Exhibit 10.1
Execution Copy
Albireo
pharma, Inc.
Common
Stock
(par value $0.01
per share)
SALES
AGREEMENT
February 25, 2021
Xxxxx and Company, LLC
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Ladies and Gentlemen:
Albireo Pharma, Inc.,
a Delaware corporation (the “Company”), confirms its agreement (this “Agreement”)
with Xxxxx and Company, LLC (“Cowen”), as follows:
1. Issuance
and Sale of Shares. The Company agrees that, from time to time during the term of this Agreement, on the terms and subject
to the conditions set forth herein, it may issue and sell through Cowen, acting as agent and/or principal, shares (the “Placement
Shares”) of the Company’s common stock, par value $0.01 per share (the “Common Stock”),
having an aggregate offering price of up to $100,000,000. Notwithstanding anything to the contrary contained herein, the parties
hereto agree that compliance with the limitation set forth in this Section 1 on the number of shares of Common Stock
issued and sold under this Agreement shall be the sole responsibility of the Company, and Cowen shall have no obligation in connection
with such compliance. The issuance and sale of Common Stock through Cowen will be effected pursuant to the Registration Statement
(as defined below) filed by the Company, which became effective upon filing with the Securities and Exchange Commission (the “Commission”),
although nothing in this Agreement shall be construed as requiring the Company to use the Registration Statement (as defined below)
to issue the Placement Shares.
The Company has filed
or will file, in accordance with the provisions of the Securities Act of 1933, as amended, and the rules and regulations thereunder
(collectively, the “Securities Act”), with the Commission a registration statement on Form S-3,
including a base prospectus, relating to certain securities, including Common Stock, to be issued from time to time by the Company,
and which incorporates by reference certain documents that the Company has filed or will file in accordance with the provisions
of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder (collectively, the “Exchange
Act”). The Company has prepared a prospectus specifically relating to the Placement Shares (the “Sales
Prospectus”) included as part of such registration statement. The Company will make available to Cowen, for use by
Cowen, copies of the Sales Prospectus, as supplemented from time to time by any prospectus supplement relating to the Placement
Shares. Except where the context otherwise requires, such registration statement, as amended when it became effective, including
all documents filed as part thereof or incorporated by reference therein, and including any information contained in a Prospectus
(as defined below) subsequently filed with the Commission pursuant to Rule 424(b) under the Securities Act or deemed
to be a part of such registration statement pursuant to Rule 430B or 462(b) of the Securities Act, is herein called the
“Registration Statement.” The Sales Prospectus, including all documents incorporated therein by reference,
which is included in the Registration Statement, as it may be supplemented by one or more prospectus supplements, in the form in
which such prospectus and/or Sales Prospectus have most recently been filed by the Company with the Commission pursuant to Rule 424(b) under
the Securities Act, together with any “issuer free writing prospectus,” as defined in Rule 433 of the Securities
Act regulations (“Rule 433”), relating to the Placement Shares that (i) is consented to by
Cowen, hereinafter referred to as a “Permitted Free Writing Prospectus,” (ii) is required to be
filed with the Commission by the Company or (iii) is exempt from filing pursuant to Rule 433(d)(5)(i), in each case in
the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s
records pursuant to Rule 433(g), is herein called the “Prospectus.” Any reference herein to the
Registration Statement, the Prospectus or any amendment or supplement thereto shall be deemed to refer to and include the documents
incorporated by reference therein, and any reference herein to the terms “amend,” “amendment” or “supplement”
with respect to the Registration Statement or the Prospectus shall be deemed to refer to and include the filing after the execution
hereof of any document with the Commission deemed to be incorporated by reference therein. For purposes of this Agreement, all
references to the Registration Statement, the Prospectus or to any amendment or supplement thereto shall be deemed to include any
copy filed with the Commission via the Electronic Data Gathering Analysis and Retrieval System (“XXXXX”).
2. Placements.
Each time that the Company wishes to issue and sell the Placement Shares hereunder (each, a “Placement”),
it will notify Cowen by email notice (or other method mutually agreed to in writing by the parties) (a “Placement
Notice”) containing the parameters in accordance with which it desires the Placement Shares to be sold, which shall
at a minimum include the number of Placement Shares to be issued, the time period during which sales are requested to be made,
any limitation on the number of Placement Shares that may be sold in any one (1) Trading Day (as defined in Section 3)
and any minimum price below which sales may not be made, a form of which containing such minimum sales parameters necessary is
attached hereto as Schedule 1. The Placement Notice shall originate from any of the individuals from the Company
set forth on Schedule 2 (with a copy to each of the other individuals from the Company listed on such schedule),
and shall be addressed to each of the individuals from Cowen set forth on Schedule 2, as such Schedule 2
may be amended in writing from time to time in accordance herewith. The Placement Notice shall be effective upon receipt by Cowen
unless and until (i) in accordance with the notice requirements set forth in Section 4, Cowen declines to accept
the terms contained therein for any reason, in its sole discretion, (ii) the entire amount of the Placement Shares thereunder
have been sold, (iii) in accordance with the notice requirements set forth in Section 4, the Company suspends
or terminates the Placement Notice for any reason, in the Company’s sole discretion, (iv) the Company issues a subsequent
Placement Notice with parameters superseding those contained in the earlier dated Placement Notice, or (v) this Agreement
has been terminated under the provisions of Section 11. The amount of any discount, commission or other compensation
to be paid by the Company to Cowen in connection with the sale of the Placement Shares shall be calculated in accordance with
the terms set forth in Schedule 3. It is expressly acknowledged and agreed that neither the Company nor Cowen will
have any obligation whatsoever with respect to a Placement or any Placement Shares unless and until the Company delivers a Placement
Notice to Cowen that is not declined by Cowen pursuant to the terms set forth above, and then only upon the terms specified therein
and herein. In the event of a conflict between the terms of this Agreement and the terms of a Placement Notice, the terms of the
Placement Notice will control.
3. Sale
of Placement Shares by Cowen. Subject to the terms and conditions herein set forth, upon the Company’s delivery of a
Placement Notice, and unless the sale of the Placement Shares described therein has been declined, suspended, or otherwise terminated
in accordance with the terms of this Agreement, Cowen, for the period specified in the Placement Notice, will use its commercially
reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and
regulations and the rules of the Nasdaq Stock Market (“Nasdaq”) to sell such Placement Shares up
to the amount specified in, and otherwise in accordance with, the terms of such Placement Notice. Cowen will provide written confirmation
to the Company (including by email correspondence to all of the individuals of the Company set forth on Schedule 2, if receipt
of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply)
no later than the opening of the Trading Day (as defined below) immediately following the Trading Day on which it has made sales
of Placement Shares hereunder, setting forth the number of Placement Shares sold on such day, the volume-weighted average price
of the Placement Shares sold, the compensation payable by the Company to Cowen pursuant to Section 5(a) with respect
to such sales, any other deductions to the gross proceeds of Placement Shares made by Cowen pursuant to Section 5(a) to
calculate the Net Proceeds (as defined below) from such sale, and the Net Proceeds payable to the Company. In the event the Company
engages Cowen for a sale of Placement Shares that would constitute a “block” within the meaning of Rule 10b-18(a)(5) under
the Exchange Act (a “Block Sale”), the Company will provide Cowen, at Xxxxx’x request and upon
advance notice of two business days to the Company, on or prior to the Settlement Date (as defined below), the opinions of counsel,
accountant’s letter and officers’ certificates set forth in Section 8 hereof, each dated the Settlement Date,
and such other documents and information as Cowen shall reasonably request. Subject to the terms of the Placement Notice, Cowen
may sell Placement Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415
of the Securities Act, including without limitation sales made through Nasdaq or on any other existing trading market for the Common
Stock. Notwithstanding the provisions of Section 6(ww), Xxxxx shall not purchase Placement Shares for its own account
as principal unless expressly authorized to do so by the Company in a Placement Notice. The Company acknowledges and agrees that
(i) there can be no assurance that Cowen will be successful in selling Placement Shares, and (ii) Cowen will incur no
liability or obligation to the Company or any other person or entity if it does not sell Placement Shares for any reason other
than a failure by Cowen to use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable
law to sell such Placement Shares as required under this Section 3. For the purposes hereof, “Trading Day”
means any day on which the Company’s Common Stock is purchased and sold on Nasdaq. Notwithstanding any other provision of
this Agreement, the Company shall not offer, sell or deliver, or request the offer or sale, of any Placement Shares pursuant to
this Agreement and, by notice to Cowen given by telephone (confirmed promptly by email), shall cancel any instructions for the
offer or sale of any Placement Shares, and Cowen shall not be obligated to offer or sell any Placement Shares, (i) during
any period in which the Company is, or could be deemed to be, in possession of material non-public information, or (ii) at
any time from and including the date on which the Company shall issue a press release containing, or shall otherwise publicly announce,
its earnings, revenues or other results of operations (an “Earnings Announcement”) through and including
the time that the Company files a Quarterly Report on Form 10-Q or an Annual Report on Form 10-K that includes consolidated
financial statements as of and for the same period or periods, as the case may be, covered by such Earnings Announcement.
4. Suspension
of Sales.
(a) The
Company or Cowen may, upon notice to the other party in writing (including by email correspondence to each of the individuals of
the other party set forth on Schedule 2, if receipt of such correspondence is actually acknowledged by any of the
individuals to whom the notice is sent, other than via auto-reply) or by telephone (confirmed immediately by verifiable facsimile
transmission or email correspondence to each of the individuals of the other party set forth on Schedule 2), suspend
any sale of Placement Shares; provided, however, that such suspension shall not affect or impair either party’s obligations
with respect to any Placement Shares sold hereunder prior to the receipt of such notice. Each of the parties agrees that no such
notice under this Section 4 shall be effective against the other unless it is made to one of the individuals named
on Schedule 2 hereto, as such schedule may be amended in writing from time to time in accordance with Section 15.
(b) If
either Cowen or the Company has reason to believe that the exemptive provisions set forth in Rule 101(c)(1) of Regulation
M under the Exchange Act are not satisfied with respect to the Common Stock, it shall promptly notify the other party, and Cowen
may, at its sole discretion, suspend sales of the Placement Shares under this Agreement.
(c) The
Registration Statement became automatically effective upon filing of the Registration Statement with the Commission on February 25,
2021. Notwithstanding any other provision of this Agreement, during any period in which the Registration Statement is no longer
effective under the Securities Act, the Company shall promptly notify Cowen, the Company shall not request the sale of any Placement
Shares, and Cowen shall not be obligated to sell or offer to sell any Placement Shares.
5. Settlement.
(a) Settlement
of Placement Shares. Unless otherwise specified in the applicable Placement Notice, settlement for sales of Placement Shares
will occur on the second (2nd) Trading Day (or such earlier day as is industry practice for regular-way trading) following
the date on which such sales are made (each, a “Settlement Date” and the first such settlement date,
the “First Delivery Date”). The amount of proceeds to be delivered to the Company on a Settlement Date
against receipt of the Placement Shares sold (the “Net Proceeds”) will be equal to the aggregate sales
price received by Cowen at which such Placement Shares were sold, after deduction for (i) Xxxxx’x commission, discount
or other compensation for such sales payable by the Company pursuant to Section 2 hereof, (ii) any other amounts
due and payable by the Company to Cowen hereunder pursuant to Section 7(g) (Expenses) hereof, and (iii) any
transaction fees imposed by any governmental or self-regulatory organization in respect of such sales.
(b) Delivery
of Placement Shares. On or before each Settlement Date, the Company will, or will cause its transfer agent to, electronically
transfer the Placement Shares being sold by crediting Xxxxx’x or its designee’s account (provided Cowen shall have
given the Company written notice of such designee at least one (1) Trading Day prior to the Settlement Date) at The Depository
Trust Company through its Deposit and Withdrawal at Custodian System (“DWAC”) or by such other means
of delivery as may be mutually agreed upon by the parties hereto which in all cases shall be freely tradeable, transferable, registered
shares in good deliverable form. Cowen will provide DWAC instructions or instructions for delivery by other means with regard
to the electronic transfer of the Placement Shares. On each Settlement Date, Cowen will deliver the related Net Proceeds in same
day funds to an account designated by the Company on, or prior to, the Settlement Date. The Company agrees that if the Company,
or its transfer agent (if applicable), defaults in its obligation to deliver duly authorized Placement Shares on a Settlement
Date, the Company agrees that in addition to and in no way limiting the rights and obligations set forth in Section 9(a) (Indemnification
and Contribution), it will (i) hold Cowen harmless against any loss, claim, damage, or reasonable and documented expense
(including reasonable and documented legal fees and expenses), as incurred, arising out of or in connection with such default
by the Company and (ii) pay to Cowen (without duplication) any commission, discount, or other compensation to which it would
otherwise have been entitled absent such default.
6. Representations
and Warranties of the Company. The Company represents and warrants to, and agrees with, Cowen that as of each Applicable Time
(as defined in Section 20(a)):
(a) Compliance
with Registration Requirements. As of each Applicable Time other than the date of this Agreement, the Registration Statement
and any Rule 462(b) Registration Statement have been declared effective by the Commission under the Securities Act, the
Company has complied to the Commission’s satisfaction with all requests of the Commission for additional or supplemental
information relating to the Registration Statement or the Prospectus, no stop order suspending the effectiveness of the Registration
Statement or any Rule 462(b) Registration Statement is in effect and no proceedings for such purpose have been instituted
or are pending or, to the knowledge of the Company, contemplated or threatened by the Commission. The Company meets the requirements
for use of Form S-3 under the Securities Act. The sale of the Placement Shares hereunder meets the requirements of General
Instruction I.B.1 of Form S-3.
(b) No
Misstatement or Omission. The Prospectus when filed complied and, as amended or supplemented, if applicable, will comply in
all material respects with the Securities Act. Each of the Registration Statement, any Rule 462(b) Registration Statement,
the Prospectus and any post-effective amendments or supplements thereto, at the time it became effective or its date, as applicable,
complied and as of each of the Settlement Dates, if any, complied and will comply in all material respects with the Securities
Act and did not and, as of each Settlement Date, if any, 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. The Prospectus,
as amended or supplemented, as of its date, did not and, as of each of the Settlement Dates, if any, 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
two immediately preceding sentences do not apply to statements in or omissions from the Registration Statement, any Rule 462(b) Registration
Statement, or any post-effective amendment thereto, or the Prospectus, or any amendments or supplements thereto, made in reliance
upon and in conformity with information relating to Cowen furnished to the Company in writing by Cowen expressly for use therein.
There are no contracts or other documents required to be described in the Prospectus or to be filed as exhibits to the Registration
Statement which have not been described or filed as required.
(c) Offering
Materials Furnished to Cowen. As of each Applicable Time, the Company has delivered to Cowen one complete copy of the Registration
Statement and a copy of each consent and certificate of experts filed as a part thereof, and conformed copies of the Registration
Statement (without exhibits) and the Prospectus, as amended or supplemented, in such quantities and at such places as Cowen has
reasonably requested. The Registration Statement, the Prospectus and any Permitted Free Writing Prospectus (to the extent any such
Permitted Free Writing Prospectus was required to be filed with the Commission) delivered to Cowen for use in connection with the
public offering of the Placement Shares contemplated herein have been and will be identical to the versions of such documents transmitted
to the Commission for filing via XXXXX, except to the extent permitted by Regulation S-T.
(d) Emerging
Growth Company. The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities
Act. The Company agrees to notify Cowen promptly upon the Company ceasing to be an emerging growth company.
(e) Well-Known
Seasoned Issuer Status. (A) At the original effectiveness of the Registration Statement, (B) at the time of the most
recent amendment thereto for the purposes of complying with Section 10(a)(3) of the Securities Act (whether such amendment
was by post-effective amendment or incorporated report filed pursuant to Section 13 or 15(d) of the Exchange Act or in
the form of a prospectus), and (C) at the time the Company or any person acting on its behalf (within the meaning, for this
clause only, of Rule 163(c) under the Securities Act) made any offer relating to the Shares in reliance on the exemption
of Rule 163 under the Securities Act, the Company was and will be a “well-known seasoned issuer” (as defined in
Rule 405).
(f) Documents
Incorporated by Reference. The documents incorporated by reference in the Prospectus, when they were filed with the Commission,
conformed in all material respects to the requirements of the Securities Act or the Exchange Act, as applicable, and the rules and
regulations of the Commission thereunder and none of such documents contained any untrue statement of a material fact or omitted
to state any material fact required to be stated therein, or necessary to make the statements therein, in the light of the circumstances
under which they were made, not misleading; and any further documents so filed and incorporated by reference in the Prospectus,
when such documents are filed with the Commission will conform in all material respects to the requirements of the Securities Act
or the Exchange Act, as applicable, and the rules and regulations of the Commission thereunder and will not contain any untrue
statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements
therein, in the light of the circumstances under which they were made, not misleading.
(g) Distribution
of Offering Materials. The Company has not, directly or indirectly, distributed and will not distribute, prior to the completion
of Xxxxx’x distribution of the Placement Shares, any offering material in connection with the offering and sale of the Placement
Shares other than the Prospectus, the Registration Statement or any other materials, if any, permitted under the Securities Act.
(h) Not
an Ineligible Issuer. At the time of filing the Registration Statement, any Rule 462(b) Registration Statement and
any post-effective amendment thereto, and at the date hereof, the Company was not, and the Company will not be, an “ineligible
issuer,” as defined in Rule 405 of the Securities Act.
(i) Organization
and Good Standing. The Company and each of its subsidiaries (as defined in Section 20(b)) have been duly organized
and are validly existing as corporations or other legal entities in good standing (or the foreign equivalent thereof) under the
laws of their respective jurisdictions of organization. The Company and each of its subsidiaries are duly qualified to do business
and are in good standing as foreign corporations or other legal entities in each jurisdiction in which their respective ownership
or lease of property or the conduct of their respective businesses requires such qualification and have all power and authority
(corporate or other) necessary to own or hold their respective properties and to conduct the businesses in which they are engaged,
except where the failure to so qualify or have such power or authority would not (i) have, singularly or in the aggregate,
a material adverse effect on the business, properties, management, financial position, stockholders’ equity, results of operations
or prospects of the Company and its subsidiaries taken as a whole, or (ii) impair in any material respect the ability of the
Company to perform its obligations under this Agreement or to consummate any transactions contemplated by this Agreement or the
Prospectus (any such effect as described in clauses (i) or (ii), a “Material Adverse Effect”). The
subsidiaries listed in Schedule 4 to this agreement are the only Significant Subsidiaries (as defined in Section 6(gg)).
(j) The
Sales Agreement. This Agreement has been duly authorized, executed and delivered by the Company.
(k) The
Placement Shares. The Placement Shares to be sold by Cowen, acting as agent and/or principal for the Company, have been duly
authorized and, when issued and delivered by the Company against payment therefor pursuant to this Agreement, will be validly issued,
fully paid and nonassessable and will conform to the descriptions thereof in the Prospectus; and the issuance of the Placement
Shares are not subject to any preemptive or similar rights that have not been waived.
(l) Capitalization.
The Company has an authorized capitalization as set forth under the heading “Description of Capital Stock” in the
Sales Prospectus, and (i) to the Company’s knowledge, all of the outstanding shares of capital stock of the Company
issued prior to the Share Exchange Closing Date (defined below) have been duly and validly authorized and issued, are fully paid
and non-assessable, have been issued in compliance with federal and state securities laws, and conform to the description thereof
contained in the Sales Prospectus under the heading “Description of Capital Stock” and (ii) all of the outstanding
shares of capital stock of the Company issued on and after the Share Exchange Closing Date have been duly and validly authorized
and issued, are fully paid and non-assessable, have been issued in compliance with federal and state securities laws, and conform
to the description thereof contained in the Sales Prospectus under the heading “Description of Capital Stock”. To
the Company’s knowledge, all of the Company’s options, warrants and other rights to purchase or exchange any securities
for shares of the Company’s capital stock granted prior to the Share Exchange Closing Date have been duly authorized and
validly issued and were issued in compliance with federal and state securities laws. All of the Company’s options, warrants
and other rights to purchase or exchange any securities for shares of the Company’s capital stock granted on or after the
Share Exchange Closing Date have been duly authorized and validly issued and were issued in compliance with federal and state
securities laws. None of the outstanding shares of Common Stock was issued in violation of any preemptive rights, rights of first
refusal or other similar rights to subscribe for or purchase securities of the Company. As of the date the Registration Statement
is filed, there were or will be no authorized or outstanding shares of capital stock, options, warrants, preemptive rights, rights
of first refusal or other rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for,
any capital stock of the Company or any of its subsidiaries other than those described above or accurately described in the Prospectus.
The description of the Company’s stock option, stock bonus and other stock plans or arrangements, and the options or other
rights granted thereunder, as described in the Prospectus, accurately and fairly present the information required to be shown
with respect to such plans, arrangements, options and rights. Reference is made to November 3, 2016, which was the date of
the closing of the share exchange contemplated by the Amended and Restated Share Exchange Agreement dated as of July 13,
2016, by and among Biodel Inc., Albireo Limited and the sellers listed on Schedule I thereto (the “Share Exchange
Closing Date”).
(m) Capitalization
of Subsidiaries. All the outstanding shares of capital stock (if any) of each subsidiary of the Company have been duly authorized
and validly issued, are fully paid and nonassessable and, except to the extent set forth in the Prospectus, are owned by the Company
directly or indirectly through one or more wholly-owned subsidiaries, free and clear of any claim, lien, encumbrance, security
interest, restriction upon voting or transfer or any other claim of any third party.
(n) No
Conflicts. The execution, delivery and performance of this Agreement by the Company, the issue and sale of the Placement Shares
by the Company and the consummation of the transactions contemplated hereby will not (with or without notice or lapse of time
or both) (i) conflict with or result in a breach or violation of any of the terms or provisions of, constitute a default
or a Debt Repayment Triggering Event (as defined below) under, or result in the creation or imposition of any lien, encumbrance,
security interest, claim or charge upon any property or assets of the Company or any subsidiary pursuant to, 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
is subject, (ii) result in any violation of the provisions of the charter or by-laws (or analogous governing instruments,
as applicable) of the Company or any of its subsidiaries or (iii) result in the violation of any law, statute, rule, regulation,
judgment, order or decree of any court or governmental or regulatory agency or body, domestic or foreign, having jurisdiction
over the Company or any of its subsidiaries or any of their properties or assets except, in the case of clauses (i) and (iii) above,
for any such conflict, breach, violation or default that would not, individually or in the aggregate, have a Material Adverse
Effect. A “Debt Repayment Triggering Event” means any event or condition that gives, or with the giving
of notice or lapse of time would give the holder of any note, debenture or other evidence of indebtedness (or any person acting
on such holder’s behalf) the right to require the repurchase, redemption or repayment of all or a portion of such indebtedness
by the Company of any of its subsidiaries.
(o) No
Consents Required. Except for the registration of the offer and sale of the Placement Shares under the Securities Act and applicable
state securities laws, and such consents, approvals, authorizations, orders and registrations or qualifications as may be required
by the Financial Industry Regulatory Authority (“FINRA”) or Nasdaq in connection with sale of the Placement
Shares and the listing of the Placement Shares on Nasdaq, no consent, approval, authorization or order of, or filing, qualification
or registration (each an “Authorization”) with, any court, governmental or regulatory agency or body,
foreign or domestic, which has not been made, obtained or taken and is not in full force and effect, is required for the execution,
delivery and performance of this Agreement by the Company, the issuance and sale of the Placement Shares or the consummation of
the transactions contemplated hereby; and no event has occurred that allows or results in, or after notice or lapse of time or
both would allow or result in, revocation, suspension, termination or invalidation of any such Authorization or any other impairment
of the rights of the holder or maker of any such Authorization.
(p) Independent
Auditors. Ernst & Young LLP, who has audited and certified certain financial statements of the Company and its subsidiaries
included or incorporated by reference in the Registration Statement and the Prospectus, is an independent registered public accounting
firm with respect to the Company and its subsidiaries within the meaning of Article 2-01 of Regulation S-X and the Public
Company Accounting Oversight Board (United States) (the “PCAOB”).
(q) Financial
Statements. The financial statements, together with the related notes, included or incorporated by reference in the Prospectus
and the Registration Statement fairly present, in all material respects, the consolidated financial position and the results of
operations and changes in financial position of the Company and its consolidated subsidiaries at the respective dates or for the
respective periods therein specified. Such statements and related notes have been prepared in accordance with the generally accepted
accounting principles in the United States (“GAAP”) applied on a consistent basis throughout the periods
involved except as may be set forth in the related notes included or incorporated by reference in the Prospectus. The financial
statements, together with the related notes, included or incorporated by reference in the Prospectus comply in all material respects
with Regulation S-X. No other financial statements or supporting schedules or exhibits are required by Regulation S-X to be described,
included or incorporated by reference in the Registration Statement or the Prospectus. The summary and selected financial data
included or incorporated by reference in the Prospectus and the Registration Statement fairly present, in all material respects,
the information shown therein as at the respective dates and for the respective periods specified and are derived from the consolidated
financial statements incorporated by reference in the Registration Statement and the Prospectus and other financial information.
All information contained in the Registration Statement and the Prospectus regarding “non-GAAP financial measures”
(as defined in Regulation G) complies with Regulation G and Item 10 of Regulation S-K, to the extent applicable.
(r) eXtensible
Business Reporting Language. The interactive data in eXtensible Business Reporting Language included or incorporated by reference
in the Registration Statement fairly presents the information called for in all material respects and has been prepared in accordance
in all material respects with the Commission’s rules and guidelines applicable thereto.
(s) No
Material Adverse Change. Neither the Company nor any of its subsidiaries has sustained, since the date of the latest audited
financial statements included or incorporated by reference in the Prospectus: (i) any material loss or interference with its
business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or action,
order or decree of any court or governmental or regulatory authority, otherwise than as set forth or contemplated in the Prospectus;
(ii) any change in the capital stock (other than the issuance of shares of Common Stock upon exercise of stock options and
warrants and vesting of restricted stock units described as outstanding in, and the grant of options and awards under existing
equity incentive plans described in, the Registration Statement and the Prospectus) or any increase in the long-term debt of the
Company or any of its subsidiaries, otherwise than as set forth or contemplated in the Prospectus; (iii) any dividend or distribution
of any kind declared, set aside for payment, paid or made by the Company on any class of capital stock; or (iv) any material
adverse change, or any development involving a prospective material adverse change, in or affecting the business, properties, assets,
general affairs, management, financial position, prospects, stockholders’ equity or results of operations of the Company
and its subsidiaries taken as a whole, otherwise than as set forth or contemplated in the Prospectus.
(t) Legal
Proceedings. Except as set forth in Prospectus, there is no legal or governmental proceeding to which the Company or any of
its subsidiaries is a party or of which any property or assets of the Company or any of its subsidiaries is the subject, including
any proceeding before the United States Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”)
or comparable federal, state, local or foreign governmental bodies (it being understood that the interaction between the Company
and the FDA and such comparable governmental bodies relating to the testing, nonclinical and clinical development, manufacture
and product approval process shall not be deemed proceedings for purposes of this representation), which is required to be described
in the Registration Statement or the Prospectus or a document incorporated by reference therein and is not described therein, or
which, singularly or in the aggregate, if determined adversely to the Company or any of its subsidiaries, would reasonably be expected
to have a Material Adverse Effect; and no such proceedings are, to the Company’s knowledge after reasonable investigation
and due diligence inquiry (if investigation or inquiry is reasonable under the circumstances) (“Knowledge”),
threatened or contemplated by governmental or regulatory authorities or threatened by others. The Company is in compliance with
all applicable federal, state, local and foreign laws, regulations, orders and decrees governing its business as prescribed by
the FDA, or any other federal, state or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous
substances or materials, except where noncompliance would not, singularly or in the aggregate, have a Material Adverse Effect.
All preclinical and clinical studies conducted by or on behalf of the Company to support approval for commercialization of the
Company’s products have been conducted by the Company, or to the Company’s Knowledge by third parties, in compliance
with all applicable federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in
compliance as would not reasonably be expected to have, singularly or in the aggregate, a Material Adverse Effect.
(u) No
Violation or Default. Neither the Company nor any of its subsidiaries is (i) in violation of its charter or by-laws (or
analogous governing instrument, as applicable), (ii) in default in any respect, and no event has occurred which, 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, lease or other agreement or instrument to which it is a party
or by which it is bound or to which any of its property or assets is subject, or (iii) in violation in any respect of any
law, ordinance, governmental rule, regulation or court order, decree or judgment to which it or its property or assets may be subject
(including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory
authority performing functions similar to those performed by the FDA) except, in the case of clauses (ii) and (iii) above,
for any such violation or default that would not, singularly or in the aggregate, have a Material Adverse Effect.
(v) Licenses
or Permits. The Company and its subsidiaries possess all licenses, certificates, authorizations and permits issued by, and
have made all declarations and filings with, the appropriate local, state, federal or foreign governmental or regulatory agencies
or bodies (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental
or regulatory authority performing functions similar to those performed by the FDA) that are necessary for the ownership or lease
of their respective properties or the conduct of their respective businesses as now conducted or as proposed in the Prospectus
to be conducted (collectively, the “Governmental Permits”), except where any failure to possess or make
the same would not, singularly or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries are in compliance,
in all material respects, with all such Governmental Permits; and all such Governmental Permits are valid and in full force and
effect, except where the validity or failure to be in full force and effect would not, singularly or in the aggregate, have a Material
Adverse Effect. Neither the Company nor any subsidiary has received notification of any revocation, modification, suspension, termination
or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that
any such Governmental Permit will not be renewed.
(w) Regulatory
Matters. The preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in
the Prospectus (the “Company Studies and Trials”) were, or if still pending are being, conducted in
all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted
professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies
and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies
or trials not described in the Prospectus, the results of which are inconsistent with or call in question the results described
or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign,
state or local governmental body exercising comparable authority requiring the termination, suspension or material modification
of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a
Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained
(or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and
Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials,
the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the
extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and
regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who
has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the
Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material
respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of
the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed
to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the
Company and its subsidiaries solely from and after the Share Exchange Closing Date.
(x) Investment
Company Act. Neither the Company nor any of its subsidiaries is or, after giving effect to the offering of the Placement Shares
and the application of Net Proceeds as described in the Prospectus, will be required to register as an “investment company”
or an entity “controlled” by an “investment company” within the meaning of the Investment Company Act of
1940, as amended, and the rules and regulations of the Commission thereunder.
(y) No
Stabilization. Neither the Company nor, to the Company’s Knowledge, any of its officers, directors or affiliates has
taken or will take, directly or indirectly, any action designed or intended to stabilize or manipulate the price of any security
of the Company, or which caused or resulted in, or which might in the future reasonably be expected to cause or result in, stabilization
or manipulation of the price of any security of the Company.
(z) Intellectual
Property. Except as disclosed in the Prospectus, the Company or its subsidiaries own or possess the lawful right to use all
(i) valid and enforceable patents, patent applications, trademarks, trademark registrations, service marks, service xxxx
registrations, Internet domain name registrations, copyrights, copyright registrations, licenses, trade secret rights (“Intellectual
Property Rights”) and (ii) inventions, software, works of authorships, trademarks, service marks, trade names,
databases, formulae, know how, Internet domain names and other intellectual property (including trade secrets and other unpatented
and/or unpatentable proprietary confidential information, systems, or procedures) (collectively, “Intellectual Property
Assets”) necessary to conduct their respective businesses as currently conducted, and as proposed to be conducted
and described in the Prospectus. The Company and its subsidiaries have not received any opinion from their legal counsel concluding
that any activities of their respective businesses infringe, misappropriate, or otherwise violate, valid and enforceable Intellectual
Property Rights of any other person, and have not received written notice of any challenge, which is to their Knowledge still
pending, by any other person to the rights of the Company and its subsidiaries with respect to any Intellectual Property Rights
or Intellectual Property Assets owned or used by the Company or its subsidiaries. To the Company’s Knowledge, the Company
and its subsidiaries’ respective businesses as now conducted do not give rise to any infringement of, any misappropriation
of, or other violation of, any valid and enforceable Intellectual Property Rights of any other person. All licenses for the use
of the Intellectual Property Rights described in the Prospectus are valid, binding upon, and enforceable by or against the respective
parties thereto in accordance with their respective terms. The Company has complied in all material respects with, and is not
in breach nor has received any asserted or threatened claim of breach of any license of its Intellectual Property Rights, and
the Company has no knowledge of any breach or anticipated breach by any other person to any Intellectual Property license. Except
as described in the Prospectus, no claim has been made against the Company alleging the infringement by the Company of any patent,
trademark, service xxxx, trade name, copyright, trade secret, license in or other intellectual property right or franchise right
of any person. The Company has taken reasonable steps to protect, maintain and safeguard its Intellectual Property Rights, including
the execution of appropriate nondisclosure and confidentiality agreements. The consummation of the transactions contemplated by
this Agreement will not result in the loss or impairment of or payment of any additional amounts with respect to, nor require
the consent of any other person in respect of, the Company’s right to own, use, or hold for use any of the Intellectual
Property Rights as owned, used or held for use in the conduct of the business as currently conducted. No claims have been asserted
or threatened against the Company alleging a violation of any person’s privacy or personal information or data rights and
the consummation of the transactions contemplated hereby will not breach or otherwise cause any violation of any law related to
privacy, data protection, or the collection and use of personal information collected, used, or held for use by the Company in
the conduct of the Company’s business. The Company takes reasonable measures to ensure that such information is protected
against unauthorized access, use, modification, or other misuse. For purposes of this paragraph, the Company and its subsidiaries
shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing
Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.
(aa) Title
to Real and Personal Property. Except as disclosed in the Prospectus, the Company and each of its subsidiaries have good and
marketable title in and (in the case of real property) to, or have valid and marketable rights to lease or otherwise use, all items
of real or personal property which are material to the business of the Company and its subsidiaries taken as a whole, in each case
free and clear of all liens, encumbrances, security interests, claims and defects except those that (i) do not, singularly
or in the aggregate, materially affect the value of such property and do not materially interfere with the use made and proposed
to be made of such property by the Company or any of its subsidiaries or (ii) would not reasonably be expected, singularly
or in the aggregate, to have a Material Adverse Effect.
(bb) No
Labor Dispute. There is (A) no significant unfair labor practice complaint pending against the Company, or any of its
subsidiaries, nor to the Company’s Knowledge, threatened against it or any of its subsidiaries, before the National Labor
Relations Board, any state or local labor relation board or any foreign labor relations board, and no significant grievance or
significant arbitration proceeding arising out of or under any collective bargaining agreement is so pending against the Company
or any of its subsidiaries, or, to the Company’s Knowledge, threatened against it and (B) no labor disturbance by or
dispute with, employees of the Company or any of its subsidiaries exists or, to the Company’s Knowledge, is contemplated
or threatened, and the Company is not aware of any existing or imminent labor disturbance by the employees of any of its or its
subsidiaries’ principal suppliers, manufacturers, customers or contractors, that would reasonably be expected, singularly
or in the aggregate, to have a Material Adverse Effect. The Company is not aware that any key employee or significant group of
employees of the Company or any subsidiary plans to terminate employment with the Company or any such subsidiary. For purposes
of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries
as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the
Share Exchange Closing Date.
(cc) Compliance
with ERISA. No “prohibited transaction” (as defined in Section 406 of the Employee Retirement Income Security
Act of 1974, as amended, including the regulations and published interpretations thereunder (“ERISA”),
or Section 4975 of the Internal Revenue Code of 1986, as amended from time to time (the “Code”))
or “accumulated funding deficiency” (as defined in Section 302 of ERISA) or any of the events set forth in Section 4043(b) of
ERISA (other than events with respect to which the thirty (30)-day notice requirement under Section 4043 of ERISA has been
waived) has occurred or would reasonably be expected to occur with respect to any employee benefit plan of the Company or any of
its subsidiaries which would, singularly or in the aggregate, reasonably be expected to have a Material Adverse Effect. Each employee
benefit plan of the Company or any of its subsidiaries is in compliance in all material respects with applicable law, including
ERISA and the Code. The Company and its subsidiaries have not incurred, and would not reasonably be expected to incur, liability
under Title IV of ERISA with respect to the termination of, or withdrawal from, any pension plan (as defined in ERISA). Each pension
plan for which the Company or any of its subsidiaries would have any liability that is intended to be qualified under Section 401(a) of
the Code is so qualified, and nothing has occurred, whether by action or by failure to act, which would, singularly or in the aggregate,
reasonably be expected to cause the loss of such qualification. For purposes of this paragraph, the Company and its subsidiaries
shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date
and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.
(dd) Environmental
Laws and Hazardous Materials. The Company and its subsidiaries are in compliance in all material respects with all foreign,
federal, state and local rules, laws and regulations relating to the use, treatment, storage and disposal of hazardous or toxic
substances or waste and protection of health and safety or the environment which are applicable to their businesses (“Environmental
Laws”). There has been no storage, generation, transportation, handling, treatment, disposal, discharge, emission,
or other release of any kind of toxic or other wastes or other hazardous substances by, due to, or caused by the Company or any
of its subsidiaries (or, to the Company’s Knowledge, any other entity for whose acts or omissions the Company or any of its
subsidiaries is or may otherwise be liable) upon any of the property now or previously owned or leased by the Company or any of
its subsidiaries, or upon any other property, in violation of any law, statute, ordinance, rule, regulation, order, judgment, decree
or permit or which would, under any law, statute, ordinance, rule (including rule of common law), regulation, order,
judgment, decree or permit, give rise to any liability; and there has been no disposal, discharge, emission or other release of
any kind onto such property or into the environment surrounding such property of any toxic or other wastes or other hazardous substances
with respect to which the Company or any of its subsidiaries has knowledge. For purposes of this paragraph, the Company and its
subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange
Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.
(ee) Taxes.
The Company and its subsidiaries each (i) have timely filed all necessary federal, state, local and foreign tax returns, and
all such returns were true, complete and correct, (ii) have paid all federal, state, local and foreign taxes due and payable,
for which it is liable, including, without limitation, all sales and use taxes and all taxes which the Company or any of its subsidiaries
is obligated to withhold from amounts owing to employees, creditors and third parties, and (iii) do not have any tax deficiency
or claims outstanding or assessed or, to its Knowledge, proposed against any of them, except those, in each of the cases described
in clauses (i), (ii) and (iii) above, that would not, singularly or in the aggregate, have a Material Adverse Effect.
For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries
as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the
Share Exchange Closing Date.
(ff) Insurance.
The Company and each of its subsidiaries carry, or are covered by, insurance in such amounts and covering such risks as is adequate
for the conduct of their respective businesses and the value of their respective properties. Neither the Company nor any of its
subsidiaries has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage
expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not
have a Material Adverse Effect. None of (i) Albireo Limited or any of its subsidiaries prior to the Share Exchange Closing
Date or (ii) the Company or any of its subsidiaries from and after the Share Exchange Closing Date has received written notice
from any insurer, agent of such insurer or the broker of the Company or any of its subsidiaries that any material capital improvements
or any other material expenditures (other than premium payments) are required or necessary to be made in order to continue such
insurance.
(gg) Accounting
Controls. The Company and each of its subsidiaries maintains a system of “internal control over financial reporting”
(as such term is defined in Rule 13a-15(f) of the General Rules and Regulations under the Exchange Act (the “Exchange
Act Rules”)) that, except as described in the Prospectus, complies with the requirements of the Exchange Act and
has been designed by their respective principal executive and principal financial officers, or under their supervision, to provide
reasonable assurances that: (i) transactions are executed in accordance with management’s general or specific authorizations;
(ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to
maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general
or specific authorization; (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals
and appropriate action is taken with respect to any differences and (v) interactive data in eXtensible Business Reporting
Language included or incorporated by reference in the Registration Statement 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.
Except as described in the Prospectus, (1) the Company’s internal control over financial reporting is effective and
(2) since the end of the Company’s most recent audited fiscal year, there has been (A) no material weakness in
the Company’s internal control over financial reporting (whether or not remediated) and (B) 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.
(hh) Disclosure
Controls. The Company and its subsidiaries maintain disclosure controls and procedures (as such is defined in Rule 13a-15(e) of
the Exchange Act Rules) that comply with the requirements of the Exchange Act; such disclosure controls and procedures have been
designed to ensure that information required to be disclosed by the Company and its subsidiaries in reports that they file or
submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s
rules and forms, including controls and procedures designed to ensure that such information is accumulated and communicated
to the Company’s management to allow timely decisions regarding disclosures. Since the Share Exchange Closing Date, the
Company and its subsidiaries have conducted evaluations of the effectiveness of their disclosure controls as required by Rule 13a-15
of the Exchange Act.
(ii) Minute
Books. The minute books of the Company and each of its subsidiaries that would be a “significant subsidiary” within
the meaning of Rule 1-02(w) of Regulation S-X (such a significant subsidiary of the Company, a “Significant
Subsidiary”) have been made available to Xxxxx and counsel for Xxxxx, and such books (i) contain a complete
summary, in all material respects, of all meetings and actions of the board of directors (including each board committee) and
stockholders of the Company (or analogous governing bodies and interest holders, as applicable), and each of its Significant Subsidiaries
since the time of its respective incorporation or organization through the date of the latest meeting and action, and (ii) accurately
in all material respects reflect all transactions referred to in such minutes. For purposes of this paragraph, the Company and
its Significant Subsidiaries shall be deemed to refer to (1) Albireo Limited and its Significant Subsidiaries as they existed
prior to the Share Exchange Closing Date and (2) the Company and its Significant Subsidiaries solely from and after the Share
Exchange Closing Date.
(jj) No
Undisclosed Relationships. No relationship, direct or indirect, exists between or among the Company or any of its subsidiaries
on the one hand, and the directors, officers, stockholders (or analogous interest holders), customers or suppliers of the Company
or any of its affiliates on the other hand, which is required to be described in the Prospectus or a document incorporated by
reference therein and which is not so described.
(kk) No
Registration Rights. No person or entity has the right to require registration of shares of Common Stock or other securities
of the Company or any of its subsidiaries because of the filing or effectiveness of the Registration Statement or the offer or
sale of any Placement Shares, except for persons and entities who have expressly waived such right in writing or who have been
given timely and proper written notice and have failed to exercise such right within the time or times required under the terms
and conditions of such right. Except as described in the Prospectus, there are no persons with registration rights or similar
rights to have any securities registered by the Company or any of its subsidiaries under the Securities Act.
(ll) Margin
Rules. The application of the proceeds received by the Company from the issuance, sale and delivery of the Placement Shares
as described in the Prospectus will not 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.
(mm) No
Broker’s Fees. Neither the Company nor any of its subsidiaries is a party to any contract, agreement or understanding
with any person (other than this Agreement) that would give rise to a valid claim against the Company or any of its subsidiaries
or Xxxxx for a brokerage commission, finder’s fee or like payment in connection with the offering and sale of the Placement
Shares or any transaction contemplated by this Agreement or the Sales Prospectus.
(nn) No
Restrictions on Subsidiaries. Except as described in the Prospectus, no subsidiary of the Company is currently prohibited,
directly or indirectly, under any agreement or other instrument to which it is a party or is subject, 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 properties or assets
to the Company or any other subsidiary of the Company.
(oo) Forward-Looking
Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E
of the Exchange Act) contained in the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed
other than in good faith.
(pp) Listing.
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 Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange Act and is
listed on Nasdaq, and the Company has taken no action designed to, or reasonably likely to have the effect of, terminating the
registration of the Common Stock under the Exchange Act or delisting the Common Stock from Nasdaq, nor has the Company received
any notification that the Commission or FINRA is contemplating terminating such registration or listing.
(xx) Xxxxxxxx-Xxxxx
Xxx. There is and, since the Share Exchange Closing Date, has been no failure on the part of the Company or, to the Company’s
Knowledge, any of the Company’s officers or directors, in their capacities as such, to comply with any provision of the
Xxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated in connection therewith (the “Xxxxxxxx-Xxxxx
Act”), including Section 402 related to loans and Sections 302 and 906 related to certifications.
(rr) Related
Party Transactions. There are no business relationships or related-party transactions involving the Company or any subsidiary
or any other person required to be described in the Prospectus which have not been described as required.
(ss) No
Unlawful Payments. Neither the Company nor any of its subsidiaries nor, to the Company’s Knowledge, any director, officer,
employee, agent, affiliate or other person acting on behalf of the Company or any subsidiary, has (i) used any corporate
funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii) made
any direct or indirect unlawful payment to foreign or domestic government officials or employees, political parties or campaigns,
political party officials, or candidates for political office from corporate funds, (iii) violated or is in violation of
any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or any applicable anti-corruption laws, rules, or
regulations of any other jurisdiction in which the Company or any subsidiary conducts business, or (iv) made any other unlawful
bribe, rebate, payoff, influence payment, kickback, or other unlawful payment to any person. For purposes of this paragraph, the
Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to
the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing
Date.
(tt) Statistical
and Market Data. The statistical and market related data included in the Registration Statement and the Prospectus are based
on or derived from sources that the Company believes to be reliable and accurate (but has not independently verified), and such
data agree with the sources from which they are derived.
(uu) Compliance
with Money Laundering Laws. The operations of the Company and its subsidiaries are and have been conducted at all times in
compliance with all applicable financial recordkeeping and reporting requirements, including those of the U.S. Bank Secrecy Act,
as amended by Title III of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct
Terrorism Act of 2001 (USA PATRIOT Act), and the applicable anti-money laundering statutes of jurisdictions where the Company
and its subsidiaries conduct business, the rules and regulations thereunder and any related or similar rules, regulations
or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Anti-Money Laundering
Laws”), and no action, suit or proceeding by or before any court or governmental agency, authority or body or any
arbitrator involving the Company or any of its subsidiaries with respect to the Anti-Money Laundering Laws is pending or, to the
knowledge of the Company, threatened. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer
to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company
and its subsidiaries solely from and after the Share Exchange Closing Date.
(vv) Compliance
with OFAC.
| (A) | Neither the Company nor any of its
subsidiaries, nor, to the Company’s knowledge, any director, officer, employee,
agent, affiliate or representative of the Company or any of its subsidiaries, or other
person acting on behalf of the Company or any of its subsidiaries, is an individual or
entity (“Person”) that is, or is owned or controlled by a Person
that is: (i) 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 (“UNSC”), the European
Union (“EU”), Her Majesty’s Treasury (“HMT”),
or other relevant sanctions authority (collectively, “Sanctions”),
nor (ii) located, organized or resident in a country or territory that is the subject
of a U.S. government embargo (including, without limitation, Cuba, Iran, North Korea,
Sudan, Syria and the Crimea). |
| (B) | The Company will not, directly or
indirectly, use the Net Proceeds, or lend, contribute or otherwise make available such
Net Proceeds to any subsidiary, joint venture partner or other Person: (i) to fund
or facilitate any activities or business of or with any Person that, at the time of such
funding or facilitation, is the subject of Sanctions, or in any country or territory
that, at the time of such funding or facilitation, is the subject of a U.S. government
embargo; or (ii) in any other manner that will result in a violation of Sanctions
by any Person (including any Person participating in the offering, whether as agent,
underwriter, advisor, investor or otherwise). |
| (C) | For the past five (5) years,
the Company and its subsidiaries have not knowingly engaged in, are not now knowingly
engaged in, and will not engage in, any direct or indirect dealings or transactions with
any Person that at the time of the dealing or transaction is or was the subject of Sanctions
or any country or territory that, at the time of the dealing or transaction is or was
the subject of a U.S. government embargo. For purposes of this paragraph, the Company
and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries
as they existed prior to the Share Exchange Closing Date and (2) the Company and
its subsidiaries solely from and after the Share Exchange Closing Date. |
(ww) No
Associated Persons; FINRA Matters. Neither the Company nor, to the knowledge of the Company, any of its affiliates (within
the meaning of FINRA Rule 5121(f)(1)) directly or indirectly controls, is controlled by, or is under common control with,
or is an associated person (within the meaning of Article I, Section 1(ee) of the By-laws of FINRA) of, any member firm
of FINRA.
(xx) Cybersecurity.
(A) To the knowledge of the Company, there has been no security breach or incident, unauthorized access or disclosure, or
other compromise of or relating to the Company’s or its subsidiaries’ information technology and computer systems,
networks, hardware, software, data and databases (including the data and information of their respective customers, employees,
suppliers, vendors and any third party data maintained, processed or stored by the Company and its subsidiaries, and any such
data processed or stored by third parties on behalf of the Company and its subsidiaries), equipment or technology (collectively,
“IT Systems and Data”) that would result in a Material Adverse Effect; (B) neither the Company
nor its subsidiaries have been notified of, or have any knowledge of, any event or condition that would result in, any security
breach or incident, unauthorized access or disclosure or other compromise to their IT Systems and Data; and (C) the Company
and its subsidiaries have implemented appropriate controls, procedures, and technological safeguards that it believes to be necessary
and appropriate to maintain and protect the integrity, continuous operation, redundancy and security of their IT Systems and Data
reasonably consistent with industry standards and practices, or as required by applicable regulatory standards. Except as would
not reasonably be expected to result in a Material Adverse Effect, 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 Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation or modification.
For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its
subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from
and after the Share Exchange Closing Date.
(yy) Privacy
Laws. The Company and each of its subsidiaries are in material compliance with all applicable data privacy and security
laws and regulations, including, without limitation, the European Union General Data Protection Regulation (“GDPR”)
(EU 2016/679) (collectively, “Privacy Laws”). The execution, delivery and performance of this
Agreement or any other agreement referred to in this Agreement will not result in a material breach by the Company or any of its
subsidiaries of any applicable Privacy Laws. Neither the Company nor any of its subsidiaries (i) has received notice
of any actual or potential liability under, or actual or potential material 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, or (ii) is a party to
any order or decree that imposes any obligation or liability under any Privacy Law. For purposes of this paragraph, the Company
and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share
Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date
(zz) No
Reliance. The Company has not relied upon Xxxxx or legal counsel for Xxxxx for any legal, tax or accounting advice in connection
with the offering and sale of the Placement Shares.
(aaa) Xxxxx
Purchases. The Company acknowledges and agrees that Xxxxx has informed the Company that Xxxxx may, to the extent permitted
under the Securities Act and the Exchange Act, purchase and sell shares of Common Stock for its own account while this Agreement
is in effect, provided, that (i) no such purchase or sales shall take place while a Placement Notice is in effect
(except to the extent Xxxxx may engage in sales of Placement Shares purchased or deemed purchased from the Company as a “riskless
principal” or in a similar capacity) and (ii) the Company shall not be deemed to have authorized or consented to any
such purchases or sales by Xxxxx.
Any certificate signed by an officer of
the Company and delivered to Xxxxx or to counsel for Xxxxx shall be deemed to be a representation and warranty by the Company
to Xxxxx as to the matters set forth therein.
The Company acknowledges that Xxxxx and,
for purposes of the opinions to be delivered pursuant to Section 7, counsel to the Company and counsel to Xxxxx, will
rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.
7. Covenants
of the Company. The Company covenants and agrees with Xxxxx that:
(a) Registration
Statement Amendments. After the date of this Agreement and during any period in which a Prospectus relating to any Placement
Shares is required to be delivered by Xxxxx under the Securities Act (including in circumstances where such requirement may be
satisfied pursuant to Rule 172 under the Securities Act) (the “Prospectus Delivery Period”): (i) the
Company will notify Xxxxx promptly of the time when any subsequent amendment to the Registration Statement, other than documents
incorporated by reference, has been filed with the Commission and/or has become effective or any subsequent supplement to the
Prospectus has been filed and of any request by the Commission for any amendment or supplement to the Registration Statement or
Prospectus or for additional information, insofar as it relates to the transactions contemplated by this Agreement; (ii) the
Company will prepare and file with the Commission, promptly upon Xxxxx’x reasonable request, any amendments or supplements
to the Registration Statement or Prospectus, insofar as it relates to the transactions contemplated by this Agreement, that, in
Xxxxx’x reasonable opinion, may be necessary or advisable to comply with law in connection with the distribution of the
Placement Shares by Xxxxx (provided, however, that the failure of Xxxxx to make such request shall not relieve the Company
of any obligation or liability hereunder, or affect Xxxxx’x right to rely on the representations and warranties made by
the Company in this Agreement, and provided, further, that the only remedy Xxxxx shall have with respect to the
failure by the Company to make such filing shall be to cease making sales under this Agreement until such amendment or supplement
is filed); (iii) the Company will not file any amendment or supplement to the Registration Statement or Prospectus, other
than documents incorporated by reference, relating to the Placement Shares or a security convertible into the Placement Shares
unless a copy thereof has been submitted to Xxxxx within a reasonable period of time before the filing and Xxxxx has not reasonably
objected thereto (provided, however, that the failure of Xxxxx to make such objection shall not relieve the Company of
any obligation or liability hereunder, or affect Xxxxx’x right to rely on the representations and warranties made by the
Company in this Agreement, and provided, further, that the only remedy Xxxxx shall have with respect to the failure
by the Company to make such submission to Xxxxx shall be to cease making sales under this Agreement) and the Company will furnish
to Xxxxx at the time of filing thereof a copy of any document that upon filing is deemed to be incorporated by reference into
the Registration Statement or Prospectus, except for those documents available via XXXXX; and (iv) the Company will cause
each amendment or supplement to the Prospectus, other than documents incorporated by reference, to be filed with the Commission
as required pursuant to the applicable paragraph of Rule 424(b) of the Securities Act. Prior to the initial sale of
any Placement Shares, the Company shall file a final Sales Prospectus pursuant to Rule 424(b) of the Securities Act
relating to the Placement Shares.
(b) Notice
of Commission Stop Orders. The Company will advise Xxxxx, promptly after it receives notice or obtains knowledge thereof,
of the issuance or threatened issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement,
of the suspension of the qualification of the Placement Shares for offering or sale in any jurisdiction, or of the initiation
or threatening of any proceeding for any such purpose; and it will promptly use its commercially reasonable efforts to prevent
the issuance of any stop order or to obtain its withdrawal if such a stop order should be issued.
(c) Delivery
of Prospectus; Subsequent Changes. During the Prospectus Delivery Period, the Company will comply with all requirements imposed
upon it by the Securities Act, as from time to time in force, and to file on or before their respective due dates (taking into
account any extensions available under the Exchange Act that would permit the Company to continue to meet the eligibility requirements
of Form S-3) all reports and any definitive proxy or information statements required to be filed by the Company with the
Commission pursuant to Sections 13(a), 13(c), 14, 15(d) or any other provision of or under the Exchange Act. If during such
period any event occurs as a result of which the Prospectus as then amended or supplemented would include an 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
then existing, not misleading, or if during such period it is necessary to amend or supplement the Registration Statement or Prospectus
to comply with the Securities Act, the Company will promptly notify Xxxxx to suspend the offering of Placement Shares during such
period and the Company will promptly amend or supplement the Registration Statement or Prospectus (at the expense of the Company)
so as to correct such statement or omission or effect such compliance; provided, however, that the Company may delay
the filing of any amendment or supplement if, in the judgment of the Company, it is in the best interests of the Company to do
so. Until such time as the Company shall have corrected such statement or omission or effected such compliance, the Company shall
not request that Xxxxx resume the offering of Placement Shares.
(d) Listing
of Placement Shares. During the Prospectus Delivery Period, the Company will use its commercially reasonable efforts to cause
the Placement Shares to be listed on Nasdaq and to qualify the Placement Shares for sale under the securities laws of such jurisdictions
in the United States as Xxxxx reasonably designates and to continue such qualifications in effect so long as required for the
distribution of the Placement Shares; provided, however, that the Company shall not be required in connection therewith
to qualify as a foreign corporation or dealer in securities or file a general consent to service of process in any jurisdiction.
(e) Delivery
of Registration Statement and Prospectus. The Company will furnish to Xxxxx and its counsel (at the reasonable expense of
the Company) copies of the Registration Statement, the Prospectus (including all documents incorporated by reference therein)
and all amendments and supplements to the Registration Statement or Prospectus that are filed with the Commission during the Prospectus
Delivery Period (including all documents filed with the Commission during such period that are deemed to be incorporated by reference
therein), in each case as soon as reasonably practicable and in such quantities as Xxxxx may from time to time reasonably request
and, at Xxxxx’x request, will also furnish copies of the Prospectus to each exchange or market on which sales of the Placement
Shares may be made; provided, however, that the Company shall not be required to furnish any document (other than the Prospectus)
to Xxxxx to the extent such document is available on XXXXX.
(f) Earnings
Statement. The Company will make generally available to its security holders as soon as practicable, but in any event not
later than 15 months after the end of the Company’s current fiscal quarter, an earnings statement covering a 12-month period
that satisfies the provisions of Section 11(a) and Rule 158 of the Securities Act. The Company’s compliance
with the periodic reporting requirements of the Exchange Act shall be deemed to satisfy the requirements of this Section 7(f).
(g) Expenses.
The Company, whether or not the transactions contemplated hereunder are consummated or this Agreement is terminated in accordance
with the provisions of Section 11, will pay the following expenses all incident to the performance of its obligations
hereunder, including, but not limited to, expenses relating to (i) the preparation, printing and filing of the Registration
Statement and each amendment and supplement thereto, and of each Prospectus and of each amendment and supplement thereto, (ii) the
preparation, issuance and delivery of the Placement Shares, (iii) the qualification of the Placement Shares under securities
laws in accordance with the provisions of Section 7(d) of this Agreement, including filing fees (provided, however,
that any fees or disbursements of counsel for Xxxxx in connection therewith shall be paid by Xxxxx), (iv) the printing and
delivery to Xxxxx of copies of the Prospectus and any amendments or supplements thereto, and of this Agreement, (v) the fees
and expenses incurred in connection with the listing or qualification of the Placement Shares for trading on Nasdaq, (vi) the
filing fees and expenses, if any, of the Commission, (vii) the filing fees for filings with the FINRA Corporate Financing
Department, and (viii) the reasonable fees and disbursements of Xxxxx’x counsel in an amount not to exceed $50,000.
(h) Use
of Proceeds. The Company will use the Net Proceeds as described in the Prospectus in the section entitled “Use of Proceeds.”
(i) Notice
of Other Sales. During the pendency of any Placement Notice given hereunder, and for five (5) Trading Days following
the termination of any Placement Notice given hereunder, the Company shall provide Xxxxx notice as promptly as reasonably possible
before it offers to sell, contracts to sell, sells, grants any option to sell or otherwise disposes of any shares of Common Stock
(other than Placement Shares offered pursuant to the provisions of this Agreement) or securities convertible into or exchangeable
for Common Stock, warrants or any rights to purchase or acquire Common Stock; provided, that such notice shall not be required
in connection with (i) the issuance, grant or sale of Common Stock, options to purchase shares of Common Stock, restricted
shares of Common Stock, restricted stock units, other equity awards, or Common Stock issuable upon the exercise or vesting of
options, restricted stock units or other equity awards pursuant to any stock option, stock bonus or other stock plan or arrangement
described in the Prospectus, (ii) the issuance of securities in connection with an acquisition, merger or sale or purchase
of assets, (iii) the issuance or sale of Common Stock pursuant to any dividend reinvestment plan that the Company may adopt
from time to time, provided the implementation of such plan is disclosed to Xxxxx in advance, (iv) the issuance or sale of
any shares of Common Stock issuable upon the exchange, conversion or redemption of securities or the exercise of warrants, options
or other rights in effect or outstanding or disclosed in filings by the Company available on XXXXX or otherwise in writing to
Xxxxx prior to the date of the applicable Placement Notice, or (v) the issuance or sale of Common Stock, or securities convertible
into or exercisable for Common Stock, offered and sold in a privately-negotiated transaction to vendors, customers, strategic
partners or potential strategic partners and otherwise conducted in a manner so as not to be integrated with the offering of Placement
Shares. Notwithstanding the foregoing provisions, nothing herein shall be construed to restrict the Company’s ability, or
require the Company to provide notice to Xxxxx, to file a registration statement under the Securities Act.
(j)
Change of Circumstances. The
Company will, at any time during a fiscal quarter in which the Company intends to tender a Placement Notice or sell Placement
Shares, advise Xxxxx promptly after it shall have received notice or obtained knowledge of any information or fact that would
alter or affect in any material respect any opinion, certificate, letter or other document provided to Xxxxx pursuant to this
Agreement.
(k) Due
Diligence Cooperation. During the term of this Agreement, the Company will cooperate with any reasonable due diligence review
conducted by Xxxxx or its agents in connection with the transactions contemplated hereby, including, without limitation, providing
information and making available documents and senior corporate officers, at mutually convenient times during regular business
hours and at the Company’s principal offices, as Xxxxx may reasonably request.
(l) Required
Filings Relating to Placement of Placement Shares. The Company agrees that, on or before such dates as the Securities Act
shall require, the Company will (i) file a prospectus supplement with the Commission under the applicable paragraph of Rule 424(b) under
the Securities Act (each and every filing under Rule 424(b), a “Filing Date”), which prospectus
supplement will set forth, within the relevant period, the amount of Placement Shares sold through Xxxxx, the Net Proceeds and
the compensation payable by the Company to Xxxxx with respect to such Placement Shares (provided that the Company may also satisfy
its obligations under this Section 7(l)(i) by including such information in a filing under the Exchange Act),
and (ii) deliver such number of copies of each such prospectus supplement to each exchange or market on which such sales
were effected as may be required by the rules or regulations of such exchange or market. The Company shall disclose in its
quarterly reports on Form 10-Q and in its annual report on Form 10-K the number of the Placement Shares sold through
Xxxxx under this Agreement, the gross proceeds and Net Proceeds to the Company from the sale of the Placement Shares and the compensation
paid by the Company with respect to sales of the Placement Shares pursuant to this Agreement during the relevant quarter or, in
the case of an Annual Report on Form 10-K, during the fiscal year covered by such Annual Report and the fourth quarter of
such fiscal year.
(m) Representation
Dates; Certificate. On or prior to the First Delivery Date and each time the Company subsequently thereafter during the term
of this Agreement: (i) files the Prospectus relating to the Placement Shares, (ii) amends or supplements the Registration
Statement or the Sales Prospectus (other than a prospectus supplement filed in accordance with Section 7(l)) by means
of a post-effective amendment, sticker, or supplement but not by means of incorporation of document(s) by reference to the
Registration Statement or the Sales Prospectus; (iii) files an annual report on Form 10-K under the Exchange Act; (iv) files
its quarterly reports on Form 10-Q under the Exchange Act; or (v) files a current report on Form 8-K containing
amended financial information (other than a filing made in connection with the issuance of an earnings release or other information
“furnished” under Item 2.02 or Item 7.01 of Form 8-K) under the Exchange Act (each date of filing of one or more
of the documents referred to in clauses (i) through (v) shall be a “Representation Date”);
the Company shall furnish Xxxxx with certificates, in the forms attached hereto as Exhibit 7(m) within three
(3) Trading Days after such Representation Date if requested by Xxxxx. The requirement to provide the certificates under
this Section 7(m) shall be automatically waived for any Representation Date occurring at a time at which no Placement
Notice is pending, which waiver shall continue until the earlier to occur of the date the Company delivers a Placement Notice
hereunder (which for such calendar quarter shall be considered a Representation Date) and the next occurring Representation Date;
provided, however, that such waiver shall not apply for any Representation Date that is the date on which the Company
files its annual report on Form 10-K; and provided, further, that the requirement to provide the certificate
of the Chief Financial Officer of the Company under this Section 7(m) shall be automatically waived for each
Representation Date unless the Comfort Letter provided with respect to such Representation Date does not cover all financial information
and other matters ordinarily covered by accountants’ “comfort letters” to Xxxxx in connection with registered
public offerings. Notwithstanding the foregoing, if the Company subsequently decides to sell Placement Shares following a Representation
Date when the Company relied on such waiver and did not provide Xxxxx with certificates under this Section 7(m), then
before the Company delivers the Placement Notice or Xxxxx sells any Placement Shares, the Company shall provide Xxxxx with certificates,
in the forms attached hereto as Exhibit 7(m), each dated the date of the Placement Notice.
(n) Legal
Opinion. On or prior to the First Delivery Date and within five (5) Trading Days after each Representation Date with
respect to which the Company is obligated to deliver certificates in the forms attached hereto as Exhibit 7(m) for
which no waiver is applicable, the Company shall cause to be furnished to Xxxxx a written opinion of Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C. (“Company Counsel”), or other counsel satisfactory to Xxxxx, in form and substance
satisfactory to Xxxxx and its counsel, dated the date that the opinion is required to be delivered, substantially similar to the
form attached hereto as Exhibit 7(n), modified as necessary to relate to the Registration Statement and the Prospectus
as then amended or supplemented; provided, that in lieu of such opinions for subsequent Representation Dates, Company Counsel
may furnish Xxxxx with a letter (a “Reliance Letter”) to the effect that Xxxxx may rely on a prior opinion
delivered under this Section 7(n) to the same extent as if it were dated the date of such letter (except that
statements in such prior opinion shall be deemed to relate to the Registration Statement and the Prospectus as amended or supplemented
at such Representation Date).
(o) Comfort
Letter. On or prior to the First Delivery Date and within five (5) Trading Days after each Representation Date with respect
to which the Company is obligated to deliver certificates in the forms attached hereto as Exhibit 7(m) for which
no waiver is applicable, the Company shall cause its independent accountants to furnish Xxxxx a letter (the “Comfort
Letter”), dated the date the Comfort Letter is delivered, in form and substance satisfactory to Xxxxx, (i) confirming
that they are an independent registered public accounting firm within the meaning of the Securities Act and the PCAOB, (ii) stating,
as of such date, the conclusions and findings of such firm with respect to the financial information and other matters ordinarily
covered by accountants’ “comfort letters” to Xxxxx in connection with registered public offerings (the first
such letter, the “Initial Comfort Letter”) and (iii) updating the Initial Comfort Letter with any
information that would have been included in the Initial Comfort Letter had it been given on such date and modified as necessary
to relate to the Registration Statement and the Prospectus, as amended and supplemented to the date of such letter.
(p) Market
Activities. The Company will not, directly or indirectly, (i) take any action designed to cause or result in, or that
constitutes or might reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the
Company to facilitate the sale or resale of the Placement Shares or (ii) sell, bid for, or purchase the Placement Shares,
or pay anyone any compensation for soliciting purchases of the Placement Shares other than Cowen; provided, however, that the
Company may bid for and purchase shares of its common stock in accordance with Rule 10b-18 under the Exchange Act.
(q) Insurance.
The Company and its subsidiaries shall maintain, or cause to be maintained, insurance in such amounts and covering such risks
as is reasonable and customary for the business in which it is engaged.
(r) Compliance
with Laws. The Company and each of its subsidiaries shall use its reasonable best efforts to maintain, or cause to be maintained,
all material environmental permits, licenses and other authorizations required by federal, state and local law in order to conduct
their businesses as described in the Prospectus, and the Company and each of its subsidiaries shall conduct their businesses,
or cause their businesses to be conducted, in substantial compliance with such permits, licenses and authorizations and with applicable
environmental laws, except where the failure to maintain or be in compliance with such permits, licenses and authorizations would
not reasonably be expected to result in a Material Adverse Effect.
(s) Investment
Company Act. The Company will conduct its affairs in such a manner so as to reasonably ensure that neither it nor its subsidiaries
will be or become, at any time prior to the termination of this Agreement, an “investment company,” as such term is
defined in the Investment Company Act, assuming no change in the Commission’s current interpretations as to entities that
are not considered an investment company.
(t) Securities
Act and Exchange Act. The Company will use its reasonable best efforts to comply with all requirements imposed upon it by
the Securities Act and the Exchange Act as from time to time in force, so far as necessary to permit the continuance of sales
of, or dealings in, the Placement Shares as contemplated by the provisions hereof and the Prospectus.
(u) No
Offer to Sell. Other than the Prospectus and any free writing prospectus (as defined in Rule 405 under the Securities
Act) approved in advance by the Company and Cowen in its capacity as principal or agent hereunder, neither Cowen nor the Company
(including its agents and representatives, other than Cowen in its capacity as such) will make, use, prepare, authorize, approve
or refer to any written communication (as defined in Rule 405 under the Securities Act), required to be filed with the Commission,
that constitutes an offer to sell or solicitation of an offer to buy Placement Shares hereunder.
(v) Xxxxxxxx-Xxxxx
Act. The Company and its subsidiaries will use their reasonable best efforts to comply with all effective and applicable provisions
of the Xxxxxxxx-Xxxxx Act.
(w) Affirmation.
Each Placement Notice delivered by the Company to Cowen shall be deemed to be (i) an affirmation that the representations,
warranties and agreements of the Company herein contained and contained in any certificate delivered to Cowen pursuant hereto
are true and correct at the time of delivery of such Placement Notice, and (ii) an undertaking that such representations,
warranties and agreements will be true and correct on any applicable Time of Sale and Settlement Date, as though made at and as
of each such time (it being understood that such representations, warranties and agreements shall relate to the Registration Statement
and the Prospectus as amended and supplemented to the time of such Placement Notice acceptance).
(x) Renewal.
If immediately prior to the third anniversary (the “Renewal Deadline”) of the initial effective date of the Registration
Statement, the aggregate gross sales price of Placement Shares sold by the Company is less than the Maximum Amount and this Agreement
has not expired or been terminated, the Company will, prior to the Renewal Deadline, file, if it has not already done so and is
eligible to do so, a new shelf registration statement relating to the Placement Shares, in a form satisfactory to Cowen, and,
if not automatically effective, will use its best efforts to cause such registration statement to be declared effective within
60 days after the Renewal Deadline. The Company will take all other action necessary or appropriate to permit the issuance and
sale of the Placement Shares to continue as contemplated in the expired registration statement relating to the Placement Shares.
References herein to the Registration Statement shall include such new shelf registration statement.
8. Conditions
to Xxxxx’x Obligations. The obligations of Cowen hereunder with respect to a Placement will be subject to the continuing
accuracy and completeness of the representations and warranties made by the Company herein, to the due performance by the Company
of its obligations hereunder, to the completion by Cowen of a due diligence review satisfactory to Cowen in its reasonable judgment,
and to the continuing satisfaction (or waiver by Cowen in its sole discretion) of the following additional conditions:
(a) Registration
Statement Effective. The Registration Statement shall be effective and shall be available for the sale of all Placement Shares
contemplated to be issued by any Placement Notice.
(b) No
Material Notices. None of the following events shall have occurred and be continuing: (i) receipt by the Company or any
of its subsidiaries of any request for additional information from the Commission or any other federal or state governmental authority
during the period of effectiveness of the Registration Statement, the response to which would require any post-effective amendments
or supplements to the Registration Statement or the Prospectus to be filed with the Commission; (ii) the issuance by the
Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration
Statement or the initiation of any proceedings for that purpose; (iii) receipt by the Company of any notification with respect
to the suspension of the qualification or exemption from qualification of any of the Placement Shares for sale in any jurisdiction
or the initiation or threatening of any proceeding for such purpose; or (iv) the occurrence of any event that makes any material
statement made in the Registration Statement or the Prospectus or any material document incorporated or deemed to be incorporated
therein by reference untrue in any material respect or that requires the making of any changes in the Registration Statement,
related Prospectus or such documents so that, in the case of the Registration Statement, it will not contain any materially untrue
statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements
therein not misleading and, that in the case of the Prospectus, it will not contain any materially untrue statement of a material
fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in the light
of the circumstances under which they were made, not misleading.
(c) No
Misstatement or Material Omission. Cowen shall not have advised the Company that the Registration Statement or Prospectus,
or any amendment or supplement thereto, contains an untrue statement of fact that in Xxxxx’x reasonable opinion is material,
or omits to state a fact that in Xxxxx’x reasonable opinion is material and is required to be stated therein or is necessary
to make the statements therein not misleading.
(d) Material
Changes. Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission,
there shall not have been any material adverse change, on a consolidated basis, in the authorized capital stock of the Company
or any Material Adverse Effect or any development that would reasonably be expected to result in a Material Adverse Effect, or
any downgrading in or withdrawal of the rating assigned to any of the Company’s securities (other than asset backed securities)
by any rating organization or a public announcement by any rating organization that it has under surveillance or review its rating
of any of the Company’s securities (other than asset backed securities), the effect of which, in the case of any such action
by a rating organization described above, in the reasonable judgment of Cowen (without relieving the Company of any obligation
or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the offering of
the Placement Shares on the terms and in the manner contemplated in the Prospectus.
(e) Company
Counsel Legal Opinion. Cowen shall have received the opinions of Company Counsel required to be delivered pursuant to Section 7(n) on
or before the date on which such delivery of such opinion is required pursuant to Section 7(n).
(f) Cowen
Counsel Legal Opinion. Cowen shall have received from Xxxxxxx Procter LLP, counsel for Cowen, such opinion or opinions, on
or before the date on which the delivery of the Company Counsel legal opinion is required pursuant to Section 7(n),
with respect to such matters as Cowen may reasonably require, and the Company shall have furnished to such counsel such documents
as they request for enabling them to pass upon such matters.
(g) Comfort
Letter. Cowen shall have received the Comfort Letter required to be delivered pursuant to Section 7(o) on
or before the date on which such delivery of such Comfort Letter is required pursuant to Section 7(o).
(h) Representation
Certificate. Cowen shall have received the certificates required to be delivered pursuant to Section 7(m) on
or before the date on which delivery of such certificates are required pursuant to Section 7(m).
(i) Secretary’s
Certificate. On or prior to the First Delivery Date, Cowen shall have received a certificate, signed on behalf of the Company
by its corporate Secretary or Assistant Secretary (if authorized by the bylaws of the Company or resolutions of the board of directors
of the Company), in form and substance satisfactory to Cowen and its counsel.
(j) No
Suspension. Trading in the Common Stock shall not have been suspended on Nasdaq.
(k) Other
Materials. On each date on which the Company is required to deliver certificates pursuant to Section 7(m), the
Company shall have furnished to Cowen such appropriate further information, certificates and documents as Cowen may have reasonably
requested. All such opinions, certificates, letters and other documents shall have been in compliance with the provisions hereof.
The Company will furnish Cowen with such conformed copies of such opinions, certificates, letters and other documents as Cowen
shall have reasonably requested.
(l) Securities
Act Filings Made. All filings with the Commission required by Rule 424 under the Securities Act to have been filed prior
to the issuance of any Placement Notice hereunder shall have been made within the applicable time period prescribed for such filing
by Rule 424.
(m) Approval
for Listing. The Placement Shares shall either have been (i) approved for listing on Nasdaq, subject only to notice of
issuance, or (ii) the Company shall have filed an application for listing of the Placement Shares on Nasdaq at, or prior
to, the issuance of any Placement Notice.
(n) No
Termination Event. There shall not have occurred any event that would permit Cowen to terminate this Agreement pursuant to
Section 11(a).
9. Indemnification
and Contribution.
(a) Company
Indemnification. The Company agrees to indemnify and hold harmless Cowen, the directors, officers, partners, employees and
agents of Cowen and each person, if any, who (i) controls Cowen within the meaning of Section 15 of the Securities Act
or Section 20 of the Exchange Act, or (ii) is controlled by or is under common control with Cowen (a “Cowen
Affiliate”) from and against any and all losses, claims, liabilities, expenses and damages (including, but not limited
to, any and all reasonable investigative, legal and other expenses incurred in connection with, and any and all amounts paid in
settlement (in accordance with Section 9(c)) 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), as and
when incurred, to which Cowen, or any such person, 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, directly or indirectly, on (x) any untrue statement or alleged untrue statement of a material
fact contained in the Registration Statement or the Prospectus or any amendment or supplement to the Registration Statement or
the Prospectus or in any free writing prospectus or in any application or other document executed by or on behalf of the Company
in connection with this Agreement or based on written information furnished by or on behalf of the Company filed in any jurisdiction
in order to qualify the Common Stock under the securities laws thereof or filed with the Commission, (y) the omission or
alleged omission to state in any such document a material fact required to be stated in it or necessary to make the statements
in it not misleading in light of the circumstances under which they were made, or (z) any breach by the Company of any of
its representations, warranties and agreements contained in this Agreement; provided, however, that this indemnity
agreement shall not apply to the extent that such loss, claim, liability, expense or damage arises from the sale of the Placement
Shares pursuant to this Agreement and is caused directly or indirectly by an untrue statement or omission or alleged untrue statement
or omission, made in reliance upon and in conformity with written information relating to Cowen and furnished to the Company by
Cowen expressly for inclusion in the Registration Statement or Prospectus or in any free writing prospectus. This indemnity agreement
will be in addition to any liability that the Company might otherwise have.
(b) Cowen
Indemnification. Cowen agrees to indemnify and hold harmless the Company and its directors and each officer of the Company
that signed the Registration Statement, and each person, if any, who (i) controls the Company within the meaning of Section 15
of the Securities Act or Section 20 of the Exchange Act or (ii) is controlled by or is under common control with the
Company from and against any and all loss, liability, claim, damage and expense described in the indemnity contained in Section 9(a),
as and when incurred, but only with respect to untrue statements or omissions, or alleged untrue statements or omissions, made
in the Registration Statement (or any amendments thereto) or the Prospectus (or any amendment or supplement thereto) in reliance
upon and in conformity with written information relating to Cowen and furnished to the Company by Cowen expressly for inclusion
in the Registration Statement or Prospectus or in any free writing prospectus. This indemnity agreement will be in addition to
any liability that Cowen might otherwise have.
(c) Procedure.
Any party that proposes to assert the right to be indemnified under this Section 9 will, 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 in writing of the commencement of such action,
enclosing a copy of all papers served, but the failure to so notify such indemnifying party will not relieve the indemnifying
party from (i) any liability that it might have to any indemnified party otherwise than under this Section 9
and (ii) any liability that it may have to any indemnified party under the foregoing provision of this Section 9
unless, and only to the extent that, such omission results in the forfeiture or material impairment 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 (1) the employment of counsel by
the indemnified party has been authorized in writing by the indemnifying party, (2) 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, (3) 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 will not have the right to direct the defense of such action on behalf of the indemnified party) or (4) the indemnifying
party has not in fact employed counsel 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 will 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 will be reimbursed by the indemnifying party promptly as they are incurred
after the indemnifying party receives a written invoice relating to fees, disbursements and other charges. An indemnifying party
will not, in any event, be liable for any settlement of any action or claim effected without its written consent. 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 includes an unconditional
release of each indemnified party from all liability arising or that may arise out of such claim, action or proceeding.
(d) Contribution.
In order to provide for just and equitable contribution in circumstances in which the indemnification provided for in the foregoing
paragraphs of this Section 9 is applicable in accordance with its terms but for any reason is held to be unavailable
from the Company or Cowen, the Company and Cowen will 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 Cowen, 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 Cowen may be subject in such proportion as shall be appropriate to reflect the relative benefits received by the Company on
the one hand and Cowen on the other. The relative benefits received by the Company on the one hand and Cowen on the other hand
shall be deemed to be in the same proportion as the total Net Proceeds (before deducting expenses) received by the Company bear
to the total compensation received by Cowen (before deducting expenses) from the sale of Placement Shares on behalf of the Company.
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 Cowen, on the other, with respect to the statements or omission
that 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, among other things, 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 Cowen, 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 Cowen agree that it would not be just and equitable
if contributions pursuant to this Section 9(d) were to be determined by pro rata allocation or by any other method
of allocation that 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 9(d) shall be deemed to include, for the purpose of this Section 9(d), any legal
or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action
or claim to the extent consistent with Section 9(c). Notwithstanding the foregoing provisions of this Section 9(d),
Cowen shall not be required to contribute any amount in excess of the commissions received by it under this Agreement and no person
found guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled
to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 9(d),
any person who controls a party to this Agreement within the meaning of the Securities Act, and any officers, directors, partners,
employees or agents of Cowen, will have the same rights to contribution as that party, and each officer and director of the Company
who signed the Registration Statement will have the same rights to contribution as the Company, 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 9(d), will notify any such party or parties
from whom contribution may be sought, but the omission to so notify will not relieve that party or parties from whom contribution
may be sought from any other obligation it or they may have under this Section 9(d) except to the extent that
the failure to so notify such other party materially prejudiced the substantive rights or defenses of the party from whom contribution
is sought. Except for a settlement entered into pursuant to the last sentence of Section 9(c), no party will be liable
for contribution with respect to any action or claim settled without its written consent if such consent is required pursuant
to Section 9(c).
10. Representations
and Agreements to Survive Delivery. The indemnity and contribution agreements contained in Section 9 of this Agreement
and all representations and warranties of the Company herein or in certificates delivered pursuant hereto shall survive, as of
their respective dates, regardless of (i) any investigation made by or on behalf of Cowen, any controlling persons, or the
Company (or any of their respective officers, directors or controlling persons), (ii) delivery and acceptance of the Placement
Shares and payment therefor or (iii) any termination of this Agreement.
11. Termination.
(a) Cowen
shall have the right by giving written notice as hereinafter specified at any time to terminate this Agreement if (i) any
Material Adverse Effect, or any development that could reasonably be expected to result in a Material Adverse Effect has occurred
that, in the reasonable judgment of Cowen, may materially impair the ability of Cowen to sell the Placement Shares hereunder,
(ii) the Company shall have failed, refused or been unable to perform any agreement on its part to be performed hereunder;
provided, however, in the case of any failure of the Company to deliver (or cause another person to deliver) any certification,
opinion, or letter required under Sections 7(m), 7(n), or 7(o), Xxxxx’x right to terminate shall not
arise unless such failure to deliver (or cause to be delivered) continues for more than thirty (30) days from the date such delivery
was required; or (iii) any other condition of Xxxxx’x obligations hereunder is not fulfilled; provided, however,
Xxxxx’x right to terminate pursuant to this Section 11(a)(iii) shall not arise unless such condition, if
capable of being fulfilled, is not fulfilled within ten (10) days after the date the Company is provided with written notice
by Cowen that such condition has not been fulfilled, or (iv), any suspension or limitation of trading in the Placement Shares
or in securities generally on Nasdaq shall have occurred. Any such termination shall be without liability of any party to any
other party except that the provisions of Section 7(g) (Expenses), Section 9 (Indemnification and
Contribution), Section 10 (Representations and Agreements to Survive Delivery), Section 16 (Applicable
Law; Consent to Jurisdiction) and Section 17 (Waiver of Jury Trial) shall remain in full force and effect notwithstanding
such termination. If Cowen elects to terminate this Agreement as provided in this Section 11(a), Cowen shall provide
the required written notice as specified in Section 12 (Notices).
(b) The
Company shall have the right, by giving ten (10) days written notice as hereinafter specified, to terminate this Agreement
in its sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party
to any other party except that the provisions of Section 7(g), Section 9, Section 10, Section 16
and Section 17 shall remain in full force and effect notwithstanding such termination.
(c) Cowen
shall have the right, by giving ten (10) days written notice as hereinafter specified, to terminate this Agreement in its
sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to
any other party except that the provisions of Section 7(g), Section 9, Section 10, Section 16
and Section 17 shall remain in full force and effect notwithstanding such termination.
(d) Unless
earlier terminated pursuant to this Section 11, this Agreement shall automatically terminate upon the issuance and
sale of all of the Placement Shares through Cowen on the terms and subject to the conditions set forth herein; provided
that the provisions of Section 7(g), Section 9, Section 10, Section 16 and Section 17
shall remain in full force and effect notwithstanding such termination.
(e) This
Agreement shall remain in full force and effect unless terminated pursuant to Sections 11(a), (b), (c), or
(d) above or otherwise by mutual agreement of the parties; provided, however, that any such termination by
mutual agreement shall in all cases be deemed to provide that Section 7(g), Section 9, Section 10,
Section 16 and Section 17 shall remain in full force and effect. Upon termination of this Agreement, the
Company shall not have any liability to Cowen for any discount, commission or other compensation with respect to any Placement
Shares not sold through Cowen pursuant to this Agreement.
(f) Any
termination of this Agreement shall be effective on the date specified in such notice of termination; provided, however,
that such termination shall not be effective until the close of business on the date of receipt of such notice by Cowen or the
Company, as the case may be. If such termination shall occur prior to the Settlement Date for any sale of Placement Shares, such
Placement Shares shall settle in accordance with the provisions of this Agreement.
12. Notices.
All notices or other communications required or permitted to be given by any party to any other party pursuant to the terms of
this Agreement shall be in writing, unless otherwise specified in this Agreement, and if sent to Cowen, shall be delivered to
Cowen at Xxxxx and Company, LLC, 000 Xxxxxxxxx Xxxxxx, Xxx Xxxx, XX 00000, fax no. 000-000-0000, Attention: General Counsel, with
a copy to Xxxxxxx Procter LLP, fax no. 000-000-0000, Attention: Xxxxx X’Xxxxxx; or if sent to the Company, shall be delivered
to Albireo Pharma, Inc., 00 Xxxx Xxxxxx Xxxxxx, Xxxxx 0000, Xxxxxx, XX 00000, Attention: Chief Financial Officer, email:
xxxxx.xxxxxxx@xxxxxxxxxxxxx.xxx, with a copy to xxxxx.xxxxxx@xxxxxxxxxxxxx.xxx and to Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo P.C., fax no. 000-000-0000, Attention: Xxxxx X. Xxxxx. 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 (as defined below), 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
Nasdaq and commercial banks in the City of New York are open for business.
13. Successors
and Assigns. This Agreement shall inure to the benefit of and be binding upon the Company and Cowen and their respective successors
and the affiliates, controlling persons, officers and directors referred to in Section 9. 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 Cowen may assign its rights and obligations hereunder to an
affiliate of Cowen without obtaining the Company’s consent so long as such affiliate is a registered broker-dealer.
14. Adjustments
for Share Splits. The parties acknowledge and agree that all share-related numbers contained in this Agreement shall be adjusted
to take into account any share consolidation, stock split, stock dividend, recapitalization or similar event effected with respect
to the Common Stock.
15. Entire
Agreement; Amendment; Severability. This Agreement (including all schedules and exhibits attached hereto and Placement Notices
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. Neither this Agreement nor any term
hereof may be amended except pursuant to a written instrument executed by the Company and Cowen. 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.
16. Applicable
Law; Consent to Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the internal laws of
the State of New York without regard to the principles of conflicts of laws. Each party hereby irrevocably submits to the non-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.
17. Waiver
of Jury Trial. The Company and Cowen each hereby irrevocably waives any right it may have to a trial by jury in respect of
any claim based upon or arising out of this Agreement or any transaction contemplated hereby.
18. Absence
of Fiduciary Relationship. The Company acknowledges and agrees that:
(a) Cowen
has been retained solely to act as sales agent in connection with the sale of the Placement Shares and that no fiduciary, advisory
or agency relationship between the Company and Cowen has been created in respect of any of the transactions contemplated by this
Agreement, irrespective of whether Cowen has advised or is advising the Company on other matters;
(b) the
Company is capable of evaluating and understanding and understands and accepts the terms, risks and conditions of the transactions
contemplated by this Agreement;
(c) the
Company has been advised that Cowen and its affiliates are engaged in a broad range of transactions which may involve interests
that differ from those of the Company and that Cowen has no obligation to disclose such interests and transactions to the Company
by virtue of any fiduciary, advisory or agency relationship; and
(d) the
Company waives, to the fullest extent permitted by law, any claims it may have against Cowen for breach of fiduciary duty or alleged
breach of fiduciary duty in connection with the transactions contemplated by this Agreement and agrees that Cowen shall have no
liability (whether direct or indirect) to the Company in respect of such a fiduciary claim or to any person asserting a fiduciary
duty claim on behalf of or in right of the Company, including stockholders, partners, employees or creditors of the Company.
19. 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.
20. Definitions.
As used in this Agreement, the following terms have the respective meanings set forth below:
(a) “Applicable
Time” means each of the date of this Agreement, each Representation Date, the date on which a Placement Notice is given,
and any date on which Placement Shares are sold hereunder.
(b) “subsidiary”
has the meaning set forth in Rule 405 under the Securities Act.
21. Headings;
Construction. The section and exhibit headings herein are for convenience only and shall not affect the construction hereof.
Each reference in this Agreement to any Section or Schedule shall be to such Section or Schedule of this Agreement,
unless the context indicates otherwise.
[Remainder of Page Intentionally
Blank]
If the foregoing correctly
sets forth the understanding between the Company and Cowen, please so indicate in the space provided below for that purpose, whereupon
this letter shall constitute a binding agreement between the Company and Cowen.
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Very truly yours, |
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XXXXX AND COMPANY, LLC |
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By: |
/s/ Xxxxx X’Xxxxxx |
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Name: Xxxxx X’Xxxxxx |
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Title: Director |
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ACCEPTED as of the date |
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first-above written: |
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ALBIREO PHARMA, INC. |
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By: |
/s/ Xxxxxx X.X. Xxxxxx |
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Name: Xxxxxx X.X. Xxxxxx |
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Title: President and Chief Executive Office |
[Signature Page to Sales Agreement]
SCHEDULE 1
form
of PLACEMENT NOTICE
To: |
|
[ ] |
Subject: |
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Cowen at the Market Offering—Placement Notice |
Gentlemen:
Pursuant to the terms and subject to the
conditions contained in the Sales Agreement between Albireo Pharma, Inc., a Delaware corporation (the “Company”),
and Xxxxx and Company, LLC (“Cowen”) dated February 25, 2021 (the “Agreement”), I
hereby request on behalf of the Company that Cowen sell up to [ ] shares of the Company’s common stock, par value $0.01 per
share, at a minimum market price of $[ ] per share. Sales should begin on the date of this Notice and shall continue until [DATE][all
shares are sold] [the aggregate sales price of the shares reaches $[___]].
[The Company may include such other sales
parameters as it deems appropriate]
SCHEDULE 2
Albireo Pharma, Inc.
Xxxxxx X.X. Xxxxxx |
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President
and Chief Executive Officer |
Xxxxx Xxxxxxx |
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Chief Financial
Officer and Treasurer |
Xxxxx Xxxxxx |
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Chief Legal Officer, General Counsel and Secretary |
Xxxxx and Company, LLC
Xxxxxxx Xxxxxx |
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Director |
Xxxxxxx Xxxxxx |
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Director |
SCHEDULE 3
Compensation
Cowen shall be paid compensation equal to 3.0% of the gross
proceeds from the sales of Placement Shares pursuant to the terms of this Agreement.
SCHEDULE 4
Significant Subsidiaries
Albireo Limited, a limited company registered in England and
Wales
Albireo AB, a limited liability company registered in Sweden
Elobix AB, a limited liability company registered in Sweden
Albireo Security Corp., a Massachusetts corporation
Albireo Pharma Security Corporation, a Massachusetts corporation
Exhibit 7(m) – Officer
Certificate
OFFICER CERTIFICATE
[DATE]
The undersigned, the duly qualified and
elected _______________________, of Albireo Pharma, Inc., a Delaware corporation (the “Company”),
does hereby certify in such capacity and on behalf of the Company, pursuant to Section 7(m) of the Sales Agreement
dated February 25, 2021 (the “Sales Agreement”) between the Company and Xxxxx and Company, LLC,
that to the best of the knowledge of the undersigned:
(i) the
representations and warranties of the Company in Section 6 of the Sales Agreement (A) to the extent such representations
and warranties are subject to qualifications and exceptions contained therein relating to materiality or Material Adverse Effect,
are true and correct on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof,
except for those representations and warranties that speak solely as of a specific date and which were true and correct as of such
date, and (B) to the extent such representations and warranties are not subject to any qualifications or exceptions, are true
and correct in all material respects as of the date hereof as if made on and as of the date hereof with the same force and effect
as if expressly made on and as of the date hereof except for those representations and warranties that speak solely as of a specific
date and which were true and correct as of such date; and
(ii) the
Company has complied in all material respects with all agreements and satisfied all conditions on its part to be performed or satisfied
pursuant to the Sales Agreement at or prior to the date hereof.
Capitalized terms used
but not defined herein shall have the meanings ascribed to them in the Sales Agreement.
[Signature Page Follows]
IN WITNESS WHEREOF, the undersigned
has executed this certificate as of the date first written above.
Exhibit 7(m) – Chief
Financial Officer’s Certificate
CHIEF FINANCIAL OFFICER’S CERTIFICATE
[DATE]
__________, in [his/her]
capacity as Chief Financial Officer of Albireo Pharma, Inc. (the “Company”), pursuant to Section 7(m) of
the Sales Agreement dated February 25, 2021 (the “Sales Agreement”) between the Company and Xxxxx
and Company, LLC, hereby certifies that (capitalized terms used and not defined herein have the meanings ascribed to them in the
Sales Agreement):
| 1. | I have read the amounts circled
on the copies of certain pages of the Registration Statement and the Prospectus
attached hereto as Exhibit A.1 |
| 2. | With regard to these amounts, I compared such amounts to the corresponding amounts included in or derived from the Company’s
internal accounting records or schedules prepared by management from such accounting records for the applicable periods and found
them to be in agreement. |
| 3. | These amounts are accurate in all material respects, and nothing has come to my attention that would cause me to believe that
these amounts have been materially misstated or are materially misleading. |
| 4. | This certificate is being furnished to Cowen solely to assist Cowen in conducting and documenting its investigation of
the affairs of the Company in connection with the offering of the Placement Shares covered by the Registration Statement and the
Prospectus. |
[Signature page follows]
1 With respect to any Representation Date for which
the Company is required to provide this Chief Financial Officer’s Certificate pursuant to Section 7(m) of the Sales Agreement,
Exhibit A will include only the financial information and other matters ordinarily covered by accountants’ “comfort
letters” to Cowen in connection with registered public offerings but not covered by the Comfort Letter with respect to such
Representation Date.
IN WITNESS WHEREOF, the undersigned
has executed this certificate as of the date first written above.
[Signature
Page to CFO Certificate]
Exhibit A
[See attached]
Exhibit 7(n) – Form of
Company Counsel Opinion
Form of Company Counsel Opinion
| 1. | The Company is a corporation and is validly existing as a corporation
in good standing under the laws of the State of Delaware. The Company has the corporate power and authority to own, lease and operate
its properties and assets and to carry on its business as now conducted (as described in the Registration Statement and the Prospectus). |
| 2. | The Company is duly qualified and is in good standing as a foreign
corporation authorized to do business in the Commonwealth of Massachusetts. |
| 3. | The Sales Agreement has been duly and validly authorized, executed
and delivered by the Company. |
| 4. | The Placement Shares have been duly authorized and, when issued and
paid for pursuant to the terms of the Sales Agreement, will be validly issued, fully paid and nonassessable and free of any preemptive
or similar rights arising by operation of the Company’s Restated Certificate of Incorporation, as amended, or Amended and
Restated Bylaws or the DGCL or, to our knowledge, rights of first refusal or other similar rights to subscribe for the Placement
Shares under any material agreement listed in the exhibit index to (i) the Annual Report on Form 10-K for the fiscal
year ended December 31, [DATE] (the “Form 10-K”), (ii) any
Quarterly Report on Form 10-Q filed by the Company after the Form 10-K, or (iii) any Current Report on Form 8-K
filed by the Company after the Form 10-K (a “Material Agreement”). |
| 5. | The Registration Statement has become effective under the Securities
Act. To our knowledge, no stop order suspending the effectiveness of the Registration Statement under the Securities Act has been
issued and no proceedings for that purpose have been instituted or threatened. The Prospectus has been filed in accordance with
Rule 424(b) and 430B under the Securities Act. |
| 6. | The Registration Statement and the Prospectus (other than the financial
statements and schedules and other financial data included or incorporated by reference therein, as to which we express no opinion),
each appeared on its face to comply as of its respective effective or filing date in all material respects as to form with the
requirements of the Securities Act and the rules and regulations of the Commission promulgated thereunder. For purposes of
this paragraph, we have assumed that the statements made in the Registration Statement and the Prospectus are correct and complete. |
| 7. | Each of the documents incorporated by reference in the Registration
Statement or the Prospectus (the “Incorporated Documents”), when it was filed with the Commission, appeared
on its face to comply as to form in all material respects with the requirements of the Exchange Act and the rules and regulations
of the Commission promulgated thereunder. For purposes of this paragraph, we have assumed that the statements made in the Incorporated
Documents are correct and complete. |
| 8. | The execution, delivery and performance by the Company of, and the
compliance by the Company with the terms of, the Sales Agreement and the issuance, sale and delivery of the Placement Shares pursuant
to the Sales Agreement do not (i) conflict with or result in a violation of any provision of the DGCL, or any federal law
or rule or regulation of the United States of America that, in our experience, is normally applicable to transactions of the
type contemplated by the Sales Agreement, any rule or regulation of the Nasdaq Capital Market (the “Exchange”)
or any provision of the Restated Certificate of Incorporation, as amended, or Amended and Restated Bylaws of the Company, (ii) conflict
with, result in a breach of or constitute a default (or an event which with notice or lapse of time or both would become a default)
under, or result in or permit the termination or modification of, a Material Agreement that would result in a Material Adverse
Effect, (iii) conflict with or result in any breach or violation of or constitute a default under any order, writ, judgment
or decree known to us to which the Company is a party or is subject that would result in a Material Adverse Effect, or (iv) to
our knowledge, result in the creation or imposition of any lien, claim or encumbrance on any of the assets or properties of the
Company that would result in a Material Adverse Effect. |
| 9. | All the issued shares of capital stock (or analogous ownership interests,
as applicable) of each Significant Subsidiary of the Company, except to the extent set forth in the Registration Statement or the
Prospectus, are owned by the Company directly or indirectly through one or more wholly-owned subsidiaries, free and clear of any
claim, lien, encumbrance, security interest, restriction upon voting or transfer or any other claim of any third party. |
| 10. | To our knowledge, there is (i) no claim, action, suit, proceeding,
arbitration, investigation or inquiry, pending or threatened, before any court or governmental or administrative body or agency,
or any private arbitration tribunal, against the Company, or any of its officers, directors or employees (in connection with the
discharge of their duties as officers, directors and employees), of the Company, or affecting any of its properties or assets of
a character required to be described in the Registration Statement, Form 10-K, a Quarterly Report on Form 10-Q filed
by the Company after the Form 10-K, or a Current Report on Form 8-K filed by the Company after the Form 10-K, which
is not so described, and (ii) no indenture, contract, lease, mortgage, deed of trust, note agreement, loan or other agreement
or instrument of a character required to be filed as an exhibit to the Registration Statement, which is not filed as required by
the Securities Act and the rules thereunder. |
| 11. | In connection with the valid execution, delivery and performance
by the Company of the Sales Agreement, or the offer, sale, issuance or delivery of the Placement Shares or the consummation of
the transactions contemplated thereby, no consent, license, permit, waiver, approval or authorization of, or designation, declaration,
registration or filing with, any governmental or regulatory authority, self-regulatory organization, or court is required, other
than registration pursuant to the Securities Act and approval for listing of the Placement Shares on the Exchange. As stated above,
we do not express any opinion in this paragraph or otherwise as to any necessary qualification under the securities or Blue Sky
laws of any state or as to the rules and regulations of FINRA as may be applicable in effecting the transactions contemplated
by the Sales Agreement. |
| 12. | The Company is not, and after giving effect to the offering and sale
of the Placement Shares and the application of the proceeds thereof as described in the Prospectus will not be, required to register
as an Investment Company within the meaning of the Investment Company Act of 1940, as amended. |
| 13. | The Company has an authorized capitalization as set forth in the
Registration Statement and the Prospectus under the caption “Description of Capital Stock,” and the information included
in the Registration Statement and the Prospectus under the caption “Description of Capital Stock,” to the extent that
it constitutes matters of law, summaries of legal matters, documents referred to therein or legal conclusions, has been reviewed
by us and fairly summarizes the matters set forth therein in all material respects. |
| 14. | The Placement Shares to be issued and sold by the Company pursuant
to the Sales Agreement are duly listed, and admitted and authorized for trading, subject to official notice of issuance, on the
Exchange. |
| 15. | No person or entity has the right to require registration of shares
of Common Stock or other securities of the Company because of the filing or effectiveness of the Registration Statement, except
for persons and entities who have expressly waived such right or who have been given proper notice and have failed to exercise
such right within the time or times required under the terms and conditions of such right. |
Form of Company Counsel Negative
Assurance Letter
In the course of acting
as counsel for the Company in connection with the preparation of the Registration Statement and the Prospectus, we have participated
in conferences with officers, auditors and other representatives of the Company during which the contents of the Registration Statement
and the Prospectus were discussed (it being understood that while we represent the Company with respect to the offering of the
Placement Shares and certain other matters, other counsel represent the Company with respect to other matters, including matters
related to intellectual property). While the limitations inherent in the independent verification of factual matters and the character
of determinations involved in the registration process are such that we are not passing upon and do not assume any responsibility
for the accuracy, completeness or fairness of the statements contained in the Registration Statement and the Prospectus (except
as expressly and specifically set forth in our opinion letter to you dated the date hereof), subject to the foregoing and based
on such participation and discussions, no facts have come to our attention that have caused us to believe that:
(i) the
Registration Statement filed with the Commission (No. 333[●]), which registers the sale of the Placement Shares, is
not currently effective under the Securities Act;
(ii) any
required filing of the Prospectus pursuant to Rule 424(b) under the Securities Act has not been made in the manner and
within the time required by Rule 424(b);
(iii) the
Registration Statement, as of its latest effective date, including the information deemed to be a part of the Registration Statement
pursuant to Rule 430B under the Securities Act (together with the documents incorporated by reference in the Registration
Statement at that time), contained any untrue statement of a material fact or omitted to state a material fact required to be stated
therein or necessary to make the statements therein not misleading; or
(iv) the
Prospectus, as of its date, or as of the date hereof, together with the documents incorporated by reference in the Prospectus at
that time, contained or contains any untrue statement of a material fact or omitted or omits to state any material fact necessary
to make the statements therein, in the light of the circumstances under which they were made, not misleading.