Marketing Authorization Application definition

Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

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Marketing Authorization Application means an application for Regulatory Approval for a Product in a country or region of the Territory.

Marketing Authorization Application or “MAA” means: (a) in the United States, a New Drug Application (as defined in Title 21, Section 314.50 et seq. of the U.S. Code of Federal Regulations or any successor regulations), including any amendment or supplement thereto, and (b) in any other country or regulatory jurisdiction, an application for regulatory approval required for marketing or sale of a Licensed Product in such country or regulatory jurisdiction, including any amendment or supplement thereto.

Examples of Marketing Authorization Application in a sentence

• Package 3 shall include: Marketing Authorization Application dossier Sections II-V (named as per ICH guidelines) – including summaries and quality, non-clinical and clinical information data packages as required by the National Regulatory Authority where the dossier was submitted.

• In the EU, the Marketing Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted accelerated assessment.

• For purposes hereof, MAA means (a) a Biologics License Application as defined in the United States Federal Food, Drug and Cosmetics Act, as amended, and the regulations promulgated thereunder, or (b) a Marketing Authorization Application in the European Union.

• The Board undertakes to notify Nestlé at least [**] month in advance of the commencement of the [**] month period prior to the estimated submission date of the Marketing Authorization Application in Europe, such estimate to be reasonable and made in good faith by the Board.

• However, to the extent that Cornerstone unilaterally desires a new Marketing Authorization Application, then Cornerstone shall be solely responsible for all costs and expenses associated with pre-clinical and clinical testing connected with or related to relevant IND(s) and Marketing Authorization Application(s).

More Definitions of Marketing Authorization Application

Marketing Authorization Application means an application to the appropriate Regulatory Authority for approval to commercially sell a Product (but excluding pricing approval) in the Field in a particular jurisdiction (including, without limitation, a New Drug Application in the U.S.) and all amendments and supplements thereto.

Marketing Authorization Application or “MAA” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.

Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession other than the U.S.

Marketing Authorization Application or “MAA” shall mean an application for Regulatory Approval (but excluding Price Approvals) required for marketing of pharmaceutical product. Solely as used in Section 8.2, “MAA” shall mean the application for Regulatory Approval (but excluding Price Approvals) required for marketing of the first Product in the EU.

Marketing Authorization Application means a BLA or a comparable filing or filing serving to apply for Marketing Authorization in any other jurisdiction, in each case with respect to a Licensed Product.

Marketing Authorization Application means any new drug application, BLA, or other application submitted to a Competent Authority for authorization by the applicable Competent Authority to market and sell a Licensed Product commercially.