definiens: means, with respect to a given Licensed Product i n a particular country in the Territory, a pharmaceutical product that ( a ) is app roved for use in such country pursuant to a Regulat ory Approval process governing approval of a generic or interchangeable product of such Licensed Product b ased on the then - current standards for Regulatory Approval in such country, whether or not such Regulatory App roval was based upon clinical data generated by the Parti es pursuant to this Agreement or was obtained using an abbreviated, expedited or other process, and ( b ) is sold in the same country as such Licensed Product by any Third Party that is not a Sublicensee ( other than a Sublicensee that has been granted a sublicense to any [COMPANY] IP by [COMPANY] solely in connection with any settlement ) and did not purchase such pharmaceutical product i n a chain of distribution that included any of [COMPANY], its Af filiates or its or their Sublicensees