definiens: means, with respect to the Product, any pharmaceut ical product that : ( a ) has received all necessary approvals by the applica ble Regulatory Authorities in such country to marke t and sell such product as a pharmaceutical product, including required pricing ; ( b ) is marketed or sold by a Thi rd Party that has not obtained the rights to market or sell such product as a licensee, sublicensee or distributor o f Revance or Fosun or any of their respective Affiliates, licens ees or sublicensees with respect to the Product ; ( c ) is highly similar to the Product notwithstanding minor differ ences in clinically inactive components ; ( d ) has no clinically meaningful differences from the Product in terms of safety, purity, and potency ; and ( e ) is approved a s ( i ) a ( in the United States ) of the Product, or ( ii ) if not in the US, the foreign equivalent o f a of the Product in the Territory ; in each case for u se in such country pursuant to an expedited regulat ory approval process governing approval of generic biologics bas ed on the then - current standards for regulatory app roval in such country ( e.g., the BPCIA Act or an equivalent under foreign law ) and where such Regulatory Approval was based in significant part upon clinical data genera ted by Revance, Fosun or their respective Affiliate s or Sublicensees with respect to the Product