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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported): May 8, 2024
AVADEL PHARMACEUTICALS PLC
(Exact name of registrant as specified
in its charter)
Ireland |
001-37977 |
98-1341933 |
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
10
Earlsfort Terrace
Dublin 2, Ireland, D02
T380 |
Not Applicable |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: +353
1 901-5201
Not applicable
(Former name or former address,
if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
Ordinary
Shares, nominal value $0.01 per share |
AVDL |
The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 1.01 Entry into a Material Definitive Agreement.
On May 8,
2024, Avadel Pharmaceuticals plc (the “Company”) entered into an Open Market Sale AgreementSM (the “Sales
Agreement”) with Jefferies LLC (“Jefferies”) pursuant to which the Company may offer and sell its ordinary shares, nominal
value $0.01 per share (the “Ordinary Shares”), from time to time, through an “at the market offering” program
under which Jefferies will act as sales agent. The Sales Agreement replaces the Company's previous Open Market Sale AgreementSM
with Jefferies, dated February 4, 2020 (the “ADS Sales Agreement”), which provided for the sale of ADSs by the Company. The
Company terminated the ADS Sales Agreement upon effectiveness of the Sales Agreement following the mandatory exchange of the ADSs and
the direct listing of the Ordinary Shares on the Nasdaq Stock Market on April 15, 2024.
The Ordinary
Shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-267198), filed
with the Securities and Exchange Commission (the “Commission”) on August 31, 2022, as amended, and declared effective
by the Commission on September 12, 2022, as supplemented by the prospectus supplement dated May 8, 2024 (the “Prospectus Supplement”).
The Company may offer and sell Ordinary Shares having an aggregate offering price of up to $100,000,000 under the Prospectus Supplement.
Under the Sales Agreement, the Company will set the parameters for
the sale of Ordinary Shares, including the number of Ordinary Shares to be issued, the time period during which sales are requested to
be made and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, Jefferies
may sell the Ordinary Shares (a) in privately negotiated transactions with the consent of the Company; or (b) by any other method permitted
by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended,
including block transactions, sales made directly through the Nasdaq Global Market or any other existing trading market for the Ordinary
Shares. Jefferies will use its commercially reasonable efforts in conducting sales activities consistent with its normal trading and sales
practices. Jefferies and the Company each have the right, by giving written notice as specified in the Sales Agreement, to terminate the
Sales Agreement in each party’s sole discretion at any time.
The Sales Agreement provides that Jefferies will be entitled to aggregate
compensation for its services an amount equal to 3.0% of the gross proceeds of any Ordinary Shares sold through Jefferies under the Sales
Agreement. Jefferies and the Company have no obligation to sell any Ordinary Shares under the Sales Agreement and may at any time suspend
any sale under the Sales Agreement. The Company has agreed in the Sales Agreement to provide indemnification and contribution to Jefferies
against certain liabilities, including liabilities under the Securities Act of 1933, as amended.
The foregoing description of the material terms of the Sales Agreement
is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed as Exhibit
1.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The legal opinion of Arthur Cox LLP relating to the Ordinary Shares
that may be sold pursuant to Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.
This Current Report on Form 8-K shall not constitute an offer to sell
or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities
in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws
of any such state.
Item 8.01 Other Events.
Effective
May 8, 2024, the Company suspended and terminated the ATM prospectus dated September 12, 2022 (the “ADS ATM Prospectus”)
related to the sale of Ordinary Shares represented by American Depositary Shares (the “ADSs”) in an “at-the-market offering” pursuant
to the terms of the ADS Sales Agreement. The Company will not make any further sales of ADSs pursuant to the ADS Sales Agreement.
Prior to the termination of the ADS Sales Agreement, the Company had issued and sold 1,112,717 ADSs with an aggregate sales price of
$13.5 million, resulting in net proceeds to the Company of approximately $13.1 million under the ADS ATM Prospectus.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
AVADEL PHARMACEUTICALS PLC |
|
|
|
|
By: |
/s/ Jerad G. Seurer |
Date: May 8, 2024 |
|
Name: |
Jerad G. Seurer |
|
|
Title: |
General Counsel & Corporate Secretary |
Exhibit 1.1
Execution Version
OPEN
MARKET SALE AGREEMENTSM
May 8,
2024
JEFFERIES LLC
520 Madison Avenue
New York, New York 10022
Ladies and Gentlemen:
Avadel Pharmaceuticals plc,
an Irish incorporated public limited company (the “Company”), proposes, subject to the terms and conditions stated
herein, to issue and sell from time to time through Jefferies LLC, as sales agent and/or principal (the “Agent”), the
Company’s ordinary shares, nominal value $0.01 per share (the “Ordinary Shares”), on the terms set forth in this
agreement (this “Agreement”).
Section 1. DEFINITIONS
(a) Certain
Definitions. For purposes of this Agreement, capitalized terms used herein and not otherwise defined shall have the following respective
meanings:
“Affiliate”
of a Person means another Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under
common control with, such first- mentioned Person. The term “control” (including the terms “controlling,” “controlled
by” and “under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction
of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.
“Agency
Period” means the period commencing on the date of this Agreement and expiring on the earliest to occur of (x) the date
on which the Agent shall have placed the Maximum Program Amount pursuant to this Agreement and (y) the date this Agreement is terminated
pursuant to Section 7.
“BHC
Act” means the Bank Holding Company Act of 1956, as amended.
“Commission”
means the U.S. Securities and Exchange Commission.
“Exchange
Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations of the Commission thereunder.
“Floor
Price” means the minimum price set by the Company in the applicable Issuance Notice below which the Agent shall not sell Shares
during the applicable period set forth in the applicable Issuance Notice, which may be adjusted by the Company at any time during the
period set forth in the applicable Issuance Notice by delivering written notice of such change to the Agent and which in no event shall
be less than $1.00 without the prior written consent of the Agent, which may be withheld in the Agent’s sole discretion.
SM “Open Market Sale Agreement”
is a service mark of Jefferies LLC
“Issuance Amount”
means the aggregate Sales Price of the Shares to be sold by the Agent pursuant to any Issuance Notice.
“Issuance
Notice” means a written notice delivered to the Agent by the Company in accordance with this Agreement in the form attached
hereto as Exhibit A that is executed by its Chief Executive Officer, President or Chief Financial Officer.
“Issuance
Notice Date” means any Trading Day during the Agency Period that an Issuance Notice is delivered pursuant to Section 3(b)(i).
“Issuance
Price” means the Sales Price less the Selling Commission.
“Maximum
Program Amount” means Ordinary Shares with an aggregate Sales Price of the lesser of (a) the number or dollar amount of
Ordinary Shares registered under the effective Registration Statement (defined below) pursuant to which the offering is being made,
(b) the number of authorized but unissued Ordinary Shares (less Ordinary Shares issuable upon exercise, conversion or exchange of
any outstanding securities of the Company or otherwise reserved from the Company’s authorized share capital), (c) the number
or dollar amount of Ordinary Shares permitted to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable),
or (d) the number or dollar amount of Ordinary Shares for which the Company has filed a Prospectus (defined below).
“Person”
means an individual or a corporation, partnership, limited liability company, trust, incorporated or unincorporated association, joint
venture, joint stock company, governmental authority or other entity of any kind.
“Principal Market”
means the Nasdaq Global Market or such other national securities exchange on which the Ordinary Shares, including any Shares (defined
below), are then listed.
“Rule 462(b) Registration
Statement” means any registration statement filed by the Company pursuant to Rule 462(b) under the Securities
Act in connection with the offer and sale of Shares.
“Sales
Price” means the actual sale execution price of each Share placed by the Agent pursuant to this Agreement.
“Securities Act”
means the Securities Act of 1933, as amended, and the rules and regulations of the Commission thereunder.
“Selling
Commission” means three percent (3.0%) of the gross proceeds of Shares sold pursuant to this Agreement, or as otherwise
agreed between the Company and the Agent with respect to any Shares sold pursuant to this Agreement.
“Settlement
Date” means the second business day, or such other time period as required by the Exchange Act or by the rules promulgated
thereunder, following each Trading Day during the period set forth in the applicable Issuance Notice on which Shares are sold pursuant
to this Agreement, when the Company shall deliver to the Agent the amount of Shares sold on such Trading Day and the Agent shall deliver
to the Company the Issuance Price received on such sales.
“Shares”
means the Company’s Ordinary Shares issued or issuable pursuant to this Agreement.
“Trading Day”
means any day on which the Principal Market is open for trading.
Section 2. REPRESENTATIONS
AND WARRANTIES OF THE COMPANY
The Company hereby represents
and warrants to, and agrees with, the Agent that as of (1) the date of this Agreement, (2) each Issuance Notice Date, (3) each
Settlement Date, (4) each Triggering Event Date (defined below) with respect to which the Company is obligated to deliver a certificate
pursuant to Section 4(n) and (5) as of each Time of Sale (defined below) (each of the times referenced above
is referred to herein as a “Representation Date”), except as may be disclosed in the Prospectus (including any documents
incorporated by reference therein and any supplements thereto) on or before a Representation Date:
(a) Registration Statement.
The Company has prepared and filed with the Commission a shelf registration statement on Form S-3 that contains a base prospectus.
Such registration statement registers the issuance and sale by the Company of the Shares under the Securities Act. The Company may file
one or more additional registration statements from time to time that will contain a base prospectus and related prospectus or prospectus
supplement, if applicable, with respect to the Shares. Except where the context otherwise requires, such registration statement(s), including
any information deemed to be a part thereof pursuant to Rule 430B under the Securities Act, including all financial statements, exhibits
and schedules thereto and all documents incorporated or deemed to be incorporated therein by reference pursuant to Item 12 of Form S-3
under the Securities Act as from time to time amended or supplemented, is herein referred to as the “Registration Statement,”
and the prospectus constituting a part of such registration statement(s), together with any prospectus supplement filed with the Commission
pursuant to Rule 424(b) under the Securities Act relating to a particular issuance of the Shares, including all documents incorporated
or deemed to be incorporated therein by reference pursuant to Item 12 of Form S-3 under the Securities Act, in each case, as from
time to time amended or supplemented, is referred to herein as the “Prospectus,” except that if any revised prospectus
is provided to the Agent by the Company for use in connection with the offering of the Shares that is not required to be filed by the
Company pursuant to Rule 424(b) under the Securities Act, the term “Prospectus” shall refer to such revised
prospectus from and after the time it is first provided to the Agent for such use. The Registration Statement at the time it originally
became effective is herein called the “Original Registration Statement.” As used in this Agreement, the terms “amendment”
or “supplement” when applied to the Registration Statement or the Prospectus shall be deemed to include the filing by the
Company with the Commission of any document under the Exchange Act after the date hereof that is or is deemed to be incorporated therein
by reference.
All references in this Agreement
to financial statements and schedules and other information which is “contained,” “included” or “stated”
in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such
financial statements and schedules and other information which is or is deemed to be incorporated by reference in or otherwise deemed
under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified
date; and all references in this Agreement to amendments or supplements to the Registration Statement or the Prospectus shall be deemed
to mean and include, without limitation, the filing of any document under the Exchange Act which is or is deemed to be incorporated by
reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus,
as the case may be, as of any specified date. The Company’s obligations under this Agreement to furnish, provide, deliver or make
available (and all other references of like import) copies of any report or statement shall be deemed satisfied if the same is filed with
the Commission through its Electronic Data Gathering, Analysis, and Retrieval system (“EDGAR”).
At the time the Original Registration
Statement was or will be declared effective and at the time the Company’s most recent annual report on Form 10-K was filed
with the Commission, if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During
the Agency Period, each time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements
for use of Form S-3 under the Securities Act.
(b) Compliance with
Registration Requirements. The Original Registration Statement and any Rule 462(b) Registration Statement have been or will
be declared effective by the Commission under the Securities Act. The Company has complied or will comply to the Commission’s satisfaction
with all requests of the Commission for additional or supplemental information, if any. No stop order suspending the effectiveness of
the Registration Statement 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 best knowledge of the Company, are contemplated or threatened by the Commission.
The Prospectus when filed
complied or will comply in all material respects with the Securities Act and, if filed with the Commission through EDGAR (except as may
be permitted by Regulation S-T under the Securities Act), was identical to the copy thereof delivered to the Agent for use in connection
with the issuance and sale of the Shares. Each of the Registration Statement, any Rule 462(b) Registration Statement and any
post-effective amendment thereto, at the time it became or becomes effective and at each Representation Date, complied and will comply
in all material respects with the Securities Act and did not and will not contain any untrue statement of a material fact or omit to state
a material fact required to be stated therein or necessary to make the statements therein not misleading. As of the date of this Agreement,
the Prospectus and any Free Writing Prospectus (as defined below) considered together (collectively, the “Time of Sale Information”)
did not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in
the light of the circumstances under which they were made, not misleading. The Prospectus, as amended or supplemented, as of its date
and at each Representation Date, did not and will not contain any untrue statement of a material fact or omit to state a material fact
necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The representations
and warranties set forth in the three immediately preceding sentences do not apply to statements in or omissions from the Registration
Statement, 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 the Agent furnished to the Company in writing
by the Agent expressly for use therein, it being understood and agreed that the only such information furnished by the Agent to the Company
consists of the information described in Section 6(b) below. 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.
The Registration Statement and the offer and sale of the Shares as contemplated hereby meet the requirements of Rule 415 under the
Securities Act and comply in all material respects with said rule.
(c) Ineligible
Issuer Status. The Company is not an “ineligible issuer” in connection with the offering of the Shares pursuant to Rules 164,
405 and 433 under the Securities Act. Any Free Writing Prospectus that the Company is required to file pursuant to Rule 433(d) under
the Securities Act has been, or will be, filed with the Commission in accordance with the requirements of the Securities Act. Each Free
Writing Prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) under the Securities Act or that
was prepared by or on behalf of or used or referred to by the Company complies or will comply in all material respects with the requirements
of Rule 433 under the Securities Act including timely filing with the Commission or retention where required and legending, and each
such Free Writing Prospectus, as of its issue date and at all subsequent times through the completion of the issuance and sale of the
Shares did not, does not and will not include any information that conflicted, conflicts with or will conflict with the information contained
in the Registration Statement or the Prospectus, including any document incorporated by reference therein. Except for the Free Writing
Prospectuses, if any, and electronic road shows, if any, furnished to the Agent before first use, the Company has not prepared, used or
referred to, and will not, without the Agent’s prior consent, prepare, use or refer to, any Free Writing Prospectus.
(d) Incorporated
Documents. The documents incorporated or deemed to be incorporated by reference in the Registration Statement and the Prospectus,
at the time they were filed with the Commission, complied in all material respects with the requirements of the Exchange Act, as applicable,
and, when read together with the other information in the Prospectus, at the time the Registration Statement and any amendment thereto
become effective and as of each Representation Date, will not contain an 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, in light of the circumstances under which they were made,
not misleading.
(e) Exchange
Act Compliance. The documents incorporated or deemed to be incorporated by reference in the Prospectus, at the time they were or hereafter
are filed with the Commission, and any Free Writing Prospectus or amendment or supplement thereto complied and will comply in all material
respects with the requirements of the Exchange Act, and, when read together with the other information in the Prospectus, at the time
the Registration Statement and any amendments thereto becomes effective and at each Time of Sale (as defined below), as the case may be,
will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to
make the 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.
(f) Statistical
and Market-Related Data. All statistical, demographic and market-related data included in the Registration Statement or the Prospectus
are based on or derived from sources that the Company believes, after reasonable inquiry, to be reliable and accurate. To the extent required,
the Company has obtained the written consent for the use of such data from such sources.
(g) Disclosure
Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting. The Company has established and
maintains disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the Exchange Act), which (i) are designed
to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to the Company’s
principal executive officer and its principal financial officer by others within those entities, particularly during the periods in which
the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for
effectiveness as of the end of the Company’s most recent fiscal quarter; and (iii) are effective in all material respects to
perform the functions for which they were established. Since the end of the Company’s most recent audited fiscal year, there have
been no significant deficiencies or material weaknesses in the Company’s internal control over financial reporting (whether or not
remediated) and 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. The Company is not aware of any change in
its internal control over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or
is reasonably likely to materially affect, the Company’s internal control over financial reporting.
(h) This
Agreement. This Agreement has been duly authorized, executed and delivered by the Company.
(i) Authorization
of the Shares. The Shares have been duly authorized for issuance and sale pursuant to this Agreement and, when allotted and issued
and delivered by the Company against payment therefor pursuant to this Agreement, will be validly issued, fully paid and not subject to
any calls for additional payments (nonassessable), and the issuance and sale of the Shares is not subject to any preemptive rights, rights
of first refusal or other similar rights to subscribe for or purchase the Shares.
(j) No
Applicable Registration or Other Similar Rights. There are no persons with registration or other similar rights to have any equity
or debt securities registered for sale under the Registration Statement or included in the offering contemplated by this Agreement, except
for such rights as have been duly waived.
(k) No
Material Adverse Change. Except as otherwise disclosed in the Registration Statement and the Prospectus, subsequent to the respective
dates as of which information is given in the Registration Statement and the Prospectus: (i) there has been no material adverse change
in (A) the condition, financial or otherwise, or in the earnings, business, properties, operations, operating results, assets, liabilities
or prospects, whether or not arising from transactions in the ordinary course of business, of the Company and its subsidiaries, considered
as one entity or (B) the ability of the Company to consummate the transactions contemplated by this Agreement or perform its obligations
hereunder (any such change being referred to herein as a “Material Adverse Change”); (ii) the Company and its
subsidiaries, considered as one entity, have not incurred any material liability or obligation, indirect, direct or contingent, including
without limitation any losses or interference with their business from fire, explosion, flood, earthquakes, accident or other calamity,
whether or not covered by insurance, or from any strike, labor dispute or court or governmental action, order or decree, that are material,
individually or in the aggregate, to the Company and its subsidiaries, considered as one entity, and have not entered into any transactions
not in the ordinary course of business; and (iii) there has not been any material decrease in the share capital or any material increase
in any short-term or long-term indebtedness of the Company or its subsidiaries and there has been no dividend or distribution of any kind
declared, paid or made by the Company or, except for dividends paid to the Company or other subsidiaries, by any of the Company’s
subsidiaries on any class of share capital, or any repurchase or redemption by the Company or any of its subsidiaries of any class of
share capital.
(l) Independent
Accountants. Deloitte & Touche LLP, which has expressed its opinion with respect to the financial statements (which term
as used in this Agreement includes the related notes thereto) and supporting schedules filed with the Commission as a part of the Registration
Statement and the Prospectus, to the Company’s knowledge, is (i) an independent registered public accounting firm as required
by the Securities Act, the Exchange Act, and the rules of the Public Company Accounting Oversight Board (“PCAOB”),
(ii) in compliance with the applicable requirements relating to the qualification of accountants under Rule 2-01 of Regulation
S-X under the Securities Act and (iii) a registered public accounting firm as defined by the PCAOB whose registration has not been
suspended or revoked and who has not requested such registration to be withdrawn.
(m) Financial
Statements. The financial statements filed with the Commission as a part of the Registration Statement and the Prospectus present
fairly, in all material respects, the consolidated financial position of the Company and its subsidiaries as of the dates indicated and
the results of their operations, shareholders’ equity and cash flows for the periods specified. The supporting schedules included
in the Registration Statement present fairly the information required to be stated therein. Such financial statements and supporting schedules
have been prepared in conformity with generally accepted accounting principles as applied in the United States applied on a consistent
basis throughout the periods involved, except as may be expressly stated in the related notes thereto. 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 with the Commission’s rules and guidelines applicable thereto.
No other financial statements or supporting schedules are required to be included in the Registration Statement or the Prospectus. To
the Company’s knowledge, no person who has been suspended or barred from being associated with a registered public accounting firm,
or who has failed to comply with any sanction pursuant to Rule 5300 promulgated by the PCAOB, has participated in or otherwise aided
the preparation of, or audited, the financial statements, supporting schedules or other financial data filed with the Commission as a
part of the Registration Statement and the Prospectus.
(n) Company’s
Accounting System. The Company and each of its subsidiaries make and keep accurate books and records and maintain a system of internal
accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s
general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity
with generally accepted accounting principles as applied in the United States 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) the interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement
and the Prospectus fairly presents the information called for in all material respects and is prepared in accordance with the Commission’s
rules and guidelines applicable thereto.
(o) Incorporation
and Good Standing of the Company. The Company has been duly incorporated and is validly existing as a public limited company
under the laws of Ireland and is in good standing (or such equivalent concept to the extent it exists in Ireland) and has the corporate
power and authority to own, lease and operate its properties and to conduct its business as described in the Registration Statement and
the Prospectus and to enter into and perform its obligations under this Agreement. The Company is duly qualified as a public limited company
incorporated under the laws of Ireland to transact business and is in good standing in each other jurisdiction in which such qualification
is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure to so qualify
or to be in good standing would not result in a Material Adverse Change.
(p) Subsidiaries.
Each of the Company’s “subsidiaries” (for purposes of this Agreement, as defined in Rule 405 under the Securities
Act) has been duly incorporated or organized, as the case may be, and is validly existing as a corporation, partnership or limited liability
company, as applicable, in good standing (or such equivalent concept to the extent it exists under the law of such jurisdiction) under
the laws of the jurisdiction of its incorporation or organization and has the power and authority (corporate or other) to own, lease and
operate its properties and to conduct its business as described in the Registration Statement and the Prospectus. Each of the Company’s
subsidiaries is duly qualified as a non-U.S. corporation, partnership or limited liability company, as applicable, to transact business
and is in good standing (or such equivalent concept to the extent it exists under the law of such jurisdiction) in each jurisdiction in
which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where
the failure to so qualify or to be in good standing (or such equivalent concept to the extent it exists under the law of such jurisdiction)
would not result in a Material Adverse Change. All of the issued and outstanding share capital or other equity or ownership interests
of each of the Company’s subsidiaries have been duly authorized and validly issued, are fully paid and nonassessable and are owned
by the Company, directly or through subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance or adverse
claim. None of the outstanding share capital or equity interest in any subsidiary was issued in violation of preemptive or similar rights
of any security holder of such subsidiary. The constitutive or organizational documents of each of the subsidiaries comply in all material
respects with the requirements of applicable laws of its jurisdiction of incorporation or organization and are in full force and effect.
The Company does not own or control, directly or indirectly, any corporation, association or other entity other than the subsidiaries
listed in Exhibit 21 to the Company’s most recent annual report on Form 10-K.
(q) Capitalization
and Other Share Capital Matters. The authorized, issued and outstanding share capital of the Company is as set forth in the Registration
Statement and the Prospectus under the caption “Description of Share Capital” (other than for subsequent issuances, if any,
pursuant to employee benefit plans described in the Prospectus or upon the exercise of outstanding options or warrants, in each case described
in the Registration Statement and the Prospectus). The Ordinary Shares (including the Shares) conform in all material respects to the
description thereof contained in the Prospectus and such description conforms to the rights set forth in the Constitution of the Company
or relevant filings made by the Company with the Irish Companies Registration Office, as appropriate. All of the issued and outstanding
Ordinary Shares have been duly authorized and validly issued, are fully paid and not subject to any calls for additional payments (nonassessable)
and have been issued in compliance with all federal and state securities laws. None of the outstanding Ordinary Shares 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. There
are no authorized or outstanding 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 share capital of the Company or any of its subsidiaries other
than those described in the Registration Statement and the Prospectus. The descriptions of the Company’s stock option, stock bonus
and other stock plans or arrangements, and the options or other rights granted thereunder, set forth in the Registration Statement and
the Prospectus accurately and fairly presents the information required to be shown with respect to such plans, arrangements, options and
rights.
(r) Stock
Exchange Listing. The Ordinary Shares are registered pursuant to Section 12(b) or 12(g) of the Exchange Act and are
listed on the Principal Market, and the Company has taken no action designed to, or likely to have the effect of, terminating the registration
of the Ordinary Shares under the Exchange Act or delisting the Ordinary Shares from the Principal Market, nor has the Company received
any notification that the Commission or the Principal Market is contemplating terminating such registration or listing. To the Company’s
knowledge, it is in compliance with all applicable listing requirements of the Principal Market.
(s) Non-Contravention
of Existing Instruments; No Further Authorizations or Approvals Required. Neither the Company nor any of its subsidiaries is in violation
of its Constitution, charter or by-laws, partnership agreement or operating agreement or similar organizational documents, as applicable,
or is in default (or, with the giving of notice or lapse of time, would be in default) (“Default”) under any indenture,
loan, credit agreement, note, lease, license agreement, contract, franchise or other instrument (including, without limitation, any pledge
agreement, security agreement, mortgage or other instrument or agreement evidencing, guaranteeing, securing or relating to indebtedness)
to which the Company or any of its subsidiaries is a party or by which it or any of them may be bound, or to which any of their respective
properties or assets are subject (each, an “Existing Instrument”), except for such Defaults as would not be expected,
individually or in the aggregate, to result in a Material Adverse Change. The Company’s execution, delivery and performance of this
Agreement, consummation of the transactions contemplated hereby and by the Registration Statement and the Prospectus and the issuance
and sale of the Shares (including the use of proceeds from the sale of the Shares as described in the Registration Statement and the Prospectus
under the caption “Use of Proceeds”) (i) have been duly authorized by all necessary corporate action and will not result
in any violation of the provisions of the Constitution, charter or by-laws, partnership agreement or operating agreement or similar organizational
documents, as applicable, of the Company or any subsidiary (ii) will not conflict with or constitute a breach of, or Default or a
Debt Repayment Triggering Event (as defined below) under, or result in the creation or imposition of any lien, charge or encumbrance upon
any property or assets of the Company or any of its subsidiaries pursuant to, or require the consent of any other party to, any Existing
Instrument and (iii) will not result in any violation of any law, administrative regulation or administrative or court decree applicable
to the Company or any of its subsidiaries. No consent, approval, authorization or other order of, or registration or filing with, any
court or other governmental or regulatory authority or agency, is required for the Company’s execution, delivery and performance
of this Agreement and consummation of the transactions contemplated hereby and by the Registration Statement and the Prospectus, except
such as have been obtained or made by the Company and such as may be required under applicable state securities or blue sky laws or Financial
Industry Regulatory Agency (“FINRA”). As used herein, a “Debt Repayment Triggering Event” means
any event or condition which 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 or any of its subsidiaries.
(t) No
Material Actions or Proceedings. Except as otherwise disclosed in the Prospectus, there is no action, suit, proceeding, inquiry or
investigation brought by or before any legal or governmental entity now pending or, to the knowledge of the Company, threatened, against
or affecting the Company or any of its subsidiaries, which could be expected, individually or in the aggregate, to result in a Material
Adverse Change. No material labor dispute with the employees of the Company or any of its subsidiaries, or with the employees of any principal
supplier, manufacturer, customer or contractor of the Company, exists or, to the knowledge of the Company, is threatened or imminent.
(u) Intellectual
Property Rights. Except as otherwise disclosed in the Registration Statement or the Prospectus, the Company and its subsidiaries own,
or have obtained valid and enforceable licenses for, the inventions, patent applications, patents, trademarks, trade names, service names,
copyrights, trade secrets and other intellectual property described in the Registration Statement and the Prospectus as being owned or
licensed by them or which are necessary for the conduct of their respective businesses as currently conducted or as currently proposed
to be conducted (collectively, “Intellectual Property”) and the conduct of their respective businesses does not and
will not infringe, misappropriate or otherwise conflict in any material respect with any such rights of others. The Intellectual Property
of the Company has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part, and the
Company is unaware of any facts which would form a reasonable basis for any such adjudication. To the Company’s knowledge: (i) there
are no third parties who have rights to any Intellectual Property, except for customary reversionary rights of third-party licensors with
respect to Intellectual Property that is disclosed in the Registration Statement and the Prospectus as licensed to the Company or one
or more of its subsidiaries; and (ii) there is no infringement by third parties of any Intellectual Property. Except as otherwise
disclosed in the Registration Statement or the Prospectus and any related claims, assertions or challenges, there is no pending or, to
the Company’s knowledge, threatened action, suit, proceeding or claim by others: (A) challenging the Company’s rights
in or to any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit,
proceeding or claim; (B) challenging the validity, enforceability or scope of any Intellectual Property, and the Company is unaware
of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; or (C) asserting that the Company
or any of its subsidiaries infringes or otherwise violates, any product or service described in the Registration Statement or the Prospectus
as under development, infringe or violate, any patent, trademark, trade name, service name, copyright, trade secret or other proprietary
rights of others, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or
claim. The Company and its subsidiaries have complied with the terms of each agreement pursuant to which Intellectual Property has been
licensed to the Company or any subsidiary, and all such agreements are in full force and effect. To the Company’s knowledge, there
are no material defects in any of the patents or patent applications included in the Intellectual Property. The Company and its subsidiaries
have taken all reasonable steps to protect, maintain and safeguard their Intellectual Property, including the execution of appropriate
nondisclosure, confidentiality agreements and invention assignment agreements and invention assignments with their employees, and no employee
of the Company is in or has been in violation of any term of any employment contract, patent disclosure agreement, invention assignment
agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement, or any restrictive covenant to or with a former
employer where the basis of such violation relates to such employee’s employment with the Company. The duty of candor and good faith
as required by the United States Patent and Trademark Office during the prosecution of the United States patents and patent applications
included in the Intellectual Property have been complied with; and in all non-U.S. offices having similar requirements, all such requirements
have been complied with. None of the Company owned Intellectual Property or technology (including information technology and outsourced
arrangements) employed by the Company or its subsidiaries has been obtained or is being used by the Company or its subsidiary in violation
of any contractual obligation binding on the Company or its subsidiaries or any of their respective officers, directors or employees or
otherwise in violation of the rights of any persons. The product candidates described in the Registration Statement and the Prospectus
as under development by the Company or any subsidiary fall within the scope of the claims of one or more patents owned by, or exclusively
licensed to, the Company or any subsidiary.
(v) All
Necessary Permits, etc. Except as otherwise disclosed in the Prospectus, the Company and each subsidiary possess such valid and
current certificates, authorizations or permits required by state, federal or non-U.S. regulatory agencies or bodies to conduct their
respective businesses as currently conducted and as described in the Registration Statement or the Prospectus (“Permits”),
except where the failure to obtain such Permits would not, singly or in the aggregate, result in a Material Adverse Change. Neither the
Company nor any of its subsidiaries is in violation of, or in default under, any of the Permits or has received any notice of proceedings
relating to the revocation or modification of, or non-compliance with, any such certificate, authorization or permit.
(w) Title
to Properties. Except as otherwise disclosed in the Registration Statement or Prospectus, the Company and its subsidiaries have good
and marketable title to all of the real and personal property and other assets reflected as owned in the financial statements referred
to in Section 2(m) above (or elsewhere in the Registration Statement or the Prospectus), in each case free and clear
of any security interests, mortgages, liens, encumbrances, equities, adverse claims and other defects. The real property, improvements,
equipment and personal property held under lease by the Company or of its subsidiary are held under valid and enforceable leases, with
such exceptions as are not material and do not materially interfere with the use made or proposed to be made of such real property, improvements,
equipment or personal property by the Company or such subsidiary.
(x) Tax
Law Compliance. The Company and its subsidiaries have filed all necessary U.S. federal, state and non-U.S. income and franchise tax
returns or have properly requested extensions thereof and have paid all taxes required to be paid by any of them and, if due and payable,
any related or similar assessment, fine or penalty levied against any of them except as may be being contested in good faith and by appropriate
proceedings except to the extent that the failure to file any such tax returns would not be expected to result in a Material Adverse Change.
The Company has made adequate charges, accruals and reserves in the applicable financial statements referred to in Section 2(m) above
in respect of all U.S. federal, state and non-U.S. income and franchise taxes for all periods as to which the tax liability of the Company
or any of its subsidiaries has not been finally determined. Neither the Company nor any of its subsidiaries has received a material confirmation
(or material tax ruling) concerning the tax treatment of a transaction to which the Company or any of its subsidiaries is party to from
any European tax authority.
(y) Company
Not an “Investment Company.” The Company is not, and will not be, either after receipt of payment for the Shares or after
the application of the proceeds therefrom as described under “Use of Proceeds” in the Registration Statement or the Prospectus,
required to register as an “investment company” under the Investment Company Act of 1940, as amended (the “Investment
Company Act”).
(z) Passive
Foreign Investment Company. Except as disclosed in the Registration Statement and the Prospectus, the Company was not a “passive
foreign investment company,” as such term is defined in the Internal Revenue Code of 1986, as amended (the “Code”),
for the last completed fiscal year for which audited financial statements of the Company have been filed with the Commission. Neither
the Company nor any subsidiary of the Company is, and, after giving effect to the issuance and sale of the Shares and the application
of the proceeds thereof, neither of them will be, a “controlled foreign corporation” as defined by the Code.
(aa)
Insurance. Except as otherwise disclosed in the Prospectus, each of the Company and its subsidiaries are insured by recognized,
financially sound and reputable institutions with policies in such amounts and with such deductibles and covering such risks as are generally
deemed adequate and customary for their businesses including, but not limited to, policies covering real and personal property owned or
leased by the Company and its subsidiaries against theft, damage, destruction, acts of vandalism and earthquakes and policies covering
the Company and its subsidiaries for product liability claims and clinical trial liability claims. The Company has no reason to believe
that it or any of its subsidiaries will not be able (i) to renew its existing insurance coverage as and when such policies expire
or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now
conducted and at a cost that could not be expected to result in a Material Adverse Change. Neither the Company nor any of its subsidiaries
has been denied any insurance coverage which it has sought or for which it has applied.
(bb)
No Price Stabilization or Manipulation; Compliance with Regulation M. Neither the Company nor any of its subsidiaries has
taken, directly or indirectly, any action designed to or that might cause or result in stabilization or manipulation of the price of the
Ordinary Shares or of any “reference security” (as defined in Rule 100 of Regulation M under the Exchange Act (“Regulation
M”)) with respect to the Ordinary Shares, whether to facilitate the sale or resale of the Shares or otherwise, and has taken
no action which would directly or indirectly violate Regulation M.
(cc)
Related Party Transactions. There are no business relationships or related-party transactions involving the Company or any
of its subsidiaries or any other person required to be described in the Registration Statement or the Prospectus which have not been described
as required.
(dd)
FINRA Matters. All of the information provided to the Agent or to counsel for the Agent by the Company, its counsel, its
officers and directors and the holders of any securities (debt or equity) or options to acquire any securities of the Company in connection
with the offering of the Shares is true, complete, correct and compliant with FINRA rules and any letters, filings or other supplemental
information provided to FINRA pursuant to FINRA Rules or NASD Conduct Rules is true, complete and correct. The Company meets
the requirements for use of Form S-3 under the Securities Act specified in FINRA Rule 5110(b)(7)(C)(i).
(ee)
No Unlawful Contributions or Other Payments. Except as otherwise disclosed in the Prospectus, neither the Company nor any
of its subsidiaries nor, to the Company’s knowledge, any employee or agent of the Company or any subsidiary, has made any contribution
or other payment to any official of, or candidate for, any U.S. federal, state or non-U.S. office in violation of any law or of the character
required to be disclosed in the Registration Statement and the Prospectus.
(ff)
Compliance with Environmental Laws. Except as described in the Prospectus and except as could not be expected, individually
or in the aggregate, to result in a Material Adverse Effect; (i) neither the Company nor any of its subsidiaries is in violation
of any U.S. federal, state, local or non-U.S. statute, law, rule, regulation, ordinance, code, policy or rule of common law or any
judicial or administrative interpretation thereof, including any judicial or administrative order, consent, decree or judgment, relating
to pollution or protection of human health, the environment (including, without limitation, ambient air, surface water, groundwater, land
surface or subsurface strata) or wildlife, including, without limitation, laws and regulations relating to the release or threatened release
of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, petroleum or petroleum products (collectively,
“Hazardous Materials”) or to the manufacture, processing, distribution, use, treatment, storage, disposal, transport
or handling of Hazardous Materials (collectively, “Environmental Laws”), (ii) the Company and its subsidiaries
have all permits, authorizations and approvals required under any applicable Environmental Laws and are each in compliance with their
requirements, (iii) there are no pending or, to the knowledge of the Company, threatened administrative, regulatory or judicial actions,
suits, demands, demand letters, claims, liens, notices of noncompliance or violation, investigation or proceedings relating to any Environmental
Law against the Company or any of its subsidiaries and (iv) there are no events or circumstances that might reasonably be expected
to form the basis of an order for clean-up or remediation, or an action, suit or proceeding by any private party or governmental body
or agency, against or affecting the Company or any of its subsidiaries relating to Hazardous Materials or any Environmental Laws.
(gg)
Periodic Review of Costs of Environmental Compliance. In the ordinary course of its business, the Company conducts a periodic
review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course
of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures
required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints
on operating activities and any potential liabilities to third parties). No facts or circumstances have come to the Company’s attention
that could result in costs or liabilities that could be expected, individually or in the aggregate, to result in a Material Adverse Change.
(hh)
ERISA Compliance. Except as otherwise disclosed in the Prospectus, the Company and its subsidiaries and any “employee
benefit plan” (as defined under the Employee Retirement Income Security Act of 1974, as amended, and the regulations and published
interpretations thereunder (collectively, “ERISA”)) established or maintained by the Company, its subsidiaries or their
“ERISA Affiliates” (as defined below) are in compliance in all material respects with ERISA. “ERISA Affiliate”
means, with respect to the Company or any of its subsidiaries, any member of any group of organizations described in Sections 414(b),
(c), (m) or (o) of the Internal Revenue Code of 1986, as amended, and the regulations and published interpretations thereunder
(the “Code”) of which the Company or such subsidiary is a member. No “reportable event” (as defined under
ERISA) has occurred or is reasonably expected to occur with respect to any “employee benefit plan” established or maintained
by the Company, its subsidiaries or any of their ERISA Affiliates. No “employee benefit plan” established or maintained by
the Company, its subsidiaries or any of their ERISA Affiliates, if such “employee benefit plan” were terminated, would have
any “amount of unfunded benefit liabilities” (as defined under ERISA). Neither the Company, its subsidiaries nor any of their
ERISA Affiliates has incurred or reasonably expects to incur any liability under (i) Title IV of ERISA with respect to termination
of, or withdrawal from, any “employee benefit plan” or (ii) Sections 412, 4971, 4975 or 4980B of the Code. Each “employee
benefit plan” established or maintained by the Company, its subsidiaries or any of their ERISA Affiliates that is intended to be
qualified under Section 401(a) of the Code is so qualified and nothing has occurred, whether by action or failure to act, which
would cause the loss of such qualification.
(ii) Brokers.
Except as otherwise disclosed in the Prospectus, there is no broker, finder or other party that is entitled to receive from the Company
any brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated by this Agreement.
(jj)
No Outstanding Loans or Other Extensions of Credit. The Company does not have any outstanding extension of credit, in the
form of a personal loan, to or for any director or executive officer (or equivalent thereof) of the Company except for such extensions
of credit as are expressly permitted by Section 13(k) of the Exchange Act.
(kk)
Compliance with Laws. The Company and its subsidiaries have been and are in compliance with all applicable laws, rules and
regulations, except where failure to be so in compliance could not be expected, individually or in the aggregate, to result in a Material
Adverse Change.
(ll)
Dividend Restrictions. Except as disclosed in the Prospectus, no subsidiary of the Company is prohibited or restricted,
directly or indirectly, from paying dividends to the Company, or from making any other distribution with respect to such subsidiary’s
equity securities or from repaying to the Company or any other subsidiary of the Company any amounts that may from time to time become
due under any loans or advances to such subsidiary from the Company or from transferring any property or assets to the Company or to any
other subsidiary.
(mm)
No Rights of Immunity. Except as provided by laws or statutes generally applicable to transactions of the type described
in this Agreement, neither the Company nor any of its subsidiaries or any of their respective properties, assets or revenues has any right
of immunity under Irish, French, Cayman Islands, New York or United States law, from any legal action, suit or proceeding, from the giving
of any relief in any such legal action, suit or proceeding, from set-off or counterclaim, from the jurisdiction of any Irish, French,
Cayman Islands, New York or United States federal court, from service of process, attachment upon or prior judgment, or attachment in
aid of execution of judgment, or from execution of a judgment, or other legal process or proceeding for the giving of any relief or for
the enforcement of a judgment, in any such court, with respect to its obligations, liabilities or any other matter under or arising out
of or in connection with this Agreement. To the extent that the Company or any of its subsidiaries or any of their respective properties,
assets or revenues may have or may hereafter become entitled to any such right of immunity in any such court in which proceedings may
at any time be commenced, each of the Company and each subsidiary waives or will waive such right to the extent permitted by law.
(nn)
Anti-Corruption and Anti-Bribery Laws. Neither the Company nor any of its subsidiaries nor any director, officer,
or employee of the Company or any of its subsidiaries, nor to the knowledge of the Company, any agent, affiliate or other person acting
on behalf of the Company or any of its subsidiaries has, in the course of its actions for, or on behalf of, the Company or any of its
subsidiaries (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating
to political activity; (ii) made or taken any act in furtherance of an offer, promise, or authorization of any direct or indirect
unlawful payment or benefit to any non-U.S. or domestic government official or employee, including of any government-owned or controlled
entity or public international organization, or any political party, party official, or candidate for political office; (iii) violated
or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), the
UK Bribery Act 2010, or any other applicable anti-bribery or anti-corruption law; or (iv) made, offered, authorized, requested, or
taken an act in furtherance of any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment or benefit. The
Company and its subsidiaries and, to the knowledge of the Company, the Company’s affiliates have conducted their respective businesses
in compliance with the FCPA and have instituted and maintain policies and procedures designed to ensure, and which are reasonably expected
to continue to ensure, continued compliance therewith.
(oo)
Money Laundering Laws. The operations of the Company and its subsidiaries are, and have been conducted at all times, in
compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of
1970, as amended, the money laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related
or similar applicable rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the
“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 Money Laundering Laws is pending or, to
the best knowledge of the Company, threatened.
(pp)
Clinical Data. The preclinical tests and clinical trials, and other studies (collectively, “studies”)
that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending,
are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such
studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and
complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no
knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred
to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such
approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee
thereof or from any other U.S. or non-U.S. government or drug or medical device regulatory agency, or health care facility Institutional
Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received
any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials
that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated
and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
(qq)
Sanctions. Neither the Company nor any of its subsidiaries, directors, officers, or employees, nor, to the knowledge of
the Company, any agent, affiliate or other person acting on behalf of the Company or any of its subsidiaries is currently the subject
or the target of any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury or the
U.S. Department of State, the United Nations Security Council, the European Union, His Majesty’s Treasury of the United Kingdom,
or other relevant sanctions authority (collectively, “Sanctions”); nor is the Company or any of its subsidiaries located,
organized or resident in a country or territory that is the subject or the target of Sanctions, including, without limitation, the Crimea
Region of Ukraine, the so-called Donetsk People’s Republic, the so-called Luhansk People’s Republic, the non-government controlled
areas of Zaporizhzhia and Kherson regions of Ukraine, Cuba, Iran, North Korea, and Syria (each, a “Sanctioned Country”);
and the Company will not directly or indirectly use the proceeds of this offering, or lend, contribute or otherwise make available such
proceeds to any subsidiary, or any joint venture partner or other person or entity, for the purpose of financing the activities of or
business with any person, or in any country or territory, that at the time of such financing, is the subject or the target of Sanctions
or in any other manner that will result in a violation by any person (including any person participating in the transactions contemplated
hereby whether as underwriter, advisor, investor or otherwise) of applicable Sanctions. For the past five years, the Company and its subsidiaries
have not knowingly engaged in and are not now knowingly engaged in any dealings or transactions with any person that at the time of the
dealing or transaction is or was the subject or the target of Sanctions or with any Sanctioned Country.
(rr)
Sarbanes-Oxley. The Company is in compliance, in all material respects, with all applicable provisions of the Sarbanes-Oxley
Act of 2002 and the rules and regulations promulgated thereunder.
(ss)
Duties, Transfer Taxes, Etc. No stamp or other issuance or transfer taxes or duties and no capital gains, income, withholding
or other taxes are payable by the Agent in the United States or any political subdivision or taxing authority thereof or therein in connection
with the execution, delivery or performance of this Agreement by the Company or the sale and delivery by the Company of the Shares. No
stamp tax, transfer tax or issue, documentary, certification or other similar tax imposed under Irish law or by any government agency
or other taxing authority within or outside of Ireland is payable in connection with (A) the authorization, execution, delivery or
enforcement of this Agreement, (B) the allotment and issuance of the Shares, or (C) the sale, transfer and delivery of the Shares
through the facilities of The Depository Trust Company (the “DTC”).
(tt)
Cybersecurity. The Company and its subsidiaries’ information technology assets and equipment, computers, systems,
networks, hardware, software, websites, applications, and databases (collectively, “IT Systems”) are adequate for,
and operate and perform in all material respects as required in connection with the operation of the business of the Company and its subsidiaries
as currently conducted, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants.
The Company and its subsidiaries have implemented and maintained commercially reasonable physical, technical and administrative controls,
policies, procedures, and safeguards to maintain and protect their material confidential information and the integrity, continuous operation,
redundancy and security of all IT Systems and data, including “Personal Data,” used in connection with their businesses. “Personal
Data” means (i) a natural person’s name, street address, telephone number, e-mail address, photograph, social security
number or tax identification number, driver’s license number, passport number, credit card number, bank information, or customer
or account number; (ii) any information which would qualify as “personally identifying information” under the Federal
Trade Commission Act, as amended; (iii) “personal data” as defined by GDPR; (iv) any information which would qualify
as “protected health information” under the Health Insurance Portability and Accountability Act of 1996, as amended by the
Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”); and (v) any other
piece of information that allows the identification of such natural person, or his or her family, or permits the collection or analysis
of any data related to an identified person’s health or sexual orientation. There have been no breaches, violations, outages or
unauthorized uses of or accesses to same, except for those that have been remedied without material cost or liability or the duty to notify
any other person, nor any incidents under internal review or investigations relating to the same. The Company and its subsidiaries are
presently in material compliance with all applicable laws or statutes and all judgments, orders, rules and regulations of any court
or arbitrator or governmental or regulatory authority, internal policies and contractual obligations relating to the privacy and security
of IT Systems and Personal Data and to the protection of such IT Systems and Personal Data from unauthorized use, access, misappropriation
or modification.
(uu)
Compliance with Data Privacy Laws. The Company and its subsidiaries are, and at all prior times were, in material compliance
with all applicable state and U.S. federal data privacy and security laws and regulations, including without limitation HIPAA, and the
Company and its subsidiaries have taken commercially reasonable actions to prepare to comply with, and since May 25, 2018, have been
and currently are in compliance with, the European Union General Data Protection Regulation (“GDPR”) (EU 2016/679)
(collectively, the “Privacy Laws”). To ensure compliance with the Privacy Laws, the Company and its subsidiaries have
in place, comply with, and take appropriate steps reasonably designed to ensure compliance in all material respects with their policies
and procedures relating to data privacy and security and the collection, storage, use, disclosure, handling, and analysis of Personal
Data (the “Policies”). The Company and its subsidiaries have at all times made all disclosures to users or customers
required by applicable laws and regulatory rules or requirements, and none of such disclosures made or contained in any Policy have,
to the knowledge of the Company, been inaccurate or in violation of any applicable laws and regulatory rules or requirements in any
material respect. The Company further certifies that neither it nor any subsidiary: (i) has received notice of any actual or potential
liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition
that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in whole or in part,
any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is a party to any order, decree,
or agreement that imposes any obligation or liability under any Privacy Law.
(vv)
Regulatory Compliance. Each of the Company and its subsidiaries: (A) is and at all times has been in compliance with all statutes,
rules or regulations of the U.S. Food and Drug Administration (the “FDA”), the U.S. Drug Enforcement Administration
(the “DEA”) and any other comparable U.S. or non-U.S. federal, state, local or other governmental or regulatory authority,
agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) applicable to
the ownership, testing, development, manufacture, packaging, processing, use, marketing, distribution, storage, import, export or disposal
of any product candidate or component thereof under development, manufactured or distributed by the Company or each such subsidiary (collectively,
the “Applicable Laws”), except where such noncompliance would not, individually or in the aggregate, reasonably be
expected to have a Material Adverse Change; (B) has not had any product or manufacturing site (whether Company or subsidiary-owned
or that of a contract manufacturer for Company or subsidiary products) subject to a Governmental Authority (including the FDA and the
DEA) shutdown or import or export prohibition, nor have they received any unresolved FDA Form 483 or other Governmental Authority
notice of inspectional observations, warning letter, untitled letter or other correspondence or notice from the FDA, the DEA or any Governmental
Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances,
exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (collectively, the “Authorizations”);
(C) possesses all Authorizations required to conduct its business as currently conducted, except where failure to possess an Authorization
would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change, and such Authorizations are valid
and in full force and effect and the Company or such subsidiary is in compliance with the terms of such Authorizations and has fulfilled
and performed all of its obligations with respect to such Authorizations, except where such noncompliance or failure to fulfill or perform
such obligations would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; and (D) has
not received written notice that the FDA, the DEA or any Governmental Authority has taken, is taking or intends to take action to limit,
suspend, modify or revoke any material Authorizations, has no knowledge that the FDA, the DEA or any Governmental Authority is considering
such action and has no knowledge that any event has occurred which allows, or after notice or lapse of time would allow, revocation or
termination thereof or results in any other material impairment of the rights of the holder of any Authorizations.
(ww)
Other Underwriting Agreements. The Company is not a party to any agreement with an agent or underwriter for any other “at
the market” or continuous equity transaction.
(xx) Compliance with
Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all Health Care Laws. For purposes
of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301
et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all
applicable U.S. federal, state, local and non-U.S. health care fraud and abuse laws, including, without limitation, the Anti-Kickback
Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements
law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA (42 U.S.C.
Section 1320d et seq.), the Stark Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a),
the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable
laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for
Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010,
as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements
under applicable U.S. federal, state, local or non-U.S. laws or regulatory bodies; and (vi) all other local, state, U.S. federal,
national, supranational and non-U.S. laws, relating to the regulation of the Company or its subsidiaries, and (vii) the directives
and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its
subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other
action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity
is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement,
investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material
reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health
Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were
complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither
the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement
orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its
subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation
in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry,
investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
(yy) Submission of Jurisdiction.
The Company has the power to submit, and pursuant to 8(g) of this Agreement, has legally, validly, effectively and irrevocably submitted,
to the personal jurisdiction of each United States federal court and New York state court located in the Borough of Manhattan, in the
City of New York, New York, U.S.A. (each, a “New York Court”), and the Company has the power to designate, appoint
and authorize, and pursuant to Section 8(g) of this Agreement, has legally, validly, effectively and irrevocably designated,
appointed and authorized an agent for service of process in any action arising out of or relating to this Agreement or the Offered Securities
in any New York Court, and service of process effected on such authorized agent will be effective to confer valid personal jurisdiction
over the Company as provided in Section 8(g) hereof.
(zz) Enforceability of
Judgements. Any final and conclusive judgment (i) for a fixed or readily calculable sum
of money; (ii) not obtained by fraud; (iii) whose enforcement in Ireland would not be contrary to natural or constitutional
justice; (iv) which would not be contrary to Irish public policy or involve certain foreign laws which would not be enforced in Ireland;
(v) rendered by a New York Court having jurisdiction under its own domestic laws and recognized by the Irish courts as having jurisdiction
(according to Irish conflicts of laws principles and rules of Irish private international law at the time when proceedings were initiated)
to give such final judgment in respect of any suit, action or proceeding against the Company based upon this Agreement and any instruments
or agreements entered into for the consummation of the transactions contemplated herein and (vi) where rendered not in default of
appearance should normally be declared enforceable against the Company, without re-examination or review of the merits of the cause of
action in respect of which the original judgment was given or re-litigation of the matters adjudicated upon, by the courts of Ireland
except in the event any jurisdiction cannot be obtained by the courts of Ireland over the judgment debtors in the enforcement proceedings
by personal service in Ireland or outside Ireland under the applicable laws of Ireland.
(aaa) Forward-Looking Statements.
Each financial or operational projection or other “forward-looking statement” (as defined by Section 27A of the Securities
Act or Section 21E of the Exchange Act) contained in the Registration Statement or the Prospectus (i) was so included by the
Company in good faith and with reasonable basis after due consideration by the Company of the underlying assumptions, estimates and other
applicable facts and circumstances and (ii) is accompanied by meaningful cautionary statements identifying those factors that could
cause actual results to differ materially from those in such forward-looking statement. No such statement was made with the knowledge
of an executive officer or director of the Company that it was false or misleading.
(bbb) Composition Agreement/SEAS.
As of the date of this Agreement, the composition agreement relating to the Ordinary Shares dated March 27, 2024 between the Company
and the Irish Revenue Commissioners (the “Composition Agreement”) and the Special Eligibility Agreement for Securities
relating to the Ordinary Shares dated April 15, 2024 between, among others, the Company, DTC, Cede & Co. and the National
Securities Clearing Corporation (the “SEAS”), are each in force as the Company has not sent or received any notices
of termination in respect of either the Composition Agreement or the SEAS; and both the Composition Agreement and the SEAS apply to the
Shares.
(ccc) No Rated Securities.
There are no debt securities or preferred stock of, or guaranteed by, the Company or any its subsidiaries that are rated by a “nationally
recognized statistical rating organization” as that term is used in Rule 15c3-1(c)(2)(vi)(F) under the Exchange Act.
Any certificate signed by
any officer or representative of the Company or any of its subsidiaries and delivered to the Agent or counsel for the Agent in connection
with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby
on the date of such certificate.
The Company acknowledges that
the Agent and, for purposes of the opinions to be delivered pursuant to Section 4(o) hereof, counsel to the Company
and counsel to the Agent, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.
Section 3. ISSUANCE
AND SALE OF ORDINARY SHARES
(a) Sale
of Securities. On the basis of the representations, warranties and agreements herein contained, but subject to the terms and conditions
herein set forth, the Company and the Agent agree that the Company may from time to time seek to sell Shares through the Agent, acting
as sales agent, or directly to the Agent, acting as principal, as follows, with an aggregate Sales Price of up to the Maximum Program
Amount, based on and in accordance with Issuance Notices as the Company may deliver, during the Agency Period.
(b) Mechanics
of Issuances.
(i) Issuance
Notice. Upon the terms and subject to the conditions set forth herein, on any Trading Day during the Agency Period on which the conditions
set forth in Section 5(a) and Section 5 (b) shall have been satisfied, the Company may exercise
its right to request an issuance of Shares by delivering to the Agent an Issuance Notice; provided, however, that (A) in no
event may the Company deliver an Issuance Notice to the extent that (I) the sum of (x) the aggregate Sales Price of the requested
Issuance Amount, plus (y) the aggregate Sales Price of all Shares issued under all previous Issuance Notices effected pursuant to
this Agreement, would exceed the Maximum Program Amount; and (B) prior to delivery of any Issuance Notice, the period set forth for
any previous Issuance Notice shall have expired or been terminated. An Issuance Notice shall be considered delivered on the Trading Day
that it is received by e-mail to the persons set forth in Schedule A hereto and confirmed by the Company by telephone (including a voicemail
message to the persons so identified), with the understanding that, with adequate prior written notice, the Agent may modify the list
of such persons from time to time.
(ii) Agent
Efforts. Upon the terms and subject to the conditions set forth in this Agreement, upon the receipt of an Issuance Notice, the Agent
will use its commercially reasonable efforts consistent with its normal sales and trading practices to place the Shares with respect to
which the Agent has agreed to act as sales agent, subject to, and in accordance with the information specified in, the Issuance Notice,
unless the sale of the Shares described therein has been suspended, cancelled or otherwise terminated in accordance with the terms of
this Agreement. For the avoidance of doubt, the parties to this Agreement may modify an Issuance Notice at any time provided they both
agree in writing to any such modification.
(iii) Method
of Offer and Sale. The Shares may be offered and sold (A) in privately negotiated transactions with the consent of the Company
or (B) by any other method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under
the Securities Act, including block transactions, sales made directly on the Principal Market or sales made into any other existing trading
market of the Ordinary Shares. Nothing in this Agreement shall be deemed to require either party to agree to the method of offer and sale
specified in the preceding sentence, and (except as specified in clause (A) above) the method of placement of any Shares by the Agent
shall be at the Agent’s discretion.
(iv) Confirmation
to the Company. If acting as sales agent hereunder, the Agent will provide written confirmation to the Company no later than the opening
of the Trading Day next following the Trading Day on which it has placed Shares hereunder setting forth the number of shares sold on such
Trading Day, the corresponding Sales Price and the Issuance Price payable to the Company in respect thereof.
(v) Settlement.
Each issuance of Shares will be settled on the applicable Settlement Date for such issuance of Shares and, subject to the provisions of
Section 5, on or before each Settlement Date, the Company will, or will cause its transfer agent to, electronically transfer
the Shares being sold by crediting the Agent or its designee’s account at DTC through its Deposit/Withdrawal At Custodian (DWAC)
System, or by such other means of delivery as may be mutually agreed upon by the parties hereto and, upon receipt of such Shares, which
in all cases shall be freely tradable, transferable, registered shares in good deliverable form, the Agent will deliver, by wire transfer
of immediately available funds, the related Issuance Price in same day funds delivered to an account designated by the Company prior to
the Settlement Date. The Company may sell Shares to the Agent as principal at a price agreed upon by the parties at each relevant time
Shares are sold pursuant to this Agreement (each, a “Time of Sale”).
(vi) Suspension
or Termination of Sales. Consistent with standard market settlement practices, the Company or the Agent may, upon notice to the other
party hereto in writing or by telephone (confirmed immediately by verifiable email), suspend any sale of Shares, and the period set forth
in an Issuance Notice shall immediately terminate; provided, however, that (A) such suspension and termination shall not affect
or impair either party’s obligations with respect to any Shares placed or sold hereunder prior to the receipt of such notice; (B) if
the Company suspends or terminates any sale of Shares after the Agent confirms such sale to the Company, the Company shall still be obligated
to comply with Section 3(b)(v) with respect to such Shares; and (C) if the Company defaults in its obligation
to deliver Shares on a Settlement Date, the Company agrees that it will hold the Agent harmless against any loss, claim, damage or expense
(including, without limitation, penalties, interest and reasonable legal fees and expenses), as incurred, arising out of or in connection
with such default by the Company. The parties hereto acknowledge and agree that, in performing its obligations under this Agreement, the
Agent may borrow Ordinary Shares from stock lenders in the event that the Company has not delivered Shares to settle sales as required
by subsection (v) above, and may use the Shares to settle or close out such borrowings. The Company agrees that no such notice
shall be effective against the Agent unless it is made to the persons identified in writing by the Agent pursuant to Section 3(b)(i).
(vii) No
Guarantee of Placement, Etc. The Company acknowledges and agrees that (A) there can be no assurance that the Agent will be successful
in placing Shares; (B) the Agent will incur no liability or obligation to the Company or any other Person if it does not sell Shares;
and (C) the Agent shall be under no obligation to purchase Shares on a principal basis pursuant to this Agreement, except as otherwise
specifically agreed by the Agent and the Company.
(viii) Material
Non-Public Information. Notwithstanding any other provision of this Agreement, the Company and the Agent agree that the Company shall
not deliver any Issuance Notice to the Agent, and the Agent shall not be obligated to place any Shares, during any period in which the
Company is in possession of material non-public information.
(c) Fees.
As compensation for services rendered, the Company shall pay to the Agent, on the applicable Settlement Date, the Selling Commission for
the applicable Issuance Amount (including, if applicable, with respect to any suspended or terminated sale pursuant to Section 3(b)(vi) but
only for Shares actually sold by the Agent) by the Agent deducting the Selling Commission from the applicable Issuance Amount.
(d) Expenses.
The Company agrees to pay all costs, fees and expenses incurred in connection with the performance of its obligations hereunder and in
connection with the transactions contemplated hereby, including without limitation (i) all expenses incident to the issuance and
delivery of the Shares (including all printing and engraving costs); (ii) all fees and expenses of the registrar and transfer agent
of the Shares; (iii) all necessary issue, transfer and other stamp taxes in connection with the issuance and sale of the Shares to
the Agent; (iv) all fees and expenses of the Company’s counsel, independent public or certified public accountants and other
advisors; (v) all costs and expenses incurred in connection with the preparation, printing, filing, shipping and distribution of
the Registration Statement (including financial statements, exhibits, schedules, consents and certificates of experts), the Prospectus,
any Free Writing Prospectus (as defined below) prepared by or on behalf of, used by, or referred to by the Company, and all amendments
and supplements thereto, and this Agreement; (vi) all filing fees, attorneys’ fees and expenses incurred by the Company or
the Agent in connection with qualifying or registering (or obtaining exemptions from the qualification or registration of) all or any
part of the Shares for offer and sale under the state securities or blue sky laws or the provincial securities laws of Canada, and, if
requested by the Agent, preparing and printing a “Blue Sky Survey” or memorandum and a “Canadian wrapper”,
and any supplements thereto, advising the Agent of such qualifications, registrations, determinations and exemptions; (vii) the reasonable
and documented fees and disbursements of the Agent’s counsel, including the reasonable fees and expenses of counsel for the Agent
in connection with, FINRA review, if any, and approval of the Agent’s participation in the offering and distribution of the Shares;
(viii) the filing fees incident to FINRA review, if any; (ix) the costs and expenses of the Company relating to investor presentations
on any “road show” undertaken in connection with the marketing of the offering of the Shares, including, without limitation,
expenses associated with the preparation or dissemination of any electronic road show, expenses associated with the production of road
show slides and graphics, fees and expenses of any consultants engaged in connection with the road show presentations with the prior approval
of the Company, travel and lodging expenses of the representatives, employees and officers of the Company and of the Agent and any such
consultants, and one half the cost of any aircraft chartered in connection with the road show; and (x) the fees and expenses associated
with listing the Shares on the Principal Market. The fees and disbursements of Agent’s counsel pursuant to subsections (vi) and
(vii) above shall not exceed (A) $75,000 in connection with execution of this Agreement, (B) $25,000 in connection with
each Triggering Event Date involving the filing of an annual report on Form 10-K on which the Company is required to provide a certificate
pursuant to Section 4(o) and (C) $15,000 in connection with each other Triggering Event Date on which the Company
is required to provide a certificate pursuant to Section 4(o).
Section 4. ADDITIONAL
COVENANTS
The Company covenants and
agrees with the Agent as follows, in addition to any other covenants and agreements made elsewhere in this Agreement:
(a) Exchange
Act Compliance. During the Agency Period, the Company shall (i) file, on a timely basis, with the Commission all reports and
documents required to be filed under Section 13, 14 or 15 of the Exchange Act in the manner and within the time periods required
by the Exchange Act; and (ii) either (A) include in its quarterly reports on Form 10-Q and its annual reports on Form 10-K,
a summary detailing, for the relevant reporting period, (1) the number of Shares sold through the Agent pursuant to this Agreement
and (2) the net proceeds received by the Company from such sales or, in the Company’s sole discretion, (B) prepare a prospectus
supplement containing, or include in such other filing permitted by the Securities Act or Exchange Act (each an “Interim Prospectus
Supplement”), such summary information and, at least once a quarter and subject to this Section 4, file such Interim Prospectus
Supplement pursuant to Rule 424(b) under the Securities Act (and within the time periods required by Rule 424(b) and
Rule 430B under the Securities Act).
(b) Securities
Act Compliance. After the date of this Agreement, the Company shall promptly advise the Agent in writing (i) of the receipt of
any comments of, or requests for additional or supplemental information from, the Commission; (ii) of the time and date of any filing
of any post-effective amendment to the Registration Statement, any Rule 462(b) Registration Statement or any amendment or supplement
to the Prospectus or any Free Writing Prospectus; (iii) of the time and date that any post-effective amendment to the Registration
Statement or any Rule 462(b) Registration Statement becomes effective; and (iv) of the issuance by the Commission of any
stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto, any Rule 462(b) Registration
Statement or any amendment or supplement to the Prospectus or of any order preventing or suspending the use of any Free Writing Prospectus
or the Prospectus, or of any proceedings to remove, suspend or terminate from listing or quotation the Ordinary Shares from any securities
exchange upon which they are listed for trading or included or designated for quotation, or of the threatening or initiation of any proceedings
for any of such purposes. If the Commission shall enter any such stop order at any time, the Company will use its reasonable best efforts
to obtain the lifting of such order as soon as practicable. Additionally, the Company agrees that it shall comply with the provisions
of Rule 424(b) and Rule 433, as applicable, under the Securities Act and will use its reasonable efforts to confirm that
any filings made by the Company under such Rule 424(b) or Rule 433 were received in a timely manner by the Commission.
(c) Amendments
and Supplements to the Prospectus and Other Securities Act Matters. If any event shall occur or condition exist as a result of which
it is necessary to amend or supplement the Prospectus so that the Prospectus does not include an untrue statement of a material fact or
omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when the Prospectus
is delivered to a purchaser, not misleading, or if in the opinion of the Agent or counsel for the Agent it is otherwise necessary to amend
or supplement the Prospectus to comply with applicable law, including the Securities Act, the Company agrees (subject to Section 4(d) and
4(f)) to promptly prepare, file with the Commission and furnish at its own expense to the Agent, amendments or supplements to the
Prospectus so that the statements in the Prospectus as so amended or supplemented will not include an untrue statement of a material fact
or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when the Prospectus
is delivered to a purchaser, not misleading or so that the Prospectus, as amended or supplemented, will comply with applicable law including
the Securities Act. Neither the Agent’s consent to, or delivery of, any such amendment or supplement shall constitute a waiver of
any of the Company’s obligations under Section 4(d) and 4(f). Notwithstanding the foregoing, the Company
shall not be required to file such amendment or supplement if there is no pending Issuance Notice and the Company believes that it is
in its best interest not to file such amendment or supplement.
(d) Agent’s
Review of Proposed Amendments and Supplements. Prior to amending or supplementing the Registration Statement (including any registration
statement filed under Rule 462(b) under the Securities Act) or the Prospectus (excluding any amendment or supplement through
incorporation of any report filed under the Exchange Act), the Company shall furnish to the Agent for review, a reasonable amount of time
prior to the proposed time of filing or use thereof, a copy of each such proposed amendment or supplement, insofar as such proposed amendment
or supplement relates to the transactions contemplated hereby, and the Company shall not file or use any such proposed amendment or supplement
without the Agent’s prior consent, and the Company shall file with the Commission within the applicable period specified in Rule 424(b) under
the Securities Act any prospectus required to be filed pursuant to such Rule.
(e) Use
of Free Writing Prospectus. Neither the Company nor the Agent has prepared, used, referred to or distributed, or will prepare, use,
refer to or distribute, without the other party’s prior written consent, any “written communication” that constitutes
a “free writing prospectus” as such terms are defined in Rule 405 under the Securities Act with respect to the offering
contemplated by this Agreement (any such free writing prospectus being referred to herein as a “Free Writing Prospectus”).
(f) Free
Writing Prospectuses. The Company shall furnish to the Agent for review, a reasonable amount of time prior to the proposed time of
filing or use thereof, a copy of each proposed Free Writing Prospectus or any amendment or supplement thereto to be prepared by or on
behalf of, used by, or referred to by the Company and the Company shall not file, use or refer to any proposed Free Writing Prospectus
or any amendment or supplement thereto without the Agent’s consent. The Company shall furnish to the Agent, without charge, as many
copies of any Free Writing Prospectus prepared by or on behalf of, or used by the Company, as the Agent may reasonably request. If at
any time when a prospectus is required by the Securities Act (including, without limitation, pursuant to Rule 173(d)) to be delivered
in connection with sales of the Shares (but in any event if at any time through and including the date of this Agreement) there occurred
or occurs an event or development as a result of which any Free Writing Prospectus prepared by or on behalf of, used by, or referred to
by the Company conflicted or would conflict with the information contained in the Registration Statement or included or would include
an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein,
in the light of the circumstances prevailing at that subsequent time, not misleading, the Company shall promptly amend or supplement such
Free Writing Prospectus to eliminate or correct such conflict or so that the statements in such Free Writing Prospectus as so amended
or supplemented will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the
statements therein, in the light of the circumstances prevailing at such subsequent time, not misleading, as the case may be; provided,
however, that prior to amending or supplementing any such Free Writing Prospectus, the Company shall furnish to the Agent for review,
a reasonable amount of time prior to the proposed time of filing or use thereof, a copy of such proposed amended or supplemented Free
Writing Prospectus and the Company shall not file, use or refer to any such amended or supplemented Free Writing Prospectus without the
Agent’s consent, not to be unreasonably withheld.
(g) Filing
of Agent Free Writing Prospectuses. The Company shall not take any action that would result in the Agent or the Company being required
to file with the Commission pursuant to Rule 433(d) under the Securities Act a Free Writing Prospectus prepared by or on behalf
of the Agent that the Agent otherwise would not have been required to file thereunder.
(h) Copies
of Registration Statement and Prospectus. After the date of this Agreement through the last time that a prospectus is required by
the Securities Act (including, without limitation, pursuant to Rule 173(d)) to be delivered in connection with sales of the Shares,
the Company agrees to furnish the Agent with copies (which may be electronic copies) of the Registration Statement and each amendment
thereto, and with copies of the Prospectus and each amendment or supplement thereto in the form in which it is filed with the Commission
pursuant to the Securities Act or Rule 424(b) under the Securities Act, both in such quantities as the Agent may reasonably
request from time to time; and, if the delivery of a prospectus is required under the Securities Act or under the blue sky or securities
laws of any jurisdiction at any time on or prior to the applicable Settlement Date for any period set forth in an Issuance Notice in connection
with the offering or sale of the Shares and if at such time any event has occurred 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 any material fact necessary in order to make the
statements therein, in the light of the circumstances under which they were made when such Prospectus is delivered, not misleading, or,
if for any other reason it is necessary during such same period to amend or supplement the Prospectus or to file under the Exchange Act
any document incorporated by reference in the Prospectus in order to comply with the Securities Act or the Exchange Act, to notify the
Agent and to request that the Agent suspend offers to sell Shares (and, if so notified, the Agent shall cease such offers as soon as practicable);
and if the Company decides to amend or supplement the Registration Statement or the Prospectus as then amended or supplemented, to advise
the Agent promptly by telephone (with confirmation in writing) and to prepare and cause to be filed promptly with the Commission an amendment
or supplement to the Registration Statement or the Prospectus as then amended or supplemented that will correct such statement or omission
or effect such compliance; provided, however, that if during such same period the Agent is required to deliver a prospectus in respect
of transactions in the Shares, the Company shall promptly prepare and file with the Commission such an amendment or supplement.
(i) Blue
Sky Compliance. The Company shall cooperate with the Agent and counsel for the Agent to qualify or register the Shares for sale under
(or obtain exemptions from the application of) the state securities or blue sky laws or Canadian provincial securities laws of those jurisdictions
designated by the Agent, shall comply with such laws and shall continue such qualifications, registrations and exemptions in effect so
long as required for the distribution of the Shares. The Company shall not be required to qualify as a foreign corporation or to take
any action that would subject it to general service of process in any such jurisdiction where it is not presently qualified or where it
would be subject to taxation as a foreign corporation. The Company will advise the Agent promptly of the suspension of the qualification
or registration of (or any such exemption relating to) the Shares for offering, sale or trading in any jurisdiction or any initiation
or threat of any proceeding for any such purpose, and in the event of the issuance of any order suspending such qualification, registration
or exemption, the Company shall use its reasonable best efforts to obtain the withdrawal thereof as soon as practicable.
(j) Earnings
Statement. As soon as practicable, the Company will make generally available to its security holders and to the Agent an earnings
statement (which need not be audited) covering a period of at least twelve months beginning with the first fiscal quarter of the Company
occurring after the date of this Agreement which shall satisfy the provisions of Section 11(a) of the Securities Act and Rule 158
under the Securities Act.
(k) Listing;
Reservation of Shares. (a) The Company will use its reasonable best efforts to maintain the listing of the Shares on the Principal
Market; and (b) the Company will reserve and keep available at all times, free of preemptive rights, Shares for the purpose of enabling
the Company to satisfy its obligations under this Agreement.
(l) Transfer
Agent. The Company shall engage and maintain, at its expense, a registrar and transfer agent for the Shares.
(m) Due
Diligence. During the term of this Agreement, the Company will reasonably cooperate with any reasonable due diligence review conducted
by the Agent in connection with the transactions contemplated hereby, including, without limitation, providing information and making
available documents and senior corporate officers, during normal business hours and at the Company’s principal offices or virtually,
as the Agent may reasonably request from time to time.
(n) Representations
and Warranties. The Company acknowledges that each delivery of an Issuance Notice and each delivery of Shares on a Settlement Date
shall be deemed to be (i) an affirmation to the Agent that the representations and warranties of the Company contained in or made
pursuant to this Agreement are true and correct as of the date of such Issuance Notice or of such Settlement Date, as the case may be,
as though made at and as of each such date, except as may be disclosed in the Prospectus (including any documents incorporated by reference
therein and any supplements thereto); and (ii) an undertaking that the Company will advise the Agent if any of such representations
and warranties will not be true and correct as of the Settlement Date for the Shares relating to such Issuance Notice, as though made
at and as of each such date (except that such representations and warranties shall be deemed to relate to the Registration Statement and
the Prospectus as amended and supplemented relating to such Shares).
(o) Deliverables
at Triggering Event Dates; Certificates. The Company agrees that on or prior to the date of the first Issuance Notice and, during
the term of this Agreement after the date of the first Issuance Notice, upon:
(A) the
filing of the Prospectus or the amendment or supplement of any Registration Statement or Prospectus (other than a prospectus supplement
relating solely to an offering of securities other than the Shares or a prospectus filed pursuant to Section 4(a)(ii)(B)), by means
of a post-effective amendment, sticker or supplement, but not by means of incorporation of documents by reference into the Registration
Statement or Prospectus;
(B) the
filing with the Commission of an annual report on Form 10-K or a quarterly report on Form 10-Q (including any Form 10-K/A
or Form 10-Q/A containing amended financial information or a material amendment to the previously filed annual report on Form 10-K
or quarterly report on Form 10-Q), in each case, of the Company; or
(C) the
filing with the Commission of a current report on Form 8-K of the Company containing amended financial information (other than information
“furnished” pursuant to Item 2.02 or 7.01 of Form 8-K or to provide disclosure pursuant to Item 8.01 of Form 8-K
relating to reclassification of certain properties as discontinued operations in accordance with Statement of Financial Accounting Standards
No. 144) that is material to the offering of securities of the Company in the Agent’s reasonable discretion; (any such event,
a “Triggering Event Date”), the Company shall furnish the Agent (but in the case of clause (C) above only if the
Agent reasonably determines that the information contained in such current report on Form 8-K of the Company is material) with a
certificate as of the Triggering Event Date, in the form and substance satisfactory to the Agent and its counsel, substantially similar
to the form previously provided to the Agent and its counsel, modified, as necessary, to relate to the Registration Statement and the
Prospectus as amended or supplemented, (A) confirming that the representations and warranties of the Company contained in this Agreement
are true and correct, (B) confirming that the Company has performed all of its obligations hereunder to be performed on or prior
to the date of such certificate and as to the matters set forth in Section 5(a)(iii) hereof, and (C) containing
any other certification that the Agent shall reasonably request. The requirement to provide a certificate under this Section 4(o) shall
be waived for any Triggering Event Date occurring at a time when no Issuance Notice is pending or a suspension is in effect, which waiver
shall continue until the earlier to occur of the date the Company delivers instructions for the sale of Shares hereunder (which for such
calendar quarter shall be considered a Triggering Event Date) and the next occurring Triggering Event Date. Notwithstanding the foregoing,
if the Company subsequently decides to sell Shares following a Triggering Event Date when a suspension was in effect and did not provide
the Agent with a certificate under this Section 4(o), then before the Company delivers the instructions for the sale of Shares
or the Agent sells any Shares pursuant to such instructions, the Company shall provide the Agent with a certificate in conformity with
this Section 4(o) dated as of the date that the instructions for the sale of Shares are issued.
(p) Legal
Opinions. On or prior to the date of the first Issuance Notice and on or prior to each Triggering Event Date with respect to which
the Company is obligated to deliver a certificate pursuant to Section 4(o) for which no waiver is applicable and excluding
the date of this Agreement, a negative assurances letter and the written legal opinion of Goodwin Procter LLP, U.S. counsel to the Company,
Arthur Cox, Irish counsel to the Company, Polsinelli LLP, intellectual property counsel to the Company, each dated the date of delivery,
in form and substance reasonably satisfactory to Agent and its counsel, substantially similar to the form previously provided to the Agent
and its counsel, modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended or supplemented; provided,
however, the Company shall be required to furnish no more than one opinion per annual report on Form 10-K or Quarterly Report on
Form 10-Q filed by the Company. In lieu of such opinions for subsequent periodic filings, in the discretion of the Agent, the Company
may furnish a reliance letter from such counsel to the Agent, permitting the Agent to rely on a previously delivered opinion letter, modified
as appropriate for any passage of time or Triggering Event Date (except that statements in such prior opinion shall be deemed to relate
to the Registration Statement and the Prospectus as amended or supplemented as of such Triggering Event Date).
(q) Comfort
Letter. On or prior to the date of the first Issuance Notice and on or prior to each Triggering Event Date with respect to which the
Company is obligated to deliver a certificate pursuant to Section 4(o) for which no waiver is applicable and excluding
the date of this Agreement, the Company shall cause Deloitte & Touche LLP, the independent registered public accounting firm
who has audited the financial statements included or incorporated by reference in the Registration Statement, to furnish the Agent a comfort
letter, dated the date of delivery, in form and substance reasonably satisfactory to the Agent and its counsel, substantially similar
to the form previously provided to the Agent and its counsel; provided, however, that any such comfort letter will only be required on
the Triggering Event Date specified to the extent that it contains financial statements filed with the Commission under the Exchange Act
and incorporated or deemed to be incorporated by reference into a Prospectus. If requested by the Agent, the Company shall also cause
a comfort letter to be furnished to the Agent following the occurrence of any material transaction or event requiring the filing of a
current report on Form 8-K containing material amended financial information of the Company, including the restatement of the Company’s
financial statements. The Company shall be required to furnish no more than one comfort letter hereunder per calendar quarter.
(r) Secretary’s
Certificate. On or prior to the date of the first Issuance Notice and on or prior to each Triggering Event Date, the Company shall
furnish the Agent a certificate executed by the Secretary of the Company, signing in such capacity, dated the date of delivery (i) certifying
that attached thereto are true and complete copies of the resolutions duly adopted by the Board of Directors of the Company authorizing
the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby (including, without limitation,
the issuance of the Shares pursuant to this Agreement), which authorization shall be in full force and effect on and as of the date of
such certificate, (ii) certifying and attesting to the office, incumbency, due authority and specimen signatures of each Person who
executed this Agreement for or on behalf of the Company, and (iii) containing any other certification that the Agent shall reasonably
request.
(s) Agent’s
Own Account; Clients’ Account. The Company consents to the Agent trading, in compliance with applicable law, in the Ordinary
Shares for the Agent’s own account and for the account of its clients at the same time as sales of the Shares occur pursuant to
this Agreement.
(t) Investment
Limitation. The Company shall not invest, or otherwise use the proceeds received by the Company from its sale of the Shares in such
a manner as would require the Company or any of its subsidiaries to register as an investment company under the Investment Company Act.
(u) Market
Activities. The Company will not take, directly or indirectly, any action designed to or that might be reasonably expected to cause
or result in stabilization or manipulation of the price of the Shares or any other reference security, whether to facilitate the sale
or resale of the Shares or otherwise, and the Company will, and shall use commercially reasonable best efforts to cause each of its affiliates
to, comply with all applicable provisions of Regulation M. If the limitations of Rule 102 of Regulation M (“Rule 102”)
do not apply with respect to the Shares or any other reference security pursuant to any exception set forth in Section (d) of
Rule 102, then promptly upon notice from the Agent (or, if later, at the time stated in the notice), the Company will, and shall
use commercially reasonable best efforts to cause each of its affiliates to, comply with Rule 102 as though such exception were not
available but the other provisions of Rule 102 (as interpreted by the Commission) did apply. The Company shall promptly notify the
Agent if it no longer meets the requirements set forth in Section (d) of Rule 102.
(v) Notice
of Other Sale. Without the written consent of the Agent, the Company will not, directly or indirectly, offer to sell, sell, contract
to sell, grant any option to sell or otherwise dispose of any Ordinary Shares or securities convertible into or exchangeable for Ordinary
Shares (other than Shares hereunder), warrants or any rights to purchase or acquire Ordinary Shares, during the period beginning on the
third Trading Day immediately prior to the date on which any Issuance Notice is delivered to the Agent hereunder and ending on the third
Trading Day immediately following the Settlement Date with respect to Shares sold pursuant to such Issuance Notice; and will not directly
or indirectly enter into any other “at the market” or continuous equity transaction to offer to sell, sell, contract to sell,
grant any option to sell or otherwise dispose of any Ordinary Shares (other than the Shares offered pursuant to this Agreement) or securities
convertible into or exchangeable for Ordinary Shares, warrants or any rights to purchase or acquire, Ordinary Shares, prior to the termination
of this Agreement; provided, however, that such restrictions will not be required in connection with the Company’s (i) issuance
or sale of Ordinary Shares, options to purchase Ordinary Shares or Ordinary Shares, restricted share units or other share-based awards
issuable upon the exercise of options or other equity awards pursuant to any employee or director share option, incentive or benefit plan,
share purchase or ownership plan, long-term incentive plan, dividend reinvestment plan, inducement award under Principal Market rules or
other compensation plan of the Company or its subsidiaries, as in effect on the date of this Agreement, (ii) issuance or sale of
Ordinary Shares issuable upon exchange, conversion or redemption of securities or the exercise or vesting of warrants, options or other
equity awards outstanding at the date of this Agreement and (iii) modification of any outstanding options, warrants of any rights
to purchase or acquire Ordinary Shares.
Section 5. CONDITIONS
TO DELIVERY OF ISSUANCE NOTICES AND TO SETTLEMENT
(a) Conditions
Precedent to the Right of the Company to Deliver an Issuance Notice and the Obligation of the Agent to Sell Shares. The right of the
Company to deliver an Issuance Notice hereunder is subject to the satisfaction, on the date of delivery of such Issuance Notice, and the
obligation of the Agent to use its commercially reasonable efforts to place Shares during the applicable period set forth in the Issuance
Notice is subject to the satisfaction, on each Trading Day during the applicable period set forth in the Issuance Notice, of each of the
following conditions:
(i) Accuracy
of the Company’s Representations and Warranties; Performance by the Company. The Company shall have delivered the certificate
required to be delivered pursuant to Section 4(o) on or before the date on which delivery of such certificate is required
pursuant to Section 4(o). The Company shall have performed, satisfied and complied with all covenants, agreements and conditions
required by this Agreement to be performed, satisfied or complied with by the Company at or prior to such date, including, but not limited
to, the covenants contained in Section 4(p), Section 4(q) and Section 4(r).
(ii) No
Injunction. No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated
or endorsed by any court or governmental authority of competent jurisdiction or any self-regulatory organization having authority over
the matters contemplated hereby that prohibits or directly and materially adversely affects any of the transactions contemplated by this
Agreement, and no proceeding shall have been commenced that may have the effect of prohibiting or materially adversely affecting any of
the transactions contemplated by this Agreement.
(iii) Material
Adverse Changes. Except as disclosed in the Prospectus and the Time of Sale Information, (a) in the judgment of the Agent there
shall not have occurred any Material Adverse Change; and (b) there shall not have occurred any downgrading, nor shall any notice
have been given of any intended or potential downgrading or of any review for a possible change that does not indicate the direction of
the possible change, in the rating accorded any securities of the Company or any of its subsidiaries by any “nationally recognized
statistical rating organization” as such term is defined for purposes of Section 3(a)(62) of the Exchange Act.
(iv) No
Suspension of Trading in or Delisting of Ordinary Shares; Other Events. The trading of the Ordinary Shares (including without limitation
the Shares) shall not have been suspended by the Commission, the Principal Market or FINRA and the Ordinary Shares (including without
limitation the Shares) shall have been approved for listing or quotation on and shall not have been delisted from the Nasdaq Stock Market,
the New York Stock Exchange or any of their constituent markets. There shall not have occurred (and be continuing in the case of occurrences
under clauses (i) and (ii) below) any of the following: (i) trading or quotation in any of the Company’s securities
shall have been suspended or limited by the Commission or by the Principal Market or trading in securities generally on the Principal
Market shall have been suspended or limited, or minimum or maximum prices shall have been generally established on any of such stock exchanges
by the Commission or FINRA; (ii) a general banking moratorium shall have been declared by any of federal or New York, authorities;
or (iii) there shall have occurred any outbreak or escalation of national or international hostilities or any crisis or calamity,
or any change in the United States or international financial markets, or any substantial change or development involving a prospective
substantial change in United States’ or international political, financial or economic conditions, as in the judgment of the Agent
is material and adverse and makes it impracticable to market the Shares in the manner and on the terms described in the Prospectus or
to enforce contracts for the sale of securities.
(b) Documents
Required to be Delivered on each Issuance Notice Date. The Agent’s obligation to use its commercially reasonable efforts to
place Shares hereunder shall additionally be conditioned upon the delivery to the Agent on or before the Issuance Notice Date of a certificate
in form and substance reasonably satisfactory to the Agent, executed by the Chief Executive Officer or Chief Financial Officer of the
Company, to the effect that all conditions to the delivery of such Issuance Notice shall have been satisfied as at the date of such certificate
as required to be delivered pursuant to Section 4(o) (which certificate shall not be required if the foregoing representations
shall be set forth in the Issuance Notice).
(c) No
Misstatement or Material Omission. The Agent shall not have advised the Company that the Registration Statement, the Prospectus or
the Time of Sale Information, or any amendment or supplement thereto, contains an untrue statement of fact that in the Agent’s reasonable
opinion is material, or omits to state a fact that in the Agent’s reasonable opinion is material and is required to be stated therein
or is necessary to make the statements therein not misleading.
(d) Agent
Counsel Legal Opinion. The Agent shall have received from Wilmer Cutler Pickering Hale and Dorr LLP, counsel for Agent, such opinion
or opinions, on or before the date on which the delivery of the Company counsel legal opinion is required pursuant to Section 4(p),
with respect to such matters as Agent 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.
Section 6. INDEMNIFICATION
AND CONTRIBUTION
(a) Indemnification
of the Agent. The Company agrees to indemnify and hold harmless the Agent, its officers and employees, and each person, if any, who
controls the Agent within the meaning of the Securities Act or the Exchange Act against any loss, claim, damage, liability or expense,
as incurred, to which the Agent or such officer, employee or controlling person may become subject, under the Securities Act, the Exchange
Act, other federal or state statutory law or regulation, or the laws or regulations of foreign jurisdictions where Shares have been offered
or sold or at common law or otherwise (including in settlement of any litigation), insofar as such loss, claim, damage, liability or expense
(or actions in respect thereof as contemplated below) arises out of or is based upon (i) any untrue statement or alleged untrue statement
of a material fact contained in the Registration Statement, or any amendment thereto, including any information deemed to be a part thereof
pursuant to Rule 430B under the Securities Act, or the omission or alleged omission therefrom of a material fact required to be stated
therein or necessary to make the statements therein not misleading; or (ii) any untrue statement or alleged untrue statement of a
material fact contained in any Free Writing Prospectus that the Company has used, referred to or filed, or is required to file, pursuant
to Rule 433(d) of the Securities Act or the Prospectus (or any amendment or supplement thereto), or the omission or alleged
omission therefrom of a material fact necessary in order to make the statements therein, in the light of the circumstances under which
they were made, not misleading and to reimburse the Agent and each such officer, employee and controlling person for any and all documented
expenses (including the reasonable and documented out-of-pocket fees and disbursements of counsel chosen by the Agent) as such expenses
are reasonably incurred by the Agent or such officer, employee or controlling person in connection with investigating, defending, settling,
compromising or paying any such loss, claim, damage, liability, expense or action; provided, however, that the foregoing indemnity agreement
shall not apply to any loss, claim, damage, liability or expense to the extent, but only to the extent, arising out of or based upon any
untrue statement or alleged untrue statement or omission or alleged omission made in reliance upon and in conformity with written information
furnished to the Company by the Agent expressly for use in the Registration Statement, any such Free Writing Prospectus or the Prospectus
(or any amendment or supplement thereto), it being understood and agreed that the only such information furnished by the Agent to the
Company consists of the information described in subSection (b) below. The indemnity agreement set forth in this Section 6(a) shall
be in addition to any liabilities that the Company may otherwise have.
(b) Indemnification
of the Company, its Directors and Officers. The Agent agrees to indemnify and hold harmless the Company, each of its directors, each
of its officers who signed the Registration Statement and each person, if any, who controls the Company within the meaning of the Securities
Act or the Exchange Act against any loss, claim, damage, liability or expense, as incurred, to which the Company or any such director,
officer or controlling person may become subject, under the Securities Act, the Exchange Act, or other federal or state statutory law
or regulation, or the laws or regulations of foreign jurisdictions where Shares have been offered or sold or at common law or otherwise
(including in settlement of any litigation), arises out of or is based upon (i) any untrue statement or alleged untrue statement
of a material fact contained in the Registration Statement, or any amendment thereto, including any information deemed to be a part thereof
pursuant to Rule 430B under the Securities Act, or the omission or alleged omission therefrom of a material fact required to be stated
therein or necessary to make the statements therein not misleading; or (ii) any untrue statement or alleged untrue statement of a
material fact contained in any Free Writing Prospectus that the Company has used, referred to or filed, or is required to file, pursuant
to Rule 433(d) of the Securities Act or the Prospectus (or any amendment or supplement thereto), or the omission or alleged
omission therefrom of a material fact necessary in order to make the statements therein, in the light of the circumstances under which
they were made, not misleading; but, for each of (i) and (ii) above, only to the extent arising out of or based upon any untrue
statement or alleged untrue statement or omission or alleged omission made in reliance upon and in conformity with written information
furnished to the Company by the Agent expressly for use in the Registration Statement, any such Free Writing Prospectus or the Prospectus
(or any amendment or supplement thereto), it being understood and agreed that the only such information furnished by the Agent to the
Company consists of the information set forth in the first sentence of the ninth paragraph under the caption “Plan of Distribution”
in the Prospectus, and to reimburse the Company and each such director, officer and controlling person for any and all expenses (including
the reasonable and documented out-of-pocket fees and disbursements of one counsel chosen by the Company) as such expenses are reasonably
incurred by the Company or such officer, director or controlling person in connection with investigating, defending, settling, compromising
or paying any such loss, claim, damage, liability, expense or action. The indemnity agreement set forth in this Section 6(b) shall
be in addition to any liabilities that the Agent or the Company may otherwise have.
(c) Notifications
and Other Indemnification Procedures. Promptly after receipt by an indemnified party under this Section 6 of notice
of the commencement of any action, such indemnified party will, if a claim in respect thereof is to be made against an indemnifying party
under this Section 6, notify the indemnifying party in writing of the commencement thereof, but the omission so to notify
the indemnifying party will not relieve it from any liability which it may have to any indemnified party for contribution or otherwise
than under the indemnity agreement contained in this Section 6 or to the extent it is not prejudiced as a proximate result
of such failure. In case any such action is brought against any indemnified party and such indemnified party seeks or intends to seek
indemnity from an indemnifying party, the indemnifying party will be entitled to participate in, and, to the extent that it shall elect,
jointly with all other indemnifying parties similarly notified, by written notice delivered to the indemnified party promptly after receiving
the aforesaid notice from such indemnified party, to assume the defense thereof with counsel reasonably satisfactory to such indemnified
party; provided, however, if the defendants in any such action include both the indemnified party and the indemnifying party and the indemnified
party shall have reasonably concluded that a conflict may arise between the positions of the indemnifying party and the indemnified party
in conducting the defense of any such action or that there may be legal defenses available to it and/or other indemnified parties which
are different from or additional to those available to the indemnifying party, the indemnified party or parties shall have the right to
select separate counsel to assume such legal defenses and to otherwise participate in the defense of such action on behalf of such indemnified
party or parties. Upon receipt of notice from the indemnifying party to such indemnified party of such indemnifying party’s election
so to assume the defense of such action and approval by the indemnified party of counsel, the indemnifying party will not be liable to
such indemnified party under this Section 6 for any reasonable and documented out-of-pocket legal or other expenses subsequently
incurred by such indemnified party in connection with the defense thereof unless (i) the indemnified party shall have employed separate
counsel in accordance with the proviso to the preceding sentence (it being understood, however, that the indemnifying party shall not
be liable for the fees and expenses of more than one separate counsel (together with local counsel), representing the indemnified parties
who are parties to such action), which counsel (together with any local counsel) for the indemnified parties shall be selected by the
indemnified party (in the case of counsel for the indemnified parties referred to in Section 6(a) and Section 6(b) above),
(ii) the indemnifying party shall not have employed counsel satisfactory to the indemnified party to represent the indemnified party
within a reasonable time after notice of commencement of the action or (iii) the indemnifying party has authorized in writing the
employment of counsel for the indemnified party at the expense of the indemnifying party, in each of which cases the fees and expenses
of counsel shall be at the expense of the indemnifying party and shall be paid as they are incurred.
(d) Settlements.
The indemnifying party under this Section 6 shall not be liable for any settlement of any proceeding effected without its
written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to
indemnify the indemnified party against any loss, claim, damage, liability or expense by reason of such settlement or judgment. Notwithstanding
the foregoing sentence, if at any time an indemnified party shall have requested an indemnifying party to reimburse the indemnified party
for fees and expenses of counsel as contemplated by Section 6(c) hereof, the indemnifying party agrees that it shall
be liable for any settlement of any proceeding effected without its written consent if (i) such settlement is entered into more than
30 days after receipt by such indemnifying party of the aforesaid request; and (ii) such indemnifying party shall not have reimbursed
the indemnified party in accordance with such request prior to the date of such settlement. No indemnifying party shall, without the prior
written consent of the indemnified party, effect any settlement, compromise or consent to the entry of judgment in any pending or threatened
action, suit or proceeding in respect of which any indemnified party is or could have been a party and indemnity was or could have been
sought hereunder by such indemnified party, unless such settlement, compromise or consent includes an unconditional release of such indemnified
party from all liability on claims that are the subject matter of such action, suit or proceeding.
(e) Contribution.
If the indemnification provided for in this Section 6 is for any reason held to be unavailable to or otherwise insufficient
to hold harmless an indemnified party in respect of any losses, claims, damages, liabilities or expenses referred to therein, then each
indemnifying party shall contribute to the aggregate amount paid or payable by such indemnified party, as incurred, as a result of any
losses, claims, damages, liabilities or expenses referred to therein (i) in such proportion as is appropriate to reflect the relative
benefits received by the Company, on the one hand, and the Agent, on the other hand, from the offering of the Shares pursuant to this
Agreement; or (ii) if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as
is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company,
on the one hand, and the Agent, on the other hand, in connection with the statements or omissions which resulted in such losses, claims,
damages, liabilities or expenses, as well as any other relevant equitable considerations. The relative benefits received by the Company,
on the one hand, and the Agent, on the other hand, in connection with the offering of the Shares pursuant to this Agreement shall be deemed
to be in the same respective proportions as the total gross proceeds from the offering of the Shares (before deducting expenses) received
by the Company bear to the total Selling Commission received by the Agent. The relative fault of the Company, on the one hand, and the
Agent, on the other hand, shall be determined by reference to, among other things, whether any such 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, on the one
hand, or the Agent, on the other hand, and the parties’ relative intent, knowledge, access to information and opportunity to correct
or prevent such statement or omission.
The amount paid or payable
by a party as a result of the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include, subject
to the limitations set forth in Section 6(c), any reasonable and documented out-of-pocket legal or other fees or expenses
reasonably incurred by such party in connection with investigating or defending any action or claim. The provisions set forth in Section 6(c) with
respect to notice of commencement of any action shall apply if a claim for contribution is to be made under this Section 6(e);
provided, however, that no additional notice shall be required with respect to any action for which notice has been given under
Section 6(c) for purposes of indemnification.
The Company and the Agent
agree that it would not be just and equitable if contribution pursuant to this Section 6(e) were determined by pro
rata allocation or by any other method of allocation which does not take account of the equitable considerations referred to in this Section 6(e).
Notwithstanding the provisions
of this Section 6(e), the Agent shall not be required to contribute any amount in excess of the Selling Commission received
by the Agent in connection with the offering contemplated hereby. No person guilty of fraudulent misrepresentation (within the meaning
of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent
misrepresentation. For purposes of this Section 6(e), each officer and employee of the Agent and each person, if any,
who controls the Agent within the meaning of the Securities Act or the Exchange Act shall have the same rights to contribution as the
Agent, and each director of the Company, each officer of the Company who signed the Registration Statement, and each person, if any, who
controls the Company within the meaning of the Securities Act and the Exchange Act shall have the same rights to contribution as the Company.
Section 7. TERMINATION &
SURVIVAL
(a) Term.
Subject to the provisions of this Section 7, the term of this Agreement shall continue from the date of this Agreement
until the end of the Agency Period, unless earlier terminated by the parties to this Agreement pursuant to this Section 7.
The Company and the Agent hereby agree that the Open Market Sale Agreement, dated February 4, 2020, by and between the Company and
the Agent is terminated in its entirety upon the effectiveness of this Agreement.
(b) Termination;
Survival Following Termination.
(i) Either
party may terminate this Agreement prior to the end of the Agency Period, by giving written notice as required by this Agreement, upon
ten (10) Trading Days’ notice to the other party; provided that, (A) if the Company terminates this Agreement after the
Agent confirms to the Company any sale of Shares, the Company shall remain obligated to comply with Section 3(b)(v) with
respect to such Shares and (B) Section 2, Section 3(d), Section 6, Section 7
and Section 8 shall survive termination of this Agreement. If termination shall occur prior to the Settlement Date for
any sale of Shares, such sale shall nevertheless settle in accordance with the terms of this Agreement.
(ii) In
addition to the survival provision of Section 7(b)(i), the respective indemnities, agreements, representations, warranties
and other statements of the Company, of its officers and of the Agent set forth in or made pursuant to this Agreement will remain in full
force and effect, regardless of any investigation made by or on behalf of the Agent or the Company or any of its or their partners, officers
or directors or any controlling person, as the case may be, and, anything herein to the contrary notwithstanding, will survive delivery
of and payment for the Shares sold hereunder and any termination of this Agreement.
Section 8. MISCELLANEOUS
(a) Press
Releases and Disclosure. The Company may issue a press release describing the material terms of the transactions contemplated hereby
as soon as practicable following the date of this Agreement, and may file with the Commission a Current Report on Form 8-K or other
periodic report under the Exchange Act, with this Agreement attached as an exhibit thereto, describing the material terms of the transactions
contemplated hereby, and the Company shall consult with the Agent prior to making such disclosures, and the parties hereto shall use all
commercially reasonable efforts, acting in good faith, to agree upon a text for such disclosures that is reasonably satisfactory to all
parties hereto. No party hereto shall issue thereafter any press release or like public statement (including, without limitation, any
disclosure required in reports filed with the Commission pursuant to the Exchange Act) related to this Agreement or any of the transactions
contemplated hereby without the prior written approval of the other party hereto, except as may be necessary or appropriate in the reasonable
opinion of the party seeking to make disclosure to comply with the requirements of applicable law or stock exchange rules. If any such
press release or like public statement is so required, the party making such disclosure shall consult with the other party prior to making
such disclosure, and the parties shall use all commercially reasonable efforts, acting in good faith, to agree upon a text for such disclosure
that is reasonably satisfactory to all parties hereto.
(b) No
Advisory or Fiduciary Relationship. The Company acknowledges and agrees that (i) the transactions contemplated by this Agreement,
including the determination of any fees, are arm’s-length commercial transactions between the Company and the Agent, (ii) when
acting as a principal under this Agreement, the Agent is and has been acting solely as a principal and is not the agent or fiduciary of
the Company, or its shareholders, creditors, employees or any other party, (iii) the Agent has not assumed nor will assume an advisory
or fiduciary responsibility in favor of the Company with respect to the transactions contemplated hereby or the process leading thereto
(irrespective of whether the Agent has advised or is currently advising the Company on other matters) and the Agent does not have any
obligation to the Company with respect to the transactions contemplated hereby except the obligations expressly set forth in this Agreement,
(iv) the Agent and its Affiliates may be engaged in a broad range of transactions that involve interests that differ from those of
the Company, and (v) the Agent has not provided any legal, accounting, regulatory or tax advice with respect to the transactions
contemplated hereby and the Company has consulted its own legal, accounting, regulatory and tax advisors to the extent it deemed appropriate.
(c) Research
Analyst Independence. The Company acknowledges that the Agent’s research analysts and research departments are required to and
should be independent from their respective investment banking divisions and are subject to certain regulations and internal policies,
and as such the Agent’s research analysts may hold views and make statements or investment recommendations and/or publish research
reports with respect to the Company or the offering that differ from the views of their respective investment banking divisions. The Company
understands that the Agent is a full service securities firm and as such from time to time, subject to applicable securities laws, may
effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities
of the companies that may be the subject of the transactions contemplated by this Agreement.
(d) Notices.
All communications hereunder shall be in writing and shall be mailed, hand delivered or telecopied and confirmed to the parties hereto
as follows:
If to the Agent:
Jefferies LLC
520 Madison Avenue
New York, NY 10022
Facsimile: (646) 786-5719
Attention: General Counsel
with a copy (which shall not constitute notice) to:
Wilmer Cutler Pickering Hale and Dorr LLP
7 World Trade Center
250 Greenwich Street
New York, NY 10007
Attention: Lisa Firenze, Esq.
Facsimile: (212) 937-7263
If to the Company:
Avadel Pharmaceuticals plc
16640 Chesterfield Grove Road, Suite 200
Chesterfield, MO 63005
Attention: Jerad Seurer, Esq.
Facsimile: (636) 449-1420
with a copy (which shall not constitute notice) to:
Goodwin Procter LLP
100 Northern Avenue
Boston, MA 02210
Attention: Robert E. Puopolo, Esq.
Facsimile: (617) 321-4362
Any party hereto may change the address for receipt
of communications by giving written notice to the others in accordance with this Section 8(d).
(e) Successors.
This Agreement will inure to the benefit of and be binding upon the parties hereto, and to the benefit of the employees, officers and
directors and controlling persons referred to in Section 6, and in each case their respective successors, and no other
person will have any right or obligation hereunder. The term “successors” shall not include any purchaser of the Shares as
such from the Agent merely by reason of such purchase.
(f) Partial
Unenforceability. The invalidity or unenforceability of any Article, Section, paragraph or provision of this Agreement shall not affect
the validity or enforceability of any other Article, Section, paragraph or provision hereof. If any Article, Section, paragraph or provision
of this Agreement is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and
only such minor changes) as are necessary to make it valid and enforceable.
(g) Recognition of
U.S. Special Resolutions Regimes. In the event that the Agent is a Covered Entity and becomes subject to a proceeding under a U.S.
Special Resolution Regime, the transfer from the Agent of this Agreement, and any interest and obligation in or under this Agreement,
will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and
any such interest and obligation, were governed by the laws of the United States or a state of the United States. In the event that the
Agent is a Covered Entity or the Agent or a BHC Act Affiliate of the Agent becomes subject to a proceeding under a U.S. Special Resolution
Regime, Default Rights under this Agreement that may be exercised against the Agent are permitted to be exercised to no greater extent
than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the
United States or a state of the United States. For purposes of this Agreement, (A) “BHC Act Affiliate” has the meaning
assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k); (B) “Covered
Entity” means any of the following: (i) a “covered entity” as that term is defined in, and interpreted in accordance
with, 12 C.F.R. § 252.82(b); (ii) a “covered bank” as that term is defined in, and interpreted in accordance with,
12 C.F.R. § 47.3(b); or (iii) a “covered FSI” as that term is defined in, and interpreted in accordance with, 12
C.F.R. § 382.2(b); (C) “Default Right” has the meaning assigned to that term in, and shall be interpreted in accordance
with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable; and (D) “U.S. Special Resolution Regime” means each
of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Dodd-Frank Wall
Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
(h) Governing
Law Provisions. This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York applicable
to agreements made and to be performed in such state. Any legal suit, action or proceeding arising out of or based upon this Agreement
or the transactions contemplated hereby may be instituted in the federal courts of the United States of America located in the Borough
of Manhattan in the City of New York or the courts of the State of New York in each case located in the Borough of Manhattan in the City
of New York (collectively, the “Specified Courts”), and each party irrevocably submits to the exclusive jurisdiction
(except for proceedings instituted in regard to the enforcement of a judgment of any such court , as to which such jurisdiction is non-exclusive)
of such courts in any such suit, action or proceeding. Service of any process, summons, notice or document by mail to such party’s
address set forth above shall be effective service of process for any suit, action or other proceeding brought in any such court. The
parties irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding in the Specified
Courts and irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such suit, action or other
proceeding brought in any such court has been brought in an inconvenient forum.
(i) General
Provisions. This Agreement constitutes the entire agreement of the parties to this Agreement and supersedes all prior written or oral
and all contemporaneous oral agreements, understandings and negotiations with respect to the subject matter hereof. This Agreement may
be executed in two or more counterparts, each one of which shall be an original, with the same effect as if the signatures thereto and
hereto were upon the same instrument, and may be delivered by facsimile transmission or by electronic delivery of a portable document
format (PDF) file. This Agreement may not be amended or modified unless in writing by all of the parties hereto, and no condition herein
(express or implied) may be waived unless waived in writing by each party whom the condition is meant to benefit. The Article and
Section headings herein are for the convenience of the parties only and shall not affect the construction or interpretation of this
Agreement.
[Signature Page Immediately Follows]
If the foregoing is in accordance
with your understanding of our agreement, kindly sign and return to the Company the enclosed copies hereof, whereupon this instrument,
along with all counterparts hereof, shall become a binding agreement in accordance with its terms
|
Very truly yours, |
|
|
|
|
|
AVADEL PHARMACEUTICALS PLC |
|
|
|
|
|
By: |
/s/ Gregory J. Divis |
|
|
Name: |
Gregory J. Divis |
|
|
Title: |
Chief Executive Officer |
The foregoing Agreement is
hereby confirmed and accepted by the Agent in New York, New York as of the date first above written.
JEFFERIES LLC |
|
|
|
|
By: |
/s/ Michael Magarro |
|
|
Name: Michael Magarro |
|
|
Title: Managing Director |
|
EXHIBIT A
ISSUANCE NOTICE
[Date]
Jefferies LLC
520 Madison Avenue
New York, New York 10022
Attn: [__________]
Reference
is made to the Open Market Sale Agreement between Avadel Pharmaceuticals plc (the “Company”) and Jefferies LLC (the
“Agent”) dated as of May 8, 2024. The Company confirms that all conditions to the delivery of this Issuance
Notice are satisfied as of the date hereof.
Date of Delivery
of Issuance Notice (determined pursuant to Section 3(b)(i)):
_______________________
Issuance Amount (equal to the total Sales Price for such Shares):
|
$ |
|
|
Number of days in selling period: |
|
|
|
First date of selling period: |
|
|
|
Last date of selling period: |
|
|
|
Settlement Date(s) if other than standard T+[2] settlement: |
|
|
|
|
Floor Price Limitation (in no event less than $1.00 without the prior
written consent of the Agent, which consent may be withheld in the Agent’s sole discretion): $ ____ per share
|
AVADEL PHARMACEUTICALS PLC |
|
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By: |
|
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|
Name: |
|
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Title: |
Schedule A
Notice Parties
The Company
Greg Divis
Thomas McHugh
Craig Dull
The Agent
Donald Lynaugh
Jack Fabbri
Matthew Kim
Exhibit 5.1
8 May 2024
Board of Directors
Avadel Pharmaceuticals Public Limited Company
10 Earlsfort Terrace
Dublin 2
D02 T380
Ireland
| Re: | Avadel Pharmaceuticals Public Limited Company |
Dear Sirs,
We are acting as Irish counsel to Avadel
Pharmaceuticals Public Limited Company, a public company limited by shares, incorporated under the laws of Ireland, company number 572535,
with its registered office at Ten Earlsfort Terrace, Dublin 2, D02 T380, Ireland (the “Company”) in connection
with the registration statement (the “Registration Statement”) on Form S-3 filed with the United States Securities
and Exchange Commission (the “SEC”) on 31 August 2022 under the Securities Act of 1933, as amended (the “Securities
Act”) with respect to the offering, issuance and sale by the Company, from time to time, of up to $100,000,000 ordinary shares,
nominal value US$0.01 per share (the “Ordinary Shares”) that may be issued and sold from time to time pursuant to the
terms of an Open Market Sale AgreementSM (the “Shares”) entered into by and between the Company and Jefferies
LLC on 8 May 2024 (the “Sales Agreement”), the base prospectus contained in the Registration Statement (the “Base
Prospectus”) and the terms of the Sales Agreement prospectus supplement filed on 8 May 2024 (the “Sales Agreement
Prospectus” and together with the Base Prospectus and the Registration Statement, the “Prospectus Documents”).
The issue and sale of the Shares pursuant to the Sales Agreement and the Prospectus Documents is referred to herein as the “Transaction”.
| 1.1 | This Opinion is confined to and given in all respects on the basis of the laws of Ireland (meaning Ireland
exclusive of Northern Ireland) in force as at the date hereof as currently applied by the courts of Ireland. We have made no investigation
of and we express no opinion as to the laws of any other jurisdiction or the effect thereof. |
| 1.2 | This Opinion is also strictly confined to the matters expressly stated herein at paragraph 2 below
and is not to be read as extending by implication or otherwise to any other matter. |
| (a) | the documents listed in the schedule (the “Schedule”) to this Opinion (the “Transaction
Documents”); |
| (b) | the searches listed at paragraph 1.5 below (the “Searches”); and |
| (c) | such other documents and records as we have deemed necessary to enable us to render the opinions set forth
below. |
| 1.4 | In giving this Opinion, we have examined and relied on copies of the Transaction Documents sent to us
by e-mail in pdf or other electronic format. |
| 1.5 | For the purpose of giving this Opinion, we have caused to be made the following legal searches against
the Company on 8 May 2024: |
| (a) | on the file of the Company maintained by the Registrar of Companies in Dublin for mortgages, debentures
or similar charges or notices thereof and for the appointment of any receiver, examiner or liquidator; |
| (b) | in the Judgments Office of the High Court for unsatisfied judgments, orders, decrees and the like for
the five years immediately preceding the date of the search; and |
| (c) | in the Central Office of the High Court in Dublin for any proceedings and petitions filed in the last
two years. |
Subject to the assumptions and qualifications
set out in this Opinion and to any matters not disclosed to us, we are of the opinion that:
| 2.1 | the Company is a public company limited by shares and is duly incorporated and validly existing under
the laws of Ireland. |
| 2.2 | the Company does not have any immunity from the jurisdiction of any court or from any legal process (whether
through service or notice, attachment prior to judgment, attachment in aid of execution, execution or otherwise) under the laws of Ireland. |
| 2.3 | the Shares, when issued and allotted in accordance with all necessary corporate action of the Company
shall be validly issued, fully paid up and non-assessable (which term means that no further sums are required to be paid by the holders
thereof in connection with the issuance of such Shares). |
For the purpose of giving this Opinion,
we assume the following without any responsibility on our part if any assumption proves to have been untrue as we have not verified independently
any assumption:
Registration Statement
and the Shares
| 3.1 | that, when filed with the SEC, the Sales Agreement Prospectus will not differ in any material respect
from the final draft that we have examined and that before any Shares are offered, issued and sold, the Prospectus Documents and any amendments
to the Prospectus Documents (including post-effective amendments) will have become effective under the Securities Act; |
| 3.2 | that the filing of the Prospectus Documents with the SEC has been authorised by all necessary actions
under all applicable laws other than Irish law; |
| 3.3 | that the Sales Agreement has been duly executed and delivered by all parties thereto other than the Company; |
| 3.4 | that any Shares issued under the Prospectus Documents will be in consideration of the receipt by the Company
prior to the issuance of such Shares pursuant thereto of either cash or the release of a liability of the Company for a liquidated sum,
at least equal to the nominal value of such Shares and any premium required to be paid up on the Shares pursuant to their terms of issuance; |
| 3.5 | that, at the time of any issuance of any Shares, the Company will have sufficient authorised but unissued
share capital to issue the required number of Shares, and the Company will not have prior to, or by virtue of, such issuance, exceeded
or exceed the maximum number of Shares permitted to be issued pursuant to the constitution of the Company (the “Constitution”)
and the Companies Act; |
| 3.6 | that the Shares will, when issued, be allotted and issued in the manner contemplated by the Prospectus
Documents and the Sales Agreement; |
| 3.7 | that, in respect of any Shares issued after the date of this Opinion, the Company validly exists under
the laws of Ireland and has the necessary corporate power and authority to issue such Shares; |
| 3.8 | that any issuance of Shares will be in compliance with the Companies Act, the Irish Takeover Panel Act
1997, Takeover Rules 2022, and all applicable Irish company, takeover, securities, market abuse, insider dealing laws and other rules and
regulations; |
| 3.9 | that all Shares issued and sold under the Transaction Documents will be issued and sold in compliance
with all applicable laws (other than Irish law), including applicable U.S. federal and state securities law, and in accordance with the
Transaction Documents; |
| 3.10 | that at the time of the allotment and issuance of the Shares, such allotment and issuance shall not be
in contravention or breach of: |
| (b) | any agreement, undertaking, arrangement, deed or covenant affecting the Company or to which the Company
is a party or otherwise bound or subject; |
| (c) | any law, rule or regulation to which the Company or its properties is subject excluding the laws
of Ireland; |
| (d) | any judicial or regulatory order or decree of any governmental authority; or |
| (e) | any consent, approval, license, authorisation or validation of, or filing, recording or registration with,
any governmental authority; |
| 3.11 | that, at the time of the allotment and issuance of the Shares, the authority of the Company and the directors
of the Company to allot and issue the Shares, as provided for in the Companies Act and the Constitution, is in full force and effect and
that the statutory pre-emption rights have been disapplied in respect of any allotment and issuance of the Shares; |
| 3.12 | that the Company will continue to renew its authority to allot and issue the Shares in accordance with
the terms and conditions set out in the Constitution and Companies Act and that, where such authority has not been renewed, the Company
will not allot or issue the Shares after such authority has expired; |
| 3.13 | that from the date of the board resolutions set out in Schedule, no other corporate or other action has
been taken by the Company to amend, alter or repeal those resolutions; |
| 3.14 | that any power of attorney granted by the Company in respect of the issuance and allotment of the Shares
shall have been duly granted, approved and executed in accordance with the Constitution, the Companies Act, the Powers of Attorney Act
1996 of Ireland and all other applicable laws, rules and regulations; |
| 3.15 | that the Shares will be paid up in consideration of the receipt by the Company prior to, or simultaneously
with, the issuance of the Shares of cash at least equal to the nominal value of such Shares and that where Shares are issued without the
requirement for the payment of cash consideration by or on behalf of the relevant subsidiary, then such Shares shall either be fully paid
up by the Company or one of its subsidiaries within the time permitted by section 1027(1) of the Companies Act (and, in the
case of the Company or a subsidiary incorporated in Ireland, in a manner permitted by sections 82(6) and 1043(1) of the
Companies Act) or issued in accordance with section 1028(2) of the Companies Act; |
| 3.16 | that the Prospectus Documents do not constitute (and is not intended/required to constitute) a prospectus
within the meaning of Part 23 of the Companies Act and to the extent that any offer of Shares is being made to investors in any member
state of the European Union (“Member State”), the obligation to propose and publish a prospectus pursuant to Irish
prospectus law, or in particular pursuant to the European Union (Prospectus) Regulations 2019, does not arise; |
Authenticity and Bona Fides
| 3.17 | the truth, completeness, accuracy and authenticity of all Transaction Documents submitted to us as originals
or copies of originals (and in the case of copies, conformity to the originals of such copies), the genuineness of all signatories, stamps
and seals thereon and where incomplete Transaction Documents have been submitted to us that the originals of such Transaction Documents
are identical to the last draft of the complete Transaction Documents submitted to us; |
| 3.18 | that the copies produced to us of minutes of meetings and/or of resolutions correctly record the proceedings
at such meetings and/or the subject matter which they purport to record and that any meetings referred to in such copies were duly convened,
duly quorate and held, that those present at any such meetings were entitled to attend and vote at the meeting and acted bona fide throughout
and that no further resolutions have been passed or other action taken which would or might alter the effectiveness thereof and that such
resolutions have not been amended or rescinded and are in full force and effect; |
| 3.19 | that there is, at the relevant time of the allotment and issuance of the Shares, no matter affecting the
authority of the directors to allot and issue the Shares, not disclosed by the Constitution or the resolutions produced to us, which would
have any adverse implications in relation to the opinions expressed in this Opinion; |
| 3.20 | that each director of the Company has disclosed any interest which he or she may have in the Transaction
in accordance with the provisions of the Companies Act and the Constitution and none of the directors of the Company has any interest
in the Transaction except to the extent permitted by the Constitution; |
| 3.21 | the absence of fraud, coercion, duress or undue influence and lack of bad faith on the part of the Company
and its respective officers, employees, agents and advisers and that the Company will issue the Shares in good faith, for its legitimate
and bona fide business purposes; |
| 3.22 | that the Constitution effective as of 20 December 2016 is the current constitution of the Company,
is up to date and has not been amended or superseded and that there are no other terms governing the Shares other than those set out in
the Constitution; |
Solvency and Insolvency
| 3.23 | that (i) the parties to the Transaction Documents were solvent and able to pay their debts within
the meaning of section 570 of the Companies Act or any analogous provisions under any applicable laws immediately after the execution
and delivery of the Transaction Documents; (ii) the parties to the Transaction Documents will not as a consequence of doing any act
or thing which any Transaction Document contemplates, permits or requires the relevant party to do, be unable to pay its debts within
the meaning of section 570 of the Companies Act or any analogous provisions under any applicable laws; (iii) no liquidator,
receiver or examiner or other similar or analogous officer has been appointed in relation to any of the assets or undertakings of the
parties to the Transaction Documents; and (iv) no petition for the making of a winding-up order or the appointment of an examiner
or any similar officer or any similar or analogous procedure in any jurisdiction has been presented in relation to the parties to the
Transaction Documents; |
Accuracy of Searches and Warranties
| 3.24 | the accuracy and completeness of the information disclosed in the searches referred to in paragraph 1.5
above and that such information has not since the time of such search or enquiry been altered (it should be noted that searches at the
Companies Registration Office, Dublin, do not necessarily reveal whether or not a prior charge has been created or a resolution has been
passed or a petition presented or any other action taken for the winding-up of or the appointment of a receiver or an examiner to the
Company); |
| 3.25 | the truth, completeness and accuracy of all representations and statements as to factual matters contained
in the Transaction Documents; |
Commercial Benefit
| 3.26 | that the Transaction Documents have been entered into for bona fide commercial purposes, on arm’s
length terms and for the benefit of each party thereto and are in those parties’ respective commercial interests and for their respective
corporate benefit; |
Financial Assistance and Connected
Transactions
| 3.27 | that the Company is not, by entering into the Transaction Documents or performing its obligations thereunder,
providing financial assistance for the purpose of an acquisition (by way of subscription, purchase, exchange or otherwise) made or to
be made by any person of any shares in the Company which would be prohibited by section 82 of the Companies Act; and |
| 3.28 | that none of the transactions contemplated by the Transaction Documents is prohibited by virtue of section 239
of the Companies Act, which prohibits certain transactions between companies and its directors or persons connected with its directors. |
The opinions set out in this Opinion
are subject to the following reservations:
General Matters
| 4.1 | A particular course of dealing among the parties or an oral amendment, variation or waiver may result
in an Irish court finding that the terms of the Transaction Documents have been amended, varied or waived even if such course of dealing
or oral amendment, variation or waiver is not reflected in writing among the parties. |
| 4.2 | No opinion is expressed on the irrevocability of, or on the enforceability of the delegation of, any power
of attorney under the Transaction Documents. |
| 4.3 | No opinion is expressed on any deed of assignment, transfer, accession or similar document executed after
the date of this Opinion in relation to any of the rights and obligations contained in the Transaction Documents. |
| 4.4 | No opinion is expressed on any deed or agreement envisaged by the Transaction Documents to be entered
at a future date or any future action taken by a party under the Transaction Documents. |
| 4.5 | We express no opinion as to whether the Transaction Documents breach any other agreement or instrument. |
Sanctions
| 4.6 | If a party to any Transaction Document or to any transfer of, or payment in respect of, the Transaction
Documents is controlled by or otherwise connected with a person (or is itself) resident in, incorporated in or constituted under the laws
of a country which is the subject of United Nations, European Union or Irish sanctions or sanctions under the Treaty on the Functioning
of the European Union, as amended, or is otherwise the target of any such sanctions, then obligations to that party under the relevant
Transaction Documents or in respect of the relevant transfer or payment may be unenforceable or void. |
Execution of Transaction Documents
| 4.7 | We note the decision in the English case of R (on the application of Mercury Tax Ltd) v. Revenue
and Customs Commissioners [2008] EWHC 2721. Although this decision will not be binding on the courts of Ireland it will be considered
as persuasive authority. One of the decisions in that case would appear to indicate that a previously executed signature page from
one document may not be transferred to another document, even where the documents in question are simply updated versions of the same
document. Our Opinion is qualified by reference to the above referenced decision. |
This Opinion is addressed to you in
connection with the registration of the Shares with the SEC. We hereby consent to the inclusion of this Opinion as an exhibit to the Registration
Statement to be filed with the SEC and any amendments thereto.
This Opinion speaks only as of its date.
We are not under any obligation to update this Opinion from time to time or to notify you of any change of law, fact or circumstances
referred to or relied upon in the giving of this Opinion.
The Opinion is governed by and is to be construed
in accordance with the laws of Ireland as interpreted by the courts of Ireland at the date hereof.
Yours faithfully
/s/ Arthur Cox LLP
ARTHUR COX LLP
Schedule 1
The Transaction Documents
| 1. | A copy of the Registration Statement. |
| 2. | A copy of the Base Prospectus. |
| 3. | A copy of the Sales Agreement Prospectus. |
| 4. | A copy of the Sales Agreement. |
| 5. | The results of the Searches. |
| 6. | A copy of the certificate of incorporation of the Company dated 1 December 2015. |
| 7. | A copy of the certificate of incorporation on change of name of the Company dated 9 May 2016. |
| 8. | A copy of the certificate of incorporation for the re-registration of the Company as a public limited
company dated 21 November 2016. |
| 9. | A copy of the memorandum and articles of association of the Company as adopted by resolution of the shareholder
of the Company on 20 December 2016, effective at 11:59:59 pm (Central European Time) on 31 December 2016. |
| 10. | A copy of the corporate certificate of the secretary of the Company dated 8 May 2024 certifying,
amongst other things, the Board’s approval of the Transaction and the issuance of the Shares. |
| 11. | A copy of the letter of status from the Irish Companies Registration Office dated 7 May 2024. |
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