definiens: means : ( a ) with respect to each Licensed Product, the first sale for which revenue has beenrecognized by [COMPANY] or its Affiliates or Sublicensees for use or consumption by the general public of such Licensed Product inany country in the Territory for which all Regulatory Approvals and pricing or reimbursement approvals that are legallyrequired in order to sell such Licensed Product in such country have been granted ; and ( b ) with respect to each Royalty - Bearing EPIZYME Product, the first sale for which revenue has been recognized by EPIZYME or its Affiliates or Sublicenseesfor use or consumption by the general public of such Royalty - Bearing EPIZYME Product in any country in the Territory forwhich all Regulatory Approvals and pricing or reimbursement approvals that are legally required in order to sell suchRoyalty - Bearing EPIZYME Product in such country have been granted ; in each case provided however that the followingshall not constitute a First Commercial Sale:(i ) any sale to an Affiliate or Sublicensee unless the Affiliate or Sublicense is the last entity in thedistribution chain of the Licensed Product or Royalty - Bearing EPIZYME Product, as applicable;(ii ) any use of such Licensed Product or Royalty - Bearing EPIZYME Product, as applicable, in ClinicalTrials, non - clinical Development activities or other Development activities, or disposal or transfer of Licensed Products orRoyalty - Bearing EPIZYME Products, as applicable, for a bona fide charitable purpose ; and(iii ) compassionate use