Common use of Manufacturing Activities Clause in Contracts

Manufacturing Activities. The Manufacturing Lead shall be responsible for Manufacturing or having Manufactured (using a reputable Third Party Provider) each Research Biologic, Optioned Biologic and Optioned Product, as applicable. The Manufacturing Lead shall use Commercially Reasonable Efforts to [***]. The Manufacturing Lead shall obtain supply of the required quantities of Optioned Biologics, Optioned Product and placebo used in Clinical Studies, or otherwise to support the Development activities to be conducted under a Development Plan, either by performing Manufacturing by itself or through its Affiliates, or from a reputable Third Party Provider of manufacturing services, in each case until [***]. Following [***], the Manufacturing Lead will have the sole right to determine which of its or a Third Party Provider’s manufacturing sites will be used to manufacture the Optioned Product or component of the Optioned Product and may transfer the Manufacturing from one site to another, so long as such transfer would not reasonably be likely to have a material adverse effect on continued supply or, unless Denali has exercised the Denali Worldwide Royalty Option with respect to the Optioned Product, [***] increase in costs incurred in connection with or as a result of such transfer. Notwithstanding the foregoing, prior to any such transfer, the Manufacturing Lead will notify the Non-Manufacturing Lead of its intention to transfer Manufacturing from one site to another and shall permit the Non-Manufacturing Lead to carry out an audit of the proposed new site before such transfer takes place. In the event that the Manufacturing Lead [***] then, at the request of the Non-Manufacturing Lead, [***].