definiens: means, with respect to a parti cular 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 pharmaceuti cal or biological product based on the then - current standards for regulatory approval in such country, where such regulatory approval relied on or incorporated clinical data generated by either Part y to this Agreement or their Affiliates or licensee s, or was obtained using an abbreviated, expedited, or ot her similar process ; ( b ) during the Royalty Term, is not owned or licensed by [COMPANY] under this Agreement ; and ( c ) is sold in the same country as the relevant Product by a Third Party that is not a sublicensee or Affiliate of [COMPANY], and that did not purchas e such product in a chain of distribution that included re sTORbio, or its Affiliates or its or their sublicen sees