1018-00004 · Penterra Pharmaceuticals Corp · Closing

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CLOSING CERTIFICATE OF VERIDIAN HEALTH RESEARCH NETWORK, INC.

Delivered Pursuant to the Master Clinical Trial Agreement

July 5, 2023

This Closing Certificate (this "Certificate") is delivered by Veridian Health Research Network, Inc., a Delaware corporation organized as a 501(c)(3) tax-exempt research organization ("Site Network" or "Veridian"), pursuant to the closing conditions set forth in that certain Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), by and between Penterra Pharmaceuticals Corp., a Delaware corporation ("Sponsor" or "Penterra"), and Veridian, for Protocol PPC-4871-III (the "CLARION" trial — Clinical Assessment of Response with Longitudinal Investigation in ONcology).

RECITALS

WHEREAS, on June 28, 2023, Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. entered into the MCTA governing the conduct of a Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871), an oral multi-kinase inhibitor, for the treatment of advanced hepatocellular carcinoma (HCC) in patients who have progressed on or after prior systemic therapy (the "CLARION Trial");

WHEREAS, the CLARION Trial is conducted under Protocol Number PPC-4871-III (Protocol Short Title: CLARION), ClinicalTrials.gov Identifier NCT05928174, and Investigational New Drug Application Number IND 157823, which IND is held and maintained by Penterra;

WHEREAS, the total value of the MCTA is Eighty Million Dollars ($80,000,000), covering thirty-eight (38) Veridian Network sites located across fourteen (14) states over a projected sixty (60)-month study duration, consisting of a forty-two (42)-month enrollment period followed by an eighteen (18)-month follow-up period;

WHEREAS, the CLARION Trial is designed to enroll approximately one thousand two hundred (1,200) subjects, randomized in a 2:1 ratio (penterafenib to placebo), resulting in approximately eight hundred (800) subjects assigned to the penterafenib treatment arm and approximately four hundred (400) subjects assigned to the placebo arm;

WHEREAS, this Certificate is being delivered on July 5, 2023 (the "Closing Date"), in satisfaction of the closing conditions set forth in Section 8.02 of the MCTA;

WHEREAS, this Certificate is executed and delivered by Dr. Franklin Osei, M.D., Ph.D., the duly elected and currently serving President and Chief Executive Officer of Veridian Health Research Network, Inc., who is authorized to execute and deliver this Certificate on behalf of Veridian; and

WHEREAS, the principal office of Veridian is located at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104, and Veridian's Employer Identification Number is 23-4178205.

NOW, THEREFORE, the undersigned hereby certifies as follows on behalf of Veridian. Capitalized terms used but not otherwise defined in this Certificate shall have the meanings ascribed to such terms in the MCTA.

SECTION 1: AUTHORITY AND CAPACITY OF CERTIFYING OFFICER

I, Dr. Franklin Osei, M.D., Ph.D., hereby certify that I am the duly elected and currently serving President and Chief Executive Officer of Veridian Health Research Network, Inc. I have served in this capacity since January 15, 2019, and my election and appointment have been duly authorized by the Board of Directors of Veridian in accordance with Veridian's Certificate of Incorporation and Bylaws.

I have personal knowledge of the matters set forth in this Certificate, or, where I do not have direct personal knowledge, I have made due inquiry of appropriate officers, directors, employees, and advisors of Veridian, including Gregory Callahan, Esq., Vice President, Legal & Compliance, and Dr. Margot Lanier, Ph.D., Senior Vice President, Clinical Operations, in order to inform myself regarding such matters. Based on such personal knowledge and due inquiry, I am satisfied that the certifications, representations, and statements contained herein are true and correct in all material respects.

I am authorized to execute and deliver this Closing Certificate on behalf of Veridian pursuant to resolutions duly adopted by the Board of Directors of Veridian on June 22, 2023, at a duly convened meeting at which a quorum was present, which resolutions authorized the execution, delivery, and performance of the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby, including this Certificate. The foregoing authorization is further evidenced by the Secretary's Certificate of Veridian, executed by Rachel M. Thornton, Corporate Secretary, delivered concurrently herewith on the Closing Date.

SECTION 2: REPRESENTATIONS AND WARRANTIES BRINGDOWN

I hereby certify, on behalf of Veridian, that each of the representations and warranties made by Veridian in the MCTA (including all Exhibits and Schedules thereto) is true and correct in all material respects as of the date of the MCTA (June 28, 2023) and as of the Closing Date (July 5, 2023), with the same force and effect as though each such representation and warranty had been made on and as of the Closing Date, except to the extent that any such representation or warranty expressly relates to an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date. Without limiting the generality of the foregoing, the following specific representations and warranties are confirmed to remain true and correct in all material respects:

(a) Organization and Good Standing. Veridian Health Research Network, Inc. is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. Veridian is recognized by the Internal Revenue Service as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, and such recognition remains in full force and effect without any pending or, to Veridian's knowledge, threatened revocation, suspension, or modification thereof. Veridian is duly qualified to conduct business and is in good standing in each jurisdiction where its participating network sites are located and where the nature of its activities or properties requires such qualification, including the Commonwealth of Pennsylvania, the State of Illinois, the State of New York, and each other state in which a Veridian Network site participates in the CLARION Trial as listed on Schedule 1 to the MCTA. No proceedings have been instituted or, to Veridian's knowledge, threatened to revoke or limit such qualifications.

(b) Authority and Enforceability. Veridian has full corporate power and authority to enter into, execute, deliver, and perform its obligations under the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby, including this Certificate. The execution, delivery, and performance of the MCTA and all ancillary documents have been duly authorized by all necessary corporate action of Veridian, including approval by its Board of Directors at a meeting duly convened on June 22, 2023, at which a quorum was present. No further corporate action on the part of Veridian, its Board of Directors, or its members is required to authorize the execution, delivery, and performance of the MCTA or any ancillary agreement. The MCTA constitutes, and upon execution and delivery each ancillary agreement will constitute, a legal, valid, and binding obligation of Veridian, enforceable against Veridian in accordance with its respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, and similar laws affecting creditors' rights generally and to general principles of equity.

(c) No Conflicts. The execution, delivery, and performance by Veridian of the MCTA and all ancillary agreements, and the consummation of the transactions contemplated thereby, do not and will not (i) violate, conflict with, or result in a breach of any provision of Veridian's Certificate of Incorporation (as amended and restated) or Bylaws (as amended); (ii) violate, conflict with, or result in a breach of, or constitute a default (or an event that, with the giving of notice or lapse of time or both, would constitute a default) under, any material agreement, contract, lease, license, instrument, or obligation to which Veridian is a party or by which any of its properties or assets are bound; (iii) violate any applicable law, statute, regulation, rule, judgment, order, decree, or injunction of any governmental authority applicable to Veridian or its properties; or (iv) result in the creation or imposition of any lien, charge, or encumbrance upon any property or asset of Veridian. No consent, approval, authorization, order, filing, or registration with any governmental authority or third party is required in connection with the execution, delivery, and performance of the MCTA by Veridian, except such consents, approvals, and authorizations as have been duly obtained or made as of the Closing Date.

(d) Regulatory Compliance. Veridian and each of its participating network sites are, and as of the Closing Date remain, in material compliance with all applicable federal, state, and local laws, regulations, rules, and guidelines governing the conduct of clinical trials and clinical research, including without limitation:

(i) Title 21 of the Code of Federal Regulations, Part 11 (Electronic Records; Electronic Signatures);

(ii) Title 21 of the Code of Federal Regulations, Part 50 (Protection of Human Subjects);

(iii) Title 21 of the Code of Federal Regulations, Part 54 (Financial Disclosure by Clinical Investigators);

(iv) Title 21 of the Code of Federal Regulations, Part 56 (Institutional Review Boards);

(v) Title 21 of the Code of Federal Regulations, Part 312 (Investigational New Drug Application);

(vi) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E6(R2) for Good Clinical Practice (GCP);

(vii) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164;

(viii) The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and its implementing regulations;

(ix) The Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act), codified at 42 U.S.C. § 1320a-7h, and the Centers for Medicare and Medicaid Services (CMS) Open Payments program; and

(x) All other applicable federal, state, and local laws, regulations, and guidelines relating to clinical research, including applicable state clinical trial registration requirements and informed consent laws.

Veridian has not received any written notice from any governmental authority alleging any material non-compliance with the foregoing laws, regulations, and guidelines, and there are no pending or, to Veridian's knowledge, threatened actions, proceedings, or investigations by any governmental authority with respect to any alleged material non-compliance.

(e) IRB Oversight. Institutional Review Board (IRB) approvals have been obtained or are in the process of being obtained for all lead participating sites in the CLARION Trial. Specifically:

(i) The Graystone University Institutional Review Board (IRB Registration Number: IRB00012847; Federal Wide Assurance Number: FWA00009623) has reviewed and approved the CLARION Protocol (PPC-4871-III), the informed consent form, and all related study documents for Graystone University Medical Center (Site 001, located at 1200 University Avenue, Philadelphia, PA 19104). Such approval was granted on June 30, 2023, and remains in full force and effect as of the Closing Date.

(ii) The Veridian Central IRB (IRB Registration Number: IRB00017556) has reviewed and approved the CLARION Protocol, the informed consent form template, and related study documents for non-Pennsylvania network sites, including Lakemont Medical Center (Site 002, located at 4400 North Michigan Drive, Chicago, IL 60611). Such approval was granted on July 2, 2023, and remains in full force and effect as of the Closing Date.

(iii) IRB reliance agreements are in place, or will be executed prior to site activation, for all Veridian Network sites that will rely on the Veridian Central IRB as the IRB of record, in accordance with applicable federal regulations and the requirements of the MCTA.

(f) Network Sites. All thirty-eight (38) Veridian Network sites listed on Schedule 1 to the MCTA, located across fourteen (14) states, remain eligible, willing, and able to participate in the CLARION Trial in accordance with the Protocol. No Veridian Network site has withdrawn, indicated its intention to withdraw, or become ineligible to participate in the CLARION Trial since the date of the MCTA. Each such site has the necessary infrastructure, qualified personnel, and regulatory approvals (or is in the process of obtaining such approvals) to conduct the CLARION Trial in accordance with the Protocol, GCP, and all applicable regulatory requirements. To Veridian's knowledge, no event or condition has occurred that would reasonably be expected to render any such site ineligible or unable to participate in the CLARION Trial.

(g) No Debarment. Neither Veridian nor any of its officers, directors, employees, investigators, sub-investigators, or key site personnel involved in the conduct of the CLARION Trial (i) have been debarred, suspended, excluded, or otherwise made ineligible for participation in federal healthcare programs, including Medicare and Medicaid, under 42 U.S.C. § 1320a-7; (ii) have been debarred from providing services in any capacity to a person that has an approved or pending drug product application under 21 U.S.C. § 335a(a) or (b); (iii) are the subject of any pending or, to Veridian's knowledge, threatened debarment, suspension, or exclusion proceedings; or (iv) have been convicted of a criminal offense for which a person can be debarred under 21 U.S.C. § 335a. Veridian has conducted appropriate screening and verification checks, including review of the U.S. Department of Health and Human Services Office of Inspector General List of Excluded Individuals/Entities (LEIE), the General Services Administration System for Award Management (SAM) database, and the FDA Debarment List, with respect to all investigators, sub-investigators, and key site personnel identified for the CLARION Trial, and all such checks were completed with satisfactory results.

(h) No Litigation. There is no pending or, to Veridian's knowledge, threatened litigation, arbitration, administrative proceeding, governmental investigation, or other legal proceeding of any nature before any court, arbitrator, tribunal, or governmental authority that (i) would materially impair Veridian's ability to perform its obligations under the MCTA or any ancillary agreement, (ii) challenges or seeks to prevent, enjoin, or otherwise delay the transactions contemplated by the MCTA, or (iii) would reasonably be expected to result in a material adverse change in the business, operations, financial condition, assets, or regulatory status of Veridian or any of its participating network sites. No judgment, order, writ, injunction, decree, or award has been issued by or, to Veridian's knowledge, requested of any court, arbitrator, or governmental authority that would have any such effect.

(i) Financial Disclosures. To Veridian's knowledge, all investigators identified for the CLARION Trial have completed or will complete, prior to the commencement of study activities at their respective sites, financial disclosure certifications in accordance with 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators). Veridian has implemented procedures to collect, review, and maintain financial disclosure documentation from all investigators and sub-investigators, and to update such documentation annually and upon any material change in financial interests, as required by the Protocol and the MCTA. As of the Closing Date, completed financial disclosure forms (FDA Form 3455 or equivalent) have been received from the Global Principal Investigator (Dr. Catherine Aldridge, M.D., Ph.D.) and the Co-Principal Investigator (Dr. Howard Matsuoka, M.D.), and no disqualifying financial interests have been identified. Veridian will ensure that financial disclosure forms are collected from all remaining investigators and sub-investigators prior to the initiation of study activities at each respective site.

(j) Fair Market Value. All payments and compensation arrangements contemplated by the MCTA, including the payment components described below, reflect fair market value for the services to be rendered by Veridian, its network sites, and its investigators, and are consistent with applicable Anti-Kickback Statute safe harbors (including the personal services and management contracts safe harbor at 42 C.F.R. § 1001.952(d)) and applicable guidance from the Office of Inspector General of the U.S. Department of Health and Human Services:

(i) Per-patient site fees of Fifty-Two Thousand Dollars ($52,000) per subject enrolled and randomized in the CLARION Trial;

(ii) Start-up fees of Seventy-Five Thousand Dollars ($75,000) per site for each of the thirty-eight (38) Veridian Network sites;

(iii) Annual site maintenance fees of Forty Thousand Dollars ($40,000) per site per year for each of the thirty-eight (38) Veridian Network sites;

(iv) Investigator grants totaling One Million Five Hundred Thousand Dollars ($1,500,000) in the aggregate for qualified investigators participating in the CLARION Trial; and

(v) A network coordination fee of Four Million Two Hundred Thousand Dollars ($4,200,000) payable to Veridian for its coordination, oversight, and management services across all thirty-eight (38) Veridian Network sites over the duration of the CLARION Trial.

The foregoing fee structure was established based on an independent fair market value assessment conducted by Veridian's compliance department, in consultation with an independent third-party valuation firm, and is consistent with prevailing market rates for clinical trial services of comparable scope, complexity, and therapeutic area. Veridian represents that no portion of the compensation payable under the MCTA is intended to serve as an inducement for the referral of patients or the generation of business for Penterra or any of its affiliates.

SECTION 3: PERFORMANCE OF PRE-CLOSING OBLIGATIONS

I hereby certify, on behalf of Veridian, that Veridian has performed and complied with, in all material respects, all covenants, obligations, and conditions required to be performed or complied with by Veridian under the MCTA on or prior to the Closing Date (July 5, 2023). Without limiting the generality of the foregoing, Veridian has satisfied the following pre-closing obligations:

(a) Insurance Certificates. Veridian has delivered, or caused to be delivered, to Penterra and its counsel certificates of insurance evidencing general liability and professional liability (errors and omissions) insurance coverage for each participating site institution. Such coverage maintains limits of not less than Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggregate, as required by Section 14.02 of the MCTA and Exhibit E thereto. Certificates of insurance were delivered to Penterra within fifteen (15) business days of the execution of the MCTA (i.e., on or before July 3, 2023, calculated from the execution date of June 28, 2023), in compliance with the time requirements set forth in Section 14.02(b) of the MCTA. Each such certificate of insurance names Penterra Pharmaceuticals Corp. as an additional insured and contains a provision requiring not less than thirty (30) days' prior written notice to Penterra of any cancellation, material modification, or non-renewal of coverage.

(b) IRB Approvals for Lead Sites. IRB approval has been obtained for the two lead participating sites in the CLARION Trial, as follows:

(i) Graystone University Medical Center (Site 001), located at 1200 University Avenue, Philadelphia, PA 19104, Principal Investigator: Dr. Catherine Aldridge, M.D., Ph.D. — Approved by the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847) on June 30, 2023. The approval encompasses the CLARION Protocol (PPC-4871-III, Version 3.0, dated May 15, 2023), the informed consent form (Version 2.1, dated May 22, 2023), the investigator's brochure (Edition 7, dated April 10, 2023), and all related study materials submitted to the IRB.

(ii) Lakemont Medical Center (Site 002), located at 4400 North Michigan Drive, Chicago, IL 60611, Co-Principal Investigator: Dr. Howard Matsuoka, M.D. — Approved by the Veridian Central IRB (IRB Registration Number: IRB00017556) on July 2, 2023. The approval encompasses the CLARION Protocol (PPC-4871-III, Version 3.0, dated May 15, 2023), the informed consent form template (Version 2.1, dated May 22, 2023), and all related study materials submitted to the IRB.

Copies of the IRB approval letters for both lead sites have been provided to Penterra and its counsel.

(c) Investigator Signature Pages. Executed investigator signature pages have been obtained and delivered, confirming the commitment and authorization of the following investigators to serve in their respective capacities in the CLARION Trial:

(i) Dr. Catherine Aldridge, M.D., Ph.D., Global Principal Investigator — Investigator signature page executed on June 29, 2023. The corresponding Principal Investigator Agreement, setting forth the roles, responsibilities, and obligations of Dr. Aldridge as Global Principal Investigator, has been fully executed and delivered to Penterra.

(ii) Dr. Howard Matsuoka, M.D., Co-Principal Investigator — Investigator signature page executed on June 30, 2023. The corresponding Co-Principal Investigator Agreement, setting forth the roles, responsibilities, and obligations of Dr. Matsuoka as Co-Principal Investigator, has been fully executed and delivered to Penterra.

(d) Individual Site Agreements (Lead Sites). The Individual Site Agreements (Joinders) for the two lead participating sites have been executed and delivered, as follows:

(i) The Individual Site Agreement (Joinder) for Graystone University Medical Center (Site 001) has been executed by Dr. William Corwin, M.D., President of Graystone University Medical Center, and countersigned by Dr. Franklin Osei on behalf of Veridian, and has been delivered to Penterra. The agreement incorporates by reference the terms and conditions of the MCTA and establishes the site-specific obligations and operational parameters for Site 001.

(ii) The Individual Site Agreement (Joinder) for Lakemont Medical Center (Site 002) has been executed by the authorized signatory of Lakemont Medical Center and countersigned by Dr. Franklin Osei on behalf of Veridian, and has been delivered to Penterra. The agreement incorporates by reference the terms and conditions of the MCTA and establishes the site-specific obligations and operational parameters for Site 002.

(e) Secretary's Certificate. Veridian's Secretary's Certificate has been duly executed by Rachel M. Thornton, Corporate Secretary of Veridian Health Research Network, Inc., and is being delivered concurrently herewith on the Closing Date. The Secretary's Certificate certifies (i) true and correct copies of the resolutions duly adopted by the Board of Directors of Veridian on June 22, 2023, authorizing the execution, delivery, and performance of the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby; (ii) the incumbency and specimen signatures of the authorized signatories of Veridian, namely Dr. Franklin Osei, M.D., Ph.D., President and Chief Executive Officer, and Gregory Callahan, Esq., Vice President, Legal & Compliance; and (iii) that Veridian's Certificate of Incorporation and Bylaws have not been amended, modified, or supplemented since the date last provided to Penterra.

(f) Investigator Undertakings. Executed Forms of Investigator Undertaking (in the form attached as Exhibit I to the MCTA) have been delivered for the following investigators:

(i) Dr. Catherine Aldridge, M.D., Ph.D. — Investigator Undertaking executed on June 29, 2023, confirming Dr. Aldridge's personal commitment to: conduct the CLARION Trial in accordance with the Protocol (PPC-4871-III, Version 3.0); comply with ICH E6(R2) Good Clinical Practice guidelines; comply with all applicable federal, state, and local laws and regulations, including 21 C.F.R. Parts 50, 54, 56, and 312; make and maintain all required financial disclosures; maintain the confidentiality of Penterra's proprietary information and study data; and ensure proper delegation of study tasks to qualified personnel.

(ii) Dr. Howard Matsuoka, M.D. — Investigator Undertaking executed on June 30, 2023, confirming Dr. Matsuoka's personal commitment to the same obligations as set forth above.

(g) Regulatory Compliance Representations. Veridian has duly executed and delivered the Regulatory Compliance Representations and Covenants set forth in Exhibit H to the MCTA. The executed Exhibit H confirms Veridian's compliance with and ongoing commitment to comply with 21 C.F.R. Parts 11, 50, 54, 56, and 312; ICH E6(R2) Good Clinical Practice guidelines; HIPAA and its implementing regulations at 45 C.F.R. Parts 160 and 164; the Anti-Kickback Statute (42 U.S.C. § 1320a-7b); and the Physician Payments Sunshine Act / Open Payments requirements (42 U.S.C. § 1320a-7h). Veridian represents that it has established and maintains a comprehensive compliance program designed to ensure ongoing adherence to these regulatory requirements across all thirty-eight (38) Veridian Network sites participating in the CLARION Trial.

(h) IP Side Letter. The intellectual Property Side Letter, dated as of June 28, 2023, governing the ownership, licensing, and assignment of intellectual property and inventions arising from or related to the conduct of the CLARION Trial, has been duly executed and delivered by Veridian. The IP Side Letter was executed by Dr. Franklin Osei on behalf of Veridian and delivered to Penterra and its counsel contemporaneously with the execution of the MCTA.

(i) Approved Subcontractors. Veridian hereby acknowledges and consents to the engagement of the approved subcontractors listed on Exhibit K to the MCTA, which subcontractors will provide services in connection with the conduct of the CLARION Trial. The approved subcontractors are as follows:

(i) Meridian Contract Research Organization, Inc. (CRO services, including clinical monitoring, data management, and pharmacovigilance), headquartered at 9200 Corporate Boulevard, Raleigh, NC 27615;

(ii) Pinnacle Data Solutions, Inc. (electronic data capture (EDC) platform and related technology services), headquartered at 6000 Clearwater Drive, San Diego, CA 92121; and

(iii) Northbridge Bioanalytical Laboratories, Inc. (central laboratory services, including specimen analysis, biomarker assessment, and sample storage), headquartered at 2900 Commerce Way, Baltimore, MD 21224.

Veridian confirms that it has reviewed and is satisfied with the qualifications, capabilities, and regulatory compliance standing of each approved subcontractor and agrees to cooperate with each such subcontractor in connection with the conduct of the CLARION Trial, in accordance with the terms of the MCTA.

SECTION 4: NO MATERIAL ADVERSE CHANGE

I hereby certify, on behalf of Veridian, that since the date of the MCTA (June 28, 2023), there has been no material adverse change in the business, operations, assets, liabilities, financial condition, results of operations, prospects, or regulatory status of Veridian or any of its network participating sites that would materially impair, or would reasonably be expected to materially impair, Veridian's ability to perform its obligations under the MCTA or any ancillary agreement contemplated thereby.

Without limiting the foregoing, since the date of the MCTA, there has been no material adverse change in the research capabilities, accreditation status, institutional standing, regulatory standing, or operational readiness of any of the thirty-eight (38) Veridian Network sites listed on Schedule 1 to the MCTA. No Veridian Network site has suffered any loss of accreditation, suspension of clinical research activities, issuance of a Form FDA 483, warning letter, untitled letter, or other regulatory action by the U.S. Food and Drug Administration or any other governmental authority, or any other event or development that would materially impair such site's ability to participate in the CLARION Trial.

Additionally, Veridian confirms that since the date of the MCTA, (i) there has been no change in the senior management or key personnel of Veridian that would materially affect Veridian's ability to perform under the MCTA; (ii) Veridian has not entered into any agreement, transaction, or arrangement that would conflict with or impair its obligations under the MCTA; and (iii) Veridian has not experienced any event of default, or any event that with the giving of notice or lapse of time would constitute an event of default, under any material agreement, contract, or instrument to which Veridian is a party.

SECTION 5: RECEIPT AND ACKNOWLEDGMENT OF SPONSOR DELIVERABLES

I hereby certify, on behalf of Veridian, that Veridian acknowledges receipt of the following deliverables from Penterra Pharmaceuticals Corp. as of the Closing Date:

(a) Certificate of Insurance. Certificate of Insurance issued by Briarcliff Mutual Insurance Company (Policy Number: BM-CTL-2023-04182, policy period April 1, 2023 through March 31, 2024), evidencing clinical trial liability insurance maintained by Penterra with the following limits of liability:

(i) General clinical trial liability: Twenty-Five Million Dollars ($25,000,000) per occurrence and Seventy-Five Million Dollars ($75,000,000) in the aggregate;

(ii) Subject-injury sublimit: Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate.

The Certificate of Insurance confirms that Veridian Health Research Network, Inc. and each participating Veridian Network site are named as additional insureds under the policy for claims arising out of or related to the conduct of the CLARION Trial. Veridian has reviewed the Certificate of Insurance and confirms that the coverage described therein satisfies the insurance requirements set forth in Section 14.01 of the MCTA.

(b) Closing Certificate of Penterra. The Closing Certificate of Penterra Pharmaceuticals Corp., duly executed by Nathaniel Briggs, Esq., Vice President and General Counsel of Penterra, dated as of the Closing Date (July 5, 2023), certifying the accuracy of Penterra's representations and warranties, the performance of Penterra's pre-closing obligations, and the absence of any material adverse change with respect to Penterra.

(c) Secretary's Certificate of Penterra. The Secretary's Certificate of Penterra Pharmaceuticals Corp., certifying (i) the resolutions duly adopted by the Board of Directors of Penterra authorizing the execution, delivery, and performance of the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby; and (ii) the incumbency and specimen signatures of the authorized signatories of Penterra.

(d) Officer's Certificate of Penterra. The Officer's Certificate of Penterra Pharmaceuticals Corp., confirming the bringdown of Penterra's representations and warranties as of the Closing Date and certifying that no event of default or material breach has occurred or is continuing under the MCTA.

Veridian has reviewed each of the foregoing deliverables and confirms that such deliverables are satisfactory in form and substance and comply with the requirements of the MCTA.

SECTION 6: GOVERNING LAW

This Closing Certificate shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflict of laws principles thereof that would result in the application of the laws of any other jurisdiction, consistent with the governing law provisions set forth in Section 19.08 of the MCTA.

Any dispute, controversy, or claim arising out of, relating to, or in connection with this Closing Certificate, or the breach, termination, or validity thereof, shall be subject to the dispute resolution provisions set forth in Section 19.09 of the MCTA, which provide for (i) initial escalation through good-faith negotiation between the designated senior representatives of the parties for a period of thirty (30) days following written notice of the dispute; (ii) if the dispute is not resolved through negotiation, non-binding mediation conducted under the Commercial Mediation Rules of the American Arbitration Association ("AAA") for a period of sixty (60) days; and (iii) if the dispute is not resolved through mediation, final and binding arbitration conducted in New York, New York under the Commercial Arbitration Rules of the AAA before a panel of three (3) arbitrators, with each party selecting one arbitrator and the two party-selected arbitrators selecting the third. The arbitration shall be conducted in the English language, and the award rendered by the arbitrators shall be final and binding upon the parties and may be entered and enforced in any court of competent jurisdiction.

SECTION 7: RELIANCE

This Closing Certificate is delivered with the understanding and acknowledgment that Penterra Pharmaceuticals Corp. and its counsel, Calderwood & Harkness LLP (280 Park Avenue, 34th Floor, New York, NY 10017), are entitled to rely fully on the certifications, representations, and statements contained herein in connection with the closing of the transactions contemplated by the MCTA and the satisfaction of the closing conditions set forth in Section 8.02 of the MCTA. The certifications, representations, and statements set forth herein are made for the benefit of Penterra and its counsel and shall survive the Closing Date in accordance with the survival provisions set forth in the MCTA.

This Certificate is also being delivered for the benefit of Penterra's clinical trial liability insurer, Briarcliff Mutual Insurance Company, to the extent required under Policy No. BM-CTL-2023-04182 or otherwise reasonably requested by Briarcliff Mutual Insurance Company in connection with the issuance or maintenance of clinical trial liability insurance coverage for the CLARION Trial. Briarcliff Mutual Insurance Company shall be entitled to rely on the certifications, representations, and statements contained herein to the same extent as Penterra.

Nothing in this Certificate shall be construed to create any rights in, or grant any remedy to, any person or entity other than Penterra Pharmaceuticals Corp., Calderwood & Harkness LLP, and Briarcliff Mutual Insurance Company, and their respective successors and permitted assigns.

IN WITNESS WHEREOF, the undersigned has executed this Closing Certificate as of July 5, 2023, on behalf of Veridian Health Research Network, Inc.

VERIDIAN HEALTH RESEARCH NETWORK, INC.

By: ________

Name: Dr. Franklin Osei, M.D., Ph.D.

Title: President and Chief Executive Officer

Date: July 5, 2023

Address:

750 Research Parkway, 8th Floor Philadelphia, PA 19104 Telephone: (215) 555-8200

Email: f.osei@veridianhealthresearch.org

NOTICES AND COPIES

A copy of this Closing Certificate has been delivered to each of the following:

1. Penterra Pharmaceuticals Corp.

Attn: Nathaniel Briggs, Esq.

Vice President & General Counsel 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540 Telephone: (609) 555-4100

Email: n.briggs@penterrapharma.com

2. Calderwood & Harkness LLP

Attn: Miriam Calloway, Partner

280 Park Avenue, 34th Floor New York, NY 10017 Telephone: (212) 555-7300

Email: m.calloway@calderwoodharkness.com

3. Veridian Health Research Network, Inc. (Internal Copy)

Attn: Gregory Callahan, Esq.

Vice President, Legal & Compliance 750 Research Parkway, 8th Floor Philadelphia, PA 19104 Telephone: (215) 555-8215

Email: g.callahan@veridianhealthresearch.org

4. Whitmore, Jansen & Callahan LLP

Attn: Allison Whitmore, Partner

1500 Market Street, Suite 3200 Philadelphia, PA 19102 Telephone: (215) 555-6600

Email: a.whitmore@wjclaw.com

This Closing Certificate and the certifications, representations, and statements contained herein are subject to the terms and conditions of the Master Clinical Trial Agreement dated June 28, 2023, between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. In the event of any conflict between the terms of this Certificate and the terms of the MCTA, the terms of the MCTA shall control.

CLOSING CERTIFICATE OF VERIDIAN HEALTH RESEARCH NETWORK, INC.
Delivered Pursuant to the Master Clinical Trial Agreement
July 5, 2023
This Closing Certificate (this "Certificate") is delivered by Veridian Health Research Network, Inc., a Delaware corporation organized as a 501(c)(3) tax-exempt research organization ("Site Network" or "Veridian"), pursuant to the closing conditions set forth in that certain Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), by and between Penterra Pharmaceuticals Corp., a Delaware corporation ("Sponsor" or "Penterra"), and Veridian, for Protocol PPC-4871-III (the "CLARION" trial — Clinical Assessment of Response with Longitudinal Investigation in ONcology).
RECITALS
WHEREAS, on June 28, 2023, Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. entered into the MCTA governing the conduct of a Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871), an oral multi-kinase inhibitor, for the treatment of advanced hepatocellular carcinoma (HCC) in patients who have progressed on or after prior systemic therapy (the "CLARION Trial");
WHEREAS, the CLARION Trial is conducted under Protocol Number PPC-4871-III (Protocol Short Title: CLARION), ClinicalTrials.gov Identifier NCT05928174, and Investigational New Drug Application Number IND 157823, which IND is held and maintained by Penterra;
WHEREAS, the total value of the MCTA is Eighty Million Dollars ($80,000,000), covering thirty-eight (38) Veridian Network sites located across fourteen (14) states over a projected sixty (60)-month study duration, consisting of a forty-two (42)-month enrollment period followed by an eighteen (18)-month follow-up period;
WHEREAS, the CLARION Trial is designed to enroll approximately one thousand two hundred (1,200) subjects, randomized in a 2:1 ratio (penterafenib to placebo), resulting in approximately eight hundred (800) subjects assigned to the penterafenib treatment arm and approximately four hundred (400) subjects assigned to the placebo arm;
WHEREAS, this Certificate is being delivered on July 5, 2023 (the "Closing Date"), in satisfaction of the closing conditions set forth in Section 8.02 of the MCTA;
WHEREAS, this Certificate is executed and delivered by Dr. Franklin Osei, M.D., Ph.D., the duly elected and currently serving President and Chief Executive Officer of Veridian Health Research Network, Inc., who is authorized to execute and deliver this Certificate on behalf of Veridian; and
WHEREAS, the principal office of Veridian is located at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104, and Veridian's Employer Identification Number is 23-4178205.
NOW, THEREFORE, the undersigned hereby certifies as follows on behalf of Veridian. Capitalized terms used but not otherwise defined in this Certificate shall have the meanings ascribed to such terms in the MCTA.
SECTION 1: AUTHORITY AND CAPACITY OF CERTIFYING OFFICER
I, Dr. Franklin Osei, M.D., Ph.D., hereby certify that I am the duly elected and currently serving President and Chief Executive Officer of Veridian Health Research Network, Inc. I have served in this capacity since January 15, 2019, and my election and appointment have been duly authorized by the Board of Directors of Veridian in accordance with Veridian's Certificate of Incorporation and Bylaws.
I have personal knowledge of the matters set forth in this Certificate, or, where I do not have direct personal knowledge, I have made due inquiry of appropriate officers, directors, employees, and advisors of Veridian, including Gregory Callahan, Esq., Vice President, Legal & Compliance, and Dr. Margot Lanier, Ph.D., Senior Vice President, Clinical Operations, in order to inform myself regarding such matters. Based on such personal knowledge and due inquiry, I am satisfied that the certifications, representations, and statements contained herein are true and correct in all material respects.
I am authorized to execute and deliver this Closing Certificate on behalf of Veridian pursuant to resolutions duly adopted by the Board of Directors of Veridian on June 22, 2023, at a duly convened meeting at which a quorum was present, which resolutions authorized the execution, delivery, and performance of the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby, including this Certificate. The foregoing authorization is further evidenced by the Secretary's Certificate of Veridian, executed by Rachel M. Thornton, Corporate Secretary, delivered concurrently herewith on the Closing Date.
SECTION 2: REPRESENTATIONS AND WARRANTIES BRINGDOWN
I hereby certify, on behalf of Veridian, that each of the representations and warranties made by Veridian in the MCTA (including all Exhibits and Schedules thereto) is true and correct in all material respects as of the date of the MCTA (June 28, 2023) and as of the Closing Date (July 5, 2023), with the same force and effect as though each such representation and warranty had been made on and as of the Closing Date, except to the extent that any such representation or warranty expressly relates to an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date. Without limiting the generality of the foregoing, the following specific representations and warranties are confirmed to remain true and correct in all material respects:
(a) Organization and Good Standing. Veridian Health Research Network, Inc. is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. Veridian is recognized by the Internal Revenue Service as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, and such recognition remains in full force and effect without any pending or, to Veridian's knowledge, threatened revocation, suspension, or modification thereof. Veridian is duly qualified to conduct business and is in good standing in each jurisdiction where its participating network sites are located and where the nature of its activities or properties requires such qualification, including the Commonwealth of Pennsylvania, the State of Illinois, the State of New York, and each other state in which a Veridian Network site participates in the CLARION Trial as listed on Schedule 1 to the MCTA. No proceedings have been instituted or, to Veridian's knowledge, threatened to revoke or limit such qualifications.
(b) Authority and Enforceability. Veridian has full corporate power and authority to enter into, execute, deliver, and perform its obligations under the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby, including this Certificate. The execution, delivery, and performance of the MCTA and all ancillary documents have been duly authorized by all necessary corporate action of Veridian, including approval by its Board of Directors at a meeting duly convened on June 22, 2023, at which a quorum was present. No further corporate action on the part of Veridian, its Board of Directors, or its members is required to authorize the execution, delivery, and performance of the MCTA or any ancillary agreement. The MCTA constitutes, and upon execution and delivery each ancillary agreement will constitute, a legal, valid, and binding obligation of Veridian, enforceable against Veridian in accordance with its respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, and similar laws affecting creditors' rights generally and to general principles of equity.
(c) No Conflicts. The execution, delivery, and performance by Veridian of the MCTA and all ancillary agreements, and the consummation of the transactions contemplated thereby, do not and will not (i) violate, conflict with, or result in a breach of any provision of Veridian's Certificate of Incorporation (as amended and restated) or Bylaws (as amended); (ii) violate, conflict with, or result in a breach of, or constitute a default (or an event that, with the giving of notice or lapse of time or both, would constitute a default) under, any material agreement, contract, lease, license, instrument, or obligation to which Veridian is a party or by which any of its properties or assets are bound; (iii) violate any applicable law, statute, regulation, rule, judgment, order, decree, or injunction of any governmental authority applicable to Veridian or its properties; or (iv) result in the creation or imposition of any lien, charge, or encumbrance upon any property or asset of Veridian. No consent, approval, authorization, order, filing, or registration with any governmental authority or third party is required in connection with the execution, delivery, and performance of the MCTA by Veridian, except such consents, approvals, and authorizations as have been duly obtained or made as of the Closing Date.
(d) Regulatory Compliance. Veridian and each of its participating network sites are, and as of the Closing Date remain, in material compliance with all applicable federal, state, and local laws, regulations, rules, and guidelines governing the conduct of clinical trials and clinical research, including without limitation:
(i) Title 21 of the Code of Federal Regulations, Part 11 (Electronic Records; Electronic Signatures);
(ii) Title 21 of the Code of Federal Regulations, Part 50 (Protection of Human Subjects);
(iii) Title 21 of the Code of Federal Regulations, Part 54 (Financial Disclosure by Clinical Investigators);
(iv) Title 21 of the Code of Federal Regulations, Part 56 (Institutional Review Boards);
(v) Title 21 of the Code of Federal Regulations, Part 312 (Investigational New Drug Application);
(vi) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E6(R2) for Good Clinical Practice (GCP);
(vii) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164;
(viii) The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and its implementing regulations;
(ix) The Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act), codified at 42 U.S.C. § 1320a-7h, and the Centers for Medicare and Medicaid Services (CMS) Open Payments program; and
(x) All other applicable federal, state, and local laws, regulations, and guidelines relating to clinical research, including applicable state clinical trial registration requirements and informed consent laws.
Veridian has not received any written notice from any governmental authority alleging any material non-compliance with the foregoing laws, regulations, and guidelines, and there are no pending or, to Veridian's knowledge, threatened actions, proceedings, or investigations by any governmental authority with respect to any alleged material non-compliance.
(e) IRB Oversight. Institutional Review Board (IRB) approvals have been obtained or are in the process of being obtained for all lead participating sites in the CLARION Trial. Specifically:
(i) The Graystone University Institutional Review Board (IRB Registration Number: IRB00012847; Federal Wide Assurance Number: FWA00009623) has reviewed and approved the CLARION Protocol (PPC-4871-III), the informed consent form, and all related study documents for Graystone University Medical Center (Site 001, located at 1200 University Avenue, Philadelphia, PA 19104). Such approval was granted on June 30, 2023, and remains in full force and effect as of the Closing Date.
(ii) The Veridian Central IRB (IRB Registration Number: IRB00017556) has reviewed and approved the CLARION Protocol, the informed consent form template, and related study documents for non-Pennsylvania network sites, including Lakemont Medical Center (Site 002, located at 4400 North Michigan Drive, Chicago, IL 60611). Such approval was granted on July 2, 2023, and remains in full force and effect as of the Closing Date.
(iii) IRB reliance agreements are in place, or will be executed prior to site activation, for all Veridian Network sites that will rely on the Veridian Central IRB as the IRB of record, in accordance with applicable federal regulations and the requirements of the MCTA.
(f) Network Sites. All thirty-eight (38) Veridian Network sites listed on Schedule 1 to the MCTA, located across fourteen (14) states, remain eligible, willing, and able to participate in the CLARION Trial in accordance with the Protocol. No Veridian Network site has withdrawn, indicated its intention to withdraw, or become ineligible to participate in the CLARION Trial since the date of the MCTA. Each such site has the necessary infrastructure, qualified personnel, and regulatory approvals (or is in the process of obtaining such approvals) to conduct the CLARION Trial in accordance with the Protocol, GCP, and all applicable regulatory requirements. To Veridian's knowledge, no event or condition has occurred that would reasonably be expected to render any such site ineligible or unable to participate in the CLARION Trial.
(g) No Debarment. Neither Veridian nor any of its officers, directors, employees, investigators, sub-investigators, or key site personnel involved in the conduct of the CLARION Trial (i) have been debarred, suspended, excluded, or otherwise made ineligible for participation in federal healthcare programs, including Medicare and Medicaid, under 42 U.S.C. § 1320a-7; (ii) have been debarred from providing services in any capacity to a person that has an approved or pending drug product application under 21 U.S.C. § 335a(a) or (b); (iii) are the subject of any pending or, to Veridian's knowledge, threatened debarment, suspension, or exclusion proceedings; or (iv) have been convicted of a criminal offense for which a person can be debarred under 21 U.S.C. § 335a. Veridian has conducted appropriate screening and verification checks, including review of the U.S. Department of Health and Human Services Office of Inspector General List of Excluded Individuals/Entities (LEIE), the General Services Administration System for Award Management (SAM) database, and the FDA Debarment List, with respect to all investigators, sub-investigators, and key site personnel identified for the CLARION Trial, and all such checks were completed with satisfactory results.
(h) No Litigation. There is no pending or, to Veridian's knowledge, threatened litigation, arbitration, administrative proceeding, governmental investigation, or other legal proceeding of any nature before any court, arbitrator, tribunal, or governmental authority that (i) would materially impair Veridian's ability to perform its obligations under the MCTA or any ancillary agreement, (ii) challenges or seeks to prevent, enjoin, or otherwise delay the transactions contemplated by the MCTA, or (iii) would reasonably be expected to result in a material adverse change in the business, operations, financial condition, assets, or regulatory status of Veridian or any of its participating network sites. No judgment, order, writ, injunction, decree, or award has been issued by or, to Veridian's knowledge, requested of any court, arbitrator, or governmental authority that would have any such effect.
(i) Financial Disclosures. To Veridian's knowledge, all investigators identified for the CLARION Trial have completed or will complete, prior to the commencement of study activities at their respective sites, financial disclosure certifications in accordance with 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators). Veridian has implemented procedures to collect, review, and maintain financial disclosure documentation from all investigators and sub-investigators, and to update such documentation annually and upon any material change in financial interests, as required by the Protocol and the MCTA. As of the Closing Date, completed financial disclosure forms (FDA Form 3455 or equivalent) have been received from the Global Principal Investigator (Dr. Catherine Aldridge, M.D., Ph.D.) and the Co-Principal Investigator (Dr. Howard Matsuoka, M.D.), and no disqualifying financial interests have been identified. Veridian will ensure that financial disclosure forms are collected from all remaining investigators and sub-investigators prior to the initiation of study activities at each respective site.
(j) Fair Market Value. All payments and compensation arrangements contemplated by the MCTA, including the payment components described below, reflect fair market value for the services to be rendered by Veridian, its network sites, and its investigators, and are consistent with applicable Anti-Kickback Statute safe harbors (including the personal services and management contracts safe harbor at 42 C.F.R. § 1001.952(d)) and applicable guidance from the Office of Inspector General of the U.S. Department of Health and Human Services:
(i) Per-patient site fees of Fifty-Two Thousand Dollars ($52,000) per subject enrolled and randomized in the CLARION Trial;
(ii) Start-up fees of Seventy-Five Thousand Dollars ($75,000) per site for each of the thirty-eight (38) Veridian Network sites;
(iii) Annual site maintenance fees of Forty Thousand Dollars ($40,000) per site per year for each of the thirty-eight (38) Veridian Network sites;
(iv) Investigator grants totaling One Million Five Hundred Thousand Dollars ($1,500,000) in the aggregate for qualified investigators participating in the CLARION Trial; and
(v) A network coordination fee of Four Million Two Hundred Thousand Dollars ($4,200,000) payable to Veridian for its coordination, oversight, and management services across all thirty-eight (38) Veridian Network sites over the duration of the CLARION Trial.
The foregoing fee structure was established based on an independent fair market value assessment conducted by Veridian's compliance department, in consultation with an independent third-party valuation firm, and is consistent with prevailing market rates for clinical trial services of comparable scope, complexity, and therapeutic area. Veridian represents that no portion of the compensation payable under the MCTA is intended to serve as an inducement for the referral of patients or the generation of business for Penterra or any of its affiliates.
SECTION 3: PERFORMANCE OF PRE-CLOSING OBLIGATIONS
I hereby certify, on behalf of Veridian, that Veridian has performed and complied with, in all material respects, all covenants, obligations, and conditions required to be performed or complied with by Veridian under the MCTA on or prior to the Closing Date (July 5, 2023). Without limiting the generality of the foregoing, Veridian has satisfied the following pre-closing obligations:
(a) Insurance Certificates. Veridian has delivered, or caused to be delivered, to Penterra and its counsel certificates of insurance evidencing general liability and professional liability (errors and omissions) insurance coverage for each participating site institution. Such coverage maintains limits of not less than Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggregate, as required by Section 14.02 of the MCTA and Exhibit E thereto. Certificates of insurance were delivered to Penterra within fifteen (15) business days of the execution of the MCTA (i.e., on or before July 3, 2023, calculated from the execution date of June 28, 2023), in compliance with the time requirements set forth in Section 14.02(b) of the MCTA. Each such certificate of insurance names Penterra Pharmaceuticals Corp. as an additional insured and contains a provision requiring not less than thirty (30) days' prior written notice to Penterra of any cancellation, material modification, or non-renewal of coverage.
(b) IRB Approvals for Lead Sites. IRB approval has been obtained for the two lead participating sites in the CLARION Trial, as follows:
(i) Graystone University Medical Center (Site 001), located at 1200 University Avenue, Philadelphia, PA 19104, Principal Investigator: Dr. Catherine Aldridge, M.D., Ph.D. — Approved by the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847) on June 30, 2023. The approval encompasses the CLARION Protocol (PPC-4871-III, Version 3.0, dated May 15, 2023), the informed consent form (Version 2.1, dated May 22, 2023), the investigator's brochure (Edition 7, dated April 10, 2023), and all related study materials submitted to the IRB.
(ii) Lakemont Medical Center (Site 002), located at 4400 North Michigan Drive, Chicago, IL 60611, Co-Principal Investigator: Dr. Howard Matsuoka, M.D. — Approved by the Veridian Central IRB (IRB Registration Number: IRB00017556) on July 2, 2023. The approval encompasses the CLARION Protocol (PPC-4871-III, Version 3.0, dated May 15, 2023), the informed consent form template (Version 2.1, dated May 22, 2023), and all related study materials submitted to the IRB.
Copies of the IRB approval letters for both lead sites have been provided to Penterra and its counsel.
(c) Investigator Signature Pages. Executed investigator signature pages have been obtained and delivered, confirming the commitment and authorization of the following investigators to serve in their respective capacities in the CLARION Trial:
(i) Dr. Catherine Aldridge, M.D., Ph.D., Global Principal Investigator — Investigator signature page executed on June 29, 2023. The corresponding Principal Investigator Agreement, setting forth the roles, responsibilities, and obligations of Dr. Aldridge as Global Principal Investigator, has been fully executed and delivered to Penterra.
(ii) Dr. Howard Matsuoka, M.D., Co-Principal Investigator — Investigator signature page executed on June 30, 2023. The corresponding Co-Principal Investigator Agreement, setting forth the roles, responsibilities, and obligations of Dr. Matsuoka as Co-Principal Investigator, has been fully executed and delivered to Penterra.
(d) Individual Site Agreements (Lead Sites). The Individual Site Agreements (Joinders) for the two lead participating sites have been executed and delivered, as follows:
(i) The Individual Site Agreement (Joinder) for Graystone University Medical Center (Site 001) has been executed by Dr. William Corwin, M.D., President of Graystone University Medical Center, and countersigned by Dr. Franklin Osei on behalf of Veridian, and has been delivered to Penterra. The agreement incorporates by reference the terms and conditions of the MCTA and establishes the site-specific obligations and operational parameters for Site 001.
(ii) The Individual Site Agreement (Joinder) for Lakemont Medical Center (Site 002) has been executed by the authorized signatory of Lakemont Medical Center and countersigned by Dr. Franklin Osei on behalf of Veridian, and has been delivered to Penterra. The agreement incorporates by reference the terms and conditions of the MCTA and establishes the site-specific obligations and operational parameters for Site 002.
(e) Secretary's Certificate. Veridian's Secretary's Certificate has been duly executed by Rachel M. Thornton, Corporate Secretary of Veridian Health Research Network, Inc., and is being delivered concurrently herewith on the Closing Date. The Secretary's Certificate certifies (i) true and correct copies of the resolutions duly adopted by the Board of Directors of Veridian on June 22, 2023, authorizing the execution, delivery, and performance of the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby; (ii) the incumbency and specimen signatures of the authorized signatories of Veridian, namely Dr. Franklin Osei, M.D., Ph.D., President and Chief Executive Officer, and Gregory Callahan, Esq., Vice President, Legal & Compliance; and (iii) that Veridian's Certificate of Incorporation and Bylaws have not been amended, modified, or supplemented since the date last provided to Penterra.
(f) Investigator Undertakings. Executed Forms of Investigator Undertaking (in the form attached as Exhibit I to the MCTA) have been delivered for the following investigators:
(i) Dr. Catherine Aldridge, M.D., Ph.D. — Investigator Undertaking executed on June 29, 2023, confirming Dr. Aldridge's personal commitment to: conduct the CLARION Trial in accordance with the Protocol (PPC-4871-III, Version 3.0); comply with ICH E6(R2) Good Clinical Practice guidelines; comply with all applicable federal, state, and local laws and regulations, including 21 C.F.R. Parts 50, 54, 56, and 312; make and maintain all required financial disclosures; maintain the confidentiality of Penterra's proprietary information and study data; and ensure proper delegation of study tasks to qualified personnel.
(ii) Dr. Howard Matsuoka, M.D. — Investigator Undertaking executed on June 30, 2023, confirming Dr. Matsuoka's personal commitment to the same obligations as set forth above.
(g) Regulatory Compliance Representations. Veridian has duly executed and delivered the Regulatory Compliance Representations and Covenants set forth in Exhibit H to the MCTA. The executed Exhibit H confirms Veridian's compliance with and ongoing commitment to comply with 21 C.F.R. Parts 11, 50, 54, 56, and 312; ICH E6(R2) Good Clinical Practice guidelines; HIPAA and its implementing regulations at 45 C.F.R. Parts 160 and 164; the Anti-Kickback Statute (42 U.S.C. § 1320a-7b); and the Physician Payments Sunshine Act / Open Payments requirements (42 U.S.C. § 1320a-7h). Veridian represents that it has established and maintains a comprehensive compliance program designed to ensure ongoing adherence to these regulatory requirements across all thirty-eight (38) Veridian Network sites participating in the CLARION Trial.
(h) IP Side Letter. The intellectual Property Side Letter, dated as of June 28, 2023, governing the ownership, licensing, and assignment of intellectual property and inventions arising from or related to the conduct of the CLARION Trial, has been duly executed and delivered by Veridian. The IP Side Letter was executed by Dr. Franklin Osei on behalf of Veridian and delivered to Penterra and its counsel contemporaneously with the execution of the MCTA.
(i) Approved Subcontractors. Veridian hereby acknowledges and consents to the engagement of the approved subcontractors listed on Exhibit K to the MCTA, which subcontractors will provide services in connection with the conduct of the CLARION Trial. The approved subcontractors are as follows:
(i) Meridian Contract Research Organization, Inc. (CRO services, including clinical monitoring, data management, and pharmacovigilance), headquartered at 9200 Corporate Boulevard, Raleigh, NC 27615;
(ii) Pinnacle Data Solutions, Inc. (electronic data capture (EDC) platform and related technology services), headquartered at 6000 Clearwater Drive, San Diego, CA 92121; and
(iii) Northbridge Bioanalytical Laboratories, Inc. (central laboratory services, including specimen analysis, biomarker assessment, and sample storage), headquartered at 2900 Commerce Way, Baltimore, MD 21224.
Veridian confirms that it has reviewed and is satisfied with the qualifications, capabilities, and regulatory compliance standing of each approved subcontractor and agrees to cooperate with each such subcontractor in connection with the conduct of the CLARION Trial, in accordance with the terms of the MCTA.
SECTION 4: NO MATERIAL ADVERSE CHANGE
I hereby certify, on behalf of Veridian, that since the date of the MCTA (June 28, 2023), there has been no material adverse change in the business, operations, assets, liabilities, financial condition, results of operations, prospects, or regulatory status of Veridian or any of its network participating sites that would materially impair, or would reasonably be expected to materially impair, Veridian's ability to perform its obligations under the MCTA or any ancillary agreement contemplated thereby.
Without limiting the foregoing, since the date of the MCTA, there has been no material adverse change in the research capabilities, accreditation status, institutional standing, regulatory standing, or operational readiness of any of the thirty-eight (38) Veridian Network sites listed on Schedule 1 to the MCTA. No Veridian Network site has suffered any loss of accreditation, suspension of clinical research activities, issuance of a Form FDA 483, warning letter, untitled letter, or other regulatory action by the U.S. Food and Drug Administration or any other governmental authority, or any other event or development that would materially impair such site's ability to participate in the CLARION Trial.
Additionally, Veridian confirms that since the date of the MCTA, (i) there has been no change in the senior management or key personnel of Veridian that would materially affect Veridian's ability to perform under the MCTA; (ii) Veridian has not entered into any agreement, transaction, or arrangement that would conflict with or impair its obligations under the MCTA; and (iii) Veridian has not experienced any event of default, or any event that with the giving of notice or lapse of time would constitute an event of default, under any material agreement, contract, or instrument to which Veridian is a party.
SECTION 5: RECEIPT AND ACKNOWLEDGMENT OF SPONSOR DELIVERABLES
I hereby certify, on behalf of Veridian, that Veridian acknowledges receipt of the following deliverables from Penterra Pharmaceuticals Corp. as of the Closing Date:
(a) Certificate of Insurance. Certificate of Insurance issued by Briarcliff Mutual Insurance Company (Policy Number: BM-CTL-2023-04182, policy period April 1, 2023 through March 31, 2024), evidencing clinical trial liability insurance maintained by Penterra with the following limits of liability:
(i) General clinical trial liability: Twenty-Five Million Dollars ($25,000,000) per occurrence and Seventy-Five Million Dollars ($75,000,000) in the aggregate;
(ii) Subject-injury sublimit: Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate.
The Certificate of Insurance confirms that Veridian Health Research Network, Inc. and each participating Veridian Network site are named as additional insureds under the policy for claims arising out of or related to the conduct of the CLARION Trial. Veridian has reviewed the Certificate of Insurance and confirms that the coverage described therein satisfies the insurance requirements set forth in Section 14.01 of the MCTA.
(b) Closing Certificate of Penterra. The Closing Certificate of Penterra Pharmaceuticals Corp., duly executed by Nathaniel Briggs, Esq., Vice President and General Counsel of Penterra, dated as of the Closing Date (July 5, 2023), certifying the accuracy of Penterra's representations and warranties, the performance of Penterra's pre-closing obligations, and the absence of any material adverse change with respect to Penterra.
(c) Secretary's Certificate of Penterra. The Secretary's Certificate of Penterra Pharmaceuticals Corp., certifying (i) the resolutions duly adopted by the Board of Directors of Penterra authorizing the execution, delivery, and performance of the MCTA and all ancillary agreements, instruments, and certificates contemplated thereby; and (ii) the incumbency and specimen signatures of the authorized signatories of Penterra.
(d) Officer's Certificate of Penterra. The Officer's Certificate of Penterra Pharmaceuticals Corp., confirming the bringdown of Penterra's representations and warranties as of the Closing Date and certifying that no event of default or material breach has occurred or is continuing under the MCTA.
Veridian has reviewed each of the foregoing deliverables and confirms that such deliverables are satisfactory in form and substance and comply with the requirements of the MCTA.
SECTION 6: GOVERNING LAW
This Closing Certificate shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflict of laws principles thereof that would result in the application of the laws of any other jurisdiction, consistent with the governing law provisions set forth in Section 19.08 of the MCTA.
Any dispute, controversy, or claim arising out of, relating to, or in connection with this Closing Certificate, or the breach, termination, or validity thereof, shall be subject to the dispute resolution provisions set forth in Section 19.09 of the MCTA, which provide for (i) initial escalation through good-faith negotiation between the designated senior representatives of the parties for a period of thirty (30) days following written notice of the dispute; (ii) if the dispute is not resolved through negotiation, non-binding mediation conducted under the Commercial Mediation Rules of the American Arbitration Association ("AAA") for a period of sixty (60) days; and (iii) if the dispute is not resolved through mediation, final and binding arbitration conducted in New York, New York under the Commercial Arbitration Rules of the AAA before a panel of three (3) arbitrators, with each party selecting one arbitrator and the two party-selected arbitrators selecting the third. The arbitration shall be conducted in the English language, and the award rendered by the arbitrators shall be final and binding upon the parties and may be entered and enforced in any court of competent jurisdiction.
SECTION 7: RELIANCE
This Closing Certificate is delivered with the understanding and acknowledgment that Penterra Pharmaceuticals Corp. and its counsel, Calderwood & Harkness LLP (280 Park Avenue, 34th Floor, New York, NY 10017), are entitled to rely fully on the certifications, representations, and statements contained herein in connection with the closing of the transactions contemplated by the MCTA and the satisfaction of the closing conditions set forth in Section 8.02 of the MCTA. The certifications, representations, and statements set forth herein are made for the benefit of Penterra and its counsel and shall survive the Closing Date in accordance with the survival provisions set forth in the MCTA.
This Certificate is also being delivered for the benefit of Penterra's clinical trial liability insurer, Briarcliff Mutual Insurance Company, to the extent required under Policy No. BM-CTL-2023-04182 or otherwise reasonably requested by Briarcliff Mutual Insurance Company in connection with the issuance or maintenance of clinical trial liability insurance coverage for the CLARION Trial. Briarcliff Mutual Insurance Company shall be entitled to rely on the certifications, representations, and statements contained herein to the same extent as Penterra.
Nothing in this Certificate shall be construed to create any rights in, or grant any remedy to, any person or entity other than Penterra Pharmaceuticals Corp., Calderwood & Harkness LLP, and Briarcliff Mutual Insurance Company, and their respective successors and permitted assigns.
IN WITNESS WHEREOF, the undersigned has executed this Closing Certificate as of July 5, 2023, on behalf of Veridian Health Research Network, Inc.
VERIDIAN HEALTH RESEARCH NETWORK, INC.
By: ________
Name: Dr. Franklin Osei, M.D., Ph.D.
Title: President and Chief Executive Officer
Date: July 5, 2023
Address:
750 Research Parkway, 8th Floor Philadelphia, PA 19104 Telephone: (215) 555-8200
Email: f.osei@veridianhealthresearch.org
NOTICES AND COPIES
A copy of this Closing Certificate has been delivered to each of the following:
1. Penterra Pharmaceuticals Corp.
Attn: Nathaniel Briggs, Esq.
Vice President & General Counsel 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540 Telephone: (609) 555-4100
Email: n.briggs@penterrapharma.com
2. Calderwood & Harkness LLP
Attn: Miriam Calloway, Partner
280 Park Avenue, 34th Floor New York, NY 10017 Telephone: (212) 555-7300
Email: m.calloway@calderwoodharkness.com
3. Veridian Health Research Network, Inc. (Internal Copy)
Attn: Gregory Callahan, Esq.
Vice President, Legal & Compliance 750 Research Parkway, 8th Floor Philadelphia, PA 19104 Telephone: (215) 555-8215
Email: g.callahan@veridianhealthresearch.org
4. Whitmore, Jansen & Callahan LLP
Attn: Allison Whitmore, Partner
1500 Market Street, Suite 3200 Philadelphia, PA 19102 Telephone: (215) 555-6600
Email: a.whitmore@wjclaw.com
This Closing Certificate and the certifications, representations, and statements contained herein are subject to the terms and conditions of the Master Clinical Trial Agreement dated June 28, 2023, between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. In the event of any conflict between the terms of this Certificate and the terms of the MCTA, the terms of the MCTA shall control.