Contract analysis

ARTICLE 1 — DEFINITIONS AND INCORPORATION BY REFERENCE

Section 1.1 — Defined Terms All capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to them in the MCTA. In addition, the following definitions shall apply to this Agreement: (a) "MCTA" means that certain Master Clinical Trial Agreement dated June 28, 2023, between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., including all Exhibits and Sche

Section 1.2 — Incorporation of MCTA Terms (a) The terms and conditions of the MCTA are hereby incorporated by reference into this Individual Site Agreement as if fully set forth herein. The Site acknowledges that it has received, reviewed, and understands the MCTA and all Exhibits and Schedules thereto, and agrees to be bound by the terms and conditions thereof as if it were a direct party thereto, subject to the sit

Section 2.1 — Site Identification The following information identifies the Site for purposes of this Agreement and the Study: The full site address and additional contact information are set forth in Schedule A to this Agreement.

Section 2.2 — Site Principal Investigator (a) The Site Principal Investigator for the Study at this Site shall be the individual identified in Schedule A to this Agreement. The Site PI shall be responsible for the overall conduct of the Study at this Site and shall serve as the responsible individual investigator under 21 C.F.R. § 312.53. (b) The Site PI must meet all qualifications set forth in Section 4.3 of the MC

Section 2.3 — Sub-Investigators and Study Personnel (a) A list of qualified sub-investigators and key study personnel authorized to conduct Study activities at this Site shall be identified in Schedule A to this Agreement. This list shall be updated by the Site as necessary to reflect additions, removals, or changes in study personnel, and all updates shall be communicated to the Sponsor and Meridian CRO in a timely

Section 2.4 — Site Facilities and Capabilities (a) The Site hereby certifies that it possesses adequate facilities, equipment, and qualified personnel to conduct the Study in accordance with the Protocol, ICH E6(R2) GCP Guidelines, and all applicable regulatory requirements. Without limiting the foregoing, the Site certifies that it has access to appropriate clinical space for subject screening, enrollment, and follo

ARTICLE 3 — SCOPE OF WORK AND PROTOCOL COMPLIANCE

Section 3.1 — Conduct of the Study (a) The Site shall conduct the Study at this Site in strict accordance with Protocol PPC-4871-III (CLARION), the ICH E6(R2) Good Clinical Practice Guidelines, the Declaration of Helsinki (as most recently amended), and all applicable federal, state, and local laws and regulations, including without limitation the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) and th

Section 3.2 — Protocol Deviations (a) The Site shall not deviate from the Protocol in any material respect except as: (i) authorized in writing by the Sponsor in advance of such deviation, including through Protocol amendments approved by the Veridian Central IRB; or (ii) necessary to protect the immediate safety, rights, or well-being of a study subject, in which case the deviation shall be documented as a medically

Section 3.3 — Regulatory Compliance (a) The Site shall comply with all applicable provisions of the Code of Federal Regulations, including without limitation: (i) 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures); (ii) 21 C.F.R. Part 50 (Protection of Human Subjects); (iii) 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators); (iv) 21 C.F.R. Part 56 (Institutional Review Boards); and (v) 21

Section 3.4 — Use of Approved Subcontractors (a) The Sponsor has approved the following subcontractors for the performance of specified Study-related functions, as set forth in Exhibit K to the MCTA: (i) Meridian Contract Research Organization, Inc. ("Meridian CRO"), serving as the Sponsor's contracted CRO for clinical monitoring, data management, pharmacovigilance, and regulatory affairs; (ii) Pinnacle Data Solution

Section 4.1 — IRB of Record (a) The Veridian Central IRB shall serve as the IRB of record for Site 005 for purposes of the Study. The Site acknowledges and agrees that the Veridian Central IRB will provide initial and continuing review and approval of the Study at this Site, including review of the Protocol, informed consent documents, investigator brochure, recruitment materials, and other study-related documents. (

Section 4.2 — IRB Approval as Condition Precedent (a) The Site shall not enroll any subjects in the Study, administer the Investigational Product to any subject, or initiate any other Study-related procedures involving human subjects until the Veridian Central IRB has granted initial approval for the conduct of the Study at this Site. IRB approval must encompass the Protocol, the informed consent form (including any

Section 4.3 — Continuing Review and Amendments (a) The Site shall ensure that continuing IRB review and approval of the Study is maintained at all times during the conduct of the Study at this Site, as required by 21 C.F.R. Part 56 and the policies of the Veridian Central IRB. The Site shall provide documentation of each continuing review approval to the Sponsor and Meridian CRO promptly upon receipt. (b) Protocol am

ARTICLE 5 — BUDGET AND PAYMENT

Section 5.1 — Budget The site-specific budget for the conduct of the Study at Site 005 is set forth in Schedule B to this Agreement. The budget has been prepared in accordance with and is consistent with the master budget framework set forth in Exhibit B to the MCTA. The key components of the site-specific budget are as follows: All amounts set forth in the budget are inclusive of the Site's costs for personnel, faci

Section 5.2 — Payment Milestones (Per-Patient Fees) Payment of per-patient fees shall be made in four (4) equal milestone installments of Thirteen Thousand Dollars ($13,000) each per enrolled subject, as follows: (a) Milestone 1 — Randomization: Twenty-five percent (25%) of the per-patient fee ($13,000) shall be payable upon confirmation of a subject's randomization in the Study; (b) Milestone 2 — Week 12 Assessment:

Section 5.3 — Start-Up Fees The start-up fee for this Site shall be Seventy-Five Thousand Dollars ($75,000), payable in two (2) equal installments as follows: (a) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) shall be payable upon Site Activation; and (b) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) shall be payable upo

Section 5.4 — Annual Site Maintenance Fees The annual site maintenance fee for this Site shall be Forty Thousand Dollars ($40,000) per year, payable annually in advance on each anniversary of Site Activation. For partial years at the beginning or end of the Study, the annual site maintenance fee shall be prorated on a per-diem basis based on a 365-day year. The annual site maintenance fee is intended to compensate th

Section 5.5 — Payment Terms All payments under this Agreement shall be made Net Forty-Five (45) days from the Sponsor's receipt of a proper and complete invoice submitted by Veridian on behalf of the Site in accordance with the invoicing procedures set forth in the MCTA. Payments shall be made by wire transfer or automated clearing house (ACH) transfer to the bank account designated by Veridian. The Sponsor shall not

Section 5.6 — Invoicing (a) Veridian shall submit invoices to the Sponsor on behalf of this Site in accordance with the invoicing procedures set forth in Article 7 of the MCTA. Invoices shall be submitted on a monthly basis, or at such other frequency as may be agreed by the Parties, and shall include sufficient detail to identify the milestone payments, start-up fees, and site maintenance fees to which each invoice

Section 6.1 — Sponsor Indemnification of Site (a) Penterra Pharmaceuticals Corp. shall indemnify, defend, and hold harmless Weston Memorial Health System, its Site Principal Investigator, sub-investigators, study coordinators, research nurses, and other site staff participating in the Study (collectively, the "Site Indemnitees"), from and against any and all claims, damages, losses, liabilities, costs, and expenses (

Section 6.2 — Carve-Outs from Sponsor Indemnification The Sponsor's indemnification obligations under Section 6.1 shall not extend to, and the Sponsor shall have no obligation to indemnify any Site Indemnitee against, any claims, damages, losses, liabilities, costs, or expenses to the extent arising from or attributable to: (i) The negligence, recklessness, or willful misconduct of the Site, the Site PI, any sub-inve

Section 6.3 — Site Indemnification of Sponsor (a) Weston Memorial Health System and Veridian Health Research Network, Inc. shall, jointly and severally, indemnify, defend, and hold harmless Penterra Pharmaceuticals Corp., its officers, directors, employees, agents, affiliates, and successors (collectively, the "Sponsor Indemnitees"), from and against any and all claims, damages, losses, liabilities, costs, and expens

Section 6.4 — Notice of Claims (a) Any Party seeking indemnification under this Article 6 (the "Indemnified Party") shall provide written notice to the Party from whom indemnification is sought (the "Indemnifying Party") within thirty (30) calendar days of becoming aware of any claim, demand, action, or proceeding for which indemnification may be sought (a "Claim"). Such notice shall include a description of the Clai

Section 6.5 — Defense and Settlement The procedures for the defense and settlement of indemnified Claims, including the Indemnifying Party's right to assume the defense of any Claim, the Indemnified Party's right to participate in such defense at its own expense, and the conditions under which settlement may be effected with or without the consent of the Indemnified Party, shall be as set forth in Exhibit D to the MC

Section 7.1 — Sponsor Insurance (a) The Sponsor represents that it maintains clinical trial liability insurance coverage through Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with a policy period of April 1, 2023 through March 31, 2024, renewable annually. Such policy provides the following coverage limits: (b) Weston Memorial Health System shall be named as an additional insured under the S

Section 7.2 — Site Insurance (a) Weston Memorial Health System shall maintain, at its own expense, general liability insurance and professional liability (medical malpractice) insurance coverage throughout the term of the Study at this Site, with minimum coverage limits of not less than Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggregate. Such coverage shall extend

Section 7.3 — Certificate Exchange The Parties shall exchange certificates of insurance within fifteen (15) business days of execution of this Agreement and annually thereafter during the term of the Study, as further detailed in Sections 7.1(c) and 7.2(b) above. Each Party shall cooperate with the other Parties in providing such additional information regarding its insurance coverage as may be reasonably requested.

Section 8.1 — SAE Reporting (a) The Site shall report all serious adverse events ("SAEs") occurring at this Site to the Sponsor and Meridian CRO within twenty-four (24) hours of the Site's awareness of the SAE, in accordance with the reporting procedures set forth in Exhibit J to the MCTA. For purposes of this Agreement, a serious adverse event is any adverse event that results in death, is life-threatening, requires

Section 8.2 — IND Safety Reports (a) The Sponsor is responsible for the preparation and submission of IND safety reports to the FDA and to all participating investigators in accordance with 21 C.F.R. § 312.32, including: (i) Seven (7) calendar day reports for suspected adverse reactions that are both serious and unexpected and are fatal or life-threatening; and (ii) Fifteen (15) calendar day reports for all other sus

Section 8.3 — Coordination with Meridian CRO (a) Meridian Contract Research Organization, Inc. serves as the Sponsor's contracted CRO for the Study, with responsibility for clinical monitoring, data management, pharmacovigilance, and regulatory affairs support. The Site acknowledges and agrees that Meridian CRO acts on behalf of the Sponsor in the performance of these functions. (b) The Site shall cooperate fully wit

Section 9.1 — Data Ownership (a) Penterra Pharmaceuticals Corp. retains exclusive ownership of all clinical trial data generated at this Site in connection with the Study, including without limitation all case report forms, electronic data capture records, source data transcribed into the Study database, laboratory results, imaging data, biospecimen analyses, pharmacokinetic data, and any other data collected pursuan

Section 9.2 — Electronic Data Capture (a) The Site shall enter all Study data into the electronic data capture (EDC) platform provided by Pinnacle Data Solutions, Inc., in accordance with the Protocol, the data management plan, and the requirements of 21 C.F.R. Part 11 governing electronic records and electronic signatures. (b) The Site shall ensure that all study personnel who access or enter data into the EDC platf

Section 9.3 — Source Document Retention (a) The Site shall retain all source documents, study records, regulatory files, and other documentation related to the conduct of the Study at this Site for a minimum period of fifteen (15) years following the completion, termination, or discontinuation of the Study, or for such longer period as may be required by applicable federal, state, or local law, whichever period is lo

Section 9.4 — Access to Records The Sponsor, Meridian CRO, the FDA, and other regulatory authorities having jurisdiction over the Study shall have the right, upon reasonable notice, to access, review, and copy all records, source documents, regulatory files, and other documentation related to the conduct of the Study at this Site, including but not limited to subject medical records (to the extent permitted by applic

Section 10.1 — Confidentiality Obligations (a) The confidentiality provisions of the MCTA, as set forth in Exhibit F thereto, are hereby incorporated into this Agreement by reference and shall apply to all Confidential Information disclosed to or received by the Site in connection with the Study. (b) The term of the confidentiality obligations shall be ten (10) years from the date of each disclosure of Confidential I

Section 10.2 — Permitted Disclosures Notwithstanding the foregoing confidentiality obligations, the Site may disclose Confidential Information to the extent that such disclosure is: (a) Required in connection with submissions to the Veridian Central IRB or any other institutional review board or ethics committee having jurisdiction over the Study; (b) Required by applicable law, regulation, or legal process, includin

ARTICLE 11 — INTELLECTUAL PROPERTY AND PUBLICATION RIGHTS

Section 11.1 — Pre-Existing intellectual Property Each Party retains all right, title, and interest in and to its pre-existing intellectual property, including patents, patent applications, trade secrets, know-how, copyrights, trademarks, and other proprietary rights that existed prior to the Effective Date or that are developed independently of the Study. Nothing in this Agreement or the MCTA shall be construed to g

Section 11.2 — Study Inventions The ownership, assignment, and licensing of inventions, discoveries, improvements, and other intellectual property conceived, developed, or first reduced to practice in the course of or as a result of activities conducted under the Study (collectively, "Study Inventions") shall be governed by the IP Side Letter executed concurrently with the MCTA on June 28, 2023, by and between Penter

Section 11.3 — Publication Rights (a) Site investigators, including the Site PI and sub-investigators, may publish the results of the Study in peer-reviewed scientific or medical journals, present such results at professional conferences, or otherwise disseminate Study findings, subject to the following conditions: (i) Prior to submission for publication or presentation, the Site PI shall provide the Sponsor with a c

ARTICLE 12 — TERM AND TERMINATION

Section 12.1 — Term (a) This Agreement shall be effective as of the Effective Date and shall continue in full force and effect for the duration of the Study at this Site, including all enrollment, treatment, follow-up, and close-out activities, unless earlier terminated in accordance with this Article 12. (b) The projected Study timeline contemplates a forty-two (42) month enrollment period, with a target first-patie

Section 12.2 — Termination (a) This Agreement may be terminated in accordance with the termination provisions set forth in Article 14 of the MCTA, which provisions are incorporated herein by reference. (b) Either Party may terminate this Agreement for material breach by another Party, provided that the terminating Party delivers written notice of the material breach to the breaching Party specifying the nature of the

Section 12.3 — Wind-Down (a) Upon termination or expiration of this Agreement for any reason, a wind-down period of one hundred twenty (120) calendar days shall apply, during which the Parties shall cooperate in good faith to ensure the orderly conclusion of Study activities at this Site and the protection of enrolled subjects' safety and well-being. (b) During the wind-down period, subjects who are in active treatme

ARTICLE 13 — REPRESENTATIONS AND WARRANTIES

Section 13.1 — Site Representations Weston Memorial Health System hereby represents and warrants to the Sponsor and the Network as follows: (a) The Site is a nonprofit corporation duly organized, validly existing, and in good standing under the laws of the State of Georgia, and is a member institution of the Veridian Health Research Network; (b) The Site has the corporate power and authority to execute, deliver, and

Section 13.2 — Sponsor Representations As set forth in the MCTA, Penterra Pharmaceuticals Corp. has represented and warranted to the Network, and hereby reaffirms to the Site, as follows: (a) The Sponsor is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware, and is publicly traded on the Nasdaq Stock Market under the ticker symbol "PTRA"; (b) The Sponsor holds

Section 13.3 — Regulatory Compliance Representations Each Party represents and warrants to the other Parties that: (a) It is in compliance with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and all applicable state anti-kickback and self-referral laws with respect to the arrangements contemplated by this Agreement and the MCTA; (b) It is in compliance with the Physician Payments Sunshine Act (42 U.S.C.

ARTICLE 14 — DISPUTE RESOLUTION

Section 14.1 — Governing Law This Agreement and the MCTA, and all claims or causes of action (whether in contr