employment with us was terminated.

        Upon a change in control, all performance units held by each of our named executive officers will automatically vest. The vested performance units may be redeemed for cash or in the form of the same. The value of the performance units is calculated based on the difference between the fair market value of a unit of membership interest in Monosol Rx LLC on the date the performance unit was deemed granted and the fair market value of a unit of membership interest in Monosol Rx LLC at the time of a change in control.

        We have assumed our fair market value to be $100,000,000 (or $0.636 per membership interest) as of December 29, 2006, which is based upon the most recent valuation by our board of advisors as of September 18, 2006, in anticipation of our private placement of preferred members interests. It is possible that our value could have been higher or lower at December 29, 2006, if appraised independently at that time. In accordance with the foregoing assumptions, the following table provides the potential realizable value of the performance units held by our named executive officers.

Name

  Potential Realizable Value($)
A. Mark Schobel   $ 1,708,749
Keith Kendall   $ 375,000
Joseph Fuisz   $ 2,129,730
Dr. Pradeep Sanghvi   $ 458,656
Carl Fischer   $ 87,845

Limitations On Liability And Indemnification Of Directors And Officers

        We have adopted provisions in our certificate of incorporation that limit or eliminate the personal liability of its directors to the maximum extent permitted by the Delaware General Corporation Law, or

103



DGCL. The DGCL expressly permits a corporation to provide that its directors will not be liable for monetary damages for a breach of their fiduciary duties as directors, except for liability:

        These limitations of liability do not generally affect the availability of equitable remedies such as injunctive relief or rescission. Our certificate of incorporation and bylaws also authorize us to indemnify our officers, directors, employees and other agents to the fullest extent permitted under the DGCL and we may advance expenses to our directors, officers, employees and other agents in connection with a legal proceeding, subject to limited exceptions. In addition, we maintain directors' and officers' liability insurance for our officers and directors.

        As permitted by the DGCL, our certificate of incorporation and bylaws provide that:

        In March 2007, we entered into separate indemnification agreements with each of our directors. Prior to the completion of this offering, we will enter into separate indemnification agreements with each of our board members and certain of our officers that will require us to indemnify them to the fullest extent permitted by the DGCL. These indemnification agreements will also require us to advance any expenses incurred by the board members and certain officers as a result of any proceeding against them as to which they could be indemnified.

        The limited liability and indemnification provisions in our certificate of incorporation and bylaws and in any indemnification agreements we enter into may discourage stockholders from bringing a lawsuit against our board members for breach of their fiduciary duties and may reduce the likelihood of derivative litigation against our board members and officers, even though a derivative action, if successful, may otherwise benefit us and our stockholders. A stockholder's investment in us may be adversely affected to the extent we pay the costs of settlement or damage awards against our directors and officers under these indemnification provisions.

        At present, there is no pending litigation or proceeding involving any of our directors, officers, employees or agents in which indemnification by us is sought, nor are we aware of any threatened litigation or proceeding that may result in a claim for indemnification.

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PRINCIPAL STOCKHOLDERS

        The following table sets forth information regarding the beneficial ownership of the common stock of MonoSol Rx, Inc. before and after the completion of this offering (on a pro forma basis, after giving effect to the conversion of the membership interest for common stock as described under "Corporate Formation Transactions") and shows the number and percentage owned by:

        Beneficial ownership and percentage ownership are determined in accordance with the rules of the SEC. This information does not necessarily indicate beneficial ownership for any other purpose. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of common stock underlying options or warrants held by that person that are currently exercisable or will become exercisable within 60 days are deemed outstanding and are included in the number of shares beneficially owned, while the shares are not deemed outstanding for purposes of computing percentage ownership of any other person. There are currently no options or warrants outstanding. To our knowledge, except as indicated in the footnotes to this table and subject to community property laws where applicable, the persons named in the table have sole voting and investment power with respect to all shares of our common stock shown as beneficially owned by them.

        The address for those individuals for which an address is not otherwise indicated is: c/o MonoSol Rx, Inc., 30 Technology Drive, Warren, New Jersey 07059.

 
  Shares Beneficially Owned
 
 
  Prior to the Offering
  After the Offering
 
 
  Number
  %
  Number
  %
 
Director and executive officers:                  
  A. Mark Schobel              
  Keith J. Kendall              
  Dr. Pradeep Sanghvi              
  Carl Fischer              
  Joseph Fuisz              
  Douglas Bratton              
  Dr. Gregory Brown              
  John Cochran              
  Robert Flanagan              
  Frank Tanki              
All directors and executive officers as a group       %     %

Five percent stockholders:

 

 

 

 

 

 

 

 

 
  MRX Partners, LLC(1)     20.5 %     15.0 %
  MonoLine RX, L.P.(1)     20.1 %     14.8 %
  MonoLine RX II, L.P.(1)     36.6 %     26.9 %
  Halifax Monosol Investors, L.P.(2)     15.7 %     11.5 %

*
Represents beneficial ownership of less than 1%.

(1)
Sole voting and dispositive power is held by Douglas Bratton, the President of Bratton Capital Management L.P.

(2)
Sole voting and dispositive power is held by David Dupree, the Managing Director and Chief Executive Officer of The Halifax Group.

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

Corporate Transaction

        In accordance with the agreement and plan of merger, after the merger our equity will continue to be owned by the same entities in the same proportions as before the merger. After completion of this offering, our existing equity owners, which include the direct and indirect holders of membership interests in Monosol Rx LLC, will own 11,029,412 shares of our common stock representing approximately 73.4% of the voting power of our outstanding capital stock. See "Principal Stockholders" for more information regarding the ownership of our common stock.

Unsecured Note—Dr. Richard Fuisz

        In conjunction with Monosol Rx LLC's formation in January 2004 we assumed an unsecured note payable to Dr. Richard Fuisz with a principal amount of approximately $904,000. At December 31, 2006 the note was repaid and $347,650 was outstanding at December 31, 2005. Interest expense on the note was $21,890, $38,386 and $41,324 for the years ended December 31, 2006, 2005 and 2004, respectively.

Monosol, LLC Asset Purchase

        In December 2006, we sold an asset consisting of a small film casting machine to Monosol, LLC for $200,000. The asset was part of the original capital contribution to Monosol Rx LLC by Monosol, LLC made in 2004 at the time the company was formed. The machine was found to be unsuitable for pharmaceutical applications and as such not used in our operations. Prior to the transaction, in order to determine an appropriate sales price we obtained independent estimates from dealers in the secondary market. The sales price was in excess of the estimates obtained. In addition, during 2006 we received $54,000 in rent from Monosol, LLC for use of the asset.

Melton Road Lease Amendment and Guarantee

        In September 2006, Monosol Rx LLC, with the landlord's agreement and acceptance, assigned to us all rights and obligations of the existing lease. As part of the agreement Monosol, LLC agreed to guarantee lease payments in an aggregate amount of $218,423 through March 2008. In January 2007, the landlord released Monosol, LLC from its guarantee in consideration for us providing a security deposit in the amount of three months rent and amending the date we need to provide notice to the landlord that we do not intend to renew our lease from six months to nine months prior to the end of the current lease term.

Monosol, LLC Cost Allocation

        The statements of operations include certain shared costs allocated to us by Monosol, LLC. Charges for rent, insurance, employee fringe benefits, and other overhead costs are based on the ratio of payroll expense of our employees to aggregate payroll expense for Monosol, LLC employees. In the opinion of management, the costs charged have been allocated on a basis that is believed to be reasonable within the structure of Monosol, LLC. However, the costs charged are not necessarily indicative of the level of expenses that may have been incurred if we and the Predecessor had operated as a stand alone entity. The total amount of costs allocated to us was $250,000, $696,000 and $727,000 for 2006, 2005 and 2004, respectively. As of October 2006 the cost allocation arrangement with Monosol, LLC was terminated.

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Consulting Agreements

        In conjunction with our purchase of all of the assets of Kosmos, Dr. Richard Fuisz and his son, Mr. Joseph Fuisz, significant shareholders in Kosmos, entered into consulting agreements with the Company. These consulting agreements were each for a three year term and provided for a monthly and annual fee of $13,333 and $160,000, respectively, plus the reimbursement of certain expenses. Including reimbursed fees, we paid Dr. Fuisz $163,301, $179,806 and $148,925 for 2006, 2005, and 2004 respectively, and Joseph Fuisz $224,117, $281,010 and $197,319 for 2006, 2005, and 2004, respectively, under the agreements. The consulting agreement between us and Joseph Fuisz, was terminated in September 2006, when Mr. Fuisz entered into an employment agreement with us. This employment agreement was amended and restated in May 2007, and will automatically terminate on December 31, 2007. At this time, we will enter into a new one-year consulting agreement with Joseph Fuisz, the terms of which are set forth in an exhibit to his amended and restated employment agreement.

        In September 2006, the consulting agreement between us and Dr. Fuisz was extended through September 2009 with substantially the same terms. We have agreed to provide Dr. Fuisz with a one-time fee of $100,000 under his consulting agreement within 15 days after the date that the registration statement becomes effective. We will have no obligation to pay this fee in the event that the registration statement becomes effective after December 31, 2007.

        We agreed to transfer the assets and properties relating to certain technology and intellectual property unrelated to thin film to a new Delaware limited liability company, 55% of the interests of which will be owned by Dr. Fuisz and 45% of the interests of which will be owned by our members as of the date of such transfer. We have also agreed to release Dr. Fuisz from all claims that we may have now or in the future against him, with the exception of claims arising under certain agreements between us and Dr. Fuisz or his affiliates. We have also agreed to indemnify Dr. Fuisz to the same extent we have agreed to indemnify our officers and directors.

        We were a guarantor through May 2007 of a lease for office space in Washington, D.C. that is used by Dr. Fuisz and Joseph Fuisz. We made payments to Dr. Fuisz in connection with the lease of $28,386, $29,893 and $41,133 for 2006, 2005 and 2004 respectively. We have agreed to extend this lease on a month to month basis.

Revolving Credit Facility

        We have received a letter of commitment from MonoLine RX, L.P., MonoLine RX II, L.P., their respective affiliates, and Halifax Monosol Investors, L.P., whose beneficial ownership of us is described under "Principal Stockholders". Two of our directors, Douglas Bratton and John Cochran are control persons with respect to MonoLine RX, L.P. and MonoLine RX II, L.P. The commitment is to fund a $10,000,000 revolving credit facility, subject to standard conditions, including the completion of definitive documentation. For a description of this facility, see "Management's Discussion and Analysis—Liquidity and Capital Resources—Sources of Liquidity".

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DESCRIPTION OF CAPITAL STOCK

General

        Upon completion of this offering, the total amount of our authorized capital stock will consist of 100,000,000 shares of common stock, par value $.01 per share, and 20,000,000 shares of preferred stock, par value $.01 per share. As of August 29, 2007, there was one share of common stock outstanding and no shares of preferred stock outstanding. As of August 29, 2007, Monosol Rx LLC was the only record holder of our common stock. In addition, as of August 29, 2007, 1,502,941 shares of our common stock were reserved for grants under our stock incentive plan, and options to purchase a total of zero shares of our common stock were outstanding. As of August 29, 2007, pursuant to our predecessor's performance unit plans there were 32,622,044 units outstanding which will be converted into 2,288,835 stock appreciation rights.

        Immediately after this offering, there will be 15,029,412 shares of our common stock and no shares of preferred stock outstanding.

        The following description of our capital stock does not purport to be complete and is subject to, and is qualified by, our certificate of incorporation and bylaws, which are filed as exhibits to the registration statement of which this prospectus is a part, and by the applicable provisions of Delaware law.

Common Stock

        The holders of our common stock are entitled to one vote for each share held of record on each matter submitted to a vote of stockholders, including the election of directors, and do not have any right to cumulative votes in the election of directors.

        Subject to the rights and preferences of the holders of any series of preferred stock which may at the time be outstanding, holders of our common stock are entitled to such dividends as our board of directors may declare from time to time out of legally available funds. Dividends on the common stock are not cumulative.

        In the event of any liquidation, dissolution or winding-up of our affairs, after payment of all of its debts and liabilities, and subject to the rights and preferences of the holders of any outstanding shares of any series of its preferred stock, the holders of our common stock will be entitled to receive their pro rata distribution of any of our remaining assets.

        Holders of our common stock have no conversion, preemptive or other subscription rights and there are no redemption rights or sinking fund provisions with respect to the common stock. The shares of our common stock to be sold in this offering when issued and paid for will be validly issued, fully paid and non-assessable.

Preferred Stock

        We are authorized to issue up to 20,000,000 shares of preferred stock. Our certificate of incorporation authorizes our board, from time to time, without any further stockholder action or approval: to issue these shares in one or more classes or series; to establish from time to time the

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number of shares to be included in each class or series; and to fix the designation, powers, preferences, and rights of the shares of each wholly unissued class or series and any of its qualifications, limitations or restrictions. In some circumstances, the issuance of shares of preferred stock may render more difficult or tend to discourage a merger, tender offer or proxy contest, the assumption of control by a holder of a large block of our securities or the removal of incumbent management. Our board may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of our common stock. We currently have no plans to issue any shares of preferred stock.

Certain Provisions of Our Certificate of Incorporation, Bylaws and Delaware Law

        Provisions of our certificate of incorporation, bylaws and Delaware law, which are summarized below, may be deemed to have an anti-takeover effect and may delay, defer or prevent a tender offer or takeover attempt that a stockholder may consider in such stockholder's best interest, including those attempts that may result in a premium over the market price for our common stock. These provisions include restrictions on stockholder's ability to take action by written consents, elimination of the ability of stockholders to call special meetings, advance notice procedures for stockholder proposals and director nominations, and certain Delaware law provisions.

        Our certificate of incorporation provides that our board of directors will consist of one or more directors, the exact number of which will be fixed from time to time by the board. Our board of directors will consist of six directors.

        Our bylaws provide that any newly created directorships on our board, or any other vacancy on the board, may be filled by a majority of the board then in office, even if a quorum is not present, or by a plurality of votes cast at a meeting of the stockholders. Any director elected in accordance with the preceding sentence will hold office for the remainder of the full term of office of the director whom he or she replaced or until such director's successor shall have been elected and qualified.

        Our bylaws deny stockholders the right to call a special meeting of stockholders. Our bylaws provide that a special meeting of stockholders may be called only by our board.

        Our certificate of incorporation and bylaws deny stockholders the ability to act by written consent without a meeting, unless the holders of 662/3% of our issued and outstanding stock act by such a written consent. All other stockholder action must take place at a meeting of stockholders.

        At an annual meeting of stockholders, only business that is properly brought before the meeting will be conducted or considered. To be properly brought before an annual meeting of stockholders, business must be specified in the notice of the meeting (or any supplement to that notice), brought before the meeting by or at the direction of the board (or any duly authorized committee of the board) or properly brought before the meeting by a stockholder. For business to be properly brought before an annual meeting by a stockholder, the stockholder must have given timely written notice of the business in proper written form to our secretary.

        To be timely, a stockholder's notice must be delivered to or mailed and received at our principal executive offices not less than 60 days nor more than 180 days prior to the anniversary date of the last

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annual meeting; provided, however, that in the event that the annual meeting is called for a date that is not within 45 days before or after the anniversary date, notice by the stockholder must be received not later than the close of business on the 10th day following the day on which notice of the date of the annual meeting was mailed or public disclosure of the date of the annual meeting was made, whichever first occurs.

        To be in proper written form, a stockholder's notice to the secretary must set forth as to each matter the stockholder proposes to bring before the annual meeting:

        Similarly, at a special meeting of stockholders, only such business as is properly brought before the meeting will be conducted or considered. To be properly brought before a special meeting, business must be specified in the notice of the meeting (or any supplement to that notice).

        Under our bylaws, only persons who are properly nominated will be eligible for election to be members of our board. To be properly nominated, a director candidate must be nominated at an annual meeting of the stockholders or any special meeting called for the purpose of electing directors by or at the direction of our board (or any duly authorized committee of the board) or properly nominated by a stockholder. To properly nominate a director, a stockholder must:

        To be timely, a stockholder's notice must be delivered to or mailed and received at our executive offices:

        To be in proper written form, a stockholder's notice to the secretary must be accompanied by a written consent of each proposed nominee to being named as a nominee and to serve as a director if elected and must set forth:

the name, age, business address and residence address of the person;

the principal occupation or employment of the person;

the class or series and number of shares of our capital stock that are owned beneficially or of record by the person; and

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any other information relating to the person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for election of directors pursuant to Section 14 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the rules and regulations promulgated thereunder; and

as to the stockholder giving the notice:

the name and record address of such stockholder;

the class or series and number of shares of our capital stock that are owned beneficially or of record by such stockholder;

a description of all arrangements or understandings between such stockholder and each proposed nominee and any other person or persons (including their names) under which the nomination(s) are to be made by such stockholder; and

a representation that the stockholder intends to appear in person or by proxy at the meeting to nominate the persons named in its notice.

        Our certificate of incorporation can only be amended by the approval of a majority of the stockholders. Our bylaws provide that the board of directors or the stockholders have the right to alter, amend or repeal the bylaws. In addition, our certificate of incorporation grants our board of directors the authority to amend and repeal our bylaws without a stockholder vote in any manner not inconsistent with the laws of the State of Delaware or our certificate of incorporation.

        We will be subject to the provisions of Section 203 of the DGCL regulating corporate takeovers. In general, those provisions prohibit a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date that the stockholder became an interested stockholder, unless:

Section 203 defines "business combination" to include the following:

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        In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling, controlled by, or under common control with the entity or person.

Nasdaq Global Market Listing

        We have applied to have our common stock included for quotation on The Nasdaq Global Market under the symbol "MSRX."

Transfer Agent And Registrar

        Upon the closing of this offering, the transfer agent and registrar for our common stock will be The Bank of New York.

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MATERIAL U.S. FEDERAL TAX CONSIDERATIONS
FOR NON-U.S. HOLDERS OF OUR COMMON STOCK

        The following is a general discussion of the material U.S. federal income and estate tax considerations applicable to non-U.S. holders with respect to their ownership and disposition of shares of our common stock. This discussion is for general information only and is not tax advice. Accordingly, all prospective non-U.S. holders of our common stock should consult their own tax advisors with respect to the United States federal, state, local and non-U.S. tax consequences of the acquisition, ownership and disposition of our common stock. For purposes of this discussion, a "non-U.S. holder" means a beneficial owner of our common stock who is not for U.S. federal income tax purposes:

        If a partnership holds our common stock, the tax treatment of its partners generally will depend on the status of the partner and upon the activities of the partnership. Accordingly, partnerships that are prospective investors in our common stock, and partners in such partnerships, should consult their tax advisors.

        This discussion is based on current provisions of the United States Internal Revenue Code of 1986, as amended, existing and proposed United States Treasury Regulations promulgated thereunder, current administrative rulings and judicial decisions, all of which are in effect as of the date of this prospectus and all of which are subject to change or to differing interpretation. Any change, which may or may not be retroactive, could alter the tax consequences to non-U.S. holders described in this prospectus.

        This discussion does not address all aspects of U.S. federal income and estate taxation that may be relevant to a particular non-U.S. holder in light of that non-U.S. holder's circumstances nor does it address any aspects of U.S. state, local or non-U.S. taxes. This discussion does not address the consequences to non-U.S. holders subject to special rules, including, U.S. expatriates; "controlled foreign corporations" or "passive foreign investment companies;" or non-U.S. holders that own more than 5% of our common stock.

        There can be no assurance that the Internal Revenue Service, or IRS, will not challenge one of the tax consequences described herein, and we have not obtained, nor do we intend to obtain, an opinion of counsel with respect to the U.S. federal income or estate tax consequences to a non-U.S. holder of the acquisition, ownership, or disposition of our common stock. We urge prospective investors to consult with their own tax advisors regarding the U.S. federal, estate, state and local, and non-U.S. income and other tax considerations of acquiring, holding and disposing of shares of our common stock.

Distributions with respect to Our Common Stock

        We have not declared or paid distributions on our common stock since our inception and do not intend to pay any distributions on our common stock in the foreseeable future. In the event we do pay

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distributions on our common stock, however, these distributions generally will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earnings and profits, the excess will be treated first as a tax-free return of the non-U.S. holder's investment, up to such holder's tax basis in the common stock and then any remaining excess will be treated as gain from the sale of common stock, subject to the tax treatment described below in "Gain on Sale or Other Disposition of Our Common Stock."

        Dividends paid to a non-U.S. holder generally will be subject to withholding of U.S. federal income tax at a 30% rate or such lower rate as may be provided by an applicable income tax treaty. In order to obtain a reduced rate of withholding, a non-U.S. holder will be required to provide an Internal Revenue Service Form W8-BEN certifying its entitlement to a reduced rate of withholding under a treaty. If we determine, at a time reasonably close to the date of payment of a distribution on our common stock, that the distribution will not qualify as a dividend because we do not anticipate having current or accumulated earnings and profits, we intend not to withhold any U.S. federal income tax on the distribution as permitted by United States Treasury Regulations.

        Dividends paid to a non-U.S. holder that are treated as "effectively connected" with a trade or business conducted by such non-U.S. holder within the United States (and, if an applicable income tax treaty so provides, are also attributable to a permanent establishment of such non-U.S. holder), known as "United States trade or business income," are generally exempt from the 30% withholding tax if the non-U.S. holder provides a properly completed Internal Revenue Service Form W-8ECI and satisfies certain other requirements. However, such United States trade or business income, net of specified deductions and credits, is taxed at the same graduated U.S. federal income tax rates applicable to United States persons. Additionally, United States trade or business income received by a non-U.S. holder that is a corporation may also be subject to an additional "branch profits tax" at a 30% rate or such lower rate specified by an applicable income tax treaty.

        A non-U.S. holder that is eligible for a reduced rate of United States withholding or other withholding exclusion under an income tax treaty may obtain a refund or credit of any excess amounts withheld by timely filing an appropriate claim for refund or credit with the IRS.

Gain on Sale or Other Disposition of Our Common Stock

        In general, a non-U.S. holder will not be subject to any U.S. federal income tax or withholding tax on any gain recognized upon such holder's sale or other disposition of shares of our common stock unless:

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United States Federal Estate Tax

        Shares of our common stock that are owned or treated as owned by an individual non-U.S. holder at the time of such non-U.S. holder's death will be included in such individual's gross estate for U.S. federal estate tax purposes, unless an applicable estate tax or other treaty provides otherwise, and therefore may be subject to U.S. federal estate tax.

Backup Withholding, Information Reporting and Other Reporting Requirements

        We must report to the IRS and to each non-U.S. holder the gross amount of any dividends paid to such holder with respect to our common stock, and the tax withheld, if any, upon the payment of such dividends. In addition, information reporting and backup withholding (at a rate of 28% through 2010, and 31% thereafter) generally will apply to the proceeds of a disposition of our common stock by a non-U.S. holder effected by or through the United States office of a broker unless the holder certifies its status as a non-U.S. holder and satisfies certain other qualifications, or otherwise establishes an exemption. Generally, such information reporting and backup withholding will not apply to a payment of disposition proceeds if the transaction is effected outside the United States through a non-U.S. office of a non-U.S. broker. However, for information reporting purposes, certain brokers with substantial United States ownership or operations are treated in a manner similar to United States brokers. Non-U.S. holders should consult their own tax advisors regarding the application of the information reporting and backup withholding rules to them.

        Copies of information returns may be made available under the provisions of a specific treaty or agreement to the tax authorities of the country in which a non-U.S. holder resides or is incorporated.

        Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules from a payment to a non-U.S. holder can be refunded or credited against the non-U.S. holder's U.S. federal income tax liability, if any, provided that an appropriate claim is timely filed with the IRS.

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SHARES ELIGIBLE FOR FUTURE SALE

        Prior to this offering, there was no public market for our common stock. Future sales of substantial amounts of our common stock in the public market, or the perception that these sales could occur, could adversely affect the price of our common stock.

        Upon completion of this offering, we will have approximately 15,029,412 shares of our common stock outstanding (approximately 15,629,412 shares if the underwriters exercise their overallotment option in full). Of those shares, the 4,000,000 shares of common stock sold in this offering (4,600,000 shares if the underwriters exercise their overallotment option in full) will be freely transferable without restriction, unless purchased by our affiliates. The remaining approximately 11,029,412 shares of common stock to be outstanding immediately following the completion of this offering, which are "restricted securities" under Rule 144 of the Securities Act of 1933, as amended, or Rule 144, as well as any other shares held by our affiliates, may not be resold except pursuant to an effective registration statement or an applicable exemption from registration, including an exemption under Rule 144.

Lock-Up Agreements

        The holders of approximately 11,029,412 shares of outstanding common stock as of the closing of this offering, including all of our officers and directors, have entered into lock-up agreements under which they have generally agreed, subject to certain exceptions, not to offer or sell any shares of common stock or securities convertible into or exchangeable or exercisable for shares of common stock for a period of at least 180 days from the date of this prospectus without the prior written consent of Cowen and Company, LLC. See "Underwriting—No sales of similar securities."

Rule 144

        In general, under Rule 144, an affiliate of ours who beneficially owns shares of our common stock that are not restricted securities, or a person who beneficially owns for more than one year shares of our common stock that are restricted securities, may generally sell, within any three-month period, a number of shares that does not exceed the greater of:

        Sales under Rule 144 are also subject to requirements with respect to manner of sale, notice and the availability of current public information about us. Generally, a person who was not our affiliate at any time during the three months before the sale, and who has beneficially owned shares of our common stock that are restricted securities for at least two years, may sell those shares without regard to the volume limitations, manner of sale provisions, notice requirements or the requirements with respect to availability of current public information about us.

        Rule 144 does not supersede the contractual obligations of our security holders set forth in the lock-up agreements described above.

Rule 701

        Generally, an employee, officer, director or consultant who purchased shares of our common stock before the effective date of the registration statement of which this prospectus is a part, or who holds options as of that date, under a written compensatory plan or contract, may rely on the resale provisions of Rule 701 under the Securities Act of 1933, as amended. Under Rule 701, these persons

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who are not our affiliates may generally sell their eligible securities, commencing 90 days after the effective date of the registration statement of which this prospectus is a part, without having to comply with the public information, holding period, volume limitation or notice provisions of Rule 144. These persons who are our affiliates may generally sell their eligible securities under Rule 701, commencing 90 days after the effective date of the registration statement of which this prospectus is a part, without having to comply with Rule 144's one-year holding period restriction.

        Neither Rule 144 nor Rule 701 supersedes the contractual obligations of our security holders set forth in the lock-up agreements described above.

        The 11,029,412 shares of our common stock that were outstanding prior to this offering will become eligible for sale, pursuant to Rule 144 or Rule 701, as applicable, and subject to the lock-up agreements described above.

2007 Stock Incentive Plan

        We intend to file a registration statement on Form S-8 under the Securities Act to register the shares of common stock available for issuance under our 2007 Stock Incentive Plan. Subject to the lock-up agreements, shares issued under these plans after the effective date of such registration statement will be available for sale in the open market and, for our affiliates, subject to the conditions and restrictions of Rule 144. As of August 29, 2007, no options to purchase shares of our common stock were outstanding under our 2007 Stock Incentive Plan, and 1,502,941 shares of our common stock were available for future grant under the 2007 Stock Incentive Plan.

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UNDERWRITING

        We and the underwriters for the offering named below have entered into an underwriting agreement with respect to the common stock being offered. Subject to the terms and conditions of the underwriting agreement, each underwriter has severally agreed to purchase from us the number of shares of our common stock set forth opposite its name below. Cowen and Company, LLC is the representative of the underwriters.

Underwriters

  Number of Shares
Cowen and Company, LLC    
CIBC World Markets Corp.    
Susquehanna Financial Group, LLLP    
     
     
   

 

 

 
  Total    
   

        The obligations of the underwriters may be terminated upon the occurrence of the events specified in the underwriting agreement. The underwriters have agreed, severally and not jointly, to purchase all of the shares sold under the underwriting agreement if any of these shares are purchased, other than those shares covered by the overallotment option described below. If an underwriter defaults, the underwriting agreement provides that the purchase commitments of the non-defaulting underwriters may be increased or the underwriting agreement may be terminated.

        We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act of 1933, as amended, and to contribute to payments the underwriters may be required to make in respect thereof.

        The underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions specified in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

        Overallotment Option to Purchase Additional Shares.    We have granted to the underwriters an option to purchase up to 600,000 additional shares of common stock at the public offering price, less the underwriting discount. This option is exercisable for a period of 30 days. The underwriters may exercise this option solely for the purpose of covering overallotments, if any, made in connection with the sale of common stock offered hereby. To the extent that the underwriters exercise this option, the underwriters will purchase additional shares from us in approximately the same proportion as shown in the table above.

        Discounts and Commissions.    The following table shows the public offering price, underwriting discount and proceeds, before expenses to us. These amounts are shown assuming both no exercise and full exercise of the underwriters' option to purchase additional shares.

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        We estimate that the total expenses of the offering, excluding underwriting discount, will be approximately $            and are payable by us.

 
   
  Total
 
  Per Share
  Without
Overallotment

  With Overallotment
Public offering price            
Underwriting discount            
Proceeds, before expenses, to us            

        The underwriters propose to offer the shares of common stock to the public at the public offering price set forth on the cover of this prospectus. The underwriters may offer the shares of common stock to securities dealers at the public offering price less a concession not in excess of $             per share. The underwriters may allow, and the dealers may reallow, a discount not in excess of $             per share to other dealers. If all of the shares are not sold at the public offering price, the underwriters may change the offering price and other selling terms.

        Discretionary Accounts.    The underwriters do not intend to confirm sales of the shares to any accounts over which they have discretionary authority.

        Market Information.    Prior to this offering, there has been no public market for shares of our common stock. The initial public offering price will be determined by negotiations between us and the representative of the underwriters. In addition to prevailing market conditions, the factors to be considered in these negotiations will include:

        An active trading market for the shares may not develop. It is also possible that after the offering the shares will not trade in the public market at or above the initial public offering price.

        We have applied for the quotation of our common stock on the Nasdaq Global Market under the symbol "MSRX."

        Stabilization.    In connection with this offering, the underwriters may engage in stabilizing transactions, overallotment transactions, syndicate short covering transactions, penalty bids and purchases to cover positions created by short sales.

119



        These stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of our common stock. As a result, the price of our common stock in the open market may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the price of our common stock. These transactions may be effected on the Nasdaq Global Market, in the over-the-counter market or otherwise and, if commenced, may be discontinued at any time.

        Lock-Up Agreements.    Pursuant to certain "lock-up" agreements, we and our executive officers, directors and certain of our other stockholders, have agreed, subject to certain exceptions, not to offer, sell, contract to sell, announce any intention to sell, pledge or otherwise dispose of, enter into any swap or other agreement that transfers, in whole or in part, the economic consequence of ownership of, directly or indirectly, or file with the SEC a registration statement under the Securities Act relating to, any common stock or securities convertible into or exchangeable or exercisable for any common stock without the prior written consent of Cowen and Company, LLC, for a period of 180 days after the date of the pricing of the offering. The 180-day restricted period will be automatically extended if (i) during the last 17 days of the 180-day restricted period we issue an earnings release or material news or a material event relating to us occurs or (ii) prior to the expiration of the 180-day restricted period, we announce that we will release earnings results or become aware that material news or a material event will occur during the 16-day period beginning on the last day of the 180-day restricted period, in either of which case the restrictions described above will continue to apply until the expiration of the 18-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event.

        This lock-up provision applies to common stock and to securities convertible into or exchangeable or exercisable for or repayable with common stock. It also applies to common stock owned now or acquired later by the person executing the agreement or for which the person executing the agreement later acquires the power of disposition. The exceptions permit us, among other things and subject to restrictions, to: (a) issue common stock or options pursuant to employee benefit plans, or (b) issue common stock upon exercise of outstanding options or warrants. The exceptions permit parties to the "lock up" agreements, among other things and subject to restrictions, to: (a) participate in tenders involving the acquisition of a majority of our stock, (b) participate in transfers or exchanges involving common stock or securities convertible into common stock or (c) make certain gifts. In addition, the

120



lock-up provision will not restrict broker-dealers from engaging in market making and similar activities conducted in the ordinary course of their business.

        Directed Share Program.    At our request, the underwriters have reserved up to 200,000 shares of our common stock for sale, at the initial public offering price, through a directed share program to members of our management, and our employees and directors. There can be no assurance that any of the reserved shares will be so purchased. The number of shares available for sale to the general public in the offering will be reduced to the extent the reserved shares are purchased in the directed share program. Any reserved shares of common stock not purchased through the directed share program will be offered to the general public on the same basis as the other common stock offered hereby.

        Electronic Offer, Sale and Distribution of Shares.    A prospectus in electronic format may be made available on the websites maintained by one or more of the underwriters or selling group members, if any, participating in this offering and one or more of the underwriters participating in this offering may distribute prospectuses electronically. The representatives may agree to allocate a number of shares to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the underwriters and selling group members that will make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or any underwriter in its capacity as underwriter, and should not be relied upon by investors.

        Other Relationships.    Certain of the underwriters and their affiliates have provided, and may in the future provide, various investment banking, commercial banking and other financial services for us and our affiliates for which they have received, and may in the future receive, customary fees.

Selling Restrictions.

        United Kingdom.    Each of the underwriters has represented and agreed that:

        Switzerland.    The securities will not be offered, directly or indirectly, to the public in Switzerland and this prospectus does not constitute a public offering prospectus as that term is understood pursuant to article 652a or 1156 of the Swiss Federal Code of Obligations.

        European Economic Area.    In relation to each Member State of the European Economic Area (Iceland, Norway and Lichtenstein in addition to the member states of the European Union) that has implemented the Prospectus Directive, each, a Relevant Member State, each underwriter has

121



represented and agreed that with effect from and including the date on which the Prospectus Directive is implemented in that Relevant Member State, or the Relevant Implementation Date, it has not made and will not make an offer of the securities to the public in that Relevant Member State prior to the publication of a prospectus in relation to the securities that has been approved by the competent authority in that Relevant Member State or, where appropriate, approved in another Relevant Member State and notified to the competent authority in that Relevant Member State, all in accordance with the Prospectus Directive, except that it may, with effect from and including the Relevant Implementation Date, make an offer of the securities to the public in that Relevant Member State at any time:

        Each person in a Relevant Member State who receives any communication in respect of, or who acquires any securities under, the offer contemplated in this prospectus will be deemed to have represented, warranted and agreed to and with us and each underwriter that:

        For the purposes of the provisions in the two immediately preceding paragraphs, the expression an "offer of the securities to the public" in relation to the securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, as the same may be varied in that Relevant Member State by any measure implementing the Prospectus Directive in that Relevant Member State, and the expression "Prospectus Directive" means Directive 2003/71/EC and includes any relevant implementing measure in each Relevant Member State.

122



LEGAL MATTERS

        The validity of the common stock offered hereby will be passed upon for us by Fulbright & Jaworski L.L.P., Dallas, Texas. Willkie Farr & Gallagher LLP, New York, New York, is counsel for the underwriters in connection with this offering.


EXPERTS

        The financial statements of Monosol Rx LLC for the year ended December 31, 2004, and as of and for the years ended December 31, 2005 and 2006, have been included herein and in the registration statement in reliance upon the report of KPMG LLP, an independent registered public accounting firm, appearing elsewhere in this prospectus, and upon and the authority of said firm as experts in accounting and auditing.


WHERE YOU CAN FIND ADDITIONAL INFORMATION

        We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock we are offering. This prospectus, which constitutes a part of the registration statement, does not contain all of the information in the registration statement and the exhibits which are part of the registration statement. For further information with respect to us and our common stock, we refer you to the registration statement and to the exhibits to the registration statement. Statements contained in this prospectus about the contents of any contract or any other document are not necessarily complete, and, in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference.

        You may read and copy the registration statement of which this prospectus is a part at the SEC's Public Reference Room, which is located at 100 F Street, N.E., Room 1580, Washington, D.C. 20549.

        You can request copies of the registration statement by writing to the SEC and paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for more information about the operation of the SEC's Public Reference Room. In addition, the SEC maintains an Internet website, which is located at www.sec.gov, that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC. You may access the registration statement of which this prospectus is a part at the SEC's Internet website. Upon completion of this offering, we will be subject to the information reporting requirements of the Securities Exchange Act of 1934, and we will file reports, proxy statements and other information with the SEC.

        This prospectus includes statistical data obtained from industry publications. These industry publications generally indicate that the authors of these publications have obtained information from sources believed to be reliable but do not guarantee the accuracy and completeness of their information. While we believe these industry publications to be reliable, we have not independently verified their data.

123



Monosol Rx LLC

INDEX TO FINANCIAL STATEMENTS

 
  Page
Report of Independent Registered Public Accounting Firm   F-2
Financial Statements    
  Balance sheets   F-3
  Statements of operations   F-4
  Statements of changes in members' equity   F-5
  Statements of cash flows   F-6
Notes to financial statements   F-8

F-1



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Members
Monosol Rx LLC:

We have audited the accompanying balance sheets of Monosol Rx LLC as of December 31, 2006 and 2005, and the related statements of operations, changes in members' equity, and cash flows for each of the years in the three-year period ended December 31, 2006. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Monosol Rx LLC as of December 31, 2006 and 2005, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2006, in conformity with U.S. generally accepted accounting principles.

As discussed in Note 1 to the financial statements, effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards (SFAS) No. 151, Inventory Costs—an Amendment of ARB No. 43, Chapter 4.

/s/ KPMG LLP

Chicago, Illinois

May 14, 2007

F-2



Monosol Rx LLC

Balance sheets

 
  December 31,
 
 
  2006
  2005
 
 
  (in thousands)

 
ASSETS              
Current assets:              
  Cash and cash equivalents   $ 15,256   $ 1,332  
  Trade receivables     567     196  
  Other receivables     11     4  
  Due from the Predecessor     200      
  Inventories     455     665  
  Prepaid expenses and other current assets     170     99  
   
 
 
    Total current assets     16,659     2,296  
Property and equipment, net     8,556     7,614  
Other assets     300     496  
Intangible asset, net     1,664     1,900  
   
 
 
    $ 27,179   $ 12,306  
   
 
 

LIABILITIES AND MEMBERS' EQUITY

 

 

 

 

 

 

 
Current liabilities:              
  Current maturities of long-term debt   $   $ 278  
  Accounts payable     1,096     1,239  
  Due to the Predecessor         10  
  Accrued expenses     733     189  
   
 
 
    Total current liabilities     1,829     1,716  
   
 
 

Other liabilities — asset retirement obligations

 

 

87

 

 


 
Long-term debt, less current maturities         5,925  
   
 
 
    Total non-current liabilities     87     5,925  
   
 
 

Members' equity:

 

 

 

 

 

 

 
  Preferred A interests, no par value, 100,000,000 units authorized; 16,886,750 issued and outstanding in 2006 and none in 2005     16,887      
  Preferred A-1 interests, no par value, 100,000,000 units authorized; 21,526,850 issued and outstanding in 2006 and none in 2005     21,883      
  Common interests, no par value, 500,000,000 units authorized; 63,000,000 issued and outstanding in 2006 and 12,500,000 in 2005     11,088     11,304  
  Additional paid in capital         5,204  
  Accumulated deficit     (24,595 )   (11,843 )
   
 
 
    Total members' equity   $ 25,263   $ 4,665  
   
 
 
    $ 27,179   $ 12,306  
   
 
 

See accompanying notes to financial statements.

F-3



Monosol Rx LLC
Statements of operations

 
  Year ended December 31,
 
 
  2006
  2005
  2004
 
 
  (in thousands, except per interest data)

 
Revenues:                    
  Manufacture and supply revenue   $ 1,765   $ 1,458   $ 1,947  
  Co-development and research fees     950     665     100  
   
 
 
 
    Total revenues     2,715     2,123     2,047  

Costs and expenses:

 

 

 

 

 

 

 

 

 

 
  Manufacture and supply     1,623     1,282     1,388  
  General and administrative     11,296     7,372     3,168  
  Research and development     1,993     1,258     1,010  
   
 
 
 
    Total costs and expenses     14,912     9,912     5,566  
   
 
 
 
    Operating loss     (12,197 )   (7,789 )   (3,519 )
Other income, principally related-party     64     41      
Interest income     226     46      
Interest expense     (845 )   (581 )   (41 )
   
 
 
 
    Net loss attributable to membership interest holders   $ (12,752 ) $ (8,283 ) $ (3,560 )
   
 
 
 
    Net loss per membership interest:                    
      Basic and Diluted   $ (0.10 ) $ (0.07 ) $ (0.03 )
   
 
 
 
    Weighted average number of membership interests outstanding:                    
      Basic and Diluted     123,626     118,785     118,785  

See accompanying notes to financial statements.

F-4



Monosol Rx LLC
Statements of changes in members' equity
(in thousands, except for unit data)

 
  Members Contribution Interest
   
   
   
   
 
 
  Preferred A Interests
  Preferred A-1 Interests
  Common Interests
   
   
   
   
 
 
  Additional
Paid
In Capital

  Accumulated
Deficit

  Predecessor
Division
Equity

  Total
Members'
Equity

 
 
  Units
  Amount
  Units
  Amount
  Units
  Amount
 
Balance, December 31, 2003     $     $     $   $       1,862   $ 1,862  
  Formation of MonoSol Rx, LLC and contribution of net assets                       12,500,000     11,304             (1,862 )   9,442  
  Net loss                                         (3,560 )       (3,560 )
   
 
 
 
 
 
 
 
 
 
 
Balance, December 31, 2004               12,500,000     11,304         (3,560 )       7,744  
  Issuance of unit purchase warrants                                   3,024             3,024  
  Capital contribution related to debt modification                                   2,180             2,180  
  Net loss                                         (8,283 )       (8,283 )
   
 
 
 
 
 
 
 
 
 
 
Balance, December 31, 2005               12,500,000     11,304     5,204     (11,843 )       4,665  
  Issuance of unit purchase warrants                                   4,668             4,668  
  Authorization and issuance of additional units                       50,500,000                              
  Issuance of Series A—preferred interest   16,886,750     16,887                                       16,887  
  Conversion of Tranche A&B Note Series A-1—preferred interest             21,526,850     21,883               (9,872 )           12,011  
  Return of capital contribution to Predecessor                             (216 )                 (216 )
  Net loss                                         (12,752 )       (12,752 )
   
 
 
 
 
 
 
 
 
 
 
Balance, December 31, 2006   16,886,750   $ 16,887   21,526,850   $ 21,883   63,000,000   $ 11,088   $   $ (24,595 )     $ 25,263  
   
 
 
 
 
 
 
 
 
 
 

See accompanying notes to financial statements.

F-5



Monosol Rx LLC
Statements of cash flows

 
  Year ended December 31,
 
 
  2006
  2005
  2004
 
 
  (in thousands)

 
Cash flows from operating activities:                    
  Net loss   $ (12,752 ) $ (8,283 ) $ (3,560 )
  Adjustments to reconcile net loss to net cash used in operating activities:                    
    Depreciation and amortization     1,730     479     295  
    Asset retirement obligation accretion     2          
    Amortization of debt discount     248     83      
    Amortization of intangible     236     236     222  
    Non-cash interest expense     575     452      
    Write-down of unapplied vendor credit     296          
    Loss from disposal of assets     226          
    Loss from impairment of assets     132          
    Bad debt expense     16          
    Compensation expense related to the issuance of debt and warrants         25      
    Write-off of accounts receivable         296      
    Changes in operating assets and liabilities:                    
      Trade receivables     (387 )   647     (1,073 )
      Other receivables     (7 )        
      Inventories     210     29     (695 )
      Prepaid expenses     (71 )   (51 )   (47 )
      Accounts payable     (143 )   (306 )   1,200  
      Due to the Predecessor     (10 )   (129 )   232  
      Accrued expenses     544     127     (17 )
      Other assets     (100 )        
   
 
 
 
        Net cash used in operating activities     (9,255 )   (6,395 )   (3,443 )
   
 
 
 
Cash flows from investing activities:                    
  Capital expenditures     (3,378 )   (2,761 )   (1,194 )
  Proceeds from sale of assets     18          
   
 
 
 
        Net cash used in investing activities     (3,360 )   (2,761 )   (1,194 )
   
 
 
 

F-6



Monosol Rx LLC
Statements of cash flows (Continued)

 
  Year ended December 31,
 
 
  2006
  2005
  2004
 
 
  (in thousands)

 
Cash flows from financing activities:                    
  Contributed capital   $ 16,887   $   $ 5,181  
  Principal payments on long-term debt     (348 )   (278 )   (278 )
  Proceeds from debt and warrants issuances     10,000     10,500      
   
 
 
 
        Net cash provided by financing activities     26,539     10,222     4,903  
   
 
 
 
        Net increase in cash and cash equivalents     13,924     1,066     266  
Cash and cash equivalents:                    
  Beginning of year     1,332     266      
   
 
 
 
  Ending of year   $ 15,256   $ 1,332   $ 266  
   
 
 
 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

 

 
  Cash payments for interest   $ 22   $ 38   $ 41  
Supplemental schedule of noncash investing activities:                    
  Formation of Monosol Rx LLC:                    
    Assets acquired and liabilities assumed from Predecessor and Kosmos:                    
      Other assets—future vendor credits to be applied to capital expenditures   $   $   $ 1,196  
      Property and equipment             2,045  
      Intangible assets             2,358  
      Accounts payable             (345 )
      Long-term debt             (904 )
   
 
 
 
    $   $   $ 4,350  
   
 
 
 
 
Other asset—vendor credits applied to capital expenditures

 

$


 

$


 

$

700

 
  Contributed capital related to debt conversion     12,011          
  Contributed capital related to debt modification         2,180      
  Return of capital contribution to Predecessor     216          
  Asset retirement obligation included in property and equipment     85          
  Accounts receivable from the Predecessor related to asset transfer     200          
  Capital contribution—fixed assets from Predecessor             1,688  
  Capital contribution—intercompany payable owed to Predecessor             79  
  Offset of due to Monosol, LLC with amounts due from Predecessor             94  

See accompanying notes to financial statements.

F-7



Monosol Rx LLC

Notes to financial statements

(in thousands, except per share amounts)

(1)   Nature of Business and Significant Accounting Policies

F-8


 
  Balance
Beginning
of Year

  Charged to
Costs and
Expenses

  Acquisitions
  Deductions
  Balance at End
of Year

Allowance for bad debts                    
2004          
2005     381     381  
2006     16       16

F-9



F-10


F-11



F-12


F-13


(2)   Purchase of Assets from Kosmos Pharma Limited

Receivables   $ 1,196
Property and equipment     252
Technology intangible asset     2,358
   
  Total assets acquired     3,806
   
Accounts payable     345
Long-term debt     904
   
  Total liabilities assumed     1,249
   
  Net assets acquired   $ 2,557
   

(3)   Cash and Liquidity

(4)   Major Customers

F-14


(5)   Trade Receivables

 
  2006
  2005
Trade receivable   $ 583   $ 196
  Less allowance for bad debts     16    
   
 
    $ 567   $ 196
   
 

(6)   Inventory

        Inventory consists of the following at December 31, 2006 and 2005:

 
  2006
  2005
Raw material   $ 242   $ 234
Packaging material     213     221
Finished goods         210
   
 
    $ 455   $ 665
   
 

(7)   Property and Equipment

 
  2006
  2005
Machinery and equipment   $ 6,698   $ 4,028
Furniture and fixtures     544     247
Leasehold improvements     3,469     2,016
Construction in process     242     2,098
   
 
      10,953     8,389

Less accumulated depreciation and amortization

 

 

2,397

 

 

775
   
 
    $ 8,556   $ 7,614
   
 

(8)   Other Assets

F-15


(9)   Intangible Asset

 
  2006
  2005
Purchased intangible   $ 2,358   $ 2,358

Less accumulated amortization

 

 

694

 

 

458
   
 
    $ 1,664   $ 1,900
   
 

(10) Long-Term Debt

Unsecured term note due to member   $ 348  
Note Payable Tranche A     5,365  
Note Payable Tranche B     5,587  
Less discounts on notes     (5,097 )
Less current maturities     (278 )
   
 
    $ 5,925  
   
 

F-16


(11) Commitments and Contingent Liabilities

F-17


 
  Amount
Year:      
  2007   $ 588
  2008     536
  2009     539
  2010     532
  2011     556
  Thereafter     128
   
    $ 2,879
   

(12) Employee Benefit Plans

(13) Research and Development Arrangements

F-18


(14) Performance Units Plan

F-19


 
  Units
  Weighted
Average
Grant Date
Fair Value(1)

  Weighted
Average
Per Unit
Base
Value

  Aggregate
Intrinsic Value(2)

Outstanding at December 31, 2005   3,750   $ 15,178   $ 0.10      
Granted   17,637   $ 83,250   $ 0.53      
Exercised                    
Forfeited/cancelled/expired   (172 )   15,565   $ 0.10      
   
                 
Outstanding at December 31, 2006   21,215   $ 56,902   $ 0.36   $ 9,016
   
                 
Vested at December 31, 2006   6,131   $ 19,738   $ 0.13   $ 4,852
   
                 
Exercisable at December 31, 2006                    
 
   
  2005
   
   
  2004
   
 
  2005
  2005
  2004
  2004
 
  Weighted
Average
Grant Date
Fair Value(1)

  Weighted
Average
Grant Date
Fair Value(1)

 
  Units
  Weighted Average Per Unit
Base
Value

  Units
  Weighted Average Per Unit
Base
Value

Outstanding at beginning of year   2,775   $ 12,586   $ 0.08              
Granted   994   $ 18,845   $ 0.12   2,775   $ 12,586   $ 0.08
Exercised                            
Forfeited/cancelled/expired   (19 ) $ 17,857   $ 0.11              
   
             
           
Outstanding at end of year   3,750   $ 15,178   $ 0.10   2,775   $ 12,586   $ 0.08
   
             
           
Exercisable at end of year                            
   
             
           

F-20


 
  Units
  Weighted Average Grant
Date Fair Value

  Weighted Average
Per Unit Base Value

Nonvested at December 31, 2003            
Granted   2,775   $ 12,586   $ 0.08
Vested   (1,250 ) $ 12,500   $ 0.08
Forfeited          
   
           

Nonvested at December 31, 2004

 

1,525

 

$

12,725

 

$

0.08
Granted   994   $ 18,845   $ 0.12
Vested   (69 ) $ 13,750   $ 0.09
Forfeited   (19 ) $ 17,587   $ 0.11
   
           

Nonvested at December 31, 2005

 

2,431

 

$

16,207

 

$

0.10
Granted   17,637   $ 83,250   $ 0.53
Vested   (4,812 ) $ 24,190   $ 0.15
Forfeited   (172 ) $ 15,565   $ 0.10
   
           
Nonvested at December 31, 2006   15,084   $ 72,008   $ 0.46
   
           

(15) Related-Party Transactions

F-21


(16) Asset Retirement Obligations

 
  Amount
Balance at December 31, 2005   $
Liability incurred, September 2006     85
Accretion     2
   
Balance at December 31, 2006   $ 87
   

(17) Preferred Interests

F-22


(18) Subsequent Events

(19) Planned Transactions (unaudited)

F-23



Monosol Rx LLC

Balance Sheets

(in thousands, except unit data)

Assets

  June 30, 2007
  December 31, 2006
 
 
  (Unaudited)

   
 
Current assets:              
  Cash and cash equivalents   $ 7,781   $ 15,256  
  Trade receivables     1,392     567  
  Other receivables     36     11  
  Due from the Predecessor         200  
  Inventories     800     455  
  Prepaid expenses and other current assets     269     170  
   
 
 
    Total current assets     10,278     16,659  

Property and equipment, net

 

 

9,796

 

 

8,556

 
Other assets     1     300  
Deferred offering costs     1,092      
Intangible assets, net     1,546     1,664  
   
 
 
    $ 22,713   $ 27,179  
   
 
 
Liabilities and Members' Equity              

Current liabilities:

 

 

 

 

 

 

 
  Accounts payable   $ 2,364   $ 1,096  
  Accrued expenses     872     733  
  Deferred revenue     867      
   
 
 
    Total current liabilities     4,103     1,829  
   
 
 
Non-current liabilities:              
  Deferred revenue     689      
  Asset retirement obligations     75     87  
   
 
 
    Total non-current liabilities     764     87  
   
 
 
Members' equity:              
  Preferred A interests, no par value, 100,000,000 units authorized; 16,886,750 issued and outstanding, respectively     16,887     16,887  
  Preferred A-1 interests, no par value, 100,000,000 units authorized; 21,526,850 issued and outstanding, respectively     21,883     21,883  
  Common interests, no par value, 500,000,000 units authorized; 118,785,104 and 63,000,000 issued and outstanding at June 30, 2007 and December 31, 2006, respectively     11,243     11,088  
 
Accumulated deficit

 

 

(32,167

)

 

(24,595

)
   
 
 
    Total members' equity     17,846     25,263  
   
 
 
    $ 22,713   $ 27,179  
   
 
 

See accompanying notes to unaudited financial statements.

F-24



Monosol Rx LLC

Statements of Operations

(Unaudited)

(in thousands, except per interest data)

 
  Three months ended June 30,
  Six months ended June 30,
 
 
  2007
  2006
  2007
  2006
 
Revenues:                          
  Manufacture and supply revenue   $ 814   $ 182   $ 1,243   $ 1,145  
  Co-development and research fees     837     160     917     350  
   
 
 
 
 
    Total revenues     1,651     342     2,160     1,495  

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 
  Manufacture and supply     850     223     1,101     867  
  General and administrative     4,112     2,518     7,557     4,441  
  Research and development     680     466     1,365     845  
   
 
 
 
 
    Total costs and expenses     5,642     3,207     10,023     6,153  
     
Operating loss

 

 

(3,991

)

 

(2,865

)

 

(7,863

)

 

(4,658

)
Other income, principally related-party         14         27  
Interest income     121     50     291     53  
Interest expense         (273 )       (461 )
   
 
 
 
 
      Net loss attributable to membership interest holders   $ (3,870 ) $ (3,074 ) $ (7,572 ) $ (5,039 )
   
 
 
 
 
Net loss per membership interest:                          
  Basic and Diluted   $ (0.02 ) $ (0.03 ) $ (0.05 ) $ (0.04 )
Weighted average number of membership interests outstanding:                          
  Basic and Diluted     157,199     118,785     157,199     118,785  

See accompanying notes to unaudited financial statements.

F-25



Monosol Rx LLC

Statements Of Changes In Members' Equity

For The Six Months Ended June 30, 2007

(Unaudited)

(In thousands except unit data)

 
  Members Contribution Interest
   
   
 
 
  Preferred A Interests
  Preferred A-1 Interests
  Common Interests
   
   
 
 
  Accumulated
Deficit

  Total
Members'
Equity

 
 
  Units
  Amount
  Units
  Amount
  Units
  Amount
 
Balance, December 31, 2006   16,886,750   $ 16,887   21,526,850   $ 21,883   63,000,000   $ 11,088   $ (24,595 ) $ 25,263  
   
 
 
 
 
 
 
 
 
Warrants Issued to Common Interests                       55,785,104     155           155  

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,572

)

 

(7,572

)
   
 
 
 
 
 
 
 
 

Balance, June 30, 2007

 

16,886,750

 

$

16,887

 

21,526,850

 

$

21,883

 

118,785,104

 

$

11,243

 

$

(32,167

)

$

17,846

 
   
 
 
 
 
 
 
 
 

See accompanying notes to unaudited financial statements.

F-26



Monosol Rx LLC

Statements of Cash Flows

(Unaudited)

(In thousands)

 
  For the Six months ended June 30,
 
 
  2007
  2006
 
Cash flows from operating activities:              
  Net loss   $ (7,572 ) $ (5,039 )
  Adjustments to reconcile net loss to net cash used in operating activities:              
    Depreciation and amortization     1,228     622  
    Asset retirement obligation accretion     5      
    Amortization of debt discount         131  
    Amortization of intangible     118     118  
    Non-cash interest expense         317  
    Write-down of unapplied vendor credit         296  
    Loss from disposal of assets         95  
    Bad debt expense     43      
    Changes in operating assets and liabilities:              
      Trade receivables     (868 )   (22 )
      Other receivables     (25 )   (7 )
      Inventories     (345 )   (65 )
      Prepaid expenses     (99 )   30  
      Accounts payable     92     175  
      Due to the Predecessor         (10 )
      Accrued expenses     139     144  
      Deferred revenue     1,556      
      Other assets     99      
   
 
 
        Net cash used in operating activities     (5,629 )   (3,215 )
   
 
 
Cash flows from investing activities:              
  Capital expenditures     (1,924 )   (1,971 )
   
 
 
        Net cash used in investing activities     (1,924 )   (1,971 )
   
 
 
Cash flows from financing activities:              
  Proceeds from asset transfer to the Predecessor     200      
  Principal payments on long-term debt         (139 )
  Proceeds from debt and warrant issuances     155     9,500  
  Deferred offering costs     (277 )    
   
 
 
        Net cash provided by financing activities     78     9,361  
   
 
 
        Net (decrease) increase in cash and cash equivalents     (7,475 )   4,175  

Cash and cash equivalents:

 

 

 

 

 

 

 
  Beginning of period     15,256     1,332  
   
 
 
  End of period   $ 7,781   $ 5,507  
   
 
 
Supplemental disclosure of cash flow information:              
  Cash payments for interest   $   $ 7  
  Other asset — vendor credits applied to capital expenditures   $ 200   $  

See accompanying notes to unaudited financial statements.

F-27



Monosol Rx LLC


Notes to Financial Statements


(Unaudited, in thousands)

(1)   Nature of Business and Basis of Presentation

(2)   Significant Accounting Policies

F-28


(3)   Balance Sheet Details

 
  June 30,
2007

  December 31,
2006

Trade receivable   $ 1,451   $ 583
  Less allowance for bad debts     59     16
   
 
    Total trade receivables   $ 1,392   $ 567
   
 
 
  June 30,
2007

  December 31,
2006

Raw material   $ 386   $ 242
Packaging material     345     213
Finished goods     69    
   
 
  Total inventories   $ 800   $ 455
   
 

F-29


 
  June 30,
2007

  December 31,
2006

Machinery and equipment   $ 7,034   $ 6,698
Furniture and fixtures     564     544
Leasehold improvements     3,518     3,469
Construction in process     2,305     242
   
 
      13,421     10,953
Less accumulated depreciation and amortization     3,625     2,397
   
 
  Total property and equipment   $ 9,796   $ 8,556
   
 

(4)   Commitments and Contingent Liabilities

F-30


(5)   Operating Leases

(6)   Performance Unit Plans

F-31


 
  Units
  Weighted Average
Grant Date
Fair Value(1)

  Weighted Average
Per Unit
Base Value

  Aggregate
Intrinsic
Value(2)

Outstanding at December 31, 2006   21,215   $ 56,902   $ 0.36   $ 9,016
Granted   210   $ 100,000   $ 0.64   $ 0
Effect of warrant conversion   11,773   $ 57,280 (3) $ 0.36      
Exercised                  
Forfeited/cancelled/expired   (22 ) $ 100,000   $ 0.64      
   
                 
Outstanding at June 30, 2007   33,176   $ 57,280   $ 0.36   $ 9,016
   
                 
Vested at June 30, 2007   12,225   $ 26,612   $ 0.17   $ 5,707
Exercisable at June 30, 2007                    
 
  Units
  Weighted
Average Grant
Date Fair Value(1)

  Weighted Average
Per Unit
Base Value

Nonvested at December 31, 2006   15,084   $ 72,008   $ 0.46
Granted   210   $ 100,000   $ 0.64
Effect of warrant conversion completion   11,773   $ 57,280 (3) $ 0.36
Vested   (6,094 ) $ 33,528   $ 0.21
Forfeited   (22 ) $ 100,000   $ 0.64
   
           
Nonvested at June 30, 2007   20,951   $ 75,174   $ 0.48
   
           

F-32


(7)   Member's Equity

(8)   Related Party Transactions

(9)   Net Loss Per Membership Interest

F-33


(10) Planned Transactions

F-34




4,000,000 Shares

LOGO

Common Stock


PROSPECTUS


Cowen and Company

CIBC World Markets

Susquehanna Financial Group, LLLP

                        , 2007

Until                        , 2007, all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This requirement is in addition to the dealers' obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.



PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13.    Other expenses of issuance and distribution.

        Set forth below are the expenses (other than underwriting discounts and commissions) expected to be incurred in connection with the issuance and distribution of the securities registered hereby. With the exception of the Securities and Exchange Commission registration fee and the Nasdaq Global Market filing fee, the amounts set forth below are estimates.

SEC Registration Fee   $ 2,648
NASD Filing Fee   $ 9,125
Nasdaq Global Market Listing Fee   $ 100,000
Printing and Engraving Expenses   $ 300,000
Fees and Expenses of Legal Counsel   $ 1,800,000
Accounting Fees and Expenses   $ 500,000
Transfer Agent and Registrar Fees   $ 10,000
Miscellaneous   $ 178,227
   
  Total   $ 2,900,000
   

Item 14.    Indemnification of directors and officers.

        Our certificate of incorporation provides that none of our directors will be personally liable to us or our stockholders for monetary damages for breaches of fiduciary duty, except for (i) breach of our director's duty of loyalty to us or our stockholders, (ii) acts or omissions that are not in good faith, or which involve intentional misconduct or a knowing violation of law, (iii) unlawful payments of dividends, stock purchases, or redemptions as provided in Section 174 of the Delaware General Corporation Law, or DGCL, or (iv) any transaction from which the director derives an improper personal benefit.

        Our bylaws provide that, to the fullest extent permitted by applicable law, we will indemnify, hold harmless, and advance expenses to any person that is made or threatened to be made a party to an action or proceeding by reason of the fact that he or she is or was one of our directors or officers. However, we are not required to indemnify such person for a proceeding initiated by or on behalf of such person, unless our board of directors authorizes indemnification for that particular proceeding.

        Section 145 of the DGCL provides that a corporation has the power to indemnify a director, officer, employee, or agent of the corporation and certain other persons serving at the request of the corporation in related capacities against expenses (including attorneys' fees), judgments, fines, and amounts paid in settlements actually and reasonably incurred by the person in connection with a threatened, pending, or completed action, suit or proceeding to which he or she is or is threatened to be made a party by reason of such position, if such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation, indemnification is limited to expenses (including attorneys' fees) actually and reasonably incurred by the person in connection with defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation and no indemnification shall be made with respect to any claim, issue, or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but

II-1



in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.

        In addition, Section 145 of the DGCL requires that, to the extent that a present or former director or officer of a corporation has been successful on the merits or otherwise in defense of any action, suit, or proceeding described above, or defense of any claim, issue, or matter therein, such person shall be indemnified against expenses (including attorneys' fees) actually and reasonably incurred by such person in connection therewith.

        Section 145 of the DGCL also provides that expenses (including attorneys' fees) incurred by an officer or director in defending any civil, criminal, administrative, or investigative action, suit, or proceeding may be advanced by the corporation upon receipt of an undertaking by such person to repay such amount if it is ultimately determined that such person is not entitled to indemnification by the corporation under Section 145 of the DGCL.

        We expect to obtain insurance policies under which our directors and officers are insured, within the limits and subject to the limitations of those policies, against certain expenses in connection with the defense of, and certain liabilities which may be imposed as a result of, actions, suits or proceedings to which they are parties by reason of being or having been directors or officers.

        Prior to the completion of this offering, we will enter into indemnification agreements with each of our officers and directors under which we agreed to indemnify each of them against: (a) expenses, judgments, and settlements paid in connection with third-party claims and (b) expenses and settlements paid in connection with claims on our behalf, in each case provided that the director acted in good faith. In addition, we will agree to indemnify each director to the extent permitted by the DGCL, our certificate of incorporation and our bylaws against all expenses, judgments, and amounts paid in settlement unless the director's conduct constituted a breach of his or her duty of loyalty to the stockholders. Subject to the director's obligation to pay us in the event that he or she is not entitled to indemnification, we will pay the expenses of the director prior to a final determination as to whether the director is entitled to indemnification.

        Reference is also made to the Underwriting Agreement filed as Exhibit 1.1 to the Registration Statement for information concerning the underwriters' obligation to indemnify us and our officers and directors in certain circumstances.

Item 15.    Recent sales of unregistered securities.

        Set forth below is information regarding securities sold by us since March 1, 2004 which were not registered under the Securities Act of 1933, as amended, or Securities Act.

        From February 2005 to April 2005, we conducted an offering in which we issued and sold promissory notes and related warrants to seven investors for an aggregate offering price of approximately $5,000,000 in exchange for cash.

        From August 2005 to November 2006 we conducted on offering in which we issued and sold promissory notes and related warrants to two investors for an aggregate offering price of approximately $15,500,000 in exchange for cash.

        In September 2006, we issued and sold two series of preferred membership interests in Monosol Rx LLC to nine investors for an aggregate offering price of approximately $38,913,600 in exchange for cash. A portion of the proceeds of this offering was used to retire our outstanding indebtedness, including accrued interest, under the promissory notes described above.

        No underwriters were involved in the foregoing sales of securities. The securities were issued to U.S. investors in reliance upon the exemption from registration requirements of the Securities Act, as set forth in Section 4(2) under the Securities Act and Rule 506 of Regulation D promulgated

II-2



thereunder relating to sales by an issuer not involving any public offering to the extent an exemption from such registration was required. The purchaser of our notes, warrants, and preferred membership interests described above represented to us in connection with their purchase that they were accredited investors and were acquiring the securities for investment and not distribution, that they could bear the risks of the investment, and could hold the securities for an indefinite period of time.

        The purchasers received written disclosures that the securities had not been registered under the Securities Act and that any resale must be made pursuant to a registration or an available exemption from such registration. The sales of these securities were made without general solicitation or advertising.

Item 16.    Exhibits.


Exhibit
   
   
  1.1*       Form of Underwriting Agreement

  2.1*

 

 

 

Form of Agreement and Plan of Merger between Monosol Rx LLC and MonoSol Rx, Inc.

  3.1**

 

 

 

Certificate of Incorporation of MonoSol Rx, Inc.

  3.2**

 

 

 

Bylaws of MonoSol Rx, Inc.

  5.1*

 

 

 

Opinion of Fulbright & Jaworski L.L.P. as to the legality of the securities being registered

10.1**

 

 

 

Executive Employment Agreement dated November 17, 2005 by and between Monosol Rx LLC and A. Mark Schobel

10.2**

 

 

 

Executive Employment Agreement dated June 16, 2006 by and between Monosol Rx LLC and Keith J. Kendall

10.3**

 

 

 

Amended and Restated Executive Employment Agreement dated May 12, 2007 by and between Monosol Rx LLC and Joseph Fuisz

10.4**

 

 

 

Executive Employment Agreement dated August 1, 2006 by and between Monosol Rx LLC and Pradeep Sanghvi

10.5**

 

 

 

Executive Employment Agreement dated January 1, 2007 by and between Monosol Rx LLC and Carl G. Fischer

10.6**+

 

 

 

Supply Agreement dated March 15, 2007 by and between Monosol Rx LLC and Adams Respiratory Operations, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.7**+

 

 

 

Development Agreement dated March 15, 2007 by and between Monosol Rx LLC and Adams Respiratory Products, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.8**+

 

 

 

License Agreement dated March 15, 2007 by and between Monosol Rx LLC and Adams Respiratory Operations, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.9**+

 

 

 

Exclusive Strategic Supply Agreement dated February 8, 2007 by and between Monosol Rx LLC and Philip Morris USA Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)
         

II-3



10.10**+

 

 

 

Agreement dated October 12, 2006 by and between Monosol Rx LLC and Medtech Products, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.11**+

 

 

 

Supply Agreement dated March 20, 2007 by and between Monosol Rx LLC and L. Perrigo Company (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.12**+

 

 

 

Benzydamine Development Agreement dated April 1, 2006 by and between Monosol Rx LLC and Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.13**+

 

 

 

Commercial Supply Agreement dated June 4, 2004 by and between Monosol Rx LLC and Dr. Harold Katz LLC (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.14**+

 

 

 

Development and Supply Agreement dated June 29, 2006 by and between Monosol Rx LLC and Vita Health Products Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.15**

 

 

 

Form of Director and Officer Indemnification Agreement

10.16

 

 

 

MonoSol Rx, Inc. 2007 Stock Incentive Plan

10.17

 

 

 

Form of Stock Option Agreement under the MonoSol Rx, Inc. 2007 Stock Incentive Plan

10.18

 

 

 

Form of Restricted Stock Agreement under the MonoSol Rx, Inc. 2007 Stock Incentive Plan

10.19

 

 

 

Amended and Restated Performance Unit Appreciation Plan adopted August 24, 2007

10.20**

 

 

 

Summary of Director Compensation

10.21**

 

 

 

Monosol Rx, LLC Amended and Restated Performance Units Plan Amended and Restated Effective September 18, 2006

10.22**

 

 

 

Monosol Rx, LLC Amended and Restated Performance Units Plan B Amended and Restated Effective September 18, 2006

10.23**

 

 

 

Letter Agreement dated May 13, 2007 from Monosol Rx LLC to Joseph M. Fuisz related to the Performance Units Plan established January 22, 2004, as amended

10.24**

 

 

 

Separation Agreement and General Release dated July 17, 2007 by and between Carl G. Fischer and MonoSol Rx, LLC

10.25

 

 

 

Executive Employment Agreement dated August 24, 2007 by and among Monosol Rx LLC, MonoSol Rx, Inc. and A. Mark Schobel

10.26

 

 

 

Executive Employment Agreement dated August 24, 2007 by and among Monosol Rx LLC, MonoSol Rx. Inc. and Keith J. Kendall

10.27

 

 

 

Commitment Letter dated August 24, 2007 by and among MonoSol Rx LLC, MonoLine RX, L.P., MonoLine RX II, L.P., their respective affiliates, and Halifax Monosol Investors, L.P.

16.1**

 

 

 

Letter regarding change in certifying accountant

21.1*

 

 

 

List of Subsidiaries of MonoSol Rx, Inc.
         

II-4



23.1

 

 

 

Consent of KPMG LLP

23.2*

 

 

 

Consent of Fulbright & Jaworski L.L.P. (contained in Exhibit 5.1)

24.1**

 

 

 

Powers of attorney (included on the signature page hereof)

*
To be filed by amendment.

**
Previously filed.

+
Confidential treatment has been requested with respect to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended. Omitted portions have been filed separately with the Securities and Exchange Commission.

Item 17.    Undertakings.

        (1)   The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the Underwriting Agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

        (2)   Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

        (3)   The undersigned registrant hereby undertakes that:

II-5



SIGNATURES

        Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Amendment No. 3 to the Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Warren, State of New Jersey on August 29, 2007.

    MONOSOL RX, INC.

 

 

By:

/s/  
KEITH J. KENDALL      
     
Keith J. Kendall
Executive Vice President and Chief Financial Officer

        Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

Signature
  Title
  Date

 

 

 

 

 
*
A. Mark Schobel
  Chief Executive Officer, President and Director (Principal Executive Officer)   August 29, 2007

/s/  
KEITH J. KENDALL      
Keith J. Kendall

 

Executive Vice President, Chief Financial Officer, Treasurer and Secretary (Principal Financial Officer and Principal Accounting Officer)

 

August 29, 2007


*

Douglas Bratton


 


Chairman of the Board and Director


 


August 29, 2007


*

Dr. Gregory Brown


 


Director


 


August 29, 2007


*

John Cochran


 


Director


 


August 29, 2007


*

Robert Flanagan


 


Director


 


August 29, 2007


*

Frank Tanki


 


Director


 


August 29, 2007
/s/  *KEITH J. KENDALL      
      *Attorney-in-fact
   


EXHIBIT INDEX

Exhibits
   
   
  1.1*       Form of Underwriting Agreement

  2.1*

 

 

 

Form of Agreement and Plan of Merger between Monosol Rx LLC and MonoSol Rx, Inc.

  3.1**

 

 

 

Certificate of Incorporation of MonoSol Rx, Inc.

  3.2**

 

 

 

Bylaws of MonoSol Rx, Inc.

  5.1*

 

 

 

Opinion of Fulbright & Jaworski L.L.P. as to the legality of the securities being registered

10.1**

 

 

 

Executive Employment Agreement dated November 17, 2005 by and between Monosol Rx LLC and A. Mark Schobel

10.2**

 

 

 

Executive Employment Agreement dated June 16, 2006 by and between Monosol Rx LLC and Keith J. Kendall

10.3**

 

 

 

Amended and Restated Executive Employment Agreement dated May 12, 2007 by and between Monosol Rx LLC and Joseph Fuisz

10.4**

 

 

 

Executive Employment Agreement dated August 1, 2006 by and between Monosol Rx LLC and Pradeep Sanghvi

10.5**

 

 

 

Executive Employment Agreement dated January 1, 2007 by and between Monosol Rx LLC and Carl G. Fischer

10.6**+

 

 

 

Supply Agreement dated March 15, 2007 by and between Monosol Rx LLC and Adams Respiratory Operations, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.7**+

 

 

 

Development Agreement dated March 15, 2007 by and between Monosol Rx LLC and Adams Respiratory Products, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.8**+

 

 

 

License Agreement dated March 15, 2007 by and between Monosol Rx LLC and Adams Respiratory Operations, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.9**+

 

 

 

Exclusive Strategic Supply Agreement dated February 8, 2007 by and between Monosol Rx LLC and Philip Morris USA Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.10**+

 

 

 

Agreement dated October 12, 2006 by and between Monosol Rx LLC and Medtech Products, Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.11**+

 

 

 

Supply Agreement dated March 20, 2007 by and between Monosol Rx LLC and L. Perrigo Company (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)
         


10.12**+

 

 

 

Benzydamine Development Agreement dated April 1, 2006 by and between Monosol Rx LLC and Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.13**+

 

 

 

Commercial Supply Agreement dated June 4, 2004 by and between Monosol Rx LLC and Dr. Harold Katz LLC (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.14**+

 

 

 

Development and Supply Agreement dated June 29, 2006 by and between Monosol Rx LLC and Vita Health Products Inc. (Asterisks located within the exhibit denote information which has been deleted pursuant to a confidential treatment filing with the Securities and Exchange Commission)

10.15**

 

 

 

Form of Director and Officer Indemnification Agreement

10.16

 

 

 

MonoSol Rx, Inc. 2007 Stock Incentive Plan

10.17

 

 

 

Form of Stock Option Agreement under the MonoSol Rx, Inc. 2007 Stock Incentive Plan

10.18

 

 

 

Form of Restricted Stock Agreement under the MonoSol Rx, Inc. 2007 Stock Incentive Plan

10.19

 

 

 

Amended and Restated Performance Unit Appreciation Plan adopted August 24, 2007

10.20**

 

 

 

Summary of Director Compensation

10.21**

 

 

 

MonoSol Rx, LLC Amended and Restated Performance Units Plan Amended and Restated Effective September 18, 2006

10.22**

 

 

 

MonoSol Rx, LLC Amended and Restated Performance Units Plan B Amended and Restated Effective September 18, 2006

10.23**

 

 

 

Letter Agreement dated May 13, 2007 from Monosol Rx LLC to Joseph M. Fuisz related to the Performance Units Plan established January 22, 2004, as amended

10.24**

 

 

 

Separation Agreement and General Release dated July 17, 2007 by and between Carl G. Fischer and MonoSol Rx, LLC

10.25

 

 

 

Executive Employment Agreement dated August 24, 2007 by and among Monosol Rx LLC, MonoSol Rx, Inc. and A. Mark Schobel

10.26

 

 

 

Executive Employment Agreement dated August 24, 2007 by and among Monosol Rx LLC, MonoSol Rx, Inc. and Keith J. Kendall

10.27

 

 

 

Commitment Letter dated August 24, 2007 by and among MonoSol Rx LLC, MonoLine RX, L.P., MonoLine RX II, L.P., their respective affiliates, and Halifax Monosol Investors, L.P.

16.1**

 

 

 

Letter regarding change in certifying accountant

21.1*

 

 

 

List of Subsidiaries of MonoSol Rx, Inc.

23.1

 

 

 

Consent of KPMG LLP

23.2*

 

 

 

Consent of Fulbright & Jaworski L.L.P. (contained in Exhibit 5.1)

24.1**

 

 

 

Powers of attorney (included on the signature page hereof)

*
To be filed by amendment.

**
Previously filed.

+
Confidential treatment has been requested with respect to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended. Omitted portions have been filed separately with the Securities and Exchange Commission.



QuickLinks

Calculation of Registration Fee
PROSPECTUS SUMMARY
Self-Funded Initiatives
Disclosed Partnered Prescription Products
Partnered OTC Pharmaceuticals and Other Products
The Offering
Summary Financial Data
RISK FACTORS
SPECIAL NOTES REGARDING FORWARD-LOOKING STATEMENTS
USE OF PROCEEDS
DIVIDEND POLICY
CAPITALIZATION
DILUTION
SELECTED FINANCIAL DATA
UNAUDITED PRO FORMA FINANCIAL STATEMENTS
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
BUSINESS
Triaminic® Thin Strips and Triaminic® Softchews Sales Trends
Potential Self-Funded Initiative Candidates
Self-Funded Initiatives
Disclosed Partnered Prescription Products
Partnered OTC Pharmaceuticals and Other Products
MANAGEMENT
COMPENSATION DISCUSSION AND ANALYSIS
Summary Compensation Table
Grants of Plan-Based Awards
Outstanding Equity Awards at December 31, 2006
Potential Payments Upon Termination Without a Change in Control
Potential Payments Upon a Change in Control Without Termination
PRINCIPAL STOCKHOLDERS
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
DESCRIPTION OF CAPITAL STOCK
MATERIAL U.S. FEDERAL TAX CONSIDERATIONS FOR NON-U.S. HOLDERS OF OUR COMMON STOCK
SHARES ELIGIBLE FOR FUTURE SALE
UNDERWRITING
LEGAL MATTERS
EXPERTS
WHERE YOU CAN FIND ADDITIONAL INFORMATION
Monosol Rx LLC INDEX TO FINANCIAL STATEMENTS
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Monosol Rx LLC Balance sheets
Monosol Rx LLC Statements of operations
Monosol Rx LLC Statements of changes in members' equity (in thousands, except for unit data)
Monosol Rx LLC Statements of cash flows
Monosol Rx LLC Statements of cash flows (Continued)
Monosol Rx LLC Notes to financial statements (in thousands, except per share amounts)
Monosol Rx LLC Balance Sheets (in thousands, except unit data)
Monosol Rx LLC Statements of Operations (Unaudited) (in thousands, except per interest data)
Monosol Rx LLC Statements Of Changes In Members' Equity For The Six Months Ended June 30, 2007 (Unaudited) (In thousands except unit data)
Monosol Rx LLC Statements of Cash Flows (Unaudited) (In thousands)
Monosol Rx LLC Notes to Financial Statements (Unaudited, in thousands)
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
SIGNATURES
EXHIBIT INDEX

Exhibit 10.16

 

MONOSOL RX, INC.
2007 STOCK INCENTIVE PLAN

 

1.             Purpose. The purpose of the plan is to facilitate the ability of Monosol Rx, Inc., a Delaware corporation (the “Company”) and its subsidiaries to attract, motivate and retain eligible employees, directors and other personnel through the use of equity-based and other incentive compensation opportunities. Awards made under the plan may take the form of options to purchase shares of the Company’s common stock, $.01 par value (the “Common Stock”) granted pursuant to Section 5, stock appreciation rights granted pursuant to Section 6, restricted stock and deferred stock rights issued or granted pursuant to Section 7, other types of stock-based and cash incentive awards made pursuant to Section 8, or performance-based awards made pursuant to Section 9.

 

2.             Administration.

 

2.1           The Committee. The Plan will be administered by the compensation committee of the Company’s board of directors, except the entire board will have sole authority for granting and administering awards to non-employee directors.

 

2.2           Responsibility and Authority of the Committee. Subject to the provisions of the Plan, the committee, acting in its discretion, will have responsibility and the power and authority to (a) select the persons to whom awards will be made, (b) prescribe the terms and conditions of each award and make amendments thereto, (c) construe, interpret and apply the provisions of the Plan and of any agreement or other document evidencing an award made under the Plan, and (d) make any and all determinations and take any and all other actions as it deems necessary or desirable in order to carry out the terms of the Plan. The committee may obtain at the Company’s expense such advice, guidance and other assistance from outside compensation consultants and other professional advisers as the committee deems appropriate in connection with the proper administration of the plan.

 

2.3           Delegation of Authority by Committee. Subject to the requirements of applicable law, the committee may delegate to any person or group or subcommittee of persons (who may, but need not be members of the committee) such Plan-related functions within the scope of its responsibility, power and authority as it deems appropriate.

 

2.4           Indemnification. The Company shall indemnify and hold harmless each member of the Committee and any employee or director of the Company to whom any duty or power relating to the administration or interpretation of the Plan is delegated from and against any loss, cost, liability (including any sum paid in settlement of a claim with the approval of the Board), damage and expense (including reasonable legal and other expenses incident thereto) arising out of or incurred in connection with the Plan, unless and except to the extent attributable to such person’s fraud or willful misconduct.

 

3.             Share Limitation. Subject to adjustments required or permitted by the plan, the Company may issue a total of 1,502,641 shares of Common Stock under the plan. For these purposes, the following shares of Common Stock will not be taken into account and will remain available for issuance under the plan: (a) shares covered by awards that expire or are canceled,

 



 

forfeited, settled in cash or otherwise terminated, (b) shares delivered to the Company and shares withheld by the Company for the payment or satisfaction of purchase price or tax withholding obligations associated with the exercise or settlement of an award, and (c) shares covered by stock-based awards assumed by the Company in connection with the acquisition of another company or business.

 

4.             Eligibility to Receive Awards. Awards may be granted under the plan to any present or future director, officer, employee, consultant or adviser of or to the Company or any of its subsidiaries. For purposes of the plan, a subsidiary is any entity in which the Company has a direct or indirect ownership interest of at least 50%.

 

5.             Stock Option Awards.

 

5.1           General. Stock options granted under the Plan will have such vesting and other terms and conditions as the committee, acting in its discretion in accordance with the Plan, may determine, either at the time the option is granted or, if the holder’s rights are not adversely affected, at any subsequent time.

 

5.2           Minimum Exercise Price. The exercise price per share of Common Stock covered by an option granted under the plan may not be less than 100% of the fair market value per share on the date the option is granted (110% in the case of “incentive stock options” (within the meaning of Section 422 of the Code) granted to an employee who is a 10% stockholder within the meaning of Section 422(b)(6) of the Code). Unless otherwise determined by the Committee or required by applicable law, the fair market value of a share of Common Stock as of any given date shall be the closing sale price per share of Common Stock reported on a consolidated basis for securities listed on the principal stock exchange or market on which the Common Stock is traded on the date as of which such value is being determined or, if there is no sale on that day, then on the last previous day on which a sale was reported; provided, however, that, the fair market value of a share of  Common Stock on the date of the initial public offering of the Common Stock shall be the initial public offering price per share.

 

5.3           No Repricing of Options. The repricing of stock options granted under the plan is prohibited in the absence of stockholder approval.

 

5.4           Maximum Duration. Unless sooner terminated in accordance with its terms, an option granted under the plan will automatically expire on the tenth anniversary of the date it is granted or, in the case of an “incentive stock option” granted to an employee who is a 10% stockholder, the fifth anniversary of the date it is granted.

 

5.5           Effect of Termination of Employment or Service. The committee may establish such exercise and other conditions applicable to an option following the termination of the optionee’s employment or other service with the Company and its subsidiaries as the committee deems appropriate on a grant-by-grant basis.

 

5.6           Method of Exercise. An option granted under the plan may be exercised by transmitting to the Secretary of the Company (or other person designated for this purpose by the committee) a written notice identifying the option that is being exercised and specifying the number of whole shares to be purchased pursuant to that option, together with payment in full of

 

2



 

the exercise price and the withholding taxes due in connection with the exercise, unless and except to the extent that other arrangements satisfactory to the Company have been made for such payment(s). The exercise price may be paid in cash or in any other manner the committee, in its discretion, may permit, including, without limitation, (a) by the delivery of previously-owned shares, (b) by a combination of a cash payment and delivery of previously-owned shares, or (c) pursuant to a cashless exercise program established and made available through a registered broker-dealer in accordance with applicable law. Any shares transferred to the Company (or withheld upon exercise) in connection with the exercise of an option shall be valued at fair market value for purposes of determining the extent to which the exercise price and/or tax withholding obligation is satisfied by such transfer (or withholding) of shares.

 

5.7           Transferability. Except as otherwise provided, no option shall be assignable or transferable except upon the optionee’s death to a beneficiary designated by the optionee in a manner prescribed or approved for this purpose by the committee or, if no designated beneficiary shall survive the optionee, pursuant to the optionee’s will or by the laws of descent and distribution, and, during an optionee’s lifetime, options may be exercised only by the optionee or the optionee’s guardian or legal representative. Notwithstanding the foregoing, an optionee may make an inter vivos transfer of an option (other than an “incentive stock option”) pursuant to a domestic relations order (within the meaning of Rule 16a-12 promulgated under the Exchange Act) in settlement of marital property rights, or by gift to any “family member” (within the meaning of Item A.1.(5) of the General Instructions to Form S-8 or any successor provision).

 

5.8           Rights as a Stockholder. No shares of Common Stock shall be issued in respect of the exercise of an option until payment of the exercise price and the applicable tax withholding obligations has been made or provided for to the satisfaction of the Company, and the holder of an option shall have no rights as a stockholder with respect to any shares covered by the option until such shares are duly and validly issued by the Company to or on behalf of such holder.

 

6.             Stock Appreciation Rights.

 

6.1           General. The committee may grant stock appreciation rights (“SARs”), either alone or in connection with the grant of an option, upon such vesting and other terms and conditions as the committee, acting in its discretion in accordance with the Plan, including, as applicable, Section 5 (relating to options), may determine, either at the time the SARs are granted or, if the holder’s rights are not adversely affected, at any subsequent time. Upon exercise, the holder of an SAR shall be entitled to receive cash and/or a number of whole shares of Common Stock having a fair market value equal to the product of X and Y, where—

 

X = the number of whole shares of Common Stock as to which the SAR is being exercised, and

 

Y = the excess of the fair market value per share of Common Stock on the date of exercise over the fair market value per share of Common Stock on the date the SAR is granted (or such greater base value as the committee may prescribe at the time the SAR is granted).

 

3



 

6.2           Method of Exercise. An outstanding and exercisable SAR may be exercised by transmitting to the Secretary of the Company (or other person designated for this purpose by the committee) a written notice identifying the SAR that is being exercised and specifying the number of shares as to which the SAR is being exercised, together with payment in full of the withholding taxes due in connection with the exercise, unless and except to the extent that other arrangements satisfactory to the Company have been made for such payment. The committee may impose such additional or different conditions for exercise of an SAR as it deems appropriate. No fractional shares will be issued in connection with the exercise of an SAR.

 

7.             Restricted Stock and Deferred Stock Awards.

 

7.1           General. Under a restricted stock award, shares of Common Stock will be issued by the Company to the recipient at the time of the award. Under a deferred stock award, the recipient will be entitled to receive shares of Common Stock in the future. The shares covered by a restricted stock award and the right to receive shares under a deferred stock award will be subject to such vesting and other conditions and restrictions as the committee, acting in its discretion in accordance with the plan, may determine.

 

7.2           Minimum Purchase Price. Unless the committee, acting in accordance with applicable law, determines otherwise, the purchase price payable for shares of Common Stock transferred pursuant to a restricted or deferred stock award must be at least equal to the par value of the shares.

 

7.3           Issuance of Restricted Stock. Shares of Common Stock issued pursuant to a restricted stock award may be evidenced by book entries on the Company’s stock transfer records pending satisfaction of the applicable vesting conditions. If a stock certificate for restricted shares is issued, the certificate will bear an appropriate legend to reflect the nature of the conditions and restrictions applicable to the shares. The Company may require that any or all such stock certificates be held in custody by the Company until the applicable conditions are satisfied and other restrictions lapse. The committee may establish such other conditions as it deems appropriate in connection with the issuance of certificates for restricted shares, including, without limitation, a requirement that the recipient deliver a duly signed stock power, endorsed in blank, for the shares covered by the award.

 

7.4           Certificates for Vested Stock. The recipient of a restricted or deferred stock award will be entitled to receive a certificate, free and clear of conditions and restrictions (except as may be imposed in order to comply with applicable law), for shares that vest in accordance with the award, subject, however, to the payment or satisfaction of applicable withholding taxes. The delivery of vested shares covered by a deferred stock award may be deferred if and to the extent provided by the terms of the award, subject, however, to the applicable deferral requirements of Section 409A of the Code.

 

7.5           Rights as a Stockholder. Subject to and except as otherwise provided by the terms of a restricted stock award, the holder of restricted shares of Common Stock will be entitled to receive dividends paid on, and exercise voting rights associated with, such shares as if the shares were fully vested. The holder of a deferred stock award shall no rights as a stockholder

 

4



 

with respect to shares covered by a deferred stock award unless and until the award vests and the shares are issued; provided, however, that the committee, in its discretion, may provide for the crediting and payment of dividend equivalents on shares covered by a deferred stock award.

 

7.6           Nontransferability. Neither a restricted or deferred stock award nor restricted shares of Common Stock issued pursuant to any such award may be sold, assigned, transferred, disposed of, pledged or otherwise hypothecated other than to the Company or its designee in accordance with the terms of the award or of the plan, and any attempt to do so shall be null and void and, unless the committee determines otherwise, shall result in the immediate forfeiture of the award or the restricted shares, as the case may be.

 

7.7           Termination of Service Before Vesting; Forfeiture. Unless the committee determines otherwise, shares of restricted stock and non-vested deferred stock awards will be forfeited upon the recipient’s termination of employment or other service with the Company and its subsidiaries. If shares of restricted stock are forfeited, any certificate representing such shares will be canceled on the books of the Company and the recipient will be entitled to receive from the Company an amount equal to any cash purchase price previously paid for such shares. If a non-vested deferred stock award is forfeited, the recipient will have no further right to receive the shares of Common Stock covered by the non-vested award.

 

8.             Other Stock-Based Awards and Cash Incentive Awards. The committee is authorized, subject to limitations under applicable law, to grant to participants such other awards that may be denominated or payable in, valued in whole or in part by reference to, or otherwise based on, or related to, Common Stock or factors that may influence the value of Common Stock, including, without limitation, stock bonuses, dividend equivalents, convertible or exchangeable debt securities, other rights convertible or exchangeable into Common Stock, purchase rights for Common Stock, awards with value and payment contingent upon performance of the Company or business units thereof or any other factors designated by the Committee, and awards valued by reference to the book value of Common Stock or the value of securities of or the performance of specified subsidiaries or affiliates or other business units and awards designed to comply with or take advantage of other applicable law. The committee shall determine the terms and conditions of such awards. In addition, cash incentive awards, including annual incentive awards and long-term incentive awards, denominated and settled in cash, may be granted under this Section, which awards may be earned at such times, under such circumstances (including based on achievement of performance goals and/or future service requirements), in such installments or otherwise and under such other circumstances as the committee may determine at the date of grant or thereafter.

 

9.             Limits on Transferability; Beneficiaries. Except as otherwise provided, no award or other right or interest of a participant under the plan shall be pledged, hypothecated or otherwise encumbered or subject to any lien, obligation or liability of such participant to any party (other than the Company or an affiliate thereof), or assigned or transferred by such participant otherwise than by will or the laws of descent and distribution or to a beneficiary upon the death of a participant, and such awards or rights that may be exercisable shall be exercised during the lifetime of the participant only by the participant or his or her guardian or legal representative. Notwithstanding the foregoing, awards and other rights (other than ISOs) granted under the plan may be transferred to one or more persons during a participant’s lifetime, and may

 

5



 

be exercised by or settled with the transferee(s) in accordance with the terms of such award, but only if and to the extent such transfers are permitted by the committee, subject to any terms and conditions as the committee, acting in its good faith discretion, may impose thereon. A beneficiary, transferee, or other person claiming any rights under the plan from or through any participant shall be subject to all terms and conditions of the plan and any award agreement applicable to such participant, except as otherwise determined by the committee, and to any additional terms and conditions deemed necessary or appropriate by the committee in connection with the lawful and orderly administration of the plan. For purposes hereof, the term “beneficiary” shall mean the legal representatives of a participant’s estate entitled by will or the laws of descent and distribution to receive the benefits under a participant’s award upon a participant’s death, provided that, if and to the extent authorized by the committee, a participant may be permitted to designate a beneficiary, in which case the “beneficiary” instead will be the person, persons, trust or trusts (if any are then surviving) which have been designated by the participant in his or her most recent written beneficiary designation filed with the Committee to receive the benefits specified under the participant’s Award upon such participant’s death.

 

10.           Capital Changes, Reorganization or Sale of the Company.

 

10.1         Adjustments Upon Changes in Capitalization. The aggregate number and class of shares issuable under the plan, the number and class of shares and the exercise price per share covered by each outstanding option, the number and class of shares and the base price per share covered by each outstanding SAR, and the number and class of shares covered by each outstanding deferred stock award or other-equity-based award, and any per-share base or purchase price or target market price included in the terms of any such award, and related terms shall be subject to adjustment in order to equitably reflect the effect on issued shares of Common Stock resulting from a split-up, spin-off, recapitalization, consolidation of shares or any similar capital adjustment, and/or to reflect a change in the character or class of shares covered by the plan and an award.

 

10.2         Cash, Stock or Other Property for Stock. Except as otherwise provided in this Section, in the event of an Exchange Transaction (as defined below), all option and SAR holders shall be permitted to exercise their outstanding options and SARs in whole or in part (whether or not otherwise exercisable) immediately prior to such Exchange Transaction, and any outstanding options and SARs which are not exercised before the Exchange Transaction shall thereupon terminate. Notwithstanding the preceding sentence, if, as part of an Exchange Transaction, the stockholders of the Company receive capital stock of another corporation (“Exchange Stock”) in exchange for their shares of Common Stock (whether or not such Exchange Stock is the sole consideration), the Company may cause all options and SARs for Common Stock that are outstanding at the time of the Exchange Transaction to be converted into options or SARs (as the case may be) for shares of Exchange Stock. The number of shares of Exchange Stock and the exercise price per share under a converted option will be adjusted such that (a) the ratio of the exercise price per share to the value per share at the time of the conversion (which value will be equal to the consideration payable for each share of Common Stock in the Exchange Transaction) is the same as the ratio of the per share exercise price to the value of per share of Common Stock under the original option; and (b) the aggregate difference

 

6



 

between the value of the shares of Exchange Stock and the exercise price under the converted option immediately after the Exchange Transaction is the same as the aggregate difference between the value of the shares of Common Stock and the exercise price under the original option immediately before the Exchange Transaction. Similar adjustments will be made to the number of shares of Exchange Stock and the base value per share covered by SARs that are converted. Unless the Company’s board of directors determines otherwise, the vesting and other terms and conditions of the converted options and SARs shall be substantially the same as the vesting and corresponding other terms and conditions of the original options and SARs. The Company’ board of directors, acting in its discretion, may accelerate vesting of other non-vested awards, and cause cash settlements and/or other adjustments to be made to any outstanding awards (including, without limitation, options and SARs) as it deems appropriate in the context of an Exchange Transaction, taking into account with respect to other awards the manner in which outstanding options and SARs are being treated. If a participant’s employment or other service is terminated within two years after an Exchange Transaction for any reason other than voluntary termination by the participant or termination by the acquiring or successor company for good cause, then any options or other awards that were granted under the plan and that were assumed by the acquiring or successor entity in connection with the Exchange Transaction will, upon such termination, become fully vested and nonforfeitable.

 

10.3         Definition of Exchange Transaction. For purposes of the plan, the term “Exchange Transaction” means a merger (other than a merger of the Company in which the holders of Common Stock immediately prior to the merger have the same proportionate ownership of Common Stock in the surviving corporation immediately after the merger), consolidation, acquisition or disposition of property or stock, separation, reorganization (other than a mere reincorporation or the creation of a holding company), liquidation of the Company or any other similar transaction or event so designated by the Company’s board of directors in its sole discretion, as a result of which the stockholders of the Company receive cash, stock or other property in exchange for or in connection with their shares of Common Stock.

 

10.4         Fractional Shares. In the event of any adjustment in the number of shares covered by any award pursuant to the provisions hereof, any fractional shares resulting from such adjustment shall be disregarded, and each such award shall cover only the number of full shares resulting from the adjustment.

 

10.5         Determination of Board to be Final. All adjustments under this Section shall be made by the Company’s board of directors, and its determination as to what adjustments shall be made, and the extent thereof, shall be final, binding and conclusive.

 

11.           Termination and Amendment of the Plan. The board of directors of the Company may terminate the plan at any time or amend the plan at any time and from time to time; provided, however, that:

 

(a)           no such action shall impair or adversely alter any awards theretofore granted under the plan, except with the consent of the recipient or holder, nor shall any such action deprive any such person of any shares which he or she may have acquired through or as a result of the plan; and

 

(b)           to the extent necessary under applicable law or the requirements of any stock exchange or market upon which the shares of Common Stock may then be listed, no

 

7



 

amendment shall be effective unless approved by the stockholders of the Company in accordance with applicable law.

 

12.           Limitation of Rights. Nothing contained in the plan or in any award agreement shall confer upon any recipient of an award any right with respect to the continuation of his or her employment or other service with the Company or a subsidiary or other affiliate, or interfere in any way with the right of the Company and its subsidiaries and other affiliates at any time to terminate such employment or other service or to increase or decrease, or otherwise adjust, the compensation and/or other terms and conditions of the recipient’s employment or other service.

 

13.           Miscellaneous.

 

13.1         Governing Law. The plan and the rights of all persons claiming under the plan shall be governed by the laws of the State of Delaware, without giving effect to conflicts of laws principles thereof.

 

13.2         Shares Issued Under Plan. Shares of Common Stock available for issuance under the plan may be authorized and unissued, held by the Company in its treasury or otherwise acquired for purposes of the plan. No fractional shares of Common Stock will be issued under the plan.

 

13.3         Compliance with Law. The Company will not be obligated to issue or deliver shares of Common Stock pursuant to the plan unless the issuance and delivery of such shares complies with applicable law, including, without limitation, the Securities Act of 1933, as amended, the Exchange Act, and the requirements of any stock exchange or market upon which the Common Stock may then be listed, and shall be further subject to the approval of counsel for the Company with respect to such compliance.

 

13.4         Transfer Orders; Placement of Legends. All certificates for shares of Common Stock delivered under the plan shall be subject to such stock-transfer orders and other restrictions as the Company may deem advisable under the rules, regulations, and other requirements of the Securities and Exchange Commission, any stock exchange or market upon which the Common Stock may then be listed, and any applicable federal or state securities law. The Company may cause a legend or legends to be placed on any such certificates to make appropriate reference to such restrictions.

 

13.5         Decisions and Determinations Final. All decisions and determinations made by the Company’s board of directors pursuant to the provisions hereof and, except to the extent rights or powers under the Plan are reserved specifically to the discretion of the board of directors, all decisions and determinations of the committee, shall be final, binding and conclusive on all persons.

 

13.6         Withholding of Taxes. As a condition to the exercise and/or settlement of any award or the lapse of restrictions on any award or shares, or in connection with any other event that gives rise to a federal or other governmental tax withholding obligation on the part of the Company or a subsidiary with respect to an award, the Company and/or the subsidiary may (a) deduct or withhold (or cause to be deducted or withheld) from any payment or distribution otherwise payable to the award recipient, whether or not such payment or distribution is covered

 

8



 

by the plan, or (b) require the recipient to remit cash (through payroll deduction or otherwise) or make other arrangements permitted by the Company, in each case in an amount or of a nature sufficient in the opinion of the Company to satisfy or provide for the satisfaction of such withholding obligation. If the event giving rise to the withholding obligation involves a transfer of shares of Common Stock, then, at the sole discretion of the committee, the recipient may satisfy the withholding obligations associated with such transfer by electing to have the Company withhold shares of Common Stock or by tendering previously-owned shares of Common Stock, in each case having a fair market value equal to the amount of tax to be withheld.

 

14.           Term of the Plan. The plan shall be effective as of the date of its adoption by the Board, subject to the approval of the stockholders of the Company within twelve months from the date of such adoption by the Board. The plan shall expire on the tenth anniversary of the date of its adoption by the Board, unless sooner terminated by the Board. The rights of any person with respect to an Award made under the plan that is outstanding at the time of the termination of the plan shall not be affected solely by reason of the termination of the plan and shall continue in accordance with the terms of the award and of the plan, as each is then in effect or is thereafter amended.

 

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Exhibit 10.17

 

STOCK OPTION AGREEMENT
UNDER THE MONOSOL Rx, INC.
2007 STOCK INCENTIVE PLAN

 

AGREEMENT (the “Agreement”) is made as of the          day of               , 20    , by and between MONOSOL Rx, INC., a Delaware corporation (the “Company”), and                                    ( the “Optionee”) pursuant to the Monosol Rx, Inc. 2007 Stock Incentive Plan (the “Plan”).

 

1.             Grant of Option; Tax Status. The Company hereby grants to the Optionee an option to purchase up to              shares of the Company’s common stock (the “Common Stock”), at a purchase price per share of $                 subject to the provisions of this Agreement and the Plan. Inconsistencies between this Agreement and the Plan will be governed by the applicable provisions of the Plan. The Executive acknowledges receipt of a copy of the Plan. This option is [not] intended to qualify as an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code of 1986.

 

2.             Term. Unless sooner terminated in accordance with this Agreement or the Plan, the option will automatically expire on the tenth anniversary of the date hereof.

 

3.             Vesting Schedule. Except as otherwise provided in this Agreement, the option shall become vested and exercisable in accordance with the following schedule, based upon the period of the Optionee’s continuous employment or other service with the Company following the date hereof:

 

Period of Service

 

Vesting Percentage

 

Less than 1 Year

 

0

%

At least 1 Year

 

25

%

At least 2 Years

 

50

%

At least 3 Years

 

75

%

4 or more Years

 

100

%

 

4.             Non-Transferability. This option may not be assigned or transferred except upon the Optionee’s death to a beneficiary designated by the Optionee in a manner prescribed or approved for this purpose by the compensation committee of the Company’s board of directors (the “Committee”) or, if no designated beneficiary shall survive the Optionee, pursuant to the Optionee’s will or by the laws of descent and distribution. During the Optionee’s lifetime, this option may be exercised only by the Optionee or the Optionee’s guardian or legal representative. Notwithstanding the foregoing, the Committee, in its sole discretion, may permit the inter vivos transfer of this option by gift to any “family member” (within the meaning of Item A.1.(5) of the

 



 

General Instructions to Form S-8 or any successor provision), on such terms and conditions as the Committee deems appropriate.

 

5.             Termination of Employment or other Service.

 

(a)           If the Optionee’s employment or other service with the Company or its subsidiaries is terminated due to the Optionee’s death or Disability (as defined below), then: (1) that portion of the option that is not then vested exercisable will terminate upon the date of the Optionee’s termination of employment or other service, and (2) that portion of the option, if any, that is then vested and exercisable will terminate if and to the extent it is not exercised before the first anniversary of the Optionee’s termination of employment or service or, if earlier, the expiration of the stated term of the option. As used herein, the term “Disability” means the inability of the Optionee to perform the principal duties of the Optionee’s employment by reason of a physical or mental illness or injury that is expected to last indefinitely or result in death, as determined by a duly licensed physician selected by the Company.

 

(b)           If the Optionee’s employment or other service is terminated by the Company or its subsidiaries for cause (which determination shall be made in the sole and absolute discretion of the Committee), then this option (whether or not then vested and exercisable) shall immediately terminate and cease to be exercisable.

 

(c)           If the Optionee’ s employment or other service with the Company or its affiliates is terminated for any reason other than those set forth in Section 5(a) or (b) above, then: (1) that portion of the option that is not then vested exercisable will terminate upon the date of the Optionee’s termination of employment or other service, and (2) that portion of the option, if any, that is then vested and exercisable shall terminate if and to the extent it is not exercised within three months after such termination of employment or service (or, if earlier, the expiration of the stated term of the option).

 

6.             Method of Exercise. This option may be exercised by transmitting to the Secretary of the Company (or such other person designated by the Committee) a written notice identifying the option being exercised and specifying the number of whole shares being purchased, together with payment of the exercise price and the amount of the applicable tax withholding obligations (unless other arrangements are made for the payment of such exercise price and/or the satisfaction of such withholding obligations). The exercise price and withholding obligation may be paid in whole or in part (a) in cash or by check, (b) by means of a cashless exercise procedure to the extent permitted by law, (c) if permitted by the Committee, by the surrender of previously-owned shares of Common Stock (to the extent of the fair market value thereof), and/ or (d) subject to applicable law, by any other form of consideration deemed appropriate by the Committee.

 

7.             Stockholder Rights. No shares of Common Stock will be issued in respect of the exercise of this option until payment of the exercise price and the applicable tax withholding obligations have been made or arranged to the satisfaction of the Company. The holder of this option shall have no rights as a stockholder with respect to any shares of Common Stock covered by this option until the shares of Common Stock are issued pursuant to the exercise of this option.

 

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8.             Compliance with Law. The Company will not be obligated to issue or deliver shares of Common Stock pursuant to this option unless the issuance and delivery of such shares complies with applicable law, including, without limitation, the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the requirements of any stock exchange or market upon which the Common Stock may then be listed. The Company may prevent or delay the exercise of this option if and to the extent the Company deems necessary or advisable in order to avoid a violation of applicable law or its own policies regarding the purchase and sale of Common Stock. If, during the period of any such ban or delay, the term of this option would expire, then the term of this option will be extended for thirty (30) days after the Company removes the restriction against exercise.

 

9.             Transfer Orders; Legends. All certificates for shares of Common Stock delivered under this option shall be subject to such stock-transfer orders and other restrictions as the Company may deem advisable under the rules, regulations, and other requirements of the Securities and Exchange Commission, any stock exchange or market upon which the Common Stock may then be listed, and any applicable federal or state securities law. The Company may cause a legend or legends to be placed on any such certificates to make appropriate reference to such restrictions.

 

10.           No Rights Conferred. Nothing contained in the Plan or this Agreement shall confer upon the Optionee any right with respect to the continuation of the Optionee’s employment or other service with the Company or its subsidiaries or interfere in any way with the right of the Company and its subsidiaries at any time to terminate such employment or other service or to otherwise modify the terms and conditions of the Optionee’s employment or other service.

 

11.           Provisions of the Plan. The provisions of the Plan, the terms of which are hereby incorporated by reference, shall govern if and to the extent that there are inconsistencies between those provisions and the provisions hereof. The Optionee acknowledges receipt of a copy of the Plan prior to the execution of this Agreement. Capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Plan.

 

12.           Miscellaneous This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and, except as otherwise provided in the Plan, may not be modified other than by written instrument executed by the parties.

 

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IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.

 

 

MONOSOL Rx, INC.

 

 

 

 

 

By:

 

 

 

 

 

 

 

 

 

 

Optionee

 

4




Exhibit 10.18

 

MONOSOL Rx, INC.
RESTRICTED STOCK AGREEMENT

 

AGREEMENT made as of the          day of                           , 20    , between Monosol Rx, Inc. (the “Company”) and                                      (the “Executive”), pursuant to the Monosol Rx, Inc. 2007 Stock Incentive Plan (the “Plan”).

 

1.             Restricted Stock Award. The Company has awarded              shares of its common stock (the “Shares”) to the Executive subject to the provisions of this Agreement and the Plan. Inconsistencies between this Agreement and the Plan will be governed by the applicable provisions of the Plan. The Executive acknowledges receipt of a copy of the Plan.

 

2.             Vesting.

 

(a)           General. Except as otherwise provided, the Shares will become vested (if at all) [upon the                anniversary of the date of this Agreement/in accordance with the following vesting schedule/upon attainment of the performance objectives set forth below], provided the Executive remains continuously employed by the Company or a subsidiary of the Company through the applicable vesting date[s].

 

(b)           Accelerated Vesting. Any outstanding unvested Shares will become vested (1) upon the termination of the Executive’s employment with the Company and its subsidiaries by reason of the Executive’s death or “disability” (as defined below), or (2) immediately prior to the occurrence of a “change in control” (as defined below), provided that the Executive remains in the continuous employ of the Company or a subsidiary until, or is terminated by the Company or a subsidiary within six months before, such change in control (other than a termination for cause, as determined in good faith by the Company’s board of directors).

 

(c)           Definitions. The term “disability” means the inability of the Executive to perform the principal duties of the Executive’s employment by reason of a physical or mental illness or injury that is expected to last indefinitely or result in death, as determined by a duly licensed physician selected by the Company. The term “change in control” means a change in the ownership or effective control of the Company or in the ownership of a substantial portion of the assets of the Company within the meaning of Section 409A of the Internal Revenue Code of 1986.

 

3.             Termination of Employment or Service. Except as otherwise provided in Section 2 above, in the event of the termination of the Executive’s employment with the Company and its subsidiaries, the Executive’s interest in any unvested Shares then held by the Executive will be immediately forfeited and such Shares will be canceled on the books of the Company.

 

4.             Restrictions on Transfer. Unvested Shares held by the Executive under this Agreement may not be sold, assigned, transferred, pledged, hypothecated, encumbered or dispose of in any way, whether by operation of law or otherwise, and may not be subjected to execution, attachment or similar process, and any attempt to do so will be null and void.

 

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5.             Dividends and Voting Rights. If cash dividends are paid by the Company with respect to its common stock, the amount of the dividends payable with respect to unvested Shares covered by this Agreement will be credited to a bookkeeping account in the name of the Executive and will be paid by the Company to the Executive if, as and when the corresponding Shares become vested. If Shares covered by this Agreement are forfeited, then any dividends with respect to such Shares that are credited to the Executive’s account will thereupon be forfeited as well. The Executive will be entitled to exercise voting rights with respect to the unvested Shares held by the Executive under this Agreement.

 

6.             Issuance of Shares. The Executive is the record owner of the Shares on the Company’s books, subject to the vesting conditions and restrictions set forth in this Agreement. By executing this Agreement, the Executive expressly authorizes the Company to cancel, reacquire, retire or retain, at its election, any unvested Shares if and when they are forfeited in accordance with this Agreement. The Executive will execute and deliver such other documents and take such other actions, if any, as the Company may reasonably request in order to evidence such action with respect to any unvested Shares that are forfeited. If, as and when Shares become vested, subject to the satisfaction of applicable withholding and other legal requirements, the vested Shares will no longer be subject to the transfer restrictions contained in this Agreement and the Company’s books will be updated accordingly. For the avoidance of doubt, if the Shares becomes vested as a result of a change in control, the Executive will be entitled to participate in the change in control transaction (if any) with respect to such Shares (less any Shares withheld to satisfy applicable tax withholding) on the same basis and in the same manner as other stockholders of the Company. The Company may place such legends or notations on certificates or its books relating to unvested Shares as it deems appropriate in connection with the proper administration and enforcement of the vesting conditions and transfer restrictions imposed by this Agreement.

 

7.             Tax Withholding. By executing this Agreement, the Executive authorizes the Company to deduct from any compensation or any other payment of any kind (including withholding the issuance of Shares) due to the Executive the amount of any federal, state, local or foreign taxes required by law to be withheld as a result of the grant or vesting of the Shares in whole or in part; provided, however, that the value of the Shares and/or cash withheld may not exceed the statutory minimum withholding amount required by law. In lieu of such deduction, the Company may condition the issuance of a certificate or other evidence of ownership for vested Shares upon the Executive’s payment of cash to the Company or making other arrangements satisfactory to the Committee for the payment of such withholding obligation.

 

8.             Capital Changes. In the event of a stock dividend, stock split, spin off or other recapitalization with respect to the outstanding shares of the Company’s common stock, the Company will make such adjustments to the Shares covered by this Agreement as are made to outstanding shares of Company stock that are not covered by this Agreement and any securities or other property issued or distributed by the Company in connection with any such capital change will be subject to the same vesting conditions and transfer restrictions applicable to the Shares in respect of which such property or other securities will have been issued or distributed.

 

9.             No Service or Other Rights. Nothing contained in the Plan or this Agreement shall confer upon the Executive any right with respect to the continuation of the

 

2



 

Executive’s employment or other service with the Company or any subsidiary of the Company or interfere in any way with the right of the Company or any subsidiary of the Company at any time to terminate such relationship. Compensation attributable to the award of Shares shall not be taken into account as compensation for purposes of determining the Executive’s benefits or entitlements under any employee pension, savings, group insurance, severance or other benefit plan or arrangement in which the Executive participates, unless and except to the extent otherwise specifically provided by such plan or arrangement.

 

10.           Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its principles of conflict of laws.

 

11.           Miscellaneous. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and may not be modified other than by written instrument executed by the parties.

 

IN WITNESS WHEREOF, this Agreement has been executed as of the date first above written.

 

 

MONOSOL Rx, INC.

 

 

 

 

 

By:

 

 

 

Title:

 

 

 

 

 

 

 

 

 

Executive

 

3




Exhibit 10.19

 

MONOSOL RX LLC
AMENDED AND RESTATED
PERFORMANCE UNIT APPRECIATION PLAN

 

Monosol Rx LLC, a Delaware limited liability company (“LLC”), maintains two performance unit plans (Plan A and Plan B), pursuant to which participating employees and other service providers hold performance units, each representing the right to receive the appreciation in value of a unit of membership interest in Monosol Rx LLC from the date the performance unit is granted to the date the performance unit is settled. It is contemplated that LLC will be merged into MonoSol Rx, Inc., a newly formed Delaware corporation (the “Company”) and that, immediately after the merger, the Company will issue shares of its common stock pursuant to an initial public offering (the “IPO”). In order to properly reflect the effect of the reorganization of LLC on outstanding performance unit awards, the Company hereby amends and restates the performance unit plans into a single plan (the “Plan”) upon the terms and conditions set forth herein, contingent upon and effective at the time of the aforesaid merger transaction.

 

ARTICLE I
DEFINITIONS

 

1.1           “Base Price” shall mean the Fair Market Value of a unit of membership interest in LLC on the date a Unit is granted, subject to adjustment for capital changes in accordance with the Plan.

 

1.2           “Board” shall mean the board of directors of the Company.

 

1.3           “Committee” shall mean the compensation committee of the Board.

 

1.4           “Company” shall mean MonoSol Rx, Inc. and any successor thereto.

 

1.5           “Effective Time” shall mean the effective time of the merger of LLC into the Company, as described in the introductory paragraph.

 

1.6           “Fair Market Value” shall mean, (a) with respect to a Unit, the fair market value of a unit of membership interest in the Company, as determined in good faith by the Advisory Board of LLC on the date the Unit is granted, and (b) with respect to an SAR, the NASDAQ market closing price per share of Company common stock on the date of reference or, if no shares of Company common stock are traded on that day, the closing price per share on the next preceding day on which such shares are traded, provided; however, that, for the purpose of adjusting outstanding Units as of the Effective Time to reflect the effect of the merger on outstanding holders of membership interests in the LLC, the Fair Market Value per share of Company common stock will be deemed to be equal to the per share IPO price.

 

1.7           “LLC” shall mean Monosol Rx LLC, a Delaware limited liability company.

 

1.8           “Lock Lock-Up Period” shall mean the period beginning with the Effective Time and ending on the 180th day after the Effective Time; provided, that if (i) during the last 17 days of said 180-day period, the Company issues an earnings release, or material news

 

1



 

or a material event relating to the Company occurs, or (ii) before the expiration of said 180-day period, the Company announces that it will release earnings results within 16 days after the end of said 180-day period, then, in any of such events, the Lock-Up Period shall be extended until the expiration of the 18-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event.

 

1.9           “Participant” shall mean an individual who, at the Effective Time, holds Units which are adjusted as of the Effective Time in accordance with the Plan.

 

1.10         “SARs” shall mean the stock appreciation rights resulting from the Unit adjustments made under the Plan to reflect the effect on the holders of outstanding LLC membership interests of the merger of LLC into the Company.

 

1.11         “Unit” shall mean the right to receive the increase in value of a unit of membership interest in LLC from the date the Unit is granted to the settlement date.

 

ARTICLE II
ADMINISTRATION

 

2.1           General. The Plan will be administered by the Committee. Subject to the provisions hereof, the Committee shall have full power in its discretion to construe and interpret the Plan and any award or other agreement or instrument entered into or issued under the Plan; establish, amend, or waive rules and regulations for the Plan’s administration; amend the terms and conditions of any outstanding award; and determine whether and on what terms and conditions outstanding awards will be adjusted in accordance with the Plan.

 

2.2           Delegation of Authority. Subject to the requirements of applicable law, the Committee may delegate to any person or group or subcommittee of persons (who may, but need not be members of the Board) such Plan-related functions within the scope of its responsibility, power and authority as it deems appropriate.

 

2.3           Decisions Binding. All determinations and decisions made by the Committee pursuant to the provisions of the Plan shall be final, conclusive, and binding on all persons.

 

2.4           Indemnity of Committee. The Company shall indemnify and hold harmless the members of the Committee and any employee of the Company or other individual to whom the Committee delegates authority or responsibility under the Plan against any and all claims, loss, damage, expense or liability arising from any action or failure to act with respect to the Plan, except in the case of gross negligence or willful misconduct.

 

ARTICLE III
PLAN AWARDS

 

3.1           Units. Immediately prior to the Effective Time, each Participant is credited with the number of Units, each of which represents the right, upon settlement, to receive the difference between the fair market value of a unit of LLC membership interest on the applicable settlement date over the fair market value per unit of LLC membership on the date the Unit was granted. All outstanding Units are subject to adjustment in order to reflect capital changes made

 

2



 

with respect to the LLC, consistent with adjustments made to outstanding units of membership interests held by the members of the LLC.

 

3.2           Conversion to SARs. As of the Effective Time, all outstanding Units will be converted into economically equivalent SARs. The conversion will be made in accordance with the methodology described in Section 1.424-1 of the Treasury Regulations such that, with respect to each Unit award, (a) the aggregate difference between the Fair Market Value and Base Price of the Company shares covered by an SAR immediately after the Effective Time is equal to the aggregate difference between the Fair Market Value and Base Price of the Units covered by the award immediately prior to the Effective Time, and (b) the ratio of the Base Price per share and the Fair Market Value per share of Company common stock immediately after the Effective Time is equal to the ratio of the Base Price per Unit and the Fair Market Value of a unit of membership interest in the LLC immediately prior to the Effective Time. The Committee’s determination as to the conversion of Unit awards into stock appreciation rights shall be binding and conclusive on all persons.

 

3.3           Terms and Conditions of SARs.

 

3.3.1        General. The Committee may establish such terms and conditions governing SARs as it deems appropriate, subject to the terms of the Plan. The Committee may issue certificates or agreements reflecting the terms and conditions of each Participant’s SARs, provided, however, that the terms and provisions of the Plan will govern in the event and to the extent that a provision in an individual certificate or agreement is inconsistent with the Plan.

 

3.3.2        Vesting. All SARs will be fully vested and exercisable (subject to any restrictions set forth in the Plan) upon completion of the IPO.

 

3.3.3        Term. Each SAR will expire if and to the extent it is not exercised before the tenth anniversary of the date the corresponding Unit award was granted.

 

3.3.4        Manner of Exercise. Subject to applicable law and uniform Company-imposed trading restrictions, a vested SAR may be exercised at any time, other than during the Lock-Up Period, prior to the expiration of the vested SAR by transmitting to the Secretary of the Company (or other person designated for this purpose by the Committee) a written notice of exercise specifying the number of shares covered by the exercise and accompanied by payment in full of the withholding taxes due in connection with the exercise, unless and except to the extent that other arrangements satisfactory to the Company have been made for such payment. The Board, acting in its discretion and subject to the provisions of applicable law, may permit a Participant to elect to satisfy the withholding obligation associated with the exercise of an SAR by directing that the Company withhold shares of stock at the time of settlement with a fair market value sufficient to cover the amount of the withholding tax obligation. The Committee may permit the use of a broker-facilitated cashless exercise procedure in connection with the exercise of SARs and the payment of applicable withholding taxes.

 

3.3.5        Settlement of SARs. An SAR that is exercised will be settled in the form of shares of Company stock having a Fair Market Value equal to the number of shares covered by the exercise multiplied by the difference between the Fair Market Value per share on the exercise date and the Base Price per share. Shares of Company stock issued in settlement of an SAR may be subject to such legends, restrictions, and other conditions as the Board, acting upon the advice of counsel, deems necessary or advisable in order to comply with applicable law and

 

3



 

the Plan. Participants will receive cash in lieu of fractional shares that would otherwise be issued in settlement of an SAR exercise. As between the Company and the Participants, the Company shall have the sole obligation to issue shares of Company stock in settlement of an SAR. Notwithstanding the preceding sentence, the persons who own the outstanding membership interests in the LLC immediately prior to the merger will be solely responsible for providing shares of Company common stock to the Company when and as necessary in order to fund the settlement of the SARs.

 

3.4           Death of a Participant. If a Participant dies, the deceased Participant’s beneficiary will be entitled to exercise the outstanding SARs held by the Participant at the time of the Participant’s death, subject to any limitations, restrictions or conditions applicable to such SARs prior to the Participant’s death. Each Participant may designate a beneficiary by filing a written beneficiary designation with the Company in such manner and subject to such requirements as the Committee may prescribe. A previously-filed beneficiary designation will be automatically revoked upon the filing of a new beneficiary designation. If a deceased Participant does not designate a beneficiary or no designated beneficiary survives the Participant, then the deceased Participant’s beneficiary will be his or her estate.

 

3.5           Change in Control. If a “change in control” (as defined below) occurs, then, unless the SARs are converted into equivalent stock appreciation rights or stock options with respect to stock of the acquiring or successor company, the Company will cause all then outstanding SARs to be redeemed immediately before the change in control based upon the value of the underlying Shares at the time of the change in control. For the purpose hereof, the term “change in control” means the occurrence, after the effective date of the Plan, in a single transaction or series of transactions, of any one of the following events or circumstances: (i) merger, consolidation or reorganization of the Company where the beneficial owners of the interests or securities possessing the right to vote with respect to the Company immediately preceding the merger, consolidation or reorganization beneficially own less than 50% of the interests or securities possessing the right to vote with respect to the survivor entity, after giving effect to such merger, consolidation, or reorganization; (ii) acquisition by any person or group, as defined for purposes of Section 13(d)(3) of the Securities Exchange Act of 1934, as amended, of beneficial ownership of interests or securities possessing the right to vote with respect to the Company where the beneficial owners of the interests or securities possessing the right to vote with respect to the Company immediately preceding such acquisition own less than 60% of the interests or securities possessing the right to vote with respect to the Company, after giving effect to such acquisition; (iii) approval by the stockholders of the Company of a plan of liquidation or dissolution with respect to the Company, provided such liquidation or dissolution is consummated; or (iv) the sale, exchange, or contribution of all or substantially all the Company’s assets to an entity where the beneficial owners of the interests or securities possessing the right to vote with respect to the Company immediately preceding the sale, exchange, or contribution beneficially own less than 50% of the interests or securities possessing the right to vote with respect to the acquiring entity.

 

ARTICLE IV
MISCELLANEOUS

 

4.1           Amendment or Termination. The Board may terminate the Plan or amend the Plan or any agreement made under the Plan at any time and from time to time; provided,

 

4



 

however, that no such action may adversely affect the value of a Participant’s or Beneficiary’s accrued interest under the Plan without the Participant’s or Beneficiary’s written consent.

 

4.2           Arbitration. Any dispute that arises with respect to the rights of a Participant or Beneficiary under the Plan shall be resolved by arbitration under the appropriate rules of the American Arbitration Association. Any arbitration shall be conducted in the metropolitan area closest to the location of the principal office of the Company in which the Participant performs or last performed services for the Company. All administrative fees connected with initiating a demand for arbitration shall be advanced by the Company, subject, however, to final apportionment by the arbitrator in his or her award. The arbitrator’s award shall be binding and may be enforced in any court having jurisdiction thereof by filing a petition for enforcement of such award.

 

4.3           No Right to Employment or Retention. Nothing herein contained shall be construed as giving any Participant the right to be retained in the employment or service of the Company or any other person.

 

4.4           No Assignment. Except as otherwise specified herein with respect to deceased Participants, no SAR may be assigned, alienated, transferred or subject to anticipation, either by voluntary or involuntary act of any Participant or Beneficiary or by operation of law, nor shall any SAR be subject to the demands or claims of any creditor of such person, nor be liable in any way for such person’s debts, obligations or liabilities.

 

4.5           Applicable Law; Validity. The validity of the Plan or any of its provisions shall be determined under and construed according to the laws of the State of Delaware. If any provision of the Plan shall be held illegal or invalid for any reason, such determination shall not affect the remaining provisions of the Plan and it shall be construed as if said illegal or invalid provision had never been included.

 

5




Exhibit 10.25

 

Execution Copy

 

EXECUTIVE EMPLOYMENT AGREEMENT

 

This Executive Employment Agreement (the ‘Agreement”) is made and entered into as of August 24, 2007, by and among Monosol Rx LLC (the “LLC”), MonoSol Rx, Inc. (the “Company”), and Alexander Mark Schobel (the “Executive”).

 

W I T N E S S E T H:

 

WHEREAS, the Executive is currently employed by LLC as its President and Chief Executive Officer under an Executive Employment Agreement made as of November 17, 2005; and

 

WHEREAS, the parties contemplate that, before the end of 2007, the LLC will merge with and into the Company and the Company will issue shares of its common stock pursuant to an initial public offering (the “Company IPO”), as described in the registration statement filed by the Company with the SEC on May 14, 2007, as amended; and

 

WHEREAS, the parties desire that, contingent upon and effective at the time of the contemplated Company IPO (the “IPO Date”), the Executive will be employed by the Company as its President and CEO upon the terms and conditions of this Agreement and that this Agreement will supersede said November 17, 2005 Executive Employment Agreement.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants herein set forth, and for other good and valuable consideration, the parties hereto, intending to be legally bound, hereby agree as follows:

 

1.             Employment. During the term of this Agreement, the Executive agrees to be employed by and to serve the Company as its President and Chief Executive Officer, and the Company agrees to employ and retain Executive in such capacity. The Executive shall report directly to the board of directors of the Company (the “Board’). The Company will use its reasonable efforts to ensure that the Executive will be a member of the Board during the term of this Agreement. The Executive shall: (i) devote his entire business time, energy and skill to the affairs of the Company; (ii) faithfully, loyally, and industriously perform all duties incident to the position of President and Chief Executive Officer, as well as any other duties consistent with the stature and responsibility of the Executive’s position as may from time to time be assigned by the Board; and (iii) comply with Company policies in effect from time to time. Notwithstanding any provision herein to the contrary, Executive shall not be precluded from devoting reasonable periods of time required for serving as a member of one or more advisory boards or boards of directors of companies or organizations or engaging in other minor business activities, so long as such memberships or activities do not interfere with the performance of Executive’s duties hereunder and are not directly or indirectly competitive with, nor contrary to, the business or other interests of the Company, subject to prior approval by the Board, which approval shall be granted in the Board’s reasonable sole discretion.

 

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2.             Employment Term.. The Employment Term of the Executive under this Agreement shall begin on the IPO Date and continue through December 31, 2010. Thereafter, the Employment Term will automatically renew for successive one-year periods unless either party gives notice of non-renewal to the other at least 90 days before the end of the initial term or then current renewal term, as the case may be.

 

3.             Compensation.

 

A.            Base Salary. The Company shall pay Executive a base salary (the “Base Salary”) at a rate of $350,000.00 per annum, payable in accordance with the standard payroll practices of the Company. The Compensation Committee of the Board (the “Compensation Committee”) will review Executive’s Base Salary at least annually and may increase but not decrease the then current annual rate.

 

B.            Bonus.

 

(i)            Bonus for 2007. The Executive’s annual bonus for the calendar year ending December 31, 2007 will be no less than the amount the Executive would have been entitled to receive pursuant to the terms of his 2007 LLC bonus opportunity. Such bonus will be determined by the Compensation Committee and will be payable by the Company by March 15, 2008, subject to Executive’s continuing employment.

 

(ii)           Annual Bonus after 2007. For each calendar year after 2007, Executive shall he eligible for a target bonus opportunity of at least 75% of Executive’s Base Salary for such calendar year, provided the Company achieves performance targets established by the Compensation Committee. It is anticipated that the annual bonus amount, if any, for a calendar year will be determined by the Compensation Committee and paid by the Company by March 15 of the following year. Except as otherwise provided by this Agreement, the Executive must be employed by the Company on the day any bonus payment is due and payable in order to receive said bonus payment. If the Company exceeds established performance targets, the Compensation Committee may, in its sole discretion, increase the amount of the Annual Bonus.

 

C.            Initial Equity Participation Awards. Contingent upon and immediately prior to the Company IPO, Executive will hold fully vested stock appreciation rights (“SARs”) with respect to shares of the Company’s common stock pursuant to the conversion of the LLC equity appreciation rights held by the Executive immediately prior to the merger of the LLC into the Company. In addition, at the time of the Company IPO, the Company will make the following awards to the Executive pursuant to the Company’s 2007 Stock Incentive Plan (the “Stock Incentive Plan”): (1) SARs covering a number of shares equal to the difference between 4% of the number of outstanding shares of Company common stock upon completion of the Company IPO (determined on a fully diluted

 

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basis with regard to SARs outstanding immediately prior to the Company IPO) and the number of shares of Company common stock covered by the SARs held by the Executive immediately prior to the Company IPO, with a base price per share equal to the Company IPO price per share, and (2) a restricted stock award for a number of shares of Company common stock equal to .47% of the aggregate number of outstanding shares of Company common stock upon completion of the Company IPO (determined on a fully diluted basis with regard to the number of shares authorized for issuance under the terms of the Stock Incentive Plan in effect upon completion of the Company IPO). The newly awarded SARs will vest in 36 equal monthly installments beginning on the last day of the month next following the month in which the Company IPO is completed, and the restricted stock award shall become vested on the third anniversary of the date the Company IPO is completed, in each case subject to Executive’s continuing employment on the applicable vesting date. Vesting of the SARs and the restricted stock award will accelerate if and when Executive’s employment terminates for any reason other than by the Company for “Cause” (as defined below) or by the Executive without “Good Reason” (as defined below). The SARs and the restricted shares will otherwise be subject to the terms and conditions of the applicable award agreement and the Stock Incentive Plan except to the extent inconsistent with the provisions hereof.

 

4.             Additional Benefits.

 

A.            Executive Benefits. During the Employment Term, Executive shall be eligible to participate in such employee benefit plans as are generally available to other senior executives of the Company.

 

B.            Paid Time Off. The Executive will be allowed to take up to four weeks of vacation each year, and shall be eligible for such sick leave and other paid time off in accordance with Company policies applicable to other executives generally.

 

C.            Expense Reimbursement. The Company will pay or reimburse Executive for reasonable expenses incurred by Executive in connection with the performance of  his duties and responsibilities under this Agreement, subject to presentation of vouchers and compliance with generally applicable business expense reimbursement policies of the Company.

 

5.             Termination.

 

A.            Termination for Cause. The Company may terminate Executive’s employment for “Cause” if Executive:

 

(i) is convicted of or pleads nolo contendre to a felony;

 

(ii) commits fraud or a material act or omission involving dishonesty with respect to the Company or any of its respective employees, customers or affiliates;

 

(iii) willfully and repeatedly fails or refuses to carry out the material responsibilities of Executive’s employment by the Company (except where due to physical or mental incapacity);

 

(iv) engages in willful misconduct, or a pattern of behavior which has had or is reasonably likely to have a significant adverse effect on the Company;

 

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(v) willfully engages in any act or omission which is in material violation of Company policy, including but not limited to engaging in insider trading transactions or disseminating inside information; or

 

(vi) commits a material breach of Executive’s material obligations under this Agreement, including but not limited to Section 8.

 

A decision to terminate the Executive’s employment for Cause must be made, if at all, by the affirmative vote of a majority of the members of the Board (not including Executive) at a meeting of the Board called and held for such purpose (after reasonable notice to Executive and an opportunity for Executive, together with counsel, to be heard before the Board) finding that, in the good faith opinion of the Board, Executive engaged in conduct set forth above and specifying the particulars thereof in reasonable detail. If the act or omission giving rise to the termination for Cause is curable by Executive, the Board will provide 30 days written notice to Executive of its intent to terminate Executive for Cause, with an explanation of the reason(s) for the termination for Cause, and if Executive cures the act or omission within the 30 day notice period, the Board will rescind the notice of termination and Executive’s employment will not be terminated for Cause at the end of the 30 day notice period. If Executive has previously been afforded the opportunity to cure particular behavior and successfully cured under this provision, the Board will have no obligation to provide Executive with notice and an opportunity to cure a recurrence of that behavior prior to a termination for Cause. Unless Executive receives 30 days notice and an opportunity to cure under this Section, Executive’s termination for Cause will be effective immediately upon the Board’s mailing or transmitting written notice of such termination to Executive. For purposes of this Section 5A., an action or inaction shall not be treated as “willful misconduct” if authorized by the Board or taken in the good faith belief that it was in, or not opposed to, the best interests of the Company.

 

B.            Termination by Reason of Permanent Disability. In a manner consistent with the Americans with Disabilities Act and the Family and Medical Leave Act, this Agreement may be terminated at the Company’s option immediately upon notice to Executive if Executive shall suffer a Permanent Disability. For purposes of this Agreement, the term “Permanent Disability” shall mean the Executive’s inability to perform the essential functions of his job under this Agreement, with or without reasonable accommodation, for a period of 150 consecutive days or for an aggregate of 180 days, whether or not consecutive, in any twelve (12) month period, due to illness, accident or other physical or mental incapacity, as determined by a duly licensed physician mutually agreed to by both the Executive and the Company.

 

C.            Termination by Reason of Death. In the event of the Executive’s death, the Executive’s employment shall be deemed to have terminated on the date of Executive’s death.

 

D.            Voluntary Resignation. Executive may terminate this Agreement at any time, subject to providing 90 days’ written notice to the Company. The Company may waive such notice and/or set an earlier termination date, without pay in lieu of notice.

 

E.             Termination without Cause. The Company may terminate Executive’s employment under this Agreement at any time without Cause upon 90 days prior written notice

 

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to Executive. The Company, at its sole discretion, may relieve Executive of his active duties during the notice period. The Company may also provide 90 days pay in lieu of notice. Executive’s termination without Cause will be effective upon the expiration of the 90-day notice period. For purposes of this Agreement, (1) a termination of employment by the Company that purports to be for Cause, but is not in full compliance with all of the substantive and procedural requirements relating to a termination for Cause under this Agreement, shall be treated as a termination of employment without Cause; and (2) the Executive will be deemed to have been terminated by the Company without Cause if the term of this Agreement expires by reason of non-renewal by the Company pursuant to Section 2.

 

F.             Termination for Good Reason The Executive may terminate his employment under this agreement at any time for Good Reason upon the occurrence of any one or more of the following acts or omissions which, if curable, is not cured within 30 days after notice of the occurrence is provided by Executive: (1) any action by the Company which results in a material diminution in Executive’s position, authority, duties or responsibilities (including status, offices, titles and reporting requirements contemplated by this Agreement); (2) a material breach by the Company of its obligations under this Agreement, including, without limitation, a reduction of Executive’s Base Salary or target bonus opportunity in violation of this Agreement; or (3) the Company’s requiring the Executive to be based at any office location that is more than 50 miles from its current headquarters in Warren, New Jersey, except for travel reasonably required in connection with the performance of the Executive’s responsibilities hereunder. Notwithstanding the foregoing, if a “Change in Control” occurs, the Executive will not have “Good Reason” to terminate his employment under this Agreement merely by reason of the fact that he no longer serves as the Chief Executive Officer of a publicly traded company or merely because he reports to the senior executive officer of a company that acquires the Company.

 

6.             Obligations of the Company Upon Termination.

 

A.            Termination for Cause. In the event that the Executive’s employment under this Agreement is terminated for Cause, the Company shall have no obligation to pay the Base Salary or any other compensation provided under this Agreement, to or for the benefit of the Executive for any period after the effective date of such termination, or to pay the Target Bonus or any other bonus or incentive compensation for the fiscal year in which such termination occurs; provided, however, that the Company shall promptly provide: (i) all base salary earned by the Executive through the effective date of such termination; and (ii) any benefits under any plans of the Company in which the Executive is a participant, to the full extent of the Executive’s rights under such plans.

 

B.            Termination by Reason of Death or Permanent Disability. In the event that the Executive’s employment under this Agreement terminates due to his death or is terminated by the Company due to the Executive’s Permanent Disability, the Company shall promptly provide to the Executive (or his estate or other beneficiaries, as the case may be): (i) a cash payment equal to the sum of any previously unpaid Base Salary earned by the Executive through the date on which his employment terminates, any unpaid bonus earned by the Executive for the year preceding the year in which his employment terminates, and any accrued and unused vacation pay for the year in which his employment terminates; (ii) any benefits under any plans

 

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of the Company in which the Executive is a participant, to the full extent of the Executive’s (or his beneficiaries’) rights under such plans; (iii) a cash payment equal to the Executive’s Target Bonus for the year of termination, pro-rated for the number of days Executive is employed during the calendar year in which his employment terminates (“Pro Rata Bonus”); and (iv) accelerated vesting of outstanding unvested stock options, SARs, restricted stock and other equity-based compensation awards as if the Executive’s employment had continued through the end of the year in which his employment terminates or, in the case of any such award that is subject to “cliff vesting,” pro rata accelerated vesting based upon the numerator of months in the vesting period that have elapsed as of the date his employment terminates. Stock options and SARs that are or become vested upon termination of the Executive’s employment due to death or Permanent Disability will be exercisable for at least one year after the date of such termination or, if earlier, until the expiration of the stated term of the award.

 

C.            Voluntary Resignation. In the event that the Executive voluntarily resigns from his employment with the Company, the Company may, at its discretion, continue the Executive’s employment with the Company for the full duration of the 90-day notice period. In the event of said termination, the Company shall have no obligation to pay the Base Salary or any other compensation provided under this Agreement to or for the benefit of the Executive for any period after the end of said notice period; provided, however, that the Company shall promptly provide: (i) all Base Salary earned by the Executive through the date of such termination; (iii) any unpaid bonus earned by the Executive for the year preceding the year in which his employment terminates, and (iii) any benefits under any plans of the Company in which Executive is a participant, to the full extent of the Executive’s rights under such plans.

 

D.            Termination by Company Without Cause or by Executive for Good Reason—Unrelated to Change in Control. In the event that the Executive’s employment under this Agreement is terminated by the Company without Cause (pursuant to Section 5E) or by the Executive for Good Reason (pursuant to Section 5F), the Company shall provide to the Executive: (i) a cash payment equal to the sum of any previously unpaid Base Salary earned by the Executive through the date on which his employment terminates, any unpaid bonus earned by the Executive for the year preceding the year in which his employment terminates, and any accrued and unused vacation pay for the year in which his employment terminates; (ii) any benefits under any plans of the Company in which the Executive is a participant, to the full extent of the Executive’s (or his beneficiaries’) rights under such plans; (iii) a cash payment equal to the Executive’s Pro Rata Bonus for the year of termination; (iv) monthly payments for a period (the “Severance Period”) of 18 months following the termination of Executive’s or, if longer, until the expiration of the Employment Term, equal to 1/12 of the sum of Executive’s Base Salary and Target Bonus (in each case determined without regard to any reduction prior to the termination of Executive’s employment); (v) continuing coverage under the Company’s group health and life insurance plans in which the Executive is a participant immediately before the termination of his employment (or any successor plans), at the same levels and on the same terms and conditions as are provided to similarly situated executives during the Severance Period (or, if such coverage is not permitted by law or the applicable plan, the cash equivalent of such coverage, grossed up if and to the extent necessary to negate the tax impact of such payment and to negate the gross-up payment); and (vi) full and immediate vesting of outstanding unvested stock options, SARs, restricted stock and other equity-based compensation awards, with any such stock options and SARs remaining exercisable for at least one year after the date the

 

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Executive’s employment terminates or, if earlier, until the expiration of the stated term of the award. The payments and benefits described in parts (iv) – (vi) of this subsection shall be conditioned upon and subject to the Executive’s continuing compliance with his obligations under Section 8 of this Agreement, and the Executive’s execution and delivery of a general release substantially in the form annexed hereto as Exhibit A.

 

E.             Termination in Conjunction with a Change in Control.

 

1.             Severance Protection Upon Involuntary Termination. In the event that, during the period beginning one hundred and eighty (180) days before the effective date of a Change in Control (as defined below) and ending twenty four (24) months following the effective date of a Change in Control, the Executive’s employment is terminated by the Company without Cause (pursuant to Section 5E) or by the Executive for Good Reason (pursuant to Section 5F), the Executive shall be entitled to the payments and benefits described in the preceding Section 6D except (1) in lieu of the severance payments described in part (iv) of Section 6D, Executive will be entitled to receive an immediate cash payment of an amount equal to 3.0 times the sum of the Executive’s Base Salary and Target Bonus (in each case determined without regard to any reduction prior to the termination of Executive’s employment); and (2) the benefit continuation period described in part (v) of Section 6D will be three years from the date the Executive’s employment terminates. The payments and benefits described in the preceding sentence and in parts (v) and (vi) of Section 6D and the single sum severance payment described in the preceding sentence shall be conditioned upon and subject to the Executive’s continuing compliance with his obligations under Section 8 of this Agreement, and the Executive’s execution and delivery of a general release substantially in the form annexed hereto as Exhibit A.

 

2.             Definition of Change in Control. For the purposes of this Agreement, a “Change in Control” shall be deemed to have occurred if (a) any person (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (“Exchange Act”)) becomes the beneficial owner (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of 40% or more of the combined voting power of the then outstanding voting securities of the Company; or (b) there shall have been consummated a consolidation, merger or reorganization of the Company, unless (1) the stockholders of the Company immediately before such consolidation, merger or reorganization own, directly or indirectly, at least a majority of the combined voting power of the outstanding voting securities of the corporation or other entity resulting from such consolidation, merger or reorganization, (2) individuals who were members of the Board immediately prior to the execution of the agreement providing for such consolidation, merger or reorganization constitute a majority of the board of directors of the surviving corporation or of a corporation directly or indirectly beneficially owning a majority of the voting securities of the surviving corporation, and (3) no person beneficially owns more than 40% of the combined voting power of the then outstanding voting securities of the surviving corporation (other than a person who is (A) the Company or a subsidiary of the Company, (B) an employee benefit plan maintained by the Company, the surviving corporation or any subsidiary, or (C) the beneficial owner of 40% or more of the combined voting power of the outstanding voting securities of the Company immediately prior to such consolidation, merger or reorganization); or (c)  individuals who, as of the date following the IPO Date, constitute the entire Board (the “Incumbent Board”) cease for any reason to constitute a majority of the Board,

 

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provided that any individual becoming a director subsequent to the IPO Date whose appointment or nomination for election by the Company’s stockholders, was approved by a vote of at least two-thirds of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board; or (d) the stockholders of the Company approve the complete liquidation or dissolution of the Company, or a sale or other disposition of all or substantially all of the assets of the Company (other than to an entity described in (b) above).

 

F.             409A Compliance. The Company shall take all reasonable actions to ensure that none of the amounts earned or payable under this Agreement and the Plan will violate Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”). To the extent necessary to comply with the restriction in Section 409A(a)(2)(B) of the Code concerning payments to “specified employees,” any amounts payable on account of the Executive’s separation from service shall be paid (or commence to be paid in the case of any payments to be made in installments) on the first business day of the seventh month following Executive’s date of termination (or death, if earlier) and the first such payment shall include the cumulative amount of any payments that would have been made prior to such date if not for such restriction, together with interest at an annual rate equal to the minimum rate required by the Code in order to avoid the imputation of interest on short-term loans between employers and employees.

 

7.             Excise Tax Gross Up. If Executive becomes entitled to one or more payments (with a “payment” including, without limitation, payments in connection with a Change In Control or the vesting of a stock option or other equity award or other non-cash benefit or property), whether pursuant to the terms of this Agreement or any other plan, arrangement, or agreement with the Company or any affiliated company (the “Total Payments”), which are or become subject to the tax imposed by Section 4999 of the Code or a successor provision of the Code (the “Excise Tax”), the Company shall pay to Executive at the time specified below an additional amount (the “Gross-up Payment”) (which shall include, without limitation, reimbursement for any penalties and interest that may accrue in respect of such Excise Tax) such that the net amount retained by Executive, after reduction for any Excise Tax (including any penalties or interest thereon) on the Total Payments and any federal, state and local income or employment tax and Excise Tax on the Gross-up Payment provided for by this Section, but before reduction for any federal,  state, or local income or employment tax on the Total Payments, shall be equal to the sum of (a) the Total Payments, and (b) an amount equal to the product of any deductions by the Executive disallowed for federal, state, or local income tax purposes because of the inclusion of the Gross-up Payment in Executive’s adjusted gross income multiplied by the highest applicable marginal rate of federal, state, or local income taxation, respectively, for the calendar year in which the Gross-up Payment is to be made. For purposes of determining whether any of the Total Payments will be subject to the Excise Tax and the amount of such Excise Tax:

 

(i)            The Total Payments shall be treated as “parachute payments” within the meaning of Section  280G(b)(2) of the Code, and all “excess parachute payments” within the meaning of Section 280G(b)(1) of the Code shall be treated as subject to the Excise Tax, unless, and except to the extent that, in the written opinion of independent compensation consultants, counsel or auditors of nationally recognized standing (“Independent  Advisors”) selected by the

 

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Company and reasonably acceptable to Executive, the Total Payments (in whole or in part) do not constitute parachute payments, or such excess parachute payments (in whole or in part) represent reasonable compensation for services actually rendered within the meaning of Section 280G(b)(4) of the Code in excess of the base amount within the meaning of Section 280G(b)(3) of the Code or are otherwise not subject to the Excise Tax;

 

(ii)           The amount of the Total Payments which shall be treated as subject to the Excise Tax shall be equal to the lesser of (A) the total amount of the Total Payments or (B) the total amount of excess parachute payments within the meaning of Section 280G(b)(1) of the Code (after applying clause (i) above); and

 

(iii)          The value of any non-cash benefits or any deferred payment or benefit shall be determined by the Independent Advisors in accordance with the principles of Sections 280G(d)(3) and (4) of the Code.

 

For purposes of determining the amount of  the Gross-up Payment, Executive shall be deemed (A) to pay federal income taxes at the highest marginal rate of federal income taxation for the calendar year in which the Gross-up Payment is to be made; (B) to pay any applicable state and local income taxes at the highest marginal rate of taxation for the calendar year in which the Gross-up Payment is to be made, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state and  local taxes if paid in such year (determined without regard to limitations on deductions based upon the amount of Executive’s adjusted gross income); and (C) to have otherwise allowable deductions for federal, state, and local income tax purposes at least equal to those disallowed because of the inclusion of the Gross-up Payment in Executive’s adjusted gross income. In the event that the Excise Tax is subsequently determined to be less than the amount taken into account hereunder at the time the Gross-up Payment is made, Executive shall repay to the Company at the time that the amount of such reduction in Excise Tax is finally determined (but, if previously paid to the taxing authorities, not prior to the time the amount of such reduction is refunded to Executive or otherwise realized as a benefit by Executive) (the “Repayment Date”) the portion of the Gross-up Payment that would not have been paid if such Excise Tax had been applied in initially calculating the Gross-up Payment, plus interest on the amount of such repayment at the rate provided in Section 1274(b)(2)(B) of the Code from the Repayment Date until paid. In the event that the Excise Tax is determined to exceed the amount taken into account hereunder at the time the Gross-up Payment is made (including by reason of any payment the existence or amount of which cannot be determined at the time of the Gross-up Payment), the Company shall make an additional Gross-up Payment in respect of such excess (plus any interest and penalties payable with respect to such excess) at the time that the amount of such excess is finally determined.

 

The Gross-up Payment provided for above shall be paid to the Executive (or to the IRS on behalf of the Executive) on the 30th day (or such earlier date as the Excise Tax becomes due and payable to the taxing authorities) after it has been determined that the Total Payments (or any portion thereof) are subject to the Excise Tax; provided, however, that if the amount of such Gross-up Payment or portion thereof cannot be finally determined on or before  such day, the Company shall pay to Executive on such day an estimate, as determined by the Independent Advisors, of the minimum amount of such payments and shall pay the remainder of such payments (together with interest at the rate provided in Section 1274(b)(2)(B) of the Code),

 

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as soon as the amount thereof can be determined. In the event that the amount of the estimated payments exceeds the amount subsequently determined to have been due, such excess shall constitute a loan by the Company to Executive, payable on the fifth day after demand by the Company (together with interest at the rate provided in Section 1274(b)(2)(B) of the Code). If more than one Gross-up Payment is made, the amount of each Gross-up Payment shall be computed so as not to duplicate any prior Gross-up Payment subject to the Company’s compliance with the provisions of this Section. The Company shall have the right to control all proceedings with the Internal Revenue Service that may arise in connection with the determination and assessment of any Excise Tax and, at its sole option, the Company may pursue or forego any and all administrative appeals, proceedings, hearings, and conferences with any taxing authority in respect of such Excise Tax (including any interest or penalties thereon); provided, however, that the Company’s control over any such proceedings shall be limited to issues with respect to which a Gross-up Payment would be payable hereunder, and Executive shall be entitled to settle or contest any other issue raised by the Internal Revenue Service or any other taxing authority. Executive shall cooperate with the Company in any proceedings relating to the determination and assessment of any Excise Tax and shall not take any position or action that would materially increase the amount of any Gross-up Payment hereunder.

 

8.             Covenants of the Executive.

 

In order to induce the Company to enter into this Agreement and employ the Executive hereunder, the Executive hereby covenants and agrees as follows. For all purposes under this Section 8 herein, the Company’s “business” shall mean film based delivery systems to deliver drug actives, nutraceuticals, cosmaceuticals or flavors, and soluble film based packaging systems and such other lines of business in which the Company is actively engaged or actively pursuing and with respect to which Executive has oversight responsibility or is otherwise substantively involved.

 

A.            Non-Competition. During the Employment Term, including any extensions thereof, and for a period of 18 months immediately following the termination of Executive’s employment under this Agreement for any reason other than death (the “Restrictive Period”), except as provided herein, Executive shall not directly or indirectly: (a) engage in or in any manner be connected or concerned, whether as an officer, director, stockholder, partner, owner, employee, advisor, creditor, or otherwise with the development, operation, management, or conduct of any business in the United States that competes with the business of the Company being conducted at the time of such termination; (b) solicit or otherwise attempt to divert business from or interfere in the Company’s relationship with any supplier of the Company or any customer served by the Company or and potential customer identified by Company during the period of Executive’s employment hereunder; or (c) solicit, hire or otherwise interfere with the Company’s relationship with any person then or previously employed by Company; provided, however, that, after the termination of Executive’s employment, Executive shall not be bound by the Covenant set forth in this subparagraph following a material breach by the Company of any of its obligations to the Executive hereunder or in the event of the cessation or dissolution of the Company’s business. As used herein, “cessation or dissolution” means total liquidation of the Company and does not include a cessation of business due to any Change in Control. Nothing contained herein shall prohibit Executive from owning up to 3% of the stock of

 

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a publicly traded company that competes with the business of the Company or, following the termination of his employment with the Company, prevent the Executive from being employed by or otherwise affiliated with a line of business of another company that engages in multiple lines of business so long as the Executive is not employed by, does not provide services with respect to and is not otherwise involved in the line or lines of business of such other company that compete with the Company.

 

B.            Confidentiality. During the Employment Term, and following the termination of this Agreement for any reason for as long as the information remains confidential, Executive shall not make any use, for his own benefit or for the benefit of a business or entity other than Company, of any verbal or written secret or confidential information. Such confidential information shall include, but not be limited to, customer lists, trade secrets, sales, marketing or consignment information, vendor lists or operational resource information, forms, processes or procedures, budget and financial statements or information, files, records, documents, compilation of data, engineering drawings, computer print-outs, or any other data of or pertaining to the Company, its business, customers and financial affairs, or its services not generally known within the Company’s trade and which was acquired by him during his affiliation with the Company. Executive shall not remove from the Company premises or retain without the Company’s written consent any of the Company’s confidential information as defined herein, or copies thereof or extracts therefrom. Executive shall hold in a fiduciary capacity for the benefit of the Company all secret or confidential information, knowledge, or data of the Company or its business or production operations obtained by Executive during his employment by the Company, which shall not be generally known to the public or recognized as standard practice (whether or riot developed by Executive) and shall not, during his employment hereunder or after the termination of such employment, communicate or divulge any such information, knowledge or data to any person, firm or corporation other than the Company or persons, firms or corporations designated by the Company. Executive acknowledges that this information is treated as confidential by the Company, that the Company takes meaningful steps to protect the confidentiality of this information, and that Company has at all times directed Executive to maintain the confidentiality of this information. Immediately upon termination of this Agreement, Executive shall return all of the Company’s property to it, including any and all copies of said property.

 

C.            Ownership of Work Product. Executive agrees that Company shall own all intellectual property including trade secrets, patents, patentable inventions, discoveries and improvements that relate to Company’s business that Executive conceives, develops during the period of his employment with the Company or delivers to the Company while performing services pursuant to this Agreement (“Work Product”). Executive further agrees to deliver to the Company, and that the Company shall thereafter own for all purposes, all Work Product conceived or developed by the Executive relating to the business of the Company which does not otherwise belong to Employee’s former employer or to which the former employer has no legal right or claim. Executive hereby irrevocably extinguishes for the benefit of the Company and its assigns any moral right to the Work Product recognized by applicable law. All Work Product shall be considered a work made for hire by Executive and owned by Company. If any of the Work Product may not, by operation of law, be considered work made for hire by Executive for Company, or if ownership of all right, title and interest of the intellectual property rights therein shall not otherwise vest exclusively in the Company, Executive agrees to assign, and upon

 

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creation thereof automatically assign, without further consideration, the ownership of all trade secrets, copyrights, patentable inventions, and other intellectual property rights therein to Company, its successors and assigns. Company, its successors, and assigns, shall have the right to obtain and hold in its or their own name copyrights, patents, registrations and any other protection available in the foregoing. For purposes hereof, a “trade secret” shall mean any information, including, but not limited to, technical or nontechnical data, formulae, patterns, compilations, programs, devices, methods, techniques, drawings. processes, financial data, financial plans, product plans or lists of actual or potential customers or suppliers that derive economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from their disclosure or use and are the subject of efforts that are reasonable under the circumstances to maintain their secrecy. Executive agrees to perform, upon the reasonable request of Company and at no cost to the Company (other than travel out of pocket costs where applicable), during or after the period(s) that this Agreement remains in effect, such further acts as may be necessary or desirable to transfer, perfect and defend the Company’s ownership of Work Product, or to enforce the Company’s Work Product against third parties. When requested, Executive shall promptly and at no cost to the Company (other than travel out of pocket costs, where applicable): (a) execute, acknowledge and deliver any requested affidavits and documents of assignment and conveyance; (b) obtain and aid in the enforcement of copyright and, if applicable, patents with respect to the Work Product in any countries; (c) provide testimony in connection with any enforcement proceeding or any proceeding affecting the right, title or interest of Company in any Work Product; and (d) perform any other acts deemed necessary or desirable to carry out the purposes of this Agreement.

 

D.            Inventions. All discoveries, designs, improvements, ideas and inventions, whether patentable or not, relating to (or suggested by or resulting from) products, services, or other technology of Company or relating to (or suggested by or resulting from) methods or processes used or usable in connection with the business of Company that have been, or may be, conceived, developed or made by Executive during the Employment Term (hereinafter “Inventions”), either solely or jointly with others, shall automatically become the sole property of Company. Executive shall immediately disclose to Company all such Inventions and shall, without additional compensation, execute all assignments and other documents deemed necessary by Company to perfect Company’s title thereto, or to the patents issued thereon, or to otherwise secure and protect Company’s property rights therein. These obligations shall continue beyond the termination of Executive’s employment with respect to Inventions conceived, developed or made by Executive during employment with Company. The Company acknowledges and agrees that the provisions of this paragraph shall not apply to any invention for which no equipment, supplies, facilities or trade secret (or proprietary) information of Company is used by Executive and which is developed entirely on Executive’s own time, unless (a) such invention related to the business of Company or to Company’s actual or demonstrably anticipated research or development; or (b) such invention results from any work performed by Executive for Company.

 

E.             Acknowledgment. Executive acknowledges that all of the restrictions set forth in this Section entitled “Covenants of the Executive” are reasonable in scope, both individually and in the aggregate, and essential to the preservation of Company’s business and proprietary interests and that the enforcement thereof will not in any manner preclude Executive,

 

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in the event of Executive’s termination of employment with Company for any reason, from becoming gainfully employed in such manner and to such extent as to provide a standard of living for himself, the members of his family, and those dependent upon him of at least the sort and fashion to which he and they have become accustomed and may expect. The Company and the Executive further agree that if any particular provision or portion of this Section 8 shall be adjudicated to be invalid or unenforceable, such adjudication shall apply only with respect to the operation of such provision in the particular jurisdiction in which such adjudication is made. The Company and Executive also agree that in the event that any restriction herein shall be found to be void or unenforceable if some part or parts thereof were deleted or the period or area of application reduced, such restriction shall apply with such modification as may be necessary to make it valid and enforceable to the fullest extent possible consonant with applicable law.

 

G.            Representations and Warranties. Executive represents and warrants to the Company as follows: (a) Executive is under no contractual or other restriction or obligation which may conflict with or be inconsistent with the execution of this Agreement or with the performing of any duties for Company, or any other rights of Company; (b) neither Company nor any of its affiliates nor any of their respective officers, directors, employees, agents or employees has requested that Executive communicate or otherwise make available to any such parties at any time any proprietary information, data, trade secrets, or other confidential information belonging to Executive’s former employers or others.

 

H.            Severability. All of the covenants of Executive contained in this Section entitled “Covenants of the Executive” shall each be construed as an agreement independent of any other provision in this Agreement, and the existence of any claim or cause of action of Executive against Company, whether predicated on this Agreement or otherwise, shall not constitute a defense to the enforcement by Company of such covenants. Both parties hereby expressly agree that it is not the intention of either party to violate any public policy, statutory or common law. If any sentence, paragraph, clause or combination of the same of this Agreement is in violation of the law of any state where applicable, such sentence, paragraph, clause or combination of the same shall be void in the jurisdictions where it is unlawful, and the remainder of such paragraph and this Agreement shall remain binding on the parties to the extent that it may be lawfully done under existing applicable laws. In the event that any part of any covenant of this Agreement is determined by a court of law to be overly broad thereby making the covenant unenforceable, the parties hereto agree, and it is their desire that such court shall substitute a judicially enforceable limitation in its place, and that as so modified the covenant shall be binding upon the parties as if originally set forth herein.

 

I.              Remedies. The Executive agrees that irreparable harm would result from any breach by Executive of the covenants of this Section 8 in particular, and this Agreement in general, and that monetary damages alone would not provide the Company adequate relief for any such breach. Accordingly, if Executive breaches any covenant in this Section 8, the parties acknowledge that equitable or injunctive relief in favor of the Company is a proper remedy, and nothing in this Agreement shall be construed as precluding the Company from seeking such equitable or injunctive relief in a court of competent jurisdiction for Executive’s violations of Section 8. Any award of equitable or injunctive relief shall not preclude the Company from seeking or recovering any lawful compensatory damages that may have resulted from a breach of

 

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the covenants of this Agreement. Any waiver or failure to seek enforcement or remedy for any breach or suspected breach of any covenant of Executive in this Agreement shall not be deemed a waiver of such provision in the future. Furthermore, the existence of any claim of Executive against the Company, whether based upon this Agreement or otherwise, shall not operate as a defense to the Company’s enforcement of any provision of this Agreement. Proceedings seeking equitable and injunctive relief to enforce the terms of this Section 8 may be brought in any court of competent jurisdiction.

 

9              Indemnification. Subject to the Company’s by-laws, to the fullest extent allowed or permitted under any provision of applicable law, the Company shall indemnify Executive against any losses, claims, damages or liabilities incurred by Executive arising out of any claim based upon acts performed or omitted to be performed by Executive in connection with his employment with the Company.

 

10.           Attorneys’ Fees. In any action brought by any party under this Agreement to enforce any of its terms, or any appeal therefrom, each party shall bear its own costs and expenses, including its own attorneys’ fees; provided, however, that the Executive (or his beneficiary, as the case may be) will be entitled to reimbursement for reasonable costs and expenses, including reasonable attorneys’ fees, with respect to such action if and to the extent that the Executive (or beneficiary) is the prevailing party.

 

11.           Cooperation. Executive agrees that, after the termination of his employment, he shall cooperate on a reasonable basis in the truthful and honest prosecution and/or defense of any claim in which the Company, its affiliates and/or its subsidiaries may have an interest (subject to reasonable limitations and the Executive’s other commitments concerning time and place), which may include, without limitation, making himself available on a reasonable basis to participate in any proceeding involving the Company, its affiliates and/or its subsidiaries, appearing for depositions and testimony without requiring a subpoena, and producing and/or providing any documents or names of other persons with relevant information. The Company agrees to reimburse Executive for all expenses reasonably incurred by him and to pay reasonable compensation to Executive for and in connection with services provided by him pursuant to this section.

 

12.           Travel Restrictions. As is reasonable, Executive has the right to refuse travel to destinations deemed politically unstable or otherwise hostile and/or those that may represent a danger to the Executive’s health and well-being.

 

13.           Notices. Any notices permitted or required under this Agreement shall be deemed given upon the date of personal delivery or forty-eight (48) hours after deposit in the United States mail, postage fully paid, certified mail, return receipt requested, addressed to the following address:

 

If to the Company:

 

Chairman of the Board of Directors

 

 

c/o MonoSol Rx, Inc.

 

 

30 Technology Drive

 

 

Warren Township, NJ 07059

 

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With copies to:

 

Compensation Committee Chairperson

 

 

c/o MonoSol Rx, Inc.

 

 

30 Technology Drive

 

 

Warren Township, NJ 07059; and

 

 

 

 

 

John Cochran

 

 

201 Main Street, Suite 1900

 

 

Fort Worth, Texas 76102

 

 

 

If to the Executive:

 

Alexander Mark Schobel

 

 

6 Demott Drive

 

 

Whitehouse Station, NJ 08889

 

Either party may change the address to which notices to such party shall be delivered personally or mailed by giving notice thereof to the other party hereto.

 

14.           Venue; Jurisdiction. The validity, construction, interpretation, and enforceability of this Agreement shall be determined and governed by the laws of the State of New Jersey without giving effect to the principles of conflicts of law. For the purpose of litigating any dispute that arises under this Agreement, the parties hereby consent to exclusive jurisdiction of, and agree that such litigation shall be conducted in, any state or federal court located in the State of New Jersey.

 

15.           Binding Effect; Assignment. Executive shall not, without the prior written consent of the Company, assign, transfer, or otherwise convey this Agreement, or any right or interest herein. This Agreement, and all rights and obligations of the Company or any of its successors, may be assigned or otherwise transferred to any of its successors and shall be binding upon and inure to the benefit of its successors. As used herein, the term “successor” shall mean any person, corporation or other entity that, by merger, consolidation, purchase of stock, assets, liquidation, voluntary or involuntary assignment, or otherwise, acquires all or a substantial part of the assets of the Company or succeeds to one or more lines of business of the Company.

 

16.           Entire Agreement. This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements, understandings and arrangements, both oral and written, between the parties hereto with respect to such subject matter, it being understood that this Agreement shall not supersede the Executive’s existing employment agreement with LLC unless and until the Executive’s employment by the Company pursuant to this Agreement becomes effective in accordance with Section 2 hereof. This Agreement may not be modified, amended, altered or rescinded in any manner, except by written instrument signed by all of the parties hereto; provided, however, that any waiver by either party with respect to any provision hereof, or the breach of any provision hereof by the other party, need be signed only by the party waiving such provision or breach; and provided, further, that the waiver by either party hereto of a breach or compliance with any

 

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provision of this Agreement shall not operate nor be construed as a waiver of any subsequent breach or compliance.

 

17.           Severability. In case any one or more of the provisions of this Agreement shall be held by any court of competent jurisdiction to be illegal, invalid or unenforceable in any respect, the remainder of this Agreement, or the application of such provision to persons or circumstances other than those to which it is held to be illegal, invalid, or unenforceable, shall not he affected thereby.

 

I8.            Section Headings  The section headings contained in this Agreement are for reference purposes only and shall not affect in any manner the meaning or interpretation of this Agreement.

 

19.           Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument.

 

20.           Survival. The provisions of Sections 6-11 of this Agreement shall survive any termination of this Agreement and the termination of Executive’s employment by either party for any reason.

 

IN WITNESS WHEREOF, the parties hereto have executed and delivered this Agreement as of the day and year first above written.

 

 

MONOSOL RX, INC.

 

 

 

By:

/s/ John S. Cochran

 

 

 

MONOSOL RX, LLC

 

 

 

 

 

By:

/s/ John S. Cochran

 

 

 

 

 

/s/ Alexander Mark Schobel

 

Alexander Mark Schobel

 

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Execution Copy

 

EXHIBIT A
GENERAL RELEASE

 

In exchange for certain payments and benefits to be provided to me by MonoSol Rx, Inc. pursuant to the Employment Agreement dated as of              , 2007, between the undersigned executive (the “Executive”), Monosol LLC and MonoSol Rx, Inc., the Executive hereby knowingly and voluntarily waives, releases and discharges MonoSol Rx, Inc., its predecessors, successors, parent corporations, subsidiaries, affiliates and each of their employees, officers and directors, agents, trustees, and fiduciaries (the “Company”) from any and all claims, liabilities, demands, and causes of action, which he may have or claim to have against the Company, including any and all claims arising out of or relating in any way to the Executive’s employment and/or separation of employment from the Company. This General Release specifically waives and releases all rights, claims, causes of action, demands, and liabilities which may arise up to and including the date the Executive signs this General Release. This General Release does not, however, waive or release any rights or claims which may arise after the date the Executive signs this General Release.

 

This General Release of claims includes, but is not limited to:

 

a.             all State and Federal statutory claims including, but not limited to, claims arising under Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act, the Older Worker Benefit Protection Act, the Americans with Disabilities Act, the Family and Medical Leave Act, the Sarbanes-Oxley Act, the Employee Retirement Income Security Act, the Fair Labor Standards Act, the Worker Adjustment and Retraining Notification Act, the New Jersey Law Against Discrimination, the New Jersey Civil Rights Act, the New Jersey Civil Union Act, the New Jersey Wage and Hour Law, the New Jersey Conscientious Employee Protection Act, the New Jersey Domestic Partnership Act, and the New Jersey Family Leave Act;

 

b.             All claims arising under the United States and New Jersey Constitutions;

 

c.             All claims arising under any Executive Order or derived from or based upon any State or Federal regulations;

 

d.             All common law claims including, but not limited to, claims for wrongful or constructive discharge, public policy claims, retaliation claims, claims for breach of an express or implied contract, claims for breach of an implied covenant of good faith and fair dealing, intentional infliction of emotional distress, defamation, fraud, conspiracy, loss of consortium, tortious interference with contract or prospective economic advantage, promissory estoppel and negligence;

 

e.             All claims for any compensation including, but not limited to, back wages, front pay, overtime pay, bonuses or awards, fringe benefits, reinstatement, retroactive seniority, pension benefits, or any other form of economic loss;

 

f.              All claims for personal injury including, but not limited to, physical injury, mental anguish, emotional distress, pain and suffering, embarrassment,

 

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humiliation, damage to name or reputation, liquidated damages, and punitive damages; and

 

g.             All claims for costs and attorneys’ fees.

 

The Executive hereby acknowledges that the Company is advising him in writing that he should consult with an attorney prior to executing this General Release. The Executive hereby states that he has had the opportunity to discuss this General Release with whomever the Executive wished, including an attorney of his own choosing. The Executive further states that he has had the opportunity to read, review, and consider all of the provisions of this General Release; that the Executive understands its provisions and its binding effect on him; and that the Executive is entering into this General Release freely, voluntarily, and without duress or coercion. The Executive acknowledges that he has not relied upon the Company’s employees, officers or directors, counsel, agents or accountants for any legal, tax or other advice, and the Executive has, to the extent the Executive deems necessary, consulted with his own advisors as to these matters.

 

The Executive represents that he has not filed any grievance, charge, claim, or complaint of any kind seeking personal recovery or personal injunctive relief against the Company or any of its owners, officers, directors, employees or agents, with respect to any matter, including but not limited to, his employment with the Company and/or the separation of that employment. Nothing contained in this paragraph shall prohibit the Executive from (a) bringing any action to enforce the terms of this Agreement and General Release; (b) filing a timely charge or complaint with the Equal Employment Opportunity Commission (“EEOC”) regarding the validity of this Agreement and General Release; (c) filing a timely charge or complaint with the EEOC or participating in any investigation or proceeding conducted by the EEOC regarding any claim of employment discrimination (although the Executive has waived any right to personal recovery or personal injunctive relief in connection with any such charge or complaint).

 

The Executive understands that he has twenty-one (21) calendar days within which to consider this General Release before signing it. The Executive also understands that he is free to use as much of the twenty-one (21) calendar day period as he wishes or considers necessary before deciding to sign this General Release. The Executive may revoke his signature of this General Release within seven (7) calendar days of signing it by delivering written notice of revocation to Theresa Wood, Director of Human Resources, 30 Technology Drive, Warren, New Jersey 07059. If Executive has not revoked his signature of this Agreement by written notice delivered within the seven (7) calendar day period, it becomes effective immediately thereafter.

 

The Executive understands that his failure or refusal to execute this General Release or his timely revocation of this General Release will result in forfeiture of any severance payments and benefits.

 

BY SIGNING THIS GENERAL RELEASE, EXECUTIVE ACKNOWLEDGES THAT:

 

HE HAS READ IT;

 

HE UNDERSTANDS IT AND KNOWS HE IS GIVING UP IMPORTANT RIGHTS;

 

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HE AGREES WITH EVERYTHING IN IT;

 

HE HAS BEEN ADVISED TO CONSULT WITH AN ATTORNEY PRIOR TO EXECUTING THIS GENERAL RELEASE; AND

 

HE HAS SIGNED THIS GENERAL RELEASE KNOWINGLY AND VOLUNTARILY.

 

 

 

 

 

Executive

 

 

 

 

 

MONOSOL RX, INC.

 

 

 

 

 

By:

 

 

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Exhibit 10.26

 

Execution Copy

 

EXECUTIVE EMPLOYMENT AGREEMENT

 

This Executive Employment Agreement (the ‘Agreement”) is made and entered into as of August 24, 2007, by and among Monosol Rx LLC (the “LLC”), MonoSol Rx, Inc. (the “Company”), and Keith J. Kendall (the “Executive”).

 

W I T N E S S E T H:

 

WHEREAS, the Executive is currently employed by LLC as its Senior Vice President and Chief Financial Officer under an Executive Employment Agreement dated June 16, 2006; and

 

WHEREAS, the parties contemplate that, before the end of 2007, the LLC will merge with and into the Company and the Company will issue shares of its common stock pursuant to an initial public offering (the “Company IPO”), as described in the registration statement filed by the Company with the SEC on May 14, 2007, as amended; and

 

WHEREAS, the parties desire that, contingent upon and effective at the time of the contemplated Company IPO (the “IPO Date”), the Executive will be employed by the Company as its Executive Vice President and Chief Financial Officer upon the terms and conditions of this Agreement and that this Agreement will supersede said June 16, 2006 Executive Employment Agreement.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants herein set forth, and for other good and valuable consideration, the parties hereto, intending to be legally bound, hereby agree as follows:

 

1.             Employment. During the term of this Agreement, the Executive agrees to be employed by and to serve the Company as its Executive Vice President and Chief Financial Officer, and the Company agrees to employ and retain Executive in such capacity. The Executive shall report directly to the President and CEO (hereafter the “CEO”). The Executive shall also serve as the Company’s Corporate Secretary and Treasurer unless and until the Company re-assigns those positions to one or more other persons. The Executive shall: (i) devote his entire business time, energy and skill to the affairs of the Company; (ii) faithfully, loyally, and industriously perform all duties incident to the position of Executive Vice President and Chief Financial Officer and, as applicable, Corporate Secretary and Treasurer, as well as any other duties consistent with the stature and responsibility of the Executive’s position as may from time to time be assigned by the CEO; and (iii) comply with Company policies in effect from time to time. Notwithstanding any provision herein to the contrary, Executive shall not be precluded from devoting reasonable periods of time required for serving as a member of one or more advisory boards or boards of directors of companies or organizations or engaging in other minor business activities, so long as such memberships or activities do not interfere with the performance of Executive’s duties hereunder and are not directly or indirectly competitive with,

 

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nor contrary to, the business or other interests of the Company, subject to prior approval by the Board, which approval shall be granted in the Board’s reasonable sole discretion.

 

2.             Employment Term.. The Employment Term of the Executive under this Agreement shall begin on the IPO Date and continue through December 31, 2010. Thereafter, the Employment Term will automatically renew for successive one-year periods unless either party gives notice of non-renewal to the other at least 90 days before the end of the initial term or then current renewal term, as the case may be.

 

3.             Compensation.

 

A.            Base Salary. The Company shall pay Executive a base salary (the “Base Salary”) at a rate of $325,000.00 per annum, payable in accordance with the standard payroll practices of the Company. The Compensation Committee of the Board (the “Compensation Committee”) will review Executive’s Base Salary at least annually and may increase but not decrease the then current annual rate.

 

B.            Bonus.

 

(i)            Bonus for 2007. The Executive’s annual bonus for the calendar year ending December 31, 2007 will be no less than the amount the Executive would have been entitled to receive pursuant to the terms of his 2007 LLC bonus opportunity. Such bonus will be determined by the Compensation Committee and will be payable by the Company by March 15, 2008, subject to Executive’s continuing employment.

 

(ii)           Annual Bonus after 2007. For each calendar year after 2007, Executive shall he eligible for a target bonus opportunity of at least 75% of Executive’s Base Salary for such calendar year, provided the Company achieves performance targets established by the Compensation Committee. It is anticipated that the annual bonus amount, if any, for a calendar year will be determined by the Compensation Committee and paid by the Company by March 15 of the following year. Except as otherwise provided by this Agreement, the Executive must be employed by the Company on the day any bonus payment is due and payable in order to receive said bonus payment. If the Company exceeds established performance targets, the Compensation Committee may, in its sole discretion, increase the amount of the Annual Bonus.

 

C.            Initial Equity Participation Awards. Contingent upon and immediately prior to the Company IPO, Executive will hold fully vested stock appreciation rights (“SARs”) with respect to shares of the Company’s common stock pursuant to the conversion of the LLC equity appreciation rights held by the Executive immediately prior to the merger of the LLC into the Company. In addition, at the time of the Company IPO, the Company will make the following awards to the Executive pursuant to the Company’s 2007 Stock Incentive Plan (the “Stock Incentive Plan”): (1) SARs covering a number of shares equal to the difference between 3% of the number of outstanding shares of Company common stock upon completion of the Company IPO (determined on a fully diluted basis with regard to SARs outstanding immediately

 

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prior to the Company IPO) and the number of shares of Company common stock covered by the SARs held by the Executive immediately prior to the Company IPO, with a base price per share equal to the Company IPO price per share, and (2) a restricted stock award for a number of shares of Company common stock equal to ..24% of the aggregate number of outstanding shares of Company common stock upon completion of the Company IPO (determined on a fully diluted basis with regard to the number of shares authorized for issuance under the terms of the Stock Incentive Plan in effect upon completion of the Company IPO). The newly awarded SARs will vest in 36 equal monthly installments beginning on the last day of the month next following the month in which the Company IPO is completed, and the restricted stock award shall become vested on the third anniversary of the date the Company IPO is completed, in each case subject to Executive’s continuing employment on the applicable vesting date. Vesting of the SARs and the restricted stock award will accelerate if and when Executive’s employment terminates for any reason other than by the Company for “Cause” (as defined below) or by the Executive without “Good Reason” (as defined below). The SARs and the restricted shares will otherwise be subject to the terms and conditions of the applicable award agreement and the Stock Incentive Plan except to the extent inconsistent with the provisions hereof.

 

4.             Additional Benefits.

 

A.            Executive Benefits. During the Employment Term, Executive shall be eligible to participate in such employee benefit plans as are generally available to other senior executives of the Company.

 

B.            Paid Time Off. The Executive will be allowed to take up to four weeks of vacation each year, and shall be eligible for such sick leave and other paid time off in accordance with Company policies applicable to other executives generally.

 

C.            Expense Reimbursement. The Company will pay or reimburse Executive for reasonable expenses incurred by Executive in connection with the performance of  his duties and responsibilities under this Agreement, subject to presentation of vouchers and compliance with generally applicable business expense reimbursement policies of the Company.

 

5.             Termination.

 

A.            Termination for Cause. The Company may terminate Executive’s employment for “Cause” if Executive:

 

(i) is convicted of or pleads nolo contendre to a felony;

 

(ii) commits fraud or a material act or omission involving dishonesty with respect to the Company or any of its respective employees, customers or affiliates;

 

(iii) willfully and repeatedly fails or refuses to carry out the material responsibilities of Executive’s employment by the Company (except where due to physical or mental incapacity);

 

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(iv) engages in willful misconduct, or a pattern of behavior which has had or is reasonably likely to have a significant adverse effect on the Company;

 

(v) willfully engages in any act or omission which is in material violation of Company policy, including but not limited to engaging in insider trading transactions or disseminating inside information; or

 

(vi) commits a material breach of Executive’s material obligations under this Agreement, including but not limited to Section 8.

 

A decision to terminate the Executive’s employment for Cause must be made, if at all, by the affirmative vote of a majority of the members of the Board (not including Executive) at a meeting of the Board called and held for such purpose (after reasonable notice to Executive and an opportunity for Executive, together with counsel, to be heard before the Board) finding that, in the good faith opinion of the Board, Executive engaged in conduct set forth above and specifying the particulars thereof in reasonable detail. If the act or omission giving rise to the termination for Cause is curable by Executive, the Board will provide 30 days written notice to Executive of its intent to terminate Executive for Cause, with an explanation of the reason(s) for the termination for Cause, and if Executive cures the act or omission within the 30 day notice period, the Board will rescind the notice of termination and Executive’s employment will not be terminated for Cause at the end of the 30 day notice period. If Executive has previously been afforded the opportunity to cure particular behavior and successfully cured under this provision, the Board will have no obligation to provide Executive with notice and an opportunity to cure a recurrence of that behavior prior to a termination for Cause. Unless Executive receives 30 days notice and an opportunity to cure under this Section, Executive’s termination for Cause will be effective immediately upon the Board’s mailing or transmitting written notice of such termination to Executive. For purposes of this Section 5A., an action or inaction shall not be treated as “willful misconduct” if authorized by the Board or taken in the good faith belief that it was in, or not opposed to, the best interests of the Company.

 

B.            Termination by Reason of Permanent Disability. In a manner consistent with the Americans with Disabilities Act and the Family and Medical Leave Act, this Agreement may be terminated at the Company’s option immediately upon notice to Executive if Executive shall suffer a Permanent Disability. For purposes of this Agreement, the term “Permanent Disability” shall mean the Executive’s inability to perform the essential functions of his job under this Agreement, with or without reasonable accommodation, for a period of 150 consecutive days or for an aggregate of 180 days, whether or not consecutive, in any twelve (12) month period, due to illness, accident or other physical or mental incapacity, as determined by a duly licensed physician mutually agreed to by both the Executive and the Company.

 

C.            Termination by Reason of Death. In the event of the Executive’s death, the Executive’s employment shall be deemed to have terminated on the date of Executive’s death.

 

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D.            Voluntary Resignation. Executive may terminate this Agreement at any time, subject to providing 90 days’ written notice to the Company. The Company may waive such notice and/or set an earlier termination date, without pay in lieu of notice.

 

E.             Termination without Cause. The Company may terminate Executive’s employment under this Agreement at any time without Cause upon 90 days prior written notice to Executive. The Company, at its sole discretion, may relieve Executive of his active duties during the notice period. The Company may also provide 90 days pay in lieu of notice. Executive’s termination without Cause will be effective upon the expiration of the 90-day notice period. For purposes of this Agreement, (1) a termination of employment by the Company that purports to be for Cause, but is not in full compliance with all of the substantive and procedural requirements relating to a termination for Cause under this Agreement, shall be treated as a termination of employment without Cause; and (2) the Executive will be deemed to have been terminated by the Company without Cause if the term of this Agreement expires by reason of non-renewal by the Company pursuant to Section 2.

 

F.             Termination for Good Reason The Executive may terminate his employment under this agreement at any time for Good Reason upon the occurrence of any one or more of the following acts or omissions which, if curable, is not cured within 30 days after notice of the occurrence is provided by Executive: (1) any action by the Company which results in a material diminution in Executive’s position, authority, duties or responsibilities as Executive Vice President and Chief Financial Officer of the Company (including status, offices, titles and reporting requirements contemplated by this Agreement); (2) a material breach by the Company of its obligations under this Agreement, including, without limitation, a reduction of Executive’s Base Salary or target bonus opportunity in violation of this Agreement; or (3) the Company’s requiring the Executive to be based at any office location that is more than 50 miles from its current headquarters in Warren, New Jersey, except for travel reasonably required in connection with the performance of the Executive’s responsibilities hereunder. Notwithstanding the foregoing, a re-assignment by the Company to one or more other persons of the position and responsibilities of Corporate Secretary and/or Treasurer will not be grounds for a Good Reason termination by the Executive; and if a “Change in Control” occurs, the Executive will not have “Good Reason” to terminate his employment under this Agreement merely by reason of the fact that he no longer serves as the Chief Financial Officer of a publicly traded company or merely because he reports to the senior executive officer of a company that acquires the Company.

 

6.             Obligations of the Company Upon Termination.

 

A.            Termination for Cause. In the event that the Executive’s employment under this Agreement is terminated for Cause, the Company shall have no obligation to pay the Base Salary or any other compensation provided under this Agreement, to or for the benefit of the Executive for any period after the effective date of such termination, or to pay the Target Bonus or any other bonus or incentive compensation for the fiscal year in which such termination occurs; provided, however, that the Company shall promptly provide: (i) all base salary earned by the Executive through the effective date of such termination; and (ii) any

 

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benefits under any plans of the Company in which the Executive is a participant, to the full extent of the Executive’s rights under such plans.

 

B.            Termination by Reason of Death or Permanent Disability. In the event that the Executive’s employment under this Agreement terminates due to his death or is terminated by the Company due to the Executive’s Permanent Disability, the Company shall promptly provide to the Executive (or his estate or other beneficiaries, as the case may be): (i) a cash payment equal to the sum of any previously unpaid Base Salary earned by the Executive through the date on which his employment terminates, any unpaid bonus earned by the Executive for the year preceding the year in which his employment terminates, and any accrued and unused vacation pay for the year in which his employment terminates; (ii) any benefits under any plans of the Company in which the Executive is a participant, to the full extent of the Executive’s (or his beneficiaries’) rights under such plans; (iii) a cash payment equal to the Executive’s Target Bonus for the year of termination, pro-rated for the number of days Executive is employed during the calendar year in which his employment terminates (“Pro Rata Bonus”); and (iv) accelerated vesting of outstanding unvested stock options, SARs, restricted stock and other equity-based compensation awards as if the Executive’s employment had continued through the end of the year in which his employment terminates or, in the case of any such award that is subject to “cliff vesting,” pro rata accelerated vesting based upon the numerator of months in the vesting period that have elapsed as of the date his employment terminates. Stock options and SARs that are or become vested upon termination of the Executive’s employment due to death or Permanent Disability will be exercisable for at least one year after the date of such termination or, if earlier, until the expiration of the stated term of the award.

 

C.            Voluntary Resignation. In the event that the Executive voluntarily resigns from his employment with the Company, the Company may, at its discretion, continue the Executive’s employment with the Company for the full duration of the 90-day notice period. In the event of said termination, the Company shall have no obligation to pay the Base Salary or any other compensation provided under this Agreement to or for the benefit of the Executive for any period after the end of said notice period; provided, however, that the Company shall promptly provide: (i) all Base Salary earned by the Executive through the date of such termination; (iii) any unpaid bonus earned by the Executive for the year preceding the year in which his employment terminates, and (iii) any benefits under any plans of the Company in which Executive is a participant, to the full extent of the Executive’s rights under such plans.

 

D.            Termination by Company Without Cause or by Executive for Good Reason—Unrelated to Change in Control. In the event that the Executive’s employment under this Agreement is terminated by the Company without Cause (pursuant to Section 5E) or by the Executive for Good Reason (pursuant to Section 5F), the Company shall provide to the Executive: (i) a cash payment equal to the sum of any previously unpaid Base Salary earned by the Executive through the date on which his employment terminates, any unpaid bonus earned by the Executive for the year preceding the year in which his employment terminates, and any accrued and unused vacation pay for the year in which his employment terminates; (ii) any benefits under any plans of the Company in which the Executive is a participant, to the full extent of the Executive’s (or his beneficiaries’) rights under such plans; (iii) a cash payment

 

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equal to the Executive’s Pro Rata Bonus for the year of termination; (iv) monthly payments for a period (the “Severance Period”) of 18 months following the termination of Executive’s or, if longer, until the expiration of the Employment Term, equal to 1/12 of the sum of Executive’s Base Salary and Target Bonus (in each case determined without regard to any reduction prior to the termination of Executive’s employment); (v) continuing coverage under the Company’s group health and life insurance plans in which the Executive is a participant immediately before the termination of his employment (or any successor plans), at the same levels and on the same terms and conditions as are provided to similarly situated executives during the Severance Period (or, if such coverage is not permitted by law or the applicable plan, the cash equivalent of such coverage, grossed up if and to the extent necessary to negate the tax impact of such payment and to negate the gross-up payment); and (vi) full and immediate vesting of outstanding unvested stock options, SARs, restricted stock and other equity-based compensation awards, with any such stock options and SARs remaining exercisable for at least one year after the date the Executive’s employment terminates or, if earlier, until the expiration of the stated term of the award. The payments and benefits described in parts (iv) – (vi) of this subsection shall be conditioned upon and subject to the Executive’s continuing compliance with his obligations under Section 8 of this Agreement, and the Executive’s execution and delivery of a general release substantially in the form annexed hereto as Exhibit A.

 

E.             Termination in Conjunction with a Change in Control.

 

1.             Severance Protection Upon Involuntary Termination. In the event that, during the period beginning one hundred and eighty (180) days before the effective date of a Change in Control (as defined below) and ending twenty four (24) months following the effective date of a Change in Control, the Executive’s employment is terminated by the Company without Cause (pursuant to Section 5E) or by the Executive for Good Reason (pursuant to Section 5F), the Executive shall be entitled to the payments and benefits described in the preceding Section 6D except (1) in lieu of the severance payments described in part (iv) of Section 6D, Executive will be entitled to receive an immediate cash payment of an amount equal to 2.75 times the sum of the Executive’s Base Salary and Target Bonus (in each case determined without regard to any reduction prior to the termination of Executive’s employment); and (2) the benefit continuation period described in part (v) of Section 6D will be 33 months from the date the Executive’s employment terminates. The payments and benefits described in the preceding sentence and in parts (v) and (vi) of Section 6D and the single sum severance payment described in the preceding sentence shall be conditioned upon and subject to the Executive’s continuing compliance with his obligations under Section 8 of this Agreement, and the Executive’s execution and delivery of a general release substantially in the form annexed hereto as Exhibit A.

 

2.             Definition of Change in Control. For the purposes of this Agreement, a “Change in Control” shall be deemed to have occurred if (a) any person (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (“Exchange Act”)) becomes the beneficial owner (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of 40% or more of the combined voting power of the then outstanding voting securities of the Company; or (b) there shall have been consummated a consolidation, merger or reorganization of the Company, unless (1) the stockholders of the Company immediately before

 

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such consolidation, merger or reorganization own, directly or indirectly, at least a majority of the combined voting power of the outstanding voting securities of the corporation or other entity resulting from such consolidation, merger or reorganization, (2) individuals who were members of the Board immediately prior to the execution of the agreement providing for such consolidation, merger or reorganization constitute a majority of the board of directors of the surviving corporation or of a corporation directly or indirectly beneficially owning a majority of the voting securities of the surviving corporation, and (3) no person beneficially owns more than 40% of the combined voting power of the then outstanding voting securities of the surviving corporation (other than a person who is (A) the Company or a subsidiary of the Company, (B) an employee benefit plan maintained by the Company, the surviving corporation or any subsidiary, or (C) the beneficial owner of 40% or more of the combined voting power of the outstanding voting securities of the Company immediately prior to such consolidation, merger or reorganization); or (c)  individuals who, as of the date following the IPO Date, constitute the entire Board (the “Incumbent Board”) cease for any reason to constitute a majority of the Board, provided that any individual becoming a director subsequent to the IPO Date whose appointment or nomination for election by the Company’s stockholders, was approved by a vote of at least two-thirds of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board; or (d) the stockholders of the Company approve the complete liquidation or dissolution of the Company, or a sale or other disposition of all or substantially all of the assets of the Company (other than to an entity described in (b) above).

 

F.             409A Compliance. The Company shall take all reasonable actions to ensure that none of the amounts earned or payable under this Agreement and the Plan will violate Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”). To the extent necessary to comply with the restriction in Section 409A(a)(2)(B) of the Code concerning payments to “specified employees,” any amounts payable on account of the Executive’s separation from service shall be paid (or commence to be paid in the case of any payments to be made in installments) on the first business day of the seventh month following Executive’s date of termination (or death, if earlier) and the first such payment shall include the cumulative amount of any payments that would have been made prior to such date if not for such restriction, together with interest at an annual rate equal to the minimum rate required by the Code in order to avoid the imputation of interest on short-term loans between employers and employees.

 

7.             Excise Tax Gross Up. If Executive becomes entitled to one or more payments (with a “payment” including, without limitation, payments in connection with a Change In Control or the vesting of a stock option or other equity award or other non-cash benefit or property), whether pursuant to the terms of this Agreement or any other plan, arrangement, or agreement with the Company or any affiliated company (the “Total Payments”), which are or become subject to the tax imposed by Section 4999 of the Code or a successor provision of the Code (the “Excise  Tax”), the Company shall pay to Executive at the time specified below an additional amount (the “Gross-up Payment”) (which shall include, without limitation, reimbursement for any penalties and interest that may accrue in respect of such Excise Tax) such that the net amount retained by Executive, after reduction for any Excise Tax (including any penalties or interest thereon) on the Total Payments and any federal, state and local income or employment tax and Excise Tax on the Gross-up Payment provided for by this

 

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Section, but before reduction for any federal,  state, or local income or employment tax on the Total Payments, shall be equal to the sum of (a) the Total Payments, and (b) an amount equal to the product of any deductions by the Executive disallowed for federal, state, or local income tax purposes because of the inclusion of the Gross-up Payment in Executive’s adjusted gross income multiplied by the highest applicable marginal rate of federal, state, or local income taxation, respectively, for the calendar year in which the Gross-up Payment is to be made. For purposes of determining whether any of the Total Payments will be subject to the Excise Tax and the amount of such Excise Tax:

 

(i)            The Total Payments shall be treated as “parachute payments” within the meaning of Section  280G(b)(2) of the Code, and all “excess parachute payments” within the meaning of Section 280G(b)(1) of the Code shall be treated as subject to the Excise Tax, unless, and except to the extent that, in the written opinion of independent compensation consultants, counsel or auditors of nationally recognized standing (“Independent  Advisors”) selected by the Company and reasonably acceptable to Executive, the Total Payments (in whole or in part) do not constitute parachute payments, or such excess parachute payments (in whole or in part) represent reasonable compensation for services actually rendered within the meaning of Section 280G(b)(4) of the Code in excess of the base amount within the meaning of Section 280G(b)(3) of the Code or are otherwise not subject to the Excise Tax;

 

(ii)           The amount of the Total Payments which shall be treated as subject to the Excise Tax shall be equal to the lesser of (A) the total amount of the Total Payments or (B) the total amount of excess parachute payments within the meaning of Section 280G(b)(1) of the Code (after applying clause (i) above); and

 

(iii)          The value of any non-cash benefits or any deferred payment or benefit shall be determined by the Independent Advisors in accordance with the principles of Sections 280G(d)(3) and (4) of the Code.

 

For purposes of determining the amount of  the Gross-up Payment, Executive shall be deemed (A) to pay federal income taxes at the highest marginal rate of federal income taxation for the calendar year in which the Gross-up Payment is to be made; (B) to pay any applicable state and local income taxes at the highest marginal rate of taxation for the calendar year in which the Gross-up Payment is to be made, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state and  local taxes if paid in such year (determined without regard to limitations on deductions based upon the amount of Executive’s adjusted gross income); and (C) to have otherwise allowable deductions for federal, state, and local income tax purposes at least equal to those disallowed because of the inclusion of the Gross-up Payment in Executive’s adjusted gross income. In the event that the Excise Tax is subsequently determined to be less than the amount taken into account hereunder at the time the Gross-up Payment is made, Executive shall repay to the Company at the time that the amount of such reduction in Excise Tax is finally determined (but, if previously paid to the taxing authorities, not prior to the time the amount of such reduction is refunded to Executive or otherwise realized as a benefit by Executive) (the “Repayment Date”) the portion of the Gross-up Payment that would not have been paid if such Excise Tax had been applied in initially calculating the Gross-up Payment, plus interest on the amount of such repayment at the rate

 

9



 

provided in Section 1274(b)(2)(B) of the Code from the Repayment Date until paid. In the event that the Excise Tax is determined to exceed the amount taken into account hereunder at the time the Gross-up Payment is made (including by reason of any payment the existence or amount of which cannot be determined at the time of the Gross-up Payment), the Company shall make an additional Gross-up Payment in respect of such excess (plus any interest and penalties payable with respect to such excess) at the time that the amount of such excess is finally determined.

 

The Gross-up Payment provided for above shall be paid to the Executive (or to the IRS on behalf of the Executive) on the 30th day (or such earlier date as the Excise Tax becomes due and payable to the taxing authorities) after it has been determined that the Total Payments (or any portion thereof) are subject to the Excise Tax; provided, however, that if the amount of such Gross-up Payment or portion thereof cannot be finally determined on or before  such day, the Company shall pay to Executive on such day an estimate, as determined by the Independent Advisors, of the minimum amount of such payments and shall pay the remainder of such payments (together with interest at the rate provided in Section 1274(b)(2)(B) of the Code), as soon as the amount thereof can be determined. In the event that the amount of the estimated payments exceeds the amount subsequently determined to have been due, such excess shall constitute a loan by the Company to Executive, payable on the fifth day after demand by the Company (together with interest at the rate provided in Section 1274(b)(2)(B) of the Code). If more than one Gross-up Payment is made, the amount of each Gross-up Payment shall be computed so as not to duplicate any prior Gross-up Payment subject to the Company’s compliance with the provisions of this Section. The Company shall have the right to control all proceedings with the Internal Revenue Service that may arise in connection with the determination and assessment of any Excise Tax and, at its sole option, the Company may pursue or forego any and all administrative appeals, proceedings, hearings, and conferences with any taxing authority in respect of such Excise Tax (including any interest or penalties thereon); provided, however, that the Company’s control over any such proceedings shall be limited to issues with respect to which a Gross-up Payment would be payable hereunder, and Executive shall be entitled to settle or contest any other issue raised by the Internal Revenue Service or any other taxing authority. Executive shall cooperate with the Company in any proceedings relating to the determination and assessment of any Excise Tax and shall not take any position or action that would materially increase the amount of any Gross-up Payment hereunder.

 

8.             Covenants of the Executive.

 

In order to induce the Company to enter into this Agreement and employ the Executive hereunder, the Executive hereby covenants and agrees as follows. For all purposes under this Section 8 herein, the Company’s “business” shall mean film based delivery systems to deliver drug actives, nutraceuticals, cosmaceuticals or flavors, and soluble film based packaging systems and such other lines of business in which the Company is actively engaged or actively pursuing and with respect to which Executive has oversight responsibility or is otherwise substantively involved.

 

A.            Non-Competition. During the Employment Term, including any extensions thereof, and for a period of 18 months immediately following the termination of

 

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Executive’s employment under this Agreement for any reason other than death (the “Restrictive Period”), except as provided herein, Executive shall not directly or indirectly: (a) engage in or in any manner be connected or concerned, whether as an officer, director, stockholder, partner, owner, employee, advisor, creditor, or otherwise with the development, operation, management, or conduct of any business in the United States that competes with the business of the Company being conducted at the time of such termination; (b) solicit or otherwise attempt to divert business from or interfere in the Company’s relationship with any supplier of the Company or any customer served by the Company or and potential customer identified by Company during the period of Executive’s employment hereunder; or (c) solicit, hire or otherwise interfere with the Company’s relationship with any person then or previously employed by Company; provided, however, that, after the termination of Executive’s employment, Executive shall not be bound by the Covenant set forth in this subparagraph following a material breach by the Company of any of its obligations to the Executive hereunder or in the event of the cessation or dissolution of the Company’s business. As used herein, “cessation or dissolution” means total liquidation of the Company and does not include a cessation of business due to any Change in Control. Nothing contained herein shall prohibit Executive from owning up to 3% of the stock of a publicly traded company that competes with the business of the Company or, following the termination of his employment with the Company, prevent the Executive from being employed by or otherwise affiliated with a line of business of another company that engages in multiple lines of business so long as the Executive is not employed by, does not provide services with respect to and is not otherwise involved in the line or lines of business of such other company that compete with the Company.

 

B.            Confidentiality. During the Employment Term, and following the termination of this Agreement for any reason for as long as the information remains confidential, Executive shall not make any use, for his own benefit or for the benefit of a business or entity other than Company, of any verbal or written secret or confidential information. Such confidential information shall include, but not be limited to, customer lists, trade secrets, sales, marketing or consignment information, vendor lists or operational resource information, forms, processes or procedures, budget and financial statements or information, files, records, documents, compilation of data, engineering drawings, computer print-outs, or any other data of or pertaining to the Company, its business, customers and financial affairs, or its services not generally known within the Company’s trade and which was acquired by him during his affiliation with the Company. Executive shall not remove from the Company premises or retain without the Company’s written consent any of the Company’s confidential information as defined herein, or copies thereof or extracts therefrom. Executive shall hold in a fiduciary capacity for the benefit of the Company all secret or confidential information, knowledge, or data of the Company or its business or production operations obtained by Executive during his employment by the Company, which shall not be generally known to the public or recognized as standard practice (whether or riot developed by Executive) and shall not, during his employment hereunder or after the termination of such employment, communicate or divulge any such information, knowledge or data to any person, firm or corporation other than the Company or persons, firms or corporations designated by the Company. Executive acknowledges that this information is treated as confidential by the Company, that the Company takes meaningful steps to protect the confidentiality of this information, and that Company has at all times directed Executive to maintain the confidentiality of this information. Immediately upon termination of

 

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this Agreement, Executive shall return all of the Company’s property to it, including any and all copies of said property.

 

C.            Ownership of Work Product. Executive agrees that Company shall own all intellectual property including trade secrets, patents, patentable inventions, discoveries and improvements that relate to Company’s business that Executive conceives, develops during the period of his employment with the Company or delivers to the Company while performing services pursuant to this Agreement (“Work Product”). Executive further agrees to deliver to the Company, and that the Company shall thereafter own for all purposes, all Work Product conceived or developed by the Executive relating to the business of the Company which does not otherwise belong to Employee’s former employer or to which the former employer has no legal right or claim. Executive hereby irrevocably extinguishes for the benefit of the Company and its assigns any moral right to the Work Product recognized by applicable law. All Work Product shall be considered a work made for hire by Executive and owned by Company. If any of the Work Product may not, by operation of law, be considered work made for hire by Executive for Company, or if ownership of all right, title and interest of the intellectual property rights therein shall not otherwise vest exclusively in the Company, Executive agrees to assign, and upon creation thereof automatically assign, without further consideration, the ownership of all trade secrets, copyrights, patentable inventions, and other intellectual property rights therein to Company, its successors and assigns. Company, its successors, and assigns, shall have the right to obtain and hold in its or their own name copyrights, patents, registrations and any other protection available in the foregoing. For purposes hereof, a “trade secret” shall mean any information, including, but not limited to, technical or nontechnical data, formulae, patterns, compilations, programs, devices, methods, techniques, drawings. processes, financial data, financial plans, product plans or lists of actual or potential customers or suppliers that derive economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from their disclosure or use and are the subject of efforts that are reasonable under the circumstances to maintain their secrecy. Executive agrees to perform, upon the reasonable request of Company and at no cost to the Company (other than travel out of pocket costs where applicable), during or after the period(s) that this Agreement remains in effect, such further acts as may be necessary or desirable to transfer, perfect and defend the Company’s ownership of Work Product, or to enforce the Company’s Work Product against third parties. When requested, Executive shall promptly and at no cost to the Company (other than travel out of pocket costs, where applicable): (a) execute, acknowledge and deliver any requested affidavits and documents of assignment and conveyance; (b) obtain and aid in the enforcement of copyright and, if applicable, patents with respect to the Work Product in any countries; (c) provide testimony in connection with any enforcement proceeding or any proceeding affecting the right, title or interest of Company in any Work Product; and (d) perform any other acts deemed necessary or desirable to carry out the purposes of this Agreement.

 

D.            Inventions. All discoveries, designs, improvements, ideas and inventions, whether patentable or not, relating to (or suggested by or resulting from) products, services, or other technology of Company or relating to (or suggested by or resulting from) methods or processes used or usable in connection with the business of Company that have been, or may be, conceived, developed or made by Executive during the Employment Term (hereinafter

 

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“Inventions”), either solely or jointly with others, shall automatically become the sole property of Company. Executive shall immediately disclose to Company all such Inventions and shall, without additional compensation, execute all assignments and other documents deemed necessary by Company to perfect Company’s title thereto, or to the patents issued thereon, or to otherwise secure and protect Company’s property rights therein. These obligations shall continue beyond the termination of Executive’s employment with respect to Inventions conceived, developed or made by Executive during employment with Company. The Company acknowledges and agrees that the provisions of this paragraph shall not apply to any invention for which no equipment, supplies, facilities or trade secret (or proprietary) information of Company is used by Executive and which is developed entirely on Executive’s own time, unless (a) such invention related to the business of Company or to Company’s actual or demonstrably anticipated research or development; or (b) such invention results from any work performed by Executive for Company.

 

E.             Acknowledgment. Executive acknowledges that all of the restrictions set forth in this Section entitled “Covenants of the Executive” are reasonable in scope, both individually and in the aggregate, and essential to the preservation of Company’s business and proprietary interests and that the enforcement thereof will not in any manner preclude Executive, in the event of Executive’s termination of employment with Company for any reason, from becoming gainfully employed in such manner and to such extent as to provide a standard of living for himself, the members of his family, and those dependent upon him of at least the sort and fashion to which he and they have become accustomed and may expect. The Company and the Executive further agree that if any particular provision or portion of this Section 8 shall be adjudicated to be invalid or unenforceable, such adjudication shall apply only with respect to the operation of such provision in the particular jurisdiction in which such adjudication is made. The Company and Executive also agree that in the event that any restriction herein shall be found to be void or unenforceable if some part or parts thereof were deleted or the period or area of application reduced, such restriction shall apply with such modification as may be necessary to make it valid and enforceable to the fullest extent possible consonant with applicable law.

 

G.            Representations and Warranties. Executive represents and warrants to the Company as follows: (a) Executive is under no contractual or other restriction or obligation which may conflict with or be inconsistent with the execution of this Agreement or with the performing of any duties for Company, or any other rights of Company; (b) neither Company nor any of its affiliates nor any of their respective officers, directors, employees, agents or employees has requested that Executive communicate or otherwise make available to any such parties at any time any proprietary information, data, trade secrets, or other confidential information belonging to Executive’s former employers or others.

 

H.            Severability. All of the covenants of Executive contained in this Section entitled “Covenants of the Executive” shall each be construed as an agreement independent of any other provision in this Agreement, and the existence of any claim or cause of action of Executive against Company, whether predicated on this Agreement or otherwise, shall not constitute a defense to the enforcement by Company of such covenants. Both parties hereby expressly agree that it is not the intention of either party to violate any public policy, statutory or

 

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common law. If any sentence, paragraph, clause or combination of the same of this Agreement is in violation of the law of any state where applicable, such sentence, paragraph, clause or combination of the same shall be void in the jurisdictions where it is unlawful, and the remainder of such paragraph and this Agreement shall remain binding on the parties to the extent that it may be lawfully done under existing applicable laws. In the event that any part of any covenant of this Agreement is determined by a court of law to be overly broad thereby making the covenant unenforceable, the parties hereto agree, and it is their desire that such court shall substitute a judicially enforceable limitation in its place, and that as so modified the covenant shall be binding upon the parties as if originally set forth herein.

 

I.              Remedies. The Executive agrees that irreparable harm would result from any breach by Executive of the covenants of this Section 8 in particular, and this Agreement in general, and that monetary damages alone would not provide the Company adequate relief for any such breach. Accordingly, if Executive breaches any covenant in this Section 8, the parties acknowledge that equitable or injunctive relief in favor of the Company is a proper remedy, and nothing in this Agreement shall be construed as precluding the Company from seeking such equitable or injunctive relief in a court of competent jurisdiction for Executive’s violations of Section 8. Any award of equitable or injunctive relief shall not preclude the Company from seeking or recovering any lawful compensatory damages that may have resulted from a breach of the covenants of this Agreement. Any waiver or failure to seek enforcement or remedy for any breach or suspected breach of any covenant of Executive in this Agreement shall not be deemed a waiver of such provision in the future. Furthermore, the existence of any claim of Executive against the Company, whether based upon this Agreement or otherwise, shall not operate as a defense to the Company’s enforcement of any provision of this Agreement. Proceedings seeking equitable and injunctive relief to enforce the terms of this Section 8 may be brought in any court of competent jurisdiction.

 

9              Indemnification. Subject to the Company’s by-laws, to the fullest extent allowed or permitted under any provision of applicable law, the Company shall indemnify Executive against any losses, claims, damages or liabilities incurred by Executive arising out of any claim based upon acts performed or omitted to be performed by Executive in connection with his employment with the Company.

 

10.           Attorneys’ Fees. In any action brought by any party under this Agreement to enforce any of its terms, or any appeal therefrom, each party shall bear its own costs and expenses, including its own attorneys’ fees; provided, however, that the Executive (or his beneficiary, as the case may be) will be entitled to reimbursement for reasonable costs and expenses, including reasonable attorneys’ fees, with respect to such action if and to the extent that the Executive (or beneficiary) is the prevailing party.

 

11.           Cooperation. Executive agrees that, after the termination of his employment, he shall cooperate on a reasonable basis in the truthful and honest prosecution and/or defense of any claim in which the Company, its affiliates and/or its subsidiaries may have an interest (subject to reasonable limitations and the Executive’s other commitments concerning time and place), which may include, without limitation, making himself available on a

 

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reasonable basis to participate in any proceeding involving the Company, its affiliates and/or its subsidiaries, appearing for depositions and testimony without requiring a subpoena, and producing and/or providing any documents or names of other persons with relevant information. The Company agrees to reimburse Executive for all expenses reasonably incurred by him and to pay reasonable compensation to Executive for and in connection with services provided by him pursuant to this section.

 

12.           Travel Restrictions. As is reasonable, Executive has the right to refuse travel to destinations deemed politically unstable or otherwise hostile and/or those that may represent a danger to the Executive’s health and well-being.

 

13.           Notices. Any notices permitted or required under this Agreement shall be deemed given upon the date of personal delivery or forty-eight (48) hours after deposit in the United States mail, postage fully paid, certified mail, return receipt requested, addressed to the following address:

 

 

If to the Company:

Chairman of the Board of Directors

 

 

c/o MonoSol Rx, Inc.

 

 

30 Technology Drive

 

 

Warren Township, NJ 07059

 

 

 

 

With copies to:

Compensation Committee Chairperson

 

 

c/o MonoSol Rx, Inc.

 

 

30 Technology Drive

 

 

Warren Township, NJ 07059; and

 

 

 

 

 

John Cochran

 

 

201 Main Street, Suite 1900

 

 

Fort Worth, Texas 76102

 

 

 

 

If to the Executive:

Keith J. Kendall

 

 

195 Beaumonte Way

 

 

Bridgewater, NJ 08807

 

Either party may change the address to which notices to such party shall be delivered personally or mailed by giving notice thereof to the other party hereto.

 

14.           Venue; Jurisdiction. The validity, construction, interpretation, and enforceability of this Agreement shall be determined and governed by the laws of the State of New Jersey without giving effect to the principles of conflicts of law. For the purpose of litigating any dispute that arises under this Agreement, the parties hereby consent to exclusive jurisdiction of, and agree that such litigation shall be conducted in, any state or federal court located in the State of New Jersey.

 

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15.           Binding Effect; Assignment. Executive shall not, without the prior written consent of the Company, assign, transfer, or otherwise convey this Agreement, or any right or interest herein. This Agreement, and all rights and obligations of the Company or any of its successors, may be assigned or otherwise transferred to any of its successors and shall be binding upon and inure to the benefit of its successors. As used herein, the term “successor” shall mean any person, corporation or other entity that, by merger, consolidation, purchase of stock, assets, liquidation, voluntary or involuntary assignment, or otherwise, acquires all or a substantial part of the assets of the Company or succeeds to one or more lines of business of the Company.

 

16.           Entire Agreement. This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements, understandings and arrangements, both oral and written, between the parties hereto with respect to such subject matter, it being understood that this Agreement shall not supersede the Executive’s existing employment agreement with LLC unless and until the Executive’s employment by the Company pursuant to this Agreement becomes effective in accordance with Section 2 hereof. This Agreement may not be modified, amended, altered or rescinded in any manner, except by written instrument signed by all of the parties hereto; provided, however, that any waiver by either party with respect to any provision hereof, or the breach of any provision hereof by the other party, need be signed only by the party waiving such provision or breach; and provided, further, that the waiver by either party hereto of a breach or compliance with any provision of this Agreement shall not operate nor be construed as a waiver of any subsequent breach or compliance.

 

17.           Severability. In case any one or more of the provisions of this Agreement shall be held by any court of competent jurisdiction to be illegal, invalid or unenforceable in any respect, the remainder of this Agreement, or the application of such provision to persons or circumstances other than those to which it is held to be illegal, invalid, or unenforceable, shall not he affected thereby.

 

I8.            Section Headings  The section headings contained in this Agreement are for reference purposes only and shall not affect in any manner the meaning or interpretation of this Agreement.

 

19.           Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument.

 

[The remainder of this page is intentionally left blank.]

 

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20.           Survival. The provisions of Sections 6-11 of this Agreement shall survive any termination of this Agreement and the termination of Executive’s employment by either party for any reason.

 

IN WITNESS WHEREOF, the parties hereto have executed and delivered this Agreement as of the day and year first above written.

 

 

MONOSOL RX, INC.

 

 

 

 

 

By:

/s/ John S. Cochran

 

 

 

MONOSOL RX, LLC

 

 

 

 

 

By:

/s/ John S. Cochran

 

 

 

 

 

/s/ Keith J. Kendall

 

Keith J. Kendall

 

17



 

Execution Copy

 

EXHIBIT A
GENERAL RELEASE

 

In exchange for certain payments and benefits to be provided to me by MonoSol Rx, Inc. pursuant to the Employment Agreement dated as of                    , 2007, between the undersigned executive (the “Executive”), Monosol LLC and MonoSol Rx, Inc., the Executive hereby knowingly and voluntarily waives, releases and discharges MonoSol Rx, Inc., its predecessors, successors, parent corporations, subsidiaries, affiliates and each of their employees, officers and directors, agents, trustees, and fiduciaries (the “Company”) from any and all claims, liabilities, demands, and causes of action, which he may have or claim to have against the Company, including any and all claims arising out of or relating in any way to the Executive’s employment and/or separation of employment from the Company. This General Release specifically waives and releases all rights, claims, causes of action, demands, and liabilities which may arise up to and including the date the Executive signs this General Release. This General Release does not, however, waive or release any rights or claims which may arise after the date the Executive signs this General Release.

 

This General Release of claims includes, but is not limited to:

 

a.                                       all State and Federal statutory claims including, but not limited to, claims arising under Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act, the Older Worker Benefit Protection Act, the Americans with Disabilities Act, the Family and Medical Leave Act, the Sarbanes-Oxley Act, the Employee Retirement Income Security Act, the Fair Labor Standards Act, the Worker Adjustment and Retraining Notification Act, the New Jersey Law Against Discrimination, the New Jersey Civil Rights Act, the New Jersey Civil Union Act, the New Jersey Wage and Hour Law, the New Jersey Conscientious Employee Protection Act, the New Jersey Domestic Partnership Act, and the New Jersey Family Leave Act;

 

b.                                      All claims arising under the United States and New Jersey Constitutions;

 

c.                                       All claims arising under any Executive Order or derived from or based upon any State or Federal regulations;

 

d.                                      All common law claims including, but not limited to, claims for wrongful or constructive discharge, public policy claims, retaliation claims, claims for breach of an express or implied contract, claims for breach of an implied covenant of good faith and fair dealing, intentional infliction of emotional distress, defamation, fraud, conspiracy, loss of consortium, tortious interference with contract or prospective economic advantage, promissory estoppel and negligence;

 

e.                                       All claims for any compensation including, but not limited to, back wages, front pay, overtime pay, bonuses or awards, fringe benefits, reinstatement, retroactive seniority, pension benefits, or any other form of economic loss;

 

f.                                         All claims for personal injury including, but not limited to, physical injury, mental anguish, emotional distress, pain and suffering, embarrassment,

 

1



 

humiliation, damage to name or reputation, liquidated damages, and punitive damages; and

 

g.                                      All claims for costs and attorneys’ fees.

 

The Executive hereby acknowledges that the Company is advising him in writing that he should consult with an attorney prior to executing this General Release. The Executive hereby states that he has had the opportunity to discuss this General Release with whomever the Executive wished, including an attorney of his own choosing. The Executive further states that he has had the opportunity to read, review, and consider all of the provisions of this General Release; that the Executive understands its provisions and its binding effect on him; and that the Executive is entering into this General Release freely, voluntarily, and without duress or coercion. The Executive acknowledges that he has not relied upon the Company’s employees, officers or directors, counsel, agents or accountants for any legal, tax or other advice, and the Executive has, to the extent the Executive deems necessary, consulted with his own advisors as to these matters.

 

The Executive represents that he has not filed any grievance, charge, claim, or complaint of any kind seeking personal recovery or personal injunctive relief against the Company or any of its owners, officers, directors, employees or agents, with respect to any matter, including but not limited to, his employment with the Company and/or the separation of that employment. Nothing contained in this paragraph shall prohibit the Executive from (a) bringing any action to enforce the terms of this Agreement and General Release; (b) filing a timely charge or complaint with the Equal Employment Opportunity Commission (“EEOC”) regarding the validity of this Agreement and General Release; (c) filing a timely charge or complaint with the EEOC or participating in any investigation or proceeding conducted by the EEOC regarding any claim of employment discrimination (although the Executive has waived any right to personal recovery or personal injunctive relief in connection with any such charge or complaint).

 

The Executive understands that he has twenty-one (21) calendar days within which to consider this General Release before signing it. The Executive also understands that he is free to use as much of the twenty-one (21) calendar day period as he wishes or considers necessary before deciding to sign this General Release. The Executive may revoke his signature of this General Release within seven (7) calendar days of signing it by delivering written notice of revocation to Theresa Wood, Director of Human Resources, 30 Technology Drive, Warren, New Jersey 07059. If Executive has not revoked his signature of this Agreement by written notice delivered within the seven (7) calendar day period, it becomes effective immediately thereafter.

 

The Executive understands that his failure or refusal to execute this General Release or his timely revocation of this General Release will result in forfeiture of any severance payments and benefits.

 

BY SIGNING THIS GENERAL RELEASE, EXECUTIVE ACKNOWLEDGES THAT:

 

HE HAS READ IT;

 

HE UNDERSTANDS IT AND KNOWS HE IS GIVING UP IMPORTANT RIGHTS;

 

HE AGREES WITH EVERYTHING IN IT;

 

2



 

HE HAS BEEN ADVISED TO CONSULT WITH AN ATTORNEY PRIOR TO EXECUTING THIS GENERAL RELEASE; AND

 

HE HAS SIGNED THIS GENERAL RELEASE KNOWINGLY AND VOLUNTARILY.

 

 

 

 

 

Executive

 

 

 

 

 

MONOSOL RX, INC.

 

 

 

 

 

By:

 

 

3




Exhibit 10.27

 

August 24, 2007

 

Monosol Rx, LLC
30 Technology Drive

Warren, NJ 07059

 

Gentlemen:

 

You have advised us that Monosol Rx, LLC, a Delaware limited liability company (the “Borrower”), seeks financing for ongoing working capital requirements and other general purposes, as more fully described in the attached Summary of Terms and Conditions (the “Term Sheet”).  The Term Sheet describes the general terms and conditions for a $10,000,000 senior secured revolving credit facility (the “Facility”).

 

Based on and subject to the terms and conditions set forth in this commitment letter (the “Commitment Letter”) and in the Term Sheet, we hereby advise you of our commitment to provide (or to cause one or more of our respective affiliates to provide) the Facility, in the amounts set forth beside the signatures of the undersigned below.

 

The term of this Commitment Letter shall, except as otherwise set forth herein, commence on the date of this Commitment Letter and shall expire on the earlier of (i) 360 days after the date of this letter, and (ii) the date of execution and delivery of the definitive financing documentation for the Facility (the “Closing Date”).

 

The commitments made under this Commitment Letter are based on the financial and other information regarding the Borrower previously provided to us.  Accordingly, those commitments are subject to the satisfaction of each of the following conditions:

 

(i)                                     Each of the terms and conditions set forth in this Commitment Letter and in the Term Sheet;

 

(ii)                                  The absence of a material breach of any representation, warranty or agreement of the Borrower set forth in this Commitment Letter;

 

(iii)                               No change, occurrence or development that would reasonably be expected to have a material adverse effect on the business, assets, liabilities, operations, condition (financial or otherwise) or prospects of the Borrower shall have occurred or become known to us;

 

(iv)                              The information concerning the Borrower shall not differ in any material adverse manner from the information and other matters previously disclosed to us before the date of this Commitment Letter;

 

(v)                                 Material compliance with all applicable laws and regulations by the Borrower;

 



 

(vi)                              The negotiation, execution and delivery of definitive documentation for the Facility consistent with the Term Sheet; and

 

(vii)                           The board of directors of Monosol Rx, Inc. shall have made no decision to discontinue the pursuit of its currently proposed initial public offering.

 

No delay in the commencement or completion of that initial public offering shall be deemed a failure to satisfy any of the aforementioned conditions set forth in this Commitment Letter or in the Term Sheet.

 

You represent, warrant and covenant that: (i) all information other than Projections (as defined below), that has been or is, after the date of this Commitment Letter, made available to the undersigned by you or any of your representatives in connection with the transactions described in this Commitment Letter (the “Information”) is and will be complete and correct in all material respects as of the date made available to us and does not and will not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements contained therein not materially misleading; and (ii) all financial projections concerning the Borrower that have been or, after the date of this Commitment Letter, are made available to us by you or any of your representatives (the “Projections”) have been or will be prepared in good faith based on assumptions you believe to be reasonable.  You agree to furnish us such Information and Projections as we may reasonably request and to supplement the Information and the Projections from time to time until the Closing Date so that the representation, warranty and covenant in the preceding sentence is correct on the Closing Date.

 

This Commitment Letter is addressed solely to you, as the Borrower, and is not intended to confer any obligations to or on, or benefits to or on any other person.

 

You may disclose the terms of this Commitment Letter and the Term Sheet (i) to your attorneys, financial advisors and accountants, (ii) to any underwriters or proposed underwriters in connection with your proposed initial public offering and (iii) in any filing with the Securities and Exchange Commission (including any amendment to your Registration Statement on Form S-1) or with the National Association of Securities Dealers in connection with your proposed initial public offering.  You acknowledge and agree that we may share with our affiliates any information relating to the Facility, this Commitment Letter and the Term Sheet.  The provisions of this paragraph shall remain in full force and effect regardless of whether definitive financial documentation shall be executed and delivered and notwithstanding the termination of this Commitment Letter.

 

Our commitment with respect to the Facility under this Commitment Letter shall terminate at 5:00 p.m. eastern daylight time on August 31, 2007 (the “Acceptance Deadline”), unless this Commitment Letter is accepted by you in writing and delivered to us before such time.

 

2



 

This Commitment Letter, together with the Term Sheet, embodies the entire agreement and understanding between you and us with respect to the specific matters set forth in this Commitment Letter and the Term Sheet and supersedes all prior agreements and understandings related to the subject matter of this Commitment Letter and the Term Sheet.

 

This Commitment Letter shall be governed by and construed in accordance with the laws of the State of New York without regard to the conflicts of law provisions of the State of New York.  You and we irrevocably waive all right to trial by jury in any action, proceeding or counterclaim arising out of or relating to this Commitment Letter or the Term Sheet.

 

This Commitment Letter may be executed in any number of counterparts, each of which shall be an original, and all of which, when taken together, shall constitute one agreement.  Delivery of an executed signature page of this Commitment Letter by facsimile transmission shall be effective as delivery of a manually executed counterpart of this Commitment Letter, provided that the facsimile transmission shall be promptly followed by the original thereof.

 

Neither this Commitment Letter nor the Term Sheet may be amended, and no provision of this Commitment Letter or the Term Sheet waived or modified, except by an instrument in writing signed by the undersigned and you.

 

This Commitment Letter may not be assigned by you without the prior written consent of the undersigned, and any purported assignment without such consent shall be null and void.

 

Please indicate your acceptance of this Commitment Letter and the Term Sheet by signing in the space provided and returning an original copy bearing your signature to us on or before the Acceptance Deadline.  We are pleased to have the opportunity to assist you in connection with this proposed financing transaction.

 

 

Very truly yours,

 

 

 

 

 

MONOLINE RX, L.P.

 

 

 

 

By:

BRATTON CAPITAL, INC.,

 

 

its General Partner

 

 

 

 

By:

/s/ John Cochran

 

 

 

Name:

John Cochran

 

 

 

Title:

V.P.

 

 

 

 

 

 

 

 

 

 

 

 

MONOLINE RX II, L.P.

 

 

 

 

By:

BRATTON CAPITAL, INC.,

 

 

its General Partner

 

 

 

 

By:

/s/ John Cochran

 

 

 

Name:

John Cochran

 

 

 

Title:

V.P.

 

 

 

 

 

Aggregate amount of commitment of MonoLine RX,

 

L.P., MonoLine RX II, L.P. and affiliated entities:

 

         $8,327,000

 

3



 

 

HALIFAX MONOSOL INVESTORS, L.P.

 

 

 

 

By:

HALIFAX GENPAR MONOSOL, LLC,

 

 

its General Partner

 

 

 

 

By:

/s/ A. Judson Hill

 

 

 

Name:

A. Judson Hill

 

 

 

Title:

Managing Director

 

 

 

 

 

Amount of commitment:             $1,673,000

 

 

ACCEPTED AND AGREED TO ON

 

 

AUGUST 24, 2007:

 

 

 

 

 

MONOSOL RX, LLC

 

 

 

 

By:

MONOSOL RX GENPAR, L.P., its Manager

 

 

 

 

By:

BRATTON CAPITAL, INC., its General Partner

 

 

 

 

 

By:

/s/ John Cochran

 

 

 

Name:

John Cochran

 

 

 

 

Title:

V.P.

 

 

 

4



 

Attachment to Commitment Letter

 

MONOSOL RX, LLC
SUMMARY OF TERMS AND CONDITIONS
$10,000,000 SENIOR SECURED CREDIT FACILITY
August 24, 2007

 

 

BORROWER:

 

Monosol Rx, LLC, a Delaware limited liability company (the “Borrower”)

 

 

 

LENDERS:

 

MonoLine RX, L.P., MonoLine RX II, L.P. and Halifax Monosol Investors, L.P., or their respective appointed affiliates (collectively, the “Lenders”)

 

 

 

FACILITY:

 

A $10,000,000 revolving credit facility (the “Facility”).  Subject to the limitations described in this term sheet, revolving credit loans may be repaid and reborrowed.

 

 

 

AVAILABILITY OF LOANS:

 

Loans under the Facility shall be available until the earlier of (i) the Maturity Date (as defined below) and (ii) the date that the board of directors of Monosol Rx, Inc. determines that Monosol Rx, Inc. will not further pursue its currently proposed initial public offering.

 

 

 

MATURITY DATE:

 

All amounts outstanding under the Facility shall be due and payable in full on the earliest of (i) the fifth business day after the completion of Monosol Rx, Inc.’s currently proposed initial public offering; (ii) the fifth business day after the completion of any private equity financing of the Borrower in lieu of Monosol Rx, Inc.’s currently proposed initial public offering, and (iii) 360 days after the date of the Borrower’s acceptance of the Commitment Letter to which this term sheet is attached (the “Maturity Date”).

 

 

 

PURPOSE:

 

The Facility shall be used (i) for the Borrower’s general company purposes, including, without limitation, working capital and capital expenditures in the ordinary course of business, and (ii) to pay the Borrower’s fees and expenses related to the Facility.

 

 

 

SECURITY:

 

The Lenders shall receive first priority perfected security interest in all assets, tangible and intangible, of the Borrower (the “Collateral”).  All such security interests shall be created on terms, and pursuant to customary documentation satisfactory to the Lenders and none of the Collateral shall be subject to any other security interests except as permitted in writing by the Lenders.

 



 

INTEREST RATE:

 

For each loan, the LIBOR Rate plus 400 basis points.  The LIBOR Rate shall mean the rate per annum appearing on Reuters Screen LIBOR 01 Page (or any successor or substitute page of such service, or any successor for such service), at approximately 11:00 a.m. London time two business days before making the applicable loan, offered for U.S. dollar deposits with a maturity comparable to that of the applicable loan.  LIBOR Rate and all fees shall be calculated on a 360-day basis.

 

 

 

INTEREST
PAYMENTS:

 

Interest on loans will be due and payable on the Maturity Date.

 

 

 

COMMITMENT
FEE:

 

The Borrower shall pay a total commitment fee of 75 basis points with 50% payable at the time of the Borrower’s acceptance of the Commitment Letter, and the remaining 50% payable on the Maturity Date.  The commitment fee shall be allocated between the Lenders in accordance with the amounts of their commitments.

 

 

 

LOANS UNDER
THE
CREDIT
FACILITY:

 

Borrowings may be requested upon ten (10) business days’ notice.  Notice must be given to each Lender by 1:00 p.m. Eastern time, on the day on which the notice is required.

 

 

 

REPAYMENT:

 

The Facility shall be repaid in full, including any unpaid interest, on the Maturity Date.

 

 

 

OPTIONAL
PREPAYMENTS:

 

Loans may be prepaid before the Maturity Date at any time without penalty.  Any such prepayment shall not reduce the amount of the Facility.

 

 

 

CONDITIONS
PRECEDENT TO
CLOSING:

 

1.The negotiation, execution and delivery of definitive credit documentation for the Facility in form and substance satisfactory to the Lenders.

 

 

 

 

 

2.All governmental and other third-party consents and approvals necessary in connection with the Facility shall have been obtained and remain in effect.

 

 

 

 

 

3.No change, occurrence or development that would reasonably be expected to have a material adverse effect on the business, assets, liabilities, operations, condition (financial or otherwise) or prospects of the Borrower shall have occurred or become known to the Lenders.

 

6



 

 

 

4.There shall be no pending or threatened litigation, bankruptcy or insolvency, injunction, order or claim with respect to the Borrower that could reasonably be expected to have a material adverse effect on the financial condition of the Borrower, or on the ability of the Borrower to perform its obligations under the Facility.

 

 

 

 

 

5.The Lenders shall have received payment of the commitment fees that are due and payable at or before the closing date of the Facility.

 

 

 

CONDITIONS
PRECEDENT TO
ALL
BORROWINGS:

 

Customary for facilities of this nature, including, but not limited to, company existence; company and governmental authorization; financial information; no material adverse changes; compliance with laws and agreements; title to assets; material contracts; no material litigation; payment of taxes; financial condition; and full disclosure.

 

 

 

AFFIRMATIVE
COVENANTS:

 

Customary for facilities of this nature, including, but not limited to, receipt of financial information; notification of litigation (with a materiality threshold to be determined), investigations and other adverse changes; payment and performance of obligations; conduct of business; maintenance of existence; maintenance of property and insurance (including hazard and business interruption coverage); maintenance of records and accounts; inspection of property and books and records; compliance with laws; and payment of taxes.

 

 

 

NEGATIVE
COVENANTS:

 

Customary for facilities of this nature, including, but not limited to, restrictions and limitations on: indebtedness (except for unsecured debt; liens; guaranty obligations; material changes in business; mergers (other than the proposed merger of the Borrower with and into Monosol Rx, Inc.); sales of assets outside of the ordinary course of business; acquisitions of businesses; loans and investments; transactions with affiliates; and prepayments of or material amendments to indebtedness (including, without limitation, repayment of any subordinated debt).

 

 

 

EVENTS OF
DEFAULT:

 

Customary for facilities of this nature, including, but not limited to, failure to pay any interest, principal or fees under the Facility when due; failure to perform any covenant or agreement; representations or warranties being inaccurate or false when made; invalidity of any security interest in favor of the Lenders; insolvency or bankruptcy; judgment defaults; and change in control.

 

 

 

ASSIGNMENTS
AND
PARTICIPATIONS:

 

Lenders will not be permitted to make assignments or participations without the consent of the Borrower.

 

7



 

WAIVERS AND
AMENDMENTS:

 

Amendments and waivers of the provisions of the definitive credit documentation will require the approval of the Required Lenders, except that the consent of all the Lenders affected thereby shall be required with respect to (i) increases in commitments, (ii) reductions of principal, interest or fees, (iii) extensions of scheduled maturities or times for payment, and (iv) releases of all or substantially all of the value of the Collateral. “Required Lenders” means, on any date of determination, those Lenders who collectively hold more than 50% of the Facility, or if the Facility has been terminated, those Lenders who collectively hold more than 50% of the aggregate outstandings.

 

 

 

WAIVER OF JURY
TRIAL,
GOVERNING LAW:

 

Waiver of jury trial, submission to jurisdiction in New York, New York and mandatory binding arbitration in New York, New York; New York law (without reference to choice of law provisions) to govern.

 

 

 

MISCELLANEOUS:

 

This summary of terms and conditions does not purport to summarize all the conditions, covenants, representations, warranties and other provisions that would be contained in definitive credit documentation for the Facility.

 

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Exhibit 23.1


CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Members
Monosol Rx LLC:
 
 

We consent to the use of our report dated May 14, 2007, with respect to the balance sheets of Monosol Rx LLC as of December 31, 2006 and 2005, and the related statements of operations, changes in members' equity and cash flows for each of the years in the three-year period ended December 31, 2006, included herein and to the reference to our firm under the heading "Experts" in the prospectus.

/S/  KPMG LLP

Chicago, Illinois
August 29, 2007




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CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM