Common use of Regulatory Affairs Clause in Contracts

Regulatory Affairs. Genentech and/or its sublicensee(s) shall be responsible for all interactions with regulatory authorities in the Territory with respect to such Lead Products and will bear the associated costs, and, subject to Genentech’s payment obligations herein, shall own any IND and NDA filings made with respect to such Lead Products. Genentech shall regularly (and on at least a semi-annual basis) provide Curis, via the JSC or CSC, as applicable, with an update describing the progress made to date towards obtaining Regulatory Approval of any such Lead Product(s) and the plans for achieving such Regulatory Approval(s) in the future.

Appears in 4 contracts

Samples: Collaborative Research, Development and License Agreement, Collaborative Research, Development and License Agreement (Curis Inc), Collaborative Research, Development and License Agreement (Curis Inc)

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