,,ii  #aag? ,,congress  #b;d ,session   
,s4 #djbf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #g1 #bjbb,ms4   
,smi? 7= h]self & ,ms4 ,/ab5[7 introduc$
 ! foll[+ bill2 :i* 0 read twice &      
ref]r$ to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions  ,a      
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to grant eligible      
rese>*]s access to eligible products at 
a disc\nt$ price = qualifi$ rese>*1 & = 
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,disc\nt$ ,drugs =     
,cl9ical ,trials ,act4  #b4 ,disc\nt$   
sales ( eligible products = qualifi$    
rese>* purposes  7a7 ,9 g5]al ,*apt] ,v 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cea et seq47 is    
am5d$ by ins]t+ aft] section #eje-a (   
su* ,act 7#ba ,u4,s4,c4 #cee-a7 ! foll[+
 new section3  #eje-b4 ,disc\nt$ sales (
 eligible products = qualifi$ rese>*    
purposes  7a7 ,application by rese>*]   
,to obta9 an eligible product = qualifi$
 rese>* at ! disc\nt$ price1 an         

individual or entity %all submit to !   
,secret>y an application c]tify+ &      
demon/rat+ t-- 7#a7 ! individual or     
entity is an eligible rese>*]2  7#b7 !  
product be+ s\ght is an eligible        
product2  7#c7 ! rese>*] seeks to use ! 
eligible product = qualifi$ rese>*2 &   
7#d7 ! am\nt ( ! eligible product s\ght 
is reasonable = complet+ ! qualifi$     
rese>*4  7b7 ,duties ( ,secret>y ,!     
,secret>y %all-- 7#a7 review ea*        
application submitt$ "u subsection 7a7 9
 a timely mann]2  7#b7 provide to !     
applicant1 )9 a reasonable "t ( su*     
submission-- 7,a7 a writt5 ord] specify+
 ! suffici5t quantity ( ! eligible      
product approv$ to be pur*as$ by !      
eligible rese>*] at ! disc\nt$ price2 or
  7,b7 a writt5 d5ial ( ! application2  
7#c7 require manufactur]s & lic5se      
hold]s to report to ! ,secret>y any     
additional in=mation det]m9$ by !       
,secret>y to be necess>y to c>ry out ?is
 section2 &  7#d7 annually publi%       
in=mation on ! numb] & types (          

applications grant$ & d5i$ "u ?is       
section4  7c7 ,acquisition ( disc\nt$   
drug ,^u receipt f an eligible rese>*] (
 an ord] obta9$ "u subsection           
7b77#b77;,a7 = ! acquisition ( an       
eligible product = qualifi$ rese>*1 !   
manufactur] or lic5se hold] ( ! eligible
 product %all sell to ! eligible rese>*]
 ! quantity specifi$ 9 ! ord] at !      
disc\nt$ price4  7d7 ,civil action =    
failure ,to provide suffici5t quantity (
 an eligible product  7#a7 ,9 g5]al ,an 
eligible rese>*] may br+ a civil action 
aga9/ ! manufactur] or lic5se hold] ( an
 eligible product seek+ relief "u ?is   
subsection 9 an appropriate di/rict c\rt
 ( ! ,unit$ ,/ates alleg+ t !           
manufactur] or lic5se hold] has decl9$  
to provide ! quantity ( ! eligible      
product specifi$ 9 a writt5 ord] f !    
,secret>y to ! eligible rese>*] = !     
disc\nt$ price4  7#b7 ,elem5ts ,to      
prevail 9 a civil action br\ght "u      
p>agraph 7#a71 an eligible rese>*] %all 
prove1 by a prepond]ance ( ! evid5ce1   

t-- 7,a7 ! eligible rese>*] has-- 7i7   
obta9$ a writt5 ord] = ! specifi$       
quantity ( ! eligible product f !       
,secret>y 9 accordance ) subsection     
7b77#b77;,a72 &  7ii7 provid$ a copy ( !
 ord] to ! manufactur] or lic5se hold]2 
&  7,b7 z ( ! date on :i* ! civil action
 is fil$1 ! eligible rese>*] has n      
obta9$ ! specifi$ quantity ( ! eligible 
product at ! disc\nt$ price by #ca days 
aft] ! date on :i* ! manufactur] or     
lic5se hold] receiv$ ! eligible         
rese>*]'s reque/ = ! eligible product1  
includ+ a copy ( ! writt5 ord]4  7#c7   
,affirmative def5se ,9 a civil action   
br\ght "u p>agraph 7#a71 x %all be an   
affirmative def5se1 on :i* ! def5dant   
has ! burd5 ( p]suasion by a            
prepond]ance ( ! evid5ce-- 7,a7 t1 on ! 
date on :i* ! eligible rese>*] reque/$  
to pur*ase ! specifi$ quantity ( !      
eligible product f ! manufactur] or     
lic5se hold]-- 7i7 nei!r ! manufactur]1 
lic5se hold]1 nor any ( _! ag5ts1       
:olesal]s1 or di/ributors1 0 engag$ 9 ! 

manufactur+ or comm]cial m>ket+ ( !     
eligible product2 &  7ii7 nei!r !       
manufactur]1 lic5se hold]1 nor any ( _! 
ag5ts1 :olesal]s1 or di/ributors1       
o!rwise _h access to inv5tory ( !       
eligible product to supply ! specifi$   
quantity to ! eligible rese>*] at !     
disc\nt$ price2  7,b7 t-- 7i7 !         
manufactur] or lic5se hold] sells !     
eligible product ?r\gh ag5ts1           
di/ributors1 or :olesal]s2  7ii7 !      
manufactur] has plac$ no re/rictions1   
explicit or implicit1 on its ag5ts1     
di/ributors1 or :olesal]s on sell+ !    
eligible product to eligible rese>*]s2 &
  7iii7 ! eligible product c be pur*as$ 
by ! eligible rese>*] 9 ! specifi$      
quantity at ! disc\nt$ price or a l[]   
price f ! ag5ts1 di/ributors1 or        
:olesal]s ( ! manufactur] or lic5se     
hold]2 or  7,c7 t ! manufactur] or      
lic5se hold] made an (f] to sell !      
specifi$ quantity ( ! eligible product  
to ! eligible rese>*] = ! disc\nt$ price
 & ! eligible rese>*] did n accept su*  

(f] by ! date t is #ad days aft] ! date 
on :i* ! eligible product rese>*]       
receiv$ su* (f]4  7#d7 ,me?ods =        
transmission ( reque/s = eligible       
products ,a writt5 reque/ = an eligible 
product1 (f] to sell an eligible        
product1 or acceptance ( su* an (f]     
betwe5 ! eligible rese>*] & !           
manufactur] or lic5se hold] ( ! eligible
 product %all be made by-- 7,a7 c]tifi$ 
or regi/]$ mail ) return receipt        
reque/$2  7,b7 p]sonal deliv]y2 or  7,c7
 electronic means4  7#e7 ,rem$ies ,if an
 eligible rese>*] prevails 9 a civil    
action br\ght "u p>agraph 7#a71 ! c\rt  
%all-- 7,a7 ord] ! manufactur] or lic5se
 hold] to provide to ! eligible rese>*] 
)\t delay ! specifi$ quantity ( !       
eligible product at ! disc\nt$ price2   
7,b7 aw>d to ! eligible rese>*]         
reasonable attorney's fees & co/s ( !   
civil action2 &  7,c7 aw>d to ! eligible
 rese>*] a monet>y am\nt suffici5t to   
det] ! manufactur] or lic5se hold] f    
fail+ to provide eligible rese>*]s ) a  

suffici5t quantity ( an eligible product
 at ! disc\nt$ price1 if ! c\rt f9ds1 by
 a prepond]ance ( ! evid5ce1 t !        
manufactur] or lic5se hold]1 )\t a      
legitimate bus9ess ju/ification-- 7i7   
delay$ provid+ ! specifi$ quantity to ! 
eligible rese>*]2 or  7ii7 fail$ to     
comply ) a writt5 ord] "u subsection    
7b77#b77;,a74  7#f7 ,maximum monet>y    
am\nt ,a monet>y am\nt aw>d$ "u p>agraph
 7#e7 %all n be great] ?an ! rev5ue t ! 
manufactur] or lic5se hold] e>n$ on !   
eligible product beg9n+ on ! date t is  
#ca days aft] ! date on :i* !           
manufactur] or lic5se hold] receiv$ !   
reque/ & end+ on ! date on :i* !        
eligible rese>*] receiv$ ! specifi$     
quantity ( ! eligible product4  7#g7    
,avoidance ( delay ,! c\rt may issue an 
ord] "u p>agraph 7#e77;,a7 be=e conduct+
 fur!r proce$+s t may be necess>y to    
det]m9e-- 7,a7 :e!r ! eligible rese>*]  
is entitl$ to an aw>d "u subp>agraph    
7,b7 or 7,c7 ( p>agraph 7#e72 or  7,b7 !
 am\nt ( any su* aw>d4  7e7 ,limitation 

( liability ,a manufactur] or lic5se    
hold] ( an eligible product obta9$ by an
 eligible rese>*] pursuant to ?is       
section %all n be liable = any claim "u 
,f$]al1 ,/ate1 or local law aris+ out ( 
! failure ( ! eligible rese>*] to foll[ 
adequate safegu>ds to assure safe use ( 
! eligible product1 includ+ ) respect to
 transportation1 h&l+1 use1 or disposal4
  7f7 ,rule ( con/ruction ,?is section  
%all n be con/ru$ to-- 7#a7 und]m9e or  
abrogate any requirem5t impos$ pursuant 
to a risk evaluation & mitigation       
/rategy "u section #eje-a2 or  7#b7     
int]f]e ) ! private "r ( action af=d$ "u
 section #faj ( division ,n ( ! ,fur!r  
,consolidat$ ,appropriations ,act1 #bjbj
 7,public ,law #aaf-id7 7#ba ,u4,s4,c4  
#cee-b2 commonly ref]r$ to z ! ,,creates
 ,act74  7g7 ,def9itions ,9 ?is section3
 7#a7 ,commission] ,! t]m ,commission]  
means ! ,commission] ( ,food & ,drugs4  
7#b7 ,comb9ation product ,! t]m         
comb9ation product means a comb9ation   
product describ$ 9 section #ejc7;g74    

7#c7 ,disc\nt$ price ,! t]m disc\nt$    
price means ! direct co/s to !          
manufactur] or lic5se hold] ( produc+ ! 
eligible product4  7#d7 ,eligible       
product ,! t]m eligible product means-- 
7,a7 any-- 7i7 drug approv$ "u section  
#eje7;c7 ( ?is ,act or biological       
product lic5s$ "u section #cea7;a7 ( !  
,public ,heal? ,s]vice ,act2  7ii7      
comb9ation product includ+ su* a drug or
 biological product2 or  7iii7 product1 
includ+ any device1 t is m>ket$ or      
int5d$ = use ) su* a drug or biological 
product2 &  7,b7 any product t is-- 7i7 
a cov]$ "p ,d drug 7z def9$ 9 section   
#ahfj;,d-#b7;e7 ( ! ,social ,security   
,act7 eligible = placem5t on1 ) respect 
to a plan ye>1 a specialty ti] 7z def9$ 
9 section #dbc4efj ( title #db1 ,code ( 
,f$]al ,regulations7 ( a =mul>y = su*   
plan ye> ( a prescription drug plan "u  
"p ,d ( title ,,xviii ( su* ,act or an  
,,ma-,,pd plan "u "p ,c ( su* title2 or 
7ii7 a drug 7includ+ any biological     
product71 or comb9ation product1 ^: co/ 

is det]m9$ by ! ,commission] to be      
prohibitive to ! advancem5t ( qualifi$  
rese>*4  7#e7 ,eligible rese>*] ,! t]m  
eligible rese>*] means any individual   
seek+ to obta9 an eligible product =    
qualifi$ rese>*4  7#f7 ,lic5se hold] ,! 
t]m lic5se hold] means ! hold] ( an     
application approv$ "u subsection 7c7 or
 7j7 ( section #eje ( ?is ,act1 or a    
lic5se "u subsection 7a7 or 7k7 (       
section #cea ( ! ,public ,heal? ,s]vice 
,act1 = an eligible product4  7#g7      
,qualifi$ rese>* ,! t]m qualifi$ rese>* 
means any ( ! foll[+3 7,a7 ,rese>* 9    
fur!rance ( an application "u subsection
 7c7 or 7j7 ( section #eje ( ?is ,act4  
7,b7 ,rese>* 9 fur!rance ( an           
application = a lic5se "u subsection 7a7
 or 7k7 ( section #cea ( ! ,public      
,heal? ,s]vice ,act4  7,c7 ,rese>* = :i*
 an exemption = inve/igational use is   
grant$ pursuant to section #eje7;i7 (   
?is ,act or section #cea7;a7 ( ! ,public
 ,heal? ,s]vice ,act4  7,d7 ,rese>* us+ 
an approv$ drug = an approv$ indication 

) ! purpose ( evaluat+ & comp>+ !       
cl9ical effectiv5ess1 risks1 or b5efits 
( #b or m ( any ( ! foll[+3 7i7 ,heal?  
c>e int]v5tions1 protocols = treatm5t1  
c>e managem5t1 deliv]y proc$ures1       
diagno/ic tools1 or integrative         
practices4  7ii7 ,drugs 7includ+        
biological products71 devices1 or       
comb9ation products4  7iii7 ,any o!r    
treatm5ts1 s]vices1 practices1 or items 
be+ us$ 9 ! treatm5t1 managem5t1 or     
diagnosis (1 or prev5tion (1 illness or 
injury 9 individuals4  7#h7 ,suffici5t  
quantity ,! t]m suffici5t quantity means
 an am\nt ( an eligible product no      
great] ?an ! eligible rese>*] det]m9es  
to be necess>y to accompli% ! qualifi$  
rese>* & fulfill any relat$ regulatory  
requirem5ts4  4  7b7 ,regulations ,n    
lat] ?an #ahj days ( ! date ( enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 act+ ?r\gh ! ,commission] (  
,food & ,drugs1 %all promulgate f9al    
regulations to c>ry out section #eje-b (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic     

,act1 z add$ by subsection 7a71 includ+ 
regulations-- 7#a7 to appropriately     
calculate ! disc\nt$ price applicable ) 
respect to an eligible product 7z su*   
t]ms are def9$ 9 su* section #eje-b72 & 
7#b7 ) respect to civil actions "u      
subsection 7d7 ( su* section #eje-b4