definiens: means, on a Licensed Product - by - Licensed Product and country - by - country basis, the first sale of such Licensed Prod uct in such country for use or consumption by the g eneral public ( following receipt of all Regulatory Approva ls that are required in order to sell such Licensed Product in such country ) and for which any of [COMPANY] or its Af filiates or Sublicensees has invoiced sales of Lice nsed Products in the Territory ; provided, however, that the following will not constitute a First Commercia l Sale : ( a ) any sale to an Affiliate or Sublicensee, unless such Affiliate or Sublicensee is the last Person i n the distribution chain of the Licensed Product ; ( b ) any use of such Licensed Product in Clinical Trials or non - clinical development activities with respect to such License d Product by or on behalf of a Party ; or ( c ) any di sposal or transfer of such Licensed Product for a bona fide c haritable purpose, compassionate use or samples