definiens: means with respect to milestone 5, with respect to a particular Licensed Product, the first commercial sale in an arms -length transaction of such Product by COMPANY, its Affiliates or its Sublicensees to a Third Party in a country in the Territory after receipt of all regulatory approvals ( including without limitation, pricing approvals ) for such Licensed Product in such country, provided, however, that the First Commercial Sale shall not include any transfer of a Licen sed Product ( i ) between or among COMPANY and its Affiliates or its Sublicensees for resale to a Third Party, or ( ii ) Licensed Products sold or distributed for clinical studies, compassionate use, named patient programs, sales under a treatment IND, non -registrational studies or other circumstances where any Licensed Product(s ) are sold at cost or supplied without charge, such as promotional samples, or donations ( e.g., to not for profit institutions for non -commercial purposes )