definiens: means ( i ) with respect to the United States, the first sale of the Product byEgalet in an arm ’s length sale for use or consumption by the general public of such Product in the United States and(ii ) with respect to other countries in the Territory, the first sale of such Product in such country in an arm ’s lengthsale after the application or submission required to market the Product in such country has received the relevantRegulatory Approvals, provided however that the following shall not constitute a First Commercial Sale : ( a ) any sale to an Affiliate or sublicensee unless the Affiliate or sublicensee is the lastentity in the distribution chain of the Product ; ( b ) any use of such Product in clinical trials ( including post - Regulatory Approval clinicaltrials ), non - clinical development activities or other development activities with respect to suchProduct, or disposal or transfer of Products for a bona fide charitable purpose ; and ( c ) compassionate use