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136 STAT. 1881 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(ii) 2026 AND SUBSEQUENT YEARS.—In order for an agreement with a manufacturer to be in effect under this section with respect to plan year 2026 or a subse- quent plan year, the manufacturer shall enter into such agreement not later than a calendar quarter or semi-annual deadline established by the Secretary. ‘‘(2) PROVISION OF APPROPRIATE DATA.—Each manufacturer with an agreement in effect under this section shall collect and have available appropriate data, as determined by the Secretary, to ensure that it can demonstrate to the Secretary compliance with the requirements under the program. ‘‘(3) COMPLIANCE WITH REQUIREMENTS FOR ADMINISTRATION OF PROGRAM.—Each manufacturer with an agreement in effect under this section shall comply with requirements imposed by the Secretary, as applicable, for purposes of administering the program, including any determination under subparagraph (A) of subsection (c)(1) or procedures established under such subsection (c)(1). ‘‘(4) LENGTH OF AGREEMENT.— ‘‘(A) IN GENERAL.—An agreement under this section shall be effective for an initial period of not less than 12 months and shall be automatically renewed for a period of not less than 1 year unless terminated under subpara- graph (B). ‘‘(B) TERMINATION.— ‘‘(i) BY THE SECRETARY.—The Secretary shall pro- vide for termination of an agreement under this section for a knowing and willful violation of the requirements of the agreement or other good cause shown. Such termination shall not be effective earlier than 30 days after the date of notice to the manufacturer of such termination. The Secretary shall provide, upon request, a manufacturer with a hearing concerning such a termination, and such hearing shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the Sec- retary determines appropriate. ‘‘(ii) BY A MANUFACTURER.—A manufacturer may terminate an agreement under this section for any reason. Any such termination shall be effective, with respect to a plan year— ‘‘(I) if the termination occurs before January 31 of a plan year, as of the day after the end of the plan year; and ‘‘(II) if the termination occurs on or after January 31 of a plan year, as of the day after the end of the succeeding plan year. ‘‘(iii) EFFECTIVENESS OF TERMINATION.—Any termi- nation under this subparagraph shall not affect dis- counts for applicable drugs of the manufacturer that are due under the agreement before the effective date of its termination. ‘‘(5) EFFECTIVE DATE OF AGREEMENT.—An agreement under this section shall take effect at the start of a calendar quarter or another date specified by the Secretary. ‘‘(c) DUTIES DESCRIBED.—The duties described in this subsection are the following: Effective dates. Hearings. Time period. Determination. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00065 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw