Washington, D.C. 20549 |
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THE SECURITIES ACT OF 1933 |
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Delaware |
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82-3827296 |
(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number) |
Copies to:
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Lori J. Braender
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David S. Rosenthal, Esq.
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SVP – General Counsel and Secretary
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Dechert LLP
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30 Technology Drive
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1095 Avenue of the Americas
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Warren, New Jersey 07059
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New York, New York 10036
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Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☒
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Smaller reporting company
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☒ |
Emerging growth company
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☒ |
Title of each class of
securities to be registered
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Amount
to be
Registered (1)
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Proposed
Maximum
Offering Price
per Unit (1)(2)
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Proposed
Maximum
Aggregate
Offering Price
(1)(3)
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Amount of
Registration Fee
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||||||||||||
Primary Offering
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||||||||||||||||
Common Stock, par value $0.001 per share (4)
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||||||||||||||||
Preferred Stock, par value $0.001 per share (4)
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||||||||||||||||
Debt Securities (4)
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||||||||||||||||
Warrants (4)
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||||||||||||||||
Units (4)
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||||||||||||||||
Rights (4)
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||||||||||||||||
Primary Offering Total
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$
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150,000,000
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$
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18,180
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||||||||||||
Secondary Offering
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||||||||||||||||
Common Stock, par value $0.001 per share
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2,228,082
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(5)
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$
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3.705
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(6)
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$
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8,255,043.81
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(6)
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$
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1,000.51
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||||||
Shares of Common Stock issuable upon exercise of Warrants
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2,000,000
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(5)
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$
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4.25
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(7)
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$
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8,500,000
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(7)
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$
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1,030.20
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||||||
Secondary Offering Total
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$
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16,755,043.81
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$
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2,030.71
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||||||||||||
TOTAL
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$
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166,755,043.81
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$
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20,210.71
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(1) |
Not specified as to each class of securities to be registered pursuant to General Instruction II.D. to Form S-3.
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(2) |
The proposed maximum offering price per unit will be determined from time to time by the registrant in connection with the issuance by the registrant of the securities registered hereunder.
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(3) |
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended (the “Securities Act”).
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(4) |
With respect to the primary offering, the securities being registered consist of such indeterminate number of shares of common stock and preferred stock, such indeterminate number of warrants, such indeterminate number of units, such
indeterminate principal amount of debt securities, and such indeterminate number of rights to purchase common stock, preferred stock, debt securities and units as may be determined from time to time at indeterminate prices. The securities
registered also include such indeterminate number of shares of common stock and preferred stock and such indeterminate principal amount of debt securities as may be issued upon conversion of or exchange for preferred stock or debt
securities that provide for conversion or exchange, upon exercise of warrants or rights or pursuant to the anti-dilution provisions of any such securities. With respect to the primary offering, in no event will the aggregate maximum
offering price of all securities issued pursuant to this registration statement exceed $150,000,000, or, if any debt securities are issued at an original issue discount, such greater amount as will result in an aggregate initial offering
price of $150,000,000, less the aggregate dollar amount of all securities previously issued hereunder. Any securities registered hereunder may be sold separately or as units with other securities registered hereunder. No separate
consideration will be received for any securities registered hereunder that are issued in exchange for, or upon conversion of, as the case may be, the shares of preferred stock, debt securities, warrants or rights.
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(5) |
Pursuant to Rule 416 promulgated under the Securities Act, there are also registered hereunder such indeterminate number of additional shares of common stock that may be issued in connection with the anti-dilution provisions or stock
splits, stock dividends, recapitalizations or similar events.
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(6) |
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(c) of the Securities Act, based upon the average of the high and low sales prices on the NASDAQ Global Market on September 4, 2019 of
the shares of common stock of the Registrant.
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(7) |
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) of the Securities Act.
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a base prospectus covering the offering, issuance and sale by the registrant of up to a maximum aggregate offering price of $150,000,000 of the registrant’s common stock, preferred stock, debt securities, warrants, units and and/or
rights;
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•
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an equity distribution agreement prospectus covering the offering, issuance and sale by the registrant of up to a maximum aggregate offering price of approximately $17.7 million of the registrant’s common stock that may be issued
and sold from time to time under an equity distribution agreement with Piper Jaffray & Co., or Piper Jaffray; and
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•
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a selling stockholder prospectus covering the sale of up to 4,228,082 shares of the registrant’s common stock by the selling stockholders.
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21 | |
22
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24
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24 | |
24 | |
24 |
• |
Libervant™, a buccal soluble film formulation of diazepam used as a rescue therapy for breakthrough epileptic seizures and an adjunctive therapy for use in recurrent convulsive seizures, for which a
pre-new drug application (NDA) meeting was held in December 2018 with the FDA. The meeting resulted in a plan to complete a small single-dose crossover study comparing Libervant to the reference listed drug, Diastat®. This study was
initiated in the first quarter of 2019, and enrollment into the study was completed in May 2019. The Company also began a rolling NDA submission process during the second quarter of 2019. The Company has completed the crossover study
and is evaluating the data generated and plans to complete the NDA filing by the end of the year; and
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Exservan™, an oral soluble film formulation of riluzole for the treatment of Amyotrophic Lateral Sclerosis, or ALS, for which we submitted an NDA in the first quarter of 2019; the Prescription Drug User
Fee Act (PDUFA) goal date for FDA action is November 30, 2019.
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AQST-108, a sublingual soluble film formulation for the treatment of anaphylaxis and severe allergic reactions, which is intended to provide an adjunct and or alternative to injection treatments such as
EpiPen. After the Company’s first human proof of concept trials, a re-formulated and more advanced prototype has been developed, for which we completed additional phase 1 proof of concept trials. The Company is evaluating the data
generated from these trials and plans on seeking a pre-IND meeting with the FDA before the end of the year; and
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AQST-305, a sublingual soluble film formulation of octreotide for the treatment of acromegaly and neuroendocrine tumors. As a result of early stage clinical proof of concept studies, re-formulation work
is currently underway.
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designation or classification;
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aggregate principal amount or aggregate offering price;
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maturity;
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original issue discount, if any;
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rates and times of payment of interest or dividends, if any;
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redemption, conversion, exchange or sinking fund terms, if any;
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conversion or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or exchange prices or rates and in the securities or other property receivable upon conversion or
exchange;
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ranking;
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restrictive covenants, if any;
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voting or other rights, if any; and
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important U.S. federal income tax considerations.
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the names of those underwriters or agents;
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applicable fees, discounts and commissions to be paid to them;
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details regarding over-allotment options, if any; and
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the estimated net proceeds to us.
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risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and
clinical trials;
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the risks of delays in FDA approval of our drug candidates or failure to receive approval;
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the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory
limitations);
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the risk that a competitor obtains orphan drug exclusivity and blocks our product for the same indication for seven years;
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risk of development of our sales and marketing capabilities;
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risk of legal costs associated with and the outcome of our patent litigation challenging third party at risk generic sale of our proprietary products;
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risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our
short-term and longer term cash requirements and other cash needs, at the times and in the amounts needed;
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risk of availability of refinancing of existing debt facilities;
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risk of failure to satisfy all debt covenants and of any default under our senior secured notes;
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risk related to government claims against Indivior for which we license, manufacture and sell Suboxone and which accounts for the substantial part of our current
operating revenues;
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risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties;
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risk of the rate and degree of market acceptance of our products and product candidates;
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the success of any competing products, including generics;
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risk of the size and growth of our product markets;
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risk of the effectiveness and safety of our products and product candidates;
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risk of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities;
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risks associated with intellectual property rights and infringement claims relating to the Company’s products;
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risk of unexpected patent developments;
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the impact of existing and future legislation and regulatory provisions on product exclusivity;
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legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access;
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claims and concerns that may arise regarding the safety or efficacy of the Company’s products and product candidates;
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risk of loss of significant customers;
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risks related to legal proceedings, including patent infringement, investigative and antitrust litigation matters;
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changes in governmental laws and regulations;
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risk of product recalls and withdrawals; and
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uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items.
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the title of the series of debt securities;
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any limit upon the aggregate principal amount that may be issued;
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• |
the maturity date or dates;
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the form of the debt securities of the series;
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the applicability of any guarantees;
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whether or not the debt securities will be secured or unsecured, and the terms of any secured debt;
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whether the debt securities rank as senior debt, senior subordinated debt, subordinated debt or any combination thereof, and the terms of any subordination;
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if the price (expressed as a percentage of the aggregate principal amount thereof) at which such debt securities will be issued is a price other than the principal amount thereof, the portion of the principal amount thereof payable
upon declaration of acceleration of the maturity thereof, or if applicable, the portion of the principal amount of such debt securities that is convertible into another security or the method by which any such portion shall be
determined;
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the interest rate or rates, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment
dates or the method for determining such dates;
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our right, if any, to defer payment of interest and the maximum length of any such deferral period;
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if applicable, the date or dates after which, or the period or periods during which, and the price or prices at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption
provisions and the terms of those redemption provisions;
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the date or dates, if any, on which, and the price or prices at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series
of debt securities and the currency or currency unit in which the debt securities are payable;
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the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof;
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any and all terms, if applicable, relating to any auction or remarketing of the debt securities of that series and any security for our obligations with respect to such debt securities and any other terms which may be advisable in
connection with the marketing of debt securities of that series;
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whether the debt securities of the series shall be issued in whole or in part in the form of a global security or securities; the terms and conditions, if any, upon which such global security or securities may be exchanged in whole
or in part for other individual securities; and the depositary for such global security or securities;
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if applicable, the provisions relating to conversion or exchange of any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible or exchangeable, including the conversion or
exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional (at our option or the holders’ option) conversion or exchange features, the applicable conversion or exchange period and the
manner of settlement for any conversion or exchange;
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if other than the full principal amount thereof, the portion of the principal amount of debt securities of the series which shall be payable upon declaration of acceleration of the maturity thereof;
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additions to or changes in the covenants applicable to the particular debt securities being issued, including, among others, the consolidation, merger or sale covenant;
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additions to or changes in the events of default with respect to the securities and any change in the right of the trustee or the holders to declare the principal, premium, if any, and interest, if any, with respect to such
securities to be due and payable;
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additions to or changes in or deletions of the provisions relating to covenant defeasance and legal defeasance;
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additions to or changes in the provisions relating to satisfaction and discharge of the indenture;
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additions to or changes in the provisions relating to the modification of the indenture both with and without the consent of holders of debt securities issued under the indenture;
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the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars;
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whether interest will be payable in cash or additional debt securities at our or the holders’ option and the terms and conditions upon which the election may be made;
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the terms and conditions, if any, upon which we will pay amounts in addition to the stated interest, premium, if any and principal amounts of the debt securities of the series to any holder that is not a “United States person” for
federal tax purposes;
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any restrictions on transfer, sale or assignment of the debt securities of the series; and
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any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, any other additions or changes in the provisions of the indenture, and any terms that may be required by us or advisable
under applicable laws or regulations.
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if we fail to pay interest when due and payable and our failure continues for 90 days and the time for payment has not been extended;
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if we fail to pay the principal, premium or sinking fund payment, if any, when due and payable at maturity, upon redemption or repurchase or otherwise, and the time for payment has not been extended;
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if we fail to observe or perform any other covenant contained in the debt securities or the indenture, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90 days after we
receive notice from the trustee or we and the trustee receive notice from the holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and
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if specified events of bankruptcy, insolvency or reorganization occur.
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the direction so given by the holder is not in conflict with any law or the applicable indenture; and
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subject to its duties under the Trust Indenture Act, the trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the proceeding.
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the holder has given written notice to the trustee of a continuing event of default with respect to that series;
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the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made a written request and such holders have offered reasonable indemnity to the trustee or security satisfactory to
it against any loss, liability or expense or to be incurred in compliance with instituting the proceeding as trustee; and
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the trustee does not institute the proceeding and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting directions within 90 days after the
notice, request and offer.
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to cure any ambiguity, defect or inconsistency in the indenture;
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to comply with the provisions described above under “Description of Debt Securities—Consolidation, Merger or Sale;”
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to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act;
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to add to, delete from or revise the conditions, limitations, and restrictions on the authorized amount, terms, or purposes of issue, authentication and delivery of debt securities, as set forth in the indenture;
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to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided above under “Description of Debt Securities—General” to establish the form of any certifications
required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities;
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to evidence and provide for the acceptance of appointment under any indenture by a successor trustee;
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to provide for uncertificated debt securities and to make all appropriate changes for such purpose;
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to add such new covenants, restrictions, conditions or provisions for the benefit of the holders, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions,
conditions or provisions an event of default or to surrender any right or power conferred to us in the indenture; or
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to make any change that does not adversely affect the interests of any holder of debt securities of any series in any material respect.
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extending the fixed maturity of any debt securities of any series;
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reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any series of any debt securities; or
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reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver.
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register the transfer or exchange of debt securities of the series;
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replace stolen, lost or mutilated debt securities of the series;
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maintain paying agencies;
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hold monies for payment in trust;
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recover excess money held by the trustee;
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compensate and indemnify the trustee; and
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appoint any successor trustee.
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issue, register the transfer of, or exchange any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be
selected for redemption and ending at the close of business on the day of the mailing; or
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register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part.
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the title of such securities;
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the offering and exercise price or prices and aggregate number of warrants offered;
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the currency or currencies for which the warrants may be purchased;
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if applicable, the designation and terms of the securities with which the warrants are issued, and the number of warrants issued with each such security or each principal amount of such security;
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if applicable, the date on and after which the warrants and the related securities will be separately transferable;
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if applicable, the minimum or maximum amount of such warrants which may be exercised at any one time;
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in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at which, and currency in which, this principal amount of debt securities may be
purchased upon such exercise;
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in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which, and the currency
in which, these shares may be purchased upon such exercise;
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the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;
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the terms of any rights to redeem or call the warrants;
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the terms of any rights to force the exercise of the warrants;
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any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the dates on which the right to exercise the warrants will commence and expire;
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the manner in which the warrant agreements and warrants may be modified;
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a discussion of any material or special U.S. federal income tax consequences of holding or exercising the warrants;
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the terms of the securities issuable upon exercise of the warrants; and
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any other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable
indenture; or
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in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
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the title and aggregate number of the rights;
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the subscription price or a formula for the determination of the subscription price for the rights and the currency or currencies in which the subscription price may be payable;
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if applicable, the designation and terms of the securities with which the rights are issued and the number of rights issued with each such security or each principal amount of such security;
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the number or a formula for the determination of the number of the rights issued to each stockholder;
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the extent to which the rights are transferable;
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in the case of rights to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one right;
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in the case of rights to purchase common stock or preferred stock, the type of stock and number of shares of stock purchasable upon exercise of one right;
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the date on which the right to exercise the rights will commence, and the date on which the rights will expire (subject to any extension);
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if applicable, the minimum or maximum amount of the rights that may be exercised at any one time;
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the extent to which such rights include an over-subscription privilege with respect to unsubscribed securities;
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if applicable, the procedures for adjusting the subscription price and number of shares of common stock or preferred stock purchasable upon the exercise of each right upon the occurrence of certain events, including stock splits,
reverse stock splits, combinations, subdivisions or reclassifications of common stock or preferred stock;
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the effect on the rights of any merger, consolidation, sale or other disposition of our business;
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the terms of any rights to redeem or call the rights;
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information with respect to book-entry procedures, if any;
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the terms of the securities issuable upon exercise of the rights;
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• |
if applicable, the material terms of any standby underwriting, backstop or other purchase arrangement that we may enter into in connection with the rights offering;
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if applicable, a discussion of certain U.S. Federal income tax considerations; and
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any other terms of the rights, including terms, procedures and limitations relating to the exchange and exercise of the rights.
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the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately;
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any provisions of the governing unit agreement that differ from those described below; and
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any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.
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underwritten public offerings;
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negotiated transactions;
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block trades;
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“At the Market Offerings,” within the meaning of Rule 415(a)(4) of the Securities Act, into an existing trading market, at prevailing market prices; or
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through a combination of these methods.
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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at negotiated prices.
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the name or names of the underwriters, dealers or agents, if any;
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if the securities are to be offered through the selling efforts of brokers or dealers, the plan of distribution and the terms of any agreement, arrangement, or understanding entered into with broker(s) or
dealer(s) prior to the effective date of the registration statement, and, if known, the identity of any broker(s) or dealer(s) who will participate in the offering and the amount to be offered through each;
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the purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale;
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if any of the securities being registered are to be offered otherwise than for cash, the general purposes of the distribution, the basis upon which the securities are to be offered, the amount of
compensation and other expenses of distribution, and by whom they are to be borne;
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any delayed delivery arrangements;
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any over-allotment or other options under which underwriters may purchase additional securities from us;
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any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation;
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any public offering price;
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any discounts, commissions or concessions allowed or reallowed or paid to dealers;
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the identity and relationships of any finders, if applicable; and
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any securities exchange or market on which the securities may be listed.
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• |
our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 14, 2019;
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our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 29, 2019;
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our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019, as filed with the SEC on May 8, 2019 and August 6, 2019;
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our Current Reports on Form 8-K filed with the SEC on May 8, 2019, June 18, 2019 and July 16, 2019, to the extent the
information in such reports is filed and not furnished; and
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the description of our common stock contained in our Registration Statement on Form 8-A, filed with the SEC on July 20, 2018,
including any amendments or reports filed for the purposes of updating this description.
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11 |
• |
Libervant™, a buccal soluble film formulation of diazepam used as a rescue therapy for breakthrough epileptic seizures and an adjunctive therapy for use in recurrent convulsive seizures, for which a
pre-new drug application (NDA) meeting was held in December 2018 with the FDA. The meeting resulted in a plan to complete a small single-dose crossover study comparing Libervant to the reference listed drug, Diastat®. This study
was initiated in the first quarter of 2019, and enrollment into the study was completed in May 2019. The Company also began a rolling NDA submission process during the second quarter of 2019. The Company has completed the crossover
study and is evaluating the data generated and plans to complete the NDA filing by the end of the year; and
|
• |
Exservan™, an oral soluble film formulation of riluzole for the treatment of Amyotrophic Lateral Sclerosis, or ALS, for which we submitted an NDA in the first quarter of 2019; the Prescription Drug
User Fee Act (PDUFA) goal date for FDA action is November 30, 2019.
|
• |
AQST-108, a sublingual soluble film formulation for the treatment of anaphylaxis and severe allergic reactions, which is intended to provide an adjunct and or alternative to injection treatments such
as EpiPen. After the Company’s first human proof of concept trials, a re-formulated and more advanced prototype has been developed, for which we completed additional phase 1 proof of concept trials. The Company is evaluating the
data generated from these trials and plans on seeking a pre-IND meeting with the FDA before the end of the year; and
|
• |
AQST-305, a sublingual soluble film formulation of octreotide for the treatment of acromegaly and neuroendocrine tumors. As a result of early stage clinical proof of concept studies, re-formulation
work is currently underway.
|
Common stock offered by us
|
Shares of common stock having an aggregate offering price of up to $17,718,617.
|
Common stock to be outstanding after this offering
|
Up to 29,805,670 shares (as more fully described in the notes following this table), assuming sales of 4,763,069 shares of our common stock in this offering at an offering price of $3.72 per share, which
was the last reported sale price of our common stock on the Nasdaq Global Select Market on September 4, 2019. The actual number of shares issued will vary depending on the sales price under this offering.
|
Plan of Distribution
|
“At-the-market offering” that may be made from time to time, if at all, through our sales agent, Piper Jaffray. See “Plan of Distribution” on page 10.
|
Use of Proceeds
|
We currently intend to use the net proceeds from this offering, if any, primarily for working capital, capital expenditures, research and development and general corporate purposes. See “Use of
Proceeds” within this prospectus.
|
Risk Factors
|
Investing in our common stock involves significant risks. See “Risk Factors” beginning on page 5 of this prospectus, and under similar headings in other documents incorporated by reference into this
prospectus, for a discussion of factors that you should read and consider before investing in our common stock.
|
Nasdaq listing symbol
|
AQST
|
• |
1,983,142 shares of common stock issuable upon exercise of outstanding options pursuant to our stock incentive plans at a weighted average option exercise price of $11.26 per share as of June 30, 2019;
|
• |
142,852 shares of common stock issuable upon vesting of restricted stock units outstanding under our stock incentive plans as of June 30, 2019; and
|
• |
2,000,000 shares of common stock issuable upon exercise of outstanding warrants, at an exercise price of $4.25 per share, as of July 15, 2019.
|
• |
risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and
clinical trials;
|
• |
the risks of delays in FDA approval of our drug candidates or failure to receive approval;
|
• |
the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory
limitations);
|
• |
the risk that a competitor obtains orphan drug exclusivity and blocks our product for the same indication for seven years;
|
• |
risk of development of our sales and marketing capabilities;
|
• |
risk of legal costs associated with and the outcome of our patent litigation challenging third party at risk generic sale of our proprietary products;
|
• |
risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our
short-term and longer term cash requirements and other cash needs, at the times and in the amounts needed;
|
• |
risk of availability of refinancing of existing debt facilities;
|
• |
risk of failure to satisfy all debt covenants and of any default under our senior secured notes;
|
• |
risk related to government claims against Indivior for which we license, manufacture and sell Suboxone and which accounts for the substantial part of our
current operating revenues;
|
• |
risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties;
|
• |
risk of the rate and degree of market acceptance of our products and product candidates;
|
• |
the success of any competing products, including generics;
|
• |
risk of the size and growth of our product markets;
|
• |
risk of the effectiveness and safety of our products and product candidates;
|
• |
risk of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities;
|
• |
risks associated with intellectual property rights and infringement claims relating to the Company’s products;
|
• |
risk of unexpected patent developments;
|
• |
the impact of existing and future legislation and regulatory provisions on product exclusivity;
|
• |
legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access;
|
• |
claims and concerns that may arise regarding the safety or efficacy of the Company’s products and product candidates;
|
• |
risk of loss of significant customers;
|
• |
risks related to legal proceedings, including patent infringement, investigative and antitrust litigation matters;
|
• |
changes in governmental laws and regulations;
|
• |
risk of product recalls and withdrawals; and
|
• |
uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items.
|
Assumed offering price per share
|
$
|
3.72
|
||||||
Net tangible book value (deficit) per share as of June 30, 2019
|
$
|
(0.99
|
)
|
|||||
Increase in net tangible book value per share attributable to new investors
|
$
|
0.73
|
||||||
As adjusted net tangible book value per share after this offering
|
$
|
(0.26
|
)
|
|||||
Net dilution per share to new investors participating in this offering
|
$
|
3.98
|
• |
1,983,142 shares of common stock issuable upon exercise of outstanding options pursuant to our stock incentive plans at a weighted average option exercise price of $11.26 per share as of June 30, 2019;
|
• |
142,852 shares of common stock issuable upon vesting of restricted stock units outstanding under our stock incentive plans as of June 30, 2019; and
|
• |
2,000,000 shares of common stock issuable upon exercise of outstanding warrants, at an exercise price of $4.25 per share, as of July 15, 2019.
|
• |
our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 14, 2019;
|
• |
our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 29, 2019;
|
• |
our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019, as filed with the SEC on May 8, 2019 and August 6, 2019;
|
• |
our Current Reports on Form 8-K filed with the SEC on May 8, 2019, June 18, 2019 and July 16, 2019, to the extent the
information in such reports is filed and not furnished; and
|
• |
the description of our common stock contained in our Registration Statement on Form 8-A, filed with the SEC on July 20, 2018,
including any amendments or reports filed for the purposes of updating this description.
|
The information in this prospectus is not complete and may be changed. We may not
sell these securities or accept an offer to buy 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 offers to buy these securities in any state where such offer or sale is not permitted.
|
Page | |
1
|
|
2
|
|
4 | |
5 | |
6 | |
8 | |
9
|
|
12 | |
14 | |
16 | |
16 | |
16 | |
16 |
• |
Libervant™, a buccal soluble film formulation of diazepam used as a rescue therapy for breakthrough epileptic seizures and an adjunctive therapy for use in recurrent convulsive seizures, for which a
pre-new drug application (NDA) meeting was held in December 2018 with the FDA. The meeting resulted in a plan to complete a small single-dose crossover study comparing Libervant to the reference listed drug, Diastat®. This study
was initiated in the first quarter of 2019, and enrollment into the study was completed in May 2019. The Company also began a rolling NDA submission process during the second quarter of 2019. The Company has completed the crossover
study and is evaluating the data generated and plans to complete the NDA filing by the end of the year; and
|
• |
Exservan™, an oral soluble film formulation of riluzole for the treatment of Amyotrophic Lateral Sclerosis, or ALS, for which we submitted an NDA in the first quarter of 2019; the Prescription Drug
User Fee Act (PDUFA) goal date for FDA action is November 30, 2019.
|
• |
AQST-108, a sublingual soluble film formulation for the treatment of anaphylaxis and severe allergic reactions, which is intended to provide an adjunct and or alternative to injection treatments such
as EpiPen. After the Company’s first human proof of concept trials, a re-formulated and more advanced prototype has been developed, for which we completed additional phase 1 proof of concept trials. The Company is evaluating the
data generated from these trials and plans on seeking a pre-IND meeting with the FDA before the end of the year; and
|
• |
AQST-305, a sublingual soluble film formulation of octreotide for the treatment of acromegaly and neuroendocrine tumors. As a result of early stage clinical proof of concept studies, re-formulation
work is currently underway.
|
Common Stock offered
by the Selling
Stockholders
|
Up to 4,228,082 shares of Common Stock, which includes (i) 2,000,000 Warrant Shares and (ii) 2,228,082 Piggyback Shares.
|
|
|
Use of proceeds
|
We are not selling any shares of Common Stock under this prospectus and will not receive any of the proceeds from the sale of shares of Common Stock by the Selling Stockholders. To the extent Warrants
are exercised for cash, we will receive the exercise price thereof.
|
|
|
Risk factors
|
Investing in our Common Stock involves significant risks. See “Risk Factors” beginning on page 5 of this prospectus, and under similar headings in other documents incorporated by reference into this
prospectus, for a discussion of factors that you should read and consider before investing in our Common Stock.
|
NASDAQ listing
symbol
|
AQST
|
• |
risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and
clinical trials;
|
• |
the risks of delays in FDA approval of our drug candidates or failure to receive approval;
|
• |
the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory
limitations);
|
• |
the risk that a competitor obtains orphan drug exclusivity and blocks our product for the same indication for seven years;
|
• |
risk of development of our sales and marketing capabilities;
|
• |
risk of legal costs associated with and the outcome of our patent litigation challenging third party at risk generic sale of our proprietary products;
|
• |
risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our
short-term and longer term cash requirements and other cash needs, at the times and in the amounts needed;
|
• |
risk of availability of refinancing of existing debt facilities;
|
• |
risk of failure to satisfy all debt covenants and of any default under our senior secured notes;
|
• |
risk related to government claims against Indivior for which we license, manufacture and sell Suboxone and which accounts for the substantial part of our
current operating revenues;
|
• |
risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties;
|
• |
risk of the rate and degree of market acceptance of our products and product candidates;
|
• |
the success of any competing products, including generics;
|
• |
risk of the size and growth of our product markets;
|
• |
risk of the effectiveness and safety of our products and product candidates;
|
• |
risk of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities;
|
• |
risks associated with intellectual property rights and infringement claims relating to the Company’s products;
|
• |
risk of unexpected patent developments;
|
• |
the impact of existing and future legislation and regulatory provisions on product exclusivity;
|
• |
legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access;
|
• |
claims and concerns that may arise regarding the safety or efficacy of the Company’s products and product candidates;
|
• |
risk of loss of significant customers;
|
• |
risks related to legal proceedings, including patent infringement, investigative and antitrust litigation matters;
|
• |
changes in governmental laws and regulations;
|
• |
risk of product recalls and withdrawals; and
|
• |
uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items.
|
Beneficial Ownership Before
This Offering (1)
|
Beneficial Ownership After This
Offering (3)
|
|||||||||||||||||||
Selling Stockholder
|
Number of
Shares Owned
|
Percentage of
Outstanding
Shares (2)
|
Shares
Offered
Hereby
|
Number of
Shares Owned
|
Percentage of
Outstanding
Shares (2)
|
|||||||||||||||
FFI Fund Ltd.
|
308,571
|
1.2
|
%
|
308,571
|
--
|
--
|
||||||||||||||
FYI Ltd.
|
68,571
|
*
|
68,571
|
--
|
--
|
|||||||||||||||
Entities affiliated with Madryn Asset Management (4)
|
1,428,572
|
5.4
|
%
|
1,428,572
|
--
|
--
|
||||||||||||||
Morgan Stanley & Co. LLC
|
142,857
|
*
|
142,857
|
--
|
--
|
|||||||||||||||
Olifant Fund, Ltd.
|
51,429
|
*
|
51,429
|
--
|
--
|
|||||||||||||||
Keith J. Kendall
|
766,314
|
3.0
|
%
|
662,477
|
103,837
|
*
|
||||||||||||||
A. Mark Schobel
|
1,147,818
|
4.6
|
%
|
1,043,981
|
103,837
|
*
|
||||||||||||||
John T. Maxwell
|
162,644
|
*
|
153,614
|
9,030
|
*
|
|||||||||||||||
Daniel Barber
|
132,472
|
*
|
101,959
|
30,513
|
*
|
|||||||||||||||
Theresa Wood
|
81,254
|
*
|
80,765
|
489
|
*
|
|||||||||||||||
Peter Boyd
|
66,793
|
*
|
50,239
|
16,554
|
*
|
|||||||||||||||
Lori Braender
|
32,250
|
*
|
11,000
|
21,250
|
*
|
|||||||||||||||
Gregory Brown, M.D.
|
86,210
|
*
|
75,085
|
11,125
|
*
|
|||||||||||||||
Santo Costa
|
28,452
|
*
|
17,327
|
11,125
|
*
|
|||||||||||||||
James S. Scibetta
|
42,760
|
*
|
31,635
|
11,125
|
*
|
(1) |
Includes (a) shares of our Common Stock held by the applicable Selling Stockholder and (b) shares of Common Stock issuable upon exercise or conversion of warrants or stock options that are currently
exercisable or convertible or are exercisable or convertible within 60 days of September 6, 2019 beneficially owned by the applicable Selling Stockholder.
|
(2) |
Based on a denominator equal to the sum of (a) 25,042,601 shares of our Common Stock outstanding on September 6, 2019, and (b) the number of shares of Common Stock issuable upon exercise or conversion of convertible securities that are currently exercisable or convertible or are exercisable or convertible within 60 days of September
6, 2019 beneficially owned by the applicable Selling Stockholder.
|
(3) |
For purposes of this table, the Company assumes that all of the shares covered by this prospectus will be sold by the Selling Stockholders.
|
(4) |
Consists of (i) 521,425 shares of Common Stock issuable upon the exercise of warrants held by Madryn Health Partners, LP (“Madryn Health Partners”), and (ii) 907,147 shares of Common Stock issuable
upon the exercise of warrants held by Madryn Health Partners (Cayman Master), LP (“Madryn Health Partners (Cayman)” and, together with Madryn Health Partners, the “Madryn Funds”). Madryn Asset Management, LP (“Madryn Asset
Management”) is the investment advisor to each of the Madryn Funds. Madryn Health Advisors, LP (“Madryn Health Advisors”) is the general partner of each of the Madryn Funds. Each of Madryn Asset Management and Madryn Health Advisors
may be deemed to beneficially own the shares of Common Stock issuable upon the exercise of warrants held by the Madryn Funds. Each of Madryn Asset Management and Madryn Health Advisors disclaims beneficial ownership of such shares
except to the extent of its respective pecuniary interest therein. The address of each of Madryn Asset Management, Madryn Health Advisors and the Madryn Funds is 140 East 45th Street, 15th Floor, New York, New York 10017.
|
•
|
in the over-the-counter market;
|
•
|
in transactions otherwise than on these exchanges or systems or in the over-the-counter market;
|
•
|
through the writing of options, whether such options are listed on an options exchange or otherwise;
|
•
|
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
|
•
|
block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
|
•
|
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
|
•
|
an exchange distribution in accordance with the rules of the applicable exchange;
|
•
|
privately negotiated transactions;
|
•
|
short sales;
|
•
|
sales pursuant to Rule 144 of the Securities Act of 1933, as amended, or the Securities Act;
|
•
|
broker-dealers may agree with the Selling Stockholders to sell a specified number of such security at a stipulated price per security;
|
•
|
a combination of any such methods of sale; or
|
•
|
any other method permitted pursuant to applicable law.
|
• |
our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 14, 2019;
|
• |
our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 29, 2019;
|
• |
our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019, as filed with the SEC on May 8, 2019 and August 6, 2019;
|
• |
our Current Reports on Form 8-K filed with the SEC on May 8, 2019, June 18, 2019 and July 16, 2019, to the extent the
information in such reports is filed and not furnished; and
|
• |
the description of our common stock contained in our Registration Statement on Form 8-A, filed with the SEC on July 20, 2018,
including any amendments or reports filed for the purposes of updating this description.
|
Item 14.
|
Other Expenses of Issuance and Distribution
|
SEC registration fee
|
$
|
20,210.71
|
||
FINRA filing fee | 23,000 |
|||
Accounting fees and expenses
|
70,000
|
|||
Legal fees and expenses
|
125,000
|
|||
Transfer agent fees and expenses
|
*
|
|||
Trustee fees and expenses
|
*
|
|||
Printing and miscellaneous expenses
|
7,500
|
|||
Total
|
$
|
*
|
||
* These fees cannot be estimated at this time, as they are calculated based on the securities offered and the number of issuances. In accordance with Rule 430B, an estimate of the aggregate expenses in connection with the sale and
distribution of the securities being offered will be included in the applicable prospectus supplement
|
Item 15.
|
Indemnification of Officers and Directors
|
•
|
transaction from which the director derives an improper personal benefit;
|
•
|
act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
|
•
|
unlawful payment of dividends or redemption of shares; or
|
•
|
breach of a director’s duty of loyalty to the corporation or its stockholders.
|
Item 16.
|
Exhibits and Financial Statement Schedules
|
Item 17.
|
Undertakings
|
Exhibit
Number
|
Description
of Document
|
|
1.1*
|
Form of Underwriting Agreement.
|
|
Equity Distribution Agreement dated as of September 11, 2019, between the Registrant and Piper Jaffray & Co.
|
||
Amended and Restated Certificate of Incorporation of Aquestive Therapeutics, Inc., dated as of July 27, 2018 (filed as Exhibit 3.1 to the Current Report on Form 8-K of the Company, as filed on July 27, 2018, and incorporated by
reference herein).
|
||
Amended and Restated Bylaws of Aquestive Therapeutics, Inc. (filed as Exhibit 3.6 to the Registration Statement on Form S-1 of the Company (File No. 333-225924), as filed on June 27, 2018, and incorporated by reference herein).
|
||
Form of Common Stock Certificate of Aquestive Therapeutics, Inc. (filed as Exhibit 4.1 to the Registration Statement on Form S-1 of the Company (File No. 333-225924), as filed on June 27, 2018, and incorporated by reference herein).
|
||
4.2*
|
Form of certificate of designation with respect to any preferred stock issued hereunder and the related form of preferred stock certificate
|
|
Form of indenture to be entered into between registrant and a trustee acceptable to the registrant.
|
||
4.4*
|
Form of warrant agreement.
|
|
4.5*
|
Form of warrant certificate.
|
|
4.6*
|
Form of debt security.
|
|
4.7*
|
Form of rights certificate.
|
|
4.8*
|
Form of unit agreement.
|
|
4.9*
|
Form of unit certificate.
|
|
Opinion of Dechert LLP.
|
||
Opinion of Dechert LLP.
|
||
Opinion of Dechert LLP.
|
||
Consent of KPMG LLP.
|
||
Consent of Dechert LLP (included in its Opinion filed as Exhibit 5.1 hereto).
|
||
23.3 | Consent of Dechert LLP (included in its Opinion filed as Exhibit 5.2 hereto). | |
23.4 |
Consent of Dechert LLP (included in its Opinion filed as Exhibit 5.3 hereto). | |
Powers of Attorney (included on signature page).
|
||
25.1**
|
Statement of Eligibility of Trustee under the Indenture.
|
*
|
To be filed, if applicable, by amendment or as an exhibit to a document filed under the Securities Exchange Act of 1934, as amended, and incorporated by reference herein.
|
**
|
To be filed separately pursuant to Section 305(b)(2) of the Trust Indenture Act of 1939, as amended, and the appropriate rules and regulations thereunder.
|
AQUESTIVE THERAPEUTICS, INC.
|
||
By:
|
/s/ Keith J. Kendall
|
|
Keith J. Kendall
|
||
President and Chief Executive Officer
|
Name and Signature
|
Title
|
Date
|
||
/s/ Keith J. Kendall
|
President and Chief Executive
|
September 11, 2019
|
||
Keith J. Kendall
|
Officer and Member of the Board of Directors (Principal Executive Officer)
|
|||
/s/ John T. Maxwell
|
Chief Financial Officer
|
September 11, 2019
|
||
John T. Maxwell
|
(Principal Financial and Accounting Officer)
|
|||
/s/ Santo J. Costa
|
Chairman of the Board of
|
September 11, 2019
|
||
Santo J. Costa
|
Directors
|
|||
/s/ Douglas K. Bratton
|
Director
|
September 11, 2019
|
||
Douglas K. Bratton
|
||||
/s/ Gregory B. Brown, M.D.
|
Director
|
September 11, 2019
|
||
Gregory B. Brown, M.D.
|
||||
/s/ John S. Cochran
|
Director
|
September 11, 2019
|
||
John S. Cochran
|
||||
/s/ Nancy S. Lurker
|
Director
|
September 11, 2019
|
||
Nancy S. Lurker
|
||||
/s/ James S. Scibetta
|
Director
|
September 11, 2019
|
||
James S. Scibetta
|
Very truly yours,
|
|||
AQUESTIVE THERAPEUTICS, INC.
|
|||
By:
|
/s/ John T. Maxwell
|
Name:
|
John T. Maxwell
|
||
Title:
|
Chief Financial Officer
|
PIPER JAFFRAY & CO.
|
||
By:
|
/s/ Neil A. Riley
|
Name:
|
Neil A. Riley
|
||
Title:
|
Managing Director
|
From:
|
Aquestive Therapeutics, Inc.
|
To:
|
Piper Jaffray & Co.
|
Attention:
|
|
Neil A. Riley
Neil.A.Riley@pjc.com
|
|
Connor N. Anderson
Connor.N.Anderson@pjc.com
|
|
Tom Wright
Thomas.E.Wright@pjc.com
|
|
Jay A. Hershey
Jay.A.Hershey@pjc.com
|
|
|
|
Date:
|
[●], 20[●]
|
Subject:
|
Equity Distribution Agreement – Placement Notice
|
Gentlemen:
|
AQUESTIVE THERAPEUTICS, INC.
|
|
By:
|
Name:
|
||
Title:
|
Page
|
|||
ARTICLE I DEFINITIONS
|
1
|
||
Section 1.1
|
Definitions of Terms
|
1
|
|
ARTICLE II ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES
|
4
|
||
Section 2.1
|
Designation and Terms of Securities
|
4
|
|
Section 2.2
|
Form of Securities and Trustee’s Certificate
|
5
|
|
Section 2.3
|
Denominations: Provisions for Payment
|
5
|
|
Section 2.4
|
Execution and Authentications
|
6
|
|
Section 2.5
|
Registration of Transfer and Exchange
|
7
|
|
Section 2.6
|
Temporary Securities
|
8
|
|
Section 2.7
|
Mutilated, Destroyed, Lost or Stolen Securities
|
8
|
|
Section 2.8
|
Cancellation
|
8
|
|
Section 2.9
|
Benefits of Indenture
|
9
|
|
Section 2.10
|
Authenticating Agent
|
9
|
|
Section 2.11
|
Global Securities
|
9
|
|
ARTICLE III REDEMPTION OF SECURITIES AND SINKING FUND PROVISIONS
|
10
|
||
Section 3.1
|
Redemption
|
10
|
|
Section 3.2
|
Notice of Redemption
|
10
|
|
Section 3.3
|
Payment Upon Redemption
|
11
|
|
Section 3.4
|
Sinking Fund
|
11
|
|
Section 3.5
|
Satisfaction of Sinking Fund Payments with Securities
|
11
|
|
Section 3.6
|
Redemption of Securities for Sinking Fund
|
11
|
|
ARTICLE IV COVENANTS
|
12
|
||
Section 4.1
|
Payment of Principal, Premium and Interest
|
12
|
|
Section 4.2
|
Maintenance of Office or Agency
|
12
|
|
Section 4.3
|
Paying Agents
|
12
|
|
Section 4.4
|
Appointment to Fill Vacancy in Office of Trustee
|
13
|
|
Section 4.5
|
Compliance with Consolidation Provisions
|
13
|
|
ARTICLE V SECURITYHOLDERS’ LISTS AND REPORTS BY THE COMPANY AND THE TRUSTEE
|
13
|
||
Section 5.1
|
Company to Furnish Trustee Names and Addresses of Securityholders
|
13
|
|
Section 5.2
|
Preservation of Information; Communications With Securityholders
|
13
|
|
Section 5.3
|
Reports by the Company
|
14
|
|
Section 5.4
|
Reports by the Trustee
|
14
|
|
ARTICLE VI REMEDIES OF THE TRUSTEE AND SECURITYHOLDERS ON EVENT OF DEFAULT
|
14
|
||
Section 6.1
|
Events of Default
|
14
|
|
Section 6.2
|
Collection of Indebtedness and Suits for Enforcement by Trustee
|
15
|
|
Section 6.3
|
Application of Moneys Collected
|
16
|
|
Section 6.4
|
Limitation on Suits
|
16
|
Section 6.5
|
Rights and Remedies Cumulative; Delay or Omission Not Waiver
|
17
|
|
Section 6.6
|
Control by Securityholders
|
17
|
|
Section 6.7
|
Undertaking to Pay Costs
|
17
|
|
ARTICLE VII CONCERNING THE TRUSTEE
|
18
|
||
Section 7.1
|
Certain Duties and Responsibilities of Trustee
|
18
|
|
Section 7.2
|
Certain Rights of Trustee
|
19
|
|
Section 7.3
|
Trustee Not Responsible for Recitals or Issuance or Securities
|
19
|
|
Section 7.4
|
May Hold Securities
|
20
|
|
Section 7.5
|
Moneys Held in Trust
|
20
|
|
Section 7.6
|
Compensation and Reimbursement
|
20
|
|
Section 7.7
|
Reliance on Officer’s Certificate
|
20
|
|
Section 7.8
|
Disqualification; Conflicting Interests
|
20
|
|
Section 7.9
|
Corporate Trustee Required; Eligibility
|
21
|
|
Section 7.10
|
Resignation and Removal; Appointment of Successor
|
21
|
|
Section 7.11
|
Acceptance of Appointment By Successor
|
22
|
|
Section 7.12
|
Merger, Conversion, Consolidation or Succession to Business
|
22
|
|
Section 7.13
|
Preferential Collection of Claims Against the Company
|
23
|
|
Section 7.14
|
Notice of Default
|
23
|
|
ARTICLE VIII CONCERNING THE SECURITYHOLDERS
|
23
|
||
Section 8.1
|
Evidence of Action by Securityholders
|
23
|
|
Section 8.2
|
Proof of Execution by Securityholders
|
23
|
|
Section 8.3
|
Who May Be Deemed Owners
|
24
|
|
Section 8.4
|
Certain Securities Owned by Company Disregarded
|
24
|
|
Section 8.5
|
Actions Binding on Future Securityholders
|
24 | |
ARTICLE IX SUPPLEMENTAL INDENTURES
|
24
|
||
Section 9.1
|
Supplemental Indentures Without the Consent of Securityholders
|
24
|
|
Section 9.2
|
Supplemental Indentures With Consent of Securityholders
|
25 | |
Section 9.3
|
Effect of Supplemental Indentures
|
25
|
|
Section 9.4
|
Securities Affected by Supplemental Indentures
|
26
|
|
Section 9.5
|
Execution of Supplemental Indentures
|
26
|
|
ARTICLE X SUCCESSOR ENTITY
|
26
|
||
Section 10.1
|
Company May Consolidate, Etc.
|
26
|
|
Section 10.2
|
Successor Entity Substituted
|
27
|
|
Section 10.3
|
Evidence of Consolidation, Etc. to Trustee
|
27
|
|
ARTICLE XI SATISFACTION AND DISCHARGE
|
27
|
||
Section 11.1
|
Satisfaction and Discharge of Indenture
|
27
|
|
Section 11.2
|
Discharge of Obligations
|
28
|
|
Section 11.3
|
Deposited Moneys to be Held in Trust
|
28
|
|
Section 11.4
|
Payment of Moneys Held by Paying Agents
|
28
|
|
Section 11.5
|
Repayment to Company
|
28
|
ARTICLE XII IMMUNITY OF INCORPORATORS, STOCKHOLDERS, OFFICERS AND DIRECTORS
|
28
|
||
Section 12.1
|
No Recourse
|
28
|
|
ARTICLE XIII MISCELLANEOUS PROVISIONS
|
29
|
||
Section 13.1
|
Effect on Successors and Assigns
|
29
|
|
Section 13.2
|
Actions by Successor
|
29
|
|
Section 13.3
|
Surrender of Company Powers
|
29
|
|
Section 13.4
|
Notices
|
29
|
|
Section 13.5
|
Governing Law
|
29
|
|
Section 13.6
|
Treatment of Securities as Debt
|
29
|
|
Section 13.7
|
Certificates and Opinions as to Conditions Precedent
|
30
|
|
Section 13.8
|
Payments on Business Days
|
30
|
|
Section 13.9
|
Conflict with Trust Indenture Act
|
30
|
|
Section 13.10
|
Counterparts
|
30
|
|
Section 13.11
|
Separability
|
30
|
|
Section 13.12
|
Compliance Certificates
|
30
|
Section 1.1 |
Definitions of Terms.
|
Section 2.1 |
Designation and Terms of Securities.
|
Section 2.2 |
Form of Securities and Trustee’s Certificate.
|
Section 2.3 |
Denominations: Provisions for Payment.
|
Section 2.4 |
Execution and Authentications.
|
Section 2.5 |
Registration of Transfer and Exchange.
|
Section 2.6 |
Temporary Securities.
|
Section 2.7 |
Mutilated, Destroyed, Lost or Stolen Securities.
|
Section 2.8 |
Cancellation.
|
Section 2.9 |
Benefits of Indenture.
|
Section 2.10 |
Authenticating Agent.
|
Section 2.11 |
Global Securities.
|
Section 3.1 |
Redemption.
|
Section 3.2 |
Notice of Redemption.
|
Section 3.3 |
Payment Upon Redemption.
|
Section 3.4 |
Sinking Fund.
|
Section 3.5 |
Satisfaction of Sinking Fund Payments with Securities.
|
Section 3.6 |
Redemption of Securities for Sinking Fund.
|
Section 4.1 |
Payment of Principal, Premium and Interest.
|
Section 4.2 |
Maintenance of Office or Agency.
|
Section 4.3 |
Paying Agents.
|
Section 4.4 |
Appointment to Fill Vacancy in Office of Trustee.
|
Section 4.5 |
Compliance with Consolidation Provisions.
|
Section 5.1 |
Company to Furnish Trustee Names and Addresses of Securityholders.
|
Section 5.2 |
Preservation of Information; Communications With Securityholders.
|
Section 5.3 |
Reports by the Company.
|
Section 5.4 |
Reports by the Trustee.
|
Section 6.1 |
Events of Default.
|
Section 6.2 |
Collection of Indebtedness and Suits for Enforcement by Trustee.
|
Section 6.3 |
Application of Moneys Collected.
|
Section 6.4 |
Limitation on Suits.
|
Section 6.5 |
Rights and Remedies Cumulative; Delay or Omission Not Waiver.
|
Section 6.6 |
Control by Securityholders.
|
Section 6.7 |
Undertaking to Pay Costs.
|
Section 7.1 |
Certain Duties and Responsibilities of Trustee.
|
Section 7.2 |
Certain Rights of Trustee.
|
Section 7.3 |
Trustee Not Responsible for Recitals or Issuance or Securities.
|
Section 7.4 |
May Hold Securities.
|
Section 7.5 |
Moneys Held in Trust.
|
Section 7.6 |
Compensation and Reimbursement.
|
Section 7.7 |
Reliance on Officer’s Certificate.
|
Section 7.8 |
Disqualification; Conflicting Interests.
|
Section 7.9 |
Corporate Trustee Required; Eligibility.
|
Section 7.10 |
Resignation and Removal; Appointment of Successor.
|
Section 7.11 |
Acceptance of Appointment By Successor.
|
Section 7.12 |
Merger, Conversion, Consolidation or Succession to Business.
|
Section 7.13 |
Preferential Collection of Claims Against the Company.
|
Section 7.14 |
Notice of Default
|
Section 8.1 |
Evidence of Action by Securityholders.
|
Section 8.2 |
Proof of Execution by Securityholders.
|
Section 8.3 |
Who May Be Deemed Owners.
|
Section 8.4 |
Certain Securities Owned by Company Disregarded.
|
Section 8.5 |
Actions Binding on Future Securityholders.
|
Section 9.1 |
Supplemental Indentures Without the Consent of Securityholders.
|
Section 9.2 |
Supplemental Indentures With Consent of Securityholders.
|
Section 9.3 |
Effect of Supplemental Indentures.
|
Section 9.4 |
Securities Affected by Supplemental Indentures.
|
Section 9.5 |
Execution of Supplemental Indentures.
|
Section 10.1 |
Company May Consolidate, Etc.
|
Section 10.2 |
Successor Entity Substituted.
|
Section 10.3 |
Evidence of Consolidation, Etc. to Trustee.
|
Section 11.1 |
Satisfaction and Discharge of Indenture.
|
Section 11.2 |
Discharge of Obligations.
|
Section 11.3 |
Deposited Moneys to be Held in Trust.
|
Section 11.4 |
Payment of Moneys Held by Paying Agents.
|
Section 11.5 |
Repayment to Company.
|
Section 12.1 |
No Recourse.
|
Section 13.1 |
Effect on Successors and Assigns.
|
Section 13.2 |
Actions by Successor.
|
Section 13.3 |
Surrender of Company Powers.
|
Section 13.4 |
Notices.
|
|
|
|
|
|
|
Section 13.5 |
Governing Law.
|
Section 13.6 |
Treatment of Securities as Debt.
|
Section 13.7 |
Certificates and Opinions as to Conditions Precedent.
|
Section 13.8 |
Payments on Business Days.
|
Section 13.9 |
Conflict with Trust Indenture Act.
|
Section 13.10 |
Counterparts.
|
Section 13.12 |
Compliance Certificates.
|
By:
|
|
Name:
|
|
Title:
|
|
[TRUSTEE], as Trustee
|
|
By:
|
|
Name:
|
|
Title:
|
1095 Avenue of the Americas
New York, NY 10036-6797
+1 212 698 3500 Main
+1 212 698 3599 Fax
www.dechert.com
|
|
Re: |
Registration Statement on Form S-3
|
(i) |
the Registration Statement;
|
(ii) |
the Company’s Amended and Restated Certificate of Incorporation, as originally filed with the Secretary of State of the State of Delaware on July 27, 2018 (the “Certificate”);
|
(iii) |
the Company’s Amended and Restated Bylaws, effective as of July 24, 2018 (together with the Certificate, the “Charter”);
|
(iv) |
a Certificate of Good Standing with respect to the Company issued by the Secretary of State of the State of Delaware, as of a recent date; and
|
(v) |
the resolutions of the board of directors of the Company, relating to, among other things, the authorization and approval of the preparation and filing of the Registration Statement,
|
1. |
The Common Stock, when (a) duly issued and sold in accordance with the Registration Statement and applicable Prospectus Supplement, or upon conversion or exchange of Debt Securities or Preferred Stock or upon exercise of Rights or
Warrants as contemplated by the Registration Statement and applicable Prospectus Supplement, and (b) delivered to the purchaser or purchasers thereof against receipt by the Company of such lawful consideration therefor as the Board of
Directors (or a duly authorized committee thereof) may determine and at a price per share not less than the per share par value of the Common Stock, will be validly issued, fully paid and non-assessable.
|
2. |
The Preferred Stock, when (a) duly issued and sold in accordance with the Registration Statement and applicable Prospectus Supplement, or upon conversion or exchange of Debt Securities or upon exercise of Rights or Warrants as
contemplated by the Registration Statement and applicable Prospectus Supplement, and (b) delivered to the purchaser or purchasers thereof against receipt by the Company of such lawful consideration therefor as the Board of Directors (or
a duly authorized committee thereof) may determine and at a price per share not less than the per share par value of the Preferred Stock, will be validly issued, fully paid and non-assessable.
|
3. |
The Warrants, when (a) duly executed, issued and sold in accordance with the Registration Statement and applicable Prospectus Supplement and the provisions of an applicable, valid and binding warrant agreement and (b) delivered to
the purchaser or purchasers thereof against receipt by the Company of such lawful consideration therefor as the Board of Directors (or a duly authorized committee thereof) may determine, will be valid and binding obligations of the
Company enforceable against the Company in accordance with their respective terms.
|
4. |
The Debt Securities, when (a) duly executed by the Company and authenticated by the applicable Trustee in accordance with the provisions of the valid and binding Indenture (including any amendments or supplements thereto) and issued
and sold (x) in accordance with the Registration Statement and applicable Prospectus Supplement or (y) upon conversion or exchange of Preferred Stock or upon exercise of Rights or Warrants as contemplated by the Registration Statement
and applicable Prospectus Supplement, and (b) delivered to the purchaser or purchasers thereof against receipt by the Company of such lawful consideration therefor as the Board of Directors (or a duly authorized committee thereof) may
determine, will be valid and binding obligations of the Company enforceable against the Company in accordance with their respective terms.
|
5. |
The Rights, when (a) duly issued in accordance with the Registration Statement and applicable Prospectus Supplement and the provisions of an applicable subscription certificate and any applicable and valid and binding subscription
agreement, and (b) delivered to the purchaser or purchasers thereof against receipt by the Company of such lawful consideration therefor as the Board of Directors (or a duly authorized committee thereof) may determine, will be validly
issued and binding obligations of the Company enforceable against the Company in accordance with their respective terms.
|
6. |
The Units, when (a) duly executed, issued and sold in accordance with the Registration Statement and applicable Prospectus Supplement and the provisions of any applicable and valid and binding unit agreement, and (b) delivered to the
purchaser or purchasers thereof against receipt by the Company of such lawful consideration therefor as the Board of Directors (or a duly authorized committee thereof) may determine, will be valid and binding obligations of the Company
enforceable against the Company in accordance with their respective terms.
|
Very truly yours,
|
|
/s/ Dechert LLP
|
1095 Avenue of the Americas
New York, NY 10036-6797
+1 212 698 3500 Main
+1 212 698 3599 Fax
www.dechert.com
|
|
|
|
Re: |
Registration Statement and Equity Distribution Agreement Prospectus on Form S-3
|
(i) |
the Registration Statement;
|
(ii) |
the Prospectus;
|
(iii) |
the Company’s Amended and Restated Certificate of Incorporation, as originally filed with the Secretary of State of the State of Delaware on July 27, 2018;
|
(iv) |
the Company’s Amended and Restated Bylaws, effective as of July 24, 2018;
|
(v) |
a Certificate of Good Standing with respect to the Company issued by the Secretary of State of the State of Delaware, as of a recent date;
|
(vi) |
the form of the Equity Distribution Agreement; and
|
(vii) |
the resolutions of the board of directors of the Company, relating to, among other things, (a) the authorization and approval of the preparation and filing of the Registration Statement and the Prospectus, and (b) the authorization
to enter into the Equity Distribution Agreement.
|
Very truly yours,
|
|
/s/ Dechert LLP
|
1095 Avenue of the Americas
New York, NY 10036-6797
+1 212 698 3500 Main
+1 212 698 3599 Fax
www.dechert.com
|
|
|
|
Re: |
Registration Statement and Selling Stockholder Prospectus on Form S-3
|
(i) |
the Registration Statement;
|
(ii) |
the Prospectus;
|
(iii) |
the Company’s Amended and Restated Certificate of Incorporation, as originally filed with the Secretary of State of the State of Delaware on July 27, 2018;
|
(iv) |
the Company’s Amended and Restated Bylaws, effective as of July 24, 2018;
|
(v) |
a Certificate of Good Standing with respect to the Company issued by the Secretary of State of the State of Delaware, as of a recent date;
|
(vi) |
the form of Warrant; and
|
(vii) |
the resolutions of the board of directors of the Company, relating to, among other things, the authorization and approval of the preparation and filing of the Registration Statement and the Prospectus.
|
Very truly yours,
|
|
/s/ Dechert LLP
|