PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2463
involved shall file written descriptions of such agreement that are sufficient to disclose all the terms and conditions of the agreement. SEC. 1113. FILING DEADLINES.
21 USC 355 note.
Any filing required under section 1112 shall be filed with the Assistant Attorney General and the Commission not later than 10 business days after the date the agreements are executed. SEC. 1114. DISCLOSURE EXEMPTION.
21 USC 355 note.
Any information or documentary material filed with the Assistant Attorney General or the Commission pursuant to this subtitle shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this section is intended to prevent disclosure to either body of the Congress or to any duly authorized committee or subcommittee of the Congress. SEC. 1115. ENFORCEMENT.
21 USC 355 note.
(a) CIVIL PENALTY.—Any brand name drug company or generic drug applicant which fails to comply with any provision of this subtitle shall be liable for a civil penalty of not more than $11,000, for each day during which such entity is in violation of this subtitle. Such penalty may be recovered in a civil action brought by the United States, or brought by the Commission in accordance with the procedures established in section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)). (b) COMPLIANCE AND EQUITABLE RELIEF.—If any brand name drug company or generic drug applicant fails to comply with any provision of this subtitle, the United States district court may order compliance, and may grant such other equitable relief as the court in its discretion determines necessary or appropriate, upon application of the Assistant Attorney General or the Commission. SEC. 1116. RULEMAKING.
21 USC 355 note.
The Commission, with the concurrence of the Assistant Attorney General and by rule in accordance with section 553 of title 5, United States Code, consistent with the purposes of this subtitle— (1) may define the terms used in this subtitle; (2) may exempt classes of persons or agreements from the requirements of this subtitle; and (3) may prescribe such other rules as may be necessary and appropriate to carry out the purposes of this subtitle. SEC. 1117. SAVINGS CLAUSE.
21 USC 355 note.
Any action taken by the Assistant Attorney General or the Commission, or any failure of the Assistant Attorney General or the Commission to take action, under this subtitle shall not at any time bar any proceeding or any action with respect to any agreement between a brand name drug company and a generic drug applicant, or any agreement between generic drug applicants, under any other provision of law, nor shall any filing under this subtitle constitute or create a presumption of any violation of any competition laws.
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