Regulatory Authority

Regulatory Authority. Means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing or sale of a Radius study drug that becomes subject to a Work Statement, including the FDA and EMEA.

Regulatory Authority. 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 pharmaceutical products before such pharmaceutical product may be tested, marketed, promoted, distributed or sold in such country, including such governmental bodies that have jurisdiction over the pricing of such pharmaceutical product. The term 'Regulatory... Authority' includes the KFDA, the FDA, and the European Agency for the Evaluation of Medicinal Products or EMEA View More

Regulatory Authority. Those agencies or authorities responsible for regulation of Product as described within the Product Master Plan

Regulatory Authority. Means Governmental Authority with responsibility for granting Regulatory Approvals in a particular jurisdiction, including, without limitation, the FDA, and where applicable any ethics committee or any equivalent review board.

Regulatory Authority. The U.S. or foreign government agency or health authority that regulates and grants recommendations for approvals for the manufacture and sale of pharmaceutical products.

Regulatory Authority. Shall mean, with respect to a country in the Territory, any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval including Market Clearance for such country or countries.

Regulatory Authority. The United States Food & Drug Administration or any agency, commission, official or other instrumentality of any federal, state, county, city or other political subdivision, domestic or foreign, that performs a function for such territory or political subdivision similar to the function performed by the FDA for the United States, with regard to the approval, licensing, registration or authorization to test, manufacture, promote, market, distribute, use, store, import, transport or sell a... pharmaceutical product in such territory or political subdivision. View More

Regulatory Authority. The term "Regulatory Authority" shall mean the principal governmental organization or agency that has the right to approve the sale and, if applicable price, of Products in a given country, including, without limitation, the FDA, the EMEA and the Ministry of Health, Labour and Welfare in Japan.

Regulatory Authority. Any Governmental Entity in any country of the Territory competent to approve pharmaceutical products for manufacturing, marketing, distribution and sale in any country of the Territory and/or to approve the price for pharmaceutical products to be sold in any country of the Territory

Regulatory Authority. Any local, state, or federal regulatory authority having jurisdiction or exercising regulatory or similar oversight with respect to Lender, CSO, or Third Party Service Providers (except that nothing herein shall be deemed to constitute an acknowledgement by any party hereto that any Regulatory Authority has jurisdiction or exercises regulatory or similar oversight with respect to the Loans, the Program or any party hereto with respect to the performance of their respective obligations... hereunder). View More