Common use of Contract Research Organizations (CROs Clause in Contracts

Contract Research Organizations (CROs. [optional if there is a CRO; if not this Article will remain blank] 11.1 Pursuant to 21 C.F.R. Part 312.52, Collaborator may retain one or more CROs to assist Collaborator in managing and monitoring the study. VA acknowledges Collaborator’s right to transfer, in whole or in part, without the consent of VA, any of Collaborator’s obligations under this CRADA to any such CROs. The Parties acknowledge that the CROs are independent contractors of Collaborator, and when assuming any obligation of Collaborator, must comply with 21 C.F.R. Part 312. 11.2 Collaborator agrees that responsibility for the quality and integrity of the data, including VA Confidential Information, remains with Collaborator after the data is received by the Collaborator. Collaborator represents and warrants that: (1) Collaborator and CRO have entered into a separate contract whereby CRO has assumed obligations and liability for any obligations that CRO undertakes pursuant to this CRADA; (2) Collaborator’s use of CRO in managing and monitoring the study will not impact Collaborator’s indemnification and liability responsibilities as set forth in Article 12; and (3) CRO will abide by the terms and conditions of this CRADA as applicable.