definiens: means, with respect to each Vaccine Composition, t he first sale for which revenue has been recognized by [COMPANY] or its Affi liates or Sublicensees to any Third Party for which all Regulatory Approvals ( including pricing and reimbur sement approvals ) that are legally required in orde r to sell such Vaccine Composition in such country have been granted ; in each case provided, however, that the following shall not constitute a First Commercial S ale : ( a ) any sale to an Affiliate or Sublicensee un less the Affiliate or Sublicensee is the last entity in the distribution chain of the Vaccine Composition, ( b ) any use of such Vaccine Composition in clinical trials ( includ ing post - Regulatory Approval clinical trials ), non- clinical development activities or other development activit ies with respect to such Vaccine Composition, or di sposal or transfer of such Vaccine Composition for a bona fid e charitable purpose, and ( c ) compassionate use