Marketing Application definition

Marketing Application means an application for Product marketing authorization which has not yet been approved by the FDA or other regulatory authority, including, without limitation, FDA New Drug Application, FDA Biologics License Application, and other similar marketing applications promulgated by regulatory authorities.

Marketing Application means an application for marketing authorization which has not yet been approved by the FDA or other Regulatory Authority, including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.

Marketing Application means the application or submission for marketing authorization of a Licensed Product filed with the United Sates Food and Administrations, or equivalent regulatory agency if filed in a country other than the United States.

Examples of Marketing Application in a sentence

• Again, similar to the FDA, each country will mandate a specific financial consideration for the Marketing Application dossiers being submitted.

• Should Lilly elect to sublicense, or to co-market or co-promote Licensed Product with a Third Person in the Territory, Lilly shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Marketing Application, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person, subject to payment of the compensation amounts as agreed for any such access and use by such Third Person.

• No later than [***] prior to the anticipated First Commercial Sale of any Cost Share Product and in any event no later than the first filing of a Marketing Application for a BLA for such Cost Share Product, the Parties shall form a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”).

• Nothing in this Article 5 shall be deemed to require Genzyme to file Marketing Applications and obtain Marketing Application Approvals in each country in the Territory; Genzyme shall determine in good faith where and when to file and maintain such applications and approvals in a manner consistent with its obligation to use its commercially reasonable and diligent efforts to commercialize Aldurazyme.

• A submission for European Marketing Application Authorisation is planned by the end of 2015.

More Definitions of Marketing Application

Marketing Application means an application, submitted to a Regulatory Authority in any jurisdiction, for Regulatory Approval required in order to Commercialize a product as a drug, including a BLA.

Marketing Application means a BLA, supplemental BLA, MAA or similar application for Regulatory Approval that is filed with the applicable Regulatory Authority(ies) in a particular country or jurisdiction.

Marketing Application means an application for:

Marketing Application means a marketing authorization application filed by or under authority of Genzyme with the requisite health regulatory authority of any country requesting approval for commercialization of Aldurazyme for a particular indication in such country, including as applicable, the MAA.

Marketing Application means a New Drug Application (NDA), Worldwide Marketing Authorization (WMA), or Marketing Application Authorization (MAA) or similar application or submission for marketing authorization of a Product filed with a Regulatory Authority including without limitation the FDA.

Marketing Application means a BLA, supplemental BLA, NDA, MAA or similar application for Regulatory Approval that is filed with the applicable Regulatory Authority(ies) in a particular country or jurisdiction.

Marketing Application means an ap- plication for approval of a new drug filed under section 505(b) of the act or an application for a biologics license submitted under section 351 of the Pub- lic Health Service Act (42 U.S.C. 262).