Common use of Transfer of HMI Manufacturing Responsibilities Clause in Contracts

Transfer of HMI Manufacturing Responsibilities. (a) As part of the Parties’ negotiations of each of the Development Supply Agreement(s), Development Quality Assurance Agreement(s), Commercial Supply Agreement(s), or Commercial Quality Assurance Agreement(s), as applicable to a Candidate or Product, if [***] determines, based on those criteria set out in Section 8.1.3 below (Objective Criteria), that [***] (i) [***] or (ii) [***], then (A) subject to Section 8.1.3 (Objective Criteria) and the JMC’s approval or the Executive Officer’s agreement (or, in the event of any disagreement by the JMC and the Executive Officers as to whether the Objective Criteria have been met, the determination by the arbitrators that such Objective Criteria have not been met in accordance with Section 8.1.4 (Dispute Resolution)), HMI will contract with and transfer Manufacturing for such Candidate or Product to that Designated CMO agreed upon by the Parties; and (B) [***]. In HMI’s agreement with each applicable Designated CMO, HMI shall ensure that (1) NVS has the same rights in respect of the Designated CMO that NVS has under Section 8.6.1 (Manufacturing Related Rights), (2) NVS is a Third Party beneficiary to all such agreements with the right to enforce provisions contained therein, and (3) NVS is permitted to order such Candidate or Product directly from the Designated CMO pursuant to the terms of such HMI-Designated CMO agreement. (b) In the event that NVS reasonably determines, based on those criteria set out in Section 8.1.3 (Objective Criteria) below, that the available Designated CMOs are unable to Manufacture or supply such Candidate or Product (i) [***] or (ii) [***], then (A) the NVS Manufacturing Date shall be deemed to occur with respect to such Candidate or Product; and (B) NVS shall be entitled to Manufacture such Candidate or Product, as applicable, itself. Notwithstanding NVS’ right to Manufacture Candidates and Products itself commencing on the NVS Manufacturing Date, NVS shall also be entitled, where the Parties have agreed that a Designated CMO is capable of Manufacturing or supplying such Candidate or Product and such Designated CMO becomes able to Manufacture or supply such Candidate or Product (1) [***] or (2) [***] to have such Candidate and Product Manufactured by such alternative Designated CMO.