Exhibit 10.1


 


AT THE MARKET OFFERING AGREEMENT


 


December 10, 2021


 


Ladenburg Thalmann & Co. Inc.


277 Park Avenue, 26th Floor


New York, NY 10172


 


Ladies and
Gentlemen:


       


Jaguar Health, Inc., a Delaware
corporation (the “Company”), confirms its agreement (this “Agreement”) with Ladenburg Thalmann &
Co. Inc. (the “Manager”) as follows:


 


1.            
Definitions. The terms that follow, when used in this Agreement and any Terms Agreement, shall have the meanings indicated.


 


“Accountants” shall
have the meaning ascribed to such term in Section 4(m).


 


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


 


“Action”
shall have the meaning ascribed to such term in Section 3(q).


 


“Affiliate”
shall have the meaning ascribed to such term in Section 3(p).


 


“Applicable
Time” shall mean, with respect to any Shares, the time of sale of such Shares pursuant to this Agreement or any relevant Terms
Agreement.


 


“Base Prospectus”
shall mean the base prospectus contained in the Registration Statement at the Execution Time.


 


“Board”
shall have the meaning ascribed to such term in Section 2(b)(iii).


 


“Broker
Fee” shall have the meaning ascribed to such term in Section 2(b)(v).


 


“Business
Day” shall mean 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 that banks shall not be deemed to be authorized or obligated to be closed due to a “shelter
in place,” “non-essential employee”  or similar closure of physical branch locations at the direction of any governmental
authority if such banks’ electronic funds transfer systems (including for wire transfers) are open for use by customers on such
day.


 






     


     


    

 


“Commission”
shall mean the United States Securities and Exchange Commission.


 


“Common
Stock” shall have the meaning ascribed to such term in Section 2.


 


“Common
Stock Equivalents” shall have the meaning ascribed to such term in Section 3(g).


 


“Company
Counsel” shall have the meaning ascribed to such term in Section 4(l).


 


“DTC”
shall have the meaning ascribed to such term in Section 2(b)(vii).


 


“Effective
Date” shall mean each date and time that the Registration Statement and any post-effective amendment or amendments thereto became
or becomes effective.


 


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


 


“Execution
Time” shall mean the date and time that this Agreement is executed and delivered by the parties hereto.


 


“Filing
Date” shall have the meaning ascribed to such term in Section 4(w).


 


“Free Writing
Prospectus” shall mean a free writing prospectus, as defined in Rule 405.


 


“GAAP”
shall have the meaning ascribed to such term in Section 3(n).


 


“Incorporated
Documents” shall mean the documents or portions thereof filed with the Commission on or prior to the Effective Date that are
incorporated by reference in the Registration Statement or the Prospectus and any documents or portions thereof filed with the Commission
after the Effective Date that are deemed to be incorporated by reference in the Registration Statement or the Prospectus.


 


“Intellectual
Property Rights” shall have the meaning ascribed to such term in Section 3(v).


 



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“Issuer
Free Writing Prospectus” shall mean an issuer free writing prospectus, as defined in Rule 433.


 


“Lien”
shall mean a lien, charge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.


 


“Losses”
shall have the meaning ascribed to such term in Section 7(d).


 


“Material
Adverse Effect” shall have the meaning ascribed to such term in Section 3(b).


 


“Material
Permits” shall have the meaning ascribed to such term in Section 3(t).


 


“Net Proceeds”
shall have the meaning ascribed to such term in Section 2(b)(v).


 


“Permitted
Free Writing Prospectus” shall have the meaning ascribed to such term in Section 4(g).


 


“Placement”
shall have the meaning ascribed to such term in Section 2(c).


 


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


 


“Prospectus”
shall mean the Base Prospectus, as supplemented by the most recently filed Prospectus Supplement (if any).


 


“Prospectus
Supplement” shall mean each prospectus supplement relating to the Shares prepared and filed pursuant to Rule 424(b) from
time to time.


 


“Registration
Statement” shall mean the shelf registration statement (File Number 333-261283) on Form S-3, including exhibits and
financial statements and any prospectus supplement relating to the Shares that is filed with the Commission pursuant to Rule 424(b)
and deemed part of such registration statement pursuant to Rule 430B, as amended on each Effective Date and, in the event any post-effective
amendment thereto becomes effective, shall also mean such registration statement as so amended.


 


“Representation
Date” shall have the meaning ascribed to such term in Section 4(k).


 


“Required
Approvals” shall have the meaning ascribed to such term in Section 3(e).


 






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“Rule 158”,
 “Rule 163”, “Rule 164”, “Rule 172”, “Rule 173”,
 “Rule 405”, “Rule 415”, “Rule 424”, “Rule 430B”
and “Rule 433” refer to such rules under the Act.


 


“Sales
Notice” shall have the meaning ascribed to such term in Section 2(b)(i).


 


“SEC Reports”
shall have the meaning ascribed to such term in Section 3(m).


 


“Settlement
Date” shall have the meaning ascribed to such term in Section 2(b)(vii).


 


“Subsidiary”
means any subsidiary of the Company and shall, where applicable, also include any direct or indirect subsidiary of the Company hereafter
formed or acquired.


 


“Terms
Agreement” shall have the meaning ascribed to such term in Section 2(a).


 


“Time of
Delivery” shall have the meaning ascribed to such term in Section 2(c).


 


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


 


“Trading
Market” means Nasdaq Capital Market.


 


2.                 
Sale and Delivery of Shares. The Company proposes to issue and sell through or to the Manager, as sales agent and/or principal,
from time to time during the term of this Agreement and on the terms set forth herein, up to the $15,000,000 of shares (the “Shares”)
of the Company’s common stock, $0.0001 par value per share (“Common Stock”), from time to time during the
term of this Agreement and on the terms set forth herein; provided, however, that in no event shall the Company issue
or sell through the Manager such number of Shares that (a) exceeds the number or dollar amount of shares of Common Stock registered on
the Registration Statement, pursuant to which the offering is being made, less the dollar amount of securities issued under the Registration
Statement prior to the date of this Agreement, (b) exceeds the number of authorized but unissued shares of Common Stock (less the number
of shares of Common Stock issuable upon exercise, conversion or exchange of any outstanding securities of the Company or otherwise reserved
from the Company’s authorized capital stock), or (c) would cause the Company or the offering of the Shares to not satisfy the eligibility
and transaction requirements for use of Form S-3, including, if applicable, General Instruction I.B.6 of Registration Statement on Form
S-3 (the lesser of (a), (b) and (c), the “Maximum Amount”).


 






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(a)              Appointment
of Manager as Selling Agent; Terms Agreement. For purposes of selling the Shares through the Manager, the Company hereby appoints
the Manager as exclusive agent of the Company for the purpose of selling the Shares of the Company pursuant to this Agreement and the
Manager agrees to use its commercially reasonable efforts to sell the Shares on the terms and subject to the conditions stated herein.
The Company agrees that, whenever it determines to sell the Shares directly to the Manager as principal, it will enter into a separate
agreement (each, a “Terms Agreement”) in substantially the form of Annex I hereto, relating to such sale in
accordance with Section 2 of this Agreement.


 


(b)              
Agent Sales. Subject to the terms and conditions and in reliance upon the representations and warranties herein set forth,
the Company will issue and agrees to sell Shares from time to time through the Manager, acting as sales agent, and the Manager agrees
to use its commercially reasonable efforts to sell, as sales agent for the Company, on the following terms:


 


(i)                
The Shares are to be sold on a daily basis or otherwise as shall be agreed to by the Company and the Manager on any day that (A) is
a Trading Day, (B) the Company has instructed the Manager by telephone (confirmed promptly by electronic mail) to make such sales
(“Sales Notice”) and (C) the Company has satisfied its obligations under Section 6 of this Agreement. The Company will
designate the maximum amount of the Shares to be sold by the Manager daily (subject to the limitations set forth in Section 2(d)) and
the minimum price per Share at which such Shares may be sold. Subject to the terms and conditions hereof, the Manager shall use its commercially
reasonable efforts to sell on a particular day all of the Shares designated for the sale by the Company on such day. The gross sales price
of the Shares sold under this Section 2(b) shall be the market price for the shares of Common Stock sold by the Manager under this
Section 2(b) on the Trading Market at the time of sale of such Shares.


 


(ii)             
The Company acknowledges and agrees that (A) there can be no assurance that the Manager will be successful in selling the
Shares, (B) the Manager will incur no liability or obligation to the Company or any other person or entity if it does not sell the
Shares for any reason other than a failure by the Manager to use its commercially reasonable efforts consistent with its normal trading
and sales practices and applicable law and regulations to sell such Shares as required under this Agreement, and (C) the Manager
shall be under no obligation to purchase Shares on a principal basis pursuant to this Agreement, except as otherwise specifically agreed
by the Manager and the Company pursuant to a Terms Agreement.


 






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(iii)           
The Company shall not authorize the issuance and sale of, and the Manager shall not be obligated to use its commercially reasonable
efforts to sell, any Share at a price lower than the minimum price therefor designated from time to time by the Company’s Board
of Directors (the “Board”), or a duly authorized committee thereof, or such duly authorized officers of the Company,
and notified to the Manager in writing. The Company or the Manager may, upon notice to the other party hereto by telephone (confirmed
promptly by electronic mail), suspend the offering of the Shares for any reason and at any time; provided, however, that
such suspension or termination shall not affect or impair the parties’ respective obligations with respect to the Shares sold hereunder
prior to the giving of such notice. While a suspension is in effect, any obligation
under Sections 4(k), 4(l) and 4(m) with respect to the delivery of certificates, opinions, or comfort letters to the Manager,
shall be waived.


 


(iv)            
The Manager may sell Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415
under the Act, including without limitation sales made directly on the Trading Market, on any other existing trading market for the Common
Stock or to or through a market maker. The Manager may also sell Shares in privately negotiated transactions, provided that the Manager
receives the Company’s prior written approval for any sales in privately negotiated transactions and if so provided in the “Plan
of Distribution” section of the Prospectus Supplement.


 


(v)             The
compensation to the Manager for sales of the Shares under this Section 2(b) shall be a placement fee of 3% of the gross sales price of
the Shares sold pursuant to this Section 2(b) (“Broker Fee”). The foregoing rate of compensation shall not apply when
the Manager acts as principal, in which case the Company may sell Shares to the Manager as principal at a price agreed upon at the relevant
Applicable Time pursuant to a Terms Agreement. The remaining proceeds, after deduction of the Broker Fee and deduction of any transaction
fees imposed by any clearing firm, execution broker, or governmental or self-regulatory organization in respect of such sales, shall
constitute the net proceeds to the Company for such Shares (the “Net Proceeds”).


 


(vi)           
The Manager shall provide written confirmation (which may be by facsimile or electronic mail) to the Company following the close
of trading on the Trading Market each day in which the Shares are sold under this Section 2(b) setting forth the number of the Shares
sold on such day, the aggregate gross sales proceeds and the Net Proceeds to the Company, and the compensation payable by the Company
to the Manager with respect to such sales.


 






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(vii)         
Settlement for sales of the Shares pursuant to this Section 3(a) will occur at 10:00 a.m. (Eastern Time), or at such
time as the Company and the Manager may mutually agree, on the second business day following the date on which such sales are made (each
such day, a “Settlement Date”). On or before the Trading Day prior to each Settlement Date, the Company will, or will
cause its transfer agent to, electronically transfer the Shares being sold by crediting the Manager’s or its designee’s account
(provided that the Manager shall have given the Company written notice of such designee at least one Trading Day prior to the Settlement
Date) at The Depository Trust Company (“DTC”) through its Deposit and Withdrawal at Custodian System or by such other
means of delivery as may be mutually agreed upon by the parties hereto which Shares in all cases shall be freely tradable, transferable,
registered shares in good deliverable form. On each Settlement Date, the Manager will deliver the related Net Proceeds in same day funds
to an account designated by the Company. The Company agrees that, if the Company, or its transfer agent (if applicable), defaults in its
obligation to deliver duly authorized Shares on a Settlement Date, in addition to and in no way limiting the rights and obligations set
forth in Section 7 hereto, the Company will (i) hold the Manager harmless against any loss, claim, damage, or reasonable, documented expense
(including reasonable and documented legal fees and expenses), as incurred, arising out of or in connection with such default by the Company,
and (ii) pay to the Manager any commission, discount or other compensation to which the Manager would otherwise have been entitled absent
such default.


 


(viii)       
At each Applicable Time, Settlement Date, Representation Date and Filing Date, the Company shall be deemed to have affirmed each
representation and warranty contained in this Agreement as if such representation and warranty were made as of such date, modified as
necessary to relate to the Registration Statement and the Prospectus as amended as of such date. Any obligation of the Manager to use
its commercially reasonable efforts to sell the Shares on behalf of the Company shall be subject to the continuing accuracy of the representations
and warranties of the Company herein, to the performance by the Company of its obligations hereunder and to the continuing satisfaction
of the additional conditions specified in Section 6 of this Agreement.


 


(ix)         
If the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders
of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or
other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement
or other similar transaction) (a “Distribution” and the record date for the determination of stockholders entitled
to receive the Distribution, the “Record Date”), the Company hereby covenants that, in connection with any sales of
Shares pursuant to a Sales Notice on the Record Date, the Company covenants and agrees that the Company shall issue and deliver such Shares
to the Manager on the Record Date and the Record Date shall be the Settlement Date and the Company shall cover any additional costs of
the Manager in connection with the delivery of Shares on the Record Date.


 






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(c)              
Term Sales. If the Company wishes to sell the Shares pursuant to this Agreement but other than as set forth in Section 2(b)
of this Agreement (each, a “Placement”), the Company will notify the Manager of the proposed terms of such Placement.
If the Manager, acting as principal, wishes to accept such proposed terms (which it may decline to do for any reason in its sole discretion)
or, following discussions with the Company wishes to accept amended terms, the Manager and the Company will enter into a Terms Agreement
setting forth the terms of such Placement. The terms set forth in a Terms Agreement will not be binding on the Company or the Manager
unless and until the Company and the Manager have each executed such Terms Agreement accepting all of the terms of such Terms Agreement.
In the event of a conflict between the terms of this Agreement and the terms of a Terms Agreement, the terms of such Terms Agreement will
control. A Terms Agreement may also specify certain provisions relating to the reoffering of such Shares by the Manager. The commitment
of the Manager to purchase the Shares pursuant to any Terms Agreement shall be deemed to have been made on the basis of the representations
and warranties of the Company herein contained and shall be subject to the terms and conditions herein set forth. Each Terms Agreement
shall specify the number of the Shares to be purchased by the Manager pursuant thereto, the price to be paid to the Company for such Shares,
any provisions relating to rights of, and default by, underwriters acting together with the Manager in the reoffering of the Shares, and
the time and date (each such time and date being referred to herein as a “Time of Delivery”) and place of delivery
of and payment for such Shares. Such Terms Agreement shall also specify any requirements for opinions of counsel, accountants’ letters
and officers’ certificates pursuant to Section 6 of this Agreement and any other information or documents required by the Manager.


 


(d)              
Maximum Number of Shares. Under no circumstances shall the Company cause or request the offer or sale of any Shares if,
after giving effect to the sale of such Shares, the aggregate amount of Shares sold pursuant to this Agreement would exceed the lesser
of (A) together with all sales of Shares under this Agreement, the Maximum Amount, (B) the amount available for offer and sale under the
currently effective Registration Statement and (C) the amount authorized from time to time to be issued and sold under this Agreement
by the Board, a duly authorized committee thereof or a duly authorized executive committee, and notified to the Manager in writing. Under
no circumstances shall the Company cause or request the offer or sale of any Shares pursuant to this Agreement at a price lower than the
minimum price authorized from time to time by the Board, a duly authorized committee thereof or a duly authorized executive officer, and
notified to the Manager in writing. Further, under no circumstances shall the Company cause or permit the aggregate offering amount of
Shares sold pursuant to this Agreement to exceed the Maximum Amount.


 






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(e)              
Regulation M Notice. Unless the exceptive provisions set forth in Rule 101(c)(1) of Regulation M under the Exchange
Act are satisfied with respect to the Shares, the Company shall give the Manager at least one Business Day’s prior notice of its
intent to sell any Shares in order to allow the Manager time to comply with Regulation M.


 


3.                 
Representations and Warranties. The Company represents and warrants to, and agrees with, the Manager at the Execution Time
and on each such time the following representations and warranties are repeated or deemed to be made pursuant to this Agreement, as set
forth below or in the Registration Statement, the Prospectus or the Incorporated Documents.


 


(a)                
Subsidiaries. The Company has no direct or indirect subsidiaries other than Napo Pharmaceuticals, Inc. (“Napo Pharma”),
SPL Operaciones Botanicos Peruanos S.R.L., SPL South America One LLC, Napo EU S.p.A. (“Napo EU”), and Amazonian Region Botanical
Products LLC (each a “Subsidiary,” and collectively, the “Subsidiaries”). Except for Napo EU, for which Napo Pharma
owns a majority of the capital stock, 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.


 


(b)              
Organization and Qualification. The Company 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. The Company is not in violation of any of the provisions
of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. The Company is 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, would not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or
enforceability of this Agreement, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition
(financial or otherwise) of the Company or (iii) a material adverse effect on the Company’s ability to perform in any material respect
on a timely basis its obligations under this Agreement (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 and Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate
the transactions contemplated by this Agreement and otherwise to carry out its obligations hereunder. The execution and delivery of this
Agreement by the Company and the consummation by it of the transactions contemplated hereby 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 or its stockholders in connection herewith
other than in connection with the Required Approvals. This Agreement has been duly executed and delivered by the Company and constitutes
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 of this Agreement by the Company, the issuance and sale of the Shares
and the consummation by the Company of the other transactions contemplated herein do not and will not (i) conflict with or violate any
provision of the Company’s certificate 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 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 debt or otherwise) or other understanding to which the Company is a party or by which any
property or asset of the Company 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 is subject (including federal and state securities laws and regulations), or by which any property or asset of the Company
is bound or affected, except in the case of each of clauses (ii) and (iii), such as could 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” (defined as 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, including
the Trading Market) in connection with the execution, delivery and performance by the Company of this Agreement, other than (i) the filings
required by this Agreement, (ii) the filing with the Commission of the Prospectus Supplement, (iii) the filing of application(s) to and
approval by the Trading Market for the listing of the 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 and the rules and regulations of the Financial Industry Regulatory
Authority, Inc. (“FINRA”) (collectively, the “Required Approvals”).


 






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(f)               
Issuance of Shares. The Shares are duly authorized and, when issued and paid for in accordance with this Agreement, will
be duly and 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. The issuance
by the Company of the Shares has been registered under the Act and all of the Shares are freely transferable and tradable by the purchasers
thereof without restriction (other than any restrictions arising solely from an act or omission of such a purchaser). The Shares are being
issued pursuant to the Registration Statement and the issuance of the Shares has been registered by the Company under the Act. The “Plan
of Distribution” section within the Registration Statement permits the issuance and sale of the Shares as contemplated by this
Agreement. Upon receipt of the Shares, the purchasers of such Shares will have good and marketable title to such Shares and the Shares
will be freely tradable on the Trading Market.


 


(g)              
Capitalization. The capitalization of the Company is as set forth in the Registration Statement, the Base Prospectus, the
Prospectus Supplement and the Prospectus. Except as set forth in the SEC Reports, 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 plan and
pursuant to the conversion or exercise of securities exercisable, exchangeable or convertible into Common Stock (“Common Stock
Equivalents”). No Person has any right of first refusal, preemptive right, right of participation, or any similar right to participate
in the transactions contemplated by this Agreement, except for such rights described in Section 3(e)(iv). Except (i) pursuant to the Company’s
stock option plans and (ii) pursuant to agreements or instruments filed as exhibits to Incorporated Documents, there are no outstanding
options, warrants, script 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 contracts, commitments, understandings or arrangements by which the Company is or may become bound to issue additional
shares of Common Stock or Common Stock Equivalents. The issuance and sale of the Shares will not obligate the Company to issue shares
of Common Stock or other securities to any Person. There are no outstanding securities or instruments of the Company 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.
All of the outstanding shares of capital stock of the Company are 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. There are no stockholders 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)               
Registration Statement. The Company meets the requirements for use of Form S-3 under the Act and has prepared and filed
with the Commission the Registration Statement, including a related Base Prospectus, for registration under the Act of the offering and
sale of the Shares. Such Registration Statement is effective and available for the offer and sale of the Shares as of the date hereof.
As filed, the Base Prospectus contains all information required by the Act and the rules thereunder, and, except to the extent the Manager
shall agree in writing to a modification, shall be in all substantive respects in the form furnished to the Manager prior to the Execution
Time or prior to any such time this representation is repeated or deemed to be made. The Registration Statement, at the Execution Time,
each such time this representation is repeated or deemed to be made, and at all times during which a prospectus is required by the Act
to be delivered (whether physically or through compliance with Rule 172, 173 or any similar rule) in connection with any offer or
sale of the Shares, meets the requirements set forth in Rule 415(a)(1)(x). The initial Effective Date of the Registration Statement
was not earlier than the date three years before the Execution Time. The Company meets the transaction requirements with respect to the
aggregate market value of securities being sold pursuant to this offering and during the twelve (12) months prior to this offering, as
set forth in General Instruction I.B.6 of Form S-3.


 


(i)                
Accuracy of Incorporated Documents. The Incorporated Documents, when they were filed with the Commission, conformed in all
material respects to the requirements of the Exchange Act and the rules thereunder, and none of the Incorporated Documents, when they
were filed with the Commission, contained any untrue statement of a material fact or omitted to state a material fact necessary to make
the statements therein, in light of the circumstances under which they were made not misleading; and any further documents so filed and
incorporated by reference in the Registration Statement, the Base Prospectus, the Prospectus Supplement or the Prospectus, when such documents
are filed with the Commission, will conform in all material respects to the requirements of the Exchange Act and the rules thereunder,
as applicable, and will not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
therein, in light of the circumstances under which they were made, not misleading.


 


(j)                
Ineligible Issuer. (i) At the earliest time after the filing of the Registration Statement that the Company or another
offering participant made a bona fide offer (within the meaning of Rule 164(h)(2)) of the Shares and (ii) as of the Execution
Time and on each such time this representation is repeated or deemed to be made (with such date being used as the determination date for
purposes of this clause (ii)), the Company was not and is not an Ineligible Issuer (as defined in Rule 405), without taking
account of any determination by the Commission pursuant to Rule 405 that it is not necessary that the Company be considered an Ineligible
Issuer.


 






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(k)              
Free Writing Prospectus. The Company is eligible to use Issuer Free Writing Prospectuses. Each Issuer Free Writing Prospectus
does not include any information the substance of which conflicts with the information contained in the Registration Statement, including
any Incorporated Documents and any prospectus supplement deemed to be a part thereof that has not been superseded or modified; and each
Issuer Free Writing Prospectus does not contain any untrue statement of a material fact or omit to state any material fact necessary in
order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The foregoing sentence
does not apply to statements in or omissions from any Issuer Free Writing Prospectus based upon and in conformity with written information
furnished to the Company by the Manager specifically for use therein. Any Issuer Free Writing Prospectus that the Company is required
to file pursuant to Rule 433(d) has been, or will be, filed with the Commission in accordance with the requirements of the Act and the
rules thereunder. Each Issuer Free Writing Prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) or that
was prepared by or behalf of or used by the Company complies or will comply in all material respects with the requirements of the Act
and the rules thereunder. The Company will not, without the prior consent of the Manager, prepare, use or refer to, any Issuer Free Writing
Prospectuses.


 


(l)                
Proceedings Related to Registration Statement. The Registration Statement is not the subject of a pending proceeding or
examination under Section 8(d) or 8(e) of the Act, and the Company is not the subject of a pending proceeding under Section 8A
of the Act in connection with the offering of the Shares. The Company has not received any notice that the Commission has issued or intends
to issue a stop-order with respect to the Registration Statement or that the Commission otherwise has suspended or withdrawn the effectiveness
of the Registration Statement, either temporarily or permanently, or intends or has threatened in writing to do so.


 






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(m)            
SEC Reports. The Company has complied in all material respects with requirements to file all reports, schedules, forms,
statements and other documents required to be filed by it under the 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 to file such material)
(the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, 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 Act and the Exchange Act, as applicable, and none of the SEC Reports, when filed, included
an 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 agreements and documents described
in the Registration Statement, the Prospectus, the Prospectus Supplement and the SEC Reports conform to the descriptions thereof contained
therein and there are no agreements or other documents required by the Securities Act and the rules and regulations thereunder to be described
in the Registration Statement, the Prospectus, the Prospectus Supplement or the SEC Reports or to be filed with the Commission as exhibits
to the Registration Statement, that have not been so described or filed. Each agreement or other instrument (however characterized or
described) to which the Company is a party or by which it is or may be bound or affected and (i) that is referred to in the Registration
Statement, the Prospectus, the Prospectus Supplement or the SEC Reports, or (ii) is material to the Company’s business, has
been duly authorized and validly executed by the Company, is in full force and effect in all material respects and is enforceable against
the Company and, to the Company’s knowledge, the other parties thereto, in accordance with its terms, except (x) as such enforceability
maybe limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors’ rights generally, (y) as enforceability
of any indemnification or contribution provision may be limited under the federal and state securities laws, and (z) that the remedy
of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion
of the court before which any proceeding therefore may be brought. None of such agreements or instruments has been assigned by the Company,
and neither the Company nor, to the best of the Company’s knowledge, any other party is in default thereunder and, to the best of
the Company’s knowledge, no event has occurred that, with the lapse of time or the giving of notice, or both, would constitute a
default thereunder. To the best of the Company’s knowledge, performance by the Company of the material provisions of such agreements
or instruments will not result in a violation of any existing applicable law, rule, regulation, judgment, order or decree of any governmental
agency or court, domestic or foreign, having jurisdiction over the Company or any of its assets or businesses, including, without limitation,
those relating to environmental laws and regulations.


 


(n)              
Financial Statements. The consolidated financial statements incorporated by reference in the Registration Statement, the
Prospectus or the Incorporated Documents and any amendments thereof or supplements thereto 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 or as
amended or corrected in a subsequent 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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(o)              
Accountants. The Company’s accountants are RBSM LLP. To the knowledge of the Company, such accountants, which the
Company expects will express their opinion with respect to the financial statements to be included in the Company’s next Annual
Report on Form 10-K, are a registered public accounting firm as required by the Act.


 


(p)              
Material Adverse Events. Since the date of the latest audited financial statements included within the SEC Reports, except
as specifically disclosed in a subsequent SEC Report filed prior to the date hereof, (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 required
to be 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” (defined as 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 144 under the Act), except
pursuant to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential
treatment of information. No event, liability or development has occurred or exists with respect to the Company or its business, properties,
operations or financial condition, that would be required to be disclosed by the Company under applicable securities laws at the time
this representation is deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation
is deemed made. Unless otherwise disclosed in a SEC Report filed prior to the date hereof, the Company has not: (i) issued any securities
or incurred any liability or obligation, direct or contingent, for borrowed money; or (ii) declared or paid any dividend or made any other
distribution on or in respect to its capital stock.


 


(q)             
Litigation. 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 or any of its properties before or by any court, arbitrator, governmental
or administrative agency or regulatory authority (federal, state, county, local or foreign) (collectively, an “Action”)
which (i) adversely affects or challenges the legality, validity or enforceability of this Agreement or the Shares or (ii) could, if there
were an unfavorable decision, reasonably be expected to result in a Material Adverse Effect. Neither the Company, nor, to the knowledge
of the Company, 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 under the Exchange Act or the Act.


 






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(r)               
Labor Relations. No material 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 employees
is a member of a union that relates to such employee’s relationship with the Company, the Company is not a party to a collective
bargaining agreement, and the Company believe that their relationships with their employees are good. No executive officer, to the knowledge
of the Company, 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, and
the continued employment of each such executive officer does not subject the Company to any liability with respect to any of the foregoing
matters. The Company is 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.


 


(s)               
No Existing Defaults. The Company (i) is not 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), nor has the Company 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 not in violation of any order of any court, arbitrator or governmental body, or (iii) is not or has been in violation
of any statute, rule 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 reasonably be expected to result in a Material Adverse Effect.


 


(t)                Regulatory
Permits. The Company 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 Registration Statement, the Base Prospectus,
any Prospectus Supplement or the Prospectus, except where the failure to possess such permits could not reasonably be expected to result
in a Material Adverse Effect (“Material Permits”), and the Company has not received any notice of proceedings relating
to the revocation or modification of any Material Permit. For clarity, the Company has not received the approval of any regulatory agency
to market any of its product candidates.


 






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(u)              
Title to Assets. The Company does not own any real property. The Company has good and marketable title in all personal property
owned by them that is material to the business of the Company, free and clear of all Liens, except for 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
Liens for the payment of federal, state or other taxes, the payment of which is neither delinquent nor subject to penalties. Any real
property and facilities held under lease by the Company are held by them under valid, subsisting and enforceable leases of which the Company
are in compliance, except where such non-compliance would not reasonably be expected to have a Material Adverse Effect.


 


(v)              
Intellectual Property. The Company has, or has 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
necessary for use in connection with its business as described in the SEC Reports and for which the failure to have such rights would
have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). The Company has not 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, except for Intellectual Property Rights that are within
two years of the end of their term and, or the abandonment of which, would not reasonably be expected to have a Material Adverse Effect.
The Company has not 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 would 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 has taken reasonable security measures to protect the secrecy, confidentiality and value of all of its intellectual property,
except where failure to do so would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.


 


(w)            
Insurance. The Company is insured by insurers of recognized financial responsibility against such losses and risks and in
such amounts as are prudent and customary in the business in which the Company is engaged, including, but not limited to, directors and
officers insurance coverage. The Company has no 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.


 






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(x)              Affiliate
Transactions. Except as set forth in the Registration Statement, the Base Prospectus, any Prospectus Supplement or the Prospectus,
none of the officers or directors of the Company and, to the knowledge of the Company, none of the employees of the Company is presently
a party to any transaction with the Company (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,
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 or partner, in each
case in excess of $120,000, other than (i) for payment of salary or consulting fees for services rendered, (ii) reimbursement for expenses
incurred on behalf of the Company and (iii) for other employee benefits, including stock option agreements under any stock option plan
of the Company.


 


(y)            
Sarbanes Oxley Compliance. The Company is in material compliance with all provisions of the Sarbanes-Oxley Act of 2002 which
are applicable to it as of the Effective Date and the date hereof. The Company maintains 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 has established disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) for the Company 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 Company’s disclosure controls and procedures as of the end of the period covered by the Company’s 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 Company’s
internal control over financial reporting (as such term is defined in the Exchange Act) that has materially affected, or is reasonably
likely to materially affect, the Company’s and its Subsidiaries’ internal control over financial reporting.


 






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(z)           
Finder’s Fees. Other than payments to be made to the Manager, no brokerage or finder’s fees or commissions are
or will be payable by the Company to any broker, financial advisor or consultant, finder, placement agent, investment banker, bank or
other Person with respect to the transactions contemplated by this Agreement. The Manager 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 this Agreement.


 


(aa)           
No Other Sales Agency Agreement. The Company has not entered into any other sales agency agreements or other similar arrangements
with any agent or any other representative in respect of at the market offerings of the Shares.


 


(bb)          
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 Shares, (ii) sold, bid for, purchased, or paid any compensation for soliciting purchases
of, any of the Shares 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 Manager in connection with the placement of
the Shares.


 


(cc)           
Listing and Maintenance Requirements. The issuance and sale of the Shares as contemplated in this Agreement does not contravene
the rules and regulations of the Trading Market. 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. Except as disclosed in the Registration Statement, the Base Prospectus, any Prospectus Supplement or the Prospectus,
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 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 of the Depository Trust Company (or such other established clearing corporation) in connection with such electronic
transfer.


 






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(dd)          
Application of Takeover Protections. Except as set forth in the Registration Statement, the Base Prospectus, any Prospectus
Supplement or the Prospectus, the Company and its Board 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 of the Shares.


 


(ee)           
Investment Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for the Shares,
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 currently intends to conduct its business in a manner so that it will not become subject to the Investment Company Act of
1940, as amended.


 


(ff)             
Solvency. Based on the financial condition of the Company as of the Effective Date and the date hereof, (i) the Company’s
fair saleable value of its 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, 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 debt when such amounts are required to be paid. Within one year of the date hereof, 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 SEC Reports set forth as of the dates thereof all outstanding secured and unsecured Indebtedness of the Company or for
which the Company has commitments. For the purposes of this Agreement, “Indebtedness” shall mean (a) any liabilities
for borrowed money or amounts owed in excess of $50,000 (other than accrued liabilities and trade accounts payable incurred in the ordinary
course of business), (b) 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 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 (c) the present value
of any lease payments in excess of $50,000 due under leases required to be capitalized in accordance with GAAP. The Company is not in
default with respect to any Indebtedness.


 






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(gg)          
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 (i) has made or filed all necessary United States federal, and state income and all foreign
income and franchise tax returns and have paid or accrued all taxes shown as due thereon, and the Company has no knowledge of a tax deficiency
which has been asserted or threatened against the Company or any report and declaration 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 know of no basis for any such claim.
The provisions for taxes payable, if any, shown on the financial statements filed with or as part of the Registration Statement are sufficient
for all accrued and unpaid taxes, whether or not disputed, and for all periods to and including the dates of such consolidated financial
statements. The term “taxes” mean all federal, state, local, foreign, and other net income, gross income, gross receipts,
sales, use, ad valorem, transfer, franchise, profits, license, lease, service, service use, withholding, payroll, employment, excise,
severance, stamp, occupation, premium, property, windfall profits, customs, duties or other taxes, fees, assessments, or charges of any
kind whatsoever, together with any interest and any penalties, additions to tax, or additional amounts with respect thereto. The term
 “returns” means all returns, declarations, reports, statements, and other documents required to be filed in respect to taxes.


 


(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 (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 as otherwise disclosed in the SEC Reports and 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, and the Company has not received any written notice, warning letter or other communication from the FDA or any other
governmental entity, except as disclosed in the SEC Reports, which (i) contests the 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, (iv) enjoins production at any facility of the Company, (v) enters or proposes to enter into a consent decree of permanent
injunction with the Company, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company, 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)             
Foreign Corrupt Practices. Neither the Company, nor to the knowledge of the Company, any agent or other person acting on
behalf of the Company, 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 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 the Foreign Corrupt Practices Act of 1977, as amended.


 


(jj)             
Environmental Laws.    The Company and its 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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(kk)          
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.


 


(ll)             
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”).


 


(mm)         
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 the Manager’s
request.


 


(nn)          
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 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.


 


(oo)          
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.


 


(pp)          
FINRA Member Shareholders. There are no affiliations with any FINRA member firm among the Company’s officers, directors
or, to the knowledge of the Company, any five percent (5%) or greater stockholder of the Company, except as set forth in the Registration
Statement, the Base Prospectus, any Prospectus Supplement or the Prospectus.


 






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4.             
Agreements. The Company agrees with the Manager that:


 


(a)              
Right to Review Amendments and Supplements to Registration Statement and Prospectus. During any period when the delivery
of a prospectus relating to the Shares is required (including in circumstances where such requirement may be satisfied pursuant to Rule 172,
173 or any similar rule) to be delivered under the Act in connection with the offering or the sale of Shares, the Company will not file
any amendment to the Registration Statement or supplement (including any Prospectus Supplement) to the Base Prospectus unless the Company
has furnished to the Manager a copy for its review prior to filing and will not file any such proposed amendment or supplement to which
the Manager reasonably objects. The Company has properly completed the Prospectus, in a form approved by the Manager, and filed such Prospectus,
as amended at the Execution Time, with the Commission pursuant to the applicable paragraph of Rule 424(b) by the Execution Time and
will cause any supplement to the Prospectus to be properly completed, in a form approved by the Manager, and will file such supplement
with the Commission pursuant to the applicable paragraph of Rule 424(b) within the time period prescribed thereby and will provide
evidence reasonably satisfactory to the Manager of such timely filing. The Company will promptly advise the Manager (i) when the
Prospectus, and any supplement thereto, shall have been filed (if required) with the Commission pursuant to Rule 424(b), (ii) when,
during any period when the delivery of a prospectus (whether physically or through compliance with Rule 172, 173 or any similar rule)
is required under the Act in connection with the offering or sale of the Shares, any amendment to the Registration Statement shall have
been filed or become effective (other than any annual report of the Company filed pursuant to Section 13(a) or 15(d) of the Exchange Act),
(iii) of any request by the Commission or its staff for any amendment of the Registration Statement, or any Rule 462(b) Registration
Statement, or for any supplement to the Prospectus or for any additional information, (iv) of the issuance by the Commission of any
stop order suspending the effectiveness of the Registration Statement or of any notice objecting to its use or the institution or threatening
of any proceeding for that purpose and (v) of the receipt by the Company of any notification with respect to the suspension of the
qualification of the Shares for sale in any jurisdiction or the institution or threatening of any proceeding for such purpose. The Company
will use commercially reasonable efforts to prevent the issuance of any such stop order or the occurrence of any such suspension or objection
to the use of the Registration Statement and, upon such issuance, occurrence or notice of objection, to obtain as soon as possible the
withdrawal of such stop order or relief from such occurrence or objection, including, if necessary, by filing an amendment to the Registration
Statement or a new registration statement and using commercially reasonable efforts to have such amendment or new registration statement
declared effective as soon as practicable.


 






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(b)              
Subsequent Events. If, at any time on or after an Applicable Time but prior to the related Settlement Date, any event occurs
as a result of which the Registration Statement or Prospectus would include any untrue statement of a material fact or omit to state any
material fact necessary to make the statements therein in the light of the circumstances under which they were made or the circumstances
then prevailing not misleading, the Company will (i) notify promptly the Manager so that any use of the Registration Statement or
Prospectus may cease until such are amended or supplemented; (ii) amend or supplement the Registration Statement or Prospectus to
correct such statement or omission; and (iii) supply any amendment or supplement to the Manager in such quantities as the Manager
may reasonably request.


 


(c)              
Notification of Subsequent Filings. During any period when the delivery of a prospectus relating to the Shares is required
(including in circumstances where such requirement may be satisfied pursuant to Rule 172, 173 or any similar rule) to be delivered
under the Act, any event occurs as a result of which the Prospectus as then supplemented would include any untrue statement of a material
fact or omit to state any material fact necessary to make the statements therein in the light of the circumstances under which they were
made not misleading, or if it shall be necessary to amend the Registration Statement, file a new registration statement or supplement
the Prospectus to comply with the Act or the Exchange Act or the respective rules thereunder, including in connection with use or delivery
of the Prospectus, the Company promptly will (i) notify the Manager of any such event, (ii) subject to Section 4(a), prepare
and file with the Commission an amendment or supplement or new registration statement which will correct such statement or omission or
effect such compliance, (iii) use commercially reasonable efforts to have any amendment to the Registration Statement or new registration
statement declared effective as soon as practicable in order to avoid any disruption in use of the Prospectus and (iv) supply any
supplemented Prospectus to the Manager in such quantities as the Manager may reasonably request.


 


(d)              
Earnings Statements. As soon as practicable, the Company will make generally available to its security holders and to the
Manager an earnings statement or statements of the Company and its Subsidiaries which will satisfy the provisions of Section 11(a)
of the Act and Rule 158.


 


(e)              
Delivery of Registration Statement. Upon the request of the Manager, the Company will furnish to the Manager and counsel
for the Manager, without charge, signed copies of the Registration Statement (including exhibits thereto) and, so long as delivery of
a prospectus by the Manager or dealer may be required by the Act (including in circumstances where such requirement may be satisfied pursuant
to Rule 172, 173 or any similar rule), as many copies of the Prospectus and each Issuer Free Writing Prospectus and any supplement
thereto as the Manager may reasonably request. The Company will pay the expenses of printing or other production of all documents relating
to the offering.


 






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(f)               
Qualification of Shares. The Company will arrange, if necessary, for the qualification of the Shares for sale under the
laws of such jurisdictions as the Manager may designate and will maintain such qualifications in effect so long as required for the distribution
of the Shares; provided that in no event shall the Company be obligated to qualify to do business in any jurisdiction where it is not
now so qualified or to take any action that would subject it to service of process in suits, other than those arising out of the offering
or sale of the Shares, in any jurisdiction where it is not now so subject.


 


(g)              
Free Writing Prospectus. The Company agrees that, unless it has or shall have obtained the prior written consent of the
Manager, and the Manager agrees with the Company that, unless it has or shall have obtained, as the case may be, the prior written consent
of the Company, it has not made and will not make any offer relating to the Shares that would constitute an Issuer Free Writing Prospectus
or that would otherwise constitute a “free writing prospectus” (as defined in Rule 405) required to be filed by the Company
with the Commission or retained by the Company under Rule 433. Any such free writing prospectus consented to by the Manager or the
Company is hereinafter referred to as a “Permitted Free Writing Prospectus.” The Company agrees that (i) it has
treated and will treat, as the case may be, each Permitted Free Writing Prospectus as an Issuer Free Writing Prospectus and (ii) it
has complied and will comply, as the case may be, with the requirements of Rules 164 and 433 applicable to any Permitted Free Writing
Prospectus, including in respect of timely filing with the Commission, legending and record keeping.


 


(h)              
Subsequent Equity Issuances. Neither the Company nor any Subsidiary will offer, sell, issue, contract to sell, contract
to issue or otherwise dispose of, directly or indirectly, any other shares of Common Stock or any Common Stock Equivalents (other than
the Shares) during the term of this Agreement without the prior written consent of the Manager (i) without giving the Manager at
least three Business Days’ prior written notice specifying the nature of the proposed transaction and the date of such proposed
transaction and (ii) unless the Manager suspends acting under this Agreement for such period of time requested by the Company or
as deemed appropriate by the Manager in light of the proposed transaction; provided, however, that (i) the Company may issue
and sell Common Stock pursuant to any employee stock option plan, stock ownership plan or dividend reinvestment plan of the Company in
effect at the Execution Time, and (ii) the Company may offer and sell shares of Common Stock or any Common Stock Equivalents in a privately
negotiated transaction to vendors, service providers, strategic partners or potential strategic partners which are not issued for capital
raising purposes and which are conducted in a manner so as not to be integrated with the offering of Shares hereby, and (iii) with as
much notice as reasonably practicable, the Company may issue Common Stock issuable upon the conversion or exercise of Common Stock Equivalents
outstanding; and provided, further, that the Company may issue shares of Common Stock or any Common Stock Equivalents pursuant
to Section 3(a)(9) of the Act, so long as, prior to delivering any Sales Notice, they file a Current Report on Form 8-K for any material
issuances pursuant to Section 3(a)(9) that are required to be disclosed.


 






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(i)                Market
Manipulation. Until the termination of this Agreement, the Company will not take, directly or indirectly, any action designed to
or that would constitute or that might reasonably be expected to cause or result in, under the Exchange Act or otherwise, stabilization
or manipulation in violation of the Act, Exchange Act or the rules and regulations thereunder of the price of any security of the Company
to facilitate the sale or resale of the Shares or otherwise violate any provision of Regulation M under the Exchange Act.


 


(j)                
Notification of Incorrect Certificate. The Company will, at any time during the term of this Agreement, as supplemented
from time to time, advise the Manager immediately after it shall have received notice or obtained knowledge thereof, of any information
or fact that would alter or affect any opinion, certificate, letter and other document provided to the Manager pursuant to Section 6
herein.


 


(k)              
Certification of Accuracy of Disclosure. Upon commencement of the offering of the Shares under this Agreement (and upon
the recommencement of the offering of the Shares under this Agreement following the termination of a suspension of sales hereunder lasting
more than 30 Trading Days), and each time that (i) the Registration Statement or Prospectus shall be amended or supplemented, other than
by means of Incorporated Documents, (ii) the Company files its Annual Report on Form 10-K under the Exchange Act, (iii) the Company files
its quarterly reports on Form 10-Q under the Exchange Act, (iv) the Company files a Current Report on Form 8-K containing amended financial
information (other than information that is furnished and not filed), if the Manager reasonably determines that the information in such
Form 8-K is material, or (v) the Shares are delivered to the Manager as principal at the Time of Delivery pursuant to a Terms Agreement
(such commencement or recommencement date and each such date referred to in (i), (ii), (iii), (iv) and (v) above, a “Representation
Date”), unless waived by the Manager, the Company shall furnish or cause to be furnished to the Manager forthwith a certificate
dated and delivered on the Representation Date, in form reasonably satisfactory to the Manager to the effect that the statements contained
in the certificate referred to in Section 6 of this Agreement which were last furnished to the Manager are true and correct at the Representation
Date, as though made at and as of such date (except that such statements shall be deemed to relate to the Registration Statement and the
Prospectus as amended and supplemented to such date) or, in lieu of such certificate, a certificate of the same tenor as the certificate
referred to in said Section 6, modified as necessary to relate to the Registration Statement and the Prospectus as amended and supplemented
to the date of delivery of such certificate. The requirement to provide a certificate under this Section 4(k) shall be waived
for any Representation Date occurring at a time at which no Sales Notice is pending, which waiver shall continue until the earlier to
occur of the date the Company delivers a Sales Notice hereunder (which for such calendar quarter shall be considered a Representation
Date) and the next occurring Representation Date; provided, however, that such waiver shall not apply for any
Representation Date on which the Company files its Annual Report on Form 10-K. Notwithstanding the foregoing, if the Company subsequently
decides to sell Shares following a Representation Date when the Company relied on such waiver and did not provide the Manager with a certificate
under this Section 4(k), then before the Company delivers the Sales Notice or the Manager sells any Shares, the Company shall provide
the Manager with a certificate dated the date of the Sales Notice.


 






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(l)                
Legal Opinions; Negative Assurance. At each Representation Date, unless waived by the Manager, the Company shall furnish
or cause to be furnished forthwith to the Manager and to counsel to the Manager a written opinion of counsel to the Company (“Company
Counsel”) addressed to the Manager and in form and substance reasonably satisfactory to the Manager, including a negative assurance
representation; provided, however, that if the Company Counsel
has previously furnished to the Manager such written opinion and negative assurance of such counsel substantially in the form previously
agreed between the Company and the Manager, then the Company Counsel may, in respect of any future Representation Date, furnish the Manager
with a letter signed by such counsel (each, a “Reliance Letter”) in lieu of such opinion and negative assurance of
such counsel to the effect that the Manager may rely on the prior opinion and negative assurance of such counsel delivered pursuant to
this Section 4(l) to the same extent as if it were dated the date of such Reliance Letter (except that statements in such prior opinion
and negative assurance shall be deemed to relate to the Registration Statement and the Prospectus as amended or supplemented to the date
of such Reliance Letter).


 


(m)                          Auditor
 “Comfort” Letter. At each Representation Date, unless waived by the Manager, the Company shall cause (1) the Company’s
auditors (the “Accountants”), or other independent accountants satisfactory to the Manager forthwith to furnish the
Manager a letter, and (2) the Chief Financial Officer of the Company forthwith to furnish the Manager a certificate, in each case
dated on such Representation Date, in form satisfactory to the Manager, of the same tenor as the letters and certificate referred to
in Section 6 of this Agreement but modified to relate to the Registration Statement and the Prospectus, as amended and supplemented to
the date of such letters and certificate.


 


(n)                          Due
Diligence Session. Upon commencement of the offering of the Shares under this Agreement (and upon the recommencement of the offering
of the Shares under this Agreement following the termination of a suspension of sales hereunder lasting more than 30 Trading Days), and
at each Representation Date, the Company will, upon the Manager’s reasonable request, conduct a due diligence session, in form
and substance, reasonably satisfactory to the Manager, which shall include representatives of management and Accountants. The Company
shall cooperate timely with any reasonable due diligence request from or review conducted by the Manager or its agents from time to time
in connection with the transactions contemplated by this Agreement, including, without limitation, providing information and available
documents and access to appropriate corporate officers and the Company’s agents during regular business hours, and timely furnishing
or causing to be furnished such certificates, letters and opinions from the Company, its officers and its agents, as the Manager may
reasonably request. The Company shall reimburse the Manager for Manager’s counsel’s time in each such due diligence update
session, up to a maximum of $3,000 per update, plus any incidental expense incurred by the Manager in connection therewith.


 






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(o)                          
Acknowledgment of Trading. The Company consents to the Manager trading in the Common Stock for the Manager’s own account
and for the account of its clients at the same time as sales of the Shares occur pursuant to this Agreement or pursuant to a Terms Agreement.


 


(p)                          Disclosure
of Shares Sold. The Company will disclose in its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, as applicable,
the number of Shares sold through the Manager under this Agreement, the Net Proceeds to the Company and the compensation paid by the
Company with respect to sales of Shares pursuant to this Agreement during the relevant quarter; and, if required by any subsequent change
in Commission policy or request, more frequently by means of a Current Report on Form 8-K or a further Prospectus Supplement.


 


(q)                          
Rescission Right. If to the knowledge of the Company, the conditions set forth in Section 6 shall not have been satisfied
as of the applicable Settlement Date, the Company will offer to any person who has agreed to purchase Shares from the Company as the result
of an offer to purchase solicited by the Manager the right to refuse to purchase and pay for such Shares.


 


(r)                         Bring
Down of Representations and Warranties. Each acceptance by the Company of an offer to purchase the Shares hereunder, and each execution
and delivery by the Company of a Terms Agreement, shall be deemed to be an affirmation to the Manager that the representations and warranties
of the Company contained in or made pursuant to this Agreement are true and correct as of the date of such acceptance or of such Terms
Agreement as though made at and as of such date, and an undertaking that such representations and warranties will be true and correct
as of the Settlement Date for the Shares relating to such acceptance or as of the Time of Delivery relating to such sale, as the case
may be, as though made at and as of such date (except that such representations and warranties shall be deemed to relate to the Registration
Statement and the Prospectus as amended and supplemented relating to such Shares).


 






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(s)                    Reservation of Shares. The Company shall ensure that there are at all times sufficient shares of Common Stock to provide
for the issuance, free of any preemptive rights, out of its authorized but unissued shares of Common Stock or shares of Common Stock held
in treasury, of the maximum aggregate number of Shares authorized for issuance by the Board pursuant to the terms of this Agreement. The
Company will use its commercially reasonable efforts to cause the Shares to be listed for trading on the Trading Market and to maintain
such listing.


 


(t)                    Obligation
Under Exchange Act. During any period when the delivery of a prospectus relating to the Shares is required (including in circumstances
where such requirement may be satisfied pursuant to Rule 172, 173 or any similar rule) to be delivered under the Act, the Company
will file all documents required to be filed with the Commission pursuant to the Exchange Act within the time periods required by the
Exchange Act and the regulations thereunder.


 


(u)                      DTC
Facility. The Company shall cooperate with Manager and use its reasonable efforts to permit the Shares to be eligible for clearance
and settlement through the facilities of DTC.


 


(v)                      Use
of Proceeds. The Company will apply the Net Proceeds from the sale of the Shares in the manner set forth in the Prospectus.


 


(w)                     Filing
of Prospectus Supplement. In the event any sales are made pursuant to this Agreement which are not made in “at the market”
offerings as defined in Rule 415, including, without limitation, any Placement pursuant to a Terms Agreement, the Company shall file
a Prospectus Supplement describing the terms of such transaction, the amount of Shares sold, the price thereof, the Manager’s compensation,
and such other information as may be required pursuant to Rule 424 and Rule 430B, as applicable, within the time required by Rule 424.


 


(x)                     Additional
Registration Statement. To the extent that the Registration Statement is not available for the sales of the Shares as contemplated
by this Agreement, the Company shall file a new registration statement with respect to any additional shares of Common Stock necessary
to complete such sales of the Shares and shall cause such registration statement to become effective as promptly as practicable. After
the effectiveness of any such registration statement, all references to “Registration Statement” included in this
Agreement shall be deemed to include such new registration statement, including all documents incorporated by reference therein pursuant
to Item 12 of Form S-3, and all references to “Base Prospectus” included in this Agreement shall be deemed to
include the final form of prospectus, including all documents incorporated therein by reference, included in any such registration statement
at the time such registration statement became effective.


 






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5.                 
Payment of Expenses. The Company agrees to pay the costs and expenses incident to the performance of its obligations under
this Agreement, whether or not the transactions contemplated hereby are consummated, including without limitation: (i) the preparation,
printing or reproduction and filing with the Commission of the Registration Statement (including financial statements and exhibits thereto),
the Prospectus and each Issuer Free Writing Prospectus, and each amendment or supplement to any of them; (ii) the printing (or reproduction)
and delivery (including postage, air freight charges and charges for counting and packaging) of such copies of the Registration Statement,
the Prospectus, and each Issuer Free Writing Prospectus, and all amendments or supplements to any of them, as may, in each case, be reasonably
requested for use in connection with the offering and sale of the Shares; (iii) the preparation, printing, authentication, issuance
and delivery of certificates for the Shares, including any stamp or transfer taxes in connection with the original issuance and sale of
the Shares; (iv) the printing (or reproduction) and delivery of this Agreement, any blue sky memorandum and all other agreements
or documents printed (or reproduced) and delivered in connection with the offering of the Shares; (v) the registration of the Shares
under the Exchange Act, if applicable, and the listing of the Shares on the Trading Market; (vi) any registration or qualification
of the Shares for offer and sale under the securities or blue sky laws of the several states (including filing fees and the reasonable
fees and expenses of counsel for the Manager relating to such registration and qualification); (vii) the transportation and other
expenses incurred by or on behalf of Company representatives in connection with presentations to prospective purchasers of the Shares;
(viii) the fees and expenses of the Company’s accountants and the fees and expenses of counsel (including local and special
counsel) for the Company; (ix) the filing fee under FINRA Rule 5110; (x) the reasonable fees and expenses of the Manager’s counsel,
not to exceed $75,000 (excluding any periodic due diligence fees provided for under Section 4(n)), which shall be paid on or before the
Execution Time; (xi) and all other costs and expenses incident to the performance by the Company of its obligations hereunder.


 


6.                 
Conditions to the Obligations of the Manager. The obligations of the Manager under this Agreement and any Terms Agreement
shall be subject to (i) the accuracy of the representations and warranties on the part of the Company contained herein as of the
Execution Time, each Representation Date, and as of each Applicable Time, Settlement Date and Time of Delivery, (ii) the performance
by the Company of its obligations hereunder and (iii) the following additional conditions:


 


(a)              
Filing of Prospectus Supplement. The Prospectus, and any supplement thereto, required by Rule 424 to be filed with
the Commission have been filed in the manner and within the time period required by Rule 424(b) with respect to any sale of Shares;
each Prospectus Supplement shall have been filed in the manner required by Rule 424(b) within the time period required hereunder
and under the Act; any other material required to be filed by the Company pursuant to Rule 433(d) under the Act, shall have been
filed with the Commission within the applicable time periods prescribed for such filings by Rule 433; and no stop order suspending
the effectiveness of the Registration Statement or any notice objecting to its use shall have been issued and no proceedings for that
purpose shall have been instituted or threatened.


 






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(b)              
Delivery of Opinion. The Company shall have caused the Company Counsel to furnish to the Manager, as requested by the Manager
and upon reasonable advance notice in connection with any offering of the Shares, its opinion and negative assurance statement required
to be delivered pursuant to Section 4(l), dated as of such date and addressed to the Manager in form and substance acceptable to the Manager.


 


(c)              
Delivery of Officer’s Certificate. The Company shall have furnished or caused to be furnished to the Manager, to the
extent requested by the Manager and upon reasonable advance notice in connection with any offering of the Shares, a certificate of the
Company signed by the Chief Executive Officer or the President and the principal financial or accounting officer of the Company, dated
as of such date, to the effect that the signers of such certificate have carefully examined the Registration Statement, the Prospectus,
any Prospectus Supplement and any documents incorporated by reference therein and any supplements or amendments thereto and this Agreement
and that:


 


(i)              
the representations and warranties of the Company in this Agreement are true and correct on and as of such date with the same effect
as if made on such date and the Company has complied with all the agreements and satisfied all the conditions on its part to be performed
or satisfied at or prior to such date;


 


(ii)             
no stop order suspending the effectiveness of the Registration Statement or any notice objecting to its use has been issued and
no proceedings for that purpose have been instituted or, to the Company’s knowledge, threatened; and


 


(iii)           
since the date of the most recent financial statements included in the Registration Statement, the Prospectus and the Incorporated
Documents, there has been no Material Adverse Effect on the condition (financial or otherwise), earnings, business or properties of the
Company and its subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business, except as
set forth in or contemplated in the Registration Statement and the Prospectus.


 


(d)              
Delivery of Accountants’ “Comfort” Letter. The Company shall have requested and caused the Accountants
to have furnished to the Manager letters (which may refer to letters previously delivered to the Manager), dated as of such date, in form
and substance satisfactory to the Manager, confirming that they are independent accountants within the meaning of the Act and the Exchange
Act and the respective applicable rules and regulations adopted by the Commission thereunder and that they have performed a review of
any unaudited interim financial information of the Company included or incorporated by reference in the Registration Statement and the
Prospectus and provide customary “comfort” as to such review in form and substance satisfactory to the Manager.


 






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(e)              
No Material Adverse Event. Since the respective dates as of which information is disclosed in the Registration Statement,
the Prospectus and the Incorporated Documents, except as otherwise stated therein, there shall not have been (i) any change or decrease
in previously reported results specified in the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any
change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business
or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of
business, except as set forth in or contemplated in the Registration Statement, the Prospectus and the Incorporated Documents (exclusive
of any amendment or supplement thereto) the effect of which, in any case referred to in clause (i) or (ii) above, is, in the
sole judgment of the Manager, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery
of the Shares as contemplated by the Registration Statement (exclusive of any amendment thereof), the Incorporated Documents and the Prospectus
(exclusive of any amendment or supplement thereto).


 


(f)               
Payment of All Fees. The Company shall have paid the required Commission filing fees relating to the Shares within the time
period required by Rule 456(b)(1)(i) of the Act without regard to the proviso therein and otherwise in accordance with Rules 456(b)
and 457(r) of the Act and, if applicable, shall have updated the “Calculation of Registration Fee” table in accordance with
Rule 456(b)(1)(ii) either in a post-effective amendment to the Registration Statement or on the cover page of a prospectus filed
pursuant to Rule 424(b).


 


(g)              
No FINRA Objections. FINRA shall not have raised any objection with respect to the fairness and reasonableness of the terms
and arrangements under this Agreement.


 


(h)              
Listing of Shares. Prior to the date of the first Sales Notice, the Company shall have submitted to the Trading Market a
Listing of Additional Shares Notification Form for the listing of the Shares, and will use commercially reasonable efforts to cause the
Shares to be listed on the Trading Market.


 


(i)              
Other Assurances. Prior to each Settlement Date and Time of Delivery, as applicable, the Company shall have furnished to
the Manager such further information, certificates and documents as the Manager may reasonably request.


 






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If any of the conditions specified
in this Section 6 shall not have been fulfilled when and as provided in this Agreement, or if any of the opinions and certificates mentioned
above or elsewhere in this Agreement shall not be reasonably satisfactory in form and substance to the Manager and counsel for the Manager,
this Agreement and all obligations of the Manager hereunder may be canceled at, or at any time prior to, any Settlement Date or Time of
Delivery, as applicable, by the Manager. Notice of such cancellation shall be given to the Company in writing or by telephone or facsimile
confirmed in writing.


 


The documents required to
be delivered by this Section 6 shall be delivered to the office of Sheppard, Mullin, Richter & Hampton LLP, counsel for the Manager,
at 30 Rockefeller Plaza, New York, New York 10112, on each such date as provided in this Agreement.


 


7.                 
Indemnification and Contribution.


 


(a)              Indemnification
by Company. The Company agrees to indemnify and hold harmless the Manager, the directors, officers, employees and agents of the Manager
and each person who controls the Manager within the meaning of either the Act or the Exchange Act against any and all losses, claims,
damages or liabilities, joint or several, to which they or any of them may become subject under the Act, the Exchange Act or other Federal
or state statutory law or regulation, at common law or otherwise, insofar as such losses, claims, damages or liabilities (or actions
in respect thereof) arise out of or are based upon any untrue statement or alleged untrue statement of a material fact contained in the
Registration Statement for the registration of the Shares as originally filed or in any amendment thereof, or in the Base Prospectus,
any Prospectus Supplement, the Prospectus, any Issuer Free Writing Prospectus, or in any amendment thereof or supplement thereto, or
arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary
to make the statements therein not misleading or result from or relate to any breach of any of the representations, warranties, covenants
or agreements made by the Company in this Agreement, and agrees to reimburse each such indemnified party for any legal or other expenses
reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided,
however, that the Company will not be liable in any such case to the extent that any such loss, claim, damage or liability arises
out of or is based upon any such untrue statement or alleged untrue statement or omission or alleged omission made therein in reliance
upon and in conformity with written information furnished to the Company by the Manager specifically for inclusion therein. This indemnity
agreement will be in addition to any liability that the Company may otherwise have.


 


(b)             Indemnification
by Manager. The Manager agrees to indemnify and hold harmless the Company, each of its directors, each of its officers who signs
the Registration Statement, and each person who controls the Company within the meaning of either the Act or the Exchange Act, to the
same extent as the foregoing indemnity from the Company to the Manager, but only with reference to written information relating to the
Manager furnished to the Company by the Manager specifically for inclusion in the documents referred to in the foregoing indemnity; provided,
however, that in no case shall the Manager be responsible for any amount in excess of the Broker Fee applicable to the Shares
and paid hereunder. This indemnity agreement will be in addition to any liability which the Manager may otherwise have.


 






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(c)              
Indemnification Procedures. Promptly after receipt by an indemnified party under this Section 7 of notice of the commencement
of any action, such indemnified party will, if a claim in respect thereof is to be made against the indemnifying party under this Section 7,
notify the indemnifying party in writing of the commencement thereof; but the failure so to notify the indemnifying party (i) will
not relieve it from liability under paragraph (a) or (b) above unless and to the extent it did not otherwise learn of such action
and such failure results in the forfeiture by the indemnifying party of substantial rights and defenses and (ii) will not, in any
event, relieve the indemnifying party from any obligations to any indemnified party other than the indemnification obligation provided
in paragraph (a) or (b) above. The indemnifying party shall be entitled to appoint counsel of the indemnifying party’s
choice at the indemnifying party’s expense to represent the indemnified party in any action for which indemnification is sought
(in which case the indemnifying party shall not thereafter be responsible for the fees and expenses of any separate counsel retained by
the indemnified party or parties except as set forth below); provided, however, that such counsel shall be reasonably satisfactory
to the indemnified party. Notwithstanding the indemnifying party’s election to appoint counsel to represent the indemnified party
in an action, the indemnified party shall have the right to employ separate counsel (including local counsel), and the indemnifying party
shall bear the reasonable fees, costs and expenses of such separate counsel if (i) the use of counsel chosen by the indemnifying
party to represent the indemnified party would present such counsel with a conflict of interest, (ii) the actual or potential defendants
in, or targets of, any such action include both the indemnified party and the indemnifying party and the indemnified party shall have
reasonably concluded that there may be legal defenses available to it and/or other indemnified parties which are different from or additional
to those available to the indemnifying party, (iii) the indemnifying party shall not have employed counsel reasonably satisfactory
to the indemnified party to represent the indemnified party within a reasonable time after notice of the institution of such action or
(iv) the indemnifying party shall authorize the indemnified party to employ separate counsel at the expense of the indemnifying party.
An indemnifying party will not, without the prior written consent of the indemnified parties, settle or compromise or consent to the entry
of any judgment with respect to any pending or threatened claim, action, suit or proceeding in respect of which indemnification or contribution
may be sought hereunder (whether or not the indemnified parties are actual or potential parties to such claim or action) unless such settlement,
compromise or consent includes an unconditional release of each indemnified party from all liability arising out of such claim, action,
suit or proceeding.


 






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(d)              
Contribution. In the event that the indemnity provided in paragraph (a), (b) or (c) of this Section 7
is unavailable to or insufficient to hold harmless an indemnified party for any reason, the Company and the Manager agree to contribute
to the aggregate losses, claims, damages and liabilities (including legal or other expenses reasonably incurred in connection with investigating
or defending the same) (collectively “Losses”) to which the Company and the Manager may be subject in such proportion
as is appropriate to reflect the relative benefits received by the Company on the one hand and by the Manager on the other from the offering
of the Shares; provided, however, that in no case shall the Manager be responsible for any amount in excess of the Broker
Fee applicable to the Shares and paid hereunder. If the allocation provided by the immediately preceding sentence is unavailable for any
reason, the Company and the Manager severally shall contribute in such proportion as is appropriate to reflect not only such relative
benefits but also the relative fault of the Company on the one hand and of the Manager on the other in connection with the statements
or omissions which resulted in such Losses as well as any other relevant equitable considerations. Benefits received by the Company shall
be deemed to be equal to the total net proceeds from the offering (before deducting expenses) received by it, and benefits received by
the Manager shall be deemed to be equal to the Broker Fee applicable to the Shares and paid hereunder as determined by this Agreement.
Relative fault shall be determined by reference to, among other things, whether any untrue or any alleged untrue statement of a material
fact or the omission or alleged omission to state a material fact relates to information provided by the Company on the one hand or the
Manager on the other, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent
such untrue statement or omission. The Company and the Manager agree that it would not be just and equitable if contribution were determined
by pro rata allocation or any other method of allocation which does not take account of the equitable considerations referred to above.
Notwithstanding the provisions of this paragraph (d), no person guilty of fraudulent misrepresentation (within the meaning of Section 11(f)
of the Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of
this Section 7, each person who controls the Manager within the meaning of either the Act or the Exchange Act and each director,
officer, employee and agent of the Manager shall have the same rights to contribution as the Manager, and each person who controls the
Company within the meaning of either the Act or the Exchange Act, each officer of the Company who shall have signed the Registration Statement
and each director of the Company shall have the same rights to contribution as the Company, subject in each case to the applicable terms
and conditions of this paragraph (d).


 


8.                 
Termination.


 


(a)              
The Company shall have the right, by giving written notice as hereinafter specified, to terminate the provisions of this Agreement
relating to the solicitation of offers to purchase the Shares in its sole discretion at any time upon five (5) Business Days’ prior
written notice. Any such termination shall be without liability of any party to any other party except that (i) with respect to any
pending sale, through the Manager for the Company, the obligations of the Company, including in respect of compensation of the Manager,
shall remain in full force and effect notwithstanding the termination and (ii) the provisions of Sections 5, 6, 7, 8, 9, 10,
12 and 14 of this Agreement shall remain in full force and effect notwithstanding such termination.


 






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(b)              
The Manager shall have the right, by giving written notice as hereinafter specified, to terminate the provisions of this Agreement
relating to the solicitation of offers to purchase the Shares in its sole discretion at any time. Any such termination shall be without
liability of any party to any other party except that the provisions of Sections 5, 6, 7, 8, 9, 10, 12 and 14 of this Agreement shall
remain in full force and effect notwithstanding such termination.


 


(c)              
This Agreement shall remain in full force and effect until the earlier of December _, 2024 and such date that this Agreement is
terminated pursuant to Sections 8(a) or (b) above or otherwise by mutual agreement of the parties, provided that any such termination
by mutual agreement shall in all cases be deemed to provide that Sections 5, 6, 7, 8, 9, 10, 12 and 14 shall remain in full force
and effect.


 


(d)              
Any termination of this Agreement shall be effective on the date specified in such notice of termination, provided that such termination
shall not be effective until the close of business on the date of receipt of such notice by the Manager or the Company, as the case may
be. If such termination shall occur prior to the Settlement Date or Time of Delivery for any sale of the Shares, such sale of the Shares
shall settle in accordance with the provisions of Section 2(b) of this Agreement.


 


(e)              
In the case of any purchase of Shares by the Manager pursuant to a Terms Agreement, the obligations of the Manager pursuant to
such Terms Agreement shall be subject to termination, in the absolute discretion of the Manager, by prompt oral notice given to the Company
prior to the Time of Delivery relating to such Shares, if any, and confirmed promptly by facsimile or electronic mail, if since the time
of execution of the Terms Agreement and prior to such delivery and payment, (i) trading in the Common Stock shall have been suspended
by the Commission or the Trading Market or trading in securities generally on the Trading Market shall have been suspended or limited
or minimum prices shall have been established on such exchange, (ii) a banking moratorium shall have been declared either by Federal
or New York State authorities or (iii) there shall have occurred any outbreak or escalation of hostilities, declaration by the United
States of a national emergency or war, or other calamity or crisis the effect of which on financial markets is such as to make it, in
the sole judgment of the Manager, impractical or inadvisable to proceed with the offering or delivery of the Shares as contemplated by
the Prospectus (exclusive of any amendment or supplement thereto).


 






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9.               
Representations and Indemnities to Survive. The respective agreements, representations, warranties, indemnities and other
statements of the Company or its officers and of the Manager set forth in or made pursuant to this Agreement will remain in full force
and effect, regardless of any investigation made by the Manager or the Company or any of the officers, directors, employees, agents or
controlling persons referred to in Section 7, and will survive delivery of and payment for the Shares.


 


10.             
Waiver. By executing this Agreement, the Manager hereby agrees to waive the Company’s compliance with the covenant
set forth in Section 4.19(b) of the Underwriting Agreement, dated July 19, 2019, by and between the Company and the Manager with respect
to the transactions contemplated by this Agreement. Such waiver shall only be limited to the transactions contemplated by this Agreement
while this Agreement remains in effect.


 


11.             
Notices. All communications hereunder will be in writing and effective only on receipt, and will be mailed, delivered, e-mailed
or facsimiled to the addresses of the Company and the Manager, respectively, set forth on the signature page hereto.


 


12.             
Successors. This Agreement will inure to the benefit of and be binding upon the parties hereto and their respective successors
and the officers, directors, employees, agents and controlling persons referred to in Section 7, and no other person will have any
right or obligation hereunder.


 


13.             
No Fiduciary Duty. The Company hereby acknowledges that (a) the purchase and sale of the Shares pursuant to this Agreement
is an arm’s-length commercial transaction between the Company, on the one hand, and the Manager and any affiliate through which
it may be acting, on the other, (b) the Manager is acting solely as sales agent and/or principal in connection with the purchase
and sale of the Company’s securities and not as a fiduciary of the Company and (c) the Company’s engagement of the Manager
in connection with the offering and the process leading up to the offering is as independent contractors and not in any other capacity.
Furthermore, the Company agrees that it is solely responsible for making its own judgments in connection with the offering (irrespective
of whether the Manager has advised or is currently advising the Company on related or other matters). The Company agrees that it will
not claim that the Manager has rendered advisory services of any nature or respect, or owe an agency, fiduciary or similar duty to the
Company, in connection with such transaction or the process leading thereto.


 






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14.             
Integration. This Agreement and any Terms Agreement supersede all prior agreements and understandings (whether written or
oral) between the Company and the Manager with respect to the subject matter hereof.


 


15.             
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 the Manager. 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.


 


16.              
Applicable Law. This Agreement and any Terms Agreement will be governed by and construed in accordance with the laws of
the State of New York applicable to contracts made and to be performed within the State of New York. Each of the Company and the
Manager: (i) agrees that any legal suit, action or proceeding arising out of or relating to this Agreement shall be instituted exclusively
in New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, (ii) waives
any objection which it may have or hereafter to the venue of any such suit, action or proceeding, and (iii) irrevocably consents to the
jurisdiction of the New York Supreme Court, County of New York, and the United States District Court for the Southern District of New
York in any such suit, action or proceeding. Each of the Company and the Manager further agrees to accept and acknowledge service of any
and all process which may be served in any such suit, action or proceeding in the New York Supreme Court, County of New York, or in the
United States District Court for the Southern District of New York and agrees that service of process upon the Company mailed by certified
mail to the Company’s address shall be deemed in every respect effective service of process upon the Company, in any such suit,
action or proceeding, and service of process upon the Manager mailed by certified mail to the Manager’s address shall be deemed
in every respect effective service process upon the Manager, in any such suit, action or proceeding. If either party shall commence an
action or proceeding to enforce any provision of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed
by the other party for its reasonable attorney’s fees and other costs and expenses incurred with the investigation, preparation
and prosecution of such action or proceeding.


 


17.             Waiver
of Jury Trial. The Company hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial
by jury in any legal proceeding arising out of or relating to this Agreement, any Terms Agreement or the transactions contemplated hereby
or thereby. 


 


18.             
Counterparts. This Agreement and any Terms Agreement may be signed in one or more counterparts, each of which shall constitute
an original and all of which together shall constitute one and the same agreement, which may be delivered by facsimile or in .pdf file
via e-mail.


 


***************************


 






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19.             
Headings. The section headings used in this Agreement and any Terms Agreement are for convenience only and shall not affect
the construction hereof.


         


If the foregoing is in accordance
with your understanding of our agreement, please sign and return to us the enclosed duplicate hereof, whereupon this letter and your acceptance
shall represent a binding agreement among the Company and the Manager.


 


Very truly yours,


 


Jaguar Health,
inc.


 


	By:	/s/ Lisa A. Conte	 
	Name:  Lisa A. Conte
	Title: President and Chief Executive Officer




 


Address for Notice:


200 Pine Street, Suite 400

San Francisco, California 94104


Email: lconte@jaguar.health


Fax: 415.371.8311


Attn: Lisa A. Conte, President and CEO


 


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


Reed Smith LLP

101 Second Street, Suite 1800

San Francisco, California 94105-3659


Attn: Donald C. Reinke, Esq.






The foregoing Agreement is hereby confirmed and accepted
as of the date first written above.


 


LADENBURG THALMANN & CO. INC.


 


	By:	/s/ Nicholas Stergis	 
	Name: Nicholas Stergis
	Title: Managing Partner




 


Address for Notice:


277 Park Avenue, 26th Floor


New York, NY 10172


Attn: General Counsel and Head of
Investment Banking





 






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Form of Terms Agreement


ANNEX I 


JAGUAR HEALTH, INC.


TERMS AGREEMENT


 


Dear Sirs:


 


Jaguar
Health, Inc. (the “Company”) proposes, subject to the terms and conditions stated herein and in the At The Market Offering
Agreement, dated December __, 2021 (the “At The Market Offering Agreement”), between the Company and Ladenburg Thalmann
 & Co. Inc. (“Manager”), to issue and sell to Manager the securities specified in the Schedule I hereto
(the “Purchased Shares”).


 


Each
of the provisions of the At The Market Offering Agreement not specifically related to the solicitation by the Manager, as agent of the
Company, of offers to purchase securities is incorporated herein by reference in its entirety, and shall be deemed to be part of this
Terms Agreement to the same extent as if such provisions had been set forth in full herein. Each of the representations and warranties
set forth therein shall be deemed to have been made at and as of the date of this Terms Agreement and the Time of Delivery, except that
each representation and warranty in Section 3 of the At The Market Offering Agreement which makes reference to the Prospectus (as
therein defined) shall be deemed to be a representation and warranty as of the date of the At The Market Offering Agreement in relation
to the Prospectus, and also a representation and warranty as of the date of this Terms Agreement and the Time of Delivery in relation
to the Prospectus as amended and supplemented to relate to the Purchased Shares.


 


An
amendment to the Registration Statement (as defined in the At The Market Offering Agreement), or a supplement to the Prospectus, as the
case may be, relating to the Purchased Shares, in the form heretofore delivered to the Manager is now proposed to be filed with the Securities
and Exchange Commission.


 


Subject
to the terms and conditions set forth herein and in the At The Market Offering Agreement which are incorporated herein by reference, the
Company agrees to issue and sell to the Manager and the latter agrees to purchase from the Company the number of shares of the Purchased
Shares at the time and place and at the purchase price set forth in the Schedule I hereto.





 






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If
the foregoing is in accordance with your understanding, please sign and return to us a counterpart hereof, whereupon this Terms Agreement,
including those provisions of the At The Market Offering Agreement incorporated herein by reference, shall constitute a binding agreement
between the Manager and the Company.


 


Jaguar Health, Inc.  


 


	By:	 	 
	 	Name: 	 
	 	Title:	 


 



ACCEPTED as of the date first written above.


 


LADENBURG THALMANN & CO. INC.


 


	By:	 	 
	 	Name:	 
	 	Title:	 


 






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Schedule I