The Secretary, in coordination with the Attorney General and the Secretary of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security countermeasure (as defined in section 247d-6b of this title), a qualified countermeasure (as defined in section 247d-6a of this title), or a qualified pandemic or epidemic product (as defined in section 247d-6d of this title) for the purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. The Secretary may convene such meeting or consultation at the request of the Secretary of Homeland Security, the Attorney General, the Chairman of the Federal Trade Commission (referred to in this section as the "Chairman"), or any interested person, or upon initiation by the Secretary. The Secretary shall give prior notice of any such meeting or consultation, and the topics to be discussed, to the Attorney General, the Chairman, and the Secretary of Homeland Security.
A meeting or consultation conducted under subparagraph (A) shall-
The Secretary may not require participants to disclose confidential commercial or proprietary information.
The Secretary shall maintain a complete verbatim transcript of each meeting or consultation conducted under this subsection. Such transcript (or a portion thereof) shall not be disclosed under section 552 of title 5 to the extent that the Secretary, in consultation with the Attorney General and the Secretary of Homeland Security, determines that disclosure of such transcript (or portion thereof) would pose a threat to national security. The transcript (or portion thereof) with respect to which the Secretary has made such a determination shall be deemed to be information described in subsection (b)(3) of such section 552.
Subject to clause (ii), it shall not be a violation of the antitrust laws for any person to participate in a meeting or consultation conducted in accordance with this paragraph.
Clause (i) shall not apply to any agreement or conduct that results from a meeting or consultation and that is not covered by an exemption granted under paragraph (4).
The Secretary shall submit each written agreement regarding covered activities that is made pursuant to meetings or consultations conducted under paragraph (1) to the Attorney General and the Chairman for consideration. In addition to the proposed agreement itself, any submission shall include-
It shall not be a violation of the antitrust laws for a person to engage in conduct in accordance with a written agreement to the extent that such agreement has been granted an exemption under paragraph (4), during the period for which the exemption is in effect.
The Attorney General, in consultation with the Chairman, shall grant, deny, grant in part and deny in part, or propose modifications to an exemption request regarding a written agreement submitted under paragraph (2), in a written statement to the Secretary, within 15 business days of the receipt of such request. An exemption granted under this paragraph shall take effect immediately.
The Attorney General may extend the 15-day period referred to in subparagraph (A) for an additional period of not to exceed 10 business days.
An exemption shall be granted regarding a written agreement submitted in accordance with paragraph (2) only to the extent that the Attorney General, in consultation with the Chairman and the Secretary, finds that the conduct that will be exempted will not have any substantial anticompetitive effect that is not reasonably necessary for ensuring the availability of the countermeasure or product involved.
An exemption granted under paragraph (4) shall be limited to covered activities, and such exemption shall be renewed (with modifications, as appropriate, consistent with the finding described in paragraph (4)(C)), on the date that is 3 years after the date on which the exemption is granted unless the Attorney General in consultation with the Chairman determines that the exemption should not be renewed (with modifications, as appropriate) considering the factors described in paragraph (4).
Consideration by the Attorney General for granting or renewing an exemption submitted under this section shall be considered an antitrust investigation for purposes of the Antitrust Civil Process Act (15 U.S.C. 1311 et seq.).
The use of any information acquired under an agreement for which an exemption has been granted under paragraph (4), for any purpose other than specified in the exemption, shall be subject to the antitrust laws and any other applicable laws.
Not later than one year after the date of enactment of this Act1 and biannually thereafter, the Attorney General and the Chairman shall report to Congress on the use of the exemption from the antitrust laws provided by this subsection.
The applicability of this section shall expire after December 31, 2024.
In this section:
The term "antitrust laws"-
The term "countermeasure or product" refers to a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product (as those terms are defined in subsection (a)(1)).
Except as provided in subparagraph (B), the term "covered activities" includes any activity relating to the development, manufacture, distribution, purchase, or storage of a countermeasure or product.
The term "covered activities" shall not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an agreement for which an exemption has been granted under subsection (a)(4), the following activities involving 2 or more persons:
1See References in Text note below.
42 U.S.C. § 247d-7f
EDITORIAL NOTES
REFERENCES IN TEXTThe Antitrust Civil Process Act, referred to in subsec. (a)(6), is Pub. L. 87-664, Sept. 19, 1962, 76 Stat. 548, which is classified principally to chapter 34 (§1311 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1311 of Title 15 and Tables.The date of enactment of this Act, referred to in subsec. (a)(8), probably means the date of enactment of Pub. L. 109-417 which was approved Dec. 19, 2006. This section was originally enacted as section 405 of Pub. L. 109-417 prior to renumbering as section 319L-1 of act July 1, 1944, ch. 373.
CODIFICATIONSection was formerly set out as a note under section 247d-6a of this title prior to renumbering by Pub. L. 116-22.
PRIOR PROVISIONSA prior section 247d-7f, act July 1, 1944, ch. 373, title III, §319M, as added Pub. L. 109-417, title IV, §402, Dec. 19, 2006, 120 Stat. 2872; amended Pub. L. 113-5, title IV, §404, Mar. 13, 2013, 127 Stat. 197, which related to National Biodefense Science Board and working groups, was transferred to section 247d-7g of this title.
AMENDMENTS2024-Subsec. (b). Pub. L. 118-42 substituted "December 31, 2024" for "March 8, 2024". Pub. L. 118-35 substituted "March 8, 2024" for "January 19, 2024". 2023-Subsec. (b). Pub. L. 118-22 substituted "after January 19, 2024" for "at the end of the 17-year period that begins on the date of enactment of this Act".2019-Subsec. (a)(1)(A). Pub. L. 116-22, §701(e)(1)(A), substituted "The Secretary, in coordination" for "The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary'), in coordination" and made technical amendments to references in original act which appear in text as references to sections 247d-6b, 247d-6a, and 247d-6d of this title.Subsec. (b). Pub. L. 116-22, §701(e)(1)(B), substituted "17-year" for "12-year".2013-Subsec. (b). Pub. L. 113-5 substituted "12-year" for "6-year".
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2013 AMENDMENT Pub. L. 113-5, title IV, §402(e)(2), Mar. 13, 2013, 127 Stat. 195, provided that: "This subsection [amending this section] shall take effect as if enacted on December 17, 2012."
- Secretary
- The term "Secretary" means the Secretary of Housing and Urban Development.1See References in Text note below.
- Service
- The term "Service" means the Public Health Service;