definiens: shall mean any approv als, product and/or establishment licenses, registrations, permits, or authorizations of any fe deral, state or local regulatory agency, department, bureau or other governmental entity or Regulatory Authority, necess ary for the manufacture, distribution, use, storage, importation, export, transport and sale of the Prod uct in a regulatory jurisdiction . 1.39 shall mean any natio nal, supra - national ( e.g., the European Commission, the Council of the European Union, or t he EMA ), regional, state or local regulatory agency, department, bureau or other governmental entity in the Territory responsible for issuing any technical, medical and scientific licenses, registrations, authorizati ons and/or approvals of the Product including any m arketing authorizations based upon such approvals and pricin g, third party reimbursement or labeling approvals that are necessary for the manufacture, distribution, use, s torage, importation, export, transport and sale of the Product in a regulatory jurisdiction