definiens: shall mean the technical, medical and scientific licenses, registrations, authorizations and approvals ( including, without limitation, approvals of New Drug Applications ( ), investigational new drug applications ( ), supplement s and amendments, pre - and post - approvals, pricing approvals, and labeling approvals ) of any national, supra - national, 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 . If an explicit regulatory approval as defined above is not required, then shall mean all the regulatory requirements to penn it the above cited activities must be met, as confirmed by [COMPANY] through review of the related data and documentation . For the sake of clarity, Regulatory Approval shall not be deemed to have been obtained in a country until any applicable governmental pricing and governmental reimbursement approvals have also been obtained in such country