definiens: means the technical, medical and scientific licenses, registrations, authorizations and approvals ( including, without limitation, approvals of Drug Approval Applications, supplement s and amendments, pre - and post - approvals, Pricing Approvals, and labeling approvals ) of any national, supra - nationa l, regional, state or local regulatory agency, department, bureau, commission, councilor other govenunental entity, necessary for the commercial Manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of Product(s ) in a regulator y jurisdiction in the Field, in the Territory . [ For the sake of clarity, Regulatory Approval shall not be deemed to have been [ * J obtained in a country other than the United States until any applicable Pricing Approvals have [ * J also been obtained in such country . Regulatory Approval of a Product shall be deemed to have [ * J been obtained in the United States immediately upon approval of Drug Approval Application for [ * J such Product in the United States ] . [ * J 1.117 means any national ( e.g., FDA ), supra - national ( e.g., the European Commission, the Council of the European Union, or the European Agency for the Evaluation of Medicinal Products ) ; regional, state or local regulatory agency, department, bureau, commission, councilor other governmental entity in each country of the Territory that 16 ' Confident ial Treatment Requested