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136 STAT. 1856 PUBLIC LAW 117–169—AUG. 16, 2022 information and documents requested by the Sec- retary necessary to make determinations under this subsection. ‘‘(III) ITEMS DESCRIBED.—The items described in this clause are the following: ‘‘(aa) The manufacturing schedule for such biosimilar biological product submitted to the Food and Drug Administration during its review of the application under such section 351(k). ‘‘(bb) Disclosures (in filings by the manu- facturer of such biosimilar biological product with the Securities and Exchange Commission required under section 12(b), 12(g), 13(a), or 15(d) of the Securities Exchange Act of 1934 about capital investment, revenue expecta- tions, and actions taken by the manufacturer that are typical of the normal course of busi- ness in the year (or the 2 years, as applicable) before marketing of a biosimilar biological product) that pertain to the marketing of such biosimilar biological product, or comparable documentation that is distributed to the share- holders of privately held companies. ‘‘(C) AGGREGATION RULE.— ‘‘(i) IN GENERAL.—All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986, or in a partnership, shall be treated as one manufacturer for purposes of paragraph (2)(D)(iv). ‘‘(ii) PARTNERSHIP DEFINED.—In clause (i), the term ‘partnership’ means a syndicate, group, pool, joint ven- ture, or other organization through or by means of which any business, financial operation, or venture is carried on by the manufacturer of the biological product and the manufacturer of the biosimilar biological product. ‘‘(2) RULES DESCRIBED.—The rules described in this para- graph are the following: ‘‘(A) DELAYED SELECTION AND NEGOTIATION FOR 1 YEAR.—If a determination of high likelihood is made under paragraph (3), the Secretary shall delay the inclusion of the biological product as a selected drug on the list pub- lished under subsection (a) until such list is published with respect to the initial price applicability year that is 1 year after the initial price applicability year for which the biological product would have been included as a selected drug on such list. ‘‘(B) IF NOT LICENSED AND MARKETED DURING THE INI- TIAL DELAY.— ‘‘(i) IN GENERAL.—If, during the time period between the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection (a) but for subparagraph (A) and the selected drug publica- tion date with respect to the initial price applicability year that is 1 year after the initial price applicability Time periods. Determination. Time period. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00040 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw