definiens: means a pharmaceutical product which, with respec t to a Licensed Product ( a ) has been licensed as a biosimilar or interchang eable product by the FDA pursuant to Section 351(k ) of the Public Health Service Act ( 42 U.S.C. § 262(k ) ), as may be amended, or any subsequent or superseding la w, statute or regulation, ( b ) has been authorized as a similar biological medicinal product in the EU pursuant to Directive 2001 / EC/83, as may be amended, or any subsequent or superseding law, statute or regulation, or ( c ) has otherwise 3 CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FRO M THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETI TIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED . OMISSIONS ARE IDE NTIFIED AS [ * * * ] achieved analogous regulatory approval based upon r eference to a Licensed Product from another applica ble Regulatory Authority