,,ii  #aai? ,,congress  #a/ ,session    
,s4 #aicj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #c1 #bjbe ,mr4   
,cassidy introduc$ ! foll[+ bill2 :i* 0 
read twice & ref]r$ to ! ,committee on  
,f9ance  ,a ,,bill  ,to am5d title ,,xi 
( ! ,social ,security ,act to e/abli% a 
rese>* & developm5t-int5sive small      
biote* manufactur] exception f ! ,m$ic>e
 drug price negotiation program4  #a4   
,%ort title  ,?is ,act may be cit$ z !  
,small ,biote* ,innovation ,act4  #b4   
,rese>* & developm5t-int5sive small     
biote* manufactur] exception f ,m$ic>e  
drug price negotiation program  ,section
 #aaib7;d77#b7 ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #acbj;f-#a7;d77#b77 
is am5d$ by add+ at ! end ! foll[+ new  
subp>agraph3  7,d7  ,rese>* &           
developm5t-int5sive small biote*        
manufactur] exception = #bjbi &         
subsequ5t ye>s  7i7  ,9 g5]al  ,)       
respect to initial price applicability  
ye>s 7beg9n+ ) initial price            
applicability ye> #bjbi71 subject to !  

succe$+ provisions ( ?is subp>agraph1 ! 
t]m negotiation eligible drug %all n    
include a qualify+ s+le s\rce drug 7z   
def9$ 9 subsection 7e77 ( a rese>* &    
developm5t-int5sive small biote*        
manufactur] 7z def9$ 9 clause 7ii774    
7ii7  ,def9itions  ,9 ?is subp>agraph3  
7,i7 ,applicable p]c5t ,! t]m applicable
 p]c5t means--  7aa7 9 ! case ( a small 
biote* manufactur] t has #a qualify+    
s+le s\rce drug1 #cj p]c5t2  7bb7 9 !   
case ( a small biote* manufactur] t has 
#b qualify+ s+le s\rce drugs1 #dj p]c5t2
  7cc7 9 ! case ( a small biote*        
manufactur] t has #c qualify+ s+le s\rce
 drugs1 #ej p]c5t2  7dd7 9 ! case ( a   
small biote* manufactur] t has #d       
qualify+ s+le s\rce drugs1 #fj p]c5t2 & 
7ee7 9 ! case ( a small biote*          
manufactur] t has #e qualify+ s+le s\rce
 drugs1 #gj p]c5t4  7,,ii7  ,small      
biote* manufactur] def9$  ,! t]m small  
biote* manufactur] means a manufactur]  
t--  7aa7 has #e or less qualify+ s+le  
s\rce drugs2 &  7bb7 is n own$ by1      

controll$ by1 or subject to !           
jurisdiction or direction ( a gov]nm5t (
 a =eign c\ntry1 or organiz$ "u ! laws (
 a =eign c\ntry t is a cov]$ nation 7z  
def9$ 9 section #dhgb7;f7 ( title #aj1  
,unit$ ,/ates ,code74  7,,iii7  ,rese>* 
& developm5t-int5sive small biote*      
manufactur] def9$  ,! t]m rese>* &      
developm5t-int5sive small biote*        
manufactur] means a small biote*        
manufactur] t inve/s at lea/ !          
applicable p]c5t ( _! net rev5ue f !    
av]age ( ! previ\s ?ree ye>s 9 rese>* & 
developm5t 7det]m9$ bas$ on g5]ally     
accept$ acc\nt+ pr9ciples74  7iii7      
,treatm5t 9 case ( acquisition  ,a drug 
%all n be consid]$ to be a qualify+ s+le
 s\rce drug ( a rese>* &                
developm5t-int5sive small biote*        
manufactur] if ! manufactur] ( su* drug 
is acquir$ aft] #bjbi by ano!r          
manufactur] t does n meet ! def9ition ( 
a rese>* & developm5t-int5sive small    
biote* manufactur]1 effective at !      
beg9n+ ( ! plan ye> imm$iately foll[+   

su* acquisition4  7iv7  ,annual         
application  ,9 ord] = a qualify+ s+le  
s\rce drug ( a rese>* &                 
developm5t-int5sive small biote*        
manufactur] to be eligible = ! exception
 "u ?is subp>agraph ) respect to an     
initial price applicability ye> 7beg9n+ 
) initial price applicability ye>       
#bjbi71 ! manufactur] %all submit an    
application to ! ,secret>y 7at a "t     
specifi$ by ! ,secret>y7 conta9+--  7,i7
 in=mation on ! net product rev5ue &    
rese>* & developm5t exp5ditures ( !     
manufactur] dur+ ! relevant "t p]iod2   
7,,ii7 a c]tification t ! in=mation     
submitt$ by ! manufactur] "u subclause  
7,i7 is accurate & complete to ! be/ ( !
 manufactur]'s k2 &  7,,iii7 su* o!r    
in=mation z ! ,secret>y may specify4    
7v7  ,dispute ,resolution  ,! ,secret>y 
%all develop a process "u :i* a         
manufactur] may appeal a det]m9ation by 
! ,secret>y t ! manufactur] is n a      
rese>* & developm5t-int5sive small      
biote* manufactur]4 ,su* process %all   

conclude1 ) respect to a manufactur]1 n 
lat] ?an ! select$ drug publication date
 ) respect to ! initial price           
applicability ye> = :i* ! manufactur]   
submitt$ an application "u clause 7iv74 
4