definiens: means, on a Product - by - Product and country - by - country basis, any pharmaceutical product soldby a Third Party, other than as a sublicensee to this Agreement that:(a ) contains the same active ingredients as the applicable Product, in the same dosage form ( e.g., oral ) as the applicable Product;or ( b ) is A / B Rated with respect to such Product or otherwise approved by the Regulatory Authority in such country as asubstitutable generic for such Product ; or ( c ) is approved in the applicable field by a Regulatory Authority pursuant to an NDA filedby a Third Party under Section 505(b)(2 ) or 505(j)(2 ) of the FFDCA ( or an equivalent Regulatory Approval Application filed outsidethe U.S. ), contains the active ingredients in the Product, and relies on the finding of safety and/or effectiveness in the RegulatoryApproval of the Product . For the purposes of this definition, means, inside the U.S., as determined by the FDA, applying the definition of9 CONFIDENTIAL TREATMENT REQUESTEDCertain information in this document has been omitted and filed separately with the Securities and Exchange Commission