definiens: means, with respect to the Product in a particular country or jurisdiction, anypharmaceutical product that ( a ) ( i ) contains the same active pharmaceutical ingredients as the Product, in the sameformulation and dosage form as the Product, for intravaginal administration and is approved by the RegulatoryAuthority in such country ( for an indication in the Field ) ; or ( ii ) is approved by the Regulatory Authority in such countryor jurisdiction as a substitutable generic for the Product ( for an indication in the Field ) in a manner that relied on orincorporated data submitted by either Party or either of their Affiliates or sublicensees ( Sublicensees in the case ofAMAG ) in connection with the Regulatory Filings for the Product, including through an ANDA or 505(b)(2 ) NDA, or anyenabling legislation thereof ; and ( b ) is sold in such country or jurisdiction by a Third Party that is not a sublicensee(Sublicensees in the case of AMAG ) . Any product or component thereof ( including any Product or component thereof)licensed, marketed, sold, manufactured or produced by AMAG or its Affiliates or Sublicensees will not constitute aGeneric Product