definiens: means, with respect to a Product on a country - by- country basis, the first sale by [COMPANY] or its Affiliates Sublicensees or, with respect to a Generic Product, the first sale by a T hird Party, in each case, in an arms - length transaction to a Third Party ( other than a Sublicensee ) for use or consumption by the general public of that Product o r Generic Product in a country after all required Regulatory Approvals for commercial sale of that Pr oduct or Generic Product have been obtained in such country . A sale of a Product for : ( a ) clinical study purposes ; ( b ) compassionate use, named patie nt sales or patient assistance programs ; ( c ) similar u ses in a limited number to support Regulatory Approvals, such as test marketing programs or other similar programs or studies ( provided that the Product is not otherwise generally available for pu rchase in such country ) ; or ( d ) early access progra ms, in each case ( ( a ) — ( d ) ), will not constitute a Fir st Commercial Sale of such Product . In addition, sa les of a Product by and between [COMPANY] and its Affilia tes or Sublicensees will not constitute a First Commercial Sale