Marketing Authorization definition

Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in a country.

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Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

Marketing Authorization means approval from the relevant Governmental Authority necessary to market and sell Product in the Territory as a pharmaceutical or commercial product in any formulation or dosage form, together with ah subsequent submissions, supplements and amendments thereto.

Examples of Marketing Authorization in a sentence

Subject to the terms and conditions of this Agreement, Licensee shall be solely responsible for the Development of the Compounds and the Products in the Field in the Territory at its own cost and expense, including the performance of Clinical Trials of the Products in the Field in the Territory necessary for obtaining Marketing Authorization in the Territory.
Licensor shall be solely responsible for the Development of the Compounds and the Products in the Field outside the Territory at its own cost and expense, including the performance of Clinical Trials of the Products in the Field outside the Territory necessary for obtaining Marketing Authorization in Greater China.
Licensee shall use Commercially Reasonable Efforts to Develop and obtain Marketing Authorization for at least (i) [***] Product, (ii) [***] Product, (iii) [***] Product, and (iv) [***] Product, in each case in the Field in the Territory.

More Definitions of Marketing Authorization

Marketing Authorization or "MA" means the authorization granted by the relevant Governmental Authority for the marketing, sale and/or distribution of the Product.

Marketing Authorization means the procurement of registrations and permits required by applicable government authorities in a country in the Territory for the marketing, sale, and distribution of a Product in such country;

Marketing Authorization means an approved New Drug Application as defined in the FFDCA and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification, necessary or reasonably useful to market the Product in countries or regulatory jurisdictions in the Territory other than the United States, including applicable pricing and reimbursement approvals.

Marketing Authorization means such governmental approval (including pricing approval, where required) for the marketing of a Product in a country of the Territory as is necessary to enable sale and distribution of the Product in such country, which approval results from an NDA Filing or an equivalent filing.

Marketing Authorization means the authorization to sell the Product, as granted by the relevant Governmental or Regulatory Authorities.

Marketing Authorization means the granting or authorization, by an appropriate governmental agency, to commercialize a pharmaceutical product; by way of example, the FDA is an appropriate governmental agency.

Marketing Authorization means, with respect to a country, the regulatory authorization required to market and sell Product in such country as granted by the relevant Governmental Authority.