definiens: means, with respect to a Product, a biological product that : ( a ) ( i ) isbiosimilar to such Product based upon data derived from ( A ) analytical studies thatdemonstrate that such biological product is highly similar to such Product, ( B ) animalstudies, or ( C ) one or more clinical studies that are sufficient to demonstrate safety, purity, and potency in one or more Indications for which a BLA for such Product has beenapproved ; and ( ii ) utilizes the same mechanism of action as such Product ; or ( b ) ( i ) ( A)has the same amino acid sequence as the relevant Product, ( B ) in the United States, is,, or with respect to suchProduct as evaluated by the FDA, or ( C ) outside the United States, or to such Product, asdetermined by an applicable Regulatory Authority, and ( ii ) is not an Authorized Biosimilarof such Product ; where2 means any biological product that is sold under the BLA filed byNovartis or its Affiliate or sublicensee for such Product . A Product licensed or producedby [COMPANY] or its Affiliates or sublicensees will not constitute a Biosimilar Product