SIGNATURE PAGE TO MASTER CLINICAL TRIAL AGREEMENT
Execution Version
MASTER CLINICAL TRIAL AGREEMENT
dated as of June 28, 2023
by and between
PENTERRA PHARMACEUTICALS CORP.
a Delaware corporation
("Sponsor")
and
VERIDIAN HEALTH RESEARCH NETWORK, INC.
a Delaware corporation
("Site Network")
for
Protocol No. PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
Agreement: Master Clinical Trial Agreement (the "Agreement"), dated as of June 28, 2023, by and between Penterra Pharmaceuticals Corp., a corporation organized and existing under the laws of the State of Delaware, with its principal place of business at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540 ("Sponsor"), and Veridian Health Research Network, Inc., a corporation organized and existing under the laws of the State of Delaware and exempt from federal income taxation under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal place of business at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104 ("Site Network").
Protocol Reference: Protocol No. PPC-4871-III; Protocol Short Title: CLARION (Clinical Assessment of Response with Longitudinal Investigation in ONcology).
ClinicalTrials.gov Identifier: NCT05928174
IND Number: IND 157823 (United States Food and Drug Administration)
IN WITNESS WHEREOF, the undersigned has caused this Agreement to be executed by its duly authorized representative as of the date set forth below. The undersigned hereby represents and warrants that he has been duly authorized by the Board of Directors of Veridian Health Research Network, Inc., pursuant to a resolution duly adopted at a meeting of the Board of Directors held on June 14, 2023, at which a quorum was present and acting throughout, to execute this Agreement on behalf of the Site Network and to bind the Site Network to all of the terms, conditions, obligations, representations, warranties, covenants, and agreements contained herein.
[SIGNATURE PAGE — SITE NETWORK]
VERIDIAN HEALTH RESEARCH NETWORK, INC.
By: ________
Name: Franklin Osei, M.D., Ph.D.
Title: President and Chief Executive Officer
Date of Execution: June 28, 2023
Entity EIN: 23-4178205
Address for Notices. For purposes of Section 22.1 (Notices) of the Agreement, all notices, demands, requests, consents, approvals, and other communications required or permitted to be given under the Agreement shall be sent to the Site Network at the following address:
Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, Pennsylvania 19104
Attention: Gregory Callahan, Esq., Vice President, Legal & Compliance
Telephone: (215) 555-0147
Email: gcallahan@veridianresearch.org
With a copy (which shall not constitute notice) to:
Whitmore, Jansen & Callahan LLP 1500 Market Street, Suite 3200 Philadelphia, Pennsylvania 19102
Attention: Allison Whitmore, Esq.
Telephone: (215) 555-0283
Email: awhitmore@wjclaw.com
Acknowledgment of Receipt and Agreement. By executing this signature page, Veridian Health Research Network, Inc. hereby acknowledges receipt of, and agrees to be legally bound by, all terms, conditions, obligations, representations, warranties, covenants, and agreements of the Master Clinical Trial Agreement, including, without limitation, all Exhibits (A through K) and Schedule 1 attached thereto and incorporated therein by reference, each of which the undersigned has reviewed and approved. Without limiting the generality of the foregoing, the Site Network specifically acknowledges and agrees to the terms set forth in the following Exhibits and Schedule, each of which is incorporated into and forms an integral part of the Agreement:
(a) Exhibit A — Protocol Synopsis (PPC-4871-III / CLARION), setting forth the clinical and scientific objectives, study design, enrollment targets, primary and secondary endpoints, and investigational product information for Protocol No. PPC-4871-III;
(b) Exhibit B — Budget and Payment Schedule, setting forth the total contract value of Eighty Million Dollars ($80,000,000.00), inclusive of all per-patient costs, pass-through expenses, site activation fees, close-out costs, and performance milestone payments, together with the payment schedule, invoicing procedures, and reconciliation mechanisms applicable thereto;
(c) Exhibit C — Form of Individual Site Agreement (Joinder), the form of agreement to be executed by each Participating Site within the Veridian Health Research Network to evidence such site's agreement to participate in the Protocol and to be bound by the terms of the Agreement;
(d) Exhibit D — Subject-Injury Indemnification Provisions, setting forth the Sponsor's obligations with respect to the indemnification, defense, and hold harmless of the Site Network, Participating Sites, and their respective investigators and study personnel in connection with injuries sustained by study subjects arising out of the administration of the investigational product in accordance with the Protocol;
(e) Exhibit E — Insurance Requirements and Certificate Forms, specifying the types and minimum amounts of insurance coverage to be maintained by each party during the term of the Agreement, including clinical trial liability insurance, general commercial liability insurance, professional liability insurance, and workers' compensation insurance, together with the required certificate of insurance forms;
(f) Exhibit F — Confidentiality and Data Protection Provisions, setting forth the obligations of each party with respect to the protection of Confidential Information, including provisions governing the use, disclosure, storage, and return or destruction of Confidential Information, as well as compliance with applicable data protection and privacy laws, including the Health Insurance Portability and Accountability Act of 1996, as amended ("HIPAA"), the General Data Protection Regulation (EU) 2016/679 ("GDPR"), and applicable state privacy laws;
(g) Exhibit G — Intellectual Property and Publication Rights, setting forth the ownership, licensing, and assignment provisions applicable to inventions, discoveries, data, results, and other intellectual property arising out of the conduct of the Protocol, as well as the rights and obligations of the parties with respect to the publication and presentation of study results;
(h) Exhibit H — Regulatory Compliance Representations and Covenants, setting forth the representations, warranties, and covenants of each party with respect to compliance with applicable laws, regulations, and guidelines governing the conduct of clinical trials, including 21 C.F.R. Parts 11, 50, 54, 56, and 312, ICH E6(R2) Guidelines for Good Clinical Practice, and applicable institutional review board or independent ethics committee requirements;
(i) Exhibit I — Form of Investigator Undertaking, the form of undertaking to be executed by each Principal Investigator and Sub-Investigator at each Participating Site, confirming such investigator's qualifications, agreement to comply with the Protocol and applicable regulatory requirements, and acknowledgment of his or her responsibilities under the Agreement;
(j) Exhibit J — Safety Reporting Procedures, setting forth the procedures and timelines for the reporting of adverse events, serious adverse events, suspected unexpected serious adverse reactions, and other safety information, including the obligations of the Site Network and each Participating Site with respect to safety data collection, documentation, and transmission to the Sponsor and applicable regulatory authorities;
(k) Exhibit K — Approved Subcontractors List, identifying the third-party vendors, contract research organizations, central laboratories, and other subcontractors approved by the Sponsor for use by the Site Network and Participating Sites in connection with the conduct of the Protocol; and
(l) Schedule 1 — List of Participating Veridian Network Sites, identifying thirty-eight (38) Participating Sites across fourteen (14) states within the Veridian Health Research Network that have been selected for participation in the Protocol, together with the name of the designated Principal Investigator and the target enrollment allocation for each such site.
The Site Network further acknowledges receipt of, and agrees to be bound by the terms of, the intellectual Property Side Letter, dated as of June 28, 2023, executed concurrently herewith by and between the Sponsor and the Site Network, which supplements and, to the extent expressly stated therein, modifies certain provisions of Exhibit G to the Agreement.
Governing Law. This signature page and the Agreement to which it is attached are governed by and shall be construed and enforced in accordance with the laws of the State of New York, without giving effect to any choice of law or conflict of law rules or provisions (whether of the State of New York or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of New York, as more fully set forth in Section 23.1 (Governing Law) of the Agreement.
Counterparts; Electronic Delivery. This signature page may be delivered by facsimile transmission or by electronic transmission (including by delivery of a portable document format (.pdf) file via electronic mail or other electronic means) and any signature page so delivered shall be deemed an original for all purposes, with the same force and effect as if such signature page bore an original ink signature. The Agreement may be executed in any number of counterparts, each of which when so executed and delivered shall be deemed to be an original, and all of which counterparts, taken together, shall constitute one and the same instrument. No party shall raise the use of electronic transmission or the fact that any signature was transmitted or communicated through the use of electronic means as a defense to the formation or enforceability of this Agreement, and each party hereby forever waives any such defense.
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[Signature Page of Penterra Pharmaceuticals Corp. Follows]