definiens: shall mean, ( i ) with respect to a Licensed Product that is a pharmaceutical product ( a ) in the United States, any pharmaceutical product that is approved by the FDA and determined by the FDA to be therapeutically equivalent to the Licensed Product, as evidenced by a therapeutic equivalence code published in the Orange Book, or ( b ) in any other country or jurisdict ion, any other pharmaceutical product that is recognized by the applicable Regulatory Authority in such country or jurisdiction as a generic drug or therapeutically equivalent to such Licensed Product, and ( ii ) with respect to a Licensed Product that is a device ( a ) in the United States, any device product that is approved by the FDA pursuant to a 510(k ) or a Premarket Approval ( PMA ) premarketing authorization and determined by the FDA to be substantially equivalent to the Licensed Product, as evidenced in the FDA ’s database of or applicable pricing compendium, or ( b ) in any other country or jurisdiction, any other device product that is recognized by the applicable Regulatory Authority in such country or jurisdiction as a g eneric device product or substantially equivalent to such Licensed Product, that, in the case of each of ( i ) and ( ii ) above, ( A ) has the same active ingredient(s ), administration route, dosage form and strength as such Licensed Product and ( B ) is offered f or sale or sold in such country or jurisdiction by a Third Party that is not a Sublicensee . Any product or component thereof ( including any Licensed Product or component thereof ) licensed, marketed, sold, manufactured or produced by a Party or its Affiliat es or Sublicensees will not constitute a Generic Product