; or (B) to the holder of an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for which any FDA-granted exclusivity with respect to a drug related to such invention that was terminated under this section. (2) Royalty The reasonable royalty described under paragraph (1) shall be a percentage of sales of the entity paying the royalty, 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. (3) Requirements (A) In general The royalty described under paragraph (2) shall be subject to the applicable royalty rate requirements of section 319B of the Public Health Service Act, as added by section 5 of this Act. (B) Multiple affected parties In the case of more than one recipient of a royalty, the royalty shall be divided among each such recipient (including any manufacturer) in a manner agreed upon by the manufacturer and other recipients, or, in the absence of such an agreement, in a manner the Secretary determines to be appropriate. (4) Exception for Government-owned inventions An entity that accepts an open, nonexclusive license for a federally owned invention described under section 207 of title 35, United States Code, is not required to pay a royalty under this section. (d) Definitions In this section: (1) Covered license The term covered license means a license that allows a licensee to make, use, offer to sell, or sell, export, or import into the United States or any other country or territory a COVID–19 related invention pursuant to— (A) section 207 of title 35, United States Code