definiens: means, with respect to any Licensed Product in a particular country in the Territory, any Gene Therapy Product that ( a ) is marketed for the prevention, treatmen t or cure of Hemophilia B and sold by a Third Party that is not a Sublicensee of, or a Third Party Distributor for, Partner or any of its Affiliates ( and such Gene The rapy Product is not otherwise licensed, supplied, o r otherwise permitted or marketed by a Party or its Affiliates or Sublicensees ), ( b ) compr ises an AAV5 viral vector carrying the Padua variant of the Fact or IX gene, and ( c ) is approved through an abbrevia ted process ( such as, in the United States, a under the Pat ient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, Title VII, Subtitle A, Biologics Price Competition and In novation Act of 2009 ( codified, in part at 42 U.S.C