; (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 covered drug; (4) the costs associated with development and manufacturing of the covered drug; (5) the size of the affected patient population in the United States and globally; and (6) the therapeutic efficacy of the covered drug. (c) Excessive pricing remedy If the Secretary determines pursuant to subsection (b) that the price of a covered drug is excessive, the Secretary— (1) shall waive or void any FDA-granted exclusivities with respect to the covered drug, effective on the date that the excessive price determination is made; and (2) shall grant open, nonexclusive licenses allowing any person to make, use, offer to sell, or sell, or import into the United States such drug, and to rely upon the regulatory test data of such drug, and to access and use otherwise confidential information, including know-how, related to the manufacture of such drug in accordance with subsection (d). (d) Reasonable royalty (1) In general An entity accepting an open, nonexclusive license under subsection (c)(2) shall pay a reasonable royalty with respect to sales within the United States to the holder of a patent that claims the covered drug or that claims a use of the covered drug or to the holder of an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act for which any FDA-granted exclusivity with respect to the covered drug was terminated under subsection (c)(1). (2) Royalty rate Such royalty rate shall be— (A) a percentage of sales, where the percentage rate is no higher than the average royalty rate estimated from the data provided by the Internal Revenue Service for pharmaceutical manufacturer Federal income tax returns; or (B) an amount as determined by the Secretary, taking into account— (i) the therapeutic efficacy of the covered drug