Marketing Approval definition

Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

Marketing Approval means the act of a Regulatory Authority necessary for the marketing and sale of the Product in a country or regulatory jurisdiction, including, without limitation, the approval of the NDA by the FDA, EC Approval, and Japanese Approval.

Marketing Approval means, with respect to a Licensed Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the Commercialization of such Licensed Product in such jurisdiction, including, with respect to the United States, approval of an Approval Application for such Licensed Product by the FDA and with respect to the European Union, approval of an Approval Application for such Licensed Product by the European Commission.

Examples of Marketing Approval in a sentence

• Upon receiving Marketing Approval for a POZEN Product, the Parties agree to coordinate the application for any patent term extension or supplementary protection certificates that may be available.

• At least once each Calendar Year during the Term until first Marketing Approval of a [**] Licensed Product for the [**] indication, one or more members of the internal program team at COBI with responsibility for development of Licensed Product will meet in person with representatives of AVEO at COBI facilities for a formal update meeting during which COBI will present to AVEO the status and results to date of research and development activities related to Licensed Product.

• COBI will use Commercially Reasonable Efforts during the Term to develop, manufacture and obtain Marketing Approval for, and commercialize a Licensed Product in a [**] indication throughout the U.S. and EU, and to meet the development and commercialization timelines set forth in the development and commercialization plans furnished to AVEO pursuant to the first sentence of this Section 3.5(a).

• For the sake of clarity, COBI will have met its obligation to use Commercially Reasonable Efforts to develop, manufacture and obtain Marketing Approval for [**] Licensed Product upon approval of the [**] Licensed Product in the [**] indication.

• In addition, in the course of obtaining Marketing Approval, COBI will use Commercially Reasonable Efforts to secure regulatory, data and market exclusivity for each Licensed Product for which Marketing Approval is obtained to the extent available from the applicable Regulatory Authorities.

More Definitions of Marketing Approval

Marketing Approval means all approvals from the relevant Regulatory Authority in a given country necessary to market and sell a pharmaceutical product in such country, including pricing and reimbursement approvals if required for marketing or sale of such product in such country.

Marketing Approval means all approvals, licenses, registrations or authorizations of the Competent Authorities in a country, necessary for the marketing and sale of the Product in such country, including the approval of an MAA or an NDA.

Marketing Approval means final approval of an NDA by the FDA, or final approval of a comparable document filed with an equivalent health regulatory authority in any other country or in the European Union (using the centralized process or mutual recognition), including all required marketing, pricing or reimbursement approvals.

Marketing Approval means final approval of an NDA by the FDA for the United States, or final approval of a comparable document filed with an equivalent health regulatory authority in any other country or in the European Union (using the centralized process or mutual recognition), including all required marketing, pricing or reimbursement approvals.

Marketing Approval or “MA” means those Regulatory Approval(s) required by applicable laws and regulations in a particular country or territory in order to sell or commercially supply a medicinal product and/or device in that country or territory;

Marketing Approval means the obtaining of all necessary regulatory approvals (excluding the obtainment of pricing reimbursement approval) required from the applicable regulatory authority in the territory in order to commercially sell or market the Product for human consumption in such territory, and satisfaction of any related regulatory registration and notification requirements.

Marketing Approval means the regulatory approval necessary to market and sell a Sublicensed Product in a country.