definiens: means intravesical delivery for treatmen t of cancers of the urinary tract . The [ … * * * … ] that [ … * * * … ] ( x ) means, on a country - by - c ountry basis, the first sale of a Licensed Product in such country for use or consump tion by the general public ( following receipt of al l Regulatory Approvals that are required in order to sell such Licensed Product in such country ) and for which any of UroGen or its Affiliates or sublicensees has inv oiced sales of such Licensed Product in such countr y ; provided, however, that the following shall not con stitute a First Commercial Sale : ( a ) any sale to an Affiliate or sublicensee, unless such Affiliate or sublicensee i s the last Person in the distribution chain of the Licensed Product ; ( b ) any use of such Licensed Product in cl inical trials or non - clinical development activitie s ; or ( c ) any disposal or transfer of such Licensed Product for a bona fide charitable purpose, compassionate use, o r samples