definiens: shall mean all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport and sale of a Product in a regulatory jurisdiction . shall be deemed to occur upon frrst receipt of notice from a Regulatory Authority that a Product has been appro\ed for commercial sale . For countries where governmental approval is required for pricing or for the Product to be reimbursed by national health insurance ( i.e., other than the United States ), shall not be deemed to occur until such pricing or reimbursement approval is obtained . Marketing Approval shall be deemed to have occurred in such a country where government approval of pricing or reimbursement has not been obtained if, at any time, the Party begins the commercial sale of such Product in the country without obtaining pricing approval or reimbursement, with the date of such Marketing Approval to be deemed to occur on the date of the First Commercial Sale of the Product in the country