definiens: means, for any product, and on a country - by - country basis in each country in which that product is sold, the first arm's - length sale to a Third Party for use or consumption by an end - user ( e.g., a physician ) of that product in that country, after obtaining Regulatory Approval of that product in that country . A First Commercial Sale shall not include a sale of any product for use in clinical trials, for research or for other non­commercial uses, or supply of a product as part of a compassionate use or similar program . For purposes of this Agreement, means all necessary approvals ( including supplements, amendments, pre - and post - approvals, pricing and reimbursement approvals ), licenses, registrations or authorizations of any national, supra - national ( e.g., the European Medicines Evaluation Agency ), regional, state or local regulatory agency, department, bureau, commission, councilor other governmental entity, have been obtained for the manufacture, distribution, use or sale of that product in a regulatory jurisdiction