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EXHIBIT C

FORM OF INDIVIDUAL SITE AGREEMENT (JOINDER)

to the

MASTER CLINICAL TRIAL AGREEMENT

dated June 28, 2023

by and between

PENTERRA PHARMACEUTICALS CORP.

and

VERIDIAN HEALTH RESEARCH NETWORK, INC.

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

[This form is to be completed and executed by each Veridian Network participating site institution to become a party to the MCTA. All bracketed items are to be completed with site-specific information prior to execution.]

INDIVIDUAL SITE AGREEMENT (JOINDER)

This Individual Site Agreement (this "Site Agreement") is entered into as of \\\\\\\\\\\\\\\\\\\\ (the "Site Agreement Effective Date") by and among:

1. Penterra Pharmaceuticals Corp., a Delaware corporation with its principal offices at 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540 ("Sponsor");

2. Veridian Health Research Network, Inc., a Delaware 501(c)(3) corporation with its principal offices at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104 ("Network"); and

3. \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ [Full Legal Name of Site Institution], a \\\\\\\\\\\\\\\\ [state] \\\\\\\\\\\\\\\\ [entity type] with its principal offices at \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ [address] (the "Site" or "Institution").

Sponsor, Network, and the Site are each referred to herein individually as a "Party" and collectively as the "Parties."

RECITALS

WHEREAS, Sponsor and Network entered into that certain Master Clinical Trial Agreement dated June 28, 2023 (as amended from time to time, the "MCTA"), governing the conduct of Protocol PPC-4871-III, entitled "CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology" (the "Protocol"), across participating institutions within the Veridian Health Research Network;

WHEREAS, the MCTA provides that each participating institution within the Network shall execute this Form of Individual Site Agreement (Exhibit C to the MCTA) to become bound by the terms and conditions of the MCTA as a Participating Site;

WHEREAS, the Site is a member institution of the Veridian Health Research Network and desires to participate in the conduct of the Protocol at the Site in accordance with the MCTA and this Site Agreement;

WHEREAS, the Site has identified \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\_ [name of Principal Investigator] as the Principal Investigator for the conduct of the Protocol at the Site;

WHEREAS, the Site's Institutional Review Board or reliance IRB, as applicable, has reviewed and approved, or will review and approve, the Protocol and all associated informed consent documents prior to the enrollment of any subjects at the Site; and

WHEREAS, the investigational product that is the subject of the Protocol, penterafenib (PPC-4871), is currently being studied under Investigational New Drug Application No. IND 157823 filed with the United States Food and Drug Administration and is registered on ClinicalTrials.gov under identifier NCT05928174;

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and in the MCTA, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1 — DEFINITIONS AND INCORPORATION BY REFERENCE

Section 1.1 — Definitions

All capitalized terms used but not otherwise defined in this Site Agreement shall have the meanings ascribed to them in the MCTA. In addition to the definitions set forth in the MCTA, the following terms shall have the meanings set forth below when used in this Site Agreement:

(a) "IRB" means the Institutional Review Board or Ethics Committee identified in Site-Specific Schedule C attached hereto, which shall serve as the IRB of record for the conduct of the Protocol at the Site.

(b) "Principal Investigator" or "PI" means the individual identified in Site-Specific Schedule B attached hereto who is designated by the Site as the principal investigator responsible for the conduct of the Protocol at the Site.

(c) "Site" means the Institution identified in the preamble to this Site Agreement and the physical facility or facilities where the Protocol will be conducted, as specified in Site-Specific Schedule A attached hereto.

(d) "Site Activation Date" means the date on which Sponsor provides written confirmation (which may be delivered by email from Sponsor's clinical operations team or the CRO) that the Site has satisfied all pre-activation conditions set forth in this Site Agreement and the MCTA and is authorized to begin enrollment of subjects in the Protocol.

(e) "Site Agreement Effective Date" means the date first written above in the preamble to this Site Agreement.

(f) "Site Number" means \\\\\\\\\\\\\\ as assigned by Sponsor for purposes of identifying the Site within the Protocol.

Section 1.2 — Incorporation of MCTA

The terms and conditions of the MCTA, including all Exhibits and Schedules thereto (Exhibits A through K and Schedule 1), are hereby incorporated by reference into this Site Agreement as if fully set forth herein. The Site acknowledges that it has received and reviewed a complete copy of the MCTA and all Exhibits and Schedules thereto.

In the event of any conflict or inconsistency between the terms of this Site Agreement and the terms of the MCTA, the MCTA shall control and govern, except to the extent that this Site Agreement contains site-specific modifications that have been expressly agreed to in writing by all three Parties and are set forth in the Site-Specific Schedules attached hereto (Schedules A through D). For the avoidance of doubt, no site-specific modification shall be effective unless it is explicitly identified as a modification to the corresponding provision of the MCTA and is signed or initialed by authorized representatives of all three Parties.

All Exhibits to the MCTA are binding on the Site as if the Site were a direct party thereto, including without limitation the following:

(a) Exhibit A — Protocol Synopsis;

(b) Exhibit B — Budget and Payment Schedule (as modified by Site-Specific Schedule D hereto);

(d) Exhibit E — Insurance Requirements;

(e) Exhibit F — Confidentiality and Data Protection;

(f) Exhibit G — Intellectual Property and Publication Rights;

(g) Exhibit H — Regulatory Compliance Representations;

(h) Exhibit I — Form of Investigator Undertaking;

(i) Exhibit J — Safety Reporting Procedures; and

(j) Exhibit K — Approved Subcontractors List.

The Site agrees to comply with all obligations imposed on a "Participating Site" or "Site" under the MCTA and each Exhibit and Schedule thereto as if such obligations were set forth in full in this Site Agreement.

ARTICLE 2 — JOINDER AND ASSUMPTION OF OBLIGATIONS

Section 2.1 — Joinder

By executing this Site Agreement, the Site hereby agrees to be bound by and subject to all terms, conditions, representations, warranties, covenants, and obligations of a "Participating Site" or "Site" under the MCTA, with the same force and effect as if the Site were an original signatory thereto. This Site Agreement constitutes a joinder to the MCTA, and the Site shall be deemed a party to the MCTA from and after the Site Agreement Effective Date for all purposes related to the conduct of the Protocol at the Site.

The Network hereby confirms that the Site is a member institution of the Veridian Health Research Network and is listed on Schedule 1 to the MCTA (Network Member Institutions). If the Site is not currently listed on Schedule 1, the Network shall update Schedule 1 to include the Site concurrently with the execution of this Site Agreement.

Section 2.2 — Assumption of Obligations

The Site hereby assumes all obligations of a Participating Site under the MCTA, including but not limited to the following:

(a) Protocol Compliance. Conduct of the Protocol in strict compliance with the approved protocol document (including all amendments thereto approved by the IRB and Sponsor), applicable federal, state, and local law, Good Clinical Practice as set forth in ICH Guideline E6(R2), and all applicable regulations of the United States Food and Drug Administration, including without limitation 21 C.F.R. 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).

(b) IRB Approval. Maintenance of continuous IRB approval for the Protocol throughout the conduct of study activities at the Site, including timely submission of continuing review applications, protocol amendments, informed consent revisions, safety reports, and all other materials required by the IRB of record.

(c) Safety Reporting. Compliance with all safety reporting obligations as set forth in Exhibit J to the MCTA, including but not limited to the reporting of all serious adverse events ("SAEs") to Sponsor (or its designated CRO, Meridian Contract Research Organization, Inc.) within twenty-four (24) hours of site awareness, and the reporting of all adverse events, protocol deviations, and other safety-related information in the timeframes and formats specified in the Protocol and Exhibit J.

(d) Privacy and Data Protection. Compliance with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164 ("HIPAA"), including the Privacy Rule and the Security Rule, and all applicable state privacy and data protection laws. The Site shall ensure that appropriate authorizations for the use and disclosure of protected health information are obtained from each study subject as part of the informed consent process.

(e) Record Retention. Retention of all source documents, medical records, study files, regulatory correspondence, and other records related to the Protocol for a minimum period of fifteen (15) years following study completion at the Site, or for such longer period as may be required by applicable law, regulation, or institutional policy, whichever is longer. The Site shall not destroy, discard, or transfer any study records without the prior written consent of Sponsor.

(f) Confidentiality. Compliance with the confidentiality obligations set forth in Exhibit F to the MCTA, which obligations shall remain in effect for a period of ten (10) years from the date of disclosure of any Confidential Information, regardless of the termination or expiration of this Site Agreement or the MCTA.

(g) Monitoring, Inspection, and Audit. Permitting Sponsor, Meridian Contract Research Organization, Inc. (the "CRO"), and applicable regulatory authorities (including but not limited to the FDA, the Office for Human Research Protections, and the Office of Inspector General) to inspect and audit the Site's facilities, records, source documents, regulatory files, pharmacy records, and other materials related to the conduct of the Protocol, upon reasonable notice and during normal business hours. The Site shall make every reasonable effort to accommodate monitoring visits conducted by the CRO on a schedule mutually agreed upon by the Site and the CRO, and shall make the PI and key site personnel available during such visits.

(h) Anti-Kickback and Fair Market Value Compliance. Compliance with the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the Centers for Medicare & Medicaid Services Open Payments reporting requirements, and fair market value requirements as set forth in Exhibit H to the MCTA. The Site acknowledges and agrees that all compensation payable under this Site Agreement and the MCTA has been negotiated at arm's length and reflects fair market value for the services to be rendered, and that no payment is intended to induce or reward the referral of subjects or patients for the Protocol or for any other purpose prohibited by applicable law.

Section 2.3 — Network Responsibility

The Network remains jointly responsible with the Site for the performance of obligations under the MCTA, subject to the terms, conditions, and limitations set forth in the MCTA. The Site acknowledges that the Network serves as the administrative and coordinating entity for all participating sites within the Veridian Health Research Network and that the Network's obligations under the MCTA, including without limitation the Network's obligations with respect to oversight, quality assurance, and regulatory coordination, are not diminished, altered, or otherwise affected by the Site's execution of this Site Agreement.

The Site further acknowledges that the Network may exercise certain administrative functions on behalf of the Site, including but not limited to the coordination of IRB reliance agreements, the centralized collection and dissemination of safety data, and the facilitation of communications between the Site and Sponsor. The Site agrees to cooperate with the Network in the discharge of such administrative functions and to respond promptly to all requests for information from the Network related to the conduct of the Protocol.

ARTICLE 3 — PRINCIPAL INVESTIGATOR

Section 3.1 — Designation of Principal Investigator

The Site hereby designates the individual identified in Site-Specific Schedule B attached hereto as the Principal Investigator for the conduct of the Protocol at the Site. The PI shall have overall responsibility for the proper conduct of the Protocol at the Site, including responsibility for subject safety, data integrity, compliance with the Protocol and applicable regulations, and supervision of all sub-investigators and site staff involved in Protocol-related activities.

The PI must be qualified by training, education, and experience to assume responsibility for the proper conduct of the Protocol at the Site, as required by 21 C.F.R. § 312.53(a). As evidence of such qualification, the PI shall provide to Sponsor, prior to Site Activation, the following documents:

(i) A duly executed FDA Form 1572 (Statement of Investigator);

(ii) A current curriculum vitae demonstrating relevant medical training, board certifications, research experience, and GCP training;

(iii) A current and unrestricted medical license issued by the state in which the Site is located; and

(iv) An executed Investigator Undertaking in the form attached as Exhibit I to the MCTA.

Section 3.2 — Sub-Investigators

Site-Specific Schedule B shall include a complete list of all sub-investigators who are authorized to conduct Protocol-related activities at the Site under the supervision of the PI. Each sub-investigator must meet the following requirements:

(a) Be listed on the PI's FDA Form 1572;

(b) Execute the Investigator Undertaking in the form attached as Exhibit I to the MCTA;

(d) Complete and submit a financial disclosure certification in accordance with 21 C.F.R. Part 54.

The Site shall promptly notify Sponsor and the Network of any additions to, or removals from, the list of sub-investigators, and shall submit updated FDA Form 1572 documentation reflecting any such changes within ten (10) business days. No sub-investigator may begin performing Protocol-related activities until the sub-investigator has been added to the FDA Form 1572 and the updated form has been submitted to Sponsor.

Section 3.3 — Replacement of Principal Investigator

The Site may not replace the PI without the prior written consent of Sponsor, which consent shall not be unreasonably withheld, conditioned, or delayed. If the PI becomes unable or unwilling to continue serving as the principal investigator for the Protocol at the Site, whether due to illness, departure from the Institution, regulatory action, loss of medical licensure, or any other reason, the Site shall:

(a) Promptly notify Sponsor and the Network in writing of the PI's inability or unwillingness to continue, providing a detailed explanation of the circumstances;

(b) Propose a qualified replacement PI who meets all requirements set forth in Section 3.1 above; and

(c) Provide Sponsor with the proposed replacement PI's curriculum vitae, FDA Form 1572, financial disclosure certification, and other documentation required under the MCTA.

Sponsor shall review the proposed replacement PI and shall notify the Site and the Network of its approval or disapproval within thirty (30) calendar days of receipt of the complete documentation package for the proposed replacement. If Sponsor does not approve a replacement PI within such thirty (30)-day period, or if the Site is unable to propose a qualified replacement, Sponsor may terminate this Site Agreement in accordance with the provisions of Article 8 hereof.

During any period in which the Site does not have an approved PI, the Site shall suspend all enrollment activities and shall continue to provide appropriate medical care to subjects already enrolled at the Site, under the supervision of a qualified physician designated by the Site and acceptable to Sponsor.

Section 3.4 — Financial Disclosure

The PI and all sub-investigators listed on the FDA Form 1572 must complete and submit financial disclosure certifications in the form required under 21 C.F.R. Part 54, as set forth in the template referenced in the MCTA. Such certifications must be submitted:

(a) Prior to Site Activation;

(b) Annually thereafter, within thirty (30) days following each anniversary of the Site Activation Date; and

(c) Within thirty (30) days of any change in the financial interests of the PI or any sub-investigator that could affect the certification previously submitted.

The Site shall ensure that the PI and all sub-investigators are aware of their obligations under 21 C.F.R. Part 54 and shall promptly notify Sponsor and the Network of any disclosable financial interests or arrangements that arise during the conduct of the Protocol at the Site. Failure to comply with financial disclosure requirements may result in suspension or termination of the Site's participation in the Protocol.

ARTICLE 4 — SITE-SPECIFIC BUDGET AND PAYMENT

Section 4.1 — Budget Allocation

The site-specific budget for the Site is set forth in Site-Specific Schedule D attached hereto, which budget is based upon and consistent with the Budget and Payment Schedule attached as Exhibit B to the MCTA. The total per-patient fee is Fifty-Two Thousand Dollars ($52,000) per subject (screen-to-completion), payable in four (4) milestone-based installments as follows:

(i) Milestone 1 — Randomization: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon randomization of the subject into the Protocol;

(ii) Milestone 2 — Week 12 Assessment: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of the Week 12 study assessment for the subject;

(iii) Milestone 3 — Week 24 Assessment: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of the Week 24 study assessment for the subject; and

(iv) Milestone 4 — Study Completion / Final Visit: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of all study activities for the subject, including the final study visit and resolution of all outstanding data queries related to such subject.

The Site's projected enrollment target is set forth in Site-Specific Schedule D. For reference, the total planned enrollment across all thirty-eight (38) Veridian Network participating sites is one thousand two hundred (1,200) subjects, randomized in a 2:1 ratio (penterafenib to placebo). The Site acknowledges that projected enrollment targets are estimates and that actual enrollment may vary based on subject availability, Site performance, and overall study enrollment progress.

Section 4.2 — Start-Up Fees

The Site shall receive a non-refundable start-up fee of Seventy-Five Thousand Dollars ($75,000), payable in two (2) installments as follows:

(i) Thirty-Seven Thousand Five Hundred Dollars ($37,500) payable upon Site Activation; and

(ii) Thirty-Seven Thousand Five Hundred Dollars ($37,500) payable upon enrollment (randomization) of the first subject at the Site.

The start-up fee is intended to cover costs associated with site preparation, regulatory submissions, IRB review, staff training, equipment calibration, pharmacy set-up, and other activities necessary to prepare the Site for the conduct of the Protocol. The start-up fee is non-refundable once paid, except in the case of the Site's material breach of this Site Agreement or the MCTA prior to enrollment of the first subject, in which case Sponsor may seek recovery of the start-up fee as part of its remedies under the MCTA.

Section 4.3 — Annual Site Maintenance Fees

The Site shall receive an annual site maintenance fee of Forty Thousand Dollars ($40,000), payable annually in advance on each anniversary of the Site Activation Date, for the duration of the Site's participation in the Protocol. The estimated average duration of site participation is three and one-half (3.5) years per site, although actual duration may vary depending on enrollment timelines and study conduct at the Site.

The annual site maintenance fee is intended to cover ongoing fixed costs associated with the conduct of the Protocol at the Site, including but not limited to facility overhead, regulatory file maintenance, IRB continuing review submissions, staff retention, and other administrative costs. In the event of termination of this Site Agreement prior to any anniversary of the Site Activation Date, the annual site maintenance fee shall be prorated based on the number of days elapsed since the most recent anniversary (or the Site Activation Date, for the first year).

Section 4.4 — Investigator Grants

Investigator grants for publication and academic support shall be disbursed in accordance with the terms set forth in the MCTA and Exhibit G thereto. The total investigator grant pool across all participating sites is One Million Five Hundred Thousand Dollars ($1,500,000). Grants shall be disbursed upon acceptance of manuscripts based on Protocol data for publication in peer-reviewed journals, in accordance with the procedures and eligibility criteria set forth in Exhibit G. The PI and sub-investigators at the Site shall be eligible for investigator grants on the same terms and conditions as investigators at other participating sites within the Veridian Health Research Network.

Section 4.5 — Invoicing and Payment Terms

The Site shall submit invoices to Sponsor (or its designee, currently Meridian Contract Research Organization, Inc.) in accordance with the invoicing procedures specified in Exhibit B to the MCTA. All invoices shall be submitted in writing (electronic submission is acceptable) and shall include the following information:

(a) The Protocol Number (PPC-4871-III);

(b) The Site Number assigned by Sponsor;

(c) The applicable milestone or fee category (e.g., Milestone 1 — Randomization, Start-Up Fee Installment 1, Annual Site Maintenance Fee);

(d) The subject identification number(s), if applicable;

(e) The date(s) on which the milestone was achieved;

(f) The amount invoiced; and

(g) Such other information as may be reasonably required by Sponsor or the CRO.

Payment terms are Net Forty-Five (45) days from Sponsor's (or its designee's) receipt of a proper and complete invoice. Invoices that are incomplete, contain errors, or lack required supporting documentation may be returned to the Site for correction, in which case the forty-five (45)-day payment period shall recommence upon receipt of the corrected invoice. Sponsor shall notify the Site of any deficiencies in an invoice within ten (10) business days of receipt.

All payments shall be made by wire transfer or ACH deposit to the bank account designated by the Site in Site-Specific Schedule D. The Site shall promptly notify Sponsor and the Network in writing of any changes to its banking or payment information.

Section 4.6 — Taxes

All payments under this Site Agreement and the MCTA are exclusive of applicable taxes. The Site shall be solely responsible for any federal, state, or local income, sales, use, excise, or other taxes arising from or related to payments received under this Site Agreement, except to the extent that such taxes are required by law to be withheld by Sponsor. If the Site is a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code, the Site shall provide Sponsor with a copy of its Employer Identification Number (EIN) and its tax-exempt determination letter from the Internal Revenue Service. Sponsor shall not be required to gross up any payments to account for taxes or withholdings.

ARTICLE 5 — INDEMNIFICATION

Section 5.1 — Sponsor Indemnification of Site

Sponsor's indemnification obligations with respect to the Site, its PI, sub-investigators, officers, directors, employees, agents, and site staff are as set forth in Exhibit D to the MCTA, which provisions are incorporated herein by reference in their entirety and shall apply to the Site as if the Site were specifically named therein as an indemnified party.

Without limiting the generality of the foregoing, Sponsor shall defend, indemnify, and hold harmless the Site, the PI, all sub-investigators, and all officers, directors, employees, and agents of the Site (collectively, the "Site Indemnitees") from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of litigation) arising from or related to:

(a) Injury to or death of a study subject caused by the investigational product (penterafenib) when administered in accordance with the Protocol and in compliance with all applicable safety instructions provided by Sponsor;

(b) Any defect in the design, manufacture, formulation, labeling, packaging, storage, or distribution of the investigational product;

(d) Any negligence or willful misconduct of Sponsor, its employees, agents, or contractors (including the CRO).

Subject-injury medical care costs incurred by or on behalf of study subjects shall be subject to the following limitations: (i) a per-subject cap of Five Hundred Thousand Dollars ($500,000); and (ii) an aggregate cap across all participating sites of Fifteen Million Dollars ($15,000,000). Notwithstanding the foregoing, claims arising from product-defect (as described in clause (b) above) shall not be subject to any per-subject or aggregate cap.

Sponsor's indemnification obligations under this Section 5.1 shall not apply to losses, claims, or damages to the extent arising from:

(i) The negligence or willful misconduct of the Site, the PI, any sub-investigator, or any employee, agent, or representative of the Site;

(ii) Unauthorized deviation from the Protocol by the Site, the PI, or any sub-investigator, unless such deviation was directed or approved by Sponsor in writing; or

(iii) The Site's or the Network's breach of the MCTA, this Site Agreement, or applicable law.

Section 5.2 — Site Indemnification of Sponsor

The Site, jointly and severally with the Network (to the extent provided in the MCTA), shall defend, indemnify, and hold harmless Sponsor, its officers, directors, employees, agents, and contractors (collectively, the "Sponsor Indemnitees") from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of litigation) arising from or related to:

(a) The negligence or willful misconduct of the Site, the PI, any sub-investigator, or any employee, agent, or representative of the Site in connection with the conduct of the Protocol;

(b) Protocol deviations committed by the Site, the PI, or any sub-investigator that were not authorized or approved by Sponsor in writing; and

The Site's indemnification obligations under this Section 5.2 shall be subject to a cap of Five Million Dollars ($5,000,000) per site, per occurrence. The aggregate indemnification liability of the Network and all Veridian Network participating sites under the MCTA shall not exceed Twenty Million Dollars ($20,000,000) in the aggregate.

Section 5.3 — Notice of Claims

The indemnified party shall provide written notice to the indemnifying party of any claim, demand, action, suit, or proceeding for which indemnification is sought under this Article 5 within thirty (30) calendar days of the indemnified party's becoming aware of such claim. Such notice shall include a reasonably detailed description of the claim and the factual basis therefor, together with copies of any relevant correspondence, pleadings, or other documents received by the indemnified party.

Failure to provide timely notice as required by this Section 5.3 shall not relieve the indemnifying party of its indemnification obligations hereunder, except to the extent that the indemnifying party demonstrates that it has been materially prejudiced by such failure.

Section 5.4 — Defense and Settlement

The procedures governing the defense, management, and settlement of indemnified claims shall be as set forth in Exhibit D to the MCTA, which procedures are incorporated herein by reference. Without limiting the foregoing, no party shall settle any claim for which indemnification is sought under this Article 5 without the prior written consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned, or delayed. The indemnifying party shall have the right to assume control of the defense of any indemnified claim, using counsel of its choosing, provided that the indemnified party shall have the right to participate in such defense at its own expense with counsel of its own choosing.

ARTICLE 6 — INSURANCE

Section 6.1 — Sponsor Insurance

Sponsor represents and warrants that it maintains clinical trial liability insurance coverage through Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with the following minimum coverage limits:

(a) Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000);

(b) Aggregate limit: Seventy-Five Million Dollars ($75,000,000);

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

Sponsor shall name the Site (along with the Network and each other Participating Site) as an additional insured under such policy with respect to liabilities arising from the conduct of the Protocol. The current policy period is April 1, 2023 through March 31, 2024, renewable annually. Sponsor shall maintain such coverage, or substantially equivalent coverage, throughout the term of the Protocol and for a period of not less than three (3) years following completion or termination of all study activities under the Protocol.

Sponsor shall provide the Site with a certificate of insurance evidencing such coverage within fifteen (15) business days of the execution of this Site Agreement and shall provide updated certificates annually and upon any material change, renewal, or replacement of the policy.

Section 6.2 — Site Insurance

The Site shall obtain and maintain, at its own expense, general liability and professional liability (medical malpractice) insurance coverage with minimum limits of not less than:

(a) Five Million Dollars ($5,000,000) per occurrence; and

(b) Ten Million Dollars ($10,000,000) in the aggregate.

Such coverage shall be maintained throughout the term of this Site Agreement and for a period of not less than three (3) years following completion or termination of all study activities at the Site. If the Site's coverage is provided on a claims-made basis, the Site shall maintain tail coverage or an extended reporting period endorsement for a minimum of three (3) years following the expiration or termination of the policy.

Evidence of coverage, in the form of a certificate of insurance, must be provided to Sponsor within fifteen (15) business days of execution of this Site Agreement and annually thereafter on each anniversary of the Site Agreement Effective Date. The Site shall notify Sponsor and the Network promptly (and in any event within ten (10) business days) of any material change in, cancellation of, or non-renewal of such coverage.

If the Site is a government entity or is otherwise self-insured, the Site shall provide Sponsor with evidence of its self-insurance program or governmental immunity, together with a letter from an authorized representative of the Site confirming the scope and limits of such self-insurance or immunity.

Section 6.3 — Exchange of Certificates

The Parties shall exchange certificates of insurance within fifteen (15) business days of execution of this Site Agreement and annually thereafter during the term of the Protocol. Each Party shall promptly notify the other Parties of any material changes to its insurance coverage, including any reduction in limits, cancellation, or non-renewal.

ARTICLE 7 — IRB APPROVAL

Section 7.1 — IRB of Record

The IRB of record for the conduct of the Protocol at the Site is identified in Site-Specific Schedule C attached hereto. The Site shall ensure that the IRB of record has appropriate registration with the Office for Human Research Protections (OHRP) and, if applicable, with the FDA, and that the IRB of record has a current Federalwide Assurance (FWA) on file with OHRP.

If the Site relies on a central or external IRB for the review and oversight of the Protocol, including the Veridian Central IRB, the Site shall execute an IRB Authorization Agreement (IAA) or equivalent reliance agreement prior to Site Activation, in accordance with the requirements of the revised Common Rule (45 C.F.R. Part 46, as amended effective January 21, 2019) and applicable FDA regulations. A copy of the executed IAA shall be provided to Sponsor and the Network and shall be maintained in the Site's regulatory files.

For Sites located in the Commonwealth of Pennsylvania, the Graystone University Institutional Review Board (IRB Registration No. IRB00012847; FWA No. FWA00018965) shall serve as the lead reviewing IRB for the Protocol, and all such Pennsylvania Sites shall rely on the Graystone University IRB under an executed IAA. For Sites located outside the Commonwealth of Pennsylvania, the Veridian Central IRB may serve as the reviewing IRB under an IAA consistent with the revised Common Rule requirements, or the Site may use its own institutional IRB as the IRB of record, subject to Sponsor's approval.

Section 7.2 — Continuing IRB Approval

The Site shall maintain continuous, uninterrupted IRB approval for the Protocol throughout the conduct of study activities at the Site. The Site shall be responsible for the timely submission of all materials required by the IRB of record, including without limitation:

(a) Protocol amendments (including all Sponsor-initiated and investigator-initiated amendments);

(b) Revised informed consent forms;

(c) Continuing review applications (at intervals not to exceed twelve (12) months, or more frequently if required by the IRB);

(d) Reports of serious adverse events, unanticipated problems involving risks to subjects or others, and protocol deviations, in accordance with the IRB's reporting requirements and Exhibit J to the MCTA;

(e) Safety reports and IND Safety Reports provided by Sponsor; and

(f) Any other documents or correspondence required by the IRB of record.

In the event that the Site's IRB approval lapses, is suspended, or is withdrawn for any reason, the Site shall immediately suspend all enrollment activities and all study activities at the Site (except for activities necessary to protect the safety and welfare of subjects already enrolled in the Protocol) and shall notify Sponsor and the Network in writing within twenty-four (24) hours of becoming aware of such lapse, suspension, or withdrawal. If IRB approval is not reinstated within thirty (30) calendar days, Sponsor may terminate this Site Agreement in accordance with Article 8.

Section 7.3 — Informed Consent

The Site shall obtain documented informed consent from each study subject prior to the performance of any Protocol-specific procedures, in accordance with 21 C.F.R. Part 50, ICH Guideline E6(R2), and applicable state law. The informed consent process shall be conducted using the IRB-approved informed consent form, which shall include all elements of informed consent required by 21 C.F.R. § 50.25 and shall incorporate HIPAA authorization language as required by 45 C.F.R. § 164.508.

The PI or a qualified and authorized sub-investigator shall personally conduct or supervise the informed consent process for each subject, ensuring that the subject has sufficient time to consider participation, that all questions are answered to the subject's satisfaction, and that the subject's consent is given voluntarily and without coercion or undue influence. A copy of the signed informed consent form shall be provided to the subject, and the original shall be maintained in the subject's study file at the Site.

ARTICLE 8 — TERM AND TERMINATION

Section 8.1 — Term

This Site Agreement shall become effective upon execution by all three Parties (Sponsor, Network, and Site) and shall remain in full force and effect until the earliest of the following:

(a) Completion of all study activities and fulfillment of all obligations at the Site under the Protocol, including the submission of all final data, resolution of all data queries, return or destruction of all unused investigational product, and submission of the final study close-out report to the IRB;

(b) Termination of the MCTA in accordance with its terms; or

Section 8.2 — Termination for Convenience by Sponsor

Sponsor may terminate this Site Agreement, in whole or in part, for any reason or no reason, upon sixty (60) days' prior written notice to the Site and the Network. In the event of termination for convenience by Sponsor, Sponsor shall compensate the Site in accordance with Section 8.5(d) below.

Section 8.3 — Termination for Cause

Either Party may terminate this Site Agreement immediately upon written notice to the other Parties if any of the following events occurs:

(a) A Party materially breaches any provision of this Site Agreement or the MCTA and fails to cure such breach within thirty (30) calendar days after receipt of written notice specifying the breach in reasonable detail;

(b) A Party becomes subject to any regulatory action, debarment, exclusion, or sanction by the FDA, OHRP, OIG, or any other governmental authority that prevents or materially impairs the conduct of the Protocol at the Site;

(c) The Site loses IRB approval for the Protocol and is unable to obtain reinstatement of such approval within thirty (30) calendar days; or

(d) The PI is replaced or becomes unavailable and Sponsor does not approve a replacement PI within thirty (30) calendar days, as provided in Section 3.3 above.

Section 8.4 — Termination by Site

The Site may terminate this Site Agreement upon ninety (90) days' prior written notice to Sponsor and the Network, provided that the Site complies with all wind-down obligations set forth in Section 8.5 below and cooperates with Sponsor and the Network to ensure the safety and continuity of care for all subjects enrolled at the Site. The Site's notice of termination shall include a detailed description of the reasons for termination and a proposed plan for the orderly wind-down of study activities at the Site.

Section 8.5 — Wind-Down Obligations

EXHIBIT C
FORM OF INDIVIDUAL SITE AGREEMENT (JOINDER)
to the
MASTER CLINICAL TRIAL AGREEMENT
dated June 28, 2023
by and between
PENTERRA PHARMACEUTICALS CORP.
and
VERIDIAN HEALTH RESEARCH NETWORK, INC.
Protocol: PPC-4871-III Study Title: CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology Investigational Product: Penterafenib (PPC-4871) IND Number: IND 157823 ClinicalTrials.gov Identifier: NCT05928174
[This form is to be completed and executed by each Veridian Network participating site institution to become a party to the MCTA. All bracketed items are to be completed with site-specific information prior to execution.]
INDIVIDUAL SITE AGREEMENT (JOINDER)
This Individual Site Agreement (this "Site Agreement") is entered into as of \\\\\\\\\\\\\\\\\\\\ (the "Site Agreement Effective Date") by and among:
1. Penterra Pharmaceuticals Corp., a Delaware corporation with its principal offices at 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540 ("Sponsor");
2. Veridian Health Research Network, Inc., a Delaware 501(c)(3) corporation with its principal offices at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104 ("Network"); and
3. \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ [Full Legal Name of Site Institution], a \\\\\\\\\\\\\\\\ [state] \\\\\\\\\\\\\\\\ [entity type] with its principal offices at \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ [address] (the "Site" or "Institution").
Sponsor, Network, and the Site are each referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS, Sponsor and Network entered into that certain Master Clinical Trial Agreement dated June 28, 2023 (as amended from time to time, the "MCTA"), governing the conduct of Protocol PPC-4871-III, entitled "CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology" (the "Protocol"), across participating institutions within the Veridian Health Research Network;
WHEREAS, the MCTA provides that each participating institution within the Network shall execute this Form of Individual Site Agreement (Exhibit C to the MCTA) to become bound by the terms and conditions of the MCTA as a Participating Site;
WHEREAS, the Site is a member institution of the Veridian Health Research Network and desires to participate in the conduct of the Protocol at the Site in accordance with the MCTA and this Site Agreement;
WHEREAS, the Site has identified \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\_ [name of Principal Investigator] as the Principal Investigator for the conduct of the Protocol at the Site;
WHEREAS, the Site's Institutional Review Board or reliance IRB, as applicable, has reviewed and approved, or will review and approve, the Protocol and all associated informed consent documents prior to the enrollment of any subjects at the Site; and
WHEREAS, the investigational product that is the subject of the Protocol, penterafenib (PPC-4871), is currently being studied under Investigational New Drug Application No. IND 157823 filed with the United States Food and Drug Administration and is registered on ClinicalTrials.gov under identifier NCT05928174;
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and in the MCTA, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1 — DEFINITIONS AND INCORPORATION BY REFERENCE
Section 1.1 — Definitions
All capitalized terms used but not otherwise defined in this Site Agreement shall have the meanings ascribed to them in the MCTA. In addition to the definitions set forth in the MCTA, the following terms shall have the meanings set forth below when used in this Site Agreement:
(a) "IRB" means the Institutional Review Board or Ethics Committee identified in Site-Specific Schedule C attached hereto, which shall serve as the IRB of record for the conduct of the Protocol at the Site.
(b) "Principal Investigator" or "PI" means the individual identified in Site-Specific Schedule B attached hereto who is designated by the Site as the principal investigator responsible for the conduct of the Protocol at the Site.
(c) "Site" means the Institution identified in the preamble to this Site Agreement and the physical facility or facilities where the Protocol will be conducted, as specified in Site-Specific Schedule A attached hereto.
(d) "Site Activation Date" means the date on which Sponsor provides written confirmation (which may be delivered by email from Sponsor's clinical operations team or the CRO) that the Site has satisfied all pre-activation conditions set forth in this Site Agreement and the MCTA and is authorized to begin enrollment of subjects in the Protocol.
(e) "Site Agreement Effective Date" means the date first written above in the preamble to this Site Agreement.
(f) "Site Number" means \\\\\\\\\\\\\\ as assigned by Sponsor for purposes of identifying the Site within the Protocol.
Section 1.2 — Incorporation of MCTA
The terms and conditions of the MCTA, including all Exhibits and Schedules thereto (Exhibits A through K and Schedule 1), are hereby incorporated by reference into this Site Agreement as if fully set forth herein. The Site acknowledges that it has received and reviewed a complete copy of the MCTA and all Exhibits and Schedules thereto.
In the event of any conflict or inconsistency between the terms of this Site Agreement and the terms of the MCTA, the MCTA shall control and govern, except to the extent that this Site Agreement contains site-specific modifications that have been expressly agreed to in writing by all three Parties and are set forth in the Site-Specific Schedules attached hereto (Schedules A through D). For the avoidance of doubt, no site-specific modification shall be effective unless it is explicitly identified as a modification to the corresponding provision of the MCTA and is signed or initialed by authorized representatives of all three Parties.
All Exhibits to the MCTA are binding on the Site as if the Site were a direct party thereto, including without limitation the following:
(a) Exhibit A — Protocol Synopsis;
(b) Exhibit B — Budget and Payment Schedule (as modified by Site-Specific Schedule D hereto);
(c) Exhibit D — Subject-Injury Indemnification Provisions;
(d) Exhibit E — Insurance Requirements;
(e) Exhibit F — Confidentiality and Data Protection;
(f) Exhibit G — Intellectual Property and Publication Rights;
(g) Exhibit H — Regulatory Compliance Representations;
(h) Exhibit I — Form of Investigator Undertaking;
(i) Exhibit J — Safety Reporting Procedures; and
(j) Exhibit K — Approved Subcontractors List.
The Site agrees to comply with all obligations imposed on a "Participating Site" or "Site" under the MCTA and each Exhibit and Schedule thereto as if such obligations were set forth in full in this Site Agreement.
ARTICLE 2 — JOINDER AND ASSUMPTION OF OBLIGATIONS
Section 2.1 — Joinder
By executing this Site Agreement, the Site hereby agrees to be bound by and subject to all terms, conditions, representations, warranties, covenants, and obligations of a "Participating Site" or "Site" under the MCTA, with the same force and effect as if the Site were an original signatory thereto. This Site Agreement constitutes a joinder to the MCTA, and the Site shall be deemed a party to the MCTA from and after the Site Agreement Effective Date for all purposes related to the conduct of the Protocol at the Site.
The Network hereby confirms that the Site is a member institution of the Veridian Health Research Network and is listed on Schedule 1 to the MCTA (Network Member Institutions). If the Site is not currently listed on Schedule 1, the Network shall update Schedule 1 to include the Site concurrently with the execution of this Site Agreement.
Section 2.2 — Assumption of Obligations
The Site hereby assumes all obligations of a Participating Site under the MCTA, including but not limited to the following:
(a) Protocol Compliance. Conduct of the Protocol in strict compliance with the approved protocol document (including all amendments thereto approved by the IRB and Sponsor), applicable federal, state, and local law, Good Clinical Practice as set forth in ICH Guideline E6(R2), and all applicable regulations of the United States Food and Drug Administration, including without limitation 21 C.F.R. 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).
(b) IRB Approval. Maintenance of continuous IRB approval for the Protocol throughout the conduct of study activities at the Site, including timely submission of continuing review applications, protocol amendments, informed consent revisions, safety reports, and all other materials required by the IRB of record.
(c) Safety Reporting. Compliance with all safety reporting obligations as set forth in Exhibit J to the MCTA, including but not limited to the reporting of all serious adverse events ("SAEs") to Sponsor (or its designated CRO, Meridian Contract Research Organization, Inc.) within twenty-four (24) hours of site awareness, and the reporting of all adverse events, protocol deviations, and other safety-related information in the timeframes and formats specified in the Protocol and Exhibit J.
(d) Privacy and Data Protection. Compliance with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164 ("HIPAA"), including the Privacy Rule and the Security Rule, and all applicable state privacy and data protection laws. The Site shall ensure that appropriate authorizations for the use and disclosure of protected health information are obtained from each study subject as part of the informed consent process.
(e) Record Retention. Retention of all source documents, medical records, study files, regulatory correspondence, and other records related to the Protocol for a minimum period of fifteen (15) years following study completion at the Site, or for such longer period as may be required by applicable law, regulation, or institutional policy, whichever is longer. The Site shall not destroy, discard, or transfer any study records without the prior written consent of Sponsor.
(f) Confidentiality. Compliance with the confidentiality obligations set forth in Exhibit F to the MCTA, which obligations shall remain in effect for a period of ten (10) years from the date of disclosure of any Confidential Information, regardless of the termination or expiration of this Site Agreement or the MCTA.
(g) Monitoring, Inspection, and Audit. Permitting Sponsor, Meridian Contract Research Organization, Inc. (the "CRO"), and applicable regulatory authorities (including but not limited to the FDA, the Office for Human Research Protections, and the Office of Inspector General) to inspect and audit the Site's facilities, records, source documents, regulatory files, pharmacy records, and other materials related to the conduct of the Protocol, upon reasonable notice and during normal business hours. The Site shall make every reasonable effort to accommodate monitoring visits conducted by the CRO on a schedule mutually agreed upon by the Site and the CRO, and shall make the PI and key site personnel available during such visits.
(h) Anti-Kickback and Fair Market Value Compliance. Compliance with the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the Centers for Medicare & Medicaid Services Open Payments reporting requirements, and fair market value requirements as set forth in Exhibit H to the MCTA. The Site acknowledges and agrees that all compensation payable under this Site Agreement and the MCTA has been negotiated at arm's length and reflects fair market value for the services to be rendered, and that no payment is intended to induce or reward the referral of subjects or patients for the Protocol or for any other purpose prohibited by applicable law.
Section 2.3 — Network Responsibility
The Network remains jointly responsible with the Site for the performance of obligations under the MCTA, subject to the terms, conditions, and limitations set forth in the MCTA. The Site acknowledges that the Network serves as the administrative and coordinating entity for all participating sites within the Veridian Health Research Network and that the Network's obligations under the MCTA, including without limitation the Network's obligations with respect to oversight, quality assurance, and regulatory coordination, are not diminished, altered, or otherwise affected by the Site's execution of this Site Agreement.
The Site further acknowledges that the Network may exercise certain administrative functions on behalf of the Site, including but not limited to the coordination of IRB reliance agreements, the centralized collection and dissemination of safety data, and the facilitation of communications between the Site and Sponsor. The Site agrees to cooperate with the Network in the discharge of such administrative functions and to respond promptly to all requests for information from the Network related to the conduct of the Protocol.
ARTICLE 3 — PRINCIPAL INVESTIGATOR
Section 3.1 — Designation of Principal Investigator
The Site hereby designates the individual identified in Site-Specific Schedule B attached hereto as the Principal Investigator for the conduct of the Protocol at the Site. The PI shall have overall responsibility for the proper conduct of the Protocol at the Site, including responsibility for subject safety, data integrity, compliance with the Protocol and applicable regulations, and supervision of all sub-investigators and site staff involved in Protocol-related activities.
The PI must be qualified by training, education, and experience to assume responsibility for the proper conduct of the Protocol at the Site, as required by 21 C.F.R. § 312.53(a). As evidence of such qualification, the PI shall provide to Sponsor, prior to Site Activation, the following documents:
(i) A duly executed FDA Form 1572 (Statement of Investigator);
(ii) A current curriculum vitae demonstrating relevant medical training, board certifications, research experience, and GCP training;
(iii) A current and unrestricted medical license issued by the state in which the Site is located; and
(iv) An executed Investigator Undertaking in the form attached as Exhibit I to the MCTA.
Section 3.2 — Sub-Investigators
Site-Specific Schedule B shall include a complete list of all sub-investigators who are authorized to conduct Protocol-related activities at the Site under the supervision of the PI. Each sub-investigator must meet the following requirements:
(a) Be listed on the PI's FDA Form 1572;
(b) Execute the Investigator Undertaking in the form attached as Exhibit I to the MCTA;
(c) Provide a current curriculum vitae and documentation of completed GCP training; and
(d) Complete and submit a financial disclosure certification in accordance with 21 C.F.R. Part 54.
The Site shall promptly notify Sponsor and the Network of any additions to, or removals from, the list of sub-investigators, and shall submit updated FDA Form 1572 documentation reflecting any such changes within ten (10) business days. No sub-investigator may begin performing Protocol-related activities until the sub-investigator has been added to the FDA Form 1572 and the updated form has been submitted to Sponsor.
Section 3.3 — Replacement of Principal Investigator
The Site may not replace the PI without the prior written consent of Sponsor, which consent shall not be unreasonably withheld, conditioned, or delayed. If the PI becomes unable or unwilling to continue serving as the principal investigator for the Protocol at the Site, whether due to illness, departure from the Institution, regulatory action, loss of medical licensure, or any other reason, the Site shall:
(a) Promptly notify Sponsor and the Network in writing of the PI's inability or unwillingness to continue, providing a detailed explanation of the circumstances;
(b) Propose a qualified replacement PI who meets all requirements set forth in Section 3.1 above; and
(c) Provide Sponsor with the proposed replacement PI's curriculum vitae, FDA Form 1572, financial disclosure certification, and other documentation required under the MCTA.
Sponsor shall review the proposed replacement PI and shall notify the Site and the Network of its approval or disapproval within thirty (30) calendar days of receipt of the complete documentation package for the proposed replacement. If Sponsor does not approve a replacement PI within such thirty (30)-day period, or if the Site is unable to propose a qualified replacement, Sponsor may terminate this Site Agreement in accordance with the provisions of Article 8 hereof.
During any period in which the Site does not have an approved PI, the Site shall suspend all enrollment activities and shall continue to provide appropriate medical care to subjects already enrolled at the Site, under the supervision of a qualified physician designated by the Site and acceptable to Sponsor.
Section 3.4 — Financial Disclosure
The PI and all sub-investigators listed on the FDA Form 1572 must complete and submit financial disclosure certifications in the form required under 21 C.F.R. Part 54, as set forth in the template referenced in the MCTA. Such certifications must be submitted:
(a) Prior to Site Activation;
(b) Annually thereafter, within thirty (30) days following each anniversary of the Site Activation Date; and
(c) Within thirty (30) days of any change in the financial interests of the PI or any sub-investigator that could affect the certification previously submitted.
The Site shall ensure that the PI and all sub-investigators are aware of their obligations under 21 C.F.R. Part 54 and shall promptly notify Sponsor and the Network of any disclosable financial interests or arrangements that arise during the conduct of the Protocol at the Site. Failure to comply with financial disclosure requirements may result in suspension or termination of the Site's participation in the Protocol.
ARTICLE 4 — SITE-SPECIFIC BUDGET AND PAYMENT
Section 4.1 — Budget Allocation
The site-specific budget for the Site is set forth in Site-Specific Schedule D attached hereto, which budget is based upon and consistent with the Budget and Payment Schedule attached as Exhibit B to the MCTA. The total per-patient fee is Fifty-Two Thousand Dollars ($52,000) per subject (screen-to-completion), payable in four (4) milestone-based installments as follows:
(i) Milestone 1 — Randomization: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon randomization of the subject into the Protocol;
(ii) Milestone 2 — Week 12 Assessment: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of the Week 12 study assessment for the subject;
(iii) Milestone 3 — Week 24 Assessment: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of the Week 24 study assessment for the subject; and
(iv) Milestone 4 — Study Completion / Final Visit: Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of all study activities for the subject, including the final study visit and resolution of all outstanding data queries related to such subject.
The Site's projected enrollment target is set forth in Site-Specific Schedule D. For reference, the total planned enrollment across all thirty-eight (38) Veridian Network participating sites is one thousand two hundred (1,200) subjects, randomized in a 2:1 ratio (penterafenib to placebo). The Site acknowledges that projected enrollment targets are estimates and that actual enrollment may vary based on subject availability, Site performance, and overall study enrollment progress.
Section 4.2 — Start-Up Fees
The Site shall receive a non-refundable start-up fee of Seventy-Five Thousand Dollars ($75,000), payable in two (2) installments as follows:
(i) Thirty-Seven Thousand Five Hundred Dollars ($37,500) payable upon Site Activation; and
(ii) Thirty-Seven Thousand Five Hundred Dollars ($37,500) payable upon enrollment (randomization) of the first subject at the Site.
The start-up fee is intended to cover costs associated with site preparation, regulatory submissions, IRB review, staff training, equipment calibration, pharmacy set-up, and other activities necessary to prepare the Site for the conduct of the Protocol. The start-up fee is non-refundable once paid, except in the case of the Site's material breach of this Site Agreement or the MCTA prior to enrollment of the first subject, in which case Sponsor may seek recovery of the start-up fee as part of its remedies under the MCTA.
Section 4.3 — Annual Site Maintenance Fees
The Site shall receive an annual site maintenance fee of Forty Thousand Dollars ($40,000), payable annually in advance on each anniversary of the Site Activation Date, for the duration of the Site's participation in the Protocol. The estimated average duration of site participation is three and one-half (3.5) years per site, although actual duration may vary depending on enrollment timelines and study conduct at the Site.
The annual site maintenance fee is intended to cover ongoing fixed costs associated with the conduct of the Protocol at the Site, including but not limited to facility overhead, regulatory file maintenance, IRB continuing review submissions, staff retention, and other administrative costs. In the event of termination of this Site Agreement prior to any anniversary of the Site Activation Date, the annual site maintenance fee shall be prorated based on the number of days elapsed since the most recent anniversary (or the Site Activation Date, for the first year).
Section 4.4 — Investigator Grants
Investigator grants for publication and academic support shall be disbursed in accordance with the terms set forth in the MCTA and Exhibit G thereto. The total investigator grant pool across all participating sites is One Million Five Hundred Thousand Dollars ($1,500,000). Grants shall be disbursed upon acceptance of manuscripts based on Protocol data for publication in peer-reviewed journals, in accordance with the procedures and eligibility criteria set forth in Exhibit G. The PI and sub-investigators at the Site shall be eligible for investigator grants on the same terms and conditions as investigators at other participating sites within the Veridian Health Research Network.
Section 4.5 — Invoicing and Payment Terms
The Site shall submit invoices to Sponsor (or its designee, currently Meridian Contract Research Organization, Inc.) in accordance with the invoicing procedures specified in Exhibit B to the MCTA. All invoices shall be submitted in writing (electronic submission is acceptable) and shall include the following information:
(a) The Protocol Number (PPC-4871-III);
(b) The Site Number assigned by Sponsor;
(c) The applicable milestone or fee category (e.g., Milestone 1 — Randomization, Start-Up Fee Installment 1, Annual Site Maintenance Fee);
(d) The subject identification number(s), if applicable;
(e) The date(s) on which the milestone was achieved;
(f) The amount invoiced; and
(g) Such other information as may be reasonably required by Sponsor or the CRO.
Payment terms are Net Forty-Five (45) days from Sponsor's (or its designee's) receipt of a proper and complete invoice. Invoices that are incomplete, contain errors, or lack required supporting documentation may be returned to the Site for correction, in which case the forty-five (45)-day payment period shall recommence upon receipt of the corrected invoice. Sponsor shall notify the Site of any deficiencies in an invoice within ten (10) business days of receipt.
All payments shall be made by wire transfer or ACH deposit to the bank account designated by the Site in Site-Specific Schedule D. The Site shall promptly notify Sponsor and the Network in writing of any changes to its banking or payment information.
Section 4.6 — Taxes
All payments under this Site Agreement and the MCTA are exclusive of applicable taxes. The Site shall be solely responsible for any federal, state, or local income, sales, use, excise, or other taxes arising from or related to payments received under this Site Agreement, except to the extent that such taxes are required by law to be withheld by Sponsor. If the Site is a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code, the Site shall provide Sponsor with a copy of its Employer Identification Number (EIN) and its tax-exempt determination letter from the Internal Revenue Service. Sponsor shall not be required to gross up any payments to account for taxes or withholdings.
ARTICLE 5 — INDEMNIFICATION
Section 5.1 — Sponsor Indemnification of Site
Sponsor's indemnification obligations with respect to the Site, its PI, sub-investigators, officers, directors, employees, agents, and site staff are as set forth in Exhibit D to the MCTA, which provisions are incorporated herein by reference in their entirety and shall apply to the Site as if the Site were specifically named therein as an indemnified party.
Without limiting the generality of the foregoing, Sponsor shall defend, indemnify, and hold harmless the Site, the PI, all sub-investigators, and all officers, directors, employees, and agents of the Site (collectively, the "Site Indemnitees") from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of litigation) arising from or related to:
(a) Injury to or death of a study subject caused by the investigational product (penterafenib) when administered in accordance with the Protocol and in compliance with all applicable safety instructions provided by Sponsor;
(b) Any defect in the design, manufacture, formulation, labeling, packaging, storage, or distribution of the investigational product;
(c) Any breach by Sponsor of the MCTA, this Site Agreement, or the Protocol; and
(d) Any negligence or willful misconduct of Sponsor, its employees, agents, or contractors (including the CRO).
Subject-injury medical care costs incurred by or on behalf of study subjects shall be subject to the following limitations: (i) a per-subject cap of Five Hundred Thousand Dollars ($500,000); and (ii) an aggregate cap across all participating sites of Fifteen Million Dollars ($15,000,000). Notwithstanding the foregoing, claims arising from product-defect (as described in clause (b) above) shall not be subject to any per-subject or aggregate cap.
Sponsor's indemnification obligations under this Section 5.1 shall not apply to losses, claims, or damages to the extent arising from:
(i) The negligence or willful misconduct of the Site, the PI, any sub-investigator, or any employee, agent, or representative of the Site;
(ii) Unauthorized deviation from the Protocol by the Site, the PI, or any sub-investigator, unless such deviation was directed or approved by Sponsor in writing; or
(iii) The Site's or the Network's breach of the MCTA, this Site Agreement, or applicable law.
Section 5.2 — Site Indemnification of Sponsor
The Site, jointly and severally with the Network (to the extent provided in the MCTA), shall defend, indemnify, and hold harmless Sponsor, its officers, directors, employees, agents, and contractors (collectively, the "Sponsor Indemnitees") from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of litigation) arising from or related to:
(a) The negligence or willful misconduct of the Site, the PI, any sub-investigator, or any employee, agent, or representative of the Site in connection with the conduct of the Protocol;
(b) Protocol deviations committed by the Site, the PI, or any sub-investigator that were not authorized or approved by Sponsor in writing; and
(c) Any breach by the Site or the Network of the MCTA, this Site Agreement, or applicable law.
The Site's indemnification obligations under this Section 5.2 shall be subject to a cap of Five Million Dollars ($5,000,000) per site, per occurrence. The aggregate indemnification liability of the Network and all Veridian Network participating sites under the MCTA shall not exceed Twenty Million Dollars ($20,000,000) in the aggregate.
Section 5.3 — Notice of Claims
The indemnified party shall provide written notice to the indemnifying party of any claim, demand, action, suit, or proceeding for which indemnification is sought under this Article 5 within thirty (30) calendar days of the indemnified party's becoming aware of such claim. Such notice shall include a reasonably detailed description of the claim and the factual basis therefor, together with copies of any relevant correspondence, pleadings, or other documents received by the indemnified party.
Failure to provide timely notice as required by this Section 5.3 shall not relieve the indemnifying party of its indemnification obligations hereunder, except to the extent that the indemnifying party demonstrates that it has been materially prejudiced by such failure.
Section 5.4 — Defense and Settlement
The procedures governing the defense, management, and settlement of indemnified claims shall be as set forth in Exhibit D to the MCTA, which procedures are incorporated herein by reference. Without limiting the foregoing, no party shall settle any claim for which indemnification is sought under this Article 5 without the prior written consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned, or delayed. The indemnifying party shall have the right to assume control of the defense of any indemnified claim, using counsel of its choosing, provided that the indemnified party shall have the right to participate in such defense at its own expense with counsel of its own choosing.
ARTICLE 6 — INSURANCE
Section 6.1 — Sponsor Insurance
Sponsor represents and warrants that it maintains clinical trial liability insurance coverage through Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with the following minimum coverage limits:
(a) Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000);
(b) Aggregate limit: Seventy-Five Million Dollars ($75,000,000);
(c) Subject-injury sublimit: Ten Million Dollars ($10,000,000) per occurrence / Fifty Million Dollars ($50,000,000) in the aggregate.
Sponsor shall name the Site (along with the Network and each other Participating Site) as an additional insured under such policy with respect to liabilities arising from the conduct of the Protocol. The current policy period is April 1, 2023 through March 31, 2024, renewable annually. Sponsor shall maintain such coverage, or substantially equivalent coverage, throughout the term of the Protocol and for a period of not less than three (3) years following completion or termination of all study activities under the Protocol.
Sponsor shall provide the Site with a certificate of insurance evidencing such coverage within fifteen (15) business days of the execution of this Site Agreement and shall provide updated certificates annually and upon any material change, renewal, or replacement of the policy.
Section 6.2 — Site Insurance
The Site shall obtain and maintain, at its own expense, general liability and professional liability (medical malpractice) insurance coverage with minimum limits of not less than:
(a) Five Million Dollars ($5,000,000) per occurrence; and
(b) Ten Million Dollars ($10,000,000) in the aggregate.
Such coverage shall be maintained throughout the term of this Site Agreement and for a period of not less than three (3) years following completion or termination of all study activities at the Site. If the Site's coverage is provided on a claims-made basis, the Site shall maintain tail coverage or an extended reporting period endorsement for a minimum of three (3) years following the expiration or termination of the policy.
Evidence of coverage, in the form of a certificate of insurance, must be provided to Sponsor within fifteen (15) business days of execution of this Site Agreement and annually thereafter on each anniversary of the Site Agreement Effective Date. The Site shall notify Sponsor and the Network promptly (and in any event within ten (10) business days) of any material change in, cancellation of, or non-renewal of such coverage.
If the Site is a government entity or is otherwise self-insured, the Site shall provide Sponsor with evidence of its self-insurance program or governmental immunity, together with a letter from an authorized representative of the Site confirming the scope and limits of such self-insurance or immunity.
Section 6.3 — Exchange of Certificates
The Parties shall exchange certificates of insurance within fifteen (15) business days of execution of this Site Agreement and annually thereafter during the term of the Protocol. Each Party shall promptly notify the other Parties of any material changes to its insurance coverage, including any reduction in limits, cancellation, or non-renewal.
ARTICLE 7 — IRB APPROVAL
Section 7.1 — IRB of Record
The IRB of record for the conduct of the Protocol at the Site is identified in Site-Specific Schedule C attached hereto. The Site shall ensure that the IRB of record has appropriate registration with the Office for Human Research Protections (OHRP) and, if applicable, with the FDA, and that the IRB of record has a current Federalwide Assurance (FWA) on file with OHRP.
If the Site relies on a central or external IRB for the review and oversight of the Protocol, including the Veridian Central IRB, the Site shall execute an IRB Authorization Agreement (IAA) or equivalent reliance agreement prior to Site Activation, in accordance with the requirements of the revised Common Rule (45 C.F.R. Part 46, as amended effective January 21, 2019) and applicable FDA regulations. A copy of the executed IAA shall be provided to Sponsor and the Network and shall be maintained in the Site's regulatory files.
For Sites located in the Commonwealth of Pennsylvania, the Graystone University Institutional Review Board (IRB Registration No. IRB00012847; FWA No. FWA00018965) shall serve as the lead reviewing IRB for the Protocol, and all such Pennsylvania Sites shall rely on the Graystone University IRB under an executed IAA. For Sites located outside the Commonwealth of Pennsylvania, the Veridian Central IRB may serve as the reviewing IRB under an IAA consistent with the revised Common Rule requirements, or the Site may use its own institutional IRB as the IRB of record, subject to Sponsor's approval.
Section 7.2 — Continuing IRB Approval
The Site shall maintain continuous, uninterrupted IRB approval for the Protocol throughout the conduct of study activities at the Site. The Site shall be responsible for the timely submission of all materials required by the IRB of record, including without limitation:
(a) Protocol amendments (including all Sponsor-initiated and investigator-initiated amendments);
(b) Revised informed consent forms;
(c) Continuing review applications (at intervals not to exceed twelve (12) months, or more frequently if required by the IRB);
(d) Reports of serious adverse events, unanticipated problems involving risks to subjects or others, and protocol deviations, in accordance with the IRB's reporting requirements and Exhibit J to the MCTA;
(e) Safety reports and IND Safety Reports provided by Sponsor; and
(f) Any other documents or correspondence required by the IRB of record.
In the event that the Site's IRB approval lapses, is suspended, or is withdrawn for any reason, the Site shall immediately suspend all enrollment activities and all study activities at the Site (except for activities necessary to protect the safety and welfare of subjects already enrolled in the Protocol) and shall notify Sponsor and the Network in writing within twenty-four (24) hours of becoming aware of such lapse, suspension, or withdrawal. If IRB approval is not reinstated within thirty (30) calendar days, Sponsor may terminate this Site Agreement in accordance with Article 8.
Section 7.3 — Informed Consent
The Site shall obtain documented informed consent from each study subject prior to the performance of any Protocol-specific procedures, in accordance with 21 C.F.R. Part 50, ICH Guideline E6(R2), and applicable state law. The informed consent process shall be conducted using the IRB-approved informed consent form, which shall include all elements of informed consent required by 21 C.F.R. § 50.25 and shall incorporate HIPAA authorization language as required by 45 C.F.R. § 164.508.
The PI or a qualified and authorized sub-investigator shall personally conduct or supervise the informed consent process for each subject, ensuring that the subject has sufficient time to consider participation, that all questions are answered to the subject's satisfaction, and that the subject's consent is given voluntarily and without coercion or undue influence. A copy of the signed informed consent form shall be provided to the subject, and the original shall be maintained in the subject's study file at the Site.
ARTICLE 8 — TERM AND TERMINATION
Section 8.1 — Term
This Site Agreement shall become effective upon execution by all three Parties (Sponsor, Network, and Site) and shall remain in full force and effect until the earliest of the following:
(a) Completion of all study activities and fulfillment of all obligations at the Site under the Protocol, including the submission of all final data, resolution of all data queries, return or destruction of all unused investigational product, and submission of the final study close-out report to the IRB;
(b) Termination of the MCTA in accordance with its terms; or
(c) Termination of this Site Agreement in accordance with this Article 8.
Section 8.2 — Termination for Convenience by Sponsor
Sponsor may terminate this Site Agreement, in whole or in part, for any reason or no reason, upon sixty (60) days' prior written notice to the Site and the Network. In the event of termination for convenience by Sponsor, Sponsor shall compensate the Site in accordance with Section 8.5(d) below.
Section 8.3 — Termination for Cause
Either Party may terminate this Site Agreement immediately upon written notice to the other Parties if any of the following events occurs:
(a) A Party materially breaches any provision of this Site Agreement or the MCTA and fails to cure such breach within thirty (30) calendar days after receipt of written notice specifying the breach in reasonable detail;
(b) A Party becomes subject to any regulatory action, debarment, exclusion, or sanction by the FDA, OHRP, OIG, or any other governmental authority that prevents or materially impairs the conduct of the Protocol at the Site;
(c) The Site loses IRB approval for the Protocol and is unable to obtain reinstatement of such approval within thirty (30) calendar days; or
(d) The PI is replaced or becomes unavailable and Sponsor does not approve a replacement PI within thirty (30) calendar days, as provided in Section 3.3 above.
Section 8.4 — Termination by Site
The Site may terminate this Site Agreement upon ninety (90) days' prior written notice to Sponsor and the Network, provided that the Site complies with all wind-down obligations set forth in Section 8.5 below and cooperates with Sponsor and the Network to ensure the safety and continuity of care for all subjects enrolled at the Site. The Site's notice of termination shall include a detailed description of the reasons for termination and a proposed plan for the orderly wind-down of study activities at the Site.
Section 8.5 — Wind-Down Obligations
Upon any termination or expiration of this Site Agreement, regardless of the reason therefor, the Site shall comply with a wind-down period of one hundred twenty (120) days (or such shorter period as may be mutually agreed upon by the Parties in writing) during which the following obligations shall apply:
(a) Subject Transition and Continuity of Care. Subjects who are in active treatment at the time of termination must be transitioned to another participating site within the Veridian Health Research Network, or, if no suitable receiving site is available, must be permitted to complete their current treatment cycle at the Site, as directed by Sponsor and the PI in consultation with each subject's treating physician and in accordance with applicable ethical and medical standards. The safety and welfare of enrolled subjects shall be the paramount consideration in all transition decisions.
(b) Safety Reporting. The Site shall continue to comply with all safety reporting obligations under the Protocol and Exhibit J to the MCTA throughout the wind-down period and for such additional period as may be required by applicable law and regulation.
(c) Return of Materials. The Site shall deliver to Sponsor or its designee all study records, data (including electronic data), case report forms, regulatory files, correspondence, unused investigational product, and all other Sponsor-provided materials within thirty (30) days following the end of the wind-down period, or at such earlier time as Sponsor may reasonably request. All unused investigational product shall be returned to Sponsor or destroyed in accordance with Sponsor's instructions and applicable regulatory requirements, with appropriate documentation of disposal.
(d) Compensation. Sponsor shall compensate the Site for (i) all documented, reasonable wind-down costs incurred by the Site in connection with the transition and close-out of study activities; and (ii) all per-patient milestone payments earned through the date of termination for subjects who have achieved one or more milestones set forth in Section 4.1. Any start-up fees or annual site maintenance fees that have been paid but not yet earned (on a prorated basis) shall be subject to reconciliation between the Parties.
Section 8.6 — Survival
The following provisions of this Site Agreement (and the corresponding provisions of the MCTA) shall survive any termination or expiration of this Site Agreement and shall continue in full force and effect in accordance with their respective terms: Article 5 (Indemnification), Article 6 (Insurance), confidentiality obligations (Exhibit F to the MCTA, which shall survive for a period of ten (10) years from the date of disclosure), data ownership (Article 9 and Exhibit G to the MCTA), record retention obligations (Section 9.3, fifteen (15) years post-study completion), publication rights (Article 10), regulatory compliance representations (Article 11), dispute resolution (Article 14), and any other provisions which by their nature or express terms are intended to survive termination or expiration.
ARTICLE 9 — DATA OWNERSHIP AND RECORDS
Section 9.1 — Ownership of Clinical Trial Data
Sponsor retains exclusive ownership of all clinical trial data, including but not limited to all case report form data, electronic data capture records, laboratory data, biomarker data, pharmacokinetic data, imaging data, patient-reported outcome data, and any other data generated at the Site in connection with the conduct of the Protocol, consistent with the applicable provisions of the MCTA and Exhibit G thereto. Such data shall constitute Sponsor's Confidential Information and shall be subject to the confidentiality obligations set forth in Exhibit F to the MCTA.
The Site shall have access to its own site-specific data for internal, non-commercial purposes, including quality assurance, medical record-keeping, and academic research, subject to the confidentiality obligations of the MCTA. The Site shall not use, disclose, publish, or otherwise disseminate any clinical trial data owned by Sponsor except as expressly permitted by the MCTA, Exhibit G, and Article 10 of this Site Agreement.
Section 9.2 — Electronic Data Capture
The Site shall enter all study data into the electronic data capture (EDC) system provided by Pinnacle Data Solutions, Inc., in accordance with Sponsor's data management plan and all applicable requirements of 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures). The Site shall ensure that all personnel who access or enter data into the EDC system have received appropriate training on the use of the system and on the requirements of 21 C.F.R. Part 11, and that each such individual has a unique user identification and password.
The Site shall enter data into the EDC system in a timely manner, as specified in the data management plan, and shall respond to data queries issued by the CRO or Sponsor within the timeframes specified therein. The Site shall maintain source documents that support all data entered into the EDC system, and shall make such source documents available for review during monitoring visits and audits.
Section 9.3 — Record Retention
The Site shall retain all source documents, medical records, study files, regulatory correspondence, IRB documentation, pharmacy records, informed consent forms, and all other records related to the conduct of the Protocol at the Site for a minimum period of fifteen (15) years following study completion at the Site, or for such longer period as may be required by applicable federal, state, or local law, regulation, or institutional policy, whichever is longer. For purposes of this Section, "study completion" means the date on which Sponsor provides written confirmation that all study activities and obligations at the Site have been completed.
The Site shall not destroy, discard, dispose of, or transfer any study records without the prior written consent of Sponsor. If the Site intends to discontinue storage of study records at the Site's facilities (whether due to institutional closure, relocation, or otherwise), the Site shall notify Sponsor at least ninety (90) days in advance and shall cooperate with Sponsor to arrange for the transfer of such records to Sponsor or its designee.
ARTICLE 10 — PUBLICATION RIGHTS
Section 10.1 — Investigator Publication Rights
The PI and sub-investigators at the Site may publish or present the results of the Protocol, subject to and in accordance with the publication provisions set forth in Exhibit G to the MCTA. The Site acknowledges and agrees that the right to publish is subject to the following conditions and restrictions:
(a) Pre-Submission Review. Prior to submission of any manuscript, abstract, poster, or presentation based on or incorporating Protocol data, the PI or sub-investigator shall provide Sponsor with a complete copy of the proposed publication for review at least sixty (60) days in advance of the anticipated date of submission. Sponsor shall review the proposed publication and shall provide comments, if any, within thirty (30) days of receipt.
(b) Confidential Information. Sponsor may request the removal of Confidential Information from the proposed publication, and the PI or sub-investigator shall comply with such request.
(c) Patent Protection Delay. If Sponsor determines that the proposed publication contains patentable subject matter, Sponsor may request an additional delay of the submission for a period of up to ninety (90) days beyond the initial sixty (60)-day review period, for the sole purpose of enabling Sponsor to file patent applications covering such subject matter. The PI or sub-investigator shall comply with such request.
(d) Multi-Center Publications. The MCTA and Exhibit G contain provisions governing the coordination of multi-center publications across the Veridian Health Research Network. The PI and sub-investigators at the Site shall comply with such provisions, including any requirements regarding authorship, acknowledgment, and the timing of individual site publications relative to the primary multi-center publication.
Nothing in this Article 10 shall be construed to prevent the PI or sub-investigators from presenting or discussing Protocol data in the context of patient care, educational activities, or internal institutional research meetings, provided that appropriate measures are taken to protect the confidentiality of Sponsor's Confidential Information.
ARTICLE 11 — REGULATORY COMPLIANCE REPRESENTATIONS
Section 11.1 — Site Representations
The Site hereby represents and warrants to Sponsor and the Network, as of the Site Agreement Effective Date and on a continuing basis throughout the term of this Site Agreement, as follows:
(a) Organization and Good Standing. The Site is duly organized, validly existing, and in good standing under the laws of its state of organization, and has the legal capacity and authority to conduct clinical research and to provide medical care to study subjects.
(b) Authority and Capacity. The Site has the full right, power, and authority to enter into this Site Agreement and to perform its obligations hereunder. The execution, delivery, and performance of this Site Agreement have been duly authorized by all necessary corporate, institutional, or governmental action on the part of the Site, and this Site Agreement constitutes a legal, valid, and binding obligation of the Site, enforceable against the Site in accordance with its terms.
(c) No Debarment or Exclusion. Neither the Site, the PI, nor any sub-investigator or other individual who will be involved in the conduct of the Protocol at the Site is debarred, excluded, suspended, proposed for debarment, or otherwise ineligible to participate in federal healthcare programs (including Medicare and Medicaid) or in FDA-regulated activities under 21 U.S.C. § 335a (Generic Drug Enforcement Act), 42 U.S.C. § 1320a-7 (Exclusion of Certain Individuals and Entities from Participation in Medicare and State Health Care Programs), or any similar federal or state law or regulation. The Site shall promptly notify Sponsor and the Network if any such debarment, exclusion, or ineligibility occurs during the term of this Site Agreement.
(d) Fair Market Value. All payments to be made to the Site under this Site Agreement and the MCTA reflect fair market value for the services to be rendered by the Site and the PI in connection with the conduct of the Protocol, and are not intended to, and do not, induce or reward the referral of subjects or patients for enrollment in the Protocol or for any other purpose in violation of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b) or any other applicable law.
(e) Compliance with Law. The Site will comply with all applicable federal, state, and local laws, rules, and regulations in connection with the performance of its obligations under this Site Agreement and the MCTA, including without limitation all FDA regulations, HIPAA, applicable state privacy and data breach notification laws, and the regulations and guidance of the Office for Human Research Protections.
(f) Sunshine Act / Open Payments. The Site will comply with the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the Centers for Medicare & Medicaid Services Open Payments reporting requirements, and will cooperate with Sponsor in reporting all applicable payments and transfers of value to physicians and teaching hospitals as required by applicable law. The Site shall ensure that the PI and all sub-investigators are aware of their obligations under the Sunshine Act and shall provide Sponsor with such information as Sponsor may reasonably request in order to comply with its reporting obligations.
ARTICLE 12 — APPROVED SUBCONTRACTORS AND CRO
Section 12.1 — Approved Third Parties
The Site acknowledges and agrees that Sponsor has engaged the following approved subcontractors for the conduct of the Protocol, as listed in Exhibit K to the MCTA:
(a) Meridian Contract Research Organization, Inc. — CRO services including clinical monitoring, data management, safety reporting, pharmacovigilance, biostatistics, and regulatory support. Principal offices at 9200 Corporate Boulevard, Raleigh, NC 27615.
(b) Pinnacle Data Solutions, Inc. — Electronic data capture (EDC) platform and related data management technology. Principal offices at 6000 Clearwater Drive, San Diego, CA 92121.
(c) Northbridge Bioanalytical Laboratories, Inc. — Central laboratory services, including clinical chemistry, hematology, urinalysis, pharmacokinetic sample analysis, and biomarker assays. Principal offices at 2900 Commerce Way, Baltimore, MD 21224.
The Site shall cooperate with such approved subcontractors as reasonably necessary for the proper conduct of the Protocol, including providing access to Site facilities and study records during monitoring visits, responding to data queries in a timely manner, shipping laboratory samples in accordance with specified procedures, and complying with the data management and safety reporting processes established by the CRO. The Site's obligations to cooperate with approved subcontractors shall not relieve Sponsor of its responsibilities under the MCTA for the acts and omissions of such subcontractors.
Section 12.2 — Site Subcontracting
The Site shall not subcontract, delegate, or assign any of its obligations under this Site Agreement or the MCTA to any third party without the prior written consent of Sponsor, which consent may be granted or withheld in Sponsor's sole discretion. Any approved subcontract shall be in writing and shall contain terms and conditions consistent with and no less restrictive than those contained in this Site Agreement and the MCTA, including without limitation provisions relating to confidentiality, data protection, regulatory compliance, and indemnification. The Site shall remain fully responsible for the performance of any subcontracted obligations, regardless of Sponsor's approval of such subcontract.
ARTICLE 13 — CONFIDENTIALITY
The confidentiality provisions set forth in Exhibit F to the MCTA are incorporated herein by reference in their entirety and shall apply to the Site, the PI, all sub-investigators, and all employees, agents, and representatives of the Site as if each were a direct party to Exhibit F.
The term of the confidentiality obligations is ten (10) years from the date of disclosure of any Confidential Information, regardless of the termination or expiration of this Site Agreement or the MCTA.
The scope of Confidential Information includes, without limitation, all Protocol-related information (including the Protocol document, investigator's brochure, study design, endpoints, and statistical analysis plans), investigational product specifications (including chemical composition, formulation, manufacturing processes, and analytical methods), study data (including interim and final results, safety data, and individual subject data), financial terms (including payment schedules, budget information, and fee structures), and all other proprietary or non-public information disclosed by Sponsor to the Site or the Network in connection with the Protocol.
Permitted disclosures of Confidential Information include, without limitation, disclosures to:
(a) The Site's IRB of record, to the extent necessary for IRB review and oversight of the Protocol;
(b) Regulatory authorities, to the extent required by law, regulation, or order (provided that the Site shall give Sponsor prior notice of any such disclosure to the extent legally permissible);
(c) The Site's legal counsel, accountants, and other professional advisors, provided that such individuals are bound by obligations of confidentiality no less restrictive than those contained in Exhibit F; and
(d) The Site's employees, sub-investigators, and site staff who have a need to know such information for the purpose of conducting the Protocol and who have been informed of and agree to comply with the confidentiality obligations set forth herein.
ARTICLE 14 — DISPUTE RESOLUTION
This Site Agreement shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflict-of-law rules or provisions that would cause the application of the laws of any other jurisdiction. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Site Agreement.
Any dispute, controversy, or claim arising out of or relating to this Site Agreement, the MCTA, or the breach, termination, or validity thereof (a "Dispute") shall be resolved in accordance with the escalation procedures set forth in the MCTA, which are summarized as follows:
(1) Negotiation. The designated representatives of each Party shall attempt to resolve the Dispute through good-faith negotiation for a period of thirty (30) calendar days following delivery of written notice of the Dispute by one Party to the other Parties.
(2) Mediation. If the Dispute is not resolved through negotiation within the thirty (30)-day period described above, any Party may submit the Dispute to mediation under the Commercial Mediation Rules of the American Arbitration Association ("AAA"). The mediation shall be conducted in New York, New York, and the Parties shall attempt to resolve the Dispute through mediation for a period of sixty (60) calendar days following the appointment of the mediator. The costs of mediation shall be shared equally among the Parties.
(3) Binding Arbitration. If the Dispute is not resolved through mediation within the sixty (60)-day period described above, any Party may submit the Dispute to binding arbitration in New York, New York, under the Commercial Arbitration Rules of the AAA. The arbitration shall be conducted by a panel of three (3) arbitrators, each of whom shall have experience in pharmaceutical or life sciences disputes. Each Party shall select one arbitrator, and the two Party-selected arbitrators shall select the third arbitrator, who shall serve as the chairperson of the panel. The arbitrators shall render a reasoned written award within ninety (90) days following the close of the arbitration hearing. The arbitrators' award shall be final and binding upon the Parties and may be entered as a judgment in any court of competent jurisdiction.
Notwithstanding the foregoing, any Party may seek temporary restraining orders, preliminary injunctions, or other forms of interim or emergency equitable relief from the state and federal courts located in New York County, New York, without first complying with the negotiation, mediation, and arbitration procedures set forth above, to the extent necessary to prevent irreparable harm or to preserve the status quo pending the resolution of the Dispute through the procedures described herein. Each Party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts located in New York County, New York, for purposes of any such application for injunctive relief.
ARTICLE 15 — NOTICES
All notices, requests, demands, consents, approvals, and other communications required or permitted under this Site Agreement shall be in writing and shall be delivered to the Parties at the following addresses (or at such other address as a Party may designate in writing to the other Parties from time to time):
If to Sponsor:
Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
Attn: Nathaniel Briggs, Esq., Vice President & General Counsel
Telephone: (609) 555-4200
Email: n.briggs@penterra.com
With a copy to:
Samantha Novak, Director, Clinical Contracts Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540 Telephone: (609) 555-4218
E

EXHIBIT C

FORM OF INDIVIDUAL SITE AGREEMENT (JOINDER)

MASTER CLINICAL TRIAL AGREEMENT

PENTERRA PHARMACEUTICALS CORP.

VERIDIAN HEALTH RESEARCH NETWORK, INC.

INDIVIDUAL SITE AGREEMENT (JOINDER)

RECITALS

Record

Parties

Dates

Amounts