definiens: shall mean ( i ) all m ammalian therapeutic and diagnostic uses which make use of an AP endonucleas e inhibitor ( ) and wherein the APE inhibitor is methox yamine or a Methoxyamine Analog and ( ii ) diagnostic and/or analytical kits i n the field of cancer that are related to the development and commercialization of an APE inhibitor . ” 1.4 After Section 1.42 of the Agreement, a new S ection 1.43 is added as follows : shall mean AP endonuclease inhibitors having an amino - oxy group that binds to AP ( apurini c / apyrimidine ) sites in DNA . ” 1.5 After new Section 1.43 of the Agreement, a n ew Section 1.44 is added as follows : shall mea n a drug or biological product that has received and been granted market exclusivity for a specified period by the U.S. gove rnment to treat a qualified disease or condition under the criteria specified i n the Orphan Drug Act and FDA ’s implementing regulations at 21 CFR part 316 . ” 2