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136 STAT. 1859 PUBLIC LAW 117–169—AUG. 16, 2022 as a selected drug on the list published under sub- section (a) if Secretary determined that the manufac- turer of the biosimilar biological product described in paragraph (1)(A)— ‘‘(I) is the same as the manufacturer of the reference product described in such paragraph or is treated as being the same pursuant to paragraph (1)(C); or ‘‘(II) has, based on information from items described in paragraph (1)(B)(ii)(I)(bb), entered into any agreement described in such paragraph with the manufacturer of the reference product described in paragraph (1)(A) that— ‘‘(aa) requires or incentivizes the manufac- turer of the biosimilar biological product to submit a request described in paragraph (1)(B); or ‘‘(bb) restricts the quantity (either directly or indirectly) of the biosimilar biological product that may be sold in the United States over a specified period of time. ‘‘(3) HIGH LIKELIHOOD.—For purposes of this subsection, there is a high likelihood described in paragraph (1) or para- graph (2), as applicable, if the Secretary finds that— ‘‘(A) an application for licensure under section 351(k) of the Public Health Service Act for the biosimilar biological product has been accepted for review or approved by the Food and Drug Administration; and ‘‘(B) information from items described in sub clauses (I)(bb) and (III) of paragraph (1)(B)(ii) submitted to the Secretary by the manufacturer requesting a delay under such paragraph provides clear and convincing evidence that such biosimilar biological product will, within the time period specified under paragraph (1)(A) or (2)(B)(i)(I), be marketed. ‘‘(4) REBATE.— ‘‘(A) IN GENERAL.—For purposes of subparagraphs (B)(ii)(II) and (C)(ii) of paragraph (2), in the case of a biological product for which the inclusion on the list under subsection (a) was delayed under this subsection and for which the Secretary has negotiated and entered into an agreement under section 1193 with respect to such biological product, the manufacturer shall be required to pay a rebate to the Secretary at such time and in such manner as determined by the Secretary. ‘‘(B) AMOUNT.—Subject to subparagraph (C), the amount of the rebate under subparagraph (A) with respect to a biological product shall be equal to the estimated amount— ‘‘(i) in the case of a biological product that is a covered part D drug (as defined in section 1860D– 2(e)), that is the sum of the products of— ‘‘(I) 75 percent of the amount by which— ‘‘(aa) the average manufacturer price, as reported by the manufacturer of such covered part D drug under section 1927 (or, if not reported by such manufacturer under section Estimate. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00043 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw