For Development. Subject to the oversight of the JSC and JDC, and in accordance with Applicable Law, Pliant will Manufacture or have Manufactured Licensed Products for Clinical Supply for use in the FIH Study during the Initial Development Period for such Licensed Product in accordance with the applicable Clinical Supply Agreement and applicable Clinical Quality Assurance Agreement, and NVS will be responsible for Manufacture of Licensed Products for all other Clinical Studies, including, for the avoidance of doubt, the Hepatic Impairment Study. To the extent that Pliant engages a Third Party to Manufacture Licensed Product, then Pliant shall only engage a Third Party that is [***] suitable for Manufacture of Licensed Product. The Parties will collaborate via the JDC to identify a suitable Third Party for such Manufacturing activities. NVS will be responsible for Manufacture of all Selected Research Compounds and Research Products for use in Development and Clinical Studies. At any time that Pliant is Manufacturing or having Manufactured Licensed Products, NVS may elect, at its sole discretion, to transfer any responsibility for Manufacture of Licensed Product for which Pliant is responsible under this Section 8.1(b), from Pliant to NVS.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Pliant Therapeutics, Inc.), Collaboration and License Agreement (Pliant Therapeutics, Inc.)