Designated CMO definition

Designated CMO means any Third Party contract manufacturer mutually agreed upon by the Parties, such agreement not to be unreasonably withheld, conditioned, or delayed.
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Designated CMO means any CMO selected by Dicerna, its Affiliate or their Sublicensees as its primary manufacturer of Product for commercial sales.
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Designated CMO has the meaning set forth in Section 7.1.1(c)(ii) (Subsequent Manufacturing Technology Transfer).
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Examples of Designated CMO in a sentence

  • 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.

  • Subject to Section 4.3.4 (Sublicense and License Requirements), (a) NVS may sublicense its rights under Section 4.1.3 (Manufacturing License); and (b) HMI may license or sublicense its rights under clauses (i) and (iii) under Section 4.1.3 (Manufacturing License), in each of (a) and (b), to any Designated CMO.

  • 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.

  • The Parties’ regulatory teams will collaborate with respect to substantive correspondence in support of (a) that portion of Jointly-Agreed Regulatory Submissions related to any In-Vivo [***] Product; and (b) that portion of Regulatory Submissions related to Manufacturing by HMI or its Designated CMO of Candidates and Products, in the case of each of ((a) and (b)), excluding any portion of such correspondence that contains any data or information relating to any Other Components.

  • The Parties’ regulatory teams will collaborate with respect to substantive correspondence in support of (a) that portion of Jointly-Agreed Regulatory Submissions related to any In-Vivo SCD Product; and (b) that portion of Regulatory Submissions related to Manufacturing by HMI or its Designated CMO of Candidates and Products, in the case of each of ((a) and (b)), excluding any portion of such correspondence that contains any data or information relating to any Other Components.

  • In respect of GMP Batches, all MBRs and Executed Batch Records generated by Protiva or its Permitted Contractors for the Manufacture of Manufactured Product under this Agreement shall be made available by Protiva to Dicerna, its Affiliate, their Sublicensee, any Designated CMO and Secondary CMO, as applicable, in accordance with the Quality Agreement but shall remain the property and Confidential Information of Protiva.