As filed with the Securities and Exchange Commission on December 21, 2023
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
MEIRAGTX HOLDINGS PLC
(Exact name of registrant as specified in its charter)
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Cayman Islands
(State or other jurisdiction of
incorporation or organization)
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98-1448305
(I.R.S. Employer
Identification Number)
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450 East 29th Street, 14th Floor
New York, New York 10016
(646) 860-7985
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Alexandria Forbes, Ph.D.
MeiraGTx, LLC
450 East 29th Street, 14th Floor
New York, New York 10016
(646) 860-7985
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Peter N. Handrinos
Keith Halverstam
Latham & Watkins LLP
200 Clarendon Street
Boston, Massachusetts 02116
+1 617 948 6000
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From time to time after the effective date of this registration statement.
If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ☐
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective on filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Securities Exchange Act of 1934, as amended.
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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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 7(a)(2)(B) of the Securities Act. ☐
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
EXPLANATORY NOTE
This registration statement contains:
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a base prospectus which covers the offering, issuance and sale by us of up to $250,000,000 in the aggregate of the securities identified above from time to time in one or more offerings; and
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a sales agreement prospectus supplement covering the offering, issuance and sale by us of up to a maximum aggregate offering price of $100,000,000 of our ordinary shares that may be issued and sold under a sales agreement with BofA Securities, Inc.
The base prospectus immediately follows this explanatory note. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in a prospectus supplement to the base prospectus. The sales agreement prospectus supplement immediately follows the base prospectus. The $100,000,000 of ordinary shares that may be offered, issued and sold under the sales agreement prospectus supplement is included in the $250,000,000 of securities that may be offered, issued and sold by us under the base prospectus. Upon termination of the sales agreement with BofA Securities, Inc., any portion of the $100,000,000 included in the sales agreement prospectus supplement that is not sold pursuant to the sales agreement will be available for sale in other offerings pursuant to the base prospectus and a corresponding prospectus supplement, and if no shares are sold under the sales agreement, the full $100,000,000 of securities may be sold in other offerings pursuant to the base prospectus and a corresponding prospectus supplement.
The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion, dated December 21, 2023.
PROSPECTUS
$250,000,000
Ordinary shares
Preferred shares
Warrants
Purchase contracts
Units
We may offer and sell up to $250,000,000 in the aggregate of the securities identified above from time to time in one or more offerings. This prospectus provides you with a general description of the securities.
Each time we offer and sell securities, we will provide a supplement to this prospectus that contains specific information about the offering and the amounts, prices and terms of the securities. The supplement may also add, update or change information contained in this prospectus with respect to that offering. You should carefully read this prospectus and the applicable prospectus supplement before you invest in any of our securities.
We may offer and sell the securities described in this prospectus and any prospectus supplement to or through one or more underwriters, dealers and agents, or directly to purchasers, or through a combination of these methods. If any underwriters, dealers or agents are involved in the sale of any of the securities, their names and any applicable purchase price, fee, commission or discount arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus supplement. See the sections of this prospectus entitled “About this Prospectus” and “Plan of Distribution” for more information. No securities may be sold without delivery of this prospectus and the applicable prospectus supplement describing the method and terms of the offering of such securities.
INVESTING IN OUR SECURITIES INVOLVES RISKS. SEE THE “RISK FACTORS” ON PAGE 6 OF THIS PROSPECTUS AND ANY SIMILAR SECTION CONTAINED IN THE APPLICABLE PROSPECTUS SUPPLEMENT CONCERNING FACTORS YOU SHOULD CONSIDER BEFORE INVESTING IN OUR SECURITIES.
Our ordinary shares are listed on The Nasdaq Global Select Market under the symbol “MGTX.” On December 18, 2023, the last reported sale price of our ordinary shares on The Nasdaq Global Select Market was $4.52 per share.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2023.
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the U.S. Securities and Exchange Commission, or the SEC, using a “shelf” registration process. By using a shelf registration statement, we may sell securities from time to time and in one or more offerings up to a total dollar amount of $250,000,000 as described in this prospectus. Each time that we offer and sell securities, we will provide a prospectus supplement to this prospectus that contains specific information about the securities being offered and sold and the specific terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings. The prospectus supplement or free writing prospectus may also add, update or change information contained in this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus and the applicable prospectus supplement or free writing prospectus, you should rely on the prospectus supplement or free writing prospectus, as applicable. Before purchasing any securities, you should carefully read both this prospectus and the applicable prospectus supplement (and any applicable free writing prospectuses), together with the additional information described under the heading “Where You Can Find More Information; Incorporation by Reference.”
We have not authorized anyone to provide you with any information or to make any representations other than those contained in this prospectus, any applicable prospectus supplement or any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We will not make an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus and the applicable prospectus supplement to this prospectus is accurate only as of the date on its respective cover, that the information appearing in any applicable free writing prospectus is accurate only as of the date of that free writing prospectus, and that any information incorporated by reference is accurate only as of the date of the document incorporated by reference, unless we indicate otherwise. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus incorporates by reference, and any prospectus supplement or free writing prospectus may contain and incorporate by reference, market data and industry statistics and forecasts that are based on independent industry publications and other publicly available information. Although we believe these sources are reliable, we do not guarantee the accuracy or completeness of this information and we have not independently verified this information. In addition, the market and industry data and forecasts that may be included or incorporated by reference in this prospectus, any prospectus supplement or any applicable free writing prospectus may involve estimates, assumptions and other risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” contained in this prospectus, the applicable prospectus supplement and any applicable free writing prospectus, and under similar headings in other documents that are incorporated by reference into this prospectus. Accordingly, investors should not place undue reliance on this information.
Unless the context otherwise requires, references in this prospectus to “Meira,” “MeiraGTx,” “we,” “us,” “our” or “the Company” refer to MeiraGTx Holdings plc and its subsidiaries.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the information incorporated by reference in this prospectus contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this prospectus and the information incorporated by reference in this prospectus that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding expectations regarding meetings with global regulatory authorities and the FDA, product pipeline, anticipated product benefits, goals and strategic priorities, product candidate development and status and expectations relating to clinical trials, growth expectations or targets, pre-clinical and clinical data expectations in respect of collaborations and expectations related to financing arrangements and the intended use of proceeds thereunder, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s expectations at the time such statements are made. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the important factors discussed under the heading “Risk Factors” in any of our filings with the SEC pursuant to Section 13(a), 13(c) 14 or 15(d) of the Securities Exchange Act of the 1934, as amended (the “Exchange Act”). These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this prospectus and the information incorporated by reference in this prospectus. Any such forward-looking statements represent management’s estimates as of the date of the relevant document. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date such statements are made.
WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
Available Information
We are subject to the informational requirements of the Exchange Act, and are required to file reports, proxy statements and other information with the SEC. The SEC maintains a website that contains reports, proxy and information statements and other information about issuers, such as us, who file electronically with the SEC. The address of that website is http://www.sec.gov.
Our website address is www.meiragtx.com. The information on our website, however, is not, and should not be deemed to be, a part of this prospectus.
This prospectus and any prospectus supplement are part of a registration statement that we filed with the SEC and do not contain all of the information in the registration statement. The full registration statement may be obtained from the SEC or us, as provided below. Forms of the documents establishing the terms of the offered securities are or may be filed as exhibits to the registration statement or documents incorporated by reference in the registration statement. Statements in this prospectus or any prospectus supplement about these documents are summaries and each statement is qualified in all respects by reference to the document to which it refers. You should refer to the actual documents for a more complete description of the relevant matters. You may inspect a copy of the registration statement through the SEC’s website, as provided above.
Incorporation by Reference
The SEC’s rules allow us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically update and supersede that information. Any statement contained in this prospectus or a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or a subsequently filed document incorporated by reference modifies or replaces that statement.
This prospectus and any accompanying prospectus supplement incorporate by reference the documents set forth below that have previously been filed with the SEC (other than those documents or the portions of those documents not deemed to be filed):
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Our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 11, 2023, for the quarter ended June 30, 2023, filed with the SEC on August 10, 2023 and for the quarter ended September 30, 2023, filed with the SEC on November 14, 2023.
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Our Current Reports on Form 8-K, filed with the SEC on April 26, 2023, May 9, 2023, June 12, 2023, August 10, 2023, October 30, 2023 and December 21, 2023; and
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All reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of this offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will also be incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of
the filing of such reports and documents. We are not, however, incorporating by reference any documents or portions thereof, whether specifically listed above or filed in the future, that are not deemed “filed” with the SEC, including our stock performance graph or any information furnished pursuant to Items 2.02 or 7.01 of Form 8-K or related exhibits furnished pursuant to Item 9.01 of Form 8-K.
You may request a free copy of any of the documents incorporated by reference in this prospectus by writing or telephoning us at the following address:
MeiraGTx Holdings plc
450 East 29th Street, 14th Floor
New York, New York 10016
(646) 860-7985
Exhibits to the filings will not be sent, however, unless those exhibits have specifically been incorporated by reference in this prospectus or any accompanying prospectus supplement.
PROSPECTUS SUMMARY
The Company
We are a vertically integrated, clinical-stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. We have core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology that allows precise, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, we have taken a portfolio approach by licensing, acquiring and developing technologies that give us depth across both product candidates and indications. Our initial focus is on three distinct areas of unmet medical need: ocular diseases, including both inherited retinal diseases as well as large degenerative ocular diseases, neurodegenerative diseases, and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, we plan to expand our focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.
MeiraGTx Holdings plc was formed on May 1, 2018 under the laws of the Cayman Islands. Our predecessor, MeiraGTx Limited, a limited company under the laws of England and Wales, was formed on March 20, 2015. In connection with our initial public offering, we reorganized whereby MeiraGTx Limited became a wholly owned subsidiary of MeiraGTx Holdings plc.
RISK FACTORS
Investment in any securities offered pursuant to this prospectus and the applicable prospectus supplement involves risks. You should carefully consider the risk factors incorporated by reference to our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K we have filed and will file after the date of this prospectus, and all other information contained or incorporated by reference into this prospectus, as updated by our subsequent filings under the Exchange Act, and the risk factors and other information contained in the applicable prospectus supplement and any applicable free writing prospectus before acquiring any of such securities. The occurrence of any of these risks might cause you to lose all or part of your investment in the offered securities. There may be other unknown or unpredictable economic, business, competitive, regulatory or other factors that could have material adverse effects on our future results. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. If any of these risks actually occurs, our business, financial condition, results of operations or cash flow could be seriously harmed. This could cause the trading price of our securities to decline, resulting in a loss of all or part of your investment. Please also carefully read the section entitled “Special Note Regarding Forward-Looking Statements” included in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
USE OF PROCEEDS
We intend to use the net proceeds from the sale of the securities as set forth in the applicable prospectus supplement.
DESCRIPTION OF SHARE CAPITAL
Share Capital
The authorized share capital of MeiraGTx Holdings plc consists of $50,000 divided into 1,288,327,750 shares, nominal value $0.00003881 per share. As of September 30, 2023, there were 59,597,151 ordinary shares issued and outstanding.
Ordinary Shares
General
All of our issued and outstanding ordinary shares are fully paid and non-assessable. Certificates representing our issued and outstanding ordinary shares are generally not issued and legal title to our issued shares is recorded in registered form in the register of members. Holders of our ordinary shares have no preemptive, subscription, redemption or conversion rights.
Our board of directors may provide for other classes of shares, including classes of preferred shares, out of our authorized but unissued share capital, which could be utilized for a variety of corporate purposes, including future offerings to raise capital for corporate purposes or for use in employee benefit plans. Such additional classes of shares shall have such rights, restrictions, preferences, privileges and payment obligations as determined by our board of directors. If we issue any preferred shares, the rights, preferences and privileges of holders of our ordinary shares will be subject to, and may be adversely affected by, the rights of the holders of such preferred shares. See “— Variation of rights.”
Dividends
The holders of our ordinary shares are entitled to such dividends as may be declared by our board of directors subject to the Companies Act (as amended) of the Cayman Islands (the “Companies Law”), and our amended and restated memorandum and articles of association. Dividends and other distributions on issued and outstanding ordinary shares may be paid out of the funds of the Issuer lawfully available for such purpose, subject to any preference of any outstanding shares and the contractual limitations in our outstanding indebtedness. Dividends and other distributions will be distributed among the holders of our ordinary shares on a pro rata basis.
Voting rights
Voting at any shareholders’ meeting is by show of hands, unless voting by way of poll demanded by the chairman of the board of directors or any shareholder present or voting by proxy. On a show of hands every shareholder present in person or by proxy shall have one vote and on a poll every shareholder present in person or by proxy shall have one vote for each ordinary share on all matters upon which the ordinary shares are entitled to vote.
A quorum required for a meeting of shareholders consists of holders with at least one-third of the votes eligible to be cast at any such general meeting of the Issuer.
An ordinary resolution to be passed by the shareholders requires the affirmative vote of a simple majority of the votes cast by persons present (in person or by proxy) and voting in a general meeting at which a quorum is present, while a special resolution requires the affirmative vote of not less than two thirds of the votes cast by persons present (in person or by proxy) and voting in a general meeting at which a quorum is present. An ordinary resolution or a special resolution may also be adopted by way of unanimous written resolution signed by or on behalf of each shareholder who would have been entitled to vote on such matter at a general meeting without a meeting being held. A special resolution will be required for matters such as certain merger or consolidation transactions, the change of name of the Company, making changes to our amended and restated memorandum and articles of association, or the voluntary winding up of the Company.
Variation of rights
The rights attached to any class of shares (unless otherwise provided by the terms of issue of that class), such as voting, dividends and the like, may only be materially and adversely varied or abrogated with the sanction of a resolution passed by not less than two-thirds of the votes attaching to the shares of the relevant class cast in a meeting of the holders of the shares of that class, or by the written consent of the holders of not less than two-thirds of the shares of that class. The rights conferred upon the holders of the shares of any class shall not (unless otherwise provided by the terms of issue of that class) be deemed to be varied by the creation or issue of further shares ranking in priority to or pari passu with such previously existing shares.
Transfer of ordinary shares
Any of our shareholders may transfer all or any of his or her ordinary shares by an instrument of transfer in the usual or common form or any other form approved by our board of directors, subject to the applicable restrictions of our amended and restated memorandum and articles of association, such as the suspension of transfers for a period immediately preceding a general meeting, or the determination that a proposed transfer is not eligible.
Liquidation
On a return of capital on winding up or otherwise (other than on conversion, redemption or purchase of ordinary shares), assets available for distribution among the holders of ordinary shares shall be distributed among the holders of the ordinary shares on a pro rata basis.
Directors
The management of our Company is vested in our board of directors. The quorum necessary for any meeting of our board of directors shall consist of at least a majority of the members of our board of directors and questions arising at any meeting shall be decided by a majority of votes.
Our amended and restated memorandum and articles of association provide that our board of directors will be divided into three classes with staggered, three-year terms. At each annual meeting of shareholders, the successors to directors whose terms then expire will be elected to serve from the time of election and qualification until the third annual meeting following election. The election of directors shall be by a plurality of the votes of the shares entitled to vote on the election of directors.
In addition, subject to the maximum number of directors designated by resolution of the board of directors, additional directors may be appointed from time to time by the board of directors or by ordinary resolution either as a result of a casual vacancy or as an additional director.
Directors may be removed or replaced by an ordinary resolution of the shareholders.
Indemnity of directors and officers
Our amended and restated memorandum and articles of association provide that our board of directors and officers shall be indemnified from and against all liability which they incur in execution of their duty in their respective offices, except liability incurred by reason of such director’s or officer’s dishonesty, willful default or fraud.
Differences in Corporate Law
Cayman Islands companies are governed by the Companies Law. The Companies Law is modeled on English law but does not follow recent English Law statutory enactments, and differs from laws applicable to United States corporations and their shareholders. Set forth below is a summary of some significant differences between the provisions of the Companies Law applicable to us and, for comparison purposes, the laws applicable to companies incorporated in the State of Delaware and their shareholders.
Mergers and similar arrangements
The Companies Law allows for the merger of two or more companies into either one consolidated company or one or more company(ies) merged into another so as to form a single surviving company. The merger or consolidation of two or more companies under Cayman Islands law requires the directors of the companies to enter into and to approve a written plan of merger or consolidation, which must also be authorized by a special resolution of each constituent company, in which regard see “— Ordinary Shares — Voting Rights” above, and such other authorization, if any, as may be specified in such companies’ articles of association. In relation to any merger or consolidation under the Companies Law, dissenting shareholders have certain limited appraisal rights in circumstances which are similar to those available to dissenting shareholders of a Delaware corporation, providing rights to receive payment in cash for the judicially determined fair value of the shares. Appraisal rights are ordinarily available where the consideration offered under the merger is payable in cash or, in some instances, the unlisted securities of a third party.
The Companies Law also includes statutory provisions that facilitate the reconstruction and amalgamation of companies, provided that such a scheme of arrangement is approved by (i) in respect of shareholders, 75% in value of the shareholders or each class of shareholders who attend and vote, either in person or by proxy, at a meeting or meetings convened for that purpose; or (ii) in respect of creditors, a majority in number representing 75% in value of creditors or each class of creditors who attend and vote, either in person or by proxy, at a meeting or meetings convened for that purpose. The convening of meetings to consider any such scheme of arrangement, and the implementation of the scheme, must be sanctioned by the Grand Court of the Cayman Islands. While a dissenting shareholder has the right to express to the court the view that the transaction ought not to be approved, the court can be expected to approve the arrangement if it determines that:
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the company is not proposing to act illegally or beyond the scope of its corporate authority and the statutory provisions as to the dual majority vote have been met;
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the shareholders have been fairly represented at the meeting in question and the classes properly delineated;
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the arrangement is such that a businessman would reasonably approve; and
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the arrangement is not one that would more properly be sanctioned under some other provision of the Companies Law or that would amount to a “fraud on the minority”.
If a scheme of arrangement is thus approved, the dissenting shareholders would have no rights comparable to appraisal rights, which would otherwise ordinarily be available to dissenting shareholders of a Delaware corporation.
When a tender offer to acquire shares is made and accepted (within four months) by holders of not less than 90% of the shares subject to such offer, the offeror may, within a two-month period following the expiration of the initial four month period, require the holders of the remaining shares to transfer such shares on the terms of the offer. An objection can be made to the Grand Court of the Cayman Islands but this is unlikely to succeed unless there is evidence of fraud, bad faith, collusion or inequitable treatment of shareholders.
Shareholders’ suits
We are not aware of any reported class action having been brought in a Cayman Islands court. Derivative actions have been brought in the Cayman Islands courts, and the Cayman Islands courts have confirmed the availability for such actions. In principle, we will normally be the proper plaintiff and a derivative action may not be brought by a shareholder. However, based on English authorities, which would in all likelihood be of persuasive authority in the Cayman Islands, there are exceptions to the foregoing principle, including when:
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a company acts or proposes to act illegally or ultra vires (beyond the scope of its authority);
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the act complained of, although not ultra vires, could be effected if duly authorized by a special resolution that has not been obtained; and
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those who control the company are perpetrating a “fraud on the minority.”
Fiduciary duties of directors
Under Delaware corporate law, a director of a Delaware corporation has a fiduciary duty to the corporation and its shareholders. This duty has two components, the duty of care and the duty of loyalty. The duty of care requires that a director act in good faith, with the care that an ordinarily prudent person would exercise under similar circumstances. Under this duty, a director must inform himself of, and disclose to shareholders, all material information reasonably available regarding a significant transaction. The duty of loyalty requires that a director must act in a manner he or she reasonably believes to be in the best interests of the corporation. A director must not use his or her corporate position for personal gain or advantage. This duty prohibits self-dealing by a director and mandates that the best interests of the corporation and its shareholders take precedence over any interest possessed by a director, officer or controlling shareholder and not shared by the shareholders generally. In general, actions of a director are presumed to have been made on an informed basis, in good faith and in the honest belief that the action taken was in the best interests of the corporation. However, this presumption may be rebutted by evidence of a breach of one of the fiduciary duties. Should such evidence be presented concerning a transaction by a director, the director must prove the procedural fairness of the transaction and that the transaction was of fair value to the corporation.
As a matter of Cayman Islands law, a director of a Cayman Islands company is in the position of a fiduciary with respect to the company and therefore it is considered that he owes the following duties to the company: a duty to act in good faith and in what he considers to be in the best interests of the company; a duty not to make a profit out of his position as director (unless the company permits him to do so); a duty to exercise his powers for the purposes for which they are conferred; and a duty not to put himself in a position where the interests of the company conflict with his personal interest or his duty to a third party. A director of a Cayman Islands company owes to the company a duty to act with skill and care. A director will need to exhibit in the performance of his duties both the degree of skill that may reasonably be expected from a subjective perspective determined by reference to his knowledge and experience and the skill and care objectively to be expected from a person occupying office as a director of the company.
Under our amended and restated memorandum and articles of association, directors who are in any way, whether directly or indirectly, interested in a contract or proposed contract with our company must declare the nature of their interest at a meeting of the board of directors. Following such declaration, a director may vote in respect of any contract or proposed contract notwithstanding his interest; provided that, in exercising any such vote, such director’s duties remain as described above.
Written consent of shareholders
Under Delaware corporate law, unless otherwise provided in the certificate of incorporation, any action to be taken at any annual or special meeting of shareholders of a corporation may be taken by written consent of the holders of outstanding stock having not less than the minimum number of votes that would be necessary to take that action at a meeting at which all shareholders entitled to vote were present and voted. In addition, a corporation may eliminate the right of shareholders to act by written consent through amendment to its certificate of incorporation.
Cayman Islands law and our amended and restated memorandum and articles of association provide that shareholders may adopt an ordinary resolution or a special resolution by way of unanimous written resolution signed by or on behalf of each shareholder who would have been entitled to vote on such matter at a general meeting without a meeting being held.
Shareholder proposals
Under Delaware corporate law, a shareholder has the right to put any proposal before the shareholders at the annual meeting, provided that such shareholder complies with the notice provisions in the governing documents. A special meeting may be called by the board of directors or any other person authorized to do so in the governing documents, but shareholders may be precluded from calling special meetings.
Under the laws of the Cayman Islands, a shareholder can only put a proposal before the shareholders at any general meeting in respect of any matter requiring a special resolution if it is set out in the notice
calling the meeting. There is no right to introduce new business in respect of any matter requiring a special resolution at any meeting. A general meeting may be called by the board of directors or any other person authorized to do so in the articles of association, but shareholders may be precluded from calling general meetings. Under our amended and restated memorandum and articles of association, general meetings shall also be convened on the requisition in writing of any shareholder or shareholders entitled to attend and vote at general meetings of the company and to exercise at least a majority of the voting power permitted to be exercised at any such meeting, deposited at the office specifying the objects of the meeting for a date no later than 21 days from the date of deposit of the requisition signed by such shareholders, and if the directors do not convene such meeting for a date not later than 45 days after the date of such deposit, such shareholders themselves may convene the general meeting in the same manner, as nearly as possible, as that in which general meetings may be convened by the directors, and all reasonable expenses incurred by such shareholders as a result of the failure of the directors to convene the general meeting shall be reimbursed to them by the company. As an exempted Cayman Islands company, we are not obliged by law to call shareholders’ annual general meetings.
Under Delaware corporate law, a corporation is required to set a minimum quorum of one-third of the issued and outstanding shares for a shareholders meeting. Cayman Islands law permits a company’s articles to have any quorum. See “— Ordinary Shares — Voting Rights.”
Cumulative voting
Under Delaware corporate law, cumulative voting for elections of directors is not permitted unless the corporation’s certificate of incorporation specifically provides for it. Cumulative voting potentially facilitates the representation of minority shareholders on a board of directors since it permits a minority shareholder to cast all the votes to which such shareholder is entitled on a single director, which increases such shareholder’s voting power with respect to electing such director.
There are no prohibitions in relation to cumulative voting under the laws of the Cayman Islands, but our amended and restated memorandum and articles of association do not provide for cumulative voting. As a result, our shareholders are not afforded any less protection or fewer rights on this issue than shareholders of a Delaware corporation.
Election and removal of directors
Under Delaware corporate law, unless otherwise specified in the certificate of incorporation or bylaws of a corporation, directors are elected by a plurality of the votes of the shares entitled to vote on the election of directors and may be removed with or without cause (or, with respect to a classified board, only with cause unless the certificate of incorporation provides otherwise) by the approval of a majority of the outstanding shares entitled to vote.
Similarly, as permitted by the Companies Law and pursuant to our amended and restated memorandum and articles of association, our board of directors will be divided into three classes with staggered, three-year terms. At each annual meeting of shareholders, the successors to directors whose terms then expire will be elected to serve from the time of election and qualification until the third annual meeting following election. The election of directors shall be by a plurality of the votes of the shares entitled to vote on the election of directors.
In addition, subject to the maximum number of directors designated by resolution of the board of directors, additional directors may be appointed from time to time by the board of Directors or by ordinary resolution either as a result of a casual vacancy or as an additional director.
Directors may be removed or replaced by an ordinary resolution of the shareholders.
Written consent of directors
Under Delaware corporate law, a written consent of the directors must be unanimous to take effect. The position under our amended and restated memorandum and articles of association is the same in this regard.
Indemnification of directors and executive officers and limitation of liability
Cayman Islands law does not limit the extent to which a company’s amended and restated memorandum and articles of association may provide for indemnification of officers and directors, except to the extent any such provision may be held by the Cayman Islands courts to be contrary to public policy, such as to provide indemnification against civil fraud or the consequences of committing a crime. Our amended and restated memorandum and articles of association provide that our board of directors and officers shall be indemnified from and against all liability which they incur in execution of their duty in their respective offices, except liability incurred by reason of such directors’ or officers’ dishonesty, willful default or fraud. This standard of conduct is generally the same as permitted under Delaware corporate law.
Enforcement of civil liabilities
The Cayman Islands has a less developed body of securities laws as compared to the United States and provides less protection to investors. Additionally, Cayman Islands companies may not have standing to sue before the Federal courts of the United States. Although there is no statutory enforcement in the Cayman Islands of judgments obtained in the United States, the courts of the Cayman Islands will recognize a foreign judgment as the basis for a claim at common law in the Cayman Islands provided such judgment:
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is one in respect of which the foreign court had jurisdiction over the defendant according to Cayman Islands conflict of law rules;
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is final and conclusive;
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is either for a liquidated sum not in respect of penalties or taxes or a fine or similar fiscal or revenue obligations or, in certain circumstances, for in personam non-money relief; and
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was neither obtained in a manner, nor is of a kind enforcement of which is contrary to natural justice or the public policy of the Cayman Islands.
As a result of English case law, which will likely be highly persuasive in the Cayman Islands, the Cayman Islands Courts may also have discretion to enforce judgments obtained in foreign bankruptcy proceedings in other circumstances.
Anti-Money Laundering, Counter-Terrorism Financing, Prevention of Proliferation Financing and Financial Sanctions Compliance — Cayman Islands
If any person resident in the Cayman Islands knows or suspects, or has reasonable grounds for knowing or suspecting, that another person is engaged in criminal conduct, is involved with terrorism or terrorist property or proliferation financing or is the business combination partner of a financial sanction and the information for that knowledge or suspicion came to their attention in the course of business in the regulated sector or other trade, profession, business or employment, the person will be required to report such knowledge or suspicion to (i) the Financial Reporting Authority of the Cayman Islands, pursuant to the Proceeds of Crime Act (as amended) of the Cayman Islands if the disclosure relates to criminal conduct, money laundering or proliferation financing or is the business combination partner of a financial sanction; or (ii) a police officer of the rank of constable or higher, or the Financial Reporting Authority, pursuant to the Terrorism Act (as amended) of the Cayman Islands, if the disclosure relates to involvement with terrorism or terrorist financing and property. Such a report will not be treated as a breach of confidence or of any restriction upon the disclosure of information imposed by any enactment or otherwise. We reserve the right to refuse to make any payment to a shareholder if our directors or officers suspect or are advised that the payment to such shareholder might result in a breach of applicable anti-money laundering, counterterrorist financing, prevention of proliferation financing and financial sanctions or other laws or regulations by any person in any relevant jurisdiction, or if such refusal is considered necessary or appropriate to ensure our compliance with any such laws or regulations in any applicable jurisdiction.
Variation of rights of shares
Under Delaware corporate law, a corporation may vary the rights of a class of shares with the approval of a majority of the outstanding shares of such class, unless the certificate of incorporation provides otherwise.
Under Cayman Islands law and our amended and restated memorandum and articles of association, if our share capital is divided into more than one class of shares, we may only materially and adversely vary or abrogate the rights attached to any class with the sanction of a resolution passed by not less than two-thirds of the votes attaching to the shares of the relevant class cast in a meeting of the holders of the shares of that class, or by the written consent of the holders of not less than two-thirds of the shares of that class.
Sale of assets
Under Delaware corporate law, a vote of the shareholders is required to approve a sale of assets only when all or substantially all assets are being sold to a person other than a subsidiary of the company.
The Companies Law contains no specific restrictions on the powers of directors to dispose of assets of a company. As a matter of general law, in the exercise of those powers, the directors must discharge their duties of care and to act in good faith, for a proper purpose and in the interests of the company.
Transactions with interested shareholders
The Delaware General Corporation Law contains a business combination statute applicable to Delaware corporations whereby, unless the corporation has specifically elected not to be governed by such statute by amendment to its certificate of incorporation, it is prohibited from engaging in certain business combinations with an “interested shareholder” for three years following the date that such person becomes an interested shareholder. An interested shareholder generally is a person or a group who or which owns or owned 15% or more of the target’s outstanding voting stock within the past three years.
This has the effect of limiting the ability of a potential acquirer to make a two-tiered bid for the target in which all shareholders would not be treated equally. The statute does not apply if, among other things, prior to the date on which such shareholder becomes an interested shareholder, the board of directors approves either the business combination or the transaction which resulted in the person becoming an interested shareholder. This encourages any potential acquirer of a Delaware corporation to negotiate the terms of any acquisition transaction with the target’s board of directors.
Cayman Islands law has no comparable statute. As a result, we cannot avail ourselves of the types of protections afforded by the Delaware business combination statute. However, although Cayman Islands law does not regulate transactions between a company and its significant shareholders, it does provide that such transactions must be entered into bona fide in the best interests of the company and not with the effect of constituting a fraud on the minority shareholders.
Rights of non-resident or foreign shareholders
There are no limitations imposed by our amended and restated memorandum and articles of association on the rights of non-resident or foreign shareholders to hold or exercise voting rights on our shares. As similarly provided under Delaware corporate law, there are no restrictions on foreign or non-resident ownership or management of a Cayman Islands exempted company under Cayman Islands law. In addition, there are no provisions in our amended and restated memorandum and articles of association governing the ownership threshold above which shareholder ownership must be disclosed.
Dissolution and winding up
Under the Delaware General Corporation Law, unless the board of directors approves the proposal to dissolve, dissolution must be approved by shareholders holding 100% of the total voting power of the corporation. Only if the dissolution is initiated by the board of directors may it be approved by a simple majority of the corporation’s outstanding shares. Delaware law allows a Delaware corporation to include in its certificate of incorporation a supermajority voting requirement in connection with a dissolution initiated by the board of directors. Under the Companies Law and our amended and restated memorandum and articles of association, our company may be voluntarily dissolved, liquidated or wound up only by a special resolution of our shareholders, in which regard see “— Ordinary Shares — Voting Rights” above. In addition, a company may be wound up by the Grand Court of the Cayman Islands if the company is unable to pay its debts or if the court is of the opinion that it is just and equitable that our company is wound up.
Inspection of books and records
Under Delaware corporate law, any shareholder of a corporation may for any proper purpose inspect or make copies of the corporation’s stock ledger, list of shareholders and other books and records.
Our shareholders will have no general right under Cayman Islands law to inspect or obtain copies of our list of shareholders or corporate records except our memorandum and restated articles of association.
Amendment of governing documents
Under Delaware corporate law, a corporation’s certificate of incorporation may be amended only if adopted and declared advisable by the board of directors and approved by a majority of the outstanding shares entitled to vote, and the bylaws may be amended with the approval of a majority of the outstanding shares entitled to vote and may, if so provided in the certificate of incorporation, also be amended by the board of directors. As permitted by Cayman Islands law, our amended and restated memorandum and articles of association may be amended with the sanction of a special resolution of shareholders.
Transfer Agent and Registrar
The transfer agent and registrar for our ordinary shares is Computershare Trust Company, N.A.
Stock Exchange Listing
Our ordinary shares are listed on the Nasdaq Global Select Market under the symbol “MGTX.”
DESCRIPTION OF WARRANTS
We may issue warrants for the purchase of our ordinary shares or preferred shares. We may issue warrants independently or together with other securities, and the warrants may be attached to or separate from any offered securities. Each series of warrants will be issued under a separate warrant agreement to be entered into between us and the investors or a warrant agent. The following summary of material provisions of the warrants and warrant agreements are subject to, and qualified in their entirety by reference to, all the provisions of the warrant agreement and warrant certificate applicable to a particular series of warrants. The terms of any warrants offered under a prospectus supplement may differ from the terms described below. We urge you to read the applicable prospectus supplement and any related free writing prospectus, as well as the complete warrant agreements and warrant certificates that contain the terms of the warrants.
The particular terms of any issue of warrants will be described in the prospectus supplement relating to the issue.
Those terms may include:
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the number of ordinary shares or preferred shares purchasable upon the exercise of warrants to purchase such shares and the price at which such number of shares may be purchased upon such exercise;
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the designation, stated value and terms (including, without limitation, liquidation, dividend, conversion and voting rights) of the series of preferred shares purchasable upon exercise of warrants to purchase preferred shares;
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the principal amount of debt securities that may be purchased upon exercise of a debt warrant and the exercise price for the warrants, which may be payable in cash, securities or other property;
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the date, if any, on and after which the warrants and the related debt securities, preferred ordinary shares will be separately transferable;
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the terms of any rights to redeem or call the warrants;
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the date on which the right to exercise the warrants will commence and the date on which the right will expire;
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United States federal income tax consequences applicable to the warrants; and
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any additional terms of the warrants, including terms, procedures, and limitations relating to the exchange, exercise and settlement of the warrants.
Holders of equity warrants will not be entitled to:
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vote, consent or receive dividends;
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receive notice as shareholders with respect to any meeting of shareholders for the election of our directors or any other matter; or
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exercise any rights as shareholders of MeiraGTx Holdings plc.
Each warrant will entitle its holder to purchase the principal amount of debt securities or the number of shares of preferred shares, as applicable, at the exercise price set forth in, or calculable as set forth in, the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise the warrants at any time up to the specified time on the expiration date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants will become void.
A holder of warrant certificates may exchange them for new warrant certificates of different denominations, present them for registration of transfer and exercise them at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement. Until any warrants to purchase debt securities are exercised, the holder of the warrants will not have any rights of holders of the debt securities that can be purchased upon exercise, including any rights to receive payments of principal, premium or interest on the underlying debt securities or to enforce covenants in the applicable indenture. Until any warrants to purchase ordinary shares or preferred shares are exercised, the holders of the warrants will not have any rights of holders of the underlying ordinary shares or preferred shares, including any rights to receive dividends or payments upon any liquidation, dissolution or winding up of the Company, if any.
DESCRIPTION OF PURCHASE CONTRACTS
We may issue purchase contracts for the purchase or sale of debt or equity securities issued by us. Each purchase contract will entitle the holder thereof to purchase or sell, and obligate us to sell or purchase, on specified dates, such securities at a specified purchase price, which may be based on a formula, all as set forth in the applicable prospectus supplement. Any purchase contracts we issue will be physically settled by delivery of such securities. The applicable prospectus supplement will also specify the methods by which the holders may purchase or sell such securities and any acceleration, cancellation or termination provisions or other provisions relating to the settlement of a purchase contract.
DESCRIPTION OF UNITS
We may issue units consisting of any combination of the other types of securities offered under this prospectus in one or more series. We may evidence each series of units by unit certificates that we will issue under a separate agreement. We may enter into unit agreements with a unit agent. Each unit agent will be a bank or trust company that we select. We will indicate the name and address of the unit agent in the applicable prospectus supplement relating to a particular series of units.
The following description, together with the additional information included in any applicable prospectus supplement, summarizes the general features of the units that we may offer under this prospectus. You should read any prospectus supplement and any free writing prospectus that we may authorize to be provided to you related to the series of units being offered, as well as the complete unit agreements that contain the terms of the units. Specific unit agreements will contain additional important terms and provisions and we will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference from another report that we file with the SEC, the form of each unit agreement relating to units offered under this prospectus.
If we offer any units, certain terms of that series of units will be described in the applicable prospectus supplement, including, without limitation, the following, as applicable:
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the title of the series of units;
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identification and description of the separate constituent securities comprising the units;
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the price or prices at which the units will be issued;
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the date, if any, on and after which the constituent securities comprising the units will be separately transferable;
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a discussion of certain United States federal income tax considerations applicable to the units; and
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any other terms of the units and their constituent securities.
GLOBAL SECURITIES
Book-Entry, Delivery and Form
Unless we indicate differently in any applicable prospectus supplement or free writing prospectus, the securities initially will be issued in book-entry form and represented by one or more global notes or global securities, or collectively, global securities. The global securities will be deposited with, or on behalf of, The Depository Trust Company, New York, New York, as depositary, or DTC, and registered in the name of Cede & Co., the nominee of DTC. Unless and until it is exchanged for individual certificates evidencing securities under the limited circumstances described below, a global security may not be transferred except as a whole by the depositary to its nominee or by the nominee to the depositary, or by the depositary or its nominee to a successor depositary or to a nominee of the successor depositary.
DTC has advised us that it is:
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a limited-purpose trust company organized under the New York Banking Law;
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a “banking organization” within the meaning of the New York Banking Law;
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a member of the Federal Reserve System;
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a “clearing corporation” within the meaning of the New York Uniform Commercial Code; and
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a “clearing agency” registered pursuant to the provisions of Section 17A of the Exchange Act.
DTC holds securities that its participants deposit with DTC. DTC also facilitates the settlement among its participants of securities transactions, such as transfers and pledges, in deposited securities through electronic computerized book-entry changes in participants’ accounts, thereby eliminating the need for physical movement of securities certificates. “Direct participants” in DTC include securities brokers and dealers, including underwriters, banks, trust companies, clearing corporations and other organizations. DTC is a wholly-owned subsidiary of The Depository Trust & Clearing Corporation, or DTCC. DTCC is the holding company for DTC, National Securities Clearing Corporation and Fixed Income Clearing Corporation, all of which are registered clearing agencies. DTCC is owned by the users of its regulated subsidiaries. Access to the DTC system is also available to others, which we sometimes refer to as indirect participants, that clear through or maintain a custodial relationship with a direct participant, either directly or indirectly. The rules applicable to DTC and its participants are on file with the SEC.
Purchases of securities under the DTC system must be made by or through direct participants, which will receive a credit for the securities on DTC’s records. The ownership interest of the actual purchaser of a security, which we sometimes refer to as a beneficial owner, is in turn recorded on the direct and indirect participants’ records. Beneficial owners of securities will not receive written confirmation from DTC of their purchases. However, beneficial owners are expected to receive written confirmations providing details of their transactions, as well as periodic statements of their holdings, from the direct or indirect participants through which they purchased securities. Transfers of ownership interests in global securities are to be accomplished by entries made on the books of participants acting on behalf of beneficial owners. Beneficial owners will not receive certificates representing their ownership interests in the global securities, except under the limited circumstances described below.
To facilitate subsequent transfers, all global securities deposited by direct participants with DTC will be registered in the name of DTC’s partnership nominee, Cede & Co., or such other name as may be requested by an authorized representative of DTC. The deposit of securities with DTC and their registration in the name of Cede & Co. or such other nominee will not change the beneficial ownership of the securities. DTC has no knowledge of the actual beneficial owners of the securities. DTC’s records reflect only the identity of the direct participants to whose accounts the securities are credited, which may or may not be the beneficial owners. The participants are responsible for keeping account of their holdings on behalf of their customers.
So long as the securities are in book-entry form, you will receive payments and may transfer securities only through the facilities of the depositary and its direct and indirect participants. We will maintain an office or agency in the location specified in the prospectus supplement for the applicable securities, where notices and demands in respect of the securities may be delivered to us and where certificated securities may be surrendered for payment, registration of transfer or exchange.
Conveyance of notices and other communications by DTC to direct participants, by direct participants to indirect participants and by direct participants and indirect participants to beneficial owners will be governed by arrangements among them, subject to any legal requirements in effect from time to time.
Redemption notices will be sent to DTC. If less than all of the securities of a particular series are being redeemed, DTC’s practice is to determine by lot the amount of the interest of each direct participant in the securities of such series to be redeemed.
Neither DTC nor Cede & Co. (or such other DTC nominee) will consent or vote with respect to the securities. Under its usual procedures, DTC will mail an omnibus proxy to us as soon as possible after the record date. The omnibus proxy assigns the consenting or voting rights of Cede & Co. to those direct participants to whose accounts the securities of such series are credited on the record date, identified in a listing attached to the omnibus proxy. So long as securities are in book-entry form, we will make payments on those securities to the depositary or its nominee, as the registered owner of such securities, by wire transfer of immediately available funds. If securities are issued in definitive certificated form under the limited circumstances described below and unless if otherwise provided in the description of the applicable securities herein or in the applicable prospectus supplement, we will have the option of making payments by check mailed to the addresses of the persons entitled to payment or by wire transfer to bank accounts in the United States designated in writing to the applicable trustee or other designated party at least 15 days before the applicable payment date by the persons entitled to payment, unless a shorter period is satisfactory to the applicable trustee or other designated party.
Redemption proceeds, distributions and dividend payments on the securities will be made to Cede & Co., or such other nominee as may be requested by an authorized representative of DTC. DTC’s practice is to credit direct participants’ accounts upon DTC’s receipt of funds and corresponding detail information from us on the payment date in accordance with their respective holdings shown on DTC records. Payments by participants to beneficial owners will be governed by standing instructions and customary practices, as is the case with securities held for the account of customers in bearer form or registered in “street name.” Those payments will be the responsibility of participants and not of DTC or us, subject to any statutory or regulatory requirements in effect from time to time. Payment of redemption proceeds, distributions and dividend payments to Cede & Co., or such other nominee as may be requested by an authorized representative of DTC, is our responsibility, disbursement of payments to direct participants is the responsibility of DTC, and disbursement of payments to the beneficial owners is the responsibility of direct and indirect participants.
Except under the limited circumstances described below, purchasers of securities will not be entitled to have securities registered in their names and will not receive physical delivery of securities. Accordingly, each beneficial owner must rely on the procedures of DTC and its participants to exercise any rights under the securities and the indenture.
The laws of some jurisdictions may require that some purchasers of securities take physical delivery of securities in definitive form. Those laws may impair the ability to transfer or pledge beneficial interests in securities.
DTC may discontinue providing its services as securities depositary with respect to the securities at any time by giving reasonable notice to us. Under such circumstances, in the event that a successor depositary is not obtained, securities certificates are required to be printed and delivered.
As noted above, beneficial owners of a particular series of securities generally will not receive certificates representing their ownership interests in those securities. However, if:
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DTC notifies us that it is unwilling or unable to continue as a depositary for the global security or securities representing such series of securities or if DTC ceases to be a clearing agency registered under the Exchange Act at a time when it is required to be registered and a successor depositary is not appointed within 90 days of the notification to us or of our becoming aware of DTC’s ceasing to be so registered, as the case may be; or
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we determine, in our sole discretion, not to have such securities represented by one or more global securities,
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an Event of Default has occurred and is continuing with respect to such series of securities,
we will prepare and deliver certificates for such securities in exchange for beneficial interests in the global securities. Any beneficial interest in a global security that is exchangeable under the circumstances described in the preceding sentence will be exchangeable for securities in definitive certificated form registered in the names that the depositary directs. It is expected that these directions will be based upon directions received by the depositary from its participants with respect to ownership of beneficial interests in the global securities.
Euroclear and Clearstream
If so provided in the applicable prospectus supplement, you may hold interests in a global security through Clearstream Banking S.A., which we refer to as Clearstream, or Euroclear Bank S.A./N.V., as operator of the Euroclear System, which we refer to as Euroclear, either directly if you are a participant in Clearstream or Euroclear or indirectly through organizations that are participants in Clearstream or Euroclear. Clearstream and Euroclear will hold interests on behalf of their respective participants through customers’ securities accounts in the names of Clearstream and Euroclear, respectively, on the books of their respective U.S. depositaries, which in turn will hold such interests in customers’ securities accounts in such depositaries’ names on DTC’s books.
Clearstream and Euroclear are securities clearance systems in Europe. Clearstream and Euroclear hold securities for their respective participating organizations and facilitate the clearance and settlement of securities transactions between those participants through electronic book-entry changes in their accounts, thereby eliminating the need for physical movement of certificates.
Payments, deliveries, transfers, exchanges, notices and other matters relating to beneficial interests in global securities owned through Euroclear or Clearstream must comply with the rules and procedures of those systems. Transactions between participants in Euroclear or Clearstream, on the one hand, and other participants in DTC, on the other hand, are also subject to DTC’s rules and procedures.
Investors will be able to make and receive through Euroclear and Clearstream payments, deliveries, transfers and other transactions involving any beneficial interests in global securities held through those systems only on days when those systems are open for business. Those systems may not be open for business on days when banks, brokers and other institutions are open for business in the United States.
Cross-market transfers between participants in DTC, on the one hand, and participants in Euroclear or Clearstream, on the other hand, will be effected through DTC in accordance with the DTC’s rules on behalf of Euroclear or Clearstream, as the case may be, by their respective U.S. depositaries; however, such cross-market transactions will require delivery of instructions to Euroclear or Clearstream, as the case may be, by the counterparty in such system in accordance with the rules and procedures and within the established deadlines (European time) of such system. Euroclear or Clearstream, as the case may be, will, if the transaction meets its settlement requirements, deliver instructions to its U.S. depositary to take action to effect final settlement on its behalf by delivering or receiving interests in the global securities through DTC, and making or receiving payment in accordance with normal procedures for same-day fund settlement. Participants in Euroclear or Clearstream may not deliver instructions directly to their respective U.S. depositaries.
Due to time zone differences, the securities accounts of a participant in Euroclear or Clearstream purchasing an interest in a global security from a direct participant in DTC will be credited, and any such crediting will be reported to the relevant participant in Euroclear or Clearstream, during the securities settlement processing day (which must be a business day for Euroclear or Clearstream) immediately following the settlement date of DTC. Cash received in Euroclear or Clearstream as a result of sales of interests in a global security by or through a participant in Euroclear or Clearstream to a direct participant in DTC will be received with value on the settlement date of DTC but will be available in the relevant Euroclear or Clearstream cash account only as of the business day for Euroclear or Clearstream following DTC’s settlement date.
Other
The information in this section of this prospectus concerning DTC, Clearstream, Euroclear and their respective book-entry systems has been obtained from sources that we believe to be reliable, but we do not
take responsibility for this information. This information has been provided solely as a matter of convenience. The rules and procedures of DTC, Clearstream and Euroclear are solely within the control of those organizations and could change at any time. Neither we nor the trustee nor any agent of ours or of the trustee has any control over those entities and none of us takes any responsibility for their activities. You are urged to contact DTC, Clearstream and Euroclear or their respective participants directly to discuss those matters. In addition, although we expect that DTC, Clearstream and Euroclear will perform the foregoing procedures, none of them is under any obligation to perform or continue to perform such procedures and such procedures may be discontinued at any time. Neither we nor any agent of ours will have any responsibility for the performance or nonperformance by DTC, Clearstream and Euroclear or their respective participants of these or any other rules or procedures governing their respective operations.
PLAN OF DISTRIBUTION
We may sell the securities from time to time pursuant to underwritten public offerings, negotiated transactions, block trades or a combination of these methods or through underwriters or dealers, through agents and/or directly to one or more purchasers. The securities may be distributed from time to time in one or more transactions:
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices;
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at negotiated prices; or
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in privately negotiated transactions.
Each time that we sell securities covered by this prospectus, we will provide a prospectus supplement or supplements that will describe the method of distribution and set forth the terms and conditions of the offering of such securities, including the offering price of the securities and the proceeds to us, if applicable.
Offers to purchase the securities being offered by this prospectus may be solicited directly. Agents may also be designated to solicit offers to purchase the securities from time to time. Any agent involved in the offer or sale of our securities will be identified in a prospectus supplement.
If a dealer is utilized in the sale of the securities being offered by this prospectus, the securities will be sold to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to be determined by the dealer at the time of resale.
If an underwriter is utilized in the sale of the securities being offered by this prospectus, an underwriting agreement will be executed with the underwriter at the time of sale and the name of any underwriter will be provided in the prospectus supplement that the underwriter will use to make resales of the securities to the public. In connection with the sale of the securities, we or the purchasers of securities for whom the underwriter may act as agent, may compensate the underwriter in the form of underwriting discounts or commissions. The underwriter may sell the securities to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions from the underwriters and/or commissions from the purchasers for which they may act as agent.
Unless otherwise indicated in a prospectus supplement, an agent will be acting on a best efforts basis and a dealer will purchase securities as a principal, and may then resell the securities at varying prices to be determined by the dealer.
Any compensation paid to underwriters, dealers or agents in connection with the offering of the securities, and any discounts, concessions or commissions allowed by underwriters to participating dealers will be provided in the applicable prospectus supplement. Underwriters, dealers and agents participating in the distribution of the securities may be deemed to be underwriters within the meaning of the Securities Act and any discounts and commissions received by them and any profit realized by them on resale of the securities may be deemed to be underwriting discounts and commissions. We may enter into agreements to indemnify underwriters, dealers and agents against civil liabilities, including liabilities under the Securities Act, or to contribute to payments they may be required to make in respect thereof and to reimburse those persons for certain expenses.
Any ordinary shares will be listed on The Nasdaq Global Select Market, but any other securities may or may not be listed on a national securities exchange. To facilitate the offering of securities, certain persons participating in the offering may engage in transactions that stabilize, maintain or otherwise affect the price of the securities. This may include over-allotments or short sales of the securities, which involve the sale by persons participating in the offering of more securities than were sold to them. In these circumstances, these persons would cover such over-allotments or short positions by making purchases in the open market or by exercising their over-allotment option, if any. In addition, these persons may stabilize or maintain the price of the securities by bidding for or purchasing securities in the open market or by imposing penalty bids, whereby selling concessions allowed to dealers participating in the offering may be reclaimed if securities
sold by them are repurchased in connection with stabilization transactions. The effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might otherwise prevail in the open market. These transactions may be discontinued at any time.
We may engage in “at-the-market” offerings into an existing trading market in accordance with Rule 415(a)(4) under the Securities Act. In addition, we may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If the applicable prospectus supplement so indicates, in connection with those derivatives, the third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including in short sale transactions. If so, the third party may use securities pledged by us or borrowed from us or others to settle those sales or to close out any related open borrowings of securities, and may use securities received from us in settlement of those derivatives to close out any related open borrowings of securities. The third party in such sale transactions will be an underwriter and, if not identified in this prospectus, will be named in the applicable prospectus supplement (or a post-effective amendment). In addition, we may otherwise loan or pledge securities to a financial institution or other third party that in turn may sell the securities short using this prospectus and an applicable prospectus supplement. Such financial institution or other third party may transfer its economic short position to investors in our securities or in connection with a concurrent offering of other securities.
The specific terms of any lock-up provisions in respect of any given offering will be described in the applicable prospectus supplement.
The underwriters, dealers and agents may engage in transactions with us, or perform services for us, in the ordinary course of business for which they receive compensation.
LEGAL MATTERS
The validity of the ordinary shares and preferred shares offered hereby will be passed upon for us by Walkers (Cayman) LLP. The validity of the warrants, purchase contracts and units offered hereby will be passed upon for us by Latham & Watkins LLP. Additional legal matters may be passed upon for us or any underwriters, dealers or agents, by counsel that we will name in the applicable prospectus supplement.
EXPERTS
The consolidated financial statements of MeiraGTx Holdings plc and subsidiaries appearing in MeiraGTx Holdings plc’s Annual Report on Form 10-K for the year ended December 31, 2022 have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon, included therein, and incorporated herein by reference. Such consolidated financial statements are, and audited financial statements to be included in subsequently filed documents will be, incorporated herein in reliance upon the report of Ernst & Young LLP pertaining to such financial statements (to the extent covered by consents filed with the Securities and Exchange Commission) given on the authority of such firm as experts in accounting and auditing.
$250,000,000
Ordinary shares
Preferred shares
Warrants
Purchase contracts
Units
PROSPECTUS
, 2023
The information in this prospectus supplement is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion, dated December 21, 2023.
PROSPECTUS SUPPLEMENT
Up to $100,000,000
Ordinary Shares
We have entered into a sales agreement with BofA Securities, Inc. (the “Sales Agent”), dated December 21, 2023, relating to the sale of our ordinary shares offered by this prospectus supplement. In accordance with the terms of the sales agreement, under this prospectus supplement we may offer and sell our ordinary shares, $0.00003881 nominal value per share, having an aggregate offering price of up to $100,000,000 from time to time through BofA Securities, Inc., acting as the Sales Agent.
Our ordinary shares are listed on The Nasdaq Global Select Market under the symbol “MGTX.” On December 18, 2023, the last reported sale price of our ordinary shares on The Nasdaq Global Select Market was $4.52 per share.
Sales of our ordinary shares, if any, under this prospectus supplement will be made by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, or the Securities Act. The Sales Agent is not required to sell any specific amount, but will act as our sales agent using commercially reasonable efforts consistent with its normal trading and sales practices on mutually agreed terms between the Sales Agent and us. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.
The aggregate compensation payable to Sales Agent is up to 3.0% of the gross sales price of our ordinary shares sold through it pursuant to the sales agreement. In connection with the sale of the ordinary shares on our behalf, the Sales Agent will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of the Sales Agent will be deemed to be underwriting commissions or discounts. We have also agreed to provide indemnification and contribution to the Sales Agent with respect to certain liabilities, including liabilities under the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”). See “Plan of Distribution” beginning on page S-10 for additional information regarding the compensation to be paid to the Sales Agent.
We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, are subject to certain reduced public company reporting requirements for this prospectus and future filings.
Investing in our securities involves risks. See the “Risk Factors” on page S-6 of this prospectus supplement and in the documents incorporated by reference in this prospectus supplement concerning factors you should consider before investing in our ordinary shares.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
BofA Securities
The date of this prospectus supplement is , 2023
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS SUPPLEMENT
This sales agreement prospectus supplement is part of a registration statement that we have filed with the U.S. Securities and Exchange Commission, or the SEC, utilizing a “shelf” registration process. By using a shelf registration statement, we may offer ordinary shares having an aggregate offering price of up to $100,000,000 from time to time under this prospectus supplement at prices and on terms to be determined by market conditions at the time of offering.
We provide information to you about this offering of our ordinary shares in two separate documents that are bound together: (1) this sales agreement prospectus supplement, which describes the specific details regarding this offering; and (2) the accompanying base prospectus, which provides general information, some of which may not apply to this offering. Generally, when we refer to this “prospectus supplement,” we are referring to both documents combined. If information in this prospectus supplement is inconsistent with the accompanying base prospectus, you should rely on this prospectus supplement. To the extent there is a conflict between the information contained in this prospectus supplement, on the one hand, and the information contained in any document incorporated by reference in this prospectus supplement, on the other hand, you should rely on the information in this prospectus supplement. If any statement in one of these documents is inconsistent with a statement in another document having a later date-for example, a document incorporated by reference in this prospectus supplement — the statement in the document having the later date modifies or supersedes the earlier statement.
We have not, and the Sales Agent has not, authorized anyone to provide you with information other than that contained in this prospectus supplement, the accompanying base prospectus and any free writing prospectus. We are not, and the Sales Agent is not, making an offer to sell or soliciting any offer to buy these securities in any jurisdiction where the offer or sale is not permitted or in which the person making that offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make an offer or solicitation. You should assume that the information appearing in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any free writing prospectus that we have authorized for use in connection with this offering is accurate only as of the date of those respective documents. Our business, financial condition, results of operations and prospects may have changed since those dates. You should read this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any free writing prospectus that we have authorized for use in connection with this offering in their entirety before making an investment decision.
Before buying any of the ordinary shares that we are offering, we urge you to carefully read this prospectus supplement, the accompanying base prospectus and all of the information incorporated by reference herein and therein, as well as the additional information described under the heading “Where You Can Find More Information; Incorporation by Reference.” These documents contain important information that you should consider when making your investment decision.
We are offering to sell, and seeking offers to buy, ordinary shares only in jurisdictions where offers and sales are permitted. The distribution of this prospectus supplement and the offering of the ordinary shares in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus supplement must inform themselves about, and observe any restrictions relating to, the offering of the ordinary shares and the distribution of this prospectus supplement outside the United States. This prospectus supplement does not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.
Unless the context otherwise requires, references in this prospectus to “Meira,” “MeiraGTx,” “we,” “us,” “our” or “the Company” refer to MeiraGTx Holdings plc and its subsidiaries.
WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
Available Information
We are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, which we may refer to as the “Exchange Act” in this prospectus, and are required to file reports, proxy statements and other information with the SEC. The SEC maintains a website that contains reports, proxy and information statements and other information about issuers, such as us, who file electronically with the SEC. The address of that website is http://www.sec.gov.
Our website address is www.meiragtx.com. The information on our website, however, is not, and should not be deemed to be, a part of this prospectus.
This prospectus and any prospectus supplement are part of a registration statement that we filed with the SEC and do not contain all of the information in the registration statement. The full registration statement may be obtained from the SEC or us, as provided below. Forms of the documents establishing the terms of the offered securities are or may be filed as exhibits to the registration statement or documents incorporated by reference in the registration statement. Statements in this prospectus or any prospectus supplement about these documents are summaries and each statement is qualified in all respects by reference to the document to which it refers. You should refer to the actual documents for a more complete description of the relevant matters. You may inspect a copy of the registration statement through the SEC’s website, as provided above.
Incorporation by Reference
The SEC’s rules allow us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically update and supersede that information. Any statement contained in this prospectus or a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or a subsequently filed document incorporated by reference modifies or replaces that statement.
This prospectus and any accompanying prospectus supplement incorporate by reference the documents set forth below that have previously been filed with the SEC (other than those documents or the portions of those documents not deemed to be filed):
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Our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 11, 2023, for the quarter ended June 30, 2023, filed with the SEC on August 10, 2023 and for the quarter ended September 30, 2023, filed with the SEC on November 14, 2023;
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Our Current Reports on Form 8-K, filed with the SEC on April 26, 2023, May 9, 2023, June 12, 2023, August 10, 2023, October 30, 2023 and December 21, 2023; and
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All reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the termination of this offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will also be
incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of such reports and documents. We are not, however, incorporating by reference any documents or portions thereof, whether specifically listed above or filed in the future, that are not deemed “filed” with the SEC, including our stock performance graph or any information furnished pursuant to Items 2.02 or 7.01 of Form 8-K or related exhibits furnished pursuant to Item 9.01 of Form 8-K.
You may request a free copy of any of the documents incorporated by reference in this prospectus by writing or telephoning us at the following address:
MeiraGTx Holdings plc
450 East 29th Street, 14th Floor
New York, New York 10016
(646) 860-7985
Exhibits to the filings will not be sent, however, unless those exhibits have specifically been incorporated by reference in this prospectus or any accompanying prospectus supplement.
PROSPECTUS SUPPLEMENT SUMMARY
This summary provides a general overview of selected information and does not contain all of the information you should consider before buying our ordinary shares. Therefore, you should read this entire prospectus supplement, the accompanying base prospectus and any free writing prospectus that we have authorized for use in connection with this offering carefully, including the information incorporated by reference, before deciding to invest in our ordinary shares. Investors should carefully consider the information set forth under “Risk Factors” beginning on page S-7 of this prospectus supplement and incorporated by reference to our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q.
Overview
We are a vertically integrated, clinical-stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. We have core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology that allows precise, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, we have taken a portfolio approach by licensing, acquiring and developing technologies that give us depth across both product candidates and indications. Our initial focus is on three distinct areas of unmet medical need: ocular diseases, including both inherited retinal diseases as well as large degenerative ocular diseases, neurodegenerative diseases, and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, we plan to expand our focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.
MeiraGTx Holdings plc was formed on May 1, 2018, under the laws of the Cayman Islands. Our predecessor, MeiraGTx Limited, a limited company under the laws of England and Wales, was formed on March 20, 2015. In connection with our initial public offering, we reorganized whereby MeiraGTx Limited became a wholly owned subsidiary of MeiraGTx Holdings plc.
Our principal executive offices are located at 450 East 29th Street, 14th Floor, New York, New York 10016 and our telephone number is (646) 860-7985.
Emerging Growth Company Status
We qualify as an emerging growth company as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in 2012. As an emerging growth company, we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:
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not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended;
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reduced disclosure obligations regarding our executive compensation; and
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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
We may take advantage of these provisions until December 31, 2023. Effective as of December 31, 2023, we will no longer be allowed to take advantage of the reduced reporting requirements that are applicable to emerging growth companies. Until such time, however, we are permitted and will continue to rely on various exemptions from certain disclosure requirements as an emerging growth.
THE OFFERING
Ordinary shares offered by us
Our ordinary shares having an aggregate offering price of up to $100,000,000.
Ordinary shares to be outstanding after this offering
81,721,045 ordinary shares (as more fully described in the notes following this table), assuming sales of 21,413,276 ordinary shares in this offering at an offering price of $4.52 per share, the last reported sale price of our ordinary shares on the Nasdaq on December 18, 2023. The actual number of shares issued will vary depending on the sales price under this offering.
“At the market offerings” that may be made from time to time on The Nasdaq Global Select Market or other existing trading market for our ordinary shares through our agent, BofA Securities, Inc. See the section entitled “Plan of Distribution” on page S-10 of this prospectus supplement.
We intend to use the net proceeds of this offering for general corporate purposes, which may include the development and commercialization of our product candidates, research and development, manufacturing, general and administrative expenses, license or technology acquisitions, and working capital and capital expenditures. See the section entitled “Use of Proceeds” on page S-10 of this prospectus supplement.
See “Risk Factors” beginning on page S-7 of this prospectus supplement and the other information included in, or incorporated by reference into, this prospectus supplement for a discussion of certain factors you should carefully consider before deciding to invest in our ordinary shares.
Nasdaq Global Select Market symbol
MGTX
The number of our ordinary shares to be outstanding immediately after this offering is based on 59,597,151 ordinary shares outstanding as of September 30, 2023 and excludes:
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8,307,672 ordinary shares issuable upon exercise of share options outstanding under our 2018 Incentive Award Plan, or 2018 Plan, at a weighted-average exercise price of $12.95 per share, as of September 30, 2023;
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2,661,250 ordinary shares issuable upon vesting of restricted share units outstanding, as of September 30, 2023;
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14,049 ordinary shares subject to forfeiture outstanding, as of September 30, 2023;
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185,000 ordinary shares underlying outstanding deferred share units granted as of September 30, 2023
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245,100 ordinary shares reserved for future issuance under our 2018 Plan, as of September 30, 2023, as well as any automatic increases in the number of our ordinary shares reserved for future issuance under our 2018 Plan;
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2,523,103 ordinary shares reserved for future issuance under our 2018 Employee Share Purchase Plan, or our 2018 ESPP as well as any automatic increases in the number of our ordinary shares reserved for future issuance under our 2018 ESPP;
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warrants to purchase (i) 400,000 ordinary shares at an exercise price of $15.00 and (ii) 300,000 ordinary shares at an exercise price of $20.00 that were outstanding as of September 30, 2023; and
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4,000,000 ordinary shares that were issued and sold in a private placement transaction on October 30, 2023.
RISK FACTORS
Investment in any securities offered pursuant to this prospectus supplement and the accompanying base prospectus involves risks. You should carefully consider the risk factors described below and in our Annual Report on Form 10-K for the year ended December 31, 2022 incorporated by reference in this prospectus supplement, any amendment or update thereto reflected in subsequent filings with the SEC, including in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and all other information contained or incorporated by reference in this prospectus supplement, as updated by our subsequent filings under the Exchange Act. The risks and uncertainties we have described are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations. The occurrence of any of these risks might cause you to lose all or part of your investment in the offered securities.
Risks Relating to this Offering
If you purchase our ordinary shares sold in this offering, you will experience immediate and potentially substantial dilution in the net tangible book value of your shares. In addition, we may issue additional equity or convertible debt securities in the future, which may result in additional dilution to you.
The price per share of our ordinary shares being offered may be higher than the net tangible book value per share of our outstanding ordinary shares prior to this offering. For a more detailed discussion of the foregoing, see the section entitled “Dilution” below. To the extent outstanding stock options or warrants are exercised, there will be further dilution to new investors. In addition, to the extent we need to raise additional capital in the future and we issue additional ordinary shares or securities convertible or exchangeable for our ordinary shares, our then existing shareholders may experience dilution and the new securities may have rights senior to those of our ordinary shares offered in this offering.
We have broad discretion over the use of the net proceeds from this offering and may not use them effectively.
Our management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in the section entitled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our management might not apply our net proceeds in ways that ultimately increase the value of your investment. The failure by our management to apply these funds effectively could harm our business. Pending their use, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government. These investments may not yield a favorable return to our shareholders. If we do not invest or apply the net proceeds from this offering in ways that enhance shareholder value, we may fail to achieve expected financial results, which could cause our share price to decline.
Future sales or issuances of our ordinary shares in the public markets, or the perception of such sales, could depress the trading price of our ordinary shares.
The sale of a substantial number of our ordinary shares or other equity-related securities in the public markets, or the perception that such sales could occur, could depress the market price of our ordinary shares and impair our ability to raise capital through the sale of additional equity securities. We may sell large quantities of our ordinary shares at any time pursuant to this prospectus supplement or in one or more separate offerings. We cannot predict the effect that future sales of ordinary shares or other equity-related securities would have on the market price of our ordinary shares.
The actual number of ordinary shares we will issue under the sales agreement, at any one time or in total, is uncertain.
Subject to certain limitations in the sales agreement and compliance with applicable law, we have the discretion to deliver a placement notice to the Sales Agent at any time throughout the term of the sales agreement. The number of ordinary shares that are sold by the Sales Agent after delivering a placement notice
will fluctuate based on the market price of our ordinary shares during the sales period and limits we set with the Sales Agent. Because the price per ordinary share sold will fluctuate based on the market price of our ordinary shares during the sales period, it is not possible at this stage to predict the number of ordinary shares that will be ultimately issued.
The ordinary shares offered hereby will be sold in “at the market offerings,” and investors who buy shares at different times will likely pay different prices.
Investors who purchase ordinary shares in this offering at different times will likely pay different prices, and so may experience different outcomes in their investment results. We will have discretion, subject to market demand, to vary the timing, prices, and numbers of ordinary shares sold, and there is no minimum or maximum sales price. Investors may experience a decline in the value of their shares as a result of ordinary share sales made at prices lower than the prices they paid.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein and any free writing prospectus that we have authorized for use in connection with this offering may contain forward-looking statements. All statements other than statements of historical facts contained in this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein and any free writing prospectus, including, but not limited to, statements regarding our expected use of proceeds, if any, from this offering, future results of operations and financial position, our product candidate development, anticipated future milestones regarding pre-clinical and clinical data and reporting of such data, meetings with regulatory authorities regarding pathways for regulatory approval of our product candidates, timing and results of data from our trials and timing of the initiation of trials in respect of our product candidates, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. This prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein and any free writing prospectus may also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein and any free writing prospectus are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the respective dates of this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein and any free writing prospectus, as applicable, and are subject to a number of risks, uncertainties and assumptions, including those described under “Risk Factors” and elsewhere in this prospectus supplement. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained in this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein and any free writing prospectus, whether as a result of any new information, future events, changed circumstances or otherwise.
USE OF PROCEEDS
We may issue and sell our ordinary shares having aggregate sales proceeds of up to $100,000,000 from time to time. Because there is no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time.
We intend to use the net proceeds of this offering for general corporate purposes, which may include the development and commercialization of our product candidates, research and development, manufacturing, general and administrative expenses, license or technology acquisitions, and working capital and capital expenditures. The amounts and timing of our actual expenditures will depend on numerous factors, including the progress of our clinical trials and other development efforts and other factors described under “Risk Factors” in this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference herein and therein, as well as the amount of cash used in our operations. We may find it necessary or advisable to use the net proceeds for other purposes, and we will have broad discretion in the application of the net proceeds. Pending the use of the net proceeds described above, we plan to invest the net proceeds from this offering in a variety of capital preservation investments, including short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our ordinary shares. We intend to retain future earnings, if any, to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future. However, if we do pay a cash dividend on our ordinary shares in the future, we will only pay such dividend out of our profits or share premium (subject to solvency requirements) as permitted under Cayman Islands law and our outstanding indebtedness.
DILUTION
If you invest in our ordinary shares, your interest will be diluted to the extent of the difference between the price per share you pay in this offering and the net tangible book value per share of our ordinary shares immediately after this offering. Our net tangible book value of our ordinary shares as of September 30, 2023 was approximately $66.9 million, or approximately $1.12 per share of ordinary shares based upon 59,597,151 shares outstanding. Net tangible book value per share is equal to our total tangible assets, less our total liabilities, divided by the total number of shares outstanding as of September 30, 2023.
After giving effect to the sale of our ordinary shares in the aggregate amount of $100,000,000 at an assumed offering price of $4.52 per share, the last reported sale price of our ordinary shares on The Nasdaq Global Select Market on December 18, 2023, and after deducting estimated commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of September 30, 2023 would have been $163.7 million, or $2.00 per ordinary share. This represents an immediate increase in net tangible book value of $0.88 per ordinary share to our existing shareholders and an immediate dilution in net tangible book value of $2.52 per ordinary share to new investors in this offering.
The following table illustrates this calculation on a per ordinary share basis. The as adjusted information is illustrative only and will adjust based on the actual price to the public, the actual number of ordinary shares sold and other terms of the offering determined at the time our ordinary shares are sold pursuant to this prospectus supplement. The as adjusted information assumes that all of our ordinary shares in the aggregate amount of $100,000,000 is sold at the assumed offering price of $4.52 per ordinary share, the last reported sale price of our ordinary shares on The Nasdaq Global Select Market on December 18, 2023. The ordinary shares sold in this offering, if any, will be sold from time to time at various prices.
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Assumed public offering price per ordinary share
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4.52 |
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Net tangible book value per ordinary share as of September 30, 2023
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1.12 |
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Increase in net tangible book value per ordinary share attributable to the
offering
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0.88 |
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As adjusted net tangible book value per ordinary share after giving effect to the offering
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$ |
2.00 |
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Dilution per share to new investors participating in the offering
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$ |
2.52 |
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The above discussion and table are based on 59,597,151 ordinary shares outstanding as of September 30, 2023. The number of ordinary shares outstanding as of September 30, 2023 excludes:
•
8,307,672 ordinary shares issuable upon exercise of share options outstanding under our 2018 Incentive Award Plan, or 2018 Plan, at a weighted-average exercise price of $12.95 per share, as of September 30, 2023;
•
2,661,250 ordinary shares issuable upon vesting of restricted share units outstanding, as of September 30, 2023;
•
14,049 ordinary shares subject to forfeiture outstanding, as of September 30, 2023;
•
185,000 ordinary shares underlying outstanding deferred share units granted as of September 30, 2023
•
245,100 ordinary shares reserved for future issuance under our 2018 Plan, as of September 30, 2023, as well as any automatic increases in the number of our ordinary shares reserved for future issuance under our 2018 Plan;
•
2,523,103 ordinary shares reserved for future issuance under our 2018 ESPP as well as any automatic increases in the number of our ordinary shares reserved for future issuance under our 2018 ESPP;
•
warrants to purchase (i) 400,000 ordinary shares at an exercise price of $15.00 and (ii) 300,000 ordinary shares at an exercise price of $20.00 that were outstanding as of September 30, 2023; and
•
4,000,000 ordinary shares that were issued and sold in a private placement transaction on October 30, 2023.
The foregoing table does not give effect to the exercise of any outstanding options, warrants or vesting of any restricted share units or restricted shares. To the extent options or warrants are exercised or restricted share units or restricted shares vest, there may be further dilution to new investors.
MATERIAL CAYMAN ISLANDS TAX CONSIDERATIONS
The following discussion is a summary of the material Cayman Islands tax considerations relating to the purchase, ownership and disposition of our ordinary shares. There is, at present, no direct taxation in the Cayman Islands and interest, dividends and gains payable to the Company will be received free of all Cayman Islands taxes. The company has received an undertaking from the Government of the Cayman Islands to the effect that, for a period of twenty years from the date of the undertaking, no law that thereafter is enacted in the Cayman Islands imposing any tax or duty to be levied on profits, income or on gains or appreciation, or any tax in the nature of estate duty or inheritance tax, will apply to any property comprised in or any income arising under the Company, or to the shareholders thereof, in respect of any such property or income.
No stamp duty in the Cayman Islands is payable in respect of the issue of any ordinary shares or an instrument of transfer in respect of an ordinary share.
MATERIAL UNITED KINGDOM TAX CONSIDERATIONS
The following statements are of a general nature and do not purport to be a complete analysis of all potential UK tax consequences of acquiring, holding and disposing of our ordinary shares. They are based on current UK tax law and on the current published practice of His Majesty’s Revenue and Customs (“HMRC”) (which may not be binding on HMRC), as of the date of this prospectus supplement, all of which are subject to change, possibly with retrospective effect. They are intended to address only certain United Kingdom (“UK”) tax consequences for holders of our ordinary shares who are tax resident in (and only in) the UK, and in the case of individuals, domiciled in (and only in) the UK (except where expressly stated otherwise) who are the absolute beneficial owners of our ordinary shares and any dividends paid on them and who hold our ordinary shares as investments (other than in an individual savings account or a self-invested personal pension). They do not address the UK tax consequences which may be relevant to certain classes of holders of our ordinary shares such as traders, brokers, dealers, banks, financial institutions, insurance companies, investment companies, collective investment schemes, tax-exempt organizations, trustees, persons connected with us or a member of our group, persons holding our ordinary shares as part of hedging or conversion transactions, holders of our ordinary shares who have (or are deemed to have) acquired our ordinary shares by virtue of an office or employment, and holders of our ordinary shares who are or have been officers or employees of us or a company forming part of our group.
The following is intended only as a general guide and is not intended to be, nor should it be considered to be, legal or tax advice to any particular prospective subscriber for, or purchaser of, our ordinary shares. Accordingly, prospective subscribers for, or purchasers of, our ordinary shares who are in any doubt as to their tax position regarding the acquisition, ownership and disposition of our ordinary shares or who are subject to tax in a jurisdiction other than the UK should consult their own tax advisers.
The Company
It is the intention of the directors to conduct the affairs of the Company so that the central management and control of the Company is exercised in the UK. As a result, the Company is expected to be treated as resident in the UK for UK tax purposes. Accordingly we expect to be subject to UK taxation on our income and gains, except where an exemption or relief applies.
Taxation of dividends
Withholding tax
We will not be required to withhold UK tax at source when paying dividends on our ordinary shares.
Income tax
An individual holder of our ordinary shares who is resident for tax purposes in the UK may, depending on his or her particular circumstances, be subject to UK tax on dividends received from us. An individual holder of our ordinary shares who is not resident for tax purposes in the UK should not be chargeable to UK income tax on dividends received from us unless he or she carries on (whether solely or in partnership) any trade, profession or vocation in the UK through a branch or agency to which our ordinary shares are attributable. There are certain exceptions for trading in the UK through independent agents, such as some brokers and investment managers.
All dividends received by a UK resident individual holder of our ordinary shares from us or from other sources will form part of that holder’s total income for income tax purposes and will constitute the top slice of that income. A nil rate of income tax will apply to the first £1,000 (for the tax year 2023/24, expected to reduce to £500 from 6 April 2024) of taxable dividend income received by the holder of our ordinary shares in a tax year. Income within the nil rate band will be taken into account in determining whether income in excess of the nil rate band falls within the basic rate, higher rate or additional rate tax bands. Where the dividend income is above the nil rate band, any excess amount will be taxed at 8.75 per cent. to the extent that the excess amount falls within the basic rate tax band, 33.75 per cent. to the extent that the excess amount falls within the higher rate tax band and 39.35 per cent. to the extent that the excess amount falls within the additional rate tax band.
Corporation tax
Corporate holders of our ordinary shares which are resident for tax purposes in the UK should not be subject to UK corporation tax on any dividend received from us so long as the dividends qualify for exemption and certain conditions are met (including, for example, the conditions in section 931G of the Corporation Tax Act 2009 and applicable anti-avoidance conditions). If the conditions for exemption are not met or cease to be satisfied, or such a holder elects for an otherwise exempt dividend to be taxable, the holder will be subject to UK corporation tax on dividends received from us, at the rate of corporation tax applicable to that holder (the main rate of UK corporation tax is currently 25 per cent.).
Corporate holders of our ordinary shares which are not resident in the UK will not generally be subject to UK corporation tax on dividends unless they are carrying on a trade, profession or vocation in the UK through a permanent establishment in connection with which such shares are attributable. A holder of our ordinary shares who is resident outside the UK may be subject to non-UK taxation on dividend income under local law.
Taxation of capital gains
UK resident holders of our ordinary shares
A disposal or deemed disposal of our ordinary shares by an individual or corporate holder of such shares who is tax resident in the UK may, depending on that holder’s circumstances and subject to any available exemptions or reliefs, give rise to a chargeable gain or allowable loss for the purposes of UK taxation of chargeable gains.
Any chargeable gain (or allowable loss) will generally be calculated by reference to the consideration received for the disposal of our ordinary shares less the allowable cost to the holder of acquiring such shares.
The applicable tax rates for individual holders of our ordinary shares realizing a gain on the disposal of such shares is, broadly, 10% for basic rate taxpayers and 20% for higher and additional rate taxpayers. For corporate holders of our ordinary shares, corporation tax is generally charged on chargeable gains at the rate applicable to the relevant corporate holder.
Non-UK holders of our ordinary shares
Holders of our ordinary shares who are not resident in the UK and, in the case of an individual holder of our ordinary shares, not temporarily non-resident, should not be liable for UK tax on capital gains realized on a sale or other disposal of our ordinary shares unless (i) such shares are attributable to a trade, profession or vocation carried on in the UK through a branch or agency or, in the case of a corporate holder of our ordinary shares, through a permanent establishment or (ii) where certain conditions are met, the Company derives 75% or more of its gross asset value from UK land. Holders of our ordinary shares who are not resident in the UK may be subject to non-UK taxation on any gain under local law.
Generally, an individual holder of our ordinary shares who has ceased to be resident in the UK for tax purposes for a period of five years or less and who disposes of our ordinary shares during that period may be liable on their return to the UK to UK taxation on any capital gain realized (subject to any available exemption or relief).
UK stamp duty (“Stamp Duty”) and UK stamp duty reserve tax (“SDRT”)
The statements below are intended as a general guide to the current position relating to Stamp Duty and SDRT and apply to any holders of our ordinary shares irrespective of their place of tax residence.
No Stamp Duty or SDRT will be payable on the issue of our ordinary shares.
Stamp Duty will in principle be payable on any instrument of transfer of ordinary shares that is executed in the UK or that relates to any property situated, or to any matter or thing done or to be done, in the UK. If arising, Stamp Duty is payable at the rate of 0.5% of the amount or value of the consideration
given for the transfer (rounded up to the next £5.00). An exemption from Stamp Duty is available on an instrument transferring ordinary shares where the amount or value of the consideration is £1,000 or less and it is certified on the instrument that the transaction effected by the instrument does not form part of a larger transaction or series of transactions in respect of which the aggregate amount or value of the consideration exceeds £1,000. Certain categories of person, including intermediaries, brokers, dealers, depositary receipt issuers and clearance systems (and their nominees or agents), may not be liable to Stamp Duty or may be liable at the higher rate of 1.5%. Holders of ordinary shares should be aware that, even where an instrument of transfer is in principle subject to Stamp Duty, Stamp Duty is not required to be paid unless it is necessary to rely on the instrument for legal purposes, for example to register a change of ownership or in litigation in a UK court.
Provided that the ordinary shares are not registered in any register maintained in the UK by or on behalf of the Company and are not paired with any shares issued by a UK incorporated company, any agreement to transfer the ordinary shares will not be subject to SDRT. The ordinary shares are not paired with any shares issued by a UK incorporated company and we currently do not intend that any register of the ordinary shares will be maintained in the UK.
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO U.S. HOLDERS
The following discussion is a summary of the material U.S. federal income tax consequences to U.S. Holders (as defined below) of the ownership and disposition of our ordinary shares issued pursuant to this offering. It is not a comprehensive description of all tax considerations that may be relevant to a particular person’s decision to acquire our ordinary shares. The effects of any applicable state, local, or non-U.S. laws, and other U.S. federal tax laws such as estate and gift tax laws, are not discussed. This discussion is based on the U.S. Internal Revenue Code of 1986, as amended (the “Code”), U.S. Treasury regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the U.S. Internal Revenue Service (the “IRS”), all as in effect as of the date of this prospectus. All of the foregoing authorities are subject to change, which change could apply retroactively and could alter the tax consequences of the ownership and disposition of our ordinary shares described below. We have not sought and will not seek any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the tax consequences of the ownership and disposition of our ordinary shares.
This discussion is limited to U.S. Holders that hold our ordinary shares as capital assets (generally, property held for investment). This discussion does not address all U.S. federal income tax consequences relevant to a U.S. Holder’s particular circumstances, including the impact of the Medicare contribution tax on net investment income, the special tax accounting rules under Section 451(b) of the Code, and the alternative minimum tax. In addition, this following discussion does not address all U.S. federal income tax consequences relevant to U.S. Holders subject to particular rules, including, without limitation:
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U.S. expatriates and certain former citizens or long-term residents of the United States;
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persons whose functional currency is not the U.S. dollar;
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persons holding our ordinary shares as part of a hedge, straddle or other risk reduction strategy or as part of a conversion transaction or other integrated investment;
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banks, insurance companies, and other financial institutions;
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real estate investment trusts or regulated investment companies;
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brokers, dealers, or traders in securities, commodities, or currencies;
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S corporations or partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and investors therein);
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pension plans;
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tax-exempt organizations or governmental organizations;
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individual retirement accounts or other tax deferred accounts;
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persons who acquired our ordinary shares pursuant to the exercise of any employee share option or otherwise as compensation;
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persons that own or are deemed to own 10% or more of our ordinary shares by vote or value;
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persons subject to special tax accounting rules as a result of any item of gross income with respect to our ordinary shares being taken into account in an applicable financial statement;
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persons that hold our ordinary shares through or in connection with a permanent establishment, trade or business, or fixed base outside the United States;
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persons deemed to sell our ordinary shares under the constructive sale provisions of the Code.
If an entity taxable as a partnership for U.S. federal income tax purposes holds our ordinary shares, the U.S. federal income tax treatment of a partner in such partnership will depend on the status of the partner, the activities of the partnership, and certain determinations made at the partner level. Partnerships holding our ordinary shares and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences applicable to them.
U.S. HOLDERS ARE URGED TO CONSULT THEIR TAX ADVISORS REGARDING THE APPLICATION OF THE U.S. FEDERAL TAX RULES TO THEIR PARTICULAR CIRCUMSTANCES AS WELL AS THE U.S. STATE, LOCAL, AND NON-U.S. TAX CONSEQUENCES TO THEM OF THE PURCHASE, OWNERSHIP, AND DISPOSITION OF OUR ORDINARY SHARES.
For purposes of this discussion, a “U.S. Holder” is a beneficial owner of our ordinary shares that, for U.S. federal income tax purposes, is or is treated as any of the following:
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an individual who is a citizen or resident of the United States;
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a corporation created or organized in or under the laws of the United States, any state therein, or the District of Columbia;
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an estate, the income of which is subject to U.S. federal income tax regardless of its source; or
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a trust that (1) is subject to the primary supervision of a U.S. court and the control of one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code), or (2) has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes.
Taxation of Dividends and Other Distributions on Our Ordinary Shares
The discussion in this section is subject to the discussion below under “Passive Foreign Investment Company Rules”.
As discussed above under “Dividend Policy,” we do not anticipate paying any cash dividends in the foreseeable future. In the event we do make distributions of cash or property, the gross amount of any such distribution to U.S. Holders with respect to our ordinary shares will be included in such holders’ gross income as dividend income when actually or constructively received to the extent the distribution is paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). To the extent the amount of the distribution exceeds our current and accumulated earnings and profits, it will be treated first as a return of tax basis in the ordinary shares, and to the extent the amount of the distribution exceeds such tax basis, the excess amount will be taxed as capital gain. We do not intend to calculate our earnings and profits under U.S. federal income tax principles. Therefore, a U.S. Holder should expect that distributions will generally be reported as dividend income for such purposes. Dividends we pay will not be eligible for the dividends-received deduction available to corporations in respect of dividends received from U.S. corporations.
Subject to certain limitations, dividends paid by qualified foreign corporations to certain non-corporate U.S. Holders may be taxable at preferential tax rates. A non-U.S. corporation is generally treated as a qualified foreign corporation with respect to dividends paid on stock that is readily tradable on a securities market in the United States, such as the Nasdaq Global Select Market, on which our ordinary shares are listed. There can be no assurance that our ordinary shares are, or will continue to be, readily tradable on an established securities exchange. Consequently, there can be no assurance that dividends paid on our ordinary shares will be afforded the reduced tax rates. Non-corporate U.S. Holders should consult their tax advisers regarding the availability of the reduced tax rate on dividends. Dividends will be included in a U.S. Holder’s income on the date of the U.S. Holder’s receipt of the dividend.
Our dividends will generally constitute foreign source income for foreign tax credit limitation purposes. Any tax withheld with respect to distributions on the ordinary shares may, subject to a number of complex limitations, be claimed as a foreign tax credit against such U.S. Holder’s U.S. federal income tax liability or, at such U.S. Holder’s election, may be claimed as a deduction for U.S. federal income tax purposes. An election to deduct foreign taxes instead of claiming a foreign tax credit applies to all foreign taxes paid or accrued in the taxable year. The limitation on foreign taxes eligible for a credit is calculated separately with respect to specific classes of income. For this purpose, dividends distributed by us with respect to the ordinary shares generally will constitute “passive category income.” The rules with respect to the foreign tax credit are complex and may depend upon a U.S. Holder’s particular circumstances, there are significant and complex limits on a U.S. Holder’s ability to claim foreign tax credits, and recently released U.S. Treasury regulations may in some circumstances prohibit a U.S. Holder from claiming a foreign tax credit with respect to certain non-U.S. taxes that are not creditable under applicable income tax treaties (although IRS Notice 2023-55 provides temporary relief from the application of certain aspects of these U.S. Treasury regulations for
taxable years ending on or before December 31, 2023). U.S. Holders should consult their tax advisors regarding the availability of the foreign tax credit in light of their particular circumstances.
Sale or other Taxable Disposition of our Ordinary Shares
The discussion in this section is subject to the discussion below under “Passive Foreign Investment Company Rules”.
A U.S. Holder will recognize gain or loss on any sale, exchange or other taxable disposition of our ordinary shares equal to the difference between the amount realized (in U.S. dollars) on the disposition and such holder’s tax basis (in U.S. dollars) in the ordinary shares. Any such gain or loss will be capital gain or loss, and will be long-term capital gain or loss if such U.S. Holder held the ordinary shares for more than one year at the time of the disposition. Long-term capital gains recognized by certain non-corporate U.S. Holders, including individuals, generally will be taxable at reduced rates. The deductibility of capital losses is subject to limitations. Any such gain or loss a U.S. Holder recognizes generally will be treated as U.S. source income or loss for foreign tax credit limitation purposes. U.S. Holders should consult their tax advisors regarding the proper treatment of gain or loss in their particular circumstances.
U.S. Holders should consult their tax advisors regarding the proper treatment of gain or loss in their particular circumstances.
Passive Foreign Investment Company Rules
Based on the current and anticipated value of our assets and the composition of our income, assets and operations, we do not expect to be classified as a passive foreign investment company (“PFIC”) for the current taxable year. However, the application of the PFIC rules is subject to uncertainty in several respects, and there can be no assurance that we have not been treated as a PFIC in prior taxable years or will not be treated as a PFIC in the future. A non-U.S. corporation will be classified as a PFIC for any taxable year in which, after applying certain look-through rules, either:
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at least 75% of its gross income for such taxable year is passive income, or
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at least 50% of the value of its assets (based on an average of the quarterly values of the assets during a taxable year) is attributable to assets that produce or are held for the production of passive income.
For purposes of the above calculations, if a non-U.S. corporation owns, directly or indirectly, 25% or more of the total value of the outstanding shares of another corporation, it will be treated as if it (a) held a proportionate share of the assets of such other corporation and (b) received directly a proportionate share of the income of such other corporation. Passive income generally includes dividends, interest, rents, royalties and capital gains, but generally excludes rents and royalties which are derived in the active conduct of a trade or business and which are received from a person other than a related person.
A separate determination must be made with respect to each taxable year as to whether we are a PFIC (after the close of each such taxable year). As a result, our PFIC status may change. Because the value of our assets for purposes of the asset test (including goodwill) will generally be determined by reference to the market price of our ordinary shares, our PFIC status will depend in large part on the market price of our ordinary shares, which may fluctuate significantly. In addition, changes in the composition of our income or assets may cause us to become a PFIC, including by how, and how quickly we spend the cash we raise in any offering, including this offering. Finally, until such time as we start generating material revenue from operations, our PFIC status may depend, in part or in full, on the treatment of payments we receive from other sources (including tax credits), which is uncertain, and the magnitude of such payments compared to passive income from investments.
If we are classified as a PFIC in any taxable year with respect to which a U.S. Holder owns our ordinary shares, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns our ordinary shares, regardless of whether we continue to meet the tests described above unless (1) we cease to be a PFIC and the U.S. Holder has made a “deemed sale” election under the PFIC rules, or (2) the U.S. Holder makes a QEF Election (as defined below) with
respect to all taxable years in which we are a PFIC during the U.S. Holder’s holding period or makes a purging election to cause a deemed sale of our ordinary shares at their fair market value in conjunction with a QEF Election. If a deemed sale election is made, the U.S. Holder will be deemed to have sold our ordinary shares it holds at their fair market value and any gain from such deemed sale would be subject to the rules described below. After the deemed sale election, so long as we do not become a PFIC in a subsequent taxable year, the ordinary shares with respect to which such election was made will not be treated as shares in a PFIC and the U.S. Holder will not be subject to the rules described below with respect to any “excess distribution” it receives from us or any gain from an actual sale or other disposition of our ordinary shares. If we are treated as a PFIC with respect to a U.S. Holder, and subsequently cease to be a PFIC, such U.S. Holder should consult its tax advisors as to the possibility and consequences of making a deemed sale election.
If we are treated as a PFIC for any taxable year during which a U.S. Holder holds our ordinary shares, such holder will be subject to special tax rules with respect to any “excess distribution” received and any gain recognized from a sale or other disposition (including a pledge) of our ordinary shares, unless such holder makes a QEF Election or a mark-to-market election as discussed below. Distributions a U.S. Holder receives in a taxable year that are greater than 125% of the average annual distributions such holder received during the shorter of the three preceding taxable years or such holder’s holding period for the ordinary shares will be treated as an excess distribution. Under these special tax rules, if a U.S. Holder receives any excess distribution or realizes any gain from a sale or other disposition of the ordinary shares:
•
the excess distribution or gain will be allocated ratably over such holder’s holding period for our ordinary shares,
•
the amount allocated to the current taxable year, and any taxable year before the first taxable year in which we were a PFIC, will be treated as ordinary income, and
•
the amount allocated to each other year will be subject to the highest tax rate in effect for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year.
The tax liability for amounts allocated to years before the year of disposition or “excess distribution” cannot be offset by any net operating losses for such years, and gains (but not losses) realized on the sale or other taxable disposition of our ordinary shares cannot be treated as capital gains.
If we are a PFIC, a U.S. Holder generally will be subject to similar rules with respect to distributions we receive from, and our dispositions of the stock of, any of our direct or indirect subsidiaries or any other entities in which we hold equity interests that also are PFICs, or lower-tier PFICs, as if such U.S. Holder held its proportionate share of the stock of such lower-tier PFICs directly. U.S. Holders should consult their tax advisors regarding the application of the PFIC rules to lower-tier PFICs.
Certain elections may be available that would result in alternative treatments (such as mark-to-market treatment of our ordinary shares). U.S. Holders can avoid the interest charge on excess distributions or gain relating to our ordinary shares by making a mark-to-market election with respect to the ordinary shares, provided that the ordinary shares are “marketable stock.” Our ordinary shares will be marketable stock if they are “regularly traded” on certain U.S. stock exchanges or on a non-U.S. stock exchange that meets certain conditions. For these purposes, the ordinary shares will be considered regularly traded during any calendar year during which they are traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. Any trades that have as one of their principal purposes meeting this requirement will be disregarded. Our ordinary shares will be listed on the Nasdaq Global Select Market, which is a qualified exchange for these purposes. Consequently, if our ordinary shares remain listed on the Nasdaq Global Select Market and are “regularly traded”, the mark-to-market election may be available to U.S. Holders. However, a mark-to-market election generally cannot be made for equity interests in any lower-tier PFICs that we own, unless shares of such lower-tier PFIC are themselves marketable stock. As a result, even if a U.S. Holder validly makes a mark-to-market election with respect to our ordinary shares, the U.S. Holder may continue to be subject to the rules described above with respect to any “excess distribution” in respect of its indirect interest in any of our investments that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. Each U.S. Holder should consult its tax advisor as to the whether a mark-to-market election is
available or advisable with respect to our ordinary shares, as well as the impact of such election on interests in any lower-tier PFICs.
The adverse consequences of owning stock in a PFIC could also be mitigated if a U.S. Holder makes a valid “qualified electing fund” election (“QEF Election”), which, among other things, would require a U.S. Holder to include currently in income its pro rata share of the PFIC’s net capital gain and ordinary earnings, based on earnings and profits as determined for U.S. federal income tax purposes. We cannot provide any assurance that we would provide the information necessary for U.S. Holders of our ordinary shares to make QEF Elections in the event we are or were classified as a PFIC.
If we are considered a PFIC, U.S. Holders will also be subject to annual information reporting requirements. A U.S. Holder’s failure to file the annual report may result in substantial penalties and extend the statute of limitations with respect to the U.S. Holder’s federal income tax return. If we are or become a PFIC, U.S. Holders should consult their tax advisors regarding any reporting requirements that may apply to them.
U.S. Holders are urged to consult their tax advisors regarding the application of the PFIC rules to the ownership and disposition of our ordinary shares and the potential availability of a mark-to-market or QEF election.
Information Reporting and Backup Withholding
Dividend payments with respect to our ordinary shares and proceeds from the sale, exchange, or other taxable disposition of our ordinary shares may be subject to information reporting to the IRS and U.S. backup withholding. Certain U.S. Holders are exempt from backup withholding, including corporations and certain tax-exempt organizations. A U.S. Holder will be subject to backup withholding if such holder is not a corporation or otherwise exempt and such holder:
•
fails to furnish the holder’s taxpayer identification number, which for an individual is ordinarily such individual’s social security number;
•
furnishes an incorrect taxpayer identification number;
•
is notified by the IRS that the holder previously failed to properly report payments of interest or dividends; or
•
fails to certify under penalties of perjury that the holder has furnished a correct taxpayer identification number and that the IRS has not notified the holder that the holder is subject to backup withholding.
Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or a credit against the U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS. U.S. Holders should consult their tax advisors regarding their qualification for an exemption from backup withholding and the procedures for obtaining such an exemption.
Additional Reporting Requirements
Certain U.S. Holders who are individuals (and certain entities) that hold an interest in “specified foreign financial assets” (which may include our ordinary shares) are required to report information relating to such assets, subject to certain exceptions (including an exception for our ordinary shares held in accounts maintained by certain U.S. financial institutions). Penalties can apply if U.S. Holders fail to satisfy such reporting requirements. U.S. Holders should consult their tax advisors regarding the applicability of these requirements to their acquisition, ownership, and disposition of our ordinary shares.
PLAN OF DISTRIBUTION
We have entered into a Sales Agreement (the “Sales Agreement”) with BofA Securities, Inc., as our sales agent, under which we may offer and sell from time to time our ordinary shares having an aggregate offering price of up to $100,000,000. The Sales Agent may act as agent on our behalf or purchase ordinary shares as principal.
Sales, if any, of ordinary shares under the Sales Agreement may be made in transactions that are deemed to be “at the market offerings” pursuant to Rule 415(a)(4) of the Securities Act, ordinary brokers’ transactions on or through The Nasdaq Global Select Market or any other market venue where the securities may be traded, in the over-the-counter market, in negotiated transactions, or through a combination of any such methods of sale. The Sales Agent may also sell our ordinary shares by any other method permitted by law.
The ordinary shares may be sold at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices.
We will designate the maximum amount of ordinary shares to be sold through the Sales Agent on a daily basis or otherwise as we and the Sales Agent agree and the minimum price per share at which such ordinary shares may be sold. Subject to the terms and conditions of the Sales Agreement, the Sales Agent will use its commercially reasonable efforts consistent with its normal sales and trading practices and applicable law and regulations to sell on our behalf all of the designated ordinary shares. We may instruct the Sales Agent not to sell any ordinary shares if the sales cannot be effected at or above the price designated by us in any such instruction. We or the Sales Agent, with respect to itself only, may suspend the offering of our ordinary shares by notifying the other party.
The Sales Agent will provide to us written confirmation no later than the opening of the trading day immediately following the trading day on which it has made sales of ordinary shares under the Sales Agreement. Each confirmation will include the number of ordinary shares sold on such day, the compensation payable by the Company to the Sales Agent and the net proceeds payable to us. We will report at least quarterly the number of ordinary shares sold through the Sales Agent under the Sales Agreement and the net proceeds to us (before expenses).
We will pay the Sales Agent a commission of up to 3.0% of the gross sales price per share of ordinary shares sold through such agent under the Sales Agreement. We have also agreed to reimburse the Sales Agent for certain of its expenses.
Settlement of any sales of ordinary shares will occur on the second trading day following the date on which such sales were made (or such earlier day as is industry practice for regular-way trading). There is no arrangement for funds to be received in an escrow, trust or similar arrangement. Sales of our ordinary shares as contemplated in this prospectus supplement will be settled through the facilities of Computershare Trust Company, N.A., or by such other means as we and the Sales Agent may agree.
The offering of our ordinary shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all of our ordinary shares subject to the Sales Agreement, or (ii) termination of the Sales Agreement by us or by the Sales Agent as provided therein.
In connection with the sale of the ordinary shares on our behalf, the Sales Agent will be deemed to be an “underwriter” within the meaning of the Securities Act, and the compensation paid to the Sales Agent will be deemed to be underwriting commissions or discounts.
We have agreed to provide indemnification and contribution to the Sales Agent against certain liabilities, including civil liabilities under the Securities Act.
This summary of the material provisions of the Sales Agreement does not purport to be a complete statement of its terms and conditions. A copy of the Sales Agreement is filed as an exhibit to the registration statement of which this prospectus supplement forms a part.
The Sales Agent and its affiliates have from time to time provided, and may in the future provide, various investment banking, commercial banking, fiduciary and advisory services for us for which it has received, and may in the future receive, customary fees and expenses. The Sales Agent and its affiliates may from time to time engage in other transactions with and perform services for us in the ordinary course of its business.
LEGAL MATTERS
The validity of the ordinary shares being offered by this prospectus has been passed upon for us by Walkers (Cayman) LLP, 190 Elgin Avenue, George Town, Grand Cayman KY1-9001, Cayman Islands. Certain other matters will be passed upon for us by Latham & Watkins LLP. BofA Securities, Inc. is being represented by Cooley LLP, New York, New York in connection with this offering.
EXPERTS
The consolidated financial statements of MeiraGTx Holdings plc and subsidiaries appearing in MeiraGTx Holdings plc’s Annual Report on Form 10-K for the year ended December 31, 2022 have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon, included therein, and incorporated herein by reference. Such consolidated financial statements are, and audited financial statements to be included in subsequently filed documents will be, incorporated herein in reliance upon the report of Ernst & Young LLP pertaining to such financial statements (to the extent covered by consents filed with the Securities and Exchange Commission) given on the authority of such firm as experts in accounting and auditing.
Up to $100,000,000
Ordinary Shares
PROSPECTUS SUPPLEMENT
BofA Securities
, 2023
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14.
Other Expenses of Issuance and Distribution
Except for the SEC registration fee, the following is an estimate of the expenses (all of which are to be paid by the registrant) that we may incur in connection with the securities being registered hereby.
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SEC registration fee
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|
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|
$ |
36,900 |
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|
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Printing expenses
|
|
|
|
$ |
(1)
|
|
|
| |
Legal fees and expenses
|
|
|
|
$ |
(1)
|
|
|
| |
Accounting fees and expenses
|
|
|
|
$ |
(1)
|
|
|
| |
Transfer agent fees and expenses
|
|
|
|
$ |
(1)
|
|
|
| |
Warrant agent fees and expenses
|
|
|
|
$ |
(1)
|
|
|
| |
Miscellaneous
|
|
|
|
$ |
(1)
|
|
|
| |
Total
|
|
|
|
$ |
(1)
|
|
|
(1)
These fees are calculated based on the securities offered and the number of issuances and accordingly cannot be estimated at this time.
Item 15.
Indemnification of Directors and Officers
Cayman Islands law does not limit the extent to which a company’s amended and restated memorandum and articles of association may provide for indemnification of officers and directors, except to the extent any such provision may be held by the Cayman Islands courts to be contrary to public policy, such as to provide indemnification against civil fraud or the consequences of committing a crime. Our amended and restated memorandum and articles of association provide that our board of directors and officers shall be indemnified from and against all liability which they incur in execution of their duty in their respective offices, except liability incurred by reason of such directors’ or officers’ dishonesty, willful default or fraud.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is theretofore unenforceable.
Our amended and restated memorandum and articles of association provides:
“Every Director (including for the purposes of this Article any alternate Director appointed pursuant to the provisions of these Articles), Secretary, assistant Secretary, or other Officer (but not including the Company’s auditors) and the personal representatives of the same (each an “Indemnified Person”) shall be indemnified and secured harmless against all actions, proceedings, costs, charges, expenses, losses, damages or liabilities incurred or sustained by such Indemnified Person, other than by reason of such Indemnified Person’s own dishonesty, willful default or fraud as determined by a court of competent jurisdiction, in or about the conduct of the Company’s business or affairs (including as a result of any mistake of judgment) or in the execution or discharge of his duties, powers, authorities or discretions, including without prejudice to the generality of the foregoing, any costs, expenses, losses or liabilities incurred by such Indemnified Person in defending (whether successfully or otherwise) any civil proceedings concerning the Company or its affairs in any court whether in the Cayman Islands or elsewhere.
No Indemnified Person shall be liable:
(a) for the acts, receipts, neglects, defaults or omissions of any other Director or Officer or agent of the Company; or
(b) for any loss on account of defect of title to any property of the Company; or
(c) on account of the insufficiency of any security in or upon which any money of the Company shall be invested; or
(d) for any loss incurred through any bank, broker or other similar Person; or
(e) for any loss occasioned by any negligence, default, breach of duty, breach of trust, error of judgement or oversight on such Indemnified Person’s part; or
(f) for any loss, damage or misfortune whatsoever which may happen in or arise from the execution or discharge of the duties, powers, authorities, or discretions of such Indemnified Person’s office or in relation thereto;
unless the same shall happen through such Indemnified Person’s own dishonesty, willful default or fraud as determined by a court of competent jurisdiction.”
We have entered into indemnification agreements with each of our directors and officers. These indemnification agreements require us, among other things, to indemnify our directors and officers for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request.
We maintain a general liability insurance policy that covers certain liabilities of directors and officers of our corporation arising out of claims based on acts or omissions in their capacities as directors or officers.
In any underwriting agreement we enter into in connection with the sale of ordinary shares being registered hereby, the underwriters will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control us within the meaning of the Securities Act of 1933, as amended, or the Securities Act, against certain liabilities.
Item 16.
Exhibits
(a) Exhibits
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Exhibit
Number
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Description
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24.1
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107
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*
To be filed by amendment or incorporated by reference in connection with the offering of the securities.
Item 17.
Undertakings
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
provided, however, that paragraphs (a)(1)(i), (a)(1)(ii), and (a)(1)(iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is a part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(B) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As
provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
(5) That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities:
The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
(iv) Any other communications that is an offer in the offering made by the undersigned registrant to the purchaser.
(b) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
(d) The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act (the “Act”) in accordance with the rules and regulations prescribed by the SEC under section 305(b)(2) of the Act.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New York, New York, on the 21st day of December 2023.
MeiraGTx Holdings plc
By:
/s/ Alexandria Forbes, Ph.D.
Alexandria Forbes, Ph.D.
President and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Alexandria Forbes and Richard Giroux, or either of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to file and sign any and all amendments, including post-effective amendments and any registration statement for the same offering that is to be effective under Rule 462(b) of the Securities Act, to this registration statement, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their substitute or substitutes may lawfully do or cause to be done by virtue hereof. This power of attorney shall be governed by and construed with the laws of the State of Delaware and applicable federal securities laws.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.
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SIGNATURE
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TITLE
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DATE
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/s/ Alexandria Forbes, Ph.D.
Alexandria Forbes, Ph.D.
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President, Chief Executive Officer and Director (principal executive officer)
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December 21, 2023
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/s/ Richard Giroux
Richard Giroux
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Chief Operating Officer and Chief Financial Officer (principal financial officer and principal accounting officer) and MeiraGTx Holding plc’s authorized representative in the United States
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December 21, 2023
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/s/ Keith R. Harris, Ph.D.
Keith R. Harris, Ph.D.
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Chairman of the Board of Directors
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December 21, 2023
|
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/s/ Ellen Hukkelhoven, Ph.D.
Ellen Hukkelhoven, Ph.D.
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Director
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December 21, 2023
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/s/ Martin Indyk, Ph.D.
Martin Indyk, Ph.D.
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Director
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December 21, 2023
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SIGNATURE
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TITLE
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DATE
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/s/ Lord Mendoza
Lord Mendoza
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Director
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December 21, 2023
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/s/ Nicole Seligman
Nicole Seligman
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Director
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December 21, 2023
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/s/ Thomas E. Shenk, Ph.D.
Thomas E. Shenk, Ph.D.
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Director
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December 21, 2023
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/s/ Debra Yu, M.D.
Debra Yu, M.D.
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Director
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December 21, 2023
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Exhibit 1.2
MEIRAGTX HOLDINGS PLC
Ordinary Shares
(nominal value $0.00003881 per share)
Sales Agreement
December 21, 2023
BofA Securities, Inc.
One Bryant Park
New York, NY 10036
Ladies and Gentlemen:
MeiraGTx Holdings plc, a Cayman Islands exempted
company (the “Company”), confirms its agreement (this “Agreement”) with BofA Securities,
Inc. (the “Agent”), as follows:
1.
Issuance and Sale of Placement Shares. The Company agrees that, from time to time during the term of this Agreement, on
the terms and subject to the conditions set forth herein, it may issue and sell through the Agent up to $100,000,000 of ordinary shares
(the “Placement Shares”) of the Company, nominal value $0.00003881 per share (the “Ordinary Shares”);
provided, however, that in no event shall the Company issue or sell through the
Agent such number or dollar amount of Placement Shares that would (a) exceed the number or dollar amount of Ordinary Shares registered
on the effective Registration Statement (defined below) pursuant to which the offering is being made, (b) exceed 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) exceed 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) exceed the number
or dollar amount of Ordinary Shares for which the Company has filed a Prospectus Supplement (defined below) (the lesser of (a), (b), (c)
and (d), the “Maximum Amount”). Notwithstanding anything to the contrary contained herein, the parties
hereto agree that compliance with the limitations set forth in this Section 1 on the amount of Placement Shares issued and sold
under this Agreement shall be the sole responsibility of the Company and that the Agent shall have no obligation in connection with such
compliance. The offer and sale of Placement Shares through the Agent will be effected pursuant to the Registration Statement (as defined
below) filed by the Company after such Registration Statement has been declared effective by the Securities and Exchange Commission (the
“Commission”), although nothing in this Agreement shall be construed as requiring the Company to use the Registration
Statement to issue Ordinary Shares.
The Company has filed or will file, in accordance
with the provisions of the Securities Act of 1933, as amended (the “Securities Act”) and the rules and regulations
thereunder (the “Securities Act Regulations”), with the Commission a shelf registration statement on Form S-3,
including a base prospectus, relating to certain securities, including the Placement Shares to be issued from time to time by the Company,
and which incorporates by reference documents that the Company has filed or will file in accordance with the provisions of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), and the rules and regulations thereunder. The Company
has prepared a prospectus or a prospectus supplement to the base prospectus included as part of the registration statement, which prospectus
or prospectus supplement specifically relates to the Placement Shares to be issued from time to time by the Company (the “Prospectus
Supplement”). The Company will furnish to the Agent, for use by the Agent, copies of the prospectus included as part of
such registration statement, as supplemented, if necessary, by the Prospectus Supplement, relating to the Placement Shares to be issued
from time to time by the Company. 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 (which shall be a Prospectus Supplement), with respect
to the Placement Shares. Except where the context otherwise requires, such registration statement(s), including all documents filed as
part thereof or incorporated by reference therein, and including any information contained in a Prospectus (as defined below) subsequently
filed with the Commission pursuant to Rule 424(b) under the Securities Act Regulations or deemed to be a part of such registration statement
pursuant to Rule 430B of the Securities Act Regulations, is herein called the “Registration Statement.” The
base prospectus or base prospectuses, including all documents incorporated therein by reference, included in the Registration Statement,
as it may be supplemented, if necessary, by the Prospectus Supplement, in the form in which such prospectus or prospectuses and/or Prospectus
Supplement have most recently been filed by the Company with the Commission pursuant to Rule 424(b) under the Securities Act Regulations,
together with the then issued Issuer Free Writing Prospectus(es), is herein called the “Prospectus.”
Any reference herein to the Registration Statement,
any Prospectus Supplement, Prospectus or any Issuer Free Writing Prospectus (defined below), and any amendments and supplements thereto,
shall be deemed to refer to and include the documents, if any, incorporated by reference therein (the “Incorporated Documents”),
including, unless the context otherwise requires, the documents, if any, filed as exhibits to such Incorporated Documents. Any reference
herein to the terms “amend,” “amendment” or “supplement” with respect to the Registration Statement,
any Prospectus Supplement, the Prospectus or any Issuer Free Writing Prospectus shall be deemed to refer to and include the filing of
any document under the Exchange Act on or after the most-recent effective date of the Registration Statement, or the date of the Prospectus
Supplement, Prospectus or such Issuer Free Writing Prospectus, as the case may be, and incorporated therein by reference. For purposes
of this Agreement, all references to the Registration Statement, the Prospectus or to any amendment or supplement thereto shall be deemed
to include the most recent copy filed with the Commission pursuant to its Electronic Data Gathering Analysis and Retrieval system, or
if applicable, the Interactive Data Electronic Application system when used by the Commission (collectively, “EDGAR”).
2.
Placements. Each time that the Company wishes to issue and sell Placement Shares hereunder (each, a “Placement”),
it will notify the Agent by email notice (or other method mutually agreed to by the parties) of the number of Placement Shares to be issued,
the time period during which sales are requested to be made, any limitation on the number of Placement Shares that may be sold in any
one Trading Date (defined below) and any minimum price below which sales may not be made (a “Placement Notice”),
the form of which is attached hereto as Schedule 1. The Placement Notice shall originate from any of the individuals from the Company
set forth on Schedule 3 (with a copy to each of the other individuals from the Company listed on such schedule), and shall be addressed
to each of the individuals from the Agent set forth on Schedule 3, as such Schedule 3 may be amended from time to time in
accordance herewith. The Placement Notice shall be effective unless and until (i) the Agent declines to accept the terms contained therein
for any reason, in its sole discretion within two (2) Business Days (defined below) of receipt of such Placement Notice, (ii) the entire
amount of the Placement Shares thereunder have been sold, (iii) the Company suspends or terminates the Placement Notice or (iv) this Agreement
has been terminated under the provisions of Section 12. The amount of any discount, commission or other compensation to be paid
by the Company to Agent in connection with the sale of the Placement Shares shall be calculated in accordance with the terms set forth
in Schedule 2. It is expressly acknowledged and agreed that neither the Company nor the Agent will have any obligation whatsoever
with respect to a Placement or any Placement Shares unless and until the Company delivers a Placement Notice to the Agent and the Agent
does not decline such Placement Notice pursuant to the terms set forth above, and then only upon the terms specified therein and herein.
In the event of a conflict between the terms of this Agreement and the terms of a Placement Notice, the terms of the Placement Notice
will control.
3.
Sale of Placement Shares by Agent. Subject to the provisions of Section 5(a), the Agent, for the period specified
in the Placement Notice, will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable
state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market LLC (the “Exchange”),
to sell the Placement Shares up to the amount specified, and otherwise in accordance with the terms of such Placement Notice. The Agent
will provide written confirmation to the Company no later than the opening of the Trading Day (as defined below) immediately following
the Trading Day on which it has made sales of Placement Shares hereunder setting forth the number of Placement Shares sold on such day,
the compensation payable by the Company to the Agent pursuant to Section 2 with respect to such sales, and the Net Proceeds (as
defined below) payable to the Company, with an itemization of the deductions made by the Agent (as set forth in Section 5(b)) from
the gross proceeds that it receives from such sales. Subject to the terms of the Placement Notice, the Agent may sell Placement Shares
by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act
Regulations, including sales made directly on or through the Exchange or any other existing trading market for the Ordinary Shares, in
negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices. Subject
to the terms of the Placement Notice, the Agent may also sell Placement Shares by any other method permitted by law with the prior written
consent of the Company. “Trading Day” means any day on which Ordinary Shares are traded on the Exchange.
4. Suspension of Sales. The Company or the Agent may, upon notice to the other party in writing (including by email correspondence
to each of the individuals of the other party set forth on Schedule 3, if receipt of such correspondence is actually acknowledged
by any of the individuals to whom the notice is sent, other than via auto-reply) or by telephone (confirmed immediately by verifiable
facsimile transmission or email correspondence to each of the individuals of the other party set forth on Schedule 3), suspend
any sale of Placement Shares (a “Suspension”); provided, however, that such Suspension shall not
affect or impair any party’s obligations with respect to any Placement Shares sold hereunder prior to the receipt of such notice.
While a Suspension is in effect any obligation under Sections 7(l), 7(m), 7(n) and 7(t) with respect to the
delivery of certificates, opinions, or comfort letters to the Agent, shall be waived. Each of the parties agrees that no such notice under
this Section 4 shall be effective against any other party unless it is made to one of the individuals named on Schedule 3
hereto, as such Schedule may be amended from time to time. Notwithstanding any other provision of this Agreement, during any period in
which the Company is in possession of material non-public information, the Company and the Agent agree that (i) no sale of Placement Shares
will take place, (ii) the Company shall not request the sale of any Placement Shares, and (iii) the Agent shall not be obligated to sell
or offer to sell any Placement Shares. If either the Agent or the Company has reason to believe that the exemptive provisions set forth
in Rule 101(c)(1) of Regulation M under the Exchange Act are not satisfied with respect to the Ordinary Shares, it shall promptly notify
the other party, and the Agent may, at its sole discretion, suspend sales of the Placement Shares under this Agreement.
5. Sale and Delivery to the Agent; Settlement.
(a)
Sale of Placement Shares. On the basis of the representations and warranties herein contained and subject to the
terms and conditions herein set forth, upon the Agent’s acceptance of the terms of a Placement Notice, and unless the sale of the
Placement Shares described therein has been declined, suspended, or otherwise terminated in accordance with the terms of this Agreement,
the Agent, for the period specified in the Placement Notice, will use its commercially reasonable efforts consistent with its normal trading
and sales practices and applicable laws, rules and regulations to sell such Placement Shares up to the amount specified in, and otherwise
in accordance with the terms of such Placement Notice. The Company acknowledges and agrees that (i) there can be no assurance that the
Agent will be successful in selling Placement Shares, (ii) the Agent will incur no liability or obligation to the Company or any other
person or entity if it does not sell Placement Shares for any reason other than a failure by the Agent to use its commercially reasonable
efforts consistent with its normal trading and sales practices and applicable laws, rules and regulations to sell such Placement Shares
as required under this Agreement and (iii) the Agent shall be under no obligation to purchase Placement Shares on a principal basis pursuant
to this Agreement, except as otherwise agreed by the Agent and the Company.
(b)
Settlement of Placement Shares. Unless otherwise specified in the applicable Placement Notice, settlement for sales
of Placement Shares will occur on the second (2nd) Trading Day (or such earlier day as is industry
practice for regular-way trading) following the date on which such sales are made (each, a “Settlement Date”).
The Agent shall notify the Company of each sale of Placement Shares no later than the opening of the Trading Day immediately following
the Trading Day on which it has made sales of Placement Shares hereunder. The amount of proceeds to be delivered to the Company on a Settlement
Date against receipt of the Placement Shares sold (the “Net Proceeds”) will be equal to the aggregate sales
price received by the Agent, after deduction for (i) the Agent’s commission, discount or other compensation for such sales payable
by the Company pursuant to Section 2 hereof, and (ii) any transaction fees imposed by any Governmental Authority (defined below)
in respect of such sales.
(c)
Delivery of Placement Shares. On or before each Settlement Date, the Company will, or will cause its transfer agent to,
electronically transfer the Placement Shares being sold by crediting the Agent’s or its designee’s account (provided the Agent
shall have given the Company written notice of such designee at least one Trading Day prior to the Settlement Date) at The Depository
Trust Company through its Deposit and Withdrawal at Custodian System or by such other means of delivery as may be mutually agreed upon
by the parties hereto which in all cases shall be freely tradable, transferable, registered shares in good deliverable form. On each Settlement
Date, the Agent will deliver the related Net Proceeds in same day funds to an account designated by the Company on, or prior to, the Settlement
Date. The Company agrees that if the Company, or its transfer agent (if applicable), defaults in its obligation to deliver Placement Shares
on a Settlement Date, through no fault of the Agent, the Company agrees that in addition to and in no way limiting the rights and obligations
set forth in Section 10(a) hereto, it will (i) hold the Agent harmless against any loss, claim, damage, or reasonable and documented
expense (including reasonable and documented legal fees and expenses), as incurred, arising out of or in connection with such default
by the Company or its transfer agent (if applicable) and (ii) pay to the Agent any commission, discount, or other compensation to which
it would otherwise have been entitled absent such default.
(d)
Denominations; Registration. Certificates for the Placement Shares, if any, shall be in such denominations and registered
in such names as the Agent may request in writing at least one full Business Day (as defined below) before the Settlement Date. The certificates
for the Placement Shares, if any, will be made available by the Company for examination and packaging by the Agent in The City of New
York not later than noon (New York time) on the Business Day prior to the Settlement Date.
(e)
Limitations on Offering Size. Under no circumstances shall the Company cause or request the offer or sale of any
Placement Shares if, after giving effect to the sale of such Placement Shares, the aggregate gross sales proceeds of Placement Shares
sold pursuant to this Agreement would exceed the lesser of (A) together with all sales of Placement Shares under this Agreement, the Maximum
Amount and (B) the amount authorized from time to time to be issued and sold under this Agreement by the Company’s board of directors,
a duly authorized committee thereof or a duly authorized executive committee, and notified to the Agent in writing. Under no circumstances
shall the Company cause or request the offer or sale of any Placement Shares pursuant to this Agreement at a price lower than the minimum
price authorized from time to time by the Company’s board of directors, a duly authorized committee thereof or a duly authorized
executive committee. Further, under no circumstances shall the Company cause or permit the aggregate offering amount of Placement Shares
sold pursuant to this Agreement to exceed the Maximum Amount.
6. Representations and Warranties of the Company. The Company represents and warrants to, and agrees with Agent that as of
the date of this Agreement and as of each Applicable Time (as defined below), unless such representation, warranty or agreement specifies
a different time:
(a)
Registration Statement and Prospectus. The Company and the transactions contemplated by this Agreement meet the requirements
for and comply with the applicable conditions set forth in Form S-3 (including General Instructions I.A and I.B) under the Securities
Act. The Registration Statement has been or will be filed with the Commission and will have been declared effective by the Commission
under the Securities Act prior to the issuance of any Placement Notices by the Company. The Prospectus Supplement will name the Agent
as the agent in the section entitled “Plan of Distribution.” The Company has not received, and has no notice of, any order
of the Commission preventing or suspending the use of the Registration Statement, or threatening or instituting proceedings for that purpose.
The Registration Statement and the offer and sale of Placement Shares as contemplated hereby meet the requirements of Rule 415 under the
Securities Act and comply in all material respects with said Rule. Any statutes, regulations, contracts or other documents that are required
to be described in the Registration Statement or the Prospectus or to be filed as exhibits to the Registration Statement have been so
described or filed. Copies of the Registration Statement, the Prospectus, and any such amendments or supplements and all Incorporated
Documents that were filed with the Commission on or prior to the date of this Agreement have been delivered, or are available through
EDGAR, to Agent and its counsel. The Company has not distributed and, prior to the later to occur of each Settlement Date and completion
of the distribution of the Placement Shares, will not distribute any offering material in connection with the offering or sale of the
Placement Shares other than the Registration Statement and the Prospectus and any Issuer Free Writing Prospectus (as defined below) to
which the Agent has consented, such consent not to be unreasonably withheld, conditioned or delayed. The Ordinary Shares are registered
pursuant to Section 12(b) of the Exchange Act and are currently listed on the Exchange under the trading symbol “MGTX.” 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, delisting the Ordinary Shares from the Exchange, nor has the Company received any notification that the Commission or the
Exchange is contemplating terminating such registration or listing. To the Company’s knowledge, it is in compliance with all applicable
listing requirements of the Exchange.
(b)
No Misstatement or Omission. The Registration Statement, when it became or becomes effective, and the Prospectus, and any
amendment or supplement thereto, on the date of such Prospectus or amendment or supplement, conformed and will conform in all material
respects with the requirements of the Securities Act. At each Settlement Date, the Registration Statement and the Prospectus, as of such
date, will conform in all material respects with the requirements of the Securities Act. The Registration Statement, as of the date it
became or becomes effective, did not, and 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 not misleading. The Prospectus and any amendment and supplement thereto,
on the date thereof and at each Applicable Time (defined below), did not or will not include an untrue statement of a material fact or
omit to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not
misleading. The Incorporated Documents in the Prospectus or any Prospectus Supplement did not, and any further documents filed and incorporated
by reference therein will not, when filed with the Commission, contain an untrue statement of a material fact or omit to state a material
fact required to be stated in such document or necessary to make the statements in such document, in light of the circumstances under
which they were made, not misleading. The foregoing shall not apply to statements in, or omissions from, any such document made in reliance
upon, and in conformity with, information furnished to the Company by Agent specifically for use in the preparation thereof.
(c)
Conformity with Securities Act and Exchange Act. The Registration Statement, the Prospectus, any Issuer Free Writing Prospectus
or any amendment or supplement thereto, and the Incorporated Documents in the Registration Statement, the Prospectus or any amendment
or supplement thereto, when such documents were or are filed with the Commission under the Securities Act or the Exchange Act or became
or become effective under the Securities Act, as the case may be, conformed or will conform in all material respects with the requirements
of the Securities Act and the Exchange Act, as applicable.
(d)
[Reserved]
(e)
Status Under the Securities Act. The Company was not and is not an ineligible issuer as defined in Rule 405 under the Securities
Act at the times specified in Rules 164 and 433 under the Securities Act in connection with the offering of the Placement Shares.
(f)
Independent Accountants. The accountants who certified the financial statements and supporting schedules included in the
Registration Statement and the Prospectus are independent public accountants as required by the Securities Act, the Securities Act Regulations
and the Public Company Accounting Oversight Board (“PCAOB”).
(g)
Financial Statements. The financial statements included, or incorporated by reference, in the Registration Statement and
the Prospectus, together with the related schedules and notes, present fairly, in all material respects, the financial position of the
Company and its consolidated subsidiaries at the dates indicated and the statement of operations, shareholders’ equity and cash
flows of the Company and its consolidated subsidiaries for the periods specified; said financial statements have been prepared in conformity
with U.S. generally accepted accounting principles (“GAAP”) applied on a consistent basis throughout the periods
involved. The supporting schedules, if any, present fairly, in all material respects, in accordance with GAAP the information required
to be stated therein. The selected financial data and the summary financial information included, or incorporated by reference, in the
Registration Statement and the Prospectus present fairly, in all material respects, the information shown therein and have been compiled
on a basis consistent with that of the audited financial statements included therein. Except as included therein, no historical or pro
forma financial statements or supporting schedules are required to be included or incorporated by reference in the Registration Statement
and the Prospectus under the Securities Act or the Securities Act Regulations. The interactive data in eXtensible Business Reporting Language
included or incorporated by reference in the Registration Statement and the Prospectus fairly presents the information called for in all
material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto.
(h)
No Material Adverse Change in Business. Except as otherwise stated therein, since the respective dates as of which information
is given in the Registration Statement or the Prospectus, (A) there has been no material adverse change in the condition, financial or
otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise,
whether or not arising in the ordinary course of business (a “Material Adverse Effect”), (B) there have been
no transactions entered into by the Company or any of its subsidiaries, other than those in the ordinary course of business, which are
material with respect to the Company and its subsidiaries considered as one enterprise, and (C) there has been no dividend or distribution
of any kind declared, paid or made by the Company on any class of its shares.
(i)
Good Standing of the Company. The Company has been duly incorporated and is validly existing as an exempted company in good
standing under the laws of the Cayman Islands and has 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;
and the Company is duly qualified as a foreign corporation 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 so to qualify or to be in good standing would not reasonably be expected to result in a Material Adverse Effect.
(j)
Good Standing of Subsidiaries. Each “significant subsidiary” of the Company (as such term is defined in Rule
1-02 of Regulation S-X) (each, a “Subsidiary” and, collectively, the “Subsidiaries”)
has been duly incorporated or organized and is validly existing in good standing under the laws of the jurisdiction of its incorporation
or organization, has corporate or similar 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 is duly qualified to transact business and is in good standing 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 would not result in a Material Adverse Effect. Except as otherwise disclosed
in the Registration Statement and the Prospectus, all of the issued and outstanding share capital or other equity interests of each Subsidiary
has been duly authorized and validly issued, is fully paid and non-assessable and owned by the Company, directly or through subsidiaries,
free and clear of any security interest, mortgage, pledge, lien, encumbrance, claim or equity. None of the outstanding shares of any Subsidiary
were issued in violation of the preemptive or similar rights of any securityholder of such Subsidiary. The only subsidiaries of the Company
are (A) the subsidiaries listed on Exhibit 21.1 to the Company's most recent Annual Report
on Form 10-K filed with the Commission, and (B) certain other subsidiaries which, considered in the aggregate as a single subsidiary,
do not constitute a “significant subsidiary” as defined in Rule 1-02 of Regulation S-X.
(k)
Capitalization. The authorized, issued and outstanding Ordinary Shares of the Company are as set forth in the Registration
Statement and the Prospectus under the caption “Description of Share Capital” (except for subsequent issuances, if any, pursuant
to this Agreement, pursuant to reservations, agreements or employee benefit plans referred to in the Registration Statement and the Prospectus
or pursuant to the exercise of convertible securities or options referred to in the Registration Statement and the Prospectus). The outstanding
Ordinary Shares of the Company have been duly authorized and validly issued and are fully paid and non-assessable. None of the outstanding
Ordinary Shares of the Company were issued in violation of the preemptive or other similar rights of any securityholder of the Company.
(l)
Authorization of Agreement. This Agreement has been duly authorized, executed and delivered by the Company and is a legal,
valid and binding agreement of the Company enforceable in accordance with its terms, except to the extent that enforceability may be limited
by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally and by general equitable
principles.
(m)
Authorization of the Placement Shares. The Placement Shares have been duly authorized for issuance and sale pursuant to
this Agreement and, when issued and delivered by the Company against payment therefor pursuant to this Agreement, will be validly issued,
fully paid and nonassessable, and the issuance and sale of the Placement Shares is not subject to any preemptive rights, rights of first
refusal or other similar rights to subscribe for or purchase the Placement Shares.
(n)
Registration Rights. There are no persons with registration rights or other similar rights to have any securities registered
for sale pursuant to the Registration Statement or otherwise registered for sale or sold by the Company under the Securities Act pursuant
to this Agreement.
(o)
Absence of Violations, Defaults and Conflicts. Neither the Company nor any of its Subsidiaries is (A) in violation of its
charter, by-laws or similar organizational document, (B) in default in the performance or observance of any obligation, agreement, covenant
or condition contained in any contract, indenture, mortgage, deed of trust, loan or credit agreement, note, lease or other agreement or
instrument 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 the
properties or assets of the Company or any subsidiary is subject (collectively, “Agreements and Instruments”),
except for such defaults that would not, reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect, or
(C) in violation of any law, statute, rule, regulation, judgment, order, writ or decree of any arbitrator, court, governmental body, regulatory
body, administrative agency or other authority, body or agency having jurisdiction over the Company or any of its subsidiaries or any
of their respective properties, assets or operations (each, a “Governmental Entity”), except for such violations
that would not reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect. The execution, delivery and
performance of this Agreement and the consummation of the transactions contemplated herein and in the Registration Statement and the Prospectus
(including the issuance and sale of the Placement Shares and the use of the proceeds from the sale of the Placement Shares as described
therein under the caption “Use of Proceeds”) and compliance by the Company with its obligations hereunder have been duly authorized
by all necessary corporate action and do not and will not, whether with or without the giving of notice or passage of time or both, conflict
with or constitute a breach of, or default or Repayment Event (as defined below) under, or result in the creation or imposition of any
lien, charge or encumbrance upon any properties or assets of the Company or any subsidiary pursuant to, the Agreements and Instruments
(except for such conflicts, breaches, defaults or Repayment Events or liens, charges or encumbrances that would not, singly or in the
aggregate, result in a Material Adverse Effect), nor will such action result in any violation of the provisions of the charter, by-laws
or similar organizational document of the Company or any of its subsidiaries or any law, statute, rule, regulation, judgment, order, writ
or decree of any Governmental Entity. As used herein, a “Repayment Event” means any event or condition which gives 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.
(p)
Absence of Labor Dispute. Except as would not reasonably be expected to result in a Material Adverse Effect, no labor dispute
with the employees of the Company or any of its subsidiaries exists or, to the knowledge of the Company, is imminent, and to the Company’s
knowledge, there is no existing or imminent labor disturbance by the employees of any of its or any subsidiary’s principal suppliers,
manufacturers, customers or contractors.
(q)
Absence of Proceedings. Except as disclosed in the Registration Statement and the Prospectus, there is no action, suit,
proceeding, inquiry or investigation before or brought by any Governmental Entity now pending or, to the knowledge of the Company, threatened,
against or affecting the Company or any of its subsidiaries, which would reasonably be expected to, singly or in the aggregate, result
in a Material Adverse Effect, or which would reasonably be expected to singly or in the aggregate, materially and adversely affect their
respective properties or assets or the consummation of the transactions contemplated in this Agreement or the performance by the Company
of its obligations hereunder; and the aggregate of all pending legal or governmental proceedings to which the Company or any such subsidiary
is a party or of which any of their respective properties or assets is the subject which are not described in the Registration Statement
and the Prospectus, including ordinary routine litigation incidental to the business, would not reasonably be expected to, singly or in
the aggregate, result in a Material Adverse Effect.
(r)
Accuracy of Exhibits. There are no contracts or documents which are required to be described in the Registration Statement
or the Prospectus or to be filed as exhibits to the Registration Statement which have not been so described and filed as required.
(s)
Absence of Further Requirements. No filing with, or authorization, approval, consent, license, order, registration, qualification
or decree of, any Governmental Entity is necessary or required for the performance by the Company of its obligations hereunder, in connection
with the offering, issuance or sale of the Placement Shares hereunder or the consummation of the transactions contemplated by this Agreement,
except as have been already obtained or as may be required under the Securities Act, the Securities Act Regulations, the rules of the
Exchange, state securities laws or the rules of the Financial Industry Regulatory Authority, Inc. (“FINRA”).
(t)
Possession of Licenses and Permits. The Company and its subsidiaries possess such permits, licenses, approvals, consents
and other authorizations (collectively, “Governmental Licenses”) issued by the appropriate Governmental Entities
necessary to conduct the business now operated by them, except where the failure so to possess would not, singly or in the aggregate,
result in a Material Adverse Effect. The Company and its subsidiaries are in compliance with the terms and conditions of all Governmental
Licenses, except where the failure so to comply would not reasonably be expected to, singly or in the aggregate, result in a Material
Adverse Effect. All of the Governmental Licenses are valid and in full force and effect, except when the invalidity of such Governmental
Licenses or the failure of such Governmental Licenses to be in full force and effect would not reasonably be expected to, singly or in
the aggregate, result in a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any notice of proceedings
relating to the revocation or modification of any Governmental Licenses which, singly or in the aggregate, if the subject of an unfavorable
decision, ruling or finding, would result in a Material Adverse Effect.
(u)
Title to Property. The Company and its subsidiaries have good and marketable title to all real property owned by them and
good title to all other properties owned by them, in each case, free and clear of all mortgages, pledges, liens, security interests, claims,
restrictions or encumbrances of any kind except such as (A) are described in the Registration Statement and the Prospectus or (B) do not,
singly or in the aggregate, materially affect the value of such property and do not materially interfere with the use made and proposed
to be made of such property by the Company or any of its subsidiaries; and all of the leases and subleases material to the business of
the Company and its subsidiaries, considered as one enterprise, and under which the Company or any of its subsidiaries holds properties
described in the Registration Statement or the Prospectus, are in full force and effect, and neither the Company nor any such subsidiary
has any notice of any material claim of any sort that has been asserted by anyone adverse to the rights of the Company or any subsidiary
under any of the leases or subleases mentioned above, or affecting or questioning the rights of the Company or such subsidiary to the
continued possession of the leased or subleased premises under any such lease or sublease.
(v)
Possession of Intellectual Property. The Company and its subsidiaries own or possess, or can acquire on reasonable terms,
adequate patents, patent rights, licenses, inventions, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable
proprietary or confidential information, systems or procedures), trademarks, service marks, trade names or other intellectual property
necessary to carry on the business as now operated by them, and as proposed to be operated in the future, as disclosed in the Registration
Statement and the Prospectus (collectively, “Intellectual Property”). To the Company’s knowledge, except
as disclosed in the Registration Statement and the Prospectus, the conduct of the Company and its subsidiaries’ respective businesses
does not and will not infringe any issued patents or misappropriate any trade secrets of third parties. 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. Neither the Company nor any of its subsidiaries
has received any notice of any claim, or is otherwise aware, of any patent infringement or trade secret misappropriation. Neither the
Company nor any of its subsidiaries has received any notice of any claim, or is otherwise aware, of any facts or circumstances which would
render any Intellectual Property of the Company invalid or inadequate to protect the interest of the Company or any of its subsidiaries
therein. 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 or
the Prospectus as owned by or licensed to the Company or its subsidiaries; and (ii) there is no infringement by third parties of any Intellectual
Property. There is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others: challenging
the Company’s rights in or to any Intellectual Property of the Company, and the Company is unaware of any facts which would form
a reasonable basis for any such action, suit, proceeding or claim. Except as would not reasonably be expected, individually or in the
aggregate, to have a material Adverse Effect, 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 its subsidiaries, 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 (Y) to the Company’s knowledge, 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 foreign offices having similar requirements, all such requirements have been complied with. To the Company’s knowledge, 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 or the Prospectus as under development by the Company
or its subsidiaries fall within the scope of the claims of one or more patents or patent applications owned by, or exclusively licensed
to, the Company or its subsidiaries.
(w)
Environmental Laws. Except as described in the Registration Statement and the Prospectus or would not, singly or in the
aggregate, result in a Material Adverse Effect, (A) neither the Company nor any of its subsidiaries is in violation of any federal, state,
local or foreign 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, asbestos-containing materials or mold (collectively,
“Hazardous Materials”) or to the manufacture, processing, distribution, use, treatment, storage, disposal, transport
or handling of Hazardous Materials (collectively, “Environmental Laws”), (B) 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, (C) 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, investigations or proceedings relating to any Environmental
Law against the Company or any of its subsidiaries and (D) to the knowledge of the Company, there are no events or circumstances that
would 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 Entity, against or affecting the Company or any of its subsidiaries relating to Hazardous Materials or any Environmental
Laws.
(x)
Accounting Controls. The Company and each of its subsidiaries maintain effective internal control over financial reporting
(as defined under Rule 13a-15 and 15d-15 under the Exchange Act Regulations) and a system of internal accounting controls sufficient to
provide reasonable assurances that (A) transactions are executed in accordance with management’s general or specific authorization;
(B) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain accountability
for assets; (C) access to assets is permitted only in accordance with management’s general or specific authorization; (D) the recorded
accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to
any differences; and (E) the interactive data in eXtensible Business Reporting Language 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. Except as described in the Registration Statement and the Prospectus, since
the end of the Company’s most recent audited fiscal year, there has been (1) no material weakness in the Company’s internal
control over financial reporting (whether or not remediated) and (2) no change in the Company’s internal control over financial
reporting that has materially and adversely affected, or is reasonably likely to materially and adversely affect, the Company’s
internal control over financial reporting. The Company and each of its Subsidiaries maintain an effective system of disclosure controls
and procedures (as defined in Rule 13a-15 and Rule 15d-15 under the 1934 Act Regulations) that are designed to ensure that information
required to be disclosed by the Company in the reports that it files or submits under the 1934 Act is recorded, processed, summarized
and reported, within the time periods specified in the Commission’s rules and forms, and is accumulated and communicated to the
Company’s management, including its principal executive officer or officers and principal financial officer or officers, as appropriate,
to allow timely decisions regarding disclosure and which have been evaluated by management of the Company for effectiveness as of the
end of the Company’s most recent fiscal quarter.
(y)
Compliance with Sarbanes-Oxley Act. There is and has been no failure on the part of the Company or, to the Company’s
knowledge, any of the Company’s directors or officers, in their capacities as such, to comply in all material respects with any
applicable provisions of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) and the rules and regulations
promulgated thereunder. Each of the principal executive officer and the principal financial officer of the Company (or each former principal
executive officer of the Company and each former principal financial officer of the Company as applicable) has made all certifications
required by Sections 302 and 906 of the Sarbanes-Oxley Act with respect to all reports, schedules, forms, statements and other documents
required to be filed by it or furnished by it to the Commission. For purposes of the preceding sentence, “principal executive officer”
and “principal financial officer” shall have the meanings given to such terms in the Sarbanes-Oxley Act.
(z)
Payment of Taxes. All United States federal and U.K. income and other material tax returns of the Company and its subsidiaries
required by law to be filed have been filed and all taxes shown by such returns or otherwise assessed, which are due and payable, have
been paid, except assessments against which appeals have been taken and as to which adequate reserves have been provided. The Company
and its subsidiaries have filed all other tax returns that are required to have been filed by them pursuant to applicable foreign, state,
local or other law except insofar as the failure to file such returns would not result in a Material Adverse Effect, and have paid all
taxes due pursuant to such returns or pursuant to any assessment received by the Company and its subsidiaries, except for such taxes,
if any, as are being contested in good faith and as to which adequate reserves have been established by the Company. The charges, accruals
and reserves on the books of the Company in respect of any income and corporation tax liability for any years not finally determined are
adequate to meet any assessments or re-assessments for additional income tax for any years not finally determined, except to the extent
of any inadequacy that would not result in a Material Adverse Effect.
(aa)
No Stamp or Transfer Taxes. Except as disclosed in the Registration Statement and the Prospectus, no documentary, registration,
transfer, stamp or other similar taxes or duties including, for the avoidance of doubt, UK stamp duty and UK stamp duty reserve tax (“Transfer
Taxes”) are payable by or on behalf of the Agent, the Company or any of its subsidiaries in the United Kingdom or to any
taxing authority thereof or therein in connection with (i) the execution, delivery or consummation of this Agreement, (ii) the creation,
allotment and issuance of the Placement Shares, (iii) the sale and delivery of the Placement Shares to the Agent in the manner contemplated
herein, or (iv) the resale and delivery of the Placement Shares by the Agent in the manner contemplated herein.
(bb)
Insurance. The Company and its subsidiaries carry or are entitled to the benefits of insurance, with financially sound and
reputable insurers, in such amounts and covering such risks as is generally maintained by similarly sized companies of established repute
engaged in the same or similar business, and all such insurance is in full force and effect. The Company has no reason to believe that
it or any of its subsidiaries will not be able (A) to renew its existing insurance coverage as and when such policies expire or (B) 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 would not result in a Material Adverse Effect. Neither of the Company nor any of its subsidiaries has been denied any insurance
coverage which it has sought or for which it has applied.
(cc)
Investment Company Act. The Company is not, and will not be, either after receipt of payment for the Placement 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”).
(dd)
No Price Stabilization or Manipulation; Compliance with Regulation M. The Company has not taken, directly or indirectly,
in relation to the offering of the Placement Shares or otherwise, any action or engaged in any course of conduct in breach of, and has
taken adequate measures and has adequate procedures in place in order to ensure compliance with, and none of the issue of the Placement
Shares, the sale of the Placement Shares and the consummation of the transactions contemplated by this Agreement will constitute a violation
by the Company of, any applicable U.K., US or any other relevant jurisdiction “insider dealing,” “insider trading”
or similar legislation and, so far as the Company is aware, no person acting on its behalf has breached or is in breach of any relevant
market abuse or insider trading law or regulation, including any reporting obligations to the Commission or any other authority. None
of the Company nor any affiliate of the Company has taken, nor will the Company or any affiliate of the Company take, directly or indirectly,
any action which is designed, or would be expected, to cause or result in, or which constitutes, the stabilization or manipulation of
the price of any security of the Company to facilitate the sale or resale of the Placement Shares or to result in a violation of Regulation
M under the Exchange Act.
(ee)
Foreign Corrupt Practices Act. None of the Company, any of its subsidiaries or, to the knowledge of the Company, any director,
officer, agent, employee, affiliate or other person acting on behalf of the Company or any of its subsidiaries is aware of or has taken
any action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as
amended, and the rules and regulations thereunder (the “FCPA”), including, without limitation, making use of
the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization
of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign
official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign
political office, in contravention of the FCPA and the Company and, to the knowledge of the Company, its affiliates have conducted their
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.
(ff)
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
rules, regulations or guidelines, issued, administered or enforced by any Governmental Entity (collectively, the “Money Laundering
Laws”); and no action, suit or proceeding by or before any Governmental Entity 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.
(gg)
OFAC. None of the Company, any of its subsidiaries or, to the knowledge of the Company, any director, officer, agent, employee,
affiliate or representative of the Company or any of its subsidiaries is an individual or entity (“Person”)
currently the subject or target of any sanctions administered or enforced by the United States Government, including, without limitation,
the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), the United Nations Security
Council (“UNSC”), the European Union, His Majesty’s Treasury (“HMT”), or other
relevant sanctions authority (collectively, “Sanctions”), nor is the Company located, organized or resident
in a country or territory that is the subject of Sanctions; and the Company will not directly or indirectly use the proceeds of the sale
of the Placement Shares, or lend, contribute or otherwise make available such proceeds to any subsidiaries, joint venture partners or
other Person, to fund any activities of or business with any Person, or in any country or territory, that, at the time of such funding,
is the subject of Sanctions or in any other manner that will result in a violation by any Person (including any Person participating in
the transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions.
(hh)
Lending Relationship. Except as disclosed in the Registration Statement and the Prospectus, the Company (i) does
not have any material lending or other relationship with any bank or lending affiliate of the Agent and (ii) does not intend to use any
of the proceeds from the sale of the Placement Shares to repay any outstanding debt owed to any affiliate of the Agent.
(ii)
Statistical and Market-Related Data. Any statistical 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 in all
material respects and, to the extent required, the Company has obtained the written consent to the use of such data from such sources.
(jj)
Regulatory Matters. Except as described in the Registration Statement and the Prospectus, and except as would not, individually
or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) neither the Company nor any of its subsidiaries
has received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the U.S. Food
and Drug Administration or other Governmental Entity, alleging or asserting material noncompliance with the Federal Food, Drug and Cosmetic
Act (21 U.S.C. § 301 et seq.) (the “FFDCA”), section 351 of the Public Health Service Act (42 U.S.C. §
262) (“section 351 of the PHSA”) or similar state, federal or foreign law or regulation; (ii) the Company and
any subsidiary, and to the Company’s knowledge, their respective directors, officers, employees or agents, are and have been in
compliance in all material respects with all applicable health care laws, including without limitation, (A) the FFDCA and PHSA; (B) all
applicable federal, state, local and all applicable foreign healthcare related fraud and abuse laws, including, without limitation, the
federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal
False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including, but not limited
to, 18 U.S.C. §§ 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion law (42 U.S.C. § 1320a-7), the civil monetary
penalties law (42 U.S.C. § 1320a-7a) and the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); (C) Medicare (Title
XVIII of the Social Security Act); (D) Medicaid (Title XIX of the Social Security Act); (E) HIPAA, as amended by the Health Information
Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); (F) the regulations promulgated pursuant to such
laws; and (G) any other similar local, state, federal, or foreign laws (collectively, “Health Care Laws”); (iii)
neither the Company nor any subsidiary has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement,
investigation, arbitration or other action from any U.S. or non-U.S. Governmental Entity or third party alleging that any product operation
or activity is in violation of any Health Care Law or has any knowledge that any such Governmental Entity or third party is considering
any such claim, litigation, arbitration, action, suit, investigation or proceeding; (iv) neither the Company nor any subsidiary has received
written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any applicable
Governmental Licenses or has any knowledge that any such Governmental Entity is considering such action; (v) the Company and each subsidiary
has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions
and supplements or amendments as required by all Health Care Laws and that all such material reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected
or supplemented by a subsequent submission); (vi) neither the Company nor any subsidiary or any of their respective directors, officers,
employees or, to the Company’s knowledge, or agents is or has been debarred, suspended or excluded, or has been convicted of any
crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health
care program; and (vii) the Company is not a party to, and does not have any ongoing reporting obligations pursuant to any corporate integrity
agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement
imposed by any Government Entity.
(kk)
Preclinical and Clinical Studies. The preclinical and clinical studies conducted by or on behalf of the Company have been
and, if still pending, are being conducted in accordance with experimental protocols, procedures and controls pursuant to all applicable
Health Care Laws and Governmental Licenses; the descriptions of the results of such preclinical and clinical studies contained in the
Registration Statement and the Prospectus are accurate and complete in all material respects and fairly present the data derived from
such preclinical and clinical studies; except to the extent disclosed in the Registration Statement and the Prospectus, the Company is
not aware of any preclinical or clinical studies, the results of which the Company believes reasonably call into question the preclinical
or clinical study results described in the Registration Statement and the Prospectus when viewed in the context in which such results
are described; and neither the Company nor any of its Subsidiaries has received any notices or correspondence from any Governmental Authority
requiring the termination or suspension, or except as disclosed in the Registration Statement and the Prospectus, any modification of
any preclinical or clinical study conducted by or on behalf of the Company, except as described in the Registration Statement and the
Prospectus or as would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect.
(ll)
Cybersecurity. (i)(x) To the Company’s knowledge, there has been no material security breach or attack or other compromise
of or relating to any of the Company’s and its subsidiaries’ information technology and computer systems, networks, hardware,
software, data (including the data of their respective employees, suppliers, vendors and any third party data maintained by or on behalf
of them), equipment or technology (“IT Systems and Data”) and (y) the Company and its subsidiaries have not
been notified of, and have no knowledge of any event or condition that would reasonably be expected to result in, any security breach,
attack or compromise to their IT Systems and Data, (ii) the Company and its subsidiaries have complied, and are presently in compliance,
with, all applicable laws, statutes or any applicable judgment, order, rule or regulation of any court or arbitrator or governmental or
regulatory authority and all applicable industry guidelines, standards, internal policies and contractual obligations relating to the
privacy and security of IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation
or modification, except in the case of this clause (ii), individually or in the aggregate, would not reasonably be expected to have a
Material Adverse Effect and (iii) the Company and its subsidiaries have implemented backup and disaster recovery technology consistent
with industry standards and practices.
(mm)
Passive Foreign Investment Company. Subject to the qualifications, limitations, exceptions and assumptions set forth in
the Registration Statement and the Prospectus, the Company believes that it was not a passive foreign investment company (“PFIC”)
within the meaning of Section 1297 of the Internal Revenue Code of 1986, as amended, for its most recently completed taxable year and
it does not expect to be a PFIC for its current taxable year.
(nn)
Proper Form. This Agreement is in proper form to be enforceable in the Cayman Islands in accordance with its terms; to ensure
the legality, validity, enforceability or admissibility into evidence in the Cayman Islands of this Agreement it is not necessary that
this Agreement be filed or recorded with any court or other authority in the Cayman Islands (other than court filings in the ordinary
course of proceedings) or that any stamp or similar tax in the Cayman Islands (other than court fees or similar documentary tax payable
in the ordinary course of proceedings) be paid on or in respect of this Agreement or any other documents to be furnished hereunder or
thereunder.
(oo)
No Immunity. Neither the Company nor any of its subsidiaries has any right of immunity under New York or United States law
or the law of the Cayman Islands, 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 New York or United States federal court or court in the Cayman
Islands, 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 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, the Company and any such subsidiary waives or will waive such right to the extent
permitted by law and has consented to such relief and enforcement as provided in Section 16 of this Agreement.
(pp)
Valid Choice of Law. The Company has the power to submit, and pursuant to Section 18 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 18 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
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 18 hereof.
(qq)
Final Judgments. Any final judgment for a fixed or readily calculable sum of money rendered by a New York Court having jurisdiction
under its own domestic laws 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 would be enforceable against the Company without
re-examination of the merits of the underlying dispute, by an action commenced on the foreign judgment debt in the Grand Court of the
Cayman Islands, provided such judgment (A) is given by a foreign court of competent jurisdiction; (B) imposes on the judgment debtor a
liability to pay a liquidated sum for which the judgment has been given; (C) is final; (D) is not in respect of taxes, a fine or penalty;
and (E) was not obtained in a manner and is not of a kind the enforcement of which is contrary to natural justice or the public policy
of the Cayman Islands.
(rr)
No Rated Securities. Neither the Company nor its subsidiaries have any debt securities or preferred shares that are rated
by any “nationally recognized statistical rating agency” (as defined in Section 3(a)(62) of the Exchange Act).
(ss)
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, to the Company’s knowledge, the holders of any securities (debt or equity) or options to acquire any
securities of the Company in connection with the offering of the Placement Shares is true, complete, correct in all material respects
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 in all material respects. The Company meets the definition of the term “experienced
issuer” specified in FINRA Rule 5110(j)(6).
(tt)
Brokers. Except pursuant to this Agreement, 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.
(uu)
Conformity with EDGAR Filing. The Prospectus delivered to Agent for use in connection with the sale of the Placement Shares
pursuant to this Agreement will be identical to the versions of the Prospectus created to be transmitted to the Commission for filing
via EDGAR, except to the extent permitted by Regulation S-T.
(vv)
Market Capitalization. At the time the Registration Statement was or will be originally declared effective, and at the time
the Company’s most recent Annual Report on Form 10-K was filed with the Commission, the Company met or will meet the then applicable
requirements for the use of Form S-3 under the Securities Act, including, but not limited to, General Instruction I.B.1 of Form S-3. The
Company is not a shell company (as defined in Rule 405 under the Securities Act) and has not been a shell company for at least 12 calendar
months previously and if it has been a shell company at any time previously, has filed current Form 10 information (as defined in General
Instruction I.B.6 of Form S-3) with the Commission at least 12 calendar months previously reflecting its status as an entity that is not
a shell company.
(ww)
No Material Defaults. Neither the Company nor any of the Subsidiaries has defaulted on any installment on indebtedness for
borrowed money or on any rental on one or more long-term leases, which defaults, individually or in the aggregate, would have a Material
Adverse Effect. The Company has not filed a report pursuant to Section 13(a) or 15(d) of the Exchange Act since the filing of its last
Annual Report on Form 10-K, indicating that it (i) has failed to pay any dividend or sinking fund installment on preferred shares or (ii)
has defaulted on any installment on indebtedness for borrowed money or on any rental on one or more long-term leases, which defaults,
individually or in the aggregate, would have a Material Adverse Effect.
(xx)
No Reliance. The Company has not relied upon the Agent or legal counsel for the Agent for any legal, tax or accounting advice
in connection with the offering and sale of the Placement Shares.
(yy)
Margin Rules. Neither the issuance, sale and delivery of the Placement Shares nor the application of the proceeds thereof
by the Company as described in the Registration Statement and the Prospectus will violate Regulation T, U or X of the Board of Governors
of the Federal Reserve System or any other regulation of such Board of Governors.
(zz)
Underwriter 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.
(aaa)
Agent Purchases. The Company acknowledges and agrees that Agent has informed the Company that the Agent may, to the extent
permitted under the Securities Act and the Exchange Act, purchase and sell Ordinary Shares for its own account while this Agreement is
in effect, provided, that the Company shall not be deemed to have authorized or consented to any such purchases or sales by the
Agent.
(bbb)
No Misstatement or Omission in an Issuer Free Writing Prospectus. Each Issuer Free Writing Prospectus, as of its issue date
and as of each Applicable Time (as defined in Section 26 below), did not, does not and will not, through the completion of the
Placement for which such Issuer Free Writing Prospectus is used, include any information that conflicted, conflicts or will conflict with
the information contained in the Registration Statement or the Prospectus, including any Incorporated Document deemed to be a part thereof
that has not been superseded or modified. The foregoing sentence does not apply to statements in or omissions from any Issuer Free Writing
Prospectus based upon and in conformity with written information furnished to the Company by the Agent specifically for use therein.
Any certificate signed by an officer of the Company
and delivered to the Agent or to counsel for the Agent pursuant to or in connection with this Agreement shall be deemed to be a representation
and warranty by the Company, as applicable, to the Agent as to the matters set forth therein.
7. Covenants
of the Company. The Company covenants and agrees with Agent that:
(a)
Registration Statement Amendments. After the date of this Agreement and during any period in which a Prospectus relating
to any Placement Shares is required to be delivered by Agent under the Securities Act (including in circumstances where such requirement
may be satisfied pursuant to Rule 172 under the Securities Act or similar rule), (i) the Company will notify the Agent promptly of the
time when any subsequent amendment to the Registration Statement, other than Incorporated Documents, has been filed with the Commission
and/or has become effective or any subsequent supplement to the Prospectus has been filed and of any request by the Commission for any
amendment or supplement to the Registration Statement or Prospectus or for additional information, (ii) the Company will prepare and file
with the Commission, promptly upon the Agent’s request, any amendments or supplements to the Registration Statement or Prospectus
that, in the Agent’s reasonable opinion, may be necessary or advisable in connection with the distribution of the Placement Shares
by the Agent (provided, however, that the failure of the Agent to make such request shall not relieve the Company of any
obligation or liability hereunder, or affect the Agent’s right to rely on the representations and warranties made by the Company
in this Agreement and provided, further, that the only remedy the Agent shall have with respect to the failure by the Company
to make such filing shall be to cease making sales under this Agreement until such amendment or supplement is filed); (iii) the Company
will not file any amendment or supplement to the Registration Statement or Prospectus relating to the Placement Shares (other than Incorporated
Documents) or a security convertible into the Placement Shares unless a copy thereof has been submitted to Agent within a reasonable period
of time before the filing and the Agent has not reasonably objected thereto (provided, however, that the failure of the
Agent to make such objection shall not relieve the Company of any obligation or liability hereunder, or affect the Agent’s right
to rely on the representations and warranties made by the Company in this Agreement and provided, further, that the only
remedy the Agent shall have with respect to the failure by the Company to obtain such consent shall be to cease making sales under this
Agreement) and the Company will furnish to the Agent at the time of filing thereof a copy of any document that upon filing is deemed to
be an Incorporated Document in the Registration Statement or Prospectus, except for those documents available via EDGAR; and (iv) the
Company will cause each amendment or supplement to the Prospectus to be filed with the Commission as required pursuant to the applicable
paragraph of Rule 424(b) of the Securities Act or, in the case of any Incorporated Document, to be filed with the Commission as required
pursuant to the Exchange Act, within the time period prescribed (the determination to file or not file any amendment or supplement with
the Commission under this Section 7(a), based on the Company’s reasonable opinion or reasonable objections, shall be made
exclusively by the Company).
(b)
Notice of Commission Stop Orders. The Company will advise the Agent, promptly after it receives notice or obtains knowledge
thereof, of the issuance or threatened issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement,
of the suspension of the qualification of the Placement Shares for offering or sale in any jurisdiction, or of the initiation or threatening
of any proceeding for any such purpose; and it will promptly use its commercially reasonable efforts to prevent the issuance of any stop
order or to obtain its withdrawal if such a stop order should be issued. The Company will advise the Agent promptly after it receives
any request by the Commission for any amendments to the Registration Statement or any amendment or supplements to the Prospectus or any
Issuer Free Writing Prospectus or for additional information related to the offering of the Placement Shares or for additional information
related to the Registration Statement, the Prospectus or any Issuer Free Writing Prospectus.
(c)
Delivery of Prospectus; Subsequent Changes. During any period in which a Prospectus relating to the Placement Shares is
required to be delivered by the Agent under the Securities Act with respect to the offer and sale of the Placement Shares, (including
in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act or similar rule), the Company will
comply in all material respects with all requirements imposed upon it by the Securities Act, as from time to time in force, and to file
on or before their respective due dates all reports and any definitive proxy or information statements required to be filed by the Company
with the Commission pursuant to Sections 13(a), 13(c), 14, 15(d) or any other provision of or under the Exchange Act. If the Company has
omitted any information from the Registration Statement pursuant to Rule 430B under the Securities Act, it will use its commercially reasonable
efforts to comply with the provisions of and make all requisite filings with the Commission pursuant to said Rule 430B and to notify the
Agent promptly of all such filings. If during such period any event occurs as a result of which the Prospectus as then amended or supplemented
would include an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the
light of the circumstances then existing, not misleading, or if during such period it is necessary to amend or supplement the Registration
Statement or Prospectus to comply with the Securities Act, the Company will promptly notify the Agent to suspend the offering of Placement
Shares during such period and the Company will promptly amend or supplement the Registration Statement or Prospectus (at the expense of
the Company) so as to correct such statement or omission or effect such compliance; provided, however, that the Company may delay
any such amendment or supplement if, in the reasonable judgment of the Company, it is in the interests of the Company to do so. Until
such time as the Company shall have corrected such misstatement or omission or effected such compliance, the Company shall not notify
the Agent to resume the offering of Placement Shares.
(d)
Listing of Placement Shares. During any period in which the Prospectus relating to the Placement Shares is required to be
delivered by the Agent under the Securities Act with respect to the offer and sale of the Placement Shares, the Company will use its commercially
reasonable efforts to cause the Placement Shares to be listed on the Exchange.
(e)
Delivery of Registration Statement and Prospectus. The Company will furnish to the Agent and its counsel (at the expense
of the Company) copies of the Registration Statement, the Prospectus (including all Incorporated Documents) and all amendments and supplements
to the Registration Statement or Prospectus that are filed with the Commission during any period in which a Prospectus relating to the
Placement Shares is required to be delivered under the Securities Act (including all documents filed with the Commission during such period
that are deemed to be Incorporated Documents), in each case as soon as reasonably practicable and in such quantities as the Agent may
from time to time reasonably request and, at the Agent’s request, will also furnish copies of the Prospectus to each exchange or
market on which sales of the Placement Shares may be made; provided, however, that the Company shall not be required to
furnish any document (other than the Prospectus) to the Agent to the extent such document is available on EDGAR.
(f)
Earnings Statement. The Company will make generally available to its security holders as soon as practicable, but in any
event not later than 15 months after the end of the Company’s current fiscal quarter, an earnings statement covering a 12-month
period that satisfies the provisions of Section 11(a) and Rule 158 of the Securities Act.
(g)
Use of Proceeds. The Company will use the Net Proceeds as described in the Prospectus in the section entitled “Use
of Proceeds.”
(h)
Notice of Other Sales. Without the prior 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 (other than the Placement 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 during the period beginning on the fifth (5th) Trading Day immediately
prior to the date on which any Placement Notice is delivered to Agent hereunder and ending on the fifth (5th) Trading Day immediately
following the final Settlement Date with respect to Placement Shares sold pursuant to such Placement Notice (or, if the Placement Notice
has been terminated or suspended prior to the sale of all Placement Shares covered by a Placement Notice, the date of such suspension
or termination); and will not directly or indirectly in any other “at the market offering” or continuous equity transaction
offer to sell, sell, contract to sell, grant any option to sell or otherwise dispose of any Ordinary Shares (other than the Placement
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 later of the termination of this Agreement and the sixtieth (60th)
day immediately following the final Settlement Date with respect to Placement Shares sold pursuant to such Placement Notice; provided,
however, that such restrictions will not be required in connection with the Company’s issuance or sale of (i) Ordinary Shares,
options to purchase Ordinary Shares, other securities under the Company’s existing share incentive plans or equity incentive plans
or Ordinary Shares issuable upon the exercise of options, pursuant to any employee or director share option or benefits plan, share ownership
plan or dividend reinvestment plan (but not Ordinary Shares subject to a waiver to exceed plan limits in its dividend reinvestment plan)
of the Company whether now in effect or hereafter implemented, (ii) Ordinary Shares issuable upon conversion of securities or the exercise
of warrants, options or other rights in effect or outstanding, and disclosed in filings by the Company available on EDGAR or otherwise
in writing to the Agent and (iii) Ordinary Shares or securities convertible into or exchangeable for Ordinary Shares as consideration
for mergers, acquisitions, other business combinations or strategic alliances occurring after the date of this Agreement which are not
issued for capital raising purposes.
(i)
Change of Circumstances. The Company will, at any time during the pendency of a Placement Notice advise the Agent promptly
after it shall have received notice or obtained knowledge thereof, of any information or fact that would alter or affect in any material
respect any opinion, certificate, letter or other document required to be provided to the Agent pursuant to this Agreement.
(j)
Due Diligence Cooperation. The Company will cooperate with any reasonable due diligence review conducted by the Agent or
its representatives in connection with the transactions contemplated hereby, including, without limitation, providing information and
making available documents and senior corporate officers, during regular business hours and at the Company’s principal offices,
as the Agent may reasonably request.
(k)
Required Filings Relating to Placement of Placement Shares. The Company shall disclose, in its quarterly reports on Form
10-Q and in its annual report on Form 10-K to be filed by the Company with the Commission from time to time, the number of the Placement
Shares sold through the Agent under this Agreement, and the net proceeds to the Company from the sale of the Placement Shares pursuant
to this Agreement during the relevant quarter or, in the case of an Annual Report on Form 10-K, during the fiscal year covered by such
Annual Report and the fourth quarter of such fiscal year. The Company agrees that on such dates as the Securities Act shall require, the
Company will (i) file a prospectus supplement with the Commission under the applicable paragraph of Rule 424(b) under the Securities Act
(each and every filing date under Rule 424(b), a “Filing Date”), which prospectus supplement will set forth,
within the relevant period, the amount of Placement Shares sold through the Agent, the Net Proceeds to the Company and the compensation
payable by the Company to the Agent with respect to such Placement Shares, and (ii) deliver such number of copies of each such prospectus
supplement to each exchange or market on which such sales were effected as may be required by the rules or regulations of such exchange
or market.
(l) Representation Dates; Certificate. (1) Prior to the date of the first Placement Notice and (2) following delivery of the
first Placement Notice, each time the Company:
(i) files
the Prospectus relating to the Placement Shares (other than as part of any filing prior to the time of initial effectiveness of the Registration
Statement) or amends or supplements (other than a prospectus supplement relating solely to an offering of securities other than the Placement
Shares) the Registration Statement or the Prospectus relating to the Placement Shares 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 the Prospectus relating
to the Placement Shares;
(ii) files
an annual report on Form 10-K under the Exchange Act (including any Form 10-K/A containing amended financial information or a material
amendment to the previously filed Form 10-K);
(iii)
files its quarterly reports on Form 10-Q under the Exchange Act;
(iv)
files a current report on Form 8-K containing amended financial information (other than information “furnished” pursuant
to Items 2.02 or 7.01 of Form 8-K or to provide disclosure pursuant to Item 8.01 of Form 8-K relating to the reclassification of certain
properties as discontinued operations in accordance with Statement of Financial Accounting Standards No. 144) under the Exchange Act;
or
(v) as
the Agent may reasonably request (each date of filing of one or more of the items referred to in clauses (i) through (iv) shall be a
“Representation Date”);
the Company shall furnish the Agent (but in the
case of clause (iv) above only if the Agent reasonably determines that the information contained in such Form 8-K is material) with a
certificate dated the Representation 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. The requirement to provide a certificate under this Section 7(l) shall be waived for any Representation
Date occurring at a time at which no Placement Notice is pending (including, for purposes of clarity, during which a Suspension is in
effect), which waiver shall continue until the earlier to occur of the date the Company delivers a Placement Notice hereunder or instructions
for the sale of Placement Shares under a suspended Placement Notice (which for such calendar quarter shall be considered a Representation
Date) and the next occurring Representation Date for which the requirement to provide a certificate under this Section 7(l) is
not waived pursuant to the terms hereof. Notwithstanding the foregoing, if the Company subsequently decides to sell Placement Shares following
a Representation Date when the Company relied on such waiver and did not provide the Agent with a certificate under this Section 7(l),
then before the Company delivers the instructions for the sale of Placement Shares or the Agent sells any Placement Shares pursuant to
such instructions, the Company shall provide the Agent with a certificate in conformity with this Section 7(l) dated as of the
date of the Placement Notice or the date that the instructions for the sale of Placement Shares are issued, as applicable.
(m)
Legal Opinions. (i)(1) Prior to the date of the first Placement Notice and (2) on or prior to each Representation Date with
respect to which the Company is obligated to deliver a certificate pursuant to Section 7(l) for which no waiver is applicable and
excluding the date of this Agreement, the Company shall cause to be furnished to the Agent written opinions of Latham & Watkins LLP
(“Latham”) and Walkers Global (“Walkers” and, together with Latham, “Company Counsel”),
or other counsel reasonably satisfactory to the Agent, 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, that the Company shall be required to furnish to
Agent no more than one opinion from each of Latham and Walkers hereunder per calendar quarter; provided, further, that in
lieu of such opinions for subsequent periodic filings under the Exchange Act, counsel may furnish the Agent with a letter (a “Reliance
Letter”) to the effect that the Agent may rely on a prior opinion delivered under this Section 7(m) to the same extent
as if it were dated the date of such letter (except that statements in such prior opinion shall be deemed to relate to the Registration
Statement and the Prospectus as amended or supplemented as of the date of the Reliance Letter). (ii) (1) Prior to the date of the first
Placement Notice, the Company shall cause to be furnished to the Agents the written opinion of Fox Rothschild LLP, intellectual property
and patent counsel for the Company (“IP Counsel”), or other counsel reasonably satisfactory to the Agents, in form
and substance reasonably satisfactory to Agents and their counsel, substantially similar to the form previously provided to the Agents
and their counsel.
(n)
Comfort Letter. (1) Prior to the date of the first Placement Notice and (2) on or prior to each Representation Date with
respect to which the Company is obligated to deliver a certificate pursuant to Section 7(l) for which no waiver is applicable and
excluding the date of this Agreement, the Company shall cause its independent registered public accounting firm to furnish the Agent letters
(the “Comfort Letters”), dated the date the Comfort Letter is delivered, which shall meet the requirements set
forth in this Section 7(n); provided, that if reasonably requested by the Agent, the Company shall cause a Comfort Letter
to be furnished to the Agent within ten (10) Trading Days of the date of occurrence of any material transaction or event, including the
restatement of the Company’s financial statements. The Comfort Letter from the Company’s independent registered public accounting
firm shall be in a form and substance reasonably satisfactory to the Agent, (i) confirming that they are an independent registered public
accounting firm within the meaning of the Securities Act and the PCAOB, (ii) stating, as of such date, the conclusions and findings of
such firm with respect to the financial information and other matters ordinarily covered by accountants’ “comfort letters”
to underwriters in connection with registered public offerings (the first such letter, the “Initial Comfort Letter”)
and (iii) updating the Initial Comfort Letter with any information that would have been included in the Initial Comfort Letter had it
been given on such date and modified as necessary to relate to the Registration Statement and the Prospectus, as amended and supplemented
to the date of such letter.
(o)
Market Activities. The Company will not, directly or indirectly, without giving effect to the activities of the Agent (i)
take any action designed to cause or result in, or that constitutes or would reasonably be expected to constitute, the stabilization or
manipulation of the price of any security of the Company to facilitate the sale or resale of Ordinary Shares in violation of the Exchange
Act, the Securities Act or the Securities Act Regulations or (ii) sell, bid for, or purchase Ordinary Shares in violation of Regulation
M under the Exchange Act, or pay anyone any compensation for soliciting purchases of the Placement Shares other than the Agent.
(p)
Investment Company Act. The Company will conduct its affairs in such a manner so as to reasonably ensure that neither it
nor any of its Subsidiaries will be or become, at any time prior to the termination of this Agreement, required to register as an “investment
company,” as such term is defined in the Investment Company Act.
(q)
No Offer to Sell. Other than an Issuer Free Writing Prospectus approved in advance by the Company and the Agent in its capacity
as agent hereunder, neither the Agent nor the Company (including its agents and representatives, other than the Agent in its capacity
as such) will make, use, prepare, authorize, approve or refer to any written communication (as defined in Rule 405 under the Securities
Act), required to be filed with the Commission, that constitutes an offer to sell or solicitation of an offer to buy Placement Shares
hereunder.
(r)
Blue Sky and Other Qualifications. The Company will use its commercially reasonable efforts, in cooperation with
the Agent, to qualify the Placement Shares for offering and sale, or to obtain an exemption for the Placement Shares to be offered and
sold, under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Agent may designate and
to maintain such qualifications and exemptions in effect for so long as required for the distribution of the Placement Shares (but in
no event for less than one year from the date of this Agreement); provided, however, that the Company shall not be obligated
to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction
in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise
so subject. In each jurisdiction in which the Placement Shares have been so qualified or exempt, the Company will file such statements
and reports as may be required by the laws of such jurisdiction to continue such qualification or exemption, as the case may be, in effect
for so long as required for the distribution of the Placement Shares (but in no event for less than one year from the date of this Agreement).
(s)
Sarbanes-Oxley Act. The Company and the Subsidiaries will maintain and keep accurate books and records reflecting their
assets and maintain internal accounting controls in a manner designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles
and including those policies and procedures that (i) pertain to the maintenance of records that in reasonable detail accurately and fairly
reflect the transactions and dispositions of the assets of the Company, (ii) provide reasonable assurance that transactions are recorded
as necessary to permit the preparation of the Company’s consolidated financial statements in accordance with generally accepted
accounting principles, (iii) that receipts and expenditures of the Company are being made only in accordance with management’s and
the Company’s directors’ authorization, and (iv) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on its financial statements.
The Company and the Subsidiaries will maintain such controls and other procedures, including, without limitation, those required by Sections
302 and 906 of the Sarbanes-Oxley Act, and the applicable regulations thereunder that are designed to ensure that information required
to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported,
within the time periods specified in the Commission’s rules and forms, including, without limitation, controls and procedures designed
to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated
and communicated to the Company’s management, including its principal executive officer and principal financial officer, or persons
performing similar functions, as appropriate to allow timely decisions regarding required disclosure and to ensure that material information
relating to the Company or the Subsidiaries is made known to them by others within those entities, particularly during the period in which
such periodic reports are being prepared.
(t)
Secretary’s Certificate; Further Documentation. Prior to the date of the first Placement Notice, the Company shall
deliver to the Agent a certificate of the Secretary of the Company and attested to by an executive officer of the Company, dated as of
such date, certifying as to (i) the Certificate of Incorporation of the Company, (ii) the By-laws of the Company, (iii) the resolutions
of the Board of Directors of the Company authorizing the execution, delivery and performance of this Agreement and the issuance of the
Placement Shares and (iv) the incumbency of the officers duly authorized to execute this Agreement and the other documents contemplated
by this Agreement. On or prior to each Representation Date with respect to which the Company is obligated to deliver a certificate pursuant
to Section 7(l) for which no waiver is applicable and excluding the date of this Agreement, the Company shall have furnished to
the Agent such further information, certificates and documents as the Agent may reasonably request.
(u)
[Reserved]
(v)
Value Added Tax. All sums payable to the Agent shall be considered exclusive of any value added tax chargeable pursuant
to the Value Added Tax Act 1994 (“VAT”). Where the Company is obliged to pay VAT on any amount payable hereunder
to the Agent, the Company shall in addition to the sum payable hereunder pay an amount equal to any applicable VAT to the extent not recoverable
by the Agent and subject to receipt of a valid VAT invoice from the Agent.
(w)
Share Register. The Company will at all times ensure that: (i) no register in respect of the Ordinary Shares is kept in
the United Kingdom by or on behalf of the Company; and (ii) the Ordinary Shares are not paired with shares or securities issued by a body
corporate incorporated in the United Kingdom.
8. Payment of Expenses. The Company will pay all expenses incident to the performance of its obligations under this Agreement,
including (i) the preparation and filing of the Registration Statement, including any fees required by the Commission, and the printing
or electronic delivery of the Prospectus as originally filed and of each amendment and supplement thereto, in such number as the Agent
shall deem necessary, (ii) the printing and delivery to the Agent of this Agreement and such other documents as may be reasonably required
pursuant to this Agreement in connection with the offering, purchase, sale, issuance or delivery of the Placement Shares, (iii) the preparation,
issuance and delivery of the certificates, if any, for the Placement Shares to the Agent, including any share or other transfer taxes
and any capital duties, stamp duties or other duties or taxes payable upon the sale, issuance or delivery of the Placement Shares to the
Agent, (iv) the fees and disbursements of the counsel, accountants and other advisors to the Company, (v)
the fees and disbursements of the outside legal counsel to the Agents of $75,000 in connection with execution of this Agreement and (B)
$7,500 in connection with each Representation Date on which the Company is required to provide a certificate pursuant to Section 7(l),
(vi) the qualification or exemption of the Placement Shares under state securities laws in accordance with the provisions of Section
7(r) hereof, including filing fees, but excluding fees of the Agent’s counsel, (vii) the printing and delivery to the Agent
of copies of any Permitted Issuer Free Writing Prospectus and the Prospectus and any amendments or supplements thereto in such number
as the Agent shall reasonably deem necessary, (viii) the preparation, printing and delivery to the Agent of copies of the blue sky survey,
(ix) the fees and expenses of the transfer agent and registrar for the Ordinary Shares, (x) the filing and other fees incident to any
review by FINRA of the terms of the sale of the Placement Shares including the fees of the Agent’s counsel (subject to the cap,
set forth in clause (v) above), and (xi) the fees and expenses incurred in connection with the listing of the Placement Shares on the
Exchange.
9. Conditions to Agent’s Obligations. The obligations of the Agent hereunder with respect to a Placement will be subject
to the continuing accuracy and completeness of the representations and warranties made by the Company herein, to the due performance in
all material respects by the Company of its obligations hereunder, to the completion by the Agent of a due diligence review satisfactory
to it in its reasonable judgment, and to the continuing satisfaction (or waiver by the Agent in its sole discretion) in all material respects
of the following additional conditions:
(a)
Registration Statement Effective. The Registration Statement shall have become effective and shall be available for the
(i) resale of all Placement Shares issued to the Agent and not yet sold by the Agent and (ii) sale of all Placement Shares contemplated
to be issued by any Placement Notice.
(b)
No Material Notices. None of the following events shall have occurred and be continuing: (i) receipt by the Company of any
request for additional information from the Commission or any other federal or state Governmental Authority during the period of effectiveness
of the Registration Statement, the response to which would require any post-effective amendments or supplements to the Registration Statement
or the Prospectus; (ii) the issuance by the Commission or any other federal or state Governmental Authority of any stop order suspending
the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose; (iii) receipt by the Company of
any notification with respect to the suspension of the qualification or exemption from qualification of any of the Placement Shares for
sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (iv) the occurrence of any event that
makes any statement of a material fact made in the Registration Statement or the Prospectus or any Incorporated Document or deemed Incorporated
Document untrue or that requires the making of any changes in the Registration Statement, the Prospectus or such documents so that, in
the case of the Registration Statement, it will not contain an untrue statement of a material fact or omit to state any material fact
required to be stated therein or necessary to make the statements therein not misleading and, that in the case of the Prospectus, it will
not contain 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 the light of the circumstances under which they were made, not misleading.
(c)
No Misstatement or Material Omission. Agent shall not have advised the Company that the Registration Statement or Prospectus,
or any amendment or supplement thereto, contains an untrue statement of fact that in 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)
Material Changes. Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission,
there shall not have been any material adverse change in the authorized share capital of the Company or any Material Adverse Effect or
any development that would cause a Material Adverse Effect, or a downgrading in or withdrawal of the rating assigned to any of the Company’s
securities (other than asset backed securities) by any rating organization or a public announcement by any rating organization that it
has under surveillance or review its rating of any of the Company’s securities (other than asset backed securities), the effect
of which, in the case of any such action by a rating organization described above, in the reasonable judgment of the Agent (without relieving
the Company of any obligation or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed
with the offering of the Placement Shares on the terms and in the manner contemplated in the Prospectus.
(e)
Legal Opinions. The Agent shall have received the opinions of Company Counsel and IP Counsel required to be delivered pursuant
to Section 7(m) on or before the date on which such delivery of such opinions is required pursuant to Section 7(m).
(f) Comfort
Letter. The Agent shall have received the Comfort Letter required to be delivered pursuant to Section 7(n) on or before the
date on which such delivery of such Comfort Letter is required pursuant to Section 7(n).
(g) Representation Certificate. The Agent shall have received the certificate required to be delivered pursuant to Section
7(l) on or before the date on which delivery of such certificate is required pursuant to Section 7(l).
(h) Agent
Counsel Negative Assurances Letter. Agent shall have received from Cooley LLP, counsel for Agent, the negative assurances letter,
on or before the date on which the delivery of the Company counsel legal opinion is required pursuant to Section7(m), 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.
(i) No
Suspension. Trading in the Ordinary Shares shall not have been suspended on the Exchange and the Ordinary Shares shall not have been
delisted from the Exchange.
(j) Other
Materials. On each date on which the Company is required to deliver a certificate pursuant to Section 7(l), the Company shall
have furnished to the Agent such appropriate further information, certificates, letters and other documents as the Agent may reasonably
request. All such certificates, letters and other documents will be in compliance with the provisions hereof.
(k) Securities
Act Filings Made. All filings with the Commission required by Rule 424 under the Securities Act to have been filed prior to the issuance
of any Placement Notice hereunder shall have been made within the applicable time period prescribed for such filing by Rule 424.
(l) Approval
for Listing. The Placement Shares shall either have been (i) approved for listing on the Exchange, subject only to notice of issuance,
or (ii) the Company shall have filed an application for listing of the Placement Shares on the Exchange at, or prior to, the issuance
of any Placement Notice and the Exchange shall not have provided any objections thereto.
(m) FINRA. If applicable, FINRA shall have raised no objection to the terms of this offering and the amount of compensation
allowable or payable to the Agent as described in the Prospectus.
(n) No
Termination Event. There shall not have occurred any event that would permit the Agent to terminate this Agreement pursuant to Section
12(a).
10. Indemnification
and Contribution.
(a) Company
Indemnification. The Company agrees to indemnify and hold harmless the Agent, its affiliates and their respective partners, members,
directors, officers, employees and agents and each person, if any, who controls the Agent or any affiliate within the meaning of Section
15 of the Securities Act or Section 20 of the Exchange Act as follows:
(i)
against any and all loss, liability, claim, damage and expense whatsoever, as incurred, joint or several, arising out of or based
upon any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement (or any amendment thereto),
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 arising out of any untrue statement or alleged untrue statement of a material fact included in any related Issuer Free
Writing Prospectus 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;
(ii)
against any and all loss, liability, claim, damage and expense whatsoever, as incurred, joint or several, to the extent of the
aggregate amount paid in settlement of any litigation, or any investigation or proceeding by any Governmental Authority, commenced or
threatened, or of any claim whatsoever based upon any such untrue statement or omission, or any such alleged untrue statement or omission;
provided that (subject to Section 10(d) below) any such settlement is effected with the written consent of the Company,
which consent shall not unreasonably be delayed or withheld; and
(iii)
against any and all expense whatsoever, as incurred (including the reasonable fees and disbursements of counsel), reasonably incurred
in investigating, preparing or defending against any litigation, or any investigation or proceeding by any Governmental Authority, commenced
or threatened, or any claim whatsoever based upon any such untrue statement or omission, or any such alleged untrue statement or omission
(whether or not a party), to the extent that any such expense is not paid under (i) or (ii) above,
provided, however, that this indemnity
agreement shall not apply to any loss, liability, claim, damage or expense to the extent arising out of any untrue statement or omission
or alleged untrue statement or omission made solely in reliance upon and in conformity with the Agent Information (as defined below).
(b) Agent Indemnification. Agent agrees to indemnify and hold harmless the Company and its directors and each officer of the
Company who signed the Registration Statement, and each person, if any, who controls the Company within the meaning of Section 15 of the
Securities Act or Section 20 of the Exchange Act against any and all loss, liability, claim, damage and expense described in the indemnity
contained in Section 10(a), as incurred, but only with respect to untrue statements or omissions, or alleged untrue statements
or omissions, made in the Registration Statement (or any amendments thereto), the Prospectus (or any amendment or supplement thereto)
or any Issuer Free Writing Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with information relating
to the Agent and furnished to the Company in writing by the Agent expressly for use therein. The Company hereby acknowledges that the
only information that the Agent has furnished to the Company expressly for use in the Registration Statement, the Prospectus or any Issuer
Free Writing Prospectus (or any amendment or supplement thereto) are the statements set forth in
the first sentence of the twelfth paragraph under the caption “Plan of Distribution” in the Prospectus (the “Agent
Information”).
(c) Procedure.
Any party that proposes to assert the right to be indemnified under this Section 10 will, promptly after receipt of notice of
commencement of any action against such party in respect of which a claim is to be made against an indemnifying party or parties under
this Section 10, notify each such indemnifying party of the commencement of such action, enclosing a copy of all papers served,
but the omission so to notify such indemnifying party will not relieve the indemnifying party from (i) any liability that it might have
to any indemnified party otherwise than under this Section 10 and (ii) any liability that it may have to any indemnified party
under the foregoing provision of this Section 10 unless, and only to the extent that, such omission results in the forfeiture
of substantive rights or defenses by the indemnifying party. If any such action is brought against any indemnified party and it notifies
the indemnifying party of its commencement, the indemnifying party will be entitled to participate in and, to the extent that it elects
by delivering written notice to the indemnified party promptly after receiving notice of the commencement of the action from the indemnified
party, jointly with any other indemnifying party similarly notified, to assume the defense of the action, with counsel reasonably satisfactory
to the indemnified party, and after notice from the indemnifying party to the indemnified party of its election to assume the defense,
the indemnifying party will not be liable to the indemnified party for any other legal expenses except as provided below and except for
the reasonable costs of investigation subsequently incurred by the indemnified party in connection with the defense. The indemnified
party will have the right to employ its own counsel in any such action, but the fees, expenses and other charges of such counsel will
be at the expense of such indemnified party unless (1) the employment of counsel by the indemnified party has been authorized in writing
by the indemnifying party, (2) the indemnified party has reasonably concluded (based on advice of counsel) that there may be legal defenses
available to it or other indemnified parties that are different from or in addition to those available to the indemnifying party, (3)
a conflict or potential conflict exists (based on advice of counsel to the indemnified party) between the indemnified party and the indemnifying
party (in which case the indemnifying party will not have the right to direct the defense of such action on behalf of the indemnified
party) or (4) the indemnifying party has not in fact employed counsel to assume the defense of such action or counsel reasonably satisfactory
to the indemnified party, in each case, within a reasonable time after receiving notice of the commencement of the action; in each of
which cases the reasonable fees, disbursements and other charges of counsel will be at the expense of the indemnifying party or parties.
It is understood that the indemnifying party or parties shall not, in connection with any proceeding or related proceedings in the same
jurisdiction, be liable for the reasonable fees, disbursements and other charges of more than one separate firm (plus local counsel)
admitted to practice in such jurisdiction at any one time for all such indemnified party or parties. All such fees, disbursements and
other charges will be reimbursed by the indemnifying party promptly after the indemnifying party receives a written invoice relating
to fees, disbursements and other charges in reasonable detail. An indemnifying party will not, in any event, be liable for any settlement
of any action or claim effected without its written consent. No indemnifying party shall, without the prior written consent of each indemnified
party, settle or compromise or consent to the entry of any judgment in any pending or threatened claim, action or proceeding relating
to the matters contemplated by this Section 10 (whether or not any indemnified party is a party thereto), unless such settlement,
compromise or consent (1) includes an express and unconditional release of each indemnified party, in form and substance reasonably satisfactory
to such indemnified party, from all liability arising out of such litigation, investigation, proceeding or claim and (2) does not include
a statement as to or an admission of fault, culpability or a failure to act by or on behalf of any indemnified party.
(d)
Settlement Without Consent if Failure to Reimburse. If an indemnified party shall have requested an indemnifying
party to reimburse the indemnified party for reasonable fees and expenses of counsel for which it is entitled to be reimbursed under this
Section 10, such indemnifying party agrees that it shall be liable for any settlement of the nature contemplated by Section
10(a)(ii) effected without its written consent if (1) such settlement is entered into more than 45 days after receipt by such indemnifying
party of the aforesaid request, (2) such indemnifying party shall have received notice of the terms of such settlement at least 30 days
prior to such settlement being entered into and (3) such indemnifying party shall not have reimbursed such indemnified party in accordance
with such request prior to the date of such settlement.
(e)
Contribution. In order to provide for just and equitable contribution in circumstances in which the indemnification provided
for in the foregoing paragraphs of this Section 10 is applicable in accordance with its terms but for any reason is held to be
unavailable or insufficient from the Company or the Agent, the Company and the Agent will contribute to the total losses, claims, liabilities,
expenses and damages (including any investigative, legal and other expenses reasonably incurred in connection with, and any amount paid
in settlement of, any action, suit or proceeding or any claim asserted) to which the Company and the Agent may be subject in such proportion
as shall be appropriate to reflect the relative benefits received by the Company on the one hand and the Agent on the other hand. The
relative benefits received by the Company on the one hand and the Agent on the other hand shall be deemed to be in the same proportion
as the total net proceeds from the sale of the Placement Shares (net of commissions to the Agent but before deducting expenses) received
by the Company bear to the total compensation received by the Agent from the sale of Placement Shares on behalf of the Company. If, but
only if, the allocation provided by the foregoing sentence is not permitted by applicable law, the allocation of contribution shall be
made in such proportion as is appropriate to reflect not only the relative benefits referred to in the foregoing sentence but also the
relative fault of the Company, on the one hand, and the Agent, on the other hand, with respect to the statements or omission that resulted
in such loss, claim, liability, expense or damage, or action in respect thereof, as well as any other relevant equitable considerations
with respect to such offering. Such relative fault shall be determined by reference to, among other things, whether the untrue or alleged
untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company
or the Agent, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such
statement or omission. The Company and the Agent agree that it would not be just and equitable if contributions pursuant to this Section
10(e) were to be determined by pro rata allocation or by any other method of allocation that does not take into account the equitable
considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, liability, expense,
or damage, or action in respect thereof, referred to above in this Section 10(e) shall be deemed to include, for the purpose of
this Section 10(e), any legal or other expenses reasonably incurred by such indemnified party in connection with investigating
or defending any such action or claim to the extent consistent with Section 10(c) hereof. Notwithstanding the foregoing provisions
of this Section 10(e), the Agent shall not be required to contribute any amount in excess of the commissions received by it under
this Agreement and no person found guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities
Act) will be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section
10(e), any person who controls a party to this Agreement within the meaning of the Securities Act, any affiliate of the Agent and
any officers, directors, partners, employees or agents of the Agent or any of its affiliates, will have the same rights to contribution
as that party, and each director of the Company and each officer of the Company who signed the Registration Statement will have the same
rights to contribution as the Company, subject in each case to the provisions hereof. Any party entitled to contribution, promptly after
receipt of notice of commencement of any action against such party in respect of which a claim for contribution may be made under this
Section 10(e), will notify any such party or parties from whom contribution may be sought, but the omission to so notify will not
relieve that party or parties from whom contribution may be sought from any other obligation it or they may have under this Section
10(e) except to the extent that the failure to so notify such other party materially prejudiced the substantive rights or defenses
of the party from whom contribution is sought. Except for a settlement entered into pursuant to the last sentence of Section 10(c)
hereof, no party will be liable for contribution with respect to any action or claim settled without its written consent if such consent
is required pursuant to Section 10(c) hereof.
(f)
Transfer Taxes. The Company will indemnify and hold harmless the Agent against any Transfer Taxes, including any interest
and penalties, incurred in connection with (i) the creation, allotment and issuance of the Placement Shares by the Company; (ii) the delivery
of the Placement Shares by the Company to or for the account of the Agent; (iii) the initial sale and delivery (including any agreement
for sale or delivery) by the Agent of the Placement Shares to purchasers thereof, and (iv) the execution and delivery of this Agreement.
11. Representations
and Agreements to Survive Delivery. The indemnity and contribution agreements contained in Section 10 of this Agreement and
all representations and warranties of the Company herein or in certificates delivered pursuant hereto shall survive, as of their respective
dates, regardless of (i) any investigation made by or on behalf of the Agent, any controlling persons, or the Company (or any of their
respective officers, directors, employees or controlling persons), (ii) delivery and acceptance of the Placement Shares and payment therefor
or (iii) any termination of this Agreement.
12. Termination.
(a)
The Agent may terminate this Agreement, by written notice to the Company, as hereinafter specified at any time (1) if there has
been, since the time of execution of this Agreement or since the date as of which information is given in the Prospectus, any change,
or any development or event involving a prospective change, in the condition, financial or otherwise, or in the business, properties,
earnings, results of operations or prospects of the Company, whether or not arising in the ordinary course of business, which individually
or in the aggregate, in the sole judgment of the Agent is material and adverse and makes it impractical or inadvisable to market the Placement
Shares or to enforce contracts for the sale of the Placement Shares, (2) if there has occurred any material adverse change in the financial
markets in the United States or the international financial markets, any outbreak of hostilities or escalation thereof or other calamity
or crisis or any change or development involving a prospective change in national or international political, financial or economic conditions,
in each case the effect of which is such as to make it, in the judgment of the Agent, impracticable or inadvisable to market the Placement
Shares or to enforce contracts for the sale of the Placement Shares, (3) if trading in the Ordinary Shares has been suspended or limited
by the Commission or the Exchange, or if trading generally on the Exchange has been suspended or limited, or minimum prices for trading
have been fixed on the Exchange, (4) if any suspension of trading of any securities of the Company on any exchange or in the over-the-counter
market shall have occurred and be continuing, (5) if a major disruption of securities settlements or clearance services in the United
States shall have occurred and be continuing, or (6) if a banking moratorium has been declared by either U.S. Federal or New York authorities.
Any such termination shall be without liability of any party to any other party except that the provisions of Section 8 (Payment
of Expenses), Section 10 (Indemnification and Contribution), Section 11 (Representations and Agreements to Survive Delivery),
Section 17 (Governing Law and Time; Waiver of Jury Trial) and Section 18 (Consent to Jurisdiction) hereof shall remain in
full force and effect notwithstanding such termination. If the Agent elects to terminate this Agreement as provided in this Section
12(a), the Agent shall provide the required notice as specified in Section 13 (Notices).
(b)
The Company shall have the right, by giving one (1) day’s notice as hereinafter specified to terminate this Agreement in
its sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any
other party except that the provisions of Section 8, Section 10, Section 11, Section 17 and Section 18
hereof shall remain in full force and effect notwithstanding such termination.
(c)
The Agent shall have the right, by giving one (1) day’s notice as hereinafter specified to terminate this Agreement in its
sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other
party except that the provisions of Section 8, Section 10, Section 11, Section 17 and Section 18 hereof
shall remain in full force and effect notwithstanding such termination.
(d)
Unless earlier terminated pursuant to this Section 12, this Agreement shall automatically terminate upon the issuance and
sale of all of the Placement Shares through the Agent on the terms and subject to the conditions set forth herein; provided that the provisions
of Section 8, Section 10, Section 11, Section 17 and Section 18 hereof shall remain in full force and
effect notwithstanding such termination.
(e)
This Agreement shall remain in full force and effect unless terminated pursuant to Sections 12(a), (b), (c)
or (d) above or otherwise by mutual agreement of the parties; provided, however, that any such termination by mutual
agreement shall in all cases be deemed to provide that Section 8, Section 10, Section 11, Section 17 and Section
18 shall remain in full force and effect notwithstanding such termination.
(f)
Any termination of this Agreement shall be effective on the date specified in such notice of termination; provided, however,
that such termination shall not be effective until the close of business on the date of receipt of such notice by the Agent or the Company,
as the case may be. If such termination shall occur prior to the Settlement Date for any sale of Placement Shares, such Placement Shares
shall settle in accordance with the provisions of this Agreement.
13. Notices.
All notices or other communications required or permitted to be given by any party to any other party pursuant to the terms of this Agreement
shall be in writing, unless otherwise specified, and if sent to the Agent, shall be delivered to:
BofA Securities, Inc.
One Bryant Park, New York, NY 10036
Attention: ATM Execution and ECM Legal
Cooley LLP
55 Hudson Yards
New York, NY 10001-2157
Attention: Daniel I. Goldberg
and if to the Company, shall be delivered to:
MeiraGTx Holdings plc
450 East 29th Street, 14th Floor
New York, New York 10016
Attention: Rich Giroux
with copies (which shall not constitute notice)
to:
and
Latham & Watkins LLP
200 Clarendon Street, 27th Floor
Boston, MA 02116
Attention: Peter N. Handrinos
Each party to this Agreement may change such address
for notices by sending to the parties to this Agreement written notice of a new address for such purpose. Each such notice or other communication
shall be deemed given (i) when delivered personally or by verifiable facsimile transmission (with an original to follow) on or before
4:30 p.m., New York City time, on a Business Day or, if such day is not a Business Day, on the next succeeding Business Day, (ii) by Electronic
Notice as set forth in the next paragraph, (iii) on the next Business Day after timely delivery to a nationally-recognized overnight courier
or (iv) on the Business Day actually received if deposited in the U.S. mail (certified or registered mail, return receipt requested, postage
prepaid). For purposes of this Agreement, “Business Day” shall mean any day on which the Exchange and commercial
banks in the City of New York are open for business.
An electronic communication (“Electronic
Notice”) shall be deemed written notice for purposes of this Section 13 if sent to the electronic mail address specified
by the receiving party under separate cover. Electronic Notice shall be deemed received at the time the party sending Electronic Notice
receives verification of receipt by the receiving party. Any party receiving Electronic Notice may request and shall be entitled to receive
the notice on paper, in a nonelectronic form (“Nonelectronic Notice”) which shall be sent to the requesting
party within ten (10) days of receipt of the written request for Nonelectronic Notice.
14.
Successors and Assigns. This Agreement shall inure to the benefit of and be binding upon the Company and the Agent and their
respective successors and the parties referred to in Section 10 hereof. References to any of the parties contained in this Agreement shall
be deemed to include the successors and permitted assigns of such party. Nothing in this Agreement, express or implied, is intended to
confer upon any party other than the parties hereto or their respective successors and permitted assigns any rights, remedies, obligations
or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement. Neither party may assign its rights
or obligations under this Agreement without the prior written consent of the other party; provided, however, that the Agent
may assign its rights and obligations hereunder to an affiliate thereof without obtaining the Company’s consent so long as such
affiliate is a registered broker dealer and Agent provides notice of such assignment to the Company.
15.
Adjustments for Share Splits. The parties acknowledge and agree that all share-related numbers contained in this Agreement
shall be adjusted to take into account any share split, share dividend or similar event effected with respect to the Placement Shares.
16.
Entire Agreement; Amendment; Severability; Waiver. This Agreement (including all schedules and exhibits attached hereto
and Placement Notices issued pursuant hereto) constitutes the entire agreement and supersedes all other prior and contemporaneous agreements
and undertakings, both written and oral, among the parties hereto with regard to the subject matter hereof. Neither this Agreement nor
any term hereof may be amended except pursuant to a written instrument executed by the Company and the Agent. In the event that any one
or more of the provisions contained herein, or the application thereof in any circumstance, is held invalid, illegal or unenforceable
as written by a court of competent jurisdiction, then such provision shall be given full force and effect to the fullest possible extent
that it is valid, legal and enforceable, and the remainder of the terms and provisions herein shall be construed as if such invalid, illegal
or unenforceable term or provision was not contained herein, but only to the extent that giving effect to such provision and the remainder
of the terms and provisions hereof shall be in accordance with the intent of the parties as reflected in this Agreement. No implied waiver
by a party shall arise in the absence of a waiver in writing signed by such party. No failure or delay in exercising any right, power,
or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or further
exercise thereof or the exercise of any right, power, or privilege hereunder.
17.
GOVERNING LAW AND TIME; WAIVER OF JURY TRIAL. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS
OF THE STATE OF NEW YORK WITHOUT REGARD TO THE PRINCIPLES OF CONFLICTS OF LAWS. SPECIFIED TIMES OF DAY REFER TO NEW YORK CITY TIME. EACH
PARTY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING
ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
18.
Consent to Jurisdiction. Any legal suit, action or proceeding arising out of or based upon this Agreement or the
transactions contemplated hereby (“Related Proceedings”) shall be instituted in (i) the federal courts of the
United States of America located in the City and County of New York, Borough of Manhattan or (ii) the courts of the State of New York
located in the City and County of New York, Borough of Manhattan (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 (a “Related Judgment”), 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. Each party not located in the United States irrevocably appoints MeiraGTx, LLC
as its agent to receive service of process or other legal summons for purposes of any such suit, action or proceeding that may be instituted
in any state or federal court in the City and County of New York. With respect to any Related Proceeding, each party irrevocably waives,
to the fullest extent permitted by applicable law, all immunity (whether on the basis of sovereignty or otherwise) from jurisdiction,
service of process, attachment (both before and after judgment) and execution to which it might otherwise be entitled in the Specified
Courts, and with respect to any Related Judgment, each party waives any such immunity in the Specified Courts or any other court of competent
jurisdiction, and will not raise or claim or cause to be pleaded any such immunity at or in respect of any such Related Proceeding or
Related Judgment, including, without limitation, any immunity pursuant to the United States Foreign Sovereign Immunities Act of 1976,
as amended.
19. Judgment Currency. The obligations of the Company pursuant to this Agreement in respect of any sum due to the Agent shall,
notwithstanding any judgment in a currency other than United States dollars, not be discharged until the first business day, following
receipt by the Agent of any sum adjudged to be so due in such other currency, on which (and only to the extent that) the Agent may in
accordance with normal banking procedures purchase United States dollars with such other currency; if the United States dollars so purchased
are less than the sum originally due to the Agent hereunder, the Company agrees, as a separate obligation and notwithstanding any such
judgment, to indemnify the Agent against such loss.
20. Gross Up. All payments made by the Company under this Agreement, if any, will be made without withholding or deduction for
or on account of any present or future taxes, duties, assessments or governmental charges of whatever nature (other than taxes on net
income) imposed or levied by any jurisdiction or any political subdivision or any taxing authority thereof or therein unless the Company
is or becomes required by law to withhold or deduct such taxes, duties, assessments or other governmental charges. In such event, the
Company shall pay such additional amounts as will result, after such withholding or deduction, in the receipt by the Agent and each person
controlling the Agent, as the case may be, of the amounts that would otherwise have been received had no withholding or deduction been
made.
21. Recognition
of the U.S. Special Resolution Regimes.
(a)
In the event that the Agent is a Covered Entity 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.
(b)
In the event that the Agent is a Covered Entity 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 is 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
(c)
For purposes of this Section 12, 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). “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). “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.
“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.
22. Counterparts.
This Agreement may be executed in two or more counterparts, each of which shall be deemed an original,
but all of which together shall constitute one and the same instrument, and may be delivered by facsimile transmission or by electronic
delivery of a portable document format (PDF) file (including any electronic signature covered by the U.S. federal ESIGN Act of 2000,
Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com).
23. Construction.
The section and exhibit headings herein are for convenience only and shall not affect the construction hereof. References herein to any
law, statute, ordinance, code, regulation, rule or other requirement of any Governmental Authority shall be deemed to refer to such law,
statute, ordinance, code, regulation, rule or other requirement of any Governmental Authority as amended, reenacted, supplemented or
superseded in whole or in part and in effect from time to time and also to all rules and regulations promulgated thereunder.
24. Permitted
Free Writing Prospectuses. The Company represents, warrants and agrees that, unless it obtains the prior written consent of the Agent,
which shall not be unreasonably withheld, conditioned or delayed, and the Agent represents, warrants and agrees that, unless it obtains
the prior written consent of the Company, which shall not be unreasonably withheld, conditioned or delayed, it has not made and will
not make any offer relating to the Placement Shares that would constitute an Issuer Free Writing Prospectus, or that would otherwise
constitute a “free writing prospectus,” as defined in Rule 405, required to be filed with the Commission. Any such free writing
prospectus consented to by the Agent or by the Company, as the case may be, is hereinafter referred to as a “Permitted Free Writing
Prospectus.” The Company represents and warrants that it has treated and agrees that it will treat each Permitted Free Writing
Prospectus as an “issuer free writing prospectus,” as defined in Rule 433, and has complied and will comply with the requirements
of Rule 433 applicable to any Permitted Free Writing Prospectus, including timely filing with the Commission where required, legending
and record keeping. For the purposes of clarity, the parties hereto agree that all free writing prospectuses, if any, listed in Exhibit
24 hereto are Permitted Free Writing Prospectuses.
25. Absence of Fiduciary Relationship. The Company acknowledges and agrees that:
(a) the Agent is acting solely as agent in connection with the public offering of the Placement Shares and in connection with each
transaction contemplated by this Agreement and the process leading to such transactions, and no fiduciary or advisory relationship between
the Company or any of its respective affiliates, shareholders (or other equity holders), creditors or employees or any other party, on
the one hand, and the Agent, on the other hand, has been or will be created in respect of any of the transactions contemplated by this
Agreement, irrespective of whether or not the Agent has advised or is advising the Company on other matters, and the Agent has no obligation
to the Company with respect to the transactions contemplated by this Agreement except the obligations expressly set forth in this Agreement;
(b) it
is capable of evaluating and understanding, and understands and accepts, the terms, risks and conditions of the transactions contemplated
by this Agreement;
(c) neither
the Agent nor its affiliates have provided any legal, accounting, regulatory or tax advice with respect to the transactions contemplated
by this Agreement and it has consulted its own legal, accounting, regulatory and tax advisors to the extent it has deemed appropriate;
(d) it is aware that the Agent and its affiliates are engaged in a broad range of transactions which may involve interests that differ
from those of the Company and the Agent and its affiliates have no obligation to disclose such interests and transactions to the Company
by virtue of any fiduciary, advisory or agency relationship or otherwise; and
(e) it
waives, to the fullest extent permitted by law, any claims it may have against the Agent or its affiliates for breach of fiduciary duty
or alleged breach of fiduciary duty in connection with the sale of Placement Shares under this Agreement and agrees that the Agent and
its affiliates shall not have any liability (whether direct or indirect, in contract, tort or otherwise) to it in respect of such a fiduciary
duty claim or to any person asserting a fiduciary duty claim on its behalf or in right of it or the Company, employees or creditors of
Company.
26. Definitions. As used in this Agreement, the following terms have the respective meanings set forth below:
“Applicable Time” means
(i) each Representation Date (ii) the time of each sale of any Placement Shares pursuant to this Agreement and (iii) each Settlement Date.
“Governmental Authority”
means (i) any federal, provincial, state, local, municipal, national or international government or governmental authority, regulatory
or administrative agency, governmental commission, department, board, bureau, agency or instrumentality, court, tribunal, arbitrator or
arbitral body (public or private); (ii) any self-regulatory organization; or (iii) any political subdivision of any of the foregoing.
“Issuer Free Writing Prospectus”
means any “issuer free writing prospectus,” as defined in Rule 433, relating to the Placement Shares that (1) is required
to be filed with the Commission by the Company, (2) is a “road show” that is a “written communication” within
the meaning of Rule 433(d)(8)(i) whether or not required to be filed with the Commission, or (3) is exempt from filing pursuant to Rule
433(d)(5)(i) because it contains a description of the Placement Shares or of the offering that does not reflect the final terms, in each
case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s
records pursuant to Rule 433(g) under the Securities Act Regulations.
“Rule 164,” “Rule
172,” “Rule 405,” “Rule 415,” “Rule 424,”
“Rule 424(b),” “Rule 430B,” and “Rule 433” refer to such
rules under the Securities Act Regulations.
All references in this Agreement to financial
statements and schedules and other information that 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 that is incorporated by reference in the Registration Statement or the Prospectus, as the
case may be.
All references in this Agreement to the Registration
Statement, the Prospectus or any amendment or supplement to any of the foregoing shall be deemed to include the copy filed with the Commission
pursuant to EDGAR; all references in this Agreement to any Issuer Free Writing Prospectus (other than any Issuer Free Writing Prospectuses
that, pursuant to Rule 433, are not required to be filed with the Commission) shall be deemed to include the copy thereof filed with the
Commission pursuant to EDGAR; and all references in this Agreement to “supplements” to the Prospectus shall include, without
limitation, any supplements, “wrappers” or similar materials prepared in connection with any offering, sale or private placement
of any Placement Shares by the Agent outside of the United States.
[Signature Page Follows]
If the foregoing correctly sets forth the understanding
between the Company and the Agent, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute
a binding agreement between the Company and the Agent.
| |
Very truly yours, |
| |
|
| |
MEIRAGTX HOLDINGS PLC |
| |
|
|
| |
By: |
/s/ Richard
Giroux |
| |
|
Name: Richard Giroux |
| |
|
Title: Richard Giroux |
| |
ACCEPTED as of the date first-above
written: |
| |
|
| |
BOFA SECURITIES, INC. |
| |
|
|
| |
By: |
/s/ Greg Butz |
| |
|
Name: Greg Butz |
| |
|
Title: Managing Director |
Signate Page to Sales Agreement
Schedule
1
Form of Placement Notice
| |
|
| From: |
MeiraGTx Holdings plc |
| |
|
| To: |
[•] |
| |
Attention: [•] |
| |
|
| Subject: |
Placement Notice |
| |
|
| Date: |
[•], 202[•] |
Ladies and Gentlemen:
Pursuant to the terms and subject to the conditions
contained in the Sales Agreement between MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”),
and BofA Securities, Inc. (“Agent”), dated December 21, 2023, the Company hereby requests that the Agent
sell up to [•] of the Company’s Ordinary Shares, nominal value $0.00003881 per share, at a minimum market price of $[•]
per share, during the time period beginning [month, day, time] and ending [month, day, time].
Schedule
2
Compensation
The Company shall pay to the Agent in cash, upon
each sale of Placement Shares pursuant to this Agreement, an amount up to 3.0% of the aggregate gross proceeds from each sale of Placement
Shares.
Schedule
3
Notice Parties
The Company
Alexandria Forbes, Ph.D.
Richard Giroux
Robert Wollin
The Agent
ATM Execution Team
Exhibit 24
Permitted Free Writing Prospectus
None.
Exhibit 5.1
| 21 December 2023 |
Our Ref: SF/AB/151627 |
| |
|
|
MeiraGTx Holdings plc
c/o Walkers Corporate Limited
190 Elgin Avenue
George Town
Grand Cayman KY1-9008
Cayman Islands |
|
Dear Addressees
MeiraGTx
Holdings plc
We have been asked to provide this legal opinion
to you with regards to the laws of the Cayman Islands in connection with the registration by MeiraGTx Holdings plc (the "Company")
under the United States Securities Act of 1933, as amended (the "Securities Act"), of:
| 1. | pursuant to the terms of the Base Prospectus (as defined in Schedule 1) and one or more supplements to
the Base Prospectus (each, a "Prospectus Supplement") relating to the registration for issue and sale by the Company
of certain of the Company’s securities (the "Securities") consisting of: |
| (a) | ordinary shares with a nominal value of US$0.00003881 per share in the capital of the Company (the "Ordinary
Shares"); |
| (b) | preferred shares in the capital of the Company (the "Preferred Shares"); |
| (c) | warrants to purchase Ordinary Shares or Preferred Shares (the "Warrants"); |
| (d) | purchase contracts for the purchase or sale of debt of equity securities in the Company; and |
| (e) | units consisting of any combination of Ordinary Shares, Preferred Shares or Warrants in one or more series;
and |
| 2. | pursuant to the terms of the Base Prospectus and the Prospectus (as defined in Schedule 1), ordinary shares
with a nominal value of US$0.00003881 per share in the capital of the Company and with an aggregate offering price of US$100,000,000 (the
"Sales Agreement Shares") to be issued in accordance with the terms and conditions of the Sales Agreement (as defined
in Schedule 1). |
For the purposes of giving this opinion, we have
examined and relied upon the originals or copies of the documents listed in Schedule 1.
Walkers
190 Elgin Avenue, George Town
Grand Cayman KY1-9001, Cayman Islands
T +1 345 949 0100 F +1 345 949 7886
www.walkersglobal.com
We are Cayman Islands Attorneys at Law and express
no opinion as to any laws other than the laws of the Cayman Islands in force and as interpreted at the date of this opinion. We have not,
for the purposes of this opinion, made any investigation of the laws, rules or regulations of any other jurisdiction.
Based upon the foregoing examinations and the
assumptions and qualifications set out below and having regard to legal considerations which we consider relevant, and under the laws
of the Cayman Islands, we give the following opinion in relation to the matters set out below.
| 1. | The Company is an exempted company duly incorporated with limited liability, validly existing under the
laws of the Cayman Islands and in good standing with the Registrar of Companies in the Cayman Islands (the "Registrar"). |
| 2. | With respect to the Ordinary Shares and the Preferred Shares: when (a) the board of directors of the Company
(the "Board") has taken all necessary corporate action to approve the issuance thereof, the terms of the offering thereof
and related matters; (b) the provisions of the applicable definitive purchase, underwriting or similar agreement approved by the Board
have been satisfied and payment of the consideration specified therein (being not less than their par value) has been made; and (c) the
name of the registered owner thereof has been entered in the Register of Members of the Company confirming that such shares have been
issued credited as fully paid, then the Ordinary Shares and/or the Preferred Shares (as applicable) will have been duly authorised and
validly issued, fully paid and non-assessable (meaning that no additional sums may be levied on the holder thereof in respect of the shares
by the Company). |
| 3. | The Sales Agreement Shares have been duly authorised by all necessary corporate action of the Company.
Upon the issue of the Sales Agreement Shares (by the entry of the name of the registered owner thereof in the Register of Members of the
Company confirming that such Sales Agreement Shares have been issued credited as fully paid), delivery and payment therefore by the purchaser
in accordance with the Memorandum and Articles of Association (as defined in Schedule 1) and the Sales Agreement and in the manner contemplated
by the Registration Statement (as defined in Schedule 1), the Sales Agreement Shares will be validly issued, fully paid and non-assessable
(meaning that no additional sums may be levied on the holder thereof in respect of the shares by the Company). |
The foregoing opinion is given based on the following
assumptions.
| 1. | The originals of all documents examined in connection with this opinion are authentic. The signatures,
initials and seals on the Documents (as defined in Schedule 1) are genuine and are those of a person or persons given power to execute
the Documents under the Resolutions (as defined in Schedule 1). All documents purporting to be sealed have been so sealed. All copies
are complete and conform to their originals. The Documents conform in every material respect to the latest drafts of the same produced
to us and, where provided in successive drafts, have been marked up to indicate all changes to such Documents. |
| 2. | We have relied upon the statements and representations of directors, officers and other representatives
of the Company as to factual matters. |
Walkers
190 Elgin Avenue, George Town
Grand Cayman KY1-9001, Cayman Islands
T +1 345 949 0100 F +1 345 949 7886
www.walkersglobal.com
| 3. | The Memorandum and Articles of Association reviewed by us will be the memorandum and articles of association
of the Company in effect upon the issuance of the Ordinary Shares, the Preferred Shares and the Sales Agreement Shares. |
| 4. | Each Prospectus Supplement and the documents or agreements referred to therein will be duly authorised,
executed and delivered by or on behalf of all relevant parties prior to the issue and sale of Ordinary Shares and Preferred Shares and
will be legal, valid, binding and enforceable against all relevant parties in accordance with their terms. |
| 5. | The Company will offer, issue and sell the Ordinary Shares and the Preferred Shares in the manner contemplated
by the Base Prospectus, Prospectus and any Prospectus Supplement and the documents or agreements referred to therein and otherwise in
compliance with all applicable United States federal and state securities laws. |
| 6. | The Company Records (as defined in Schedule 1) are complete and accurate and all matters required by law
and the Memorandum and Articles of Association to be recorded therein are completely and accurately so recorded. |
| 7. | The accuracy and completeness of all factual representations made in the Registration Statement and all
other documents reviewed by us. |
| 8. | The Company will receive consideration in money or money’s worth for each of the Ordinary Shares,
Preferred Shares and Sales Agreement Shares when issued, such price in any event not being less than the stated par or nominal value of
each Ordinary Share, Preferred Share and Sales Agreement Shares. |
| 9. | The Resolutions are and shall remain in full force and effect and have not been and will not be rescinded
or amended. The Resolutions have been duly executed (and where by a corporate entity such execution has been duly authorised if so required)
by or on behalf of each Director and the signatures and initials thereon are those of a person or persons in whose name the Resolutions
have been expressed to be signed. |
| 10. | The Documents are within the capacity and power of, and has been or will be duly authorised, executed
and delivered by, each of the parties thereto (other than the Company). |
| 11. | The Documents constitute or, when executed and delivered, will constitute the legal, valid and binding
obligations of each of the parties thereto enforceable in accordance with its terms as a matter of the laws of all relevant jurisdictions
(other than the Cayman Islands). |
| 12. | All preconditions to the issue of the Sales Agreement Shares under the terms of the Sales Agreement will
be satisfied or duly waived prior to the issue of the Sales Agreement Shares and there will be no breach of the terms of the Sales Agreement. |
| 13. | There are no provisions of the laws of any jurisdiction outside the Cayman Islands which would be contravened
by the issuance and allotment of the Ordinary Shares, the Preferred Shares or the Sales Agreement Shares and, insofar as any obligation
expressed to be incurred under any of the Documents is to be performed in or is otherwise subject to the laws of any jurisdiction outside
the Cayman Islands, its performance will not be illegal by virtue of the laws of that jurisdiction. |
Walkers
190 Elgin Avenue, George Town
Grand Cayman KY1-9001, Cayman Islands
T +1 345 949 0100 F +1 345 949 7886
www.walkersglobal.com
| 14. | There is nothing under any law (other than the laws of the Cayman Islands) which would or might affect
any of the opinions set forth above. |
| 15. | Our opinion as to good standing is based solely upon receipt of the Certificate of Good Standing (as defined
in Schedule 1) issued by the Registrar. The Company shall be deemed to be in good standing under section 200A of the Companies Act on
the date of issue of the certificate if all fees and penalties under the Companies Act have been paid and the Registrar has no knowledge
that the Company is in default under the Companies Act. |
This opinion is limited to the matters referred
to herein and shall not be construed as extending to any other matter or document not referred to herein. This opinion is given
solely for your benefit and the benefit of your legal advisers acting in that capacity in relation to this transaction and may not be
relied upon by any other person, other than persons entitled to rely upon it pursuant to the provisions of the Securities Act, without
our prior written consent.
This opinion shall be construed in accordance
with the laws of the Cayman Islands.
We hereby consent to the use of this opinion as
an exhibit to the Registration Statement and further consent to all references to us in the Registration Statement and any amendments
thereto.
Yours faithfully
/s/ WALKERS (CAYMAN)
LLP
Walkers
190 Elgin Avenue, George Town
Grand Cayman KY1-9001, Cayman Islands
T +1 345 949 0100 F +1 345 949 7886
www.walkersglobal.com
Schedule
1
LIST OF DOCUMENTS
EXAMINED
| 1. | The Certificate of Incorporation of the Company dated 1 May
2018, the Amended and Restated Memorandum and Articles of Association of the Company dated 19 June 2019 (the "Memorandum and
Articles of Association") and each of the Register of Directors, Register of Officers and Register of Mortgages and Charges
of the Company (together, the "Company Records"). |
| 2. | The Cayman Online Registry Information System (CORIS), the Cayman Islands' General Registry's online database,
searched on 20 December 2023. |
| 3. | A Certificate of Good Standing dated 11 December 2023 in respect
of the Company issued by the Registrar (the "Certificate of Good Standing"). |
| 4. | A copy of the executed written resolutions of the Directors
of the Company dated 17 December 2023 (the "Resolutions"). |
| 5. | Copies of the following documents (the "Documents"): |
| (a) | the Registration Statement on Form S-3 containing a base prospectus related to the Securities (the "Base
Prospectus") and a sales agreement prospectus supplement relating to the Sales Agreement Shares (the "Prospectus")
to be filed by the Company with the United States Securities and Exchange Commission to (the "Registration Statement");
and |
| (b) | the executed Sales Agreement dated 21 December 2023 between the Company and BofA Securities, Inc., relating
to the sale of the Sales Agreement Shares (the "Sales Agreement"). |
Walkers
190 Elgin Avenue, George Town
Grand Cayman KY1-9001, Cayman Islands
T +1 345 949 0100 F +1 345 949 7886
www.walkersglobal.com
Exhibit 5.2
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1271 Avenue of the Americas |
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New York, New York 10020-1401 |
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Tel: +1.212.906.1200 Fax: +1.212.751.4864 |
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www.lw.com |
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FIRM / AFFILIATE OFFICES |
| Austin |
Milan |
| Beijing |
Munich |
| Boston |
New York |
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Brussels |
Orange County |
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Century City |
Paris |
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Chicago |
Riyadh |
| December 21, 2023 |
Dubai |
San Diego |
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Düsseldorf |
San Francisco |
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Frankfurt |
Seoul |
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Hamburg |
Silicon Valley |
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Hong Kong |
Singapore |
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Houston |
Tel Aviv |
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London |
Tokyo |
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Los Angeles |
Washington, D.C. |
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Madrid |
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MeiraGTx Holdings plc
450 East 29th Street, 14th Floor
New York, NY 10016
Re: Registration
Statement on Form S-3
To the addressee set forth above:
We have acted as special
counsel to MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), in connection with its
filing on the date hereof with the Securities and Exchange Commission (the “Commission”) of a registration
statement on Form S-3 (as amended, the “Registration Statement”), including a base prospectus (the “Base
Prospectus”), which provides that it will be supplemented by one or more prospectus supplements (each such prospectus supplement,
together with the Base Prospectus, a “Prospectus”), under the Securities Act of 1933, as amended (the “Act”),
relating to the registration for issue and sale by the Company of (i) the Company’s ordinary shares, nominal value $0.00003881
per share (“Ordinary Shares”), (ii) the Company’s preferred shares, nominal value $0.00003881 per
share (“Preferred Shares”), (iii) warrants (“Warrants”), (iv) purchase
contracts (“Purchase Contracts”) and (v) units (“Units”). The Ordinary Shares,
Preferred Shares, Warrants, Purchase Contracts and Units are referred to herein collectively as the “Securities.”
This opinion is being furnished
in connection with the requirements of Item 601(b)(5) of Regulation S-K under the Act, and no opinion is expressed herein as to
any matter pertaining to the contents of the Registration Statement or related applicable Prospectus, other than as expressly stated
herein with respect to the issue of the Securities.
As such counsel, we have
examined such matters of fact and questions of law as we have considered appropriate for purposes of this letter. With your consent,
we have relied upon certificates and other assurances of officers of the Company and others as to factual matters without having independently
verified such factual matters. We are opining herein as to the internal laws of the State of New York, and we express no opinion with
respect to the applicability thereto, or the effect thereon, of the laws of any other jurisdiction, or as to any matters of municipal
law or the laws of any local agencies within any state. Various matters concerning the laws of the Cayman Islands are addressed in the
opinion of Walkers, which has been separately provided to you. We express no opinion with respect to those matters.
Subject to the foregoing
and the other matters set forth herein, it is our opinion that, as of the date hereof:
1. When
the applicable warrant agreement has been duly authorized, executed and delivered by all necessary corporate action of the Company, and
when the specific terms of a particular issuance of Warrants have been duly established in accordance with the terms of the applicable
warrant agreement and authorized by all necessary corporate action of the Company, and such Warrants have been duly executed, authenticated,
issued and delivered against payment therefor in accordance with the terms of the applicable warrant agreement and in the manner contemplated
by the applicable Prospectus and by such corporate action (assuming the securities issuable upon exercise of such Warrants have been
duly authorized and reserved for issuance by all necessary corporate action), such Warrants will be the legally valid and binding obligations
of the Company, enforceable against the Company in accordance with their terms.
2. When
the applicable purchase contract agreement has been duly authorized, executed and delivered by all necessary corporate action of the
Company, and when the specific terms of a particular issue of Purchase Contracts have been duly authorized in accordance with the terms
of the applicable purchase contract agreement and authorized by all necessary corporate action of the Company, and such Purchase Contracts
have been duly executed, authenticated, issued and delivered against payment therefor in accordance with the terms of the applicable
purchase contract agreement and in the manner contemplated by the applicable Prospectus and by such corporate action (assuming the securities
issuable under such Purchase Contracts have been duly authorized and reserved for issuance by all necessary corporate action), such Purchase
Contracts will be the legally valid and binding obligations of the Company, enforceable against the Company in accordance with their
terms.
3. When
the applicable unit agreement has been duly authorized, executed and delivered by all necessary corporate action of the Company, and
when the specific terms of a particular issuance of Units have been duly authorized in accordance with the terms of the applicable unit
agreement and authorized by all necessary corporate action of the Company, and such Units have been duly executed, authenticated, issued
and delivered against payment therefor in accordance with the terms of the applicable unit agreement and in the manner contemplated by
the applicable Prospectus and by such corporate action (assuming the securities issuable upon exercise of such Units have been duly authorized
and reserved for issuance by all necessary corporate action), such Units will be the legally valid and binding obligations of the Company,
enforceable against the Company in accordance with their terms.
Our opinions are subject
to: (i) the effect of bankruptcy, insolvency, reorganization, preference, fraudulent transfer, moratorium or other similar laws
relating to or affecting the rights and remedies of creditors; (ii) (a) the effect of general principles of equity, whether
considered in a proceeding in equity or at law (including the possible unavailability of specific performance or injunctive relief),
(b) concepts of materiality, reasonableness, good faith and fair dealing, and (c) the discretion of the court before which
a proceeding is brought; and (iii) the invalidity under certain circumstances under law or court decisions of provisions providing
for the indemnification of or contribution to a party with respect to a liability where such indemnification or contribution is contrary
to public policy. We express no opinion as to (a) any provision for liquidated damages, default interest, late charges, monetary
penalties, make-whole premiums or other economic remedies to the extent such provisions are deemed to constitute a penalty, (b) consents
to, or restrictions upon, governing law, jurisdiction, venue, arbitration, remedies, or judicial relief, (c) waivers of rights or
defenses, (d) any provision requiring the payment of attorneys’ fees, where such payment is contrary to law or public policy,
(e) any provision permitting, upon acceleration of any debt securities of the Company, collection of that portion of the stated
principal amount thereof which might be determined to constitute unearned interest thereon, (f) the creation, validity, attachment,
perfection, or priority of any lien or security interest, (g) advance waivers of claims, defenses, rights granted by law, or notice,
opportunity for hearing, evidentiary requirements, statutes of limitation, trial by jury or at law, or other procedural rights, (h) waivers
of broadly or vaguely stated rights, (i) provisions for exclusivity, election or cumulation of rights or remedies, (j) provisions
authorizing or validating conclusive or discretionary determinations, (k) grants of setoff rights, (l) proxies, powers and
trusts, (m) provisions prohibiting, restricting, or requiring consent to assignment or transfer of any right or property, (n) any
provision to the extent it requires that a claim with respect to a security denominated in other than U.S. dollars (or a judgment in
respect of such a claim) be converted into U.S. dollars at a rate of exchange at a particular date, to the extent applicable law otherwise
provides, and (o) the severability, if invalid, of provisions to the foregoing effect.
With your consent, we have
assumed (a) that each of the Warrants, Purchase Contracts and Units and warrant agreements, purchase contract agreements and unit
agreements governing such Securities (collectively, the “Documents”) will be governed by the internal laws
of the State of New York, (b) that each of the Documents has been or will be duly authorized, executed and delivered by the parties
thereto, (c) that each of the Documents constitutes or will constitute legally valid and binding obligations of the parties thereto
other than the Company, enforceable against each of them in accordance with their respective terms, and (d) that the status of each
of the Documents as legally valid and binding obligations of the parties will not be affected by any (i) breaches of, or defaults
under, agreements or instruments, (ii) violations of statutes, rules, regulations or court or governmental orders, or (iii) failures
to obtain required consents, approvals or authorizations from, or to make required registrations, declarations or filings with, governmental
authorities.
This opinion is for your
benefit in connection with the Registration Statement and may be relied upon by you and by persons entitled to rely upon it pursuant
to the applicable provisions of the Act. We consent to your filing this opinion as an exhibit to the Registration Statement and to the
reference to our firm contained in the Prospectus under the heading “Legal Matters.” We further consent to the incorporation
by reference of this letter and consent into any registration statement or post-effective amendment to the Registration Statement filed
pursuant to Rule 462(b) under the Act with respect to the Securities. In giving such consent, we do not thereby admit that
we are in the category of persons whose consent is required under Section 7 of the Act or the rules and regulations of the
Commission thereunder.
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Sincerely, |
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/s/ Latham & Watkins LLP |
Exhibit 23.3
Consent of Independent Registered Public Accounting
Firm
We consent to the reference to our firm under
the caption "Experts" in the Registration Statement (Form S-3) and related Prospectus of MeiraGTx Holdings plc and Subsidiaries
for the registration of ordinary shares, preferred shares, warrants, purchase contracts and units and to the incorporation by reference
therein of our report dated March 14, 2023, with respect to the consolidated financial statements of MeiraGTx Holdings plc and Subsidiaries,
included in its Annual Report (Form 10-K) for the year ended December 31, 2022, filed with the Securities and Exchange Commission.
/s/ Ernst & Young LLP
Jericho, New York
December 21, 2023
Exhibit 107
Calculation of Filing Fee Tables
Form S-3
(Form Type)
MeiraGTx Holdings Plc
(Exact Name of Registrant as Specified in its Charter)
Table 1: Newly Registered and Carry Forward
Securities
CALCULATION OF REGISTRATION FEE
| |
Security
Type |
Security
Class Title |
Fee
Calculation
Rule |
Amount
Registered |
Proposed
Maximum
Offering
Price Per
Unit(1) |
Maximum
Aggregate
Offering
Price(1)(4) |
Fee
Rate |
Amount
of
Registration
Fee |
Carry
Forward
Form
Type |
Carry
Forward
File
Number |
Carry
Forward
Initial
Effective
Date |
Filing
Fee
Previously Paid
In Connection
with Unsold
Securities to be
Carried
Forward |
| Newly
Registered Securities |
Fees
to Be
Paid |
Equity |
Ordinary
shares, nominal value $0.00003881 per share |
457(o) |
(1)(2)(3) |
(1)(2) |
(1)(2) |
— |
— |
|
|
|
|
Fees
to Be
Paid |
Equity |
Preferred
shares, nominal value $0.00003881 per share |
457(o) |
(1)(2) |
(1)(2) |
(1)(2) |
— |
— |
|
|
|
|
Fees
to Be
Paid |
Other |
Warrants |
457(o) |
(1) |
(1) |
(1) |
— |
— |
|
|
|
|
Fees
to Be
Paid |
Other |
Purchase
contracts |
457(o) |
(1) |
(1) |
(1) |
— |
— |
|
|
|
|
Fees
to Be
Paid |
Other |
Units |
457(o) |
(1) |
(1) |
(1) |
— |
— |
|
|
|
|
Fees
to Be
Paid |
Unallocated
(Universal)
Shelf |
|
|
$250,000,000(4) |
|
$250,000,000(3) |
0.00014760 |
$36,900 |
|
|
|
|
| Carry
Forward Securities |
| Carry
Forward Securities |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
| |
Total
Offering Amounts |
|
$250,000,000 |
0.00014760 |
$36,900 |
|
|
|
|
| |
Total
Fees Previously Paid |
|
— |
|
— |
— |
|
|
|
| |
Total
Fee Offsets |
|
— |
|
— |
— |
|
|
|
| |
Net
Fee Due |
|
|
|
$36,900 |
|
|
|
|
| (1) | There are being registered hereunder an unspecified number or aggregate principal amount (as applicable)
of the registrant’s ordinary shares, preferred shares, warrants, purchase contracts and units as may from time to time be offered
at unspecified prices, with the maximum aggregate offering price of such securities not to exceed the amount described in footnote (4)
below. In addition, an unspecified number of additional shares of ordinary shares is being registered as may be issued from time to time
upon conversion of any securities that are convertible into ordinary shares or pursuant to any anti-dilution adjustments with respect
to any such convertible securities. |
| (2) | Includes rights to acquire ordinary shares or preferred shares of the Company under any shareholder rights
plan then in effect, if applicable under the terms of any such plan. |
| (3) | Pursuant to Rule 416 under the Securities Act the registrant is also registering an indeterminate number
of additional ordinary shares issuable by reason of any stock dividend, stock split, recapitalization or other similar transaction. |
| (4) | Estimated solely for the purpose of calculating the registration fee. No separate consideration will be
received for ordinary shares that are issued upon conversion of preferred shares or upon exercise of warrants or units registered hereunder.
The aggregate maximum offering price of all securities issued pursuant to this registration statement will not exceed $250,000,000. |
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