Sec. 312. Notice and certification of agreements
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Section 1111(7) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( 21 U.S.C. 355 note) is amended by inserting or the owner of a patent for which a claim of infringement could reasonably be asserted against any person for making, using, offering to sell, selling, or importing into the United States a biological product that is the subject of a biosimilar biological product application before the period at the end. Section 1112 of such Act ( 21 U.S.C. 355 note) is amended by adding at the end the following: The Chief Executive Officer or the company official responsible for negotiating any agreement under subsection
(a)or
(b)that is required to be filed under subsection
(c)shall, within 30 days of such filing, execute and file with the Assistant Attorney General and the Commission a certification as follows: I declare that the following is true, correct, and complete to the best of my knowledge: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification— represent the complete, final, and exclusive agreement between the parties; include any ancillary agreements that are contingent upon, provide a contingent condition for, were entered into within 30 days of, or are otherwise related to, the referenced agreement; and include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection
(a)or
(b)of such section 1112 and have not been reduced to writing. . .
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Sec. 312
Notice and certification of agreements
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