Regulatory Authority

Regulatory Authority. Means any applicable governmental authority responsible for granting Regulatory Approvals or pricing approvals for Licensed Products, including the FDA, the European Medicines Agency and any corresponding national or regional regulatory authorities.

Regulatory Authority. Means any agency or authority responsible for regulation of Client Product in the United States, including the FDA. If Cytovance agrees to manufacture Client Product in accordance with EMA regulations, then "Regulatory Authority" also includes the EMA.

Regulatory Authority. Means any international, national or other governmental, regulatory or administrative authority or other body competent to grant, maintain and extend approvals, registrations or other consents for the Manufacturing, importation, marketing, distribution or sale of pharmaceutical products and APIs, including without limitation the Products.

Regulatory Authority. The meaning set forth in the License Agreement

Regulatory Authority. Means, in respect of a particular country or jurisdiction, the governmental authority (any court, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision) having responsibility for granting in such country or jurisdiction Orphan Drug Designations and any other necessary regulatory approval, authorization, permit, or license to test, manufacture, market, sell, export, label, and for Medicare or insurance reimbursement of,... Licensed Product; including, the European Medicines Agency of the European Union ("EMA"), the Therapeutic Goods Administration of Australia ("TGA"), and the Ministry of Health, Labour and Welfare of Japan. View More

Regulatory Authority. Any applicable Governmental Authority involved in granting Regulatory Authorization in any country or jurisdiction, including Without limitation, in the U.S., the FDA and any other applicable Governmental Authority having jurisdiction over the Life Cells or over Licensee Products

Regulatory Authority. Means any national, supra national, regional, state or local regulatory authority, department, bureau, commission, council or other governmental authority (including the FDA) that is responsible for overseeing the development, testing, use, making, transport, storage or commercialization of a product or service.

Regulatory Authority. Shall mean any regulatory agency, ministry, department or other governmental body having authority in any country or region to control the development, manufacture, marketing, and sale of pharmaceutical products, including the FDA.

Regulatory Authority. A federal, national, multinational or other regulatory agency or governmental entity involved in the granting of marketing approval for a pharmaceutical product in a country (e.g., the FDA).

Regulatory Authority. The Federal Deposit Insurance Corporation and any local, state, or federal regulatory authority having jurisdiction or exercising regulatory authority or similar oversight with respect to Bank, RLPC, MEGA, Mid-West, UFC2, or Servicers.