definiens: of a Product means ( i ) a pharmaceutical product containing as the sole active ingredient(s ) an antibody ( or antibodies ) havingthe same primary sequence as the Antibody(ies ) in such Product, and which can be commercially soldwithout infringing a Valid Claim in a patent in the Collaborator Technology and/or Sponsored ResearchTechnology, or ( ii ) a biological product that, through reference to a Product that has already received regulatory approvalfrom the applicable Regulatory Authority ( with respect to such Product, a ), is eligiblefor Regulatory Approval in a country or jurisdiction pursuant to the least restrictive abbreviated follow - onbiological approval pathway established by the Regulatory Authority in such country or jurisdictionpursuant to laws ( as may be amended, or any subsequent or superseding law ) or otherwise is approved oreligible for Regulatory Approval in reliance, in whole or in part, on the prior Regulatory Approval of aReference Product or on the safety and efficacy data generated for the prior Regulatory Approval of aReference Product, including any biological product that ( a ) has been approved or would be eligible forapproval as a biosimilar or interchangeable product by the FDA pursuant to Section 351(k ) of the PublicHealth Service Act ( 42 U.S.C. 262(k ) ), as may be amended, or any subsequent or superseding law, statute orregulation, ( b ) has been approved or would be eligible for approval as a similar biological medicine productby EMA as described in CHMP/437/04, issued 30 October 2005, as may be amended, or any subsequent orsuperseding law, statute or regulation or ( c ) has otherwise obtained Regulatory Approval from a RegulatoryAuthority analogous to those regulatory approvals described in clauses ( a ) and ( b ) in this paragraph, including the FDA ’s approval of any ANDA or Section 505(b)(2 ) Application