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1018-00004 · Penterra Pharmaceuticals Corp · Transaction Documents/Execution
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SIGNATURE PAGE TO MASTER CLINICAL TRIAL AGREEMENT

Execution Version

Master Clinical Trial Agreement dated as of June 28, 2023 (the "Agreement")

by and among

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

Veridian Health Research Network, Inc., a Delaware corporation ("Site Network")

and the Participating Site Institutions identified therein

Protocol: PPC-4871-III Trial Name: CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology Investigational Product: Penterafenib (PPC-4871) ClinicalTrials.gov Identifier: NCT05928174 IND Number: IND 157823

INTRODUCTORY RECITAL

The undersigned institution, Graystone University Medical Center, a Pennsylvania nonprofit corporation and a member institution of the Veridian Health Research Network, is executing this Signature Page as a Lead Participating Site Institution under the Agreement. Graystone University Medical Center is designated as Site 001 in Schedule 1 to the Agreement and shall serve as the lead clinical site for the conduct of Protocol PPC-4871-III (the "CLARION" trial) within the Veridian Health Research Network.

By executing this Signature Page, Graystone University Medical Center hereby acknowledges and agrees that it shall be bound by all of the terms and conditions of the Agreement, including without limitation all Exhibits (Exhibit A through Exhibit K) and Schedule 1 attached thereto, as each may be amended, supplemented, or otherwise modified from time to time in accordance with the provisions of the Agreement.

Graystone University Medical Center further acknowledges that it has reviewed, and agrees to comply in all material respects with, Protocol PPC-4871-III, as well as all applicable regulatory requirements, including, without limitation, Title 21 of the Code of Federal Regulations Parts 11 (Electronic Records; Electronic Signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application), the International Council for Harmonisation Guideline for Good Clinical Practice E6(R2) ("ICH E6(R2) GCP Guidelines"), and the Health Insurance Portability and Accountability Act of 1996, as amended, and the regulations promulgated thereunder at 45 C.F.R. Parts 160 and 164 ("HIPAA").

The Institutional Review Board of record for the conduct of Protocol PPC-4871-III at this site shall be the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847), which shall maintain oversight responsibility for all human subjects research activities conducted at this site under the Agreement.

The Principal Investigator designated for the conduct of the CLARION trial at Graystone University Medical Center is Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology, Graystone University Medical Center. Dr. Aldridge shall additionally serve as the Global Principal Investigator for Protocol PPC-4871-III across all Veridian Health Research Network participating sites, as set forth in Section 5.2(a) of the Agreement and as further described in Exhibit B (Statement of Work) thereto.

SIGNATURE BLOCK — GRAYSTONE UNIVERSITY MEDICAL CENTER

IN WITNESS WHEREOF, the undersigned institution has caused this Signature Page to the Master Clinical Trial Agreement to be duly executed by its authorized representative as of the date set forth below.

GRAYSTONE UNIVERSITY MEDICAL CENTER a Pennsylvania nonprofit corporation

1200 University Avenue Philadelphia, PA 19104

By: ________

Name: Dr. William Corwin, M.D.

Title: President

Date: June 28, 2023

ACKNOWLEDGMENT OF KEY TERMS

By executing this Signature Page, Graystone University Medical Center hereby acknowledges, confirms, and agrees to each of the following key financial, operational, and legal terms as set forth in the Agreement:

A. Total Deal Value and Financial Terms

1. Total Agreement Value. The total deal value of the Agreement across all Veridian Health Research Network participating sites is Eighty Million Dollars ($80,000,000) over the projected life of the CLARION trial, subject to adjustment based on enrollment rates, site activation schedules, and protocol amendment activity as set forth in Exhibit C (Budget and Payment Schedule) to the Agreement.

2. Per-Patient Site Fees. Per-patient site fees under the Agreement shall be Fifty-Two Thousand Dollars ($52,000) per enrolled subject, payable in four (4) equal milestone-based installments of Thirteen Thousand Dollars ($13,000) each, as follows:

(a) First Installment ($13,000): Payable upon confirmed randomization of the subject into the CLARION trial, as documented by the electronic data capture system and verified by the Sponsor's clinical research associate;

(b) Second Installment ($13,000): Payable upon successful completion of the Week 12 clinical assessment visit, including all required efficacy and safety evaluations specified in the Schedule of Assessments set forth in Protocol PPC-4871-III;

(c) Third Installment ($13,000): Payable upon successful completion of the Week 24 clinical assessment visit, including all required efficacy, safety, and pharmacokinetic evaluations specified in the Schedule of Assessments; and

(d) Fourth Installment ($13,000): Payable upon study completion or final visit (including early termination visits where applicable), receipt of all outstanding case report forms, resolution of all data queries, and return or destruction of unused investigational product.

3. Start-Up Fees. Start-up fees specific to Graystone University Medical Center shall be Seventy-Five Thousand Dollars ($75,000), payable in two (2) equal installments of Thirty-Seven Thousand Five Hundred Dollars ($37,500) each, as follows:

(a) First Start-Up Installment ($37,500): Payable upon site activation, defined as the date on which the Sponsor issues a site activation letter confirming that all regulatory, contractual, and operational prerequisites for patient enrollment have been satisfied; and

(b) Second Start-Up Installment ($37,500): Payable upon enrollment (i.e., randomization) of the first patient at Graystone University Medical Center.

4. Annual Site Maintenance Fees. Graystone University Medical Center shall receive annual site maintenance fees of Forty Thousand Dollars ($40,000) per annum, payable in advance on each anniversary of the site-activation date, commencing on the first anniversary thereof. Such fees shall be prorated for any partial year at the end of the trial on a per diem basis calculated as $40,000 divided by 365.

5. Payment Terms. All payments under the Agreement shall be made within forty-five (45) calendar days from the Sponsor's receipt of a proper invoice, submitted in the form and manner set forth in Exhibit C (Budget and Payment Schedule) to the Agreement. Invoices shall be submitted through the Veridian Health Research Network centralized invoicing platform, with the exception of start-up fees which may be invoiced directly by the site institution.

B. Indemnification Provisions

Graystone University Medical Center acknowledges the indemnification provisions set forth in Exhibit D to the Agreement, including the following:

(a) Sponsor Indemnification for Subject Injury. The Sponsor shall indemnify, defend, and hold harmless Graystone University Medical Center and its trustees, officers, employees, agents, and investigators (collectively, "Site Indemnitees") against claims arising from injury to clinical trial subjects to the extent caused by the investigational product or the Protocol, subject to a per-subject medical care cap of Five Hundred Thousand Dollars ($500,000) and an aggregate cap of Fifteen Million Dollars ($15,000,000) across all participating sites for the duration of the trial;

(b) Product-Defect Claims. Sponsor indemnification for claims arising from defects in the manufacture, formulation, labeling, or packaging of the investigational product (Penterafenib, PPC-4871) shall be uncapped and shall survive termination or expiration of the Agreement;

(c) Reciprocal Site Indemnity Obligations. Graystone University Medical Center, as a participating site institution, shall indemnify, defend, and hold harmless the Sponsor and its directors, officers, employees, and agents against claims arising from the negligence, willful misconduct, or material breach of the Agreement by the site institution or its personnel, subject to a limit of Five Million Dollars ($5,000,000) per site per occurrence and an aggregate limit of Twenty Million Dollars ($20,000,000) across all Veridian Health Research Network participating sites for the duration of the Agreement.

C. Insurance Obligations

Graystone University Medical Center acknowledges its obligation, as set forth in Section 14.3 of the Agreement, to obtain and maintain throughout the term of the Agreement the following minimum insurance coverage:

(a) Commercial general liability insurance with limits of not less than Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the annual aggregate; and

(b) Professional liability (medical malpractice) insurance with limits of not less than Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the annual aggregate.

Certificates of insurance evidencing the foregoing coverage, naming Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. as additional insureds, shall be delivered to the Sponsor within fifteen (15) business days of the execution of this Signature Page to the Master Clinical Trial Agreement.

D. Confidentiality. Graystone University Medical Center acknowledges and agrees that confidential information disclosed under or in connection with the Agreement shall remain subject to the confidentiality obligations set forth in Article 12 of the Agreement for a period of ten (10) years from the date of each disclosure of such information, subject to the exceptions and permitted disclosures enumerated therein.

E. Data Ownership and Record Retention

Graystone University Medical Center acknowledges and agrees that Penterra Pharmaceuticals Corp. shall retain exclusive ownership of all clinical trial data generated in connection with Protocol PPC-4871-III, including, without limitation, all case report form data, electronic data capture records, biomarker and pharmacokinetic data, imaging data, and any analyses or compilations thereof. Graystone University Medical Center shall retain all source documents, including original medical records, laboratory reports, and other primary documentation, for a minimum period of fifteen (15) years following the date of study completion or early termination at the site, or for such longer period as may be required by applicable law, regulation, or institutional policy.

F. Publication Rights

Graystone University Medical Center acknowledges that any proposed publication or public presentation of results, data, or findings arising from Protocol PPC-4871-III shall be subject to the Sponsor's prior review and approval in accordance with Section 13.4 of the Agreement. The Sponsor shall have a review period of sixty (60) calendar days from receipt of a complete draft manuscript or presentation. The Sponsor may request an additional delay of up to ninety (90) calendar days beyond the initial review period for the sole purpose of filing patent applications or other intellectual property protections related to the investigational product or the data generated in the trial.

G. Governing Law and Dispute Resolution

Graystone University Medical Center acknowledges and agrees that the Agreement shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to its conflict of laws principles. Any dispute arising under or in connection with the Agreement shall be resolved in accordance with the escalation procedure set forth in Section 19.2 of the Agreement, which provides as follows:

(a) Negotiation. The parties shall first attempt to resolve any dispute through good-faith negotiation between designated senior representatives of each party for a period of thirty (30) calendar days following written notice of the dispute;

(b) Mediation. If the dispute is not resolved through negotiation, the parties shall submit the dispute to mediation administered by the American Arbitration Association ("AAA") under its Commercial Mediation Rules for a period of sixty (60) calendar days from the commencement of mediation;

(c) Binding Arbitration. If the dispute is not resolved through mediation, it shall be submitted to final and binding arbitration in New York, New York, administered by the AAA under its Commercial Arbitration Rules, before a panel of three (3) arbitrators selected in accordance with those rules. The decision of the arbitrators shall be final and binding upon the parties and may be entered as a judgment in any court of competent jurisdiction.

REPRESENTATIONS OF SIGNING AUTHORITY

By executing this Signature Page, Dr. William Corwin, M.D., in his capacity as President of Graystone University Medical Center, hereby represents and warrants to the Sponsor and to the Site Network as follows:

1. Due Authorization. Dr. Corwin has been duly authorized by the Board of Trustees (or equivalent governing body) of Graystone University Medical Center to execute this Signature Page and to bind the institution to the terms and conditions of the Agreement, including all Exhibits and Schedules thereto. Such authorization was granted by resolution of the Board of Trustees adopted at a duly convened meeting held on or prior to the date hereof, and such resolution has not been amended, modified, or rescinded as of the date of this Signature Page.

2. No Conflict. The execution, delivery, and performance of the Agreement by Graystone University Medical Center does not and will not (a) violate or conflict with the articles of incorporation, bylaws, or other organizational documents of Graystone University Medical Center, (b) violate or conflict with any law, regulation, order, judgment, or decree applicable to Graystone University Medical Center, or (c) conflict with, result in a breach of, or constitute a default under any material contract, agreement, or other instrument to which Graystone University Medical Center is a party or by which it or any of its assets are bound.

3. Internal Approvals and IRB Status. Graystone University Medical Center has obtained all necessary internal institutional approvals for its participation in Protocol PPC-4871-III under the Agreement, including institutional review and approval from the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847), or, in the alternative, such IRB approval will be obtained in full prior to the enrollment of any human subjects at this site. Graystone University Medical Center acknowledges that it shall not randomize, dose, or conduct any study procedures on any subject under Protocol PPC-4871-III until a valid IRB approval letter has been issued and copies thereof have been delivered to the Sponsor and to the Site Network.

DESIGNATION OF KEY SITE PERSONNEL

The following individuals are hereby designated as key site personnel for the conduct of Protocol PPC-4871-III at Graystone University Medical Center, as contemplated by Section 5.2 of the Agreement and Exhibit F (Key Personnel Designation Form) thereto:

Any changes to the designation of the Principal Investigator or other key site personnel shall require the prior written consent of the Sponsor and shall be made in accordance with the procedures set forth in Section 5.2(c) of the Agreement.

NOTICE INFORMATION

All notices, demands, requests, consents, approvals, and other communications required or permitted to be given under the Agreement to Graystone University Medical Center shall be in writing and shall be deemed duly given in accordance with Section 20.1 of the Agreement when delivered to the following addresses:

If to Graystone University Medical Center:

Dr. William Corwin, M.D. President Graystone University Medical Center 1200 University Avenue Philadelphia, PA 19104

With a copy to Veridian Health Research Network, Inc.:

Gregory Callahan, Esq. Vice President, Legal & Compliance Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, PA 19104

And a copy to Veridian's outside counsel:

Allison Whitmore, Esq. Whitmore, Jansen & Callahan LLP 1500 Market Street, Suite 3200 Philadelphia, PA 19102

Any party may change its address for notice purposes by giving written notice of such change to the other parties in accordance with the foregoing provisions.

COUNTERPART EXECUTION

This Signature Page may be executed in one or more counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one and the same instrument. The parties agree that delivery of an executed counterpart of this Signature Page by facsimile transmission, electronic mail in portable document format (PDF), or other electronic transmission method (including via Brightwater Software, Ashford Health IT, or any other electronic signature platform approved by the parties) shall be effective as delivery of a manually executed counterpart hereof.

CROSS-REFERENCE TO OTHER SIGNATURE PAGES

The Agreement is also being executed by the following parties, whose respective signature pages are attached to or delivered concurrently with the Agreement:

1. Penterra Pharmaceuticals Corp. — Signature page executed by Nathaniel Briggs, Esq., Vice President & General Counsel, on behalf of the Sponsor.

2. Veridian Health Research Network, Inc. — Signature page executed by Dr. Franklin Osei, M.D., Ph.D., President & Chief Executive Officer, on behalf of the Site Network.

In addition to this Signature Page executed by Graystone University Medical Center (Site 001) as the Lead Participating Site Institution, Individual Site Agreements in the form of joinder agreements substantially in the form of Exhibit J to the Agreement are being or will be executed by each of the remaining thirty-seven (37) Veridian Health Research Network participating sites, including, without limitation:

• Lakemont Medical Center (Site 002)

• Haverford Regional Medical Center (Site 003)

• Cedar Falls University Hospital (Site 004)

• Weston Memorial Health System (Site 005)

and such other participating site institutions as are identified in Schedule 1 to the Agreement, as Schedule 1 may be amended from time to time upon the addition of new sites in accordance with Section 3.4 of the Agreement.

EFFECTIVE DATE

This Signature Page is executed as of June 28, 2023 (the "Signing Date").

The Agreement shall become effective upon the satisfaction or waiver of all conditions precedent set forth in Section 2.1 of the Agreement. The targeted closing date for satisfaction of all such conditions precedent is July 5, 2023 (the "Closing Date"), with an anticipated effective date of July 18, 2023 (the "Effective Date").

The conditions precedent to the effectiveness of the Agreement include, without limitation:

(a) Delivery by Graystone University Medical Center and all other lead participating site institutions of certificates of insurance meeting the requirements of Section 14.3 of the Agreement;

(b) Receipt by the Sponsor of written IRB approval from the Graystone University Institutional Review Board (IRB00012847) and from the institutional review boards of record for each of the other designated lead participating sites under the Agreement;

(c) Delivery to the Sponsor of fully executed investigator signature pages, in the form of Exhibit G to the Agreement, by the Global Principal Investigator (Dr. Catherine Aldridge, M.D., Ph.D.) and by the designated principal investigators at each lead participating site; and

(d) Satisfaction of such other conditions as are specified in Section 2.1 of the Agreement.

In the event that all conditions precedent are not satisfied or waived by the Closing Date, the parties shall consult in good faith regarding an extension of the Closing Date, provided that if such conditions are not satisfied or waived within sixty (60) calendar days following the Signing Date, any party may terminate the Agreement by written notice to the other parties in accordance with Section 2.1(d) of the Agreement.

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ACKNOWLEDGED AND AGREED

GRAYSTONE UNIVERSITY MEDICAL CENTER Lead Participating Site Institution — Site 001

GRAYSTONE UNIVERSITY MEDICAL CENTER a Pennsylvania nonprofit corporation

By: ________

Name: Dr. William Corwin, M.D.

Title: President

Date: June 28, 2023

Address:

1200 University Avenue Philadelphia, PA 19104

This Signature Page constitutes an integral part of the Master Clinical Trial Agreement dated as of June 28, 2023, by and among Penterra Pharmaceuticals Corp., Veridian Health Research Network, Inc., and the Participating Site Institutions identified therein. This document is confidential and is subject to the confidentiality provisions of Article 12 of the Agreement. Any unauthorized reproduction, distribution, or disclosure of this document is strictly prohibited.

RoleNameTitle / Credentials
Principal Investigator / Global Principal InvestigatorDr. Catherine Aldridge, M.D., Ph.D.Professor of Oncology, Graystone University Medical Center; Global Principal Investigator for Protocol PPC-4871-III (CLARION Trial)
Institutional Contact for Contract AdministrationTo be designated by Graystone University Medical CenterCoordination through Veridian Health Research Network Director of Sponsored Research Agreements, Patricia Dunne, per the MCTA's Network Coordination Framework (Section 4.6 of the Agreement)
IRB of RecordGraystone University Institutional Review BoardIRB Registration Number: IRB00012847