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

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Therapeutic interchange means an authorized exchange of therapeutic alternate drug products in accordance with a previously established and approved written protocol.