,,ib  ,union ,cal5d> ,no4 #cj  #aaf?    
,,congress  #a/ ,session  ,h4 ,r4 #adii 
,report ,no4 #aaf-eb1 ,"p ,i  ,,9 ,,!   
,,h\se ,,( ,,repres5tatives  ,m>* #e1   
#bjai ,mr4 ,ru% introduc$ ! foll[+ bill2
 :i* 0 ref]r$ to ! ,committee on ,en]gy 
& ,comm]ce1 & 9 addition to ! ,committee
 on ! ,judici>y1 = a p]iod to be        
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,may #aj1 #bjai ,additional    
sponsors3 ,mr4 ,pallone1 ,mr4 ,ruiz1    
,mrs4 ,d+ell1 ,mrs4 ,craig1 ,ms4 ,e%oo1 
,mr4 ,k5n$y1 ,ms4 ,matsui1 ,mr4 ,van    
,drew1 ,ms4 ,cl>ke ( ,new ,york1 ,mr4   
,khanna1 ,ms4 ,s*ak[sky1 ,mr4 ,pappas1  
,mr4 ,coh51 ,mr4 ,wel*1 ,mr4 ,l>son (   
,connecticut1 ,mr4 ,ha/+s1 ,mr4 ,neguse1
 ,ms4 ,f9k5au]1 ,mr4 ,case1 ,mr4        
,quigley1 ,ms4 ,wild1 ,mr4 ,langev91    
,mr4 ,coop]1 ,mr4 ,rask91 ,mr4 ,david   
,scott ( ,georgia1 ,ms4 ,muc>sel-,p[ell1
 ,mr4 ,?ompson ( ,mississippi1 ,ms4     
,/ev5s1 ,mr4 ,cisn]os1 ,ms4 ,kelly (    

,ill9ois1 ,mr4 ,ca/5 ( ,ill9ois1 ,ms4   
,h\lahan1 ,mr4 ,c>son ( ,indiana1 ,mr4  
,c>bajal1 ,ms4 ,davids ( ,kansas1 ,mr4  
,smi? ( ,wa%+ton1 ,mr4 ,connolly1 & ,ms4
 ,und]wood  ,may #aj1 #bjai ,report$ f !
 ,committee on ,en]gy & ,comm]ce ) an   
am5dm5t ,/rike out all aft] ! enact+    
clause & ins]t ! "p pr9t$ 9 italic  ,may
 #aj1 #bjai ,committee on ! ,judici>y   
dis*>g$2 committ$ to ! ,committee ( !   
,:ole ,h\se on ! ,/ate ( ! ,union &     
ord]$ to be pr9t$ ,= text ( introduc$   
bill1 see copy ( bill z introduc$ on    
,m>* #e1 #bjai  ,a ,,bill  ,to prohibit 
br& "n drug manufactur]s f comp5sat+    
g5]ic drug manufactur]s to delay ! entry
 ( a g5]ic drug into ! m>ket1 & to      
prohibit biological product manufactur]s
 f comp5sat+ biosimil> & int]*angeable  
product manufactur]s to delay entry (   
biosimil> & int]*angeable products1 & = 
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,protect+ ,consum]     
,access to ,g5]ic ,drugs ,act ( #bjai4  
#b4 ,unlawful agreem5ts  7a7 ,agreem5ts 

prohibit$ ,subject to subsections 7b7 & 
7c71 x %all be unlawful = an ,,nda or   
,,bla hold] & a subsequ5t fil] 7or = two
 subsequ5t fil]s7 to ent] into1 or c>ry 
out1 an agreem5t resolv+ or settl+ a    
cov]$ pat5t infr+em5t claim on a f9al or
 int]im basis if "u su* agreem5t--  7#a7
 a subsequ5t fil] directly or indirectly
 receives f su* hold] 7or 9 ! case ( su*
 an agreem5t betwe5 two subsequ5t fil]s1
 ! o!r subsequ5t fil]7 any?+ ( value1   
includ+ a lic5se2 &  7#b7 ! subsequ5t   
fil] agrees to limit or =ego rese>* on1 
or developm5t1 manufactur+1 m>ket+1 or  
sales1 = any p]iod ( "t1 ( ! cov]$      
product t is ! subject ( ! application  
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
subsection 7g77#h74  7b7 ,exclusion ,x  
%all n be unlawful "u subsection 7a7 if 
a p>ty to an agreem5t describ$ 9 su*    
subsection demon/rates by cle> & conv9c+
 evid5ce t ! value describ$ 9 subsection
 7a77#a7 is comp5sation solely = o!r    
goods or s]vices t ! subsequ5t fil] has 
promis$ to provide4  7c7 ,limitation    

,no?+ 9 ?is section %all prohibit an    
agreem5t resolv+ or settl+ a cov]$ pat5t
 infr+em5t claim 9 :i* ! consid]ation   
grant$ by ! ,,nda or ,,bla hold] to !   
subsequ5t fil] 7or f "o subsequ5t fil]  
to ano!r7 z "p ( ! resolution or        
settlem5t includes only "o or m ( !     
foll[+3  7#a7 ,! "r to m>ket ! cov]$    
product t is ! subject ( ! application  
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
subsection 7g77#h7 9 ! ,unit$ ,/ates    
be=e ! expiration (-- 7,a7 any pat5t t  
is ! basis ( ! cov]$ pat5t infr+em5t    
claim2 or  7,b7 any pat5t "r or o!r     
/atutory exclusivity t w\ld prev5t !    
m>ket+ ( su* cov]$ product4  7#b7 ,a    
paym5t = reasonable litigation exp5ses n
 to exce$ #g1ejj1jjj 9 ! aggregate4     
7#c7 ,a cov5ant n to sue on any claim t 
su* cov]$ product infr+es a pat5t4  7d7 
,en=cem5t by ,f$]al ,trade ,commission  
7#a7 ,g5]al application ,! requirem5ts (
 ?is section apply1 accord+ to _! t]ms1 
to an ,,nda or ,,bla hold] or subsequ5t 
fil] t is--  7,a7 a p]son1 p>tn]%ip1 or 

corporation ov] :i* ! ,commission has   
au?ority pursuant to section #e7;a77#b7 
( ! ,f$]al ,trade ,commission ,act 7#ae 
,u4,s4,c4 #de7;a77#b772 or  7,b7 a      
p]son1 p>tn]%ip1 or corporation ov] :i* 
! ,commission w\ld h au?ority pursuant  
to su* section b = ! fact t su* p]son1  
p>tn]%ip1 or corporation is n organiz$  
to c>ry on bus9ess = its own pr(it or t 
( its memb]s4  7#b7 ,unfair or deceptive
 acts or practices en=cem5t au?ority    
7,a7 ,9 g5]al ,a violation ( ?is section
 %all be treat$ z an unfair or deceptive
 act or practice 9 violation ( section  
#e7;a77#a7 ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #de7;a77#a774  7,b7
 ,p[]s ( ,commission ,except z provid$ 9
 subp>agraph 7,c7 & p>agraphs 7#a77;,b7 
& 7#c7--  7i7 ! ,commission %all en=ce  
?is section 9 ! same mann]1 by ! same   
means1 & ) ! same jurisdiction1 p[]s1 & 
duties z ?\gh all applicable t]ms &     
provisions ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #da et seq47 7     
incorporat$ into & made a "p ( ?is      

section2 &  7ii7 any ,,nda or ,,bla     
hold] or subsequ5t fil] t violates ?is  
section %all be subject to ! p5alties & 
entitl$ to ! privileges & immunities    
provid$ 9 ! ,f$]al ,trade ,commission   
,act4  7,c7 ,judicial review ,9 ! case (
 a cease & desi/ ord] issu$ by !        
,commission "u section #e ( ! ,f$]al    
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7 = violation ( ?is section1 a p>ty  
to su* ord] may obta9 judicial review ( 
su* ord] z provid$ 9 su* section #e1    
except t-- 7i7 su* review may only be   
obta9$ 9--  7,i7 ! ,unit$ ,/ates ,c\rt (
 ,appeals = ! ,di/rict ( ,columbia      
,circuit2  7,,ii7 ! ,unit$ ,/ates ,c\rt 
( ,appeals = ! circuit 9 :i* ! ultimate 
p>5t entity1 z def9$ 9 section          
#hja4a7;a77#c7 ( title #af1 ,code (     
,f$]al ,regulations1 or any successor   
!reto1 ( ! ,,nda or ,,bla hold] 7if any 
su* hold] is a p>ty to su* ord]7 is     
incorporat$ z ( ! date t ! application  
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
subsection 7g77#h7 or an approv$        

application t is deem$ to be a lic5se = 
a biological product "u section #cea7k7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7k77 pursuant to section  
#gjjb7;e77#d7 ( ! ,biologics ,price     
,competition & ,innovation ,act ( #bjji 
7,public ,law #aaa-adh2 #abd ,/at4 #hag7
 is submitt$ to ! ,commission] ( ,food &
 ,drugs2 or  7,,iii7 ! ,unit$ ,/ates    
,c\rt ( ,appeals = ! circuit 9 :i* !    
ultimate p>5t entity1 z s def9$1 ( any  
subsequ5t fil] t is a p>ty to su* ord]  
is incorporat$ z ( ! date t !           
application describ$ 9 subp>agraph 7,a7 
or 7,b7 ( subsection 7g77#h7 is submitt$
 to ! ,commission] ( ,food & ,drugs2 &  
7ii7 ! petition = review %all be fil$ 9 
! c\rt n lat] ?an #cj days aft] su* ord]
 is s]v$ on ! p>ty seek+ review4  7#c7  
,additional en=cem5t au?ority  7,a7     
,civil p5alty ,! ,commission may comm5ce
 a civil action to recov] a civil p5alty
 9 a di/rict c\rt ( ! ,unit$ ,/ates     
aga9/ any ,,nda or ,,bla hold] or       
subsequ5t fil] t violates ?is section4  

7,b7 ,special rule = recov]y ( p5alty if
 cease & desi/ ord] issu$  7i7 ,9 g5]al 
,if ! ,commission has issu$ a cease &   
desi/ ord] 9 a proce$+ "u section #e ( !
 ,f$]al ,trade ,commission ,act 7#ae    
,u4,s4,c4 #de7 = violation ( ?is        
section--  7,i7 ! ,commission may       
comm5ce a civil action "u subp>agraph   
7,a7 to recov] a civil p5alty aga9/ any 
p>ty to su* ord] at any "t be=e !       
expiration ( ! #a-ye> p]iod beg9n+ on ! 
date on :i* su* ord] becomes f9al "u    
section #e7;g7 ( su* ,act 7#ae ,u4,s4,c4
 #de7;g772 &  7,,ii7 9 su* civil action1
 ! f9d+s ( ! ,commission z to ! mat]ial 
facts 9 su* proce$+ %all be conclusive1 
unless--  7aa7 ! t]ms ( su* ord]        
expressly provide t ! ,commission's     
f9d+s %all n be conclusive2 or  7bb7 su*
 ord] became f9al by reason ( section   
#e7;g77#a7 ( su* ,act 7#ae ,u4,s4,c4    
#de7;g77#a771 9 :i* case su* f9d+s %all 
be conclusive if support$ by evid5ce4   
7ii7 ,relation%ip to p5alty = violation 
( an ord] ,! p5alty provid$ 9 clause 7i7

 = violation ( ?is section is sep>ate f 
& 9 addition to any p5alty t may be     
incurr$ = violation ( an ord] ( !       
,commission "u section #e7l7 ( ! ,f$]al 
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7l774  7,c7 ,am\nt ( p5alty  7i7 ,9  
g5]al ,! am\nt ( a civil p5alty impos$ 9
 a civil action "u subp>agraph 7,a7 on a
 p>ty to an agreem5t describ$ 9         
subsection 7a7 %all be suffici5t to det]
 violations ( ?is section1 b 9 no ev5t  
great] ?an--  7,i7 if su* p>ty is !     
,,nda or ,,bla hold] 7or1 9 ! case ( an 
agreem5t betwe5 two subsequ5t fil]s1 !  
subsequ5t fil] :o gave ! value describ$ 
9 subsection 7a77#a771 ! great] (-- 7aa7
 #c times ! value receiv$ by su* ,,nda  
or ,,bla hold] 7or by su* subsequ5t     
fil]7 t is reasonably attributable to ! 
violation ( ?is section2 or  7bb7 #c    
times ! value giv5 to ! subsequ5t fil]  
7or to ! o!r subsequ5t fil]7 reasonably 
attributable to ! violation ( ?is       
section2 &  7,,ii7 if su* p>ty is !     
subsequ5t fil] 7or1 9 ! case ( an       

agreem5t betwe5 two subsequ5t fil]s1 !  
subsequ5t fil] :o receiv$ ! value       
describ$ 9 subsection 7a77#a771 #c times
 ! value receiv$ by su* subsequ5t fil] t
 is reasonably attributable to !        
violation ( ?is section4  7ii7 ,factors 
= consid]ation ,9 det]m9+ su* am\nt1 !  
c\rt %all take into acc\nt-- 7,i7 !     
nature1 circum/ances1 ext5t1 & gravity (
 ! violation2  7,,ii7 ) 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 or ,,bla
 hold] 7or1 9 ! case ( an agreem5t      
betwe5 two subsequ5t fil]s1 ! subsequ5t 
fil] :o gave ! value describ$ 9         
subsection 7a77#a771 comp5sation receiv$
 by ! subsequ5t fil] 7or1 9 ! case ( an 
agreem5t betwe5 two subsequ5t fil]s1 !  
subsequ5t fil] :o receiv$ ! value       
describ$ 9 subsection 7a77#a771 & !     
am\nt ( comm]ce affect$2 &  7,,iii7 o!r 
matt]s t ju/ice requires4  7,d7         
,injunctions & o!r equitable relief ,9 a

 civil action "u subp>agraph 7,a71 !    
,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#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$]al law4  7#e7           
,pres]vation ( au?ority ( ,commission   
,no?+ 9 ?is section %all be con/ru$ to  
affect any au?ority ( ! ,commission "u  
any o!r provision ( law4  7e7 ,f$]al    
,trade ,commission rulemak+ ,!          
,commission may1 9 its discretion1 by   
rule promulgat$ "u section #eec ( title 
#e1 ,unit$ ,/ates ,code1 exempt f ?is   
section c]ta9 agreem5ts describ$ 9      
subsection 7a7 if ! ,commission f9ds su*
 agreem5ts to be 9 fur!rance ( m>ket    
competition & = ! b5efit ( consum]s4    
7f7 ,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 ( ! ,f$]al ,trade         
,commission ,act 7#ae ,u4,s4,c4 #de7 to 
! ext5t t su* section #e applies to     
unfair me?ods ( competition4 ,no?+ 9 ?is
 section %all modify1 impair1 limit1 or 
sup]s$e ! "r ( a subsequ5t fil] to ass]t
 claims or c\nt]claims aga9/ any p]son1 
"u ! antitru/ laws or o!r laws relat+ to
 unfair competition4  7g7 ,def9itions ,9
 ?is section3  7#a7 ,agreem5t resolv+ or
 settl+ a cov]$ pat5t infr+em5t claim ,!
 t]m agreem5t resolv+ or settl+ a cov]$ 
pat5t infr+em5t claim means any agreem5t
 t-- 7,a7 resolves or settles a cov]$   
pat5t infr+em5t claim2 or  7,b7 is      
cont+5t ^u1 provides = a cont+5t        
condition =1 or is o!rwise relat$ to !  
resolution or settlem5t ( a cov]$ pat5t 
infr+em5t claim4  7#b7 ,commission ,!   
t]m ,commission means ! ,f$]al ,trade   
,commission4  7#c7 ,cov]$ pat5t         
infr+em5t claim ,! t]m cov]$ pat5t      
infr+em5t claim means an allegation made
 by ! ,,nda or ,,bla hold] to a         
subsequ5t fil] 7or1 9 ! case ( an       

agreem5t betwe5 two subsequ5t fil]s1 by 
"o subsequ5t fil] to ano!r71 :e!r or n  
includ$ 9 a compla9t fil$ ) a c\rt (    
law1 t-- 7,a7 ! submission ( !          
application describ$ 9 subp>agraph 7,a7 
or 7,b7 ( p>agraph 7#i71 or !           
manufacture1 use1 (f]+ = sale1 sale1 or 
importation into ! ,unit$ ,/ates ( a    
cov]$ product t is ! subject ( su* an   
application--  7i7 9 ! case ( an        
agreem5t betwe5 an ,,nda or ,,bla hold] 
& a subsequ5t fil]1 infr+es any pat5t   
own$ by1 or exclusively lic5s$ to1 !    
,,nda or ,,bla hold] ( ! cov]$ product2 
or  7ii7 9 ! case ( an agreem5t betwe5  
two subsequ5t fil]s1 infr+es any pat5t  
own$ by ! subsequ5t fil]2 or  7,b7 9 !  
case ( an agreem5t betwe5 an ,,nda or   
,,bla hold] & a subsequ5t fil]1 ! cov]$ 
product to be manufactur$ "u su*        
application uses a cov]$ product z      
claim$ 9 a publi%$ pat5t application4   
7#d7 ,cov]$ product ,! t]m cov]$ product
 means a drug 7z def9$ 9 section        
#bja7;g7 ( ! ,f$]al ,food1 ,drug1 &     

,cosmetic ,act 7#ba ,u4,s4,c4           
#cba7;g7771 includ+ a biological product
 7z def9$ 9 section #cea7;i7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bfb7;i774  7#e7 ,,nda or ,,bla hold] ,!
 t]m ,,nda or ,,bla hold] means-- 7,a7 !
 hold] (--  7i7 an approv$ new drug     
application fil$ "u section #eje7;b77#a7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;b77#a77 = a   
cov]$ product2 or  7ii7 a biologics     
lic5se application fil$ "u section      
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a77 ) respect to a
 biological product2  7,b7 a p]son own+ 
or controll+ en=cem5t ( ! pat5t on-- 7i7
 ! li/ publi%$ "u section #eje7;j77#g7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7;j77#g77 9         
connection ) ! application describ$ 9   
subp>agraph 7,a77i72 or  7ii7 any li/   
publi%$ "u section #cea ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7
 compris$ ( pat5ts associat$ ) biologics
 lic5se applications fil$ "u section    

#cea7;a7 ( su* ,act 7#db ,u4,s4,c4      
#bfb7;a772 or  7,c7 ! pr$ecessors1      
subsidi>ies1 divisions1 gr\ps1 &        
affiliates controll$ by1 controll+1 or  
"u common control ) any entity describ$ 
9 subp>agraph 7,a7 or 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#f7 ,pat5t
 ,! t]m pat5t means a pat5t issu$ by !  
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice4
  7#g7 ,/atutory exclusivity ,! t]m     
/atutory exclusivity means ^?           
prohibitions on ! submission or approval
 ( drug applications "u clauses 7ii7    
?r\gh 7iv7 ( section #eje7;c77#c77;,e7  
7#e- & #c-ye> exclusivity71 clauses 7ii7
 ?r\gh 7iv7 ( section #eje7;j77#e77;,f7 
7#e-ye> & #c-ye> exclusivity71 section  
#eje7;j77#e77;,b77iv7 7#ahj-;day        
exclusivity71 section #ebg 7orphan drug 
exclusivity71 section #eje;,a 7p$iatric 
exclusivity71 or section #eje;,e        
7qualifi$ infecti\s disease product     

exclusivity7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;c77#c77;,e71                      
#cee7;j77#e77;,b77iv71                  
#cee7;j77#e77;,f71 #cfj;cc1 #cee;a1     
#cee;f71 or prohibitions on ! submission
 or lic5s+ ( biologics lic5se           
applications "u section #cea7k77#f7     
7int]*angeable biological product       
exclusivity7 or section #cea7k77#g7     
7biological product ref]5ce product     
exclusivity7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 
7#h7 ,subsequ5t fil] ,! t]m subsequ5t   
fil] means-- 7,a7 9 ! case ( a drug1 a  
p>ty t owns or controls an abbreviat$   
new drug application submitt$ pursuant  
to section #eje7;j7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77 or a new drug application     
submitt$ pursuant to section            
#eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba,u4,s4,c4            
#cee7;b77#b77 & fil$ "u section         
#eje7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4  

#cee7;b77#a77 or has ! exclusive rights 
to di/ribute ! cov]$ product t is !     
subject ( su* application2 or  7,b7 9 ! 
case ( a biological product1 a p>ty t   
owns or controls an application fil$ ) !
 ,food & ,drug ,adm9i/ration "u section 
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k77 or has !        
exclusive rights to di/ribute !         
biological product t is ! subject ( su* 
application4  7h7 ,effective date ,?is  
section applies ) respect to agreem5ts  
describ$ 9 subsection 7a7 ent]$ into on 
or aft] ! date ( ! enactm5t ( ?is ,act4 
#c4 ,notice & c]tification ( agreem5ts  
7a7 ,notice ( all agreem5ts ,section    
#aaaa7g7 ( ! ,m$ic>e ,prescription      
,drug1 ,improvem5t1 & ,mod]nization ,act
 ( #bjjc 7#ba ,u4,s4,c4 #cee note7 is   
am5d$ by ins]t+ or ! own] ( a pat5t =   
:i* a claim ( infr+em5t c\ld reasonably 
be ass]t$ aga9/ any p]son = mak+1 us+1  
(f]+ to sell1 sell+1 or import+ into !  
,unit$ ,/ates a biological product t is 
! subject ( a biosimil> biological      

product application be=e ! p]iod at !   
end4  7b7 ,c]tification ( agreem5ts     
,section #aaab ( su* ,act 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 7c7 %all1 )9 #cj    
days ( su* fil+1 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$]al ,trade ,commission & !  
,dep>tm5t ( ,ju/ice "u section #aaab ( !
 ,m$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 7 ent]$  
into )9 #cj days (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  4  #d4 ,=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 #b ( ! ,protect+
 ,consum] ,access to ,g5]ic ,drugs ,act 
( #bjai or aft] t ! agreem5t has        
violat$4  #e4 ,commission litigation    
au?ority ,section #af7;a77#b7 ( ! ,f$]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 by  
ins]t+ aft] subp>agraph 7,e7 ! foll[+3  
7,f7 "u section #b7;d77#c77;,a7 ( !     
,protect+ ,consum] ,access to ,g5]ic    
,drugs ,act ( #bjai2  4  #f4 ,/atute (  

limitations  7a7 ,9 g5]al ,except z     
provid$ 9 subsection 7b71 ! ,commission 
%all comm5ce any adm9i/rative proce$+ or
 civil action to en=ce section #b ( ?is 
,act n lat] ?an #f ye>s aft] ! date on  
:i* ! p>ties to ! agreem5t file !       
,notice ( ,agreem5t z provid$ by section
 #aaab7;c77#b7 & 7d7 ( ! ,m$ic>e        
,prescription ,drug1 ,improvem5t1 &     
,mod]nization ,act ( #bjjc 7#ba         
,u4,s4,c4 #cee note74  7b7 ,civil action
 aft] issuance ( cease & desi/ ord] ,if 
! ,commission has issu$ a cease & desi/ 
ord] "u section #e ( ! ,f$]al ,trade    
,commission ,act 7#ae ,u4,s4,c4 #de7 =  
violation ( section #b ( ?is ,act & !   
proce$+ = ! issuance ( su* ord] 0       
comm5c$ )9 ! p]iod requir$ by subsection
 7a7 ( ?is section1 su* subsection does 
n prohibit ! comm5cem5t1 aft] su* p]iod1
 ( a civil action "u section            
#b7;d77#c77;,a7 aga9/ a p>ty to su* ord]
 or a civil action "u subsection 7l7 (  
su* section #e = violation ( su* ord]4  
,may #aj1 #bjai ,report$ f ! ,committee 

on ,en]gy & ,comm]ce ) an am5dm5t ,may  
#aj1 #bjai ,committee on ! ,judici>y    
dis*>g$2 committ$ to ! ,committee ( !   
,:ole ,h\se on ! ,/ate ( ! ,union &     
ord]$ to be pr9t$