,i #aae? ,,congress #b;d ,session ,h4 ,r4 #fdgh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #bc1 #bjah,mr4 ,s>banes 7= himself & ,mr4 ,johnson ( ,ohio7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to enhance competition = prescription drugs by increas+ ! ability ( ! ,dep>tm5t ( ,ju/ice & ,f$]al ,trade ,commission to en=ce exi/+ antitru/ laws reg>d+ biologic & biosimil> products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,biosimil>s ,competition ,act ( #bjah4 #b4 ,lic5sure pa?way = biosimil> biological products ,section #cea7l7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7l77 is am5d$ by add+ at ! end ! foll[+3 7#aj7 ,notification ( agreem5ts 7,a7 ,requirem5ts 7i7 ,agreem5t betwe5 biosimil> product applicant & ref]5ce product sponsor ,if a subsection 7k7 applicant & ! ref]5ce product sponsor ent] into an agreem5t describ$ 9 subp>agraph 7,b71 ! applicant & sponsor %all ea* file ! agreem5t 9 accordance ) subp>agraph 7,c74 7ii7 ,agreem5t betwe5 biosimil> product applicants ,if #b or m subsection 7k7 applicants = biosimil> products ) ! same ref]5ce product ent] into an agreem5t describ$ 9 subp>agraph 7,b71 ! applicants %all ea* file ! agreem5t 9 accordance ) subp>agraph 7,c74 7,b7 ,subject matt] ( agreem5t ,an agreem5t describ$ 9 ?is subp>agraph-- 7i7 is an agreem5t betwe5 a subsection 7k7 applicant & ! ref]5ce product sponsor or betwe5 #b or m subsection 7k7 applicants reg>d+ ! manufacture1 m>ket+1 or sale (-- 7,i7 ! biosimil> product 7or biosimil> products7 = :i* an application 0 submitt$ "u subsection 7k72 or 7,,ii7 ! ref]5ce product2 7ii7 includes any agreem5t betwe5 a subsection 7k7 applicant & ! ref]5ce product sponsor or betwe5 #b or m subsection 7k7 applicants t is cont+5t ^u1 provides a cont+5t condition =1 or o!rwise relates to an agreem5t describ$ 9 clause 7i72 & 7iii7 excludes any agreem5t t solely conc]ns-- 7,i7 pur*ase ord]s = raw mat]ial supplies2 7,,ii7 equipm5t & facility contracts2 7,,iii7 employm5t or consult+ contracts2 or 7,,iv7 packag+ & label+ contracts4 7,c7 ,fil+ 7i7 ,9 g5]al ,! text ( an agreem5t requir$ to be fil$ by subp>agraph 7,a7 %all be fil$ ) ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division ( ! ,dep>tm5t ( ,ju/ice 79 ?is p>agraph ref]r$ to z ! ,assi/ant ,attorney ,g5]al7 & ! ,f$]al ,trade ,commission n lat] ?an-- 7,i7 #aj bus9ess days aft] ! date on :i* ! agreem5t is execut$2 & 7,,ii7 prior to ! date ( ! fir/ comm]cial m>ket+ (1 = agreem5ts describ$ 9 subp>agraph 7,a77i71 ! biosimil> product t is ! subject ( ! application or1 = agreem5ts describ$ 9 subp>agraph 7,a77ii71 any biosimil> product t is ! subject ( an application describ$ 9 su* subp>agraph4 7ii7 ,if agreem5t n r$uc$ to text ,if an agreem5t requir$ to be fil$ by subp>agraph 7,a7 has n be5 r$uc$ to text1 ! p]sons requir$ to file ! agreem5t %all ea* file writt5 descriptions ( ! agreem5t t are suffici5t to disclose all ! t]ms & conditions ( ! agreem5t4 7iii7 ,c]tification ,! *ief executive (fic] or ! company (ficial responsible = negotiat+ any agreem5t requir$ to be fil$ by subp>agraph 7,a7 %all include 9 any fil+ "u ?is p>agraph a c]tification z foll[s3 ,i decl>e "u p5alty ( p]jury t ! foll[+ is true & correct3 ,! mat]ials fil$ ) ! ,f$]al ,trade ,commission & ! ,dep>tm5t ( ,ju/ice "u section #cea7l77#aj7 ( ! ,public ,heal? ,s]vice ,act1 ) respect to ! agreem5t ref]5c$ 9 ?is c]tification3 7#a7 repres5t ! complete1 f9al1 & exclusive agreem5t betwe5 ! p>ties2 7#b7 include any ancill>y agreem5ts t are cont+5t ^u1 provide a cont+5t condition =1 or are o!rwise relat$ to1 ! ref]5c$ agreem5t2 & 7#c7 include writt5 descriptions ( any oral agreem5ts1 repres5tations1 commitm5ts1 or promises betwe5 ! p>ties t are responsive to su* section & h n be5 r$uc$ to writ+44 7,d7 ,disclosure exemption ,any in=mation or docum5t>y mat]ial fil$ ) ! ,assi/ant ,attorney ,g5]al or ! ,f$]al ,trade ,commission pursuant to ?is p>agraph %all be exempt f disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 & no su* in=mation or docum5t>y mat]ial may be made public1 except z may be relevant to any adm9i/rative or judicial action or proce$+4 ,no?+ 9 ?is subp>agraph prev5ts disclosure ( in=mation or docum5t>y mat]ial to ei!r body ( ! ,congress or to any duly au?oriz$ committee or subcommittee ( ! ,congress4 7,e7 ,en=cem5t 7i7 ,civil p5alty ,any p]son t violates a provision ( ?is p>agraph %all be liable = a civil p5alty ( n m ?an ! maximum am\nt ( a civil p5alty "u section #aaae7;a7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc1 z adju/$ pursuant to applicable law1 = ea* day dur+ :i* su* p]son is 9 violation ( ?is p>agraph4 ,su* p5alty may be recov]$ 9 a civil action-- 7,i7 br\ght by ! ,unit$ ,/ates2 or 7,,ii7 br\ght by ! ,f$]al ,trade ,commission 9 accordance ) ! proc$ures e/abli%$ 9 section #af7;a77#a7 ( ! ,f$]al ,trade ,commission ,act4 7ii7 ,compliance & equitable relief ,if any p]son violates any provision ( ?is p>agraph1 ! ,unit$ ,/ates di/rict c\rt may ord] compliance1 & may grant su* o!r equitable relief z ! c\rt 9 its discretion det]m9es necess>y or appropriate1 ^u application ( ! ,assi/ant ,attorney ,g5]al or ! ,f$]al ,trade ,commission4 7,f7 ,rulemak+ ,! ,f$]al ,trade ,commission1 ) ! concurr5ce ( ! ,assi/ant ,attorney ,g5]al & by rule 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code1 consi/5t ) ! purposes ( ?is p>agraph-- 7i7 may def9e ! t]ms us$ 9 ?is p>agraph2 7ii7 may exempt classes ( p]sons or agreem5ts f ! requirem5ts ( ?is p>agraph2 & 7iii7 may prescribe su* o!r rules z may be necess>y & appropriate to c>ry out ! purposes ( ?is p>agraph4 7,g7 ,sav+s clause ,any action tak5 by ! ,assi/ant ,attorney ,g5]al or ! ,f$]al ,trade ,commission1 or any failure ( ! ,assi/ant ,attorney ,g5]al or ! ,commission to take action1 "u ?is p>agraph %all n at any "t b> any proce$+ or any action ) respect to any agreem5t betwe5 a subsection 7k7 applicant & ! ref]5ce product sponsor1 or any agreem5t betwe5 subsection 7k7 applicants1 "u any o!r provision ( law1 nor %all any fil+ "u ?is p>agraph con/itute or create a presumption ( any violation ( any competition laws4 4