Contract analysis

ARTICLE 1 — DEFINITIONS As used in this Agreement, the following terms shall have the meanings ascribed to them below. Capitalized terms used but not defined in this Agreement shall have the meanings ascribed to them in the MCTA. 1.1 "Agreement" means this Co-Principal Investigator Agreement, together with all exhibits, schedules, appendices, and attachments hereto, as may be amended from time to time in accordance w

ARTICLE 2 — APPOINTMENT AND TERM 2.1 Appointment. Penterra hereby appoints Dr. Howard Matsuoka as Co-Principal Investigator for the Study at Lakemont Medical Center (Site 002). Dr. Matsuoka hereby accepts such appointment and agrees to serve as Co-PI for the Study at the Site, subject to the terms and conditions of this Agreement, the Protocol, the MCTA, the Lakemont Individual Site Agreement (Joinder), and all Appli

ARTICLE 3 — CO-PRINCIPAL INVESTIGATOR RESPONSIBILITIES 3.1 General Duties. The Co-PI shall conduct the Study at Lakemont Medical Center in strict accordance with the Protocol (PPC-4871-III), GCP (ICH E6(R2)), and all Applicable Law. The Co-PI shall exercise the degree of care, skill, and diligence expected of a reasonably qualified physician-investigator conducting a Phase III clinical trial in oncology. The Co-PI sh

ARTICLE 4 — SAFETY REPORTING OBLIGATIONS 4.1 SAE Reporting. The Co-PI shall report all Serious Adverse Events occurring in Study subjects at the Site to Penterra and Meridian CRO within twenty-four (24) hours of becoming aware of the event, using the SAE reporting procedures and forms set forth in Exhibit J of the MCTA. Initial SAE reports shall contain all available information at the time of reporting, including th

ARTICLE 5 — REGULATORY OBLIGATIONS 5.1 FDA Form 1572. The Co-PI shall execute and maintain a current FDA Form 1572 (Statement of Investigator) for the duration of the Study, in accordance with 21 C.F.R. § 312.53. The initial Form 1572 shall be completed and submitted to Penterra prior to commencement of Study activities at the Site, as a condition to site activation under Section 2.4. The Co-PI shall promptly update

ARTICLE 6 — FINANCIAL DISCLOSURE 6.1 Initial Certification. Prior to the enrollment of the first Study subject at the Site, the Co-PI shall execute and deliver to Penterra a Financial Disclosure Certification in the form set forth in the MCTA (which incorporates the template certification form required by 21 C.F.R. Part 54), a copy of which is attached hereto as Exhibit B. Such certification shall disclose the presen

ARTICLE 7 — COMPENSATION 7.1 Per-Patient Fees. The Co-PI's compensation for services rendered in connection with the Study is incorporated within the per-patient site fees established in the MCTA and the Lakemont Individual Site Agreement (Joinder), which provide for a total per-subject payment of Fifty-Two Thousand Dollars ($52,000) for each subject enrolled, randomized, and completing Study activities at the Site.

ARTICLE 8 — INTELLECTUAL PROPERTY AND DATA OWNERSHIP 8.1 Clinical Trial Data Ownership. All Clinical Trial Data generated in connection with the Study at the Site shall be the exclusive property of Penterra, consistent with the terms and conditions of the MCTA and the IP Side Letter executed concurrently by Penterra and Veridian on June 28, 2023. The Co-PI hereby irrevocably assigns, transfers, and conveys to Penterr

ARTICLE 9 — PUBLICATION RIGHTS 9.1 Right to Publish. The Co-PI retains the right to publish or present the results of the Study in peer-reviewed scientific journals, at scientific conferences, and in other academic and professional settings, subject to the review and delay provisions set forth in this Article 9 and in Exhibit G of the MCTA. Both Parties acknowledge the importance of publication of clinical trial resu

ARTICLE 10 — TERM AND TERMINATION 10.1 Term. The Term of this Agreement shall be as set forth in Section 2.3 of this Agreement. 10.2 Termination by Penterra. Penterra may terminate this Agreement under any of the following circumstances: (a) For Cause. Upon written notice to the Co-PI if the Co-PI materially breaches any provision of this Agreement, the Protocol, or Applicable Law, and fails to cure such breach withi

ARTICLE 11 — CONFIDENTIALITY 11.1 Obligations. The Co-PI shall hold all Confidential Information received from Penterra or generated in connection with the Study in strict confidence for a period of ten (10) years from the date of disclosure or generation of such information, consistent with the confidentiality provisions set forth in Exhibit F of the MCTA. The Co-PI shall not disclose, publish, or disseminate Confid

ARTICLE 12 — INDEMNIFICATION 12.1 Sponsor Indemnification of Co-PI. Subject to the terms and conditions set forth in this Article 12 and in Exhibit D of the MCTA, Penterra shall defend, indemnify, and hold harmless the Co-PI, and the Co-PI's heirs, executors, administrators, successors, and assigns, from and against any and all third-party claims, demands, actions, suits, proceedings, losses, damages, liabilities, ju