,,ii  #aac? ,,congress  #a/ ,session    
,s4 #ejd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #g1 #bjac ,mr4    
,frank5 7= himself1 ,mr4 ,vitt]1 ,mr4   
,durb91 ,mrs4 ,%ahe51 & ,mr4 ,s&]s7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to ensure t     
valid g5]ic drugs may ent] ! m>ket4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,fair ,& ,imm$iate ,release ( ,g5]ic    
,drugs ,act or ! ,,fair ,g5]ics ,act4   
#b4 #ahj-;,day exclusivity p]iod        
am5dm5ts reg>d+ fir/ applicant /atus    
7a7 ,am5dm5ts to ,f$]al ,food1 ,drug1 & 
,cosmetic ,act  7#a7 ,9 g5]al ,section  
#eje7;j77#e77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#e77;,b77 is am5d$--  7,a7 9   
clause 7iv77,,ii7--  7i7 by /rik+ item  
7bb72 &  7ii7 by r$esignat+ items 7cc7 &
 7dd7 z items 7bb7 & 7cc71 respectively2
 &  7,b7 by add+ at ! end ! foll[+3  7v7

 ,fir/ applicant def9$ ,z us$ 9 ?is     
subsection1 ! t]m fir/ applicant means  
an applicant--  7,i7 7aa7 t1 on ! fir/  
day on :i* a sub/antially complete      
application conta9+ a c]tification      
describ$ 9 p>agraph 7#b77;,a77vii77,,iv7
 is submitt$ = approval ( a drug1       
submits a sub/antially complete         
application t conta9s & lawfully ma9ta9s
 a c]tification describ$ 9 p>agraph     
7#b77;,a77vii77,,iv7 = ! drug2 &  7bb7 t
 has n ent]$ into a disqualify+ agreem5t
 describ$ "u clause 7vii77,,ii72 or     
7,,ii7 7aa7 = ! drug t is n describ$ 9  
subclause 7,i7 & t1 ) respect to !      
applicant & drug1 ea* requirem5t        
describ$ 9 clause 7vi7 is satisfi$2 &   
7bb7 t has n ent]$ into a disqualify+   
agreem5t describ$ "u clause 7vii77,,ii74
  7vi7 ,requirem5t ,! requirem5ts       
describ$ 9 ?is clause are ! foll[+3     
7,i7 ,! applicant describ$ 9 clause     
7v77,,ii7 submitt$ & lawfully ma9ta9s a 
c]tification describ$ 9 p>agraph        
7#b77;,a77vii77,,iv7 or a /atem5t       

describ$ 9 p>agraph 7#b77;,a77viii7 =   
ea* unexpir$ pat5t = :i* a fir/         
applicant describ$ 9 clause 7v77,i7 _h  
submitt$ a c]tification describ$ 9      
p>agraph 7#b77;,a77vii77,,iv7 on ! fir/ 
day on :i* a sub/antially complete      
application conta9+ su* a c]tification 0
 submitt$4  7,,ii7 ,) reg>d to ea* su*  
unexpir$ pat5t = :i* ! applicant        
describ$ 9 clause 7v77,,ii7 submitt$ a  
c]tification describ$ 9 p>agraph        
7#b77;,a77vii77,,iv71 no action = pat5t 
infr+em5t 0 br\ght aga9/ su* applicant  
)9 ! #de-;day p]iod specifi$ 9 p>agraph 
7#e77;,b77iii72 or if an action 0 br\ght
 )9 su* "t p]iod1 su* an action 0 )drawn
 or dismiss$ by a c\rt 7includ+ a       
di/rict c\rt7 )\t a decision t ! pat5t 0
 valid & infr+$2 or if an action 0      
br\ght )9 su* "t p]iod & 0 n )drawn or s
 dismiss$1 su* applicant has obta9$ !   
decision ( a c\rt 7includ+ a di/rict    
c\rt7 t ! pat5t is invalid or n infr+$  
7includ+ any sub/antive det]m9ation t   
!re is no cause ( action = pat5t        

infr+em5t or invalidity1 & includ+ a    
settlem5t ord] or cons5t decree sign$ & 
ent]$ by ! c\rt /at+ t ! pat5t is       
invalid or n infr+$74  7,,iii7 ,if an   
applicant describ$ 9 clause 7v77,i7 has 
begun comm]cial m>ket+ ( su* drug1 !    
applicant describ$ 9 clause 7v77,,ii7   
does n beg9 comm]cial m>ket+ ( su* drug 
until ! date t is #cj days aft] ! date  
on :i* ! applicant describ$ 9 clause    
7v77,i7 began su* comm]cial m>ket+4  4  
7#b7 ,con=m+ am5dm5t ,section           
#eje7;j77#e77;,d77i77,,iv7 ( su* ,act   
7#ba ,u4,s4,c4                          
#cee7;j77#e77;,d77i77,,iv77 is am5d$ by 
/rik+ ,! fir/ applicant & ins]t+ ,! fir/
 applicant1 z def9$ 9 subp>agraph       
7,b77v77,i714  7b7 ,applicability ,!    
am5dm5ts made by subsection 7a7 %all    
apply only ) respect to an application  
fil$ "u section #eje7;j7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77 to :i* ! am5dm5ts   
made by section #aajb7;a7 ( ! ,m$ic>e   
,prescription ,drug1 ,improvem5t1 &     

,mod]nization ,act ( #bjjc 7,public ,law
 #ajh-agc7 apply4  #c4 #ahj-;,day       
exclusivity p]iod am5dm5ts reg>d+       
agreem5ts to def] comm]cial m>ket+  7a7 
,am5dm5ts to ,f$]al ,food1 ,drug1 &     
,cosmetic ,act  7#a7 ,limitations on    
agreem5ts to def] comm]cial m>ket+ date 
,section #eje7;j77#e77;,b7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#e77;,b771 z am5d$ by
 section #b1 is fur!r am5d$ by add+ at !
 end ! foll[+3  7vii7 ,agreem5t by fir/ 
applicant to def] comm]cial m>ket+2     
limitation on accel]ation ( def]r$      
comm]cial m>ket+ date  7,i7 ,agreem5t to
 def] approval or comm]cial m>ket+ date 
,an agreem5t describ$ 9 ?is subclause is
 an agreem5t betwe5 a fir/ applicant & !
 hold] ( ! application = ! li/$ drug or 
an own] ( "o or m ( ! pat5ts z to :i*   
any applicant submitt$ a c]tification   
qualify+ su* applicant = ! #ahj-;day    
exclusivity p]iod :]eby t applicant     
agrees1 directly or indirectly1 7aa7 n  
to seek an approval ( its application t 

is made effective on ! e>lie/ possible  
date "u ?is subp>agraph1 subp>agraph    
7,f7 ( ?is p>agraph1 section #eje;,a1 or
 section #ebg1 7bb7 n to beg9 !         
comm]cial m>ket+ ( its drug on ! e>lie/ 
possible date aft] receiv+ an approval (
 its application t is made effective "u 
?is subp>agraph1 subp>agraph 7,f7 ( ?is 
p>agraph1 section #eje;,a1 or section   
#ebg1 or 7cc7 to bo? items 7aa7 & 7bb74 
7,,ii7 ,agreem5t t disqualifies         
applicant f fir/ applicant /atus ,an    
agreem5t describ$ 9 ?is subclause is an 
agreem5t betwe5 an applicant & ! hold] (
 ! application = ! li/$ drug or an own] 
( "o or m ( ! pat5ts z to :i* any       
applicant submitt$ a c]tification       
qualify+ su* applicant = ! #ahj-;day    
exclusivity p]iod :]eby t applicant     
agrees1 directly or indirectly1 n to    
seek an approval ( its application or n 
to beg9 ! comm]cial m>ket+ ( its drug   
until a date t is aft] ! expiration ( ! 
#ahj-;day exclusivity p]iod aw>d$ to    
ano!r applicant ) respect to su* drug   

7)\t reg>d to :e!r su* #ahj-;day        
exclusivity p]iod is aw>d$ be=e or aft] 
! date ( ! agreem5t74  7viii7           
,limitation on accel]ation ,if an       
agreem5t describ$ 9 clause 7vii77,i7    
includes m ?an #a possible date :5 an   
applicant may seek an approval ( its    
application or beg9 ! comm]cial m>ket+ (
 its drug--  7,i7 ! applicant may seek  
an approval ( its application or beg9   
su* comm]cial m>ket+ on ! date t is !   
e>li] (--  7aa7 ! late/ date set =? 9 ! 
agreem5t on :i* t applicant c receive an
 approval t is made effective "u ?is    
subp>agraph1 subp>agraph 7,f7 ( ?is     
p>agraph1 section #eje;,a1 or section   
#ebg1 or beg9 ! comm]cial m>ket+ ( su*  
drug1 )\t reg>d to any o!r provision (  
su* agreem5t pursuant to :i* ! comm]cial
 m>ket+ c\ld beg9 on an e>li] date2 or  
7bb7 #ahj days aft] ano!r fir/ applicant
 beg9s comm]cial m>ket+ ( su* drug2 &   
7,,ii7 ! late/ date set =? 9 ! agreem5t 
on :i* t applicant c receive an approval
 t is made effective "u ?is subp>agraph1

 subp>agraph 7,f7 ( ?is p>agraph1       
section #eje;,a1 or section #ebg1 or    
beg9 ! comm]cial m>ket+ ( su* drug1 )\t 
reg>d to any o!r provision ( su*        
agreem5t pursuant to :i* comm]cial      
m>ket+ c\ld beg9 on an e>li] date1 %all 
be ! date us$ to det]m9e :e!r an        
applicant is disqualifi$ f fir/         
applicant /atus pursuant to clause      
7vii77,,ii74  4  7#b7 ,notification (   
,,fda ,section #eje7;j7 ( su* ,act 7#ba 
,u4,s4,c4 #cee7;j77 is am5d$ by add+ at 
! end ! foll[+3  7#aa7 7,a7 ,! hold] (  
an abbreviat$ application "u ?is        
subsection %all submit to ! ,secret>y a 
notification t includes--  7i7 7,i7 !   
text ( any agreem5t ent]$ into by su*   
hold] describ$ "u p>agraph              
7#e77;,b77vii77,i72 or  7,,ii7 if su* an
 agreem5t has n be5 r$uc$ to text1 a    
writt5 detail$ description ( su*        
agreem5t t is suffici5t to disclose all 
! t]ms & conditions ( ! agreem5t2 &     
7ii7 ! text1 or a writt5 detail$        
description 9 ! ev5t ( an agreem5t t has

 n be5 r$uc$ to text1 ( any o!r         
agreem5ts t are cont+5t ^u1 provide a   
cont+5t condition =1 or are o!rwise     
relat$ to an agreem5t describ$ 9 clause 
7i74  7,b7 ,! notification describ$ "u  
subp>agraph 7,a7 %all be submitt$ n lat]
 ?an #aj bus9ess days aft] execution ( !
 agreem5t describ$ 9 subp>agraph        
7,a77i74 ,su* notification is 9 addition
 to any notification requir$ "u section 
#aaab ( ! ,m$ic>e ,prescription ,drug1  
,improvem5t1 & ,mod]nization ,act (     
#bjjc4  7,c7 ,any in=mation or docum5t>y
 mat]ial fil$ ) ! ,secret>y 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$+4 ,no?+ 9 ?is p>agraph is int5d$ 
to prev5t disclosure to ei!r body ( !   
,congress or to any duly au?oriz$       
committee or subcommittee ( ! ,congress4
  4  7#c7 ,prohibit$ acts ,section      

#cja7;e7 ( su* ,act 7#ba ,u4,s4,c4      
#cca7;e77 is am5d$ by /rik+ #eje 7i7 or 
7k7 & ins]t+ #eje 7i71 7j77#aa71 or 7k74
  7b7 ,infr+em5t ( pat5t ,section       
#bga7;e7 ( title #ce1 ,unit$ ,/ates     
,code1 is am5d$ by add+ at ! end !      
foll[+3  7#g7 ,! exclusive rem$y "u ?is 
section = an infr+em5t ( a pat5t = :i* !
 ,secret>y ( ,heal? & ,human ,s]vices   
has publi%$ in=mation pursuant to       
subsection 7b77#a7 or 7c77#b7 ( section 
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act %all be an action br\ght 
"u ?is subsection )9 ! #de-;day p]iod   
describ$ 9 subsection 7j77#e77;,b77iii7 
or 7c77#c77;,c7 ( section #eje ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act4  
4  7c7 ,applicability  7#a7 ,limitations
 on accel]ation ( def]r$ comm]cial      
m>ket+ date ,! am5dm5t made by          
subsection 7a77#a7 %all apply only )    
respect to--  7,a7 an application fil$  
"u section #eje7;j7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77 to :i* ! am5dm5ts made by     

section #aajb7;a7 ( ! ,m$ic>e           
,prescription ,drug1 ,improvem5t1 &     
,mod]nization ,act ( #bjjc 7,public ,law
 #ajh-agc7 apply2 &  7,b7 an agreem5t   
describ$ "u section                     
#eje7;j77#e77;,b77vii77,i7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7z add$  
by subsection 7a77#a77 execut$ aft] !   
date ( enactm5t ( ?is ,act4  7#b7       
,notification ( ,,fda ,! am5dm5ts made  
by p>agraphs 7#b7 & 7#c7 ( subsection   
7a7 %all apply only ) respect to an     
agreem5t describ$ "u section            
#eje7;j77#e77;,b77vii77,i7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7z add$  
by subsection 7a77#a77 execut$ aft] !   
date ( enactm5t ( ?is ,act4