Contract analysis

ARTICLE 1 — DEFINITIONS Capitalized terms used in this Agreement and not otherwise defined herein shall have the meanings ascribed to them in the MCTA. The following terms shall have the meanings set forth below: 1.1 "Agreement" means this Principal Investigator Agreement, including all appendices and exhibits attached hereto and incorporated herein by reference, as may be amended from time to time in accordance with

ARTICLE 2 — APPOINTMENT AND TERM 2.1 Appointment. Penterra hereby appoints Dr. Catherine Aldridge, M.D., Ph.D. as the Global Principal Investigator for Protocol PPC-4871-III (CLARION). Dr. Aldridge hereby accepts such appointment and agrees to perform the duties and responsibilities set forth in this Agreement, the MCTA, and the Protocol with due diligence, professional competence, and in compliance with all Applicab

ARTICLE 3 — GLOBAL PRINCIPAL INVESTIGATOR RESPONSIBILITIES 3.1 Overall Oversight. Dr. Aldridge shall serve as the Global Principal Investigator for the CLARION trial and shall provide overall scientific and medical oversight of the Study across all thirty-eight (38) Veridian Network sites located in fourteen (14) states. In this capacity, Dr. Aldridge shall: (a) serve as the primary scientific point of contact betwee

ARTICLE 4 — SAFETY REPORTING OBLIGATIONS 4.1 SAE Reporting. Dr. Aldridge shall report all Serious Adverse Events (SAEs) occurring at Site 001 to Penterra and Meridian CRO within twenty-four (24) hours of becoming aware of the event, utilizing the safety reporting procedures, forms, and electronic reporting systems set forth in the MCTA (Exhibit J — Safety Reporting Procedures). SAE reports shall include all available

ARTICLE 5 — REGULATORY OBLIGATIONS AND COMPLIANCE 5.1 GCP and Regulatory Compliance. Dr. Aldridge shall conduct the Study in full compliance with GCP as set forth in ICH E6(R2), the applicable provisions of Title 21 of the Code of Federal Regulations (including Parts 11, 50, 54, 56, and 312), and all other Applicable Law. Dr. Aldridge shall ensure that all study procedures, data collection activities, and safety repo

ARTICLE 6 — FINANCIAL DISCLOSURE 6.1 Initial Disclosure. Prior to the commencement of any Study-related activities at Site 001 and prior to the activation of any participating Veridian Network site under Dr. Aldridge's oversight as Global PI, Dr. Aldridge shall complete and submit to Penterra a Financial Disclosure Certification in the form required under 21 C.F.R. Part 54, substantially in the form attached hereto a

ARTICLE 7 — COMPENSATION 7.1 Fair Market Value. All compensation payable to Dr. Aldridge under this Agreement has been determined by the Parties, after arm's-length negotiation and with reference to independent fair market value assessments, to reflect the fair market value of the services rendered by Dr. Aldridge in her capacities as site Principal Investigator at Site 001 and as Global Principal Investigator for th

ARTICLE 8 — DATA OWNERSHIP AND STUDY RECORDS 8.1 Sponsor Data Ownership. Consistent with the terms and conditions of the MCTA, Penterra retains exclusive ownership of all Study Data generated in connection with Protocol PPC-4871-III (CLARION) across all participating Sites, including Site 001. Dr. Aldridge acknowledges and agrees that all clinical trial data, case report forms (whether paper or electronic), electroni

ARTICLE 9 — PUBLICATION RIGHTS 9.1 Academic Freedom. Penterra recognizes and respects the importance of academic freedom and the right of Dr. Aldridge, as an academic clinical investigator affiliated with Graystone University Medical Center, to publish the results of research conducted under the CLARION Protocol. The publication provisions set forth in this Article 9 are intended to balance the legitimate interests o

ARTICLE 10 — CONFIDENTIALITY 10.1 Obligations. Dr. Aldridge shall maintain in strict confidence all Confidential Information of Penterra disclosed to her or to which she has access in connection with the Study, including without limitation the Protocol and all amendments thereto, Investigational Product specifications, formulations, manufacturing processes, pre-clinical and clinical data, Study Data, statistical anal

ARTICLE 11 — TERM AND TERMINATION 11.1 Term. The Term of this Agreement shall be as set forth in Section 2.2 of this Agreement. 11.2 Termination for Cause. Either Party may terminate this Agreement upon thirty (30) days' prior written notice to the other Party if the other Party commits a material breach of any provision of this Agreement that remains uncured at the expiration of such thirty (30) day notice period. T

ARTICLE 12 — INDEMNIFICATION 12.1 Sponsor Indemnification. As set forth in and subject to the terms and conditions of the MCTA (Exhibit D — Subject-Injury Indemnification Provisions), Penterra shall indemnify, defend, and hold harmless Dr. Aldridge and her agents, employees, and representatives (collectively, the "Investigator Indemnified Parties") from and against any and all claims, demands, actions, suits, losses,

ARTICLE 13 — REPRESENTATIONS AND WARRANTIES 13.1 Investigator Representations. Dr. Aldridge hereby represents and warrants to Penterra as follows: (a) Qualifications. She possesses the qualifications, training, clinical expertise, and professional experience, including board certification in Medical Oncology and Hematology by the American Board of Internal Medicine, necessary to assume and fulfill the responsibilitie