definiens: means, with respect to a Product, a biological product that : ( I ) ( a ) is biosimilar to such Product based upon data derived from ( i ) analytical studies that demonstrate that such biological product is highly similar to sLlch Product, ( ii ) animal studies, or ( iii ) 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 been approved ; and ( b ) utilizes the same mechanism of action as such Product ; or ( 2 ) ( a ) ( I ) in the United States, is or with respect to such Product as evaluated by the FDA and ( ii ) outside the United States, or to such Product, as determined by an applicable Regulatory Authority, and ( b ) is not an Authorized Generic Version of such Product ; where means any biological product that is sold under the BLA filed by [COMPANY] or its an Affiliate or sublicensee for such Product . A Product licensed or produced by [COMPANY] or its Affiliates will not constitute a Biosimilar Product