definiens: means, on a Co - Co Product - by - Co - Co Product basis, the first sale for which revenue has been recognized by a Party or its Affiliates or Sublicensees in accordance with Acco unting Principles consistently applied for use or consumpt ion by the general public of such Co - Co Product in a country for which all Regulatory Approvals that may be lega lly required in order to sell such Co - Co Product in such country have been granted ; in each case, provided, however, that the following shall not constitute a First Co - Co Sale : ( a ) any sale to an Affiliate or Sublicensee of a Party unless the Affiliate or Sublicensee is t he last entity in the distribution chain of the Co - Co Product ; ( b ) an y use of such Co - Co Product in Clinical Trials, non -clinical development activities or other development activit ies with respect to such Co - Co Product by or on beh alf of a Party, or disposal or transfer of such Co - Co Produc t for a bona fide charitable purpose ; and ( c ) compa ssionate use, in each case for which no payment is received by a Party, its Affiliates or Sublicensees