,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #fd  ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$
 ,,/ates  ,janu>y #i1 #bjai,ms4 ,klobu*>
 7= h]self & ,mr4 ,grassley7 introduc$ !
 foll[+ bill2 :i* 0 read twice & ref]r$ 
to ! ,committee on ! ,judici>y  ,a      
,,bill  ,to prohibit br& "n drug        
companies f comp5sat+ g5]ic drug        
companies to delay ! entry ( a g5]ic    
drug into ! m>ket1 & to prohibit        
biological product manufactur]s f       
comp5sat+ biosimil> & int]*angeable     
companies to delay ! entry ( biosimil>  
biological products & int]*angeable     
biological products4  #a4 ,%ort title   
,?is ,act may be cit$ z ! ,pres]ve      
,access to ,af=dable ,g5]ics &          
,biosimil>s ,act4  #b4 ,congressional   
f9d+s & decl>ation ( purposes  7a7      
,f9d+s ,congress f9ds ! foll[+3 7#a7 ,9 
#aihd1 ! ,drug ,price ,competition &    
,pat5t ,t]m ,re/oration ,act 7,public   
,law #ih-dag7 7ref]r$ to 9 ?is ,act z ! 
#aihd ,act71 0 enact$ ) ! int5t (       
facilitat+ ! e>ly entry ( g5]ic drugs   

:ile pres]v+ inc5tives = innovation4    
7#b7 ,prescription drugs make up        
approximately #aj p]c5t ( ! national    
heal? c>e sp5d+4  7#c7 ,initially1 !    
#aihd ,act 0 successful 9 facilitat+    
g5]ic competition to ! b5efit ( consum]s
 & heal? c>e pay]s1 al?\gh #hh p]c5t (  
all prescriptions disp5s$ 9 ! ,unit$    
,/ates are g5]ic drugs1 !y acc\nt = only
 #bh p]c5t ( all exp5ditures4  7#d7     
,g5]ic drugs co/ sub/antially less ?an  
br& "n drugs1 ) disc\nts (f ! br& price 
av]ag+ #hj to #he p]c5t4  7#e7 ,f$]al   
doll>s curr5tly acc\nt = ov] #dj p]c5t (
 ! #cbe1jjj1jjj1jjj sp5t on retail      
prescription drugs1 & ?is %>e is expect$
 to rise to #dg p]c5t by #bjbe4  7#f7   
7,a7 ,9 rec5t ye>s1 ! int5t ( ! #aihd   
,act has be5 subv]t$ by c]ta9 settlem5t 
agreem5ts 9 :i* br& "n companies transf]
 value to _! pot5tial g5]ic competitors 
to settle claims t ! g5]ic company is   
infr++ ! br&$ company's pat5ts4  7,b7   
,^! rev]se paym5t settlem5t agreem5ts-- 
7i7 all[ a br&$ company to %>e its      

monopoly pr(its ) ! g5]ic company z a   
way to protect ! br&$ company's         
monopoly2 &  7ii7 h unduly delay$ !     
m>ket+ ( l[-co/ g5]ic drugs contr>y to  
free competition1 ! int]e/s ( consum]s1 
& ! pr9ciples und]ly+ antitru/ law4     
7,c7 ,because ( ! price disp>ity betwe5 
br& "n & g5]ic drugs1 su* agreem5ts are 
m pr(itable = bo? ! br& & g5]ic         
manufactur]s ?an competition & w become 
increas+ly common unless prohibit$4     
7,d7 ,^! agreem5ts result 9 consum]s    
los+ ! b5efits t ! #aihd ,act 0 int5d$  
to provide4  7#g7 ,9 #bjaj1 ! ,biologics
 ,price ,competition & ,innovation ,act 
7,public ,law #aaa-adh7 7ref]r$ to 9 ?is
 ,act z ! ,,bpcia71 0 enact$ ) ! int5t (
 facilitat+ ! e>ly entry ( biosimil> &  
int]*angeable foll[-on v]sions ( br&$   
biological products :ile pres]v+        
inc5tives = innovation4  7#h7           
,biological drugs play an important role
 9 treat+ _m s]i\s illnesses1 f canc]s  
to g5etic disord]s4 ,!y are also        
exp5sive1 repres5t+ m ?an #dj p]c5t (   

all prescription drug sp5d+4  7#i7      
,competition f biosimil> & int]*angeable
 biological products promises to l[]    
drug co/s & increase pati5t access to   
biological m$ic9es4 ,b rev]se paym5t    
settlem5t agreem5ts also ?reat5 to delay
 ! entry ( biosimil> & int]*angeable    
biological products1 :i* w\ld und]m9e ! 
goals ( ,,bpcia4  7b7 ,purposes ,!      
purposes ( ?is ,act are-- 7#a7 to       
enhance competition 9 ! ph>maceutical   
m>ket by /opp+ anticompetitive agreem5ts
 betwe5 br& "n & g5]ic drug & biosimil> 
biological product manufactur]s t limit1
 delay1 or o!rwise prev5t competition f 
g5]ic drugs & biosimil> biological      
products2 &  7#b7 to support ! purpose &
 int5t ( antitru/ law by prohibit+      
anticompetitive practices 9 !           
ph>maceutical indu/ry t h>m consum]s4   
#c4 ,unlawful comp5sation = delay  7a7  
,9 g5]al ,! ,f$]al ,trade ,commission   
,act 7#ae ,u4,s4,c4 #dd et seq47 is     
am5d$ by ins]t+ aft] section #bf 7#ae   
,u4,s4,c4 #eg;c-#b7 ! foll[+3  #bg4     

,pres]v+ access to af=dable g5]ics &    
biosimil>s  7a7 ,9 g5]al  7#a7 ,en=cem5t
 proce$+ ,! ,commission may initiate a  
proce$+ to en=ce ! provisions ( ?is     
section aga9/ ! p>ties to any agreem5t  
resolv+ or settl+1 on a f9al or int]im  
basis1 a pat5t infr+em5t claim1 9       
connection ) ! sale ( a drug product or 
biological product4  7#b7 ,presumption &
 violation  7,a7 ,9 g5]al ,subject to   
subp>agraph 7,b71 9 su* a proce$+1 an   
agreem5t %all be presum$ to h           
anticompetitive effects & %all be a     
violation ( ?is section if--  7i7 an    
,,&a fil] or a biosimil> biological     
product application fil] receives any?+ 
( value1 includ+ an exclusive lic5se2 & 
7ii7 ! ,,&a fil] or biosimil> biological
 product application fil] agrees to     
limit or =ego rese>*1 developm5t1       
manufactur+1 m>ket+1 or sales ( ! ,,&a  
product or biosimil> biological product1
 z applicable1 = any p]iod ( "t4  7,b7  
,exception ,subp>agraph 7,a7 %all n     
apply if ! p>ties to su* agreem5t       

demon/rate by cle> & conv9c+ evid5ce t--
  7i7 ! value describ$ 9 subp>agraph    
7,a77i7 is comp5sation solely = o!r     
goods or s]vices t ! ,,&a fil] or       
biosimil> biological product application
 fil] has promis$ to provide2 or  7ii7 !
 procompetitive b5efits ( ! agreem5t    
outweigh ! anticompetitive effects ( !  
agreem5t4  7b7 ,limitations ,9 det]m9+  
:e!r ! settl+ p>ties h met _! burd5 "u  
subsection 7a77#b77;,b71 ! fact f9d]    
%all n presume--  7#a7 t entry w\ld n h 
occurr$ until ! expiration ( ! relevant 
pat5t or /atutory exclusivity2 or  7#b7 
t ! agreem5t's provision = entry ( !    
,,&a product or biosimil> biological    
product prior to ! expiration ( !       
relevant pat5t or /atutory exclusivity  
means t ! agreem5t is procompetitive4   
7c7 ,exclusions ,no?+ 9 ?is section %all
 prohibit a resolution or settlem5t ( a 
pat5t infr+em5t claim 9 :i* !           
consid]ation grant$ by ! ,,nda hold] or 
biological product lic5se hold] to !    
,,&a fil] or biosimil> biological       

product application fil]1 respectively1 
z "p ( ! resolution or settlem5t        
includes only "o or m ( ! foll[+3  7#a7 
,! "r to m>ket ! ,,&a product or        
biosimil> biological product 9 ! ,unit$ 
,/ates prior to ! expiration (--  7,a7  
any pat5t t is ! basis = ! pat5t        
infr+em5t claim2 or  7,b7 any pat5t "r  
or o!r /atutory exclusivity t w\ld      
prev5t ! m>ket+ ( su* ,,&a product or   
biosimil> biological product4  7#b7 ,a  
paym5t = reasonable litigation exp5ses n
 to exce$ #g1ejj1jjj4  7#c7 ,a cov5ant n
 to sue on any claim t ! ,,&a product or
 biosimil> biological product infr+es a 
,unit$ ,/ates pat5t4  7d7 ,en=cem5t     
7#a7 ,en=cem5t ,a violation ( ?is       
section %all be treat$ z a violation (  
section #e4  7#b7 ,judicial review  7,a7
 ,9 g5]al ,any p>ty t is subject to a   
f9al ord] ( ! ,commission1 issu$ 9 an   
adm9i/rative adjudicative proce$+ "u !  
au?ority ( subsection 7a77#a71 may1 )9  
#cj days ( ! issuance ( su* ord]1       
petition = review ( su* ord] 9--  7i7 ! 

,unit$ ,/ates ,c\rt ( ,appeals = !      
,di/rict ( ,columbia ,circuit2  7ii7 !  
,unit$ ,/ates ,c\rt ( ,appeals = !      
circuit 9 :i* ! ultimate p>5t entity1 z 
def9$ 9 section #hja4a7;a77#c7 ( title  
#af1 ,code ( ,f$]al ,regulations1 or any
 successor !reto1 ( ! ,,nda hold] or    
biological product lic5se hold] is      
incorporat$ z ( ! date t ! ,,nda or     
biological product lic5se application1 z
 applicable1 is fil$ ) ! ,commission] ( 
,food & ,drugs2 or  7iii7 ! ,unit$      
,/ates ,c\rt ( ,appeals = ! circuit 9   
:i* ! ultimate p>5t entity ( ! ,,&a fil]
 or biosimil> biological product        
application fil] is incorporat$ z ( !   
date t ! ,,&a or biosimil> biological   
product application is fil$ ) !         
,commission] ( ,food & ,drugs4  7,b7    
,treatm5t ( f9d+s ,9 a proce$+ =        
judicial review ( a f9al ord] ( !       
,commission1 ! f9d+s ( ! ,commission z  
to ! facts1 if support$ by evid5ce1 %all
 be conclusive4  7e7 ,antitru/ laws     
,no?+ 9 ?is section %all modify1 impair1

 limit1 or sup]s$e ! applicability ( !  
antitru/ laws z def9$ 9 subsection 7a7 (
 ! fir/ section ( ! ,clayton ,act 7#ae  
,u4,s4,c4 #ab7;a771 & ( section #e ( ?is
 ,act to ! ext5t t section #e applies to
 unfair me?ods ( competition4 ,no?+ 9   
?is section %all modify1 impair1 limit1 
or sup]s$e ! "r ( an ,,&a fil] or       
biosimil> biological product application
 fil] to ass]t claims or c\nt]claims    
aga9/ any p]son1 "u ! antitru/ laws or  
o!r laws relat+ to unfair competition4  
7f7 ,p5alties  7#a7 ,=feiture ,ea* p>ty 
t violates or assi/s 9 ! violation ( ?is
 section %all =feit & pay to ! ,unit$   
,/ates a civil p5alty suffici5t to det] 
violations ( ?is section1 b 9 no ev5t   
great] ?an #c times ! value receiv$ by !
 p>ty t is reasonably attributable to ! 
violation ( ?is section4 ,if no su*     
value has be5 receiv$ by ! ,,nda hold]  
or biological product lic5se hold]1 !   
p5alty to ! ,,nda hold] or biological   
product lic5se hold] %all be suffici5t  
to det] violations1 b 9 no ev5t great]  

?an #c times ! value giv5 to ! ,,&a fil]
 or biosimil> biological product        
application fil] reasonably attributable
 to ! violation ( ?is section4 ,su*     
p5alty %all accrue to ! ,unit$ ,/ates & 
may be recov]$ 9 a civil action br\ght  
by ! ,commission1 9 its own "n by any ( 
its attorneys designat$ by x = su*      
purpose1 9 a di/rict c\rt ( ! ,unit$    
,/ates aga9/ any p>ty t violates ?is    
section4 ,9 su* actions1 ! ,unit$ ,/ates
 di/rict c\rts are emp[]$ to grant      
m&atory injunctions & su* o!r & fur!r   
equitable relief z !y deem appropriate4 
7#b7 ,cease & desi/  7,a7 ,9 g5]al ,if !
 ,commission has issu$ a cease & desi/  
ord] ) respect to a p>ty 9 an           
adm9i/rative adjudicative proce$+ "u !  
au?ority ( subsection 7a77#a71 an action
 br\ght pursuant to p>agraph 7#a7 may be
 comm5c$ aga9/ su* p>ty at any "t be=e !
 expiration ( #a ye> aft] su* ord]      
becomes f9al pursuant to section #e7;g74
  7,b7 ,exception ,9 an action "u       
subp>agraph 7,a71 ! f9d+s ( !           

,commission z to ! mat]ial facts 9 !    
adm9i/rative adjudicative proce$+ )     
respect to ! violation ( ?is section by 
a p>ty %all be conclusive unless--  7i7 
! t]ms ( su* cease & desi/ ord]         
expressly provide t ! ,commission's     
f9d+s %all n be conclusive2 or  7ii7 !  
ord] became f9al by reason ( section    
#e7;g77#a71 9 :i* case su* f9d+ %all be 
conclusive if support$ by evid5ce4  7#c7
 ,civil p5alty ,9 det]m9+ ! am\nt ( !   
civil p5alty describ$ 9 ?is section1 !  
c\rt %all take into acc\nt--  7,a7 !    
nature1 circum/ances1 ext5t1 & gravity (
 ! violation2  7,b7 ) respect to !      
violator1 ! degree ( culpability1 any   
hi/ory ( violations1 ! ability to pay1  
any effect on ! ability to cont9ue do+  
bus9ess1 pr(its e>n$ by ! ,,nda hold] or
 biological product lic5se hold]1       
comp5sation receiv$ by ! ,,&a fil] or   
biosimil> biological product application
 fil]1 & ! am\nt ( comm]ce affect$2 &   
7,c7 o!r matt]s t ju/ice requires4  7#d7
 ,rem$ies 9 addition ,rem$ies provid$ 9 

?is subsection are 9 addition to1 & n 9 
lieu (1 any o!r rem$y provid$ by ,f$]al 
law4 ,no?+ 9 ?is p>agraph %all be       
con/ru$ to affect any au?ority ( !      
,commission "u any o!r provision ( law4 
7g7 ,def9itions ,9 ?is section3 7#a7    
,agreem5t ,! t]m agreem5t means any?+ t 
w\ld con/itute an agreem5t "u section #a
 ( ! ,%]man ,act 7#ae ,u4,s4,c4 #a7 or  
section #e ( ?is ,act4  7#b7 ,agreem5t  
resolv+ or settl+ a pat5t infr+em5t     
claim ,! t]m agreem5t resolv+ or settl+ 
a pat5t infr+em5t claim includes any    
agreem5t t is ent]$ into )9 #cj days ( !
 resolution or ! settlem5t ( ! claim1 or
 any o!r agreem5t t is cont+5t ^u1      
provides a cont+5t condition =1 or is   
o!rwise relat$ to ! resolution or       
settlem5t ( ! claim4  7#c7 ,,&a ,! t]m  
,,&a means an abbreviat$ new drug       
application fil$ "u section #eje7;j7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7;j77 or a new drug  
application fil$ "u section #eje7;b77#b7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   

,act 7#ba ,u4,s4,c4 #cee7;b77#b774  7#d7
 ,,&a fil] ,! t]m ,,&a fil] means a p>ty
 t owns or controls an ,,&a fil$ ) !    
,food & ,drug ,adm9i/ration or has !    
exclusive rights "u su* ,,&a to         
di/ribute ! ,,&a product4  7#e7 ,,&a    
product ,! t]m ,,&a product means !     
product to be manufactur$ "u ! ,,&a t is
 ! subject ( ! pat5t infr+em5t claim4   
7#f7 ,biological product ,! t]m         
biological product has ! mean+ giv5 su* 
t]m 9 section #cea7;i77#a7 ( ! ,public  
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7;i77#a774  7#g7 ,biological product
 lic5se application ,! t]m biological   
product lic5se application means an     
application "u section #cea7;a7 ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a774  7#h7 ,biological  
product lic5se hold] ,! t]m biological  
product lic5se hold] means--  7,a7 !    
hold] ( an approv$ biological product   
lic5se application = a biological       
product2  7,b7 a p]son own+ or controll+
 en=cem5t ( any pat5ts t claim !        

biological product t is ! subject ( su* 
approv$ application2 or  7,c7 !         
pr$ecessors1 subsidi>ies1 divisions1    
gr\ps1 & affiliates controll$ by1       
controll+1 or "u common control ) any ( 
! entities describ$ 9 subp>agraphs 7,a7 
& 7,b7 7su* control to be presum$ by    
direct or indirect %>e own]%ip ( #ej    
p]c5t or great]71 z well z ! lic5sees1  
lic5sors1 successors1 & assigns ( ea* ( 
! entities4  7#i7 ,biosimil> biological 
product ,! t]m biosimil> biological     
product means ! product to be           
manufactur$ "u ! biosimil> biological   
product application t is ! subject ( !  
pat5t infr+em5t claim4  7#aj7 ,biosimil>
 biological product application ,! t]m  
biosimil> biological product application
 means an application "u section #cea7k7
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb7k77 = lic5sure ( a       
biological product z biosimil> to1 or   
int]*angeable )1 a ref]5ce product4     
7#aa7 ,biosimil> biological product     
application fil] ,! t]m biosimil>       

biological product application fil]     
means a p>ty t owns or controls a       
biosimil> biological product application
 fil$ ) ! ,food & ,drug ,adm9i/ration or
 has ! exclusive rights "u su*          
application to di/ribute ! biosimil>    
biological product4  7#ab7 ,drug product
 ,! t]m drug product has ! mean+ giv5   
su* t]m 9 section #cad4c7;b7 ( title    
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulation74  7#ac7 ,,nda ,! 
t]m ,,nda means a new drug application  
fil$ "u section #eje7;b7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b774  7#ad7 ,,nda hold] 
,! t]m ,,nda hold] means-- 7,a7 ! hold] 
( an approv$ ,,nda application = a drug 
product2  7,b7 a p]son own+ or controll+
 en=cem5t ( ! pat5t li/$ 9 ! ,approv$   
,drug ,products ,) ,!rapeutic           
,equival5ce ,evaluations 7commonly kn[n 
z ! ,,fda ,orange ,book7 9 connection ) 
! ,,nda2 or  7,c7 ! pr$ecessors1        
subsidi>ies1 divisions1 gr\ps1 &        
affiliates controll$ by1 controll+1 or  

"u common control ) any ( ! entities    
describ$ 9 subp>agraphs 7,a7 & 7,b7 7su*
 control to be presum$ by direct or     
indirect %>e own]%ip ( #ej p]c5t or     
great]71 z well z ! lic5sees1 lic5sors1 
successors1 & assigns ( ea* ( !         
entities4  7#ae7 ,p>ty ,! t]m p>ty means
 any p]son1 p>tn]%ip1 corporation1 or   
o!r legal entity4  7#af7 ,pat5t         
infr+em5t ,! t]m pat5t infr+em5t means  
infr+em5t ( any pat5t or ( any fil$     
pat5t application1 ext5sion1 reissue1   
r5ewal1 division1 cont9uation1          
cont9uation 9 "p1 reexam9ation1 pat5t   
t]m re/oration1 pat5ts ( addition1 &    
ext5sions !re(4  7#ag7 ,pat5t infr+em5t 
claim ,! t]m pat5t infr+em5t claim means
 any allegation made to an ,,&a fil] or 
biosimil> biological product application
 fil]1 :e!r or n includ$ 9 a compla9t   
fil$ ) a c\rt ( law1 t its ,,&a or ,,&a 
product1 or biological product lic5se   
application or biological product1 may  
infr+e any pat5t held by1 or exclusively
 lic5s$ to1 ! ,,nda hold] or biological 

product lic5se hold] ( ! drug product or
 biological product1 z applicable4      
7#ah7 ,/atutory exclusivity ,! t]m      
/atutory exclusivity means ^?           
prohibitions on ! approval ( drug       
applications "u clauses 7ii7 ?r\gh 7iv7 
( section #eje7;c77#c77;,e7 7#e- &      
#c-ye> data exclusivity71 section #ebg  
7orphan drug exclusivity71 or section   
#eje;,a 7p$iatric exclusivity7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;c77#c77;,e71       
#cfj;cc1 #cee;a71 or on ! lic5s+ (      
biological product applications "u      
section #cea7k77#g7 7#ab-ye>            
exclusivity7 or p>agraph 7#b7 or 7#c7 ( 
section #cea7m7 7p$iatric exclusivity7 (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bfb7 or "u section #ebg ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7orphan drug exclusivity74  4  7b7      
,effective date ,section #bg ( ! ,f$]al 
,trade ,commission ,act1 z add$ by ?is  
section1 %all apply to all agreem5ts    
describ$ 9 section #bg7;a77#a7 ( t ,act 

ent]$ into aft] ,june #ag1 #bjac4       
,section #bg7;f7 ( ! ,f$]al ,trade      
,commission ,act1 z add$ by ?is section1
 %all apply to agreem5ts ent]$ into on  
or aft] ! date ( enactm5t ( ?is ,act4   
#d4 ,c]tification ( agreem5ts ,section  
#aaab ( ! ,m$ic>e ,prescription ,drug1  
,improvem5t1 & ,mod]nization ,act (     
#bjjc 7#ba ,u4,s4,c4 #cee note7 is am5d$
 by add+ at ! end ! foll[+3  7d7        
,c]tification ,! ,*ief ,executive ,(fic]
 or ! company (ficial responsible =     
negotiat+ any agreem5t "u subsection 7a7
 or 7b7 t is requir$ to be fil$ "u      
subsection 7c71 )9 #cj days aft] su*    
fil+1 %all execute & file ) ! ,assi/ant 
,attorney ,g5]al & ! ,commission a      
c]tification z foll[s3 ,i decl>e t !    
foll[+ is true1 correct1 & complete to !
 be/ ( my k3 ,! mat]ials fil$ ) ! ,f$]al
 ,trade ,commission & ! ,dep>tm5t (     
,ju/ice "u section #aaab ( subtitle ,b (
 title ,,xi ( ! ,m$ic>e ,prescription   
,drug1 ,improvem5t1 & ,mod]nization ,act
 ( #bjjc1 ) respect to ! agreem5t       

ref]5c$ 9 ?is c]tification--  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 subsection 7a7 or   
7b7 ( su* section #aaab & h n be5 r$uc$ 
to writ+4  4  #e4 ,=feiture ( #ahj-;day 
exclusivity p]iod ,section              
#eje7;j77#e77;,d77i77,v7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is  
am5d$ by ins]t+ section #bg ( ! ,f$]al  
,trade ,commission ,act or aft] t !     
agreem5t has violat$4  #f4 ,commission  
litigation au?ority ,section #af7;a77#b7
 ( ! ,f$]al ,trade ,commission ,act 7#ae
 ,u4,s4,c4 #ef7;a77#b77 is am5d$-- 7#a7 
9 subp>agraph 7,d71 by /rik+ or aft] !  
semicolon2  7#b7 9 subp>agraph 7,e71 by 
ins]t+ or aft] ! semicolon2 &  7#c7     

ins]t+ aft] subp>agraph 7,e7 ! foll[+3  
7,f7 "u section #bg2  4  #g4 ,/atute (  
limitations ,! ,f$]al ,trade ,commission
 %all comm5ce any en=cem5t proce$+      
describ$ 9 section #bg ( ! ,f$]al ,trade
 ,commission ,act1 z add$ by section #c1
 except = an action describ$ 9 section  
#bg7;f77#b7 ( ! ,f$]al ,trade           
,commission ,act1 n lat] ?an #f ye>s    
aft] ! date on :i* ! p>ties to !        
agreem5t file ! c]tification "u section 
#aaab7;d7 ( ! ,m$ic>e ,prescription     
,drug ,improvem5t & ,mod]nization ,act (
 #bjjc 7#ba ,u4,s4,c4 #cee note74  #h4  
,sev]ability ,if any provision ( ?is    
,act1 an am5dm5t made by ?is ,act1 or ! 
application ( su* provision or am5dm5t  
to any p]son or circum/ance is held to  
be uncon/itutional1 ! rema9d] ( ?is     
,act1 ! am5dm5ts made by ?is ,act1 & !  
application ( ! provisions ( su* ,act or
 am5dm5ts to any p]son or circum/ance   
%all n be affect$4