Regulatory Authority(ies)

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

Regulatory Authority(ies). Any governmental authority in a country or region that regulates the manufacture or sale of Company's products, including, but not limited to, the United States Food and Drug Administration.

Regulatory Authority(ies). The regulatory entities with regulatory authority over the manufacture, storage, testing, or use of pharmaceutical products (including the Product), as well as any successor entity thereto, in the Territory. In the United States, "Regulatory Authority" includes the FDA. In the European Union, "Regulatory Authority" includes the EMA. In Canada, "Regulatory Authority" includes the Canadian Therapeutic Products Directorate. In Japan, "Regulatory Authority" includes the PMDA.