,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #ddci  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,augu/ #e1 #bjbj,ms4   
,smi? 7= h]self1 ,mr4 ,m]kley1 ,ms4     
,baldw91 ,mrs4 ,gillibr&1 & ,ms4 ,h>ris7
 introduc$ ! foll[+ bill2 :i* 0 read    
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to require any ,,covid-#ai  
drug develop$ 9 :ole or 9 "p ) ,f$]al   
support to be af=dable & accessible by  
prohibit+ monopolies & price g\g+1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,make ,m$ications      
,af=dable by ,prev5t+ ,p&emic           
,price-g\g+ ,act ( #bjbj or ! ,,mmappp  
,act ( #bjbj4  #b4 ,requirem5ts = lic5s+
 ( new ,,covid-#ai treatm5t & prev5tion 
te*nologies to meet dome/ic & global    
dem&  7a7 ,nonexclusive lic5se requir$  
,any cov]$ lic5se grant$ by ! ,f$]al    
,gov]nm5t %all be an op51 nonexclusive  
lic5se4  7b7 ,contractor1 assignee1     
exclusive lic5see ,not)/&+ any o!r      
provision ( law1 any contractor1        

assignee1 or exclusive lic5see to an    
inv5tion develop$ 9 :ole or 9 "p 9 "w   
p]=m$ "u a cov]$ transaction %all grant 
an op51 non-exclusive lic5se4 ,if any   
su* contractor1 assignee1 or exclusive  
lic5see refuses to grant su* lic5se1 !  
,f$]al ,gov]nm5t %all grant ! lic5se4   
7c7 ,reasonable royalty  7#a7 ,9 g5]al  
,except z provid$ 9 p>agraph 7#d71 an   
entity t accepts an op51 nonexclusive   
lic5se "u ?is section %all pay a        
reasonable royalty ) respect to sales )9
 ! ,unit$ ,/ates to-- 7,a7 ! hold] ( a  
pat5t t claims ! ,,covid-#ai relat$     
inv5tion2 or  7,b7 ! hold] ( an         
application approv$ "u section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 or section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb7 = :i* any ,,fda-grant$  
exclusivity ) respect to a drug relat$  
to su* inv5tion t 0 t]m9at$ "u ?is      
section4  7#b7 ,royalty ,! reasonable   
royalty describ$ "u p>agraph 7#a7 %all  
be a p]c5tage ( sales ( ! entity pay+ ! 

royalty1 :]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$]al income tax returns4  7#c7        
,requirem5ts  7,a7 ,9 g5]al ,! royalty  
describ$ "u p>agraph 7#b7 %all be       
subject to ! applicable royalty rate    
requirem5ts ( section #cai;,b ( !       
,public ,heal? ,s]vice ,act1 z add$ by  
section #e ( ?is ,act4  7,b7 ,multiple  
affect$ p>ties ,9 ! case ( m ?an "o     
recipi5t ( a royalty1 ! royalty %all be 
divid$ among ea* su* recipi5t 7includ+  
any manufactur]7 9 a mann] agre$ ^u by !
 manufactur] & o!r recipi5ts1 or1 9 !   
abs5ce ( su* an agreem5t1 9 a mann] !   
,secret>y det]m9es to be appropriate4   
7#d7 ,exception = ,gov]nm5t-own$        
inv5tions ,an entity t accepts an op51  
nonexclusive lic5se = a f$]ally own$    
inv5tion describ$ "u section #bjg (     
title #ce1 ,unit$ ,/ates ,code1 is n    
requir$ to pay a royalty "u ?is section4
  7d7 ,def9itions ,9 ?is section3 7#a7  

,cov]$ lic5se ,! t]m cov]$ lic5se means 
a lic5se t all[s a lic5see to make1 use1
 (f] to sell1 or sell1 export1 or import
 into ! ,unit$ ,/ates or any o!r c\ntry 
or t]ritory a ,,covid-#ai relat$        
inv5tion pursuant to-- 7,a7 section #bjg
 ( title #ce1 ,unit$ ,/ates ,code2 &    
7,b7 section #ab ( ! ,/ev5son-,wydl]    
,te*nology ,innovation ,act ( #aihj 7#ae
 ,u4,s4,c4 #cgaj;a74  7#b7 ,cov]$       
transaction ,! t]m cov]$ transaction    
means any contract1 fund+ agreem5t1     
lic5se1 o!r transaction1 or o!r         
arrangem5t ent]$ into betwe5 a p>ty & ! 
,f$]al ,gov]nm5t on or aft] ! date (    
enactm5t ( ?is ,act ) respect to rese>* 
& developm5t reg>d+ a drug t-- 7,a7 is  
int5d$ or anticipat$ to be us$ to       
diagnose1 mitigate1 prev5t1 or treat    
,,covid-#ai2 &  7,b7 consi/s (-- 7i7 a  
lic5s+ agreem5t pursuant to section #bjg
 ( title #ce1 ,unit$ ,/ates ,code2  7ii7
 a coop]ative rese>* & developm5t       
agreem5t & lic5s+ agreem5t pursuant to  
section #ab ( ! ,/ev5son-,wydl]         

,te*nology ,innovation ,act ( #aihj 7#ae
 ,u4,s4,c4 #cgaj;a72  7iii7 a fund+     
agreem5t1 z def9$ "u section #bja (     
title #ce1 ,unit$ ,/ates ,code2 or  7iv7
 any o!r transaction ent]$ into pursuant
 to-- 7,i7 section #cai,l1 #dba1 or #dhj
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bdg;d-#g;e1 #bhe;b-#c1       
#bhg;a72  7,,ii7 section #aje ( !       
,national ,in/itutes ( ,heal? ,re=m ,act
 ( #bjjf 7#db ,u4,s4,c4 #bhdn72 or      
7,,iii7 section #bcga ( title #aj1      
,unit$ ,/ates ,code4  7#c7 ,,covid-#ai  
relat$ inv5tion ,! t]m ,,covid-#ai      
relat$ inv5tion means any inv5tion t    
claims a drug t is manufactur$1 us$1    
design$1 develop$1 modifi$1 lic5s$1 or  
procur$ to diagnose1 mitigate1 prev5t1  
treat1 or cure ,,covid-#ai2 a use ( su* 
drug2 a =m ( su* drug2 a me?od ( use (  
su* drug2 or a me?od ( manufactur+ su*  
drug4  7#d7 ,,fda-grant$ exclusivity ,! 
t]m ,,fda-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$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;c77#c77;,e774  7,b7     
,subsection 7j77#e77;,b77iv7 or clause  
7ii71 7iii71 or 7iv7 ( subsection       
7j77#e77;,f7 ( su* ,act 7#ba ,u4,s4,c4  
#cee7;c77#c77;,e774  7,c7 ,section      
#eje;,a ( su* ,act 7#ba ,u4,s4,c4       
#cee;a74  7,d7 ,section #eje;,e ( su*   
,act 7#ba ,u4,s4,c4 #cee;f74  7,e7      
,section #ebg ( su* ,act 7#ba ,u4,s4,c4 
#cfj;cc74  7,f7 ,section #cea7k77#g7 ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb7k77#g774  7,g7 ,any o!r  
provision ( law t provides = m>ket+ or  
data exclusivity 7or ext5sion (         
exclusivity7 ) respect to a drug4  7#e7 
,op51 nonexclusive lic5se ,! t]m op51   
nonexclusive lic5se means a lic5se t    
all[s a qualifi$ lic5see1 subject to !  
provisions ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq47 & ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bja et seq47-- 7,a7 to  

make1 use1 (f] to sell1 sell1 export1 or
 import into ! ,unit$ ,/ates & any o!r  
c\ntry & t]ritory an inv5tion2  7,b7 to 
ref]5ce or rely ^u e>li]-submitt$       
regulatory te/ data or ! e>li] grant (  
m>ket+ approval ( a treatm5t or vacc9e  
relat$ to su* inv5tion2 &  7,c7 to      
access & use o!rwise confid5tial "k-h[  
relat+ to ! manufacture ( su* inv5tion4 
#c4 ,requirem5ts = reasonable pric+ (   
f$]ally support$ ,,covid-#ai drugs  7a7 
,reasonable pric+ requirem5ts ,any cov]$
 transaction %all include t]ms &        
conditions requir+ t ! pric+ ( ! drug by
 ! p>ty ref]r$ to 9 section #b7;d77#b7  
be fair & reasonable1 & facilitate      
global access1 tak+ into consid]ation-- 
7#a7 ! impact ( ! price on access to !  
drug 9 ! ,unit$ ,/ates1 tak+ into       
consid]ation racial disp>ities 9        
,,covid-#ai cases & fatalities & o!r    
socioeconomic disp>ities2  7#b7 ! impact
 ( ! price on heal? program sp5d+ &     
budgets 9 ! ,unit$ ,/ates2  7#c7 ! risk 
adju/$ value ( ,f$]al subsidies &       

inve/m5ts relat$ to ! drug2  7#d7 ! co/s
 associat$ ) developm5t & manufactur+ ( 
! drug2  7#e7 ! size ( ! affect$ pati5t 
population 9 ! ,unit$ ,/ates & globally2
 &  7#f7 ! !rapeutic efficacy ( ! drug4 
7b7 ,def9itions ,9 ?is section3 7#a7    
,cov]$ transaction ,! t]m cov]$         
transaction has ! mean+ giv5 to su* t]m 
9 section #b4  7#b7 ,drug ,! t]m drug   
has ! mean+ giv5 to su* t]m 9 section   
#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cba74    
#d4 ,report+ on ! exp5ditures (         
manufactur]s ) respect to ,,covid-#ai   
drugs  7a7 ,cov]$ drug ,= purposes ( ?is
 section1 ! t]m cov]$ drug means a drug 
t is int5d$ or anticipat$ to be us$ to  
diagnose1 mitigate1 prev5t1 or treat    
,,covid-#ai4  7b7 ,report+ requir$ ,!   
manufactur] ( a cov]$ drug %all submit a
 report describ$ 9 subsection 7c7 to !  
,secret>y ^u-- 7#a7 ! submission ( an   
application = approval ( ! drug "u      
subsection 7b7 or 7j7 ( section #eje ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  

7#ba ,u4,s4,c4 #cee72  7#b7             
inve/igational use ( ! drug "u section  
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 
or section #cea7;a77#c7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7;a77#c772  7#c7 ! submission ( an  
application = lic5s+ ! drug "u          
subsection 7a7 or 7k7 ( section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb72  7#d7 ! issuance ( an  
au?orization = em]g5cy use ( ! drug "u  
section #efd ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#c72 or  7#e7 ! m>ket+ ( !     
drug4  7c7 ,cont5ts ,a report "u        
subsection 7a71 consi/5t ) ! /&>d =     
disclosures describ$ 9 section          
#bac4c7;d7 ( title #ab1 ,code ( ,f$]al  
,regulations 7z 9 effect on ! date (    
enactm5t ( ?is ,act71 %all address !    
exp5ditures ( ! manufactur] ) respect to
 ! cov]$ drug & include1 at a m9imum--  
7#a7 ! sponsor or sponsors ( ! cov]$    
drug2  7#b7 ! curr5t :olesale           

acquisition co/ ( ! cov]$ drug :5       
applicable2  7#c7 ! total exp5ditures ( 
! manufactur]1 specifi$ by individual   
co/s1 on-- 7,a7 mat]ials & manufactur+ =
 ! cov]$ drug2 &  7,b7 acquir+ pat5ts & 
lic5s+ = ! cov]$ drug2  7#d7 ! total    
am\nt & p]c5tage ( rese>* & developm5t  
exp5ditures = ! cov]$ drug t 0 d]iv$ f  
,f$]al funds2  7#e7 ! total am\nt ( any 
,f$]al b5efits receiv$ by ! manufactur] 
) respect to ! cov]$ drug1 includ+--    
7,a7 ! specific am\nts & p]iods ( impact
 = ea* su* b5efit2  7,b7 ! specific     
value ( any tax cr$its1 includ+ b5efits 
f pati5t assi/ance programs & donat$    
samples2  7,c7 cl9ical & precl9ical     
inve/m5ts2  7,d7 any ,f$]al b5efit t[>d 
manufactur+ co/s1 includ+ build+ or     
retr(itt+ facilities2  7,e7 ,f$]al      
grants1 includ+ f ! ,national ,in/itutes
 ( ,heal?1 ! ,c5t]s = ,disease ,control 
& ,prev5tion1 ! ,dep>tm5t ( ,def5se1 !  
,dep>tm5t ( ,en]gy1 or o!r ,f$]al       
dep>tm5ts or ag5cies2  7,f7 pat5t       
applications t b5efitt$ f su* grants2   

7,g7 pat5t ext5sions2  7,h7 exclusivity 
p]iods2 &  7,i7 waiv]s ( fees2  7#f7 !  
total exp5ditures ( ! manufactur] on    
rese>* & developm5t1 itemiz$ by basic & 
precl9ical rese>* & by cl9ical rese>*1  
report$ sep>ately = ea* cl9ical trial1 =
 ! cov]$ drug to demon/rate t ! cov]$   
drug meets applicable /atutory /&>ds =  
approval "u section #eje ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee71 lic5sure "u section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb71 an exemption =    
inve/igational use "u section #eje7;i7 (
 ! ,f$]al ,food1 ,drug1 or ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;i77 or section
 #cea7;a77#c7 ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bfb7;a77#c771 or  
au?orization "u section #efd ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb-#c71 z applicable2   
7#g7 ! total exp5ditures ( ! manufactur]
 on pursu+ new or exp&$ indications or  
dosage *anges = ! cov]$ drug "u section 
#eje ( ! ,f$]al ,food1 ,drug1 &         

,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb72  7#h7 ! total
 exp5ditures ( ! manufactur] on c>ry+   
out po/m>ket requirem5ts relat$ to su*  
drug1 includ+ "u section #eje7o77#c7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7o77#c772  7#i7 !    
specific exp5ditures associat$ ) m>ket+ 
& adv]tis+ co/s = ! cov]$ drug2  7#aj7  
any anticipat$ royalty fees f lic5s+ to 
o!r manufactur]s2 &  7#aa7 ) respect to 
! manufactur]-- 7,a7 all /ock-bas$      
p]=mance metrics us$ by ! manufactur] to
 det]m9e executive comp5sation ov] !    
prec$+ #ab mon?s2 &  7,b7 any additional
 in=mation ! manufactur] *ooses to      
provide relat$ to drug pric+ decisions4 
7d7 ,civil monet>y p5alties  7#a7       
,failure to submit ,any manufactur] ( a 
cov]$ drug t fails to submit a report z 
requir$ by ?is section1 foll[+          
notification by ! ,secret>y to !        
manufactur] t ! manufactur] is n 9      
compliance ) ?is section1 %all be       

subject to a civil monet>y p5alty (     
#ajj1jjj = ea* day on :i* ! violation   
cont9ues4  7#b7 ,false in=mation ,any   
manufactur] ( a cov]$ drug t kn[+ly     
provides false in=mation 9 a report "u  
?is section is subject to a civil       
monet>y p5alty 9 an am\nt n to exce$    
#ajj1jjj = ea* item ( false in=mation4  
7e7 ,public po/+  7#a7 ,9 g5]al ,subject
 to p>agraph 7#c71 ! ,secret>y %all po/ 
ea* report submitt$ "u subsection 7b7 on
 ! public website ( ! ,dep>tm5t ( ,heal?
 & ,human ,s]vices no lat] ?an #cj days 
aft] ! submission ( ! report4  7#b7     
,=mat ,! ,secret>y %all ensure t su*    
reports are-- 7,a7 us]-fri5dly to !     
public2 &  7,b7 writt5 9 pla9 language t
 consum]s c readily und]/&4  7#c7       
,protect$ in=mation ,no?+ 9 ?is section 
%all be con/ru$ to au?orize ! public    
disclosure ( in=mation submitt$ by a    
manufactur] t is prohibit$ f disclosure 
by any applicable law conc]n+ !         
protection ( trade secrets1 comm]cial   
in=mation1 & o!r in=mation4  7f7        

,def9ition ,9 ?is section1 ! t]m drug   
has ! mean+ giv5 to su* t]m 9 section   
#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cba74    
#e4 ,pric+ requirem5ts = exi/+ treatm5ts
 & vacc9es 9 a public heal? em]g5cy     
,title ,,iii ( ! ,public ,heal? ,s]vice 
,act is am5d$ by ins]t+ aft] section    
#cai;,a 7#db ,u4,s4,c4 #bdg;d-#a7 !     
foll[+ new section3  #cai;,b4 ,pric+    
requirem5ts = treatm5ts & vacc9es 9 a   
public heal? em]g5cy  7a7 ,def9itions ,=
 purposes ( ?is section3 7#a7 ,! t]m    
cov]$ drug means a drug 7includ+ any    
vacc9e7 us$ to diagnose1 mitigate1      
prev5t1 or treat a disease or disord] ) 
respect to :i* !re is or 0 9 effect a   
decl>ation ( a public heal? em]g5cy "u  
section #cai4  7#b7 ,! t]m cov]$ p]iod  
means ! p]iod end+ if & :5 !            
circum/ances :i* l$ to an applicable    
public heal? em]g5cy cease to exi/ & are
 unlikely to recur4  7#c7 ,! t]m        
,,fda-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$]al    
,food1 ,drug1 & ,cosmetic ,act4  7,b7   
,subsection 7j77#e77;,b77iv7 or clause  
7ii71 7iii71 or 7iv7 ( subsection       
7j77#e77;,f7 ( su* ,act4  7,c7 ,section 
#eje;,a ( su* ,act4  7,d7 ,section      
#eje;,e ( su* ,act4  7,e7 ,section #ebg 
( su* ,act4  7,f7 ,section #cea7k77#g7 (
 ?is ,act4  7,g7 ,any o!r provision (   
law t provides = m>ket+ or data         
exclusivity 7or ext5sion ( exclusivity7 
) respect to a drug4  7#d7 ,! t]m       
:olesale acquisition co/ has ! mean+    
giv5 t t]m 9 section                    
#ahdg;,a7c77#f77;,b7 ( ! ,social        
,security ,act4  7b7 ,det]m9ation (     
excessive price ,dur+ any cov]$ p]iod ) 
respect to a cov]$ drug1 ! ,secret>y    
%all det]m9e t ! price ( a cov]$ drug is
 excessive if ! :olesale acquisition co/
 7or a m relevant measure ( price7 ( !  
cov]$ drug is n fair & reasonable1 or   
does n facilitate global access1 tak+   

into consid]ation-- 7#a7 ! impact ( !   
price on access to ! cov]$ drug 9 !     
,unit$ ,/ates1 tak+ into consid]ation   
racial disp>ities & o!r socioeconomic   
disp>ities2  7#b7 ! impact ( ! price on 
heal? program sp5d+ & budgets 9 ! ,unit$
 ,/ates2  7#c7 ! risk adju/$ value (    
,f$]al subsidies & inve/m5ts relat$ to !
 cov]$ drug2  7#d7 ! co/s associat$ )   
developm5t & manufactur+ ( ! cov]$ drug2
  7#e7 ! size ( ! affect$ pati5t        
population 9 ! ,unit$ ,/ates & globally2
 &  7#f7 ! !rapeutic efficacy ( ! cov]$ 
drug4  7c7 ,excessive pric+ rem$y ,if ! 
,secret>y det]m9es pursuant to          
subsection 7b7 t ! price ( a cov]$ drug 
is excessive1 ! ,secret>y-- 7#a7 %all   
waive or void any ,,fda-grant$          
exclusivities ) respect to ! cov]$ drug1
 effective on ! date t ! excessive price
 det]m9ation is made2 &  7#b7 %all grant
 op51 nonexclusive lic5ses all[+ any    
p]son to make1 use1 (f] to sell1 or     
sell1 or import into ! ,unit$ ,/ates su*
 drug1 & to rely ^u ! regulatory te/    

data ( su* drug1 & to access & use      
o!rwise confid5tial in=mation1 includ+  
"k-h[1 relat$ to ! manufacture ( su*    
drug 9 accordance ) subsection 7d74  7d7
 ,reasonable royalty  7#a7 ,9 g5]al ,an 
entity accept+ an op51 nonexclusive     
lic5se "u subsection 7c77#b7 %all pay a 
reasonable royalty ) respect to sales )9
 ! ,unit$ ,/ates to ! hold] ( a pat5t t 
claims ! cov]$ drug or t claims a use ( 
! cov]$ drug or to ! hold] ( an         
application approv$ "u section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea ( ! ,public ,heal? ,s]vice
 ,act = :i* any ,,fda-grant$ exclusivity
 ) respect to ! cov]$ drug 0 t]m9at$ "u 
subsection 7c77#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 !     

!rapeutic efficacy ( ! cov]$ drug2  7ii7
 ! size ( ! affect$ pati5t population 9 
! ,unit$ ,/ates & globally2  7iii7 !    
risk adju/$ value ( ,f$]al subsidies &  
inve/m5ts relat$ to ! cov]$ drug2  7iv7 
! ext5t to :i* ! manufactur] ( ! cov]$  
drug has recov]$ risk adju/$ inve/m5ts  
relat$ to ! cov]$ drug1 includ+ !       
inve/m5ts relat$ to ! inv5tion1         
regulatory te/ data1 & any o!r relevant 
rese>* & developm5t co/s2 &  7v7 any o!r
 in=mation ! ,secret>y det]m9es         
appropriate4  7#c7 ,sales )9 o!r        
c\ntries ,an entity accept+ an op51     
nonexclusive lic5se "u subsection       
7c77#b7 %all pay a reasonable royalty ) 
respect to sales )9 o!r c\ntries bas$ on
 ! royalty rate paid 9 ! ,unit$ ,/ates  
times ! ratio betwe5 t c\ntry's gross   
dome/ic product p] capita divid$ by !   
,unit$ ,/ates gross dome/ic product p]  
capita 9 ! la/ ye> su* data 0 available 
= bo? c\ntries1 b su* royalty %all be   
due only if !re are grant$ pat5ts or    
data exclusivity rights 9 t c\ntry at ! 

"t ( sale4  7e7 ,requirem5ts  7#a7 ,9   
g5]al ,a royalty rate "u subsection 7d7 
%all be consi/5t ) mak+ ! cov]$ drug    
available to pur*as]s1 includ+          
gov]nm5tal & 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 
cov]$ drug = :i* an op51 nonexclusive   
lic5se 0 issu$ "u subsection 7c7 to be  
sold at an excessive price1 z det]m9$ "u
 subsection 7b74  7#b7 ,multiple affect$
 p>ties ,9 ! case t !re is "o or m      
hold]s or inve/ors 9 ! pat5t$ inv5tions 
relat$ to ! cov]$ drug1 ! 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 nonexclusive
 lic5se "u subsection 7c77#b7 %all sell 
! cov]$ drug at a price n high] ?an !   
excessive price det]m9$ = ! cov]$ drug  

"u subsection 7b74  7f7 ,cl>ification   
,an op51 nonexclusive lic5se "u         
subsection 7c77#b7 %all be liable1      
subject to adequate protection ( !      
legitimate int]e/s ( any p>ty utiliz+ ! 
lic5se1 to be t]m9at$ only if !         
circum/ances :i* l$ to ! grant+ ( ! op51
 nonexclusive lic5se cease to exi/ & are
 unlikely to recur4 ,! ,secret>y may    
review1 ^u reque/1 ! cont9u$ exi/5ce (  
^! circum/ances4  4