Common use of Collaboration on Regulatory Strategy Clause in Contracts

Collaboration on Regulatory Strategy. Clovis Oncology and RMS (acting through the Project Team) will collaborate on the regulatory strategy in the Markets for obtaining Regulatory Approvals for the combination use of the Clovis Oncology Compound in conjunction with the IVD developed under the Project Plan and this Agreement, and in the preparation and/or exchange of any documentation necessary to support any INDs, NDAs, PMAs or other applications for such Regulatory Approvals. The Parties will also consult and coordinate their respective efforts to implement such regulatory strategies in the Markets, including without limitation by meeting jointly with the applicable Regulatory Authorities to ensure that the regulatory strategy for the EGFR Assay and/or IVD and Clovis Oncology Compound is acceptable to such Regulatory Authorities, and by keeping each other reasonably informed with respect to any related regulatory interactions with the FDA and other Regulatory Authorities in the Markets.