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Contract analysis

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Contract analysis / mcta-second-draft.docx
mcta-second-draft.docx
1018-00004 · 10 clauses
High · 5 Medium · 4 Standard · 0
ARTICLE 1 — DEFINITIONS High
⚑ Indemnity / guarantee obligation
ARTICLE 1 — DEFINITIONS As used in this Agreement, the following capitalized terms shall have the meanings set forth below. Capitalized terms used but not otherwise defined in this Article 1 shall have the meanings ascribed to them elsewhere in this Agreement. 1.1 "Adverse Event" or "AE" means any untoward medical occurrence in a Subject who has been administered the Investigational Product, whether or not such occur
ARTICLE 2 — SCOPE OF AGREEMENT
ARTICLE 2 — SCOPE OF AGREEMENT 2.1 Purpose. Sponsor hereby engages Site Network to coordinate and facilitate the participation of its member institutions as clinical trial sites for the conduct of Protocol PPC-4871-III (CLARION), and Site Network hereby accepts such engagement, subject to the terms and conditions set forth in this Agreement. Site Network shall serve as the central administrative and coordinating enti
ARTICLE 3 — RESPONSIBILITIES OF SPONSOR Medium
⚑ Liability cap to check against exposure
ARTICLE 3 — RESPONSIBILITIES OF SPONSOR 3.1 Protocol Development. Sponsor shall be responsible for the design, development, and finalization of the Protocol, including all protocol amendments. Sponsor shall provide Site Network and each Site with the current version of the Protocol and all amendments thereto in a timely manner. Sponsor shall consult with the Global Principal Investigator regarding substantive protoco
ARTICLE 4 — RESPONSIBILITIES OF SITE NETWORK Medium
⚑ Forum / governing law
ARTICLE 4 — RESPONSIBILITIES OF SITE NETWORK 4.1 Site Coordination. Veridian shall coordinate and oversee the participation of its thirty-eight (38) member institutions in the Study, shall facilitate the execution of Individual Site Agreements by each member institution, and shall serve as the central administrative point of contact between Sponsor and the participating Sites. Veridian shall designate a Network Study
ARTICLE 5 — PRINCIPAL INVESTIGATOR OBLIGATIONS High
⚑ Indemnity / guarantee obligation
ARTICLE 5 — PRINCIPAL INVESTIGATOR OBLIGATIONS 5.1 Global Principal Investigator. Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology, Graystone University Medical Center, 1200 University Avenue, Philadelphia, Pennsylvania 19104, shall serve as the Global Principal Investigator for the Study. Dr. Aldridge shall be responsible for overall scientific and medical oversight of the Study across all participating Si
ARTICLE 6 — BUDGET AND PAYMENT High
⚑ Indemnity / guarantee obligation
ARTICLE 6 — BUDGET AND PAYMENT 6.1 Total Deal Value. The total projected value of payments under this Agreement across all Veridian Network Sites over the projected life of the Study is Eighty Million Dollars ($80,000,000), subject to adjustment based on actual enrollment, the number of activated Sites, and other variables as set forth in this Article 6 and the Budget and Payment Schedule attached as Exhibit B. 6.2 B
ARTICLE 7 — REGULATORY COMPLIANCE Medium
⚑ Liability cap to check against exposure
ARTICLE 7 — REGULATORY COMPLIANCE 7.1 Applicable Regulations. The Study shall be conducted in compliance with all Applicable Law, including without limitation the Federal Food, Drug, and Cosmetic Act, the regulations promulgated thereunder at 21 C.F.R. Parts 11 (Electronic Records; Electronic Signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review
ARTICLE 8 — STUDY DATA OWNERSHIP AND DATA MANAGEMENT High
⚑ Non-compete / exclusivity restraint
ARTICLE 8 — STUDY DATA OWNERSHIP AND DATA MANAGEMENT 8.1 Ownership of Study Data. Sponsor shall retain exclusive ownership of all Study Data, including but not limited to all data entered into the EDC Platform, case report forms (whether electronic or paper-based), electronic data, biomarker data, pharmacokinetic and pharmacodynamic data, imaging data, patient-reported outcome data, safety and adverse event data, lab
ARTICLE 9 — INTELLECTUAL PROPERTY Medium
⚑ Forum / governing law
ARTICLE 9 — INTELLECTUAL PROPERTY 9.1 Pre-Existing intellectual Property. Each Party retains all right, title, and interest in and to its pre-existing intellectual property, including all patents, patent applications, copyrights, trade secrets, know-how, and other proprietary rights that were owned or controlled by such Party prior to the Effective Date or that are developed by such Party independently of, and withou
ARTICLE 10 — INDEMNIFICATION High
⚑ Indemnity / guarantee obligation
ARTICLE 10 — INDEMNIFICATION This Article 10 incorporates the terms of the Indemnification Term Sheet exchanged between the Parties on May 5, 2023, and reflects Sponsor's responses to Site Network's initial markup of the indemnification provisions dated April 28, 2023. 10.1 Sponsor Indemnification of Site Network and Investigators. (a) Penterra shall indemnify, defend, and hold harmless Veridian, each participating S