definiens: means the European Union as it is constituted as of the time of the relevant First Commercial Sale . For the purposes of this Section 3 .1 only, the term shall mean the first sale by Company, its Affiliates or a sublicen see, whether at retail, wholesale or otherwise, of any Licensed Product following marketing approval in the country of sale to a third party that is not an Affiliate or a sublicensee ( a ) . The following are not Commercial Sales : ( i ) a trans fer or sale by Company to a sublicensee hereunder or by a sublicensee here under to another such sublicensee, unless any such sublicensee is the end user of the Licensed Product, in which case such transfer shall be deemed to be a Commercial Sale ; ( ii ) a transfer by Company, or any Affiliate or any sublicensee hereunder, to a third party for purposes of clinical trials, as free samples, or un der compassionate use, patient assistance, named pa tient or other similar programs or studies where the Licensed Prod uct is supplied and/or delivered without charge, or for other testing, or a commercially reasonable number of uni ts of Licensed Product transferred for no considera tion for marketing purposes ( e.g., samples ), but not for res ale by the third party ; ( iii ) the use of Licensed P roduct by Company or any of its Affiliates or sublicensees fo r research and development purposes ; or ( iv ) sales made to a distributor prior to commercial launch of a Licensed Product, until the earlier of such time as Company recognizes the reve nue for such transfers pursuant to US GAAP or such time as the distributor makes any sale of such Licensed Pro duct