definiens: shall mean, with respect to a given Product in a g iven country, the first commercial transfer or disposition for value of such Product by Provention or a Related Party to a Third Party ( other than a Related Party ) for end use or c onsumption of such Product in such country after re ceipt of Marketing Approval for such Product in such coun try, excluding, however, transfers or dispositions of Product, without consideration : ( i ) in connection w ith patient assistance programs ; ( ii ) for charitabl e or promotional purposes ; ( iii ) for preclinical, clinic al, regulatory or governmental purposes or under so -called or other limited access programs ; o r ( iv ) for use in any tests or studies reasonably n ecessary to comply with Applicable Law, regulation or reques t by a Regulatory Authority . For clarity, First Commercial Sale shall be determined on a Product - by -Product and country - by - country basis