definiens: means the first sale of a Product by [COMPANY] or its Affiliates or their Sublicensees to a Third Party ( excluding any Sublicensee ) for end use or consumption of such Product in a given country after Regulatory Approval required to market and sell the Product has been granted with respect to such Product in such country i n which such Product is sold . Furthermore, for purposes of clarity, the term as used in this Agreement shall not include : ( a ) sales for purposes of testing any Product, or of any Product samples ; ( b ) any distribution or other sale s olely for so -called treatment investigational new drug sales, named patient sales, compassionate or emergency use sales or pre -license sales, in each case provided that such Product is distributed without charge or sold at or below cost ; ( c ) any sale of a Product by [COMPANY] to its Affiliate ( or their Sublicensees ), unless there is a subsequent resale of the Product by such Affiliate or Sublicensee ; nor ( d ) other similar non -commercial sales