Examples of Designated CMO in a sentence
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.
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.
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.
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.
The Designated CMO would operate on the basis of extended collective licensing and serve as a one-stop shop where licenses for the digital transmission right in all recordings could be secured in a single transaction at reasonable fees.The Designated CMO would be authorized to represent not only the digital transmission right in recordings of which at least one co-owner was a member but also rights in recordings of which no co-owner was a member.
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 instances where no co-owner of a recording is a member of the Designated CMO, the non-member co-owners would have the same three-year window in which to claim royalty payments.In addition, in instances where no co-owner of a recording is a member of the Designated CMO, any co-owner of that recording may serve an opt-out notice on the Designated CMO.
The Designated CMO would distribute royalties to non- member co-owners for licensed digital transmissions of their recordings if the non-member co- owners claim their royalties within three years after the royalties accrue.
The rights of co-owners who are not members of the Designated CMO would be protected.