RSV IND definition

RSV IND means the [***].
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Examples of RSV IND in a sentence

  • Thereafter, (i) Merck or its designee shall be the owner of the RSV IND and all associated Regulatory Filings, (ii) Merck shall have the sole responsibility for all regulatory activities with respect to the RSV Collaboration mRNA Constructs, and (iii) Merck shall be the sole point of contact with Regulatory Authorities in all matters relating to the RSV Collaboration mRNA Constructs.

  • Notwithstanding anything in Section 5 or elsewhere in the Agreement to the contrary, the Parties agree that during the Moderna Lead Period, Moderna will have primary responsibility for conducting communications with the TGA (and any other applicable Regulatory Authorities) that pertain to the RSV IND or relate to the performance of the RSV Phase I Study or otherwise relate to the Moderna RSV Lead Activities, including [***].

  • Moderna will be responsible for preparing and submitting the RSV IND, and the RSV IND will be the property of Moderna and held in the name of Moderna; provided, however, prior to making such submission with the TGA (or any other applicable Regulatory Authority), Moderna shall submit to the JSC a draft of the RSV IND and any correspondence pertaining to such RSV IND to be submitted therewith to the TGA (or any other applicable Regulatory Authority).

  • Notwithstanding anything in Section 5 or elsewhere in the Agreement to the contrary, but subject to Sections 2.3 and 2.4 of this Third Amendment, the Parties acknowledge and agree that during the Moderna Lead Period, Moderna will have primary responsibility for preparing and maintaining all Regulatory Filings with respect to the RSV IND and RSV Phase I Study, and conducting the RSV Phase I Study, in each case in accordance with this Third Amendment and the Amended RSV R&D Plan.

Related to RSV IND

  • Brewery manufacturing license means a license issued in accordance with

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • WTO GPA country end product means an article that--

  • Major Countries means Canada, France, Germany, Italy, Japan, Spain, United Kingdom and the United States.

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.