CROs Sample Clauses
CROs. (i) Subject to the terms and conditions of this Agreement, Dermira shall, in relation to the Development of the Product in the Development Indication in the Development Territory, have primary responsibility for selection and appointment of (i) the CROs that will manage any Phase 3 Study, or any Post-Approval Study in the Development Indication, (ii) the institutions at which a Phase 3 Study, and any Post-Approval Study in the Development Indication, will be performed (“Institutions”), and (iii) the principal investigator at each Institution designated to supervise the work of all persons who assist in performing a Phase 3 Study, or any Post-Approval Study in the Development Indication, at such Institution (each, an “Investigator”), including replacement Investigators.
(ii) Dermira’s selection, removal and/or replacement of the CROs for the Phase 3 Study, and any Post-Approval Study in the Development Indication shall be subject to discussion at the JDT and the approval by the JDC and the JSC, if applicable, and as the case may be, as a Development Matter under Section 4.25, provided that Dermira may not remove and/or replace [*] CROs at any one time.
(iii) The form of any agreement with either CRO entered into hereunder (a “CRO Agreement”) shall, in the case of a CRO Agreement to be entered into by or on behalf of Dermira, be subject to approval by UCB. 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.
(iv) If either or both CROs is or are unable or unwilling to continue in such role, Dermira’s Contact shall promptly notify UCB’s Contact thereof, and Dermira shall use Commercially Reasonable Efforts to find a suitable replacement, subject to Section 5.10(a)(ii).
CROs. Surrozen’s right to transfer possession of the Biological Materials and Identified Antibody(ies) and/or Derivative Antibody(ies) to third parties is expressly limited under the terms of this Agreement. Surrozen shall have the right to transfer the Biological Materials, Identified Antibody(ies) and/or Derivative Antibody(ies) solely to CROs for the express purpose of performing research in the Field of Use on behalf of Surrozen. If Surrozen transfers any Biological Materials, Identified Antibody(ies) and/or Derivative Antibody(ies) to CROs, it hereby agrees that such CROs shall be required to comply with the terms and conditions of this Agreement. For the purpose of this Agreement, Surrozen shall remain responsible for the performance of its rights and obligations set out in this Agreement by such recipient CROs, including the confidentiality and material handling protections set forth in this Agreement.
CROs. Any agreement(s) with a CRO for the conduct of a Clinical Trial in Japan shall be agreed upon and signed jointly by the CRO on the one side and by BMKK, in its own capacity and as agent for ImClone pursuant to Section 3.2(b) below, and MJ on the other, but only after consultation, review and approval of such CRO agreement by the SCJ; provided, that BMKK may also enter into a CRO agreement without MJ and without the consent of the other Parties, and vice-versa, (x) in order to perform Development obligations undertaken by MJ or BMKK under Section 3.1(c) or (y) if and to the extent needed to cure a breach of such other Party’s Development obligations under this Agreement. Further, except where a CRO is used, BMKK, in its own capacity and as agent for ImClone pursuant to Section 3.2(b) below, and MJ shall both sign all Clinical Trial agreements with each Clinical Trial site for studies conducted in Japan under the Annual Development Plan and Budget, unless agreed to otherwise by the JJDC or SCJ or unless and to the extent necessary in order to cure a breach of this Agreement by the other Party.
CROs. Apellis may delegate any of its responsibilities to its Affiliates (subject to Section 15.1) and/or one (1) or more CROs. CROs performing any material aspect of the Trial as of the Effective Date are listed in Exhibit B.
CROs. FibroGen China shall ensure any such Clinical Trials are conducted through a FibroGen China Affiliate incorporated in the Territory. In the event that FibroGen China engages a Third Party contract research organization (“CRO”) to undertake any Clinical Trial (or any portion of any Clinical Trial), FibroGen China shall ensure that such CRO is qualified in the Territory and capable of producing data acceptable to the CFDA and other applicable Regulatory Authorities in the Territory. FibroGen China shall discuss any possible engagement of a CRO with the China Committee. FibroGen China shall ensure that any Clinical Trials conducted in China shall be conducted only at hospitals that are accredited by the CFDA.