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MASTER CLINICAL TRIAL AGREEMENT

Protocol PPC-4871-III

(CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)

Final Agreed Draft — Circulated for Execution

June 23, 2023

PENTERRA PHARMACEUTICALS CORP. ("Sponsor")

and

VERIDIAN HEALTH RESEARCH NETWORK, INC. ("Site Network")

Calderwood & Harkness LLP Matter No. 1018-00004

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MASTER CLINICAL TRIAL AGREEMENT

This Master Clinical Trial Agreement (together with all Exhibits and Schedules attached hereto, this "Agreement") is entered into as of June 23, 2023 (the "Signing Date"), by and between:

PENTERRA PHARMACEUTICALS CORP., a Delaware corporation, with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540 (hereinafter referred to as "Sponsor" or "Penterra");

and

VERIDIAN HEALTH RESEARCH NETWORK, INC., a Delaware corporation organized as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104 (hereinafter referred to as "Site Network" or "Veridian").

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

RECITALS

WHEREAS, Sponsor is the holder of Investigational New Drug Application No. 157823 ("IND 157823") filed with the United States Food and Drug Administration (the "FDA") for penterafenib (PPC-4871), an oral multi-kinase inhibitor targeting FGFR1-4, VEGFR1-3, and PDGFR-alpha/beta kinase pathways, and Sponsor intends to conduct a Phase III, randomized, double-blind, placebo-controlled clinical trial designated as Protocol PPC-4871-III (the "CLARION" trial) for the treatment of advanced hepatocellular carcinoma ("HCC") in subjects who have received at least one prior line of systemic therapy;

WHEREAS, Sponsor completed Phase II clinical evaluation of PPC-4871 in January 2023 (Study PPC-4871-II, NCT04817293), demonstrating a thirty-eight percent (38%) objective response rate ("ORR") in patients with advanced HCC, with a manageable safety profile and a median duration of response of seven point four (7.4) months, thereby providing the scientific basis for advancement to Phase III evaluation;

WHEREAS, the CLARION trial has been registered on ClinicalTrials.gov under identifier NCT05928174 and Sponsor has received written acknowledgment from the FDA of its protocol design;

WHEREAS, Veridian operates a network of thirty-eight (38) academic medical centers and affiliated research institutions located across fourteen (14) states within the United States, and possesses the institutional infrastructure, scientific expertise, clinical research operations capacity, and qualified investigators necessary to support the conduct of large-scale, multi-center oncology clinical trials;

WHEREAS, Sponsor desires to engage Veridian and its participating sites to conduct the CLARION trial in accordance with the Protocol and applicable regulatory requirements, and Veridian desires to participate in such engagement and to make its network of sites available for the conduct of the Study, subject to the terms and conditions set forth herein;

WHEREAS, Sponsor has separately engaged Meridian Contract Research Organization, Inc. ("Meridian CRO"), a full-service contract research organization with offices at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, under a Master Services Agreement dated January 15, 2023 (the "CRO Agreement"), to perform certain monitoring, data management, pharmacovigilance, safety reporting, and biostatistics services in connection with the CLARION trial;

WHEREAS, the Parties, through their respective legal counsel — Calderwood & Harkness LLP (280 Park Avenue, 34th Floor, New York, New York 10017) for Sponsor and Whitmore, Jansen & Callahan LLP (1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102) for Veridian — have negotiated the terms and conditions of this Agreement in good faith and at arm's length over a period of approximately five (5) months; and

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by each Party, the Parties hereby agree as follows:

ARTICLE I — DEFINITIONS

Section 1.1 — Definitions. As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not defined in this Section 1.1 shall have the meanings ascribed to them elsewhere in this Agreement.

"Additional Insured" means Veridian and each Participating Site Institution that is named as an additional insured under the Sponsor Insurance Policy, as more fully described in Article XI and Exhibit E.

"Adverse Event" or "AE" means any untoward medical occurrence in a Study Subject administered the Investigational Product or placebo, whether or not considered related to the Investigational Product, as defined in the ICH E6(R2) Guidelines and 21 C.F.R. § 312.32, including but not limited to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.

"Affiliate" means, with respect to any Party, any entity that directly or indirectly controls, is controlled by, or is under common control with such Party. For purposes of this definition, "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting securities, by contract, or otherwise, and the terms "controlled by" and "under common control with" shall be construed accordingly. Ownership of fifty percent (50%) or more of the voting securities of an entity shall be deemed to constitute control.

"Agreement" means this Master Clinical Trial Agreement, together with all Exhibits and Schedules attached hereto and incorporated herein by reference, and any amendments or modifications hereto executed in writing by both Parties.

"Approved Subcontractors" means those third-party service providers engaged by Sponsor and listed in Exhibit K attached hereto, which as of the date hereof include Meridian Contract Research Organization, Inc., Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc.

"Budget" means the budget and payment schedule set forth in Exhibit B attached hereto, as may be amended from time to time by mutual written agreement of the Parties.

"CLARION" or "CLARION Trial" means the Phase III clinical trial conducted pursuant to Protocol PPC-4871-III, as further described in the Protocol Synopsis attached as Exhibit A.

"Clinical Trial Data" means all data, results, reports, analyses, case report forms (whether in paper or electronic format), source data, biological sample data, pharmacokinetic data, pharmacodynamic data, biomarker data, imaging data, safety data, efficacy data, statistical analyses, and any other data or information collected, generated, derived, or produced in connection with, or arising out of, the conduct of the Study.

"Closing Date" means the date on which all Conditions Precedent set forth in Article XVII have been satisfied or waived in writing by the Party entitled to the benefit of such condition.

"Conditions Precedent" means the conditions to closing set forth in Section 17.1 of this Agreement.

"Confidential Information" has the meaning set forth in Section 12.1 of this Agreement.

"CRO" means Meridian Contract Research Organization, Inc., a Delaware corporation with offices at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, engaged by Sponsor under the CRO Agreement to perform certain services in connection with the Study.

"EDC" means the electronic data capture system provided by Pinnacle Data Solutions, Inc. for use in connection with the Study, including all related software, platforms, and interfaces.

"Effective Date" means the date on which the last Condition Precedent set forth in Article XVII is satisfied or waived, and this Agreement becomes fully operative in accordance with its terms.

"FDA" means the United States Food and Drug Administration, and any successor agency thereto.

"GCP" means Good Clinical Practice as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") in its Guideline for Good Clinical Practice E6(R2), effective November 9, 2016, as may be amended, supplemented, or superseded from time to time.

"Global Principal Investigator" means Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, who shall serve as the overall principal investigator for the CLARION trial across all Participating Sites, as further described in Article V.

"HIPAA" means the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended by the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act"), and all regulations promulgated thereunder, including without limitation the Standards for Privacy of Individually Identifiable Health Information (the "Privacy Rule") and the Security Standards for the Protection of Electronic Protected Health Information (the "Security Rule") set forth at 45 C.F.R. Parts 160 and 164.

"IND" means Investigational New Drug Application No. 157823 filed by Sponsor with the FDA for penterafenib (PPC-4871), as may be amended or supplemented from time to time.

"Individual Site Agreement" means a joinder agreement in substantially the form attached hereto as Exhibit C, to be executed by each Participating Site Institution, incorporating by reference the terms and conditions of this Agreement and setting forth site-specific information, including the identity of the principal investigator, IRB of record, and any site-specific modifications authorized hereunder.

"Institutional Review Board" or "IRB" means the institutional review board, ethics committee, or other body responsible for the ethical oversight and approval of clinical research at each Participating Site, constituted and operating in accordance with 21 C.F.R. Part 56 and applicable institutional policies.

"Investigational Product" means penterafenib (PPC-4871), the oral multi-kinase inhibitor compound under investigation in the CLARION trial, and the matching placebo, in all dosage forms, strengths, and formulations supplied by Sponsor for use in the Study.

"Investigator" means any principal investigator, co-principal investigator, or sub-investigator who is authorized to direct or supervise the conduct of the Study at a Participating Site, as identified on the applicable FDA Form 1572 and Individual Site Agreement.

"Medically Necessary Protocol Deviation" means a deviation from the Protocol undertaken by an Investigator in the exercise of his or her medical judgment to protect the immediate safety, rights, or welfare of a Study Subject, where adherence to the Protocol would, in the Investigator's reasonable medical judgment, have posed an unacceptable risk to the Study Subject.

"Network Coordination Fee" means the administrative and coordination fee payable to Veridian in the amount and on the schedule set forth in Section 7.3(c) and Exhibit B.

"Participating Site" or "Participating Site Institution" means each academic medical center, hospital, research institution, or other clinical facility within the Veridian network that is listed on Schedule 1 and that has duly executed an Individual Site Agreement in the form of Exhibit C.

"Payment Terms" means Net forty-five (45) calendar days from the date of Sponsor's receipt of a proper and complete invoice submitted by Veridian in accordance with Section 7.5.

"Per-Patient Fee" means Fifty-Two Thousand Dollars ($52,000) per Study Subject, payable in accordance with the milestone-based payment structure set forth in Section 7.3(b).

"Protocol" means Protocol PPC-4871-III (CLARION), the clinical study protocol for the CLARION trial, including any amendments thereto approved by Sponsor and the applicable IRB(s), as described in the Protocol Synopsis attached as Exhibit A.

"Protocol Synopsis" means the summary of the Protocol attached hereto as Exhibit A.

"Serious Adverse Event" or "SAE" means any Adverse Event that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is a medically important event that may jeopardize the Study Subject or may require medical or surgical intervention to prevent one of the foregoing outcomes, as defined in 21 C.F.R. § 312.32.

"Site Staff" means all investigators, sub-investigators, study coordinators, clinical research nurses, pharmacists, laboratory technicians, and other personnel at a Participating Site who are involved in the conduct of the Study.

"Sponsor Insurance Policy" means the clinical trial liability insurance policy issued by Briarcliff Mutual Insurance Company (55 Constitution Plaza, Hartford, Connecticut 06103), Policy Number BM-CTL-2023-04182, as described in Article XI and Exhibit E.

"Start-Up Fee" means Seventy-Five Thousand Dollars ($75,000) per Participating Site, payable in accordance with Section 7.3(a).

"Study" means the CLARION trial conducted pursuant to the Protocol at the Participating Sites, including all screening, enrollment, randomization, treatment, follow-up, and close-out activities.

"Study Subject" means each individual human subject who provides informed consent and is enrolled in the Study at a Participating Site.

"Subject Injury" means any physical injury, illness, or medical condition sustained by a Study Subject that is directly attributable to (a) the administration of the Investigational Product when administered in accordance with the Protocol, or (b) study procedures performed in accordance with the Protocol, excluding any injury, illness, or condition that is attributable to the negligence or willful misconduct of an Investigator or Site Staff or that results from the natural progression of the Study Subject's underlying disease.

"Sunshine Act" means Section 6002 of the Patient Protection and Affordable Care Act, codified at 42 U.S.C. § 1320a-7h, and the regulations promulgated thereunder at 42 C.F.R. Parts 402 and 403, requiring the reporting of payments and other transfers of value made by pharmaceutical and device manufacturers to physicians and teaching hospitals through the Centers for Medicare & Medicaid Services Open Payments program.

"Total Deal Value" means Eighty Million Dollars ($80,000,000), representing the aggregate value of all payments contemplated under this Agreement across all Participating Sites over the projected life of the Study, as further detailed in Article VII and Exhibit B.

"Veridian Central IRB" means the centralized institutional review board maintained and operated by Veridian for the purpose of providing ethical review and oversight of clinical research protocols conducted at Participating Sites that do not maintain their own IRB and that have entered into IRB Authorization Agreements with Veridian, in accordance with 21 C.F.R. Part 56.

"Wind-Down Period" means the period of one hundred twenty (120) calendar days following the date on which a notice of termination is delivered by either Party in accordance with Article XVIII, during which the Parties shall undertake the wind-down activities described in Section 18.4.

ARTICLE II — SCOPE OF AGREEMENT

Section 2.1 — Purpose. Sponsor hereby engages Veridian and its Participating Sites, and Veridian hereby accepts such engagement, to conduct the CLARION trial at up to thirty-eight (38) Veridian Network sites located across fourteen (14) states within the United States, in accordance with the Protocol, GCP, all applicable laws and regulations, and the terms and conditions set forth in this Agreement. Veridian shall serve as the coordinating network organization, providing centralized administrative, regulatory, and operational support for the Participating Sites in connection with the conduct of the Study. The engagement contemplated hereunder represents a comprehensive arrangement for the clinical evaluation of penterafenib (PPC-4871) in the treatment of advanced hepatocellular carcinoma, with a Total Deal Value of Eighty Million Dollars ($80,000,000).

Section 2.2 — Protocol. The Study shall be conducted pursuant to Protocol PPC-4871-III (CLARION), as described in the Protocol Synopsis attached hereto as Exhibit A and incorporated herein by reference. The Protocol is designed as a Phase III, randomized, double-blind, placebo-controlled 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 planned enrollment target is one thousand two hundred (1,200) Study Subjects, randomized in a 2:1 ratio, with eight hundred (800) subjects assigned to the penterafenib treatment arm and four hundred (400) subjects assigned to the placebo control arm. The primary endpoint of the Study is overall survival ("OS"). Key secondary endpoints include progression-free survival ("PFS"), objective response rate ("ORR") as assessed by RECIST v1.1 criteria, and duration of response ("DOR"). Exploratory endpoints include pharmacokinetic assessments, biomarker analyses, patient-reported outcomes, and health-related quality of life measures.

Section 2.3 — Projected Timeline. The Parties anticipate the following projected timeline for the Study, subject to adjustment based on actual enrollment rates, regulatory requirements, and other factors:

(a) Enrollment Period: Forty-two (42) months from the date of first patient in ("FPI"), with a target FPI date of August 14, 2023.

(b) Follow-Up Period: Eighteen (18) months following the enrollment of the last Study Subject.

(d) Projected Last Patient In: February 2027.

(e) Projected Study Completion: August 2028.

The foregoing timeline is a good-faith estimate and does not constitute a binding commitment. The Parties acknowledge that actual timelines may vary based on enrollment rates, regulatory developments, safety considerations, and other factors outside the reasonable control of either Party. The Parties shall meet on a quarterly basis, or more frequently as circumstances warrant, to review enrollment progress and adjust timelines as necessary.

Section 2.4 — Individual Site Agreements. Each Participating Site Institution shall, prior to initiating any Study activities, execute an Individual Site Agreement in substantially the form attached hereto as Exhibit C. Each Individual Site Agreement shall incorporate by reference the terms and conditions of this Agreement, identify the principal investigator designated for such site, specify the applicable IRB of record, and include any site-specific addenda or modifications approved in writing by Sponsor. An Individual Site Agreement shall become effective upon execution by the Participating Site Institution, Veridian, and Sponsor. Veridian shall be responsible for coordinating the execution of Individual Site Agreements and shall use commercially reasonable efforts to ensure that all Individual Site Agreements are fully executed prior to the commencement of Study activities at each Participating Site.

Section 2.5 — Relationship to CRO Agreement. The Parties acknowledge that Sponsor has separately contracted with Meridian Contract Research Organization, Inc. under a Master Services Agreement dated January 15, 2023 (the "CRO Agreement") for the performance of certain monitoring, data management, pharmacovigilance, safety reporting, and biostatistics services in connection with the CLARION trial. Veridian and each Participating Site shall cooperate with Meridian CRO as reasonably required in connection with the performance of such services, including by providing access to study sites, source documents, Study Subjects (subject to applicable consent and privacy requirements), and Site Staff during monitoring visits. Nothing in this Agreement shall be construed to create any contractual relationship between Veridian or any Participating Site and Meridian CRO; the CRO Agreement is a separate and independent contractual arrangement between Sponsor and Meridian CRO, and Sponsor shall remain responsible for the acts and omissions of Meridian CRO in connection with the Study.

Section 2.6 — Approved Subcontractors. Sponsor's approved subcontractors for the Study are listed in Exhibit K attached hereto and, as of the date hereof, include the following:

(a) Meridian Contract Research Organization, Inc. — performing monitoring, data management, pharmacovigilance, safety reporting, and biostatistics services.

(b) Pinnacle Data Solutions, Inc. — providing the electronic data capture ("EDC") platform and related technology services.

(c) Northbridge Bioanalytical Laboratories, Inc. — serving as the central laboratory for specimen processing, analysis, and biomarker assessments.

Sponsor may add or remove Approved Subcontractors by providing written notice to Veridian and updating Exhibit K. Each Approved Subcontractor shall be bound by confidentiality obligations at least as restrictive as those set forth in Article XII.

ARTICLE III — RESPONSIBILITIES OF SPONSOR

Section 3.1 — IND Maintenance. Sponsor shall maintain IND 157823 in good standing with the FDA throughout the term of the Study and shall bear sole responsibility for all regulatory submissions, amendments, annual reports, safety reports, and correspondence with the FDA and other regulatory authorities in connection with the IND and the Study. Sponsor shall promptly notify Veridian and the Global Principal Investigator of any material communication from the FDA regarding the IND or the Study, including without limitation any clinical hold, request for additional information, or notice of deficiency.

Section 3.2 — Supply of Investigational Product. Sponsor shall supply penterafenib (PPC-4871) and matching placebo in quantities sufficient for the conduct of the Study at all Participating Sites, at no cost to Veridian, any Participating Site, or any Study Subject. Sponsor shall be responsible for the manufacture, quality control, quality assurance, labeling, packaging, and distribution of the Investigational Product in compliance with current Good Manufacturing Practice ("cGMP") requirements set forth in 21 C.F.R. Parts 210 and 211 and applicable FDA guidance. Sponsor shall ensure that adequate supplies of the Investigational Product are delivered to each Participating Site in a timely manner, and shall work with Veridian and Participating Sites to establish and maintain appropriate procedures for the receipt, storage, dispensing, accounting, and return or destruction of the Investigational Product. Sponsor shall bear all costs associated with the supply and distribution of the Investigational Product, including shipping, temperature-controlled storage, and interactive response technology ("IRT") systems for randomization and drug supply management.

Section 3.3 — Protocol and Amendments. Sponsor shall provide the Protocol and any amendments thereto to Veridian and each Participating Site in a timely manner. Any Protocol amendment shall be communicated in writing to Veridian and all Participating Sites, and shall require applicable IRB approval prior to implementation at any Participating Site, except in circumstances where an immediate change is necessary to eliminate an apparent immediate hazard to Study Subjects, in which case the amendment may be implemented prior to IRB approval in accordance with 21 C.F.R. § 312.30(b)(2). Sponsor shall consult with the Global Principal Investigator regarding any proposed Protocol amendments that may have a material impact on the conduct of the Study.

Section 3.4 — Monitoring. Sponsor, through Meridian CRO, shall conduct monitoring visits at each Participating Site in accordance with ICH E6(R2) Guidelines and 21 C.F.R. Part 312. Monitoring activities shall include, without limitation, on-site monitoring, remote monitoring, centralized statistical monitoring, source data verification, review of informed consent documentation, verification of subject eligibility, and assessment of compliance with the Protocol, GCP, and applicable regulations. Sponsor shall ensure that monitoring visits are conducted with reasonable frequency and that monitors are appropriately trained and qualified. Monitoring reports shall be prepared and maintained by Meridian CRO and made available to Sponsor.

Section 3.5 — Safety Reporting. Sponsor shall fulfill all IND safety reporting obligations under 21 C.F.R. § 312.32, including the submission of IND safety reports to the FDA. Fatal and life-threatening suspected adverse reactions shall be reported to the FDA as soon as possible but no later than seven (7) calendar days after Sponsor first receives the information ("7-day reports"), with a follow-up report submitted within eight (8) additional calendar days. All other IND safety reports shall be submitted to the FDA no later than fifteen (15) calendar days after Sponsor first receives the information ("15-day reports"). Sponsor shall provide IND safety report information to all participating investigators in accordance with 21 C.F.R. § 312.32(c)(2) and shall coordinate safety reporting activities with Meridian CRO in accordance with the CRO Agreement.

Section 3.6 — Insurance. Sponsor shall obtain and maintain clinical trial liability insurance throughout the term of the Study and for the post-termination period specified in Article XI, with coverage limits and terms as set forth in Section 11.1 and Exhibit E. Sponsor shall name Veridian and each Participating Site Institution as additional insureds under the Sponsor Insurance Policy.

Section 3.7 — Regulatory Compliance. Sponsor shall comply with all applicable laws, rules, and regulations in connection with the conduct of the Study, including without limitation: (a) 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) ICH E6(R2) Guidelines for Good Clinical Practice; (c) HIPAA, to the extent applicable; (d) the Anti-Kickback Statute (42 U.S.C. § 1320a-7b); and (e) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h). Sponsor shall designate qualified personnel to oversee regulatory compliance in connection with the Study and shall cooperate with Veridian and Participating Sites to ensure that all regulatory requirements are met.

ARTICLE IV — RESPONSIBILITIES OF VERIDIAN AND PARTICIPATING SITES

Section 4.1 — Site Activation. Veridian shall use commercially reasonable efforts to activate each of the thirty-eight (38) Participating Sites listed on Schedule 1 in a timely manner consistent with the projected timeline set forth in Section 2.3. Site activation shall include, without limitation, the execution of Individual Site Agreements, obtainment of IRB approval, completion of site feasibility and qualification assessments, execution of required regulatory documents (including FDA Forms 1572 and financial disclosure certifications), site initiation training, and EDC system access provisioning. Veridian shall provide Sponsor with regular status reports on the progress of site activation activities and shall promptly notify Sponsor of any delays or issues that may materially affect the activation timeline.

Section 4.2 — Conduct of Study. Each Participating Site shall conduct the Study in strict accordance with the Protocol, GCP, all applicable federal, state, and local laws and regulations, and the terms and conditions of this Agreement and the applicable Individual Site Agreement. Each Participating Site shall use its best efforts to enroll Study Subjects in accordance with the enrollment targets and timelines established by Sponsor and shall ensure that all Study procedures are performed by qualified personnel in accordance with the Protocol.

Section 4.3 — Qualified Investigators. Veridian shall ensure that each Participating Site designates a qualified principal investigator who meets the requirements of 21 C.F.R. § 312.53 and who is appropriately trained and experienced in the conduct of clinical research in oncology. The Global Principal Investigator for the CLARION trial shall be Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, 1200 University Avenue, Philadelphia, Pennsylvania 19104. The Co-Principal Investigator shall be Dr. Howard Matsuoka, M.D., Associate Professor of Hepatology & Oncology at Lakemont Medical Center, 4400 North Michigan Drive, Chicago, Illinois 60611. Each Investigator shall be subject to the approval of Sponsor, and Veridian shall provide Sponsor with the curriculum vitae, medical license information, and other qualifying documentation for each proposed Investigator prior to the execution of the applicable Individual Site Agreement.

Section 4.4 — IRB Approval. Each Participating Site must obtain and maintain IRB approval for the Protocol, the informed consent document, and all other study-related documents prior to enrolling any Study Subject. The lead sites — Graystone University Medical Center and Lakemont Medical Center — shall obtain approval from their respective individual institutional review boards. Graystone University Medical Center shall rely upon the Graystone University IRB (IRB Registration Number: IRB00012847) as its IRB of record. The remaining Participating Sites may rely upon the Veridian Central IRB pursuant to IRB Authorization Agreements executed in accordance with 21 C.F.R. § 56.114 and the applicable policies and procedures of the Veridian Central IRB. Each Participating Site shall be responsible for ensuring that ongoing IRB approval is maintained throughout the conduct of the Study at such site, including by submitting continuing review applications, amendments, safety reports, and other required submissions in a timely manner.

Section 4.5 — Informed Consent. Each Participating Site shall obtain informed consent from each Study Subject prior to the conduct of any study-related procedures, in accordance with 21 C.F.R. Part 50, ICH E6(R2) Guidelines, and applicable IRB requirements. The informed consent document shall be approved by the applicable IRB and shall include all required elements set forth in 21 C.F.R. § 50.25, including a description of the Study, the risks and benefits of participation, the availability of alternative treatments, the voluntary nature of participation, the provisions for treatment of study-related injuries (as described in Article IX), and such other information as may be required by the applicable IRB or by applicable law. Each Participating Site shall maintain original signed and dated informed consent documents as part of the Study records.

Section 4.6 — Safety Reporting by Sites. Each Participating Site shall report all Serious Adverse Events to Sponsor and Meridian CRO within twenty-four (24) hours of the Investigator first becoming aware of such event, using the forms and procedures specified in Exhibit J attached hereto. Each Participating Site shall also report all Adverse Events, protocol deviations, and other safety-related information in accordance with the Protocol and the safety reporting procedures set forth in Exhibit J. Each Participating Site shall cooperate fully with Sponsor and Meridian CRO in the investigation, follow-up, and resolution of all safety-related events and shall provide such additional information and documentation as may be reasonably requested.

Section 4.7 — Data Collection and Recording. Each Participating Site shall enter all Study data into the EDC system provided by Pinnacle Data Solutions, Inc. in a timely, accurate, and complete manner, in accordance with the Protocol, the EDC data entry guidelines, and applicable data management plans. Source documents shall be created and maintained at each Participating Site for all Study activities and shall be available for review by monitors, auditors, and regulatory authorities upon reasonable notice. Each Participating Site shall ensure that all data entries are made by authorized Site Staff and that all corrections to data entries are documented, dated, and explained in accordance with GCP requirements.

Section 4.8 — Site Staff Qualifications. Each Participating Site shall ensure that all Site Staff involved in the conduct of the Study are adequately trained, qualified, and experienced to perform their assigned Study-related duties. Each Participating Site shall maintain documentation of Site Staff training, including Protocol-specific training, GCP training, EDC training, and any other training required by Sponsor or by applicable regulations. Each Participating Site shall designate a qualified study coordinator to serve as the primary point of contact for Sponsor, Meridian CRO, and Veridian with respect to day-to-day Study operations at such site.

Section 4.9 — Cooperation with Monitoring. Each Participating Site shall provide reasonable access to monitors from Meridian CRO for the conduct of on-site monitoring visits, including access to Study Subjects (subject to applicable consent and privacy requirements), source documents, case report forms, the Investigational Product and accountability records, laboratory records, and all other Study-related documents and materials. Each Participating Site shall also provide reasonable access to representatives of the FDA, other regulatory authorities, and Sponsor's quality assurance auditors for the conduct of inspections, audits, and other regulatory activities, and shall cooperate fully with any such inspection or audit.

Section 4.10 — Regulatory Filings. Each Investigator shall complete and maintain a current FDA Form 1572 (Statement of Investigator) and shall file financial disclosure certifications in accordance with 21 C.F.R. Part 54. Each Investigator shall promptly notify Sponsor and Veridian of any changes to the information provided on the Form 1572 or in the financial disclosure certification. Each Participating Site shall also be responsible for submitting and maintaining all required regulatory filings with the applicable IRB, including initial applications, continuing review submissions, protocol amendments, safety reports, and final study close-out reports.

Section 4.11 — HIPAA Compliance. Each Participating Site shall comply with all applicable requirements of HIPAA and the HITECH Act, including the Privacy Rule and the Security Rule, in connection with the collection, use, disclosure, and protection of protected health information ("PHI") of Study Subjects. Each Participating Site shall obtain appropriate research authorizations from Study Subjects for the use and disclosure of PHI in connection with the Study, or shall obtain a waiver of authorization from the applicable IRB or privacy board in accordance with 45 C.F.R. § 164.512(i)(2). Each Participating Site shall implement and maintain appropriate administrative, technical, and physical safeguards to protect the privacy and security of PHI in connection with the Study.

Section 4.12 — Anti-Kickback and Sunshine Act Compliance. Veridian and each Participating Site represent and warrant that all payments received under this Agreement reflect fair market value for the services rendered and are consistent with applicable Anti-Kickback Statute safe harbors, including without limitation the personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d). Veridian and each Participating Site further represent and warrant that no payments received hereunder are intended to induce or reward the referral of Study Subjects, patients, or healthcare services, or to otherwise violate the Anti-Kickback Statute (42 U.S.C. § 1320a-7b). All reportable payments and transfers of value to physicians, teaching hospitals, and other covered recipients shall be tracked and disclosed by Sponsor in compliance with the Physician Payments Sunshine Act and the Centers for Medicare & Medicaid Services Open Payments program.

ARTICLE V — PRINCIPAL INVESTIGATOR

Section 5.1 — Global Principal Investigator. Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, 1200 University Avenue, Philadelphia, Pennsylvania 19104, shall serve as the Global Principal Investigator for the CLARION trial. In this capacity, Dr. Aldridge shall be responsible for providing overall scientific leadership and medical oversight for the Study across all Participating Sites, coordinating with Sponsor on Protocol design and amendments, serving as the primary medical contact for safety and efficacy matters, leading the publications committee established pursuant to Article XIV, and performing such other duties as are customary for a global principal investigator in a multi-center Phase III oncology trial. Dr. Aldridge shall also serve as the principal investigator at Graystone University Medical Center (Site 001).

Section 5.2 — Co-Principal Investigator. Dr. Howard Matsuoka, M.D., Associate Professor of Hepatology & Oncology at Lakemont Medical Center, 4400 North Michigan Drive, Chicago, Illinois 60611, shall serve as the Co-Principal Investigator for the CLARION trial. In this capacity, Dr. Matsuoka shall support Dr. Aldridge in the scientific oversight and coordination of the Study, serve as a co-chair of the publications committee, and serve as the principal investigator at Lakemont Medical Center (Site 002). Dr. Matsuoka shall assume the responsibilities of the Global Principal Investigator during any period of absence or unavailability of Dr. Aldridge.

Section 5.3 — Investigator Obligations. Each Investigator, including the Global Principal Investigator and the Co-Principal Investigator, shall comply with the Protocol, GCP, all applicable federal, state, and local laws and regulations, and the Investigator Undertaking attached hereto as Exhibit I. Each Investigator shall assume personal responsibility for the conduct of the Study at his or her Participating Site and shall ensure that adequate time, resources, and personnel are dedicated to the conduct of the Study. Each Investigator shall execute and maintain a current FDA Form 1572 and financial disclosure certification, and shall cooperate with Sponsor, Meridian CRO, and applicable regulatory authorities in connection with the monitoring, auditing, and inspection of the Study.

Section 5.4 — Replacement of Investigators. Replacement of a principal investigator at any Participating Site requires the prior written approval of Sponsor, which approval shall not be unreasonably withheld, conditioned, or delayed. In the event that a principal investigator at a Participating Site becomes unable or unwilling to continue serving in such capacity, or is removed for cause, Veridian shall promptly notify Sponsor and shall propose a qualified replacement investigator for Sponsor's review and approval. No Study activities shall be conducted at the affected Participating Site during any period in which a qualified principal investigator is not designated and approved, except as necessary to ensure the safety and welfare of currently enrolled Study Subjects. Replacement of the Global Principal Investigator or the Co-Principal Investigator shall require the mutual written agreement of both Parties.

ARTICLE VI — STUDY SUBJECTS

Section 6.1 — Enrollment Target. The planned enrollment target for the Study is one thousand two hundred (1,200) Study Subjects across all Participating Sites. The Parties shall work together in good faith to achieve this enrollment target within the forty-two (42) month enrollment period specified in Section 2.3. Enrollment targets for individual Participating Sites shall be established by Sponsor in consultation with Veridian and the Global Principal Investigator, based on site capabilities, patient population, and historical enrollment performance.

Section 6.2 — Randomization. Study Subjects who meet all inclusion criteria and none of the exclusion criteria set forth in the Protocol shall be randomized in a 2:1 ratio, with eight hundred (800) subjects assigned to the penterafenib (PPC-4871) treatment arm and four hundred (400) subjects assigned to the placebo control arm. Randomization shall be performed using the interactive response technology ("IRT") system designated by Sponsor. Randomization shall be stratified by geographic region, prior therapy, and other factors as specified in the Protocol.

Section 6.3 — Enrollment Period. The enrollment period for the Study shall be forty-two (42) months from the date of FPI. The Parties may extend the enrollment period by mutual written agreement if enrollment targets are not met within the initial forty-two (42) month period, subject to regulatory and budgetary considerations.

Section 6.4 — Inclusion/Exclusion Criteria. Study Subjects shall be enrolled only if they meet all inclusion criteria and none of the exclusion criteria as set forth in the Protocol (Exhibit A). Each Participating Site shall be responsible for verifying subject eligibility prior to randomization.

Section 6.5 — Subject Screening. Each Participating Site shall follow the Protocol-specified screening procedures to assess the eligibility of potential Study Subjects. Per-Patient Fees shall begin to accrue at the time of randomization in accordance with the milestone payment structure set forth in Section 7.3(b). Screening failures shall not be subject to Per-Patient Fees, but reasonable and documented screening costs may be reimbursed in accordance with the Budget set forth in Exhibit B.

ARTICLE VII — BUDGET AND PAYMENT

Section 7.1 — Total Deal Value. The total value of this Agreement across all Participating Sites over the projected life of the Study is Eighty Million Dollars ($80,000,000) (the "Total Deal Value"). This figure represents the maximum aggregate amount payable under this Agreement and encompasses all components set forth in Section 7.2 below. The Total Deal Value may be increased only by mutual written agreement of the Parties, including through the use of the Contingency Reserve as set forth in Section 7.7.

Section 7.2 — Budget Components. The Total Deal Value is comprised of the following components:

(a) Per-Patient Site Fees: Fifty-Two Thousand Dollars ($52,000) per Study Subject multiplied by one thousand two hundred (1,200) planned subjects, for a total of Sixty-Two Million Four Hundred Thousand Dollars ($62,400,000).

(b) Start-Up Fees: Seventy-Five Thousand Dollars ($75,000) per Participating Site multiplied by thirty-eight (38) Participating Sites, for a total of Two Million Eight Hundred Fifty Thousand Dollars ($2,850,000).

(c) Annual Site Maintenance Fees: Forty Thousand Dollars ($40,000) per Participating Site per year multiplied by thirty-eight (38) Participating Sites multiplied by an average of three and one-half (3.5) years of active participation, for a total of Five Million Three Hundred Twenty Thousand Dollars ($5,320,000).

(d) Investigator Grants (Academic Publication Support): One Million Five Hundred Thousand Dollars ($1,500,000), to be disbursed upon acceptance of manuscripts for peer-reviewed publication as set forth in Section 7.3(e) and Article XIV.

(e) Network Coordination/Administrative Fee: Four Million Two Hundred Thousand Dollars ($4,200,000) payable to Veridian central in quarterly installments as set forth in Section 7.3(c).

(f) Technology/EDC Integration Costs (Pinnacle Data Solutions): One Million Two Hundred Thirty Thousand Dollars ($1,230,000), representing costs for EDC platform configuration, integration, validation, and ongoing support.

(g) Contingency/Change Order Reserve: Two Million Five Hundred Thousand Dollars ($2,500,000), available for unanticipated costs, protocol amendments, additional study procedures, or other changes requiring additional funding, subject to Section 7.7.

Section 7.3 — Payment Schedule. Payments under this Agreement shall be made in accordance with the following schedule:

(a) Start-Up Fees: Fifty percent (50%) of the Start-Up Fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) per Participating Site shall be payable upon site activation, defined as the date on which the applicable Individual Site Agreement has been fully executed, IRB approval has been obtained, and the site has been cleared by Sponsor to commence screening activities. The remaining fifty percent (50%) of the Start-Up Fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) per Participating Site shall be payable upon the enrollment of the first Study Subject at such site.

(b) Per-Patient Fees: Per-Patient Fees shall be paid on a milestone basis as follows:

(i) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon randomization of the Study Subject.

(ii) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon completion of the Study Subject's Week 12 assessment.

(iii) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon completion of the Study Subject's Week 24 assessment.

(iv) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon study completion or final visit for the Study Subject, including all end-of-study assessments and data clean-up activities.

(c) Network Coordination Fee: The Network Coordination Fee shall be payable in quarterly installments of Three Hundred Thousand Dollars ($300,000) each, commencing on the Effective Date and continuing for fourteen (14) consecutive quarters, for a total of Four Million Two Hundred Thousand Dollars ($4,200,000). Quarterly installments shall be due within forty-five (45) calendar days following the end of each calendar quarter.

(d) Annual Site Maintenance Fees: Annual Site Maintenance Fees shall be paid annually in advance on each anniversary of the site-activation date for each Participating Site. The Annual Site Maintenance Fee for a partial year shall be prorated on a daily basis.

(e) Investigator Grants: Investigator grants shall be disbursed upon acceptance of manuscripts for publication in peer-reviewed journals, as described in Section 14.6, subject to the aggregate limit of One Million Five Hundred Thousand Dollars ($1,500,000).

Section 7.4 — Payment Terms. All amounts due under this Agreement shall be payable Net forty-five (45) calendar days from the date of Sponsor's receipt of a proper and complete invoice submitted by Veridian in accordance with Section 7.5. Payments shall be made in United States Dollars by wire transfer of immediately available funds to the bank account designated by Veridian in writing. Late payments shall bear interest at the lesser of one and one-half percent (1.5%) per month or the maximum rate permitted by applicable law.

Section 7.5 — Invoicing. Veridian shall submit invoices on behalf of itself and the Participating Sites on a monthly basis, or at such other intervals as may be agreed upon by the Parties. Each invoice shall set forth in reasonable detail the services performed, the milestones achieved, the amounts due by component, and such other information as Sponsor may reasonably request. Invoices shall be directed to:

Penterra Pharmaceuticals Corp.

Attn: Samantha Novak, Director of Clinical Contracts

200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540

Email: s.novak@penterra.com

Sponsor shall notify Veridian in writing within fifteen (15) business days of receipt of any invoice if Sponsor disputes any amount set forth therein, specifying the nature and basis of the dispute in reasonable detail. Undisputed amounts shall be paid in accordance with the Payment Terms regardless of any dispute with respect to other amounts on the same invoice. The Parties shall work in good faith to resolve any invoicing disputes within thirty (30) calendar days.

Section 7.6 — Taxes. Each Party shall be responsible for the payment of its own taxes, including without limitation federal, state, and local income taxes, franchise taxes, and employment taxes. The Parties acknowledge Veridian's status as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code. Sponsor shall have no obligation to withhold or remit taxes on payments made to Veridian, provided that Veridian has furnished Sponsor with a valid IRS determination letter and a completed IRS Form W-9 or applicable substitute form. Each Participating Site Institution shall provide appropriate tax documentation to Veridian and/or Sponsor upon request.

Section 7.7 — Contingency Reserve. The Contingency/Change Order Reserve of Two Million Five Hundred Thousand Dollars ($2,500,000) shall be available for unanticipated costs, including without limitation costs arising from Protocol amendments, additional study procedures, regulatory requirements, extended enrollment periods, or other changes to the Study scope. Use of the Contingency Reserve shall require the prior written approval of both Parties, which approval shall be documented in a written change order specifying the nature of the change, the amounts to be expended, and the affected Budget components. Any unused portion of the Contingency Reserve shall be retained by Sponsor upon completion or termination of the Study.

Section 7.8 — Fair Market Value. The Parties represent and warrant that all payments under this Agreement have been determined through arm's-length negotiation and reflect the fair market value of the services to be rendered and the costs to be incurred in connection with the Study. No payment under this Agreement is intended to induce or reward the referral of Study Subjects, patients, or healthcare services, or to otherwise violate the Anti-Kickback Statute (42 U.S.C. § 1320a-7b) or any other applicable law or regulation. The Parties have independently considered relevant factors, including the nature and scope of the services, the time and effort required, the qualifications and experience of the personnel involved, and the fair market value assessments of independent third-party consultants, in establishing the payment amounts set forth herein.

Section 7.9 — Detailed Budget. The detailed line-item budget and payment schedule for the Study is set forth in Exhibit B attached hereto and incorporated herein by reference. In the event of any conflict between the provisions of this Article VII and the terms of Exhibit B, the provisions of this Article VII shall control.

ARTICLE VIII — INDEMNIFICATION

Section 8.1 — Sponsor Indemnification of Site Network, Sites, and Investigators. Penterra shall indemnify, defend, and hold harmless Veridian, each Participating Site Institution, each Investigator, each sub-investigator, and each member of Site Staff (collectively, the "Site Indemnitees"), and their respective officers, directors, trustees, employees, agents, successors, and assigns, from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, judgments, settlements, penalties, fines, costs, and expenses (including reasonable attorneys' fees, court costs, expert witness fees, and costs of defense) (collectively, "Losses") arising out of or in connection with:

(a) any Subject Injury caused by the Investigational Product when administered in accordance with the Protocol;

(b) any defect in the Investigational Product, whether arising from manufacture, design, formulation, labeling, packaging, storage, or distribution;

(c) any breach of this Agreement or the Protocol by Sponsor or any of Sponsor's agents, employees, or Approved Subcontractors (including Meridian CRO); or

(d) any negligence, gross negligence, or willful misconduct of Sponsor or any of Sponsor's agents, employees, or Approved Subcontractors in connection with the Study.

The indemnification obligation of Sponsor under Section 8.1(b) with respect to product-defect claims shall be uncapped and shall apply without regard to any aggregate or per-occurrence limitation. The indemnification obligations of Sponsor under Sections 8.1(a), 8.1(c), and 8.1(d) shall be subject to the limitations set forth in this Article VIII, including the carve-outs set forth in Section 8.2.

Section 8.2 — Carve-Outs from Sponsor Indemnification. Notwithstanding anything to the contrary in Section 8.1, Sponsor's indemnification obligations under Section 8.1 shall not apply to the extent, and only to the extent, that Losses arise from or are attributable to:

(i) the negligence, gross negligence, or willful misconduct of a Participating Site, any Investigator, any sub-investigator, or any member of Site Staff in connection with the conduct of the Study;

(ii) a Protocol deviation that was neither authorized by Sponsor nor constituted a Medically Necessary Protocol Deviation undertaken for the immediate safety, rights, or welfare of a Study Subject in accordance with Section 8.4; or

(iii) a breach of this Agreement, the applicable Individual Site Agreement, or applicable law or regulation by Veridian, a Participating Site, any Investigator, or any member of Site Staff.

In the event that Losses are attributable to a combination of causes that include both indemnifiable claims under Section 8.1 and excluded claims under this Section 8.2, the Parties shall allocate responsibility for such Losses in proportion to their respective degrees of fault, as determined by agreement of the Parties or, if the Parties are unable to agree, by a court of competent jurisdiction or arbitration panel.

Section 8.3 — Subject Medical Care Costs. In addition to its indemnification obligations under Section 8.1, Sponsor shall cover the reasonable and customary medical costs for the treatment of study-related injuries sustained by Study Subjects that are not covered by such Study Subject's own health insurance, health plan, or other third-party payor. Sponsor's obligation under this Section 8.3 shall be subject to the following limitations:

(a) Per-Subject Cap: Sponsor's maximum liability for medical care costs under this Section 8.3 with respect to any individual Study Subject shall not exceed Five Hundred Thousand Dollars ($500,000).

(b) Aggregate Cap: Sponsor's maximum aggregate liability for medical care costs under this Section 8.3 across all Participating Sites and all Study Subjects shall not exceed Fifteen Million Dollars ($15,000,000).

The foregoing caps shall not apply to, or limit, Sponsor's indemnification obligations under Section 8.1 with respect to product-defect claims, which remain uncapped as set forth therein.

Section 8.4 — Medically Necessary Protocol Deviations. Liability for Losses arising from a Medically Necessary Protocol Deviation undertaken by an Investigator in good faith and in the exercise of his or her reasonable medical judgment for the immediate safety, rights, or welfare of a Study Subject shall remain with Sponsor under Section 8.1(a), provided that the following conditions are satisfied:

(a) The Investigator promptly reports the deviation to Sponsor and Meridian CRO, and in no event later than forty-eight (48) hours after the deviation occurs;

(b) The Investigator documents the medical justification for the deviation in the Study Subject's source documents and case report form; and

(c) The deviation was undertaken in circumstances where adherence to the Protocol would, in the Investigator's reasonable medical judgment, have posed an unacceptable risk to the Study Subject.

This provision is intended to ensure that Investigators are not deterred from taking medically appropriate action to protect Study Subject safety by concerns about the scope of Sponsor's indemnification obligations.

Section 8.5 — Site Network/Investigator Indemnification of Sponsor. Veridian and each Participating Site Institution shall, severally and not jointly, indemnify, defend, and hold harmless Sponsor and its officers, directors, employees, agents, Affiliates, successors, and assigns from and against any and all Losses arising out of or in connection with:

(a) the negligence, gross negligence, or willful misconduct of Site Staff in connection with the conduct of the Study;

(b) Protocol deviations that were not authorized by Sponsor and that do not constitute Medically Necessary Protocol Deviations as defined herein; or

(c) any breach of this Agreement, the applicable Individual Site Agreement, or applicable law or regulation by Veridian, a Participating Site, any Investigator, or any member of Site Staff.

Section 8.6 — Cap on Site Indemnification. The indemnification obligations of Veridian and each Participating Site Institution under Section 8.5 shall be subject to the following limitations:

(a) Per-Site, Per-Occurrence Cap: The maximum liability of any individual Participating Site Institution under Section 8.5 shall not exceed Five Million Dollars ($5,000,000) per occurrence.

(b) Aggregate Cap: The maximum aggregate liability of Veridian and all Participating Site Institutions under Section 8.5, combined, shall not exceed Twenty Million Dollars ($20,000,000).

Section 8.7 — Notice of Claims. The indemnified party shall provide written notice to the indemnifying party within thirty (30) calendar days of becoming aware of any claim, demand, action, suit, or proceeding for which indemnification is sought under this Article VIII, specifying in reasonable detail the nature and basis of such claim and the amount of Losses claimed or estimated. Failure to provide timely notice under this Section 8.7 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, in which case the indemnifying party's obligations shall be reduced to the extent of such material prejudice.

Section 8.8 — Defense and Settlement. Upon receipt of a notice of claim under Section 8.7, the indemnifying party shall have the right, but not the obligation, to assume and control the defense of any indemnified claim, using legal counsel of its choosing that is reasonably acceptable to the indemnified party. If the indemnifying party elects to assume the defense, the indemnified party shall cooperate fully with the indemnifying party and its counsel, including by providing access to relevant documents, witnesses, and information. The indemnified party shall have the right to participate in the defense at its own expense. No settlement, compromise, or consent to judgment of any indemnified claim shall be made without the prior written consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned, or delayed; provided, however, that if a settlement involves only the payment of money by the indemnifying party and includes a full and unconditional release of the indemnified party, the indemnified party's consent shall not be required.

Section 8.9 — Detailed Provisions. Detailed indemnification terms, including additional procedures for notice, defense, settlement, and allocation, are set forth in Exhibit D attached hereto and incorporated herein by reference. In the event of any conflict between the provisions of this A

CONFIDENTIAL TREATMENT REQUESTED — This document and the information contained herein are confidential and proprietary. Unauthorized reproduction, distribution, or disclosure is strictly prohibited.
MASTER CLINICAL TRIAL AGREEMENT
Protocol PPC-4871-III
(CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
Final Agreed Draft — Circulated for Execution
June 23, 2023
PENTERRA PHARMACEUTICALS CORP. ("Sponsor")
and
VERIDIAN HEALTH RESEARCH NETWORK, INC. ("Site Network")
Calderwood & Harkness LLP Matter No. 1018-00004
TABLE OF CONTENTS
Right-click to update Table of Contents
MASTER CLINICAL TRIAL AGREEMENT
This Master Clinical Trial Agreement (together with all Exhibits and Schedules attached hereto, this "Agreement") is entered into as of June 23, 2023 (the "Signing Date"), by and between:
PENTERRA PHARMACEUTICALS CORP., a Delaware corporation, with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540 (hereinafter referred to as "Sponsor" or "Penterra");
and
VERIDIAN HEALTH RESEARCH NETWORK, INC., a Delaware corporation organized as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104 (hereinafter referred to as "Site Network" or "Veridian").
Sponsor and Site Network are sometimes referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS, Sponsor is the holder of Investigational New Drug Application No. 157823 ("IND 157823") filed with the United States Food and Drug Administration (the "FDA") for penterafenib (PPC-4871), an oral multi-kinase inhibitor targeting FGFR1-4, VEGFR1-3, and PDGFR-alpha/beta kinase pathways, and Sponsor intends to conduct a Phase III, randomized, double-blind, placebo-controlled clinical trial designated as Protocol PPC-4871-III (the "CLARION" trial) for the treatment of advanced hepatocellular carcinoma ("HCC") in subjects who have received at least one prior line of systemic therapy;
WHEREAS, Sponsor completed Phase II clinical evaluation of PPC-4871 in January 2023 (Study PPC-4871-II, NCT04817293), demonstrating a thirty-eight percent (38%) objective response rate ("ORR") in patients with advanced HCC, with a manageable safety profile and a median duration of response of seven point four (7.4) months, thereby providing the scientific basis for advancement to Phase III evaluation;
WHEREAS, the CLARION trial has been registered on ClinicalTrials.gov under identifier NCT05928174 and Sponsor has received written acknowledgment from the FDA of its protocol design;
WHEREAS, Veridian operates a network of thirty-eight (38) academic medical centers and affiliated research institutions located across fourteen (14) states within the United States, and possesses the institutional infrastructure, scientific expertise, clinical research operations capacity, and qualified investigators necessary to support the conduct of large-scale, multi-center oncology clinical trials;
WHEREAS, Sponsor desires to engage Veridian and its participating sites to conduct the CLARION trial in accordance with the Protocol and applicable regulatory requirements, and Veridian desires to participate in such engagement and to make its network of sites available for the conduct of the Study, subject to the terms and conditions set forth herein;
WHEREAS, Sponsor has separately engaged Meridian Contract Research Organization, Inc. ("Meridian CRO"), a full-service contract research organization with offices at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, under a Master Services Agreement dated January 15, 2023 (the "CRO Agreement"), to perform certain monitoring, data management, pharmacovigilance, safety reporting, and biostatistics services in connection with the CLARION trial;
WHEREAS, the Parties, through their respective legal counsel — Calderwood & Harkness LLP (280 Park Avenue, 34th Floor, New York, New York 10017) for Sponsor and Whitmore, Jansen & Callahan LLP (1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102) for Veridian — have negotiated the terms and conditions of this Agreement in good faith and at arm's length over a period of approximately five (5) months; and
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by each Party, the Parties hereby agree as follows:
ARTICLE I — DEFINITIONS
Section 1.1 — Definitions. As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not defined in this Section 1.1 shall have the meanings ascribed to them elsewhere in this Agreement.
"Additional Insured" means Veridian and each Participating Site Institution that is named as an additional insured under the Sponsor Insurance Policy, as more fully described in Article XI and Exhibit E.
"Adverse Event" or "AE" means any untoward medical occurrence in a Study Subject administered the Investigational Product or placebo, whether or not considered related to the Investigational Product, as defined in the ICH E6(R2) Guidelines and 21 C.F.R. § 312.32, including but not limited to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
"Affiliate" means, with respect to any Party, any entity that directly or indirectly controls, is controlled by, or is under common control with such Party. For purposes of this definition, "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting securities, by contract, or otherwise, and the terms "controlled by" and "under common control with" shall be construed accordingly. Ownership of fifty percent (50%) or more of the voting securities of an entity shall be deemed to constitute control.
"Agreement" means this Master Clinical Trial Agreement, together with all Exhibits and Schedules attached hereto and incorporated herein by reference, and any amendments or modifications hereto executed in writing by both Parties.
"Approved Subcontractors" means those third-party service providers engaged by Sponsor and listed in Exhibit K attached hereto, which as of the date hereof include Meridian Contract Research Organization, Inc., Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc.
"Budget" means the budget and payment schedule set forth in Exhibit B attached hereto, as may be amended from time to time by mutual written agreement of the Parties.
"CLARION" or "CLARION Trial" means the Phase III clinical trial conducted pursuant to Protocol PPC-4871-III, as further described in the Protocol Synopsis attached as Exhibit A.
"Clinical Trial Data" means all data, results, reports, analyses, case report forms (whether in paper or electronic format), source data, biological sample data, pharmacokinetic data, pharmacodynamic data, biomarker data, imaging data, safety data, efficacy data, statistical analyses, and any other data or information collected, generated, derived, or produced in connection with, or arising out of, the conduct of the Study.
"Closing Date" means the date on which all Conditions Precedent set forth in Article XVII have been satisfied or waived in writing by the Party entitled to the benefit of such condition.
"Conditions Precedent" means the conditions to closing set forth in Section 17.1 of this Agreement.
"Confidential Information" has the meaning set forth in Section 12.1 of this Agreement.
"CRO" means Meridian Contract Research Organization, Inc., a Delaware corporation with offices at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, engaged by Sponsor under the CRO Agreement to perform certain services in connection with the Study.
"EDC" means the electronic data capture system provided by Pinnacle Data Solutions, Inc. for use in connection with the Study, including all related software, platforms, and interfaces.
"Effective Date" means the date on which the last Condition Precedent set forth in Article XVII is satisfied or waived, and this Agreement becomes fully operative in accordance with its terms.
"FDA" means the United States Food and Drug Administration, and any successor agency thereto.
"GCP" means Good Clinical Practice as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") in its Guideline for Good Clinical Practice E6(R2), effective November 9, 2016, as may be amended, supplemented, or superseded from time to time.
"Global Principal Investigator" means Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, who shall serve as the overall principal investigator for the CLARION trial across all Participating Sites, as further described in Article V.
"HIPAA" means the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended by the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act"), and all regulations promulgated thereunder, including without limitation the Standards for Privacy of Individually Identifiable Health Information (the "Privacy Rule") and the Security Standards for the Protection of Electronic Protected Health Information (the "Security Rule") set forth at 45 C.F.R. Parts 160 and 164.
"IND" means Investigational New Drug Application No. 157823 filed by Sponsor with the FDA for penterafenib (PPC-4871), as may be amended or supplemented from time to time.
"Individual Site Agreement" means a joinder agreement in substantially the form attached hereto as Exhibit C, to be executed by each Participating Site Institution, incorporating by reference the terms and conditions of this Agreement and setting forth site-specific information, including the identity of the principal investigator, IRB of record, and any site-specific modifications authorized hereunder.
"Institutional Review Board" or "IRB" means the institutional review board, ethics committee, or other body responsible for the ethical oversight and approval of clinical research at each Participating Site, constituted and operating in accordance with 21 C.F.R. Part 56 and applicable institutional policies.
"Investigational Product" means penterafenib (PPC-4871), the oral multi-kinase inhibitor compound under investigation in the CLARION trial, and the matching placebo, in all dosage forms, strengths, and formulations supplied by Sponsor for use in the Study.
"Investigator" means any principal investigator, co-principal investigator, or sub-investigator who is authorized to direct or supervise the conduct of the Study at a Participating Site, as identified on the applicable FDA Form 1572 and Individual Site Agreement.
"Medically Necessary Protocol Deviation" means a deviation from the Protocol undertaken by an Investigator in the exercise of his or her medical judgment to protect the immediate safety, rights, or welfare of a Study Subject, where adherence to the Protocol would, in the Investigator's reasonable medical judgment, have posed an unacceptable risk to the Study Subject.
"Network Coordination Fee" means the administrative and coordination fee payable to Veridian in the amount and on the schedule set forth in Section 7.3(c) and Exhibit B.
"Participating Site" or "Participating Site Institution" means each academic medical center, hospital, research institution, or other clinical facility within the Veridian network that is listed on Schedule 1 and that has duly executed an Individual Site Agreement in the form of Exhibit C.
"Payment Terms" means Net forty-five (45) calendar days from the date of Sponsor's receipt of a proper and complete invoice submitted by Veridian in accordance with Section 7.5.
"Per-Patient Fee" means Fifty-Two Thousand Dollars ($52,000) per Study Subject, payable in accordance with the milestone-based payment structure set forth in Section 7.3(b).
"Protocol" means Protocol PPC-4871-III (CLARION), the clinical study protocol for the CLARION trial, including any amendments thereto approved by Sponsor and the applicable IRB(s), as described in the Protocol Synopsis attached as Exhibit A.
"Protocol Synopsis" means the summary of the Protocol attached hereto as Exhibit A.
"Serious Adverse Event" or "SAE" means any Adverse Event that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is a medically important event that may jeopardize the Study Subject or may require medical or surgical intervention to prevent one of the foregoing outcomes, as defined in 21 C.F.R. § 312.32.
"Site Staff" means all investigators, sub-investigators, study coordinators, clinical research nurses, pharmacists, laboratory technicians, and other personnel at a Participating Site who are involved in the conduct of the Study.
"Sponsor Insurance Policy" means the clinical trial liability insurance policy issued by Briarcliff Mutual Insurance Company (55 Constitution Plaza, Hartford, Connecticut 06103), Policy Number BM-CTL-2023-04182, as described in Article XI and Exhibit E.
"Start-Up Fee" means Seventy-Five Thousand Dollars ($75,000) per Participating Site, payable in accordance with Section 7.3(a).
"Study" means the CLARION trial conducted pursuant to the Protocol at the Participating Sites, including all screening, enrollment, randomization, treatment, follow-up, and close-out activities.
"Study Subject" means each individual human subject who provides informed consent and is enrolled in the Study at a Participating Site.
"Subject Injury" means any physical injury, illness, or medical condition sustained by a Study Subject that is directly attributable to (a) the administration of the Investigational Product when administered in accordance with the Protocol, or (b) study procedures performed in accordance with the Protocol, excluding any injury, illness, or condition that is attributable to the negligence or willful misconduct of an Investigator or Site Staff or that results from the natural progression of the Study Subject's underlying disease.
"Sunshine Act" means Section 6002 of the Patient Protection and Affordable Care Act, codified at 42 U.S.C. § 1320a-7h, and the regulations promulgated thereunder at 42 C.F.R. Parts 402 and 403, requiring the reporting of payments and other transfers of value made by pharmaceutical and device manufacturers to physicians and teaching hospitals through the Centers for Medicare & Medicaid Services Open Payments program.
"Total Deal Value" means Eighty Million Dollars ($80,000,000), representing the aggregate value of all payments contemplated under this Agreement across all Participating Sites over the projected life of the Study, as further detailed in Article VII and Exhibit B.
"Veridian Central IRB" means the centralized institutional review board maintained and operated by Veridian for the purpose of providing ethical review and oversight of clinical research protocols conducted at Participating Sites that do not maintain their own IRB and that have entered into IRB Authorization Agreements with Veridian, in accordance with 21 C.F.R. Part 56.
"Wind-Down Period" means the period of one hundred twenty (120) calendar days following the date on which a notice of termination is delivered by either Party in accordance with Article XVIII, during which the Parties shall undertake the wind-down activities described in Section 18.4.
ARTICLE II — SCOPE OF AGREEMENT
Section 2.1 — Purpose. Sponsor hereby engages Veridian and its Participating Sites, and Veridian hereby accepts such engagement, to conduct the CLARION trial at up to thirty-eight (38) Veridian Network sites located across fourteen (14) states within the United States, in accordance with the Protocol, GCP, all applicable laws and regulations, and the terms and conditions set forth in this Agreement. Veridian shall serve as the coordinating network organization, providing centralized administrative, regulatory, and operational support for the Participating Sites in connection with the conduct of the Study. The engagement contemplated hereunder represents a comprehensive arrangement for the clinical evaluation of penterafenib (PPC-4871) in the treatment of advanced hepatocellular carcinoma, with a Total Deal Value of Eighty Million Dollars ($80,000,000).
Section 2.2 — Protocol. The Study shall be conducted pursuant to Protocol PPC-4871-III (CLARION), as described in the Protocol Synopsis attached hereto as Exhibit A and incorporated herein by reference. The Protocol is designed as a Phase III, randomized, double-blind, placebo-controlled 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 planned enrollment target is one thousand two hundred (1,200) Study Subjects, randomized in a 2:1 ratio, with eight hundred (800) subjects assigned to the penterafenib treatment arm and four hundred (400) subjects assigned to the placebo control arm. The primary endpoint of the Study is overall survival ("OS"). Key secondary endpoints include progression-free survival ("PFS"), objective response rate ("ORR") as assessed by RECIST v1.1 criteria, and duration of response ("DOR"). Exploratory endpoints include pharmacokinetic assessments, biomarker analyses, patient-reported outcomes, and health-related quality of life measures.
Section 2.3 — Projected Timeline. The Parties anticipate the following projected timeline for the Study, subject to adjustment based on actual enrollment rates, regulatory requirements, and other factors:
(a) Enrollment Period: Forty-two (42) months from the date of first patient in ("FPI"), with a target FPI date of August 14, 2023.
(b) Follow-Up Period: Eighteen (18) months following the enrollment of the last Study Subject.
(c) Total Estimated Study Duration: Sixty (60) months from FPI.
(d) Projected Last Patient In: February 2027.
(e) Projected Study Completion: August 2028.
The foregoing timeline is a good-faith estimate and does not constitute a binding commitment. The Parties acknowledge that actual timelines may vary based on enrollment rates, regulatory developments, safety considerations, and other factors outside the reasonable control of either Party. The Parties shall meet on a quarterly basis, or more frequently as circumstances warrant, to review enrollment progress and adjust timelines as necessary.
Section 2.4 — Individual Site Agreements. Each Participating Site Institution shall, prior to initiating any Study activities, execute an Individual Site Agreement in substantially the form attached hereto as Exhibit C. Each Individual Site Agreement shall incorporate by reference the terms and conditions of this Agreement, identify the principal investigator designated for such site, specify the applicable IRB of record, and include any site-specific addenda or modifications approved in writing by Sponsor. An Individual Site Agreement shall become effective upon execution by the Participating Site Institution, Veridian, and Sponsor. Veridian shall be responsible for coordinating the execution of Individual Site Agreements and shall use commercially reasonable efforts to ensure that all Individual Site Agreements are fully executed prior to the commencement of Study activities at each Participating Site.
Section 2.5 — Relationship to CRO Agreement. The Parties acknowledge that Sponsor has separately contracted with Meridian Contract Research Organization, Inc. under a Master Services Agreement dated January 15, 2023 (the "CRO Agreement") for the performance of certain monitoring, data management, pharmacovigilance, safety reporting, and biostatistics services in connection with the CLARION trial. Veridian and each Participating Site shall cooperate with Meridian CRO as reasonably required in connection with the performance of such services, including by providing access to study sites, source documents, Study Subjects (subject to applicable consent and privacy requirements), and Site Staff during monitoring visits. Nothing in this Agreement shall be construed to create any contractual relationship between Veridian or any Participating Site and Meridian CRO; the CRO Agreement is a separate and independent contractual arrangement between Sponsor and Meridian CRO, and Sponsor shall remain responsible for the acts and omissions of Meridian CRO in connection with the Study.
Section 2.6 — Approved Subcontractors. Sponsor's approved subcontractors for the Study are listed in Exhibit K attached hereto and, as of the date hereof, include the following:
(a) Meridian Contract Research Organization, Inc. — performing monitoring, data management, pharmacovigilance, safety reporting, and biostatistics services.
(b) Pinnacle Data Solutions, Inc. — providing the electronic data capture ("EDC") platform and related technology services.
(c) Northbridge Bioanalytical Laboratories, Inc. — serving as the central laboratory for specimen processing, analysis, and biomarker assessments.
Sponsor may add or remove Approved Subcontractors by providing written notice to Veridian and updating Exhibit K. Each Approved Subcontractor shall be bound by confidentiality obligations at least as restrictive as those set forth in Article XII.
ARTICLE III — RESPONSIBILITIES OF SPONSOR
Section 3.1 — IND Maintenance. Sponsor shall maintain IND 157823 in good standing with the FDA throughout the term of the Study and shall bear sole responsibility for all regulatory submissions, amendments, annual reports, safety reports, and correspondence with the FDA and other regulatory authorities in connection with the IND and the Study. Sponsor shall promptly notify Veridian and the Global Principal Investigator of any material communication from the FDA regarding the IND or the Study, including without limitation any clinical hold, request for additional information, or notice of deficiency.
Section 3.2 — Supply of Investigational Product. Sponsor shall supply penterafenib (PPC-4871) and matching placebo in quantities sufficient for the conduct of the Study at all Participating Sites, at no cost to Veridian, any Participating Site, or any Study Subject. Sponsor shall be responsible for the manufacture, quality control, quality assurance, labeling, packaging, and distribution of the Investigational Product in compliance with current Good Manufacturing Practice ("cGMP") requirements set forth in 21 C.F.R. Parts 210 and 211 and applicable FDA guidance. Sponsor shall ensure that adequate supplies of the Investigational Product are delivered to each Participating Site in a timely manner, and shall work with Veridian and Participating Sites to establish and maintain appropriate procedures for the receipt, storage, dispensing, accounting, and return or destruction of the Investigational Product. Sponsor shall bear all costs associated with the supply and distribution of the Investigational Product, including shipping, temperature-controlled storage, and interactive response technology ("IRT") systems for randomization and drug supply management.
Section 3.3 — Protocol and Amendments. Sponsor shall provide the Protocol and any amendments thereto to Veridian and each Participating Site in a timely manner. Any Protocol amendment shall be communicated in writing to Veridian and all Participating Sites, and shall require applicable IRB approval prior to implementation at any Participating Site, except in circumstances where an immediate change is necessary to eliminate an apparent immediate hazard to Study Subjects, in which case the amendment may be implemented prior to IRB approval in accordance with 21 C.F.R. § 312.30(b)(2). Sponsor shall consult with the Global Principal Investigator regarding any proposed Protocol amendments that may have a material impact on the conduct of the Study.
Section 3.4 — Monitoring. Sponsor, through Meridian CRO, shall conduct monitoring visits at each Participating Site in accordance with ICH E6(R2) Guidelines and 21 C.F.R. Part 312. Monitoring activities shall include, without limitation, on-site monitoring, remote monitoring, centralized statistical monitoring, source data verification, review of informed consent documentation, verification of subject eligibility, and assessment of compliance with the Protocol, GCP, and applicable regulations. Sponsor shall ensure that monitoring visits are conducted with reasonable frequency and that monitors are appropriately trained and qualified. Monitoring reports shall be prepared and maintained by Meridian CRO and made available to Sponsor.
Section 3.5 — Safety Reporting. Sponsor shall fulfill all IND safety reporting obligations under 21 C.F.R. § 312.32, including the submission of IND safety reports to the FDA. Fatal and life-threatening suspected adverse reactions shall be reported to the FDA as soon as possible but no later than seven (7) calendar days after Sponsor first receives the information ("7-day reports"), with a follow-up report submitted within eight (8) additional calendar days. All other IND safety reports shall be submitted to the FDA no later than fifteen (15) calendar days after Sponsor first receives the information ("15-day reports"). Sponsor shall provide IND safety report information to all participating investigators in accordance with 21 C.F.R. § 312.32(c)(2) and shall coordinate safety reporting activities with Meridian CRO in accordance with the CRO Agreement.
Section 3.6 — Insurance. Sponsor shall obtain and maintain clinical trial liability insurance throughout the term of the Study and for the post-termination period specified in Article XI, with coverage limits and terms as set forth in Section 11.1 and Exhibit E. Sponsor shall name Veridian and each Participating Site Institution as additional insureds under the Sponsor Insurance Policy.
Section 3.7 — Regulatory Compliance. Sponsor shall comply with all applicable laws, rules, and regulations in connection with the conduct of the Study, including without limitation: (a) 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) ICH E6(R2) Guidelines for Good Clinical Practice; (c) HIPAA, to the extent applicable; (d) the Anti-Kickback Statute (42 U.S.C. § 1320a-7b); and (e) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h). Sponsor shall designate qualified personnel to oversee regulatory compliance in connection with the Study and shall cooperate with Veridian and Participating Sites to ensure that all regulatory requirements are met.
ARTICLE IV — RESPONSIBILITIES OF VERIDIAN AND PARTICIPATING SITES
Section 4.1 — Site Activation. Veridian shall use commercially reasonable efforts to activate each of the thirty-eight (38) Participating Sites listed on Schedule 1 in a timely manner consistent with the projected timeline set forth in Section 2.3. Site activation shall include, without limitation, the execution of Individual Site Agreements, obtainment of IRB approval, completion of site feasibility and qualification assessments, execution of required regulatory documents (including FDA Forms 1572 and financial disclosure certifications), site initiation training, and EDC system access provisioning. Veridian shall provide Sponsor with regular status reports on the progress of site activation activities and shall promptly notify Sponsor of any delays or issues that may materially affect the activation timeline.
Section 4.2 — Conduct of Study. Each Participating Site shall conduct the Study in strict accordance with the Protocol, GCP, all applicable federal, state, and local laws and regulations, and the terms and conditions of this Agreement and the applicable Individual Site Agreement. Each Participating Site shall use its best efforts to enroll Study Subjects in accordance with the enrollment targets and timelines established by Sponsor and shall ensure that all Study procedures are performed by qualified personnel in accordance with the Protocol.
Section 4.3 — Qualified Investigators. Veridian shall ensure that each Participating Site designates a qualified principal investigator who meets the requirements of 21 C.F.R. § 312.53 and who is appropriately trained and experienced in the conduct of clinical research in oncology. The Global Principal Investigator for the CLARION trial shall be Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, 1200 University Avenue, Philadelphia, Pennsylvania 19104. The Co-Principal Investigator shall be Dr. Howard Matsuoka, M.D., Associate Professor of Hepatology & Oncology at Lakemont Medical Center, 4400 North Michigan Drive, Chicago, Illinois 60611. Each Investigator shall be subject to the approval of Sponsor, and Veridian shall provide Sponsor with the curriculum vitae, medical license information, and other qualifying documentation for each proposed Investigator prior to the execution of the applicable Individual Site Agreement.
Section 4.4 — IRB Approval. Each Participating Site must obtain and maintain IRB approval for the Protocol, the informed consent document, and all other study-related documents prior to enrolling any Study Subject. The lead sites — Graystone University Medical Center and Lakemont Medical Center — shall obtain approval from their respective individual institutional review boards. Graystone University Medical Center shall rely upon the Graystone University IRB (IRB Registration Number: IRB00012847) as its IRB of record. The remaining Participating Sites may rely upon the Veridian Central IRB pursuant to IRB Authorization Agreements executed in accordance with 21 C.F.R. § 56.114 and the applicable policies and procedures of the Veridian Central IRB. Each Participating Site shall be responsible for ensuring that ongoing IRB approval is maintained throughout the conduct of the Study at such site, including by submitting continuing review applications, amendments, safety reports, and other required submissions in a timely manner.
Section 4.5 — Informed Consent. Each Participating Site shall obtain informed consent from each Study Subject prior to the conduct of any study-related procedures, in accordance with 21 C.F.R. Part 50, ICH E6(R2) Guidelines, and applicable IRB requirements. The informed consent document shall be approved by the applicable IRB and shall include all required elements set forth in 21 C.F.R. § 50.25, including a description of the Study, the risks and benefits of participation, the availability of alternative treatments, the voluntary nature of participation, the provisions for treatment of study-related injuries (as described in Article IX), and such other information as may be required by the applicable IRB or by applicable law. Each Participating Site shall maintain original signed and dated informed consent documents as part of the Study records.
Section 4.6 — Safety Reporting by Sites. Each Participating Site shall report all Serious Adverse Events to Sponsor and Meridian CRO within twenty-four (24) hours of the Investigator first becoming aware of such event, using the forms and procedures specified in Exhibit J attached hereto. Each Participating Site shall also report all Adverse Events, protocol deviations, and other safety-related information in accordance with the Protocol and the safety reporting procedures set forth in Exhibit J. Each Participating Site shall cooperate fully with Sponsor and Meridian CRO in the investigation, follow-up, and resolution of all safety-related events and shall provide such additional information and documentation as may be reasonably requested.
Section 4.7 — Data Collection and Recording. Each Participating Site shall enter all Study data into the EDC system provided by Pinnacle Data Solutions, Inc. in a timely, accurate, and complete manner, in accordance with the Protocol, the EDC data entry guidelines, and applicable data management plans. Source documents shall be created and maintained at each Participating Site for all Study activities and shall be available for review by monitors, auditors, and regulatory authorities upon reasonable notice. Each Participating Site shall ensure that all data entries are made by authorized Site Staff and that all corrections to data entries are documented, dated, and explained in accordance with GCP requirements.
Section 4.8 — Site Staff Qualifications. Each Participating Site shall ensure that all Site Staff involved in the conduct of the Study are adequately trained, qualified, and experienced to perform their assigned Study-related duties. Each Participating Site shall maintain documentation of Site Staff training, including Protocol-specific training, GCP training, EDC training, and any other training required by Sponsor or by applicable regulations. Each Participating Site shall designate a qualified study coordinator to serve as the primary point of contact for Sponsor, Meridian CRO, and Veridian with respect to day-to-day Study operations at such site.
Section 4.9 — Cooperation with Monitoring. Each Participating Site shall provide reasonable access to monitors from Meridian CRO for the conduct of on-site monitoring visits, including access to Study Subjects (subject to applicable consent and privacy requirements), source documents, case report forms, the Investigational Product and accountability records, laboratory records, and all other Study-related documents and materials. Each Participating Site shall also provide reasonable access to representatives of the FDA, other regulatory authorities, and Sponsor's quality assurance auditors for the conduct of inspections, audits, and other regulatory activities, and shall cooperate fully with any such inspection or audit.
Section 4.10 — Regulatory Filings. Each Investigator shall complete and maintain a current FDA Form 1572 (Statement of Investigator) and shall file financial disclosure certifications in accordance with 21 C.F.R. Part 54. Each Investigator shall promptly notify Sponsor and Veridian of any changes to the information provided on the Form 1572 or in the financial disclosure certification. Each Participating Site shall also be responsible for submitting and maintaining all required regulatory filings with the applicable IRB, including initial applications, continuing review submissions, protocol amendments, safety reports, and final study close-out reports.
Section 4.11 — HIPAA Compliance. Each Participating Site shall comply with all applicable requirements of HIPAA and the HITECH Act, including the Privacy Rule and the Security Rule, in connection with the collection, use, disclosure, and protection of protected health information ("PHI") of Study Subjects. Each Participating Site shall obtain appropriate research authorizations from Study Subjects for the use and disclosure of PHI in connection with the Study, or shall obtain a waiver of authorization from the applicable IRB or privacy board in accordance with 45 C.F.R. § 164.512(i)(2). Each Participating Site shall implement and maintain appropriate administrative, technical, and physical safeguards to protect the privacy and security of PHI in connection with the Study.
Section 4.12 — Anti-Kickback and Sunshine Act Compliance. Veridian and each Participating Site represent and warrant that all payments received under this Agreement reflect fair market value for the services rendered and are consistent with applicable Anti-Kickback Statute safe harbors, including without limitation the personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d). Veridian and each Participating Site further represent and warrant that no payments received hereunder are intended to induce or reward the referral of Study Subjects, patients, or healthcare services, or to otherwise violate the Anti-Kickback Statute (42 U.S.C. § 1320a-7b). All reportable payments and transfers of value to physicians, teaching hospitals, and other covered recipients shall be tracked and disclosed by Sponsor in compliance with the Physician Payments Sunshine Act and the Centers for Medicare & Medicaid Services Open Payments program.
ARTICLE V — PRINCIPAL INVESTIGATOR
Section 5.1 — Global Principal Investigator. Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, 1200 University Avenue, Philadelphia, Pennsylvania 19104, shall serve as the Global Principal Investigator for the CLARION trial. In this capacity, Dr. Aldridge shall be responsible for providing overall scientific leadership and medical oversight for the Study across all Participating Sites, coordinating with Sponsor on Protocol design and amendments, serving as the primary medical contact for safety and efficacy matters, leading the publications committee established pursuant to Article XIV, and performing such other duties as are customary for a global principal investigator in a multi-center Phase III oncology trial. Dr. Aldridge shall also serve as the principal investigator at Graystone University Medical Center (Site 001).
Section 5.2 — Co-Principal Investigator. Dr. Howard Matsuoka, M.D., Associate Professor of Hepatology & Oncology at Lakemont Medical Center, 4400 North Michigan Drive, Chicago, Illinois 60611, shall serve as the Co-Principal Investigator for the CLARION trial. In this capacity, Dr. Matsuoka shall support Dr. Aldridge in the scientific oversight and coordination of the Study, serve as a co-chair of the publications committee, and serve as the principal investigator at Lakemont Medical Center (Site 002). Dr. Matsuoka shall assume the responsibilities of the Global Principal Investigator during any period of absence or unavailability of Dr. Aldridge.
Section 5.3 — Investigator Obligations. Each Investigator, including the Global Principal Investigator and the Co-Principal Investigator, shall comply with the Protocol, GCP, all applicable federal, state, and local laws and regulations, and the Investigator Undertaking attached hereto as Exhibit I. Each Investigator shall assume personal responsibility for the conduct of the Study at his or her Participating Site and shall ensure that adequate time, resources, and personnel are dedicated to the conduct of the Study. Each Investigator shall execute and maintain a current FDA Form 1572 and financial disclosure certification, and shall cooperate with Sponsor, Meridian CRO, and applicable regulatory authorities in connection with the monitoring, auditing, and inspection of the Study.
Section 5.4 — Replacement of Investigators. Replacement of a principal investigator at any Participating Site requires the prior written approval of Sponsor, which approval shall not be unreasonably withheld, conditioned, or delayed. In the event that a principal investigator at a Participating Site becomes unable or unwilling to continue serving in such capacity, or is removed for cause, Veridian shall promptly notify Sponsor and shall propose a qualified replacement investigator for Sponsor's review and approval. No Study activities shall be conducted at the affected Participating Site during any period in which a qualified principal investigator is not designated and approved, except as necessary to ensure the safety and welfare of currently enrolled Study Subjects. Replacement of the Global Principal Investigator or the Co-Principal Investigator shall require the mutual written agreement of both Parties.
ARTICLE VI — STUDY SUBJECTS
Section 6.1 — Enrollment Target. The planned enrollment target for the Study is one thousand two hundred (1,200) Study Subjects across all Participating Sites. The Parties shall work together in good faith to achieve this enrollment target within the forty-two (42) month enrollment period specified in Section 2.3. Enrollment targets for individual Participating Sites shall be established by Sponsor in consultation with Veridian and the Global Principal Investigator, based on site capabilities, patient population, and historical enrollment performance.
Section 6.2 — Randomization. Study Subjects who meet all inclusion criteria and none of the exclusion criteria set forth in the Protocol shall be randomized in a 2:1 ratio, with eight hundred (800) subjects assigned to the penterafenib (PPC-4871) treatment arm and four hundred (400) subjects assigned to the placebo control arm. Randomization shall be performed using the interactive response technology ("IRT") system designated by Sponsor. Randomization shall be stratified by geographic region, prior therapy, and other factors as specified in the Protocol.
Section 6.3 — Enrollment Period. The enrollment period for the Study shall be forty-two (42) months from the date of FPI. The Parties may extend the enrollment period by mutual written agreement if enrollment targets are not met within the initial forty-two (42) month period, subject to regulatory and budgetary considerations.
Section 6.4 — Inclusion/Exclusion Criteria. Study Subjects shall be enrolled only if they meet all inclusion criteria and none of the exclusion criteria as set forth in the Protocol (Exhibit A). Each Participating Site shall be responsible for verifying subject eligibility prior to randomization.
Section 6.5 — Subject Screening. Each Participating Site shall follow the Protocol-specified screening procedures to assess the eligibility of potential Study Subjects. Per-Patient Fees shall begin to accrue at the time of randomization in accordance with the milestone payment structure set forth in Section 7.3(b). Screening failures shall not be subject to Per-Patient Fees, but reasonable and documented screening costs may be reimbursed in accordance with the Budget set forth in Exhibit B.
ARTICLE VII — BUDGET AND PAYMENT
Section 7.1 — Total Deal Value. The total value of this Agreement across all Participating Sites over the projected life of the Study is Eighty Million Dollars ($80,000,000) (the "Total Deal Value"). This figure represents the maximum aggregate amount payable under this Agreement and encompasses all components set forth in Section 7.2 below. The Total Deal Value may be increased only by mutual written agreement of the Parties, including through the use of the Contingency Reserve as set forth in Section 7.7.
Section 7.2 — Budget Components. The Total Deal Value is comprised of the following components:
(a) Per-Patient Site Fees: Fifty-Two Thousand Dollars ($52,000) per Study Subject multiplied by one thousand two hundred (1,200) planned subjects, for a total of Sixty-Two Million Four Hundred Thousand Dollars ($62,400,000).
(b) Start-Up Fees: Seventy-Five Thousand Dollars ($75,000) per Participating Site multiplied by thirty-eight (38) Participating Sites, for a total of Two Million Eight Hundred Fifty Thousand Dollars ($2,850,000).
(c) Annual Site Maintenance Fees: Forty Thousand Dollars ($40,000) per Participating Site per year multiplied by thirty-eight (38) Participating Sites multiplied by an average of three and one-half (3.5) years of active participation, for a total of Five Million Three Hundred Twenty Thousand Dollars ($5,320,000).
(d) Investigator Grants (Academic Publication Support): One Million Five Hundred Thousand Dollars ($1,500,000), to be disbursed upon acceptance of manuscripts for peer-reviewed publication as set forth in Section 7.3(e) and Article XIV.
(e) Network Coordination/Administrative Fee: Four Million Two Hundred Thousand Dollars ($4,200,000) payable to Veridian central in quarterly installments as set forth in Section 7.3(c).
(f) Technology/EDC Integration Costs (Pinnacle Data Solutions): One Million Two Hundred Thirty Thousand Dollars ($1,230,000), representing costs for EDC platform configuration, integration, validation, and ongoing support.
(g) Contingency/Change Order Reserve: Two Million Five Hundred Thousand Dollars ($2,500,000), available for unanticipated costs, protocol amendments, additional study procedures, or other changes requiring additional funding, subject to Section 7.7.
Section 7.3 — Payment Schedule. Payments under this Agreement shall be made in accordance with the following schedule:
(a) Start-Up Fees: Fifty percent (50%) of the Start-Up Fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) per Participating Site shall be payable upon site activation, defined as the date on which the applicable Individual Site Agreement has been fully executed, IRB approval has been obtained, and the site has been cleared by Sponsor to commence screening activities. The remaining fifty percent (50%) of the Start-Up Fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) per Participating Site shall be payable upon the enrollment of the first Study Subject at such site.
(b) Per-Patient Fees: Per-Patient Fees shall be paid on a milestone basis as follows:
(i) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon randomization of the Study Subject.
(ii) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon completion of the Study Subject's Week 12 assessment.
(iii) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon completion of the Study Subject's Week 24 assessment.
(iv) Twenty-five percent (25%) of the Per-Patient Fee (Thirteen Thousand Dollars ($13,000)) shall be payable upon study completion or final visit for the Study Subject, including all end-of-study assessments and data clean-up activities.
(c) Network Coordination Fee: The Network Coordination Fee shall be payable in quarterly installments of Three Hundred Thousand Dollars ($300,000) each, commencing on the Effective Date and continuing for fourteen (14) consecutive quarters, for a total of Four Million Two Hundred Thousand Dollars ($4,200,000). Quarterly installments shall be due within forty-five (45) calendar days following the end of each calendar quarter.
(d) Annual Site Maintenance Fees: Annual Site Maintenance Fees shall be paid annually in advance on each anniversary of the site-activation date for each Participating Site. The Annual Site Maintenance Fee for a partial year shall be prorated on a daily basis.
(e) Investigator Grants: Investigator grants shall be disbursed upon acceptance of manuscripts for publication in peer-reviewed journals, as described in Section 14.6, subject to the aggregate limit of One Million Five Hundred Thousand Dollars ($1,500,000).
Section 7.4 — Payment Terms. All amounts due under this Agreement shall be payable Net forty-five (45) calendar days from the date of Sponsor's receipt of a proper and complete invoice submitted by Veridian in accordance with Section 7.5. Payments shall be made in United States Dollars by wire transfer of immediately available funds to the bank account designated by Veridian in writing. Late payments shall bear interest at the lesser of one and one-half percent (1.5%) per month or the maximum rate permitted by applicable law.
Section 7.5 — Invoicing. Veridian shall submit invoices on behalf of itself and the Participating Sites on a monthly basis, or at such other intervals as may be agreed upon by the Parties. Each invoice shall set forth in reasonable detail the services performed, the milestones achieved, the amounts due by component, and such other information as Sponsor may reasonably request. Invoices shall be directed to:
Penterra Pharmaceuticals Corp.
Attn: Samantha Novak, Director of Clinical Contracts
200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540
Email: s.novak@penterra.com
Sponsor shall notify Veridian in writing within fifteen (15) business days of receipt of any invoice if Sponsor disputes any amount set forth therein, specifying the nature and basis of the dispute in reasonable detail. Undisputed amounts shall be paid in accordance with the Payment Terms regardless of any dispute with respect to other amounts on the same invoice. The Parties shall work in good faith to resolve any invoicing disputes within thirty (30) calendar days.
Section 7.6 — Taxes. Each Party shall be responsible for the payment of its own taxes, including without limitation federal, state, and local income taxes, franchise taxes, and employment taxes. The Parties acknowledge Veridian's status as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code. Sponsor shall have no obligation to withhold or remit taxes on payments made to Veridian, provided that Veridian has furnished Sponsor with a valid IRS determination letter and a completed IRS Form W-9 or applicable substitute form. Each Participating Site Institution shall provide appropriate tax documentation to Veridian and/or Sponsor upon request.
Section 7.7 — Contingency Reserve. The Contingency/Change Order Reserve of Two Million Five Hundred Thousand Dollars ($2,500,000) shall be available for unanticipated costs, including without limitation costs arising from Protocol amendments, additional study procedures, regulatory requirements, extended enrollment periods, or other changes to the Study scope. Use of the Contingency Reserve shall require the prior written approval of both Parties, which approval shall be documented in a written change order specifying the nature of the change, the amounts to be expended, and the affected Budget components. Any unused portion of the Contingency Reserve shall be retained by Sponsor upon completion or termination of the Study.
Section 7.8 — Fair Market Value. The Parties represent and warrant that all payments under this Agreement have been determined through arm's-length negotiation and reflect the fair market value of the services to be rendered and the costs to be incurred in connection with the Study. No payment under this Agreement is intended to induce or reward the referral of Study Subjects, patients, or healthcare services, or to otherwise violate the Anti-Kickback Statute (42 U.S.C. § 1320a-7b) or any other applicable law or regulation. The Parties have independently considered relevant factors, including the nature and scope of the services, the time and effort required, the qualifications and experience of the personnel involved, and the fair market value assessments of independent third-party consultants, in establishing the payment amounts set forth herein.
Section 7.9 — Detailed Budget. The detailed line-item budget and payment schedule for the Study is set forth in Exhibit B attached hereto and incorporated herein by reference. In the event of any conflict between the provisions of this Article VII and the terms of Exhibit B, the provisions of this Article VII shall control.
ARTICLE VIII — INDEMNIFICATION
Section 8.1 — Sponsor Indemnification of Site Network, Sites, and Investigators. Penterra shall indemnify, defend, and hold harmless Veridian, each Participating Site Institution, each Investigator, each sub-investigator, and each member of Site Staff (collectively, the "Site Indemnitees"), and their respective officers, directors, trustees, employees, agents, successors, and assigns, from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, judgments, settlements, penalties, fines, costs, and expenses (including reasonable attorneys' fees, court costs, expert witness fees, and costs of defense) (collectively, "Losses") arising out of or in connection with:
(a) any Subject Injury caused by the Investigational Product when administered in accordance with the Protocol;
(b) any defect in the Investigational Product, whether arising from manufacture, design, formulation, labeling, packaging, storage, or distribution;
(c) any breach of this Agreement or the Protocol by Sponsor or any of Sponsor's agents, employees, or Approved Subcontractors (including Meridian CRO); or
(d) any negligence, gross negligence, or willful misconduct of Sponsor or any of Sponsor's agents, employees, or Approved Subcontractors in connection with the Study.
The indemnification obligation of Sponsor under Section 8.1(b) with respect to product-defect claims shall be uncapped and shall apply without regard to any aggregate or per-occurrence limitation. The indemnification obligations of Sponsor under Sections 8.1(a), 8.1(c), and 8.1(d) shall be subject to the limitations set forth in this Article VIII, including the carve-outs set forth in Section 8.2.
Section 8.2 — Carve-Outs from Sponsor Indemnification. Notwithstanding anything to the contrary in Section 8.1, Sponsor's indemnification obligations under Section 8.1 shall not apply to the extent, and only to the extent, that Losses arise from or are attributable to:
(i) the negligence, gross negligence, or willful misconduct of a Participating Site, any Investigator, any sub-investigator, or any member of Site Staff in connection with the conduct of the Study;
(ii) a Protocol deviation that was neither authorized by Sponsor nor constituted a Medically Necessary Protocol Deviation undertaken for the immediate safety, rights, or welfare of a Study Subject in accordance with Section 8.4; or
(iii) a breach of this Agreement, the applicable Individual Site Agreement, or applicable law or regulation by Veridian, a Participating Site, any Investigator, or any member of Site Staff.
In the event that Losses are attributable to a combination of causes that include both indemnifiable claims under Section 8.1 and excluded claims under this Section 8.2, the Parties shall allocate responsibility for such Losses in proportion to their respective degrees of fault, as determined by agreement of the Parties or, if the Parties are unable to agree, by a court of competent jurisdiction or arbitration panel.
Section 8.3 — Subject Medical Care Costs. In addition to its indemnification obligations under Section 8.1, Sponsor shall cover the reasonable and customary medical costs for the treatment of study-related injuries sustained by Study Subjects that are not covered by such Study Subject's own health insurance, health plan, or other third-party payor. Sponsor's obligation under this Section 8.3 shall be subject to the following limitations:
(a) Per-Subject Cap: Sponsor's maximum liability for medical care costs under this Section 8.3 with respect to any individual Study Subject shall not exceed Five Hundred Thousand Dollars ($500,000).
(b) Aggregate Cap: Sponsor's maximum aggregate liability for medical care costs under this Section 8.3 across all Participating Sites and all Study Subjects shall not exceed Fifteen Million Dollars ($15,000,000).
The foregoing caps shall not apply to, or limit, Sponsor's indemnification obligations under Section 8.1 with respect to product-defect claims, which remain uncapped as set forth therein.
Section 8.4 — Medically Necessary Protocol Deviations. Liability for Losses arising from a Medically Necessary Protocol Deviation undertaken by an Investigator in good faith and in the exercise of his or her reasonable medical judgment for the immediate safety, rights, or welfare of a Study Subject shall remain with Sponsor under Section 8.1(a), provided that the following conditions are satisfied:
(a) The Investigator promptly reports the deviation to Sponsor and Meridian CRO, and in no event later than forty-eight (48) hours after the deviation occurs;
(b) The Investigator documents the medical justification for the deviation in the Study Subject's source documents and case report form; and
(c) The deviation was undertaken in circumstances where adherence to the Protocol would, in the Investigator's reasonable medical judgment, have posed an unacceptable risk to the Study Subject.
This provision is intended to ensure that Investigators are not deterred from taking medically appropriate action to protect Study Subject safety by concerns about the scope of Sponsor's indemnification obligations.
Section 8.5 — Site Network/Investigator Indemnification of Sponsor. Veridian and each Participating Site Institution shall, severally and not jointly, indemnify, defend, and hold harmless Sponsor and its officers, directors, employees, agents, Affiliates, successors, and assigns from and against any and all Losses arising out of or in connection with:
(a) the negligence, gross negligence, or willful misconduct of Site Staff in connection with the conduct of the Study;
(b) Protocol deviations that were not authorized by Sponsor and that do not constitute Medically Necessary Protocol Deviations as defined herein; or
(c) any breach of this Agreement, the applicable Individual Site Agreement, or applicable law or regulation by Veridian, a Participating Site, any Investigator, or any member of Site Staff.
Section 8.6 — Cap on Site Indemnification. The indemnification obligations of Veridian and each Participating Site Institution under Section 8.5 shall be subject to the following limitations:
(a) Per-Site, Per-Occurrence Cap: The maximum liability of any individual Participating Site Institution under Section 8.5 shall not exceed Five Million Dollars ($5,000,000) per occurrence.
(b) Aggregate Cap: The maximum aggregate liability of Veridian and all Participating Site Institutions under Section 8.5, combined, shall not exceed Twenty Million Dollars ($20,000,000).
Section 8.7 — Notice of Claims. The indemnified party shall provide written notice to the indemnifying party within thirty (30) calendar days of becoming aware of any claim, demand, action, suit, or proceeding for which indemnification is sought under this Article VIII, specifying in reasonable detail the nature and basis of such claim and the amount of Losses claimed or estimated. Failure to provide timely notice under this Section 8.7 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, in which case the indemnifying party's obligations shall be reduced to the extent of such material prejudice.
Section 8.8 — Defense and Settlement. Upon receipt of a notice of claim under Section 8.7, the indemnifying party shall have the right, but not the obligation, to assume and control the defense of any indemnified claim, using legal counsel of its choosing that is reasonably acceptable to the indemnified party. If the indemnifying party elects to assume the defense, the indemnified party shall cooperate fully with the indemnifying party and its counsel, including by providing access to relevant documents, witnesses, and information. The indemnified party shall have the right to participate in the defense at its own expense. No settlement, compromise, or consent to judgment of any indemnified claim shall be made without the prior written consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned, or delayed; provided, however, that if a settlement involves only the payment of money by the indemnifying party and includes a full and unconditional release of the indemnified party, the indemnified party's consent shall not be required.
Section 8.9 — Detailed Provisions. Detailed indemnification terms, including additional procedures for notice, defense, settlement, and allocation, are set forth in Exhibit D attached hereto and incorporated herein by reference. In the event of any conflict between the provisions of this A

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MASTER CLINICAL TRIAL AGREEMENT

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