definiens: means, with respect to a Licensed Product on a co untry - by - country basis, the first ( 1st ) sale by JJEI or its Affiliates, Sub licensees, or, with respect to a Generic Equivalent, the first ( 1st ) sale by a Third Party, in each case, in an arms - len gth transaction to a Third Party ( other than a Subl icensee ) for use or consumption by the general public of that Li censed Product or Generic Equivalent in a country a fter all required Regulatory Approvals for commercial sale o f that Licensed Product or Generic Equivalent have been obtained in such country . A sale of a Licensed CONFIDENTIAL INFORMATION 5 Product for : ( i ) Clinical Trial purposes ; ( ii ) comp assionate use, named patient sales, or patient assi stance programs ; ( iii ) similar uses in a limited number to support Regulatory Approvals, such as test marketi ng programs or other similar programs or studies ( prov ided that the Licensed Product is not otherwise gen erally available for purchase in such country ) ; or ( iv ) ea rly access programs, in each case ( ( i ) – ( iv ) ), wil l not constitute a First Commercial Sale of such Licensed Product . I n addition, sales of a Licensed Product by and betw een JJEI and its Affiliates or Sublicensees will not constit ute a First Commercial Sale