Sec. 8. Definitions

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For the purposes of this Act: The term average manufacturer price , with respect to a drug, subject to subparagraph (B), has the meaning given such term in section 1927(k)(1) of the Social Security Act ( 42 U.S.C. 1396r–8(k)(1) ); or with respect to a drug for which there is no average manufacturer price as so defined, such term shall mean the wholesale acquisition cost (as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)) of the drug.

With respect to reference countries, the term average manufacturer price , as defined in subparagraph (A), shall be determined based on the price of the drug in the applicable reference country. The term biosimilar biological product means a biological product licensed pursuant to an application under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ). The term brand name drug means a drug that is— approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) or a biological product licensed under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ); subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ); and claimed in a patent or the use of which is claimed in a patent.

The term generic drug means a drug approved pursuant to an application under section (b)(2) or

(j)of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ). The term government-granted exclusivity means prohibitions on the submission or approval of drug applications granted under any of the following: 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) ). Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B)(iv) ) or clause (ii), (iii), or

(iv)of section 505(j)(5)(F) of such Act. Section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ). Section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f ). Section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ). Section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ). Any other provision of law that provides for exclusivity (or extension of exclusivity) with respect to a drug. The term manufacturer means the holder of an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or of a license issued under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). The term open, non-exclusive license means a license that authorizes any person to use a patent held by a manufacturer that claims a brand name drug or a use of a brand name drug or rely upon regulatory test data for such drug, including patents held in common by the manufacturer and other entities, needed to produce, manufacture, import, export, distribute, offer in liquidation, sell, buy, or use such brand name drug. The term Secretary means the Secretary of Health and Human Services.

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