1018-00004 · Penterra Pharmaceuticals Corp · Closing

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OFFICER'S CERTIFICATE OF PENTERRA PHARMACEUTICALS CORP.

Representations and Warranties Bringdown Certificate

Delivered Pursuant to Section 9.02(a)(iii) of the Master Clinical Trial Agreement dated June 28, 2023

Date of Certificate: July 5, 2023

RECITALS

I, Nathaniel Briggs, Esq., hereby certify that I am the duly appointed Vice President & General Counsel of Penterra Pharmaceuticals Corp., a corporation duly organized and existing under the laws of the State of Delaware (hereinafter referred to as "Penterra" or the "Company"), with its principal executive offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540, and its registered agent for service of process in the State of Delaware being Capitol Registered Agents, LLC, located at 1209 Orange Street, Wilmington, Delaware 19801. The Company's common stock is listed on The Nasdaq Global Select Market under the ticker symbol "PTRA."

This Officer's Certificate (this "Certificate") is delivered in connection with, and pursuant to the requirements of, that certain Master Clinical Trial Agreement (the "MCTA"), dated as of June 28, 2023, by and between Penterra Pharmaceuticals Corp., in its capacity as the sponsor of the clinical trial described herein (the "Sponsor"), and Veridian Health Research Network, Inc. ("Veridian" or "VHRN"), a non-profit corporation organized under the laws of the State of Delaware and recognized as an organization described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104.

The MCTA governs the conduct of Protocol PPC-4871-III, a randomized, double-blind, placebo-controlled Phase III clinical trial designated by the Sponsor under the name "CLARION" — Clinical Assessment of Response with Longitudinal Investigation in ONcology — evaluating penterafenib (PPC-4871), the Company's proprietary oral multi-kinase inhibitor, for the treatment of advanced hepatocellular carcinoma ("HCC") in patients who have progressed on or are intolerant to first-line systemic therapy. The CLARION trial is being conducted under Investigational New Drug Application Number IND 157823, filed with the United States Food and Drug Administration (the "FDA"), and has been registered on ClinicalTrials.gov under the identifier NCT05928174.

This Certificate is being delivered in connection with the satisfaction of the conditions precedent to the closing of the transactions contemplated by the MCTA on July 5, 2023 (the "Closing Date"), as required by Section 9.02(a)(iii) of the MCTA. The delivery of this Certificate constitutes one of the conditions to the obligations of Veridian to proceed with the closing under the MCTA, and accordingly this Certificate is executed and delivered by the undersigned for the purpose of satisfying such condition.

Capitalized terms used but not otherwise defined in this Certificate shall have the meanings ascribed to such terms in the MCTA, including its exhibits, schedules, and appendices.

SECTION 1: AUTHORITY AND CAPACITY

I, Nathaniel Briggs, Esq., hereby certify as follows with respect to my authority and capacity to execute and deliver this Certificate:

1.1. I am the duly appointed Vice President & General Counsel of Penterra Pharmaceuticals Corp. I have held this position since March 15, 2019, and I continue to serve in this capacity as of the date hereof. I am an authorized officer of the Company, and my appointment has been duly ratified and confirmed by the Board of Directors of Penterra (the "Board").

1.2. I am duly authorized to execute and deliver this Certificate on behalf of the Company. The authority to execute and deliver this Certificate was conferred upon me by the Board, as reflected in the resolutions adopted by the Board at a duly convened meeting held on June 22, 2023, and memorialized in the minutes of such meeting, which resolutions authorized the execution and delivery of the MCTA, all ancillary agreements and documents contemplated thereby, including this Certificate, and the performance of all obligations of the Company arising thereunder. The foregoing board resolutions have been separately certified in the Secretary's Certificate of Penterra Pharmaceuticals Corp. executed by Margaret T. Feldman, Corporate Secretary, and delivered concurrently herewith to Veridian and its counsel.

1.3. I am familiar with the terms and provisions of the MCTA, including the body thereof and each of the exhibits and schedules attached thereto, the IP Side Letter dated June 28, 2023 (the "IP Side Letter"), the Individual Site Agreements, the Investigator Agreements, and all other ancillary agreements and documents executed or to be executed in connection with the transactions contemplated by the MCTA. I have reviewed the relevant corporate records, certificates, documents, and other materials of the Company as I have deemed necessary or advisable for the purpose of making the certifications set forth herein. I have also consulted with members of the Company's regulatory affairs, clinical operations, finance, and legal departments as appropriate in connection with the preparation of this Certificate.

1.4. The total deal value under the MCTA is Eighty Million Dollars ($80,000,000), encompassing site fees, per-patient payments, investigator grants, and operational costs to be incurred across thirty-eight (38) Veridian Network sites located in fourteen (14) states over the projected sixty (60)-month study duration, which consists of an anticipated forty-two (42)-month enrollment period followed by an eighteen (18)-month minimum follow-up period. The foregoing financial commitment is consistent with the budgets and payment schedules set forth in Exhibit B to the MCTA and has been approved by the Board as part of the Company's overall clinical development plan for penterafenib.

SECTION 2: REPRESENTATIONS AND WARRANTIES BRINGDOWN

I, Nathaniel Briggs, Esq., hereby certify that each of the representations and warranties made by Penterra Pharmaceuticals Corp. in the MCTA, including without limitation those set forth in Article IV of the body of the MCTA and in the applicable Exhibits thereto, is true and correct in all material respects as of the date hereof, July 5, 2023, with the same force and effect as though such representations and warranties had been made on and as of such date, except to the extent that any such representation or warranty by its terms expressly relates to an earlier date, in which case such representation or warranty was true and correct in all material respects as of such earlier date. No event or condition has occurred since the date of the MCTA that would render any such representation or warranty untrue or incorrect in any material respect.

Without limiting the generality of the foregoing certification, I specifically confirm the truth and correctness in all material respects of the following representations and warranties of Penterra as of the date hereof:

2.1 Organization and Good Standing

Penterra Pharmaceuticals Corp. is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. The Company was incorporated in the State of Delaware on September 12, 2005, and has been continuously in good standing since such date. The Company is duly qualified to transact business and is in good standing as a foreign corporation in each jurisdiction in which the character of the properties owned or leased by it or the nature of the business conducted by it requires such qualification, including without limitation the States of New Jersey, Pennsylvania, Illinois, California, Massachusetts, New York, Texas, Florida, North Carolina, Ohio, Maryland, Georgia, Arizona, and Colorado, which include the states in which the Veridian Network sites participating in the CLARION trial are located. The failure to be so qualified or in good standing in any such jurisdiction would not, individually or in the aggregate, have a material adverse effect on the Company's ability to perform its obligations under the MCTA.

2.2 Authority and Enforceability

Penterra has full corporate power and authority to execute, deliver, and perform its obligations under the MCTA and each of the ancillary agreements contemplated thereby, including without limitation the IP Side Letter dated June 28, 2023, each Individual Site Agreement to be entered into with the participating Veridian Network site institutions, and each Investigator Agreement to be entered into with the principal investigators, co-principal investigators, and sub-investigators at each participating site. The execution, delivery, and performance of the MCTA and the ancillary agreements have been duly authorized by all necessary corporate action on the part of Penterra, including the adoption of authorizing resolutions by the Board at its meeting on June 22, 2023, and no further corporate action is required in connection therewith. The MCTA constitutes the legal, valid, and binding obligation of Penterra, enforceable against Penterra in accordance with its terms, subject to applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium, and similar laws affecting creditors' rights generally and to general principles of equity (regardless of whether enforcement is sought in a proceeding at law or in equity).

2.3 No Conflicts

The execution, delivery, and performance by Penterra of the MCTA and the ancillary agreements contemplated thereby do not and will not: (a) conflict with, violate, or result in a breach of any provision of Penterra's Amended and Restated Certificate of Incorporation, as amended to date, or Penterra's Amended and Restated Bylaws, as amended to date; (b) conflict with, violate, result in a breach or default under (with or without notice or lapse of time), or give rise to a right of termination, cancellation, or acceleration of any obligation or a loss of a benefit under any material agreement, contract, lease, mortgage, license, indenture, instrument, or other obligation to which Penterra is a party or by which it or its properties or assets are bound; or (c) violate any law, statute, regulation, rule, judgment, order, writ, decree, or injunction applicable to Penterra or its properties or assets.

No consent, approval, authorization, order, or filing with, or notice to, any federal, state, local, or foreign governmental authority, regulatory body, or self-regulatory organization is required in connection with the execution, delivery, and performance of the MCTA by Penterra, other than: (i) filings previously made with the FDA in connection with IND 157823, including the initial IND submission filed in October 2021 and all subsequent amendments, annual reports, and safety reports filed in the ordinary course; (ii) filings with the U.S. Securities and Exchange Commission (the "SEC") in the ordinary course of the Company's periodic reporting obligations under the Securities Exchange Act of 1934, as amended; and (iii) such other consents, approvals, authorizations, or filings that have already been obtained or made prior to the date hereof. Each such required consent, approval, authorization, or filing has been duly obtained or made on a timely basis and remains in full force and effect as of the date hereof.

2.4 Regulatory Compliance

Penterra holds and maintains in full force and effect all regulatory authorizations, permits, licenses, and approvals necessary for the conduct of Protocol PPC-4871-III in the United States, including without limitation IND 157823, which was initially filed with the FDA's Center for Drug Evaluation and Research ("CDER"), Division of Oncology 1, in October 2021. The Company has supplemented and amended the IND as required by applicable FDA regulations, including the filing of a Phase III protocol amendment incorporating Protocol PPC-4871-III in May 2023.

As of the Closing Date, IND 157823 is in active status with the FDA. No clinical hold or partial clinical hold has been imposed on IND 157823 at any time since its initial filing. The FDA has not communicated to Penterra any objection to, concern with, or deficiency in the design, conduct, or safety profile of Protocol PPC-4871-III that remains unresolved as of the date hereof. The Company has timely filed all required IND safety reports, annual reports, and protocol amendments with the FDA.

Penterra is in material compliance with all applicable federal, state, and local laws, rules, regulations, and guidelines governing the conduct of clinical trials and the development of pharmaceutical products, including without limitation the following:

(a) The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., and the regulations promulgated thereunder, including 21 C.F.R. Part 312 (Investigational New Drug Application), 21 C.F.R. Part 50 (Protection of Human Subjects — Informed Consent), 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators), 21 C.F.R. Part 56 (Institutional Review Boards), and 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures);

(b) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, ICH E6(R2) ("ICH GCP Guidelines"), as adopted by the FDA;

(c) The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act ("HITECH Act"), and the regulations promulgated thereunder at 45 C.F.R. Parts 160 and 164 ("HIPAA"), to the extent applicable to the Company's receipt, use, and disclosure of protected health information in connection with the CLARION trial;

(d) The federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and the safe harbor regulations promulgated thereunder at 42 C.F.R. § 1001.952; and

(e) The Physician Payments Sunshine Act, codified at 42 U.S.C. § 1320a-7h, and the implementing regulations at 42 C.F.R. Parts 402 and 403 (the "Open Payments" program).

With respect to compliance with the Anti-Kickback Statute, Penterra represents and warrants that its payment structure under the MCTA, including per-patient fees of Fifty-Two Thousand Dollars ($52,000) per enrolled subject and investigator grants totaling One Million Five Hundred Thousand Dollars ($1,500,000) in the aggregate, reflects fair market value for the services to be rendered. The Company engaged Redfield Valuation Associates, Inc., an independent valuation firm, to conduct a fair market value assessment of the per-patient fees and investigator grants, and such assessment, dated May 30, 2023, confirmed that the payment amounts are consistent with fair market value and fall within applicable safe harbors under the Anti-Kickback Statute. Penterra will comply with the Physician Payments Sunshine Act (Open Payments) reporting requirements with respect to all payments and transfers of value to covered recipients, including investigators and teaching hospital institutions, under the MCTA, and will timely report such payments to the Centers for Medicare & Medicaid Services in accordance with applicable deadlines.

2.5 Insurance. Penterra maintains clinical trial liability insurance coverage through Briarcliff Mutual Insurance Company ("Briarcliff Mutual"), under Policy Number BM-CTL-2023-04182, with a policy period commencing on April 1, 2023, and expiring on March 31, 2024, subject to annual renewal thereafter. The coverage provided under such policy includes the following limits:

(a) General Clinical Trial Liability: Twenty-Five Million Dollars ($25,000,000) per occurrence and Seventy-Five Million Dollars ($75,000,000) in the annual aggregate;

(b) Subject-Injury Sublimit: Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the annual aggregate; and

(c) Products Liability / Completed Operations: included within the general clinical trial liability limits set forth in clause (a) above.

Veridian Health Research Network, Inc. and each participating Veridian Network site institution have been named as additional insureds under Policy Number BM-CTL-2023-04182, as required by Section 12.01 of the MCTA. The additional insured endorsement extends to claims arising out of or relating to the conduct of Protocol PPC-4871-III at the participating sites. A certificate of insurance evidencing the foregoing coverage and the additional insured status of Veridian and the participating sites has been duly delivered to Veridian and to Veridian's outside legal counsel, Whitmore, Jansen & Callahan LLP, 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102, prior to the Closing Date.

The insurance coverage described above is in full force and effect as of the date hereof. Penterra has paid all premiums due under the policy through the current policy period. No notice of cancellation, non-renewal, or material change in coverage has been received by Penterra from Briarcliff Mutual. Penterra covenants and agrees to maintain insurance coverage meeting or exceeding the foregoing limits throughout the duration of the CLARION trial and for a period of not less than three (3) years following the completion of the trial or the last patient's last visit, whichever is later, as required by Section 12.03 of the MCTA.

2.6 Investigational Product

Penterafenib (PPC-4871), the investigational product to be studied in the CLARION trial, is manufactured, labeled, stored, and supplied in accordance with all applicable current Good Manufacturing Practice ("cGMP") regulations set forth at 21 C.F.R. Parts 210 and 211. The investigational product is manufactured at Penterra's FDA-registered manufacturing facility located in Research Triangle Park, North Carolina, and at the Company's contract manufacturing partner, Lionsgate Biologics Manufacturing, Inc., located in Cork, Ireland. Both facilities have been inspected by the FDA within the prior two (2) years and have received no Form FDA 483 observations of a critical or major nature that remain unresolved as of the date hereof.

Phase II clinical trials for PPC-4871 in patients with advanced hepatocellular carcinoma were completed in January 2023. The Phase II results, based on data from two hundred twelve (212) evaluable subjects, demonstrated an objective response rate ("ORR") of thirty-eight percent (38%) per RECIST v1.1 criteria, with a median duration of response of eight point four (8.4) months and a median progression-free survival of six point seven (6.7) months. The Phase II safety profile was consistent with the known class effects of multi-kinase inhibitors, and no unexpected serious adverse events were observed that would preclude advancement to Phase III clinical development.

No material safety signal, adverse finding, or other regulatory concern has arisen since the completion of the Phase II clinical program in January 2023 that would materially affect the conduct of the CLARION Phase III trial or the risk-benefit assessment of penterafenib in the intended patient population. The Company has not received any communication from the FDA or any other regulatory authority indicating that additional preclinical or clinical studies are required before initiating the Phase III trial under the current protocol.

2.7 intellectual Property

Penterra owns or has the right to use, under valid and enforceable licenses, all intellectual property rights necessary for the conduct of Protocol PPC-4871-III, including without limitation all patents, patent applications, trade secrets, know-how, and proprietary information relating to the composition of matter, methods of manufacture, methods of use, and formulation of penterafenib (PPC-4871). The Company's patent portfolio relating to PPC-4871 includes United States Patent Nos. 9,114,XXX (composition of matter), 10,227,XXX (method of treatment), and 10,894,XXX (pharmaceutical formulation), each of which is in good standing and not subject to any pending reexamination, inter partes review, or post-grant review proceeding as of the date hereof.

The IP Side Letter, executed concurrently with the MCTA on June 28, 2023, by and between Penterra and Veridian, accurately reflects the parties' agreement regarding ownership and licensing of inventions, discoveries, data, and other intellectual property arising during the conduct of the CLARION trial. As set forth in the IP Side Letter and consistent with Section 14.02 of the MCTA, Penterra retains exclusive ownership of all clinical trial data generated under the Protocol, including without limitation all case report form data, electronic data capture records, biomarker data, pharmacokinetic and pharmacodynamic data, imaging data, and safety data. Veridian retains ownership of any pre-existing intellectual property of Veridian or its network sites that is used in connection with the trial, subject to a non-exclusive, royalty-free license granted to Penterra for the purpose of utilizing such pre-existing intellectual property in connection with the analysis and reporting of the trial results and any regulatory filings relating to PPC-4871.

2.8 Financial Capacity

Penterra has sufficient financial resources to perform all of its obligations under the MCTA, including without limitation the payment of the total deal value of Eighty Million Dollars ($80,000,000) over the projected life of the CLARION trial. The Company's current financial position is adequate to fund the trial without material risk of default or inability to perform. In support of this representation, I note the following financial metrics as reported in the Company's public filings with the SEC:

(a) As of March 31, 2023 (Q1 2023), Penterra maintained cash, cash equivalents, and short-term investments of approximately Eight Hundred Ninety Million Dollars ($890,000,000);

(b) For the fiscal year ended December 31, 2022 ("FY2022"), the Company reported total revenues of approximately One Billion Eight Hundred Seventy Million Dollars ($1,870,000,000), driven primarily by sales of the Company's marketed oncology portfolio;

(c) For FY2022, the Company's research and development expenditures totaled approximately Six Hundred Twelve Million Dollars ($612,000,000), reflecting the Company's continued investment in its clinical pipeline, including the penterafenib development program; and

(d) As of the date of this Certificate, the Company's approximate market capitalization, based on the closing price of PTRA on The Nasdaq Global Select Market, is approximately Four Billion Two Hundred Million Dollars ($4,200,000,000).

The Company has not experienced any material adverse change in its financial condition since the date of its most recent periodic report filed with the SEC, and no event or development has occurred that would reasonably be expected to impair the Company's ability to fund its obligations under the MCTA in full and on a timely basis.

2.9 Litigation and Claims

There is no action, suit, proceeding, arbitration, investigation, inquiry, or claim pending before any court, tribunal, governmental agency, or regulatory body, or, to the knowledge of the undersigned after due inquiry, threatened against or affecting Penterra or any of its subsidiaries, that: (a) would reasonably be expected to materially affect Penterra's ability to perform its obligations under the MCTA; (b) relates to the investigational product, penterafenib (PPC-4871), or any component thereof; (c) relates to Protocol PPC-4871-III or the design, conduct, or anticipated results of the CLARION trial; or (d) relates to the transactions contemplated by the MCTA, including the relationships between Penterra and Veridian, the participating site institutions, or the investigators.

The Company has not received any written notice of, and has no knowledge of any basis for, any claim, demand, or communication from any governmental authority (including the FDA, the Department of Justice, the Office of Inspector General of the Department of Health and Human Services, or any state attorney general) that would, if pursued, materially affect the conduct of the CLARION trial or the Company's ability to perform its obligations under the MCTA.

2.10 Indemnification Obligations

Penterra acknowledges and confirms its indemnification obligations under the MCTA, including without limitation the provisions set forth in Article XI of the MCTA and Exhibit D thereto. Specifically, Penterra confirms the following:

(a) Penterra shall indemnify, defend, and hold harmless Veridian Health Research Network, Inc., each participating Veridian Network site institution, each principal investigator, each co-principal investigator, each sub-investigator, and each member of the site staff at participating sites (collectively, the "Indemnified Parties") from and against any and all losses, claims, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of investigation) arising out of or relating to: (i) any injury, illness, death, or adverse event suffered by a clinical trial subject that is caused by or attributable to penterafenib (PPC-4871) when administered in accordance with the Protocol; (ii) any defect in the investigational product, including defects in manufacture, formulation, labeling, storage, or supply; (iii) any breach by Penterra of its representations, warranties, covenants, or obligations under the MCTA or the Protocol; and (iv) any negligence, gross negligence, or willful misconduct on the part of Penterra, its officers, directors, employees, agents, or subcontractors.

(b) The indemnification obligation with respect to subject-injury medical care shall be subject to a per-subject cap of Five Hundred Thousand Dollars ($500,000) and an aggregate cap of Fifteen Million Dollars ($15,000,000) for all subjects enrolled across all participating sites, as set forth in Exhibit D, Section 3.02 of the MCTA.

(c) The indemnification obligation with respect to product-defect claims, as described in clause (a)(ii) above, shall be uncapped, meaning that there shall be no maximum limit on Penterra's liability for losses arising from defects in the investigational product.

(d) The Indemnified Parties shall provide written notice to Penterra of any indemnification claim within thirty (30) calendar days of the date on which the Indemnified Party first becomes aware of the facts giving rise to such claim, in accordance with the notice provisions set forth in Section 11.04 of the MCTA. Failure to provide timely notice shall not relieve Penterra of its indemnification obligations except to the extent that Penterra is materially prejudiced by such failure.

The foregoing indemnification obligations remain in full force and effect as of the date hereof and shall continue in accordance with the terms of the MCTA, including the survival provisions set forth in Section 11.06 of the MCTA.

SECTION 3: COVENANTS COMPLIANCE

I, Nathaniel Briggs, Esq., hereby certify that Penterra Pharmaceuticals Corp. has performed and complied in all material respects with all covenants, agreements, and obligations required to be performed or complied with by Penterra under the MCTA on or prior to the Closing Date, July 5, 2023. No default or breach of any covenant or obligation on the part of Penterra has occurred, and no event has occurred that, with the giving of notice or the lapse of time or both, would constitute such a default or breach.

Without limiting the generality of the foregoing certification, I specifically confirm that the following covenants and obligations have been duly performed or complied with:

(a) Delivery of Certificates of Insurance. Penterra has caused Briarcliff Mutual Insurance Company to issue and deliver to Veridian Health Research Network, Inc. and to Veridian's counsel, Whitmore, Jansen & Callahan LLP, certificates of insurance evidencing the clinical trial liability coverage described in Section 2.5 of this Certificate, including confirmation that Veridian and all participating Veridian Network site institutions have been named as additional insureds under Policy Number BM-CTL-2023-04182. Such certificates of insurance were delivered on or before July 1, 2023.

(b) Execution and Delivery of the IP Side Letter. Penterra duly executed and delivered the IP Side Letter on June 28, 2023, concurrently with the execution of the MCTA. The IP Side Letter has been fully executed by both Penterra and Veridian and is in full force and effect as of the date hereof.

(c) Provision of Protocol Synopsis and Budget. Penterra has delivered to Veridian the approved Protocol synopsis for Protocol PPC-4871-III (Exhibit A to the MCTA), the budget and payment schedule (Exhibit B to the MCTA), and all other required Exhibits and Schedules to the MCTA, including without limitation the Informed Consent Template (Exhibit C), the Indemnification Provisions (Exhibit D), the Data Privacy and Security Addendum (Exhibit E), the Monitoring Plan (Exhibit F), the Drug Supply Agreement Summary (Exhibit G), the Safety Reporting Plan (Exhibit H), the Publication Policy (Exhibit I), the Insurance Requirements (Exhibit J), the Approved Subcontractors List (Exhibit K), and the Form of Individual Site Agreement (Exhibit L). Each such Exhibit and Schedule has been reviewed and accepted by Veridian and its counsel.

(d) Provision of Approved Subcontractors List. Penterra has provided the list of approved subcontractors as set forth in Exhibit K to the MCTA, which includes the following entities:

(i) Meridian Contract Research Organization, Inc. ("Meridian CRO"), headquartered at 500 Capital Center Drive, Raleigh, North Carolina 27603, which will serve as the contract research organization responsible for clinical monitoring, data management, and operational support for the CLARION trial;

(ii) Pinnacle Data Solutions, Inc. ("Pinnacle"), headquartered at 2200 Innovation Way, Suite 600, San Diego, California 92121, which will provide the electronic data capture ("EDC") platform and related data management technology services for the trial; and

(iii) Northbridge Bioanalytical Laboratories, Inc. ("Northbridge"), headquartered at 8800 Eastern Boulevard, Baltimore, Maryland 21224, which will serve as the central laboratory for the processing and analysis of all laboratory specimens collected during the trial.

Each of the foregoing subcontractors has entered into a written agreement with Penterra that obligates such subcontractor to comply with the applicable provisions of the MCTA, including data privacy, confidentiality, and regulatory compliance obligations. Veridian has been provided with copies of the relevant provisions of each subcontractor agreement and has confirmed its acceptance of the approved subcontractors.

SECTION 4: NO MATERIAL ADVERSE CHANGE

I, Nathaniel Briggs, Esq., hereby certify that since the date of execution of the MCTA, June 28, 2023, through and including the Closing Date, July 5, 2023, there has been no material adverse change in the business, assets, condition (financial or otherwise), operations, results of operations, or prospects of Penterra Pharmaceuticals Corp. that would materially impair or reasonably be expected to materially impair Penterra's ability to perform its obligations under the MCTA.

Without limiting the generality of the foregoing, I confirm that during the period from June 28, 2023, through the date hereof: (a) Penterra has conducted its business in the ordinary course consistent with past practice; (b) there has been no material loss, damage, or destruction of any material property or asset of Penterra; (c) there has been no material change in the regulatory status of IND 157823 or any of the Company's marketed products; (d) there has been no material litigation, investigation, or governmental proceeding commenced or, to the knowledge of the undersigned, threatened against Penterra; and (e) no event has occurred that would constitute an event of default under the MCTA or that, with the giving of notice or the lapse of time or both, would constitute such an event of default.

SECTION 5: CONDITIONS PRECEDENT

I, Nathaniel Briggs, Esq., hereby certify that all conditions precedent to the obligations of Penterra Pharmaceuticals Corp. at the closing of the MCTA, as set forth in Article IX of the MCTA, have been satisfied or, where applicable, waived as of the Closing Date, July 5, 2023. Specifically, the following conditions precedent have been satisfied:

(a) Delivery of Insurance Certificates. Certificates of insurance evidencing clinical trial liability coverage under Briarcliff Mutual Insurance Company Policy Number BM-CTL-2023-04182 have been duly delivered to Veridian and its counsel, as described in Section 3(a) of this Certificate.

(b) Receipt of IRB Approvals for Lead Sites. Institutional Review Board ("IRB") approvals for the initiation of Protocol PPC-4871-III have been obtained for the lead participating sites, including:

(i) Graystone University Medical Center (Site 001), located at 1200 University Avenue, Philadelphia, Pennsylvania 19104, which received IRB approval from the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847, registered with the Office for Human Research Protections), with an approval date of June 15, 2023, and an approval expiration date of June 14, 2024; and

(ii) Lakemont Medical Center (Site 002), located at 4400 North Michigan Drive, Chicago, Illinois 60611, and additional Veridian Network sites, which have received IRB approval from the Veridian Central IRB, with an approval date of June 20, 2023.

(c) Execution and Delivery of Investigator Signature Pages. The following investigator agreements have been duly executed and delivered:

(i) The Principal Investigator Agreement with Dr. Catherine Aldridge, M.D., Ph.D., who will serve as the Global Principal Investigator for the CLARION trial at Graystone University Medical Center (Site 001), was executed on June 25, 2023;

(ii) The Co-Principal Investigator Agreement with Dr. Howard Matsuoka, M.D., who will serve as the Co-Principal Investigator at Lakemont Medical Center (Site 002), was executed on June 27, 2023; and

(iii) Additional Investigator Agreements for sub-investigators at the lead sites are in the process of being finalized and will be completed in accordance with the timelines set forth in the MCTA.

(d) Execution of Individual Site Agreement for Graystone University Medical Center. The Individual Site Agreement for Graystone University Medical Center (Site 001) has been duly executed by Dr. William Corwin, M.D., in his capacity as the authorized institutional representative of Graystone University Medical Center, and countersigned by Penterra and Veridian. The executed agreement was delivered on June 30, 2023.

(e) Delivery of Secretary's Certificate of Penterra. The Secretary's Certificate of Penterra Pharmaceuticals Corp., executed by Margaret T. Feldman, Corporate Secretary, certifying the Board resolutions authorizing the execution and delivery of the MCTA and the ancillary agreements, the incumbency and specimen signatures of the authorized officers, and attaching copies of the Company's organizational documents (including the Amended and Restated Certificate of Incorporation and the Amended and Restated Bylaws), has been delivered to Veridian and its counsel.

(f) Delivery of Closing Certificate of Penterra. This Officer's Certificate, constituting the Closing Certificate of Penterra required by Section 9.02(a)(iii) of the MCTA, is being delivered concurrently herewith.

SECTION 6: GOVERNING LAW REFERENCE

This Certificate is delivered pursuant to and in accordance with the requirements of the MCTA. This Certificate is an integral part of the closing deliverables contemplated by the MCTA and shall be construed in accordance with and subject to the terms and provisions of the MCTA. To the extent that any provision of this Certificate conflicts with or is inconsistent with any provision of the MCTA, the terms of the MCTA shall control and govern.

The MCTA is governed by and shall be 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. Any dispute arising out of or relating to this Certificate shall be resolved in accordance with the dispute resolution provisions set forth in Article XVI of the MCTA, which provides for exclusive jurisdiction in the state and federal courts located in the Borough of Manhattan, City of New York.

SECTION 7: RELIANCE

This Certificate is delivered for the benefit of, and may be relied upon by, Veridian Health Research Network, Inc. and its outside legal counsel, Whitmore, Jansen & Callahan LLP, located at 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102. Veridian and Whitmore, Jansen & Callahan LLP are each entitled to rely on the certifications, representations, and statements contained herein as though made directly to each of them in connection with the closing of the MCTA and the satisfaction of the conditions precedent set forth therein.

This Certificate may also be relied upon by each of the participating Veridian Network site institutions, including without limitation Graystone University Medical Center and Lakemont Medical Center, to the extent that the certifications contained herein are applicable to such institutions' participation in the CLARION trial and to the extent that such reliance is contemplated by the MCTA or the applicable Individual Site Agreements.

This Certificate shall not confer any rights or remedies upon any person or entity other than the parties described in the preceding paragraphs, except as otherwise expressly provided in the MCTA. The undersigned makes the certifications set forth herein in his capacity as Vice President & General Counsel of Penterra Pharmaceuticals Corp. and not in any individual or personal capacity, and the undersigned shall have no personal liability in connection with the certifications contained herein.

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SIGNATURE PAGE TO OFFICER'S CERTIFICATE OF PENTERRA PHARMACEUTICALS CORP.

IN WITNESS WHEREOF, the undersigned has executed this Officer's Certificate as of July 5, 2023.

PENTERRA PHARMACEUTICALS CORP.

By: ________

Name: Nathaniel Briggs, Esq.

Title: Vice President & General Counsel

Address:

200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540

Date: July 5, 2023

OFFICER'S CERTIFICATE OF PENTERRA PHARMACEUTICALS CORP.
Representations and Warranties Bringdown Certificate
Delivered Pursuant to Section 9.02(a)(iii) of the Master Clinical Trial Agreement dated June 28, 2023
Date of Certificate: July 5, 2023
RECITALS
I, Nathaniel Briggs, Esq., hereby certify that I am the duly appointed Vice President & General Counsel of Penterra Pharmaceuticals Corp., a corporation duly organized and existing under the laws of the State of Delaware (hereinafter referred to as "Penterra" or the "Company"), with its principal executive offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540, and its registered agent for service of process in the State of Delaware being Capitol Registered Agents, LLC, located at 1209 Orange Street, Wilmington, Delaware 19801. The Company's common stock is listed on The Nasdaq Global Select Market under the ticker symbol "PTRA."
This Officer's Certificate (this "Certificate") is delivered in connection with, and pursuant to the requirements of, that certain Master Clinical Trial Agreement (the "MCTA"), dated as of June 28, 2023, by and between Penterra Pharmaceuticals Corp., in its capacity as the sponsor of the clinical trial described herein (the "Sponsor"), and Veridian Health Research Network, Inc. ("Veridian" or "VHRN"), a non-profit corporation organized under the laws of the State of Delaware and recognized as an organization described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104.
The MCTA governs the conduct of Protocol PPC-4871-III, a randomized, double-blind, placebo-controlled Phase III clinical trial designated by the Sponsor under the name "CLARION" — Clinical Assessment of Response with Longitudinal Investigation in ONcology — evaluating penterafenib (PPC-4871), the Company's proprietary oral multi-kinase inhibitor, for the treatment of advanced hepatocellular carcinoma ("HCC") in patients who have progressed on or are intolerant to first-line systemic therapy. The CLARION trial is being conducted under Investigational New Drug Application Number IND 157823, filed with the United States Food and Drug Administration (the "FDA"), and has been registered on ClinicalTrials.gov under the identifier NCT05928174.
This Certificate is being delivered in connection with the satisfaction of the conditions precedent to the closing of the transactions contemplated by the MCTA on July 5, 2023 (the "Closing Date"), as required by Section 9.02(a)(iii) of the MCTA. The delivery of this Certificate constitutes one of the conditions to the obligations of Veridian to proceed with the closing under the MCTA, and accordingly this Certificate is executed and delivered by the undersigned for the purpose of satisfying such condition.
Capitalized terms used but not otherwise defined in this Certificate shall have the meanings ascribed to such terms in the MCTA, including its exhibits, schedules, and appendices.
SECTION 1: AUTHORITY AND CAPACITY
I, Nathaniel Briggs, Esq., hereby certify as follows with respect to my authority and capacity to execute and deliver this Certificate:
1.1. I am the duly appointed Vice President & General Counsel of Penterra Pharmaceuticals Corp. I have held this position since March 15, 2019, and I continue to serve in this capacity as of the date hereof. I am an authorized officer of the Company, and my appointment has been duly ratified and confirmed by the Board of Directors of Penterra (the "Board").
1.2. I am duly authorized to execute and deliver this Certificate on behalf of the Company. The authority to execute and deliver this Certificate was conferred upon me by the Board, as reflected in the resolutions adopted by the Board at a duly convened meeting held on June 22, 2023, and memorialized in the minutes of such meeting, which resolutions authorized the execution and delivery of the MCTA, all ancillary agreements and documents contemplated thereby, including this Certificate, and the performance of all obligations of the Company arising thereunder. The foregoing board resolutions have been separately certified in the Secretary's Certificate of Penterra Pharmaceuticals Corp. executed by Margaret T. Feldman, Corporate Secretary, and delivered concurrently herewith to Veridian and its counsel.
1.3. I am familiar with the terms and provisions of the MCTA, including the body thereof and each of the exhibits and schedules attached thereto, the IP Side Letter dated June 28, 2023 (the "IP Side Letter"), the Individual Site Agreements, the Investigator Agreements, and all other ancillary agreements and documents executed or to be executed in connection with the transactions contemplated by the MCTA. I have reviewed the relevant corporate records, certificates, documents, and other materials of the Company as I have deemed necessary or advisable for the purpose of making the certifications set forth herein. I have also consulted with members of the Company's regulatory affairs, clinical operations, finance, and legal departments as appropriate in connection with the preparation of this Certificate.
1.4. The total deal value under the MCTA is Eighty Million Dollars ($80,000,000), encompassing site fees, per-patient payments, investigator grants, and operational costs to be incurred across thirty-eight (38) Veridian Network sites located in fourteen (14) states over the projected sixty (60)-month study duration, which consists of an anticipated forty-two (42)-month enrollment period followed by an eighteen (18)-month minimum follow-up period. The foregoing financial commitment is consistent with the budgets and payment schedules set forth in Exhibit B to the MCTA and has been approved by the Board as part of the Company's overall clinical development plan for penterafenib.
SECTION 2: REPRESENTATIONS AND WARRANTIES BRINGDOWN
I, Nathaniel Briggs, Esq., hereby certify that each of the representations and warranties made by Penterra Pharmaceuticals Corp. in the MCTA, including without limitation those set forth in Article IV of the body of the MCTA and in the applicable Exhibits thereto, is true and correct in all material respects as of the date hereof, July 5, 2023, with the same force and effect as though such representations and warranties had been made on and as of such date, except to the extent that any such representation or warranty by its terms expressly relates to an earlier date, in which case such representation or warranty was true and correct in all material respects as of such earlier date. No event or condition has occurred since the date of the MCTA that would render any such representation or warranty untrue or incorrect in any material respect.
Without limiting the generality of the foregoing certification, I specifically confirm the truth and correctness in all material respects of the following representations and warranties of Penterra as of the date hereof:
2.1 Organization and Good Standing
Penterra Pharmaceuticals Corp. is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. The Company was incorporated in the State of Delaware on September 12, 2005, and has been continuously in good standing since such date. The Company is duly qualified to transact business and is in good standing as a foreign corporation in each jurisdiction in which the character of the properties owned or leased by it or the nature of the business conducted by it requires such qualification, including without limitation the States of New Jersey, Pennsylvania, Illinois, California, Massachusetts, New York, Texas, Florida, North Carolina, Ohio, Maryland, Georgia, Arizona, and Colorado, which include the states in which the Veridian Network sites participating in the CLARION trial are located. The failure to be so qualified or in good standing in any such jurisdiction would not, individually or in the aggregate, have a material adverse effect on the Company's ability to perform its obligations under the MCTA.
2.2 Authority and Enforceability
Penterra has full corporate power and authority to execute, deliver, and perform its obligations under the MCTA and each of the ancillary agreements contemplated thereby, including without limitation the IP Side Letter dated June 28, 2023, each Individual Site Agreement to be entered into with the participating Veridian Network site institutions, and each Investigator Agreement to be entered into with the principal investigators, co-principal investigators, and sub-investigators at each participating site. The execution, delivery, and performance of the MCTA and the ancillary agreements have been duly authorized by all necessary corporate action on the part of Penterra, including the adoption of authorizing resolutions by the Board at its meeting on June 22, 2023, and no further corporate action is required in connection therewith. The MCTA constitutes the legal, valid, and binding obligation of Penterra, enforceable against Penterra in accordance with its terms, subject to applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium, and similar laws affecting creditors' rights generally and to general principles of equity (regardless of whether enforcement is sought in a proceeding at law or in equity).
2.3 No Conflicts
The execution, delivery, and performance by Penterra of the MCTA and the ancillary agreements contemplated thereby do not and will not: (a) conflict with, violate, or result in a breach of any provision of Penterra's Amended and Restated Certificate of Incorporation, as amended to date, or Penterra's Amended and Restated Bylaws, as amended to date; (b) conflict with, violate, result in a breach or default under (with or without notice or lapse of time), or give rise to a right of termination, cancellation, or acceleration of any obligation or a loss of a benefit under any material agreement, contract, lease, mortgage, license, indenture, instrument, or other obligation to which Penterra is a party or by which it or its properties or assets are bound; or (c) violate any law, statute, regulation, rule, judgment, order, writ, decree, or injunction applicable to Penterra or its properties or assets.
No consent, approval, authorization, order, or filing with, or notice to, any federal, state, local, or foreign governmental authority, regulatory body, or self-regulatory organization is required in connection with the execution, delivery, and performance of the MCTA by Penterra, other than: (i) filings previously made with the FDA in connection with IND 157823, including the initial IND submission filed in October 2021 and all subsequent amendments, annual reports, and safety reports filed in the ordinary course; (ii) filings with the U.S. Securities and Exchange Commission (the "SEC") in the ordinary course of the Company's periodic reporting obligations under the Securities Exchange Act of 1934, as amended; and (iii) such other consents, approvals, authorizations, or filings that have already been obtained or made prior to the date hereof. Each such required consent, approval, authorization, or filing has been duly obtained or made on a timely basis and remains in full force and effect as of the date hereof.
2.4 Regulatory Compliance
Penterra holds and maintains in full force and effect all regulatory authorizations, permits, licenses, and approvals necessary for the conduct of Protocol PPC-4871-III in the United States, including without limitation IND 157823, which was initially filed with the FDA's Center for Drug Evaluation and Research ("CDER"), Division of Oncology 1, in October 2021. The Company has supplemented and amended the IND as required by applicable FDA regulations, including the filing of a Phase III protocol amendment incorporating Protocol PPC-4871-III in May 2023.
As of the Closing Date, IND 157823 is in active status with the FDA. No clinical hold or partial clinical hold has been imposed on IND 157823 at any time since its initial filing. The FDA has not communicated to Penterra any objection to, concern with, or deficiency in the design, conduct, or safety profile of Protocol PPC-4871-III that remains unresolved as of the date hereof. The Company has timely filed all required IND safety reports, annual reports, and protocol amendments with the FDA.
Penterra is in material compliance with all applicable federal, state, and local laws, rules, regulations, and guidelines governing the conduct of clinical trials and the development of pharmaceutical products, including without limitation the following:
(a) The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., and the regulations promulgated thereunder, including 21 C.F.R. Part 312 (Investigational New Drug Application), 21 C.F.R. Part 50 (Protection of Human Subjects — Informed Consent), 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators), 21 C.F.R. Part 56 (Institutional Review Boards), and 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures);
(b) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, ICH E6(R2) ("ICH GCP Guidelines"), as adopted by the FDA;
(c) The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act ("HITECH Act"), and the regulations promulgated thereunder at 45 C.F.R. Parts 160 and 164 ("HIPAA"), to the extent applicable to the Company's receipt, use, and disclosure of protected health information in connection with the CLARION trial;
(d) The federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and the safe harbor regulations promulgated thereunder at 42 C.F.R. § 1001.952; and
(e) The Physician Payments Sunshine Act, codified at 42 U.S.C. § 1320a-7h, and the implementing regulations at 42 C.F.R. Parts 402 and 403 (the "Open Payments" program).
With respect to compliance with the Anti-Kickback Statute, Penterra represents and warrants that its payment structure under the MCTA, including per-patient fees of Fifty-Two Thousand Dollars ($52,000) per enrolled subject and investigator grants totaling One Million Five Hundred Thousand Dollars ($1,500,000) in the aggregate, reflects fair market value for the services to be rendered. The Company engaged Redfield Valuation Associates, Inc., an independent valuation firm, to conduct a fair market value assessment of the per-patient fees and investigator grants, and such assessment, dated May 30, 2023, confirmed that the payment amounts are consistent with fair market value and fall within applicable safe harbors under the Anti-Kickback Statute. Penterra will comply with the Physician Payments Sunshine Act (Open Payments) reporting requirements with respect to all payments and transfers of value to covered recipients, including investigators and teaching hospital institutions, under the MCTA, and will timely report such payments to the Centers for Medicare & Medicaid Services in accordance with applicable deadlines.
2.5 Insurance.  Penterra maintains clinical trial liability insurance coverage through Briarcliff Mutual Insurance Company ("Briarcliff Mutual"), under Policy Number BM-CTL-2023-04182, with a policy period commencing on April 1, 2023, and expiring on March 31, 2024, subject to annual renewal thereafter. The coverage provided under such policy includes the following limits:
(a) General Clinical Trial Liability: Twenty-Five Million Dollars ($25,000,000) per occurrence and Seventy-Five Million Dollars ($75,000,000) in the annual aggregate;
(b) Subject-Injury Sublimit: Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the annual aggregate; and
(c) Products Liability / Completed Operations: included within the general clinical trial liability limits set forth in clause (a) above.
Veridian Health Research Network, Inc. and each participating Veridian Network site institution have been named as additional insureds under Policy Number BM-CTL-2023-04182, as required by Section 12.01 of the MCTA. The additional insured endorsement extends to claims arising out of or relating to the conduct of Protocol PPC-4871-III at the participating sites. A certificate of insurance evidencing the foregoing coverage and the additional insured status of Veridian and the participating sites has been duly delivered to Veridian and to Veridian's outside legal counsel, Whitmore, Jansen & Callahan LLP, 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102, prior to the Closing Date.
The insurance coverage described above is in full force and effect as of the date hereof. Penterra has paid all premiums due under the policy through the current policy period. No notice of cancellation, non-renewal, or material change in coverage has been received by Penterra from Briarcliff Mutual. Penterra covenants and agrees to maintain insurance coverage meeting or exceeding the foregoing limits throughout the duration of the CLARION trial and for a period of not less than three (3) years following the completion of the trial or the last patient's last visit, whichever is later, as required by Section 12.03 of the MCTA.
2.6 Investigational Product
Penterafenib (PPC-4871), the investigational product to be studied in the CLARION trial, is manufactured, labeled, stored, and supplied in accordance with all applicable current Good Manufacturing Practice ("cGMP") regulations set forth at 21 C.F.R. Parts 210 and 211. The investigational product is manufactured at Penterra's FDA-registered manufacturing facility located in Research Triangle Park, North Carolina, and at the Company's contract manufacturing partner, Lionsgate Biologics Manufacturing, Inc., located in Cork, Ireland. Both facilities have been inspected by the FDA within the prior two (2) years and have received no Form FDA 483 observations of a critical or major nature that remain unresolved as of the date hereof.
Phase II clinical trials for PPC-4871 in patients with advanced hepatocellular carcinoma were completed in January 2023. The Phase II results, based on data from two hundred twelve (212) evaluable subjects, demonstrated an objective response rate ("ORR") of thirty-eight percent (38%) per RECIST v1.1 criteria, with a median duration of response of eight point four (8.4) months and a median progression-free survival of six point seven (6.7) months. The Phase II safety profile was consistent with the known class effects of multi-kinase inhibitors, and no unexpected serious adverse events were observed that would preclude advancement to Phase III clinical development.
No material safety signal, adverse finding, or other regulatory concern has arisen since the completion of the Phase II clinical program in January 2023 that would materially affect the conduct of the CLARION Phase III trial or the risk-benefit assessment of penterafenib in the intended patient population. The Company has not received any communication from the FDA or any other regulatory authority indicating that additional preclinical or clinical studies are required before initiating the Phase III trial under the current protocol.
2.7 intellectual Property
Penterra owns or has the right to use, under valid and enforceable licenses, all intellectual property rights necessary for the conduct of Protocol PPC-4871-III, including without limitation all patents, patent applications, trade secrets, know-how, and proprietary information relating to the composition of matter, methods of manufacture, methods of use, and formulation of penterafenib (PPC-4871). The Company's patent portfolio relating to PPC-4871 includes United States Patent Nos. 9,114,XXX (composition of matter), 10,227,XXX (method of treatment), and 10,894,XXX (pharmaceutical formulation), each of which is in good standing and not subject to any pending reexamination, inter partes review, or post-grant review proceeding as of the date hereof.
The IP Side Letter, executed concurrently with the MCTA on June 28, 2023, by and between Penterra and Veridian, accurately reflects the parties' agreement regarding ownership and licensing of inventions, discoveries, data, and other intellectual property arising during the conduct of the CLARION trial. As set forth in the IP Side Letter and consistent with Section 14.02 of the MCTA, Penterra retains exclusive ownership of all clinical trial data generated under the Protocol, including without limitation all case report form data, electronic data capture records, biomarker data, pharmacokinetic and pharmacodynamic data, imaging data, and safety data. Veridian retains ownership of any pre-existing intellectual property of Veridian or its network sites that is used in connection with the trial, subject to a non-exclusive, royalty-free license granted to Penterra for the purpose of utilizing such pre-existing intellectual property in connection with the analysis and reporting of the trial results and any regulatory filings relating to PPC-4871.
2.8 Financial Capacity
Penterra has sufficient financial resources to perform all of its obligations under the MCTA, including without limitation the payment of the total deal value of Eighty Million Dollars ($80,000,000) over the projected life of the CLARION trial. The Company's current financial position is adequate to fund the trial without material risk of default or inability to perform. In support of this representation, I note the following financial metrics as reported in the Company's public filings with the SEC:
(a) As of March 31, 2023 (Q1 2023), Penterra maintained cash, cash equivalents, and short-term investments of approximately Eight Hundred Ninety Million Dollars ($890,000,000);
(b) For the fiscal year ended December 31, 2022 ("FY2022"), the Company reported total revenues of approximately One Billion Eight Hundred Seventy Million Dollars ($1,870,000,000), driven primarily by sales of the Company's marketed oncology portfolio;
(c) For FY2022, the Company's research and development expenditures totaled approximately Six Hundred Twelve Million Dollars ($612,000,000), reflecting the Company's continued investment in its clinical pipeline, including the penterafenib development program; and
(d) As of the date of this Certificate, the Company's approximate market capitalization, based on the closing price of PTRA on The Nasdaq Global Select Market, is approximately Four Billion Two Hundred Million Dollars ($4,200,000,000).
The Company has not experienced any material adverse change in its financial condition since the date of its most recent periodic report filed with the SEC, and no event or development has occurred that would reasonably be expected to impair the Company's ability to fund its obligations under the MCTA in full and on a timely basis.
2.9 Litigation and Claims
There is no action, suit, proceeding, arbitration, investigation, inquiry, or claim pending before any court, tribunal, governmental agency, or regulatory body, or, to the knowledge of the undersigned after due inquiry, threatened against or affecting Penterra or any of its subsidiaries, that: (a) would reasonably be expected to materially affect Penterra's ability to perform its obligations under the MCTA; (b) relates to the investigational product, penterafenib (PPC-4871), or any component thereof; (c) relates to Protocol PPC-4871-III or the design, conduct, or anticipated results of the CLARION trial; or (d) relates to the transactions contemplated by the MCTA, including the relationships between Penterra and Veridian, the participating site institutions, or the investigators.
The Company has not received any written notice of, and has no knowledge of any basis for, any claim, demand, or communication from any governmental authority (including the FDA, the Department of Justice, the Office of Inspector General of the Department of Health and Human Services, or any state attorney general) that would, if pursued, materially affect the conduct of the CLARION trial or the Company's ability to perform its obligations under the MCTA.
2.10 Indemnification Obligations
Penterra acknowledges and confirms its indemnification obligations under the MCTA, including without limitation the provisions set forth in Article XI of the MCTA and Exhibit D thereto. Specifically, Penterra confirms the following:
(a) Penterra shall indemnify, defend, and hold harmless Veridian Health Research Network, Inc., each participating Veridian Network site institution, each principal investigator, each co-principal investigator, each sub-investigator, and each member of the site staff at participating sites (collectively, the "Indemnified Parties") from and against any and all losses, claims, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of investigation) arising out of or relating to: (i) any injury, illness, death, or adverse event suffered by a clinical trial subject that is caused by or attributable to penterafenib (PPC-4871) when administered in accordance with the Protocol; (ii) any defect in the investigational product, including defects in manufacture, formulation, labeling, storage, or supply; (iii) any breach by Penterra of its representations, warranties, covenants, or obligations under the MCTA or the Protocol; and (iv) any negligence, gross negligence, or willful misconduct on the part of Penterra, its officers, directors, employees, agents, or subcontractors.
(b) The indemnification obligation with respect to subject-injury medical care shall be subject to a per-subject cap of Five Hundred Thousand Dollars ($500,000) and an aggregate cap of Fifteen Million Dollars ($15,000,000) for all subjects enrolled across all participating sites, as set forth in Exhibit D, Section 3.02 of the MCTA.
(c) The indemnification obligation with respect to product-defect claims, as described in clause (a)(ii) above, shall be uncapped, meaning that there shall be no maximum limit on Penterra's liability for losses arising from defects in the investigational product.
(d) The Indemnified Parties shall provide written notice to Penterra of any indemnification claim within thirty (30) calendar days of the date on which the Indemnified Party first becomes aware of the facts giving rise to such claim, in accordance with the notice provisions set forth in Section 11.04 of the MCTA. Failure to provide timely notice shall not relieve Penterra of its indemnification obligations except to the extent that Penterra is materially prejudiced by such failure.
The foregoing indemnification obligations remain in full force and effect as of the date hereof and shall continue in accordance with the terms of the MCTA, including the survival provisions set forth in Section 11.06 of the MCTA.
SECTION 3: COVENANTS COMPLIANCE
I, Nathaniel Briggs, Esq., hereby certify that Penterra Pharmaceuticals Corp. has performed and complied in all material respects with all covenants, agreements, and obligations required to be performed or complied with by Penterra under the MCTA on or prior to the Closing Date, July 5, 2023. No default or breach of any covenant or obligation on the part of Penterra has occurred, and no event has occurred that, with the giving of notice or the lapse of time or both, would constitute such a default or breach.
Without limiting the generality of the foregoing certification, I specifically confirm that the following covenants and obligations have been duly performed or complied with:
(a) Delivery of Certificates of Insurance. Penterra has caused Briarcliff Mutual Insurance Company to issue and deliver to Veridian Health Research Network, Inc. and to Veridian's counsel, Whitmore, Jansen & Callahan LLP, certificates of insurance evidencing the clinical trial liability coverage described in Section 2.5 of this Certificate, including confirmation that Veridian and all participating Veridian Network site institutions have been named as additional insureds under Policy Number BM-CTL-2023-04182. Such certificates of insurance were delivered on or before July 1, 2023.
(b) Execution and Delivery of the IP Side Letter. Penterra duly executed and delivered the IP Side Letter on June 28, 2023, concurrently with the execution of the MCTA. The IP Side Letter has been fully executed by both Penterra and Veridian and is in full force and effect as of the date hereof.
(c) Provision of Protocol Synopsis and Budget. Penterra has delivered to Veridian the approved Protocol synopsis for Protocol PPC-4871-III (Exhibit A to the MCTA), the budget and payment schedule (Exhibit B to the MCTA), and all other required Exhibits and Schedules to the MCTA, including without limitation the Informed Consent Template (Exhibit C), the Indemnification Provisions (Exhibit D), the Data Privacy and Security Addendum (Exhibit E), the Monitoring Plan (Exhibit F), the Drug Supply Agreement Summary (Exhibit G), the Safety Reporting Plan (Exhibit H), the Publication Policy (Exhibit I), the Insurance Requirements (Exhibit J), the Approved Subcontractors List (Exhibit K), and the Form of Individual Site Agreement (Exhibit L). Each such Exhibit and Schedule has been reviewed and accepted by Veridian and its counsel.
(d) Provision of Approved Subcontractors List. Penterra has provided the list of approved subcontractors as set forth in Exhibit K to the MCTA, which includes the following entities:
(i) Meridian Contract Research Organization, Inc. ("Meridian CRO"), headquartered at 500 Capital Center Drive, Raleigh, North Carolina 27603, which will serve as the contract research organization responsible for clinical monitoring, data management, and operational support for the CLARION trial;
(ii) Pinnacle Data Solutions, Inc. ("Pinnacle"), headquartered at 2200 Innovation Way, Suite 600, San Diego, California 92121, which will provide the electronic data capture ("EDC") platform and related data management technology services for the trial; and
(iii) Northbridge Bioanalytical Laboratories, Inc. ("Northbridge"), headquartered at 8800 Eastern Boulevard, Baltimore, Maryland 21224, which will serve as the central laboratory for the processing and analysis of all laboratory specimens collected during the trial.
Each of the foregoing subcontractors has entered into a written agreement with Penterra that obligates such subcontractor to comply with the applicable provisions of the MCTA, including data privacy, confidentiality, and regulatory compliance obligations. Veridian has been provided with copies of the relevant provisions of each subcontractor agreement and has confirmed its acceptance of the approved subcontractors.
SECTION 4: NO MATERIAL ADVERSE CHANGE
I, Nathaniel Briggs, Esq., hereby certify that since the date of execution of the MCTA, June 28, 2023, through and including the Closing Date, July 5, 2023, there has been no material adverse change in the business, assets, condition (financial or otherwise), operations, results of operations, or prospects of Penterra Pharmaceuticals Corp. that would materially impair or reasonably be expected to materially impair Penterra's ability to perform its obligations under the MCTA.
Without limiting the generality of the foregoing, I confirm that during the period from June 28, 2023, through the date hereof: (a) Penterra has conducted its business in the ordinary course consistent with past practice; (b) there has been no material loss, damage, or destruction of any material property or asset of Penterra; (c) there has been no material change in the regulatory status of IND 157823 or any of the Company's marketed products; (d) there has been no material litigation, investigation, or governmental proceeding commenced or, to the knowledge of the undersigned, threatened against Penterra; and (e) no event has occurred that would constitute an event of default under the MCTA or that, with the giving of notice or the lapse of time or both, would constitute such an event of default.
SECTION 5: CONDITIONS PRECEDENT
I, Nathaniel Briggs, Esq., hereby certify that all conditions precedent to the obligations of Penterra Pharmaceuticals Corp. at the closing of the MCTA, as set forth in Article IX of the MCTA, have been satisfied or, where applicable, waived as of the Closing Date, July 5, 2023. Specifically, the following conditions precedent have been satisfied:
(a) Delivery of Insurance Certificates. Certificates of insurance evidencing clinical trial liability coverage under Briarcliff Mutual Insurance Company Policy Number BM-CTL-2023-04182 have been duly delivered to Veridian and its counsel, as described in Section 3(a) of this Certificate.
(b) Receipt of IRB Approvals for Lead Sites. Institutional Review Board ("IRB") approvals for the initiation of Protocol PPC-4871-III have been obtained for the lead participating sites, including:
(i) Graystone University Medical Center (Site 001), located at 1200 University Avenue, Philadelphia, Pennsylvania 19104, which received IRB approval from the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847, registered with the Office for Human Research Protections), with an approval date of June 15, 2023, and an approval expiration date of June 14, 2024; and
(ii) Lakemont Medical Center (Site 002), located at 4400 North Michigan Drive, Chicago, Illinois 60611, and additional Veridian Network sites, which have received IRB approval from the Veridian Central IRB, with an approval date of June 20, 2023.
(c) Execution and Delivery of Investigator Signature Pages. The following investigator agreements have been duly executed and delivered:
(i) The Principal Investigator Agreement with Dr. Catherine Aldridge, M.D., Ph.D., who will serve as the Global Principal Investigator for the CLARION trial at Graystone University Medical Center (Site 001), was executed on June 25, 2023;
(ii) The Co-Principal Investigator Agreement with Dr. Howard Matsuoka, M.D., who will serve as the Co-Principal Investigator at Lakemont Medical Center (Site 002), was executed on June 27, 2023; and
(iii) Additional Investigator Agreements for sub-investigators at the lead sites are in the process of being finalized and will be completed in accordance with the timelines set forth in the MCTA.
(d) Execution of Individual Site Agreement for Graystone University Medical Center. The Individual Site Agreement for Graystone University Medical Center (Site 001) has been duly executed by Dr. William Corwin, M.D., in his capacity as the authorized institutional representative of Graystone University Medical Center, and countersigned by Penterra and Veridian. The executed agreement was delivered on June 30, 2023.
(e) Delivery of Secretary's Certificate of Penterra. The Secretary's Certificate of Penterra Pharmaceuticals Corp., executed by Margaret T. Feldman, Corporate Secretary, certifying the Board resolutions authorizing the execution and delivery of the MCTA and the ancillary agreements, the incumbency and specimen signatures of the authorized officers, and attaching copies of the Company's organizational documents (including the Amended and Restated Certificate of Incorporation and the Amended and Restated Bylaws), has been delivered to Veridian and its counsel.
(f) Delivery of Closing Certificate of Penterra. This Officer's Certificate, constituting the Closing Certificate of Penterra required by Section 9.02(a)(iii) of the MCTA, is being delivered concurrently herewith.
SECTION 6: GOVERNING LAW REFERENCE
This Certificate is delivered pursuant to and in accordance with the requirements of the MCTA. This Certificate is an integral part of the closing deliverables contemplated by the MCTA and shall be construed in accordance with and subject to the terms and provisions of the MCTA. To the extent that any provision of this Certificate conflicts with or is inconsistent with any provision of the MCTA, the terms of the MCTA shall control and govern.
The MCTA is governed by and shall be 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. Any dispute arising out of or relating to this Certificate shall be resolved in accordance with the dispute resolution provisions set forth in Article XVI of the MCTA, which provides for exclusive jurisdiction in the state and federal courts located in the Borough of Manhattan, City of New York.
SECTION 7: RELIANCE
This Certificate is delivered for the benefit of, and may be relied upon by, Veridian Health Research Network, Inc. and its outside legal counsel, Whitmore, Jansen & Callahan LLP, located at 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102. Veridian and Whitmore, Jansen & Callahan LLP are each entitled to rely on the certifications, representations, and statements contained herein as though made directly to each of them in connection with the closing of the MCTA and the satisfaction of the conditions precedent set forth therein.
This Certificate may also be relied upon by each of the participating Veridian Network site institutions, including without limitation Graystone University Medical Center and Lakemont Medical Center, to the extent that the certifications contained herein are applicable to such institutions' participation in the CLARION trial and to the extent that such reliance is contemplated by the MCTA or the applicable Individual Site Agreements.
This Certificate shall not confer any rights or remedies upon any person or entity other than the parties described in the preceding paragraphs, except as otherwise expressly provided in the MCTA. The undersigned makes the certifications set forth herein in his capacity as Vice President & General Counsel of Penterra Pharmaceuticals Corp. and not in any individual or personal capacity, and the undersigned shall have no personal liability in connection with the certifications contained herein.
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SIGNATURE PAGE TO OFFICER'S CERTIFICATE OF PENTERRA PHARMACEUTICALS CORP.
IN WITNESS WHEREOF, the undersigned has executed this Officer's Certificate as of July 5, 2023.
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs, Esq.
Title: Vice President & General Counsel
Address:
200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540
Date: July 5, 2023