Regulatory Authority

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. Any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in the Territory

Regulatory Authority. Means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to a product.

Regulatory Authority. Any and all bodies and organizations regulating the manufacture, importation, marketing, distribution, use and sale of any of the Products in the Territory.

Regulatory Authority. Any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the marketing and sale of a medical device or pharmaceutical product in the Territory

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 the FDA, MHRA, EMA and any other similar regulatory authorities as may be agreed upon in writing by the Parties.

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. Any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council or other entities (e.g., FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated under this Agreement.