; or (C) the predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with any of the entities described in subparagraphs (A) and (B) (such control to be presumed by direct or indirect share ownership of 50 percent or greater), as well as the licensees, licensors, successors, and assigns of each of the entities. (16) Party The term party means any person, partnership, corporation, or other legal entity. (17) Patent infringement The term patent infringement means infringement of any patent or of any filed patent application, including any extension, reissue, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patents of addition, and extensions thereof. (18) Patent infringement claim The term patent infringement claim means any allegation made to an ANDA filer or biosimilar biological product application filer, whether or not included in a complaint filed with a court of law, that its ANDA or ANDA product, or biosimilar biological product license application or biosimilar biological product, may infringe any patent held by, or exclusively licensed to, the NDA holder or biological product license holder of the drug product or biological product, as applicable. (19) Statutory exclusivity The term statutory exclusivity means those prohibitions on the submission or the approval of drug applications under clauses (ii) through (iv) of section 505(c)(3)(E), clauses (ii) through (iv) of section 505(j)(5)(F), section 527, section 505A, or section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) , 360cc, 355a, 355f), or on the submission or licensing of biological product applications under section 351(k)(7) or paragraph (2) or (3) of section 351(m) of the Public Health Service Act ( 42 U.S.C. 262 ) or under section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ). . (b) Effective date Section 27 of the Federal Trade Commission Act, as added by this section, shall apply to all