definiens: means, with respect to a Product, the first sale forwhich revenue has been recognized by PTC or its Affiliates or Sublicensees for use orconsumption by the general public of such Product in any country in the PTC Territory for whichall Regulatory Approvals and pricing or reimbursement approvals that are legally required inorder to sell such Product in such country have been granted ; in each case provided howeverthat the following shall not constitute a First Commercial Sale:(a)any sale to an Affiliate or Sublicensee unless the Affiliate or Sublicenseis the last entity in the distribution chain of the Product;(b)any use of such Product in Clinical Trials, non - clinical Developmentactivities or other Development activities with respect to such Product by or onbehalf of a Party, or disposal or transfer of such Product for a bona fide charitablepurpose ; and(c)any transfer for non - clinical or clinical studies, patient - assistanceprograms, charitable donations or compassionate use purposes