definiens: means with respect to a Product, the date of firs t shipment or sale of such Product ( in either case when [COMPANY], its Affiliate or Sublicens ee can recognize revenue in accordance with IFRS or GAAP ) to a Third Party ( other than to an Affiliate or Sub licensee for resale ) in such country for end use or consumption of the Product in such country after Market Approva l in such country is obtained or sales are permitte d by applicable Law, and excluding, however, any shipmen t, sale or invoicing or other distribution of the P roduct for use in ( a ) a clinical trial, compassionate use, nam ed patient programs, sales under a treatment Regula tory Filing, test marketing, or any non - registrational studies o r ( b ) any similar instance, in each case ( a ) and ( b ), where the Product is supplied at or below a Party ’s cost of g oods ( or otherwise not for profit ) shall not, in ea ch case of ( a ) or ( b ), constitute