definiens: means, with respect to a Licensed Product in any country in the Territory, the first commercial sale in an arms - len gth transaction of such Licensed Product to a Third Party by or on behalf of a Party, its Affiliate or sublicensee in such country following receipt of applicable Reg ulatory Approval of such Licensed Product in the Field in s uch country ; provided, however, that First Commerci al Sale shall not include any transfer of a Licensed Produc t ( i ) between or among a Party and its Affiliates o r sublicensees or ( ii ) for purposes of [ … * * * … ] or the like . 4 1.24 means an investigational new drug application, cl inical trial application, or similar application, filed with, and accepted by, a Regulat ory Authority in any country or group of countries prior to beginning Clinical Trials in that country or in tha t group of countries