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136 STAT. 1863 PUBLIC LAW 117–169—AUG. 16, 2022 that the Secretary of Health and Human Services has selected for renegotiation under section 1194(f) of such Act, the period beginning on the November 2nd of the year that begins 2 years prior to the first initial price applicability year of the price applicability period for which the maximum fair price established pursuant to such renegotiation applies and ending on the earlier of— ‘‘(A) the first date on which the manufacturer of such designated drug has agreed to a renegotiated maximum fair price under such agreement, or ‘‘(B) the date that the Secretary of Health and Human Services has made a determination described in section 1192(c)(1) of such Act with respect to such designated drug. ‘‘(4) With respect to information that is required to be submitted to the Secretary of Health and Human Services under an agreement described in section 1193(a) of the Social Security Act, the period beginning on the date on which such Secretary certifies that such information is overdue and ending on the date that such information is so submitted. ‘‘(c) SUSPENSION OF TAX.— ‘‘(1) IN GENERAL.—A day shall not be taken into account as a day during a period described in subsection (b) if such day is also a day during the period— ‘‘(A) beginning on the first date on which— ‘‘(i) the notice of terminations of all applicable agreements of the manufacturer have been received by the Secretary of Health and Human Services, and ‘‘(ii) none of the drugs of the manufacturer of the designated drug are covered by an agreement under section 1860D-14A or 1860D-14C of the Social Security Act, and ‘‘(B) ending on the last day of February following the earlier of— ‘‘(i) the first day after the date described in subparagraph (A) on which the manufacturer enters into any subsequent applicable agreement, or ‘‘(ii) the first date any drug of the manufacturer of the designated drug is covered by an agreement under section 1860D-14A or 1860D-14C of the Social Security Act. ‘‘(2) APPLICABLE AGREEMENT.—For purposes of this sub- section, the term ‘applicable agreement’ means the following: ‘‘(A) An agreement under— ‘‘(i) the Medicare coverage gap discount program under section 1860D-14A of the Social Security Act, or ‘‘(ii) the manufacturer discount program under sec- tion 1860D-14C of such Act. ‘‘(B) A rebate agreement described in section 1927(b) of such Act. ‘‘(d) APPLICABLE PERCENTAGE.—For purposes of this section, the term ‘applicable percentage’ means— ‘‘(1) in the case of sales of a designated drug during the first 90 days described in subsection (b) with respect to such drug, 65 percent, Definition. Definition. Notice. Contracts. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00047 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw