Common use of CLINICAL DEVELOPMENT COLLABORATION Clause in Contracts

CLINICAL DEVELOPMENT COLLABORATION. TSD agrees to utilize PPD exclusively for clinical and bioanalytical CRO services related to the Phase II and Phase III Trials of Products that are conducted in support of obtaining Regulatory Approval in the U.S. and in the EU, in all cases, under terms and conditions mutually acceptable to the Parties; provided that (a) PPD provides such services at [*] rates which are applied between PPD, Takeda Global Research and Development Center, Inc. (“TGRD”) and Takeda Europe Research & Development Centre Ltd. (“TeuR&D), and (b) PPD demonstrates that it has and is maintaining the requisite technical expertise and capacity to reliably provide such services in a professional and competent manner. TSD will consider in good faith using PPD for CRO services related to Phase IV trials [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. of the Products and biostatistics and data management services related to Phase II-IV trials of the Products. CRO services performed by PPD pursuant to this Section 4.9 shall be governed by that certain Global Master Agreement, Clinical Research Management Services (Phase II-IV) dated July 1, 2004, that certain Global Master Agreement, Bioanalytical Laboratory Services dated September 1, 2004 and that certain Global Master Agreement, Biostatistics and Data Management Services (Phase II-IV) dated July 13, 2005, each of which is executed among TGRD, TeuR&D and PPD Development, LP (the “Takeda MSAs”). Schedule 4.9 includes a description of initial services that will be performed by PPD under the 322 Development Plan. Individual task orders, which more fully describe the specific types of services and activities to be undertaken by PPD for each study under the 322 Development Plan, will be executed under the appropriate Takeda MSA. Each task order will be signed by TSD, as an affiliate of TGRD and TeuR&D. If PPD is asked to perform CRO services for multiple Products at the same time, PPD shall conduct such CRO services for such multiple Products pursuant to the Development Plan for each such Product, and pursuant to guidance from TSD regarding the coordination between such Products as necessary. In case of conflict between this Agreement and the Takeda MSAs regarding the assignment or license of Intellectual Property to TSD, the terms of this Agreement shall prevail.