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

“Regulatory Authority” means any government regulatory authority responsible for granting approvals for the performance of Services under this Agreement or for issuing regulations pertaining to the Manufacture and/or use of Product in the intended country of use, including the FDA.

“Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the marketing and/or pricing of a pharmaceutical product in a country or regulatory jurisdiction including the FDA, and foreign equivalents thereof,

“Regulatory Authority” means the FDA or any comparable Governmental Authority that is concerned with the safety, efficacy, reliability, manufacture, sale, advertising, promotion, reimbursement, import, export or marketing of medical products.

“Regulatory Authority” means any national (e.g., the FDA), supra-national (e.g., the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, in any jurisdiction of the world that grants Marketing Approval.

“Regulatory Authority” means the FDA, and/or any successor official body, whose approval is required by Applicable Law to Market, manufacture, test and/or Package a Product in any jurisdiction in the Territory.

“Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval or, to the extent required in such country or regulatory jurisdiction, pricing or reimbursement approval of a Product in such country or regulatory jurisdiction, including # the FDA, # the EMA and # the European Commission or its successor.

“Regulatory Approval” means any and all approvals or authorizations of a Regulatory Authority with respect to any jurisdiction, including pricing approvals that are necessary for the commercial manufacture, distribution, use, marketing or sale of a Product in such jurisdiction.

“Regulatory Authority” means, with respect to a country in the Territory, any national (e.g., the FDA), 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 Authority involved in the granting of a Regulatory Approval, for biopharmaceutical products in such country.