Moderna mRNA API definition

Moderna mRNA API means [***].
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Examples of Moderna mRNA API in a sentence

  • Moderna will Manufacture (or have Manufactured) and supply to Merck, and Merck will purchase exclusively from Moderna, [***], quantities of non-cGMP Moderna mRNA API as Merck may reasonably require in connection with the performance of its Collaboration Activities.

  • Subject to Moderna’s obligation to supply Merck with Moderna mRNA API and/or Drug Product as set forth in Section 4, all Development work performed hereunder by Moderna will terminate upon the expiration of the R&D Term, unless Moderna will perform Development activities to support Xxxxx’s Development of Product Candidates during the Post-R&D Period pursuant to Section 2.14(b).

  • Notwithstanding the foregoing described exclusivity, from and after the initiation of a Registrational Study with respect to a given Product Candidate or Elected Candidate, Merck and/or its Third Party Manufacturer can Manufacture, and Merck may purchase, cGMP Moderna mRNA API for each such Product Candidate or Elected Candidate, in accordance with Section 4.3; provided, that, [***].

  • Merck shall issue purchase orders in substantially the form set forth on Schedule 1 to Exhibit A to Moderna for the purchase of non-cGMP Moderna mRNA API (the “non-cGMP Order Form”).

  • If RSV Drug Product Manufactured by or on behalf of Moderna using Moderna mRNA API that conformed to the foregoing specifications, quality standards and requirements at the time of such Manufacture, does not conform to the applicable specifications, quality standards and requirements set forth in the Amended RSV R&D Plan due to an error or deficiency with respect to [***], Moderna will, [***], provided that [***]; provided, however, that [***].

  • If Moderna mRNA API contained within the RSV Drug Product Manufactured by or on behalf of Moderna does not conform to the specifications, quality standards and requirements set forth in the Amended RSV R&D Plan and applicable Statements of Work, Moderna will, [***].

  • Subject to Section 2.14(b) and any obligation of Moderna to supply Merck with Moderna mRNA API, Merck will be solely responsible for all Development activities during the Post-R&D Period.

  • If not previously prepared and filed, Moderna will, at Merck’s request, prepare and file with all applicable Regulatory Authorities a DMF for the Moderna mRNA API and Moderna shall also provide such other information and assistance as Merck may reasonably request in connection with the completion of and submission of applications for Regulatory Approvals for Products and the maintenance thereof.

Related to Moderna mRNA API

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.