; a use of such drug; a form of such drug; a method of use of such drug; or a method of manufacturing such drug. (4) FDA-granted exclusivity The term FDA-granted exclusivity means prohibitions on the submission or approval of drug applications granted under any of the following: (A) Clauses (ii) through (v) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) ). (B) Subsection (j)(5)(B)(iv) or clause (ii), (iii), or (iv) of subsection (j)(5)(F) of such Act ( 21 U.S.C. 355(c)(3)(E) ). (C) Section 505A of such Act ( 21 U.S.C. 355a ). (D) Section 505E of such Act ( 21 U.S.C. 355f ). (E) Section 527 of such Act ( 21 U.S.C. 360cc ). (F) Section 351(k)(7) of this Act ( 42 U.S.C. 262(k)(7) ). (G) Any other provision of law that provides for marketing or data exclusivity (or extension of exclusivity) with respect to a drug. (5) Open, nonexclusive license The term open, nonexclusive license means a license that allows a qualified licensee, subject to the provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and the Public Health Service Act ( 42 U.S.C. 201 et seq.)— (A) to make, use, offer to sell, sell, export, or import into the United States and any other country and territory an invention; (B) to reference or rely upon earlier-submitted regulatory test data or the earlier grant of marketing approval of a treatment or vaccine related to such invention