. “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 applicable government regulatory authority involved inresponsible for granting approvals for the manufacturing and marketingperformance of a Product, including,Services under this Agreement or for issuing regulations pertaining to the Manufacture and/or use of Product in the United States,intended country of use, including the FDA.

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

“Regulatory Authority” means the FDA or any applicable government regulatory authority involved in granting approvals forcomparable Governmental Authority that is concerned with the manufacturing andsafety, efficacy, reliability, manufacture, sale, advertising, promotion, reimbursement, import, export or marketing of a Product, including, in the United States, the FDA.medical products.

“Regulatory Authority” means any applicable governmentnational (e.g., the FDA), supra-national (e.g., the EMA), regional, state or local regulatory authority involvedagency, department, bureau, commission, council or other governmental entity, in granting approvals forany jurisdiction of the manufacturing and marketing of a Product, including, in the United States, the FDA.world that grants Marketing Approval.

“Regulatory Authority” means the FDA, and/or any applicable government regulatory authority involvedsuccessor official body, whose approval is required by Applicable Law to Market, manufacture, test and/or Package a Product in granting approvals for the manufacturing and marketing of a Product, including,any jurisdiction in the United States, the FDA.Territory.

“Regulatory Authority” meansmeans, in a particular country or regulatory jurisdiction, any applicable government regulatory authorityGovernmental Authority involved in granting approvals forRegulatory Approval or, to the manufacturing and marketingextent required in such country or regulatory jurisdiction, pricing or reimbursement approval of a Product, including,Product in such country or regulatory jurisdiction, including # the United States,FDA, # the FDA.EMA and # the European Commission or its successor.

“Regulatory Approval” means any applicable government regulatory authority involved in grantingand all approvals or authorizations of a Regulatory Authority with respect to any jurisdiction, including pricing approvals that are necessary for the manufacturing andcommercial manufacture, distribution, use, marketing or sale of a Product, including,Product in the United States, the FDA.such jurisdiction.

“Regulatory Authority” meansmeans, with respect to a country in the Territory, any applicable governmentnational (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 authorityagency, department, bureau, commission, council or other Governmental Authority involved in granting approvals for the manufacturing and marketinggranting of a Product, including,Regulatory Approval, for biopharmaceutical products in the United States, the FDA.such country.