Contract analysis

Section 1.1 — "Applicable Laws" means all federal, state, and local laws, statutes, regulations, rules, ordinances, executive orders, and guidance documents applicable to the conduct of the Study, including without limitation: Title 21 of the Code of Federal Regulations ("C.F.R.") Parts 11, 50, 54, 56, and 312; the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("I

Section 1.2 — "Anti-Kickback Statute" or "AKS" means Section 1128B(b) of the Social Security Act, codified at 42 U.S.C. § 1320a-7b(b), as amended from time to time, together with all regulations, safe harbors, and Office of Inspector General guidance interpreting the same.

Section 1.3 — "CRO" means Meridian Contract Research Organization, Inc., Sponsor's contracted clinical research organization engaged pursuant to a Master Services Agreement dated January 15, 2023, between Sponsor and Meridian Contract Research Organization, Inc., to perform certain clinical monitoring, data management, pharmacovigilance, and operational support services in connection with the Study.

Section 1.4 — "FDA" means the United States Food and Drug Administration, or any successor agency thereto.

Section 1.5 — "GCP" means Good Clinical Practice as defined in the ICH Guideline for Good Clinical Practice E6(R2), as updated or supplemented from time to time.

Section 1.6 — "IND" means Investigational New Drug Application No. 157823 filed with and maintained by the FDA by Sponsor with respect to penterafenib (PPC-4871), together with all amendments, supplements, and serial submissions thereto.

Section 1.7 — "Investigator" means each principal investigator, co-principal investigator, and sub-investigator at a Participating Site who has been delegated responsibility for the conduct of the Study pursuant to the Protocol and applicable regulations. As of the date of this Exhibit, the Investigators include, without limitation: Dr. Catherine Aldridge, M.D., Ph.D. (Global Principal Investigator, Graystone Univers

Section 1.8 — "Open Payments" means the reporting program established under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), administered by the Centers for Medicare & Medicaid Services ("CMS"), which requires applicable manufacturers to report certain payments and other transfers of value made to covered recipients, including physicians and teaching hospitals.

Section 1.9 — "Participating Site" means each of the thirty-eight (38) Veridian Health Research Network member institutions listed on Schedule 1 to the Agreement, together with any additional sites subsequently added to the Study pursuant to the site addition procedures set forth in Section 4.3 of the Agreement.

Section 1.10 — "Protocol" means Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology), as amended from time to time in accordance with the Agreement and Applicable Laws.

Section 1.11 — "Study" means the Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871) conducted under the Protocol in patients with advanced hepatocellular carcinoma, including all screening, treatment, follow-up, and post-study activities contemplated by the Protocol.

Section 1.12 — "Study Data" means all data, records, reports, case report forms, source documents, laboratory results, imaging data, pharmacokinetic data, biomarker data, patient-reported outcomes, and other information generated in connection with the Study, ownership and use of which is governed by Exhibit G (Data Ownership and Publication) to the Agreement.

ARTICLE II — REPRESENTATIONS AND WARRANTIES OF SPONSOR

Section 2.1 — IND Status and Regulatory Standing Sponsor represents and warrants to Site Network that, as of the date of the Agreement and as of the date of execution of this Exhibit: (a) Sponsor is the lawful holder of IND 157823, which was originally filed with the FDA in October 2021 with respect to the investigational product penterafenib (PPC-4871), a selective kinase inhibitor under development for the treatmen

Section 2.2 — Compliance with 21 C.F.R. Part 312 Sponsor represents, warrants, and covenants that it shall comply with all obligations imposed upon a sponsor of a clinical investigation under 21 C.F.R. Part 312 throughout the term of the Study, including without limitation the following: (a) Investigator Selection. Sponsor shall select Investigators who are qualified by training and experience as appropriate experts

Section 2.3 — Good Clinical Practice Compliance Sponsor represents and warrants that the Protocol has been designed in accordance with the scientific and ethical principles set forth in the ICH E6(R2) GCP Guidelines and that the Study shall be conducted in compliance with such guidelines at all times. Sponsor has established, and shall maintain throughout the term of the Study, a quality assurance and quality control

Section 2.4 — 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures) Sponsor represents and warrants that all electronic systems used for the generation, modification, maintenance, archiving, retrieval, or transmission of records required to be maintained under 21 C.F.R. Part 312 or submitted to the FDA comply with the requirements of 21 C.F.R. Part 11 regarding electronic records and electronic signatures. Su

Section 2.5 — Anti-Kickback Statute Compliance Sponsor represents and warrants to Site Network as follows with respect to compliance with the Anti-Kickback Statute: (a) All payments to be made by Sponsor under the Agreement have been determined to reflect fair market value for the legitimate services to be rendered by Site Network, the Participating Sites, and the Investigators. The payment structure under the Agreem

Section 2.6 — Sunshine Act / Open Payments Reporting Sponsor acknowledges its obligations as an "applicable manufacturer" under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations promulgated by CMS at 42 C.F.R. Parts 402 and 403 to report to CMS, on an annual basis, certain payments and other transfers of value made directly or indirectly to covered recipients (as defined ther

Section 2.7 — Fair Market Value of Investigator Compensation Sponsor represents and warrants that all compensation payable to Investigators under this Agreement, the related Principal Investigator Agreement with Dr. Catherine Aldridge, M.D., Ph.D. (Graystone University Medical Center), and the Co-Principal Investigator Agreement with Dr. Howard Matsuoka, M.D. (Lakemont Medical Center), has been determined through a d

Section 2.8 — HIPAA Compliance Sponsor represents and warrants that it has implemented, and shall maintain throughout the term of the Study and for such additional period as PHI remains in Sponsor's possession or control, administrative, physical, and technical safeguards sufficient to protect the privacy and security of Protected Health Information ("PHI") received from or on behalf of Participating Sites in connect

Section 2.9 — Insurance Sponsor represents and warrants as follows with respect to insurance coverage: (a) Sponsor maintains clinical trial liability insurance through Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with the following coverage limits: Twenty-Five Million Dollars ($25,000,000) per occurrence and Seventy-Five Million Dollars ($75,000,000) in the aggregate, including a subject-in

ARTICLE III — REPRESENTATIONS AND WARRANTIES OF SITE NETWORK

Section 3.1 — Organizational Standing and Authority Veridian Health Research Network, Inc. represents and warrants to Sponsor that: (a) Site Network is a nonprofit corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware, with its principal office located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104 (Employer Identification Number: 23-4178205).

Section 3.2 — Compliance with 21 C.F.R. Part 56 (Institutional Review Boards) Site Network represents, warrants, and covenants as follows with respect to IRB oversight of the Study: (a) Each Participating Site shall obtain and maintain Institutional Review Board approval for the Protocol, the informed consent documents, and all other study-related materials prior to the enrollment of any subject in the Study at such

Section 3.3 — Compliance with 21 C.F.R. Part 50 (Protection of Human Subjects) Site Network represents, warrants, and covenants that it and each Investigator shall comply fully with the requirements of 21 C.F.R. Part 50 regarding the protection of human subjects in clinical investigations, including the following: (a) Informed Consent. Site Network and each Investigator shall obtain and document legally effective inf

Section 3.4 — Investigator Qualifications and 21 C.F.R. Part 312 Obligations Site Network represents and warrants that each Investigator designated to conduct the Study at a Participating Site is qualified by training, education, and experience as an appropriate expert to investigate penterafenib (PPC-4871) in the patient population specified in the Protocol. In furtherance of this representation, Site Network covena

Section 3.5 — Financial Disclosure (21 C.F.R. Part 54) Site Network represents and covenants as follows with respect to financial disclosure requirements: (a) Site Network shall ensure that each Investigator and sub-investigator listed on Form FDA 1572 completes and submits to Sponsor (through Site Network) a financial disclosure certification, in the form attached as a supplement to Exhibit I to the Agreement, prior

Section 3.6 — Anti-Kickback Statute Compliance Site Network represents and warrants as follows with respect to the Anti-Kickback Statute: (a) Neither Site Network nor any Participating Site shall accept any payment under this Agreement as an inducement or reward for the referral of patients, the purchasing, leasing, or ordering of any goods, items, or services, or the generation of any business for which payment may

Section 3.7 — Sunshine Act / Open Payments Cooperation Site Network acknowledges Sponsor's reporting obligations under the Physician Payments Sunshine Act and covenants as follows: (a) Site Network shall cooperate with Sponsor in good faith to identify and accurately categorize all reportable payments and transfers of value made to covered recipients (including physicians and teaching hospitals) in connection with th

Section 3.8 — GCP Compliance Site Network represents, warrants, and covenants that it and each Investigator shall conduct the Study in strict accordance with the ICH E6(R2) GCP Guidelines, the Protocol, and all Applicable Laws. Site Network shall ensure that all site personnel involved in the conduct of the Study at each Participating Site receive adequate training on GCP requirements, including the principles of inf

Section 3.9 — HIPAA Compliance Site Network represents and warrants as follows with respect to the privacy and security of Protected Health Information: (a) Each Participating Site has implemented and shall maintain appropriate policies, procedures, administrative safeguards, physical safeguards, and technical safeguards for the use and disclosure of PHI in connection with research activities, in compliance with HIPA

Section 3.10 — Insurance Site Network represents and warrants as follows with respect to insurance coverage: (a) Each Participating Site maintains general liability insurance and professional liability (medical malpractice) insurance with coverage limits of not less than Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggregate, sufficient to cover claims arising from the

Section 3.11 — Record Retention Site Network represents and covenants that it and each Participating Site shall retain all Study-related source documents, records, case report forms, informed consent forms, IRB correspondence, regulatory submissions, investigational product accountability records, and all other records generated in connection with the Study for a minimum period of fifteen (15) years following the dat

Section 4.1 — Ongoing Compliance Each Party shall comply with all Applicable Laws throughout the term of the Study, including any amendments, revisions, or updates to such laws, regulations, and guidance documents that become effective during the Study period. Each Party shall monitor developments in the applicable regulatory landscape and shall promptly notify the other Party, in writing, of any material change in A

Section 4.2 — Regulatory Inspections and Audits (a) Inspection Notification. Each Party shall promptly notify the other Party, in writing and within five (5) business days, of receipt of any notice of an FDA inspection, audit, pre-approval inspection, directed inspection, or formal inquiry relating to the Study, any Participating Site, any Investigator, or the investigational product. Such notification shall include

Section 4.3 — Debarment and Exclusion (a) Each Party represents and warrants that, as of the date of this Exhibit, neither it nor any of its employees, officers, directors, agents, contractors, or Investigators has been debarred, suspended, proposed for debarment, or otherwise declared ineligible to participate in federal procurement or non-procurement programs under 21 U.S.C. § 335a (the FDA debarment statute) or ex

Section 4.4 — Anti-Bribery and Anti-Corruption Each Party represents and warrants that it has not and shall not, directly or indirectly, in connection with the Study or any activities under this Agreement, make, offer, promise, authorize, or approve any payment, gift, contribution, or transfer of value to any government official, employee of a regulatory authority, political party or candidate, or any other person in

Section 4.5 — Clinical Hold Notification (a) Sponsor shall promptly notify Site Network and the Global Principal Investigator (Dr. Catherine Aldridge, M.D., Ph.D.) in writing if the FDA imposes a clinical hold (whether full or partial) on IND 157823 or any portion thereof, or if Sponsor receives any communication from the FDA indicating that a clinical hold is being considered. Such notification shall be provided wit

Section 4.6 — ClinicalTrials.gov Registration and Results Reporting (a) Sponsor shall maintain the registration of the Study on ClinicalTrials.gov (Identifier: NCT05928174) throughout the term of the Study and shall ensure that all required registration information is complete, accurate, and current, in compliance with the requirements of Section 402(j) of the Public Health Service Act (42 U.S.C. § 282(j)) and applic

Section 4.7 — Protocol Amendments (a) Any amendment to the Protocol, including substantive amendments affecting Study design, eligibility criteria, dosing regimen, endpoints, or procedures, shall be submitted to all relevant IRBs for review and approval prior to implementation at any Participating Site. No Participating Site shall implement a Protocol amendment until the applicable IRB of record has granted approval,

Section 4.8 — Data Integrity and 21 C.F.R. Part 11 Both Parties shall ensure that all electronic records generated, modified, maintained, archived, retrieved, or transmitted in connection with the Study comply with the requirements of 21 C.F.R. Part 11 regarding electronic records and electronic signatures. This obligation extends to, without limitation: (a) Records entered into the electronic data capture platform o

ARTICLE V — REMEDIES FOR NON-COMPLIANCE

Section 5.1 — Notice and Cure In the event that either Party becomes aware of a material breach of any representation, warranty, or covenant set forth in this Exhibit, the non-breaching Party shall provide written notice to the breaching Party specifying with reasonable particularity the nature of the breach, the provision(s) of this Exhibit that have been breached, and the actions that the non-breaching Party believ

Section 5.2 — Suspension and Termination If a material breach identified pursuant to Section 5.1 is not cured within the applicable cure period, the non-breaching Party may exercise one or more of the following remedies: (a) Suspension of Enrollment. The non-breaching Party may direct the immediate suspension of enrollment of new subjects at one or more affected Participating Sites until such time as the breach has b

Section 5.3 — Regulatory Reporting of Non-Compliance Nothing in this Exhibit shall be construed to prevent or restrict either Party from reporting suspected violations of Applicable Laws to the FDA, the Office of Inspector General of the U.S. Department of Health and Human Services, the U.S. Department of Justice, or any other federal, state, or local regulatory authority. Each Party retains the right and obligation

ARTICLE VI — GOVERNING LAW This Exhibit shall be governed by and construed in accordance with the laws of the State of New York, without regard to principles of conflicts of law that would result in the application of the laws of any other jurisdiction, consistent with the governing law provision set forth in the Agreement. Any dispute, controversy, or claim arising out of or relating to this Exhibit, or the breach,

Section 7.1 — Survival The representations, warranties, and covenants set forth in this Exhibit shall survive the termination or expiration of the Agreement for a period of ten (10) years from the date of such termination or expiration, or such longer period as may be required by Applicable Laws, the record retention obligations set forth in Section 3.11 (fifteen (15) years following Study completion), or the confide

Section 7.2 — Amendment This Exhibit may be amended, modified, or supplemented only by a written instrument duly executed by authorized representatives of both Parties. No oral agreement, course of dealing, or course of performance shall be deemed to amend or modify the terms of this Exhibit. Any amendment to this Exhibit shall be attached to and shall become a part of the Agreement.

Section 7.3 — Conflict with Agreement In the event of any conflict or inconsistency between the terms of this Exhibit and the terms of the Agreement (including the main body of the Agreement and any other Exhibit or Schedule thereto), the terms of the Agreement shall control and prevail; provided, however, that to the extent this Exhibit expressly and specifically provides otherwise with respect to regulatory complia

Section 7.4 — Third-Party Beneficiaries Except as expressly provided in this Section, this Exhibit is for the sole benefit of the Parties and their respective successors and permitted assigns, and nothing in this Exhibit shall be construed to confer upon any other person any legal or equitable right, benefit, or remedy. Notwithstanding the foregoing, individual Investigators shall be deemed third-party beneficiaries