definiens: shall mean, on a country - by - country basis, the da te of the first arm ’s length transaction, transfer or disposition f or value to a Third Party of a Licensed Product by or on behalf of Licensee or any Affiliate or Sublicensee of Lice nsee in such country, excluding, however, transfers or dispositions of Licensed Product, without considera tion : ( i ) in connection with patient assistance pro grams ; ( ii ) for charitable or promotional purposes ; ( iii ) for precl inical, clinical, regulatory or governmental purpos es or under so - called or other limited access prog rams ; or ( iv ) for use in any tests or studies reaso nably necessary to comply with Applicable Laws, or request by the F DA or any Foreign Regulatory Authority . For clarity, First Commercial Sale shall be determined on a Licensed P roduct - by - Licensed Product and country - by - country b asis