definiens: means, with respect to any Licensed Product in a given country, anybiopharmaceutical product that is sold by a Third Party that is not a Sublicensee of [COMPANY] or its Affiliatesand such Third Party product ( a ) contains both ( i ) [ * * * ] or [ * * * ] that specifically binds to the Licensed Target, and(ii ) the same [ * * * ] and [ * * * ] as the relevant Licensed Product, or ( b ) ( i ) has been [ * * * ] as a [ * * * ] or [ * * * ] by FDApursuant to Section 351(k ) of the PHSA or any subsequent or superseding law, statute or regulation, ( ii ) has been [ * * * ] as a [ * * * ] by the European Medicines Agency pursuant to [ * * * ], as may be amended, or any subsequent orsuperseding law, statute or regulation, or ( iii ) has otherwise [ * * * ] in reliance on the prior approval of the * * * Certain information contained herein has been omitted and filed separately with the Securities andExchange Commission . Confidential treatment has been requested with respect to the omitted portions