Document:

Exhibit 10.1

 

SECURITIES PURCHASE
AGREEMENT

 

This
Securities Purchase Agreement (this “Agreement”) is dated as of November 16,
2022, between Trevena, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature
pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”).

 

WHEREAS,
subject to the terms and conditions set forth in this Agreement and pursuant to an effective registration statement under the Securities
Act (as defined below), the Company desires to issue and sell to each Purchaser, and each Purchaser, severally and not jointly, desires
to purchase from the Company, securities of the Company as more fully described in this Agreement.

 

NOW,
THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration,
the receipt and adequacy of which are hereby acknowledged, the Company and each Purchaser agree as follows:

 

ARTICLE I.

 

DEFINITIONS

 

1.1                           Definitions.
In addition to the terms defined elsewhere in this Agreement, the following terms have the meanings set forth in this Section 1.1:

 

“$”
means U.S. dollars.

 

“Acquiring
Person” shall have the meaning ascribed to such term in Section 4.7.

 

“Action”
shall have the meaning ascribed to such term in Section 3.1(j).

 

“Affiliate”
means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control
with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.

 

“Board
of Directors” means the board of directors of the Company.

 

“Business
Day” means any day other than Saturday, Sunday or other day on which commercial banks in The City of New York are authorized
or required by law to remain closed; provided, however, for clarification, commercial banks shall not be deemed to be authorized
or required by law to remain closed due to “stay at home”, “shelter-in-place”, “non-essential employee” 
or any other similar orders or restrictions or the closure of any physical branch locations at the direction of any governmental authority
so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in The City of New York generally
are open for use by customers on such day.

 

“Closing”
means the closing of the purchase and sale of the Securities pursuant to Section 2.1.

 

     

     

    

 

“Closing
Date” means the Trading Day on which all of the Transaction Documents have been executed and delivered by the applicable parties
thereto, and all conditions precedent to (i) the Purchasers’ obligations to pay the Subscription Amount and (ii) the
Company’s obligations to deliver the Securities, in each case, have been satisfied or waived, but in no event later than the second
(2nd) Trading Day following the date hereof.

 

“Commission”
means the United States Securities and Exchange Commission.

 

“Common
Stock” means the common stock of the Company, par value $0.001 per share, and any other class of securities into which such
securities may hereafter be reclassified or changed.

 

“Common
Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire
at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is
at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

 

“Company
Counsel” means Troutman Pepper Hamilton Sanders LLP, with offices located at 3000 Two Logan Square, Eighteenth and Arch Streets,
Philadelphia, PA 19103.

 

“Common
Stock Warrants” means, collectively, the Common Stock purchase warrants delivered to the Purchasers at the Closing in accordance
with Section 2.2(a) hereof, which Common Stock Warrants shall be exercisable immediately and have a term of exercise equal
to five (5) years from the Closing Date, in the form of Exhibit A-2 attached hereto.

 

“Disclosure
Schedules” means the Disclosure Schedules of the Company delivered concurrently herewith.

 

“Disclosure
Time” means, (i) if this Agreement is signed on a day that is not a Trading Day or after 9:00 a.m. (New York City
time) and before midnight (New York City time) on any Trading Day, 9:01 a.m. (New York City time) on the Trading Day immediately
following the date hereof, unless otherwise instructed as to an earlier time by the Placement Agent, and (ii) if this Agreement
is signed between midnight (New York City time) and 9:00 a.m. (New York City time) on any Trading Day, no later than 9:01 a.m. (New
York City time) on the date hereof, unless otherwise instructed as to an earlier time by the Placement Agent.

 

“Duane
Morris LLP” means Placement Agent’s counsel.

 

“Evaluation
Date” shall have the meaning ascribed to such term in Section 3.1(s).

 

“Exchange
Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

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“Exempt
Issuance” means the issuance of (a) shares of Common Stock or options to employees, officers or directors of the Company
pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors
or a majority of the members of a committee of non-employee directors established for such purpose for services rendered to the Company,
(b) securities upon the exercise or exchange of or conversion of any Securities issued hereunder and/or other securities exercisable
or exchangeable for or convertible into shares of Common Stock issued and outstanding on the date of this Agreement, provided that such
securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise
price, exchange price or conversion price of such securities (other than in connection with stock splits or combinations) or to extend
the term of such securities and (c) securities issued pursuant to acquisitions or strategic transactions approved by a majority
of the disinterested directors of the Company, provided that such securities are issued as “restricted securities” (as defined
in Rule 144) and carry no registration rights that require or permit the filing of any registration statement in connection therewith
during the prohibition period in Section 4.13(a) herein, and, provided that any such issuance shall only be to a Person (or
to the equityholders of a Person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business
synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds,
but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an
entity whose primary business is investing in securities.

 

“FCPA”
means the Foreign Corrupt Practices Act of 1977, as amended.

 

“FDA”
shall have the meaning ascribed to such term in Section 3.1(hh).

 

“FDCA”
shall have the meaning ascribed to such term in Section 3.1(hh).

 

“GAAP”
shall have the meaning ascribed to such term in Section 3.1(h).

 

“Indebtedness”
shall have the meaning ascribed to such term in Section 3.1(aa).

 

“Intellectual
Property Rights” shall have the meaning ascribed to such term in Section 3.1(p).

 

“Liens”
means a lien, charge, pledge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.

 

“Material
Adverse Effect” shall have the meaning assigned to such term in Section 3.1(b).

 

“Material
Permits” shall have the meaning ascribed to such term in Section 3.1(n).

 

“Per
Share Purchase Price” equals $3.06, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations
and other similar transactions of the Common Stock that occur after the date of this Agreement and prior to the Closing Date, provided
that the purchase price per Pre-Funded Warrant shall be the Per Share Purchase Price minus $0.001.

 

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“Par
Value” means $0.001 per share of Common Stock.

 

“Person”
means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability
company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

 

“Pharmaceutical
Product” shall have the meaning ascribed to such term in Section 3.1(hh).

 

“Placement
Agent” means H.C. Wainwright & Co., LLC.

 

“Pre-Funded
Warrant” means, collectively, the Pre-Funded Common Stock purchase warrants delivered to the Purchasers at the Closing in accordance
with Section 2.2(a) hereof, which Pre-Funded Warrants shall be exercisable immediately and shall expire when exercised in full,
in the form of Exhibit A-1 attached hereto.

 

“Proceeding”
means an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding,
such as a deposition), whether commenced or threatened.

 

“Prospectus”
means the final prospectus filed for the Registration Statement.

 

“Prospectus
Supplement” means the supplement to the Prospectus complying with Rule 424(b) of the Securities Act that is filed
with the Commission and delivered by the Company to each Purchaser at the Closing.

 

“Purchaser
Party” shall have the meaning ascribed to such term in Section 4.10.

 

“Registration
Statement” means the effective registration statement on Form S-3 (File No. 333-251006) on file with the Commission,
including all information, documents and exhibits filed with or incorporated by reference into such registration statement, which registers
the sale of the Common Stock, Warrants and the Warrant Shares to the Purchasers.

 

“Required
Approvals” shall have the meaning ascribed to such term in Section 3.1(e).

 

“Rule 144”
means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from
time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect
as such Rule.

 

“Rule 424”
means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from
time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect
as such Rule.

 

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“SEC
Reports” shall have the meaning ascribed to such term in Section 3.1(h).

 

“Securities”
means the Shares, the Warrants and the Warrant Shares.

 

“Securities
Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

“Shares”
means the shares of Common Stock issued or issuable to each Purchaser pursuant to this Agreement.

 

“Short
Sales” means all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall
not be deemed to include locating and/or borrowing shares of Common Stock).

 

“Subscription
Amount” means, as to each Purchaser, the aggregate amount to be paid for the Shares and Warrants purchased hereunder as specified
below such Purchaser’s name on the signature page of this Agreement and next to the heading “Subscription Amount,”
in United States dollars and in immediately available funds.

 

“Subsidiary”
means any subsidiary of the Company as set forth on Schedule 3.1(a) and shall, where applicable, also include any direct
or indirect subsidiary of the Company formed or acquired after the date hereof.

 

“Trading
Day” means a day on which the principal Trading Market is open for trading.

 

“Trading
Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date
in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, or the New York
Stock Exchange (or any successors to any of the foregoing).

 

“Transaction
Documents” means this Agreement, the Warrants, all exhibits and schedules thereto and hereto and any other documents or agreements
executed in connection with the transactions contemplated hereunder.

 

“Transfer
Agent” means Continental Stock Transfer & Trust Company, the current transfer agent of the Company, with a mailing
address of 1 State Street, 30th Floor, New York, New York 10004, and any successor transfer agent of the Company.

 

“Variable
Rate Transaction” shall have the meaning ascribed to such term in Section 4.13(b).

 

“Warrants”
means, collectively, Pre-Funded Warrants and the Common Stock Warrants.

 

“Warrant
Shares” means the shares of Common Stock issuable upon exercise of the Warrants.

 

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ARTICLE II.

PURCHASE AND
SALE

 

2.1           Closing.
On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchasers, severally
and not jointly, agree to purchase, up to an aggregate of $8,000,002.80 of Shares and Common Stock Warrants; provided, however, that,
to the extent that a Purchaser determines, in its sole discretion, that such Purchaser (together with such Purchaser’s Affiliates,
and any Person acting as a group together with such purchaser or any of such Purchaser’s Affiliates) would beneficially own in
excess of the Beneficial Ownership Limitation, or as such Purchaser may otherwise choose, in lieu of purchasing Shares such Purchaser
may elect to purchase Pre-Funded Warrants in lieu of Shares in such manner to result in the same aggregate purchase price being paid
by such Purchaser to the Company. The “Beneficial Ownership Limitation” shall be 4.99% (or, at the election of the Purchaser
at Closing, 9.99%) of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of the Securities
on the Closing Date. Each Purchaser’s Subscription Amount as set forth on the signature page hereto executed by such Purchaser
shall be made available for “Delivery Versus Payment” (“DVP”) settlement with the Company or its designee.
The Company shall deliver to each Purchaser its respective Shares and a Common Stock Warrant as determined pursuant to Section 2.2(a),
and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 deliverable at the Closing. Upon satisfaction
of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of the Placement Agent or such
other location as the parties shall mutually agree. Unless otherwise directed by the Placement Agent, settlement of the Shares shall
occur via DVP (i.e., on the Closing Date, the Company shall issue the Shares registered in the Purchasers’ names and addresses
and released by the Transfer Agent directly to the account(s) at the Placement Agent identified by each Purchaser; upon receipt
of such Shares, the Placement Agent shall promptly electronically deliver such Shares to the applicable Purchaser, and payment therefor
shall be made by the Placement Agent (or its clearing firm) by wire transfer to the Company). Notwithstanding anything herein to the
contrary, if at any time on or after the time of execution of this Agreement by the Company and an applicable Purchaser, through, and
including the time immediately prior to the Closing (the “Pre-Settlement Period”), such Purchaser sells to any Person
all, or any portion, of the Shares to be issued hereunder to such Purchaser at the Closing (collectively, the “Pre-Settlement
Shares”), such Purchaser shall, automatically hereunder (without any additional required actions by such Purchaser or the Company),
be deemed to be unconditionally bound to purchase, such Pre-Settlement Shares to such Purchaser at the Closing; provided, that the Company
shall not be required to deliver any Pre-Settlement Shares to such Purchaser prior to the Company’s receipt of the purchase price
of such Pre-Settlement Shares hereunder; and provided further that the Company hereby acknowledges and agrees that the forgoing shall
not constitute a representation or covenant by such Purchaser as to whether or not during the Pre-Settlement Period such Purchaser shall
sell any shares of Common Stock to any Person and that any such decision to sell any shares of Common Stock by such Purchaser shall solely
be made at the time such Purchaser elects to effect any such sale, if any.

 

Notwithstanding
the foregoing, with respect to any Notice(s) of Exercise (as defined in the applicable Warrant) delivered on or prior to 12:00 p.m. (New
York City time) on the Closing Date, which may be delivered at any time after the time of execution of the this Agreement, the Company
agrees to deliver the Warrant Shares subject to such notice(s) by 4:00 p.m. (New York City time) on the Closing Date and the
Closing Date shall be the Warrant Share Delivery Date (as defined in the applicable Warrant) for purposes hereunder.

 

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2.2                           Deliveries.

 

(a)            On
or prior to the Closing Date, the Company shall deliver or cause to be delivered to each Purchaser the following:

 

		(i)	this Agreement
                                            duly executed by the Company;

 

(ii)            a
legal opinion of Company Counsel, addressed to the Placement Agent and the Purchasers, in a form reasonably acceptable to the Placement
Agent and Purchasers;

 

(iii)          (iv)     subject
to the last sentence of Section 2.1, a copy of the irrevocable instructions to the Transfer Agent instructing the Transfer Agent
to deliver on an expedited basis via The Depository Trust Company Deposit or Withdrawal at Custodian system (“DWAC”)
Shares equal to such Purchaser’s Subscription Amount divided by the Per Share Purchase Price, registered in the name of such Purchaser;

 

(iv)          a
Common Stock Warrant registered in the name of such Purchaser to purchase up to a number of shares of Common Stock equal to 100% of such
Purchaser’s Shares , with an exercise price equal to $2.95, subject to adjustment therein;

 

(v)            for
each Purchaser of Pre-Funded Warrants pursuant to Section 2.1, a Pre-Funded Warrant registered in the name of such Purchaser to
purchase up to a number of shares of Common Stock equal to the portion of such Purchaser’s Subscription Amount applicable to Pre-Funded
Warrant divided by the Per Share Purchase Price minus $0.001, with an exercise price equal to $0.001, subject to adjustment therein;

 

(vi)          the
Company shall have provided each Purchaser with the Escrow Agent’s wire instructions, on Company letterhead and executed by the
Chief Executive Officer or Chief Financial Officer; and

 

(vii)         the
Prospectus and Prospectus Supplement (which may be delivered in accordance with Rule 172 under the Securities Act).

 

(b)           On
or prior to the Closing Date, each Purchaser shall deliver or cause to be delivered to the Company, as applicable, the following:

 

		(i)	this Agreement
                                            duly executed by such Purchaser; and

 

(ii)           such
Purchaser’s Subscription Amount, which shall be made available for DVP settlement with the Company or its designee.

 

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2.3           Closing
Conditions.

 

(a)            The
obligations of the Company hereunder in connection with the Closing are subject to the following conditions being met:

 

(i)             the
accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect,
in all respects) when made and on the Closing Date of the representations and warranties of the Purchasers contained herein (unless such
representation or warranty is as of a specific date therein in which case they shall be accurate as of such date);

 

(ii)            all
obligations, covenants and agreements of each Purchaser required to be performed at or prior to the Closing Date shall have been performed;
and

 

(iii)           the
delivery by each Purchaser of the items set forth in Section 2.2(b) of this Agreement.

 

(b)            The
respective obligations of the Purchasers hereunder in connection with the Closing are subject to the following conditions being met:

 

(i)             the
accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect,
in all respects) when made and on the Closing Date of the representations and warranties of the Company contained herein (unless such
representation or warranty is as of a specific date therein in which case they shall be accurate as of such date);

 

(ii)            all
obligations, covenants and agreements of the Company required to be performed at or prior to the Closing Date shall have been performed;

 

(iii)           the
delivery by the Company of the items set forth in Section 2.2(a) of this Agreement;

 

(iv)          there
shall have been no Material Adverse Effect with respect to the Company since the date hereof; and

 

(v)            from
the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the Commission or the Company’s
principal Trading Market, and, at any time prior to the Closing Date, trading in securities generally as reported by Bloomberg L.P. shall
not have been suspended or limited, or minimum prices shall not have been established on securities whose trades are reported by such
service, or on any Trading Market, nor shall a banking moratorium have been declared either by the United States or New York State authorities
nor shall there have occurred any material outbreak or escalation of hostilities or other national or international calamity of such
magnitude in its effect on, or any material adverse change in, any financial market which, in each case, in the reasonable judgment of
such Purchaser, makes it impracticable or inadvisable to purchase the Securities at the Closing.

 

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ARTICLE III.

REPRESENTATIONS
AND WARRANTIES

 

3.1                           Representations
and Warranties of the Company. Except as set forth in the Disclosure Schedules, which Disclosure Schedules shall be deemed a part
hereof and shall qualify any representation or otherwise made herein to the extent of the disclosure contained in the corresponding section
of the Disclosure Schedules, the Company hereby makes the following representations and warranties to each Purchaser:

 

(a)            Subsidiaries.
All of the direct and indirect subsidiaries of the Company are set forth on Schedule 3.1(a). The Company owns, directly or indirectly,
all of the capital stock or other equity interests of each Subsidiary free and clear of any Liens, and all of the issued and outstanding
shares of capital stock of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights
to subscribe for or purchase securities. If the Company has no subsidiaries, all other references to the Subsidiaries or any of them
in the Transaction Documents shall be disregarded.

 

(b)            Organization
and Qualification. The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing
and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority
to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary
is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational
or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign
corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification
necessary, except where the failure to be so qualified or in good standing, as the case may be, could not reasonably be expected to result
in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material
adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the
Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect
on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”)
and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail
such power and authority or qualification.

 

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(c)            Authorization;
Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated
by this Agreement and each of the other Transaction Documents and otherwise to carry out its obligations hereunder and thereunder. The
execution and delivery of this Agreement and each of the other Transaction Documents by the Company and the consummation by it of the
transactions contemplated hereby and thereby have been duly authorized by all necessary action on the part of the Company and no further
action is required by the Company, the Board of Directors or the Company’s stockholders in connection herewith or therewith other
than in connection with the Required Approvals. This Agreement and each other Transaction Document to which it is a party has been (or
upon delivery will have been) duly executed by the Company and, when delivered in accordance with the terms hereof and thereof, will
constitute the valid and binding obligation of the Company enforceable against the Company in accordance with its terms, except: (i) as
limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application
affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance,
injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by
applicable law.

 

(d)            No
Conflicts. The execution, delivery and performance by the Company of this Agreement and the other Transaction Documents to which
it is a party, the issuance and sale of the Securities and the consummation by it of the transactions contemplated hereby and thereby
do not and will not (i) conflict with or violate any provision of the Company’s or any Subsidiary’s certificate or articles
of incorporation, bylaws or other organizational or charter documents, or (ii) conflict with, or constitute a default (or an event
that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties
or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment, anti-dilution or similar adjustments,
acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument
(evidencing a Company or Subsidiary debt or otherwise) or other understanding to which the Company or any Subsidiary is a party or by
which any property or asset of the Company or any Subsidiary is bound or affected, or (iii) subject to the Required Approvals, conflict
with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or
governmental authority to which the Company or a Subsidiary is subject (including federal and state securities laws and regulations),
or by which any property or asset of the Company or a Subsidiary is bound or affected; except in the case of each of clauses (ii) and
(iii), such as would not reasonably be expected to result in a Material Adverse Effect.

 

(e)            Filings,
Consents and Approvals. The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to,
or make any filing or registration with, any court or other federal, state, local or other governmental authority or other Person in
connection with the execution, delivery and performance by the Company of the Transaction Documents, other than: (i) the filings
required pursuant to Section 4.6 of this Agreement, (ii) the filing with the Commission of the Prospectus Supplement, (iii) the
notice and/or application(s) to each applicable Trading Market for the issuance and sale of the Securities and the listing of the
Shares and Warrant Shares for trading thereon in the time and manner required thereby, and (iv) such filings as are required to
be made under applicable state securities laws (collectively, the “Required Approvals”).

 

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(f)            Issuance
of the Securities; Registration. The Securities are duly authorized and, when issued and paid for in accordance with the applicable
Transaction Documents, will be duly and validly issued, fully paid and nonassessable, free and clear of all Liens imposed by the Company.
The Warrant Shares, when issued in accordance with the terms of the Warrants, will be validly issued, fully paid and nonassessable, free
and clear of all Liens imposed by the Company. The Company has reserved from its duly authorized capital stock the maximum number of
shares of Common Stock issuable pursuant to this Agreement and the Warrants. The Company has prepared and filed the Registration Statement
in conformity with the requirements of the Securities Act, which became effective on December 4, 2020, including the Prospectus,
and such amendments and supplements thereto as may have been required to the date of this Agreement. The Registration Statement is effective
under the Securities Act and no stop order preventing or suspending the effectiveness of the Registration Statement or suspending or
preventing the use of the Prospectus has been issued by the Commission and no proceedings for that purpose have been instituted or, to
the knowledge of the Company, are threatened by the Commission. The Company, if required by the rules and regulations of the Commission,
shall file the Prospectus Supplement with the Commission pursuant to Rule 424(b). At the time the Registration Statement and any
amendments thereto became effective, at the date of this Agreement and at the Closing Date, the Registration Statement and any amendments
thereto conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain
any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements
therein not misleading; and the Prospectus and any amendments or supplements thereto, at the time the Prospectus or any amendment or
supplement thereto was issued and at the Closing Date, conformed and will conform in all material respects to the requirements of the
Securities Act and did not and will not contain an untrue statement of a material fact or omit to state a material fact necessary in
order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Company was at
the time of the filing of the Registration Statement eligible to use Form S-3. The Company is eligible to use Form S-3 under
the Securities Act and it meets the transaction requirements as set forth in General Instruction I.B.1 of Form S-3.

 

(g)            Capitalization.
The capitalization of the Company as of the date hereof is as set forth on Schedule 3.1(g), which Schedule 3.1(g) shall
also include the number of shares of Common Stock owned beneficially, and of record, by Affiliates of the Company as of the date hereof.
The Company has not issued any capital stock since its most recently filed periodic report under the Exchange Act, other than pursuant
to the exercise of employee stock options under the Company’s stock option plans, the issuance of shares of Common Stock to employees
pursuant to the Company’s employee stock purchase plans and pursuant to the conversion and/or exercise of Common Stock Equivalents
outstanding as of the date of the most recently filed periodic report under the Exchange Act. No Person has any right of first refusal,
preemptive right, right of participation, or any similar right to participate in the transactions contemplated by the Transaction Documents.
Except as a result of the purchase and sale of the Securities and except as set forth on Schedule 3.1(g), there are no outstanding
options, warrants, scrip rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities, rights
or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe for or acquire, any shares
of Common Stock or the capital stock of any Subsidiary, or contracts, commitments, understandings or arrangements by which the Company
or any Subsidiary is or may become bound to issue additional shares of Common Stock or Common Stock Equivalents or capital stock of any
Subsidiary. The issuance and sale of the Securities will not obligate the Company or any Subsidiary to issue shares of Common Stock or
other securities to any Person (other than the Purchasers). There are no outstanding securities or instruments of the Company or any
Subsidiary with any provision that adjusts the exercise, conversion, exchange or reset price of such security or instrument upon an issuance
of securities by the Company or any Subsidiary. There are no outstanding securities or instruments of the Company or any Subsidiary that
contain any redemption or similar provisions, and there are no contracts, commitments, understandings or arrangements by which the Company
or any Subsidiary is or may become bound to redeem a security of the Company or such Subsidiary. The Company does not have any stock
appreciation rights or “phantom stock” plans or agreements or any similar plan or agreement. All of the outstanding shares
of capital stock of the Company are duly authorized, validly issued, fully paid and nonassessable, have been issued in compliance with
all federal and state securities laws, and none of such outstanding shares was issued in violation of any preemptive rights or similar
rights to subscribe for or purchase securities. No further approval or authorization of any stockholder, the Board of Directors or others
is required for the issuance and sale of the Securities. There are no stockholder agreements, voting agreements or other similar agreements
with respect to the Company’s capital stock to which the Company is a party or, to the knowledge of the Company, between or among
any of the Company’s stockholders.

 

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(h)            SEC
Reports; Financial Statements. The Company has filed all reports, schedules, forms, statements and other documents required to be
filed by the Company under the Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof,
for the two years preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such material)
(the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, together with the Prospectus
and the Prospectus Supplement, being collectively referred to herein as the “SEC Reports”) on a timely basis or has
received a valid extension of such time of filing and has filed any such SEC Reports prior to the expiration of any such extension. As
of their respective dates, the SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange
Act, as applicable, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a
material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under
which they were made, not misleading. The Company has never been an issuer subject to Rule 144(i) under the Securities Act.
The financial statements of the Company included in the SEC Reports comply in all material respects with applicable accounting requirements
and the rules and regulations of the Commission with respect thereto as in effect at the time of filing. Such financial statements
have been prepared in accordance with United States generally accepted accounting principles applied on a consistent basis during the
periods involved (“GAAP”), except as may be otherwise specified in such financial statements or the notes thereto
and except that unaudited financial statements may not contain all footnotes required by GAAP, and fairly present in all material respects
the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations
and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments.

 

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(i)             Material
Changes; Undisclosed Events, Liabilities or Developments. Since the date of the latest audited financial statements included within
the SEC Reports, except as set forth on Schedule 3.1(i): (i) there has been no event, occurrence or development that has
had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities
(contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent
with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP
or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company
has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any
agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any
officer, director or Affiliate, except pursuant to existing Company stock option plans. The Company does not have pending before the
Commission any request for confidential treatment of information. Except for the issuance of the Securities contemplated by this Agreement,
no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist
with respect to the Company or its Subsidiaries or their respective businesses, properties, operations, assets or financial condition,
that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed
made that has not been publicly disclosed at least one (1) Trading Day prior to the date that this representation is made.

 

(j)            Litigation.
Except as set forth on Schedule 3.1(j), there is no action, suit, inquiry, notice of violation, proceeding or investigation pending
or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary or any of their respective properties
before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign)
(collectively, an “Action”). None of the Actions set forth on Schedule 3.1(j), (i) adversely affects or
challenges the legality, validity or enforceability of any of the Transaction Documents or the Securities or (ii) could, if there
were an unfavorable decision, have or reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any Subsidiary,
nor any director or officer thereof, is or has been the subject of any Action involving a claim of violation of or liability under federal
or state securities laws or a claim of breach of fiduciary duty. There has not been, and to the knowledge of the Company, there is not
pending or contemplated, any investigation by the Commission involving the Company or any current or former director or officer of the
Company. The Commission has not issued any stop order or other order suspending the effectiveness of any registration statement filed
by the Company or any Subsidiary under the Exchange Act or the Securities Act.

 

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(k)            Labor
Relations. No labor dispute exists or, to the knowledge of the Company, is imminent with respect to any of the employees of the Company,
which could reasonably be expected to result in a Material Adverse Effect. None of the Company’s or its Subsidiaries’ employees
is a member of a union that relates to such employee’s relationship with the Company or such Subsidiary, and neither the Company
nor any of its Subsidiaries is a party to a collective bargaining agreement, and the Company and its Subsidiaries believe that their
relationships with their employees are good. To the knowledge of the Company, no executive officer of the Company or any Subsidiary,
is, or is now expected to be, in violation of any material term of any employment contract, confidentiality, disclosure or proprietary
information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant in favor of any third
party, and the continued employment of each such executive officer does not subject the Company or any of its Subsidiaries to any liability
with respect to any of the foregoing matters. The Company and its Subsidiaries are in compliance with all U.S. federal, state, local
and foreign laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours,
except where the failure to be in compliance could not, individually or in the aggregate, reasonably be expected to have a Material Adverse
Effect.

 

(l)             Compliance.
Neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has occurred that has not been
waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company
or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit
agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not
such default or violation has been waived), (ii) is in violation of any judgment, decree or order of any court, arbitrator or other
governmental authority or (iii) is or has been in violation of any statute, rule, ordinance or regulation of any governmental authority,
including without limitation all foreign, federal, state and local laws relating to taxes, environmental protection, occupational health
and safety, product quality and safety and employment and labor matters, except in each case as could not have or reasonably be expected
to result in a Material Adverse Effect.

 

(m)           Environmental
Laws. The Company and the Subsidiaries (i) are in compliance with all federal, state, local and foreign laws relating to pollution
or protection of human health or the environment (including ambient air, surface water, groundwater, land surface or subsurface strata),
including laws relating to emissions, discharges, releases or threatened releases of chemicals, pollutants, contaminants, or toxic or
hazardous substances or wastes (collectively, “Hazardous Materials”) into the environment, or otherwise relating to
the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials, as well as
all authorizations, codes, decrees, demands, or demand letters, injunctions, judgments, licenses, notices or notice letters, orders,
permits, plans or regulations, issued, entered, promulgated or approved thereunder (“Environmental Laws”); (ii) have
received all permits licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses;
and (iii) are in compliance with all terms and conditions of any such permit, license or approval where in each clause (i), (ii) and
(iii), the failure to so comply could be reasonably expected to have, individually or in the aggregate, a Material Adverse Effect.

 

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(n)            Regulatory
Permits. The Company and the Subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal,
state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the SEC Reports, except
where the failure to possess such permits could not reasonably be expected to result in a Material Adverse Effect (“Material
Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or
modification of any Material Permit.

 

(o)            Title
to Assets. The Company and the Subsidiaries have good and marketable title in fee simple to all real property owned by them and good
and marketable title in all personal property owned by them that is material to the business of the Company and the Subsidiaries, in
each case free and clear of all Liens, except for (i) Liens as do not materially affect the value of such property and do not materially
interfere with the use made and proposed to be made of such property by the Company and the Subsidiaries and (ii) Liens for the
payment of federal, state or other taxes, for which appropriate reserves have been made therefor in accordance with GAAP and, the payment
of which is neither delinquent nor subject to penalties. Any real property and facilities held under lease by the Company and the Subsidiaries
are held by them under valid, subsisting and enforceable leases with which the Company and the Subsidiaries are in compliance.

 

(p)            Intellectual
Property. The Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications,
service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights
as necessary or required for use in connection with their respective businesses as described in the SEC Reports and which the failure
to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither
the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired,
terminated or been abandoned, or is expected to expire or terminate or be abandoned, within two (2) years from the date of this
Agreement. Neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within
the SEC Reports, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe
upon the rights of any Person, except as could not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge
of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any
of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy,
confidentiality and value of all of their intellectual properties, except where failure to do so could not, individually or in the aggregate,
reasonably be expected to have a Material Adverse Effect. The Company has no knowledge of any facts that would preclude it from having
valid license rights or clear title to the Intellectual Property Rights. The Company has no knowledge that it lacks or will be unable
to obtain any rights or licenses to use all Intellectual Property Rights that are necessary to conduct its business.

 

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(q)            Insurance.
The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in
such amounts as are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged, including, but not
limited to, directors and officers insurance coverage at least equal to the aggregate Subscription Amount. Neither the Company nor any
Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires
or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.

 

(r)            Transactions
With Affiliates and Employees. Except as set forth on Schedule 3.1(r), none of the officers or directors of the Company or
any Subsidiary and, to the knowledge of the Company, none of the employees of the Company or any Subsidiary is presently a party to any
transaction with the Company or any Subsidiary (other than for services as employees, officers and directors), including any contract,
agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to
or from, providing for the borrowing of money from or lending of money to or otherwise requiring payments to or from any officer, director
or such employee or, to the knowledge of the Company, any entity in which any officer, director, or any such employee has a substantial
interest or is an officer, director, trustee, stockholder, member or partner, in each case in excess of $120,000 other than for: (i) payment
of salary or consulting fees for services rendered, (ii) reimbursement for expenses incurred on behalf of the Company and (iii) other
employee benefits, including stock option agreements under any stock option plan of the Company.

 

(s)            Sarbanes-Oxley;
Internal Accounting Controls. The Company and the Subsidiaries are in compliance with any and all applicable requirements of the
Sarbanes-Oxley Act of 2002 that are effective as of the date hereof, and any and all applicable rules and regulations promulgated
by the Commission thereunder that are effective as of the date hereof and as of the Closing Date. The Company and the Subsidiaries maintain
a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance
with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of
financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance
with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the
existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company presented in its
most recently filed annual report under the Exchange Act the conclusions of the certifying officers about the effectiveness of the internal
accounting controls. The Company and the Subsidiaries have established disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) for the Company and the Subsidiaries and designed such disclosure controls and procedures to
ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded,
processed, summarized and reported, within the time periods specified in the Commission’s rules and forms. The Company’s
certifying officers have evaluated the effectiveness of the disclosure controls and procedures of the Company and the Subsidiaries as
of the end of the period covered by the most recently filed periodic report under the Exchange Act (such date, the “Evaluation
Date”). The Company presented in its most recently filed periodic report under the Exchange Act the conclusions of the certifying
officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of the Evaluation Date. Since
the Evaluation Date, there have been no changes in the internal control over financial reporting (as such term is defined in the Exchange
Act) of the Company and its Subsidiaries that have materially affected, or is reasonably likely to materially affect, the internal control
over financial reporting of the Company and its Subsidiaries.

 

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(t)             Certain
Fees. Except as set forth in the Prospectus Supplement and except for fees payable by the Company to the Placement Agent, no brokerage
or finder’s fees or commissions are or will be payable by the Company or any Subsidiary to any broker, financial advisor or consultant,
finder, placement agent, investment banker, bank or other Person with respect to the transactions contemplated by the Transaction Documents.
The Purchasers shall have no obligation with respect to any fees or with respect to any claims made by or on behalf of other Persons
for fees of a type contemplated in this Section that may be due in connection with the transactions contemplated by the Transaction
Documents.

 

(u)            Investment
Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for the Securities, will not be
or be an Affiliate of, an “investment company” within the meaning of the Investment Company Act of 1940, as amended. The
Company shall conduct its business in a manner so that it will not become an “investment company” subject to registration
under the Investment Company Act of 1940, as amended.

 

(v)            Registration
Rights. No Person has any right to cause the Company or any Subsidiary to effect the registration under the Securities Act of any
securities of the Company or any Subsidiary.

 

(w)            Listing
and Maintenance Requirements. The Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange Act,
and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration
of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating
such registration. The Company has not, in the 12 months preceding the date hereof, received notice from any Trading Market on which
the Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing or maintenance
requirements of such Trading Market. The Company is, and has no reason to believe that it will not in the foreseeable future continue
to be, in compliance with all such listing and maintenance requirements. The Common Stock is currently eligible for electronic transfer
through the Depository Trust Company or another established clearing corporation and the Company is current in payment of the fees to
the Depository Trust Company (or such other established clearing corporation) in connection with such electronic transfer.

 

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(x)             Application
of Takeover Protections. The Company and the Board of Directors have taken all necessary action, if any, in order to render inapplicable
any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar
anti-takeover provision under the Company’s certificate of incorporation (or similar charter documents) or the laws of its state
of incorporation that is or could become applicable to the Purchasers as a result of the Purchasers and the Company fulfilling their
obligations or exercising their rights under the Transaction Documents, including without limitation as a result of the Company’s
issuance of the Securities and the Purchasers’ ownership of the Securities.

 

(y)            Disclosure.
Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, the Company confirms
that neither it nor any other Person acting on its behalf has provided any of the Purchasers or their agents or counsel with any information
that it believes constitutes or might constitute material, non-public information which is not otherwise disclosed in the Prospectus
Supplement. The Company understands and confirms that the Purchasers will rely on the foregoing representation in effecting transactions
in securities of the Company. All of the disclosure furnished by or on behalf of the Company to the Purchasers regarding the Company
and its Subsidiaries, their respective businesses and the transactions contemplated hereby, including the Disclosure Schedules to this
Agreement, is true and correct and does not contain any untrue statement of a material fact or omit to state any material fact necessary
in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. The press
releases disseminated by the Company during the twelve months preceding the date of this Agreement taken as a whole do not contain any
untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the
statements therein, in the light of the circumstances under which they were made and when made, not misleading. The Company acknowledges
and agrees that no Purchaser makes or has made any representations or warranties with respect to the transactions contemplated hereby
other than those specifically set forth in Section 3.2 hereof.

 

(z)             No
Integrated Offering. Assuming the accuracy of the Purchasers’ representations and warranties set forth in Section 3.2,
neither the Company, nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly, made any offers
or sales of any security or solicited any offers to buy any security, under circumstances that would cause this offering of the Securities
to be integrated with prior offerings by the Company for purposes of any applicable shareholder approval provisions of any Trading Market
on which any of the securities of the Company are listed or designated.

 

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(aa)          Solvency.
Based on the consolidated financial condition of the Company as of the Closing Date, after giving effect to the receipt by the Company
of the proceeds from the sale of the Securities hereunder: (i) the fair saleable value of the Company’s assets exceeds the
amount that will be required to be paid on or in respect of the Company’s existing debts and other liabilities (including known
contingent liabilities) as they mature, (ii) the Company’s assets do not constitute unreasonably small capital to carry on
its business as now conducted and as proposed to be conducted including its capital needs taking into account the particular capital
requirements of the business conducted by the Company, consolidated and projected capital requirements and capital availability thereof,
and (iii) the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of
its assets, after taking into account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its
liabilities when such amounts are required to be paid. The Company does not intend to incur debts beyond its ability to pay such debts
as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt). The Company has no knowledge
of any facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization
laws of any jurisdiction within one year from the Closing Date. Schedule 3.1(aa) sets forth as of the date hereof all outstanding
secured and unsecured Indebtedness of the Company or any Subsidiary, or for which the Company or any Subsidiary has commitments. For
the purposes of this Agreement, “Indebtedness” means (x) any liabilities for borrowed money or amounts owed in
excess of $50,000 (other than trade accounts payable incurred in the ordinary course of business), (y) all guaranties, endorsements
and other contingent obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s
consolidated balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection
or similar transactions in the ordinary course of business; and (z) the present value of any lease payments in excess of $50,000
due under leases required to be capitalized in accordance with GAAP. Neither the Company nor any Subsidiary is in default with respect
to any Indebtedness.

 

(bb)          Tax
Status. Except for matters that would not, individually or in the aggregate, have or reasonably be expected to result in a Material
Adverse Effect, the Company and its Subsidiaries each (i) has made or filed all United States federal, state and local income and
all foreign income and franchise tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has
paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns,
reports and declarations and (iii) has set aside on its books provision reasonably adequate for the payment of all material taxes
for periods subsequent to the periods to which such returns, reports or declarations apply. There are no unpaid taxes in any material
amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company or of any Subsidiary know of no
basis for any such claim.

 

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(cc)          Foreign
Corrupt Practices. Neither the Company nor any Subsidiary, nor to the knowledge of the Company or any Subsidiary, any agent or other
person acting on behalf of the Company or any Subsidiary, has: (i) directly or indirectly, used any funds for unlawful contributions,
gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) made any unlawful payment
to foreign or domestic government officials or employees or to any foreign or domestic political parties or campaigns from corporate
funds, (iii) failed to disclose fully any contribution made by the Company or any Subsidiary (or made by any person acting on its
behalf of which the Company is aware) which is in violation of law or (iv) violated in any material respect any provision of FCPA.

 

(dd)          Accountants.
The Company’s independent registered public accounting firm is Ernst & Young LLP. To the knowledge and belief of the Company,
such accounting firm: (i) is a registered public accounting firm as required by the Exchange Act and (ii) shall express its
opinion with respect to the financial statements to be included in the Company’s Annual Report for the fiscal year ending December 31,
2022.

 

(ee)          Acknowledgment
Regarding Purchasers’ Purchase of Securities. The Company acknowledges and agrees that each of the Purchasers is acting solely
in the capacity of an arm’s length purchaser with respect to the Transaction Documents and the transactions contemplated thereby.
The Company further acknowledges that no Purchaser is acting as a financial advisor or fiduciary of the Company (or in any similar capacity)
with respect to the Transaction Documents and the transactions contemplated thereby and any advice given by any Purchaser or any of their
respective representatives or agents in connection with the Transaction Documents and the transactions contemplated thereby is merely
incidental to the Purchasers’ purchase of the Securities. The Company further represents to each Purchaser that the Company’s
decision to enter into this Agreement and the other Transaction Documents has been based solely on the independent evaluation of the
transactions contemplated hereby by the Company and its representatives.

 

(ff)          Acknowledgment
Regarding Purchasers’ Trading Activity. Anything in this Agreement or elsewhere herein to the contrary notwithstanding (except
for Sections 3.2(f) and 4.15 hereof), it is understood and acknowledged by the Company that: (i) none of the Purchasers has
been asked by the Company to agree, nor has any Purchaser agreed, to desist from purchasing or selling, long and/or short, securities
of the Company, or “derivative” securities based on securities issued by the Company or to hold the Securities for any specified
term, (ii) past or future open market or other transactions by any Purchaser, specifically including, without limitation, Short
Sales or “derivative” transactions, before or after the closing of this or future private placement transactions, may negatively
impact the market price of the Company’s publicly-traded securities, (iii) any Purchaser, and counter-parties in “derivative”
transactions to which any such Purchaser is a party, directly or indirectly, may presently have a “short” position in the
Common Stock and (iv) each Purchaser shall not be deemed to have any affiliation with or control over any arm’s length counter-party
in any “derivative” transaction. The Company further understands and acknowledges that (y) one or more Purchasers may
engage in hedging activities at various times during the period that the Securities are outstanding, including, without limitation, during
the periods that the value of the Warrant Shares deliverable with respect to Securities are being determined, and (z) such hedging
activities (if any) could reduce the value of the existing stockholders' equity interests in the Company at and after the time that the
hedging activities are being conducted.  The Company acknowledges that such aforementioned hedging activities do not constitute
a breach of any of the Transaction Documents.

 

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(gg)          Regulation
M Compliance.  The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly,
any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate
the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or paid any compensation for soliciting purchases of,
any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other
securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Placement Agent in connection
with the placement of the Securities.

 

(hh)          FDA.
As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal
Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled,
tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”),
such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance
with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use,
premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices,
product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would
not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any
lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or
any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication
from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval
of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of
any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders
the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold
on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company
or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any
of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its
Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and
operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and
regulations of the FDA.  The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or
use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern
as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

 

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(ii)            Stock
Option Plans. Each stock option granted by the Company under the Company’s stock option plan was granted (i) in accordance
with the terms of the Company’s stock option plan and (ii) with an exercise price at least equal to the fair market value
of the Common Stock on the date such stock option would be considered granted under GAAP and applicable law. No stock option granted
under the Company’s stock option plan has been backdated. The Company has not knowingly granted, and there is no and has been no
Company policy or practice to knowingly grant, stock options prior to, or otherwise knowingly coordinate the grant of stock options with,
the release or other public announcement of material information regarding the Company or its Subsidiaries or their financial results
or prospects.

 

(jj)            Cybersecurity. 
(i)(x) There has been no security breach or other compromise of or relating to any of the Company’s or any Subsidiary’s
information technology and computer systems, networks, hardware, software, data (including the data of its respective customers, employees,
suppliers, vendors and any third party data maintained by or on behalf of it), equipment or technology (collectively, “IT Systems
and Data”) and (y) the Company and the Subsidiaries have not been notified of, and has no knowledge of any event or condition
that would reasonably be expected to result in, any security breach or other compromise to its IT Systems and Data; (ii) the Company
and the Subsidiaries are presently in compliance with all applicable laws or statutes and all judgments, orders, rules and regulations
of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations relating to the privacy
and security of IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation
or modification, except as would not, individually or in the aggregate, have a Material Adverse Effect; (iii) the Company and the
Subsidiaries have implemented and maintained commercially reasonable safeguards to maintain and protect its material confidential information
and the integrity, continuous operation, redundancy and security of all IT Systems and Data; and (iv) the Company and the Subsidiaries
have implemented backup and disaster recovery technology consistent with industry standards and practices.

 

(kk)          Office
of Foreign Assets Control. Neither the Company nor any Subsidiary nor, to the Company's knowledge, any director, officer, agent,
employee or affiliate of the Company or any Subsidiary is currently subject to any U.S. sanctions administered by the Office of Foreign
Assets Control of the U.S. Treasury Department (“OFAC”).

 

(ll)            U.S.
Real Property Holding Corporation. The Company is not and has never been a U.S. real property holding corporation within the meaning
of Section 897 of the Internal Revenue Code of 1986, as amended, and the Company shall so certify upon Purchaser’s request.

 

(mm)        Bank
Holding Company Act. Neither the Company nor any of its Subsidiaries or Affiliates is subject to the Bank Holding Company Act of
1956, as amended (the “BHCA”) and to regulation by the Board of Governors of the Federal Reserve System (the “Federal
Reserve”). Neither the Company nor any of its Subsidiaries or Affiliates owns or controls, directly or indirectly, five percent
(5%) or more of the outstanding shares of any class of voting securities or twenty-five percent (25%) or more of the total equity of
a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve. Neither the Company nor any of its Subsidiaries
or Affiliates exercises a controlling influence over the management or policies of a bank or any entity that is subject to the BHCA and
to regulation by the Federal Reserve.

 

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(nn)          Money
Laundering. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable
financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, applicable
money laundering statutes and applicable rules and regulations thereunder (collectively, the “Money Laundering Laws”),
and no Action or Proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company
or any Subsidiary with respect to the Money Laundering Laws is pending or, to the knowledge of the Company or any Subsidiary, threatened.

 

3.2           Representations
and Warranties of the Purchasers. Each Purchaser, for itself and for no other Purchaser, hereby represents and warrants as of the
date hereof and as of the Closing Date to the Company as follows (unless as of a specific date therein, in which case they shall be accurate
as of such date):

 

(a)            Organization;
Authority. Such Purchaser is either an individual or an entity duly incorporated or formed, validly existing and in good standing
under the laws of the jurisdiction of its incorporation or formation with full right, corporate, partnership, limited liability company
or similar power and authority to enter into and to consummate the transactions contemplated by the Transaction Documents and otherwise
to carry out its obligations hereunder and thereunder. The execution and delivery of the Transaction Documents and performance by such
Purchaser of the transactions contemplated by the Transaction Documents have been duly authorized by all necessary corporate, partnership,
limited liability company or similar action, as applicable, on the part of such Purchaser. Each Transaction Document to which it is a
party has been duly executed by such Purchaser, and when delivered by such Purchaser in accordance with the terms hereof, will constitute
the valid and legally binding obligation of such Purchaser, enforceable against it in accordance with its terms, except: (i) as
limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application
affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance,
injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by
applicable law.

 

(b)            Understandings
or Arrangements. Such Purchaser is acquiring the Securities as principal for its own account and has no direct or indirect arrangement
or understandings with any other persons to distribute or regarding the distribution of such Securities (this representation and warranty
not limiting such Purchaser’s right to sell the Securities pursuant to the Registration Statement or otherwise in compliance with
applicable federal and state securities laws). Such Purchaser is acquiring the Securities hereunder in the ordinary course of its business.

 

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(c)            Purchaser
Status. At the time such Purchaser was offered the Securities, it was, and as of the date hereof it is, and on each date on which
it exercises any Warrants it will be either: (i) an “accredited investor” as defined in Rule 501(a)(1), (a)(2),
(a)(3), (a)(7), (a)(8), (a)(9), (a)(12), or (a)(13) under the Securities Act or (ii) a “qualified institutional buyer”
as defined in Rule 144A(a) under the Securities Act.

 

(d)            Experience
of Such Purchaser. Such Purchaser, either alone or together with its representatives, has such knowledge, sophistication and experience
in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Securities,
and has so evaluated the merits and risks of such investment. Such Purchaser is able to bear the economic risk of an investment in the
Securities and, at the present time, is able to afford a complete loss of such investment.

 

(e)            Access
to Information. Such Purchaser acknowledges that it has had the opportunity to review the Transaction Documents (including all exhibits
and schedules thereto) and the SEC Reports and has been afforded, (i) the opportunity to ask such questions as it has deemed necessary
of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Securities
and the merits and risks of investing in the Securities; (ii) access to information about the Company and its financial condition,
results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (iii) the
opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that
is necessary to make an informed investment decision with respect to the investment.  Such Purchaser acknowledges and agrees that
neither the Placement Agent nor any Affiliate of the Placement Agent has provided such Purchaser with any information or advice with
respect to the Securities nor is such information or advice necessary or desired.  Neither the Placement Agent nor any Affiliate
has made or makes any representation as to the Company or the quality of the Securities and the Placement Agent and any Affiliate may
have acquired non-public information with respect to the Company which such Purchaser agrees need not be provided to it.  In connection
with the issuance of the Securities to such Purchaser, neither the Placement Agent nor any of its Affiliates has acted as a financial
advisor or fiduciary to such Purchaser.

 

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(f)             Certain
Transactions and Confidentiality. Other than consummating the transactions contemplated hereunder, such Purchaser has not, nor has
any Person acting on behalf of or pursuant to any understanding with such Purchaser, directly or indirectly executed any purchases or
sales, including Short Sales, of the securities of the Company during the period commencing as of the time that such Purchaser first
received a term sheet (written or oral) from the Company or any other Person representing the Company setting forth the material terms
of the transactions contemplated hereunder and ending immediately prior to the execution hereof. Notwithstanding the foregoing, in the
case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers manage separate portions of such Purchaser’s
assets and the portfolio managers have no direct knowledge of the investment decisions made by the portfolio managers managing other
portions of such Purchaser’s assets, the representation set forth above shall only apply with respect to the portion of assets
managed by the portfolio manager that made the investment decision to purchase the Securities covered by this Agreement. Other than to
other Persons party to this Agreement or to such Purchaser’s representatives, including, without limitation, its officers, directors,
partners, legal and other advisors, employees, agents and Affiliates, such Purchaser has maintained the confidentiality of all disclosures
made to it in connection with this transaction (including the existence and terms of this transaction). Notwithstanding the foregoing,
for the avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect
to locating or borrowing shares in order to effect Short Sales or similar transactions in the future.

 

The Company acknowledges and agrees that the
representations contained in this Section 3.2 shall not modify, amend or affect such Purchaser’s right to rely on the Company’s
representations and warranties contained in this Agreement or any representations and warranties contained in any other Transaction Document
or any other document or instrument executed and/or delivered in connection with this Agreement or the consummation of the transactions
contemplated hereby. Notwithstanding the foregoing, for the avoidance of doubt, nothing contained herein shall constitute a representation
or warranty, or preclude any actions, with respect to locating or borrowing shares in order to effect Short Sales or similar transactions
in the future.

 

ARTICLE IV.

OTHER AGREEMENTS OF THE PARTIES

 

4.1            Warrant
Shares. If all or any portion of a Warrant is exercised at a time when there is an effective registration statement to cover the
issuance or resale of the Warrant Shares or if the Warrant is exercised via cashless exercise, the Warrant Shares issued pursuant to
any such exercise shall be issued free of all legends. If at any time following the date hereof the Registration Statement (or any subsequent
registration statement registering the sale or resale of the Warrant Shares) is not effective or is not otherwise available for the sale
or resale of the Warrant Shares, the Company shall immediately notify the holders of the Warrants in writing that such registration statement
is not then effective and thereafter shall promptly notify such holders when the registration statement is effective again and available
for the sale or resale of the Warrant Shares (it being understood and agreed that the foregoing shall not limit the ability of the Company
to issue, or any Purchaser to sell, any of the Warrant Shares in compliance with applicable federal and state securities laws). The Company
shall use best efforts to keep a registration statement (including the Registration Statement) registering the issuance or resale of
the Warrant Shares effective during the term of the Warrants.

 

4.2            Acknowledgment
of Dilution. The Company acknowledges that the issuance of the Securities may result in dilution of the outstanding shares of Common
Stock, which dilution may be substantial under certain market conditions. The Company further acknowledges that its obligations under
the Transaction Documents, including, without limitation, its obligation to issue the Warrant Shares pursuant to the Transaction Documents,
are unconditional and absolute and not subject to any right of set off, counterclaim, delay or reduction, regardless of the effect
of any such dilution or any claim the Company may have against any Purchaser and regardless of the dilutive effect that such issuance
may have on the ownership of the other stockholders of the Company.

 

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4.3            Furnishing
of Information; Public Information. Until the earliest of the time that (i) no Purchaser owns Securities or (ii) the Warrants
have expired, the Company covenants to maintain the registration of the Common Stock under Section 12(b) or 12(g) of the
Exchange Act and to timely file (or obtain extensions in respect thereof and file within the applicable grace period) all reports required
to be filed by the Company after the date hereof pursuant to the Exchange Act even if the Company is not then subject to the reporting
requirements of the Exchange Act.

 

4.4            Integration.
The Company shall not sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in
Section 2 of the Securities Act) that would be integrated with the offer or sale of the Securities for purposes of the rules and
regulations of any Trading Market such that it would require stockholder approval prior to the closing of such other transaction unless
stockholder approval is obtained before the closing of such subsequent transaction.

 

4.5            Exercise
Procedures. The form of Notice of Exercise included in the Warrants set forth the totality of the procedures required of the Purchasers
in order to exercise the Warrants. Without limiting the preceding sentences, no ink-original Notice of Exercise shall be required, nor
shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise form be required in order to exercise
the Warrants. No additional legal opinion, other information or instructions shall be required of the Purchasers to exercise their Warrants.
The Company shall honor exercises of the Warrants and shall deliver Warrant Shares in accordance with the terms, conditions and time
periods set forth in the Transaction Documents.

 

4.6            Securities
Laws Disclosure; Publicity. The Company shall (a) by the Disclosure Time, issue a press release disclosing the material terms
of the transactions contemplated hereby and (b) file a Current Report on Form 8-K, including the Transaction Documents as exhibits
thereto, with the Commission within the time required by the Exchange Act. From and after the issuance of such press release, the Company
represents to the Purchasers that it shall have publicly disclosed all material, non-public information delivered to any of the Purchasers
by the Company or any of its Subsidiaries, or any of their respective officers, directors, employees, Affiliates or agents, including,
without limitation, the Placement Agent, in connection with the transactions contemplated by the Transaction Documents. In addition,
effective upon the issuance of such press release, the Company acknowledges and agrees that any and all confidentiality or similar obligations
under any agreement, whether written or oral, between the Company, any of its Subsidiaries or any of their respective officers, directors,
agents, employees, Affiliates or agents, including, without limitation, the Placement Agent, on the one hand, and any of the Purchasers
or any of their Affiliates on the other hand, shall terminate and be of no further force or effect. The Company understands and confirms
that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company. The Company and
each Purchaser shall consult with each other in issuing any other press releases with respect to the transactions contemplated hereby,
and neither the Company nor any Purchaser shall issue any such press release nor otherwise make any such public statement without the
prior consent of the Company, with respect to any press release of any Purchaser, or without the prior consent of each Purchaser, with
respect to any press release of the Company, which consent shall not unreasonably be withheld or delayed, except if such disclosure is
required by law, in which case the disclosing party shall promptly provide the other party with prior notice of such public statement
or communication. Notwithstanding the foregoing, the Company shall not publicly disclose the name of any Purchaser, or include the name
of any Purchaser in any filing with the Commission or any regulatory agency or Trading Market, without the prior written consent of such
Purchaser, except: (a) as required by federal securities law in connection with the filing of final Transaction Documents with the
Commission and (b) to the extent such disclosure is required by law or Trading Market regulations, in which case the Company shall
provide the Purchasers with prior notice of such disclosure permitted under this clause (b) and reasonably cooperate with such Purchaser
regarding such disclosure.

 

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4.7            Stockholder
Rights Plan. No claim will be made or enforced by the Company or, with the consent of the Company, any other Person, that any Purchaser
is an “Acquiring Person” under any control share acquisition, business combination, poison pill (including any distribution
under a rights agreement) or similar anti-takeover plan or arrangement in effect or hereafter adopted by the Company, or that any Purchaser
could be deemed to trigger the provisions of any such plan or arrangement, by virtue of receiving Securities under the Transaction Documents
or under any other agreement between the Company and the Purchasers.

 

4.8            Non-Public
Information. Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents,
which shall be disclosed pursuant to Section 4.6, the Company covenants and agrees that neither it, nor any other Person acting
on its behalf will provide any Purchaser or its agents or counsel with any information that constitutes, or the Company reasonably believes
constitutes, material non-public information, unless prior thereto such Purchaser shall have consented to the receipt of such
information and agreed in writing with the Company to keep such information confidential. The Company understands and confirms that each
Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company. To the extent that the Company
any of its Subsidiaries, or any of their respective officers, directors, agents, employees or Affiliates delivers any material, non-public
information to a Purchaser without such Purchaser’s consent, the Company hereby covenants and agrees that such Purchaser shall
not have any duty of confidentiality to the Company, any of its Subsidiaries, or any of their respective officers, directors, agents,
employees or Affiliates, including, without limitation, the Placement Agent, or a duty to the Company, any of its Subsidiaries or any
of their respective officers, directors, agents, employees or Affiliates including, without limitation, the Placement Agent, not to trade
on the basis of, such material, non-public information, provided that the Purchaser shall remain subject to applicable law. To the extent
that any notice provided pursuant to any Transaction Document constitutes, or contains, material, non-public information regarding the
Company or any Subsidiaries, the Company shall simultaneously with the delivery of such notice file such notice with the Commission pursuant
to a Current Report on Form 8-K. The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant
in effecting transactions in securities of the Company.

 

4.9            Use
of Proceeds. Except as set forth on Schedule 4.9 attached hereto, the Company shall use the net proceeds from the sale of
the Securities hereunder for working capital purposes and shall not use such proceeds: (a) for the satisfaction of any portion of
the Company’s debt (other than payment of trade payables in the ordinary course of the Company’s business and prior practices),
(b) for the redemption of any Common Stock or Common Stock Equivalents, (c) for the settlement of any outstanding litigation
or (d) in violation of FCPA or OFAC regulations.

 

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4.10            Indemnification
of Purchasers. Subject to the provisions of this Section 4.10, the Company will indemnify and hold each Purchaser and its directors,
officers, shareholders, members, partners, employees and agents (and any other Persons with a functionally equivalent role of a Person
holding such titles notwithstanding a lack of such title or any other title), each Person who controls such Purchaser (within the meaning
of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers, shareholders, agents,
members, partners or employees (and any other Persons with a functionally equivalent role of a Person holding such titles notwithstanding
a lack of such title or any other title) of such controlling persons (each, a “Purchaser Party”) harmless from any
and all losses, liabilities, obligations, claims, contingencies, damages, costs and expenses, including all judgments, amounts paid in
settlements, court costs and reasonable attorneys’ fees and costs of investigation that any such Purchaser Party may suffer or
incur as a result of or relating to (a) any breach of any of the representations, warranties, covenants or agreements made by the
Company in this Agreement or in the other Transaction Documents or (b) any action instituted against the Purchaser Parties in any
capacity, or any of them or their respective Affiliates, by any stockholder of the Company who is not an Affiliate of such Purchaser
Party, with respect to any of the transactions contemplated by the Transaction Documents (except to the extent such action is based upon
a material breach of such Purchaser Party’s representations, warranties or covenants under the Transaction Documents or any agreements
or understandings such Purchaser Party may have with any such stockholder or any violations by such Purchaser Party of state or federal
securities laws or any conduct by such Purchaser Party which is finally judicially determined to constitute fraud, gross negligence or
willful misconduct). If any action shall be brought against any Purchaser Party in respect of which indemnity may be sought pursuant
to this Agreement, such Purchaser Party shall promptly notify the Company in writing, and the Company shall have the right to assume
the defense thereof with counsel of its own choosing reasonably acceptable to the Purchaser Party. Any Purchaser Party shall have the
right to employ separate counsel in any such action and participate in the defense thereof, but the fees and expenses of such counsel
shall be at the expense of such Purchaser Party except to the extent that (i) the employment thereof has been specifically authorized
by the Company in writing, (ii) the Company has failed after a reasonable period of time to assume such defense and to employ counsel
or (iii) in such action there is, in the reasonable opinion of counsel, a material conflict on any material issue between the position
of the Company and the position of such Purchaser Party, in which case the Company shall be responsible for the reasonable fees and expenses
of no more than one such separate counsel. The Company will not be liable to any Purchaser Party under this Agreement (y) for any
settlement by a Purchaser Party effected without the Company’s prior written consent, which shall not be unreasonably withheld
or delayed; or (z) to the extent, but only to the extent that a loss, claim, damage or liability is attributable to any Purchaser
Party’s breach of any of the representations, warranties, covenants or agreements made by such Purchaser Party in this Agreement
or in the other Transaction Documents. The indemnification required by this Section 4.10 shall be made by periodic payments of the
amount thereof during the course of the investigation or defense, as and when bills are received or are incurred. The indemnity agreements
contained herein shall be in addition to any cause of action or similar right of any Purchaser Party against the Company or others and
any liabilities the Company may be subject to pursuant to law.

 

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4.11            Reservation
of Common Stock. As of the date hereof, the Company has reserved and the Company shall continue to reserve and keep available at
all times, free of preemptive rights, a sufficient number of shares of Common Stock for the purpose of enabling the Company to
issue Shares pursuant to this Agreement and Warrant Shares pursuant to any exercise of the Warrants.

 

4.12             Listing
of Common Stock. The Company hereby agrees to use best efforts to maintain the listing or quotation of the Common Stock on the Trading
Market on which it is currently listed, and concurrently with the Closing, the Company shall apply to list or quote all of the Shares
and Warrant Shares on such Trading Market and promptly secure the listing of all of the Shares and Warrant Shares on such Trading Market.
The Company further agrees, if the Company applies to have the Common Stock traded on any other Trading Market, it will then include
in such application all of the Shares and Warrant Shares, and will take such other action as is necessary to cause all of the Shares
and Warrant Shares to be listed or quoted on such other Trading Market as promptly as possible. The Company will then take all action
reasonably necessary to continue the listing and trading of its Common Stock on a Trading Market and will comply in all respects with
the Company’s reporting, filing and other obligations under the bylaws or rules of the Trading Market. The Company agrees
to maintain the eligibility of the Common Stock for electronic transfer through the Depository Trust Company or another established clearing
corporation, including, without limitation, by timely payment of fees to the Depository Trust Company or such other established clearing
corporation in connection with such electronic transfer.

 

4.13            Subsequent
Equity Sales.

 

(a)            From
the date hereof until ninety (90) days following the Closing Date, neither the Company nor any Subsidiary shall (i) issue, enter
into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock Equivalents or
(ii) file any registration statement or amendment or supplement thereto, other than the Prospectus Supplement or filing of a registration
statement on Form S-8 in connection with any employee benefit plan.

 

(b)            From
the date hereof until one (1) year following the Closing Date, the Company shall be prohibited from effecting or entering into an
agreement to effect any issuance by the Company or any of its Subsidiaries of Common Stock or Common Stock Equivalents (or a combination
of units thereof) involving a Variable Rate Transaction. “Variable Rate Transaction” means a transaction in which
the Company (i) issues or sells any debt or equity securities that are convertible into, exchangeable or exercisable for, or include
the right to receive, additional shares of Common Stock either (A) at a conversion price, exercise price or exchange rate or other
price that is based upon, and/or varies with, the trading prices of or quotations for the shares of Common Stock at any time after the
initial issuance of such debt or equity securities or (B) with a conversion, exercise or exchange price that is subject to being
reset at some future date after the initial issuance of such debt or equity security or upon the occurrence of specified or contingent
events directly or indirectly related to the business of the Company or the market for the Common Stock or (ii) enters into, or
effects a transaction under, any agreement, including, but not limited to, an equity line of credit, whereby the Company may issue securities
at a future determined price; provided, however, that the issuance of shares of Common Stock in an “at the market”
offering with H.C. Wainwright & Co., LLC as sales agent following the expiration of the ninety (90)-day period set forth in
Section 4.13(a) above shall not be deemed a Variable Rate Transaction. Any Purchaser shall be entitled to obtain injunctive
relief against the Company to preclude any such issuance, which remedy shall be in addition to any right to collect damages.

 

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(c)            Notwithstanding
the foregoing, this Section 4.13 shall not apply in respect of an Exempt Issuance, except that no Variable Rate Transaction shall
be an Exempt Issuance.

 

4.14            Equal
Treatment of Purchasers. No consideration (including any modification of any Transaction Document) shall be offered or paid to any
Person to amend or consent to a waiver or modification of any provision of the Transaction Documents unless the same consideration is
also offered to all of the parties to such Transaction Documents. For clarification purposes, this provision constitutes a separate right
granted to each Purchaser by the Company and negotiated separately by each Purchaser, and is intended for the Company to treat the Purchasers
as a class and shall not in any way be construed as the Purchasers acting in concert or as a group with respect to the purchase, disposition
or voting of Securities or otherwise.

 

4.15            Certain
Transactions and Confidentiality. Each Purchaser, severally and not jointly with the other Purchasers, covenants that neither it,
nor any Affiliate acting on its behalf or pursuant to any understanding with it will execute any purchases or sales, including Short
Sales, of any of the Company’s securities during the period commencing with the execution of this Agreement and ending at such
time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described
in Section 4.6. Each Purchaser, severally and not jointly with the other Purchasers, covenants that until such time as the
transactions contemplated by this Agreement are publicly disclosed by the Company pursuant to the initial press release as described
in Section 4.6, such Purchaser will maintain the confidentiality of the existence and terms of this transaction and the information
included in the Disclosure Schedules. Notwithstanding the foregoing, and notwithstanding anything contained in this Agreement to the
contrary, the Company expressly acknowledges and agrees that (i) no Purchaser makes any representation, warranty or covenant hereby
that it will not engage in effecting transactions in any securities of the Company after the time that the transactions contemplated
by this Agreement are first publicly announced pursuant to the initial press release as described in Section 4.6, (ii) no Purchaser
shall be restricted or prohibited from effecting any transactions in any securities of the Company in accordance with applicable securities
laws from and after the time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial
press release as described in Section 4.6 and (iii) no Purchaser shall have any duty of confidentiality or duty not to trade
in the securities of the Company to the Company or its Subsidiaries, or any of their respective officers, directors, employees, Affiliates
or agent, including, without limitation, the Placement Agent, after the issuance of the initial press release as described in Section 4.6. 
Notwithstanding the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers
manage separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions
made by the portfolio managers managing other portions of such Purchaser’s assets, the covenant set forth above shall only apply
with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the Securities covered
by this Agreement.

 

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ARTICLE V. 

MISCELLANEOUS

 

5.1            Termination. 
This Agreement may be terminated by any Purchaser, as to such Purchaser’s obligations hereunder only and without any effect whatsoever
on the obligations between the Company and the other Purchasers, by written notice to the other parties, if the Closing has not been consummated
on or before the fifth (5th) Trading Day following the date hereof; provided, however, that no such termination
will affect the right of any party to sue for any breach by any other party (or parties).

 

5.2            Fees
and Expenses. Except as expressly set forth in the Transaction Documents to the contrary, each party shall pay the fees and expenses
of its advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party incident to the negotiation,
preparation, execution, delivery and performance of this Agreement. The Company shall pay all Transfer Agent fees (including, without
limitation, any fees required for same-day processing of any instruction letter delivered by the Company and any exercise notice delivered
by a Purchaser), stamp taxes and other taxes and duties levied in connection with the delivery of any Securities to the Purchasers.

 

5.3            Entire
Agreement. The Transaction Documents, together with the exhibits and schedules thereto, the Prospectus and the Prospectus Supplement,
contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede all prior agreements
and understandings, oral or written, with respect to such matters, which the parties acknowledge have been merged into such documents,
exhibits and schedules.

 

5.4            Notices.
Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall
be deemed given and effective on the earliest of: (a) the time of transmission, if such notice or communication is delivered via
email attachment at the email address as set forth on the signature pages attached hereto at or prior to 5:30 p.m. (New York
City time) on a Trading Day, (b) the next Trading Day after the time of transmission, if such notice or communication is delivered
via email attachment at the email address as set forth on the signature pages attached hereto on a day that is not a Trading Day
or later than 5:30 p.m. (New York City time) on any Trading Day, (c) the second (2nd) Trading Day following the date
of mailing, if sent by U.S. nationally recognized overnight courier service or (d) upon actual receipt by the party to whom such
notice is required to be given. The address for such notices and communications shall be as set forth on the signature pages attached
hereto. To the extent that any notice provided pursuant to any Transaction Document constitutes, or contains, material, non-public information
regarding the Company or any Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current
Report on Form 8-K.

 

5.5            Amendments;
Waivers. No provision of this Agreement may be waived, modified, supplemented or amended except in a written instrument signed,
in the case of an amendment, by the Company and Purchasers who at such time hold at least 50.1% in interest of the Shares and the
Pre-Funded Warrants (or, prior to the Closing, the Company and each Purchaser) or, in the case of a waiver, by the party against
whom enforcement of any such waived provision is sought, provided that if any amendment, modification or waiver disproportionately
and adversely impacts a Purchaser (or group of Purchasers), the consent of at least 50.1% in interest of such disproportionately
impacted Purchaser (or group of Purchasers) shall also be required. No waiver of any default with respect to any provision,
condition or requirement of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent
default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of any party to
exercise any right hereunder in any manner impair the exercise of any such right. Any proposed amendment or waiver that
disproportionately, materially and adversely affects the rights and obligations of any Purchaser relative to the comparable rights
and obligations of the other Purchasers shall require the prior written consent of such adversely affected Purchaser. Any amendment
effected in accordance with this Section 5.5 shall be binding upon each Purchaser and holder of Securities and the Company.

 

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5.6            Headings.
The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any
of the provisions hereof.

 

5.7            Successors
and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors and permitted assigns.
The Company may not assign this Agreement or any rights or obligations hereunder without the prior written consent of each Purchaser (other
than by merger). Any Purchaser may assign any or all of its rights under this Agreement to any Person to whom such Purchaser assigns or
transfers any Securities, provided that such transferee agrees in writing to be bound, with respect to the transferred Securities, by
the provisions of the Transaction Documents that apply to the “Purchasers.”

 

5.8            No
Third-Party Beneficiaries. The Placement Agent shall be the third party beneficiary of the representations and warranties of the Company
in Section 3.1 and the representations and warranties of the Purchasers in Section 3.2. This Agreement is intended for the benefit
of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof
be enforced by, any other Person, except as otherwise set forth in Section 4.10 and this Section 5.8.

 

5.9            Governing
Law. All questions concerning the construction, validity, enforcement and interpretation of the Transaction Documents shall be governed
by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts
of law thereof. Each party agrees that all legal Proceedings concerning the interpretations, enforcement and defense of the transactions
contemplated by this Agreement and any other Transaction Documents (whether brought against a party hereto or its respective affiliates,
directors, officers, stockholders, partners, members, employees or agents) shall be commenced exclusively in the state and federal courts
sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting
in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction
contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably
waives, and agrees not to assert in any Action or Proceeding, any claim that it is not personally subject to the jurisdiction of any such
court, that such Action or Proceeding is improper or is an inconvenient venue for such Proceeding. Each party hereby irrevocably waives
personal service of process and consents to process being served in any such Action or Proceeding by mailing a copy thereof via registered
or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this
Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein
shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If any party shall commence an Action
or Proceeding to enforce any provisions of the Transaction Documents, then, in addition to the obligations of the Company under Section 4.10,
the prevailing party in such Action or Proceeding shall be reimbursed by the non-prevailing party for its reasonable attorneys’
fees and other costs and expenses incurred with the investigation, preparation and prosecution of such Action or Proceeding.

 

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5.10            Survival.
Subject to the applicable statute of limitations, the representations and warranties contained herein shall survive the Closing and the
delivery of the Securities.

 

5.11            Execution.
This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement
and shall become effective when counterparts have been signed by each party and delivered to each other party, it being understood that
the parties need not sign the same counterpart. In the event that any signature is delivered by e-mail delivery (including any electronic
signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records Act
or other applicable law, e.g., www.docusign.com) or other transmission method, such signature shall be deemed to have been duly and validly
delivered and shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with
the same force and effect as if such signature page were an original thereof.

 

5.12            Severability.
If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid, illegal,
void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in full force
and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their commercially reasonable efforts
to find and employ an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision,
covenant or restriction. It is hereby stipulated and declared to be the intention of the parties that they would have executed the remaining
terms, provisions, covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable.

 

5.13            Rescission
and Withdrawal Right. Notwithstanding anything to the contrary contained in (and without limiting any similar provisions of) any of
the other Transaction Documents, whenever any Purchaser validly exercises a right, election, demand or option under, and to the extent
specifically contemplated by, a Transaction Document, and the Company does not timely perform its related obligations within the periods
therein provided, then such Purchaser may rescind or withdraw, in its sole discretion from time to time upon written notice to the Company,
any relevant notice, demand or election in whole or in part without prejudice to its future actions and rights; provided, however,
that in the case of a rescission of an exercise of a Warrant, the applicable Purchaser shall be required to return any shares of Common
Stock subject to any such rescinded exercise notice concurrently with the return to such Purchaser of the aggregate exercise price paid
to the Company for such shares and the restoration of such Purchaser’s right to acquire such shares pursuant to such Purchaser’s
Warrant (including, issuance of a replacement warrant certificate evidencing such restored right).

 

    33

     

    

 

5.14            Replacement
of Securities. If any certificate or instrument evidencing any Securities is mutilated, lost, stolen or destroyed, the Company shall
issue or cause to be issued in exchange and substitution for and upon cancellation thereof (in the case of mutilation), or in lieu of
and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company of
such loss, theft or destruction. The applicant for a new certificate or instrument under such circumstances shall also pay any reasonable
third-party costs (including customary indemnity) associated with the issuance of such replacement Securities.

 

5.15            Remedies.
In addition to being entitled to exercise all rights provided herein or granted by law, including recovery of damages, each of the Purchasers
and the Company will be entitled to specific performance under the Transaction Documents. The parties agree that monetary damages may
not be adequate compensation for any loss incurred by reason of any breach of obligations contained in the Transaction Documents and hereby
agree to waive and not to assert in any Action for specific performance of any such obligation the defense that a remedy at law would
be adequate.

 

5.16            Payment
Set Aside. To the extent that the Company makes a payment or payments to any Purchaser pursuant to any Transaction Document or a Purchaser
enforces or exercises its rights thereunder, and such payment or payments or the proceeds of such enforcement or exercise or any part
thereof are subsequently invalidated, declared to be fraudulent or preferential, set aside, recovered from, disgorged by or are required
to be refunded, repaid or otherwise restored to the Company, a trustee, receiver or any other Person under any law (including, without
limitation, any bankruptcy law, state or federal law, common law or equitable cause of action), then to the extent of any such restoration
the obligation or part thereof originally intended to be satisfied shall be revived and continued in full force and effect as if such
payment had not been made or such enforcement or setoff had not occurred.

 

5.17            Independent
Nature of Purchasers’ Obligations and Rights. The obligations of each Purchaser under any Transaction Document are several
and not joint with the obligations of any other Purchaser, and no Purchaser shall be responsible in any way for the performance or
non-performance of the obligations of any other Purchaser under any Transaction Document. Nothing contained herein or in any other
Transaction Document, and no action taken by any Purchaser pursuant hereto or thereto, shall be deemed to constitute the Purchasers
as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Purchasers are in
any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction
Documents. Each Purchaser shall be entitled to independently protect and enforce its rights, including, without limitation, the
rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for any other
Purchaser to be joined as an additional party in any Proceeding for such purpose. Each Purchaser has been represented by its own
separate legal counsel in its review and negotiation of the Transaction Documents. For reasons of administrative convenience only,
each Purchaser and its respective counsel have chosen to communicate with the Company through Duane Morris LLP. Duane Morris LLP
does not represent any of the Purchasers and only represents the Placement Agent. The Company has elected to provide all Purchasers
with the same terms and Transaction Documents for the convenience of the Company and not because it was required or requested to do
so by any of the Purchasers. It is expressly understood and agreed that each provision contained in this Agreement and in each other
Transaction Document is between the Company and a Purchaser, solely, and not between the Company and the Purchasers
collectively and not between and among the Purchasers.

 

    34

     

    

 

5.18             Liquidated
Damages. The Company’s obligations to pay any partial liquidated damages or other amounts owing under the Transaction Documents
is a continuing obligation of the Company and shall not terminate until all unpaid partial liquidated damages and other amounts have been
paid notwithstanding the fact that the instrument or security pursuant to which such partial liquidated damages or other amounts are due
and payable shall have been canceled.

 

5.19             Saturdays,
Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right
required or granted herein shall not be a Business Day, then such action may be taken or such right may be exercised on the next
succeeding Business Day.

 

5.20             Construction.
The parties agree that each of them and/or their respective counsel have reviewed and had an opportunity to revise the Transaction Documents
and, therefore, the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party
shall not be employed in the interpretation of the Transaction Documents or any amendments thereto. In addition, each and every reference
to share prices and shares of Common Stock in any Transaction Document shall be subject to adjustment for reverse and forward stock splits,
stock dividends, stock combinations and other similar transactions of the Common Stock that occur after the date of this Agreement.

 

5.21            WAIVER
OF JURY TRIAL. IN ANY ACTION, SUIT, OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE PARTIES EACH
KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY
AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY.

 

(Signature Pages Follow)

 

    35

     

    

 

IN WITNESS WHEREOF, the parties
hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first
indicated above.

 

	trevena,
    inc.	 	Address for Notice:
	 	 	955 Chesterbook Boulevard
	 	 	Suite 110
	 	 	Chesterbrook, Pennsylvania 19087
	 	 	 
	By:	 	 	E-mail:
    bshin@trevena.com
	 	Name: Barry Shin	 	 
	 	Title:   Senior Vice President and Chief
    Financial Officer	 	 

 

With a copy to (which shall not constitute notice):

 

Troutman Pepper Hamilton Sanders LLP

3000 Two Logan Square, Eighteenth and Arch Streets

Philadelphia, PA 19103-2799

Attention: Brian Katz 

Email:
brian.katz@troutman.com

  

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK 

SIGNATURE PAGE FOR PURCHASER FOLLOWS]

 

    36

     

    

 

[PURCHASER
SIGNATURE PAGES TO TRVN SECURITIES PURCHASE AGREEMENT]

 

IN WITNESS WHEREOF, the undersigned
have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated
above.

 
	Name of Purchaser:	

 
	Signature of Authorized Signatory of Purchaser:	 

 
	Name of Authorized Signatory:	                

 
	Title of Authorized Signatory:	 

 
	Email Address of Authorized Signatory:	 

 

Address for Notice to Purchaser:

 

Address for Delivery of Warrants to Purchaser (if not same as address
for notice):

 

Subscription Amount: $_________________

 

Shares: _________________

 

Pre-Funded
Warrant Shares: ___________ Beneficial Ownership Blocker  ̈ 4.99% or   ̈9.99%

 

Warrant
Shares: __________________ Beneficial Ownership Blocker  ̈ 4.99% or  ̈
9.99%

 

EIN
Number: _______________________

 

 ̈
Notwithstanding anything contained in this Agreement to the contrary, by checking this box (i) the obligations of the
above-signed to purchase the securities set forth in this Agreement to be purchased from the Company by the above-signed, and the
obligations of the Company to sell such securities to the above-signed, shall be unconditional and all conditions to Closing shall
be disregarded, (ii) the Closing shall occur by the second (2nd) Trading Day following the date of this Agreement
and (iii) any condition to Closing contemplated by this Agreement (but prior to being disregarded by clause (i) above)
that required delivery by the Company or the above-signed of any agreement, instrument, certificate or the like or purchase price
(as applicable) shall no longer be a condition and shall instead be an unconditional obligation of the Company or the above-signed
(as applicable) to deliver such agreement, instrument, certificate or the like or purchase price (as applicable) to such other party
on the Closing Date.

 

[SIGNATURE PAGES CONTINUE]

 

    37

     

    

 

Exhibit A-1

 

    38

     

    

 

Exhibit A-2

 

    39SUPPLY AGREEMENT

Exhibit 10.1
​
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED BECAUSE
THE INFORMATION (I) IS NOT MATERIAL AND
(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
​

SUPPLY AGREEMENT
​
供应协议
​
This Supply Agreement (this “Agreement”) is entered into by and between the following parties on November 15, 2022 (the “Effective Date”):
本供应协议(“本协议”)由以下双方于 2022年 11 月 15 日(“生效日”)签订:
​
(1) Amphastar Nanjing Pharmaceuticals, Inc., a limited liability company duly incorporated and validly existing under the laws of PRC, with the unified social credit code: [***] (the “Customer”); and 
	(1)
	美药星(南京)制药有限公司,一家根据中国法律注册并存续的有限责任公司,社会统一信用代码为:[***](“买方”);及

​
(2) Nanjing Letop Biotechnology Co., Ltd., a limited liability company duly incorporated and validly existing under the laws of PRC, with the unified social credit code: [***] (the “Supplier”).
(2) 南京乐韬生物科技有限公司,一家根据中国法律注册并存续的有限责任公司,社会统一信用代码为:[***](“供应方”)。
​
The Supplier and the Customer are sometimes referred to herein collectively as the “Parties” and individually as a “Party”. 
本协议项下供应方和买方合称为“双方”,单独称为“一方”。
​
Whereas, the Customer intends to purchase certain Products (as defined below) which are manufactured by the Supplier in the Territory based on Specifications and formula provided by the Customer, and the Supplier intends to accept such purchase order.
鉴于,买方有意购买供应方根据买方提供的质量标准及规程于区域内生产的特定产品(定义见下文),并且供应方有意接受该等采购订单。
​
Therefore, based on the principle of good faith, the Parties hereby agree as follows:
因此,双方基于诚实信用原则达成如下约定:
​

1

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	1.	General

	1.	总则

​
	1.1	Headings or titles of this Agreement are used solely for convenience and shall be given no effect in the construction or interpretation of this Agreement.

	1.1	本协议标题仅为方便查阅而设,不影响对本协议的解读或解释。

​
	1.2	Additional agreements necessary to effectuate this Agreement may be executed between the Parties.  In the event of conflicting terms, the terms of this Agreement shall prevail.

	1.2	双方可以签署为实现本协议所必需的附属协议。如有冲突,则以本协议的约定为准。

​
	1.3	When used in this Agreement, the following terms shall have the meanings set forth in this section:

	1.3	本协议中使用的术语含义解释如下:

​
	(a)	“Affiliate” means any person or entity which controls, is controlled by or is under the common control of a Party. As used in this Agreement, “control” means (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, or (ii) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity.

	(a)	关联方:指控制一方、受一方控制或与一方受共同控制的任何个人或实体。在本协议中,“控制”指(i)在公司实体中,直接或间接持有该实体不少于百分之五十(50%)的有权选举董事的投票权的股权或股份;或(ii)在非公司实体中,拥有直接或间接参与该实体的管理、决定或指导该实体管理政策的方向的权力。

​
	(b)	“Applicable Law” means all ordinances, rules, regulations, laws, and requirements of any authority applicable to the Manufacture, supply, use of the Products and/or other activities under this Agreement, as amended from time-to-time, including cGMP.

	(b)	适用的法律:指不时修订的适用于产品的制造、供应、使用和/或本协议项下其他活动的任何监管机构的所有法令、规则、法规、法律和要求,包括cGMP。

​
	(c)	“Confidential Information” means technical and business information relating to inventions, proprietary ideas and/or patentable ideas, patent applications, background intellectual property, techniques, scientific knowledge, know-how processes, existing and/or contemplated products and services, software, biological material, schematics, research and development, production, costs, 

2

​

​

		profit and margin information, finances and financial projections, customers, clients, licensees, marketing, and current or future business plans and models, regardless of whether such information is designated as “Confidential Information” at the time of disclosure.  The term “Confidential Information” does not include such information which: 

		(i)	is or becomes generally available to the public, other than through the receiving party’s disclosure, 

		(ii)	 was within the receiving party’s possession prior to it being furnished by or on behalf of the disclosing party, provided that receiving party’s source had no obligation of confidentiality to the disclosing party, 

		(iii)	becomes available to the receiving party on a non-confidential basis from an information provider other than the disclosing party, provided that the information provider did not have a duty of confidentiality to the disclosing party, or 

		(iv)	is or becomes independently developed by an employee of the receiving party without access to the Confidential Information and without violating any of the receiving party’s obligations under this Agreement, as can be demonstrated by the receiving party’s written records.

	(c)	保密信息:指与发明、专有思想和/或可转化为专利思想、专利申请、底层知识产权、技术、科学知识、专有技术流程、现有的和/或预期的产品和服务、软件、生物材料、示意图、研究和开发、生产、成本及利润信息、财务和财务预测、顾客、客户、被许可方、市场销售以及当前或未来的商业计划和模式有关的技术和商业信息,无论该等信息在披露时是否被指定为“保密信息”。“保密信息”不包括以下信息:

		(i)	在接收方披露前,已是公开或公众普遍可用的,

		(ii)	在披露方提供或代表披露方提供信息之前,接收方已拥有的信息,前提是接收方的信息来源对披露方没有保密义务,

		(iii)	接收方在非保密的基础上已从披露方以外的信息提供方获得的信息,前提是信息提供方对披露方没有保密义务,或

		(iv)	接收方的员工在未接触保密信息且未违反接收方在本协议项下的任何义务的情况下,已独立开发获得的信息,且有接收方的书面记录证明。

​
	(d)	“Contract Year” means each consecutive twelve (12) month period during the Term, the first of which shall commence on the Effective Date and shall end on the first anniversary thereof.

	(d)	合同年:指协议期限内每一连续的十二(12)个月,第一个合同年从生效日开始至一周年后结束。

3

​

​

​
	(e)	“Force Majeure” means an event beyond the reasonable control of a Party including but not limited to, a breakdown of machinery or equipment, fire, flood, sabotage, shipwreck, embargo, strike, explosion, labor trouble, pandemic and related restrictions, accident, riot, act of governmental authority (including without limitation, acts relating to raw material or product allocation, and government drug files), acts of God, acts of war and delays or failures in obtaining materials, supplies, equipment or transportation.

	(e)	不可抗力:指超出一方合理控制范围的事件,包括但不限于机器或设备损毁、火灾、洪水、破坏、海难、禁运、罢工、爆炸、罢工、流行病和相关限制、事故、暴乱,政府当局的行为(包括但不限于与原材料或产品分配有关的行为,以及政府药事文件)、天灾、战争行为以及材料、供应品、设备或运输的延误或损坏。

​
	(f)	“NMPA” means the National Medical Products Administration and any successor agency having substantially the same functions.

	(f)	NMPA:指国家药品监督管理局,或具备相同职能的任一下属机构。

​
	(g)	“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce the Products, including without limitation, the manufacturing, processing, bulk packaging and labeling, quality control testing, release and storage of the Products.

	(g)	生产:指产品生产所需的任何步骤、流程及操作,包括但不限于产品的制造、加工、批量包装和贴签、质量控制测试、放行和储存。

​
	(h)	“PRC” means the People’s Republic of China, but solely for the purposes of this Agreement, excluding the Hong Kong Special Administrative Region, the Macau Special Administrative Region and the islands of Taiwan.

	(h)	中国:指中华人民共和国,仅为本协议之目的,不包括香港特别行政区、澳门特别行政区和台湾地区。

​
	(i)	“Products” mean any or all of the products listed in Appendix A hereof.

	(i)	产品:指本协议附录A中列明的任一或全部产品。

​
	(j)	“Regulatory Dossiers” means all registration, permits, licenses, authorizations, approvals, presentations, notifications or filings (together with all applications therefore), which are filed with 

4

​

​

		or granted by the governing health authority of any country, and which are required to develop, make, use, or sell the Products.

	(j)	监管档案:指产品的研发、生产、销售及使用所需的,向任一国家的卫生政府部门提交的或由任一国家的卫生政府部门授权的所有注册、许可、执照、授权、批准、介绍、通知或备案文件(及其全部申请材料)。

​
	(k)	“Specifications” means the specifications set forth in Appendix B hereof, as such specifications may be adjusted from time to time by mutual written consent of the Parties.

	(k)	质量标准:指本协议附录B列明的质量标准,可经由双方共同书面同意不时调整。

​
	(l)	“Term” means the period during which this Agreement is in effect as set forth in Section 11.

	(l)	协议期限:指本协议第11条所约定的本协议的生效期限。

​
	(m)	“Territory” means the PRC. 

	(m)	区域:指中国。

​
	(n)	“Contract Price” means, with respect to each Product, the Selling Price for each Product as provided in Appendix A, as such Selling Price may be adjusted based on the terms and conditions of this Agreement.

	(n)	合同价格:指附录A列明的每项产品的销售价格,可根据本协议的条款和条件进行调整。

​
	2.	The Customer’s Rights and Obligations

	2.	买方权利义务

​
	2.1	The Customer shall issue purchase orders to the Supplier.  The purchase order shall specify the quantity, standard, expected delivery date and other matters mutually agreed by the Parties.  The Parties hereby agree that the Customer shall provide the Supplier with a delivery period of no less than ninety (90) days.  The Supplier shall confirm within ten (10) business days after receipt of the purchase order.

	2.1	买方应向供应方发出采购订单,采购订单中应明确数量、规格、拟要求交付时间以及其他双方共同同意的事项。双方确认,买方应为供应方提供至少九十(90)日的交货周期。供应方应当于收悉买方采购订单后十(10)个工作日内进行确认。

	2.2	The Customer is entitled to decide the quantity of Products that it purchases from the Supplier at its own discretion, and the Customer has no obligation to purchase any minimum quantity of 

5

​

​

		Products from the Supplier.

​
	2.2	买方有权自行决定向供应方购买的产品数量,买方无义务向供应方购买任何最低数量产品。

​
	3.	The Supplier’s Rights and Obligations

	3.	供应方权利义务

​
	3.1	The Supplier shall deliver the Products to the Customer according to the requirements of the purchase orders confirmed by the Supplier, and FCA rules under International Rules for the Interpretation of Trade Terms 2020 (Incoterms 2020) shall apply to such delivery.  The Parties hereby agree that the Supplier’s additional costs arising from such delivery (including but not limited to, costs for transportation, customs and late receipt of the Customer’s designated carrier) shall be borne by the Customer. 

	3.1	供应方应根据供应方确认的订单要求向买方交付产品,产品交付方式依照《国际贸易术语解释通则(2020年版)》FCA术语规则。双方确认,供应方因产品交付产生的额外费用成本(包括但不限于运输费用、出口清关费用、买方指定承运人逾期收货费用)应由买方承担。

​
	3.2	The Supplier shall Manufacture and deliver the Products in conformance with the Applicable Law and regulations and Specifications.

	3.2	供应方应依据适用法律、法规及质量标准的相关规定生产和交付产品。

​
	4.	Contract Price, Invoice and Payment

	4.	合同价格、开票及结算

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	4.1	The Supplier shall issue invoices within five (5) business days after shipment, unless the Parties determine that the Products do not conform to the Specifications, payment shall be due thirty (30) days after the date of an invoice from the Supplier.

	4.1	供应方应在发货后五(5)个工作日内向买方开具发票,除非经由双方确认产品不符合质量标准,买方应在供应方开具发票后三十(30)日内完成付款。

	4.2	During the Term of this Agreement and not more than once during any twelve (12) month period, the Contract Price may be subject to an adjustment, provided that Supplier provides the Customer with two (2) months prior written notice of such proposed Contract Price adjustment and Customer agrees with such adjustment. 

	4.2	于协议期限内,供应方可经提前两(2)个月向买方发出书面通知并取得买方同意后调整

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		合同价格,该等合同价格调整在每十二(12)个月内不得超过一(1)次。

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	4.3	If the Supplier’s manufacturing costs rise due to increased costs (e.g., due to increased power or labor costs, increased standards on environmental protection), the Parties shall separately agree on the Contract Price change after the Customer’s verification of the increased costs using information supplied by the Supplier.  During the negotiation of Contract Price change, the Supplier shall provide the relevant staff salary information, power cost invoices, environmental protection expenditure information, or other supporting materials.  If the Customer adjusts the Specifications or relevant requirements unilaterally, or direct the Supplier to purchase designated raw materials and packaging materials, the Contract Price shall be adjusted accordingly.   

	4.3	如果供应方的生产成本因相关成本增加(例如因能耗、人工成本增加、环境保护标准提高等原因增加),双方应在买方核实供应方提供的成本增加的相关信息后另行商定合同价格的变更。在双方合同价格变更沟通期间,供应方应提供相关人员工资信息、电费发票、环保支出信息等配套材料。如果买方要求单方变更质量标准或产品要求,或向供应方指定原材料、包材的采购,合同价格需相应调整。

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	5.	Supply of the Products

	5.	产品供应

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	5.1	The Supplier shall promptly notify the Customer of any circumstances that result or are likely to result in any failure or delay in the supply or delivery of any Product in writing.  If the Parties have a good faith belief, after mutual communication, that such circumstances may result in the failure or delay in the supply or delivery of such Product for more than ninety (90) days from the date of the Supplier’s written notice, the Customer shall have the right to terminate such delivery after the full payment of costs and expenses of such Product to the Supplier.

	5.1	供应方应将任何导致或可能导致任何产品交付失败或延误的问题及时书面告知买方,双方经沟通后认为该等情形将导致供应方无法于供应方发出书面通知之日起九十(90)日内完成产品交付的,买方有权在支付供应方该等产品成本及费用的情况下终止该等产品的该等交付。

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	6.	Inspection of the Products

	6.	产品检验

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	6.1	All Products received by the Customer will be subject to inspection and testing by the Customer, in accordance with the Customer’s quality assurance program, within a period of thirty (30) days 

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		from the date of receipt of such Products (“Inspection Period”).  The Customer will notify the Supplier if the results of any inspection or testing indicate that the Products do not conform to the applicable Specifications or the other requirements under this Agreement.  The Supplier will have ten (10) business days to respond to the Customer’s notice of non-conformance.  Disputes between the Parties not resolved within ten (10) business days will be resolved by an independent laboratory selected by mutual consent of the Parties.  A laboratory will be appointed not later than fifteen (15) business days after the expiry of the ten (10) business day period.  If the laboratory finds the Products to be nonconforming, then at the Customer’s sole discretion, the Supplier shall (a) promptly deliver, at the Supplier’s sole expense, the replacement Products that conform to the requirements under this Agreement, or (b) refund or credit to the Customer all payments made by the Customer with respect of such nonconforming shipment.  The Customer will, at the Supplier’s sole discretion, return or destroy the nonconforming Products at the Supplier’s sole expense, including without limitation transportation and handling costs.

	6.1	收悉产品的三十(30)天内(“检验期”),买方将根据其质量保证程序对产品质量进行检验与测试。若检验或测试结果显示产品不符合质量标准或本协议的其他要求,买方将通知供应方。供应方应在十(10)个工作日内进行回复。若在十(10)个工作日内双方未达成一致,争议将通过经双方一致认可的独立实验室解决。双方将在上述十(10)个工作日期限届满后的十五(15)个工作日内就独立实验室的选择达成一致。若实验室检验结果仍不合格,经由买方决定,供应方应:(a)立即进行产品更换且费用自理,更换的产品应满足本协议要求;或(b)将买方就此类不合格产品支付的所有款项退还给买方或调整为对买方的应付款。经由供应方决定,买方将退回或销毁不合格产品,相关费用由供应方承担,包括但不限于运输和处理费用。

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	7.	Facility Qualification

	7.	设施资质

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	7.1	The Supplier shall, take all commercially reasonable actions to qualify (and thereafter to maintain qualification of) the facility at which the Supplier Manufactures the Products, as required under Applicable Law, to enable the Customer to obtain and maintain all applicable Regulatory Dossiers in relation to the Products.  The Supplier will permit the Customer and its agents, at the Customer’s expense, during normal business hours and upon reasonable prior notice to  the Supplier, and no more than once per year, to inspect the Facility where the Products are Manufactured, handled, stored, or tested, as well as all batch records (without making any copies) and processes relating 

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		to the Manufacture, storage, handling, or testing of the Products and all Manufacturing, handling, storage, and test records regarding the Products.  The Supplier will respond to any non-conformances noted by the Customer, within thirty (30) business days of the written notification of such non-conformances, by submitting to the Customer a written report stating causes and corrective actions planned, and providing a timetable for the correction.  

	7.1	供应方应根据相关法律要求,采取一切商业上合理的措施使其生产产品的设施获得(并维持)相应资质,以确保买方能够获得并维持所有与产品有关的监管档案。供应方应允许买方及其代理商在事先通知的情况下,在正常工作时间内对与产品生产、处理、贮存或测试相关的设施、或与产品生产、贮存、处理或测试相关的批次记录(不可复制副本)和工艺流程、以及产品的所有生产、处理、贮存或测试记录进行每年不超过一(1)次的检查,相关费用由买方承担。供应方应在收到买方的不合格书面通知后三十(30)个工作日内向买方进行回复,通过纸质报告说明不合格原因与相应改正措施,并提供改正的具体时间安排。

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	8.	Manufacturing Practices

	8.	生产操作

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	8.1	The Supplier shall Manufacture the Products in conformance with the Specifications.  The Supplier shall provide the Customer with such information, including analytical and manufacturing documentation, requested by the Customer regarding quality control of the Products supplied hereunder.  The Supplier will solely be responsible for keeping proper records and documentation of the manufacturing and testing of the Products, intermediates, and starting materials, including batch records, testing records, laboratory notebooks, equipment usage, starting material batch numbers, and certifications.  The Supplier will be responsible for investigating any test results or in-process testing of the Products that do not conform with the Specification.  The Supplier will conduct such laboratory investigation, which must be approved by the Supplier’s quality unit, and the Supplier will promptly notify the Customer of any adverse reactions or other safety or toxicity problems known to or reasonably suspected by the Supplier regarding the Products or its use.  The Supplier will promptly notify the Customer of the results of any regulatory inspection, comments, responses or notices received from the NMPA or other applicable regulatory authorities, which relate to or may impact the Manufacture and supply of the Products to the Customer.

	8.1	供应方应按照质量标准进行生产,应买方书面要求,供应方应向买方提供本协议项下供应产品质量控制的相关信息,包括分析和生产文件。供应方将负责适当保存与产品、中间体和起始物料的生产与测试有关的记录和文件,包括:审批记录、测试记录、实验记录、设

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		备使用记录、起始物料批号以及检验报告。供应方将负责调查产品发生任何不符合质量标准的测试结果或过程测试,该等调查采取实验室调查,须经供应方质量部门批准方可进行。供应方将及时通知买方针对产品已知的或合理怀疑的不良反应或其他安全或毒性问题以及自NMPA或其他机构收悉的可能影响产品生产及交付的检查、意见、答复或通知。

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	9.	Recall

	9.	召回

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	9.1	During the Term, if either Party believes that it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar actions with respect to any Product (a “Recall”), the Supplier and the Customer shall consult with each other as to how best to proceed. The Parties hereby agree that the final decision as to any Recall of any such Products shall be made by the Customer; provided, however, that the Supplier will not be prohibited hereunder from taking any action that is required by Applicable Law.  The Customer shall be in charge of the Recall and establish a product recall system and recall management procedures, and the Supplier shall cooperate with the Customer as required by Applicable Law.  In the event of a Recall, the Parties shall jointly find out and confirm reasons for the Recall, and except for reasonable costs borne by the Supplier if a Recall is incurred attributable to it, the Customer shall bear all costs incurred thereby.

	9.1	于协议期限内,如果任一方认为有必要对任何产品进行召回、现场更正、市场撤回、库存回收或其他类似行动(“召回”),双方应协商达成最佳解决方案。双方同意,该等方案的最终决定权归买方所有,但前提是供应方也可根据相关法律要求采取相应行动。买方应当建立产品召回体系及召回管理程序,并负责召回工作,供应方在适用法律要求的范围内配合买方。产品发生召回的,由双方共同确认产品召回原因,除因供应方原因导致的产品召回由供应方承担合理费用外,任何与召回有关的费用由买方承担。

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	10.	Certificate of Analysis

	10.	检验报告

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	10.1	The Supplier shall supply the same information on the certificate of analysis as is listed in the Specifications incorporated as Appendix B.  No changes in Specifications will be made unless the Customer and the Supplier have agreed to such changes in writing prior to adoption of the modified Specifications.

	10.1	供应方应在检验报告中提供与附录B中所列质量标准相同的信息。除非经双方事先书面

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		同意,否则质量标准不得更改。

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	11.	Term, Amendment and Termination

	11.	协议期限、变更、解除或终止

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11.1This Agreement will remain in full force and effect for a period of three (3) Contract Years (the “Term”).  Prior to the expiry of the Term, the Parties may, in their discretion, agree to extend the Term for a mutually agreed period.
11.1本协议三个合同年的期限(“协议期限”)内保持完全效力。在协议期限届满之前,双方可经自行决定同意将协议期限延长至双方商定的期限。
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11.2During the Term, due to changes in laws and regulations, Specifications, Manufacturing procedures or other substantive conditions, this Agreement may be amended by the mutual written consent of the Parties.  Any Amendment to this Agreement and its appendices hereto shall come into force with an instrument in writing signed by the Parties.
11.2于协议期限内,因法律法规、质量标准、生产规程或其他实质性条件发生变化,经双方一致同意可对本协议进行变更,对本协议及其附录的修改,须经双方签署书面协议方能生效。
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11.3Unless otherwise provided for herein, either Party (the “Terminating Party”) may immediately terminate this Agreement by notifying the other Party (the “Terminated Party”) in writing when one of the following situations occurs:
		(a)	The Terminated Party breaches this Agreement and (i) does not rectify its default within thirty (30) days on the date of receiving written notice from the Terminating Party requiring for rectification; or (ii) there is no realistic possibility to rectify such default; or (iii) such default has resulted in the inability to achieve the purpose of this Agreement;

		(b)	The Terminated Party suffers a Force Majeure event which makes it impossible to achieve the purpose of this Agreement; 

		(c)	The Terminated Party expresses clearly or by behavior that it will not perform its obligations hereunder, or delays the performance of its obligations and has not fully performed the obligations after being notified;

		(d)	The Terminated Party loses the ability to perform its obligations hereunder, including but not limited to, entering bankruptcy proceedings, liquidation proceedings, being dissolved, being winding up, being revoked, or losing appropriate qualifications.

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11.3除本协议另有约定外,任一方(“解除方”)可在出现下述情形之一时书面通知另一方(“被解除方”)立即解除本协议:
		(a)	被解除方违反本协议约定且(i) 在收悉解除方书面通知要求其纠正违约行为之日起三十(30)日内未纠正其违约行为的;或(ii) 实际上已不存在纠正违约行为的可能;或(iii) 存在违约行为导致不能实现协议目的; 

		(b)	被解除方遭遇不可抗力且不可抗力致使不能实现协议目的;

		(c)	被解除方明确表示或以行为表明不履行本协议义务,或者迟延履行本协议义务且经催告后仍未全面履行的;

		(d)	被解除方丧失协议履行能力,包括但不限于,进入破产程序、清算程序、被解散、被注销、被吊销、丧失相应资质。

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11.4This Agreement may be terminated by mutual written consent of the Parties. 
11.4本协议可经由双方共同书面同意而终止。
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11.5Upon expiration or termination of this Agreement, the Supplier will promptly complete and invoice for all deliverables of open and accepted purchase orders received from the Customer prior to the termination or expiration of this Agreement, and the Customer shall pay to the Supplier within thirty (30) days from the date of invoice.  
11.5本协议到期或终止时,供应方应根据本协议到期或终止前已接受但未完成的买方采购订单交付产品并开具发票,买方应在供应方前述开票之日起三十(30)日内支付供应方款项。
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11.6Termination or expiration of this Agreement shall not relieve either Party of any obligation accruing prior to such termination or expiration, including, without limitation, any breach of such obligation, or from any surviving obligation under this Agreement.
11.6本协议的解除、终止或到期不免除任一方在该等解除、终止或到期前产生的任何义务,包括但不限于对该等义务的任何违约,或本协议项下的任何存续义务。
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11.7Either Party shall return or destroy all documents and materials in its possession which contain Confidential Information of the other Party within thirty (30) days after termination or expiration of this Agreement.  The receiving party may retain one copy of documents and materials which contain the disclosing party's Confidential Information for the purpose of verifying the receiving party's compliance with its obligations under this Agreement but for no other purpose whatsoever.
11.7任何一方应在本协议解除、终止或到期后三十(30)日内归还或销毁其持有的包含另一

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方保密信息的所有文件和材料。接收方可以保留包含披露方保密信息的文件和材料的一份副本,以核实接收方是否遵守其在本协议项下的义务,但不得以任何其他目的。
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11.8Unless otherwise provided for herein, after termination or expiration of this Agreement, section 1 (General), this section 11 (Term, Amendment and Termination), section 12 (Intellectual Property Rights), section 13 (Warranties), section 14 (Indemnities), section 15 (Confidential Information), section 16 (Force Majeure), section 17 (Notices), section 18 (Binding Effect), section 19 (Governing Law and Dispute Resolution), section20 (Assignment), section 21 (Severability), section 22 (Entire Agreement), section 23 (Waiver), section 24 (Publicity), section 25 (Appendices), section 26 (Counterparts and Language) shall survive.
11.8除本协议另有约定外,本协议解除、终止、到期后,本协议第1条(总则)、本11条(协议期限、变更、解除或终止)、第12条(知识产权)、第13条(保证)、第14条(赔偿)、第15条(保密信息)、第16条(不可抗力)、第17条(通知)、第18条(合同约束力)、第19条(管辖法律及争议解决)、第20条(转让)、第21条(可分割性)、第22条(完整协议)、第23条(弃权)、第24条(公开发布)、第25条(附录)及第26条(副本和语言)仍持续有效。
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	12.	Intellectual Property Rights

	12.	知识产权

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12.1The Supplier will retain ownership of all the Supplier’s Confidential Information that may be shared with the Customer during the Term of this Agreement, including retention of any manufacturing and production process for the Products (and all know-how of such process).
12.1供应方将保留在执行本协议的过程中可能与买方共享的所有供应方保密信息的所有权,包括保留任何产品的生产和制作流程(以及相应的专有技术)。
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12.2The Customer will retain ownership of all Confidential Information the Customer shares with the Supplier during the Term of this Agreement.
12.2买方将保留在执行本协议过程中与供应方共享的所有买方保密信息的所有权。
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	13.	Warranties

	13.	保证

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13.1The Supplier warrants that the Products delivered to the Customer and pursuant to this Agreement 

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shall at the time of such delivery not be adulterated or misbranded within the meaning of the Applicable Law, and that it holds all necessary intellectual property rights and licenses, filings or approvals required by all Applicable Law for the Manufacture, supply, use of the Products and/or other activities under this Agreement.  The Supplier represents and warrants that it will comply with all present and future statutes, laws, ordinances and regulations relating to the Manufacture, assembly and supply of the Products being provided hereunder, including without limitation, those enforced by the NMPA.  
13.1供应方保证其根据本协议所交付的产品不会因违背任何法律而被视为假药或贴错标签,并保证其拥有制造、供应、使用产品及/或开展本协议项下的其他活动所有必要的知识产权以及一切适用法律要求的许可、备案或批准。。供应方声明并保证其将遵守与本协议中产品的生产、制备和供应相关的所有现行和未来法令、法律、法规和条例,包括但不限于NMPA的法规。
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13.2The Parties are not authorized to, and shall not, incur any liability for which the other Party may become directly, indirectly or contingently liable, nor shall they, except as explicitly provided in this Agreement, hold themselves out as having authority to represent or act on behalf of the other Party in any capacity whatsoever, nor shall the relationship between the Parties be construed as a co-partnership, joint venture or principal-agent relationship.
13.2双方无权也不应承担另一方可能直接、间接或偶然承担的任何责任,除非本协议有明确规定,否则双方不得以任何身份自称有权代表另一方或以另一方名义行事,双方之间的关系也不得被解释为合伙、合资或委托代理关系。
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	14.	Indemnities

	14.	赔偿

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14.1Unless arising from the willful misconduct of the Supplier, the Customer will defend, indemnify and hold the Supplier and its Affiliates and their respective employees, servants and agents harmless against any liability, judgment, demand, action, suit, loss, damage, cost or other expense (including reasonable attorneys’ fees and other costs of defense) resulting from: (i) the Customer’s material breach of this Agreement or (ii) the Customer’s breach of any warranty made under this Agreement.
14.1除非因供应方故意不当行为引起,当(i)买方实质性违反本协议;或(ii) 买方违反其在本协议项下的任何保证时,买方应为供应方及供应方关联方、供应方及其关联方的雇员、服务人员、代理商提供抗辩及赔偿,以使得供应方及供应方前述主体免受任何责任、判决、要

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求、行为、诉讼、损失、损害或费用支出(包括合理的律师费及其他辩护费用)。
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14.2Unless arising from the willful misconduct of the Customer, the Supplier will defend, indemnify and hold the Customer and their Affiliates and their respective employees, servants and agents harmless against any liability resulting from any third party claims made or proceeding brought against the Customer to the extent that such liability arises from (i) the alleged or actual negligence or wilful misconduct of the Supplier; (ii) the Supplier’s material breach of this Agreement; (iii) the Supplier’s breach of any warranty made under this Agreement; or (iv) any infringement of any third party intellectual property rights in relation to the Products.
14.2除非因买方故意不当行为引起,当(i) 供应方存在被指称的或实际的过失或故意不当行为;(ii) 供应方实质性违反本协议;(iii) 供应方违反其在本协议项下的任何保证;或(iv) 供应方存在与产品有关的侵犯任何第三方知识产权的情形,供应方应为买方及买方关联方、买方及其关联方的雇员、服务人员、代理商提供抗辩及赔偿,以使得买方及买方前述主体免受损害。
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14.3Each indemnified party agrees to give the indemnifying party prompt written notice of any matter upon which such indemnified party intends to base a claim for indemnification (an “Indemnity Claim”) under Section 14.  The indemnifying party will have the right to participate jointly with the indemnified party in the indemnified party’s defense, settlement or other disposition of any Indemnity Claim.  With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the indemnified party’s becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the indemnified party in any manner, and as to which the indemnifying party will have acknowledged in writing the obligation to indemnify the indemnified party hereunder, the indemnifying party will have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the indemnifying party, in its sole discretion, will deem appropriate, provided that the indemnifying party will provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement will have obtained the written release of the indemnified party from the Indemnity Claim.  The indemnifying party shall apply for a written release from the indemnified party prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim.  If as a result thereof the indemnified party has been subject to injunctive or other equitable relief or the business of the indemnified party has been adversely affected in any matter, the application for exemption will be rejected.

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14.3受偿方同意立即书面通知赔偿方,其根据本协议第14条拟提起的赔偿主张(“赔偿主张”)。赔偿方有权参与受偿方对任何赔偿的辩护、和解或其他方式处理赔偿主要的活动。对于任何仅与经济赔偿有关且不会导致受偿方受限于禁令或其他衡平法救济,也不会以任何形式对受偿方的业务活动产生不利影响的赔偿主张,同时赔偿方已通过书面形式确认了其在本协议项下对受偿方的赔偿义务,则赔偿方拥有以其自行认为合理的方式辩护、和解或以其他方式处理上述赔偿主张的权利,但前提是赔偿方提供合理的证据证明其有能力支付任何被主张的损害赔偿,并且就任何此类和解已获得受偿方的书面免责声明。赔偿方应在辩护、和解或其他处理方式结束之前,向受偿方申请书面免责声明,若受偿方已获得禁令、衡平法救济或其业务活动已受到不利影响,免责申请将被拒绝。
​
14.4Unless otherwise provided for herein, if the Customer pays the Contract Price under this Agreement which are overdue, the Supplier shall have the right to require the Customer to pay 0.05% interest of the overdue payment per day as liquidated damages. 
14.4除本协议另有约定外,买方逾期支付供应方本协议项下合同价格,每逾期一天,供应方有权要求买方支付逾期付款部分的每日万分之五(0.05%)的利息作为违约金。
​
	15.	Confidential Information

	15.	保密信息

​
15.1The receiving party will treat as confidential and secret all information which has been or may hereafter be disclosed by the disclosing party, directly or indirectly, to the receiving party, either orally, in writing or through inspection.  The receiving party shall use the Confidential Information received only to the extent necessary to execute the Purpose of this Agreement.  The receiving party will not disclose to anyone any Confidential Information received from the disclosing party, and will use the same degree of care, but no less than a reasonable degree of care, to prevent the disclosure of the Confidential Information to others as it uses to prevent the disclosure of its own Confidential Information.  Upon request from the disclosing party, the receiving party will promptly return to the disclosing party or destroy all drawings, data, memoranda and information in physical form relating to the Confidential Information.
15.1接收方应对披露方直接或间接以口头、书面或检查的形式提供的所有信息(保密信息)进行保密。接收方仅可在履行与本协议目的所必需的范围内使用收悉的保密信息。接收方不得向任何人披露其从披露方收悉的任何保密信息,并将采取任何可行的措施保护保密信息的保密性,程度不得低于其对自身保密内容或同样性质内容的保护,并避免泄露和非授

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权使用。在披露方要求下,接收方应立即向披露方返还或销毁所有与保密信息有关的图纸、数据、备忘录和实物形式的信息。
​
15.2Each Party agrees to keep the Confidential Information confidential, which includes (but is not limited to) not disclosing the disclosing party’s Confidential Information, or any part thereof (except as otherwise may be provided herein), absent the disclosing party’s prior written consent, unless required to do so by Applicable Law, act or a valid order of a court or other governing, regulatory body with authority over the receiving party (“Required Disclosure”); provided that the receiving party will first give reasonable written notice to the disclosing party prior to any Required Disclosure and will exercise its best efforts to obtain an order or other reliable assurance that the Confidential Information disclosed will be treated at the highest level of confidentiality.  Upon receipt of notice from the receiving party of any Required Disclosure, the disclosing party may, at the disclosing party’s expense, seek to quash or restrict the disclosure of the disclosing party’s Confidential Information and the receiving party will not oppose or seek to impede the disclosing party’s efforts to obtain such relief. 
15.2每一方同意对保密信息予以保密,包括(但不限于)不得在未经披露方书面同意(除非本协议另有规定),披露披露方提供的保密信息,除非适用法律、法令或对接收方有管辖权的法院或其他管理、监管机构的有效命令要求披露(“必要披露”)。前提是接收方应在任何必要披露前向披露方发出书面通知,且需尽最大努力获得法令或其他可靠保证以确保所披露的信息得到最高级别的保密处理。在收悉接收方发出的任何必要披露的通知时,披露方可在自行承担费用的情况下寻求撤销或限制对披露方保密信息的披露,接收方不得反对或阻碍披露方获得该等救济。
​
15.3This provision of confidentiality is not intended to grant or transfer any rights to the Confidential Information to the receiving party and does not transfer or convey any rights under a patent, trademark, copyright, or other intellectual property right to or in the Confidential Information.  All Confidential Information (including all copies thereof) will at all times remain the property of the disclosing party.  Further, and unless otherwise provided in this Agreement, the disclosure of Confidential Information to a receiving party does not create, and is not intended to create, any form or type of agency by and between the disclosing party and the receiving party. 
15.3本保密条款无意向接收方授予或转让任何保密信息的任何权利,也无意于转让任何专利、商标、版权或其他知识产权项下的保密信息的任何权利。所有保密信息(包括其所有复印件)将始终为披露方所有。此外,除非本协议另有规定,向接收方披露保密信息并不产生,

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也无意在披露方和接收方之间产生任何形式或类型的代理。
​
15.4The receiving party agrees that its obligations hereunder are necessary and reasonable to protect the disclosing party, and expressly agrees that monetary damages would be inadequate to compensate the disclosing party for any breach of any covenant or agreement set forth herein and that, in addition to any and all other remedies available at law or in equity, the disclosing party will be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any actual or threatened breach of this Agreement, and no bond or other security will be required in connection with any such equitable relief.  In the event of litigation relating to this Agreement, if a court of competent jurisdiction determines that a Party has breached this Agreement, then the non-breaching party may seek recovery of its reasonable legal fees, including any appeal, in addition to any other remedies to which the non-breaching party may be entitled.
15.4接收方同意本协议项下的义务对于保护披露方均为必要且合理的,如违反本协议约定,不仅应赔偿披露方经济损失,除法律或衡平法上可获得的任何和所有其他救济之外,披露方有权针对任何实际或可能违反本协议的行为寻求衡平法救济,包括禁令和特别履行,并且无需对该等衡平法救济提供任何保函或担保。如发生与本协议有关的诉讼,如果有管辖权的法院判定一方违反了本协议,则守约方有权要求获得合理的律师费(含上诉)及采取其他补救措施。
​
	16.	Force Majeure

	16.	不可抗力

​
16.1If the performance by either Party of any obligation under this Agreement, other than the payment of money, is prevented or impaired by a Force Majeure event, such Party will be excused from performance so long as such situation continues to prevent or impair performance, provided the Party claiming such excuse must promptly notify the other Party of the existence, nature, duration and other details of the Force Majeure event and will at all times use reasonable efforts consistent with its normal business practices to resume a complete performance. 
16.1协议双方除履行付款义务外,因不可抗力的持续造成一方无法履行协议约定的义务时,该方可免除履行义务,前提是一方应立即告知另一方不可抗力的性质、持续时间及其他具体细节,并始终依照行业惯例尽合理的商业努力以恢复协议义务的履行。
​
16.2In the event of a Force Majeure event, the exempting party will advise the other Party from time to time as to the progress in remedying the situation and as to the time when the exempting party 

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expects to resume its obligations.  The exempting party shall promptly inform the other Party of elimination of such Force Majeure event.
16.2不可抗力免责方应定期告知另一方补救措施的进展以及预计何时恢复履行义务。不可抗力事件结束后,免责方应立即告知另一方。
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	17.	Notices

	17.	通知

​
17.1.All notices hereunder shall be in writing and shall be delivered personally, mailed by overnight delivery, registered or certified mail, postage prepaid, or given by facsimile to the following addresses of the respective Parties:
​
	If to the Customer:
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If to the Supplier:
​
​
​
	Address: Amphastar Nanjing Pharmaceuticals, Inc.
No. 5 Xinghe Road
Nanjing Economic and Technological Development Zone
Jiangsu, China 
Attn: General Manager
Post Code: 210038
Address: Nanjing Letop Biotechnology Co., Ltd. 
Building C5,No.9 Weidi Road,Xianlin University Town,Xianlin Street,Qixia District,Nanjing City,Jiangsu Province
Attn:Eric Xu
Post Code: 210033
​

17.1.本协议项下的所有通知均采用书面形式,应通过亲自递送、隔夜递送、挂号信、预付邮资或传真方式发送至双方的地址,具体如下:
​
买方:美药星(南京)制药有限公司
地址:中国江苏省南京经济技术开发区兴和路5号
联系人:General Manager
邮箱:210038
​
供应方:南京乐韬生物科技有限公司
地址:中国江苏省南京市栖霞区仙林大学城纬地路9号C5栋

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联系人:徐勇刚
邮编:210033
​
	18.	Binding Effect

	18.	合同约束力

​
18.1.This Agreement shall be binding upon and inure to the benefit of the Parties and their respective assigns and successors in interest.
18.1.本协议将对双方及其各自的受让人和利益继承人具有约束力并及于其各自之利益。
​
	19.	Governing Law and Dispute Resolution

	19.	管辖法律及争议解决

​
19.1The Agreement shall be construed, interpreted and governed by the laws of the PRC.
19.1本协议应受中国法律管辖并解释。
​
19.2This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) (the “Disputes”) shall first be resolved through consultation.  If the Disputes cannot be resolved through negotiation, the Dispute (including a Dispute in connection with the validity or continuity of this Agreement) shall be submitted to arbitration in Shanghai under the auspices of the Shanghai International Economic and Trade Arbitration Commission with its then effective arbitration rules.  The arbitration tribunal shall be consisted by three (3) members.  One (1) arbitrator shall be appointed by the Party initiating the arbitration, one (1) arbitrator shall be appointed by the other Party, and the third arbitrator shall be jointly selected by the two (2) appointed arbitrators.
19.2本协议以及因本协议及其内容或成立而引起的或与之相关的任何争议或诉请(包括非合同争议或诉请)(以下简称“争议”)应由双方通过友好协商解决。如不能通过协商解决的,则该争议(包括有关本协议有效性或存续性的争议)应提交上海国际经济贸易仲裁委员会,按照其届时有效的仲裁规则在上海进行仲裁。仲裁庭由三(3)名成员组成。其中一(1)名仲裁员由提起仲裁方指定,一(1)名仲裁员由答辩方指定,第三名仲裁员由该两名仲裁员共同选定。
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19.3The award of the arbitration tribunal shall be final and binding upon the Parties, and each Party may apply to a court of competent jurisdiction for enforcement of such award.  Except for matters 

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in the Dispute during a Dispute which is being resolved in accordance with this Agreement, the Parties shall continue to perform their obligations hereunder.
19.3仲裁裁决应为终局的,对双方均具有约束力,并可根据有关条款规定强制执行。在按照本协议约定解决争议期间,除争议所涉事项外,双方应继续履行其在本协议项下的义务。
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	20.	Assignment

	20.	转让

​
20.1Neither Party shall assign or transfer its rights and obligations hereunder to any other party without the prior written consent of the other Party.  Notwithstanding the foregoing, this Agreement and the rights and obligations herein may be assigned by each Party to any of its Affiliate, and either Party, may assign or sell the same in connection with the transfer or sale of substantially its entire business to which this Agreement pertains or in the event of its merger or consolidation with another company without such consent.  Any permitted assignee will assume all obligations of its assignor under this Agreement.
20.1未经另一方事先书面同意,任何一方均不得转让本协议。尽管有前述约定,一方可将其本协议项下权利义务转让给其关联方,且一方转让或出售其与本协议有关的绝大部分业务或与另一家公司合并时转让本协议则无需征得另一方同意。任一获准受让人应承担其转让人在本协议项下的所有义务。
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20.2No assignment will relieve any Party of the responsibility for the performance of any obligation hereunder.
20.2任何形式的转让都不会免除任何一方履行本协议项下任何义务的责任。
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	21.	Severability

	21.	可分割性

​
21.1.In the event that any term or provision of this Agreement is held invalid or unenforceable by a court of competent jurisdiction, the remaining terms shall be valid and enforced to the fullest extent permitted by Applicable Law.  If any term or provision of this Agreement is deemed by a court to be unenforceable because such provision is too broad in scope, the provision shall be construed in a limited scope to make it enforceable.
21.1.若本协议的任何条款或约定被有管辖权的法院认定为无效或不可强制执行,其余条款将在适用法律允许的最大范围内有效并可强制执行。如果本协议的任何条款或约定因适用范

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围过宽而被法院认定为不可强制执行,则该条款将在有限范围内进行解释以使其具有可强制执行性。
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	22.	Entire Agreement

	22.	完整协议

​
22.1.This Agreement constitutes the entire agreement between the Parties concerning the subject matter and supersedes all prior agreements or understandings between the Parties.
22.1.本协议构成双方之间关于就本协议主题事项的全部约定,并取代双方之前所有的约定或谅解。
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	23.	Waiver 

	23.	弃权

​
23.1.No waiver or modification of any of the terms of this Agreement shall be valid unless in writing and signed by authorized representatives of both Parties.  Failure by either Party to enforce any rights under this Agreement shall not be construed a waiver of any rights, nor will a waiver by a Party in one instance be construed as a continuing waiver or a waiver in other instances.
23.1.除非由双方授权代表书面签署,否则对本协议任何条款的放弃或修改均无效。任何一方未能行使本协议项下的权利不应被解释为在该情况下或任何其他情况下放弃此类权利。任何一方在某种情况下的弃权也不应被解释为持续性弃权或视为在其它情况下的弃权。
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	24.	Publicity

	24.	公开发布

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24.1.Other than as required by Applicable Law, in the absence of specific agreement between the Parties, neither Party shall originate any publicity, news release or other public announcement, written or oral, whether to the public press, to stockholders or otherwise relating to this Agreement.
24.1.除适用法律要求外,在双方间无具体协议或约定的情况下,任何一方不得向公众媒体、股东或以其他方式发起与本协议相关的任何书面或口头的宣传、新闻发布或其他公告。
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	25.	Appendices

	25.	附录

​
25.1.All appendices referenced herein are made a part of this Agreement.

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25.1.本协议中所有附录均构成本协议的一部分。
​
	26.	Counterparts and Language

	26.	副本和语言

	26.1.	This Agreement may be executed in several duplicates, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.  For the avoidance of doubt, this Agreement is concluded both in Chinese version and English version.  In the event of any discrepancy between the Chinese version and the English version, the English version shall prevail.

	26.1.	本协议可签署多份副本,每一份副本均应被视为原件,且所有副本应共同构成同一文件。为避免疑义,本协议以中文和英文书就。若中文版本和英文版本之间存在不一致之处,应以英文版本为准。

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In Witness whereof, the Parties have executed this Agreement by their duly authorized representatives.
兹证明,双方已由其正式授权代表签署本协议。
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	Amphastar Nanjing Pharmaceuticals, Inc.
	​
	Nanjing Letop Biotechnology Co., Ltd.

	美药星(南京)制药有限公司
	​
	南京乐韬生物科技有限公司

	​
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	By/签署:
	/s/Perky Qiu
	​
	By/签署:
	/s/ Eric Xu

	​
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	Name/姓名:
	邱银华  Perky Qiu
	​
	Name/姓名:
	徐勇刚  Eric Xu

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	Title/职位:
	总经理  General Manager
	​
	Title/职位:
	总经理  General Manager

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	Date/日期:
	2022-11-15
	​
	Date/日期:
	2022-11-15

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APPENDIX A: PRODUCTS AND CONTRACT PRICE
附录A:产品及合同价格
​
	

	

	

	

	No.
	Products
	Unit
	Selling Price/Unit (RMB)

	1
	 Phytol  (VK01-A0)
植物醇
	kg
	[***]

	2
	α-Tropine 
α-托品醇
	kg
	[***]

	3
	Chloracetyl Catechol 
氯乙酰儿茶酚
	kg
	[***]

	4
	Epinephrine Bitrartrate                                         酒石酸肾上腺素
	kg
	[***]

	5
	Cholic acid  
胆酸
	kg
	[***]

	6
	N-Isopropylnortropine 
N-异丙基托品醇
	kg
	[***]

	7
	1-(2, 2-dimethyl-4h-1,3-benzodioxin--6-yl)-2-(1-phenylethylamine)ethanol (SM-8)
	kg
	[***]

	8
	1-[4-[(6-Bromohexyl)oxy]butyl]benzene (SM-10)
	kg
	[***]

	9
	1-Hydroxy-2-naphthoic Acid 
1-羟基-2-萘甲酸
	kg
	[***]

	10
	17-BETA CARBOXYLIC ACID; 6a,9a-difluoro-l1~-hydroxy-l6a-methyl-l7apropionyloxy-3-oxo (F6B-A0 )
氟替卡松丙酸酯起始物料
	kg
	[***]

	11
	Butyraldehyde 
正丁醛
	L
	[***]

	12
	Benzenemethanol (S2B-A0)
富马酸福莫特罗起始物料
	kg
	[***]

​
“Selling Price” means, with respect to each Product, an amount equal to the sum of (i) the Direct Costs to manufacture such Product, plus (ii) [***]% of the amount of such Direct Costs plus any applicable taxes. 
出售价格:指金额等于产品直接成本加上直接成本的[***]%以及所适用税款的总和。
​

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“Direct Costs” means, with respect to a Product, the actual cost of raw materials, packaging components, overhead expense applied on a consistent basis with other products manufactured by ANP, and direct labor used to produce such Product.  In no event will Direct Costs include expenses related to unutilized facility capacity, or allocations for corporate overheads.
直接成本:指乙方用于产品生产及相关的实际费用,包括:原材料,包装材料,管理及人工费用。任何情况下,直接成本都不包括未参与生产的设施费用,或公司内部管理费用。
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APPENDIX B: SPECIFICATIONS
附录B:质量标准

27

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