definiens: means, on a Licensed Product - by - Licensed Product and Licensed DiagnosticProduct - by - Licensed Diagnostic Product basis, the first sale [ * * * ] by [COMPANY] or its Affiliates or Sublicensees for useor consumption by [ * * * ] of such Licensed 2 [ * * * ] Certain information in this document has been omitted and filed separately with the Securities andExchange Commission . Confidential treatment has been requested with respect to the omitted portions . Product ( or Licensed Diagnostic Product, as applicable ) in the ROW Territory for which [ * * * ] Regulatory Approvals [ * * * ] to sell such Licensed Product ( or Licensed Diagnostic Product, as applicable ) [ * * * ] have been granted ; in each case, provided, however, that the following shall not constitute a First License Sale : ( a ) any sale to an Affiliate orSublicensee unless the Affiliate or Sublicensee is the last entity in the distribution chain of the Licensed Product ( orLicensed Diagnostic Product, as applicable ) ; ( b ) any use of such Licensed Product or Licensed Diagnostic Product inClinical Trials, non - clinical development activities or other development activities with respect to such LicensedProduct or Licensed Diagnostic Product by or on behalf of a Party, or disposal or transfer of such Licensed Product orLicensed Diagnostic Product for a bona fide charitable purpose ; and ( c ) compassionate use, in each case for which nopayment is received by [COMPANY], its Affiliates or Sublicensees