ex1-1
Exhibit 1.1
AzurRx Biopharma, Inc.
9,090,910 Shares of Common Stock
(par value $0.0001 per share)
Amended and Restated Underwriting Agreement
July
22, 2021
H.C.
Wainwright & Co., LLC
As
Representative of the several
Underwriters listed
in Schedule A hereto
430
Park Avenue, 4th Floor
New
York, NY 10022
Ladies
and Gentlemen:
AzurRx
Biopharma, Inc., a company incorporated under the laws of the State
of Delaware (the “Company”), proposes to issue and
sell to the several underwriters named in Schedule A (the
“Underwriters”)
an aggregate of 9,090,910 shares of its common stock, par value
$0.0001 per share (the “Shares”). The
9,090,910 Shares to be
sold by the Company are called the “Firm Shares.” In addition, the
Company has granted to the Underwriters an option to purchase up to
an additional 1,363,636 Shares as provided in Section 2. The
additional 1,363,636 Shares that may be sold by the Company
pursuant to such option are collectively called the
“Optional
Shares.” The Firm Shares and, if and to the extent
such option is exercised, the Optional Shares, are collectively
called the “Offered
Shares.” H.C. Wainwright & Co., LLC
(“Wainwright”)
has agreed to act as representative of the several Underwriters (in
such capacity, the “Representative”) in connection
with the offering and sale of the Offered Shares. To the extent
there are no additional underwriters listed on Schedule A, the term
“Representative” as used herein shall mean you, as
Underwriter, and the term “Underwriters” shall mean
either the singular or the plural, as the context requires. This
Amended and Restated Underwriting Agreement amends, restates and
supersedes in its entirety the underwriting agreement, dated as of
July 22, 2021, between the Company and the
Underwriters.
The
Company has prepared and filed with the U.S. Securities and
Exchange Commission (the “Commission”) a shelf registration
statement on Form S-3, File No. 333-256476, including a base
prospectus (the “Base
Prospectus”) to be used in connection with the public
offering and sale of the Offered Shares. Such registration
statement, as amended, including the financial statements, exhibits
and schedules thereto, in the form in which it became effective
under the U.S. Securities Act of 1933, as amended, and the rules
and regulations promulgated thereunder (collectively, the
“Securities
Act”), including all documents incorporated or deemed
to be incorporated by reference therein and any information deemed
to be a part thereof at the time of effectiveness pursuant to Rule
430A or Rule 430B under the Securities Act, is called the
“Registration
Statement.” Any registration statement filed by the
Company pursuant to Rule 462(b) under the Securities Act in
connection with the offer and sale of the Offered Shares is called
the “Rule 462(b) Registration
Statement,” and from and after the date and time of
filing of any such Rule 462(b) Registration Statement the term
“Registration Statement” shall include the Rule 462(b)
Registration Statement. The preliminary prospectus supplement,
dated July 22, 2021, describing the Offered Shares and the offering
thereof (the “Preliminary
Prospectus Supplement”), together with the Base
Prospectus, is called the “Preliminary Prospectus,” and the
Preliminary Prospectus and any other prospectus supplement to the
Base Prospectus in preliminary form that describes the Offered
Shares and the offering thereof and is used prior to the filing of
the Prospectus (as defined below), together with the Base
Prospectus, is called a “preliminary prospectus.” As used
herein, the term “Prospectus” shall mean the final
prospectus supplement to the Base Prospectus that describes the
Offered Shares and the offering thereof, together with the Base
Prospectus, in the form first used by the Underwriters to confirm
sales of the Offered Shares or in the form first made available to
the Underwriters by the Company to meet requests of purchasers
pursuant to Rule 173 under the Securities Act.
As used
herein, “Applicable
Time” is 8:30 p.m. (New York time) on July 22, 2021.
As used herein, “free writing
prospectus” has the meaning set forth in Rule 405
under the Securities Act, and “Time of Sale Prospectus” means the
Preliminary Prospectus, as amended or supplemented immediately
prior to the Applicable Time, together with the free writing
prospectuses, if any, identified on Schedule B hereto and the
pricing information set forth on Schedule C hereto. As used
herein, “Road
Show” means a “road show” (as defined in
Rule 433 under the Securities Act) relating to the offering of the
Offered Shares contemplated hereby that is a “written
communication” (as defined in Rule 405 under the Securities
Act).
All
references in this Agreement to financial statements and schedules
and other information which are “contained,”
“included” or “stated” in, or “part
of” the Registration Statement, the Rule 462(b) Registration
Statement, the Preliminary Prospectus, any preliminary prospectus,
the Base Prospectus, the Time of Sale Prospectus or the Prospectus,
and all other references of like import, shall be deemed to mean
and include all such financial statements and schedules and other
information which is or is deemed to be incorporated by reference
in the Registration Statement, the Rule 462(b) Registration
Statement, the Preliminary Prospectus, any preliminary prospectus,
the Base Prospectus, the Time of Sale Prospectus or the Prospectus,
as the case may be.
All
references in this Agreement to amendments or supplements to the
Registration Statement, the Preliminary Prospectus, any preliminary
prospectus, the Base Prospectus, the Time of Sale Prospectus or the
Prospectus shall be deemed to mean and include the filing of any
document under the U.S. Securities Exchange Act of 1934, as
amended, and the rules and regulations promulgated thereunder
(collectively, the “Exchange
Act”) that is or is deemed to be incorporated by
reference in the Registration Statement, the Preliminary
Prospectus, any preliminary prospectus, the Base Prospectus, or the
Prospectus, as the case may be.
All
references in this Agreement to (i) the Registration
Statement, the Preliminary Prospectus, any preliminary prospectus,
the Base Prospectus or the Prospectus, any amendments or
supplements to any of the foregoing, or any free writing
prospectus, shall include any copy thereof filed with the
Commission pursuant to its Electronic Data Gathering, Analysis and
Retrieval System (“EDGAR”) and (ii) the
Prospectus shall be deemed to include any “electronic
Prospectus” provided for use in connection with the offering
of the Offered Shares as contemplated by Section 3(n) of this
Agreement.
In the
event that the Company has only one Subsidiary, then all references
herein to “Subsidiaries” of the Company shall be deemed
to refer to such single Subsidiary, mutatis mutandis. In the event that the Company has no Subsidiaries,
all other references to the Subsidiaries or any of them in this
Agreement shall be disregarded.
The
Company hereby confirms its agreements with the Underwriters as
follows:
1. Representations and Warranties of the
Company. The Company represents and warrants to each
Underwriter as of the date of this Agreement, the Applicable Time,
the First Closing Date (as hereinafter defined) and each Option
Closing Date (as hereinafter defined), if any, as
follows:
(a) Compliance with Registration
Requirements. The Registration Statement
has become effective under the Securities Act. The Company has
complied, to the Commission’s satisfaction, with all requests
of the Commission for additional or supplemental information, if
any. No stop order suspending the effectiveness of the Registration
Statement is in effect and no proceedings for such purpose have
been instituted or are pending or, to the knowledge of the Company,
are contemplated or threatened by the Commission. At the time the
Company’s Annual Report on Form 10-K for the year ended
December 31, 2020 (the “Annual Report”) was filed with the
Commission, or, if later, at the time the Registration Statement
was originally filed with the Commission, the Company met the
then-applicable registrant requirements for use of Form S-3 under
the Securities Act. The documents incorporated or deemed to be
incorporated by reference in the Registration Statement, the Time
of Sale Prospectus and the Prospectus, at the time they were or
hereafter are filed with the Commission, or became effective under
the Exchange Act, as the case may be, complied and will comply in
all material respects with the requirements of the Exchange
Act.
(b) Disclosure. Each preliminary
prospectus and the Prospectus when filed complied in all material
respects with the Securities Act and, if filed by electronic
transmission pursuant to EDGAR, was identical (except as may be
permitted by Regulation S-T under the Securities Act) to the
copy thereof delivered to the Underwriters for use in connection
with the offer and sale of the Offered Shares. Each of the
Registration Statement and any post-effective amendment thereto, at
the time it became or becomes effective and at all subsequent
times, complied and will comply in all material respects with the
Securities Act and did not and will not contain any untrue
statement of a material fact or omit to state a material fact
required to be stated therein or necessary to make the statements
therein not misleading. As of the Applicable Time, the Time of Sale
Prospectus did not, and at the time of each sale of the Offered
Shares and at the First Closing Date and the Option Closing Date,
the Time of Sale Prospectus, as then amended or supplemented by the
Company, if applicable, will not, contain any untrue statement of a
material fact or omit to state a material fact necessary to make
the statements therein, in the light of the circumstances under
which they were made, not misleading. The Prospectus, as of its
date and (as then amended or supplemented) at all subsequent times,
did not and will not contain any untrue statement of a material
fact or omit to state a material fact necessary in order to make
the statements therein, in the light of the circumstances under
which they were made, not misleading. The representations and
warranties set forth in the three immediately preceding sentences
do not apply to statements in or omissions from the Registration
Statement or any post-effective amendment thereto, or the
Prospectus or the Time of Sale Prospectus, or any amendments or
supplements thereto, made in reliance upon and in conformity with
written information relating to any Underwriter furnished to the
Company in writing by the Representative expressly for use therein,
it being understood and agreed that the only such information
consists of the information described in Section 9(a) below. There
are no contracts or other documents required to be described in the
Time of Sale Prospectus or the Prospectus or to be filed as an
exhibit to the Registration Statement which have not been described
or filed as required.
(c) Free Writing Prospectuses; Road
Show. As of the determination date referenced in Rule 164(h)
under the Securities Act, the Company was not, is not or will not
be (as applicable) an “ineligible issuer” in connection
with the offering of the Offered Shares pursuant to Rules 164, 405
and 433 under the Securities Act. Each free writing prospectus that
the Company is required to file pursuant to Rule 433(d) under the
Securities Act has been, or will be, filed with the Commission in
accordance with the requirements of the Securities Act. Each free
writing prospectus that the Company has filed, or is required to
file, pursuant to Rule 433(d) under the Securities Act or that was
prepared by or on behalf of or used or referred to by the Company
complies or will comply in all material respects with the
requirements of Rule 433 under the Securities Act, including timely
filing with the Commission or retention where required and
legending, and each such free writing prospectus, as of its issue
date and at all subsequent times through the completion of the
public offer and sale of the Offered Shares did not, does not and
will not include any information that conflicted, conflicts or will
conflict with the information contained in the Registration
Statement, the Prospectus or any preliminary prospectus and not
superseded or modified. Except for the free writing prospectuses,
if any, identified in Schedule B, and electronic road
shows, if any, furnished to you before first use, the Company has
not prepared, used or referred to, and will not, without your prior
written consent, prepare, use or refer to, any free writing
prospectus. Each Road Show, when considered together with the Time
of Sale Prospectus, does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make
the statements therein, in the light of the circumstances under
which they were made, not misleading.
(d) Form S-3. The Company and the
transactions contemplated by this Agreement meet the requirements
for, and comply with the conditions for the use of, Form S-3 under
the Securities Act, including the transaction requirements set
forth in General Instruction I.B.1 of such form. The Company is
subject to and in compliance in all material respects with the
reporting requirements of Section 13 or Section 15(d) of the
Exchange Act. The Registration Statement meets the requirements set
forth in Rule 415(a)(1)(x) under the Securities Act and complies
with said Rule, and the Prospectus Supplement will meet the
requirements set forth in Rule 424(b).
(e) Distribution of Offering Material By
the Company. Prior to the later of (i) the expiration or
termination of the option granted to the several Underwriters in
Section 2 and (ii) the completion of the Underwriters’
distribution of the Offered Shares, the Company has not distributed
and will not distribute any offering material in connection with
the offering and sale of the Offered Shares other than the
Registration Statement, the Time of Sale Prospectus, the
Prospectus, any free writing prospectus reviewed and consented to
by the Representative, and the free writing prospectuses, if any,
identified on Schedule
B hereto. The Company has not distributed and will not
distribute any offering material in connection with the offering
other than the Registration Statement and the prospectus supplement
to the Base Prospectus that described the offering hereof. The
Company (i) has not alone engaged in any Testing-the-Waters
Communication, and (ii) has not authorized anyone to engage in
Testing-the-Waters Communications. The Company has not distributed
any Written Testing-the-Waters Communications. “Testing-the-Waters Communication”
means any oral or written communication with potential investors
undertaken in reliance on Section 5(d) of the Securities Act.
“Written Testing-the-Waters
Communication” means any Testing-the-Waters
Communication that is a written communication within the meaning of
Rule 405 under the Securities Act.
(f) Financial
Information. The
consolidated financial statements of the Company included or
incorporated by reference in the Registration Statement, the Time
of Sale Prospectus and the Prospectus, if any, together with the
related notes and schedules, present fairly, in all material
respects, the consolidated financial position of the Company and
the Subsidiaries (as defined below) as of the dates indicated and
the consolidated results of operations, cash flows and changes in
stockholders’ equity of the Company for the periods specified
and have been prepared in compliance with the requirements of the
Securities Act and Exchange Act, and in conformity with U.S.
generally accepted accounting principles (“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, applied on a consistent basis during
the periods involved; there are no financial statements (historical
or pro forma) that are required to be included or incorporated by
reference in the Registration Statement, the Time of Sale
Prospectus and the Prospectus that are not included or incorporated
by reference as required; the Company and the Subsidiaries (as
defined below) do not have any material liabilities or obligations,
direct or contingent (including any off-balance sheet obligations),
not described in the Registration Statement (excluding the exhibits
thereto), the Time of Sale Prospectus and the Prospectus; and all
disclosures contained or incorporated by reference in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus and any free writing prospectuses, if any, regarding
“non-GAAP financial measures” (as such term is defined
by the rules and regulations of the Commission) comply with
Regulation G of the Exchange Act and Item 10 of Regulation S-K
under the Securities Act, to the extent applicable. The financial
data set forth in each of the Registration Statement, the Time of
Sale Prospectus and the Prospectus fairly present the information
set forth therein on a basis consistent with that of the audited
financial statements contained in the Registration Statement, the
Time of Sale Prospectus and the Prospectus. To the extent
applicable, the pro forma condensed consolidated financial
statements of the Company and its Subsidiaries and the related
notes thereto included or incorporated by reference elsewhere in
the Registration Statement, the Time of Sale Prospectus or the
Prospectus present fairly the information contained therein, have
been prepared in accordance with the Commission’s rules and
guidelines with respect to pro forma financial statements and
have been properly presented on the bases described therein, and
the assumptions used in the preparation thereof are reasonable and
the adjustments used therein are appropriate to give effect to the
transactions and circumstances referred to therein. The interactive data in eXtensible
Business Reporting Language included or incorporated by reference
in the Registration Statement and the Prospectus fairly presents
the information called for in all material respects and has been
prepared in accordance with the Commission’s rules and
guidelines applicable thereto.
(g) Conformity with EDGAR Filing.
The Preliminary Prospectus and Prospectus delivered to the
Underwriters for use in connection with the sale of the Offered
Shares pursuant to this Agreement will be identical to the versions
of the Preliminary Prospectus and Prospectus created to be
transmitted to the Commission for filing via EDGAR, except to the
extent permitted by Regulation S-T.
(h) Organization. The Company and
each of its Subsidiaries are duly organized, validly existing as a
corporation or other entity and in good standing under the laws of
their respective jurisdictions of organization. The Company and
each of its Subsidiaries are duly licensed or qualified as a
foreign corporation or other entity for transaction of business and
in good standing under the laws of each other jurisdiction in which
their respective ownership or lease of property or the conduct of
their respective businesses requires such license or qualification,
and have all corporate or other organizational power and authority
necessary to own or hold their respective properties and to conduct
their respective businesses as described in the Registration
Statement, the Time of Sale Prospectus and the Prospectus, and as
currently carried on, except where the failure to be so qualified
or in good standing or have such power or authority would not,
individually or in the aggregate, have a material adverse effect on
or affecting the assets, business, operations, earnings,
properties, financial condition, stockholders’ equity or
results of operations of the Company and the Subsidiaries taken as
a whole, or prevent or materially interfere with consummation of
the transactions contemplated hereby (a “Material Adverse
Effect”).
(i) Subsidiaries. The subsidiaries
set forth on Schedule
D (collectively, the “Subsidiaries”), are the
Company’s only significant subsidiaries (as such term is
defined in Rule 1-02 of Regulation S-X promulgated by the
Commission). The Company owns, directly or indirectly, all of the
equity interests of the Subsidiaries free and clear of any lien,
charge, security interest, encumbrance, right of first refusal or
other restriction, and all the equity interests of the Subsidiaries
are validly issued and are fully paid, nonassessable and free of
preemptive and similar rights. Except as set forth in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus, no Subsidiary is currently prohibited, directly or
indirectly, from paying any dividends to the Company, from making
any other distribution on such Subsidiary’s capital stock,
from repaying to the Company any loans or advances to such
Subsidiary from the Company or from transferring any of such
Subsidiary’s property or assets to the Company or any other
Subsidiary of the Company.
(j) No Violation or Default.
Neither the Company nor any of its Subsidiaries is (i) in
violation of its certificate of incorporation, charter or by-laws
or any other organizational documents; (ii) in default, and no
event has occurred that, with notice or lapse of time or both,
would constitute such a default, in the due performance or
observance of any term, covenant or condition contained in any
indenture, mortgage, deed of trust, loan agreement or other
agreement or instrument to which the Company or any of its
Subsidiaries is a party or by which the Company or any of its
Subsidiaries is bound or to which any of the property or assets of
the Company or any of its Subsidiaries are subject; or
(iii) in violation of any law or statute or any judgment,
order, rule or regulation of any Governmental Authority (as defined
below), except, in the case of each of clauses (ii) and (iii)
above, for any such violation or default that would not,
individually or in the aggregate, have a Material Adverse Effect.
To the Company’s knowledge, no other party under any material
contract or other agreement to which it or any of its Subsidiaries
is a party is in default in any respect thereunder where such
default would have a Material Adverse Effect.
(k) No Material Adverse Change.
Subsequent to the respective dates as of which information is given
in the Registration Statement, the Time of Sale Prospectus, the
Prospectus and the free writing prospectuses, if any (including any
document deemed incorporated by reference therein), there has not
been (i) any Material Adverse Effect or the occurrence of any
development that would reasonably be expected to have a Material
Adverse Effect, (ii) any transaction which is material to the
Company and the Subsidiaries taken as a whole, (iii) any obligation
or liability, direct or contingent (including any off-balance sheet
obligations), incurred by the Company or any Subsidiary, which is
material to the Company and the Subsidiaries taken as a whole, (iv)
any material change in the capital stock or outstanding long-term
indebtedness of the Company or any of its Subsidiaries or (v) any
dividend or distribution of any kind declared, paid or made on the
capital stock of the Company or any Subsidiary, other than in each
case above in the ordinary course of business or as otherwise
disclosed in the Registration Statement or Prospectus (including
any document deemed incorporated by reference
therein).
(l) Capitalization. The issued and
outstanding shares of capital stock of the Company have been
validly issued, are fully paid and nonassessable and are not
subject to any preemptive rights, rights of first refusal or
similar rights. The Company has an authorized, issued and
outstanding capitalization as set forth in the Registration
Statement and the Prospectus as of the dates referred to therein
(other than the grant of additional options under the
Company’s existing option plans, or changes in the number of
outstanding shares of common stock of the Company (the
“Common Stock”)
due to the issuance of shares upon the exercise or conversion of
securities exercisable for, or convertible into, Common Stock
outstanding on the date hereof or any anti-dilution provisions of
such outstanding securities) and such authorized capital stock
conforms in all material respects to the description thereof set
forth in the Registration Statement, the Time of Sale Prospectus
and the Prospectus. The description of the securities of the
Company in the Registration Statement, the Time of Sale Prospectus
and the Prospectus is complete and accurate in all material
respects. Except as disclosed in or contemplated by the
Registration Statement, the Time of Sale Prospectus or the
Prospectus, as of the date referred to therein, the Company does
not have outstanding any options to purchase, or any rights or
warrants to subscribe for, or any securities or obligations
convertible into, or exchangeable for, or any contracts or
commitments to issue or sell, any shares of capital stock or other
securities.
(m) Authorization; Enforceability.
The Company has full legal right, power and authority to enter into
this Agreement and the Representative’s Warrant Agreement (as
defined below) and perform the transactions contemplated hereby and
thereby. This Agreement and the Representative’s Warrant
Agreement has been duly authorized, executed and delivered by the
Company and is a legal, valid and binding agreement of the Company
enforceable against the Company in accordance with its respective
terms, except to the extent that enforceability may be limited by
bankruptcy, insolvency, reorganization, moratorium or similar laws
affecting creditors’ rights generally and by general
equitable principles.
(n) Authorization of the Offered
Shares and the
Representative’s Securities. The Offered Shares and
the Representative’s Securities (as defined below) have been
duly authorized for issuance and sale pursuant to this Agreement
and, when issued and delivered by the Company against payment
therefor pursuant to this Agreement and the Representative’s
Warrant Agreement, as applicable, will be duly and validly issued,
fully paid and nonassessable, free and clear of any pledge,
mortgage, hypothecation, lien, encumbrance, security interest or
other claim, including any statutory or contractual preemptive
rights, resale rights, rights of first refusal or other similar
rights, and the Offered Shares will be registered pursuant to
Section 12 of the Exchange Act. The Offered Shares and the
Representative’s Securities, when issued, will conform in all
material respects to the description thereof set forth in or
incorporated into the Registration Statement, the Time of Sale
Prospectus and the Prospectus. The shares of Common Stock issuable
upon exercise of the Representative’s Warrant (as defined
below) have been duly authorized and reserved for issuance by all
necessary corporate action on the part of the Company and when paid
for and issued in accordance with the Representative’s
Warrant Agreement, such shares of Common Stock will be validly
issued, fully paid and non-assessable
(o) No Consents Required. No
consent, approval, authorization, order, registration or
qualification of or with any Governmental Authority is required for
the execution, delivery and performance by the Company of this
Agreement and the Representative’s Warrant Agreement, the
issuance and sale by the Company of the Offered Shares and the
Representative’s Securities, except for such consents,
approvals, authorizations, orders and registrations or
qualifications as may be required under applicable state securities
laws or by the by-laws and rules of the Financial Industry
Regulatory Authority (“FINRA”) or the NASDAQ Stock Market
(the “NASDAQ”)
in connection with the sale of the Offered Shares and the
Representative’s Securities.
(p) No Preferential Rights. Except
as set forth in the Registration Statement, the Time of Sale
Prospectus and the Prospectus, (i) no person, as such term is
defined in Rule 1-02 of Regulation S-X promulgated under the
Securities Act (each, a “Person”), has the right,
contractual or otherwise, to cause the Company to issue or sell to
such Person any Common Stock or shares of any other capital stock
or other securities of the Company, (ii) no Person has any
preemptive rights, resale rights, rights of first refusal, rights
of co-sale, or any other rights (whether pursuant to a
“poison pill” provision or otherwise) to purchase any
Common Stock or shares of any other capital stock or other
securities of the Company, (iii) no Person has the right to
act as an underwriter or as a financial advisor to the Company in
connection with the offer and sale of the Common Stock, and
(iv) no Person has the right, contractual or otherwise, to
require the Company to register under the Securities Act, any
Common Stock or shares of any other capital stock or other
securities of the Company, or to include any such shares or other
securities in the Registration Statement or the offering
contemplated thereby, whether as a result of the filing or
effectiveness of the Registration Statement or the sale of the
Offered Shares as contemplated thereby or otherwise.
(q) Independent Public Accounting
Firms. Mazars USA LLP (the “Accountant”), whose report on the
consolidated financial statements of the Company is filed with the
Commission as part of the Company’s most recent Annual Report
on Form 10-K filed with the Commission and incorporated by
reference into the Registration Statement, the Time of Sale
Prospectus and the Prospectus, is and, during the periods covered
by its report, was an independent registered public accounting firm
within the meaning of the Securities Act and the Public Company
Accounting Oversight Board (United States). To the Company’s
knowledge, the Accountant is not in violation of the auditor
independence requirements of the Sarbanes-Oxley Act of 2002 (the
“Sarbanes-Oxley
Act”).
(r) Enforceability of Agreements.
All agreements between the Company and third parties expressly
referenced in the Registration Statement, the Time of Sale
Prospectus and the Prospectus are legal, valid and binding
obligations of the Company enforceable in accordance with their
respective terms, except to the extent that (i) enforceability
may be limited by bankruptcy, insolvency, reorganization,
moratorium or similar laws affecting creditors’ rights
generally and by general equitable principles and (ii) the
indemnification provisions of certain agreements may be limited by
federal or state securities laws or public policy considerations in
respect thereof.
(s) No Litigation. Except as set
forth in the Registration Statement, the Time of Sale Prospectus or
the Prospectus, there are no actions, suits or proceedings by or
before any Governmental Authority pending, nor, to the
Company’s knowledge, any audits or investigations by or
before any Governmental Authority, to which the Company or a
Subsidiary is a party or to which any property of the Company or
any of its Subsidiaries is the subject that, individually or in the
aggregate, if determined adversely to the Company or its
Subsidiaries, would reasonably be expected to have a Material
Adverse Effect and, to the Company’s knowledge, no such
actions, suits, proceedings, audits or investigations are
threatened or contemplated by any Governmental Authority or
threatened by others; and (i) there are no current or pending
audits, investigations, actions, suits or proceedings by or before
any Governmental Authority that are required under the Securities
Act to be described in the Registration Statement, the Time of Sale
Prospectus or Prospectus that are not so described; and
(ii) there are no contracts or other documents that are
required under the Securities Act to be filed as exhibits to the
Registration Statement that are not so filed.
(t) Consents and Permits. As to
each product subject to the jurisdiction of the U.S. Food and Drug
Administration (“FDA”) or any non-U.S. counterpart
that is manufactured, packaged, labeled, tested, distributed, sold,
and/or marketed by the Company or any of its Subsidiaries (each
such product, a “Product”), such Product is being
manufactured, packaged, labeled, tested, distributed, sold and/or
marketed by the Company or its Subsidiaries in material compliance
with all applicable Health Care Laws 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. There is no
pending, completed or, to the Company's knowledge, threatened,
action (including any lawsuit, arbitration, or legal or
administrative or regulatory proceeding, charge, complaint, or
investigation) against the Company or any of its Subsidiaries, and
none of the Company or any of its Subsidiaries has received any
notice, warning letter or other communication from the FDA or any
other governmental entity, which (i) contests the premarket
clearance, licensure, registration, or approval of, the uses of,
the distribution of, the manufacturing or packaging of, the testing
of, the sale of, or the labeling and promotion of any 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 Product, (iii) imposes
a clinical hold on any clinical investigation by the Company or any
of its Subsidiaries, (iv) enjoins production at any facility of the
Company or any of its Subsidiaries, (v) enters or proposes to enter
into a consent decree of permanent injunction with the Company or
any of its Subsidiaries, or (vi) otherwise alleges any violation of
any laws, rules or regulations by the Company or any of its
Subsidiaries, and which, either individually or in the aggregate,
would reasonably be expected to 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 Health Care Laws. The Company has not been informed by
the FDA or any non-U.S. counterpart that the FDA or any non-U.S.
counterpart will prohibit the marketing, sale, license or use in
the United States or in any other territory any product proposed to
be developed, produced or marketed by the Company or any Subsidiary
nor has the FDA or any non-U.S. counterpart expressed any concern
as to approving or clearing for marketing any product being
developed or proposed to be developed by the Company or any
Subsidiary. To the Company’s knowledge, there are no legal or
governmental proceedings relating to any Health Care Law pending or
threatened to which the Company is a party, nor is it aware of any
material violations of such acts or regulations by the Company,
which would have a Material Adverse Effect. For purposes of this
Agreement, “Health Care
Laws” means: (i) the Federal Food, Drug, and Cosmetic
Act and the regulations promulgated thereunder; (ii) all applicable
federal, state, local and all applicable foreign health care
related fraud and abuse laws, including, without limitation, the
U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the
U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h),
the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.),
the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all
criminal laws relating to health care fraud and abuse, including
but not limited to 18 U.S.C. Sections 286 and 287, and the health
care fraud criminal provisions under the U.S. Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d
et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil
monetary penalties law (42 U.S.C. § 1320a-7a), the statutes,
regulations and directives of applicable government funded or
sponsored healthcare programs, and the regulations promulgated
pursuant to such statutes; (iii) the Standards for Privacy of
Individually Identifiable Health Information, the Security
Standards, and the Standards for Electronic Transactions and Code
Sets promulgated under HIPAA, the Health Information Technology for
Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.),
and the regulations promulgated thereunder and any state or
non-U.S. counterpart thereof or other law or regulation the purpose
of which is to protect the privacy of individuals or prescribers;
(iv) Medicare (Title XVIII of the Social Security Act); (v)
Medicaid (Title XIX of the Social Security Act); and (vi) any and
all other applicable health care laws and regulations.
(u) Regulatory Filings. Except as
disclosed in the Registration Statement, the Time of Sale
Prospectus and the Prospectus, neither the Company nor any of its
Subsidiaries has failed to file with the applicable Governmental
Authority (including the FDA or any foreign, federal, state or
local Governmental Authority performing functions similar to those
performed by the FDA) any required filing, declaration, listing,
registration, report or submission, except for such failures that,
individually or in the aggregate, would not reasonably be expected
to have a Material Adverse Effect; except as disclosed in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus, all such filings, declarations, listings,
registrations, reports or submissions were in material compliance
with applicable laws when filed and no deficiencies have been
asserted by any applicable regulatory authority with respect to any
such filings, declarations, listings, registrations, reports or
submissions, except for any deficiencies that, individually or in
the aggregate, would not have a Material Adverse Effect. The
Company has operated and currently is, in all material respects, in
compliance with all applicable Health Care Laws. The Company has no
knowledge of any studies, tests or trials not described in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus the results of which reasonably call into question in
any material respect the results of the studies, tests and trials
described in the Registration Statement, the Time of Sale
Prospectus and the Prospectus.
(v) Intellectual Property. Except
as disclosed in the Registration Statement, the Time of Sale
Prospectus and the Prospectus, the Company and its Subsidiaries to
their knowledge own, possess, license or have other rights to use,
or could obtain on commercially reasonable terms, all foreign and
domestic patents, patent applications, trade and service marks,
trade and service mark registrations, trade names, copyrights,
licenses, inventions, trade secrets, technology, Internet domain
names, know-how and other intellectual property (collectively, the
“Intellectual
Property”), necessary for the conduct of their
respective businesses as now conducted except to the extent that
the failure to own, possess, license or otherwise hold adequate
rights to use such Intellectual Property would not, individually or
in the aggregate, have a Material Adverse Effect. Except as
disclosed in the Registration Statement, the Time of Sale
Prospectus and the Prospectus (i) to their knowledge, there are no
rights of third parties to any such Intellectual Property owned by
the Company and its Subsidiaries, except for licenses granted in
the ordinary course to third parties, or that could not,
individually or in the aggregate, reasonably be expected to result
in a Material Adverse Effect; (ii) to the Company’s
knowledge, there is no infringement by third parties of any such
Intellectual Property; (iii) there is no pending or, to the
Company’s knowledge, threatened action, suit, proceeding or
claim by others challenging the Company’s and its
Subsidiaries’ rights in or to any such Intellectual Property,
and the Company is unaware of any facts which could form a
reasonable basis for any such action, suit, proceeding or claim;
(iv) there is no pending or, to the Company’s knowledge,
threatened action, suit, proceeding or claim by others challenging
the validity or scope of any such Intellectual Property; (v) there
is no pending or, to the Company’s knowledge, threatened
action, suit, proceeding or claim by others that the Company and
its Subsidiaries infringe or otherwise violate any patent,
trademark, copyright, trade secret or other proprietary rights of
others; (vi) to the Company’s knowledge, there is no
third-party U.S. patent or published U.S. patent application which
contains claims for which an Interference Proceeding (as defined in
35 U.S.C. § 135), or the equivalent in any other jurisdiction,
has been commenced against any patent or patent application
described in the Registration Statement, the Time of Sale
Prospectus and the Prospectus as being owned by or licensed to the
Company; and (vii) to their knowledge, the Company and its
Subsidiaries have complied with the terms of each agreement
pursuant to which Intellectual Property has been licensed to the
Company or such Subsidiary, and all such agreements are in full
force and effect, except, in the case of any of clauses (i)-(vii)
above, for any such infringement by third parties or any such
pending or threatened suit, action, proceeding or claim as would
not, individually or in the aggregate, reasonably be expected to
have a Material Adverse Effect.
(w) Clinical Studies. The
preclinical studies and tests and clinical trials described in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus were, and, if still pending, are being conducted in all
material respects in accordance with the experimental protocols,
procedures and controls pursuant to, where applicable, accepted
professional and scientific standards for products or product
candidates comparable to those being developed by the Company; the
descriptions of such studies, tests and trials, and the results
thereof, contained in the Registration Statement, the Time of Sale
Prospectus and the Prospectus are accurate and complete in all
material respects; the Company is not aware of any tests, studies
or trials not described in the Registration Statement, the Time of
Sale Prospectus and the Prospectus, the results of which reasonably
call into question the results of the tests, studies and trials
described in the Registration Statement, the Time of Sale
Prospectus and the Prospectus; and the Company has not received any
written notice or correspondence from the FDA or any foreign, state
or local Governmental Authority exercising comparable authority or
any institutional review board or comparable authority requiring
the termination, suspension, clinical hold or material modification
of any tests, studies or trials.
(x) No Material Defaults. Neither
the Company nor any of the Subsidiaries has defaulted on any
installment on indebtedness for borrowed money or on any rental on
one or more long-term leases, which defaults, individually or in
the aggregate, would reasonably be expected to have a Material
Adverse Effect. The Company has not (i) failed to pay any dividend
or sinking fund installment on preferred shares or (ii) defaulted
on any installment on indebtedness for borrowed money or on any
rental on one or more long-term leases, which defaults,
individually or in the aggregate, would have a Material Adverse
Effect.
(y) Certain Market Activities.
Neither the Company nor any of its Subsidiaries has taken, directly
or indirectly, any action designed to or that might cause or result
in stabilization or manipulation of the price of the Common Stock
or of any other securities, including any “reference
security” (as defined in Rule 100 of Regulation M under the
Exchange Act (“Regulation
M”)) with respect to the Common Stock, whether to
facilitate the sale or resale of the Offered Shares or otherwise,
and has taken no action which would directly or indirectly violate
Regulation M or applicable foreign securities laws and
rules.
(z) No Reliance. The Company has
not relied upon the Underwriters or legal counsel for the
Underwriters for any legal, tax or accounting advice in connection
with the offering and sale of the Offered Shares.
(aa) Taxes.
The Company and each of its Subsidiaries have filed all federal,
state, local and foreign tax returns which have been required to be
filed and paid all taxes shown thereon through the date hereof, to
the extent that such taxes have become due and are not being
contested in good faith, except where the failure to so file or pay
would not reasonably be expected to have a Material Adverse Effect.
Except as otherwise disclosed in or contemplated by the
Registration Statement, the Time of Sale Prospectus or the
Prospectus, no tax deficiency has been determined adversely to the
Company or any of its Subsidiaries which has had, or would
reasonably be expected to have, individually or in the aggregate, a
Material Adverse Effect. The Company has no knowledge of any
federal, state, or other governmental tax deficiency, penalty or
assessment which has been or might be asserted or threatened
against it which would reasonably be expected to have a Material
Adverse Effect.
(bb) Title
to Real and Personal Property. Except as set forth in the
Registration Statement, the Time of Sale Prospectus or the
Prospectus, the Company and its Subsidiaries have good and
marketable title in fee simple to all items of real property owned
by them, good and valid title to all personal property described in
the Registration Statement, the Time of Sale Prospectus or the
Prospectus as being owned by them that are material to the
businesses of the Company or such Subsidiary, in each case free and
clear of all mortgages, liens, encumbrances and claims, except
those matters that (i) do not materially interfere with the use
made and proposed to be made of such property by the Company and
any of its Subsidiaries or (ii) would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse
Effect. Any real or personal property described in the Registration
Statement, the Time of Sale Prospectus or the Prospectus as being
leased by the Company and any of its Subsidiaries is held by them
under valid, existing and enforceable leases, free and clear of all
mortgages, liens, encumbrances and claims, except those matters
that (A) do not materially interfere with the use made or proposed
to be made of such property by the Company or any of its
Subsidiaries or (B) would not reasonably be expected, individually
or in the aggregate, to have a Material Adverse Effect. Each of the
properties of the Company and its Subsidiaries complies with all
applicable codes, laws and regulations (including, without
limitation, building and zoning codes, laws and regulations and
laws relating to access to such properties), except for such
failures to comply that would not, individually or in the
aggregate, reasonably be expected to interfere in any material
respect with the use made and proposed to be made of such property
by the Company and its Subsidiaries or otherwise have a Material
Adverse Effect. None of the Company or its Subsidiaries has
received from any Governmental Authorities any notice of any
condemnation of, or zoning change affecting, the properties of the
Company and its Subsidiaries, and the Company knows of no such
condemnation or zoning change which is threatened, except for such
that would not reasonably be expected to interfere in any material
respect with the use made and proposed to be made of such property
by the Company and its Subsidiaries or otherwise have a Material
Adverse Effect, individually or in the aggregate.
(cc) Environmental
Laws. Except as set forth in the Registration Statement, the
Time of Sale Prospectus or the Prospectus, the Company and its
Subsidiaries (i) are in compliance with any and all applicable
federal, state, local and foreign laws, rules, regulations,
decisions and orders relating to the protection of human health and
safety, the environment or hazardous or toxic substances or wastes,
pollutants or contaminants (collectively, “Environmental Laws”);
(ii) have received and are in compliance with all permits,
licenses or other approvals required of them under applicable
Environmental Laws to conduct their respective businesses as
described in the Registration Statement, the Time of Sale
Prospectus or the Prospectus; and (iii) have not received
notice of any actual or potential liability for the investigation
or remediation of any disposal or release of hazardous or toxic
substances or wastes, pollutants or contaminants, except, in the
case of any of clauses (i), (ii) or (iii) above, for any such
failure to comply or failure to receive required permits, licenses,
other approvals or liability as would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse
Effect.
(dd) Disclosure
Controls. The Company and each of its Subsidiaries maintain
systems 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
generally accepted accounting principles 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’s internal control over financial reporting is
effective and the Company is not aware of any material weaknesses
in its internal control over financial reporting (other than as set
forth in the Registration Statement, Time of Sale Prospectus or
Prospectus). Since the date of the latest audited financial
statements of the Company included in the Prospectus, there has
been no change in the Company’s internal control over
financial reporting that has materially affected, or is reasonably
likely to materially affect, the Company’s internal control
over financial reporting (other than as set forth in the
Registration Statement, Time of Sale Prospectus or Prospectus). The
Company has established disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15 and 15d-15) for the Company
and designed such disclosure controls and procedures to ensure that
material information relating to the Company and each of its
Subsidiaries is made known to the certifying officers by others
within those entities, particularly during the period in which the
Company’s Annual Report on Form 10-K or Quarterly Report on
Form 10-Q, as the case may be, is being prepared. The
Company’s certifying officers have evaluated the
effectiveness of the Company’s disclosure controls and
procedures as of a date within 90 days prior to the filing date of
the Form 10-K for the fiscal year most recently ended (such date,
the “Evaluation
Date”). The Company presented in its Form 10-K for the
fiscal year most recently ended the conclusions of the certifying
officers about the effectiveness of the disclosure controls and
procedures based on their evaluations as of the Evaluation Date and
the disclosure controls and procedures are effective. Since the
Evaluation Date, there have been no significant changes in the
Company’s internal controls (as such term is defined in Item
307(b) of Regulation S-K under the Securities Act) or, to the
Company’s knowledge, in other factors that could
significantly affect the Company’s internal
controls.
(ee) Board
of Directors. The qualifications of the persons serving as
board members and the overall composition of the board comply with
the Exchange Act, Sarbanes-Oxley Act and the listing rules of the
NASDAQ. At least one member of the Audit Committee of the board of
directors of the Company qualifies as an “audit committee
financial expert,” as such term is defined under Regulation
S-K and the listing rules of the NASDAQ. In addition, at least a
majority of the persons serving on the board of directors qualify
as “independent,” as defined under the listing rules of
the NASDAQ. The Audit Committee and Compensation Committee of the
board of directors of the Company are comprised solely of
“independent directors” as required under applicable
securities laws and the rules of the NASDAQ.
(ff) Sarbanes-Oxley.
There is and has been no failure on the part of the Company or any
of the Company’s directors or officers, in their capacities
as such, to comply in all material respects with any applicable
provisions of the Sarbanes-Oxley Act and the rules and regulations
promulgated thereunder. Each of the principal executive officer and
the principal financial officer of the Company (or each former
principal executive officer of the Company and each former
principal financial officer of the Company as applicable) has made
all certifications required by Sections 302 and 906 of the
Sarbanes-Oxley Act with respect to all reports, schedules, forms,
statements and other documents required to be filed by it or
furnished by it to the Commission. For purposes of the preceding
sentence, “principal executive officer” and
“principal financial officer” shall have the meanings
given to such terms in the Sarbanes-Oxley Act.
(gg) Brokers.
Neither the Company nor any of the Subsidiaries has incurred any
liability for any finder’s fees, brokerage commissions or
similar payments in connection with the transactions herein
contemplated, except as may otherwise exist with respect to or
pursuant to this Agreement.
(hh) Labor
Disputes and Matters. Neither the Company or any of its
Subsidiaries employs any person represented by a union or
collective bargaining unit. No labor disturbance by or dispute with
employees of the Company or any of its Subsidiaries exists or, to
the knowledge of the Company, is threatened which would reasonably
be expected to have a Material Adverse Effect.
(ii) Investment
Company Act. Neither the Company nor any of the Subsidiaries
is, or will be, either after receipt of payment for the Offered
Shares or after the application of the proceeds therefrom as
described under “Use of Proceeds” in the Registration
Statement, the Time of Sale Prospectus or the Prospectus, required
to register as an “investment company” or an entity
“controlled” by an “investment company,” as
such terms are defined in the Investment Company Act of 1940, as
amended (the “Investment
Company Act”).
(jj) Operations.
The operations of the Company and its Subsidiaries are and have
been conducted at all times in material compliance with applicable
financial record keeping and reporting requirements of applicable
law, including the Currency and Foreign Transactions Reporting Act
of 1970, as amended, the money laundering statutes of all
jurisdictions to which the Company or its Subsidiaries are subject,
the rules and regulations thereunder and any related or similar
rules, regulations or guidelines, issued, administered or enforced
by any Governmental Authority (collectively, the
“Money Laundering
Laws”); and no action, suit or proceeding by or before
any Governmental Authority involving the Company or any of its
Subsidiaries with respect to the Money Laundering Laws is pending
or, to the knowledge of the Company, threatened.
(kk) Off-Balance
Sheet Arrangements. There are no transactions, arrangements
and other relationships between and/or among the Company, and/or
any of its affiliates and any unconsolidated entity, including, but
not limited to, any structural finance, special purpose or limited
purpose entity (each, an “Off-Balance Sheet Transaction”)
that would affect materially the Company’s liquidity or the
availability of or requirements for its capital resources,
including those Off-Balance Sheet Transactions described in the
Commission’s Statement about Management’s Discussion
and Analysis of Financial Conditions and Results of Operations
(Release Nos. 33-8056; 34-45321; FR-61), required to be described
in the Registration Statement, the Time of Sale Prospectus or the
Prospectus which have not been described as required.
(ll) ERISA.
To the knowledge of the Company, each material employee benefit
plan, within the meaning of Section 3(3) of the Employee Retirement
Income Security Act of 1974, as amended (“ERISA”), that is maintained,
administered or contributed to by the Company or any of its
affiliates for employees or former employees of the Company and any
of its Subsidiaries has been maintained in material compliance with
its terms and the requirements of any applicable statutes, orders,
rules and regulations, including but not limited to ERISA and the
Internal Revenue Code of 1986, as amended (the “Code”); no prohibited transaction,
within the meaning of Section 406 of ERISA or Section 4975 of the
Code, has occurred which would result in a material liability to
the Company with respect to any such plan excluding transactions
effected pursuant to a statutory or administrative exemption; and
for each such plan that is subject to the funding rules of Section
412 of the Code or Section 302 of ERISA, no “accumulated
funding deficiency” as defined in Section 412 of the Code has
been incurred, whether or not waived, and the fair market value of
the assets of each such plan (excluding for these purposes accrued
but unpaid contributions) exceeds the present value of all benefits
accrued under such plan determined using reasonable actuarial
assumptions. Each of the material employee benefit plans of the
Company complies in all material respects with applicable
law.
(mm) Forward-Looking
Statements. Each financial or operational projection or
other “forward-looking statement” (as defined by
Section 27A of the Securities Act or Section 21E of the Exchange
Act, or as defined by any other applicable securities laws)
contained in the Registration Statement, the Time of Sale
Prospectus or the Prospectus (i) was so included by the
Company in good faith and with reasonable basis after due
consideration by the Company of the underlying assumptions,
estimates and other applicable facts and circumstances and
(ii) is accompanied by meaningful cautionary statements
identifying those factors that could cause actual results to differ
materially from those in such forward-looking statement. No such
statement was made with the knowledge of an executive officer or
director of the Company that it was false or
misleading.
(nn) Margin
Rules. Neither the issuance, sale and delivery of the
Offered Shares nor the application of the proceeds thereof by the
Company as described in the Registration Statement and the
Prospectus will violate Regulation T, U or X of the Board of
Governors of the Federal Reserve System or any other regulation of
such Board of Governors.
(oo) Insurance.
The Company and each of its Subsidiaries carry, or are covered by,
insurance in such amounts and covering such risks as the Company
and each of its Subsidiaries reasonably believe are adequate for
the conduct of their business and as is customary for companies
engaged in similar businesses in similar industries.
(pp) No
Improper Practices. (i) Neither the Company nor the
Subsidiaries, nor any director, officer, or employee of the Company
or any Subsidiary nor, to the Company’s knowledge, any agent,
affiliate or other person acting on behalf of the Company or any
Subsidiary has, in the past five years, made any unlawful
contributions to any candidate for any political office (or failed
fully to disclose any contribution in violation of applicable law)
or made any contribution or other payment to any official of, or
candidate for, any federal, state, municipal, or foreign office or
other person charged with similar public or quasi-public duty in
violation of any applicable law or of the character required to be
disclosed in the Prospectus; (ii) no relationship, direct or
indirect, exists between or among the Company or any Subsidiary or
any affiliate of any of them, on the one hand, and the directors,
officers and stockholders of the Company or any Subsidiary, on the
other hand, that is required by the Securities Act to be described
in the Registration Statement, the Time of Sale Prospectus and the
Prospectus that is not so described; (iii) no relationship,
direct or indirect, exists between or among the Company or any
Subsidiary or any affiliate of them, on the one hand, and the
directors, officers, or stockholders of the Company or any
Subsidiary, on the other hand, that is required by the rules of
FINRA to be described in the Registration Statement, the Time of
Sale Prospectus and the Prospectus that is not so described; (iv)
there are no material outstanding loans or advances or material
guarantees of indebtedness by the Company or any Subsidiary to or
for the benefit of any of their respective officers or directors or
any of the members of the families of any of them; and (v) the
Company has not offered, or caused any placement agent to offer,
Common Stock to any person with the intent to influence unlawfully
(A) a customer or supplier of the Company or any Subsidiary to
alter the customer’s or supplier’s level or type of
business with the Company or any Subsidiary or (B) a trade
journalist or publication to write or publish favorable information
about the Company or any Subsidiary or any of their respective
products or services, and, (vi) neither the Company nor any
Subsidiary nor any director, officer or employee of the Company or
any Subsidiary nor, to the Company’s knowledge, any agent,
affiliate or other person acting on behalf of the Company or any
Subsidiary has (A) violated or is in violation of any applicable
provision of the U.S. Foreign Corrupt Practices Act of 1977, as
amended, or any other applicable anti-bribery or anti-corruption
law (collectively, “Anti-Corruption Laws”), (B)
promised, offered, provided, attempted to provide or authorized the
provision of anything of value, directly or indirectly, to any
person for the purpose of obtaining or retaining business,
influencing any act or decision of the recipient or securing any
improper advantage, or (C) made any payment of funds of the Company
or any Subsidiary or received or retained any funds in violation of
any Anti-Corruption Laws.
(qq) No
Conflicts. Neither the execution of this Agreement and the
Representative’s Warrant Agreement, nor the issuance,
offering or sale of the Offered Shares and the
Representative’s Securities, nor the consummation of any of
the transactions contemplated herein or therein, nor the compliance
by the Company with the terms and provisions hereof or thereof will
conflict with, or will result in a breach of, any of the terms and
provisions of, or has constituted or will constitute a default
under, or has resulted in or will result in the creation or
imposition of any lien, charge or encumbrance upon any property or
assets of the Company pursuant to the terms of any contract or
other agreement to which the Company may be bound or to which any
of the property or assets of the Company is subject, except (i)
such conflicts, breaches or defaults as may have been waived and
(ii) such conflicts, breaches and defaults that would not
reasonably be expected to have a Material Adverse Effect; nor will
such action result (x) in any violation of the provisions of the
organizational or governing documents of the Company, or (y) in any
violation of the provisions of any statute or any order, rule or
regulation applicable to the Company or of any Governmental
Authority having jurisdiction over the Company other than, with
respect to clause (y) only, any violation that would not have a
Material Adverse Effect; provided, however, that such violation
shall not have any adverse effect with respect to the
Underwriters.
(rr) Sanctions.
(i) The Company represents that, neither the Company nor any of its
Subsidiaries (collectively, the “Entity”) or, any director,
officer, employee, agent, affiliate or representative of the
Entity, is a government, individual, or entity (in this paragraph
(tt), “Person”)
that is, or is owned or controlled by a Person that
is:
(A) the
subject of any sanctions administered or enforced by the U.S.
Department of Treasury’s Office of Foreign Assets Control
(“OFAC”), the
United Nations Security Council, the European Union, Her
Majesty’s Treasury, or other relevant sanctions authorities,
including designation on OFAC’s Specially Designated
Nationals and Blocked Persons List, OFAC’s Foreign Sanctions
Evaders List or other similar applicable legislation or rules (as
amended, collectively, “Sanctions”), nor
(B) located,
organized or resident in a country or territory that is the subject
of Sanctions that broadly prohibit dealings with that country or
territory (including Cuba, Iran, North Korea, Sudan, Syria and the
Crimea Region of the Ukraine) (the “Sanctioned
Countries”).
(ii) The
Entity represents and covenants that it will not, directly or
indirectly, use the proceeds of the offering, or lend, contribute
or otherwise make available such proceeds to any subsidiary, joint
venture partner or other Person:
(A) to
fund or facilitate any activities or business of or with any Person
or in any country or territory that, at the time of such funding or
facilitation, is the subject of Sanctions or is a Sanctioned
Country; or
(B) in
any other manner that will result in a violation of Sanctions by
any Person (including any Person participating in the offering,
whether as underwriter, advisor, investor or
otherwise).
(iii) The
Entity represents and covenants that, except as detailed in the
Registration Statement and the Prospectus, for the past 5 years, it
has not engaged in, is not now engaging in, and will not engage in,
any dealings or transactions with any Person, or in any country or
territory, that at the time of the dealing or transaction is or was
the subject of Sanctions or is or was a Sanctioned
Country.
(ss) Compliance
with Laws. Each of the Company and its Subsidiaries: (i) is
and at all times has been in compliance with all statutes, rules,
or regulations applicable to the ownership, testing, development,
manufacture, packaging, processing, use, distribution, marketing,
labeling, promotion, sale, offer for sale, storage, import, export
or disposal of any product manufactured or distributed by the
Company or its Subsidiaries (“Applicable Laws”), except as would
not, individually or in the aggregate, reasonably be expected to
have a Material Adverse Effect; (ii) has not received any FDA Form
483, notice of adverse finding, warning letter, untitled letter or
other correspondence or notice from the FDA or any other
Governmental Authority alleging or asserting noncompliance with any
Applicable Laws or any licenses, certificates, approvals,
clearances, authorizations, permits and supplements or amendments
thereto required by any such Applicable Laws (“Authorizations”); (iii) possesses
all material Authorizations and such Authorizations are valid and
in full force and effect and are not in material violation of any
term of any such Authorizations; (iv) has not received notice of
any claim, action, suit, proceeding, hearing, enforcement,
investigation, arbitration or other action from any Governmental
Authority or third party alleging that any product operation or
activity is in violation of any Applicable Laws or Authorizations
and has no knowledge that any such Governmental Authority or third
party is considering any such claim, litigation, arbitration,
action, suit, investigation or proceeding; (v) has not received
notice that any Governmental Authority has taken, is taking or
intends to take action to limit, suspend, modify or revoke any
Authorizations and has no knowledge that any such Governmental
Authority is considering such action; (vi) has filed, obtained,
maintained or submitted all material reports, documents, forms,
notices, applications, records, claims, submissions and supplements
or amendments as required by any Applicable Laws or Authorizations
and that all such reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments were
complete and correct on the date filed (or were corrected or
supplemented by a subsequent submission); and (vii) has not, either
voluntarily or involuntarily, initiated, conducted, or issued or
caused to be initiated, conducted or issued, any recall, market
withdrawal or replacement, safety alert, post-sale warning,
“dear healthcare provider” letter, or other notice or
action relating to the alleged lack of safety or efficacy of any
product or any alleged product defect or violation and, to the
Company’s knowledge, no third party has initiated, conducted
or intends to initiate any such notice or action.
(tt) Statistical
and Market-Related Data. All statistical, demographic and
market-related data included in the Registration Statement, the
Time of Sale Prospectus or the Prospectus are based on or derived
from sources that the Company believes to be reliable and accurate
or represent the Company’s good faith estimates that are made
on the basis of data derived from such sources.
(uu) Stock
Exchange Listing. The Common Stock is
registered pursuant to Section 12(b) of the Exchange Act and is
listed on the Nasdaq Capital Market of the NASDAQ, and the Company
has taken no action designed to, or likely to have the effect of,
terminating the registration of the Common Stock under the Exchange
Act or delisting the Common Stock from the Nasdaq Capital Market of
the NASDAQ. Except as set forth in the Registration Statement, the
Pricing Disclosure Package or the Prospectus, the Company has not
received any notification that the Commission or the NASDAQ is
contemplating terminating such registration or listing. To the
Company’s knowledge, it is in compliance with all applicable
listing requirements of the NASDAQ, except as disclosed in the
Registration Statement, the Time of Sale Prospectus or the
Prospectus.
(vv) Related-Party
Transactions. There are no business
relationships or related-party transactions involving the Company
or any of its Subsidiaries or any other person required to be
described in the Registration Statement, the Time of Sale
Prospectus or the Prospectus that have not been described as
required.
(ww) FINRA
Matters. All of the information provided to the Underwriters
or to counsel for the Underwriters by the Company, its counsel, its
officers and directors and the holders of any securities (debt or
equity) or options to acquire any securities of the Company in
connection with the offering of the Offered Shares is true,
complete, correct and compliant with FINRA’s rules and any
letters, filings or other supplemental information provided to
FINRA pursuant to FINRA Rules is true, complete and
correct.
(xx) Cybersecurity.
The Company and its Subsidiaries’ information technology
assets and equipment, computers, systems, networks, hardware,
software, websites, applications, and databases (collectively,
“IT Systems”)
are adequate for, and operate and perform in all material respects
as required in connection with the operation of the business of the
Company and its Subsidiaries as currently conducted, and, to the
knowledge of the Company, free and clear of all material bugs,
errors, defects, Trojan horses, time bombs, malware and other
corruptants. The Company and its Subsidiaries have implemented
commercially reasonable physical, technical and administrative
controls, policies, procedures, and safeguards to maintain and
protect their material confidential information and the integrity,
continuous operation, redundancy and security of all IT Systems and
data, including “Personal Data,” used in connection
with their businesses. “Personal Data” means (i) a natural
person’s name, street address, telephone number, e-mail
address, photograph, social security number or tax identification
number, driver’s license number, passport number, credit card
number, bank information, or customer or account number; (ii) any
information which would qualify as “personally identifying
information” under the Federal Trade Commission Act, as
amended; (iii) “personal data” as defined by GDPR; (iv)
any information which would qualify as “protected health
information” under the Health Insurance Portability and
Accountability Act of 1996, as amended by the Health Information
Technology for Economic and Clinical Health Act (collectively,
“HIPAA”); and (v) any other
piece of information that allows the identification of such natural
person, or his or her family, or permits the collection or analysis
of any data related to an identified person’s health or
sexual orientation. Except as disclosed in the Registration
Statement, the Time of Sale Prospectus or the Prospectus, there
have been no breaches, violations, outages or unauthorized uses of
or accesses to same, except for those that have been remedied
without material cost or liability or the duty to notify any other
person, nor any incidents under internal review or investigations
relating to the same. The Company and its Subsidiaries are
presently in material compliance with all applicable laws or
statutes and all judgments, orders, rules and regulations of any
court or arbitrator or governmental or regulatory authority,
internal policies and contractual obligations relating to the
privacy and security of IT Systems and Personal Data and to the
protection of such IT Systems and Personal Data from unauthorized
use, access, misappropriation or modification.
(yy) Compliance
with Data Privacy Laws. The Company and its Subsidiaries
are, and at all prior times were, in material compliance with all
applicable state and federal data privacy and security laws and
regulations, including without limitation HIPAA, and the Company
and its Subsidiaries are in compliance with the European Union
General Data Protection Regulation (“GDPR”) (EU 2016/679)
(collectively, the “Privacy
Laws”). To ensure compliance with the Privacy Laws,
the Company and its Subsidiaries have in place, comply with, and
take appropriate steps reasonably designed to ensure compliance in
all material respects with their policies and procedures relating
to data privacy and security and the collection, storage, use,
disclosure, handling, and analysis of Personal Data (the
“Policies”). The
Company and its Subsidiaries have, to the knowledge of the Company,
at all times made all disclosures to users or customers required by
applicable laws and regulatory rules or requirements, and none of
such disclosures made or contained in any Policy have, to the
knowledge of the Company, been inaccurate or in violation of any
applicable laws and regulatory rules or requirements in any
material respect. The Company further certifies that neither it nor
any Subsidiary: (i) has received notice of any actual or potential
liability under or relating to, or actual or potential violation
of, any of the Privacy Laws, and has no knowledge of any event or
condition that would reasonably be expected to result in any such
notice; (ii) is currently conducting or paying for, in whole or in
part, any investigation, remediation, or other corrective action
pursuant to any Privacy Law; or (iii) is a party to any order,
decree, or agreement that imposes any obligation or liability under
any Privacy Law.
(zz) No
Contract Terminations. Neither the Company nor any of its
Subsidiaries has sent or received any communication regarding
termination of, or intent not to renew, any of the contracts or
agreements referred to or described in the Registration Statement,
the Time of Sale Prospectus or the Prospectus, and no such
termination or non-renewal has been threatened by the Company or
any of its Subsidiaries or, to the Company’s knowledge, any
other party to any such contract or agreement, which threat of
termination or non-renewal has not been rescinded as of the date
hereof.
(aaa) Emerging
Growth Company Status. The Company is an “emerging
growth company,” as defined in Section 2(a) of the Securities
Act.
(bbb) Integration.
Neither the Company, nor any of its affiliates, nor any person
acting on its or their behalf has, directly or indirectly, made any
offers or sales of any security or solicited any offers to buy any
security, under circumstances that, to the knowledge of the
Company, would cause the offering of the Offered Shares to be
integrated with prior offerings by the Company for purposes of the
Securities Act that would require the registration of any such
securities under the Securities Act.
(ccc) Parties
to Lock-Up Agreements. As of the First Closing Date, the
Company has furnished to the Underwriters a letter agreement in the
form attached hereto as Exhibit A (the “Lock-up
Agreement”) from each of the persons listed on Exhibit B. Such Exhibit B lists under an
appropriate caption the directors and executive officers and
certain other stockholders of the Company. If any additional
persons shall become directors or executive officers of the Company
prior to the end of the Lock-up Period (as defined in Exhibit A attached hereto), the
Company shall cause each such person, prior to or contemporaneously
with their appointment or election as a director or executive
officer of the Company, to execute and deliver to Wainwright a
Lock-up Agreement.
Any
certificate signed by any officer of the Company or any of its
Subsidiaries and delivered to any Underwriter or to counsel for the
Underwriters in connection with the offering, or the purchase and
sale, of the Offered Shares shall be deemed a representation and
warranty by the Company to each Underwriter as to the matters
covered thereby.
The
Company has a reasonable basis for making each of the
representations set forth in this Section 1. The Company
acknowledges that the Underwriters and, for purposes of the
opinions to be delivered pursuant to Section 6 hereof, counsel to
the Company and counsel to the Underwriters, will rely upon the
accuracy and truthfulness of the foregoing representations and
hereby consents to such reliance.
2. Purchase, Sale and Delivery of the Offered
Shares and Representative’s Warrant
(a) The Firm Shares. Upon the terms
herein set forth, the Company agrees to issue and sell to the
several Underwriters an aggregate of 9,090,910 Firm Shares. On the
basis of the representations, warranties and agreements herein
contained, and upon the terms but subject to the conditions herein
set forth, the Underwriters agree, severally and not jointly, to
purchase from the Company the respective number of Firm Shares set
forth opposite their names on Schedule A. The purchase price
per Firm Share to be paid by the several Underwriters to the
Company shall be $0.506 per share.
(b) The First Closing Date.
Delivery of book-entry entitlements for the Firm Shares to be
purchased by the Underwriters and payment therefor shall be made at
the offices of Haynes and Boone, LLP, 30 Rockefeller Plaza,
26th
Floor, New York, NY 10012 (or such other place as may be agreed to
by the Company and the Representative) at 10:00 a.m. Eastern time,
on July 27, 2021, or such other time and date not later than 1:00
p.m. Eastern time, on July 27, 2021, as the Representative shall
designate by notice to the Company (the time and date of such
closing are called the “First
Closing Date”). The Company hereby acknowledges that
circumstances under which the Representative may provide notice to
postpone the First Closing Date as originally scheduled include,
but are not limited to, any determination by the Company or the
Representative to recirculate to the public copies of an amended or
supplemented Prospectus or a delay as contemplated by the
provisions of Section 11.
(c) The Optional Shares; Option Closing
Date. In addition, on the basis of the representations,
warranties and agreements herein contained, and upon the terms but
subject to the conditions herein set forth, the Company hereby
grants an option to the several Underwriters to purchase, severally
and not jointly, up to an aggregate of 1,363,636 Optional Shares
from the Company at the purchase price per share to be paid by the
Underwriters for the Firm Shares. The option granted hereunder may
be exercised at any time and from time to time in whole or in part
upon notice by the Representative to the Company, which notice may
be given at any time within 30 days from the date of this
Agreement. Such notice shall set forth (i) the aggregate number of
Optional Shares as to which the Underwriters are exercising the
option and (ii) the time, date and place at which book-entry
entitlements for the Optional Shares will be delivered (which time
and date may be simultaneous with, but not earlier than, the First
Closing Date; and in the event that such time and date are
simultaneous with the First Closing Date, the term
“First Closing
Date” shall refer to the time and date of delivery of
book-entry entitlements for the Firm Shares and such Optional
Shares). Any such time and date of delivery, if subsequent to the
First Closing Date, is called an “Option Closing Date,” shall be
determined by the Representative and shall not be earlier than two
or later than five full business days after delivery of such notice
of exercise. If any Optional Shares are to be purchased, (a) each
Underwriter agrees, severally and not jointly, to purchase the
number of Optional Shares (subject to such adjustments to eliminate
fractional shares as the Representative may determine) that bears
the same proportion to the total number of Optional Shares to be
purchased as the number of Firm Shares set forth on Schedule A opposite the name of
such Underwriter bears to the total number of Firm Shares and (b)
the Company agrees to sell the number of Optional Shares set forth
in the paragraph “Introductory” of this Agreement
(subject to such adjustments to eliminate fractional shares as the
Representative may determine). The Representative may cancel the
option at any time prior to its expiration by giving written notice
of such cancellation to the Company.
(d) Public Offering of the Offered
Shares. The Representative hereby advises the Company that
the Underwriters intend to offer for sale to the public, initially
on the terms set forth in the Registration Statement, the Time of
Sale Prospectus and the Prospectus, their respective portions of
the Offered Shares as soon after this Agreement has been executed
as the Representative, in its sole judgment, has determined is
advisable and practicable.
(e) Payment for the Offered Shares.
(i) Payment for the Offered Shares shall be made at the First
Closing Date (and, if applicable, at each Option Closing Date) by
wire transfer of immediately available funds to the order of the
Company. (ii) It is understood that the Representative has been
authorized, for their own account and the accounts of the several
Underwriters, to accept delivery of and receipt for, and make
payment of the purchase price for, the Firm Shares and any Optional
Shares the Underwriters have agreed to purchase. Wainwright,
individually and not as the Representative of the Underwriters, may
(but shall not be obligated to) make payment for any Offered Shares
to be purchased by any Underwriter whose funds shall not have been
received by the Representative by the First Closing Date or the
applicable Option Closing Date, as the case may be, for the account
of such Underwriter, but any such payment shall not relieve such
Underwriter from any of its obligations under this
Agreement.
(f) Delivery of the Offered Shares.
The Company shall deliver, or cause to be delivered to the
Representative for the accounts of the several Underwriters
book-entry entitlements for the Firm Shares at the First Closing
Date, against the irrevocable release of a wire transfer of
immediately available funds for the amount of the purchase price
therefor. The Company shall also deliver, or cause to be delivered
through the facilities of DTC unless the Representative shall
otherwise instruct, to the Representative for the accounts of the
several Underwriters, book-entry entitlements for the Optional
Shares the Underwriters have agreed to purchase at the First
Closing Date or the applicable Option Closing Date, as the case may
be, against the release of a wire transfer of immediately available
funds for the amount of the purchase price therefor. If the
Representative so elects, delivery of the Offered Shares will be
made by credit to the accounts designated by the Representative
through The Depository Trust Company’s full fast transfer or
DWAC programs. Time shall be of the essence, and delivery at the
time and place specified in this Agreement is a further condition
to the obligations of the Underwriters.
(g) Representative’s
Warrants. The Company hereby agrees to issue to the
Representative (and/or its designees) on the First Closing Date and
on each Option Closing Date, a warrant (“Representative’s Warrant”)
for the purchase of that number of shares of Common Stock equal to
7% of the Offered Shares issued on the First Closing Date or such
Option Closing Date, as the case may be. The Representative’s
Warrant agreement (the “Representative’s Warrant
Agreement”), shall be exercisable, in whole or in
part, immediately and expiring on the five-year anniversary of the
date of issuance, at an initial exercise price per share of Common
Stock of $0.6875, which is equal to 125% of the public offering
price of the Firm Shares. The Representative’s Warrant
Agreement and the shares of Common Stock issuable upon exercise
thereof are hereinafter referred to together as the
“Representative’s
Securities.”
3. Additional Covenants
of the
Company.
The
Company further covenants and agrees with each Underwriter as
follows:
(a) Delivery of Registration Statement,
Time of Sale Prospectus and Prospectus. The Company shall furnish to you
in New York City, without charge, prior to 10:00 a.m. New York City
time on the business day next succeeding the date of this Agreement
and during the period when a prospectus relating to the Offered
Shares is required by the Securities Act to be delivered (whether
physically or through compliance with Rule 172 under the Securities
Act or any similar rule) in connection with sales of the Offered
Shares, as many copies of the Time of Sale Prospectus, the
Prospectus and any supplements and amendments thereto or to the
Registration Statement as you may reasonably request.
(b) Representative’s Review of
Proposed Amendments and Supplements. During the period when
a prospectus relating to the Offered Shares is required by the
Securities Act to be delivered (whether physically or through
compliance with Rule 172 under the Securities Act or any similar
rule), the Company (i) will furnish to the Representative for
review, a reasonable period of time prior to the proposed time of
filing of any proposed amendment or supplement to the Registration
Statement, a copy of each such amendment or supplement and (ii)
will not amend or supplement the Registration Statement (including
any amendment or supplement through incorporation of any report
filed under the Exchange Act) without the Representative’s
prior written consent, not to be unreasonably withheld, conditioned
or delayed. Prior to amending or supplementing any preliminary
prospectus, the Time of Sale Prospectus or the Prospectus
(including any amendment or supplement through incorporation of any
report filed under the Exchange Act), the Company shall furnish to
the Representative for review, a reasonable amount of time prior to
the time of filing or use of the proposed amendment or supplement,
a copy of each such proposed amendment or supplement. The Company
shall not file or use any such proposed amendment or supplement
without the Representative’s prior written consent, not to be
unreasonably withheld, conditioned or delayed. The Company shall
file with the Commission within the applicable period specified in
Rule 424(b) under the Securities Act any prospectus required to be
filed pursuant to such Rule.
(c) Free Writing
Prospectuses.
The Company shall furnish to the Representative for review, a
reasonable amount of time prior to the proposed time of filing or
use thereof, a copy of each proposed free writing prospectus or any
amendment or supplement thereto prepared by or on behalf of, used
by, or referred to by the Company, and the Company shall not file,
use or refer to any proposed free writing prospectus or any
amendment or supplement thereto without the Representative’s
prior written consent, not to be unreasonably withheld, conditioned
or delayed. The Company shall furnish to each Underwriter, without
charge, as many copies of any free writing prospectus prepared by
or on behalf of, used by or referred to by the Company as such
Underwriter may reasonably request. If at any time when a
prospectus is required by the Securities Act to be delivered
(whether physically or through compliance with Rule 172 under the
Securities Act or any similar rule) in connection with sales of the
Offered Shares (but in any event if at any time through and
including the later of the First Closing Date or the Option Closing
Date) there occurred or occurs an event or development as a result
of which any free writing prospectus prepared by or on behalf of,
used by, or referred to by the Company conflicted or would conflict
with the information contained in the Registration Statement or
included or would include an untrue statement of a material fact or
omitted or would omit to state a material fact necessary in order
to make the statements therein, in the light of the circumstances
prevailing at such time, not misleading, the Company shall promptly
amend or supplement such free writing prospectus to eliminate or
correct such conflict so that the statements in such free writing
prospectus as so amended or supplemented will not include an untrue
statement of a material fact or omit to state a material fact
necessary in order to make the statements therein, in the light of
the circumstances prevailing at such time, not misleading, as the
case may be; provided,
however, that prior to amending or supplementing any such
free writing prospectus, the Company shall furnish to the
Representative for review, a reasonable amount of time prior to the
proposed time of filing or use thereof, a copy of such proposed
amended or supplemented free writing prospectus, and the Company
shall not file, use or refer to any such amended or supplemented
free writing prospectus without the Representative’s prior
written consent, not to be unreasonably withheld, conditioned or
delayed.
(d) Filing of Underwriter Free Writing
Prospectuses.
The Company shall not take any action that would result in an
Underwriter or the Company being required to file with the
Commission pursuant to Rule 433(d) under the Securities Act a free
writing prospectus prepared by or on behalf of such Underwriter
that such Underwriter otherwise would not have been required to
file thereunder.
(e) Amendments and Supplements to Time of
Sale Prospectus. If the Time of Sale Prospectus
is being used to solicit offers to buy the Offered Shares at a time
when the Prospectus is not yet available to prospective purchasers,
and any event shall occur or condition exist as a result of which
it is necessary to amend or supplement the Time of Sale Prospectus
so that the Time of Sale Prospectus does not include an untrue
statement of a material fact or omit to state a material fact
necessary in order to make the statements therein, in the light of
the circumstances when delivered to a prospective purchaser, not
misleading, or if any event shall occur or condition exist as a
result of which the Time of Sale Prospectus conflicts with the
information contained in the Registration Statement, or if, in the
opinion of counsel for the Underwriters, it is necessary to amend
or supplement the Time of Sale Prospectus to comply with applicable
law, the Company shall (subject to Section 3(b) and Section 3(c)
hereof) promptly prepare, file with the Commission and furnish, at
its own expense, to the Underwriters and to any dealer upon
request, either amendments or supplements to the Time of Sale
Prospectus so that the statements in the Time of Sale Prospectus as
so amended or supplemented will not include an untrue statement of
a material fact or omit to state a material fact necessary in order
to make the statements therein, in the light of the circumstances
when delivered to a prospective purchaser, not misleading or so
that the Time of Sale Prospectus, as amended or supplemented, will
no longer conflict with the information contained in the
Registration Statement, or so that the Time of Sale Prospectus, as
amended or supplemented, will comply with applicable
law.
(f) Certain
Notifications and Required Actions. During the period when a
prospectus relating to the Offered Shares is required by the
Securities Act to be delivered (whether physically or through
compliance with Rule 172 under the Securities Act or any similar
rule), the Company shall promptly advise the Representative in
writing of: (i) the receipt of any comments of, or requests for
additional or supplemental information from, the Commission;
(ii) the time and date of any filing of any post-effective
amendment to the Registration Statement or any amendment or
supplement to any preliminary prospectus, the Time of Sale
Prospectus, any free writing prospectus or the Prospectus; (iii)
the time and date that any post-effective amendment to the
Registration Statement becomes effective; and (iv) the issuance by
the Commission of any stop order suspending the effectiveness of
the Registration Statement or any post-effective amendment thereto
or any amendment or supplement to any preliminary prospectus, the
Time of Sale Prospectus or the Prospectus or of any order
preventing or suspending the use of any preliminary prospectus, the
Time of Sale Prospectus, any free writing prospectus or the
Prospectus, or of any proceedings to remove, suspend or terminate
from listing or quotation the Common Stock from any securities
exchange upon which it is listed for trading or included or
designated for quotation, or of the threatening or initiation of
any proceedings for any of such purposes. If the Commission shall
enter any such stop order at any time, the Company will use its
best efforts to obtain the lifting of such order as soon as
practicable. Additionally, the Company agrees that it shall comply
with all applicable provisions of Rule 424(b), Rule 433 and
Rule 430B under the Securities Act and will use its reasonable
efforts to confirm that any filings made by the Company under Rule
424(b) or Rule 433 were received in a timely manner by the
Commission.
(g) Amendments and Supplements to the
Prospectus and Other Securities Act Matters. If any event shall occur or
condition exist as a result of which it is necessary to amend or
supplement the Prospectus so that the Prospectus does not include
an untrue statement of a material fact or omit to state a material
fact necessary in order to make the statements therein, in the
light of the circumstances when the Prospectus is delivered
(whether physically or through compliance with Rule 172 under the
Securities Act or any similar rule) to a purchaser, not misleading,
or if in the opinion of the Representative or counsel for the
Underwriters it is otherwise necessary to amend or supplement the
Prospectus to comply with applicable law, the Company agrees
(subject to Section 3(b) and Section 3(c) hereof) to promptly
prepare, file with the Commission and furnish, at its own expense,
to the Underwriters and to any dealer upon request, amendments or
supplements to the Prospectus so that the statements in the
Prospectus as so amended or supplemented will not include an untrue
statement of a material fact or omit to state a material fact
necessary in order to make the statements therein, in the light of
the circumstances when the Prospectus is delivered (whether
physically or through compliance with Rule 172 under the Securities
Act or any similar rule) to a purchaser, not misleading or so that
the Prospectus, as amended or supplemented, will comply with
applicable law. Neither the Representative’s consent to, nor
delivery of, any such amendment or supplement shall constitute a
waiver of any of the Company’s obligations under Section 3(b)
or Section 3(c).
(h) Blue Sky Compliance. The Company shall cooperate
with the Representative and counsel for the Underwriters to qualify
or register the Offered Shares for sale under (or obtain exemptions
from the application of) the state securities or blue sky laws (or
other foreign laws as reasonably requested by the Underwriters and
agreed to by the Company) of those jurisdictions designated by the
Representative, shall comply in all material respects with such
laws and shall continue such qualifications, registrations and
exemptions in effect so long as required for the distribution of
the Offered Shares. The Company shall not be required to qualify as
a foreign corporation or other entity or to take any action that
would subject it to general service of process in any such
jurisdiction where it is not presently qualified or where it would
be subject to taxation as a foreign corporation or other entity.
The Company will advise the Representative promptly of the
suspension of the qualification or registration of (or any such
exemption relating to) the Offered Shares for offering, sale or
trading in any jurisdiction or any initiation or threat of any
proceeding for any such purpose, and in the event of the issuance
of any order suspending such qualification, registration or
exemption, the Company shall use its reasonable best efforts to
obtain the withdrawal thereof as soon as practicable.
(i) Use of Proceeds. The Company shall apply the
net proceeds from the sale of the Offered Shares sold by it in the
manner described under the caption “Use of Proceeds” in
the Registration Statement, the Time of Sale Prospectus and the
Prospectus.
(j) Transfer Agent. The Company shall engage and
maintain, at its expense, a registrar and transfer agent for the
Common Stock.
(k) Earnings Statement. The Company will make
generally available (which may be satisfied by filing with EDGAR)
to its security holders and to the Representative as soon as
practicable an earnings statement (which need not be audited)
covering a period of at least twelve months beginning with the
first fiscal quarter of the Company commencing after the date of
this Agreement that will satisfy the provisions of Section 11(a) of
the Securities Act and the rules and regulations of the Commission
thereunder.
(l) Continued Compliance with Securities
Laws. The Company will comply with the Securities Act and
the Exchange Act so as to permit the completion of the distribution
of the Offered Shares as contemplated by this Agreement, the Registration Statement, the Time
of Sale Prospectus and the Prospectus. Without limiting the
generality of the foregoing, the Company will, during the period
when a prospectus relating to the Offered Shares is required by the
Securities Act to be delivered (whether physically or through
compliance with Rule 172 under the Securities Act or any similar
rule), file on a timely basis with the Commission and the NASDAQ
all reports and documents required to be filed under the Exchange
Act.
(m) Listing. The Company will use
its best efforts to maintain the listing for trading of the shares
of Common Stock on the Nasdaq Capital Market of the
NASDAQ.
(n) Company to Provide Copy of the
Prospectus in Form That May be Downloaded from the
Internet. If
requested by the Representative, the Company shall cause to be
prepared and delivered, at its expense, within one business day
from the effective date of this Agreement, to Wainwright, an
“electronic
Prospectus” to be used by the Underwriters in
connection with the offering and sale of the Offered Shares. As
used herein, the term “electronic Prospectus” means a
form of Time of Sale Prospectus, and any amendment or supplement
thereto, that meets each of the following conditions: (i) it shall
be encoded in an electronic format, satisfactory to Wainwright,
that may be transmitted electronically by Wainwright and the other
Underwriters to offerees and purchasers of the Offered Shares;
(ii) it shall disclose the same information as the paper Time
of Sale Prospectus, except to the extent that graphic and image
material cannot be disseminated electronically, in which case such
graphic and image material shall be replaced in the electronic
Prospectus with a fair and accurate narrative description or
tabular representation of such material, as appropriate; and
(iii) it shall be in or convertible into a paper format or an
electronic format, satisfactory to Wainwright, that will allow
investors to store and have continuously ready access to the Time
of Sale Prospectus at any future time, without charge to investors
(other than any fee charged for subscription to the Internet as a
whole and for on-line time). The Company hereby confirms that it
has included or will include in the Prospectus filed pursuant to
EDGAR or otherwise with the Commission and in the Registration
Statement at the time it was declared effective an undertaking
that, upon receipt of a request by an investor or his or her
representative, the Company shall transmit or cause to be
transmitted promptly, without charge, a paper copy of the Time of
Sale Prospectus.
(o) Agreement Not to Offer or Sell Common
Stock. During the period commencing on and including the
date hereof and continuing through and including the 60th day following the
date of the Prospectus, the Company will not, without the prior
written consent of Wainwright (which consent may be withheld in its
sole discretion), directly or indirectly: (i) sell, offer to sell,
contract to sell or lend any Common Stock or Related Securities (as
defined below); (ii) effect any short sale, or establish or
increase any “put equivalent position” (as defined in
Rule 16a-1(h) under the Exchange Act) or liquidate or decrease any
“call equivalent position “ (as defined in
Rule 16a-1(b) under the Exchange Act) of any Common Stock or
Related Securities; (iii) pledge, hypothecate or grant any security
interest in any Common Stock or Related Securities; (iv) in
any other way transfer or dispose of any Common Stock or Related
Securities; (v) enter into any swap, hedge or similar
arrangement or agreement that transfers, in whole or in part, the
economic risk of ownership of any Common Stock or Related
Securities, regardless of whether any such transaction is to be
settled in securities, in cash or otherwise; (vi) announce the
offering of any Common Stock or Related Securities; (vii) file any
registration statement under the Securities Act under applicable
securities laws in respect of any Common Stock or Related
Securities (other than as contemplated by this Agreement with
respect to the Offered Shares); or (viii) publicly announce the
intention to do any of the foregoing; provided, however, that the Company may
(A) effect the transactions contemplated hereby; (B) issue shares
of Common Stock or options to purchase shares of Common Stock or
restricted stock units or similar equity securities, or issue
shares of Common Stock upon exercise of options, restricted stock
units or similar equity securities, pursuant to any options, share
bonus or other share plan or arrangement pursuant to an incentive
plan in effect on the date hereof and described in the Registration
Statement, the Time of Sale Prospectus and the Prospectus; (C)
issue up to 500,000 shares of Common Stock or Related Securities to
consultants or advisors, or to their designees, for bona fide
services provided to the Company; provided that such securities are
issued as “restricted securities” (as defined in Rule
144) and carry no registration rights that require or permit the
filing of any registration statement in connection therewith during
the prohibition period provided by this section; (D) file a
registration statement on Form S-8 in
respect of the issuance, vesting, exercise or settlement of equity
awards to officers or directors granted or to be
granted pursuant to an incentive plan in effect on the date
hereof and described in the Registration Statement Time of
Sale Prospectus and the Prospectus; (E) issue any shares
of Common Stock upon the exercise of an option or warrant or upon
the conversion of a convertible security outstanding on the date
hereof and referred to in the Registration Statement, the Time of
Sale Prospectus and the Prospectus or pursuant to the
Representative’s Warrant Agreement; (F) effect any exchanges
as may be required pursuant to the rights set forth in Section 8 of
the Certificate of Designations, Powers, Preferences and Rights of
the Company’s Series B Convertible Preferred Stock, par value
$0.0001 per share; and (G) issue Common Stock or Related Securities
pursuant to acquisitions or strategic transactions approved by a
majority of the disinterested directors of the Company, provided
that such securities are issued as “restricted
securities” (as defined in Rule 144) and carry no
registration rights that require or permit the filing of any
registration statement in connection therewith during the
prohibition period provided by this section, and provided that any
such issuance shall only be to 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 (or to the equityholders of any of the foregoing) which
is, itself or through its subsidiaries, an operating company or an
owner of an asset in a business synergistic with the business of
the Company and shall provide to the Company additional benefits in
addition to the investment of funds, but shall not include a
transaction in which the Company is issuing securities primarily
for the purpose of raising capital or to an entity whose primary
business is investing in securities. For purposes of the foregoing,
“Related
Securities” shall mean any options or warrants or
other rights to acquire Common Stock or any securities exchangeable
or exercisable for or convertible into Common Stock, or to acquire
other securities or rights ultimately exchangeable or exercisable
for, or convertible into, Common Stock.
(p) Future Reports to the
Representative. During the period of five years
hereafter, the Company will furnish to the Representative, c/o
Wainwright, at 430 Park Avenue, 4th Floor, New York,
New York 10022, Attention: Head of Investment Banking, with copies
to H.C. Wainwright & Co., LLC, 430 Park Avenue, 4th Floor, New York,
New York 10022, Attention: General Counsel: (i) as soon as
practicable after the end of each fiscal year, copies of the Annual
Report of the Company containing the balance sheet of the Company
as of the close of such fiscal year and statements of income,
stockholders’ equity and cash flows for the
year then ended and the opinion thereon of the Company’s
independent public or certified public accountant; (ii) as soon as
practicable after the filing thereof, copies of each proxy
statement, Annual Report on Form 10-K, Quarterly Report on Form
10-Q, Current Report on Form 8-K or other report filed by the
Company with the Commission, FINRA or any securities exchange; and
(iii) as soon as available, copies of any report or communication
of the Company furnished or made available generally to holders of
its capital stock; provided,
however, that the requirements of this Section 3(p) shall be
satisfied to the extent that such reports, statement,
communications, financial statements or other documents are
available on EDGAR.
(q) Investment Limitation. The
Company shall not invest or otherwise use the proceeds received by
the Company from its sale of the Offered Shares in such a manner as
would require the Company or any of its Subsidiaries to register as
an investment company under the Investment Company
Act.
(r) No Stabilization or Manipulation and
Compliance with Regulation M. The Company will not take, and
will use its reasonable best efforts to ensure that no affiliate of
the Company will take, directly or indirectly, without giving
effect to activities by the Underwriters, any action designed to or
that might cause or result in stabilization or manipulation of the
price of the Common Stock or any reference security with respect to
the Common Stock, whether to facilitate the sale or resale of the
Offered Shares or otherwise, and the Company will, and shall use
its reasonable best efforts to cause each of its affiliates to,
comply with all applicable provisions of Regulation M.
(s) Variable Rate Transactions.
From the date hereof until one (1) year following the First Closing
Date, the Company shall be prohibited, without the prior written
consent of the Representative, from effecting or entering into an
agreement to effect any issuance by the Company or any of its
Subsidiaries of Common Stock or Common Stock Equivalents (or a
combination of units thereof) involving a Variable Rate
Transaction. The Underwriters shall be entitled to obtain
injunctive relief against the Company to preclude any such
issuance, which remedy shall be in addition to any right to collect
damages. “Common Stock
Equivalents” means any securities of the Company or
the Subsidiaries which would entitle the holder thereof to acquire
at any time Common Stock, including, without limitation, any debt,
preferred stock, right, option, warrant or other instrument that is
at any time convertible into or exercisable or exchangeable for, or
otherwise entitles the holder thereof to receive, Common Stock.
“Variable Rate
Transaction” means a transaction in which the Company
(i) issues or sells any debt or equity securities that are
convertible into, exchangeable or exercisable for, or include the
right to receive additional shares of Common Stock either (A) at a
conversion price, exercise price or exchange rate or other price
that is based upon and/or varies with the trading prices of or
quotations for the shares of Common Stock at any time after the
initial issuance of such debt or equity securities, or (B) with a
conversion, exercise or exchange price that is subject to being
reset at some future date after the initial issuance of such debt
or equity security or upon the occurrence of specified or
contingent events directly or indirectly related to the business of
the Company or the market for the Common Stock or (ii) enters into,
or effects a transaction under, any agreement, including, but not
limited to, an equity line of credit, whereby the Company may issue
securities at a future determined price. Notwithstanding the
foregoing, following the 60-day period set forth in Section 3(o),
the Company shall be entitled to (i) make sales of Common Stock
under that certain Purchase Agreement, dated November 13, 2019, by
and between the Company and Lincoln Park Capital Fund, LLC, as such
agreement may be amended from time to time in accordance with the
terms thereof, and (ii) make sales and issue of shares of Common
Stock pursuant to the At The Market Offering Agreement, dated May
26, 2021, between the Company and the Representative as sales
agent.
(t) Company to Provide Interim Financial
Statements. Prior to the First Closing Date and each
applicable Option Closing Date, the Company will furnish the
Underwriters, as soon as they have been prepared by or are
available to the Company, a copy of any unaudited interim financial
statements of the Company for any period subsequent to the period
covered by the most recent financial statements appearing in the
Registration Statement and the Prospectus.
(u) Enforce Lock-Up Agreements.
During the Lock-up Period, the Company will enforce all agreements
between the Company and any of its security holders that restrict
or prohibit, expressly or in operation, the offer, sale or transfer
of Common Stock or Related Securities or any of the other actions
restricted or prohibited under the terms of the form of Lock-up
Agreement. In addition, the Company will direct the transfer agent
to place stop transfer restrictions upon any such securities of the
Company that are bound by such “lock-up” agreements for
the duration of the periods contemplated in such agreements,
including, without limitation, “lock-up” agreements
entered into by the Company’s officers and directors and
certain other stockholders pursuant to Section 1(ccc)
hereof.
The
Representative, on behalf of the several Underwriters, may, in its
sole discretion, waive in writing the performance by the Company of
any one or more of the foregoing covenants or extend the time for
their performance.
4. Payment of Expenses. The
Company agrees to pay all costs, fees and expenses incurred in
connection with the performance of its obligations hereunder and in
connection with the transactions contemplated hereby, including
without limitation (i) all expenses incident to the issuance and
delivery of the Offered Shares (including all printing and
engraving costs), (ii) all fees and expenses of the registrar and
transfer agent of the Offered Shares, (iii) all necessary issue,
transfer and other stamp taxes in connection with the issuance and
sale of the Offered Shares to the Underwriters, (iv) all fees and
expenses of the Company’s counsel, independent public or
certified public accountant and other advisors, (v) all costs and
expenses incurred in connection with the preparation, printing,
filing, shipping and distribution of the Registration Statement
(including financial statements, exhibits, schedules, consents and
certificates of experts), the Time of Sale Prospectus, the
Prospectus, each free writing prospectus prepared by or on behalf
of, used by, or referred to by the Company, and each Preliminary
Prospectus, and all amendments and supplements thereto, and this
Agreement, (vi) all filing fees, attorneys’ fees and expenses
incurred by the Company or the Underwriters in connection with
qualifying or registering (or obtaining exemptions from the
qualification or registration of) all or any part of the Offered
Shares for offer and sale under the state securities or blue sky
laws, and, if requested by the Representative, preparing and
printing a “Blue Sky Survey” or memorandum, and any
supplements thereto, advising the Underwriters of such
qualifications, registrations and exemptions, (vii) the costs, fees
and expenses incurred by the Underwriters in connection with
determining their compliance with the rules and regulations of
FINRA related to the Underwriters’ participation in the
offering and distribution of the Offered Shares, including any
related filings fees and the legal fees of, and disbursements by,
counsel to the Underwriters, (viii) the costs and expenses of the
Company relating to investor presentations on any “road
show”, including, without limitation, expenses associated
with the preparation or dissemination of any electronic road show,
expenses associated with the production of road show slides and
graphics, fees and expenses of any consultants engaged in
connection with the road show presentations with the prior approval
of the Company, reasonable travel and lodging expenses of the
Representative approved by the Company in advance, employees and
officers of the Company and any such consultants, (ix) the fees and
expenses associated with listing the Offered Shares on the Nasdaq
Capital Market of the NASDAQ, (x) all other fees, costs and
expenses of the nature referred to in Item 14 of Part II of the
Registration Statement, (xi) all actual and documented
out-of-pocket expenses and all fees of the Underwriters’
legal counsel and other out-of-pocket expenses of the Underwriters
reasonably incurred in connection with the transactions
contemplated hereby; provided, that the amount payable pursuant to
the foregoing clauses (vi), (vii) and (xi) in the aggregate shall
not exceed $125,000, (xii) the costs and fees of any escrow agent
and the actual out-of-pocket costs incurred by the Underwriters in
connection with clearing agent settlement and financing, which cost
shall not exceed $15,950, and (xiii) $35,000 to Wainwright for
non-accountable expenses. Any such amount payable to the
Underwriters may be deducted from the purchase price for the
Offered Shares.
5. Covenant of the Underwriters.
Each Underwriter severally and not jointly covenants with the
Company not to take any action that would result in the Company
being required to file with the Commission pursuant to Rule 433(d)
under the Securities Act a free writing prospectus prepared by or
on behalf of such Underwriter that otherwise would not, but for
such actions, be required to be filed by the Company under Rule
433(d).
6. Conditions of the Obligations of the
Underwriters. The respective obligations of the several
Underwriters hereunder to purchase and pay for the Offered Shares
as provided herein on the First Closing Date and, with respect to
the Optional Shares, each Option Closing Date, shall be subject to
the accuracy of the representations and warranties on the part of
the Company set forth in Section 1 hereof as of the date hereof and
as of the First Closing Date as though then made and, with respect
to the Optional Shares, as of each Option Closing Date as though
then made, to the timely performance by the Company of its
covenants and other obligations hereunder, and to each of the
following additional conditions:
(a) Comfort Letters. On the date
hereof, the Representative shall have received from Mazars USA LLP,
independent registered public accountant for the Company, a letter
dated the date thereof addressed to the Underwriters, in form and
substance satisfactory to the Representative, containing statements
and information of the type ordinarily included in
accountant’s “comfort letters” to underwriters,
delivered according to Statement of Auditing Standards No. 72 (or
any successor bulletin), with respect to the audited and unaudited
financial statements and certain financial information contained in
the Registration Statement, the Time of Sale Prospectus, and each
free writing prospectus, if any.
(b) Compliance with Registration
Requirements; No Stop Order; No Objection from FINRA. For a
period from and after the date of this Agreement and through and
including the First Closing Date and, with respect to any Optional
Shares purchased after the First Closing Date, each Option Closing
Date:
(i) The Company shall
have filed the Prospectus with the Commission (including the
information required by Rule 430A and 430B under the Securities
Act) in the manner and within the time period required by Rule
424(b) under the Securities Act; or the Company shall have filed a
post-effective amendment to the Registration Statement containing
the information required by such Rule 430A and 430B, and such
post-effective amendment shall have become effective.
(ii) No
stop order suspending the effectiveness of the Registration
Statement or any post-effective amendment to the Registration
Statement shall be in effect, and no proceedings for such purpose
shall have been instituted or threatened by the
Commission.
(iii) FINRA
shall have raised no objection to the fairness and reasonableness
of the underwriting terms and arrangements.
(c) No Material Adverse Change. For
the period from and after the date of this Agreement and through
and including the First Closing Date and, with respect to any
Optional Shares purchased after the First Closing Date, each Option
Closing Date, in the judgment of the Representative there shall not
have occurred any material adverse change in the authorized capital
stock of the Company or any Material Adverse Effect or any
development that would cause a Material Adverse
Effect.
(d) Opinion of Counsel for the
Company. On each of the First Closing Date and each Option
Closing Date, the Representative shall have received the opinion
and negative assurance letter of Lowenstein Sandler LLP, counsel
for the Company, dated as of such date in form and substance
satisfactory to the Underwriters, dated as of such
date.
(e) Opinion of Counsel for the
Underwriters. On each of the First Closing Date and each
Option Closing Date, the Representative shall have received the
opinion and negative assurance letter of Haynes and Boone, LLP,
counsel for the Underwriters in connection with the offer and sale
of the Offered Shares, in form and substance satisfactory to the
Underwriters, dated as of such date.
(f) Officers’ Certificate. On
each of the First Closing Date and each Option Closing Date, the
Representative shall have received a certificate executed by the
Chief Executive Officer or President of the Company and the Chief
Financial Officer of the Company, dated as of such date, to the
effect set forth in Section 6(b)(ii) and further to the effect
that:
(i) for the period from
and including the date of this Agreement through and including such
date, there has not occurred any Material Adverse
Effect;
(ii) the
representations, warranties and covenants of the Company set forth
in Section 1 of this Agreement are true and correct with the
same force and effect as though expressly made on and as of such
date; and
(iii) the
Company has complied with all the agreements hereunder and
satisfied all the conditions on its part to be performed or
satisfied hereunder at or prior to such date.
(g) Chief Financial Officer’s
Certificate. On each of the
First Closing Date and each Option Closing Date, the Representative
shall have received a certificate executed by the Chief Financial
Officer of the Company, dated as of such date, in form and
substance satisfactory to the Underwriters, dated as of such
date.
(h) Reserved.
(i) Bring-down Comfort Letter. (i)
On the First Closing Date and each Option Closing Date the
Representative shall have received from Mazars USA LLP, independent
registered public accounts for the Company, a letter dated such
date, in form and substance satisfactory to the Representative,
which letter shall: (a) reaffirm the statements made in the letter
furnished by them pursuant to Section 6(a), except that the
specified date referred to therein for the carrying out of
procedures shall be no more than three business days prior to the
First Closing date or the applicable Option Closing Date, as the
case may be.
(j) Rule 462(b) Registration
Statement. In the event that a Rule 462(b) Registration
Statement is filed in connection with the offering contemplated by
this Agreement, such Rule 462(b) Registration Statement shall have
been filed with the Commission on the date of this Agreement and
shall have become effective automatically upon such
filing.
(k) Nasdaq Listing. The Company
shall have submitted a listing of additional shares notification
form to the NASDAQ with respect to the Offered Shares and shall
have received no objection thereto from the NASDAQ and shall have
received a conditional listing approval that is subject only to
customary listing conditions.
(l) Additional Documents. On or
before each of the First Closing Date and each Option Closing Date,
the Representative and counsel for the Underwriters shall have
received such information, documents and opinions as they may
reasonably request for the purposes of enabling them to pass upon
the issuance and sale of the Offered Shares and
Representative’s Securities as contemplated herein, or in
order to evidence the accuracy of any of the representations and
warranties, or the satisfaction of any of the conditions or
agreements, herein contained; and all proceedings taken by the
Company in connection with the issuance and sale of the Offered
Shares and Representative’s Securities as contemplated herein
and in connection with the other transactions contemplated by this
Agreement shall be satisfactory in form and substance to the
Representative and counsel for the Underwriters.
If any
condition specified in this Section 6 is not satisfied when and as
required to be satisfied, this Agreement may be terminated by the
Representative by notice from the Representative to the Company at
any time on or prior to the First Closing Date and, with respect to
the Optional Shares, at any time on or prior to the applicable
Option Closing Date, which termination shall be without liability
on the part of any party to any other party, except that Section 4,
Section 7, Section 9 and Section 10 shall at all times be effective
and shall survive such termination.
7. Reimbursement of Underwriters’
Expenses. If this Agreement is terminated by the
Representative pursuant to Section 6, Section 11 or Section 12, or
if the sale to the Underwriters of the Offered Shares on the First
Closing Date or any Option Closing Date is not consummated because
of any refusal, inability or failure on the part of the Company to
perform any agreement herein or to comply with any provision
hereof, the Company agrees to reimburse the Representative and the
other Underwriters (or such Underwriters as have terminated this
Agreement with respect to themselves), severally, upon demand for
all out-of-pocket expenses that shall have been reasonably incurred
by the Representative and the Underwriters in connection with the
proposed purchase and the offering and sale of the Offered Shares,
including, but not limited to, fees and disbursements of counsel,
printing expenses, travel expenses, postage, facsimile and
telephone charges.
8. Effectiveness of this
Agreement. This Agreement shall become effective upon the
execution and delivery hereof by the parties hereto.
9. Indemnification.
(a) Indemnification of the
Underwriters. The Company shall indemnify and hold harmless
each Underwriter, its affiliates, the directors, officers,
employees, counsel and agents of each Underwriter and each person,
if any, who controls each Underwriter within the meaning of Section
15 of the Securities Act or Section 20 of the Exchange Act from and
against any and all losses, claims, liabilities, expenses and
damages (including any and all investigative, legal and other
expenses reasonably incurred in connection with, and any amount
paid in settlement of, any action, suit or proceeding between any
of the indemnified parties and any indemnifying parties or between
any indemnified party and any third party, or otherwise, or any
claim asserted), to which they, or any of them, may become subject
under the Securities Act, the Exchange Act or other Federal or
state statutory law or regulation, at common law or otherwise,
insofar as such losses, claims, liabilities, expenses or damages
arise out of or are based on (i) any untrue statement or alleged
untrue statement of a material fact contained in the Registration
Statement (or any amendment thereto), including any information
deemed to be a part thereof pursuant to Rules 430A, 430B or 430C,
as applicable or the omission or alleged omission therefrom of a
material fact required to be stated therein or necessary to make
the statements therein not misleading or (ii) any untrue statement
or alleged untrue statement of a material fact contained in any
preliminary prospectus, any preliminary prospectus supplement, the
Base Prospectus, any free writing prospectus, the Time of Sale
Prospectus or the Prospectus (or any amendment or supplement to any
of the foregoing) or the omission or alleged omission therefrom of
a material fact necessary in order to make the statements therein,
in the light of the circumstances under which they were made, not
misleading or (iii) any untrue statement or alleged untrue
statement of a material fact contained in any materials or
information provided to investors by, or with the approval of, the
Company in connection with the marketing of the offering of the
Offered Shares, including any roadshow or investor presentations
made to investors by the Company (whether in person or
electronically) or the omission or alleged omission therefrom of a
material fact necessary in order to make the statements therein, in
the light of the circumstances under which they were made, not
misleading; provided,
however, that the Company
shall not be liable to the extent that such loss, claim, liability,
expense or damage arises from the sale of the Offered Shares in the
public offering to any person by an Underwriter and is based on an
untrue statement or omission or alleged untrue statement or
omission made in reliance on and in conformity with Underwriter
Information. This indemnity agreement will be in addition to any
liability that the Company might otherwise have.
(b) Indemnification of the Company, its
Directors and Officers. Each Underwriter shall indemnify and
hold harmless the Company, its agents, each person, if any, who
controls the Company within the meaning of Section 15 of the
Securities Act or Section 20 of the Exchange Act, each director of
the Company and each officer of the Company who signs the
Registration Statement to the same extent as the foregoing
indemnity from the Company to each Underwriter, but only insofar as
losses, claims, liabilities, expenses or damages arise out of or
are based on any untrue statement or omission or alleged untrue
statement or omission made in reliance on and in conformity with
Underwriter Information. This indemnity will be in addition to any
liability that each Underwriter might otherwise have. The Company
hereby acknowledges that the only information that the Underwriters
have furnished to the Company expressly for use in the Registration
Statement, any preliminary prospectus, any preliminary prospectus
supplement, the Base Prospectus, any free writing prospectus, the
Time of Sale Prospectus or the Prospectus (or any amendment or
supplement to any of the foregoing) are the statements set forth in
the 3rd, 4th and 14th through
20th
paragraphs under the caption “Underwriting” in the
Preliminary Prospectus and Prospectus (the “Underwriter Information”).
Notwithstanding any other provision of this Agreement, including
this Section 9, to the contrary, in no event shall any
Underwriter’s aggregate liability for indemnification
hereunder exceed the underwriting discounts and commissions
received by it.
(c) Notifications and Other
Indemnification Procedures. Any party that proposes to
assert the right to be indemnified under this Section 9 shall,
promptly after receipt of notice of commencement of any action
against such party in respect of which a claim is to be made
against an indemnifying party or parties under this Section 9,
notify each such indemnifying party of the commencement of such
action, enclosing a copy of all papers served, but the omission so
to notify such indemnifying party shall not relieve the
indemnifying party from any liability that it may have to any
indemnified party under the foregoing provisions of this Section 9
unless, and only to the extent that, such omission results in the
forfeiture of substantive rights or defenses by the indemnifying
party. If any such action is brought against any indemnified party
and it notifies the indemnifying party of its commencement, the
indemnifying party will be entitled to participate in and, to the
extent that it elects by delivering written notice to the
indemnified party promptly after receiving notice of the
commencement of the action from the indemnified party, jointly with
any other indemnifying party similarly notified, to assume the
defense of the action, with counsel reasonably satisfactory to the
indemnified party, and after notice from the indemnifying party to
the indemnified party of its election to assume the defense, the
indemnifying party will not be liable to the indemnified party for
any legal or other expenses except as provided below and except for
the reasonable costs of investigation subsequently incurred by the
indemnified party in connection with the defense. The indemnified
party will have the right to employ its own counsel in any such
action, but the fees, expenses and other charges of such counsel
will be at the expense of such indemnified party unless (i) the
employment of counsel by the indemnified party has been authorized
in writing by the indemnifying party, (ii) the indemnified party
has reasonably concluded (based on advice of counsel) that there
may be legal defenses available to it or other indemnified parties
that are different from or in addition to those available to the
indemnifying party, (iii) the indemnified party has reasonably
concluded that a conflict or potential conflict exists (based on
advice of counsel to the indemnified party) between the indemnified
party and the indemnifying party (in which case the indemnifying
party shall not have the right to direct the defense of such action
on behalf of the indemnified party) or (iv) the indemnifying party
has not in fact employed counsel reasonably satisfactory to the
indemnified party to assume the defense of such action within a
reasonable time after receiving notice of the commencement of the
action, in each of which cases the reasonable fees, disbursements
and other charges of counsel shall be at the expense of the
indemnifying party or parties. It is understood that the
indemnifying party or parties shall not, in connection with any
proceeding or related proceedings in the same jurisdiction, be
liable for the reasonable fees, disbursements and other charges of
more than one separate firm admitted to practice in such
jurisdiction at any one time for all such indemnified party or
parties. All such fees, disbursements and other charges shall be
reimbursed by the indemnifying party promptly as they are incurred.
An indemnifying party shall not be liable for any settlement of any
action or claim effected without its written consent (which consent
will not be unreasonably withheld or delayed). No indemnifying
party shall, without the prior written consent of each indemnified
party, settle or compromise or consent to the entry of any judgment
in any pending or threatened claim, action or proceeding relating
to the matters contemplated by this Section 9 (whether or not any
indemnified party is a party thereto), unless such settlement,
compromise or consent (i) includes an unconditional release of each
indemnified party from all liability arising or that may arise out
of such claim, action or proceeding and (ii) does not include a
statement as to or an admission of fault, culpability or a failure
to act by or on behalf of any indemnified party. Notwithstanding
the foregoing, if at any time an indemnified party shall have
requested an indemnifying party to reimburse the indemnified party
for fees and expenses of counsel, such indemnifying party agrees
that it shall be liable for any settlement of the nature
contemplated by Section 9(a) effected without its written consent
if (i) such settlement is entered into more than 45 days after
receipt by such indemnifying party of the aforesaid request, (ii)
such indemnifying party shall have received notice of the terms of
such settlement at least 30 days prior to such settlement being
entered into and (iii) such indemnifying party shall not have
reimbursed such indemnified party in accordance with such request
prior to the date of such settlement.
10. Contribution. In order to
provide for just and equitable contribution in circumstances in
which the indemnification provided for in the foregoing paragraphs
of Section 9 is applicable in accordance with its terms but for any
reason is held to be unavailable from the Company or the
Underwriters, the Company and the Underwriters shall contribute to
the total losses, claims, liabilities, expenses and damages
(including any investigative, legal and other expenses reasonably
incurred in connection with, and any amount paid in settlement of,
any action, suit or proceeding or any claim asserted, but after
deducting any contribution received by the Company from persons
other than the Underwriters, such as persons who control the
Company within the meaning of the Securities Act, officers of the
Company who signed the Registration Statement and directors of the
Company, who also may be liable for contribution) to which the
Company and the Underwriters may be subject in such proportion as
shall be appropriate to reflect the relative benefits received by
the Company on the one hand and the Underwriters on the other. The
relative benefits received by the Company on the one hand and the
Underwriters on the other shall be deemed to be in the same
proportion as the total net proceeds from the offering (before
deducting expenses) received by the Company bear to the total
underwriting discounts and commissions received by the
Underwriters, in each case as set forth in the table on the cover
page of the Prospectus. If, but only if, the allocation provided by
the foregoing sentence is not permitted by applicable law, the
allocation of contribution shall be made in such proportion as is
appropriate to reflect not only the relative benefits referred to
in the foregoing sentence but also the relative fault of the
Company, on the one hand, and the Underwriters, on the other, with
respect to the statements or omissions which resulted in such loss,
claim, liability, expense or damage, or action in respect thereof,
as well as any other relevant equitable considerations with respect
to such offering. Such relative fault shall be determined by
reference to whether the untrue or alleged untrue statement of a
material fact or omission or alleged omission to state a material
fact relates to information supplied by the Company or
Representative on behalf of the Underwriters, the intent of the
parties and their relative knowledge, access to information and
opportunity to correct or prevent such statement or omission. The
Company and the Underwriters agree that it would not be just and
equitable if contributions pursuant to this Section 10 were to be
determined by pro rata allocation or by any other method of
allocation (even if the Underwriters were treated as one entity for
such purpose) which does not take into account the equitable
considerations referred to herein. The amount paid or payable by an
indemnified party as a result of the loss, claim, liability,
expense or damage, or action in respect thereof, referred to above
in this Section 10 shall be deemed to include, for purpose of this
Section 10, any legal or other expenses reasonably incurred by such
indemnified party in connection with investigating or defending any
such action or claim. Notwithstanding the provisions of this
Section 10, no Underwriter shall be required to contribute any
amount in excess of the underwriting discounts and commissions
received by it, and no person found guilty of fraudulent
misrepresentation (within the meaning of Section 11(f) of the
Securities Act) shall be entitled to contribution from any person
who was not guilty of such fraudulent misrepresentation. The
Underwriters’ obligation to contribute as provided in this
Section 10 are several in proportion to their respective
underwriting obligations and not joint. In addition,
notwithstanding anything contained herein to the contrary, no
Underwriter’s obligation to contribute as provided in this
Section 10 shall exceed the underwriting discounts and commissions
received by such Underwriter. For purposes of this Section 10, any
person who controls a party to this Agreement within the meaning of
the Securities Act will have the same rights to contribution as
that party, and each officer of the Company who signed the
Registration Statement will have the same rights to contribution as
the Company, and each director, officer, employee, counsel or agent
of any Underwriter will have the same rights to contribution as
such Underwriter, subject in each case to the provisions hereof.
Any party entitled to contribution, promptly after receipt of
notice of commencement of any action against such party in respect
of which a claim for contribution may be made under this Section
10, will notify any such party or parties from whom contribution
may be sought, but the omission so to notify will not relieve the
party or parties from whom contribution may be sought from any
other obligation it or they may have under this Section 10. No
party will be liable for contribution with respect to any action or
claim settled without its written consent (which consent will not
be unreasonably withheld).
11. Default of One or More of the Several
Underwriters. If, on the First Closing Date or any Option
Closing Date any one or more of the several Underwriters shall fail
or refuse to purchase Offered Shares that it or they have agreed to
purchase hereunder on such date, and the aggregate number of
Offered Shares which such defaulting Underwriter or Underwriters
agreed but failed or refused to purchase does not exceed 10% of the
aggregate number of the Offered Shares to be purchased on such
date, the Representative may make arrangements satisfactory to the
Company for the purchase of such Offered Shares by other persons,
including any of the Underwriters, but if no such arrangements are
made by such date, the other Underwriters shall be obligated,
severally and not jointly, in the proportions that the number of
Firm Shares set forth opposite their respective names on Schedule A
bears to the aggregate number of Firm Shares set forth opposite the
names of all such non-defaulting Underwriters, or in such other
proportions as may be specified by the Representative with the
consent of the non-defaulting Underwriters, to purchase the Offered
Shares which such defaulting Underwriter or Underwriters agreed but
failed or refused to purchase on such date. If, on the First
Closing Date or any Option Closing Date any one or more of the
Underwriters shall fail or refuse to purchase Offered Shares and
the aggregate number of Offered Shares with respect to which such
default occurs exceeds 10% of the aggregate number of Offered
Shares to be purchased on such date, and arrangements satisfactory
to the Representative and the Company for the purchase of such
Offered Shares are not made within 48 hours after such default,
this Agreement shall terminate without liability of any party to
any other party except that the provisions of Section 4, Section 7,
Section 9 and Section 10 shall at all times be effective and shall
survive such termination (except with respect to any defaulting
Underwriter hereunder). In any such case either the Representative
or the Company shall have the right to postpone the First Closing
Date or the applicable Option Closing Date, as the case may be, but
in no event for longer than seven days in order that the required
changes, if any, to the Registration Statement and the Prospectus
or any other documents or arrangements may be
effected.
As used
in this Agreement, the term “Underwriter” shall be deemed to
include any person substituted for a defaulting Underwriter under
this Section 11. Any action taken under this Section 11 shall not
relieve any defaulting Underwriter from liability in respect of any
default of such Underwriter under this Agreement.
12. Termination of this Agreement.
Prior to the purchase of the Firm Shares by the Underwriters on the
First Closing Date, this Agreement may be terminated by the
Representative by notice given to the Company if at any time: (i)
trading or quotation in any of the Company’s securities shall
have been suspended or limited by the Commission, any other
securities regulatory authority, or by the NASDAQ or trading in
securities generally on the NASDAQ, the NYSE, or the NYSE American
shall have been suspended or limited, or minimum or maximum prices
shall have been generally established on any of such stock
exchanges; (ii) a general banking moratorium shall have been
declared by any of U.S. federal or New York authorities or a major
disruption of securities settlements or clearing services in the
United States shall have occurred and be continuing; (iii) there
shall have occurred any outbreak or escalation of national or
international hostilities or any crisis or calamity, or any
substantial change in the United States or international financial
markets, or any substantial change or development involving a
prospective substantial change in United States’ or
international political, financial or economic conditions, as in
the judgment of the Representative is material and adverse and
makes it impracticable to market the Offered Shares in the manner
and on the terms described in the Time of Sale Prospectus or the
Prospectus or to enforce contracts for the sale of securities; (iv)
in the good faith judgment of the Representative there shall have
occurred any material adverse change, or any development or event
involving a prospective material adverse change, in the condition,
financial or otherwise, or in the business, properties, earnings,
results of operations or prospects of the Company and its
Subsidiaries considered as one enterprise, whether or not arising
in the ordinary course of business; or (v) the Company shall have
sustained a loss by strike, fire, flood, earthquake, accident or
other calamity of such character as in the judgment of the
Representative may interfere materially with the conduct of the
business and operations of the Company regardless of whether or not
such loss shall have been insured. Any termination pursuant to this
Section 12 shall be without liability on the part of (a) the
Company to any Underwriter, except that the Company shall be
obligated to reimburse the expenses of the Representative and the
Underwriters pursuant to Section 4 and Section 7 hereof or (b) any
Underwriter to the Company; provided, however, that the provisions
of Section 9 and Section 10 shall at all times be effective and
shall survive such termination.
13. No Advisory or Fiduciary
Relationship. The Company acknowledges and agrees that (i)
the purchase and sale of the Offered Shares pursuant to this
Agreement, including the determination of the public offering price
of the Offered Shares and any related discounts and commissions, is
an arm’s-length commercial transaction between the Company,
on the one hand, and the several Underwriters, on the other hand,
(ii) in connection with the offering contemplated hereby and the
process leading to such transaction, each Underwriter is and has
been acting solely as a principal and is not the agent or fiduciary
of the Company, or its stockholders, or its creditors, employees or
any other party, (iii) no Underwriter has assumed or will assume an
advisory or fiduciary responsibility in favor of the Company with
respect to the offering contemplated hereby or the process leading
thereto (irrespective of whether such Underwriter has advised or is
currently advising the Company on other matters) and no Underwriter
has any obligation to the Company with respect to the offering
contemplated hereby except the obligations expressly set forth in
this Agreement, (iv) the Underwriters and their respective
affiliates may be engaged in a broad range of transactions that
involve interests that differ from those of the Company, and (v)
the Underwriters have not provided any legal, accounting,
regulatory or tax advice with respect to the offering contemplated
hereby and the Company has consulted its own legal, accounting,
regulatory and tax advisors to the extent it deemed
appropriate.
14. Representations and Agreements to
Survive Delivery. The respective indemnities, contributions,
agreements, representations, warranties and other statements of the
Company, of its officers and of the several Underwriters set forth
in or made pursuant to this Agreement will remain in full force and
effect, regardless of any investigation made by or on behalf of any
Underwriter or the Company or any of its or their partners,
officers, directors or employees or any controlling person, as the
case may be, and, anything herein to the contrary notwithstanding,
will survive delivery of and payment for the Offered Shares sold
hereunder and, subject to Section 11 hereof, any termination of
this Agreement.
15. Notices. All communications
hereunder shall be in writing and shall be mailed, hand delivered
or telecopied and confirmed to the parties hereto as
follows:
If to
the
Representative:
H.C. Wainwright & Co., LLC
430
Park Avenue, 4th Floor
New
York, NY 10022
Facsimile: (212)
214-0803
Attention: Head of
Investment Banking
with a
copy
to:
Haynes and Boone, LLP
30
Rockefeller Plaza, 26th Floor
New
York, NY 10012
Attention: Rick A.
Werner, Esq.
If to
the
Company:
AzurRx Biopharma, Inc.
777
Yamato Road, Suite 502
Boca
Raton, Florida 33431
Attention: Daniel
Schneiderman
with a
copy
to:
Lowenstein Sandler
1251
Avenue of the Americas
New
York, NY 10020
Attention: James
O’Grady, Esq.
Each
party to this Agreement may change such address for notices by
sending to the parties to this Agreement written notice of a new
address for such purpose. Each such notice or other communication
shall be deemed given (i) when delivered personally or by
verifiable facsimile transmission (with an original to follow) on
or before 4:30 p.m., New York City time, on a Business Day or,
if such day is not a Business Day, on the next succeeding Business
Day, (ii) on the next Business Day after timely delivery to a
nationally-recognized overnight courier and (iii) on the
Business Day actually received if deposited in the U.S. mail
(certified or registered mail, return receipt requested, postage
prepaid). For purposes of this Agreement, “Business Day” shall mean any day
on which the Exchange and commercial banks in the City of New York
are open for business.
An
electronic communication (“Electronic Notice”) shall be
deemed written notice for purposes of this Section 15 if sent to
the electronic mail address specified by the receiving party under
separate cover. Electronic Notice shall be deemed received at the
time the party sending Electronic Notice receives verification of
receipt by the receiving party. Any party receiving Electronic
Notice may request and shall be entitled to receive the notice on
paper, in a nonelectronic form (“Nonelectronic Notice”) which shall
be sent to the requesting party within ten (10) days of receipt of
the written request for Nonelectronic Notice.
16. Successors and Assigns. This
Agreement shall inure to the benefit of and be binding upon the
Company and the Underwriters and their respective successors and
the parties referred to in Section 9 hereof. References to any of
the parties contained in this Agreement shall be deemed to include
the successors and permitted assigns of such party. Nothing in this
Agreement, express or implied, is intended to confer upon any party
other than the parties hereto or their respective successors and
permitted assigns any rights, remedies, obligations or liabilities
under or by reason of this Agreement, except as expressly provided
in this Agreement. Neither party may assign its rights or
obligations under this Agreement without the prior written consent
of the other party; provided, however, that an Underwriter may
assign its rights and obligations hereunder to an affiliate thereof
without obtaining the Company’s consent.
17. Partial Unenforceability. The
invalidity or unenforceability of any section, paragraph or
provision of this Agreement shall not affect the validity or
enforceability of any other section, paragraph or provision hereof.
If any section, paragraph or provision of this Agreement is for any
reason determined to be invalid or unenforceable, there shall be
deemed to be made such minor changes (and only such minor changes)
as are necessary to make it valid and enforceable.
18. Entire Agreement; Amendment;
Severability; Waiver. This Agreement (including all
schedules and exhibits attached hereto issued pursuant hereto)
constitutes the entire agreement and supersedes all other prior and
contemporaneous agreements and undertakings, both written and oral,
among the parties hereto with regard to the subject matter hereof.
Notwithstanding anything herein to the contrary, the engagement
agreement dated July 7, 2021, between the Company and Wainwright,
shall continue to be effective and continue to survive and be
enforceable by the parties in accordance with their terms. Neither
this Agreement nor any term hereof may be amended except pursuant
to a written instrument executed by the Company and the
Underwriters. In the event that any one or more of the provisions
contained herein, or the application thereof in any circumstance,
is held invalid, illegal or unenforceable as written by a court of
competent jurisdiction, then such provision shall be given full
force and effect to the fullest possible extent that it is valid,
legal and enforceable, and the remainder of the terms and
provisions herein shall be construed as if such invalid, illegal or
unenforceable term or provision was not contained herein, but only
to the extent that giving effect to such provision and the
remainder of the terms and provisions hereof shall be in accordance
with the intent of the parties as reflected in this Agreement. No
implied waiver by a party shall arise in the absence of a waiver in
writing signed by such party. No failure or delay in exercising any
right, power, or privilege hereunder shall operate as a waiver
thereof, nor shall any single or partial exercise thereof preclude
any other or further exercise thereof or the exercise of any right,
power, or privilege hereunder.
19. GOVERNING
LAW AND TIME; WAIVER OF JURY TRIAL. THIS AGREEMENT SHALL BE
GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE
OF NEW YORK WITHOUT REGARD TO THE PRINCIPLES OF CONFLICTS OF LAWS.
SPECIFIED TIMES OF DAY REFER TO NEW YORK CITY TIME. EACH PARTY 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 OR THE TRANSACTIONS CONTEMPLATED
HEREBY.
20. CONSENT
TO JURISDICTION. EACH PARTY HEREBY IRREVOCABLY SUBMITS TO
THE EXCLUSIVE JURISDICTION OF THE STATE AND FEDERAL COURTS SITTING
IN THE CITY OF NEW YORK, BOROUGH OF MANHATTAN, FOR THE ADJUDICATION
OF ANY DISPUTE HEREUNDER OR IN CONNECTION WITH ANY TRANSACTION
CONTEMPLATED HEREBY, AND HEREBY IRREVOCABLY WAIVES, AND AGREES NOT
TO ASSERT IN ANY SUIT, ACTION OR PROCEEDING, ANY CLAIM THAT IT IS
NOT PERSONALLY SUBJECT TO THE JURISDICTION OF ANY SUCH COURT, THAT
SUCH SUIT, ACTION OR PROCEEDING IS BROUGHT IN AN INCONVENIENT FORUM
OR THAT THE VENUE OF SUCH SUIT, ACTION OR PROCEEDING IS IMPROPER.
EACH PARTY HEREBY IRREVOCABLY WAIVES PERSONAL SERVICE OF PROCESS
AND CONSENTS TO PROCESS BEING SERVED IN ANY SUCH SUIT, ACTION OR
PROCEEDING BY MAILING A COPY THEREOF (CERTIFIED OR REGISTERED MAIL,
RETURN RECEIPT REQUESTED) TO SUCH PARTY AT THE ADDRESS IN EFFECT
FOR NOTICES TO IT UNDER THIS AGREEMENT AND AGREES THAT SUCH SERVICE
SHALL CONSTITUTE GOOD AND SUFFICIENT SERVICE OF PROCESS AND NOTICE
THEREOF. NOTHING CONTAINED HEREIN SHALL BE DEEMED TO LIMIT IN ANY
WAY ANY RIGHT TO SERVE PROCESS IN ANY MANNER PERMITTED BY
LAW.
21. Counterparts. This Agreement
may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one
and the same instrument. Delivery of an executed Agreement by one
party to the other may be made by facsimile or electronic
transmission.
22. Construction.
(a) the section and
exhibit headings herein are for convenience only and shall not
affect the construction hereof;
(b) words defined in
the singular shall have a comparable meaning when used in the
plural, and vice versa;
(c) the words
“hereof,” “hereto,” “herein”
and “hereunder” and words of similar import, when used
in this Agreement, shall refer to this Agreement as a whole and not
to any particular provision of this Agreement;
(d) wherever the word
“include,” “includes” or
“including” is used in this Agreement, it shall be
deemed to be followed by the words “without
limitation”;
(e) references herein
to any gender shall include each other gender;
(f) references herein
to any law, statute, ordinance, code, regulation, rule or other
requirement of any Governmental Authority shall be deemed to refer
to such law, statute, ordinance, code, regulation, rule or other
requirement of any Governmental Authority as amended, reenacted,
supplemented or superseded in whole or in part and in effect from
time to time and also to all rules, policies, notices, instruments
and regulations promulgated thereunder;
(g) if the last day for
the giving of any notice or the performance of any act required or
permitted under this Agreement is a day that is not a Business Day,
then the time for the giving of such notice or the performance of
such action shall be extended to the next succeeding Business
Day;
(h) “knowledge” means, as it pertains
to the Company, the actual knowledge of the executive officers and
directors of the Company, together with the knowledge which they
would have had if they had conducted a reasonable inquiry of the
relevant persons into the relevant matter; and
(i) “Governmental
Authority” means
(i) any federal, state, local, municipal, national or international
government or governmental authority, regulatory or administrative
agency, governmental commission, department, board, bureau, agency
or instrumentality, court, tribunal, arbitrator or arbitral body
(public or private); (ii) any self-regulatory organization
(including any stock exchange or quotation system); or (iii) any
political subdivision of any of the foregoing.
23. General
Provisions.
Each of
the parties hereto acknowledges that it is a sophisticated business
person who was adequately represented by counsel during
negotiations regarding the provisions hereof, including, without
limitation, the indemnification provisions of Section 9 and the
contribution provisions of Section 10, and is fully informed
regarding said provisions. Each of the parties hereto further
acknowledges that the provisions of Section 9 and Section 10 hereof
fairly allocate the risks in light of the ability of the parties to
investigate the Company, its affairs and its business in order to
assure that adequate disclosure has been made in the Registration
Statement, any preliminary prospectus, the Time of Sale Prospectus,
each free writing prospectus and the Prospectus (and any amendments
and supplements to the foregoing), as contemplated by the
Securities Act and the Exchange Act.
[Signature
Page Follows]
If the
foregoing correctly sets forth the understanding between the
Company and the Underwriters, please so indicate in the space
provided below for that purpose, whereupon this letter shall
constitute a binding agreement between the Company and the
Underwriters.
Very truly yours,
|
AZURRX
BIOPHARMA, INC.
|
|
By:
|
/s/ Daniel Schneiderman
|
|
Name:
Daniel Schneiderman
|
|
Title:
Chief Financial Officer
|
ACCEPTED as of the
date first-above written:
|
H.C.
WAINWRIGHT & CO., LLC
|
|
By:
|
/s/ Edward D. Silvera
|
|
Name:
Edward D. Silvera
|
|
Title:
Chief Operating Officer
|
Signature Page
Underwriting Agreement
Schedule A
Underwriters
|
Number
of
Firm
Shares
to
be Purchased
|
H.C. Wainwright
& Co., LLC
|
9,090,910
|
Total
|
$4,600,000.46
|
Schedule B
Free Writing Prospectuses Included in the Time of Sale
Prospectus
Issuer
Free Writing Prospectus, dated July 22, 2021, filed with the
Commission on July 22, 2021.
Issuer
Free Writing Prospectus, dated July 22, 2021, filed with the
Commission effective July 23, 2021.
Schedule C
Pricing Information
Firm
Shares: 9,090,910
Optional Shares:
1,363,636
Price
to Public: $0.550
Underwriters’
Discount: $0.044
Schedule D
Subsidiaries
AzurRx
BioPharma SAS, a company incorporated under the laws of
France
Exhibit A
Form of Lock-up Agreement
July
___, 2021
H.C. Wainwright & Co. LLC
As
Representative of the several Underwriters
c/o
H.C. Wainwright & Co. LLC
430
Park Avenue
New
York, New York 10022
Re:
AzurRx Biopharma,
Inc.
Dear
Sirs:
This
Lock-Up Agreement (this “Agreement”) is being delivered
to you in connection with the proposed Underwriting Agreement (the
“Underwriting Agreement”) between AzurRx Biopharma,
Inc., a Delaware corporation (the “Company”), and H.C.
Wainwright & Co. LLC (“Wainwright”), as
representative of a group of underwriters (collectively, the
“Underwriters”), to be named therein, and the other
parties thereto (if any), relating to the proposed public offering
of shares of the common stock, par value $0.0001 per share (the
“Common Stock”), of the Company.
In
order to induce you and the other Underwriters to enter into the
Underwriting Agreement, and in light of the benefits that the
offering of the Common Stock will confer upon the undersigned in
its capacity as a securityholder and/or an officer, director or
employee of the Company, and for good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the
undersigned agrees with each Underwriter that, during the period
beginning on and including the earlier of the date hereof and the
date of the Underwriting Agreement through and including the date
that is the 60th day after the date
of the Underwriting Agreement (the “Lock-Up Period”),
the undersigned will not, without the prior written consent of
Wainwright, directly or indirectly, (i) offer, sell, assign,
transfer, pledge, contract to sell, or otherwise dispose of, or
announce the intention to otherwise dispose of, any shares of
Common Stock whether now owned or hereafter acquired by the
undersigned (including, without limitation, Common Stock which may
be deemed to be beneficially owned by the undersigned in accordance
with the rules and regulations promulgated under the Securities Act
of 1933, as the same may be amended or supplemented from time to
time (such shares, the “Beneficially Owned Shares”)) or
securities convertible into or exercisable or exchangeable for
Common Stock, (ii) enter into any swap, hedge or similar agreement
or arrangement that transfers in whole or in part, the economic
risk of ownership of the Beneficially Owned Shares or securities
convertible into or exercisable or exchangeable for Common Stock,
whether now owned or hereafter acquired by the undersigned or with
respect to which the undersigned has or hereafter acquires the
power of disposition, or (iii) engage in any short selling of the
Common Stock or securities convertible into or exercisable or
exchangeable for Common Stock.
The
restrictions set forth in the immediately preceding paragraph shall
not apply to:
(1)
if the undersigned
is a natural person, any transfers made by the undersigned
(a) as a bona fide gift to any member of the immediate family
(as defined below) of the undersigned or to a trust the
beneficiaries of which are exclusively the undersigned or members
of the undersigned’s immediate family, (b) by will or
intestate succession upon the death of the undersigned; (c) as
a bona fide gift to a charity or educational institution or (d)
pursuant to a qualified domestic order or in connection with a
divorce settlement,
(2)
if the undersigned
is a corporation, partnership, limited liability company or other
business entity, any transfers to any shareholder, partner or
member of, or owner of a similar equity interest in, the
undersigned, as the case may be, if, in any such case, such
transfer is not for value,
(3)
if the undersigned
is a corporation, partnership, limited liability company or other
business entity, any transfer made by the undersigned (a) in
connection with the sale or other bona fide transfer in a single
transaction of all or substantially all of the undersigned’s
capital stock, partnership interests, membership interests or other
similar equity interests, as the case may be, or all or
substantially all of the undersigned’s assets, in any such
case not undertaken for the purpose of avoiding the restrictions
imposed by this Agreement or (b) to another corporation,
partnership, limited liability company or other business entity so
long as the transferee is an affiliate (as defined below) of the
undersigned and such transfer is not for value;
provided,
however, that in the case of any transfer described in
clause (1), (2) or (3) above, it shall be a condition to
the transfer that (A) the transferee executes and delivers to
Wainwright, acting on behalf of the Underwriters, not later than
one business day prior to such transfer, a written agreement, in
substantially the form of this Agreement and otherwise satisfactory
in form and substance to Wainwright, and (B) if the
undersigned is required to file a report under Section 16(a)
of the Securities Exchange Act of 1934, as amended, reporting a
reduction in beneficial ownership of shares of Common Stock or
Beneficially Owned Shares or any securities convertible into or
exercisable or exchangeable for Common Stock or Beneficially Owned
Shares during the Lock-Up Period (as the same may be extended as
described above), the undersigned shall include a statement in such
report to the effect that, in the case of any transfer pursuant to
clause (1) above, such transfer is being made as a gift or by
will or intestate succession or, in the case of any transfer
pursuant to clause (2) above, such transfer is being made to a
shareholder, partner or member of, or owner of a similar equity
interest in, the undersigned and is not a transfer for value or, in
the case of any transfer pursuant to clause (3) above, such
transfer is being made either (a) in connection with the sale or
other bona fide transfer in a single transaction of all or
substantially all of the undersigned’s capital stock,
partnership interests, membership interests or other similar equity
interests, as the case may be, or all or substantially all of the
undersigned’s assets or (b) to another corporation,
partnership, limited liability company or other business entity
that is an affiliate of the undersigned and such transfer is not
for value.
(4)
transactions relating to
shares of Common Stock or other securities acquired in the
offering;
(5)
transfers or
dispositions of shares of Common Stock or other securities to the
Company in connection with the exercise of any option or warrant
for, shares of Common Stock; provided that
(i) any such shares of Common Stock received by the
undersigned shall be subject to the terms of this agreement and
(ii) no filing by any party under the Exchange Act or other
public announcement shall be required or shall be made voluntarily
during the Restricted Period (other than a filing on a Form 4 that
reports such disposition under the transaction code
“F”);
(6)
the establishment of a
trading plan pursuant to Rule 10b5-1 under the Exchange
Act for the transfer of shares of Common
Stock, provided that
(i) such plan does not provide for the transfer of common
stock during the Lock-up Period and (ii) no filing by any
party under the Exchange Act or other public announcement shall be
required or shall be made voluntarily by or on behalf of the
undersigned or the Company in connection with the establishment of
such plan; or
(7)
transfers or
dispositions of shares of Common Stock or such other securities
pursuant to a bona fide tender offer for shares of the
Company’s capital stock, merger, consolidation or other
similar transaction made to all holders of the Company’s
securities involving a Change of Control (as defined below) of the
Company (including without limitation, the entering into of
any lock-up, voting or similar agreement pursuant to
which the undersigned may agree to transfer, sell, tender or
otherwise dispose of shares of Common Stock or other securities in
connection with such transaction) that has been approved by the
board of directors of the Company; provided that,
in the event that such Change of Control transaction is not
consummated, this clause (7) shall not be applicable and the
undersigned’s shares and other securities shall remain
subject to the restrictions contained in this
agreement.
For
purposes of this agreement, “immediate family” shall
mean a spouse, child, grandchild or other lineal descendant
(including by adoption), father, mother, brother or sister of the
undersigned; and “affiliate” shall have the meaning set
forth in Rule 405 under the Securities Act of 1933, as amended and
“Change of
Control” shall mean the transfer (whether by tender offer,
merger, consolidation or other similar transaction), in one
transactions or a series of related transactions, to a person or
group of affiliated persons (other than an Underwriter pursuant to
the offering), of the Company’s voting securities if, after
such transfer, such person or group of affiliated persons would
hold at least 90% of the outstanding voting securities of the
Company (or the surviving entity), provided that,
for the avoidance of doubt, the offering shall not constitute a
Change of Control.
The
undersigned further agrees that (i) it will not, during the
Lock-Up Period, make any demand or request for or exercise any
right with respect to the registration under the Securities Act of
1933, as amended, of any shares of Common Stock or other
Beneficially Owned Shares or any securities convertible into or
exercisable or exchangeable for Common Stock or other Beneficially
Owned Shares, and (ii) the Company may, with respect to any
Common Stock or other Beneficially Owned Shares or any securities
convertible into or exercisable or exchangeable for Common Stock or
other Beneficially Owned Shares owned or held (of record or
beneficially) by the undersigned, cause the transfer agent or other
registrar to enter stop transfer instructions and implement stop
transfer procedures with respect to such securities during the
Lock-Up Period (as the same may be extended as described above). In
addition, the undersigned hereby waives, from the date hereof until
the expiration of the 60-day period following the date of the
Underwriting Agreement and any extension of such period pursuant to
the terms hereof, any and all rights, if any, to request or demand
registration pursuant to the Securities Act of 1933, as amended, of
any shares of Common Stock that are registered in the name of the
undersigned or that are Beneficially Owned Shares.
The
undersigned hereby represents and warrants that the undersigned has
full power and authority to enter into this Agreement and that this
Agreement has been duly authorized (if the undersigned is not a
natural person), executed and delivered by the undersigned and is a
valid and binding agreement of the undersigned. This Agreement and
all authority herein conferred are irrevocable and shall survive
the death or incapacity of the undersigned (if a natural person)
and shall be binding upon the heirs, personal representatives,
successors and assigns of the undersigned.
It
is understood that, if (A) the Company notifies Wainwright
that it does not intend to proceed with the proposed public
offering of Common Stock, (B) the Underwriting Agreement
(other than the provisions thereof which survive termination) shall
terminate or be terminated prior to payment for and delivery of the
shares of Common Stock to be sold thereunder, or (C) the
proposed public offering of Common Stock shall not have been
completed by July 20, 2021, this Agreement shall immediately be
terminated and the undersigned shall be released from all
obligations under this Agreement.
[Remainder of page intentionally left blank.]
The
undersigned acknowledges and agrees that whether or not any public
offering of Common Stock actually occurs depends on a number of
factors, including market conditions.
Very
truly yours,
_________________________________________
(Name
of Stockholder - Please Print)
__________________________________________
(Signature)
___________________________________________
(Name
of Signatory if Stockholder is an entity - Please
Print)
____________________________________________
(Title
of Signatory if Stockholder is an entity - Please
Print)
Address:
___________________________________________
___________________________________________
Exhibit B
Directors, Executive Officers and Principal Stockholders Signing
Lock-up Agreement
James
Sapirstein
Daniel
Schneiderman
James
Pennington
Edward
Borkowski
Charles
Casamento
Alastair
Riddell
Vern
Schramm
Gregory
Oakes