1018-00006 · Penterra Pharmaceuticals Corp · Closing

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OFFICER'S CERTIFICATE

MERIDIAN BIO THERAPEUTICS LIMITED

Delivered pursuant to Section 8.02(d) of the Exclusive License Agreement dated October 2, 2023 (the "License Agreement"), by and between

Penterra Pharmaceuticals Corp., a Delaware corporation ("Licensor"),

and

Meridian Bio Therapeutics Limited, a Hong Kong limited company ("Licensee")

Date: October 20, 2023

The undersigned, David R. Cheung, Esq., General Counsel and an authorized officer of Meridian Bio Therapeutics Limited, a limited company duly organized and existing under the laws of the Hong Kong Special Administrative Region of the People's Republic of China (Company Registration No. 2847631), with its principal office at 18/F, Blossom Tower, 88 Queen's Road Central, Hong Kong SAR ("Meridian" or the "Licensee"), hereby certifies, in connection with the closing (the "Closing") of the transactions contemplated by that certain Exclusive License Agreement dated as of October 2, 2023 (the "Signing Date"), with an Effective Date of October 20, 2023 (the "Effective Date" or "Closing Date"), by and between Penterra Pharmaceuticals Corp., a corporation organized under the laws of the State of Delaware ("Penterra" or the "Licensor"), and Meridian (the "License Agreement"), relating to the grant of an exclusive license to develop, manufacture, and commercialize the compound designated as PPC-4187 (Penteracitinib), including all formulations, dosage forms, and improvements thereof, in the Asia-Pacific Territory as defined therein, as follows:

Reference to Ancillary Agreements. In addition to the License Agreement, Meridian and Penterra (and, where applicable, other parties) have executed or are concurrently executing the following ancillary agreements (collectively with the License Agreement, the "Transaction Documents"):

(a) that certain Escrow Agreement dated as of October 2, 2023, by and among Penterra, Meridian, and Velthorn National Bank, N.A., as escrow agent (the "Escrow Agreement");

(b) that certain Supply Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Supply Agreement");

(c) that certain Technology Transfer Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Technology Transfer Agreement");

(d) that certain Trademark License Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Trademark License Agreement"); and

(e) that certain Pharmacovigilance Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Pharmacovigilance Agreement").

Capitalized terms used but not otherwise defined in this Officer's Certificate (this "Certificate") shall have the meanings ascribed to such terms in the License Agreement. This Certificate is delivered to Penterra as a condition to the Closing under Section 8.02(d) of the License Agreement and constitutes a "closing deliverable" as such term is used therein.

Section 1. Authority and Capacity

I, David R. Cheung, hereby certify that I am the duly appointed General Counsel and an authorized officer of Meridian Bio Therapeutics Limited. I have been duly authorized by the Board of Directors of Meridian to execute and deliver this Certificate on behalf of Meridian, and I am delivering this Certificate in my capacity as an authorized officer of Meridian in connection with the Closing.

I have personal knowledge of the matters certified herein or have made due and diligent inquiry of appropriate officers, directors, and personnel of Meridian, including the Chief Executive Officer, the Chief Financial Officer, and the Chief Medical Officer, and have reviewed relevant corporate records, files, and documents, in each case to the extent necessary to confirm the accuracy and completeness of the certifications set forth in this Certificate. I am familiar with the Transaction Documents and the transactions contemplated thereby, and I have participated in the negotiation, drafting, and review of the Transaction Documents in my capacity as General Counsel of Meridian.

Section 2. Organization and Good Standing

I hereby certify that Meridian Bio Therapeutics Limited is a limited company duly organized, validly existing, and in good standing under the laws of the Hong Kong Special Administrative Region of the People's Republic of China. Meridian was incorporated on March 14, 2016, and its Company Registration Number is 2847631 as registered with the Companies Registry of Hong Kong SAR. Meridian has not been dissolved, wound up, or struck off the register of companies, and no proceedings for any such dissolution, winding up, or striking off are pending or, to the knowledge of the undersigned, threatened.

Meridian has full corporate power and authority to (a) own, lease, and operate its properties and assets, (b) carry on its business as presently conducted and as contemplated to be conducted under the Transaction Documents, and (c) execute, deliver, and perform its obligations under the License Agreement and each of the other Transaction Documents to which it is or will be a party.

Each of the following subsidiaries of Meridian that is relevant to the performance of Meridian's obligations under the Transaction Documents is duly organized, validly existing, and in good standing (or equivalent status) under the laws of its respective jurisdiction of organization:

Each such subsidiary has full corporate power and authority to own, lease, and operate its properties and assets and to carry on its business as presently conducted. None of such subsidiaries has been dissolved, wound up, or deregistered, and no proceedings for any such dissolution, winding up, or deregistration are pending or, to the knowledge of the undersigned, threatened.

Section 3. Board Authorization

I hereby certify that the Board of Directors of Meridian has duly authorized the execution, delivery, and performance by Meridian of the License Agreement and each of the other Transaction Documents to which Meridian is a party, and the consummation of all transactions contemplated thereby. Such authorization was granted by resolutions duly adopted at a meeting of the Board of Directors of Meridian held on September 28, 2023, at which a quorum was present and acting throughout, and at which such resolutions were approved by the affirmative vote of all directors present (the "Authorizing Resolutions"). True, correct, and complete copies of the Authorizing Resolutions, certified by the Company Secretary of Meridian, have been delivered to Licensor as part of the closing deliverables, as further evidenced by the Secretary's/Director's Certificate of Meridian delivered concurrently herewith (the "Secretary's Certificate").

The Authorizing Resolutions have not been rescinded, amended, modified, or revoked in any respect and remain in full force and effect as of the date hereof. No further corporate action, approval, consent, or authorization on the part of Meridian, its Board of Directors, or its shareholders is required for the valid execution, delivery, and performance of the Transaction Documents or for the consummation of the transactions contemplated thereby, including, without limitation, the payment of the upfront license fee, milestone payments, royalties, and other amounts payable by Meridian under the License Agreement.

Section 4. Representations and Warranties

I hereby certify that each of the representations and warranties made by Meridian, in its capacity as Licensee, in the License Agreement (including, without limitation, those set forth in Article V thereof) is true and correct in all material respects as of the date hereof, October 20, 2023, with the same force and effect as though each such representation and warranty had been made on and as of the date hereof. To the extent that any such representation or warranty expressly speaks as of an earlier date (including, without limitation, representations and warranties that speak as of the Signing Date or any other specified date), such representation or warranty is true and correct in all material respects as of such earlier date.

Without limiting the generality of the foregoing, no event has occurred and no condition or circumstance exists, on or prior to the date hereof, that would cause any representation or warranty made by Meridian in the License Agreement or any other Transaction Document to be untrue, incorrect, or misleading in any material respect.

Section 5. Performance of Covenants

I hereby certify that Meridian has performed and complied in all material respects with all covenants, agreements, conditions, and obligations required by the License Agreement and the other Transaction Documents to be performed or complied with by Meridian at or before the Closing Date (October 20, 2023). Without limiting the generality of the foregoing, I certify that Meridian has performed and complied with the following specific covenants and obligations:

(a) Escrow Funding. Meridian deposited the aggregate amount of Eighteen Million United States Dollars ($18,000,000) in immediately available funds into the escrow account maintained at Velthorn National Bank, N.A. (Account No. ending in 8417) on October 6, 2023, in accordance with Section 3.01 of the License Agreement and Section 2(a) of the Escrow Agreement dated October 2, 2023. Confirmation of such deposit has been received by Meridian from Velthorn National Bank, N.A. and a copy of such confirmation has been provided to Penterra.

(b) Execution and Delivery of Transaction Documents. Meridian has duly executed and delivered, or is concurrently executing and delivering, each of the Transaction Documents to which Meridian is a party, including the License Agreement, the Escrow Agreement, the Supply Agreement, the Technology Transfer Agreement, the Trademark License Agreement, and the Pharmacovigilance Agreement.

(c) Closing Deliverables. Meridian has delivered, or is concurrently delivering, all closing deliverables required of Meridian under Section 8.02 of the License Agreement, including, without limitation:

(i) this Officer's Certificate;

(ii) the Secretary's/Director's Certificate of Meridian certifying, among other things, the Authorizing Resolutions, incumbency of authorized signatories, and true, correct, and complete copies of Meridian's organizational documents (including its Articles of Association as currently in effect);

(iii) a certificate of good standing (or equivalent) for Meridian issued by the Companies Registry of Hong Kong SAR, dated not more than fifteen (15) days prior to the Closing Date; and

(iv) such other documents, instruments, and certificates as may be reasonably requested by Penterra in connection with the Closing.

(d) Legal Opinion. Meridian has caused its Hong Kong legal counsel, Lam, Cheung & Firth LLP, to deliver to Penterra a legal opinion, dated as of the Closing Date and addressed to Penterra Pharmaceuticals Corp. and Calderwood & Harkness LLP, opining as to, among other things, the due organization and existence of Meridian, the corporate power and authority of Meridian to enter into the Transaction Documents, the due authorization, execution, and delivery of the Transaction Documents by Meridian, and the enforceability of the Transaction Documents against Meridian in accordance with their respective terms, in each case subject to customary assumptions, limitations, and qualifications.

Section 6. No Material Adverse Effect

I hereby certify that, since the Signing Date (October 2, 2023) through and including the date hereof (October 20, 2023), no event, change, development, occurrence, condition, or effect has occurred or arisen that, individually or in the aggregate, has had or would reasonably be expected to have a Material Adverse Effect (as defined in Section 1.01 of the License Agreement) on Meridian, its business, assets, financial condition, results of operations, or prospects, or on Meridian's ability to consummate the transactions contemplated by the Transaction Documents or to perform its obligations thereunder, including, without limitation, its obligations to fund development activities, pay milestone payments, pay royalties, and pay the minimum annual royalty as set forth in the License Agreement.

Section 7. No Litigation or Proceedings

I hereby certify that, as of the date hereof, there is no action, suit, proceeding, claim, arbitration, mediation, investigation, inquiry, or other legal or administrative proceeding pending or, to the knowledge of the undersigned (after due and diligent inquiry), threatened in writing against Meridian or any of its Affiliates (including its subsidiaries listed in Section 2 above) before any court, arbitral tribunal, governmental authority, or regulatory body that:

(a) challenges or seeks to restrain, enjoin, prohibit, or invalidate the execution, delivery, or performance of the License Agreement or any other Transaction Document, or the consummation of any of the transactions contemplated thereby; or

(b) would, if adversely determined, materially and adversely impair or delay Meridian's ability to perform its obligations under any of the Transaction Documents, including, without limitation, its obligations to develop, seek regulatory approval for, manufacture, and commercialize PPC-4187 (Penteracitinib) in the Licensed Territory.

Section 8. No Conflicts

I hereby certify that the execution, delivery, and performance by Meridian of the License Agreement and each of the other Transaction Documents to which Meridian is a party, and the consummation of the transactions contemplated thereby, do not and will not:

(a) violate, contravene, conflict with, or result in a breach of any provision of Meridian's Memorandum of Association, Articles of Association, or other organizational or constitutional documents, as currently in effect;

(b) violate, conflict with, result in a breach or default under, give rise to any right of termination, cancellation, or acceleration under, or result in the creation of any lien or encumbrance upon any assets or properties of Meridian pursuant to, any contract, agreement, indenture, mortgage, instrument, license, permit, or other arrangement that is material to Meridian or its business and to which Meridian or any of its Affiliates is a party or by which Meridian or any of its properties or assets is bound; or

(c) violate, contravene, or conflict with any applicable law, statute, ordinance, rule, regulation, judgment, order, writ, injunction, or decree of any governmental authority, regulatory body, or court having jurisdiction over Meridian, its properties, or its operations, including, without limitation, applicable laws and regulations of Hong Kong SAR, the People's Republic of China, Japan, the Republic of Korea, the Commonwealth of Australia, and any other jurisdiction within the Licensed Territory.

Section 9. Consents and Approvals

I hereby certify that all governmental and third-party consents, approvals, authorizations, permits, licenses, registrations, declarations, notices, and filings required for the valid execution, delivery, and performance by Meridian of the Transaction Documents, and for the consummation of the transactions contemplated thereby, have been obtained or made, as applicable, and are in full force and effect, except as set forth in the following paragraphs.

PRC Technology Import/Export Filing. Meridian is currently evaluating, in consultation with its PRC legal counsel, whether a technology import/export filing is required under the Technology Import and Export Administration Regulations of the People's Republic of China (中华人民共和国技术进出口管理条例) and the related implementing rules promulgated by the Ministry of Commerce of the People's Republic of China (MOFCOM) and/or the State Administration for Market Regulation (SAMR), in connection with the technology transfer and licensing contemplated by the Technology Transfer Agreement and the License Agreement. Meridian will make such filing promptly if and to the extent required under applicable PRC law, and Meridian will notify Penterra promptly upon making any such filing and upon receipt of any registration certificate or other approval issued in connection therewith.

Antitrust and Foreign Investment. Meridian confirms, based on analysis completed on October 5, 2023 by its legal advisors, that (a) no filing under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act") is required in connection with the transactions contemplated by the Transaction Documents, as the transaction constitutes a pure intellectual property license and does not involve an acquisition of voting securities, assets, or a non-corporate interest subject to the HSR Act notification requirements; and (b) review by the Committee on Foreign Investment in the United States (CFIUS) is not applicable to the transactions contemplated by the Transaction Documents, as no acquisition of a U.S. business or critical technology by a foreign person is involved. Meridian will cooperate with Penterra in making any additional filings or notifications that may be required by antitrust or foreign investment authorities in any jurisdiction within the Licensed Territory, to the extent applicable.

Section 10. Insurance

I hereby certify that Meridian has obtained, or will obtain prior to the commencement of any clinical trial or commercial activity with respect to PPC-4187 (Penteracitinib) in the Licensed Territory, clinical trial insurance and product liability insurance coverage from Jade Dragon Insurance Limited (contact: Christine A. Lo, Underwriter) with coverage limits and terms consistent with industry standards for pharmaceutical companies engaged in development, manufacture, and commercialization activities of a similar nature and scope in the Licensed Territory. Such insurance coverage will be maintained in accordance with the requirements set forth in Section 10.04 of the License Agreement throughout the term of Meridian's development and commercialization activities under the License Agreement and for such additional period following termination or expiration of the License Agreement as required thereunder.

Section 11. Incumbency

I hereby certify that, as of the date hereof, the following persons are the duly elected or appointed officers of Meridian, holding the offices set forth opposite their respective names, and each such person is authorized to execute the Transaction Documents and any other documents, instruments, or certificates delivered in connection with the Closing on behalf of Meridian. The signature of each such person appearing on any Transaction Document or any certificate, instrument, or other document delivered in connection therewith is such person's genuine signature.

Each of the persons listed above has been duly authorized by the Board of Directors of Meridian to execute and deliver, on behalf of Meridian, the Transaction Documents and any other documents, instruments, or certificates required or contemplated to be delivered by Meridian in connection with the Closing or the transactions contemplated by the Transaction Documents.

Section 12. No Undisclosed Liabilities or Obligations

I hereby certify that Meridian has not incurred, assumed, or become subject to any liabilities, obligations, debts, claims, or commitments (whether absolute, accrued, contingent, or otherwise) that are not reflected or reserved against in Meridian's most recent audited financial statements or otherwise disclosed to Penterra in writing prior to the date hereof, and that would, individually or in the aggregate, materially impair Meridian's ability to perform its obligations under the Transaction Documents.

Without limiting the generality of the foregoing, Meridian has not incurred or assumed any undisclosed liabilities or obligations that would materially impair its ability to pay any amounts payable under the License Agreement, including, without limitation:

(a) the upfront license fee deposited into escrow pursuant to the Escrow Agreement;

(b) development milestone payments payable upon the achievement of specified development milestones as set forth in Section 6.01 of the License Agreement;

(c) commercial milestone payments payable upon the achievement of specified commercial milestones as set forth in Section 6.02 of the License Agreement;

(d) royalties on net sales of Licensed Products in the Licensed Territory as set forth in Section 6.03 of the License Agreement; and

(e) the minimum annual royalty of Two Million United States Dollars ($2,000,000) per calendar year, payable beginning in the calendar year immediately following the first commercial sale of a Licensed Product in any country in the Licensed Territory, as set forth in Section 6.04 of the License Agreement.

Section 13. Reliance

This Certificate is being delivered to Penterra Pharmaceuticals Corp. as a condition to the Closing under Section 8.02(d) of the License Agreement. Penterra and its legal counsel, Calderwood & Harkness LLP (600 Lexington Avenue, 30th Floor, New York, NY 10022, Attention: Marcus Delgado, Esq.), are entitled to rely on the certifications, representations, and statements contained herein in connection with the Closing and the consummation of the transactions contemplated by the Transaction Documents.

The certifications, representations, and statements contained in this Certificate shall survive the Closing of the transactions contemplated by the Transaction Documents in accordance with, and subject to, the survival provisions set forth in Section 11.01 of the License Agreement, and nothing in this Certificate shall limit or modify any rights or remedies available to Penterra under the License Agreement or any other Transaction Document with respect to a breach of any representation, warranty, covenant, or agreement contained therein.

Section 14. Governing Law

This Certificate shall be governed by, and construed and interpreted in accordance with, the laws of the State of New York, United States of America, without regard to any conflicts of law principles that would require the application of the laws of any other jurisdiction, consistent with the governing law provisions set forth in Section 14.08 of the License Agreement.

[Signature Page Follows]

SIGNATURE PAGE TO OFFICER'S CERTIFICATE OF MERIDIAN BIO THERAPEUTICS LIMITED

IN WITNESS WHEREOF, the undersigned has executed this Officer's Certificate as of October 20, 2023.

MERIDIAN BIO THERAPEUTICS LIMITED

By: ________

Name: David R. Cheung, Esq.

Title: General Counsel and Authorized Officer

Date: October 20, 2023

Notice Information

Copies of this Certificate have been delivered to the following persons and addresses:

(1) Licensor:

Penterra Pharmaceuticals Corp.

Attention: Anita M. Fremont, Esq., General Counsel

400 Pharma Drive, Suite 800 Princeton, New Jersey 08540 United States of America

(2) Licensor's Counsel:

Calderwood & Harkness LLP

Attention: Marcus Delgado, Esq.

600 Lexington Avenue, 30th Floor New York, New York 10022 United States of America

(3) Licensee's Counsel:

Lam, Cheung & Firth LLP

Attention: Jonathan M. Firth, Esq.

25/F, Jardine House 1 Connaught Place, Central Hong Kong SAR

CONFIDENTIAL — This Officer's Certificate and its contents are confidential and are subject to the confidentiality provisions of the License Agreement. Distribution or disclosure of this Certificate or any information contained herein to any person other than the addressees listed above is prohibited without the prior written consent of Meridian Bio Therapeutics Limited, except as required by applicable law or regulation.

Subsidiary	Entity Type	Jurisdiction	Principal Office Location
Meridian Pharma (Shanghai) Co., Ltd.	Wholly Foreign-Owned Enterprise (WFOE)	People's Republic of China	Shanghai, PRC
Meridian Japan K.K.	Kabushiki Kaisha	Japan	Tokyo, Japan
Meridian Korea Inc.	Corporation	Republic of Korea	Seoul, Republic of Korea
Meridian Bio Australia Pty Ltd	Proprietary Limited Company	Commonwealth of Australia	Sydney, New South Wales, Australia
Name	Title	Specimen Signature
Dr. Henry W.L. Tsang	Chairman & Founder	______
Angela C.Y. Fong	Chief Executive Officer	______
David R. Cheung, Esq.	General Counsel	______
Patrick S.H. Kwok	Chief Financial Officer	______
Dr. Kenji Morimoto	Chief Medical Officer	______

OFFICER'S CERTIFICATE
OF
MERIDIAN BIO THERAPEUTICS LIMITED
Delivered pursuant to Section 8.02(d) of the Exclusive License Agreement dated October 2, 2023 (the "License Agreement"), by and between
Penterra Pharmaceuticals Corp., a Delaware corporation ("Licensor"),
and
Meridian Bio Therapeutics Limited, a Hong Kong limited company ("Licensee")
Date: October 20, 2023
The undersigned, David R. Cheung, Esq., General Counsel and an authorized officer of Meridian Bio Therapeutics Limited, a limited company duly organized and existing under the laws of the Hong Kong Special Administrative Region of the People's Republic of China (Company Registration No. 2847631), with its principal office at 18/F, Blossom Tower, 88 Queen's Road Central, Hong Kong SAR ("Meridian" or the "Licensee"), hereby certifies, in connection with the closing (the "Closing") of the transactions contemplated by that certain Exclusive License Agreement dated as of October 2, 2023 (the "Signing Date"), with an Effective Date of October 20, 2023 (the "Effective Date" or "Closing Date"), by and between Penterra Pharmaceuticals Corp., a corporation organized under the laws of the State of Delaware ("Penterra" or the "Licensor"), and Meridian (the "License Agreement"), relating to the grant of an exclusive license to develop, manufacture, and commercialize the compound designated as PPC-4187 (Penteracitinib), including all formulations, dosage forms, and improvements thereof, in the Asia-Pacific Territory as defined therein, as follows:
Reference to Ancillary Agreements. In addition to the License Agreement, Meridian and Penterra (and, where applicable, other parties) have executed or are concurrently executing the following ancillary agreements (collectively with the License Agreement, the "Transaction Documents"):
(a) that certain Escrow Agreement dated as of October 2, 2023, by and among Penterra, Meridian, and Velthorn National Bank, N.A., as escrow agent (the "Escrow Agreement");
(b) that certain Supply Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Supply Agreement");
(c) that certain Technology Transfer Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Technology Transfer Agreement");
(d) that certain Trademark License Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Trademark License Agreement"); and
(e) that certain Pharmacovigilance Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Pharmacovigilance Agreement").
Capitalized terms used but not otherwise defined in this Officer's Certificate (this "Certificate") shall have the meanings ascribed to such terms in the License Agreement. This Certificate is delivered to Penterra as a condition to the Closing under Section 8.02(d) of the License Agreement and constitutes a "closing deliverable" as such term is used therein.
Section 1. Authority and Capacity
I, David R. Cheung, hereby certify that I am the duly appointed General Counsel and an authorized officer of Meridian Bio Therapeutics Limited. I have been duly authorized by the Board of Directors of Meridian to execute and deliver this Certificate on behalf of Meridian, and I am delivering this Certificate in my capacity as an authorized officer of Meridian in connection with the Closing.
I have personal knowledge of the matters certified herein or have made due and diligent inquiry of appropriate officers, directors, and personnel of Meridian, including the Chief Executive Officer, the Chief Financial Officer, and the Chief Medical Officer, and have reviewed relevant corporate records, files, and documents, in each case to the extent necessary to confirm the accuracy and completeness of the certifications set forth in this Certificate. I am familiar with the Transaction Documents and the transactions contemplated thereby, and I have participated in the negotiation, drafting, and review of the Transaction Documents in my capacity as General Counsel of Meridian.
Section 2. Organization and Good Standing
I hereby certify that Meridian Bio Therapeutics Limited is a limited company duly organized, validly existing, and in good standing under the laws of the Hong Kong Special Administrative Region of the People's Republic of China. Meridian was incorporated on March 14, 2016, and its Company Registration Number is 2847631 as registered with the Companies Registry of Hong Kong SAR. Meridian has not been dissolved, wound up, or struck off the register of companies, and no proceedings for any such dissolution, winding up, or striking off are pending or, to the knowledge of the undersigned, threatened.
Meridian has full corporate power and authority to (a) own, lease, and operate its properties and assets, (b) carry on its business as presently conducted and as contemplated to be conducted under the Transaction Documents, and (c) execute, deliver, and perform its obligations under the License Agreement and each of the other Transaction Documents to which it is or will be a party.
Each of the following subsidiaries of Meridian that is relevant to the performance of Meridian's obligations under the Transaction Documents is duly organized, validly existing, and in good standing (or equivalent status) under the laws of its respective jurisdiction of organization:
Each such subsidiary has full corporate power and authority to own, lease, and operate its properties and assets and to carry on its business as presently conducted. None of such subsidiaries has been dissolved, wound up, or deregistered, and no proceedings for any such dissolution, winding up, or deregistration are pending or, to the knowledge of the undersigned, threatened.
Section 3. Board Authorization
I hereby certify that the Board of Directors of Meridian has duly authorized the execution, delivery, and performance by Meridian of the License Agreement and each of the other Transaction Documents to which Meridian is a party, and the consummation of all transactions contemplated thereby. Such authorization was granted by resolutions duly adopted at a meeting of the Board of Directors of Meridian held on September 28, 2023, at which a quorum was present and acting throughout, and at which such resolutions were approved by the affirmative vote of all directors present (the "Authorizing Resolutions"). True, correct, and complete copies of the Authorizing Resolutions, certified by the Company Secretary of Meridian, have been delivered to Licensor as part of the closing deliverables, as further evidenced by the Secretary's/Director's Certificate of Meridian delivered concurrently herewith (the "Secretary's Certificate").
The Authorizing Resolutions have not been rescinded, amended, modified, or revoked in any respect and remain in full force and effect as of the date hereof. No further corporate action, approval, consent, or authorization on the part of Meridian, its Board of Directors, or its shareholders is required for the valid execution, delivery, and performance of the Transaction Documents or for the consummation of the transactions contemplated thereby, including, without limitation, the payment of the upfront license fee, milestone payments, royalties, and other amounts payable by Meridian under the License Agreement.
Section 4. Representations and Warranties
I hereby certify that each of the representations and warranties made by Meridian, in its capacity as Licensee, in the License Agreement (including, without limitation, those set forth in Article V thereof) is true and correct in all material respects as of the date hereof, October 20, 2023, with the same force and effect as though each such representation and warranty had been made on and as of the date hereof. To the extent that any such representation or warranty expressly speaks as of an earlier date (including, without limitation, representations and warranties that speak as of the Signing Date or any other specified date), such representation or warranty is true and correct in all material respects as of such earlier date.
Without limiting the generality of the foregoing, no event has occurred and no condition or circumstance exists, on or prior to the date hereof, that would cause any representation or warranty made by Meridian in the License Agreement or any other Transaction Document to be untrue, incorrect, or misleading in any material respect.
Section 5. Performance of Covenants
I hereby certify that Meridian has performed and complied in all material respects with all covenants, agreements, conditions, and obligations required by the License Agreement and the other Transaction Documents to be performed or complied with by Meridian at or before the Closing Date (October 20, 2023). Without limiting the generality of the foregoing, I certify that Meridian has performed and complied with the following specific covenants and obligations:
(a) Escrow Funding. Meridian deposited the aggregate amount of Eighteen Million United States Dollars ($18,000,000) in immediately available funds into the escrow account maintained at Velthorn National Bank, N.A. (Account No. ending in 8417) on October 6, 2023, in accordance with Section 3.01 of the License Agreement and Section 2(a) of the Escrow Agreement dated October 2, 2023. Confirmation of such deposit has been received by Meridian from Velthorn National Bank, N.A. and a copy of such confirmation has been provided to Penterra.
(b) Execution and Delivery of Transaction Documents. Meridian has duly executed and delivered, or is concurrently executing and delivering, each of the Transaction Documents to which Meridian is a party, including the License Agreement, the Escrow Agreement, the Supply Agreement, the Technology Transfer Agreement, the Trademark License Agreement, and the Pharmacovigilance Agreement.
(c) Closing Deliverables. Meridian has delivered, or is concurrently delivering, all closing deliverables required of Meridian under Section 8.02 of the License Agreement, including, without limitation:
(i) this Officer's Certificate;
(ii) the Secretary's/Director's Certificate of Meridian certifying, among other things, the Authorizing Resolutions, incumbency of authorized signatories, and true, correct, and complete copies of Meridian's organizational documents (including its Articles of Association as currently in effect);
(iii) a certificate of good standing (or equivalent) for Meridian issued by the Companies Registry of Hong Kong SAR, dated not more than fifteen (15) days prior to the Closing Date; and
(iv) such other documents, instruments, and certificates as may be reasonably requested by Penterra in connection with the Closing.
(d) Legal Opinion. Meridian has caused its Hong Kong legal counsel, Lam, Cheung & Firth LLP, to deliver to Penterra a legal opinion, dated as of the Closing Date and addressed to Penterra Pharmaceuticals Corp. and Calderwood & Harkness LLP, opining as to, among other things, the due organization and existence of Meridian, the corporate power and authority of Meridian to enter into the Transaction Documents, the due authorization, execution, and delivery of the Transaction Documents by Meridian, and the enforceability of the Transaction Documents against Meridian in accordance with their respective terms, in each case subject to customary assumptions, limitations, and qualifications.
Section 6. No Material Adverse Effect
I hereby certify that, since the Signing Date (October 2, 2023) through and including the date hereof (October 20, 2023), no event, change, development, occurrence, condition, or effect has occurred or arisen that, individually or in the aggregate, has had or would reasonably be expected to have a Material Adverse Effect (as defined in Section 1.01 of the License Agreement) on Meridian, its business, assets, financial condition, results of operations, or prospects, or on Meridian's ability to consummate the transactions contemplated by the Transaction Documents or to perform its obligations thereunder, including, without limitation, its obligations to fund development activities, pay milestone payments, pay royalties, and pay the minimum annual royalty as set forth in the License Agreement.
Section 7. No Litigation or Proceedings
I hereby certify that, as of the date hereof, there is no action, suit, proceeding, claim, arbitration, mediation, investigation, inquiry, or other legal or administrative proceeding pending or, to the knowledge of the undersigned (after due and diligent inquiry), threatened in writing against Meridian or any of its Affiliates (including its subsidiaries listed in Section 2 above) before any court, arbitral tribunal, governmental authority, or regulatory body that:
(a) challenges or seeks to restrain, enjoin, prohibit, or invalidate the execution, delivery, or performance of the License Agreement or any other Transaction Document, or the consummation of any of the transactions contemplated thereby; or
(b) would, if adversely determined, materially and adversely impair or delay Meridian's ability to perform its obligations under any of the Transaction Documents, including, without limitation, its obligations to develop, seek regulatory approval for, manufacture, and commercialize PPC-4187 (Penteracitinib) in the Licensed Territory.
Section 8. No Conflicts
I hereby certify that the execution, delivery, and performance by Meridian of the License Agreement and each of the other Transaction Documents to which Meridian is a party, and the consummation of the transactions contemplated thereby, do not and will not:
(a) violate, contravene, conflict with, or result in a breach of any provision of Meridian's Memorandum of Association, Articles of Association, or other organizational or constitutional documents, as currently in effect;
(b) violate, conflict with, result in a breach or default under, give rise to any right of termination, cancellation, or acceleration under, or result in the creation of any lien or encumbrance upon any assets or properties of Meridian pursuant to, any contract, agreement, indenture, mortgage, instrument, license, permit, or other arrangement that is material to Meridian or its business and to which Meridian or any of its Affiliates is a party or by which Meridian or any of its properties or assets is bound; or
(c) violate, contravene, or conflict with any applicable law, statute, ordinance, rule, regulation, judgment, order, writ, injunction, or decree of any governmental authority, regulatory body, or court having jurisdiction over Meridian, its properties, or its operations, including, without limitation, applicable laws and regulations of Hong Kong SAR, the People's Republic of China, Japan, the Republic of Korea, the Commonwealth of Australia, and any other jurisdiction within the Licensed Territory.
Section 9. Consents and Approvals
I hereby certify that all governmental and third-party consents, approvals, authorizations, permits, licenses, registrations, declarations, notices, and filings required for the valid execution, delivery, and performance by Meridian of the Transaction Documents, and for the consummation of the transactions contemplated thereby, have been obtained or made, as applicable, and are in full force and effect, except as set forth in the following paragraphs.
PRC Technology Import/Export Filing. Meridian is currently evaluating, in consultation with its PRC legal counsel, whether a technology import/export filing is required under the Technology Import and Export Administration Regulations of the People's Republic of China (中华人民共和国技术进出口管理条例) and the related implementing rules promulgated by the Ministry of Commerce of the People's Republic of China (MOFCOM) and/or the State Administration for Market Regulation (SAMR), in connection with the technology transfer and licensing contemplated by the Technology Transfer Agreement and the License Agreement. Meridian will make such filing promptly if and to the extent required under applicable PRC law, and Meridian will notify Penterra promptly upon making any such filing and upon receipt of any registration certificate or other approval issued in connection therewith.
Antitrust and Foreign Investment. Meridian confirms, based on analysis completed on October 5, 2023 by its legal advisors, that (a) no filing under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act") is required in connection with the transactions contemplated by the Transaction Documents, as the transaction constitutes a pure intellectual property license and does not involve an acquisition of voting securities, assets, or a non-corporate interest subject to the HSR Act notification requirements; and (b) review by the Committee on Foreign Investment in the United States (CFIUS) is not applicable to the transactions contemplated by the Transaction Documents, as no acquisition of a U.S. business or critical technology by a foreign person is involved. Meridian will cooperate with Penterra in making any additional filings or notifications that may be required by antitrust or foreign investment authorities in any jurisdiction within the Licensed Territory, to the extent applicable.
Section 10. Insurance
I hereby certify that Meridian has obtained, or will obtain prior to the commencement of any clinical trial or commercial activity with respect to PPC-4187 (Penteracitinib) in the Licensed Territory, clinical trial insurance and product liability insurance coverage from Jade Dragon Insurance Limited (contact: Christine A. Lo, Underwriter) with coverage limits and terms consistent with industry standards for pharmaceutical companies engaged in development, manufacture, and commercialization activities of a similar nature and scope in the Licensed Territory. Such insurance coverage will be maintained in accordance with the requirements set forth in Section 10.04 of the License Agreement throughout the term of Meridian's development and commercialization activities under the License Agreement and for such additional period following termination or expiration of the License Agreement as required thereunder.
Section 11. Incumbency
I hereby certify that, as of the date hereof, the following persons are the duly elected or appointed officers of Meridian, holding the offices set forth opposite their respective names, and each such person is authorized to execute the Transaction Documents and any other documents, instruments, or certificates delivered in connection with the Closing on behalf of Meridian. The signature of each such person appearing on any Transaction Document or any certificate, instrument, or other document delivered in connection therewith is such person's genuine signature.
Each of the persons listed above has been duly authorized by the Board of Directors of Meridian to execute and deliver, on behalf of Meridian, the Transaction Documents and any other documents, instruments, or certificates required or contemplated to be delivered by Meridian in connection with the Closing or the transactions contemplated by the Transaction Documents.
Section 12. No Undisclosed Liabilities or Obligations
I hereby certify that Meridian has not incurred, assumed, or become subject to any liabilities, obligations, debts, claims, or commitments (whether absolute, accrued, contingent, or otherwise) that are not reflected or reserved against in Meridian's most recent audited financial statements or otherwise disclosed to Penterra in writing prior to the date hereof, and that would, individually or in the aggregate, materially impair Meridian's ability to perform its obligations under the Transaction Documents.
Without limiting the generality of the foregoing, Meridian has not incurred or assumed any undisclosed liabilities or obligations that would materially impair its ability to pay any amounts payable under the License Agreement, including, without limitation:
(a) the upfront license fee deposited into escrow pursuant to the Escrow Agreement;
(b) development milestone payments payable upon the achievement of specified development milestones as set forth in Section 6.01 of the License Agreement;
(c) commercial milestone payments payable upon the achievement of specified commercial milestones as set forth in Section 6.02 of the License Agreement;
(d) royalties on net sales of Licensed Products in the Licensed Territory as set forth in Section 6.03 of the License Agreement; and
(e) the minimum annual royalty of Two Million United States Dollars ($2,000,000) per calendar year, payable beginning in the calendar year immediately following the first commercial sale of a Licensed Product in any country in the Licensed Territory, as set forth in Section 6.04 of the License Agreement.
Section 13. Reliance
This Certificate is being delivered to Penterra Pharmaceuticals Corp. as a condition to the Closing under Section 8.02(d) of the License Agreement. Penterra and its legal counsel, Calderwood & Harkness LLP (600 Lexington Avenue, 30th Floor, New York, NY 10022, Attention: Marcus Delgado, Esq.), are entitled to rely on the certifications, representations, and statements contained herein in connection with the Closing and the consummation of the transactions contemplated by the Transaction Documents.
The certifications, representations, and statements contained in this Certificate shall survive the Closing of the transactions contemplated by the Transaction Documents in accordance with, and subject to, the survival provisions set forth in Section 11.01 of the License Agreement, and nothing in this Certificate shall limit or modify any rights or remedies available to Penterra under the License Agreement or any other Transaction Document with respect to a breach of any representation, warranty, covenant, or agreement contained therein.
Section 14. Governing Law
This Certificate shall be governed by, and construed and interpreted in accordance with, the laws of the State of New York, United States of America, without regard to any conflicts of law principles that would require the application of the laws of any other jurisdiction, consistent with the governing law provisions set forth in Section 14.08 of the License Agreement.
[Signature Page Follows]
SIGNATURE PAGE TO OFFICER'S CERTIFICATE OF MERIDIAN BIO THERAPEUTICS LIMITED
IN WITNESS WHEREOF, the undersigned has executed this Officer's Certificate as of October 20, 2023.
MERIDIAN BIO THERAPEUTICS LIMITED
By: ________
Name: David R. Cheung, Esq.
Title: General Counsel and Authorized Officer
Date: October 20, 2023
Notice Information
Copies of this Certificate have been delivered to the following persons and addresses:
(1) Licensor:
Penterra Pharmaceuticals Corp.
Attention: Anita M. Fremont, Esq., General Counsel
400 Pharma Drive, Suite 800 Princeton, New Jersey 08540 United States of America
(2) Licensor's Counsel:
Calderwood & Harkness LLP
Attention: Marcus Delgado, Esq.
600 Lexington Avenue, 30th Floor New York, New York 10022 United States of America
(3) Licensee's Counsel:
Lam, Cheung & Firth LLP
Attention: Jonathan M. Firth, Esq.
25/F, Jardine House 1 Connaught Place, Central Hong Kong SAR
CONFIDENTIAL — This Officer's Certificate and its contents are confidential and are subject to the confidentiality provisions of the License Agreement. Distribution or disclosure of this Certificate or any information contained herein to any person other than the addressees listed above is prohibited without the prior written consent of Meridian Bio Therapeutics Limited, except as required by applicable law or regulation.
Subsidiary | Entity Type | Jurisdiction | Principal Office Location
Meridian Pharma (Shanghai) Co., Ltd. | Wholly Foreign-Owned Enterprise (WFOE) | People's Republic of China | Shanghai, PRC
Meridian Japan K.K. | Kabushiki Kaisha | Japan | Tokyo, Japan
Meridian Korea Inc. | Corporation | Republic of Korea | Seoul, Republic of Korea
Meridian Bio Australia Pty Ltd | Proprietary Limited Company | Commonwealth of Australia | Sydney, New South Wales, Australia
Name | Title | Specimen Signature
Dr. Henry W.L. Tsang | Chairman & Founder | ______
Angela C.Y. Fong | Chief Executive Officer | ______
David R. Cheung, Esq. | General Counsel | ______
Patrick S.H. Kwok | Chief Financial Officer | ______
Dr. Kenji Morimoto | Chief Medical Officer | ______

OFFICER'S CERTIFICATE

MERIDIAN BIO THERAPEUTICS LIMITED

SIGNATURE PAGE TO OFFICER'S CERTIFICATE OF MERIDIAN BIO THERAPEUTICS LIMITED

MERIDIAN BIO THERAPEUTICS LIMITED

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