,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #ajb  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,janu>y #aj1 #bjai,mr4 
,s&]s 7= himself1 ,mr4 ,book]1 ,mr4     
,blum5?al1 ,mrs4 ,gillibr&1 ,ms4 ,h>ris1
 & ,ms4 ,w>r57 introduc$ ! foll[+ bill2 
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to      
significantly l[] prescription drug     
prices = pati5ts 9 ! ,unit$ ,/ates by   
end+ gov]nm5t-grant$ monopolies =       
manufactur]s :o *>ge drug prices t are  
high] ?an ! m$ian prices at :i* ! drugs 
are available 9 o!r c\ntries4  #a4 ,%ort
 title ,?is ,act may be cit$ z !        
,prescription ,drug ,price ,relief ,act 
( #bjai4  #b4 ,id5tification (          
excessively pric$ drugs  7a7 ,9 g5]al ,!
 ,secret>y1 n lat] ?an #a ye> aft] !    
date ( enactm5t ( ?is ,act1 %all e/abli%
 a process to conduct a review ( all br&
 "n drugs1 n less frequ5tly ?an once p] 
cal5d> ye>1 "u :i* ! ,secret>y det]m9es 
"u subsection 7b7 :e!r ! price ( ea* su*

 drug is excessive4  7b7 ,excessive     
price det]m9ations  7#a7 ,int]national  
ref]5ce price  7,a7 ,9 g5]al ,!         
,secret>y %all det]m9e t any br& "n drug
 = :i* ! dome/ic av]age manufactur+     
price exce$s ! m$ian price *>g$ = su*   
drug 9 ! #e ref]5ce c\ntries to h an    
excessive price4 ,9 assess+ ! ext5t to  
:i* ! price is excessive1 ! ,secret>y   
%all consid] ! factors describ$ 9       
p>agraph 7#b74  7,b7 ,ref]5ce ,c\ntries 
,9 ?is ,act1 ! t]m ref]5ce c\ntries     
means ,canada1 ! ,unit$ ,k+dom1 ,g]many1
 ,france1 & ,japan4  7,c7 ,requirem5t ) 
respect to drugs = :i* c]ta9 ref]5ce    
c\ntry in=mation is n available ,!      
,secret>y %all make a det]m9ation "u    
p>agraph 7#a7 = e br& "n drug = :i*     
pric+ in=mation is available = at lea/  
#c ( ! #e ref]5ce c\ntries4  7#b7       
,det]m9ations bas$ on o!r factors ,)    
respect to any br& "n drug t is n       
det]m9$ to h an excessive price by      
op]ation ( p>agraph 7#a7 7includ+ any   
drug = :i* !re is insuffici5t data to   

make su* a det]m9ation "u su* p>agraph71
 ! ,secret>y %all det]m9e t su* drug has
 an excessive price if ! price ( ! drug 
is high] ?an reasonable tak+ into acc\nt
 ! foll[+ factors3  7,a7 ,! size ( !    
affect$ pati5t population4  7,b7 ,!     
value ( ! drug to pati5ts1 includ+ !    
impact ( ! price on access to ! drug & !
 relation%ip ( ! price ( ! drug to its  
!rapeutic heal? b5efits4  7,c7 ,! risk  
adju/$ value ( ,f$]al ,gov]nm5t         
subsidies & inve/m5ts relat$ to ! drug4 
7,d7 ,! co/s associat$ ) developm5t ( ! 
drug4  7,e7 ,:e!r ! drug provid$ a      
significant improvem5t 9 heal? outcomes1
 comp>$ to o!r !rapies available at ! "t
 ( its approval4  7,f7 ,! cumulative    
global rev5ues g5]at$ by ! drug4  7,g7  
,:e!r ! dome/ic av]age manufactur] price
 ( ! drug increas$ dur+ any annual qu>t]
 by a p]c5tage t is m ?an ! p]c5tage    
increase 9 ! consum] price index = all  
urban consum]s = ! respective annual    
qu>t]4  7,h7 ,o!r factors ! ,secret>y   
det]m9es appropriate4  7c7 ,petition =  

det]m9ation  7#a7 ,9 g5]al ,any p]son   
may petition ! ,secret>y1 9 accordance )
 section #eec7;e7 ( title #e1 ,unit$    
,/ates ,code1 to make an excessive drug 
price det]m9ation = an applicable drug  
"u subsection 7b77#b74 ,n lat] ?an #ij  
days aft] ! date ( receipt ( su* a      
petition1 subject to p>agraph 7#b71 !   
,secret>y %all--  7,a7 make a           
det]m9ation "u subsection 7b77#b7 reg>d+
 su* drug2 or  7,b7 7i7 decl9e to make  
su* a det]m9ation2 &  7ii7 make public !
 reasons :y ! ,secret>y has decl9$ to   
make su* a det]m9ation4  7#b7 ,exception
 ,! ,secret>y %all n make a det]m9ation 
"u subsection 7b77#b7 = a drug 9        
response to a petition "u ?is section m 
frequ5tly ?an once p] cal5d> ye>4  7#c7 
,public availability ,! ,secret>y %all  
make any petitions submitt$ "u ?is      
subsection1 toge!r ) any docum5tation   
relat$ to ! petitions & ! ,secret>y's   
det]m9ations on su* petitions &         
rationale = su* det]m9ations1 publicly  
available1 includ+ by po/+ su* in=mation

 on ! database "u section #e4  #c4 ,end+
 gov]nm5t-grant$ monopolies =           
excessively pric$ drugs  7a7 ,excessive 
drug price au?ority ,) respect to any   
br& "n drug1 if ! ,secret>y det]m9es "u 
section #b t ! price ( ! drug is        
excessive1 ! ,secret>y--  7#a7 %all     
waive or void any gov]nm5t-grant$       
exclusivities ) respect to su* drug1    
effective on ! date t ! excessive price 
det]m9ation "u section #b is made = su* 
drug2 &  7#b7 %all grant op51           
non-exclusive lic5ses all[+ any p]son to
 make1 use1 (f] to sell or sell1 or     
import into ! ,unit$ ,/ates su* drug1 & 
to rely ^u ! regulatory te/ data ( su*  
drug1 9 accordance ) section #d4  7b7   
,exp$it$ review ,! ,secret>y %all       
prioritize ! review (1 & act )9 #h mon?s
 ( ! date ( ! submission ( a g5]ic drug 
application or a biosimil> biological   
product application if su* application  
ref]5ces a drug lic5s$ "u subsection    
7a77#b74  7c7 ,civil actions ,if !      
,secret>y det]m9es t ! manufactur] ( an 

excessively pric$ drug 7z det]m9$ "u    
section #b7;a77 has increas$ ! price (  
su* drug dur+ ! p]iod beg9n+ on ! date  
on :i* su* price det]m9ation is made &  
end+ on ! date on :i* an entity beg9s   
manufactur+ ! drug "u an op51           
non-exclusive lic5se "u subsection      
7a77#b71 ! ,secret>y may file a civil   
action 9 ! ,unit$ ,/ates di/rict c\rt = 
! di/rict 9 :i* ! manufactur] is locat$1
 or 9 ! ,unit$ ,/ates di/rict c\rt = !  
,di/rict ( ,columbia1 to recov] damages 
9 an am\nt equal to n less ?an ! total  
am\nt ( rev5ue d]iv$ by ! manufactur] z 
a result ( any su* price increase dur+  
su* p]iod4 ,9 actions br\ght "u ?is     
subsection1 ! di/rict c\rts %all h      
jurisdiction to grant all appropriate   
relief includ+1 b n limit$ to1          
injunctive relief & comp5satory damages4
  #d4 ,excessive drug price lic5se  7a7 
,reasonable royalty  7#a7 ,9 g5]al ,an  
entity accept+ an op51 non-exclusive    
lic5se "u section #c7;a77#b7 %all pay a 
reasonable royalty to ! hold] ( a pat5t 

t claims ! drug or t claims a use ( !   
drug or to ! hold] ( an application     
approv$ "u subsection #eje7;c7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea7;a7 ( ! ,public ,heal?    
,s]vice ,act = :i* any gov]nm5t-grant$  
exclusivity ) respect to ! drug 0       
t]m9at$ "u section #e7;a77#a74  7#b7    
,royalty rate ,su* royalty rate %all    
be-- 7,a7 a p]c5tage ( sales1 :]e !     
p]c5tage rate is no high] ?an ! av]age  
royalty rate e/imat$ f ! data provid$ by
 ! ,int]nal ,rev5ue ,s]vice =           
ph>maceutical manufactur] ,f$]al income 
tax returns2 or  7,b7 an am\nt z det]m9$
 by ! ,secret>y1 tak+ into acc\nt-- 7i7 
! value ( ! drug to pati5ts2  7ii7 !    
size ( ! affect$ pati5t population2     
7iii7 ! risk adju/$ value ( ! ,f$]al    
,gov]nm5t subsidies & inve/m5ts relat$  
to ! drug2  7iv7 :e!r ! drug provid$ a  
significant improvem5t 9 heal? outcomes1
 comp>$ to o!r !rapies available at ! "t
 ( ! approval2  7v7 ! ext5t to :i* ! br&
 "n drug manufactur] has recov]$ risk   

adju/$ inve/m5ts relat$ to ! drug1      
includ+ ! inve/m5ts relat$ to !         
inv5tion1 regulatory te/ data & any o!r 
relevant rese>* & developm5t co/s2 &    
7vi7 any o!r in=mation ! ,secret>y      
det]m9es appropriate4  7b7 ,requirem5ts 
7#a7 ,9 g5]al ,a royalty rate "u        
subsection 7a7 %all be consi/5t ) mak+  
drugs available to pur*as]s1 includ+    
,f$]al1 ,/ate1 local1 & nongov]nm5tal   
pur*as]s & individuals1 at prices t are 
af=dable & reasonable4 ,"u no condition 
%all a royalty be set at a rate t w\ld  
cause a product = :i* an op51           
non-exclusive lic5se 0 issu$ "u section 
#c to be sold at an excessive price1 z  
det]m9$ "u section #b4  7#b7 ,multiple  
affect$ p>ties ,9 ! case t !re is "o or 
m hold]s or inve/ors 9 ! pat5t$         
inv5tions relat$ to ! drug 9 addition to
 ! br& "n manufactur]1 ! royalty rate   
%all be divid$ among ! hold]s or        
inve/ors 7includ+ su* manufactur]7 9 a  
mann] agre$ ^u by ! manufactur] & o!r   
hold]s or inve/ors1 or1 9 ! abs5ce ( su*

 an agreem5t1 9 a mann] ! ,secret>y     
det]m9es to be appropriate4  7#c7 ,price
 ,an entity accept+ an op51             
non-exclusive lic5se "u section         
#c7;a77#b7 %all sell ! drug at a price n
 high] ?an ! excessive price det]m9$ = t
 drug "u section #b7;b74  #e4 ,public   
excessive drug price database  7a7      
,excessive drug price database  7#a7 ,9 
g5]al ,! ,secret>y %all e/abli% & ma9ta9
 a compreh5sive1 up-to-date database (  
br& "n drugs & ! excessive price        
det]m9ations = su* drugs "u section #b4 
7#b7 ,cont5ts ,! database %all include1 
at a m9imum1 = ea* br& "n drug1 = !     
applicable cal5d> ye>--  7,a7 ! "n ( !  
drug2  7,b7 ! manufactur]2  7,c7 :e!r ! 
drug 0 det]m9$ "u section #b7;b7 to h an
 excessive price2  7,d7 ! numb] (       
petitions ! ,secret>y receiv$ "u section
 #b7;c7 to make an excessive price      
det]m9ation = ! drug1 toge!r ) !        
in=mation describ$ 9 section #b7;c77#c72
  7,e7 ! numb] ( op51 non-exclusive     
lic5ses ! ,secret>y has grant$ "u       

section #c7;a77#b7 = g5]ic drug or      
biosimil> biological product v]sions ( !
 drug2 &  7,f7 ! numb] ( applications "u
 subsection 7b77#b7 or 7j7 ( section    
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act or "u section #cea7k7 ( !
 ,public ,heal? ,s]vice ,act submitt$ to
 ! ,secret>y1 pursuant to su* a lic5se  
grant$ "u section #c7;a77#b71 & ! numb] 
( su* applications t h be5 approv$4     
7#c7 ,c]ta9 det]m9ations ,) respect to a
 det]m9ation made "u section #b7;b77#a71
 ! ,secret>y %all publi% on ! database  
su* det]m9ation 9 accordance ) p>agraph 
7#a7 )9 #cj days ( receiv+ dome/ic &    
int]national pric+ in=mation f          
manufactur]s "u section #f4  7b7 ,annual
 reports to ,congress ,n lat] ?an #fj   
days aft] ! fir/ excessive price review 
"u section #b is complete1 & annually   
!reaft]1 ! ,secret>y %all submit to     
,congress a report describ+ ! excessive 
drug price review = ! prec$+ ye>4 ,!    
report %all conta9 summ>y data reg>d+-- 
7#a7 ! total numb] ( drugs t 7 review$2 

7#b7 ! total numb] ( drugs det]m9$ to be
 excessively pric$ "u ea* ( p>agraphs   
7#a7 & 7#b7 ( section #b7;b71 & ! "n &  
manufactur] ( ea* su* drug2  7#c7 !     
total numb] ( drugs det]m9$ to be       
excessively pric$1 li/$ by manufactur]2 
7#d7 ! ext5t to :i* ! prices ( ! drugs  
id5tifi$ "u section #b 7 high] ?an      
reasonable1 on av]age2  7#e7 ! total    
numb] ( drugs = :i* an op5-non-exclusive
 lic5se has be5 grant$ "u section       
#c7;a77#b72  7#f7 ! total numb] ( g5]ic 
drug or biosimil> biological product    
applications receiv$ & approv$ t ref]5ce
 a drug s lic5s$2  7#g7 ! m$ian approval
 "t = g5]ic drug or biosimil> biological
 product applications t ref]5ce a drug s
 lic5s$2  7#h7 ! total numb] ( petitions
 ! ,secret>y receiv$ "u section #b7;c7  
to make excessive price det]m9ations =  
drugs2  7#i7 a li/ ( any manufactur]s :o
 fail$ to report in=mation z requir$ "u 
section #f2 &  7#aj7 o!r appropriate    
in=mation1 z ! ,secret>y det]m9es or z  
,congress reque/s4  7c7 ,public         

availability ,! ,secret>y %all make !   
in=mation 9 ! database describ$ 9       
subsection 7a7 & ! report 9 subsection  
7b7 publicly available1 includ+ on !    
int]net website ( ! ,food & ,drug       
,adm9i/ration1 9 a mann] t is easy to   
f9d & und]/&4  #f4 ,drug manufactur]    
report+  7a7 ,9 g5]al ,ea* manufactur]  
%all submit to ! ,secret>y1 9 su* =mat z
 ! ,secret>y may require1 an annual     
report t includes ! foll[+ in=mation =  
ea* br& "n drug ( ! manufactur]1 )      
respect to ! previ\s cal5d> ye>3  7#a7  
,! av]age manufactur] price ( ! drug 9 !
 ,unit$ ,/ates & 9 ! ref]5ce c\ntries1 =
 ! entire ye>1 & brok5 d[n = ea* qu>t] (
 ! ye>4  7#b7 ,! :olesale acquisition   
co/ ( ! drug 9 ! ,unit$ ,/ates & 9 !    
ref]5ce c\ntries1 = ! entire ye>1 &     
brok5 d[n = ea* qu>t] ( ! ye>4  7#c7    
,cumulative global rev5ues g5]at$ by !  
drug4  7#d7 ,annual net sales rev5ue    
g5]at$ by ! drug 9 ! ,unit$ ,/ates & 9 !
 ref]5ce c\ntries1 = ! entire ye>1 &    
brok5 d[n = ea* qu>t] ( ! ye>4  7#e7    

,total exp5ditures on dome/ic & =eign   
drug rese>* & developm5t relat$ to !    
drug1 itemiz$ by--  7,a7 basic &        
precl9ical rese>*2  7,b7 cl9ical rese>*1
 report$ sep>ately = ea* cl9ical trial2 
7,c7 developm5t ( alt]native dosage =ms 
& /r5g?s = ! drug molecule or           
comb9ations1 includ+ ! molecule2  7,d7  
o!r drug developm5t activities1 su* z   
noncl9ical laboratory /udies & record & 
report ma9t5ance2  7,e7 pursu+ new or   
exp&$ indications = su* drug ?r\gh      
supplem5tal applications "u section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act2 &  7,f7 c>ry+ out po/m>ket        
requirem5ts relat$ to su* drug1 includ+ 
"u section #eje7o77#c7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act4  7#f7 ,total  
exp5ditures on dome/ic & =eign m>ket+ & 
adv]tis+ relat$ to ! drug4  7#g7        
,inve/m5ts 9 human cl9ical trials relat$
 to ! drug1 by ea* trial & ea* ye>1     
includ+ grants1 rese>* contracts1 tax   
cr$its or d$uctions1 & reimbursem5ts f  
public or private heal? plans or        

insurance1 & any o!r public sector      
subsidies or inc5tives1 su* z ! fair    
m>ket value or priority review v\*]s or 
o!r consid]ations4  7#h7 ,! e/imat$ size
 ( ! affect$ pati5t population4  7#i7   
,additional in=mation ! manufactur]     
*ooses to provide relat$ to drug pric+  
decisions1 su* z in=mation relat$ to !  
me?odology us$ to set ! price ( ! drug4 
7#aj7 ,additional in=mation z !         
,secret>y det]m9es necess>y to c>ry out 
?is ,act1 includ+ in=mation = previ\s   
ye>s4  7b7 ,report due date ,applicable 
manufactur]s %all submit ! reports      
describ$ 9 subsection 7a7 n lat] ?an    
,janu>y #ae ( ! ye> foll[+ ! date (     
enactm5t ( ?is ,act1 & ( ea* ye>        
!reaft]4  7c7 ,p5alty = noncompliance   
7#a7 ,9 g5]al ,any manufactur] t fails  
to submit in=mation = a drug z requir$  
by ?is section on a timely basis or t   
kn[+ly provides false in=mation %all be 
liable = a civil monet>y p5alty1 z      
det]m9$ by ! ,secret>y "u p>agraph 7#b71
 9 addition to any o!r p5alty "u o!r    

applicable provisions ( law4  7#b7      
,am\nt ( p5alty ,! am\nt ( a civil      
p5alty "u p>agraph 7#a7 %all be equal to
 ! product (-- 7,a7 an am\nt1 z det]m9$ 
appropriate by ! ,secret>y1 :i* is--    
7i7 n less ?an #j4e p]c5t ( ! gross     
rev5ues f sales = ! previ\s cal5d> ye> (
 ! drug = :i* ! in=mation 0 n submitt$2 
&  7ii7 n great] ?an #a p]c5t ( ! gross 
rev5ues f sales = ! previ\s cal5d> ye> (
 su* drug2 &  7,b7 ! numb] ( days 9 !   
p]iod betwe5-- 7i7 ! report due date "u 
subsection 7b72 &  7ii7 ! date on :i* ! 
,secret>y receives ! in=mation requir$  
to be report$ by ! manufactur] "u ?is   
section4  7#c7 ,use ( civil p5alty ,!   
,secret>y %all collect ! civil p5alties 
"u ?is subsection & %all use su* funds  
to support competitive rese>* grant     
programs ( ! ,national ,in/itutes (     
,heal?4  #g4 ,prohibition (             
anticompetitive behavior ,no manufactur]
 may engage 9 anticompetitive behavior  
violat+ section #e7;a7 ( ! ,f$]al ,trade
 ,commission ,act 7#ae ,u4,s4,c4        

#de7;a77 ) ano!r manufactur] t may      
int]f]e ) ! issuance & implem5tation (  
op51 non-exclusive lic5ses "u ?is ,act  
or o!rwise run contr>y to ! public      
int]e/ 9 ! availability ( af=dable      
prescription drugs4  #h4 ,def9itions ,= 
! purposes ( ?is ,act3 7#a7 ,av]age     
manufactur] price  7,a7 ,9 g5]al ,! t]m 
av]age manufactur] price1 ) respect to a
 drug1 subject to subp>agraph 7,b71 has 
! mean+ giv5 su* t]m 9 section          
#aibg7k77#a7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #acifr-#h7k77#a772 or )  
respect to a drug = :i* !re is no av]age
 manufactur] price z s def9$1 su* t]m   
%all mean ! :olesale acquisition co/ 7z 
def9$ 9 section #ahdg;,a7c77#f77;,b7 ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciew-#c;a7c77#f77;,b77 ( ! drug4  7,b7
 ,application to ref]5ce c\ntries ,)    
respect to ref]5ce c\ntries1 ! t]m      
av]age manufactur] price1 z def9$ 9     
subp>agraph 7,a71 %all be det]m9$ bas$  
on ! price ( ! drug 9 ! applicable      
ref]5ce c\ntry4  7#b7 ,biosimil>        

biological product ,! t]m biosimil>     
biological product means a biological   
product lic5s$ pursuant to an           
application "u section #cea7k7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k774  7#c7 ,br& "n drug  
,! t]m br& "n drug means a drug t is--  
7,a7 approv$ "u section #eje7;c7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;c77 or a biological
 product lic5s$ "u section #cea7;a7 ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a772  7,b7 subject to   
section #ejc7;b77#a7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cec7;b77#a772 &  7,c7 claim$ 9 a pat5t 
or ! use ( :i* is claim$ 9 a pat5t4     
7#d7 ,g5]ic drug ,! t]m g5]ic drug means
 a drug approv$ pursuant to an          
application "u section 7b77#b7 or 7j7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee74  7#e7             
,gov]nm5t-grant$ exclusivity ,! t]m     
gov]nm5t-grant$ exclusivity means       
prohibitions on ! submission or approval

 ( drug applications grant$ "u any ( !  
foll[+3  7,a7 ,clauses 7ii7 ?r\gh 7v7 ( 
section #eje7;c77#c77;,e7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;c77#c77;,e774  7,b7     
,section #eje7;j77#e77;,b77iv7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 or
 clause 7ii71 7iii71 or 7iv7 ( section  
#eje7;j77#e77;,f7 ( su* ,act4  7,c7     
,section #eje;,a ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;a74  7,d7 ,section #eje;,e ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee;f74  7,e7 ,section  
#ebg ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc74 
7,f7 ,section #cea7k77#g7 ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k77#g774  7,g7 ,any o!r provision (
 law t provides = exclusivity 7or       
ext5sion ( exclusivity7 ) respect to a  
drug4  7#f7 ,manufactur] ,! t]m         
manufactur] means ! hold] ( an          
application approv$ "u section #eje ( ! 

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 or ( a lic5se issu$
 "u section #cea ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bfb74  7#g7
 ,op51 non-exclusive lic5se ,! t]m op51 
non-exclusive lic5se means a lic5se t   
au?orizes any p]son to use a pat5t held 
by a manufactur] t claims a br& "n drug 
or a use ( a br& "n drug or rely ^u     
regulatory te/ data = su* drug1 includ+ 
pat5ts held 9 common by ! manufactur] & 
o!r entities1 ne$$ to produce1          
manufacture1 import1 export1 di/ribute1 
(f] 9 liquidation1 sell1 buy1 or use su*
 br& "n drug4  7#h7 ,secret>y ,! t]m    
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices4