Contract analysis

Section 1 — Purpose and Scope This Exhibit K identifies the approved subcontractors and third-party service providers (each, an "Approved Subcontractor" and collectively, the "Approved Subcontractors") authorized by Sponsor to perform services in connection with Protocol PPC-4871-III (the "Study") pursuant to Section 8.2 of the Agreement. The Approved Subcontractors listed herein have been vetted and selected by Spon

Section 2 — Approved Subcontractors List The following entities have been approved by Sponsor as Approved Subcontractors for the conduct of the Study. The scope of services, governing agreements, key site-facing activities, and regulatory compliance information for each Approved Subcontractor are set forth below. 2.1 — Contract Research Organization (CRO) Scope of Services. Meridian CRO has been engaged by Sponsor to

Section 3 — Data Protection and Confidentiality Each Approved Subcontractor identified in Section 2 of this Exhibit K is bound by written confidentiality obligations under its respective governing agreement with Sponsor. Such confidentiality obligations are consistent with the terms set forth in Exhibit F (Confidentiality Provisions) of the Agreement, including a confidentiality term of ten (10) years from the date o

Section 4 — Regulatory Compliance Obligations Each Approved Subcontractor identified in Section 2 of this Exhibit K shall perform its respective services in connection with the Study in compliance with all Applicable Laws, including without limitation the following: (a) 21 C.F.R. Part 11 — Electronic Records; Electronic Signatures; (b) 21 C.F.R. Part 50 — Protection of Human Subjects (Informed Consent); (c) 21 C.F.R.

Section 5 — Modifications to Approved Subcontractors List Sponsor may, in its discretion, add new Approved Subcontractors to, remove existing Approved Subcontractors from, or replace Approved Subcontractors on this Exhibit K upon written notice to the Site Network. Any replacement Approved Subcontractor shall meet qualifications equivalent to, or exceeding, those of the Approved Subcontractor being replaced and shall

Section 6 — Contact Information Specific operational contact persons for each Approved Subcontractor, including designated clinical research associates (CRAs), EDC help desk representatives, and laboratory coordinators, will be provided by Sponsor to the Site Network and to each Participating Site's principal investigator and primary study coordinator promptly following execution of the Agreement and prior to the com