definiens: means the European Union as it is constituted as of the time of the relevant FirstCommercial Sale . For the purposes of this Section 3.3 only, the term shall mean the first saleby Company, its Affiliates or a sublicensee, whether at retail, wholesale or otherwise, of any Licensed Productfollowing 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 transfer or sale by Company to a sublicenseehereunder or by a sublicensee hereunder to another such sublicensee, unless any such sublicensee is the end user ofthe Licensed Product, in which case such transfer shall be deemed to be a Commercial Sale ; ( ii ) a transfer byCompany, or any Affiliate or any sublicensee hereunder, to a third party for purposes of clinical trials, as freesamples, or under compassionate use, patient assistance, named patient or other similar programs or studies wherethe Licensed Product is supplied and/or delivered without charge, or for other testing, or a commercially reasonablenumber of units of Licensed Product transferred for no consideration for marketing purposes ( e.g., samples ), but notfor resale by the third party ; ( iii ) the use of Licensed Product by Company or any of its Affiliates or sublicensees forresearch and development purposes ; or ( iv ) sales made to a distributor prior to commercial launch of a LicensedProduct, until the earlier of such time as Company recognizes the revenue for such transfers pursuant to US GAAP orsuch time as the distributor makes any sale of such Licensed Product