definiens: means, with respect to a particular Product in a particular country which has received Regulatory Approval in the applicable country, a pharmaceutical product including any biological pro duct ( a ) that ( i ) has been approved as a biosimilar or interchangeable product by the FDA pursuant to Sect ion 351(k ) of the Public Health Service Act ( 42 U.S .C. § 262(k ) ), ( ii ) has been approved as a similar biolog ical medicine product by the EMA as described in CHMP/437/04, issued 30 October 2005, or ( iii ) has o therwise obtained regulatory approval from a Regula tory Agency analogous to those Regulatory Approvals desc ribed in the foregoing clauses ( i ) or ( ii ), ( b ) tha t is approved for use in such country pursuant to a regu latory approval process governing approval of gener ic, interchangeable or biosimilar biologics of such Pro duct based on the then - current standards for regula tory approval in such country, including as based upon t he studies described in clause ( a ) above and ( c ) th at is sold in the same country as such Product by any Third Party that is not a sublicensee of [COMPANY] or its Affiliat es and did not purchase such pharmaceutical product in a chain of distribution that included any of [COMPANY], its Affili ates or their sublicensees