Regulatory Authority

Regulatory Authority. Means any national, supra-national, regional, state, or local regulatory agency, department, bureau, commission, council, or other governmental entity in the Territory involved in the granting of Regulatory Approval for the Product, including, without limitation, the FDA.

Regulatory Authority. Means any applicable government regulatory authority involved in granting approvals for the manufacturing and marketing of a Licensed Product, including, in the United States, the FDA.

Regulatory Authority. Means the FDA or with respect to any particular country, territory or union, the governmental authority, body, commission, agency or other instrumentality of such country, territory or union with the primary responsibility for the evaluation or approval of medical products before such medical products can be tested, marketed, promoted, distributed or sold in such country, including such governmental bodies that have jurisdiction over the pricing of such medical products.

Regulatory Authority. Shall mean the authority(ies) in any country in the Territory with responsibility for granting regulatory approval for the manufacturing and sale of the Product in such country, and any successor(s) thereto.

Regulatory Authority. Any national (e.g., the U.S. Food and Drug Administration), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the granting of Regulatory Approval for a Marketed Product

Regulatory Authority. Means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in the Territory, with authority over the distribution, importation, exportation, Manufacture, production, use, storage, transport, clinical testing or sale of the Product, including the FDA.

Regulatory Authority. A federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, manufacture, use, storage, import, promotion, marketing or sale of a product in a Territory

Regulatory Authority. Shall mean the FDA in the U.S., and any health regulatory authority(ies) in any country in the Territory or ROW that is a counterpart to the FDA and holds responsibility for granting regulatory marketing approval for a Product in such country, and any successor(s) thereto and any other state or local health regulatory authorities having jurisdiction for any activities contemplated by the Parties.

Regulatory Authority. Means the United States Food and Drug Administration or any successor entity and its equivalent in other countries of the Territory, including, but not limited to, EMEA.

Regulatory Authority. Means the FDA in the United States, and the equivalent regulatory authority or governmental entity having the responsibility, jurisdiction, and authority to approve the manufacture, use, importation, packaging, labeling, marketing, and sale of pharmaceutical product, biological product, delivery systems, and medical devices in any country or jurisdiction outside of the United States.