definiens: means, with respect to a Product in a country, any product that ( a ) has Regulatory Approval for use in such country pursuan t to a regulatory process governing approval of generic, interchangeable or biosimilar pharmaceutical or biological product based on the then - current standards for regulatory approv al in such country, where such Regulatory Approval relied on or incorporated clinical data ge nerated by LICENSEE pursuant to this Agreement or was obtained using an abbreviated, exp edited or other similar process ; ( b ) during the Term, is not Controlled by LICENSEE ( in the case of Products Commercialized by LICENSEE, its Affiliates, or thei r Sublicensees ) under this Agreement, and ( c ) is sold in the same country as the relevant Product by a Third Party that is not a Sublicensee of LICENSEE ( in the case of Products Co mmercialized by LICENSEE, its Affiliates, or their Sublicensees ), and that did no t purchase such product in a chain of distribution that included LICENSEE, or of any of its respective Affiliates or Sublicensees