Integrin Assays. If information relating to Pliant's proprietary [***] assays is required to be submitted to any Regulatory Authority for NVS to obtain Regulatory Approval for a Research Product, then Pliant shall file a drug master file with such Regulatory Authority that includes such information. Pliant hereby grants and will cause its Affiliates, licensees, and sublicensees to grant to NVS, and at the request of NVS, its Affiliates or sublicensees, a right of reference to, and a right to copy, access, and otherwise use, all information and data (including all CMC information) included in any such drug master file to the extent necessary to obtain Regulatory Approval for such Research Product. Notwithstanding anything to the contrary in this Agreement, Pliant will not, and will cause its Affiliates, licensees, and sublicensees not to, withdraw or inactivate any drug master file that NVS, its Affiliates or sublicensees reference or otherwise use pursuant to this Section 7.2(d). Pliant will own any such drug master file, which will be deemed the Confidential Information of Pliant. Pliant will give NVS written notice reasonably in advance of, and where possible, at least [***] Business Days prior to any material communication with Regulatory Authorities with respect to any such drug master file, and in such written notice will provide NVS with a brief description of the principal issues raised in such communication and any material changes to such drug master file that Pliant makes.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Pliant Therapeutics, Inc.), Collaboration and License Agreement (Pliant Therapeutics, Inc.)