definiens: shall mean with resp«t to a PRODUCT lila country, 1 M initial transfer of a ProduCl billed or invoiced by P&GP ( or one of its AFFILIATES or sublicensees ) to a nan·sublicensee Third Party in such country after all required REGULATORY APPROVALS havehcen granted by the REGULATORY AUTHORITY of such country . Sales in such country for clinical srudy purpose ! ! or compassionate, named palicnt use or under treatment IND programs or similar uses will nOI conSlilLile a FIRST COMMERC IAL SALE in such counlry . means an Investigational Nt - ow Drug application, Clinical Study Application or Clinical Trial Exemption ( as such terms are defined by the FDA ), or any similar application or 5ubmiS5ion for approval 10 conduct hwnan clinical investigations in accordance : wilh applicable regulDlions and requiremenlS oflhe FDA or the corresponding Regulatory Authority in any jurisdiction outside the United States