price spike revenue for any taxable insulin product shall be an amount equal to— (A) an amount equal to the product of— (i) an amount (not less than zero) equal to— (I) the wholesale acquisition cost of such insulin product in commerce for the preceding calendar year, minus (II) the wholesale acquisition cost of such insulin product in commerce for the base year, and (ii) the total number of units of such insulin product which were sold in commerce in the preceding calendar year, minus (B) an amount equal to the sum of the adjustment amounts, if any, determined under section 4(a)(5)(C) of the Emergency Access to Insulin Act of 2023 for each calendar year during the applicable period. (d) Definitions For purposes of this section— (1) Taxable insulin product The term taxable insulin product means an insulin product which has been identified by the Inspector General of the Department of Health and Human Services, under section 4(c)(2)(A) of the Emergency Access to Insulin Act of 2023 , as being subject to a price spike. (2) Other terms The terms applicable entity , price spike , price spike percentage , and price spike revenue have the same meaning given such terms under section 4(a) of the Emergency Access to Insulin Act of 2023 . . (2) Clerical amendment The table of subchapters for chapter 32 of the Internal Revenue Code of 1986 is amended by inserting after the item relating to subchapter D the following new item: SUBCHAPTER E—Certain insulin products . (3) Effective date The amendments made by this subsection shall apply to sales after the date of the enactment of this Act. 5. Biological product exclusivity (a) In general Section 351(k)(7)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(7)(A) ) is amended by striking 12 years and inserting 7 years . (b) Conforming amendments Paragraphs (2)(A) and (3)(A) of section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ) is amended by striking 12 years each place it appears and inserting 7 years .