definiens: shall mean the technical, medical and scientific licenses, registrations, authorizations and approvals ( including, without limitation, approvals of New Drug Applications ( ) or Biologic License Applications ( ), supplements 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 governmental entity, necessary for the commercial Manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of Licensed Product(s ) in a regulatory jurisdiction in the Territory . For the sake of clarity, Regulatory Approval shall not be deemed to have been obtained in a country other than the United States until any applicable governmental pricing approvals have also been obtained in such country . Regulatory Approval of a Licensed Product shall be deemed to have been obtained in the United States immediately upon BLA approval for such Licensed Product in the United States