; or (B) is contingent upon, provides for a contingent condition for, or is otherwise related to the resolution or settlement of a covered patent infringement claim. (2) Commission The term Commission means the Federal Trade Commission. (3) Covered patent infringement claim The term covered patent infringement claim means an allegation made by the NDA or BLA holder to a subsequent filer (or, in the case of an agreement between two subsequent filers, by one subsequent filer to another), whether or not included in a complaint filed with a court of law, that— (A) the submission of the application described in subparagraph (A) or (B) of paragraph (8), or the manufacture, use, offering for sale, sale, or importation into the United States of a covered product that is the subject of such an application— (i) in the case of an agreement between an NDA or BLA holder and a subsequent filer, infringes any patent owned by, or exclusively licensed to, the NDA or BLA holder of the covered product; or (ii) in the case of an agreement between two subsequent filers, infringes any patent owned by the subsequent filer; or (B) in the case of an agreement between an NDA or BLA holder and a subsequent filer, the covered product to be manufactured under such application uses a covered product as claimed in a published patent application. (4) Covered product The term covered product means a drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g) )), including a biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )). (5) NDA or BLA holder The term NDA or BLA holder means— (A) the holder of— (i) an approved new drug application filed under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b)(1) ) for a covered product; or (ii) a biologics license application filed under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) for a covered product