,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #fdgh ,,in ,,the ,,house ,,of ,,representatives ,july #bc1 #bjah,mr4 ,sarbanes 7for himself and ,mr4 ,johnson of ,ohio7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to enhance competition for prescription drugs by increasing the ability of the ,department of ,justice and ,federal ,trade ,commission to enforce existing antitrust laws regarding biologic and biosimilar products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,biosimilars ,competition ,act of #bjah4 #b4 ,licensure pathway for biosimilar biological products ,section #cea7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77 is amended by adding at the end the following3 7#aj7 ,notification of agreements 7,a7 ,requirements 7i7 ,agreement between biosimilar product applicant and reference product sponsor ,if a subsection 7k7 applicant and the reference product sponsor enter into an agreement described in subparagraph 7,b71 the applicant and sponsor shall each file the agreement in accordance with subparagraph 7,c74 7ii7 ,agreement between biosimilar product applicants ,if #b or more subsection 7k7 applicants for biosimilar products with the same reference product enter into an agreement described in subparagraph 7,b71 the applicants shall each file the agreement in accordance with subparagraph 7,c74 7,b7 ,subject matter of agreement ,an agreement described in this subparagraph-- 7i7 is an agreement between a subsection 7k7 applicant and the reference product sponsor or between #b or more subsection 7k7 applicants regarding the manufacture1 marketing1 or sale of-- 7,i7 the biosimilar product 7or biosimilar products7 for which an application was submitted under subsection 7k72 or 7,,ii7 the reference product2 7ii7 includes any agreement between a subsection 7k7 applicant and the reference product sponsor or between #b or more subsection 7k7 applicants that is contingent upon1 provides a contingent condition for1 or otherwise relates to an agreement described in clause 7i72 and 7iii7 excludes any agreement that solely concerns-- 7,i7 purchase orders for raw material supplies2 7,,ii7 equipment and facility contracts2 7,,iii7 employment or consulting contracts2 or 7,,iv7 packaging and labeling contracts4 7,c7 ,filing 7i7 ,in general ,the text of an agreement required to be filed by subparagraph 7,a7 shall be filed with the ,assistant ,attorney ,general in charge of the ,antitrust ,division of the ,department of ,justice 7in this paragraph referred to as the ,assistant ,attorney ,general7 and the ,federal ,trade ,commission not later than-- 7,i7 #aj business days after the date on which the agreement is executed2 and 7,,ii7 prior to the date of the first commercial marketing of1 for agreements described in subparagraph 7,a77i71 the biosimilar product that is the subject of the application or1 for agreements described in subparagraph 7,a77ii71 any biosimilar product that is the subject of an application described in such subparagraph4 7ii7 ,if agreement not reduced to text ,if an agreement required to be filed by subparagraph 7,a7 has not been reduced to text1 the persons required to file the agreement shall each file written descriptions of the agreement that are sufficient to disclose all the terms and conditions of the agreement4 7iii7 ,certification ,the chief executive officer or the company official responsible for negotiating any agreement required to be filed by subparagraph 7,a7 shall include in any filing under this paragraph a certification as follows3 ,i declare under penalty of perjury that the following is true and correct3 ,the materials filed with the ,federal ,trade ,commission and the ,department of ,justice under section #cea7l77#aj7 of the ,public ,health ,service ,act1 with respect to the agreement referenced in this certification3 7#a7 represent the complete1 final1 and exclusive agreement between the parties2 7#b7 include any ancillary agreements that are contingent upon1 provide a contingent condition for1 or are otherwise related to1 the referenced agreement2 and 7#c7 include written descriptions of any oral agreements1 representations1 commitments1 or promises between the parties that are responsive to such section and have not been reduced to writing44 7,d7 ,disclosure exemption ,any information or documentary material filed with the ,assistant ,attorney ,general or the ,federal ,trade ,commission pursuant to this paragraph shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code1 and no such information or documentary material may be made public1 except as may be relevant to any administrative or judicial action or proceeding4 ,nothing in this subparagraph prevents disclosure of information or documentary material to either body of the ,congress or to any duly authorized committee or subcommittee of the ,congress4 7,e7 ,enforcement 7i7 ,civil penalty ,any person that violates a provision of this paragraph shall be liable for a civil penalty of not more than the maximum amount of a civil penalty under section #aaae7;a7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc1 as adjusted pursuant to applicable law1 for each day during which such person is in violation of this paragraph4 ,such penalty may be recovered in a civil action-- 7,i7 brought by the ,united ,states2 or 7,,ii7 brought by the ,federal ,trade ,commission in accordance with the procedures established in section #af7;a77#a7 of the ,federal ,trade ,commission ,act4 7ii7 ,compliance and equitable relief ,if any person violates any provision of this paragraph1 the ,united ,states district court may order compliance1 and may grant such other equitable relief as the court in its discretion determines necessary or appropriate1 upon application of the ,assistant ,attorney ,general or the ,federal ,trade ,commission4 7,f7 ,rulemaking ,the ,federal ,trade ,commission1 with the concurrence of the ,assistant ,attorney ,general and by rule in accordance with section #eec of title #e1 ,united ,states ,code1 consistent with the purposes of this paragraph-- 7i7 may define the terms used in this paragraph2 7ii7 may exempt classes of persons or agreements from the requirements of this paragraph2 and 7iii7 may prescribe such other rules as may be necessary and appropriate to carry out the purposes of this paragraph4 7,g7 ,savings clause ,any action taken by the ,assistant ,attorney ,general or the ,federal ,trade ,commission1 or any failure of the ,assistant ,attorney ,general or the ,commission to take action1 under this paragraph shall not at any time bar any proceeding or any action with respect to any agreement between a subsection 7k7 applicant and the reference product sponsor1 or any agreement between subsection 7k7 applicants1 under any other provision of law1 nor shall any filing under this paragraph constitute or create a presumption of any violation of any competition laws4 4