definiens: shall mean the technical, medical and scientific licenses, registrations, authorizations and/ or approvals of the Licensed Product ( including the prerequisite manufacturiilg approvals or authorizations, marketing authorization based UPOIl such approvals and pricing, third party reimbursement and labeling approvals related thereto ) that are required by any national, supra - national ( e.g., the European Commission or the Council of the European Union ), regional, state or local regulatory agency, department, bureau or other governmental entity in the Territory, for the Manufacture, distribution, use or sale of Licensed Product in the Territory, as amended or supplemented from time to time . With respect to the United States, the term Health Registrations shall include, without limitation, an or a as defined in 21 C.F.R. pt . 312 and 21 C.F.R. pt . 314 respectively, for the Licensed Product, as amended or supplemented from time to time