definiens: means, on a Licensed Product - by - Licensed Product and country - by - country basis, the first sale by Licensee, or its A ffiliate or Sublicensee of such Licensed Product in such country for use or consumption by the general public ( follo wing receipt of all Regulatory Approvals that are r equired in order to sell such Licensed Product in such country ) and for which a Selling Party has invoiced sales of Licensed Products in the Territory ; provided, however, that the following shall not constitute a First Commerci al Sale : ( a ) any sale or transfer to an Affiliate or Sublice nsee, unless such Affiliate or Sublicensee is the l ast Person in the distribution chain of such Licensed Product ; or ( b ) any transfer for use of such Licensed Product in C linical Trials or non - clinical development activities with respect to such Licensed Product by or on behalf of a Selling Party, or transfer for use of such Licensed Product for a bona fide charitable purpose, compassionate use, named patient sales or samples