definiens: means the first sale of a Product by [COMPANY], or one of its Affiliates or their Sublicensees, to an unaffiliated third party after receipt of all Marketing Authorizations required to market and sell the Product have been ob tained in the country in which such Product is sold . Sales for purposes of testing the Product and sample purposes shall not be deemed a First Commercial Sale . Furthermore, for purposes of clarity, the term as used in this Agreement shall not include : ( i ) any distribution or other sale solely 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 wit hout charge or sold at or below cost ; ( ii ) intercompany transfers to Affiliates of [COMPANY] or between such entities and a Sublicensee of [COMPANY] or an Affiliate, provided a subsequent sale to an unaffiliated third party by such Affiliate of [COMPANY] or Sublicense e is not considered an intercompany transfer ; nor ( iii ) other similar non -commercial sales