Contract analysis

ARTICLE 1 — JOINDER AND INCORPORATION BY REFERENCE

Section 1.1 — Joinder Haverford Regional Medical Center hereby joins the MCTA as a participating Site and agrees to be bound by all terms, conditions, representations, warranties, covenants, and obligations of the MCTA applicable to a "Site" or "Institution" thereunder, as if Haverford Regional Medical Center were an original signatory party thereto. By executing this Agreement, the Site confirms that it has received

Section 1.2 — Defined Terms Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to such terms in the MCTA. For the avoidance of doubt, all definitions set forth in Article I of the MCTA, including but not limited to the definitions of "Adverse Event," "Confidential Information," "Good Clinical Practice" or "GCP," "Informed Consent Form," "Investigational Product," "Prot

Section 1.3 — Order of Precedence In the event of any conflict, inconsistency, or ambiguity between the terms and conditions of this Agreement and the MCTA, the terms and conditions of the MCTA shall control and take precedence; provided, however, that where such conflict or inconsistency pertains to site-specific information set forth in Appendices A, B, C, or D to this Agreement—including, without limitation, site

Section 2.1 — Site Identification The following information identifies the Site for all purposes under the MCTA and this Agreement: All correspondence, investigational product shipments, regulatory documentation, and monitoring visit communications shall be directed to the addresses and contacts identified in Appendix A, unless otherwise specified in writing by the Site.

Section 2.2 — Site Principal Investigator The principal investigator assigned to Site 003 for the conduct of the CLARION trial (the "Principal Investigator" or "PI") is identified in Appendix B attached hereto. The Principal Investigator shall be responsible for the overall conduct of the CLARION trial at the Site, including supervision of all sub-investigators and study personnel, compliance with the Protocol, and t

Section 2.3 — Sub-Investigators and Key Site Personnel A complete list of all sub-investigators and key study personnel at Site 003, including study coordinators, research nurses, pharmacists responsible for investigational product accountability, and other essential personnel, is set forth in Appendix B. Each sub-investigator identified in Appendix B shall execute an Investigator Undertaking in the form set forth in

Section 2.4 — Site Facilities and Capabilities Haverford Regional Medical Center hereby confirms that it possesses the physical facilities, clinical equipment, laboratory capabilities, qualified medical and research staff, and access to a sufficient patient population necessary to conduct the CLARION trial in accordance with Protocol PPC-4871-III, the MCTA, applicable regulations, and Good Clinical Practice guideline

ARTICLE 3 — IRB APPROVAL AND REGULATORY REQUIREMENTS

Section 3.1 — Institutional Review Board The Institutional Review Board ("IRB") of Record for Site 003 shall be the Veridian Central IRB, which serves as the central IRB for all non-Pennsylvania Veridian Network member institutions participating in the CLARION trial. The Site shall rely upon the Veridian Central IRB for initial and continuing ethical review of Protocol PPC-4871-III, the informed consent form, recruit

Section 3.2 — IRB Approval as Condition Precedent The Site shall not screen, enroll, randomize, or administer investigational product to any subject until: (a) the Veridian Central IRB has granted written approval of Protocol PPC-4871-III (including any applicable amendments), the informed consent form (in the version applicable to Site 003), and all subject-facing recruitment materials; and (b) a copy of the IRB app

Section 3.3 — Regulatory Compliance The Site shall conduct the CLARION trial and all activities under this Agreement in full compliance with all applicable federal, state, and local laws, rules, and regulations, including without limitation the following: (a) 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures); (b) 21 C.F.R. Part 50 (Protection of Human Subjects); (c) 21 C.F.R. Part 54 (Financial Disclosure

Section 3.4 — IND and Sponsor Obligations Penterra Pharmaceuticals Corp. is the holder of IND Application No. 157823 filed with the FDA for penterafenib (PPC-4871) and retains all IND-related regulatory responsibilities, including without limitation the obligation to submit IND annual reports, IND amendments, and IND safety reports to the FDA. The Site acknowledges and agrees that the Sponsor bears sole responsibilit

ARTICLE 4 — PROTOCOL CONDUCT AND SAFETY REPORTING

Section 4.1 — Protocol Compliance The Site shall conduct the CLARION trial in strict accordance with Protocol PPC-4871-III (including all amendments thereto approved by the IRB and the Sponsor), the approved informed consent form, all applicable federal, state, and local laws and regulations, and the ICH E6(R2) Good Clinical Practice guidelines. The Site shall not implement any change to, or deviation from, the Proto

Section 4.2 — Study Conduct The CLARION trial is a Phase III, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the efficacy and safety of penterafenib (PPC-4871) compared to placebo in adult subjects with advanced hepatocellular carcinoma who have received at least one prior line of systemic therapy. The study employs a two-to-one (2:1) randomization ratio, with subjects randomized

Section 4.3 — Safety Reporting The Site shall report all Serious Adverse Events ("SAEs") to the Sponsor and to Meridian Contract Research Organization, Inc. (9200 Corporate Boulevard, Raleigh, North Carolina 27615) within twenty-four (24) hours of the time at which the Site (including the Principal Investigator or any sub-investigator) first becomes aware of the event, in accordance with the Safety Reporting Procedur

Section 4.4 — Electronic Data Capture The Site shall enter all clinical trial data, including but not limited to subject demographic information, efficacy assessments, laboratory results, adverse event reports, concomitant medication records, and protocol deviation reports, into the electronic data capture ("EDC") platform provided by Pinnacle Data Solutions, Inc. (6000 Clearwater Drive, San Diego, California 92121)

Section 4.5 — Central Laboratory All pharmacokinetic ("PK"), pharmacodynamic ("PD"), biomarker, and safety laboratory analyses required under Protocol PPC-4871-III shall be performed by Northbridge Bioanalytical Laboratories, Inc. (2900 Commerce Way, Baltimore, Maryland 21224), which has been designated as the central laboratory for the CLARION trial, unless otherwise specified in the Protocol or the Laboratory Manua

Section 4.6 — Approved Subcontractors The Site acknowledges and agrees that the following entities have been approved by the Sponsor as subcontractors for the performance of specified functions in connection with the CLARION trial, as set forth in Exhibit K to the MCTA: (a) Meridian Contract Research Organization, Inc. (9200 Corporate Boulevard, Raleigh, North Carolina 27615) — serving as the contract research organi

ARTICLE 5 — BUDGET AND PAYMENT TERMS

Section 5.1 — Site Budget Allocation The per-patient site fee for the CLARION trial at Site 003 is Fifty-Two Thousand Dollars ($52,000) per subject (screen-to-completion), calculated to reflect fair market value for the investigator and institutional services required under Protocol PPC-4871-III. This per-patient fee covers all study-related procedures, investigator and coordinator time, institutional overhead, and o

Section 5.2 — Payment Milestones (Per Patient) The per-patient site fee of $52,000 shall be paid in four (4) equal milestone installments as follows: For purposes of this Section 5.2, "study completion / final visit" means the completion of all Protocol-required assessments for the subject, including the end-of-treatment visit and the safety follow-up visit, or, if applicable, the subject's withdrawal from the study

Section 5.3 — Start-Up Fees The total start-up fee payable to Site 003 is Seventy-Five Thousand Dollars ($75,000), intended to cover the costs of site qualification, regulatory submissions, staff training, systems setup, and other start-up activities associated with the initiation of the CLARION trial at the Site. The start-up fee shall be paid in two (2) equal installments as follows: (a) Fifty percent (50%), in the

Section 5.4 — Annual Site Maintenance Fees In addition to the per-patient fees and start-up fees set forth above, the Sponsor shall pay to the Site an annual site maintenance fee of Forty Thousand Dollars ($40,000) per year, payable annually in advance on each anniversary of site activation. The annual site maintenance fee is intended to cover ongoing institutional overhead, research infrastructure costs, regulatory

Section 5.5 — Payment Terms All payments due from the Sponsor to the Site under this Agreement shall be made on a Net Forty-Five (45) days basis from the date of the Sponsor's receipt of a proper, complete, and undisputed invoice from the Site. Invoices shall be submitted to Penterra's Clinical Contracts department at the following address and to the attention of the following individual: Penterra Pharmaceuticals Cor

Section 5.6 — Network Coordination Fee The Site acknowledges that Veridian Health Research Network, Inc. receives a network coordination and administrative fee in the total amount of Four Million Two Hundred Thousand Dollars ($4,200,000), calculated at a rate of Three Hundred Thousand Dollars ($300,000) per quarter over fourteen (14) quarters, paid directly by the Sponsor to the Veridian central office. The network c

Section 5.7 — Technology/EDC Integration Costs The costs associated with the integration, configuration, licensing, and ongoing maintenance of the electronic data capture platform provided by Pinnacle Data Solutions, Inc. are covered under the MCTA's technology/EDC integration allocation of One Million Two Hundred Thirty Thousand Dollars ($1,230,000) and are paid directly by the Sponsor to Pinnacle Data Solutions, In

Section 6.1 — Sponsor Indemnification of Site and Investigators Subject to the terms, conditions, and limitations set forth in this Article 6 and in the MCTA, Penterra Pharmaceuticals Corp. shall defend, indemnify, and hold harmless Haverford Regional Medical Center, its officers, directors, trustees, employees, agents, investigators, sub-investigators, and site staff (collectively, the "Site Indemnitees") from and a

Section 6.2 — Carve-Outs from Sponsor Indemnification Notwithstanding Section 6.1, Penterra's indemnification obligations under this Article 6 shall not apply to any Losses to the extent such Losses arise out of or result from: (i) The negligence, recklessness, or willful misconduct of the Site, the Principal Investigator, any sub-investigator, or any member of the Site's study personnel; (ii) Protocol deviations com

Section 6.3 — Subject-Injury Medical Care In addition to the indemnification obligations set forth in Section 6.1, Penterra shall pay or reimburse the reasonable and customary medical costs incurred for the treatment of study-related injuries sustained by subjects enrolled at Site 003, to the extent such costs are not covered by the subject's own health insurance or other third-party coverage. For purposes of this Se

Section 6.4 — Site/Investigator Indemnification of Sponsor Subject to the terms, conditions, and limitations set forth in this Article 6 and in the MCTA, Haverford Regional Medical Center shall defend, indemnify, and hold harmless Penterra Pharmaceuticals Corp., its officers, directors, employees, agents, and representatives (collectively, the "Sponsor Indemnitees") from and against any and all Losses to the extent a

Section 6.5 — Notice Requirements The Party seeking indemnification (the "Indemnified Party") shall provide written notice to the Party from which indemnification is sought (the "Indemnifying Party") within thirty (30) calendar days of the date on which the Indemnified Party first becomes aware of any claim, demand, action, suit, or proceeding for which indemnification may be sought under this Article 6. Such notice

Section 6.6 — Defense and Settlement The Indemnifying Party shall have the right, at its expense, to assume and control the defense of any claim for which indemnification is sought under this Article 6, including the right to select counsel, direct the litigation strategy, and negotiate and effectuate settlement, provided that the Indemnifying Party shall keep the Indemnified Party reasonably informed of the progress

Section 7.1 — Sponsor Insurance Penterra Pharmaceuticals Corp. represents and warrants that it maintains clinical trial liability insurance through Briarcliff Mutual Insurance Company (55 Constitution Plaza, Hartford, Connecticut 06103), under Policy No. BM-CTL-2023-04182, with the following coverage limits: The current policy period is April 1, 2023 through March 31, 2024, and the policy is renewable annually for th

Section 7.2 — Site Insurance Haverford Regional Medical Center shall obtain and maintain, at its own expense, the following minimum insurance coverage during the term of this Agreement and for a period of not less than three (3) years following the completion or termination of the CLARION trial at Site 003: (a) Commercial General Liability Insurance with a per-occurrence limit of not less than Five Million Dollars ($

Section 7.3 — Certificate Exchange The Parties shall exchange certificates of insurance evidencing the coverage required under Sections 7.1 and 7.2 within fifteen (15) business days of the execution of this Agreement and annually thereafter during the term of the MCTA. Each Party shall promptly notify the other Parties in writing of any material change in, cancellation of, or non-renewal of any required insurance cov

ARTICLE 8 — DATA OWNERSHIP, CONFIDENTIALITY, AND RECORDS

Section 8.1 — Clinical Trial Data Ownership Penterra Pharmaceuticals Corp. shall retain exclusive ownership of all clinical trial data, case report forms (whether electronic or paper), databases, analyses, reports, and other data and information generated under Protocol PPC-4871-III at the Site (collectively, "Study Data"). The Site shall have no right, title, or interest in or to the Study Data, except as expressly

Section 8.2 — Site Record Retention The Site shall maintain and retain all source documents, regulatory files, investigational product accountability records, IRB correspondence, signed informed consent forms, and all other study records relating to the conduct of the CLARION trial at Site 003 for a minimum period of fifteen (15) years following the completion of the CLARION trial at the Site (projected study complet

Section 8.3 — Confidentiality All information disclosed by the Sponsor to the Site in connection with the CLARION trial, including without limitation the Protocol, the Investigator's Brochure, the investigational product specifications, manufacturing information, proprietary analytical methods, unpublished Study Data, financial terms of this Agreement and the MCTA, and any other information designated as confidential

Section 8.4 — HIPAA Compliance The Site shall comply with all applicable provisions of HIPAA (45 C.F.R. Parts 160 and 164) in all handling, use, and disclosure of protected health information ("PHI") in connection with the CLARION trial. The Site shall obtain valid HIPAA research authorizations from each study subject, or shall obtain an IRB-approved waiver of authorization, prior to using or disclosing any PHI for r

ARTICLE 9 — INTELLECTUAL PROPERTY AND PUBLICATION RIGHTS

Section 9.1 — Pre-Existing intellectual Property Each Party retains all right, title, and interest in and to its pre-existing intellectual property, including without limitation patents, patent applications, copyrights, trademarks, trade secrets, and know-how owned or controlled by such Party prior to the Effective Date or developed independently of the CLARION trial. Nothing in this Agreement or the MCTA shall be co

Section 9.2 — Joint Inventions Any inventions, discoveries, improvements, or other intellectual property jointly conceived or first reduced to practice by employees, agents, or investigators of two or more Parties in the course of or as a result of the conduct of the CLARION trial ("Joint Inventions") shall be owned and managed in accordance with the terms and conditions set forth in the intellectual Property Side Le

Section 9.3 — Publication Rights The Site's investigators shall have the right to publish the results of the CLARION trial in peer-reviewed journals, at scientific conferences, and in other academic publications, subject to the following conditions: (a) Sponsor Review. The Site shall submit to the Sponsor a copy of any proposed publication or presentation at least sixty (60) days prior to the anticipated date of subm

ARTICLE 10 — TERM, TERMINATION, AND WIND-DOWN

Section 10.1 — Term This Individual Site Agreement shall be effective as of the Effective Date and shall continue in full force and effect for the duration of the MCTA, including any extensions or renewals thereof, unless earlier terminated in accordance with this Article 10 or the termination provisions of the MCTA. The projected enrollment period for the CLARION trial is forty-two (42) months from the date of first

Section 10.2 — Termination Either Party may terminate this Agreement upon the occurrence of a material breach by another Party that remains uncured after the expiration of the applicable cure period set forth in the MCTA. All termination rights, notice requirements, and cure periods applicable to the Site's participation in the CLARION trial are governed by the termination provisions set forth in Article XV of the MC

Section 10.3 — Wind-Down Upon termination or expiration of this Agreement or the Site's participation in the CLARION trial, a wind-down period of one hundred twenty (120) days shall apply to ensure the orderly transition and continued safety of all study subjects enrolled at Site 003. During the wind-down period: (a) Subjects who are actively receiving treatment with the investigational product shall be transitioned

ARTICLE 11 — DISPUTE RESOLUTION

Section 11.1 — Governing Law This Individual Site Agreement and the MCTA, and all claims, disputes, and controversies arising out of or relating to this Agreement or the MCTA, shall be governed by, construed in accordance with, and enforced under the laws of the State of New York, without giving effect to any choice-of-law or conflict-of-laws rules or provisions that would cause the application of the laws of any oth

Section 11.2 — Dispute Escalation Any dispute, controversy, or claim arising out of or relating to this Agreement or the MCTA, or the breach, termination, or validity thereof (a "Dispute"), shall be resolved in accordance with the following escalation procedure: (a) Negotiation. The Parties shall first attempt to resolve the Dispute through good-faith negotiation between designated senior representatives of each Part

Section 11.3 — Injunctive Relief Notwithstanding the dispute resolution provisions set forth in Section 11.2, any Party may seek temporary, preliminary, or permanent injunctive relief, specific performance, or other equitable relief from the state and federal courts located in New York County, New York, without first exhausting the negotiation, mediation, and arbitration procedures set forth in Section 11.2, where su

ARTICLE 12 — REPRESENTATIONS AND WARRANTIES

Section 12.1 — Site Representations Haverford Regional Medical Center hereby represents and warrants to the Sponsor and the Network as follows, as of the Effective Date and continuing throughout the term of this Agreement: (a) Organization and Existence. The Site is a duly organized and validly existing institution under the laws of the Commonwealth of Massachusetts and has all requisite power and authority to own it

Section 12.2 — Anti-Kickback and Sunshine Act Compliance The Site represents and warrants that the payment structure established under the MCTA and this Agreement complies with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) and applicable safe harbor regulations, including without limitation the personal services and management contracts safe harbor (42 C.F.R. § 1001.952(d)). The Site shall cooperate fully