CRO Agreement definition
Examples of CRO Agreement in a sentence
No amendment, modification, release or discharge to this Agreement, the Quality Agreement or any material amendment, modification, release or discharge to a Bioanalysis Plan, a Statistical Analysis Plan, or a CRO Agreement (to the extent provided in Section 2.4(o)) shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.
BN shall keep the JC informed of any major changes to the CRO Agreement through the JC meetings, and shall not change the CRO Agreement in any manner that may materially and adversely affect the timing and/or conduct of the PROSPECT Trial without BMS’s prior written approval, with such approval not to be unreasonably withheld or delayed.
For clarity, the CRO Agreement will not be assigned to BMS and BN will remain responsible for all obligations, including making payments, thereunder.
Each CRO Agreement entered into by Dermira, as it may be amended from time to time, shall contain provisions that comply, or permit Dermira to comply (as applicable), with its obligations under this Section 5.10 and the Safety Agreement and that are otherwise consistent with this Agreement.
Dermira shall provide a copy of each UCB approved fully-executed CRO Agreement entered into by Dermira and amendments thereto to the JDT promptly following the execution thereof, and shall ensure that no CRO shall commence any activities (other than preliminary feasibility work in order to provide a quote) with respect to any Phase 3 Study or any Post-Approval Study unless and until the JDC has received a fully-executed CRO Agreement.
Dermira (or the applicable CRO acting on Dermira’s behalf) shall monitor each Institution and any other site at which a Phase 3 Study, or any Post-Approval Study in relation to the Development of the Product in the Development Indication in the Development Territory is performed and collect Product Data therefrom, including CRFs, in compliance with Applicable Law, the Safety Agreement, and the applicable CRO Agreement.
As provided by the CRO Agreement, all Key Personnel and Approved Affiliates who may be performing work pursuant to this Scope of Work No. 1 are specifically listed in Attachment 1, attached hereto, which is incorporated by reference.
No modification, amendment, or waiver of this Scope of Work No. 1 shall be effective unless in writing and duly executed and delivered by each party to the other and otherwise in accordance with Section 3 of the CRO Agreement.
This Scope of Work No. 1 and the research contemplated herein is subject to the terms and provisions of the CRO Agreement.
Capitalized terms used herein that are not otherwise defined shall have the meaning ascribed to them in the CRO Agreement.