Contract analysis

ARTICLE I — DEFINITIONS As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not defined in this Article I shall have the meanings assigned to them elsewhere in this Agreement or, if not so defined, shall have their ordinary and customary meaning in the context of clinical research and pharmaceutical development. 1.1 "Adverse Event" or "AE" means any untow

ARTICLE II — SCOPE OF AGREEMENT 2.1 Purpose. This Agreement establishes the terms and conditions under which Veridian and its Network Sites will participate in and conduct the CLARION trial, a Phase III, randomized, double-blind, placebo-controlled study of penterafenib (PPC-4871) in subjects with advanced hepatocellular carcinoma who have received at least one prior line of systemic therapy. The Study is designed to

ARTICLE III — RESPONSIBILITIES OF SPONSOR 3.1 IND Maintenance. Penterra, as the IND holder (IND No. 157823), shall maintain the IND in good standing with the FDA throughout the duration of the Study. Sponsor shall be responsible for all communications with the FDA regarding the IND, including without limitation the submission of annual reports (21 C.F.R. § 312.33), protocol amendments (21 C.F.R. § 312.30), IND safety

ARTICLE IV — RESPONSIBILITIES OF SITE NETWORK AND INVESTIGATORS 4.1 Conduct of Study. Veridian shall ensure that each Network Site conducts the Study in accordance with the Protocol, GCP, Applicable Law, and the terms and conditions of this Agreement and the applicable Individual Site Agreement. Veridian shall exercise oversight of the Network Sites and shall take appropriate action, including corrective and preventi

ARTICLE V — BUDGET AND COMPENSATION 5.1 Total Budget. The total budget for this Agreement is Eighty Million Dollars ($80,000,000), as set forth in the Budget and Payment Schedule attached hereto as Exhibit B. The total budget is comprised of the following components: (a) Per-Patient Site Fees: Fifty-Two Thousand Dollars ($52,000) per Subject multiplied by one thousand two hundred (1,200) Subjects, for a total of Sixt

ARTICLE VI — REGULATORY COMPLIANCE 6.1 Applicable Regulations. The Study shall be conducted in compliance with all Applicable Law, including without limitation the following: (a) 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures), governing the creation, modification, maintenance, archival, retrieval, and transmission of electronic records and the use of electronic signatures; (b) 21 C.F.R. Part 50 (Protec

ARTICLE VII — STUDY DATA AND RECORDS 7.1 Data Ownership. Penterra shall retain exclusive ownership of all Study Data, including without limitation all data captured through the Pinnacle Data Solutions EDC platform, all central laboratory results generated by Northbridge Bioanalytical Laboratories, Inc., all CRO-processed data generated by Meridian CRO, and all analyses, reports, compilations, and derivative works gen

ARTICLE VIII — INTELLECTUAL PROPERTY 8.1 Pre-Existing IP. Each Party shall retain all right, title, and interest in and to its respective pre-existing intellectual property, including without limitation patents, patent applications, trade secrets, know-how, copyrights, trademarks, and other intellectual property rights owned or controlled by such Party as of the Signing Date or developed independently of the Study. N

ARTICLE IX — PUBLICATION RIGHTS 9.1 Right to Publish. The Parties recognize the importance of scientific publication and dissemination of clinical trial results to the medical and scientific community. Investigators shall have the right to publish or pre