Contract analysis

ARTICLE 1 — JOINDER AND INCORPORATION BY REFERENCE

Section 1.1 — Joinder to MCTA By executing this Individual Site Agreement, Lakemont Medical Center hereby agrees to be bound by and to perform all obligations of a "Participating Site Institution" as that term is defined and used in the MCTA, as if Lakemont were an original signatory to the MCTA. Without limiting the generality of the foregoing, Lakemont assumes all rights, benefits, and obligations of a Participatin

Section 1.2 — Incorporation by Reference The MCTA and all Exhibits and Schedules thereto, specifically Exhibits A through K and Schedule 1, are hereby incorporated by reference into this Individual Site Agreement with the same force and effect as if set forth in full herein. For the avoidance of doubt, the following Exhibits to the MCTA are incorporated by reference and shall apply to the conduct of the CLARION trial

Section 1.3 — Effective Date This Individual Site Agreement shall become effective upon the latest to occur of the following: (a) execution of this Individual Site Agreement by all parties hereto (including acknowledgment by the Co-Principal Investigator); (b) satisfaction of the conditions precedent to site activation set forth in Article 6 of this Individual Site Agreement; and (c) the effective date of the MCTA, w

ARTICLE 2 — SITE-SPECIFIC INFORMATION

Section 2.1 — Site Identification The following information identifies Site 002 for purposes of the MCTA and this Individual Site Agreement: Lakemont represents and warrants that the information set forth in this Section 2.1 is true and correct as of the date of execution of this Individual Site Agreement, and Lakemont shall promptly notify Penterra and Veridian in writing of any changes to such information during th

Section 2.2 — Principal Investigator Designation The Co-Principal Investigator for Site 002 under Protocol PPC-4871-III (CLARION) shall be: Name: Dr. Howard Matsuoka, M.D. Title: Associate Professor of Hepatology & Oncology Institutional Affiliation: Lakemont Medical Center, Department of Hepatology & Oncology, 4400 North Michigan Drive, Chicago, Illinois 60611 Dr. Matsuoka has executed, or will execute prior to the

Section 2.3 — Sub-Investigators and Key Site Personnel Lakemont shall identify all sub-investigators and key research personnel participating in the conduct of the CLARION trial at Site 002 on FDA Form 1572 and/or a curriculum vitae listing maintained in the site regulatory binder. Such listing shall be maintained and updated as required by 21 C.F.R. § 312.53 and shall be provided to Penterra (or its designee, Meridi

Section 2.4 — Site Facilities and Capabilities Lakemont represents and warrants that it possesses adequate clinical facilities, qualified staff, equipment, and other resources necessary to conduct the CLARION trial at Site 002 in accordance with Protocol PPC-4871-III, ICH E6(R2) GCP Guidelines, and all applicable federal, state, and local laws and regulations. Without limitation, Lakemont confirms the availability of

ARTICLE 3 — INSTITUTIONAL REVIEW BOARD

Section 3.1 — IRB of Record The Institutional Review Board of record for Site 002 shall be the Veridian Central Institutional Review Board (the "Veridian Central IRB"), which serves as the central IRB for all Veridian Health Research Network member sites located outside the Commonwealth of Pennsylvania. The Veridian Central IRB is registered with the Office for Human Research Protections (OHRP) and holds a current Fe

Section 3.2 — IRB Approval as Condition Precedent Enrollment of subjects at Site 002 shall not commence, and no trial-related activities involving human subjects shall be conducted at Site 002, until the Veridian Central IRB has reviewed and approved the following documents: (a) Protocol PPC-4871-III (CLARION), including any protocol amendments applicable at the time of initial review; (b) The informed consent form,

Section 3.3 — Continuing IRB Obligations Throughout the term of this Individual Site Agreement, Lakemont and the Co-Principal Investigator shall ensure compliance with all continuing review requirements, amendment submission procedures, and adverse event reporting obligations established by the Veridian Central IRB and applicable regulations. Without limitation: (a) Continuing Review. The Co-Principal Investigator sh

ARTICLE 4 — BUDGET AND PAYMENT

Section 4.1 — Site-Specific Budget Allocation The budget for Site 002 shall be in accordance with Exhibit B to the MCTA (Budget and Payment Schedule), as specifically allocated to this Site in the site-specific budget appendix attached hereto as Appendix 1 (the "Site Budget"). The Site Budget sets forth the detailed financial terms applicable to the conduct of the CLARION trial at Lakemont Medical Center, including t

Section 4.2 — Invoicing and Payment Terms Lakemont shall submit invoices to Penterra (or its designee, Meridian CRO) in accordance with the invoicing procedures set forth in Exhibit B to the MCTA and this Section 4.2. All invoices shall be submitted in a format reasonably acceptable to Penterra and shall include, at a minimum, the following information: (a) The site number (002) and the protocol number (PPC-4871-III)

Section 4.3 — Fair Market Value and Regulatory Compliance All payments to Lakemont and to the Co-Principal Investigator under this Individual Site Agreement and the MCTA represent fair market value for the services rendered, as determined by Penterra's independent fair market value analysis conducted in accordance with industry standards and applicable legal requirements. Such payments are not intended to serve, and

Section 5.1 — Conduct of the Trial Lakemont and the Co-Principal Investigator shall conduct the CLARION trial at Site 002 in strict accordance with Protocol PPC-4871-III, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E6(R2) for Good Clinical Practice (GCP), and all applicable federal, state, and local laws and regulations, including without lim

Section 5.2 — Enrollment Lakemont shall use commercially reasonable efforts to enroll subjects in the CLARION trial at Site 002 at rates consistent with the enrollment targets set forth in Appendix 1 to this Individual Site Agreement. Lakemont acknowledges that timely enrollment is critical to the success of the CLARION trial and agrees to implement appropriate recruitment strategies, approved by the Veridian Central

Section 5.3 — Safety Reporting Lakemont and the Co-Principal Investigator shall comply with the safety reporting procedures set forth in Exhibit J to the MCTA and applicable regulations, including 21 C.F.R. § 312.32 and ICH E6(R2). Without limiting the foregoing: (a) Serious Adverse Event (SAE) Reporting. All serious adverse events, as defined in the Protocol and ICH E2A guidelines, must be reported by the Co-Princip

Section 5.4 — Data Collection and Electronic Data Capture Lakemont shall enter all trial data generated at Site 002 into the electronic data capture (EDC) platform provided by Pinnacle Data Solutions, Inc. (the "EDC System"), in accordance with the data entry procedures specified in the Protocol, the EDC user guide, and 21 C.F.R. Part 11. Data entry shall be performed by authorized site personnel who have completed t

Section 5.5 — Monitoring, Audit, and Inspection Lakemont shall permit and facilitate monitoring visits by Meridian CRO, audits by Penterra (or its designees), and inspections by the FDA and other regulatory authorities at such times as may be reasonably requested, upon reasonable prior notice (except in the case of regulatory inspections, for which prior notice may not be required or feasible). Without limitation, La

Section 5.6 — Record Retention Lakemont shall retain all source documents, study records, site files, regulatory correspondence, and other documents related to the conduct of the CLARION trial at Site 002 for a minimum of fifteen (15) years following the completion of the trial (including the follow-up period), or for such longer period as may be required by applicable federal, state, or local law or regulation, or b

Section 5.7 — Subcontractors Lakemont shall not subcontract, delegate, or outsource any material portion of the trial work to be performed at Site 002 under this Individual Site Agreement without the prior written consent of Penterra. For purposes of this Section, "material portion" includes, without limitation, subject screening and enrollment, administration of investigational product, collection and entry of trial

ARTICLE 6 — CONDITIONS PRECEDENT TO SITE ACTIVATION

Section 6.1 — Conditions to Activation Site 002 shall not be activated, and no enrollment of subjects shall commence at Lakemont Medical Center, until each of the following conditions precedent has been satisfied or waived in writing by Penterra: (a) Execution of Individual Site Agreement. This Individual Site Agreement shall have been fully executed by all parties hereto, including acknowledgment by the Co-Principal

ARTICLE 7 — INDEMNIFICATION AND INSURANCE

Section 7.1 — Sponsor Indemnification As set forth in the MCTA (Article 12 and Exhibit D thereto), and subject to the terms, conditions, and limitations set forth therein and in this Section 7.1, Penterra shall defend, indemnify, and hold harmless Lakemont Medical Center, the Co-Principal Investigator (Dr. Howard Matsuoka, M.D.), all sub-investigators, research coordinators, and other site staff involved in the condu

Section 7.2 — Site/Investigator Indemnification As set forth in the MCTA, Lakemont shall defend, indemnify, and hold harmless Penterra, its officers, directors, employees, agents, and contractors (the "Sponsor Indemnitees") from and against any and all Losses arising from or in connection with: (a) The negligence or willful misconduct of Lakemont, the Co-Principal Investigator, any sub-investigator, or any other site

Section 7.3 — Sponsor Insurance Penterra represents that it maintains clinical trial liability insurance through Briarcliff Mutual Insurance Company, under Policy No. BM-CTL-2023-04182, providing the following coverage: Lakemont Medical Center, the Co-Principal Investigator (Dr. Howard Matsuoka, M.D.), and all sub-investigators and site personnel identified on FDA Form 1572 are named as additional insureds under the

Section 7.4 — Site Insurance Lakemont shall maintain, at its own expense, throughout the term of this Individual Site Agreement and for a period of not less than three (3) years following the expiration or termination of this Individual Site Agreement, general liability and professional liability (medical malpractice) insurance coverage with limits of not less than Five Million Dollars ($5,000,000) per occurrence and

ARTICLE 8 — CONFIDENTIALITY AND DATA PROTECTION

Section 8.1 — Confidentiality Lakemont acknowledges and agrees to be bound by the confidentiality provisions set forth in the MCTA and Exhibit F thereto, which are incorporated herein by reference. Without limiting the generality of such provisions, Lakemont agrees that: (a) All Confidential Information (as defined in the MCTA) disclosed by Penterra or its agents to Lakemont or any of its employees, agents, or contra

Section 8.2 — HIPAA Compliance Lakemont shall comply with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164 (collectively, "HIPAA"), with respect to all protected health information ("PHI") of trial subjects enrolled at Site 002. Without limitation: (a) Lakemont shall obtain valid research authorizations from each trial subject

Section 8.3 — Data Ownership Penterra retains exclusive ownership of all clinical trial data generated at Site 002 in connection with the CLARION trial, including but not limited to all data entered into the EDC System, all case report forms (whether electronic or paper), all central laboratory data, all biomarker and PK/PD data, and all other data collected pursuant to the Protocol (collectively, "Study Data"). Lake

ARTICLE 9 — INTELLECTUAL PROPERTY AND PUBLICATION RIGHTS

Section 9.1 — Pre-Existing intellectual Property Each party retains all right, title, and interest in and to its respective pre-existing intellectual property, including but not limited to patents, patent applications, trade secrets, know-how, copyrights, trademarks, and other proprietary rights that exist as of the Effective Date or that are developed independently of the CLARION trial. Nothing in this Individual Si

Section 9.2 — Study-Related Inventions Any inventions, discoveries, improvements, or innovations (whether or not patentable) that arise from or are conceived or reduced to practice in connection with the conduct of the CLARION trial at Site 002 ("Study-Related Inventions") shall be governed by the intellectual Property Side Letter executed concurrently with the MCTA on June 28, 2023, by and among Penterra, Veridian,

Section 9.3 — Publication Rights The Co-Principal Investigator and other site investigators at Site 002 shall have the right to publish the results of the CLARION trial, subject to the following conditions and the terms set forth in Exhibit G to the MCTA: (a) Review Period. Prior to submission of any manuscript, abstract, presentation, or other publication for external dissemination, the Co-Principal Investigator sha

ARTICLE 10 — TERM AND TERMINATION

Section 10.1 — Term This Individual Site Agreement shall remain in full force and effect from the Effective Date until the earlier of: (a) completion of all trial activities and obligations at Site 002, including the eighteen (18) month follow-up period, all data entry and query resolution, and all regulatory close-out activities (the "Study Completion Date"); (b) termination of the MCTA in accordance with its terms;

Section 10.2 — Termination for Cause Either party may terminate this Individual Site Agreement upon thirty (30) days' written notice to the other party and to Veridian in the event of a material breach of this Individual Site Agreement or the MCTA by the other party, provided that such breach remains uncured at the expiration of the thirty (30) day notice period. The notice of termination for cause shall specify the

Section 10.3 — Termination for Convenience Penterra may terminate this Individual Site Agreement for convenience, without cause, upon sixty (60) days' prior written notice to Lakemont and Veridian. Such termination shall not relieve Penterra of its obligation to pay for services properly rendered prior to the effective date of termination and during any applicable wind-down period in accordance with Section 10.4. Lak

Section 10.4 — Wind-Down Obligations Upon termination or expiration of this Individual Site Agreement for any reason, a wind-down period of one hundred twenty (120) days shall apply, commencing on the effective date of termination or expiration, to ensure the safety of trial subjects, the integrity of trial data, and compliance with applicable regulatory requirements. During the wind-down period: (a) Subject Safety a