definiens: sha ll mean, with respect to a Collaboration Product, any pharmaceutical product in the United S tates that : ( i ) contains the same active pharmaceutical ingredient as the Collaboration Prod uct ; ( ii ) is approved by the FDA in reliance, in whole or in part, on the prior Drug Approval of suc h Collaboration Product ( e.g., pursuant to 21 U.S.C. 355(b)(2 ), an abbreviated new drug applicati on ( ANDA ) pursuant to 21 U.S.C. § 355(j ), a separate NDA, compendia listing, other Drug Approva l Application or otherwise, including foreign equivalents of the foregoing ) ; ( iii ) has one or mor e Governmental or Regulatory Authority - approved indications in the United States equivalen t to the Governmental or Regulatory Authority - approved indication for such Product in the United States ; ( iv ) is bioequivalent to such Collaboration Product as determined by the FDA ; and ( v ) is sold in the United States by a Third Party that ( a ) is not a licensee or sublicensee of [COMPANY] or its Affiliates or any of their licensees o r sublicensees, ( b ) has not obtained such product fro m a chain of distribution including [COMPANY], its Affiliates or any of their licensees or sublicensee s, and ( c ) is not otherwise authorized by [COMPANY] or any of its Affiliates, licensees, sublicensees or d istributors to sell such product