; (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; and (C) to access and use otherwise confidential know-how relating to the manufacture of such invention. 3. Requirements for reasonable pricing of federally supported COVID–19 drugs (a) Reasonable pricing requirements Any covered transaction shall include terms and conditions requiring that the pricing of the drug by the party referred to in subsection (b)(1) be fair and reasonable, and facilitate global access, taking into consideration— (1) the impact of the price on access to the drug in the United States, taking into consideration racial disparities in COVID–19 cases and fatalities and other socioeconomic disparities; (2) the impact of the price on health program spending and budgets in the United States; (3) the risk adjusted value of Federal subsidies and investments related to the drug; (4) the costs associated with development and manufacturing of the drug; (5) the size of the affected patient population in the United States and globally; and (6) the therapeutic efficacy of the drug. (b) Definitions In this section: (1) Covered transaction The term covered transaction has the meaning given to such term in section 2. (2) Drug The term drug has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). 4. Reporting on the expenditures of manufacturers with respect to COVID–19 drugs (a) Covered drug For purposes of this section, the term covered drug means a drug that is intended or anticipated to be used to diagnose, mitigate, prevent, or treat COVID–19. (b) Reporting required The manufacturer of a covered drug shall submit a report described in subsection (c) to the Secretary upon— (1) the submission of an application for approval of the drug under subsection (b) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 )