Conditions: Lung Cancer Non-small Cell Lung Cancer (NSCLC)
Keywords: Epidermal Growth Factor Receptor (EGFR) Tyrosine kinase inhibitors Neoplasms Lung Diseases Respiratory Tract Diseases Pleural Diseases Pleural Neoplasms Lung Neoplasms Pleural Effusion Pleural Effusion, Malignant Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site EGFR mutation Afatinib Dasatinib Carcinoma, Bronchogenic Gene Mutation T790M mutation. Non-small cell lung cancer
Allocation: NA | Intervention model: SEQUENTIAL
Enrollment: 25
Healthy volunteers: no

Brief summary:
The purpose of this study is to:

* Find out if the study drugs Afatinib and Dasatinib can be safely given together to patients with lung cancer
* Learn how these two drugs work in cancer cells when they are combined
* Learn more about the side effects of these two drugs when combined
* Find the highest doses of the study drugs Afatinib and Dasatinib that can be given safely without causing serious side effects

Detailed description:

Arms:
arm 1: Dose escalation followed by dose expansion. Escalation cohort: Afatinib and Dasatinib. This study is divided into two parts. The first 8 - 18 people will be entered in the first part, called Phase 1A. Then this part will end.

Expansion cohort:: Afatinib and Dasatinib. The next 20 people will enter into the second part, called Phase 1B.

Interventions: intervention 1: Dasatinib - 1A intervention 2: Afatinib - 1A intervention 3: Dasatinib - 1B intervention 4: Afatinib - 1B
Intervention descriptions: intervention 1: 1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg. intervention 2: 1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg. intervention 3: In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal. intervention 4: In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal.

Protocol document:
Prot_SAP_000.pdf: 
 
 
 
Phase I Trial Evaluating Safety and Tolerability of the Irreversible Epidermal 
Growth Factor Receptor Inhibitor Afatinib (BIBW 2992) in Combination with the 
SRC Kinase Inhibitor Dasatinib for Patients with Non-small Cell Lung Cancer 
(NSCLC) 
 
NCT01999985 
Version 3.0 
March 22, 2017 


3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK 
7,7/(3$*(
3KDVH,7ULDO(YDOXDWLQJ6DIHW\DQG7ROHUDELOLW\RIWKH,UUHYHUVLEOH
(SLGHUPDO*URZWK)DFWRU5HFHSWRU,QKLELWRU$IDWLQLE%,%:LQ
&RPELQDWLRQZLWKWKH65&.LQDVH,QKLELWRU'DVDWLQLEIRU3DWLHQWVZLWK
1RQVPDOO&HOO/XQJ&DQFHU16&/&

%,3URWRFRO1XPEHU
%063URWRFRO1XPEHU&$
0&&3URWRFRO1XPEHU0&&
&KHVDSHDNH,5%3URWRFRO1XPEHU3UR

3ULQFLSDO,QYHVWLJDWRU
%HQ&UHHODQ0'06
7KRUDFLF2QFRORJ\3URJUDP
+/HH0RIILWW&DQFHU&HQWHU	5HVHDUFK,QVWLWXWH
0DJQROLD'ULYH7DPSD)/
3KRQH
)D[
EHQFUHHODQ#PRIILWWRUJ
9HUVLRQ0DUFK
%LRVWDWLVWLFLDQ
0LFKDHO6FKHOO3K'
3K)D[
PLFKDHOVFKHOO#PRIILWWRUJ



3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK 
5DGLRPLFV$QDO\VLV
(ULF.2XWZDWHU0'
'LDJQRVWLF,PDJLQJ
3K)D[
HULFRXWZDWHU#PRIILWWRUJ
&2//$%25$7256

%RHKULQJHU,QJHOKHLP*PE+
,QJHOKHLP*HUPDQ\
%ULVWRO0\HUV6TXLEE,QF
1HZ<RUN1<
678'<6,7(6
+/HH0RIILWW&DQFHU&HQWHU	5HVHDUFK,QVWLWXWH
7DPSD)ORULGD86$
$GGLWLRQDOVWXG\VLWHVZLWKLQ/&0&FRQVRUWLXPPD\EHUHYLHZHGIRUDSSURYDOIRU3+$6(
,%(;7(16,21SRUWLRQRIWULDO
3URSULHWDU\FRQILGHQWLDOLQIRUPDWLRQ
7KLVGRFXPHQWPD\QRWLQIXOORULQSDUWEHSDVVHGRQUHSURGXFHGSXEOLVKHGRURWKHUZLVHXVHGZLWKRXWSULRUZULWWHQSHUPLVVLRQ,WFRQWDLQVWUDGH
VHFUHWVDQGFRPPHUFLDOLQIRUPDWLRQWKDWDUHSULYLOHJHGRUFRQILGHQWLDODQGPD\QRWEHGLVFORVHGWRWKLUGSDUWLHVXQOHVVGLVFORVXUHLVUHTXLUHGE\
DSSOLFDEOHODZVRUUHJXODWLRQ


3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7$%/(2)&217(176
7,7/(3$*( 
7$%/(2)&217(176 
35272&2/6<1236,6 
)LJXUH)ORZFKDUWRIGHVLJQ 
678'<&$/(1'$5±3+$6(,$ 
678'<&$/(1'$5±3+$6(,% 
 
,1752'8&7,21 
 
6,*1,),&$1&( 
 
6FRSHRIWKH3UREOHP7UHDWPHQWRI16&/& 
 
(SLGHUPDO*URZWK)DFWRU5HFHSWRU(*)5,QKLELWRUVLQ/XQJ&DQFHU 
 
(*)5$'ULYHU0XWDWLRQLQ16&/& 
 
70*DWHNHHSHU(*)50XWDWLRQDQG,UUHYHUVLEOH(*)57.,LQ16&/& 
 
0HFKDQLVPVRI(*)57.,5HVLVWDQFHLQ16&/& 
 
6LJQLILFDQFHRIWKH6UF7.,'DVDWLQLELQ16&/& 
7DEOH'UXJVWKDWPD\RYHUFRPH(*)5UHVLVWDQFH$GDSWHGIURP>@ 
 
65&6LJQDOLQJLQ1RQ6PDOO&HOO/XQJ&DQFHU 
)LJXUH(*)5PXWDQW16&/&LQYLWURUHVXOWVIURP+DXUDODE 
 
&20%,1$7,212)$)$7,1,%:,7+'$6$7,1,% 
 
&$1&(55$',20,&6 
 
6FRSHRI,PDJLQJ3UREOHP 
7DEOH3RWHQWLDOO\5HSUHVHQWDWLYH&7IHDWXUHVDQG9DULDEOHV 
 
5DGLRPLFV$5DWLRQDOH6ROXWLRQ 
 
'$6$7,1,%'58*352),/( 
 
$&7,9,7<,1(;3(5,0(17$/02'(/6 
 
,Q9LWUR0ROHFXODU6WXGLHV 
 
/XQJ&DQFHU&HOO6WXGLHV 
 
,Q9LYR6WXGLHV 
)LJXUH+DXUDODEPXWDWHG16&/&PRXVHPRGHOV\QHUJLVWLFDFWLYLW\ 
 
3UHFOLQLFDO7R[LFRORJ\ 
 
&/,1,&$/3+$50$&2.,1(7,&6 
 
$EVRUSWLRQ 
 
'LVWULEXWLRQ 
 
0HWDEROLVP 
 
(OLPLQDWLRQ 
 
&OLQLFDO([SHULHQFHZLWK'DVDWLQLELQ&0/DQG3K$// 
 
6$)(7<2)'$6$7,1,%,1&/,1,&$/678',(6 

6DIHW\LQ+HPDWRORJLF0DOLJQDQF\  
7DEOH9HU\&RPPRQDQG&RPPRQ$(V5HSRUWHGLQ6XEMHFWVLQ&OLQLFDO6WXGLHV 
 
([SHULHQFHLQ3KDVH%UHDVW&DQFHU6WXGLHV 
7DEOH'UXJ5HODWHG$GYHUVH(YHQWVLQt6XEMHFWVIRU3KDVH%UHDVW&DQFHU6WXGLHV&$
DQG&$ 
 
([SHULHQFHLQ3KDVH,,3URVWDWHFDQFHUVWXGLHV 
/DERUDWRU\$EQRUPDOLWLHV 
7DEOH&7&*UDGHV/DERUDWRU\$EQRUPDOLWLHVLQ&0/DQG3K$// 
 
$17,&,3$7('$'9(56((9(176 



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
 
0\HORVXSSUHVVLRQ 
 
%OHHGLQJ5HODWHG(YHQWV 
 
)OXLG5HWHQWLRQ 
 
473URORQJDWLRQ 
 
2YHUDOO5LVN%HQHILW$VVHVVPHQW 
 
3+$6(,(;3(5,(1&(,162/,'780256 
 
-867,),&$7,21)2521&('$,/<'26,1* 
 
&RPSDULVRQRI6FKHGXOH3KDUPDFRNLQHWLFV 
 
&RPSDULVRQRI6FKHGXOH3KDUPDFRG\QDPLFV 
 
&RPSDULVRQRI6FKHGXOH7R[LFLW\ 
 
$)$7,1,%'58*352),/( 
7DEOH,QYLWURDFWLYLW\RIDIDWLQLE%,%:LQKXPDQWXPRUFHOOPRGHOVH[SUHVVLQJZLOGW\SHRUPXWDWHG
(*)5 
 
3+$50$&2/2*<$1'72;,&2/2*<352),/( 
 
&/,1,&$/(;3(5,(1&($)$7,1,% 
 
2YHUYLHZ 
7DEOH(DUO\SKDVHGHYHORSPHQWRI%,%:$GDSWHGIURP>@ 
 
'RVH6HOHFWLRQIRU6LQJOH$JHQW7ULDOVRI$IDWLQLE 
 
$GYHUVH(YHQWVZLWK$IDWLQLE 
 
&OLQLFDO(IILFDF\ 
 
3KDUPDFRNLQHWLFV 
 
3KDVH,,,,,7ULDOV 
7DEOH$IDWLQLE7ULDOVLQSDWLHQWVZLWK16&/&$GDSWHGIURP>@>@ 
 
$)$7,1,%±&20%,1$7,2163(&,),&6$)(7<0($685(6 
 
&21&/86,216)5203+$50$&2.,1(7,&6,1+80$16 
 
$)$7,1,%)2508/$7,21 
 
'26$*($'0,1,675$7,21$1'6725$*( 
 
678'<'(6,*1 
 
29(59,(: 
 
6(/(&7,212)3$7,(176 
 
,1&/86,21&5,7(5,$ 

(;&/86,21&5,7(5,$ 
 
75($70(176 
 
678'<&$/(1'$5±6((678'<&$/(1'$56(&7,21 
 
75($70(176$'0,1,67(5(' 
 
6FUHHQLQJ(YDOXDWLRQ 
 
&\FOH 
 
&\FOH 
 
7KHUDS\%H\RQG&\FOH 
 
(QGRI7UHDWPHQWYLVLW(27 
 
'26((6&$/$7,2158/(6 
 
'RVH(VFDODWLRQ6FKHPD 
7DEOH'RVH(VFDODWLRQ6FKHPD
 
'HILQLWLRQRI'RVH/LPLWLQJ7R[LFLW\'/7 
 
&21&20,7$177+(5$3< 
 
3URKLELWHGDQG5HVWULFWHG7KHUDSLHV'XULQJ6WXG\ 

3URKLELWHG7KHUDSLHV
 
5HVWULFWHG7KHUDSLHV 
 
3RWHQWLDOIRU$IDWLQLE'DVDWLQLE,QWHUDFWLRQV 
'DVDWLQLEDQG3JO\FRSURWHLQ 
 
75($70(172)3(562162)&+,/'%($5,1*327(17,$/ 



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
 
3$7,(17:,7+'5$:$/&5,7(5,$ 
 
121&203/,$1&( 
 
$&&2817$%,/,7<352&('85(6 
 
678'<3(5,2' 
 
75,$/',6&217,18$7,21 
 
6SHFLDO6LWXDWLRQV 
 
0$1$*(0(172)$'9(56((9(176 
 
5DVK 
 
'LDUUKHD 
 
1DXVHDDQG9RPLWLQJ 
 
3XOPRQDU\ 
 
)OXLG,PEDODQFH 
 
*HQHUDO'RVH0RGLILFDWLRQV%H\RQG&\FOH 
 
2%6(59$7,216 
 
0(7+2'2/2*< 
 
3ODVPD&ROOHFWLRQDQG3URFHVVLQJ 
 
&255(/$7,9(6&,(1&( 
 
6WRUHG3ODVPD6DPSOHV 
 
5DGLRPLF$QDO\VLVIRU,PDJLQJ3UHGLFWLYH0DUNHUV 
 
$VVHVVPHQW 
 
'DWD5HFRUGLQJ 
 
$66(660(172)6$)(7< 
 
6DIHW\(YDOXDWLRQ2YHUYLHZ 
 
$GYHUVH(YHQWV 
 
7LPH3HULRG5HSRUWLQJ5HTXLUHPHQWV 
 
+RVSLWDOL]DWLRQ 
 
:RUVHQLQJRISUHH[LVWLQJFRQGLWLRQV 
 
$VVHVVPHQWRIKHDOWKFDUHUHVRXUFHXVH 
 
/DERUDWRU\LQYHVWLJDWLRQV 

3K\VLFDOH[DPLQDWLRQDQGSHUIRUPDQFHVFRUH 
 
9LWDOVLJQV  
 
(.* 
 
/HIWYHQWULFXODUIXQFWLRQDVVHVVPHQW 
 
'DWDDQG6DIHW\0RQLWRULQJ&RPPLWWHH'06& 

$66(660(172)()),&$&<  
 
(YDOXDWLRQRI5HVSRQVH 
 
5HVSRQVH&ULWHULDIRU3KDVH,$ 
 
%DVHOLQHFULWHULD 
 
6SHFLILFDWLRQVE\PHWKRGVRIPHDVXUHPHQWV 
 
7XPRUUHVSRQVHHYDOXDWLRQ 
 
5HVSRQVH&ULWHULDIRU3KDVH,% 
 
5(&,67YFULWHULD 
7DEOH%HVWUHVSRQVH 

'HILQLWLRQRI(YDOXDEOH3DUWLFLSDQWV 
3DUWLFLSDQWVDUHFRQVLGHUHGHYDOXDEOHZKRUHFHLYHWKHLUILUVWGRVHRIWKHUDS\1RQHYDOXDEOHSDUWLFLSDQWVDUH
WKRVHZKRGRQRWUHFHLYHWKHILUVWGRVHRIWKHUDS\3DUWLFLSDQWVZKRZLWKGUDZFRQVHQWRUGLVFRQWLQXHGGXHWR
SURWRFROYLRODWLRQVSULRUWRWKHILUVWHYDOXDWLRQDUHQRWFRQVLGHUHGHYDOXDEOHIRUHIILFDF\ 
)RURWKHUGHILQLWLRQVVHH6HFWLRQ³3URJUHVVLRQ'HILQLWLRQV´ 
 
&RQILUPDWRU\PHDVXUHPHQWGXUDWLRQRIUHVSRQVH 

3URJUHVVLRQ'HILQLWLRQV 
 
5HSRUWLQJRI5HVXOWV 
 
678'<'58*663(&,),&$7,216 
 
352'8&7,'(17,),&$7,21 
 
'DVDWLQLE 



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
 
$IDWLQLE 
 
3$&.$*,1*$1'/$%(/,1* 
 
+$1'/,1*$1'',63(16,1*2),19(67,*$7,21$/352'8&7 
 
,19(67,*$7,21$/352'8&75(&25'6$7,19(67,*$7,21$/6,7(6 
 
5(7851$1''(6758&7,212),19(67,*$7,21$/352'8&7 
 
5HWXUQRI,QYHVWLJDWLRQDO3URGXFW 
 
'HVWUXFWLRQRI,QYHVWLJDWLRQDO3URGXFW 

$'9(56((9(176	'$7$6$)(7<021,725,1*&200,77(('60& 
 
63(&,),&$7,212)6$)(7<9$5,$%/(6 
 
'HILQLWLRQRI$GYHUVH(YHQWV 
 
3URWRFRO6SHFLILHG6LJQLILFDQW(YHQWV 
 
6HULRXV$GYHUVH(YHQWV 
 
0(7+2'6$1'7,0,1*)25$66(66,1*$1'5(&25',1*6$)(7<9$5,$%/(6 
 
$GYHUVH(YHQW5HSRUWLQJ3HULRG 
 
$VVHVVPHQWRI$GYHUVH(YHQWV 
7DEOH$GYHUVH(YHQW*UDGLQJ6HYHULW\6FDOH 
 
'DWD6DIHW\DQG0RQLWRULQJ%RDUG 
 
$'9(56((9(175(3257,1**8,'(/,1(6 
 
0HG:DWFK$5HSRUWLQJIRU*RRG&OLQLFDO3UDFWLFH 
 
5HVSRQVLELOLWLHVIRU6$(UHSRUWLQJWR&ROODERUDWRUV 
 
352&('85(6)25(/,&,7,1*5(&25',1*$1'5(3257,1*$'9(56((9(176 
 
([SHGLWHG5HSRUWLQJ5HTXLUHPHQWVIRU6HULRXV$GYHUVH(YHQWV 
 
7\SHDQG'XUDWLRQRI)ROORZXSRI3DWLHQWVDIWHU$GYHUVH(YHQWV 
 
67$7,67,&$/0(7+2'2/2*< 

3URJUHVVLRQ'HILQLWLRQ  
 
3RZHU$QDO\VLV 
 
6XEJURXS$QDO\VLV 
 
6DIHW\DQDO\VLV 
 
$'0,1,675$7,9(6(&7,21 
 
5,6.7268%-(&76 
 
$'(48$&<2)3527(&7,21$*$,1675,6. 
 
,03257$1&(2)7+(.12:/('*(72%(*$,1(' 
 
'$7$6$)(7<$1'021,725,1*3/$1 
 
,1,7,$/$1'21*2,1*021,725,1*$1'5(9,(: 
 
*22'&/,1,&$/35$&7,&( 
 
6863(16,21$1'7(50,1$7,21 
 
,167,787,21$/$1',1',9,'8$/&21)/,&762),17(5(67 

5(&25'65(7(17,21 
 
&2175,%87,216 
 
$33(1',&(6 
 
$33(1',;72;,&,7<7$%/(6 
$'9(56((9(170$1$*(0(17*8,'(/,1(3$38/238678/$56.,15$6+ 
$'9(56((9(170$1$*(0(17*8,'(/,1(',$55+($ 
$'9(56((9(170$1$*(0(17*8,'(/,1(/2&$/,=('('(0$ 
$'9(56((9(170$1$*(0(17*8,'(/,1(1$86($$1'920,7,1* 
 
$33(1',;6833/(0(17$/3+$50$&29,*,/$1&($*5((0(17 
 
$33(1',;6833/(0(17$/0$18)$&785,1*$*5((0(17 
 
/,672)$%%5(9,$7,216 
 
5()(5(1&(6 



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
35272&2/6<1236,6
5DWLRQDOH
$IDWLQLE%,%:LVDQRUDOLUUHYHUVLEOHLQKLELWRURIWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRU
(*)5W\URVLQHNLQDVH7KLVQRYHODJHQWPD\SURORQJVXUYLYDOLQSDWLHQWVZLWKDGYDQFHGQRQ
VPDOOFHOOOXQJFDQFHU65&W\URVLQHNLQDVHSURWHLQVFDQFRRSHUDWHZLWK(*)5DQGFDQDIIHFW
WXPRUFHOOJURZWKVXUYLYDOLQYDVLRQDQGDQJLRJHQHVLV)RUWKHVHUHDVRQVFRPELQHG(*)5
DQG65&W\URVLQHNLQDVHLQKLELWLRQPD\EHVXSHULRUWRHLWKHUDJHQWDORQH,Q(*)5UHVLVWDQW
DQLPDOPRGHOVDIDWLQLELQFRPELQDWLRQZLWKGDVDWLQLESURGXFHGV\QHUJLVWLFUHGXFWLRQLQWXPRU
YROXPHDWVDIHDQGDFKLHYDEOHFRQFHQWUDWLRQVLQKXPDQV7KHUHIRUHDFRPELQDWLRQ3KDVH,
WULDOLVUDWLRQDOLQKXPDQVXEMHFWV
'HVLJQ
3KDVH,WULDORIWKHLUUHYHUVLEOH(*)5LQKLELWRUDIDWLQLEZLWKWKH65&W\URVLQHNLQDVHLQKLELWRU
GDVDWLQLELQSDWLHQWVZLWKDGYDQFHGVWDJH6WDJH,,,%,9GLVHDVH1RQ6PDOO&HOO/XQJ&DQFHU
16&/&
)LJXUH)ORZFKDUWRIGHVLJQ

7UHDWPHQW5HJLPHQ
$IDWLQLERQFHGDLO\RUDOWDEOHWVWDUWLQJ'D\
'DVDWLQLERQFHGDLO\RUDOWDEOHWVWDUWLQJ'D\
3KDVH,%([WHQVLRQ
5HIUDFWRU\UHODSVHG16&/&
ZLWKHLWKHU
(*)5PXWDWLRQRU
3ULRU(*)57.,UHVSRQVH
Q 

3KDVH,$'RVH(VFDODWLRQ
5HIUDFWRU\UHODSVHG16&/&
7UDGLWLRQDO)LERQDFFL'HVLJQ
Q 
PJ%,%:
PJ'DV
PJ%,%:
PJ'DV
PJ%,%:
PJ'DV
%,%:'DVDW07'
RU0D[LPDO$GPLQLVWHUHG
'RVHLIQR'/7VHHQ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7R[LFLW\(YDOXDWLRQHYHU\GD\VIRUZHHNV
5HVSRQVH(YDOXDWLRQ'D\rGD\VWKHQHYHU\GD\VrGD\V
2EMHFWLYHV
3ULPDU\2EMHFWLYHV
'HWHUPLQHWKHVDIHW\DQGWROHUDELOLW\RIDIDWLQLELQFRPELQDWLRQZLWKGDVDWLQLELQSDWLHQWVZLWK
DGYDQFHG16&/&
'HWHUPLQHWKHPD[LPXPWROHUDWHGGRVH07'RIDIDWLQLELQFRPELQDWLRQZLWKGDVDWLQLE
6HFRQGDU\2EMHFWLYHV
(VWLPDWHWKHREMHFWLYHUHVSRQVHUDWHFRPSOHWHUHVSRQVH>&5@DQGSDUWLDOUHVSRQVH>35@
DQGFOLQLFDOEHQHILWUDWHLQSDUWLFLSDQWVZLWKDFTXLUHG(*)5UHVLVWDQFH
 (VWLPDWH WKH PRQWK SURJUHVVLRQ IUHH VXUYLYDO UDWH LQ SDUWLFLSDQWV ZLWK DFTXLUHG (*)5
UHVLVWDQFH
([SORUHWKHXWLOLW\RILPDJLQJIHDWXUHVDVDELRPDUNHUIRUFOLQLFDODFWLYLW\RIW\URVLQHNLQDVH
LQKLELWRUV
6DPSOH6L]H
7RWDOVDPSOHVL]H±DVIROORZV
 3KDVH,$'RVH(VFDODWLRQQ GHSHQGLQJRQ'/7
 3KDVH,%([WHQVLRQQ 
([SHFWHGDFFUXDOLVSDWLHQWVSHUPRQWKHVWLPDWHGWLPHWRFRPSOHWHLVPRQWKV$FFUXDO
UDWHZLOOEHPRQLWRUHGDQGLIDFFUXDOUDWHIDOOVEHORZRIH[SHFWHGUDWHDFRUUHFWLYHDFWLRQ
SODQZLOOEHGHYHORSHG



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
678'<&$/(1'$5±3+$6(,$
&\FOHOHQJWKGD\V
6FUHHQ>@
&\FOH

&\FOH

&\FOH	
VXEVHTXHQW>@
(QGRI7UHDWPHQW
9LVLW(27>@
'
'
' '
'
'

,QIRUPHG&RQVHQW
;





7R[LFLW\$VVHVVPHQW

;
;
;
;

;
;
3LOO'LDU\&KHFN



;
;

;

7XPRU(YDOXDWLRQ>@
;>@



;>@

&%&&030DJ>@
;>@
;>@
;
;
;

;

(.*
;>@


;


/9()>@
;>@




;>@

&RPSOHWH3K\VLFDO([DP
;>@

;
;
;

;
;
9LWDO6LJQVDQG36HYDOXDWLRQ>@ ;

;
;
;

;
;
%HWD+&*>@
;





3ODVPDVDPSOH

;


;


$IDWLQLE














'DVDWLQLE








&DOHQGDU)RRW1RWHV

&76FDQRI&KHVW$EGRPHQ62&HYHU\GD\VGD\VDIWHU&'SHU6HFWLRQ(YDOXDWLRQRI5HVSRQVH 


3HUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW



3HUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW 6HH6HFWLRQIRUDGGLWLRQDOLQIRUPDWLRQ



08*$RU(&+26HH6HFWLRQ7UHDWPHQWV$GPLQLVWHUHGIRUDGGLWLRQDOLQIRUPDWLRQ



3HUIRUPHGHYHU\PRQWKVGD\VDIWHUF\FOHIRU\HDURUXQWLO(QGRI7UHDWPHQW (27 YLVLW



(YHU\GD\VGD\VXQWLOWR[LFLW\RUSURJUHVVLRQIRU\HDUDQGHYHU\PRQWKVWKHUHDIWHU



3HUIRUPHGZLWKLQGD\VRIFHVVDWLRQRIVWXG\GUXJ



6FUHHQLQJSHUIRUPHGXSWRGD\VEHIRUH&'



&'ODEVDUHH[FOXGHGLISHUIRUPHGZLWKLQGD\VRIVFUHHQLQJ
3UHPHQRSDXVDOIHPDOHVRQO\



9LWDO6LJQVLQFOXGH+HLJKW:HLJKWDQG LQFOXGH%3SXOVHDQGUHVSLUDWRU\UDWHDIWHUPLQXWHVVXSLQHUHVW
6HH6HFWLRQ/DERUDWRU\,QYHVWLJDWLRQVIRUDGGLWLRQDOLQIRUPDWLRQ



&'GD\V



;



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
678'<&$/(1'$5±3+$6(,%
&\FOHOHQJWKGD\V
6FUHHQ>@
&\FOH



&\FOH
&\FOH	
VXEVHTXHQW>@
(QGRI7UHDWPHQW
(27YLVLW>@
'

'
'
'
'

,QIRUPHG&RQVHQW
;






7R[LFLW\$VVHVVPHQW

;

;
;
;
;
3LOO'LDU\&KHFN




;
;

7XPRU(YDOXDWLRQ>@
;>@




;>@


&%&&030DJ>@
;>@
;>@

;
;
;

(.*
;>@


;



/9()>@
;>@




;>@

&RPSOHWH3K\VLFDO([DP
;>@



;
;
;
9LWDO6LJQVDQG36DVVHVVPHQW>@
;



;
;
;
%HWD+&*>@
;






3ODVPDVDPSOH

;


;


$IDWLQLE















'DVDWLQLE








&DOHQGDU)RRW1RWHV


&76FDQRI&KHVW$EGRPHQ62&HYHU\GD\VGD\VDIWHU&'SHU6HFWLRQ(YDOXDWLRQRI5HVSRQVH
3HUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW


3HUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW6HH6HFWLRQIRUDGGLWLRQDOLQIRUPDWLRQ

08*$RU(&+26HH6HFWLRQ7UHDWPHQWV$GPLQLVWHUHGIRUDGGLWLRQDOLQIRUPDWLRQ

3UHPHQRSDXVDOIHPDOHVRQO\
3HUIRUPHGHYHU\ PRQWKVDIWHUF\FOHIRU\HDURUXQWLO(QGRI7UHDWPHQW(27YLVLW

(YHU\GD\VGD\VXQWLOWR[LFLW\RUSURJUHVVLRQIRU\HDUDQGHYHU\PRQWKVWKHUHDIWHU

3HUIRUPHGZLWKLQGD\VRIFHVVDWLRQRIVWXG\GUXJ

6FUHHQLQJSHUIRUPHGXSWRGD\VEHIRUH&'

&'ODEVDUHH[FOXGHGLISHUIRUPHGZLWKLQGD\VRIVFUHHQLQJ
9LWDO6LJQVLQFOXGH+HLJKW:HLJKWDQGLQFOXGH%3SXOVHDQGUHVSLUDWRU\UDWHDIWHUPLQXWHVVXSLQHUHVW

6HH6HFWLRQ/DERUDWRU\,QYHVWLJDWLRQVIRUDGGLWLRQDOLQIRUPDWLRQ

&'GD\V

;
;



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK


,1752'8&7,21

6LJQLILFDQFH

6FRSHRIWKH3UREOHP7UHDWPHQWRI16&/&
$SSUR[LPDWHO\SDWLHQWVLQWKH8QLWHG6WDWHVDUHGLDJQRVHGZLWKOXQJFDQFHU\HDUO\RI
ZKLFKLVFODVVLILHGDVQRQVPDOOFHOOOXQJFDQFHU16&/&>@(LJKW\WKUHHSHUFHQWZLOO
HYHQWXDOO\ GLH RI WKHLU GLVHDVH >@ ,Q DGGLWLRQ 16&/& UHPDLQV WKH OHDGLQJ FDXVH RI GHDWK
UHODWHG WR FDQFHU ZRUOGZLGH >@ 8QWLO  SODWLQXPEDVHG GRXEOHWV KDYH EHHQ VWDQGDUG
WKHUDS\IRUWKHPDMRULW\RIDGYDQFHG16&/&EDVHGXSRQPRGHUDWHLPSURYHPHQWLQVXUYLYDO
DQGTXDOLW\RIOLIH>@+RZHYHURYHUDOOVXUYLYDO26KDVUHDFKHGDSODWHDXHYHQZLWKWKH
HQKDQFHPHQWRIWKHVHUHJLPHQVDQGGHYHORSPHQWRIWKHVHFRQGOLQHFKHPRWKHUDS\LQ16&/&
>@7KHUHIRUH16&/&LVDSHUYDVLYHFOLQLFDOSUREOHPIRUZKLFKDGGLWLRQDOWUHDWPHQW
VWUDWHJLHVDUHXUJHQWO\QHHGHG

(SLGHUPDO*URZWK)DFWRU5HFHSWRU(*)5,QKLELWRUVLQ/XQJ&DQFHU
(*)5 LV D PHPEHU RI WKH (UE% IDPLO\ RI UHFHSWRU W\URVLQH NLQDVHV ,W LV IUHTXHQWO\
RYHUH[SUHVVHGDQGQHJDWLYHO\FRUUHODWHGZLWKSURJQRVLVLQPDQ\W\SHVRIKXPDQPDOLJQDQF\
LQFOXGLQJ16&/&>@(*)5LVDN'DSODVPDPHPEUDQHJO\FRSURWHLQFRPSRVHGRI
DQH[WUDFHOOXODUOLJDQGELQGLQJGRPDLQDWUDQVPHPEUDQHUHJLRQDQGDQLQWUDFHOOXODUW\URVLQH
NLQDVH GRPDLQ ZLWK D UHJXODWRU\ &22+WHUPLQDO VHJPHQW >@ %LQGLQJ RI OLJDQG WR (*)5
LQGXFHV QRW RQO\ KRPRGLPHUL]DWLRQ ZLWK (*)5 EXW DOVR KHWHURGLPHUL]DWLRQ ZLWK WKH RWKHU
PHPEHUVRIWKH(UE%IDPLO\RIUHFHSWRUW\URVLQHNLQDVHVVXFKDV+HU(UE%+HU(UE%
DQG +HU (UE% >@ 7KH UHFHSWRU GLPHUL]DWLRQ UHVXOWV LQ FRQVHTXHQW FRQIRUPDWLRQDO
FKDQJHV IROORZLQJ DFWLYDWLRQ RI WKH UHFHSWRU NLQDVH DQG DXWRSKRVSKRU\ODWLRQ RI VSHFLILF
W\URVLQHUHVLGXHVZLWKLQWKH&22+WHUPLQDOUHJLRQRIWKHSURWHLQ>@7KHVHHYHQWV
WULJJHULQWUDFHOOXODUVLJQDOLQJSDWKZD\VVXFKDVWKRVHPHGLDWHGE\WKHSURWHLQNLQDVHV$NWRU
H[WUDFHOOXODU±VLJQDOUHJXODWHGNLQDVH(UNERWKRIZKLFKSOD\IXQGDPHQWDOUROHVLQWKHFRQWURO
RI QXPHURXV FHOOXODU SURFHVVHV >@ ,Q UHVSRQVH WR OLJDQG ELQGLQJ WKH OLJDQG(*)5
FRPSOH[LVUDSLGO\LQWHUQDOL]HGDOORZLQJ(*)5WRLQWHUDFWZLWKYDULRXVVLJQDOLQJSURWHLQVVXFK
DV *UE RU 3,. DQG UHDFK IXOO DQG VXVWDLQHG DFWLYDWLRQ RI $NW RU (UN VLJQDOLQJ >@
7KHUHDIWHU(*)5LVHLWKHUUHF\FOHGEDFNWRWKHFHOOVXUIDFHRUSURWHRO\WLFDOO\GHJUDGHG)LJ
 5HFRJQLWLRQ RI WKH UROH RI (*)5 LQ RQFRJHQHVLV KDV OHG WR WKH GHYHORSPHQW RI (*)5
WDUJHWHGWKHUDSLHVLQFOXGLQJVPDOOPROHFXOH7.,VVXFKDVJHILWLQLEDQGHUORWLQLE%RWKRIWKHVH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
PROHFXOHV FRPSHWH ZLWK DGHQRVLQH WULSKRVSKDWH $73 DW WKH LQWUDFHOOXODU W\URVLQH NLQDVH
GRPDLQ>@

(*)5$'ULYHU0XWDWLRQLQ16&/&
7KH HSLGHUPDO JURZWK IDFWRU UHFHSWRU W\URVLQH NLQDVH LQKLELWRUV (*)57.,V KDYH EHHQ
DSSOLHGWRWKHWUHDWPHQWRI16&/&>@IROORZLQJWKHGLVFRYHU\RIWKHELRORJLFDOVLJQLILFDQFH
RI(*)5LQWKLVFDQFHU>@,QJURXSVUHSRUWHGWKDW16&/&SDWLHQWVZLWK(*)5
PXWDWLRQH[SHULHQFHDGUDPDWLFUHVSRQVHWRJHILWLQLERUHUORWLQLE>@%RWKGHOHWLRQVLQH[RQ
DQGDSRLQWPXWDWLRQWKDWVXEVWLWXWHVDQDUJLQLQHIRUDOHXFLQHDWFRGRQ/5LQH[RQ
DUHNQRZQWREHWKHPRVWFRPPRQ(*)5PXWDWLRQV>@6WXG\SDUWLFLSDQWVZLWKH[RQ
GHOHWLRQKDGORQJHUVXUYLYDOWKDQWKRVHZLWK/5SRLQWPXWDWLRQ>@7KHSUHVHQFHRI
(*)5PXWDWLRQDFWLYDWHVWKHUHFHSWRUW\URVLQHNLQDVHE\GLVUXSWLQJDXWRLQKLELWRU\LQWHUDFWLRQV
>@DQGLQGXFHVKLJKHUSKRVSKRU\ODWLRQRI(*)5FRPSDUHGZLWKZLOGW\SH(*)5>@,Q
DGGLWLRQ16&/&FHOOVZLWK(*)5PXWDWLRQFRQVWLWXWLYHO\DFWLYDWHERWK(*)5DQGGRZQVWUHDP
VLJQDOLQJEHFDXVHRIOLJDQGLQGHSHQGHQWGLPHUL]DWLRQRIWKHUHFHSWRU>@(*)5PXWDWLRQ
DOORZV JHILWLQLE WR ELQG PRUH WLJKWO\ WR (*)5 FRPSDUHG ZLWK WKH ZLOGW\SH (*)5 > @
7KHVHUHVXOWVLQGLFDWHWKDWFHOOVZLWKVSHFLILF(*)5PXWDWLRQVGHSHQGXSRQ(*)5VLJQDOLQJ
IRUJURZWKDQGGLIIHUHQWLDWLRQDQGKDYHSDUWLFXODUVHQVLWLYLW\WR(*)57.,VVXFKDVJHILWLQLE
6HYHUDOUHFHQWSKDVH,,,WULDOV:-72*>@1(->@RUVXEVHWDQDO\VLVRI,3$66
> @ GHPRQVWUDWHG WKDW VLQJOH DJHQW JHILWLQLE SURYLGHG VXSHULRU UHVSRQVH UDWHV DQG
SURJUHVVLRQIUHH VXUYLYDO 3)6 WR SODWLQXPEDVHG GRXEOHWV E\ VHOHFWLQJ IRU SDUWLFLSDQWV
KDUERULQJ(*)5PXWDWLRQ6XEVHWDQDO\VLVRI,3$66WULDOIXUWKHUUHYHDOHGWKDW(*)5PXWDWLRQ
DQGQRWFRS\QXPEHULVWKHEHVWSUHGLFWRURIJHILWLQLEUHVSRQVH>@'HVSLWHSURPLVLQJ
LQLWLDOUHVSRQVHUDWHVWKHGXUDWLRQRIUHVSRQVHWR(*)57.,LVDOPRVWLQHYLWDEO\OLPLWHGE\WKH
HPHUJHQFHRIDFTXLUHGGUXJUHVLVWDQFH

70*DWHNHHSHU(*)50XWDWLRQDQG,UUHYHUVLEOH(*)57.,LQ16&/&
$OWKRXJK16&/&SDWLHQWV ZLWK(*)5PXWDWLRQVKRZ DQLQLWLDOGUDPDWLFUHVSRQVHWR(*)5
7.,VVXFKDVJHILWLQLERUHUORWLQLEDOPRVWDOODFTXLUHUHVLVWDQFHWRWKHVHGUXJVZLWKLQRQHWR
WZR \HDUV 6SHFLILFDOO\ D VHFRQGDU\ SRLQW PXWDWLRQ LQ H[RQ  RI (*)5 WKDW VXEVWLWXWHV
PHWKLRQLQH IRU WKUHRQLQH DW DPLQR DFLG SRVLWLRQ  70 ZDV LGHQWLILHG LQ WKH 16&/&
SDWLHQWV ZKR GHYHORSHG DFTXLUHG UHVLVWDQFH WR JHILWLQLE RU HUORWLQLE > @ $ERXW  RI
16&/&SDWLHQWVZLWKDFTXLUHGUHVLVWDQFHWR(*)57.,VKDYH70VHFRQGDU\PXWDWLRQ>
@70LVORFDWHGLQWKH$73ELQGLQJFOHIWRIWKH(*)5VWUXFWXUHDQGLVWKRXJKWWREORFN
(*)57.,ELQGLQJGXHWRDOWHUDWLRQRIWKHWRSRORJ\FDXVLQJVWHULFKLQGUDQFH>
@)XUWKHUPRUHWKHSUHVHQFHRI70FRQIHUVDJURZWKDGYDQWDJHWRWKHFHOOVERWKLQYLWUR



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
DQG LQ YLYR >@ VXJJHVWLQJ WKDW 70 LWVHOI KDV RQFRJHQLF HIIHFWV E\ HQKDQFHG NLQDVH
DFWLYLW\>@$IILQLW\RI$73ELQGLQJFOHIWPD\EHLQFUHDVHGE\WKHSUHVHQFHRI70>@
7KLV PD\ SDUWLDOO\ H[SODLQ KRZ LUUHYHUVLEOH (*)57.,V VXFK DV &/ > @
3) > @ DIDWLQLE %,%:  >@ RU +., >@ RYHUFRPH WKH UHVLVWDQFH
LQGXFHG E\ 70 )LJ D +RZHYHU LUUHYHUVLEOH (*)57.,V KDYH RQO\ OLPLWHG DELOLW\ WR
RYHUFRPHDFTXLUHGUHVLVWDQFH>@DQGPD\DFWXDOO\LQGXFHWKHLURZQUHVLVWDQFHLQ
70PXWDWHGFDQFHUFHOOOLQHV>@,QOLQHZLWKWKHVHSUHFOLQLFDOUHVXOWVDIDWLQLE%,%:
 GLG QRW VKRZ SURORQJHG 26 LQ SDWLHQWV ZLWK DGYDQFHG 16&/& ZKRVH GLVHDVH
SURJUHVVHGDIWHUUHFHLYLQJFKHPRWKHUDS\ DQG DQ(*)57.,/8;/XQJ3KDVH,,E,,,WULDO
>@7KHVHUHVXOWVVXJJHVWHGWKDWVLQJOHDJHQWLUUHYHUVLEOH(*)57.,LVQRWHQRXJKWRUHYHUVH
DFTXLUHGUHVLVWDQFHFRPSOHWHO\+RZHYHURWKHUDJHQWVFRPELQHGZLWKLUUHYHUVLEOH(*)57.,V
PD\KROGSURPLVHLQRYHUFRPLQJ70DQGRWKHUDFTXLUHGUHVLVWDQFHPXWDWLRQV>@
7KH LGHQWLILFDWLRQ RI DOWHUQDWLYH WKHUDS\ WR VLQJOH DJHQW (*)57., RU VWUDWHJLHV FDSDEOH RI
RYHUFRPLQJDFTXLUHGUHVLVWDQFHWR(*)57.,LVWKXVXUJHQWO\QHHGHG

0HFKDQLVPVRI(*)57.,5HVLVWDQFHLQ16&/&
0(7 JHQH DPSOLILFDWLRQ KDV UHFHQWO\ EHHQ LGHQWLILHG DV D QRYHO PHFKDQLVP RI JHILWLQLE
UHVLVWDQFH DQG LV GHWHFWHG LQ  RI WXPRU VDPSOHV IURP 16&/& SDWLHQWV ZLWK (*)5
PXWDWLRQVZLWKDFTXLUHGJHILWLQLEUHVLVWDQFH>@%RWK0(7DQG(*)5VLJQDOLQJDFWLYDWH3,.
YLD(UE%+HULQJHILWLQLEUHVLVWDQW+&&*5FHOOVZLWK0(7DPSOLILFDWLRQ7KLVFHOOOLQH
ZDVJHQHUDWHGE\HQIRUFHGJHILQLWLEH[SRVXUHRI+&&FHOOVKDUERULQJDQH[RQGHOHWLRQ
,QWKLVVLWXDWLRQWKHFRPELQDWLRQRIJHILWLQLEDQG0(7LQKLELWRU3+$LVUHTXLUHGWRVKXW
GRZQVXUYLYDOVLJQDOLQJLQWKHVHFHOOV)LJE>@$OWKRXJKWKHUHDUHIHZVWXGLHVGHVFULELQJ
DOWHUQDWLYH WKHUDSLHV WR RYHUFRPH (*)57.,V UHVLVWDQFH LQGXFHG E\ 0(7 DPSOLILFDWLRQ WKH
FRPELQDWLRQRILQKLELWRUVWKDWEORFNWKHGRZQVWUHDPPROHFXOHVRIERWK(*)5DQG0(7VXFK
DVWKH3,.LQKLELWRUFRPELQHGZLWKWKH0(.LQKLELWRUFRXOGEHRQHVWUDWHJ\)LJE>@
$GGLWLRQDO PHFKDQLVPV RI DFTXLUHG (*)57.,V UHVLVWDQFH LQFOXGH DOWHUDWLRQ RI LQVXOLQOLNH
JURZWKIDFWRUUHFHSWRU,*)5VLJQDOLQJ>@WKHORVVRI37(1>@RUKHSDWRF\WH
JURZWKIDFWRU+*)RYHUH[SUHVVLRQ>@5HFHQWO\HSLWKHOLDOWRPHVHQFK\PDOWUDQVLWLRQ(07
KDVEHHQLGHQWLILHGDVDSULPDU\RUDFTXLUHGUHVLVWDQWPHFKDQLVPWR(*)57.,+RZHYHUWKH
VWUDWHJ\WRRYHUFRPH(07UHODWHG(*)57.,UHVLVWDQFHUHPDLQVXQFOHDU>@

6LJQLILFDQFHRIWKH6UF7.,'DVDWLQLELQ16&/&
7KH SURWRRQFRJHQH 65& LV LQYROYHG LQ WKH LQLWLDWLRQ RI FDUFLQRJHQHVLV DQG SUROLIHUDWLRQ RI
16&/& VLQFH LWV SURGXFW PHGLDWHV VLJQDOLQJ EHWZHHQ HLWKHU LQWHJULQV RU UHFHSWRU W\URVLQH
NLQDVHVDQGWKHLUGRZQVWUHDPHIIHFWRUV)LJ>@65&LVERWKDQXSVWUHDPDFWLYDWRUDQG
GRZQVWUHDPPHGLDWRURI(*)5DQG6UFSKRVSKRU\ODWLRQLVGHWHFWHGLQRI16&/&WXPRUV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
>@7KH6UF7.,GDVDWLQLELVHIIHFWLYHLQ(*)5PXWDQW16&/&FHOOVVLPLODUWR(*)57.,V
EDVHGRQWKHUHVXOWVVKRZLQJWKDW6UFLVDFWLYDWHGPRUHLQ(*)5PXWDQWFHOOVWKDQ(*)5ZLOG
W\SHFHOOV>@,QOLQHZLWKWKHVHUHVXOWV6UF7.,33FRPELQHGZLWK(*)57.,JHILWLQLEVKRZV
LQFUHDVHG OHYHOV RI DSRSWRVLV LQ (*)5 PXWDQW 16&/& FHOOV >@ 2XU FKHPLFDO DQG
SKRVSKRSURWHRPLF FKDUDFWHUL]DWLRQ LGHQWLILHG QHDUO\  GLIIHUHQW NLQDVH WDUJHWV RI GDVDWLQLE
DQGVKRZHGWKDW65&)<1DQG(*)5DUHUHOHYDQWWDUJHWVIRUGDVDWLQLEDFWLRQLQ 16&/&
>@ $ VLQJOHDUP SKDVH ,, WULDO RI SDUWLFLSDQWV ZLWK UHODSVHG UHIUDFWRU\ (*)5 PXWDQW RU
XQVHOHFWHG16&/&GHPRQVWUDWHGWKDWWKHRYHUDOOGLVHDVHFRQWUROUDWHRIVLQJOHDJHQWGDVDWLQLE
ZDVLQFOXGLQJSDUWLDOUHVSRQVH35LQRQHSDWLHQWDQGSURORQJHGVWDEOHGLVHDVH6'LQ
IRXU RWKHUV >@ 2XU UHFHQW SKDVH ,,, VWXG\ VKRZHG WKDW WKH FRPELQDWLRQ RI GDVDWLQLE DQG
(*)57., HUORWLQLE LV WROHUDEOH ZLWK  RI GLVHDVH FRQWURO UDWH LQFOXGLQJ WZR 35 DQG RQH
ERQHUHVSRQVHLQDGYDQFHG16&/&>@7KHVHUHVXOWVVXJJHVWWKHSRWHQWLDOFOLQLFDODFWLYLW\RI
GDVDWLQLELQ16&/&WUHDWPHQW
7DEOH'UXJVWKDWPD\RYHUFRPH(*)5UHVLVWDQFH $GDSWHGIURP>@
'UXJ
0DQXIDFWXUHU
0HFKDQLVPRIDFWLRQ
5HFRPPHQGHG
VLQJOHDJHQWGRVH
3KDVH
$IDWLQLE
%RHKULQJHU
,QJHOKHLP
,UUHYHUVLEOH7.,
PJGDLO\

3)
3IL]HU
,UUHYHUVLEOH7.,
PJGDLO\

+.,
3IL]HU
,UUHYHUVLEOH7.,
PJGDLO\

$54
$U4XOH'DLLFKL
6DQN\R
1RQFRPSHWLWLYHF
0HWLQKLELWRU
PJELG

0HW0DE
5RFKH*HQHQWHFK
0HWDQWLERG\
PJNJTZ

ELG WZLFHGDLO\DGPLQLVWUDWLRQTZ HYHU\WKUHHZHHNV

65&6LJQDOLQJLQ1RQ6PDOO&HOO/XQJ&DQFHU
0HPEHUV RI WKH 6UF IDPLO\ RI SURWHLQ W\URVLQH NLQDVHV 65& FDQ OLQN VLJQDOLQJ LQLWLDWHG E\
JURZWK IDFWRU LQWHJULQ DQG F\WRNLQH UHFHSWRUV RQ WKH VXUIDFH RI FHOOV WR WKHLU GRZQVWUHDP
HIIHFWRU VLJQDOLQJ FDVFDGHV )LJ  QH[W SDJH >@  8SRQ DFWLYDWLRQ E\ UHFHSWRU W\URVLQH
NLQDVHVWKURXJK6+ELQGLQJ65&LVDXWRSKRVSKRU\ODWHGDWW\URVLQH65&FRRSHUDWHV
ZLWKPXOWLSOHUHFHSWRUW\URVLQHNLQDVHVWRPRGXODWHVLJQDOLQJ>@$VRQHH[DPSOHUHOHYDQWIRU
OXQJ FDQFHU F6UF FRRSHUDWHV ZLWK WKH HSLGHUPDO JURZWK IDFWRU UHFHSWRU (*)5 DQG 6UF
NLQDVHDFWLYLW\LVUHTXLUHGIRUWUDQVIRUPDWLRQE\(*)5



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
65&VLJQDOLQJFDQUHVXOWLQDFWLYDWLRQRIGRZQVWUHDPVLJQDOLQJSDWKZD\VWKDWFRQWUROFHOOXODU
SUROLIHUDWLRQVXUYLYDOLQYDVLRQDQGPHWDVWDVLVDQGDQJLRJHQHVLV)LJXUH65&VLJQDOLQJ
FDQ DOORZ IRU HQKDQFHG FHOOXODU SUROLIHUDWLRQ E\ XSUHJXODWLQJ JHQHV LPSRUWDQW LQ FHOO F\FOH
SURJUHVVLRQVXFKDV0\FS:$)&,3F\FOLQ'DQGS.LSDQGFGF>@65&SURWHFW
FHOOV DJDLQVW DSRSWRVLV LQGXFHG E\ ORVV RI FHOO DGKHVLRQ DQG 3,.$NW DQG 6WDW DUH NH\
GRZQVWUHDP VXUYLYDO FDVFDGHV UHJXODWHG E\ 65& 65& SURPRWHV WXPRU FHOO LQYDVLRQ DQG
PHWDVWDVLVE\DIIHFWLQJFHOODGKHVLRQLQYDVLRQDQGPRWLOLW\>@&6UFFDQUHJXODWHERWKIRFDO
DGKHVLRQV DQG DGKHUHQV MXQFWLRQV QHFHVVDU\ IRU LQYDVLRQ RI WXPRU FHOOV E\ DFWLYDWLRQ RI
GRZQVWUHDP IRFDO DGKHVLRQ NLQDVH )$. S&DV DQG SD[LOOLQ >@  9DVFXODU HQGRWKHOLDO
JURZWKIDFWRU9(*)DQGK\SR[LDLQGXFLEOHIDFWRUDOSKD+,)DDUHGRZQVWUHDPWDUJHWV
IRU F6UF DQG VPDOO PROHFXOH LQKLELWRUV RI 65& FDQ QHJDWLYHO\ UHJXODWH 9(*) DQG LQKLELW
DQJLRJHQHVLV>@
(OHYDWHG65&DFWLYLW\LVIRXQGLQKXPDQWXPRUVLQFOXGLQJOXQJFDQFHUUHVXOWLQJIURPGLYHUVH
PHFKDQLVPV LQFOXGLQJ W\URVLQH SKRVSKDWDVHPHGLDWHG GHSKRVSKRU\ODWLRQ RI 7\U 
LQFUHDVHG65&SURWHLQOHYHOVLQFUHDVHGXSVWUHDPUHFHSWRUW\URVLQHNLQDVHDFWLYLW\RUORVVRI
QHJDWLYH UHJXODWRU\ SURWHLQV >  @  6PDOO PROHFXOH LQKLELWRUV RI 65& KDYH EHHQ
VKRZQ WR KDYH DQWLWXPRU SURSHUWLHV WKURXJK QHJDWLYHO\ UHJXODWLQJ FHOO SUROLIHUDWLRQ VXUYLYDO
DQJLRJHQHVLVDQGLQYDVLRQ>@$QXPEHURIVPDOOPROHFXOHRUDO65&W\URVLQHNLQDVH
LQKLELWRUV KDYH HQWHUHG HDUO\SKDVH FOLQLFDO WULDOV 2QH VXFK 65& W\URVLQH NLQDVH LQKLELWRU
GDVDWLQLE %06 LV D QRYHO ELRDYDLODEOH W\URVLQH NLQDVH LQKLELWRU WKDW KDV UHFHQWO\
FRPSOHWHGSKDVH,FOLQLFDOWULDOVLQ SDWLHQWV ZLWKVROLGWXPRUV'DVDWLQLEKDVEHHQVKRZQWR
H[HUW DQWLWXPRU HIIHFWV LQ OXQJ FDQFHU FHOOV DQG SUHFOLQLFDO GDWD VXJJHVW WKDW GDVDWLQLE FDQ
LQKLELWWXPRUJURZWKDQGLQGXFHWXPRUFHOOGHDWKLQDVXEVHWRIQRQVPDOOFHOOOXQJFDQFHUFHOO
OLQHVGHSHQGHQWRQ(*)5IRUJURZWKDQGVXUYLYDO>@
%DVHGRQWKHLPSRUWDQFHRI(*)5VLJQDOLQJLQOXQJFDQFHUWKHNQRZQFRRSHUDWLRQEHWZHHQ
(*)5DQG65&SURWHLQVDQGHYLGHQFHRIHOHYDWHG65&DFWLYLW\LQKXPDQOXQJFDQFHUVZH
SURSRVHDSKDVH,WULDORIFRPELQHGDIDWLQLEDQGGDVDWLQLELQSDWLHQWVZLWKDGYDQFHGQRQVPDOO
FHOOOXQJFDQFHU



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
,&Q0
'DVDWLQLE
%,%:
'DVD%,%:
3&



3&*5



+



+(5



+



+(5



+



+



+
&WU














'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
+&&
&WU














'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
3&
&WU












'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
3&*5
&WU












'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
+(5
&WU












'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
+&&(5
&WU












'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
+
&WU












'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
+
&WU












'DVDWLQLE
%,%:
'DVD%,%:
'UXJ&RQFQ0
9LDOLDEO\
H1975

)LJXUH(*)5PXWDQW16&/&LQYLWURUHVXOWVIURP+DXUDODE

&RPELQDWLRQRI$IDWLQLEZLWK'DVDWLQLE
*LYHQ WKH OLPLWHG DFWLYLW\ RI LUUHYHUVLEOH (*)57., >  @ WKH LGHQWLILFDWLRQ RI QHZ
WDUJHWVWRRYHUFRPH(*)57.,UHVLVWDQFHLQ16&/&LVXUJHQWO\QHHGHG:HKDYHSUHYLRXVO\
VKRZQ WKDW WKH 6UF LQKLELWRU GDVDWLQLE HIIHFWLYHO\ LQKLELWV FHOO JURZWK LQ WKH JHILWLQLEUHVLVWDQW
+&&*5 FHOOV ZLWK 0(7 DPSOLILFDWLRQ EDVHG RQ WKH UHVXOWV VKRZLQJ WKDW 6UF DFWV
GRZQVWUHDPRIERWK(*)5DQG0(7LQWKHVHFHOOV>@$QRWKHUUHSRUWGHPRQVWUDWHGWKDW
FRPELQDWLRQWKHUDS\LQFOXGLQJGDVDWLQLEKDVDFWLYLW\LQ/NEGHILFLHQW16&/&PLFHPRGHOZLWK
(07SKHQRW\SHVXJJHVWLQJWKDW6UFLVDSRVVLEOHWDUJHWDJDLQVW(*)57.,UHVLVWDQFHFDXVHG
E\(07>@7RLQYHVWLJDWHKRZVLJQDOWUDQVGXFWLRQLVDOWHUHGLQ16&/&FHOOVZLWK70
ZHJHQHUDWHG3&*5FHOOVZLWK70E\ORQJWHUPJHILWLQLEH[SRVXUHRI3&FHOOVZLWKH[RQ
 GHOHWLRQ *OREDO SKRVSKRSURWHRPLFV DSSURDFK UHYHDOHG WKDW WKH DFWLYDWLRQ RI 6UF IDPLO\
NLQDVHV ZHUH SHUVLVWHQW HYHQ ZLWK HUORWLQLE WUHDWPHQW LQ 3&*5 FHOOV VXJJHVWLQJ WKDW 6UF
IDPLO\NLQDVHVFRPSHQVDWH(*)5LQKLELWLRQLQ16&/&FHOOVZLWK70:HVWHUQEORWDVVD\V
GHPRQVWUDWHGWKDWWKHLUUHYHUVLEOH(*)57.,DIDWLQLEGLGQRWDOWHUWKHDFWLYDWLRQRI6UFIDPLO\
NLQDVHVLQ3&*5DQG+16&/&FHOOVZLWK707KH6UFLQKLELWRUGDVDWLQLEFRPELQHG



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
ZLWKDIDWLQLEDEROLVKHGWKLV6UFSKRVSKRU\ODWLRQDORQJZLWKFRPSOHWHVXSSUHVVLRQRISKRVSKR
$NWDQG(UN
,QDGGLWLRQVLJQLILFDQW3$53FOHDYDJHZDVREVHUYHGLQWKHVHFHOOVVXJJHVWLQJDSRSWRWLFFHOO
GHDWK &RQVLVWHQW ZLWK WKH HIIHFWV RQ FHOO VLJQDOLQJ DQG DSRSWRVLV GDVDWLQLE HQKDQFHV DQWL
WXPRUDFWLYLW\RIDIDWLQLELQERWK*/2FHOOSUROLIHUDWLRQDVVD\DQGFDVSDVHDSRSWRVLVDVVD\LQ
3&*5DQG+FHOOV7KHFRPELQDWLRQRIDIDWLQLEDQGGDVDWLQLEVKRZHGVLJQLILFDQWLQYLYR
WXPRUUHJUHVVLRQLQ3&*5[HQRJUDIWVWXGLHV)XUWKHUPRUHZHDOVRGHPRQVWUDWHGWKDWWKLV
FRPELQDWLRQLPSURYHG,&GRVHHYHQLQ+&&(5DQG+FHOOVZLWK0(7DPSOLILFDWLRQ
DV ZHOO DV LQ +(5 FHOOV ZLWK (07 SKHQRW\SH $OWKRXJK VLQJOHDJHQW GDVDWLQLE KDV QR
DFWLYLW\LQSDWLHQWVZLWK(*)5PXWDQW16&/&ZLWKDFTXLUHGUHVLVWDQFHWR(*)57.,>@RXU
SUHOLPLQDU\ UHVXOWV VXJJHVW D UROH IRU 6UF LQ PDLQWDLQLQJ GRZQVWUHDP VLJQDOLQJ GHVSLWH
LUUHYHUVLEOH(*)5LQKLELWRUVDQGVXSSRUWIXUWKHUVWXGLHVRILUUHYHUVLEOH(*)5FRPELQHGZLWK
GDVDWLQLELQ16&/&SDWLHQWVZKRDFTXLUHGUHVLVWDQFHWR(*)57.,

&DQFHU5DGLRPLFV
$GDSWHGIURP*LOOLHVDQG*DWHQE\ 8&$ 3URJUHVV5HSRUW
7KHHQRUPRXVSURJUHVVLQXQGHUVWDQGLQJWKHPROHFXODUFDXVHVDQGSDWKRSK\VLRORJ\RIFDQFHU
KDV QRW JHQHUDOO\ WUDQVODWHG LQWR LPSURYHG RXWFRPHV 2QH ZLGHO\ DGYRFDWHG VWUDWHJ\ IRU
LPSURYLQJFDQFHUWKHUDS\LVGHYHORSPHQWRISHUVRQDOL]HGFDQFHUPHGLFLQHLQZKLFKWUHDWPHQW
LV WDLORUHG IRU LQGLYLGXDO SDWLHQWV $V FDQFHUV DUH G\QDPLFDO V\VWHPV WKLV ZLOO UHTXLUH
PHDVXUHPHQW WRROV ZLWK WKH DELOLW\ WR UHSHDWHGO\ PHDVXUH NH\ SDUDPHWHUV DFFXUDWHO\ RYHU
WLPH

6FRSHRI,PDJLQJ3UREOHP
&OLQLFDOLPDJLQJKDVWKHNH\FKDUDFWHULVWLFVQHFHVVDU\IRUGHYHORSPHQWRISHUVRQDOL]HGFDQFHU
WKHUDS\ EXW PDQ\ TXHVWLRQV UHPDLQ +RZ PXFK XVHIXO GDWD FDQ EH REWDLQHG IURP FOLQLFDO
LPDJHV"&DQLPDJHIHDWXUHGDWDEHXVHGWREHWWHUSURJQRVHRXWFRPHUHJDUGOHVVRIWKHUDS\RU
SUHGLFWUHVSRQVHWRVSHFLILFWKHUDSLHV"$UHWKHUHNH\LPDJLQJSDUDPHWHUVWKDWFDQVHUYHDV
HDUO\ ELRPDUNHUV IRU WXPRU UHVSRQVH RU QRQUHVSRQVH WR FKHPR RU UDGLRWKHUDSLHV" ,I
UDGLRORJ\LVWRSOD\DQLQWHJUDOUROHLQSHUVRQDOL]HGFDQFHUWKHUDS\LWZLOOUHTXLUHDFTXLVLWLRQRI
LPDJHV ZLWK WKH KLJKHVW SRVVLEOH TXDOLW\ ORZHVW LQWHUWHVW YDULDQFH DQG H[WHQVLYH DQDO\VLV
WKDWZLOOEULGJHLPDJLQJIHDWXUHVWRTXDQWLWDWLYHPROHFXODUSURSHUWLHVRIWXPRUVDQGHYHQWXDOO\
RXWFRPH +LVWRULFDOO\ FOLQLFDO LPDJLQJ DSSURDFKHV KDYH WHQGHG WR EH GHVFULSWLYH DQG
TXDOLWDWLYHFKDUDFWHUL]LQJWXPRUVDVHJ³HQKDQFLQJLUUHJXODUERUGHUVFHQWUDOQHFURVLV´HWF
7KHVH IHDWXUHV KDYH WR EH PDGH PRUH TXDQWLWDWLYH WR PDWFK WKHP WR PRUH TXDQWLWDWLYH
PHDVXUHV RI WXPRU ELRORJ\ VXFK DV JHQH H[SUHVVLRQ SDWWHUQV &XUUHQWO\ WKH RQO\ WZR



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
FRPPRQO\ XVHG TXDQWLWDWLYH PHDVXUHV LQ WXPRU UDGLRORJ\ DUH WXPRU VL]H 5(&,67 RU
ELGLPHQVLRQDO PHDVXUHV DQG VWDQGDUG XSWDNH YDOXH 689 LQ )'*3(7 VFDQQLQJ 7KXV
*LOOLHV /DE SURSRVH D GHWDLOHG H[DPLQDWLRQ RI DGGLWLRQDO TXDQWLWDWLYH IHDWXUHV WKDW DUH
H[WUDFWDEOHIURP&7VFDQLPDJHVIURPWKHSDWLHQWVLQWKLVWULDOZLWKWKHK\SRWKHVLVWKDWWKHVH
DGGLWLRQDOIHDWXUHVZLOODOORZTXDQWLWDWLYHSUHGLFWLQJRUPRQLWRULQJRIUHVSRQVH&ULWLFDOWRWKH
VXFFHVV RI WKLV DSSURDFK LV WKDW LW ZLOO JHQHUDOO\ XVH VWDQGDUG RI FDUH VFDQV WKXV ZLOO QRW
UHTXLUHVFKHGXOLQJRIDGGLWLRQDOSDWLHQW YLVLWV RULQFXUDGGLWLRQDOFRVWVEH\RQGDQDO\VLV7KH
XOWLPDWHJRDOZLOOEHDQDO\VLVRIWKHVHIHDWXUHVWRGHWHUPLQHZKLFKFRPELQDWLRQVFDQEHXVHG
WR SUHGLFW FOLQLFDO RXWFRPHV LQ FRQMXQFWLRQ ZLWK RU LQ OLHX RI WKH DGGLWLRQDO PROHFXODU
ELRPDUNHUVSODQQHGIRUWKLVVWXG\
7DEOH3RWHQWLDOO\5HSUHVHQWDWLYH&7IHDWXUHVDQG9DULDEOHV




3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
$ FULWLFDO FRPSRQHQW RI WKLV DSSURDFK LV WKH DSSOLFDWLRQ RI PHWKRGV WR HIILFLHQWO\ H[WUDFW
TXDQWLILDEOH LQIRUPDWLRQ IURP UDGLRORJLF LPDJHV LH ³UDGLRPLFV´ ,QVRIDU DV SRVVLEOH WKHVH
PHWKRGVVKRXOGEHVHPLDXWRPDWHGZKHUHLQWKHUDGLRORJLVWLGHQWLILHVWKHOHVLRQDQGFRPSXWHU
VRIWZDUH SURFHHGV WR VHJPHQW UHQGHU DQG JHQHUDWH D UHSRUW RI TXDQWLWDWLYH IHDWXUHV )URP
WKHVHUHSRUWV*LOOLHV/DEFDQDVNWKHIROORZLQJTXHVWLRQV:KLFKIHDWXUHVDUHLQIRUPDWLYHHJ
KDYH D ZLGH UDQJH DQG EH PHDVXUHDEOH LQ DOO VDPSOHV" :KDW LV WKH YDULDQFH IURP RQH
PHDVXUHPHQWWRDQRWKHUDQGZKDWDUHWKHFULWLFDOVRXUFHVRIWKDWYDULDQFH"$UHWKHIHDWXUHV
ZLWKODUJHVWG\QDPLFUDQJHUHODWHGWRRXWFRPHV"

5DGLRPLFV$5DWLRQDOH6ROXWLRQ
7KHFHQWUDOK\SRWKHVLVRIFDQFHU³UDGLRPLFV´LVWKDWWXPRULPDJLQJIHDWXUHVUHIOHFWXQGHUO\LQJ
JHQHH[SUHVVLRQSDWWHUQVDQGWXPRUSDWKRSK\VLRORJ\7KLVLVVXSSRUWHGE\FRPPRQVHQVHDV
ZHOODVHPSLULFDOREVHUYDWLRQ,QWKHVLPSOHVWFDVHVFKDQJHVLQH[SUHVVLRQRIVSHFLILFJHQHV
FDQDIIHFWVSHFLILFLPDJHDEOHSDUDPHWHUVVXFKDVYDVFXODUHQGRWKHOLDOJURZWKIDFWRU9(*)
HIIHFWVRQSHUIXVLRQRUVXUYLYDOJHQHHIIHFWVRQWXPRUGHQVLW\ERWKRIZKLFKDUHPHDVXUDEOH
E\ 05, )XUWKHUPRUH WKH LGHD WKDW LPDJLQJ IHDWXUHV UHIOHFW XQGHUO\LQJ GLIIHUHQFHV LQ JHQH
H[SUHVVLRQLVWKHEDVLVIRULPDJHJXLGHGELRSV\ZKLFKKDVFOHDUO\VKRZQWKDWWXPRUVH[KLELW
GLVWLQFWUHJLRQDOYDULDWLRQVLQJHQHH[SUHVVLRQWKDWDUHFRUUHODWHGZLWKLPDJHIHDWXUHVVXFKDV
SHUIXVLRQ,PDJHIHDWXUHVDOVRXQGHUOLHWKHWUHPHQGRXVSRZHURIFRPSXWHUDLGHGGLDJQRVLV
&$'V\VWHPVVXFKDVWKRVHSLRQHHUHGE\*LJHUDQGFROOHDJXHV7KHXVHRILPDJHIHDWXUHV
KDV EHHQ HOHYDWHG WR D QHZ OHYHO WKURXJK WKH ZRUN RI .XR DQG FROOHDJXHV ZKR KDYH
FRPSDUHGH[WUDFWDEOHIHDWXUHVIURP05,RU&7WRSUHGLFWJOREDOJHQHH[SUHVVLRQSDWWHUQVLQ
JOLREODVWRPD PXOWLIRUPH *%0 DQG +&& ,Q *%0 WKHUH DUH FOHDU FRUUHODWLRQV EHWZHHQ
KLVWRSDWKRORJ\JUDGHDQG05LPDJLQJIHDWXUHV+RZHYHUWKHGLYHUVLW\RI05SKHQRW\SHVLV
JUHDWHU WKDQ WKDW RI KLVWRORJ\ HJ WXPRUV RI VLPLODU KLVWRSDWKRORJ\ FDQ H[KLELW GLVWLQFWO\
GLIIHUHQW05LPDJLQJSDWWHUQV
,Q+HSDWRFHOOXODUFDQFHU.XRTXDQWLILHGIHDWXUHVIURPFRQWUDVWHQKDQFHG&7LPDJHVLQD
WUDLQLQJ VHW IURP  SDWLHQWV 7KHVH IHDWXUHV ZHUH LQGLYLGXDOO\ ILOWHUHG DFFRUGLQJ WR WKHLU
IUHTXHQF\ LQWKHGDWDVHWVLQWHUREVHUYHU DJUHHPHQWDQGLQGHSHQGHQFHIURPRWKHUIHDWXUHV
UHVXOWLQJLQDVXEVHWRIKLJKO\LQIRUPDWLYHIHDWXUHV$PRGLILHGQHXUDOQHWZDVWKHQXVHGWR
LGHQWLI\JHQH³PRGXOHV´WKDWFRQWDLQHGVHWVRIJHQHVRXWRIWRWDOZKRVHYDULDWLRQ
ZDVFRKHUHQW7KHDOJRULWKPWKHQLGHQWLILHGFRPELQDWLRQVRILPDJLQJIHDWXUHVWKDWZHUHKLJKO\
FRUUHODWHGZLWKHDFKJHQHPRGXOH7KLVWUDLQLQJVHWZDVWKHQWHVWHGXVLQJDSHUPXWDWLRQRIWKH
RULJLQDO GDWDDQG D FRPSOHWHO\LQGHSHQGHQWGDWDVHW2QO\RIWKHLPDJLQJIHDWXUHV ZHUH
QHHGHGWRH[SODLQDOOJHQHPRGXOHVDQGIHDWXUHVFRXOGH[SODLQKDOIRIWKHP)RUHDFK



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
JHQHPRGXOHRQO\LPDJLQJIHDWXUHVZHUHQHHGHG7KXV&7IHDWXUHGDWDFDQEHXVHGWR
SUHGLFWJOREDOJHQHH[SUHVVLRQ
6LQFH EHJLQQLQJ RI  ZLWK VXSSRUW IURP WKH 1&, 4XDQWLWDWLYH ,PDJLQJ 1HWZRUN 4,1
*LOOLHVJURXSKDVEHHQSHUIRUPLQJ5DGLRPLFDQDO\VHVRI16&/&,QWKHVHVWXGLHV*LOOLHV/DE
KDYHHPSOR\HGDFRPPHUFLDOSODWIRUPVXSSOLHGE\'HILQLHQV70WRVHJPHQWUHQGHUDQGUHSRUW
*LOOLHV/DEKDYHPRGLILHGWKHVRIWZDUHVRWKDWWKHVHJPHQWDWLRQLVRSHUDWRULQGHSHQGHQWDQG
WKHVHKDYHEHHQFRPSDUHGWROHVLRQVWKDWKDYHEHHQPDQXDOO\VHJPHQWHGE\UDGLRORJLVWVDQG
UDGLDWLRQ RQFRORJLVWV LQ WZR GLIIHUHQW VWXGLHV :LWK VHJPHQWHG LPDJHV *LOOLHV /DE KDYH
JHQHUDWHGDIHDWXUHVHWWRFRQWDLQXSWRTXDQWLILHG'DQG'IHDWXUHVLQFOXGLQJVKDSH
WH[WXUH DWWHQXDWLRQ DQG VL]H IHDWXUHV $ WHVWUHWHVW VWXG\ KDV VKRZQ WKDW D ODUJH QXPEHU
!RIWKHVHIHDWXUHVKDYHKLJKUHSURGXFLELOLW\ZLWKDEURDGQDWXUDOUDQJH$VXEVHWRIWKHVH
KDYHEHHQXVHGWRGHYHORSFODVVLILHUVLQ16&/&WRLGHQWLI\EURQFKRDOYLRODUFDUFLQRPDIURP
VTXDPRXVDQGDGHQRFDUFLQRPDV6WXGLHVDUHFXUUHQWO\RQJRLQJWRGHWHUPLQHLIWKHVHIHDWXUHV
FDQEHTXDQWLWDWLYHO\UHODWHGWRJHQHH[SUHVVLRQRURXWFRPHV7RWKLVHQG*LOOLHV/DEKDYH
H[WUDFWHGLPDJHIHDWXUHVIURPSDWLHQWVFDQVDORQJZLWKJHQHH[SUHVVLRQDUUD\V7KHVHDUH
FXUUHQWO\EHLQJFRPELQHGLQWRDGDWDEDVHIRULQIRUPDWLFDQGVWDWLVWLFDQDO\VHV
16&/&LQWKH86KDVRQHRIWKHKLJKHVWPRUWDOLW\UDWHVDQGSDWLHQWVDUHURXWLQHO\LPDJHGZLWK
&7VFDQVIRUVWDJLQJDQGPRQLWRULQJUHVSHFWLYHO\7KXVDQ\DGYDQFHLQWKHDELOLW\WRSUHGLFW
UHVSRQVHDQGLQGLYLGXDOL]HWUHDWPHQWZLOOKDYHJUHDWLPSDFW,QWKHSUHVHQWVWXG\ZHSURSRVH
WR H[WHQG WKLV UDGLRPLF DQDO\VLV DSSOLFDWLRQ LQ D SURVSHFWLYH ZD\ WR 16&/& SDWLHQWV EHLQJ
WUHDWHGZLWKW\URVLQHNLQDVHLQKLELWRUV7KHVHIHDWXUHVZLOOEHFRPSDUHGWR3)6RXWFRPHLQWKH
H[SHULPHQWDODUPRIWKHVWXG\LQGHSHQGHQWO\DQGFRPELQHG
2XUJRDOLVWRSURYLGHDFFXUDWHUHVXOWVZLWKPLQLPDOVXEMHFWLYHPHGLFDOLQWHUDFWLRQ$FUXFLDO
FRPSRQHQW LV WR KDYH WKH DSSURSULDWH IHDWXUHV WR DFFXUDWHO\ DQG TXDQWLWDWLYHO\ PHDVXUH
OHVLRQV
7KXV WKH VHJPHQWDWLRQ DQG UHSRUW JHQHUDWLRQ ZLOO IROORZ PXFK WKH VDPH SURWRFRO DV WKH
FXUUHQW 16&/& WULDO +RZHYHU WKHUH DUH WZR PDMRU GHYLDWLRQV LQ WKH FXUUHQW VWXG\ WKDW DUH
LPSRUWDQW WR WKH GHYHORSPHQW RI WKH 5DGLRPLF DSSURDFK )LUVW WKH FXUUHQW VWXG\ ZLOO EH
SHUIRUPHGLQDPXOWLFHQWHUVHWWLQJ7KXVWKHLPDJHFDSWXUHPXVWEHVWDQGDUGL]HG6HFRQGWKH
FXUUHQW VWXG\ ZLOO LQYLWH FRPSDULVRQ EHWZHHQ SUH DQG SRVWWKHUDS\ &7 VFDQV WR LGHQWLI\
TXDQWLWDWLYHDQGREMHFWLYHSUHGLFWRUVRIUHVSRQVHWKDWPD\EHPRUHVHQVLWLYHWKDQWKHVWDQGDUG
5(&,67  PHDVXUHV 6XFK ³FKDQJH PHWULFV´ DGG DQ DGGLWLRQDO \HW WUDFWDEOH HOHPHQW RI
FRPSOH[LW\WKDWPD\EHULFKLQLQIRUPDWLRQ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

'$6$7,1,%'58*352),/(
'DVDWLQLE 635<&(/ LV D SRWHQW EURDGVSHFWUXP $73FRPSHWLWLYH LQKLELWRU RI  FULWLFDO
RQFRJHQLF W\URVLQH NLQDVHNLQDVH IDPLOLHV %&5$%/ 65& F.,7 3'*) UHFHSWRU ȕ
3'*)5ȕ DQG HSKULQ (3+ UHFHSWRU NLQDVHV HDFK RI ZKLFK KDV EHHQ OLQNHG WR PXOWLSOH
IRUPVRIKXPDQPDOLJQDQFLHV
'UXJGLVFRYHU\DQGQRQFOLQLFDOSKDUPDFRORJ\VWXGLHVVKRZHGWKDWGDVDWLQLE
x
.LOOV%&5$%/GHSHQGHQWOHXNHPLFFHOOOLQHVLQFOXGLQJDQXPEHUWKDWDUHUHVLVWDQWWR
LPDWLQLEGXHWRNLQDVHGRPDLQPXWDWLRQVRURYHUH[SUHVVLRQRI65&IDPLO\NLQDVHVDQGLV
HIIHFWLYHDJDLQVWDOOLPDWLQLEUHVLVWDQWNLQDVHGRPDLQPXWDWLRQVWHVWHGWRGDWHH[FHSW
7,
x
,QKLELWHGSUROLIHUDWLRQRIFDQFHUFHOOOLQHVWKDWH[SUHVVDFWLYDWHG65&RUF.,7
x
3RWHQWO\LQKLELWV9(*)VWLPXODWHGSUROLIHUDWLRQDQGPLJUDWLRQLQ+89(&V
x
+DVSRWHQWERQHDQWLUHVRUSWLYHDFWLYLW\

$FWLYLW\LQ([SHULPHQWDO0RGHOV

,Q9LWUR0ROHFXODU6WXGLHV
'DVDWLQLESRWHQWO\LQKLELWV65&NLQDVHV%&5$%/F.,73'*)5ȕDQG(3+$DQGZDVOHVV
SRWHQW DJDLQVW  RWKHU XQUHODWHG SURWHLQ W\URVLQH NLQDVHV 37.V DQG VHULQHWKUHRQLQH
NLQDVHV,PDWLQLELVOHVVSRWHQWDJDLQVWVHYHUDONH\HQ]\PHVIRUH[DPSOHGDVDWLQLEZDV
DQG!IROGPRUHSRWHQWWKDQLPDWLQLEYHUVXV%&5$%/F.,73'*)5EDQG65&
NLQDVHVUHVSHFWLYHO\
,QYLWURGDVDWLQLEZDVDEOHWRRYHUFRPHLPDWLQLEUHVLVWDQFHUHVXOWLQJIURP%&5$%/NLQDVH
GRPDLQPXWDWLRQVDFWLYDWLRQRIDOWHUQDWHVLJQDOLQJSDWKZD\VLQYROYLQJWKH65&IDPLO\NLQDVHV
/<1+&.DQGPXOWLGUXJUHVLVWDQFHJHQHRYHUH[SUHVVLRQ
'DVDWLQLELQKLELWVWKH%&5$%/NLQDVHZLWKDQLQYLWUR,&RIQ0DSRWHQF\IROGJUHDWHU
WKDQWKDWRILPDWLQLEPHV\ODWH,& Q0,QFHOOXODUDVVD\VGDVDWLQLENLOOHGRULQKLELWHG
WKHSUROLIHUDWLRQRIDOO%&5$%/GHSHQGHQWOHXNHPLFFHOOOLQHVWHVWHGWRGDWH'DVDWLQLEDOVR
GHPRQVWUDWHG XQGLPLQLVKHG DQWLWXPRU DFWLYLW\ DJDLQVW VHYHUDO SUHFOLQLFDOO\ DQG FOLQLFDOO\
GHULYHG PRGHOV RI LPDWLQLE PHV\ODWH UHVLVWDQFH (YLGHQFH WKDW 65& IDPLO\ NLQDVH RYHU
H[SUHVVLRQ PD\ SOD\ D UROH LQ FOLQLFDO UHVLVWDQFH WR LPDWLQLE PHV\ODWH ZDV GHPRQVWUDWHG LQ
WKUHH &0/ FHOO OLQHV HVWDEOLVKHG IURP SDWLHQWV ZKR IDLOHG LPDWLQLE PHV\ODWH WKHUDS\ 7KHVH
FHOOVUHPDLQHGKLJKO\VHQVLWLYHWRWKHFHOONLOOLQJHIIHFWVRIGDVDWLQLE



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7KHVHUHVXOWVGHPRQVWUDWHWKDWGDVDWLQLELVHIIHFWLYHLQUHGXFLQJWKHSUROLIHUDWLRQRUVXUYLYDORI
ERWK LPDWLQLE PHV\ODWHVHQVLWLYH DQG UHVLVWDQW FHOOV DQG LWV LQKLELWRU\ DFWLYLW\ LV QRW VROHO\
GHSHQGHQWRQ%&5$%/

/XQJ&DQFHU&HOO6WXGLHV
7ZR UHSRUWV KDYH SUHVHQWHG SUHFOLQLFDO GDWD VXJJHVWLQJ DQWLWXPRU SURSHUWLHV RI GDVDWLQLE LQ
KXPDQ OXQJ FDQFHU FHOOV > @  'DVDWLQLE LV DEOH WR LQGXFH FHOO F\FOH DUUHVW LQGXFH
DSRSWRVLV DQG LQKLELW WXPRU FHOO LQYDVLRQ LQ OXQJ FDQFHU FHOO OLQHV &HOO IDWH GHDWK YHUVXV
JURZWKDUUHVWLQOXQJFDQFHUFHOOVH[SRVHGWRGDVDWLQLELVGHSHQGHQWRQ(*)5VWDWXV,QFHOOV
ZLWK(*)5PXWDWLRQWKDWDUHGHSHQGHQWRQ(*)5IRUVXUYLYDOGDVDWLQLEUHGXFHVFHOOYLDELOLW\
WKURXJKWKHLQGXFWLRQRIDSRSWRVLVZKLOHKDYLQJPLQLPDODSRSWRWLFHIIHFWRQFHOOOLQHVZLWKZLOG
W\SH(*)57KHLQGXFWLRQRIDSRSWRVLVLQWKHVH(*)5PXWDQWFHOOOLQHVFRUUHVSRQGVWRGRZQ
UHJXODWLRQ RI$NWDQG 6WDWVXUYLYDOSURWHLQV,QFHOOOLQHV ZLWK ZLOGW\SH(*)5RUUHVLVWDQW
(*)5PXWDWLRQWKDWDUHQRWVHQVLWLYHWR(*)5LQKLELWLRQGDVDWLQLELQGXFHVD*FHOOF\FOH
DUUHVWZLWKDVVRFLDWHGFKDQJHVLQF\FOLQ'DQGSSURWHLQVDVZHOODVLQKLELWVDFWLYDWHG)$.
DQGSUHYHQWVWXPRUFHOOLQYDVLRQ7KHVHUHVXOWVGHPRQVWUDWHWKDWGDVDWLQLEFRXOGEHHIIHFWLYH
WKHUDS\IRUSDWLHQWV ZLWKOXQJFDQFHUVWKURXJKGLVUXSWLRQ RIFHOOJURZWKVXUYLYDODQGWXPRU
LQYDVLRQ)XUWKHUPRUHWKHVHUHVXOWVVXJJHVW(*)5VWDWXVLVLPSRUWDQWLQGHFLGLQJFHOOIDWHLQ
UHVSRQVHWRGDVDWLQLE

,Q9LYR6WXGLHV
7KH DFWLYLW\ RI GDVDWLQLE DJDLQVW &0/ FHOOV LQ YLWUR ZDV UHSURGXFHG LQ YLYR DJDLQVW VHYHUDO
KXPDQ&0/[HQRJUDIWPRGHOVJURZQVXEFXWDQHRXVO\LQ6&,'PLFH$JDLQVWWKH.LPDWLQLE
PHV\ODWH5&0/PRGHOGDVDWLQLEZDVFXUDWLYHLQRIWKHWUHDWHGDQLPDOV,QFRQWUDVWDW
LWVRSWLPDOGRVHDQGVFKHGXOHLPDWLQLEPHV\ODWHZDVLQDFWLYH,QOXQJFDQFHUPRXVH[HQRJUDIW
PRGHOVWKHFRPELQDWLRQRIGDVDWLQEZLWK%,%:ZDVV\QHUJLVWLFLQLQGXFLQJWXPRUYROXPH
UHGXFWLRQ)LJXUH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
)LJ16&/&PLFHPRGHO6\QHUJLVWLFDFWLYLW\
)LJ 16&/&PLFHPRGHO6\QHUJLVWLFDFWLYLW\

)LJXUH+DXUDODEPXWDWHG16&/&PRXVHPRGHOV\QHUJLVWLFDFWLYLW\

3UHFOLQLFDO7R[LFRORJ\
6LQJOHRUUHSHDWHGRUDODGPLQLVWUDWLRQRIGDVDWLQLESULQFLSDOO\DIIHFWHGWKHJDVWURLQWHVWLQDO*,
WUDFWLQFOXGLQJWKHOLYHUDQGWKHKHPDWRSRLHWLFDQGO\PSKRLGV\VWHPVLQUDWVDQGPRQNH\V
2WKHUSURPLQHQWHIIHFWVDIWHUVLQJOHRUDODGPLQLVWUDWLRQRIGDVDWLQLELQFOXGHGUHQDODQGFDUGLDF
WR[LFLW\ LQ UDWV DW OHWKDO GRVHV DQG FXWDQHRXV KHPRUUKDJH LQ PRQNH\V 'DVDWLQLE FDQ DOVR
DIIHFWWKHLPPXQHV\VWHPDQGERQHWXUQRYHU
'DVDWLQLE LQ YLWUR DFWLYLW\ LQ WKH +(5*,.U DQG 3XUNLQMHILEHU DVVD\V LQGLFDWHG D PRGHUDWH
OLDELOLW\IRUSURORQJDWLRQRIFDUGLDFYHQWULFXODUUHSRODUL]DWLRQ47LQWHUYDOLQWKHFOLQLF+RZHYHU
WKHUH ZHUH QR GDVDWLQLEUHODWHG FKDQJHV REVHUYHG LQ HOHFWURFDUGLRJUDPV QHUYRXV V\VWHP
IXQFWLRQUHVSLUDWLRQVDQGKHDUWUDWHEORRGSUHVVXUHRUDUWHULDOR[\JHQVDWXUDWLRQLQVLQJOH
GRVHGD\RUPRQWKRUDOWR[LFLW\VWXGLHVLQPRQNH\V
'DVDWLQLEZDVIRXQGWRH[KLELWDSURILOHRIEURDGVSHFWUXPSODWHOHWLQKLELWLRQEHVWW\SLILHGE\
DQWLSODWHOHWDJHQWVVXFKDVWKH*3,,E,,,DDQWDJRQLVWVLQWHJUHOLQDQGDEFL[LPDE
)LQDOO\PRGXODWLRQRI65&NLQDVHDFWLYLW\FRXOGDOVRDIIHFWRVWHRFODVWPRUSKRORJ\DQGIXQFWLRQ
DQGERQHUHPRGHOLQJ7KLVHIIHFWFRXOGSRWHQWLDOO\UHVXOWLQDQLQFUHDVHLQERQHPLQHUDOGHQVLW\
DQGDSKHQRW\SHDQDORJRXVWRRVWHRSHWURVLV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

&OLQLFDO3KDUPDFRNLQHWLFV
7KH SKDUPDFRNLQHWLFV RI GDVDWLQLE KDV EHHQ HYDOXDWHG LQ  KHDOWK\ VXEMHFWV DQG LQ 
SDWLHQWVZLWKOHXNHPLD

$EVRUSWLRQ
0D[LPXPSODVPDFRQFHQWUDWLRQV&PD[RIGDVDWLQLEDUHREVHUYHGEHWZHHQDQGKRXUV
7PD[IROORZLQJRUDODGPLQLVWUDWLRQ'DVDWLQLEH[KLELWVGRVHSURSRUWLRQDOLQFUHDVHVLQ$8&DQG
OLQHDU HOLPLQDWLRQ FKDUDFWHULVWLFV RYHU WKH GRVH UDQJH RI  PJ WR  PJGD\ 7KH RYHUDOO
PHDQWHUPLQDOKDOIOLIHRIGDVDWLQLELV±KRXUV
'DWDIURPDVWXG\RIKHDOWK\VXEMHFWVDGPLQLVWHUHGDVLQJOHPJGRVHRIGDVDWLQLE
PLQXWHVIROORZLQJFRQVXPSWLRQRIDKLJKIDWPHDOUHVXOWHGLQDLQFUHDVHLQWKHPHDQ$8&
RIGDVDWLQLE7KHREVHUYHGIRRGHIIHFWVZHUHQRWFOLQLFDOO\UHOHYDQW

'LVWULEXWLRQ
,QSDWLHQWVGDVDWLQLEKDVDQDSSDUHQW YROXPHRIGLVWULEXWLRQRI/VXJJHVWLQJWKDWWKH
GUXJLVH[WHQVLYHO\GLVWULEXWHGLQWKHH[WUDYDVFXODUVSDFH%LQGLQJRIGDVDWLQLEDQGLWVDFWLYH
PHWDEROLWHWRKXPDQSODVPDSURWHLQVLQYLWURZDVDSSUR[LPDWHO\DQGUHVSHFWLYHO\
ZLWKQRFRQFHQWUDWLRQGHSHQGHQFHRYHUWKHUDQJHRI±QJP/

0HWDEROLVP
'DVDWLQLE LV H[WHQVLYHO\ PHWDEROL]HG LQ KXPDQV SULPDULO\ E\ WKH F\WRFKURPH 3 HQ]\PH
$&<3$ZDVWKHSULPDU\HQ]\PHUHVSRQVLEOHIRUWKHIRUPDWLRQRIWKHDFWLYHPHWDEROLWH
)ODYLQFRQWDLQLQJ
PRQRR[\JHQDVH

)02
DQG
XULGLQH
GLSKRVSKDWH
JOXFXURQRV\OWUDQVIHUDVH 8*7 HQ]\PHV DUH DOVR LQYROYHG LQ WKH IRUPDWLRQ RI GDVDWLQLE
PHWDEROLWHV  ,Q KXPDQ OLYHU PLFURVRPHV GDVDWLQLE ZDV D ZHDN WLPHGHSHQGHQW LQKLELWRU RI
&<3$
7KH H[SRVXUH RI WKH DFWLYH PHWDEROLWH ZKLFK LV HTXLSRWHQW WR GDVDWLQLE UHSUHVHQWV
DSSUR[LPDWHO\RIWKHGDVDWLQLE$8&7KLVLQGLFDWHVWKDWWKHDFWLYHPHWDEROLWHRIGDVDWLQLE
LVXQOLNHO\WRSOD\DPDMRUUROHLQWKHREVHUYHGSKDUPDFRORJ\RIWKHGUXJ'DVDWLQLEDOVRKDG
VHYHUDORWKHULQDFWLYHR[LGDWLYHPHWDEROLWHV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

(OLPLQDWLRQ
(OLPLQDWLRQLVSULPDULO\YLDWKHIHFHV)ROORZLQJDVLQJOHRUDOGRVHRI>&@ODEHOHGGDVDWLQLE
DSSUR[LPDWHO\DQGRIWKHDGPLQLVWHUHGUDGLRDFWLYLW\ZDVUHFRYHUHGLQWKHXULQHDQG
IHFHVUHVSHFWLYHO\ZLWKLQGD\V8QFKDQJHGGDVDWLQLEDFFRXQWHGIRUDQGRIWKH
DGPLQLVWHUHG GRVH LQ XULQH DQG IHFHV UHVSHFWLYHO\ ZLWK WKH UHPDLQGHU RI WKH GRVH EHLQJ
PHWDEROLWHV

&OLQLFDO([SHULHQFHZLWK'DVDWLQLELQ&0/DQG3K$//
)RXUVLQJOHDUPPXOWLFHQWHUVWXGLHV ZHUHFRQGXFWHGWRGHWHUPLQHWKHHIILFDF\DQGVDIHW\RI
GDVDWLQLE LQ SDWLHQWV ZLWK &0/ RU 3KLODGHOSKLD FKURPRVRPHSRVLWLYH DFXWH O\PSKREODVWLF
OHXNHPLD3K$//UHVLVWDQWWRRULQWROHUDQWRIWUHDWPHQWZLWKLPDWLQLE5HVLVWDQFHWRLPDWLQLE
LQFOXGHG IDLOXUH WR DFKLHYH D FRPSOHWH KHPDWRORJLF UHVSRQVH ZLWKLQ ± PRQWKV RU PDMRU
F\WRJHQHWLFUHVSRQVHE\PRQWKRUSURJUHVVLRQRIGLVHDVHDIWHUDSUHYLRXVF\WRJHQHWLFRU
KHPDWRORJLF UHVSRQVH ,PDWLQLE LQWROHUDQFH LQFOXGHG LQDELOLW\ WR WROHUDWH  PJ RU PRUH RI
LPDWLQLESHUGD\RUGLVFRQWLQXDWLRQRILPDWLQLEEHFDXVHRIWR[LFLW\7KHVWXGLHVDUHRQJRLQJ
7KHUHVXOWVDUHEDVHGRQDPLQLPXPRIPRQWKVIROORZXSDIWHUWKHVWDUWRIGDVDWLQLEWKHUDS\
0RVW SDWLHQWV KDG ORQJ GLVHDVH KLVWRULHV ZLWK H[WHQVLYH SULRU WUHDWPHQW LQFOXGLQJ LPDWLQLE
F\WRWR[LFFKHPRWKHUDS\LQWHUIHURQDQGVWHPFHOOWUDQVSODQW7KHPD[LPXPLPDWLQLEGRVHKDG
EHHQ±PJGD\LQDERXWRQHKDOIRIWKHSDWLHQWVDQG!PJGD\LQWKHRWKHUKDOI
$OO SDWLHQWV ZHUH WUHDWHG ZLWK GDVDWLQLE  PJ %,' RQ D FRQWLQXRXV EDVLV 7KH PHGLDQ
GXUDWLRQVRIWUHDWPHQWZHUHEHWZHHQPRQWKV
7KHSULPDU\HIILFDF\HQGSRLQWLQFKURQLFSKDVH&0/ZDVPDMRUF\WRJHQHWLFUHVSRQVH0&\5
GHILQHGDVHOLPLQDWLRQFRPSOHWHF\WRJHQHWLFUHVSRQVH&&\5RUVXEVWDQWLDOGLPLQXWLRQE\DW
OHDVWSDUWLDOF\WRJHQHWLFUHVSRQVHRI3KKHPDWRSRLHWLFFHOOV7KHSULPDU\HQGSRLQWLQ
DFFHOHUDWHGSKDVHP\HORLGEODVWSKDVHDQGO\PSKRLGEODVWSKDVH&0/DQG3K$//ZDV
PDMRUKHPDWRORJLFUHVSRQVH0D+5GHILQHGDVHLWKHUDFRPSOHWHKHPDWRORJLFUHVSRQVHRU
QRHYLGHQFHRIOHXNHPLDDVGHILQHGLQ7DEOH
0RVWF\WRJHQHWLFUHVSRQVHVRFFXUUHGDIWHUZHHNVRIWUHDWPHQWZKHQWKHILUVWF\WRJHQHWLF
DQDO\VHVZHUHSHUIRUPHG+HPDWRORJLFDQGF\WRJHQHWLFUHVSRQVHVZHUHVWDEOHGXULQJWKH
PRQWKIROORZXSRISDWLHQWVZLWKFKURQLFSKDVHDFFHOHUDWHGSKDVHDQGP\HORLGEODVWSKDVH
&0/7KHPHGLDQGXUDWLRQVRIPDMRUKHPDWRORJLFUHVSRQVHZHUHPRQWKVLQO\PSKRLGEODVW
&0/DQGPRQWKVLQ3K$//
7KHUHZHUHQRDJHRUJHQGHUUHODWHGUHVSRQVHGLIIHUHQFHV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

6DIHW\RI'DVDWLQLELQ&OLQLFDO6WXGLHV

6DIHW\LQ+HPDWRORJLF0DOLJQDQF\
7KHGDWDSUHVHQWHGLQ7DEOHUHIOHFWH[SRVXUHWRGDVDWLQLELQSDWLHQWVZLWKOHXNHPLDLQ
FOLQLFDOVWXGLHVVWDUWLQJGRVDJHPJRQFHGDLO\PJRQFHGDLO\PJWZLFHGDLO\RU
PJWZLFHGDLO\7KHPHGLDQGXUDWLRQRIWKHUDS\ZDVPRQWKVUDQJHPRQWKV
7KHPDMRULW\ RI GDVDWLQLEWUHDWHG SDWLHQWV  >@ H[SHULHQFHG DW OHDVW  GUXJUHODWHG
DGYHUVH UHDFWLRQV DW VRPH WLPH 'UXJ ZDV GLVFRQWLQXHG IRU DGYHUVH UHDFWLRQV LQ 
RIVXEMHFWV'UXJUHODWHG$(VOHDGLQJWRGLVFRQWLQXDWLRQLQDQ\FDWHJRU\RFFXUUHG
LQdRIWKHVXEMHFWVZLWKWKHH[FHSWLRQRISOHXUDOHIIXVLRQ,QVXEMHFWVZLWK
FKURQLFSKDVH&0/GUXJUHODWHGSOHXUDO HIIXVLRQDFFRXQWHGIRUGLVFRQWLQXDWLRQLQ RIWKH
VXEMHFWV2QO\VXEMHFWLQWKHPJ4'JURXSKDGGLVFRQWLQXDWLRQGXHWRGUXJUHODWHG
SOHXUDOHIIXVLRQFRPSDUHGZLWKVXEMHFWVLQWKHPJ%,'JURXS,QVXEMHFWVZLWKDGYDQFHG
SKDVH&0/RU3K$//GUXJUHODWHGSOHXUDOHIIXVLRQDFFRXQWHGIRUGLVFRQWLQXDWLRQLQRIWKH
VXEMHFWV6L[VXEMHFWVLQWKHPJ4'JURXSKDGGLVFRQWLQXDWLRQGXHWRGUXJUHODWHG
SOHXUDOHIIXVLRQFRPSDUHGZLWKVXEMHFWVLQWKHPJ%,'JURXS
2YHUDOORIVXEMHFWVDFURVVDOOGLVHDVHSKDVHVUHSRUWHG6$(VDQ\JUDGH
'UXJUHODWHG 6$(V ZHUH UHSRUWHG LQ   RI VXEMHFWV ,Q VXEMHFWV ZLWK FKURQLF
SKDVH&0/QRWDEOHFRPPRQGUXJUHODWHG$(VLQFOXGHGG\VSQHDSOHXUDOHIIXVLRQFRQJHVWLYH
KHDUWIDLOXUHIHEULOHQHXWURSHQLDDQGWKURPERF\WRSHQLD,QPRVWFDVHVDORZHUSURSRUWLRQRI
VXEMHFWVLQWKHPJ4'JURXSUHSRUWHGGUXJUHODWHG6$(VWKDQVXEMHFWVLQWKHPJ%,'
RURWKHUGRVHJURXSV,QVXEMHFWV ZLWKDGYDQFHGSKDVH&0/RU3K$//QRWDEOHFRPPRQ
GUXJUHODWHG$(VLQFOXGHGG\VSQHDSOHXUDOHIIXVLRQGLDUUKHDDQGKHPDWRORJLFDOWR[LFLWLHV,Q
PRVWFDVHVWKHUHZDVOLWWOHGLIIHUHQFHLQWKHVH6$(VEHWZHHQWKHPJ4'DQGPJ%,'
JURXSV5DWHVRIVHYHUHGUXJUHODWHGSOHXUDOHIIXVLRQZHUHORZHULQWKHPJ4'JURXS
YVWKHPJ%,'
7KHPRVWIUHTXHQWO\UHSRUWHG$(VDUHSUHVHQWHGLQ7DEOH
7DEOH9HU\&RPPRQDQG&RPPRQ$(V5HSRUWHGLQ6XEMHFWVLQ&OLQLFDO6WXGLHV
$OO6XEMHFWV1 
3HUFHQWRI6XEMHFWV
$OO*UDGHV
*UDGHV
1HUYRXVV\VWHPGLVRUGHUV
9HU\FRPPRQKHDGDFKH





3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7DEOH9HU\&RPPRQDQG&RPPRQ$(V5HSRUWHGLQ6XEMHFWVLQ&OLQLFDO6WXGLHV
$OO6XEMHFWV1 
3HUFHQWRI6XEMHFWV
$OO*UDGHV
*UDGHV
&RPPRQQHXURSDWK\LQFOXGLQJSHULSKHUDOQHXURSDWK\


'L]]LQHVV


G\VJHXVLD


6RPQROHQFH


5HVSLUDWRU\WKRUDFLFDQGPHGLDVWLQDOGLVRUGHUV
9HU\FRPPRQSOHXUDOHIIXVLRQ


'\VSQHD


&RXJK


&RPPRQSXOPRQDU\HGHPD


OXQJLQILOWUDWLRQ


SQHXPRQLWLV


SXOPRQDU\K\SHUWHQVLRQ


*DVWURLQWHVWLQDOGLVRUGHUV
9HU\FRPPRQGLDUUKHD


1DXVHD


9RPLWLQJ


DEGRPLQDOSDLQ


&RPPRQJDVWURLQWHVWLQDOEOHHGLQJ


PXFRVDOLQIODPPDWLRQLQFOXGLQJPXFRVLWLVVWRPDWLWLV


'\VSHSVLD


DEGRPLQDOGLVWHQVLRQ


&RQVWLSDWLRQ


JDVWULWLV


FROLWLVLQFOXGLQJQHXWURSHQLFFROLWLV


RUDOVRIWWLVVXHGLVRUGHU


6NLQDQGVXEFXWDQHRXVWLVVXHGLVRUGHUV
9HU\FRPPRQVNLQUDVKD


&RPPRQSUXULWXV


DFQH


DORSHFLD


GU\VNLQ


+\SHUKLGURVLV


XUWLFDULD





3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7DEOH9HU\&RPPRQDQG&RPPRQ$(V5HSRUWHGLQ6XEMHFWVLQ&OLQLFDO6WXGLHV
$OO6XEMHFWV1 
3HUFHQWRI6XEMHFWV
$OO*UDGHV
*UDGHV
GHUPDWLWLVLQFOXGLQJHF]HPD


0XVFXORVNHOHWDODQGFRQQHFWLYHWLVVXHGLVRUGHUV
9HU\FRPPRQPXVFXORVNHOHWDOSDLQ


&RPPRQDUWKUDOJLD


0\DOJLD


PXVFOHLQIODPPDWLRQ


PXVFXODUZHDNQHVV


PXVFXORVNHOHWDOVWLIIQHVV


0HWDEROLVPDQGQXWULWLRQGLVRUGHUV
&RPPRQDQRUH[LD


DSSHWLWHGLVWXUEDQFHV


+\SHUXULFHPLD


,QIHFWLRQVDQGLQIHVWDWLRQV
9HU\&RPPRQLQIHFWLRQLQFOXGLQJEDFWHULDOYLUDOIXQJDO
QRQVSHFLILF


&RPPRQSQHXPRQLDLQFOXGLQJEDFWHULDOYLUDOIXQJDO


XSSHUUHVSLUDWRU\WUDFWLQIHFWLRQLQIODPPDWLRQ


KHUSHVYLUDOLQIHFWLRQ


HQWHURFROLWLVLQIHFWLRQ


VHSVLVLQFOXGLQJIDWDORXWFRPH


&DUGLDF'LVRUGHUV
&RPPRQSHULFDUGLDOHIIXVLRQ


DUUK\WKPLDLQFOXGLQJWDFK\FDUGLD


FRQJHVWLYHKHDUWIDLOXUHFDUGLDFG\VIXQFWLRQ


SDOSLWDWLRQV


9DVFXODUGLVRUGHUV
9HU\FRPPRQKHPRUUKDJH


&RPPRQIOXVKLQJ


K\SHUWHQVLRQ


%ORRGDQGO\PSKDWLFV\VWHPGLVRUGHUV
&RPPRQIHEULOHQHXWURSHQLD


SDQF\WRSHQLD


*HQHUDOGLVRUGHUVDQGDGPLQLVWUDWLRQVLWHFRQGLWLRQV
9HU\FRPPRQIDWLJXH


VXSHUILFLDOHGHPD





3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7DEOH9HU\&RPPRQDQG&RPPRQ$(V5HSRUWHGLQ6XEMHFWVLQ&OLQLFDO6WXGLHV
$OO6XEMHFWV1 
3HUFHQWRI6XEMHFWV
$OO*UDGHV
*UDGHV
S\UH[LD


&RPPRQDVWKHQLD


SDLQ


FKHVWSDLQ


JHQHUDOL]HGHGHPD


FKLOOV


3V\FKLDWULFGLVRUGHUV
&RPPRQLQVRPQLD


GHSUHVVLRQ


(\HGLVRUGHUV
&RPPRQYLVXDOGLVRUGHULQFOXGLQJYLVXDOGLVWXUEDQFHYLVLRQ
EOXUUHGDQGYLVXDODFXLW\UHGXFHG


GU\H\H


(DUDQGODE\ULQWKGLVRUGHUV
&RPPRQWLQQLWXV


,QYHVWLJDWLRQV
&RPPRQZHLJKWLQFUHDVHG


ZHLJKWGHFUHDVHG


,QMXU\SRLVRQLQJDQGSURFHGXUDOFRPSOLFDWLRQV
&RPPRQFRQWXVLRQ


6RXUFH635<&(/GDVDWLQLE%06%ULVWRO0\HUV6TXLEE,QYHVWLJDWRU%URFKXUH9HUVLRQ
D,QFOXGHVGUXJHUXSWLRQHU\WKHPDH[IROLDWLYHUDVKIXQJDOUDVKPDFXORSDSXODUUDVKSXVWXODUUDVKYHVLFXODUUDVK
VNLQH[IROLDWLRQDQGXUWLFDULDYHVLFXORVD

E,QFOXGHVYHQWULFXODUG\VIXQFWLRQFDUGLDFIDLOXUHFKURQLFFDUGLDFIDLOXUHFRQJHVWLYHFDUGLRP\RSDWK\FRQJHVWLYH
FDUGLRP\RSDWK\GLDVWROLFG\VIXQFWLRQHMHFWLRQIUDFWLRQGHFUHDVHGDQGYHQWULFXODUIDLOXUH

F ([FOXGHV JDVWURLQWHVWLQDO EOHHGLQJ DQG &16 EOHHGLQJ 7KHVH DGYHUVH GUXJ UHDFWLRQV DUH UHSRUWHG XQGHU WKH
JDVWURLQWHVWLQDOGLVRUGHUVV\VWHPRUJDQFODVVDQGWKHQHUYRXVV\VWHPGLVRUGHUVV\VWHPRUJDQFODVVUHVSHFWLYHO\

G,QFOXGHVDXULFXODUVZHOOLQJH\HHGHPDIDFHHGHPDJUDYLWDWLRQDOHGHPDRUELWDOHGHPDSHULRUELWDOHGHPDVFURWDO
HGHPDDQGWRQJXHHGHPD

([SHULHQFHLQ3KDVH%UHDVW&DQFHU6WXGLHV
'UXJUHODWHG$(VLQtRIWKHVXEMHFWVLQWKHFRPSOHWHG3KDVHVWXGLHVLQEUHDVWFDQFHU
DUHJLYHQLQ7DEOH$QDGGLWLRQDO3KDVH,,WULDOLQEUHDVWFDQFHUKDVUHFHQWO\EHHQUHSRUWHG
>@ZLWKVLPLODUWR[LFLW\SURILOH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7DEOH'UXJ5HODWHG$GYHUVH(YHQWVLQt6XEMHFWVIRU3KDVH%UHDVW
&DQFHU6WXGLHV&$DQG&$
3UHIHUUHG7HUP
&$Q
&$Q
PJ%,'
1 
PJ%,'
1 
PJ%,'
1 
PJ%,'
1 
1DXVHD




)DWLJXH




'LDUUKHD




5DVK




$VWKHQLD




'\VSQHD




3OHXUDOHIIXVLRQ




$QRUH[LD




+HDGDFKH




&RXJK




$EGRPLQDOSDLQ




9RPLWLQJ




)OXVKLQJ





([SHULHQFHLQ3KDVH,,3URVWDWHFDQFHUVWXGLHV
7KH DFWLYLW\ RI GDVDWLQLE KDV EHHQ GHPRQVWUDWHG LQ WZR 3KDVH ,, WULDOV RI FDVWUDWHUHVLVWDQW
SURVWDWHFDQFHU,QWKHILUVW3KDVH,,PHQZHUHWUHDWHGZLWKPJRUPJWZLFHGDLO\
'DVDWLQLEZDVJHQHUDOO\ZHOOWROHUDWHGDQGWUHDWPHQWUHODWHGDGYHUVHHYHQWVZHUHPRGHUDWH
/DFNRISURJUHVVLRQZDVDFKLHYHGLQRISDWLHQWVDWZHHN>@$QRWKHUWULDOHYDOXDWHG
WKHFRPELQDWLRQRIGDVDWLQLEZLWKGRFHWD[HOLQWKLVSRSXODWLRQ>@)LQDOO\DWULDOSHUIRUPHGLQ
FDVWUDWHUHVLVWDQWSURVWDWHFDQFHUXVLQJGDVDWLQLEPJGDLO\GRVLQJZDVIRXQGWREHVDIH
DQGZHOOWROHUDWHGZLWKIHZHUDGYHUVHHIIHFWVFRPSDUHGWRWKHSUHYLRXVWZLFHGDLO\GRVLQJWULDO
0RUHRYHUHVVHQWLDOO\HTXLYDOHQWFOLQLFDODFWLYLW\ZDVREVHUYHG>@
/DERUDWRU\$EQRUPDOLWLHV
0\HORVXSSUHVVLRQZDVFRPPRQO\UHSRUWHGLQDOOSDWLHQWSRSXODWLRQV7KHIUHTXHQF\RI*UDGH
RUQHXWURSHQLDWKURPERF\WRSHQLDDQGDQHPLDZDVKLJKHULQSDWLHQWVZLWKDGYDQFHG&0/RU
3K$//WKDQLQFKURQLFSKDVH&0/0\HORVXSSUHVVLRQZDVUHSRUWHGLQSDWLHQWVZLWKQRUPDO
EDVHOLQH ODERUDWRU\ YDOXHV DV ZHOO DV LQ SDWLHQWV ZLWK SUHH[LVWLQJ ODERUDWRU\ DEQRUPDOLWLHV
7DEOH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
,QSDWLHQWVZKRH[SHULHQFHGVHYHUHP\HORVXSSUHVVLRQUHFRYHU\JHQHUDOO\RFFXUUHGIROORZLQJ
GRVHLQWHUUXSWLRQDQGRUUHGXFWLRQSHUPDQHQWGLVFRQWLQXDWLRQRIWUHDWPHQWRFFXUUHGLQRI
SDWLHQWV*UDGHRUHOHYDWLRQVRIWUDQVDPLQDVHVRUELOLUXELQDQG*UDGHRUK\SRFDOFHPLD
DQGK\SRSKRVSKDWHPLDZHUHUHSRUWHGLQSDWLHQWVZLWKDOOSKDVHVRI&0/EXWZHUHUHSRUWHG
ZLWK DQ LQFUHDVHG IUHTXHQF\ LQ SDWLHQWV ZLWK P\HORLG RU O\PSKRLG EODVW &0/ DQG 3K$//
(OHYDWLRQV LQ WUDQVDPLQDVHV RU ELOLUXELQ ZHUH XVXDOO\ PDQDJHG ZLWK GRVH UHGXFWLRQ RU
LQWHUUXSWLRQ 3DWLHQWV GHYHORSLQJ *UDGH  RU  K\SRFDOFHPLD GXULQJ WKH FRXUVH RI GDVDWLQLE
WKHUDS\RIWHQKDGUHFRYHU\ZLWKRUDOFDOFLXPVXSSOHPHQWDWLRQ7DEOH
7DEOH&7&*UDGHV/DERUDWRU\$EQRUPDOLWLHVLQ&0/DQG3K$//

&KURQLF
Q 
$FFHOHUDWHG
Q 
%ODVW3KDVH
Q 
3K$//
Q 

3HUFHQWRI3DWLHQWV
+HPDWRORJ\3DUDPHWHUV





1HXWURSHQLD





7KURPERF\WRSHQLD





$QHPLD




%LRFKHPLVWU\3DUDPHWHUV





+\SRSKRVSKDWHPLD





+\SRFDOFHPLD





(OHYDWHG6*37$/7





(OHYDWHG6*27$67





(OHYDWHG%LOLUXELQ





(OHYDWHG&UHDWLQLQH




&7&JUDGHVQHXWURSHQLD*UDGH±î/*UDGHî/WKURPERF\WRSHQLD*UDGH±î
/*UDGHî/DQHPLDKHPRJORELQ±J/*UDGHJ/HOHYDWHGFUHDWLQLQH*UDGH!±
îXSSHUOLPLWQRUPDOUDQJH8/1*UDGH!î8/1HOHYDWHGELOLUXELQ*UDGH!±î8/1*UDGH!î
8/1HOHYDWHG6*27RU6*37*UDGH!±î8/1*UDGH!î8/1K\SRFDOFHPLD*UDGH±
PJG/*UDGHPJG/K\SRSKRVSKDWHPLD*UDGH±PJG/*UDGHPJG/

$QWLFLSDWHG$GYHUVH(YHQWV

0\HORVXSSUHVVLRQ
7UHDWPHQW ZLWK GDVDWLQLE LV DVVRFLDWHG ZLWK VHYHUH 1&, &7&$( *UDGH RU
WKURPERF\WRSHQLD QHXWURSHQLD DQG DQHPLD 7KHLU RFFXUUHQFH LV PRUH IUHTXHQW LQ SDWLHQWV
ZLWKDGYDQFHG&0/RU3K$//WKDQLQFKURQLFSKDVH&0/&RPSOHWHEORRGFRXQWVVKRXOGEH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
SHUIRUPHGZHHNO\IRUWKHILUVWPRQWKVDQGWKHQPRQWKO\WKHUHDIWHURUDVFOLQLFDOO\LQGLFDWHG
0\HORVXSSUHVVLRQ ZDV JHQHUDOO\ UHYHUVLEOH DQG XVXDOO\ PDQDJHG E\ ZLWKKROGLQJ GDVDWLQLE
WHPSRUDULO\RUGRVHUHGXFWLRQ,QD3KDVHGRVHRSWLPL]DWLRQVWXG\LQSDWLHQWVZLWKFKURQLF
SKDVH&0/*UDGHRUP\HORVXSSUHVVLRQZDVUHSRUWHGOHVVIUHTXHQWO\LQSDWLHQWVWUHDWHG
ZLWKPJRQFHGDLO\WKDQLQSDWLHQWVWUHDWHGZLWKPJWZLFHGDLO\

%OHHGLQJ5HODWHG(YHQWV
6HYHUH &16 KHPRUUKDJHV LQFOXGLQJ IDWDOLWLHV RFFXUUHG LQ d  RI SDWLHQWV UHFHLYLQJ
GDVDWLQLE 6HYHUH JDVWURLQWHVWLQDO KHPRUUKDJH RFFXUUHG LQ  RI SDWLHQWV DQG JHQHUDOO\
UHTXLUHGWUHDWPHQWLQWHUUXSWLRQVDQGWUDQVIXVLRQV2WKHUFDVHVRIVHYHUHKHPRUUKDJHRFFXUUHG
LQ  RI SDWLHQWV 0RVW EOHHGLQJ HYHQWV ZHUH DVVRFLDWHG ZLWK VHYHUH WKURPERF\WRSHQLD
,QFLGHQFHV LQ WKLV SDUDJUDSK UHIOHFW GUXJUHODWHG DGYHUVH UHDFWLRQV EDVHG RQ LQYHVWLJDWRU¶V
DWWULEXWLRQ
3DWLHQWVZHUHH[FOXGHGIURPSDUWLFLSDWLRQLQGDVDWLQLEFOLQLFDOVWXGLHVLIWKH\WRRNPHGLFDWLRQV
WKDWLQKLELWSODWHOHWIXQFWLRQRUDQWLFRDJXODQWV,QVRPHWULDOVWKHXVHRIDQWLFRDJXODQWVDVSLULQ
DQGQRQVWHURLGDODQWLLQIODPPDWRU\GUXJV16$,'VZDVDOORZHGFRQFXUUHQWO\ZLWKGDVDWLQLELI
WKHSODWHOHWFRXQWZDVWR&DXWLRQVKRXOGEHH[HUFLVHGLISDWLHQWVDUHUHTXLUHG
WRWDNHPHGLFDWLRQVWKDWLQKLELWSODWHOHWIXQFWLRQRUDQWLFRDJXODQWV

)OXLG5HWHQWLRQ
'DVDWLQLE LV DVVRFLDWHG ZLWK IOXLG UHWHQWLRQ ,Q DOO FOLQLFDO VWXGLHV VHYHUH IOXLG UHWHQWLRQ ZDV
UHSRUWHGLQRISDWLHQWVLQFOXGLQJSOHXUDODQGSHULFDUGLDOHIIXVLRQUHSRUWHGLQDQGRI
SDWLHQWVUHVSHFWLYHO\6HYHUHDVFLWHVDQGJHQHUDOL]HGHGHPDZHUHHDFKUHSRUWHGLQRI
SDWLHQWV 6HYHUH SXOPRQDU\ HGHPD ZDV UHSRUWHG LQ  RI SDWLHQWV 3DWLHQWV ZKR GHYHORS
V\PSWRPVVXJJHVWLYHRISOHXUDOHIIXVLRQVXFKDVG\VSQHDRUGU\FRXJKVKRXOGEHHYDOXDWHG
E\FKHVW;UD\6HYHUHSOHXUDOHIIXVLRQPD\UHTXLUHWKRUDFHQWHVLVDQGR[\JHQWKHUDS\)OXLG
UHWHQWLRQHYHQWVZHUHW\SLFDOO\PDQDJHGE\VXSSRUWLYHFDUHPHDVXUHVWKDWLQFOXGHGLXUHWLFVRU
VKRUWFRXUVHVRIVWHURLGV,QFLGHQFHVLQWKLVSDUDJUDSKUHIOHFWGUXJUHODWHGDGYHUVHUHDFWLRQV
EDVHGRQLQYHVWLJDWRU¶VDWWULEXWLRQ
,Q WKH 3KDVH  GRVHRSWLPL]DWLRQ VWXG\ LQ SDWLHQWV ZLWK FKURQLF SKDVH &0/ IOXLG UHWHQWLRQ
HYHQWVZHUHUHSRUWHGOHVVIUHTXHQWO\LQSDWLHQWVWUHDWHGZLWKPJRQFHGDLO\WKDQLQSDWLHQWV
WUHDWHGZLWKPJWZLFHGDLO\



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

473URORQJDWLRQ
$FRPSUHKHQVLYHHYDOXDWLRQRIGDWDIURP3KDVHVWXGLHV1 H[DPLQHGWKHSRVVLEOH
HIIHFWRIGDVDWLQLERQ(&*SDUDPHWHUVSDUWLFXODUO\WKH47FLQWHUYDO7KHPHDQ47FLQWHUYDO
FKDQJHVIURPEDVHOLQHXVLQJ)ULGHULFLD¶VPHWKRG47F)ZHUHWR PVHFWKHXSSHU
FRQILGHQFHLQWHUYDOVIRUDOOPHDQFKDQJHVIURPEDVHOLQHZHUHPVHF2QVWXG\DWRWDORI
VXEMHFWV  UHSRUWHG D 47F) ! PVHF  RI WKHVH  VXEMHFWV UHSRUWHG D 47F) !
PVHFRQERWK'D\DQG'D\1RHYHQWVRI7RUVDGHGHSRLQWHVZHUHUHSRUWHG
1LQH RI WKH  VXEMHFWV ZLWK FKURQLF SKDVH &0/ KDG 47F SURORQJDWLRQ UHSRUWHG DV DQ
DGYHUVHHYHQW2IWKHVHVXEMHFWVZHUHFRQVLGHUHGUHODWHGWRGUXJ1RQHRIWKHVXEMHFWV
ZKRUHSRUWHG47FSURORQJDWLRQZHUHIURPWKHPJ4'JURXSFRPSDUHGZLWKVXEMHFWV
IURP WKH PJ %,' JURXS 7HQ RI WKH  VXEMHFWV ZLWK DGYDQFHG GLVHDVH KDG 47F
SURORQJDWLRQ UHSRUWHG DV DQ DGYHUVH HYHQW 2I WKHVH  VXEMHFWV  ZHUH FRQVLGHUHG GUXJ
UHODWHG$OORIWKHVXEMHFWVZKRUHSRUWHG47FSURORQJDWLRQZHUHIURPWKHPJ%,'JURXS
2YHUDOO RI WKH  VXEMHFWV WUHDWHG ZLWK GDVDWLQLE   VXEMHFWV DFURVV WKH VWXGLHV
UHSRUWHGD47F)!PVHF

2YHUDOO5LVN%HQHILW$VVHVVPHQW
7KHFOLQLFDOVWXGLHVGLVFXVVHGLQ6HFWLRQLQGLFDWHWKDWWKHVDIHW\SURILOHIRUGDVDWLQLELQVROLG
WXPRUVXEMHFWVKDVEHHQVLPLODUWRWKDWLQFKURQLFSKDVH&0/VXEMHFWVZLWKWKHH[FHSWLRQRI
VHYHUH P\HORVXSSUHVVLRQ ZKLFK KDV QRW EHHQ REVHUYHG LQ VROLG WXPRU VXEMHFWV DQG LV
FRQVLGHUHG UHODWHG WR HIILFDF\ DJDLQVW WKH OHXNHPLD DV QRWHG DERYH DQG VHYHUH EOHHGLQJ
ZKLFKLVVHFRQGDU\WRWKURPERF\WRSHQLDLQPRVWLQVWDQFHV

3KDVH,([SHULHQFHLQ6ROLG7XPRUV
,Q D 3KDVH , VWXG\ &$ FRQGXFWHG E\ %ULVWRO 0\HUV 6TXLEE %06 GDVDWLQLE ZDV
DGPLQLVWHUHGRQD%,'VFKHGXOHWRVXEMHFWVZLWKUHIUDFWRU\VROLGWXPRU7RGDWHGRVHVXS
WRPJ%,'RQDGD\RQGD\RIIVFKHGXOHKDYHEHHQDGPLQLVWHUHG>@>@
1RVHYHUHFOLQLFDOWR[LFLW\KDVEHHQHQFRXQWHUHG*DVWURLQWHVWLQDOV\PSWRPVZHUHUHSRUWHGLQ
PRVW VXEMHFWV IDWLJXH ZDV UHSRUWHG LQ  VXEMHFWV  DQG UDVK LQ  VXEMHFWV 
(GHPD OHWKDUJ\ DQG KHDGDFKH ZHUH XQFRPPRQ DQG DSSHDU WR EH GRVHUHODWHG *UDGH 
DV\PSWRPDWLFK\SRFDOFHPLDZDVFRQVLGHUHGGRVHOLPLWLQJLQRQHVXEMHFW*UDGHUDVKZDV
FRQVLGHUHG GRVHOLPLWLQJ LQ WZR RWKHU VXEMHFWV DQG *UDGH  QDXVHD DQG YRPLWLQJ ZLWK
G\VDUWKULDOLJKWKHDGHGQHVVDQGOHWKDUJ\LQDNJVXEMHFWWDNLQJFRQFXUUHQWGLD]HSDPZDV
FRQVLGHUHGGRVHOLPLWLQJLQRQHVXEMHFW



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
,QDQRWKHU3KDVH,VWXG\&$GDVDWLQLE ZDVDGPLQLVWHUHGRQD4'VFKHGXOHWR
VXEMHFWVDWGRVHVXSWRPJ3OHXUDOHIIXVLRQVZHUHREVHUYHGLQWKUHHVXEMHFWVDWWKH
PJGRVHOHYHORQHZLWKSQHXPRQLDDQGWZRZLWKPDOLJQDQWHIIXVLRQ$GRVHRIPJ4'LV
FXUUHQWO\XQGHUFRQVLGHUDWLRQ+\SRFDOFHPLD*,V\PSWRPVDQGVNLQUDVKKDYHEHHQPLOGDQG
LQIUHTXHQW>@>@
7RGDWHWKHVDIHW\SURILOHLQVROLGWXPRUVXEMHFWVKDVEHHQVLPLODUWRWKDWLQ&3&0/VXEMHFWV
ZLWKWKHH[FHSWLRQRIVHYHUHP\HORVXSSUHVVLRQZKLFKKDVQRWEHHQREVHUYHGLQVROLGWXPRU
VXEMHFWV DQG LV FRQVLGHUHG UHODWHG WR HIILFDF\ DJDLQVW WKH OHXNHPLD DV QRWHG DERYH DQG
VHYHUHEOHHGLQJZKLFKLVVHFRQGDU\WRWKURPERF\WRSHQLDLQPRVWLQVWDQFHV>@

-XVWLILFDWLRQIRU2QFH'DLO\'RVLQJ
'DVDWLQLEZDVLQLWLDOO\GHYHORSHGDQGDSSURYHGIRU&0/DWDGRVHRIPJWZLFHGDLO\/DWHU
SRVWUHJLVWUDWLRQ VWXGLHV KDYH VKRZQ HTXLYDOHQW FOLQLFDO HIILFDF\ LQ &0/ XVLQJ RQFH GDLO\
GRVLQJ VFKHGXOHV 7KLV GDLO\ VFKHGXOH KDV UHFHLYHG D FRPSHQGLD OLVWLQJ DQG LV JHQHUDOO\
IDYRUHGLQERWKDFDGHPLFDQGFRPPXQLW\SUDFWLFHIRU&0/DQG$//7KLV3KDVH,VWXG\ZLOO
XVHRQFHGDLO\GRVLQJRIGDVDWLQLEEHFDXVHLWLVH[SHFWHGWRKDYHHTXLYDOHQWFOLQLFDOHIILFDF\
ZLWKIHZHUKLJKJUDGHDGYHUVHHIIHFWV>@7KHIDYRUDEOHSURILOHRIRQFHGDLO\GRVLQJKDV
EHHQ REVHUYHG LQ RWKHU 3KDVH ,, WULDOV RI DGYDQFHG VROLG WXPRUV 6HH 3KDVH ,, WULDOV DQG
GHVFULEHGLQWKHQH[WWKUHHVHFWLRQV

&RPSDULVRQRI6FKHGXOH3KDUPDFRNLQHWLFV
'DVDWLQLE XQGHUJRHV H[WHQVLYH PHWDEROLVP DIWHU LQJHVWLRQ ZLWK DQ HOLPLQDWLRQ
KDOIOLIHRIOHVVWKDQKRXUV>@,QFKURQLFSKDVH&0/GDVDWLQLEDGPLQLVWHUHG
DVPJRQFHGDLO\RUPJWZLFHGDLO\UHVXOWHGLQVLPLODUSODVPDVWHDG\VWDWH
DYHUDJHFRQFHQWUDWLRQVEXWWKHSODVPDVWHDG\VWDWHWURXJKFRQFHQWUDWLRQ&PLQ
ZDVORZHUZLWKPJRQFHGDLO\&PLQOHYHOVFRUUHODWHGZLWKGDVDWLQLEDGYHUVH
HIIHFWV>@

&RPSDULVRQRI6FKHGXOH3KDUPDFRG\QDPLFV
$OWKRXJK QRW GLUHFWO\ UHOHYDQW WR 65& LQKLELWLRQ LQ 16&/& QR VWDWLVWLFDOO\
VLJQLILFDQW GLIIHUHQFH LQ FOLQLFDO RXWFRPHV XVLQJ GDLO\ GRVLQJ YV WZLFH GDLO\ KDV
EHHQ REVHUYHG LQ %&5$%/ DGGLFWHG KHPDWRORJLF GLVRUGHUV 6SHFLILFDOO\ LQ
DGYDQFHGSKDVH &0/ QR VWDWLVWLFDOO\ VLJQLILFDQW GLIIHUHQFHV ZHUH REVHUYHG LQ
PDMRU0+&RUFRPSOHWHF\WRJHQHWLFUHVSRQVH&&5PDMRU0D+5RUFRPSOHWH
KHPDWRORJLFUHVSRQVH&+5RYHUDOOKHPDWRORJLFUHVSRQVHRURYHUDOOVXUYLYDO,Q



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
3K$//PDMRUF\WRJHQHWLFUHVSRQVHZDVPRUHIUHTXHQWLQWKHRQFHGDLO\
JURXS WKDQ LQ WKH WZLFHGDLO\ JURXS  3    7KH VDPH WUHQGV ZHUH
REVHUYHG LQ RWKHU LQGLFHV &+5  YV  0D+5  YV  DQG 2+5
YV>@
,Q FKURQLFSKDVH &0/ GDVDWLQLE GDLO\ KDG HTXLYDOHQW RXWFRPHV XVLQJ 
UDQGRPL]DWLRQRIGDLO\PJGDLO\PJ%,'DQGPJ%,'>@7KH
SULPDU\ REMHFWLYH ZDV DFKLHYHG LPDWLQLEUHVLVWDQW SDWLHQWV UHFHLYLQJ RQFHGDLO\
WKHUDS\ DWWDLQHG D 0&\5 UDWH WKDW ZDV QRQLQIHULRU WR WKH WZLFHGDLO\ VFKHGXOH
RQFHGDLO\>&,WR@WZLFHGDLO\>&,WR
@ WUHDWPHQW GLIIHUHQFH  > &, ± WR @ 7KH PDLQ
VHFRQGDU\ REMHFWLYH ZDV DOVR DFKLHYHG WKH PJ WRWDO GDLO\ GRVH ZDV
QRQLQIHULRUWRWKHPJWRWDOGDLO\GRVHDPRQJLPDWLQLEUHVLVWDQWSDWLHQWV
PJ  > &,  WR @  PJ  > &,  WR @
WUHDWPHQWGLIIHUHQFH±>&,±WR@
0RUHRYHU WKHUH LV HYLGHQFH WKDW W\URVLQH NLQDVHV DFFXPXODWH LQ VROLG WXPRUV
LQFOXGLQJ GDVDWLQLEOLNH FRPSRXQGV )RU H[DPSOH UDGLRODEHOHG GDVDWLQLE
DFFXPXODWHVLQWKHWXPRUVRIPRXVHSURVWDWHFDQFHUV>@7KLVLQGLFDWHVWKDW
DFKLHYLQJ WKHUDSHXWLF SODVPD OHYHOV IRU RYHU  KRXUV PD\ QRW EH UHTXLUHG IRU
SRWHQW65&NLQDVHLQKLELWLRQ

&RPSDULVRQRI6FKHGXOH7R[LFLW\
6WXGLHVLQ$//DQGDFFHOHUDWHGSKDVH&0/KDYHVKRZQOHVVWR[LFLW\XVLQJ
PJUDWKHUWKDQPJ%,'GRVLQJ,QSDUWLFXODUWKHUHLVOHVVLQFLGHQFHRISOHXUDO
HIIXVLRQVLQERWK$//DOOJUDGHVYHUVXV16DQG$3&0/DOOJUDGHV
 YV  3   >@ >@ ,Q $3 &0/ WKHUH ZHUH DOVR IHZHU GRVH
UHGXFWLRQVYVDQGLQWHUUXSWLRQVYVUHTXLUHGLQWKHRQFH
GDLO\ JURXS 3OHXUDO HIIXVLRQV ZHUH PDQDJHDEOH DQG OHG WR WUHDWPHQW
GLVFRQWLQXDWLRQ LQ RQO\  RQFHGDLO\ JURXS DQG  WZLFHGDLO\ JURXS RI
SDWLHQWV3HULFDUGLDOHIIXVLRQVRFFXUUHGVOLJKWO\PRUHIUHTXHQWO\LQWKHWZLFHGDLO\
JURXSRQFHGDLO\YVWZLFHGDLO\DOOJUDGHVYVJUDGHWRYV
7KHLQFLGHQFHRIFRQJHVWLYHKHDUWIDLOXUHRUFDUGLDFG\VIXQFWLRQZDVDQGLQ
WKHRQFHDQGWZLFHGDLO\JURXSVUHVSHFWLYHO\
,QFKURQLFSKDVH&0/JHQHUDOO\IHZHUDGYHUVHHIIHFWVZHUHREVHUYHGLQPJ
YVPJ%,'6SHFLILFDOO\WKHUHZHUHIHZHUJUDGH$(VYV3 
SDUWLFXODUO\JUDGHWRWKURPERF\WRSHQLDYV3 DQG



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
OHVV SOHXUDO HIIXVLRQV RI DQ\ JUDGH  YV  3    +RZHYHU WKH
GLIIHUHQFHVLQ$(VEHWZHHQPJGDLO\DQGPJELGZHUHHVVHQWLDOO\LGHQWLFDO
>@
$PHWDDQDO\VLVRI&0/GDWDFRQFOXGHGWKDWELGGRVLQJPD\EHDULVNIDFWRUIRU
SOHXUDO HIIXVLRQ >@7KHVH UHSRUWV SURPSWHG D 3KDVH ,, WULDO ZLWK GDVDWLQLE LQ
16&/&WRFKDQJHWKHLUGRVLQJIURPPJELGWRPJGDLO\>@
,QGHHGDQRULJLQDO3KDVH,,VLQJOHDJHQWGDVDWLQLELQ16&/&UHSRUWHGDKLJKUDWH
RI SOHXUDO HIIXVLRQ ZLWK  PJ %,' FDXVLQJ LQYHVWLJDWRUV WR SHUIRUP DQ
DPHQGPHQWWRPJ%,'>@$QRWKHU3KDVH,VWXG\FRPELQHGZLWKHUORWLQLELQ
16&/&REVHUYHGDKLJKHULQFLGHQFHRIVHYHUDODGYHUVHHIIHFWVLQFOXGLQJG\VSQHD
ZLWK  PJ %,' FRKRUW FRPSDUHG WR  PJ %,' FRKRUW >@ 7KHUHIRUH LW LV
UDWLRQDOHDQGHWKQLFDOWRSHUIRUPWULDOVLQVROLGWXPRUVXVLQJPJWRPJ
RQFHGDLO\UDWKHUWKDQPJWZLFHGDLO\GRVLQJVFKHPD

$)$7,1,%'58*352),/(
%,%:DIDWLQLELVDKLJKO\VHOHFWLYHDQGSRWHQWORZPROHFXODUZHLJKWLUUHYHUVLEOHLQKLELWRU
RIWKHHUE%IDPLO\RIW\URVLQHNLQDVHUHFHSWRUV(*)5HUE%+(5+(5HUE%DQG
+(5HUE%$OOUHIHUHQFHVLQWKLVSURWRFROFRQFHUQLQJ%,%:UHIHUWRWKHIUHHEDVH
FRPSRXQG%,%:%6ZKLFKLVXVHGDVWKHRUDOIRUPXODWLRQ
7KHSRWHQF\RIDIDWLQLEZDVGHWHUPLQHGLQHQ]\PDWLFDVVD\VXVLQJUHFRPELQDQWKXPDQZLOG
W\SH(*)5,&Q0DQG+(5,&Q0$SDQHORIUHFRPELQDQWKXPDQNLQDVHV
WHVWHG LQ SDUDOOHO ZDV QRW LQKLELWHG GHPRQVWUDWLQJ WKH KLJK WDUJHW VSHFLILFLW\ RI DIDWLQLE
0ROHFXODU PRGHOLQJ UHYHDOHG WKDW DIDWLQLE ELQGV FRYDOHQWO\ DQG ZLWK KLJK DIILQLW\ WR &\V
ZLWKLQWKHFDWDO\WLFFOHIWRIWKH$73ELQGLQJSRFNHWRIWKH(*)UHFHSWRU,WKDVEHHQUHSRUWHG
WKDW WKLV VSHFLILF PROHFXODU LQWHUDFWLRQ UHVXOWV LQ LUUHYHUVLEOH LQKLELWLRQ RI WKH (*)5 W\URVLQH
NLQDVHGRPDLQ
7KHHIILFDF\DQGSRWHQF\RIDIDWLQLEZDVGHPRQVWUDWHGLQYLWURLQUHFHSWRUSKRVSKRU\ODWLRQDQG
FHOO SUROLIHUDWLRQ DVVD\V LQ YDULRXV KXPDQ FDQFHU FHOO PRGHOV 7KH DQWLSUROLIHUDWLYH HIIHFWV
REVHUYHG ZLWKDIDWLQLEFRPSDUHIDYRUDEO\WRDFWLYLW\GDWDSXEOLVKHGIRUJHILWLQLELQWKHVDPH
16&/&FHOOPRGHOV,QDGGLWLRQ DIDWLQLEVXSSUHVVHG(*)5SKRVSKRU\ODWLRQDQGFORQRJHQLF
JURZWKLQWKHJHILWLQLEUHVLVWDQW1&,+PRGHOVXJJHVWLQJWKDWWXPRUFHOOVKDUERULQJWKH
70 (*)5 7., UHVLVWDQFH PXWDWLRQ UHPDLQ VHQVLWLYH WR WKLV LUUHYHUVLEOH (*)5 VPDOO
PROHFXOHLQKLELWRU7DEOH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7DEOH,QYLWURDFWLYLW\RIDIDWLQLE%,%: LQKXPDQWXPRUFHOOPRGHOVH[SUHVVLQJZLOG
W\SHRUPXWDWHG(*)5
7KH LQ YLYR DFWLYLW\ RI DIDWLQLE DJDLQVW (*)5 ZDV LQYHVWLJDWHG LQ DQ $ VXEFXWDQHRXV
[HQRJUDIWPRGHO'DLO\RUDOWUHDWPHQWZLWKDIDWLQLEDWGRVHVRIPJNJUHVXOWHGLQDQDOPRVW
FRPSOHWHLQKLELWLRQRIWXPRUJURZWKRYHUDSHULRGRIGD\V6LPLODUDQWLWXPRUDFWLYLW\ZDV
REVHUYHG LQ 1&,1 WXPRU EHDULQJ PLFH WUHDWHG ZLWK DIDWLQLE DW VLPLODU FRQFHQWUDWLRQV ,Q
WKHVHLQYLYRVWXGLHVDIDWLQLESODVPDFRQFHQWUDWLRQVRIQ0FRUUHVSRQGLQJWRDQ$8&
 RI  Q0K ZHUH UHTXLUHG IRU DQWLWXPRU DFWLYLW\ $OO DIDWLQLE GRVHV VKRZQ WR EH
HIIHFWLYHLQPRXVH[HQRJUDIWPRGHOVZHUHZHOOWROHUDWHG

3KDUPDFRORJ\DQG7R[LFRORJ\3URILOH
7KHDEVROXWHELRDYDLODELOLW\RIDIDWLQLEDIWHURUDOLQJHVWLRQZDVLQUDWVZLWKDPHGLDQW
PD[UHDFKHGDIWHUKRXUVDQGDWHUPLQDOKDOIOLIHWRIKRXUV,QUDWVWKHH[SRVXUHZDV
GRVH SURSRUWLRQDO DQG QR JHQGHUUHODWHG HIIHFWV RU FRPSRXQG DFFXPXODWLRQ ZDV REVHUYHG
$IDWLQLE LV SULPDULO\ H[FUHWHG YLD WKH IHFHV 1R UHOHYDQW LQKLELWLRQ RI F\WRFKURPH 3
LVRHQ]\PHVZDVIRXQG,QYLWURDIDWLQLELVKRZHYHUD&<3$VXEVWUDWH%HFDXVHWKLVLVQRW
FRQVLGHUHG D GRPLQDQW PHWDEROLF SDWKZD\ LQ YLYR GUXJGUXJ LQWHUDFWLRQV ZLWK &<3$
LQGXFHUVRULQKLELWRUVDUHQRWH[SHFWHG
,QYLYRDIDWLQLEZDVPHWDEROL]HGRQO\WRDPLQRUH[WHQWDQGWKHPHWDEROLVPZDVJRYHUQHGE\
DGGXFWIRUPDWLRQWRSURWHLQVRUQXFOHRSKLOLFVPDOOPROHFXOHV,WZDVIRXQGWKDWPHWDEROLVPLVRI
VXERUGLQDWHUROHIRUDIDWLQLEDQGWKDWHQ]\PHFDWDO\]HGPHWDEROLFUHDFWLRQVSOD\DQHJOLJLEOH
UROHIRUWKHPHWDEROLVPRIDIDWLQLELQYLYR2QO\DSSUR[LPDWHO\RIWKHGRVHZDVPHWDEROL]HG
E\ )02 LQ YLYR 7KH &<3$GHSHQGHQW 1GHPHWK\ODWLRQ ZDV HYHQ WRR ORZ WR EH
TXDQWLWDWLYHO\GHWHFWHGLQKXPDQYROXQWHHUV7KHUHIRUHLQWULQVLFHJJHQHWLFSUHGLVSRVLWLRQ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
RUH[WULQVLFHJE\FRPHGLFDWLRQVHIIHFWVRQWKHDFWLYLW\RI)02RU&<3$LQYLYRDUH
H[SHFWHGWREHRIOLWWOHLIDQ\UHOHYDQFHIRUWKHSKDUPDFRNLQHWLFVRIDIDWLQLE
7KHKXPDQ$'0(GDWDFRQILUPHGWKHUHVXOWVRIWKHSUHFOLQLFDO>&@$'0(VWXGLHVDQGDOO
PHWDEROLWHVRIWKHKXPDQ>&@$'0(VWXG\ZHUHREVHUYHGLQWKHUDWRUWKHPLQLSLJ
,QDFXWHWR[LFRORJ\VWXGLHVRUDODGPLQLVWUDWLRQRIVLQJOHGRVHVLQUDWVDQGPLFHLQGLFDWHGDORZ
DFXWHWR[LFSRWHQWLDORIDIDWLQLE&KDQJHVLQUHQDODQGKHSDWLFIXQFWLRQRFFXUUHGRQO\DWGRVHV
WKDWZHUHWRIROGDERYHWKHOHYHOVUHTXLUHGIRUDQWLWXPRUDFWLYLW\DIDWLQLEKDGHIIHFWVRQ
JDVWURLQWHVWLQDO IXQFWLRQ WKDW ZHUH GRVHGHSHQGHQW DQG LQ KLJK GRVHV OHDGLQJ WR SURIRXQG
LQKLELWLRQ1RDFXWHWR[LFHIIHFWVRQWKHFHQWUDOQHUYRXVV\VWHPZHUHGHWHFWHG
,QRUDOUHSHDWHGGRVHVWXGLHVIRUXSWRZHHNVLQUDWVDQGPLQLSLJVWKHPDLQWDUJHWRUJDQV
ZHUH WKH JDVWURLQWHVWLQDO WUDFW UDWV DQG PLQLSLJV NLGQH\V UDW DQG WKH VNLQ UDWV ,Q WKH
JDVWURLQWHVWLQDO WUDFW LQFUHDVLQJ V\VWHPLF H[SRVXUH ZDV DVVRFLDWHG ZLWK GRVHGHSHQGHQW
DWURSK\RIWKHHSLWKHOLXPDQGFRQFRPLWDQWIRFDOHURVLRQVXOFHUDWLRQVLQWKHVWRPDFKRIUDWVDQG
PLQLSLJV&OLQLFDOO\WKLVUHVXOWHGLQGLDUUKHDLQERWKVSHFLHVDQGIHFDORFFXOWEORRGLQDVLQJOH
PLQLSLJ ,Q UDW NLGQH\V SDSLOODU\ QHFURVLV DQG GLODWHG WXEXOHV ZHUH IRXQG 6LPLODU SDWKRORJLF
ILQGLQJVLHSDSLOODU\QHFURVLVLQUDWVDQGGRJVKDYHEHHQGHVFULEHGSUHYLRXVO\IRUWKH(*)5
VPDOOPROHFXOH LQKLELWRU JHILWLQLE +RZHYHU QHSKURWR[LFLW\ KDV QRW EHHQ UHSRUWHG DV D VLGH
HIIHFWRIJHILWLQLEWKHUDS\LQKXPDQV$VHFRQGDU\SDWKRSK\VLRORJLFHIIHFWRQUHQDOIXQFWLRQLQ
DIDWLQLEWUHDWHGDQLPDOVGXHWRGLDUUKHDLQGXFHGGHK\GUDWLRQ DQG HPDFLDWLRQ KDVWRDOVR EH
FRQVLGHUHG &XWDQHRXV DOWHUDWLRQV LH HSLWKHOLDO DWURSK\ ZHUH REVHUYHG LQ UDWV +RZHYHU
DIDWLQLELVQRWLUULWDWLQJWRLQWDFWVNLQLQDOELQRUDEELWVDQGWKHHIIHFWVREVHUYHGLQUDWVDUHPRVW
OLNHO\ UHODWHG WR WKH VSHFLILF SKDUPDFRG\QDPLF PHFKDQLVP RI (*)5 LQKLELWLRQ $ YDULHW\ RI
RUJDQVLQFOXGLQJWKHDHURGLJHVWLYHWUDFWDQGUHSURGXFWLYH RUJDQV ZHUHDIIHFWHGE\HSLWKHOLDO
DWURSK\7KHVHDWURSKLFFKDQJHVZHUHQRWVHYHUHDQGIXOO\UHYHUVHGGXULQJDZHHNUHFRYHU\
SHULRG 0LQRU FDUGLRYDVFXODU HIIHFWV LQFUHDVHG EORRG SUHVVXUH DQG KHDUW UDWH DQG D GRVH
GHSHQGHQWGHFUHDVHRI47WLPHLQWKHHOHFWURFDUGLRJUDP(&*RFFXUUHGLQDIDWLQLEWUHDWHG
PLQLSLJV7KHVHGDWDGRQRWLQGLFDWHDULVNIRU47SURORQJDWLRQUHODWHGDUUK\WKPLD%,%:
KDGQRSURDUUK\WKPLFSRWHQWLDODVGHWHUPLQHGE\WKHHIIHFWVRQ+(5*PHGLDWHGSRWDVVLXP
FXUUHQW RU RQ JXLQHD SLJ SDSLOODU\ PXVFOH DFWLRQ SRWHQWLDO FRQILJXUDWLRQ %,%: 
GHPRQVWUDWHGPXWDJHQLFSRWHQWLDOLQEDFWHULDEXWKDGQRJHQRWR[LFSRWHQWLDOLQYLYRHYHQDW
KLJKO\WR[LFOHWKDOGRVHVLQDQLPDOV%HFDXVHRILWVVSHFLILFSKDUPDFRG\QDPLFPHFKDQLVPRI
DFWLRQ%,%:LVSRWHQWLDOO\HPEU\RIHWRWR[LFDQGRUWHUDWRJHQLF



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

&OLQLFDO([SHULHQFH$IDWLQLE

2YHUYLHZ
$WWKHWLPHRI-DQSDWLHQWVKDGEHHQH[SRVHGWRDIDWLQLELQYDULRXV3KDVH,,,,
WULDOV$VXPPDU\RI3KDVH,,,WULDOVLVJLYHQLQWDEOHVEHORZ$IDWLQLEZDVDGPLQLVWHUHGWR
KHDOWK\ YROXQWHHUV LQ DQ $'0( VWXG\  WZR ELRDYDLODELOLW\ WULDOV  DQG
DQGDGUXJGUXJLQWHUDFWLRQVWXG\
0RUH WKDQ  SDWLHQWV KDYH EHHQ WUHDWHG LQ 3KDVH , PRQRWKHUDS\ WULDOV $ WRWDO RI 
SDWLHQWV ZHUH WUHDWHG LQ 3KDVH , RU ,, FRPELQDWLRQ WULDOV LQFOXGLQJ IRXU WULDOV ZLWK WKH
FRPELQDWLRQRI%,%:DQG%,%)3KDVH,,WULDOVRIDIDWLQLEKDYHIRFXVHGRQQRQ
VPDOO FHOO OXQJ FDQFHU 16&/& EUHDVW FDQFHU KHDG DQG QHFN VTXDPRXV FHOO FDUFLQRPD
+16&&DQGJOLRPD,Q3KDVH,,,WULDOVPRUHWKDQSDWLHQWVKDYHEHHQWUHDWHGHLWKHU
ZLWKDIDWLQLERUFRQWUROWUHDWPHQW7KH3KDVH,,,WULDOOHGWR)'$DSSURYDORIDIDWLQLELQ
DQRUSKDQGHVLJQDWLRQIRUILUVWOLQHWKHUDS\RI(*)5PXWDQW16&/&RQ-XO\
,QDGGLWLRQWRWKH3KDVH,,,WULDOVLQ16&/&WZRPRUH3KDVH,,,WULDOVKDYHEHJXQSDWLHQW
HQUROOPHQW3KDVH,,,7ULDOLQ16&/&LVVLPLODUWRLWLVEHLQJFRQGXFWHGLQ
GLIIHUHQW FRXQWULHV DQG XVHV D GLIIHUHQW FRPSDUDWRU FKHPRWKHUDS\ UHJLPHQ FLVSODWLQ
JHPFLWDELQHDVRSSRVHGWRFLVSODWLQSHPHWUH[HG6WXG\LVDUDQGRPL]HG3KDVH,,,
WULDOLQDGYDQFHGEUHDVWFDQFHULQSDWLHQWVSUHWUHDWHGZLWKWUDVWX]XPDEFRPSDULQJ%,%:
SOXVYLQRUHOELQHYHUVXVWUDVWX]XPDESOXVYLQRUHOELQH




3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
7DEOH(DUO\SKDVHGHYHORSPHQWRI%,%:$GDSWHGIURP>@

7DEO
H
6X
PP
DU\
RI
SUHF
OLQLF
DO
DQG
3KD
VH
,,,
UHVX
OWV
IRU
%,%
:

LQ
ERW
K
PRQ
RWKH
UDS\
DQGFRPELQDWLRQWKHUDS\VWXGLHV

'RVH6HOHFWLRQIRU6LQJOH$JHQW7ULDOVRI$IDWLQLE
7KHPRVWXSWRGDWHWULDODQGVDIHW\ LQIRUPDWLRQFDQEHIRXQGLQWKHFXUUHQW YHUVLRQRIWKH
,QYHVWLJDWRU%URFKXUH $IDWLQLEVKRZHGPRGHUDWHO\IDVWDEVRUSWLRQ ZLWKPHGLDQWPD[ YDOXHV
EHWZHHQKWRKDIWHUDGPLQLVWUDWLRQ7KHJ0HDQWHUPLQDOKDOIOLIHWRIDIDWLQLEPDLQO\
UDQJHGEHWZHHQKWRK,QJHQHUDOWKHPD[LPXPEORRGFRQFHQWUDWLRQ&PD[DQGWKH
LQWHJUDORIWKHFRQFHQWUDWLRQWLPHFXUYH$8&RIDIDWLQLELQFUHDVHGLQDGRVHSURSRUWLRQDOZD\
7KHPD[LPXPWROHUDWHGGRVH07'RIDIDWLQLEZDVLGHQWLILHGDVPJRQFHGDLO\LQSKDVH,
FRQWLQXRXVGRVLQJPRQRWKHUDS\WULDOV7KHPJGRVHLVFXUUHQWO\XVHGLQWKH3KDVH,,E,,,
WULDO  LQ 16&/& SDWLHQWV SURJUHVVLQJ RQ HUORWLQLE RU JHILWLQLE DV PD[LPXP (*)5
LQKLELWLRQ LV UHTXLUHG LQ WKLV ODVWOLQH SRSXODWLRQ HQULFKHG IRU WKH SUHVHQFH RI UHVLVWDQFH
PXWDWLRQV$VWDUWLQJGRVHRIPJLVH[SHFWHGWREHVXIILFLHQW,QSKDVH,FOLQLFDOWULDOVRI
DIDWLQLEGXUDEOHUHVSRQVHV!PRQWKVZHUHVHHQDWGDLO\GRVHVRIPJDQGOHVV,QWKLV
WULDODVWDUWLQJGRVHRIPJZLOOEHXVHGLQRUGHUWRRSWLPL]HWKHHIILFDF\WR[LFLW\EDODQFHZLWK
GDVDWLQLE
3KDVH
'HVFULSWLRQ
3ULPDU\HQGSRLQW
5HI


3UHFOLQLFDO
,QYLWURDQG LQYLYRDQDO\VLVRI%,%:
(UE%IDPLO\LQKLELWLRQ
>@

3UHFOLQLFDO
/5DQG70WUDQVJHQLFPLFH
7XPRUVKULQNDJH
>@

3UHFOLQLFDO
&RPELQDWLRQZLWKUDSDP\FLQLQ+(5PXWDQWPLFH
7XPRUVKULQNDJH
>@

,
'RVHHVFDODWLRQVWXG\RQFHGDLO\IRUGD\V±PJ
07'
>@

,
'RVHHVFDODWLRQVWXG\RQFHGDLO\IRUGD\V±PJ
07'
>@

,
'RVHHVFDODWLRQVWXG\RQFHGDLO\&RQWLQXRXV±PJ
07'
>@

,
'RVHHVFDODWLRQVWXG\RQFHGDLO\&RQWLQXRXV±PJ
07'
>@

,
'RVHHVFDODWLRQVWXG\%,%:±PJHYHU\
RUGD\VLQFRPELQDWLRQZLWKGRFHWD[HORUPJP 07'
>@



,
'RVHHVFDODWLRQVWXG\%,%:±PJGD\V
07'
>@

SRVW̻ GRFHWD[HORUPJP

,
&RQWLQXRXVVWXG\%,%:±PJSOXVSDFOLWD[HO
07'
>@

DQGEHYDFL]XPDE

,,
(*)5PXWDWLRQVJHQHDPSOLILFDWLRQ),6+SRVLWLYH
255&5DQG35
>@




3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

$GYHUVH(YHQWVZLWK$IDWLQLE
7KH$GYHUVH(YHQWV$(VREVHUYHGWRGDWHLQSKDVH,DQGSKDVH,,WULDOVDUHFRQVLVWHQWZLWK
WKRVHUHSRUWHGIRURWKHU(*)5W\URVLQHNLQDVHLQKLELWRUVGRVHGHSHQGHQWGLDUUKHDDQGVNLQ
UHODWHGDGYHUVHHYHQWVLQFOXGLQJUDVKDQGDFQH2WKHU$(VZHUHLQWKHH[SHFWHGUDQJHIRU
SDWLHQWV ZLWK DGYDQFHG FDQFHU GLVHDVH ,Q WKH %,%:  SKDVH , PRQRWKHUDS\ WULDOV WKH
PRVW IUHTXHQW GUXJUHODWHG DGYHUVH HYHQWV ZHUH DVVRFLDWHG ZLWK JDVWURLQWHVWLQDO GLVRUGHUV
GLDUUKHD QDXVHD YRPLWLQJ VWRPDWLWLV VNLQ DQG VXEFXWDQHRXV WLVVXH GLVRUGHUV UDVK GU\
VNLQSUXULWXVDFQHLIRUPUDVKDQGDFQHJHQHUDOGLVRUGHUVDQGDGPLQLVWUDWLRQVLWHFRQGLWLRQV
IDWLJXH PXFRVDO LQIODPPDWLRQ UHVSLUDWRU\ GLVRUGHUV HSLVWD[LV W\SLFDOO\ JUDGH  DQG
PHWDEROLVPDQGQXWULWLRQDOGLVRUGHUVDQRUH[LDGHK\GUDWLRQ
'LDUUKHD LV WKH VLQJOH PRVW RIWHQ UHSRUWHG JDVWURLQWHVWLQDO $( $Q LQFUHDVHG LQFLGHQFH RI
GLDUUKHDJUDGHKDVEHHQREVHUYHGLQSKDVH,,PRQRWKHUDS\WULDOV'RVHUHGXFWLRQLVFUXFLDO
WRUHGXFHWKHVHYHULW\RIGLDUUKHDDQGLWVSRWHQWLDOFRPSOLFDWLRQVVXFKDVGHK\GUDWLRQOHDGLQJ
WR VHUXP HOHFWURO\WH FKDQJHV K\SRQDWUHPLD K\SRNDOHPLD DQG K\SRPDJQHVDHPLD DQGRU
UHQDO LPSDLUPHQW 1DXVHD DQG YRPLWLQJ DUH WKH RWKHU FRPPRQO\ UHSRUWHG JDVWURLQWHVWLQDO
DGYHUVHHYHQWVDQGFDQEHJHQHUDOO\PDQDJHGVXFFHVVIXOO\ZLWKWKHXVHRIDQWLHPHWLFV
6NLQUHODWHGDGYHUVHHYHQWVSUHVHQWLQDQXPEHURIIRUPVLHUDVKLQFOXGLQJHU\WKHPDWRXV
PDFXORSDSXODUSDSXODUHWFDFQHGHUPDWLWLVDFQHLIRUPGU\VNLQVNLQUHDFWLRQDQGSUXULWLV
)ROOLFXOLWLVDVZHOODVQDLOFKDQJHVLQFOXGLQJSDURQ\FKLDDUHRWKHUUHSRUWHGPDQLIHVWDWLRQVRI
VNLQUHODWHGDGYHUVHHYHQWVZLWK%,%:(DUO\DQGDGHTXDWHPDQDJHPHQWRIVNLQUHODWHG
DGYHUVHHYHQWVFDQUHGXFHWKHIUHTXHQF\DQGWKHVHYHULW\RIWKHP
)XUWKHU$(VLQFOXGHRUDOGLVFRPIRUWVWRPDWLWLVPRXWKXOFHUDWLRQRUDOSDLQGU\PRXWKVRIW
WLVVXH GLVRUGHU DQG PXFRVDO LQIODPPDWLRQ &RQMXQFWLYLWLV DQG UKLQRUUKHD DV D UHVXOW RI
LQIODPPDWLRQLQWKHPXFRVDOPHPEUDQHVKDYHEHHQUHSRUWHG0XFRVDODQGVNLQGU\QHVVFDQ
OHDGWRHSLVWD[LVZKLFKKDVDOZD\VEHHQREVHUYHGDW&7&$(*UDGH$QRUH[LDIDWLJXHDQG
DVWKHQLDDUHDOVRIUHTXHQWO\REVHUYHG

&OLQLFDO(IILFDF\
7KH)'$DSSURYDORIDIDWLQLEZDVEDVHGRQWKHGHPRQVWUDWLRQRILPSURYHGSURJUHVVLRQIUHH
VXUYLYDO3)6LQDPXOWLFHQWHULQWHUQDWLRQDORSHQODEHOUDQGRPL]HGWULDOFDOOHG/8;
OXQJ7KLVWULDOHQUROOHGSDWLHQWVZLWKPHWDVWDWLF16&/&ZKRVHWXPRUVWHVWHGSRVLWLYHIRU
(*)5PXWDWLRQV3DWLHQWVZHUHUDQGRPL]HGWRUHFHLYHDIDWLQLEPJRUDOO\RQFHGDLO\Q 
RUSHPHWUH[HGFLVSODWLQQ 5DQGRPL]DWLRQZDVVWUDWLILHGDFFRUGLQJWR(*)5PXWDWLRQ
VWDWXVH[RQGHOHWLRQYVH[RQ/5YVµRWKHU¶DQGUDFH$VLDQYVQRQ$VLDQ7KH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
PDMRUHIILFDF\RXWFRPHZDVSURJUHVVLRQIUHHVXUYLYDO3)6DVDVVHVVHGE\DQLQGHSHQGHQW
UHYLHZFRPPLWWHH,5&
2I  SDWLHQWV HQUROOHG  ZHUH IHPDOH WKH PHGLDQ DJH ZDV  \HDUV  ZHUH
&DXFDVLDQDQGZHUH$VLDQ7KHPDMRULW\RISDWLHQWVKDGDWXPRUVDPSOHZLWKDQ(*)5
PXWDWLRQFDWHJRUL]HGDVHLWKHUH[RQGHOHWLRQRUH[RQ/5VXEVWLWXWLRQ
ZKLOHWKHUHPDLQLQJKDGµRWKHU¶PXWDWLRQV
$ VWDWLVWLFDOO\ VLJQLILFDQW SURORQJDWLRQ RI 3)6 GHWHUPLQHG E\ WKH ,5& ZDV GHPRQVWUDWHG IRU
SDWLHQWV DVVLJQHG WR WKH DIDWLQLE WUHDWPHQW DUP >+5   &,   S  
VWUDWLILHGORJUDQNWHVW@7KHPHGLDQ3)6ZDVPRQWKVLQWKHDIDWLQLEDUPDQGPRQWKV
LQWKHFKHPRWKHUDS\DUP2EMHFWLYHUHVSRQVHUDWHVZHUHDQGLQWKHDIDWLQLEDQG
FKHPRWKHUDS\ DUPV UHVSHFWLYHO\ 1R VWDWLVWLFDOO\ VLJQLILFDQW GLIIHUHQFH LQ RYHUDOO VXUYLYDO
EHWZHHQWKHWZRDUPVZDVGHPRQVWUDWHG,QSDWLHQWVZKRVHWXPRUVKDYHH[RQGHOHWLRQVRU
H[RQ/5VXEVWLWXWLRQPXWDWLRQVWKHPHGLDQ3)6ZDVPRQWKVLQWKHDIDWLQLEDUP
DQGPRQWKVLQWKHFKHPRWKHUDS\DUP
2I  HYDOXDEOH SDWLHQWV ZLWK 16&/& IURP SKDVH , WULDOV WKHUH KDYH EHHQ IRXU SDUWLDO
UHVSRQVHV35VFRQILUPHGDQGXQFRQILUPHG35UDQJLQJLQGXUDWLRQIURPPRQWKVWR
PRQWKV$OOSDWLHQWVZHUHQRQVPRNLQJ&DXFDVLDQVZLWKDGHQRFDUFLQRPDRIWKHOXQJ,QWZR
RI WKHVH WKUHH SDWLHQWV ZLWK FRQILUPHG 35 (*)5 VHTXHQFLQJ KDV VKRZQ H[RQ  LQIUDPH
GHOHWLRQV7KHVHSUHOLPLQDU\FOLQLFDOHIILFDF\GDWDVXJJHVWWKDW%,%:PD\EHHIILFDFLRXV
LQ SDWLHQWV ZLWK UHFXUUHQW 16&/& KDUERULQJ VHQVLWL]LQJ (*)5 PXWDWLRQV 7KH HIILFDF\ DQG
VDIHW\RI%,%:LQ16&/&LVEHLQJHYDOXDWHGLQDSKDVH,,WULDO,QWKLVWULDOSDWLHQWVZLWK
6WDJH,,,%,9OXQJDGHQRFDUFLQRPDZLWK(*)5PXWDWLRQLQH[RQVDQGIDLOXUHRIRQHOLQH
RIV\VWHPLFFKHPRWKHUDS\DUHWUHDWHG ZLWK %,%:DWDGRVHRIPJRQFHGDLO\XQWLO
GLVHDVHSURJUHVVLRQ3UHOLPLQDU\UHVXOWVRIWKHILUVWSDWLHQWVQHYHUVPRNHUH[VPRNHU
DQGFXUUHQWVPRNHUWUHDWHGLQWKHQGOLQHVHWWLQJKDYHVKRZQWXPRUVL]HUHGXFWLRQVLQ
WKHPDMRULW\RISDWLHQWVZLWKGLVHDVHFRQWUROUDWHRIDQGRYHUDOOUHVSRQVHUDWHRI
&,'LDUUKHDDQGVNLQUHODWHGDGYHUVHHYHQWVKDYHEHHQWKHPDLQ
VLGH HIIHFWV EXW KDYH EHHQ PDQDJHDEOH ZLWK DSSURSULDWH GRVH LQWHUUXSWLRQUHGXFWLRQ 3
7KLVWULDOKDVQRZEHHQDPHQGHGWRDOORZLQFOXVLRQRIFKHPRWKHUDS\QDwYHSDWLHQWV
$JOREDOUDQGRPL]HGSODFHERFRQWUROOHGGRXEOHEOLQGSKDVH,,,WULDO/8;/XQJLVRQHRI
VHYHUDOFXUUHQWO\RQJRLQJ3KDVH,,,WULDOVDQGLVDVVHVVLQJWKHHIILFDF\RIDIDWLQLESOXVEHVW
VXSSRUWLYH FDUH %6& ZKHQ FRPSDUHG WR SODFHER SOXV %6& LQ QRQVPDOO FHOO OXQJ FDQFHU
SDWLHQWVIDLOLQJHUORWLQLERUJHILWLQLE%DVHGRQWKHIDYRUDEOHSODQQHGLQWHULPDQDO\VLVRIVDIHW\
DQGHIILFDF\GHVFULEHGLQWKHSURWRFROWKHLQGHSHQGHQW'0&KDVDOORZHGIRUFRQWLQXDWLRQRI



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
WKHWULDO>@$GGLWLRQDO3KDVH,,,,,WULDOVDUHLQYHVWLJDWLQJDIDWLQLELQDGYDQFHGQRQVPDOOFHOO
OXQJFDQFHULQFOXGLQJ(*)5ZLOGW\SHDQGPXWDWLRQSRVLWLYHSRSXODWLRQV6HH7DEOH

)LJXUH/8;/XQJ
ZDVDUDQGRPL]HG
RSHQODEHOSKDVH,,,
WULDOZKLFK
GHPRQVWUDWHG
VXSHULRULW\RI%,%:
DIDWLQLERYHU
SHPHWUH[HGFLVSODWLQ
DVILUVWOLQHWUHDWPHQWIRU
SDWLHQWVZLWKDGYDQFHG
16&/&KDUERULQJ
(*)5PXWDWLRQV
-<DQJHWDO-&OLQ
2QFROVXSSO
DEVWU/%$

3KDUPDFRNLQHWLFV
3UHOLPLQDU\GDWDLQFOLQLFDOWULDOVLQGLFDWHWKDWDIDWLQLEZDVDEVRUEHGPRGHUDWHO\IDVWDIWHURUDO
DGPLQLVWUDWLRQ ZLWKPHGLDQWPD[YDOXHVDSSUR[LPDWHO\KRXUVDIWHUGUXJDGPLQLVWUDWLRQ,Q
JHQHUDO DIDWLQLE J0HDQ PD[LPXP SODVPD FRQFHQWUDWLRQV DQG H[SRVXUH LQFUHDVHG ZLWK
LQFUHDVLQJGRVHVDIWHUDVLQJOHGRVHDQGDWVWHDG\VWDWH+RZHYHUPRGHUDWHWRKLJKLQWHUDQG
LQWUDLQGLYLGXDOGLIIHUHQFHVLQSODVPDFRQFHQWUDWLRQVZHUHVHHQ$IDWLQLELVKLJKO\GLVWULEXWHG
RXWRIWKHEORRGDQGKDVDPRGHUDWHWRKLJKFOHDUDQFH7KHRYHUDOOJ0HDQWHUPLQDOKDOIOLIHDW
VWHDG\VWDWHZDVKRXUVLQFDQFHUSDWLHQWVDQGWRKRXUVLQKHDOWK\YROXQWHHUVDIWHU
VLQJOH GRVH DGPLQLVWUDWLRQ 6WHDG\ VWDWH ZDV UHDFKHG QR ODWHU WKDQ  GD\V DIWHU WKH ILUVW
DGPLQLVWUDWLRQ7KHPDMRUURXWHRIHOLPLQDWLRQRIDIDWLQLEZDVYLDWKHIHFHV$IWHUIRRGLQWDNHD
GHFUHDVHG V\VWHPLF H[SRVXUH ZDV REVHUYHG FRPSDUHG WR DGPLQLVWUDWLRQ RI DIDWLQLE XQGHU
IDVWHGFRQGLWLRQV7KH 3.FKDUDFWHULVWLFV LQ &DXFDVLDQFDQFHU SDWLHQWV ZHUHFRPSDUDEOHWR
WKRVH REVHUYHG LQ -DSDQHVH FDQFHU SDWLHQWV 7KH 3. FKDUDFWHULVWLFV LQ KHDOWK\ YROXQWHHUV
IROORZLQJVLQJOHGRVHZHUHFRPSDUDEOHWRWKRVHREVHUYHGLQFDQFHUSDWLHQWV,QDSRSXODWLRQ
3. DQDO\VLV LQ FDQFHU SDWLHQWV QR VWDWLVWLFDOO\ VLJQLILFDQW HIIHFW RI WKH FRYDULDWHV DOFRKRO
FRQVXPSWLRQVPRNLQJVWDWXVHWKQLFRULJLQFDQFHUW\SHDJHSUHVHQFHRIOLYHUPHWDVWDVHV
KHSDWLF LPSDLUPHQW RU OLYHU IXQFWLRQ SDUDPHWHUV DODQLQH WUDQVDPLQDVH $/7 DVSDUWDWH
WUDQVDPLQDVH$67WRWDOELOLUXELQ%,/DQGWRWDOSODVPDSURWHLQZDVREVHUYHG6WDWLVWLFDOO\
VLJQLILFDQWDOEHLWVPDOOLQFUHDVHVZHUHREVHUYHGIRUFRQFXUUHQWIRRGLQWDNHORZERG\ZHLJKW
(&2*SHUIRUPDQFHVFRUH!ORZFUHDWLQLQHFOHDUDQFHKLJKODFWDWHGHK\GURJHQDVHOHYHOV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
DQGIHPDOHJHQGHU1RQHRIWKHLQGLYLGXDOFRYDULDWHHIIHFWVUHVXOWHGLQDIUDFWLRQDOFKDQJHLQ
H[SRVXUH RI PRUH WKDQ  UHODWLYH WR WKH H[SRVXUH LQ D W\SLFDO SDWLHQW RI WKH DQDO\]HG
SRSXODWLRQ
$W UHODWLYHO\ KLJK FRQFHQWUDWLRQV DIDWLQLE LV D VXEVWUDWH DQG LQKLELWRU RI 3JS LQ SUHFOLQLFDO
PRGHOV %, SHUIRUPHG D 3KDVH , WULDO  DW WKH  PJ GRVH RI DIDWLQLE ZKLFK ZDV
GHVLJQHGWRGHWHUPLQHWKHPD[LPXPHIIHFWRISRWHQW3JSLQKLELWLRQE\ULWRQDYLURQWKH3.RI
DIDWLQLE7KHVWXG\VKRZVWKDWWKHUDWHDQGH[WHQWRIDEVRUSWLRQRIDIDWLQLEZDVLQFUHDVHGE\
FRWUHDWPHQWZLWKULWRQDYLU:KHQWDNHQLQFRPELQDWLRQZLWKULWRQDYLUWKHH[SRVXUHWRDIDWLQLE
LQFUHDVHG E\   DQG  IRU $8& $8&W] DQG &PD[ UHVSHFWLYHO\
7KHUHIRUH SDUWLFLSDQWV DUH H[FOXGHG ZKR DUH UHFHLYLQJ FRQFXUUHQW 3JS LQKLELWRUV 6HH
([FOXVLRQ&ULWHULD'DVDWLQLELVQRWD3JSLQKLELWRU%06,QYHVWLJDWRU¶VEURFKXUH

3KDVH,,,,,7ULDOV
7DEOH$IDWLQLE7ULDOVLQSDWLHQWVZLWK16&/&$GDSWHGIURP>@>@
7LWOH
3KDVH 7ULDOVWDWXV 'HVFULSWLRQ
3DWLHQWV 3ULPDU\
%,%:GRVH 5HI









/8;/XQJ,,E,,,
&RPSOHWHG
&KHPRDQG

26
PJ
>@ 





(*)57.,







SUHWUHDWHG





/8;/XQJ,,,
$QDO\VLV
&KHPRDQG

3,6DIHW\
PJ
>@ 




RQJRLQJ
(*)57.,

3,,255





SUHWUHDWHG





/8;/XQJ,,,
2QJRLQJ
%,%:
EH\RQG

3)6
PJ
>@






SURJUHVVLRQ





7ULDOVLQSDWLHQWVZKRVHWXPRUVKDUERU(*)5PXWDWLRQVILUVWOLQH











/8;/XQJ,,
$QDO\VLV
(*)5PXWDWLRQ 
255
RUPJ
>@ 




RQJRLQJ
SRVLWLYH







VW 	QGOLQH





/8;/XQJ,,,
&RPSOHWHG
(*)5PXWDWLRQ 
3)6
PJ
>@



SRVLWLYHVWOLQH




/8;̻ /XQJ

,,,
2QJRLQJ
(*)5PXWDWLRQ 
3)6
PJ
>@






SRVLWLYHVWOLQH




(*)5(*)UHFHSWRU2552EMHFWLYHUHVSRQVHUDWH262YHUDOOVXUYLYDO3)63URJUHVVLRQIUHHVXUYLYDO7.,7\URVLQH


NLQDVHLQKLELWRU








$IDWLQLE±&RPELQDWLRQ6SHFLILF6DIHW\0HDVXUHV
,QFOLQLFDOVWXGLHVDIDWLQLEKDVEHHQLQYHVWLJDWHGZLWKGRFHWD[HODWLWVFRPPRQO\XVHGGRVLQJ
UHJLPHQ7ULDOVDQG3.GDWDIURP7ULDOVXJJHVWWKDWWKHUH ZDVQR
LQIOXHQFHRIGD\VDGPLQLVWUDWLRQRIDIDWLQLEPJRQWKH3.RIGRFHWD[HOPJP,Q
DGGLWLRQ 3. GDWD IURP WULDO  GHPRQVWUDWHG WKDW WKHUH ZDV QR FOLQLFDOO\ UHOHYDQW



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
SKDUPDFRNLQHWLF LQWHUDFWLRQ REVHUYHG EHWZHHQ DIDWLQLE DQG GRFHWD[HO LQ WKH DSSOLHG GRVLQJ
VFKHGXOH
,Q7ULDODIDWLQLEZDVDGPLQLVWHUHGRQFHGDLO\DWDVWDUWLQJGRVHRIPJZKLFKZDV
UHGXFHG WR  PJ DQG ODWHU RQ WR  PJ SHU SURWRFRO DPHQGPHQWV RYHU UHSHDWHG GD\
WUHDWPHQW SHULRGV 73 FRQFRPLWDQWO\ ZLWK  PJ GDLO\ OHWUR]ROH 7KH 3. GDWD RI WKLV WULDO
VXJJHVWWKDWWKHUHZDVQRLQIOXHQFHRIDIDWLQLELQWKH3.RIOHWUR]ROHDQGYLFHYHUVD
6LQFHDIDWLQLEZDVIRXQGWREHD3JSVXEVWUDWHLQYLWUR%,SHUIRUPHGD3KDVH,WULDOLQ
KHDOWK\YROXQWHHUVWRDVVHVVWKHHIIHFWVRIWKHSRWHQW3JSLQKLELWRUULWRQDYLUGRVHPJELG
IRU  GD\V RQ WKH SKDUPDFRNLQHWLFV RI DIDWLQLE GRVH  PJ 7KH VWXG\ ZDV GHVLJQHG WR
GHWHUPLQHWKHPD[LPXPHIIHFWRI3JSLQKLELWLRQRQWKH3.RIDIDWLQLE7KHPHGLDQWPD[DQG
WHUPLQDO KDOIOLIH RI DIDWLQLE ZDV QRW DIIHFWHGKRZHYHU WKH UDWH DQG H[WHQW RI DEVRUSWLRQ RI
DIDWLQLE ZHUH LQFUHDVHG E\ FRWUHDWPHQW ZLWK ULWRQDYLU 7KH UHODWLYH ELRDYDLODELOLW\ RI DIDWLQLE
ZKHQWDNHQLQFRPELQDWLRQZLWKULWRQDYLU$8&$8&W]DQG&PD[LQFUHDVHGWR
 DQG  UHVSHFWLYHO\ 7KH LQFUHDVH LQ UDWH DQG H[WHQW RI DIDWLQLE XSRQ FR
DGPLQLVWUDWLRQRIWKH3JSDQG&<3$LQKLELWRUULWRQDYLUZLWKRXWDSSDUHQWHIIHFWRQPHGLDQ
WPD[GLVWULEXWLRQDQGHOLPLQDWLRQRIDIDWLQLESRLQWWRDQLPSDFWRIULWRQDYLURQ3JSPHGLDWHG
WUDQVSRUWSURFHVVHVGXULQJWKHDEVRUSWLRQSKDVHRIDIDWLQLE6LQFHSUHYLRXVVWXGLHVUHYHDOHG
WKDWHVSHFLDOO\&<3$HQ]\PHFDWDO\]HGPHWDEROLFUHDFWLRQVSOD\DVXERUGLQDWHUROHIRUWKH
PHWDEROLVP RI DIDWLQLE LQ YLYR WKH LQFUHDVH LQ WKH H[SRVXUH RI DIDWLQLE LQ WKH SUHVHQFH RI
ULWRQDYLUFDQEHDWWULEXWHGPRVWOLNHO\WRLQKLELWLRQRI3JSPHGLDWHGWUDQVSRUWSURFHVVHVGXULQJ
WKHDEVRUSWLRQSKDVHRIDIDWLQLE

&RQFOXVLRQV)URP3KDUPDFRNLQHWLFVLQ+XPDQV
$IDWLQLE H[KLELWHG DW OHDVW ELH[SRQHQWLDO GLVSRVLWLRQ NLQHWLFV $IWHU RUDO DGPLQLVWUDWLRQ PHGLDQ
WPD[YDOXHVZHUHDWKRXUVIRUVLQJOHGRVHDVZHOODVIRUVWHDG\VWDWHLQFDQFHUSDWLHQWV
6WHDG\VWDWHZDVUHDFKHGZLWKLQGD\VDIWHUWKHILUVWDGPLQLVWUDWLRQ$KLJKDSSDUHQWYROXPHRI
GLVWULEXWLRQGXULQJWKHWHUPLQDOSKDVHDQGDPRGHUDWHWRKLJKDSSDUHQWWRWDOERG\FOHDUDQFHIRU
DIDWLQLE KDV EHHQ FDOFXODWHG 7KH YDOXHV REWDLQHG IRU WRWDO ERG\ FOHDUDQFH DQG YROXPH RI
GLVWULEXWLRQ VKRXOG EH LQWHUSUHWHG ZLWK FDXWLRQ DV WKH DEVROXWH ELRDYDLODELOLW\ RI DIDWLQLE LQ
KXPDQVLV\HWXQNQRZQ7KHRYHUDOOJ0HDQWHUPLQDOKDOIOLIHDWVWHDG\VWDWHZDVKRXUVLQ
FDQFHUSDWLHQWVDQGWRKRXUVLQKHDOWK\YROXQWHHUVDIWHUVLQJOHGRVHDGPLQLVWUDWLRQ7KH
RYHUDOO J0HDQ DFFXPXODWLRQ UDWLRV IRU DIDWLQLE ZHUH  EDVHG RQ $8& DQG  EDVHG RQ
&PD[0RGHUDWHWRKLJKLQWHUSDWLHQWYDULDELOLW\LQDOODIDWLQLE3.SDUDPHWHUVZDVGHWHFWHG7KH
3. FKDUDFWHULVWLFV LQ &DXFDVLDQ FDQFHU SDWLHQWV ZHUH FRPSDUDEOH WR WKRVH REVHUYHG LQ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
-DSDQHVH FDQFHU SDWLHQWV 7KH 3. FKDUDFWHULVWLFV LQ KHDOWK\ YROXQWHHUV IROORZLQJ VLQJOH GRVH
ZHUHFRPSDUDEOHWRWKRVHREVHUYHGLQFDQFHUSDWLHQWV>@
$IDWLQLEPD[LPXPSODVPDFRQFHQWUDWLRQVDQGH[SRVXUHZHUHIRXQGWRLQFUHDVHPRUHWKDQGRVH
SURSRUWLRQDOO\LQKHDOWK\YROXQWHHUVGRVHUDQJHWRPJ$IDWLQLEGLVSOD\HGDIRRGHIIHFW
ZLWKDGHFUHDVHGV\VWHPLFH[SRVXUHLQWKHIHGVWDWHFRPSDUHGWRDGPLQLVWUDWLRQRIDIDWLQLEXQGHU
IDVWHGFRQGLWLRQV7KHPDMRUURXWHRIHOLPLQDWLRQRIWRWDO>&@UDGLRDFWLYLW\ZDVYLDWKHIHFHV
7KHFRQWULEXWLRQRIUHQDOH[FUHWLRQWRWKHWRWDOFOHDUDQFHZDVORZ7KHRYHUDOO
UHFRYHU\ RI >&@UDGLRDFWLYLW\ ZDV  DQG FDQ WKHUHIRUH EH UHJDUGHG DV FRPSOHWH PDVV
EDODQFH 7KH FRDGPLQLVWUDWLRQ RI WKH SRWHQW 3JS LQKLELWRU ULWRQDYLU LQFUHDVHG WKH $8&
$8&W]DQG&PD[RIDIDWLQLEWRDQGUHVSHFWLYHO\
,QDSRSXODWLRQ3.DQDO\VLVLQFDQFHUSDWLHQWVQRVWDWLVWLFDOO\VLJQLILFDQWHIIHFWRIWKHFRYDULDWHV
DOFRKRO FRQVXPSWLRQ VPRNLQJ VWDWXV HWKQLF RULJLQ FDQFHU W\SH DJH SUHVHQFH RI OLYHU
PHWDVWDVHV KHSDWLF LPSDLUPHQW RU OLYHU IXQFWLRQ SDUDPHWHUV DODQLQH WUDQVDPLQDVH $/7
DVSDUWDWH WUDQVDPLQDVH $67 WRWDO ELOLUXELQ %,/ DQG WRWDO SODVPD SURWHLQ ZDV REVHUYHG
6WDWLVWLFDOO\ VLJQLILFDQW HIIHFWV ZHUH REVHUYHG IRU FRQFXUUHQW IRRG LQWDNH ERG\ ZHLJKW (&2*
SHUIRUPDQFHVFRUHFUHDWLQLQHFOHDUDQFHODFWDWHGHK\GURJHQDVHOHYHOVDQGJHQGHUVPDOOHIIHFW
VL]H
6LQFHDIDWLQLELVQHLWKHUDQLQKLELWRUQRUPDMRUVXEVWUDWHRI&<3$LWLVQRWH[SHFWHGWRDOWHUWKH
SKDUPDFRNLQHWLFV RI GDVDWLQLE 6LQFH GDVDWLQLE LV QHLWKHU DQ LQKLELWRU LQGXFHU RU VXEVWUDWH RI
3JSLWLVQRWH[SHFWHGWRDOWHUWKHSKDUPDFRNLQHWLFVRIDIDWLQLE

$IDWLQLE)RUPXODWLRQ
7KH RUDO WDEOHWV DUH FRQYHQWLRQDO LPPHGLDWHUHOHDVH WDEOHWV FRQWDLQLQJ DIDWLQLE DV WKH
K\GURFKORULGH VDOW  7KH DYDLODEOH GRVH VWUHQJWKV  PJ  PJ DQG  PJ ILOPFRDWHG
LPPHGLDWHUHOHDVHWDEOHWVDUHSUHSDUHGLQDFRPPRQEOHQGZLWKKLJKHUGUXJORDGSHUWDEOHWV
$FRORUVFKHPHZDVHVWDEOLVKHGWRGLVWLQJXLVKEHWZHHQWKHGRVHVDQGWDEOHWVL]HV7KHPJ
ILOPFRDWHGWDEOHWVDUHOLJKWEOXHDQGRIURXQGELFRQYH[EHYHOHGJHGVKDSHZLWKDGLDPHWHURI
DSSUR[LPDWHO\PPDQGPPUHVSHFWLYHO\7KHILOPFRDWHGPJWDEOHWVDUHGDUNEOXH
7KHPJILOPFRDWHGWDEOHWVDUHDVZHOOURXQGELFRQYH[EHYHOHGJHGVKDSHZLWKDGLDPHWHU
RIDSSUR[LPDWHO\PP7KHPJILOPFRDWHGWDEOHWVDUHOLJKWEOXHURXQGELFRQYH[EHYHO
HGJHGVKDSHZLWKDGLDPHWHURIDSSUR[LPDWHO\PP$OOGRVHVDUHHLWKHURQHVLGHGHPERVVHG
ZLWKWKH%RHKULQJHU,QJHOKHLPORJRRUGRXEOHVLGHGHPERVVHGZLWKWKH%RHKULQJHU,QJHOKHLP
ORJRRQRQHVLGHDQGDFRPELQDWLRQRIWKHOHWWHU³7´ZLWKWKHGRVHVWUHQJWKRQWKHRWKHUVLGH
)RUWULDOWDEOHWVSHFLILFDWLRQVVHH3URGXFW,GHQWLILFDWLRQ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

'RVDJH$GPLQLVWUDWLRQDQG6WRUDJH
$IDWLQLEZLOOEHVHOIDGPLQLVWHUHGLQDQRSHQODEHOXQEOLQGHGPDQQHUWRDOOSDWLHQWVHQUROOHGLQ
WKH VWXG\ 'XULQJ WKH WUHDWPHQW SHULRG SDWLHQWV ZLOO UHFHLYH VLQJOHDJHQW $IDWLQLE  7DEOHWV
VKRXOGEHWDNHQDWWKHVDPHWLPHHDFKGD\ZLWKP/RIZDWHUDWOHDVWKRXUEHIRUHRU
KRXUV DIWHU DPHDO 3DWLHQWV ZKR DUH XQDEOH WR VZDOORZ WDEOHWV PD\ GLVVROYH WKH WDEOHWV LQ
GLVWLOOHGZDWHUIRUDGPLQLVWUDWLRQ
$IDWLQLE WDEOHWV ZLOO EH VXSSOLHG IRU FOLQLFDO WULDOV LQ ZKLWH KLJKGHQVLW\ SRO\HWK\OHQH +'3(
ERWWOHVZLWKFKLOGUHVLVWDQWFORVXUHVDQGVKRXOGEHVWRUHGDWWHPSHUDWXUHVEHWZHHQ&DQG
&)DQG)%DVHGRQPRQWKVVWDELOLW\GDWDIRUWKHPJDQGPJGRVDJH
VWUHQJWKRIWKHQHZO\DYDLODEOHILOPFRDWHGWDEOHWLQ+'3(ERWWOHVZLWKGHVLFFDQWDW&
5+&5+DQG&5+DSUHOLPLQDU\VKHOIOLIHRIPRQWKVKDVEHHQDVVLJQHG
IRUDOOWKHGRVDJHVWUHQJWKVLQDOOFOLPDWLF]RQHV6WRUDJHVWDWHPHQWVIRUFOLPDWLF]RQHV,,,ZLOO
EH³'RQRWVWRUHDERYH&´IRUFOLPDWLF]RQHV,,,,9WKHVWDWHPHQWZLOOUHDG³'RQRWVWRUH
DERYH&´)RUDOOFOLPDWLF]RQHVVWDWHPHQWVZLOOEH³6WRUHLQWKHRULJLQDOSDFNDJHLQRUGHU
WRSURWHFWIURPOLJKW´DQG³.HHSWKHERWWOHWLJKWO\FORVHGLQRUGHUWRSURWHFWIURPPRLVWXUH´
6HH+DQGOLQJDQG'LVSHQVLQJ

678'<'(6,*1

2YHUYLHZ
3DWLHQWV ZLWK KLVWRORJLFDOO\ SURYHQ XQUHVHFWDEOH VWDJH ,,,% ,9 16&/& DQG DQ (DVWHUQ
&RRSHUDWLYH *URXS (&2* SHUIRUPDQFH VWDWXV RI  DUH HOLJLEOH :LWK WKH H[FHSWLRQ RI
70PXWDWLRQSRVLWLYHWXPRUVSDUWLFLSDQWVPXVWKDYHUHODSVHGRUEHHQUHIUDFWRU\WRDWOHDVW
RQH OLQH RI SULRU V\VWHPLF WUHDWPHQW 6HH ,QFOXVLRQ &ULWHULD 3DWLHQWV DUH UHTXLUHG WR KDYH
DGHTXDWHKHPDWRORJLFKHSDWLFDQGUHQDOIXQFWLRQDQGKDYHUHODSVHGDIWHUDWOHDVWRQHSULRU
FKHPRWKHUDS\UHJLPHQIRUUHFXUUHQWRUPHWDVWDWLFGLVHDVH3DWLHQWVPXVWJLYHZULWWHQLQIRUPHG
FRQVHQW 7KH 6FLHQWLILF 5HYLHZ &RPPLWWHH RI WKH 0RIILWW &DQFHU &HQWHU DQG ,QVWLWXWLRQDO
5HYLHZ %RDUG PXVW DSSURYH WKH VWXG\ VHH 0RQLWRULQJ ZKLFK ZLOO EH FRQGXFWHG LQ
DFFRUGDQFHZLWKIHGHUDODQGLQVWLWXWLRQDOJXLGHOLQHV
7KLVLVDGXDODJHQWRSHQODEHOSKDVH,VWXG\(OLJLEOHSDWLHQWVZLOOEHHQUROOHGDQGWUHDWHG
DFFRUGLQJWRWKHVFKHPDRXWOLQH7KUHHSDWLHQWV ZLOOEHWUHDWHGSHUFRKRUWIRURQHF\FOH
GD\VSHUF\FOH,IQR'/7VDUHUHFRUGHGWUHDWPHQWZLOOFRQWLQXHDQGWKUHHDGGLWLRQDOSDWLHQWV
ZLOOEHWUHDWHGLQWKHVXEVHTXHQWFRKRUW+RZHYHULIDSDWLHQWGHYHORSVD'/7DQRWKHUWKUHH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
SDWLHQWVZLOOEHWUHDWHGLQWKLVFRKRUWIRURQHF\FOH,IWKHUHDUHQRPRUH'/7VGRVHHVFDODWLRQ
ZLOOFRQWLQXH,IPRUHWKDQRQHRIWKUHHSDWLHQWVGHYHORSVD'/7LQDQ\FRKRUWDQRWKHUWKUHH
SDWLHQWVZLOOEHWUHDWHGLQWKHQH[WORZHUGRVDJHFRKRUW1RLQWUDSDWLHQWGRVHHVFDODWLRQZLOOEH
SHUPLWWHG7R[LFLW\ZLOOEHJUDGHGDFFRUGLQJWRWKH1DWLRQDO&DQFHU,QVWLWXWH &RPPRQ7R[LFLW\
&ULWHULD1&,&7&YHUVLRQKWWSFWHSFDQFHUJRYIRUPV&7&$(YSGI
7KHPD[LPXPWROHUDWHGGRVH07'IRUWKLVFRPELQHGWUHDWPHQWZLOOEHGHILQHGDVHLWKHU
WKHKLJKHVWGRVDJHFRKRUWLQZKLFKVL[SDWLHQWVKDGEHHQWUHDWHGDQGWKHUHZHUH
OHVVWKDQWZR'/7VRU
$IDWLQLEDW WKHKLJKHVWWROHUDWHGGRVHLQYHVWLJDWHGPJ32GDLO\SOXVGDVDWLQLEDW
WKHKLJKHVWWROHUDWHGGRVHLQYHVWLJDWHGFRKRUWPJ32GDLO\
7KHQWZHQW\DGGLWLRQDOSDWLHQWVWRWDO ZLOOEHWUHDWHGLQD3KDVH,%H[WHQVLRQJURXSDWWKH
07' WR FRQILUP WROHUDELOLW\ DQG GHWHUPLQH WKH VHFRQGDU\ HQGSRLQW RI D SUHOLPLQDU\ FOLQLFDO
HIILFDF\VLJQDO
7XPRUVL]HZLOOEHDVVHVVHGYLDFRPSXWHGWRPRJUDSK\HYHU\rGD\V0RGLILHG5HVSRQVH
(YDOXDWLRQ&ULWHULDLQ6ROLG7XPRUV5(&,67YZLOOEHXVHGWRGHWHUPLQHWXPRUUHVSRQVH
DQGGLVHDVHSURJUHVVLRQ6HH3KDVH,$DQG3KDVH,%6WXG\FDOHQGDUV

6(/(&7,212)3$7,(176

,QFOXVLRQ&ULWHULD
>@ 3DWKRORJLFDOO\ RU F\WRORJLFDOO\ GRFXPHQWHG 6WDJH ,,,%,9 QRQVPDOO FHOO OXQJ FDQFHU RU
XQUHVHFWDEOHUHFXUUHQWGLVHDVHIROORZLQJORFRUHJLRQDOWUHDWPHQW
>@)RU3KDVH,%([WHQVLRQ2QO\
>@(LWKHURUERWKRIWKHIROORZLQJ
D$WXPRUZKLFKKDUERUVDQDFWLYDWLQJ(SLGHUPDO*URZWK)DFWRU5HFHSWRU
(*)5PXWDWLRQ
E+LVWRU\RIREMHFWLYHUHVSRQVHRUVWDEOHGLVHDVHIRUDWOHDVWPRQWKVDIWHU
WUHDWPHQWZLWKHUORWLQLEDIDWLQLERUJHILQLWLE
>@(LWKHURUERWKRIWKHIROORZLQJ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
D3URJUHVVLRQRUUHFXUUHQFHRIGLVHDVHDIWHUUHFHLYLQJSULRUFRQWLQXRXVJHILQLWLE
DIDWLQLERUHUORWLQLE
E$WXPRUNQRZQWRKDUERUDGHQRYR70PXWDWLRQZKLFKLVNQRZQWR
FRQIHU(*)57.,UHVLVWDQFH
>@3DUWLFLSDQWVDUHDOORZHGWRKDYHUHFHLYHGV\VWHPLFFKHPRWKHUDS\RU
LQYHVWLJDWLRQDOWKHUDS\LQWKHLQWHUYHQLQJSHULRGSULRUWRWULDOHQUROOPHQW
>@&DSDEOHRIJLYLQJZULWWHQLQIRUPHGFRQVHQW
>@(YDOXDEOHGLVHDVHDVIROORZV
D)RU3KDVH,$'RVH(VFDODWLRQ+DYHWKHSUHVHQFHRIDQ\HYDOXDEOHGLVHDVH
LQFOXGLQJERQHPHWDVWDVHVHIIXVLRQRUF\VWLFPHWDVWDVHV
E)RU3KDVH,%([WHQVLRQ2QO\+DYHSURJUHVVLYHDQGPHDVXUDEOHGLVHDVHDVGHILQHG
E\WKH5HVSRQVH(YDOXDWLRQ&ULWHULDLQ6ROLG7XPRUV5(&,67Y
>@5HSURGXFWLYHSRWHQWLDOPXVWEHHLWKHUWHUPLQDWHGE\VXUJHU\UDGLDWLRQRUPHQRSDXVHRU
DWWHQXDWHGE\WKHXVHRIDQDSSURYHGFRQWUDFHSWLYHPHWKRGGXULQJDQGIRUWR
PRQWKVIROORZLQJWKHVWXG\
>@$UHDWOHDVW\HDUVRIDJH
>@3DWLHQWDJUHHVWKDW,9ELVSKRVSKRQDWHVZLOOEHZLWKKHOGGXULQJWKHILUVWZHHNVRIGDVDWLQLE
WKHUDS\GXHWRULVNRIK\SRFDOFHPLD
>@+DYHUHFRYHUHGIURPSULRUGUXJUHODWHGWR[LFLW\WR*UDGH&7&$(YZLWKLQGD\VRI
LQLWLDWLRQRIRQVWXG\WUHDWPHQW
>@(&2*SHUIRUPDQFHVWDWXVRIRUDWLQLWLDOHQUROOPHQWDVDVVHVVHGE\FOLQLFLDQRU
LQYHVWLJDWRU

([FOXVLRQ&ULWHULD
>@+DYHSUHYLRXVO\FRPSOHWHGRUZLWKGUDZQIURPWKLVVWXG\RUDQ\RWKHUVWXG\LQYHVWLJDWLQJ
GDVDWLQLE3ULRUWUHDWPHQWZLWKRWKHUW\URVLQHNLQDVHVLQFOXGLQJDIDWLQLELVDFFHSWDEOH
>@3ULRUUHFHQWV\VWHPLFRULQYHVWLJDWLRQDOWKHUDS\ZLWKLQGD\VRILQLWLDWLRQRIVWXG\
WUHDWPHQW$QH[FHSWLRQLVWKDW(*)5LQKLELWRUPD\EHFRQWLQXHGXSXQWLOGD\VRI
LQLWLDWLRQRIVWXG\WUHDWPHQW>@
>@:RPHQZKRDUHSUHJQDQWRUEUHDVWIHHGLQJ:RPHQRIFKLOGEHDULQJSRWHQWLDOPXVWKDYHD
QHJDWLYHSUHJQDQF\WHVWȕ+&*WHVWLQXULQHRUVHUXPSULRUWRFRPPHQFLQJVWXG\
WUHDWPHQW



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
>@3DWLHQWVZLWKGRFXPHQWHGFHQWUDOQHUYRXVV\VWHPRUOHSWRPHQLQJHDOPHWDVWDVLVEUDLQ
PHWDVWDVLVDWWKHWLPHRIVWXG\HQWU\3DWLHQWVZLWKSULRUEUDLQPHWDVWDVLVPD\EH
FRQVLGHUHGLIWKH\KDYHFRPSOHWHGWKHLUWUHDWPHQWIRUEUDLQPHWDVWDVLVDQGQRORQJHU
UHTXLUHFRUWLFRVWHURLGV
>@3DWLHQWVZLWKGLVHDVHSURJUHVVLRQLQWKH&16RQO\
>@6HULRXVFRQFRPLWDQWGLVRUGHULQFOXGLQJDFWLYHEDFWHULDOIXQJDORUYLUDOLQIHFWLRQ
LQFRPSDWLEOHZLWKWKHVWXG\DWWKHGLVFUHWLRQRIWKHSULQFLSDOLQYHVWLJDWRU
>@ 8QFRUUHFWHG VHYHUH HOHFWURO\WH GLVRUGHU LQFOXGLQJ VHYHUH SRWDVVLXP   P(T/ RU
PDJQHVLXPP(T/GHILFLHQF\
>@$Q\JDVWURLQWHVWLQDOGLVRUGHUZLWKGLDUUKHDDVDPDMRUV\PSWRPVXFKDV&URKQ¶VRUSUH
H[LVWLQJFKURQLFGLDUUKHD&7&*UDGHRIDQ\HWLRORJ\,QFOXGHGDUHPDODEVRUSWLRQ
GLVRUGHUVWKDWLQWKHRSLQLRQRIWKHVWXG\SK\VLFLDQPD\DIIHFWDEVRUSWLRQRIHLWKHU
DIDWLQLERUGDVDWLQLE
>@3ULRUPDMRUVXUJHU\RUUDGLDWLRQWKHUDS\ZLWKLQGD\VRILQLWLDWLRQRIWUHDWPHQW
>@(OHFWURFDUGLRJUDP(&*DEQRUPDOLWLHVLQGLFDWLYHRIDUUK\WKPLDDWWKHGLVFUHWLRQRIWKH
LQYHVWLJDWRU
>@+LVWRU\RUSUHVHQFHRIFOLQLFDOO\UHOHYDQWFDUGLRYDVFXODUDEQRUPDOLWLHVVXFKDV
XQFRQWUROOHGK\SHUWHQVLRQFRQJHVWLYHKHDUWIDLOXUH1<+$FODVVLILFDWLRQRIXQVWDEOH
DQJLQDRUSRRUO\FRQWUROOHGDUUK\WKPLD0\RFDUGLDOLQIDUFWLRQZLWKLQPRQWKVSULRUWR
HQUROOPHQW
>@%DVHOLQHPRQWKEHIRUHWUHDWPHQWFDUGLDFOHIWYHQWULFXODUIXQFWLRQZLWKUHVWLQJHMHFWLRQ
IUDFWLRQRIOHVVWKDQPHDVXUHGE\PXOWLJDWHGEORRGSRROLPDJLQJRIWKHKHDUW
08*$VFDQRUHFKRFDUGLRJUDP
>@$Q\KLVWRU\RIFOLQLFDOO\VLJQLILFDQWYHQWULFXODUDUUK\WKPLDVVXFKDVYHQWULFXODUWDFK\FDUGLD
YHQWULFXODUILEULOODWLRQFRQJHQLWDOORQJ47V\QGURPHRU7RUVDGHVGHSRLQWHV
>@3URORQJHG47FLQWHUYDORQSUHHQWU\HOHFWURFDUGLRJUDP!PVHFIRUPHQDQG!
PVHFIRUZRPHQSHU$+$$&&VFLHQWLILFVWDWHPHQW>@
>@+LVWRU\RIVLJQLILFDQWEOHHGLQJGLVRUGHUXQUHODWHGWRFDQFHULQFOXGLQJGLDJQRVHGFRQJHQLWDO
EOHHGLQJGLVRUGHUVHJYRQ:LOOHEUDQG¶VGLVHDVH
>@3DWLHQWVFXUUHQWO\WDNLQJGUXJVWKDWDUHJHQHUDOO\DFFHSWHGWRKDYHDKLJKULVNRIFDXVLQJ
7RUVDGHVGH3RLQWHVLQFOXGLQJTXLQLGLQHSURFDLQDPLGHGLVRS\UDPLGHDPLRGDURQH
VRWDOROLEXWLOLGHGRIHWLOLGHHU\WKURP\FLQVFODULWKURP\FLQFKORUSURPD]LQHKDORSHULGRO
PHVRULGD]LQHWKLRULGD]LQHSLPR]LGHFLVDSULGHEHSULGLOGURSHULGROPHWKDGRQH
DUVHQLFFKORURTXLQHGRPSHULGRQHKDORIDQWULQHOHYRPHWKDG\OSHQWDPLGLQH
VSDUIOR[DFLQOLGRIOD]LQHUDQR]DOLQHDQG6W-RKQ¶VZRUW
>@3DWLHQWVZLWKSUHH[LVWLQJLQWHUVWLWLDOOXQJGLVHDVH,/'RUSHULFDUGLDOSOHXUDOHIIXVLRQRI
JUDGHRUKLJKHU7UDFHSHULFDUGLDORUSOHXUDOHIIXVLRQLVDFFHSWDEOH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
>@3DWLHQWVZKRUHTXLUHFKURQLFR[\JHQWKHUDS\IRUFKURQLFREVWUXFWLYHSXOPRQDU\GLVHDVHRU
SOHXUDOHIIXVLRQVPDOLJQDQWRUEHQLJQ
>@3DWLHQWVUHTXLULQJFRPHGLFDWLRQZLWKSRWHQW3JSLQKLELWRUVLQFOXGLQJF\FORVSRULQ
D]LWKURP\FLQHU\WKURP\FLQNHWRFRQD]ROHLWUDFRQD]ROHTXLQLGLQHSKHQREDUELWDOVDOW
ZLWKTXLQLGLQHULWRQDYLUYDOVSRGDUYHUDSDPLORULQGXFHUVLQFOXGLQJULIDPSLFLQ
>@.QRZQDFWLYHKHSDWLWLV%LQIHFWLRQNQRZQDFWLYHKHSDWLWLV&LQIHFWLRQRUNQRZQ+,9
FDUULHU
>@.QRZQRUVXVSHFWHGDFWLYHGUXJRUDOFRKRODEXVH
>@.QRZQK\SHUVHQVLWLYLW\WRDIDWLQLEGDVDWLQLERUWKHH[FLSLHQWVRIDQ\RIWKHWULDOGUXJV
>@/DERUDWRU\H[FOXVLRQFULWHULD
$EVROXWHQHXWURSKLOFRXQW$1&PP
3ODWHOHWFRXQWPP6HUXPFUHDWLQLQHWLPHVWKHXSSHUQRUPDOOLPLWRU
FDOFXODWHGPHDVXUHGFUHDWLQLQH&OHDUDQFHP/PLQ
7RWDOELOLUXELQPJG/!PRO/6,XQLWHTXLYDOHQW
$VSDUWDWHDPLQRWUDQVIHUDVH$67RU$ODQLQHDPLQRWUDQVIHUDVH$/7WKUHHWLPHVWKH
XSSHUOLPLWRIQRUPDOLIUHODWHGWROLYHUPHWDVWDVHVILYHWLPHVWKHXSSHUOLPLWRIQRUPDO

75($70(176

6WXG\&DOHQGDU±VHH6WXG\&DOHQGDU VHFWLRQ
1RWHV
x
3K\VLFDOH[DPLQDWLRQLQFOXGHVFRPSOHWHYLWDOVLJQVEORRGSUHVVXUHKHDUWUDWH
UHVSLUDWLRQUDWHWHPSHUDWXUHKHLJKWDQGZHLJKWDQG(&2*SHUIRUPDQFHVWDWXV
x
$SK\VLFLDQ+	3PXVWEHSHUIRUPHGZLWKLQGD\VRIHQUROOPHQW
x
&03 $67$/7DONDOLQHSKRVSKDWDVHWRWDOELOLUXELQDOEXPLQWRWDOSURWHLQXUHD
FUHDWLQLQHHOHFWURO\WHVJOXFRVHDQGFDOFLXP0DJ PDJQHVLXP
x
%+&*LQZRPHQRIFKLOGEHDULQJSRWHQWLDO
x
3ODVPDVDPSOHVDUHIRUIXWXUHH[SORUDWRU\UHWURVSHFWLYHVWXGLHVRQO\
x
6FDQVIRUEDVHOLQHWXPRUHYDOXDWLRQVKRXOGEHSHUIRUPHGZLWKLQGD\VSULRUWR
HQUROOPHQW



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
x
5HVSRQVHHYDOXDWLRQFDQEHSHUIRUPHGRQ&\FOH'D\rGD\VIRUSDWLHQWV
FRQWLQXLQJRQVWXG\SDVWF\FOHDVVHVVPHQWVRIUHVSRQVHZLOORFFXUHYHU\RWKHUF\FOH
'D\rGD\V
x
/9()DVVHVVPHQWZLOOFRQWLQXHHYHU\PRQWKVGD\VZKLOHRQDIDWLQLEWKHUDS\XQWLO
RQH\HDUGD\VDIWHULQLWLDWLRQRIVWXG\GUXJ

7UHDWPHQWV$GPLQLVWHUHG

6FUHHQLQJ(YDOXDWLRQ
3ULRUWRWKHUHJLVWUDWLRQDWVWXG\HQWU\DOOSDWLHQWVPXVWKDYHJLYHQZULWWHQLQIRUPHGFRQVHQWIRU
WKHVWXG\DQGPXVWKDYHFRPSOHWHGWKHSUHVWXG\HYDOXDWLRQV3DWLHQWVPXVWPHHWDOORIWKH
HOLJLELOLW\UHTXLUHPHQWVOLVWHG7KHIROORZLQJLVUHTXLUHGDVSDUWRIVWXG\VFUHHQLQJ
&RPSOHWHPHGLFDOKLVWRU\LQFOXGLQJGDWHVDQGGHVFULSWLRQRILQLWLDOGLDJQRVLVRI16&/&DQG
GRFXPHQWDWLRQRIDQ\SUHYLRXVWUHDWPHQWIRUFDQFHUFKHPRWKHUDS\VXUJHU\DQGRUUDGLDWLRQ
$Q\RQJRLQJDGYHUVHHYHQWVUHVXOWLQJIURPSULRUFDQFHUWKHUDSLHVUDGLRWKHUDS\VXUJHU\HWF
ZLOOEHUHFRUGHGZLWKLQGD\VEHIRUHHQUROOPHQWXVLQJWKH1&,&7&$(9HUVLRQ
([SDQGHG&RPPRQ7R[LFLW\&ULWHULD9HUVLRQDVZHOODVWXPRUUHODWHGVLJQVDQG
V\PSWRPV
$FRPSOHWHSK\VLFDOH[DPLQDWLRQLVUHTXLUHGSHUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW
LQFOXGLQJEXWQRWOLPLWHGWRYLWDOVLJQVKHLJKWZHLJKW(&2*3HUIRUPDQFH6WDWXVDQGLI
DSSOLFDEOHDQ\REVHUYDEOHWXPRUPHDVXUHPHQWV
&OLQLFDOODERUDWRU\WHVWLQJ&%&ZLWKGLIIHUHQWLDODQGSODWHOHWFRXQWWRWDOSURWHLQWRWDOVHUXP
ELOLUXELQDONDOLQHSKRVSKDWDVH$676*27$/76*37VHUXPFUHDWLQLQHVHUXP
HOHFWURO\WHVVHUXPJOXFRVHVHUXPXUHDVHUXPFDOFLXPVHUXPPDJQHVLXPDQGVHUXP
DOEXPLQDUHUHTXLUHGSHUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW$SUHJQDQF\WHVWIRU
IHPDOHSDWLHQWVRIFKLOGEHDULQJSRWHQWLDOLVUHTXLUHG
6HUXPPDJQHVLXPLVUHTXLUHGGXHWRSRWHQWLDOULVNRIK\SRPDJQHVDHPLDIURPGLDUUKHD
$VFUHHQLQJ(.*LVUHTXLUHG7KLVVKRXOGEHSHUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW
$VFUHHQLQJ08*$RU(&+2LVUHTXLUHG7KLVVKRXOGEHSHUIRUPHGZLWKLQGD\VSULRUWR
HQUROOPHQW /9()DVVHVVPHQWZLOOFRQWLQXHHYHU\PRQWKVGD\VZKLOHRQDIDWLQLE WKHUDS\
XQWLORQH\HDUGD\VDIWHULQLWLDWLRQRIVWXG\GUXJ
7XPRUHYDOXDWLRQ$SSURSULDWHFOLQLFDOWHVWLQJZLOOEHXVHGWRHYDOXDWHDOONQRZQVLWHVRI
PDOLJQDQWOHVLRQVLQFOXGLQJ&7VRIWKHFKHVWDQGXSSHUDEGRPHQLQFOXGLQJWKHDGUHQDO
JODQGVXOWUDVRXQGRUUDGLRQXFOLGHVFDQVRIWKHERQHVDQGRURWKHUUDGLRJUDSKLFVWXGLHV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
VKRXOGEHSHUIRUPHGZLWKLQGD\VSULRUWRHQUROOPHQW7RHQVXUHFRPSDUDELOLW\WKHEDVHOLQH
VFDQVDQGVXEVHTXHQWVFDQVXVHGWRDVVHVVUHVSRQVHPXVWEHSHUIRUPHGXVLQJLGHQWLFDO
WHFKQLTXHV)RU3KDVH,%H[WHQVLRQFRKRUWOHVLRQVPXVWEHPHDVXUDEOHDQGHYDOXDEOHE\
PRGLILHG5(&,67FULWHULD

&\FOH
&' 3DWLHQWV ZLOO KDYH &%& &03 PDJQHVLXP RQ GD\  EHIRUH DGPLQLVWUDWLRQ RI VWXG\
GUXJV$Q\UHVLGXDOWR[LFLW\IURPSULRUWKHUDS\IRUFDQFHUZLOOEHUHFRUGHG%ORRGZLOOEH
GUDZQ IRU DVVHVVPHQW RI VHUXP PDUNHUV 7KH SDWLHQW ZLOO EHJLQ DIDWLQLE DW WKH DSSURSULDWH
FRKRUWGRVHVWDUWLQJ&'RQDGDLO\EDVLV)RU3KDVH,%WKHSDWLHQWZLOOEHJLQDIDWLQLEDQG
GDVDWLQLEFRQFXUUHQWO\
&' 3KDVH ,$ RQO\ 7R[LFLW\ RI DIDWLQLE ZLOO EH DVVHVVHG  3DWLHQWV VWDUW GDVDWLQLE 7KH
SDWLHQWZLOOWDNHDIDWLQLEDQGGDVDWLQLEWDEOHWVE\PRXWKDQGZLOOFRQWLQXHWRWDNHGDLO\GRVHVRI
DIDWLQLEDQGGDVDWLQLESHUWKHGRVHHVFDODWLRQFRKRUWRQDGDLO\EDVLV
&'3DWLHQWVZLOOKDYHLQWHUYDO(.*&%&DQG&037R[LFLW\RIDIDWLQLEDQGGDVDWLQLEZLOO
EH DVVHVVHG  7KH SDWLHQW ZLOO FRQWLQXH DIDWLQLE DQG GDVDWLQLE WDEOHWV E\ PRXWK DQG ZLOO
FRQWLQXHWRWDNHGDLO\GRVHVRIDIDWLQLEDQGGDVDWLQLESHUWKHGRVHHVFDODWLRQFRKRUWRQDGDLO\
EDVLV

&\FOH
&' 3DWLHQWV ZLOO EH VHHQ E\ WKH WUHDWLQJ SK\VLFLDQ DQG KDYH FRPSOHWH +	3 &%& DQG
&03%ORRGZLOOEHGUDZQIRUDVVHVVPHQWRIVHUXPPDUNHUV7R[LFLW\RIDIDWLQLEDQGGDVDWLQLE
ZLOOEHDVVHVVHG7KHSDWLHQWZLOOFRQWLQXHDIDWLQLEDQGGDVDWLQLEWDEOHWVLQFOLQLFE\PRXWKDQG
WDNHGDLO\GRVHVRIDIDWLQLEDQGGDVDWLQLESHUWKHGRVHHVFDODWLRQFRKRUWRQDGDLO\EDVLV
&' 3DWLHQWV ZLOO XQGHUJR UHHYDOXDWLRQ IRU WXPRU PHDVXUHPHQWV  7KLV DVVHVVPHQW FDQ
RFFXURQ&'rGD\V5HVSRQVHWRWUHDWPHQWZLOOEHDVVHVVHGSHUFULWHULDDVGHVFULEHGLQ
DFFRPSDQ\LQJ(YDOXDWLRQRI5HVSRQVHVHFWLRQ

7KHUDS\%H\RQG&\FOH
&' 3DWLHQWV ZLOO EH VHHQ E\ WKH WUHDWLQJ SK\VLFLDQ DQG KDYH FRPSOHWH +	3 &%& DQG
&03$VXUYHLOODQFH(&+2RU08*$ZLOOEHSHUIRUPHG&'GD\V7KHVXUYHLOODQFH
VWXG\VKRXOGEHWKHVDPHPRGDOLW\DVWKHRULJLQDOEDVHOLQHVWXG\(&+2RU08*$7R[LFLW\RI
DIDWLQLEDQGGDVDWLQLEZLOOEHDVVHVVHG5HVXOWVRQWKHWXPRUDVVHVVPHQWDQGUHVSRQVHWR
WUHDWPHQWZLOOEHDVVHVVHGHYHU\WZRF\FOHVDIWHUF\FOH'HYDOXDWLRQ3DWLHQWVZKRKDYH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
GRFXPHQWHG UHVSRQVH RU VWDEOH GLVHDVH DQG KDYH QR '/7 PD\ FRQWLQXH RQ WKHUDS\  7KH
SDWLHQWZLOOWKHQWDNHDIDWLQLEDQGGDVDWLQLEWDEOHWVLQFOLQLFE\PRXWKDQGZLOOFRQWLQXHWRWDNH
GDLO\GRVHVRIDIDWLQLEDQGGDVDWLQLESHUWKHGRVHHVFDODWLRQFRKRUWRQDGDLO\EDVLV
3DWLHQWVFRQWLQXLQJRQWKHUDS\SDVWWZRF\FOHVZLOOEHVHHQE\WKHWUHDWLQJSK\VLFLDQHYHU\
ZHHNV DQG ZLOO KDYH FRPSOHWH SK\VLFDO H[DPLQDWLRQ &%& DQG &03 7XPRU PHDVXUHPHQW
DQGUHVSRQVHDVVHVVPHQWZLOORFFXUHYHU\ZHHNVDVRXWOLQHGDERYH'DVDWLQLEDQGDIDWLQLE
ZLOO EH FRQWLQXHG XQWLO SURJUHVVLRQ RI GLVHDVH XQDFFHSWDEOH WR[LFLW\ SDWLHQW UHTXHVW RU DW
GLVFUHWLRQRIWKHVSRQVRULQYHVWLJDWRU

(QGRI7UHDWPHQWYLVLW(27
7KRVH WKDW KDYH GRFXPHQWHG SURJUHVVLRQ DQGRU '/7 RU DQ\ RWKHU UHDVRQ WR FRPH RII RI
SURWRFROZLOOEHUHPRYHGIURPIXUWKHUWKHUDS\DQGUHDVRQVGRFXPHQWHG$WR[LFLW\DVVHVVPHQW
DQGSK\VLFDOH[DPLQDWLRQZLOOEHSHUIRUPHG,I(27YLVLWLVQRWSRVVLEOHIRUH[DPSOHGXHWR
FRQFXUUHQWH[WUDPXUDOLQSDWLHQWKRVSLWDOL]DWLRQRUGHDWKWKHVHH[WHQXDWLQJFLUFXPVWDQFHVPXVW
EH GRFXPHQWHG DQG UHYLHZHG ZLWK WKH SULPDU\ LQYHVWLJDWRUV 6HH IRU 6HFWLRQ :LWKGUDZDO
&ULWHULDIRUDGGLWLRQDOUHSRUWLQJDQGSDUWLFLSDQWZLWKGUDZDOSURFHGXUHV$OVRVHHVHFWLRQ7LPH
3HULRG5HSRUWLQJ5HTXLUHPHQWV(27YLVLWVKRXOGEHFRPSOHWHGZLWKLQGD\VRIFHVVDWLRQRI
VWXG\GUXJ

'RVH(VFDODWLRQ5XOHV

'RVH(VFDODWLRQ6FKHPD
7KHGRVHHVFDODWLRQVFKHPHLVVKRZQLQ7DEOHDQGWKHUXOHVRIGRVHHVFDODWLRQDUHVKRZQ
EHORZ  7KHVH GRVHV RI GDVDWLQLE DUH EDVHG RQ 3KDVH , GDWD WKDW DUH LPSRUWDQW IRU WHVWLQJ
DORQJZLWKSUHFOLQLFDOGDWDVXJJHVWLQJUHVSRQVHLQFHOOV>@7KHLQLWLDOGRVHRIDIDWLQLELQ
FRKRUW  ZDV FKRVHQ EDVHG RQ UHVXOWV IURP FRPELQDWLRQ 3KDVH , VWXGLHV ZLWK WD[DQHV DQG
DQRWKHUVPDOOPROHFXOHLQKLELWRU6HH3KDVH,,,H[SHULHQFH
7DEOH'RVH(VFDODWLRQ6FKHPD
Phase I Cohort
BIBW2992
 
Begins Day #1 
Dasatinib
 
Begins Day #8 
1.0 
30 mg 
100 mg 
2.0 
40 mg 
100 mg 
3.0 
40 mg 
140 mg 



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
1XPEHURI
3DWLHQWVZLWK
'/7
(VFDODWLRQ'HFLVLRQ5XOH

(QWHUSDWLHQWVDWWKHQH[WGRVHOHYHO
!
'RVHHVFDODWLRQZLOOEHVWRSSHG7KLVGRVHOHYHOZLOOEHGHFODUHGWKHPD[LPDOO\
DGPLQLVWHUHGGRVH7KUHHDGGLWLRQDOSDWLHQWVZLOOEHHQWHUHGDWWKHQH[WORZHVW
GRVHOHYHOLIRQO\SDWLHQWVZHUHWUHDWHGSUHYLRXVO\DWWKDWGRVH

(QWHUDWOHDVWPRUHSDWLHQWVDWWKLVGRVHOHYHO
x ,ISDWLHQWVH[SHULHQFH'/7SURFHHGWRWKHQH[WGRVHOHYHO
x ,ItVXIIHUV'/7WKHQGRVHHVFDODWLRQLVVWRSSHGDQGWKLVGRVHLVGHFODUHGWKH
PD[LPDOO\DGPLQLVWHUHGGRVH7KUHHDGGLWLRQDOSDWLHQWVZLOOEHHQWHUHGDWWKH
QH[WORZHVWGRVHOHYHOLIRQO\SDWLHQWVZHUHWUHDWHGSUHYLRXVO\DWWKDWGRVH
RXWRIDW
KLJKHVWGRVH
OHYHOEHORZWKH
PD[LPDOO\
DGPLQLVWHUHG
GRVH
7KLVLVZLOOEHWKHPD[LPXPWROHUDWHGGRVH07'$WOHDVWSDWLHQWVPXVWEH
HQWHUHGDWWKLVGRVH7KLVZLOOEHWKHGRVHFKRVHQIRU3KDVH,%
7KUHH SDWLHQWV DUH WUHDWHG SHU FRKRUW IRU RQH F\FOH  GD\V SHU F\FOH ,I QR '/7V DUH
UHFRUGHG RQ WKH WKUHH SDWLHQWV LQ HDFK FRKRUW WUHDWPHQW FRQWLQXHV DQG WKUHH SDWLHQWV DUH
WUHDWHGLQWKHVXEVHTXHQWFRKRUW+RZHYHULIDSDWLHQWGHYHORSVD'/7DQRWKHUWKUHHSDWLHQWV
DUHWUHDWHGLQWKLVFRKRUWIRURQHF\FOH,IWKHUHDUHQRPRUH'/7VGRVHHVFDODWLRQFRQWLQXHV,I
PRUH WKDQ RQH RI WKUHH SDWLHQWV GHYHORSV D '/7 LQ DQ\ FRKRUW WKLV GRVH LV GHFODUHG WKH
PD[LPDOO\DGPLQLVWHUHGGRVHDQGDQRWKHUWKUHHSDWLHQWVDUHWUHDWHGLQ WKHQH[WORZHUGRVDJH
FRKRUW
7KHUHFRPPHQGHGSKDVH ,%GRVHIRUWKLVFRPELQHGWUHDWPHQWZLOOEHGHILQHGDV HLWKHUWKH
KLJKHVWGRVDJHFRKRUWLQZKLFKVL[SDWLHQWVKDGEHHQWUHDWHGDQGWKHUHZHUHOHVVWKDQWZR
'/7VRUDIDWLQLEDWWKHSUHYLRXVO\GHILQHGPD[LPXPWROHUDWHGGRVHDVDVLQJOHDJHQWLH
PJGSOXVGDVDWLQLEDWWKHKLJKHVWWROHUDWHGGRVHLQYHVWLJDWHGLQWKLVLQGLFDWLRQFRKRUW
,Q3KDVH,%DPXWDWLRQDOO\VHOHFWHGSDUWLFLSDQWVWRWDOZLOOEHWUHDWHGDWWKHUHFRPPHQGHG
GRVHWRFRQILUPWROHUDELOLW\DQGHYDOXDWHIRUHDUO\UHVSRQVHVLJQDO



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

'HILQLWLRQRI'RVH/LPLWLQJ7R[LFLW\'/7
7R[LFLW\LVJUDGHGDFFRUGLQJWRWKH1DWLRQDO&DQFHU,QVWLWXWH&RPPRQ7R[LFLW\&ULWHULD1&,
&7&$( YHUVLRQ   7KH 0$' LV GHILQHG DV WKH KLJKHVW GRVH DW ZKLFK  RQH  RI VL[
SDWLHQWV H[SHULHQFHV D '/7 GXULQJ WKH ILUVW GD\ WUHDWPHQW SHULRG 2QO\ '/7V FROOHFWHG
GXULQJWKHILUVWF\FOHRIWUHDWPHQWZLOOEHXVHGIRUGRVHHVFDODWLRQGHFLVLRQEXWZLOOFRQWLQXHWR
EHFROOHFWHGWKURXJKF\FOHDQGEH\RQG$'/7LVGHILQHGDVJUDGHUDVKVHYHUHJUDGH
UDVKUHIUDFWRU\WRRSWLPDOVXSSRUWLYHFDUHJUDGHQDXVHDYRPLWLQJUHIUDFWRU\WRDQWLHPHWLFV
JUDGHGLDUUKHDUHIUDFWRU\WRDQWLGLDUUKHDPHGLFDWLRQVVHH0DQDJHPHQWRI$GYHUVH(YHQWV
±'LDUUKHDJUDGHIOXLGUHWHQWLRQUHIUDFWRU\WRGLXUHWLFVDQGSUHGQLVRQHVHH0DQDJHPHQWRI
$GYHUVH (YHQWV ± )OXLG ,PEDODQFH  ,Q DGGLWLRQ RWKHU JUDGH  QRQKHPDWRORJLF WR[LFLW\
JUDGH  KHPDWRORJLF WR[LFLW\ RU GHDWK ZLOO EH FRQVLGHUHG '/7V LI WKH HYHQW DWWULEXWLRQ LV
FRQVLGHUHG GHILQLWH RU SUREDEOH E\ WKH SULPDU\ LQYHVWLJDWRU  'LDUUKHD UHODWHG WR D NQRZQ
LQIHFWLRXVDJHQWLVQRWFRQVLGHUHGD'/7
7KH SXEOLFDWLRQ GHPRQVWUDWHG WKDW WKH SUHVHQFH RI D SDSXORSXVWXODU VNLQ UDVK VWURQJO\
FRUUHODWHGZLWKRYHUDOOVXUYLYDOLQSDWLHQWVUHFHLYLQJHUORWLQLEDIWHUIDLOLQJFKHPRWKHUDS\>@
3DWLHQWVZLWKJUDGHVNLQUDVKKDVPHGLDQVXUYLYDORIPRQWKVFRPSDUHGWRPRQWKV
DQG  PRQWKV IRU SDWLHQWV ZLWK JUDGH  DQG JUDGH  VNLQ UDVKHV UHVSHFWLYHO\  7KXV
SUHVHQFHRIDURXWLQHJUDGHUDVKSUHGLFWVEHWWHURXWFRPHWKHUHIRUHZHZDQWWRFRQWLQXH
WKHVHSDWLHQWVRQ(*)57.,WKHUDS\ZLWKPD[LPDOPHGLFDOVXSSRUWIRUVNLQUDVK7KLVLQFOXGHV
XVHRIWRSLFDODQGV\VWHPLFDQWLELRWLFVDQGRUFRUWLFRVWHURLGVDVGHVFULEHGLQ0DQDJHPHQWRI
$GYHUVH(YHQWV6NLQ5DVK

&RQFRPLWDQW7KHUDS\

3URKLELWHGDQG5HVWULFWHG7KHUDSLHV'XULQJ6WXG\

3URKLELWHG7KHUDSLHV
6XEMHFWVUHTXLULQJDQ\RIWKHIROORZLQJSURKLELWHGWKHUDSLHVVKRXOGQRWEHHQUROOHG
%LVSKRVSKRQDWHV
,QWUDYHQRXVELVSKRVSKRQDWHVZLOOEHZLWKKHOGIRUWKHILUVWZHHNVRIGDVDWLQLEWUHDWPHQWGXH
WRWKHULVNRIK\SRFDOFHPLD$IWHUWKHQHHGIRU&DVXSSOHPHQWDWLRQKDVEHHQDVVHVVHGDQG
OHYHOVGRFXPHQWHGWREH!//1VXEMHFWVRQSULRUELVSKRVSKRQDWHPD\EHUHVWDUWHGZLWK
FDXWLRQDWWKHLQYHVWLJDWRU¶VGLVFUHWLRQ
&<3$



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
'DVDWLQLELVSULPDULO\PHWDEROL]HGE\WKH&<3$HQ]\PH7KHUHIRUHSRWHQWLQKLELWRUVRI
&<3$DUHSURKLELWHGGXULQJVWXG\IRUVXFKPHGLFDWLRQVDZDVKRXWSHULRGRItGD\VLV
UHTXLUHGSULRUWRVWDUWLQJGDVDWLQLE2IQRWHDIDWLQLEGRHVQRWLQKLELW&<3$RUDQ\RWKHU
F\WRFKURPH3HQ]\PHV6XEMHFWVVKRXOGEHDGYLVHGQRWWRFRQVXPHVXEVWDQWLDOTXDQWLWLHV
RIJUDSHIUXLWMXLFH
3*O\FRSURWHLQ
7KHDGVRUSWLRQRIDIDWLQLELVLQFUHDVHGE\FRQFRPLWDQWFRQVLGHULQJWKHGRVHGHSHQGHQFHRI
DGYHUVHHYHQWVIRUVDIHW\UHDVRQVSDWLHQWVUHTXLULQJFRPHGLFDWLRQZLWKSRWHQW3JSLQKLELWRUV
LQFOXGLQJDPLRGDURQHF\FORVSRULQHHU\WKURP\FLQNHWRFRQD]ROHLWUDFRQD]ROHTXLQLGLQH
ULWRQDYLUYHUDSDPLOWDFUROLPXVGURQHGDURQHIHORGLSLQHQHOILQDYLUORSLQDYLUVDTXLQDYLU
WLFDJUHORUGLOWLD]HPFRQLYDSWDQFODULWKURP\FLQD]LWKURP\FLQUDQROD]LQHFDSWRSULORU
LQGXFHUVLQFOXGLQJ6W-RKQ
VZRUWULIDPSLFLQSKHQREDUELWDOWLSUDQDYLUFDUEDPD]HSLQHZLOO
QRWEHHQWHUHGLQWRRQJRLQJDQGSODQQHGDIDWLQLEWULDOV,QSDWLHQWVUHTXLULQJDQ\RIWKHVH
PHGLFDWLRQVDIWHUVWDUWRIDIDWLQLEWUHDWPHQWWKHGHFLVLRQIRUFRQWLQXDWLRQRIHLWKHUGUXJZLOOEH
EDVHGRQWKHLQGLYLGXDOFLUFXPVWDQFHVRIWKHSDWLHQWXSRQGLVFXVVLRQZLWKWKHUHVSRQVLEOH%,
FOLQLFDOPRQLWRU
'DVDWLQLE ZDV VKRZQ WR EH D VXEVWUDWH RI KXPDQ 3JO\FRSURWHLQ 3JS DQG EUHDVW FDQFHU
UHVLVWDQFHSURWHLQ%&53LQ0DGLQ'DUE\FDQLQHNLGQH\0'&.,,FHOOV+RZHYHUGDVDWLQLE
H[KLELWV KLJK LQWULQVLF SHUPHDELOLW\ DQG WKXV D PHDQLQJIXO LPSDFW RI 3JS RQ LWV LQWHVWLQDO
DEVRUSWLRQXSRQRUDODGPLQLVWUDWLRQLVXQOLNHO\'DVDWLQLEZDVQRWDQLQKLELWRURI3JSLQ&DFR
FHOOVDQGLVQRWH[SHFWHGWRDOWHUWKHDEVRUSWLRQDQGGLVWULEXWLRQFKDUDFWHULVWLFVRIFRPSRXQGV
WKDW DUH 3JS VXEVWUDWHV 3DUDJUDSK UHSURGXFHG YHUEDWLP IURP %06 ,QYHVWLJDWRU %URFKXUH
YSJ
'UXJVWKDWPD\LQFUHDVHGDVDWLQLESODVPDFRQFHQWUDWLRQV
&<3$,QKLELWRUV'DVDWLQLELVD&<3$VXEVWUDWH&RQFRPLWDQWXVHRIGDVDWLQLEDQG
GUXJVWKDWLQKLELW&<3$HJNHWRFRQD]ROHLWUDFRQD]ROHHU\WKURP\FLQFODULWKURP\FLQ
ULWRQDYLUDWD]DQDYLULQGLQDYLUQHID]RGRQHQHOILQDYLUVDTXLQDYLUWHOLWKURP\FLQPD\LQFUHDVH
H[SRVXUHWRGDVDWLQLEDQGVKRXOGEHDYRLGHG
,QSDWLHQWVUHFHLYLQJWUHDWPHQWZLWKGDVDWLQLEFORVHPRQLWRULQJIRUWR[LFLW\DQGDGDVDWLQLEGRVH
UHGXFWLRQVKRXOGEHFRQVLGHUHGLIV\VWHPLFDGPLQLVWUDWLRQRIDSRWHQW&<3$LQKLELWRUFDQQRW
EHDYRLGHG2IQRWHDIDWLQLEGRHVQRWLQKLELW&<3$UHIHUWRDIDWLQLE,QYHVWLJDWRU%URFKXUH
0HGLFDWLRQVWKDWSURORQJ47LQWHUYDO



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
6XEMHFWVHQUROOHGLQWKLVVWXG\VKRXOGQRWWDNHRUEHJLQWRWDNHFRQFRPLWDQWPHGLFDWLRQVNQRZQ
WRSURORQJWKH47LQWHUYDO)RUVXFKPHGLFDWLRQVDZDVKRXWSHULRGRItGD\VLVUHTXLUHGSULRU
WR VWDUWLQJ GDVDWLQLE $JHQWV ZKLFK PD\ SRVVLEO\ SURORQJ WKH 47 LQWHUYDO DUH UHVWULFWHG
0HGLFDWLRQV NQRZQ WR SURORQJ WKH 47 LQWHUYDO &ODVV , VHH KWWSZZZTWGUXJVRUJPHGLFDO
SURVGUXJOLVWVGUXJOLVWVKWPDUH'UXJVWKDWDUHJHQHUDOO\DFFHSWHGWRKDYHDULVNRIFDXVLQJ
7RUVDGHVGH3RLQWHVLQFOXGH
x
TXLQLGLQHSURFDLQDPLGHGLVRS\UDPLGH
x
DPLRGDURQHVRWDOROLEXWLOLGHGRIHWLOLGH
x
HU\WKURP\FLQFODULWKURP\FLQ
x
FKORUSURPD]LQHKDORSHULGROPHVRULGD]LQHWKLRULGD]LQHSLPR]LGH
x
FLVDSULGHEHSULGLOGURSHULGROPHWKDGRQHDUVHQLFFKORURTXLQHGRPSHULGRQH
KDORIDQWULQHOHYRPHWKDG\OSHQWDPLGLQHVSDUIOR[DFLQOLGRIOD]LQHUDQR]DOLQH
6KRXOG WKH ,QYHVWLJDWRU EHOLHYH WKDW EHJLQQLQJ WKHUDS\ ZLWK D SRWHQWLDOO\ 47 SURORQJLQJ
PHGLFDWLRQRWKHUWKDQWKHRQHVH[SOLFLWO\SURKLELWHGLVYLWDOWRDQLQGLYLGXDOVXEMHFW¶VFDUHWKH
,QYHVWLJDWRUPXVWFKHFNWKDWWKHVXEMHFW¶VSULRURQWKHUDS\(.*KDVQRWVKRZQD47F)t
PVHF LQ ZRPHQ RU ! PVHF LQ PHQ SHU $&&$+$  JXLGHOLQHV IRU SUHYHQWLRQ RI
WRUVDGHV>@>@RUDQLQFUHDVHLQ47FtPVHFRYHUWKHEDVHOLQHYDOXH

5HVWULFWHG7KHUDSLHV
$IDWLQLELVDVXEVWUDWHRI3JSDQGLWVSODVPDFRQFHQWUDWLRQVFDQEHDIIHFWHGE\WKHXVHRI3
JS LQKLELWRUV DQG LW LV DOVR OLNHO\ WKDW 3JS LQGXFHUV FRXOG DOVR LQIOXHQFH DIDWLQLE SODVPD
FRQFHQWUDWLRQV 7KH XVH RI SRWHQW 3JS LQKLELWRUV LQFOXGLQJ &\FORVSRULQ (U\WKURP\FLQ
.HWRFRQD]ROH,WUDFRQD]ROH4XLQLGLQH3KHQREDUELWDOVDOWZLWK4XLQLGLQH5LWRQDYLU9DOVSRGDU
9HUDSDPLODQGSRWHQW3JSLQGXFHUVLQFOXGLQJ6W-RKQ
VZRUWULIDPSLFLQKDVWREHDYRLGHG
GXULQJWUHDWPHQWZLWKDIDWLQLE
'UXJVWKDWPD\GHFUHDVHGDVDWLQLESODVPDFRQFHQWUDWLRQV
&<3$ ,QGXFHUV 'UXJV WKDW LQGXFH &<3$ DFWLYLW\ PD\ GHFUHDVH GDVDWLQLE SODVPD
FRQFHQWUDWLRQV ,Q SDWLHQWV LQ ZKRP &<3$ LQGXFHUV HJ SKHQ\WRLQ FDUEDPD]HSLQH
ULIDPSLFLQSKHQREDUELWDORUKLJKGRVHGH[DPHWKDVRQHDUHLQGLFDWHGDOWHUQDWLYHDJHQWVZLWK
OHVVHQ]\PHLQGXFWLRQSRWHQWLDOVKRXOGEHXVHG
'UXJVWKDWPD\KDYHWKHLUSODVPDFRQFHQWUDWLRQDOWHUHGE\GDVDWLQLE
&<3$6XEVWUDWHV&<3$VXEVWUDWHVNQRZQWRKDYHDQDUURZWKHUDSHXWLFLQGH[VXFKDV
WHUIHQDGLQH FLVDSULGH F\FORVSRULQH IHQWDQ\O SLPR]LGH TXLQLGLQH VLUROLPXV WDFUROLPXV RU



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
HUJRW DONDORLGV HUJRWDPLQH GLK\GURHUJRWDPLQH VKRXOG EH DGPLQLVWHUHG ZLWK FDXWLRQ LQ
SDWLHQWVUHFHLYLQJGDVDWLQLE
/HVVSRWHQWLQKLELWRUVLQGXFHUVDQGVXEVWUDWHVRI&<3$DUHUHVWULFWHG
6W -RKQ
V ZRUW +\SHULFXP SHUIRUDWXP 0D\ GHFUHDVH GDVDWLQLE SODVPD FRQFHQWUDWLRQV
XQSUHGLFWDEO\3DWLHQWVPD\QRWWDNH6W-RKQ
VZRUW
$QWDFLGV 1RQFOLQLFDO GDWD GHPRQVWUDWHG WKDW WKH VROXELOLW\ RI GDVDWLQLE LV S+ GHSHQGHQW
6LPXOWDQHRXVDGPLQLVWUDWLRQRIGDVDWLQLEZLWKDQWDFLGVVKRXOGEHDYRLGHG,IDQWDFLGWKHUDS\LV
QHHGHGWKHDQWDFLGGRVHVKRXOGEHDGPLQLVWHUHGDWOHDVWKRXUVEHIRUHRUKRXUVDIWHUWKH
GRVHRIGDVDWLQLE
+%ORFNHUV3URWRQ3XPS,QKLELWRUV/RQJWHUPVXSSUHVVLRQRIJDVWULFDFLGVHFUHWLRQE\+
EORFNHUV RU SURWRQ SXPS LQKLELWRUV HJ IDPRWLGLQH DQG RPHSUD]ROH LV OLNHO\ WR UHGXFH
GDVDWLQLE H[SRVXUH 7KH FRQFRPLWDQW XVH RI + EORFNHUV RU SURWRQ SXPS LQKLELWRUV ZLWK
GDVDWLQLE LV QRW UHFRPPHQGHG 7KH XVH RI DQWDFLGV VKRXOG EH FRQVLGHUHG LQ SODFH RI +
EORFNHUVRUSURWRQSXPSLQKLELWRUVLQSDWLHQWVUHFHLYLQJGDVDWLQLEWKHUDS\
0HGLFDWLRQVWKDWLQKLELW3ODWHOHW)XQFWLRQDQG$QWLFRDJXODQWV
&DXWLRQVKRXOGEHH[HUFLVHGLISDWLHQWVDUHUHTXLUHGWRWDNHPHGLFDWLRQVWKDWLQKLELWSODWHOHW
IXQFWLRQRUDQWLFRDJXODQWV
0HGLFDWLRQVWKDWGLUHFWO\DQGGXUDEO\LQKLELWSODWHOHWIXQFWLRQLQFOXGH
x
DVSLULQRUDVSLULQFRQWDLQLQJFRPELQDWLRQVFORSLGRJUHOGLS\ULGDPROH
x
WLURILEDQGLS\ULGDPROHHSRSURVWHQROHSWLILEDWLGHFLORVWD]RODEFL[LPDEWLFORSLGLQH
FLORVWD]RO
0HGLFDWLRQVWKDWGLUHFWO\DQGGXUDEO\LQKLELWDQWLFRDJXODWLRQLQFOXGH
x
ZDUIDULQKHSDULQORZPROHFXODUZHLJKWKHSDULQ>HJGDQDSDURLGGDOWHSDULQWLQ]DSDULQ
HQR[DSDULQ@
x
([FHSWLRQVORZGRVHZDUIDULQIRUSURSK\OD[LVWRSUHYHQWFDWKHWHUWKURPERVLVDQGKHSDULQ
IRUIOXVKHVRI,9OLQHV


3RWHQWLDOIRU$IDWLQLE'DVDWLQLE,QWHUDFWLRQV
7KH DYDLODEOH OLWHUDWXUH GRHV QRW SURYLGH DQ\ WKHRUHWLFDO UHDVRQ WR H[SHFW WKDW DIDWLQLE ZLOO
VLJQLILFDQWO\ DIIHFW WKH PHWDEROLVP RU HOLPLQDWLRQ RI GDVDWLQLE 'DVDWLQLE LV PHWDEROL]HG E\



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
&<3$ SULPDULO\ IODYLQFRQWDLQLQJ PRQRR[\JHQDVH )20 DQG XULGLQH GLSKRVSKDWH
JOXFXURQRV\OWUDQVIHUDVH8*7$IDWLQLEGRHVQRWLQKLELWHLWKHURIWKHVHSDWKZD\V
$IDWLQLELVSULPDULO\H[FUHWHGXQFKDQJHGDVSDUHQWFRPSRXQGLQWKHIHFHVDOWKRXJKDPLQRU
IUDFWLRQLVPHWDEROL]HGE\3JSPHFKDQLVPV,WLVQRWDVLJQLILFDQWVXEVWUDWHRI3HQ]\PHV
VXFKDV&<3$QRULVLWPHWDEROL]HGE\)207KHUHIRUHLWLVXQOLNHO\WKDWGDVDWLQLEZLOO
DIIHFWWKHSKDUPDFRNLQHWLFSURILOHRIDIDWLQLE
'DVDWLQLEDQG3JO\FRSURWHLQ
'DVDWLQLEKDVEHHQGHPRQVWUDWHGWREHDVXEVWUDWHRIKXPDQ3JO\FRSURWHLQ3JSLQ0DGLQ
'DUE\ FDQLQH NLGQH\ 0'&. ,, FHOOV >@ +RZHYHU GDVDWLQLE H[KLELWV KLJK LQWULQVLF
SHUPHDELOLW\ DQG WKXV D PHDQLQJIXO LPSDFW RI 3JS RQ LWV LQWHVWLQDO DEVRUSWLRQ XSRQ RUDO
DGPLQLVWUDWLRQLVXQOLNHO\%06,QYHVWLJDWRU%URFKXUHYSJ'DVDWLQLE
ZDVQRWDQLQKLELWRURI3JSLQ&DFRFHOOVDQGLVQRWH[SHFWHGWRDOWHUWKHDEVRUSWLRQDQG
GLVWULEXWLRQFKDUDFWHULVWLFVRIFRPSRXQGVWKDWDUH3JSVXEVWUDWHV

7UHDWPHQWRI3HUVRQVRI&KLOGEHDULQJ3RWHQWLDO
6H[XDOO\DFWLYHZRPHQRIFKLOGEHDULQJSRWHQWLDOPXVWXVHDQHIIHFWLYHPHWKRGRIELUWKFRQWURO
GXULQJWKHFRXUVHRIWKHVWXG\LQDPDQQHUVXFKWKDWULVNRIIDLOXUHLVPLQLPL]HG
3ULRUWRVWXG\HQUROOPHQWZRPHQRIFKLOGEHDULQJSRWHQWLDO:2&%3PXVWEHDGYLVHGRIWKH
LPSRUWDQFHRIDYRLGLQJSUHJQDQF\GXULQJWULDOSDUWLFLSDWLRQDQGWKHSRWHQWLDOULVNIDFWRUVIRUDQ
XQLQWHQWLRQDOSUHJQDQF\,QDGGLWLRQPHQHQUROOHGRQWKLVVWXG\VKRXOGXQGHUVWDQGWKHULVNVWR
DQ\VH[XDOSDUWQHURIFKLOGEHDULQJSRWHQWLDODQGVKRXOGSUDFWLFHDQHIIHFWLYHPHWKRGRIELUWK
FRQWURO
$OO :2&%3 0867 KDYH D QHJDWLYH SUHJQDQF\ WHVW SULRU WR ILUVW UHFHLYLQJ LQYHVWLJDWLRQDO
SURGXFWVHH6WXG\&DOHQGDU,IWKHSUHJQDQF\WHVWLVSRVLWLYHWKHSDWLHQWPXVWQRWUHFHLYH
LQYHVWLJDWLRQDOSURGXFWDQGPXVWQRWEHHQUROOHGLQWKHVWXG\
,Q DGGLWLRQ DOO:2&%3 VKRXOG EH LQVWUXFWHG WR FRQWDFW WKH ,QYHVWLJDWRU LPPHGLDWHO\ LI WKH\
VXVSHFW WKH\ PLJKW EH SUHJQDQW HJ PLVVHG RU ODWH PHQVWUXDO SHULRG DW DQ\ WLPH GXULQJ
VWXG\SDUWLFLSDWLRQ7KH,QYHVWLJDWRUPXVWLPPHGLDWHO\QRWLI\%RHKULQJHU,QJHOKHLPDQG%ULVWRO
0\HUV6TXLEELQWKHHYHQWRIDFRQILUPHGSUHJQDQF\LQDSDWLHQWSDUWLFLSDWLQJLQWKHVWXG\
)HPDOHSDWLHQWVZKRDUHQRWRIFKLOGEHDULQJSRWHQWLDOGXHWREHLQJSRVWPHQRSDXVDO\HDUV
ZLWKRXWPHQVHVRUVXUJLFDOVWHULOL]DWLRQRRSKRUHFWRP\K\VWHUHFWRP\DQGRUWXEDOOLJDWLRQGR
QRWQHHGWRXVHFRQWUDFHSWLRQ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
$OO RWKHU IHPDOH SDWLHQWV DUH FRQVLGHUHG WR KDYH FKLOGEHDULQJ SRWHQWLDO DQG VKRXOG XVH
DGHTXDWHFRQWUDFHSWLRQWKURXJKRXWWKHVWXG\IURPVFUHHQLQJXQWLOHQGRIVWXG\SDUWLFLSDWLRQRU
GD\VDIWHUODVWGRVHRIWULDOPHGLFDWLRQZKLFKHYHULVODWHU
$FFHSWDEOHPHWKRGVRIFRQWUDFHSWLRQIRU:2&%3LQFOXGHKRUPRQDOFRQWUDFHSWLRQDQGGRXEOH
EDUULHUPHWKRG'RXEOHEDUULHUPHWKRGRIFRQWUDFHSWLRQLVGHILQHGDVWZREDUULHUPHWKRGVXVHG
VLPXOWDQHRXVO\ HDFK WLPH WKH SDWLHQW KDV LQWHUFRXUVH $FFHSWHG EDUULHU PHWKRGV LQFOXGH
GLDSKUDJPIHPDOHFRQGRPFHUYLFDOFDSPDOHFRQGRPDQG,8'WKHGLDSKUDJPDQGFHUYLFDO
FDSPXVWEHXVHGLQFRQMXQFWLRQZLWKVSHUPLFLGDOMHOO\FUHDP,IKRUPRQDOFRQWUDFHSWLYHVDUH
XVHGDWOHDVWRQHEDUULHUPHWKRGVKRXOGDOVREHXVHG3DUWQHUYDVHFWRP\QDWXUDO³UK\WKP´
DQGVSHUPLFLGDOMHOO\FUHDPDUHQRWDFFHSWDEOHDVPHWKRGVRIFRQWUDFHSWLRQ
0DOH SDWLHQWV VKRXOG XVH DGHTXDWH FRQWUDFHSWLRQ WKURXJKRXW WKH VWXG\ HJ FRQGRP DQG
VSHUPLFLGDOMHOO\

3DWLHQW:LWKGUDZDO&ULWHULD
3URWRFRO WKHUDS\ ZLOO EH GLVFRQWLQXHG DW DQ\ WLPH LI DQ\ RI WKH IROORZLQJ VLWXDWLRQV RFFXU
SURJUHVVLYH GLVHDVH GHYHORSPHQW RI WR[LFLW\ WKDW LQ WKH ,QYHVWLJDWRU¶V MXGJPHQW SUHFOXGHV
IXUWKHUWKHUDS\
 SDWLHQWUHIXVDO
 SDWLHQWORVWWRIROORZXSQRQFRPSOLDQFH
 LQWHUFXUUHQWLOOQHVV
 DWWKHGLVFUHWLRQRIWKH,QYHVWLJDWRURUVSRQVRU
 VWXG\WHUPLQDWLRQ
:KHQDSDWLHQWLVUHPRYHGIURPWKHVWXG\WKH,QYHVWLJDWRUZLOOFOHDUO\GRFXPHQWWKHUHDVRQLQ
WKHPHGLFDOUHFRUGDQGFRPSOHWHWKHDSSURSULDWHFDVHUHSRUWIRUPSDJHGHVFULELQJWKHUHDVRQ
IRUGLVFRQWLQXDWLRQ,IWKHUHDVRQIRUZLWKGUDZDOIURPWKHWULDOLVWKHGHDWKRIWKHVXEMHFWWKH
WZR RSWLRQV IRU FDWHJRUL]LQJ ZLWKGUDZDO DUH HLWKHU SURJUHVVLYH GLVHDVH RU DQ DGYHUVH HYHQW
$(PRUHWKDQRQH$(PD\EHGRFXPHQWHGDVDUHDVRQIRUZLWKGUDZDO2QO\RQHHYHQWZLOO
EHFDSWXUHGDVWKHFDXVHRIGHDWK1RWHWKDWGHDWKLV DQRXWFRPHDQGQRWDQ$('HDWKV
XQHTXLYRFDOO\GXHWRSURJUHVVLRQDUHQRW6$(V$OOWULDOWUHDWPHQW±UHODWHGWR[LFLWLHVDQG6$(V
PXVWEHIROORZHGXSXQWLOUHVROXWLRQ$OOVXEMHFWVZKRKDYHQHZRUZRUVHQLQJ&7&JUDGHRU
ODERUDWRU\YDOXHVDWWKHWLPHRIZLWKGUDZDOPXVWKDYHIXUWKHUWHVWVSHUIRUPHGDQGWKHUHVXOWV
UHFRUGHGDSSURSULDWHO\XQWLOODERUDWRU\YDOXHVKDYHUHWXUQHGWR&7&JUDGHRUXQOHVVWKHVH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
YDOXHV DUH QRW OLNHO\ WR LPSURYH EHFDXVH RI WKH XQGHUO\LQJ GLVHDVH ,Q WKHVH FDVHV WKH
LQYHVWLJDWRUV PXVW UHFRUG WKHLU RSLQLRQV LQ WKH VXEMHFW¶V PHGLFDO UHFRUGV /DERUDWRU\
DEQRUPDOLWLHV VKRXOG QRW EH UHSRUWHG DV DGYHUVH HYHQWV XQOHVV DQ\ FULWHULRQ IRU DQ 6$( LV
IXOILOOHGDQGRUWKHODERUDWRU\DEQRUPDOLW\FDXVHVWKHVXEMHFWWRGLVFRQWLQXHWKHVWXG\DQGRU
WKHLQYHVWLJDWRULQVLVWVWKHDEQRUPDOLW\VKRXOGEHUHSRUWHGDVDQ$(
$WZLWKGUDZDODOORQJRLQJVWXG\UHODWHGWR[LFLWLHVDQG6$(VPXVWEHIROORZHGXQWLOUHVROXWLRQ
XQOHVVLQWKH LQYHVWLJDWRU¶VRSLQLRQWKHFRQGLWLRQLVXQOLNHO\WRUHVROYHGXH WRWKHVXEMHFW¶V
XQGHUO\LQJ GLVHDVH $IWHU ZLWKGUDZDO IURP WUHDWPHQW VXEMHFWV PXVW EH IROORZHG XS IRU DOO
H[LVWLQJDQGQHZGUXJUHODWHG$(VIRUFDOHQGDUGD\VDIWHUWKHODVWGRVHRIWULDOGUXJ$OOQHZ
GUXJUHODWHG$(VRFFXUULQJGXULQJWKDWSHULRGPXVWEHUHFRUGHGDQGFDXVDOLW\DVVLJQHGDQGDOO
VWXG\UHODWHGWR[LFLWLHVDQG6$(VPXVWEHIROORZHGXSIRUUHVROXWLRQZKHUHSRVVLEOH3K\VLFDO
H[DPLQDWLRQWXPRUPHDVXUHPHQWV&%&ZLWKGLIIHUHQWLDODQG&03DQGHYDOXDWLRQDUHWREH
SHUIRUPHGZKHQWKHSDWLHQWJRHVRIIVWXG\(27

1RQFRPSOLDQFH
$OOLQVWDQFHVRIQRQFRPSOLDQFHDQGDOOUHVXOWLQJSURWRFROGHYLDWLRQV ZLOO EHUHFRUGHGRQWKH
FDVH UHSRUW IRUPV 3DUWLFLSDQWV ZLOO EH JLYHQ RQH RSSRUWXQLW\ WR IDLO WR DGKHUH WR VWXG\
UHTXLUHPHQW IRU UHWXUQ RI D SLOO ERWWOH DQGRU D F\FOH GLDU\ ,I D VHFRQG YLRODWLRQ RFFXUV
SDUWLFLSDQWVPXVWUHWXUQWKHLUSUHYLRXVSLOOERWWOHDQGRUGLDU\EHIRUHDQ\DGGLWLRQDOVWXG\SLOOV
ZLOOEHGLVSHQVHG

$FFRXQWDELOLW\3URFHGXUHV
3DWLHQWV PXVW EULQJ EDFN HPSW\ ERWWOHV DQG DOO UHPDLQLQJ DIDWLQLE DQG GDVDWLQLE WDEOHWV VR
WKHVHFDQEHFRXQWHG7KHSDWLHQWVZLOODOVREHUHTXLUHGWRNHHSDSLOOGLDU\7KHQXPEHURI
WDEOHWVWDNHQZLOOEHUHFRUGHGRQWKHFDVHUHSRUWIRUPV

6WXG\3HULRG
3DWLHQWV ZLOO EH UHTXLUHG WR UHPDLQ RQ VWXG\ IRU WKH ILUVW WZR F\FOHV XQOHVV WKH\ GHYHORS
LQWROHUDEOH WR[LFLWLHV KDYH UDSLG SURJUHVVLRQ RU IXOILOO WKH SDWLHQW ZLWKGUDZDO FULWHULD DERYH
3DWLHQWVZLWKGRFXPHQWHGUHVSRQVHRUVWDEOHGLVHDVHFDQFRQWLQXHWKHUDS\XQWLOSURJUHVVLRQ
RULQWROHUDEOHWR[LFLW\$SDWWHUQRISDUWLFLSDQWVIDLOLQJWRDGKHUHWRVWXG\UHTXLUHPHQWVDIWHURQH
RUPRUHSUHYLRXVYLRODWLRQVRUZDUQLQJVPD\DOVRUHVXOWLQSDUWLFLSDQWVGLVFRQWLQXLQJWUHDWPHQW
6HH3DWLHQW:LWKGUDZDO&ULWHULD



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

7ULDO'LVFRQWLQXDWLRQ
)RU UHDVRQDEOH FDXVH WKH ,QYHVWLJDWRU RU VSRQVRUV PD\ WHUPLQDWH WKLV VWXG\ SUHPDWXUHO\
&RQGLWLRQV WKDW PD\ ZDUUDQW WHUPLQDWLRQ LQFOXGH EXW DUH QRW OLPLWHG WR WKH GLVFRYHU\ RI DQ
XQH[SHFWHG VLJQLILFDQW RU XQDFFHSWDEOH ULVN WR WKH SDWLHQWV HQUROOHG LQ WKH VWXG\ RU LI WKH
DFFUXDOJRDOVDUHPHW$ZULWWHQQRWLILFDWLRQRIWHUPLQDWLRQZLOOEHLVVXHG

6SHFLDO6LWXDWLRQV
3DWLHQWV ZLOO GLVFRQWLQXH WUHDWPHQW LI WKH\ H[SHULHQFH GHWHULRUDWLRQ LQ OHIW YHQWULFXODU FDUGLDF
IXQFWLRQ/9()WR&7&$(*UDGH
3DWLHQWVZLOOGLVFRQWLQXHWUHDWPHQWLIWKH\DUHGLDJQRVHGZLWKDQ,/'
,QWKHHYHQWRIDSURORQJHGFRQVHFXWLYHGD\VJUDGHGUXJUHODWHGHYHQWQRWOLVWHGLQWKH
WDEOHDERYHZKLFKLVSRRUO\WROHUDWHGE\WKHSDWLHQWWKHLQYHVWLJDWRUPD\FKRRVHWRSDXVHWKH
PHGLFDWLRQIRUXSWRGD\VWRDOORZWKHSDWLHQWWRUHFRYHUWRJUDGHRUEDVHOLQHIROORZHGE\
DGRVHUHGXFWLRQDFFRUGLQJWRDGD\VRQGD\VRIIVFKHGXOH
3UHJQDQF\ 6HH 7UHDWPHQW RI :RPHQ RI &KLOG%HDULQJ 3RWHQWLDOV IRU SROLF\ UHJDUGLQJ
PDQGDWRU\FRQWUDFHSWLRQ,QUDUHFDVHVSUHJQDQF\PLJKWRFFXULQFOLQLFDOWULDOV2QFHDIHPDOH
VXEMHFW KDV EHHQ HQUROOHG LQWR WKH FOLQLFDO WULDO DIWHU KDYLQJ WDNHQ VWXG\ PHGLFDWLRQ WKH
LQYHVWLJDWRUPXVWFDSWXUHDQ\GUXJH[SRVXUHGXULQJSUHJQDQF\7KHLQYHVWLJDWRUZLOOIROORZWKH
SUHJQDQF\XQWLORXWFRPHLVNQRZQ$Q6$(UHSRUWPXVWEHIRUZDUGHGWRWKHSKDUPDFHXWLFDO
FRPSDQ\LIWKHRXWFRPHRIWKHSUHJQDQF\UHVXOWVLQDQDERUWLRQPLVFDUULDJHRUWKHRFFXUUHQFH
RIDQ\RWKHU6$(V
3DWLHQWVZLOOGLVFRQWLQXHWUHDWPHQWLIWKH\DUHGLDJQRVHGZLWKSUHJQDQF\

0DQDJHPHQWRI$GYHUVH(YHQWV

5DVK
$SURDFWLYHDQGHDUO\DSSURDFKWRPDQDJHPHQWRIUDVKLVFUXFLDO5DVKFDQEHPDQDJHGE\D
YDULHW\RIWUHDWPHQWRSWLRQVWRUHOLHYHV\PSWRPVDQGUHGXFHWKHUDVK$JXLGHOLQHWDEOHIRU
PDQDJHPHQW RI SDSXORSXVWXODU VNLQ UDVK LV SURYLGHG LQ WKH $SSHQGL[ 0DQDJHPHQW RI 6NLQ
5DVK
7KHUHFRPPHQGDWLRQVIRUPDQDJHPHQWDUHDVIROORZV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
*HQHUDO3UHYHQWLRQ VWULFW VXQ SURWHFWLRQ XVH RI D VXQVFUHHQ RI 6XQ 3URWHFWLRQ )DFWRU 
63)  RU KLJKHU SUHIHUDEO\ FRQWDLQLQJ ]LQF R[LGH XVH RI D WKLFN DOFRKROIUHH HPROOLHQW
FUHDPDYRLGKDUVKGHWHUJHQWVDYRLGXVLQJDVRODULXP
,WLVRSWLRQDODQGUHFRPPHQGHGWKDWSDUWLFLSDQWVUHFHLYHDSUHVFULSWLRQIRUPLQRF\FOLQHPJ
RUPJELGIRUWKHLQLWLDOZHHNVRIDIDWLQLEWUHDWPHQWWRSUHYHQWSDSXORSXVWXODUVNLQUDVK
SHUGHUPDWRORJ\JXLGHOLQHV>@
&7&$(*UDGHUDVK,QLWLDWHWRSLFDOK\GURFRUWLVRQHRUFUHDPDQGFOLQGDP\FLQ
JHOVKRXOGEHXVHG
&7&$( *UDGH  UDVK 5HIHU WR $SSHQGL[ 0DQDJHPHQW RI 6NLQ 5DVK 5HOLHI IURP PDMRU
V\PSWRPVFDXVHGE\&7&$(*UDGHVNLQUHODWHGDGYHUVHHYHQWVVKRXOGEHDFKLHYHGE\D
FRPELQDWLRQ RI ORFDO DQG V\VWHPLF WKHUDSLHV ,Q 3KDVH ,, WULDOV WKLV DSSURDFK HQDEOHG
FRQWLQXHG GRVH IRU WKH PDMRULW\ RI SDWLHQWV UHTXLULQJ GRVH UHGXFWLRQ IRU VNLQ WR[LFLW\
6SHFLILFDOO\ZHUHFRPPHQGLQFOXGLQJ
6\VWHPLFDQWLELRWLFVPLQRF\FOLQHPJ32ELGRUGR[\F\FOLQH
7RSLFDOWUHDWPHQWK\GURFRUWLVRQHFUHDPFOLQGDP\FLQJHOSLPHFUROLPXV
FUHDP
2SWLRQDO
2UDORUWRSLFDODQWLKLVWDPLQHVGLSKHQK\GUDPLQHK\GUR[\]LQHFKORUSKHQHUDPLQHHWF
2UDOSUHGQLVRQHVKRUWWHUPLHGD\VWUHDWPHQWPD\EHDGGHGDWLQYHVWLJDWRU¶V
GLVFUHWLRQ
$Q\ RI WKH IROORZLQJ DGGLWLRQDO WKHUDSLHV FDQ EH SUHVFULEHG WR KHOS ZLWK UDVK PLQRF\FOLQH
EDFWULPWRSLFDOWHWUDF\FOLQHWRSLFDOFOLQGDP\FLQWRSLFDOVLOYHUVXOIDGLD]LQHGLSKHQK\GUDPLQH
RUDO SUHGQLVRQH VKRUW FRXUVH DW GLVFUHWLRQ RI LQYHVWLJDWRU 6\VWHPLF DQG WRSLFDO WUHDWPHQW
VKRXOG EH LQLWLDWHG DW WKH VWDUW RI &7&$( *UDGH  UDVK DQG FRQWLQXH XQWLO LPSURYHPHQW RU
UHVROXWLRQWR&7&$(*UDGH,IJUDGHUDVKSHUVLVWVIRUGD\VGHVSLWHWUHDWPHQWDQGLV
SRRUO\WROHUDWHGE\WKHSDWLHQWWKHLQYHVWLJDWRUPD\FKRRVHWRSDXVHWUHDWPHQWIRUXSWR
GD\VIROORZHGE\DUHGXFWLRQLQWKHGRVHRIDIDWLQLE
&7&$(*UDGHUDVK7UHDWPHQWDOJRULWKPVKRXOGIROORZ&7&$(*UDGHUDVKDOJRULWKPDV
RXWOLQHGDERYHZLWKWKHH[FHSWLRQRID6HYHUH5DVKGHILQHGDVRXWOLQHGEHORZ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
6HYHUH*UDGHUDVK,QWKHHYHQWRIVHYHUHJHQHUDOL]HGHU\WKURGHUPDRUPDFXODUSDSXODRU
YHVLFXODU HUXSWLRQ GHVTXDPDWLRQ FRYHULQJ PRUH WKDQ  RI ERG\ VXUIDFH DUHD %6$
WUHDWPHQW ZLWK DIDWLQLE DQG GDVDWLQLE VKRXOG EH SDXVHG XQWLO UHFRYHU\ WR &7&$( *UDGH 
7KLVLVLQDFFRUGDQFHZLWK/DFRXWXUHHWDO([SHUW5HY$QWLFDQFHU7KHU7UHDWPHQW
VKRXOGEHUHVXPHGDWDUHGXFHGGRVHSHU$SSHQGL[³3DSXORSXVWXODU6NLQ5DVK´,I&7&$(
*UDGH  UDVK GRHV QRW UHVROYH WR &7&$( *UDGH  DIWHU  GD\V RI VWRSSLQJ DIDWLQLE
WUHDWPHQW DQG GHVSLWH RSWLPDO VXSSRUWLYH FDUH WKH SDWLHQW VKRXOG QRW UHFHLYH DQ\ IXUWKHU
WUHDWPHQWZLWKDIDWLQLEDQGWKH(QGRI7UHDWPHQWYLVLWVKRXOGEHVFKHGXOHG
&7&$( *UDGH  3DWLHQWV H[SHULHQFLQJ *UDGH  VNLQ WR[LFLW\ VKRXOG UHFHLYH H[SHGLHQW
PHGLFDO HYDOXDWLRQ DQG FHVVDWLRQ RI DOO VWXG\ GUXJV ,I 3KDVH ,$ GXULQJ '/7 HYDOXDWLRQ
ZLQGRZD'/7ZLOOEHUHJLVWHUHG2WKHUZLVH*UDGHUDVKWKDWKDVQRWLPSURYHGWRE\
GD\VVKRXOGEHGLVFRQWLQXHGIURPVWXG\DQG(27SHUIRUPHG

'LDUUKHD
2UDOK\GUDWLRQLVHVVHQWLDOUHJDUGOHVVRIVHYHULW\DSSURSULDWHUHK\GUDWLRQ/PGD\SOXV
HTXLYDOHQWRIDFWXDOIOXLGORVVDQGHOHFWURO\WHUHSODFHPHQWKDVWREHHQVXUHGLQWKHHYHQWRI
&7&$( *UDGH  DQG *UDGH  DGYHUVH HYHQWV 6HH ³$SSHQGL[ 0DQDJHPHQW RI 'LDUUKHD´
3DUWLFLSDQWVVKRXOGEHFRXQVHOHGWRSXUFKDVHRUUHFHLYHSUHVFULSWLRQVIRU,PRGLXPEHFDXVHRI
WKHOLNHOLKRRGRIH[SHULHQFLQJDQ\HSLVRGHRIGLDUUKHD7KLVFRXQVHOLQJVKRXOGWDNHSODFHDW
&'WKHLQLWLDWLRQRIVWXG\GUXJ
)RU*UDGHLIDQ\GLDUUKHDLVH[SHULHQFHG&7&$(*UDGHWZRPJORSHUDPLGHWDEOHWV
VKRXOGEHWDNHQLPPHGLDWHO\IROORZHGE\RQHPJWDEOHWZLWKHYHU\ORRVHERZHOPRYHPHQW
XSWRDPD[LPXPGDLO\GRVHRIWDEOHWVPJ%RWKGDVDWLQLEDQGDIDWLQLEVKRXOGFRQWLQXH
DW WKH FXUUHQW GRVHV ,Q WKH HYHQW RI GLDUUKHD SDWLHQWV VKRXOG EH DGYLVHG WR DYRLG ODFWRVH
FRQWDLQLQJ SURGXFWV RU DQ\ IRRGV NQRZQ WR DJJUDYDWH GLDUUKHD ,Q SDUWLFXODU VSLF\ IRRGV
VKRXOGEHDYRLGHGDQGPHDOVGLYLGHGWRVPDOOPHDOVSHUGD\
)RU*UDGHSDWLHQWVVKRXOGEHJLQORSHUDPLGHPJDWILUVWRQVHWIROORZHGE\PJT±
KRXUVXQWLOGLDUUKHDIUHHIRUKRXUV/RPRWLOPJWDEOHWV32TKUVKRXOGEHDGGHG
DW WKH GLVFUHWLRQ RI WKH WUHDWLQJ SK\VLFLDQ DQG LV VWURQJO\ UHFRPPHQGHG LI SDWLHQWV KDYH
SUHYLRXVO\ EHHQ WUHDWHG ZLWK ORSHUDPLGH %RWK GDVDWLQLE DQG DIDWLQLE VKRXOG FRQWLQXH DW WKH
FXUUHQWGRVHV,QWUDYHQRXVIOXLGVPD\EHFRQVLGHUHGLQVHOHFWFDVHV
)RU *UDGH  RU &7&$( *UDGH  GLDUUKHD ODVWLQJ   GD\V  KRXUV GHVSLWH DGHTXDWH
DQWLGLDUUKHDOWUHDWPHQWLQ3KDVH,%DIDWLQLEDQGGDVDWLQLEPXVWEHSDXVHGXQWLOUHFRYHU\WR
&7&$(*UDGH0D[LPDOPHGLFDOVXSSRUWZLWK,PRGLXPDQG/RPRWLOVKRXOGEHIROORZHGDV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
LQ*UDGH2IQRWHLI*UDGHGLDUUKHDSHUVLVWVDIWHUGD\VRIRSWLPDOVXSSRUWLYHFDUHDQG
FHVVDWLRQRIVWXG\GUXJ'/7VKRXOGEHUHJLVWHUHG6HH'/7GHILQLWLRQDQGZLOOEHUHFRUGHG
DQG(27SHUIRUPHGZLWKDSSURSULDWHLQWHUYDO
$IWHUUHVROXWLRQRI*UDGHGLDUUKHDWRdERWKGDVDWLQLEDQGDIDWLQLEFDQEHUHLQWURGXFHGDW
WKHUHGXFHGGRVHDFFRUGLQJWRWKHGRVHUHGXFWLRQVFKHPHRIGD\VRQGD\VRIIDORQJZLWK
SURSK\ODFWLF ORSHUDPLGH DQGRU ORPRWLO ,I JUDGH  GLDUUKHD DJDLQ UHFXUV WKH SDWLHQW DJDLQ
WHPSRUDULO\GLVFRQWLQXHGIURPERWKDJHQWVDQGIRU3KDVH,$D'/7PXVWEHUHJLVWHUHG)RU
3KDVH,%ZKHQGLDUUKHDLPSURYHVWR*UDGHdWKHSDWLHQWPD\DJDLQUHDWWHPSWGDVDWLQLE	
DIDWLQLE,IGHVSLWHRSWLPDOVXSSRUWLYHFDUHDQGDWUHDWPHQWSDXVHGLDUUKHDGRHVQRWUHVROYHWR
&7&*UDGHZLWKLQGD\VWKHSDWLHQWPXVWQRWUHFHLYHDQ\IXUWKHUDIDWLQLERUGDVDWLQLE
WUHDWPHQWDQG(27VKRXOGEHSHUIRUPHGDWDSSURSULDWHLQWHUYDO
)RU*UDGHGLDUUKHDD'/7VKRXOGEHUHJLVWHUHGDQGSDWLHQWVVKRXOGEHGLVFRQWLQXHGIURP
VWXG\WUHDWPHQW1RUHDWWHPSWRIWUHDWPHQWDWWKHQH[WORZHVWGRVHFRKRUWLVSHUPLWWHG

1DXVHDDQG9RPLWLQJ
1DXVHDDQG YRPLWLQJPD\VLJQLILFDQWO\DIIHFWSDWLHQWV¶DGKHUHQFHWRWKHWUHDWPHQWDQGWKHLU
TXDOLW\ RI OLIH ,Q RUGHU WR UHGXFH WKH RFFXUUHQFH DQG WKH LQWHQVLW\ RI HPHVLV WKH SDWLHQWV
VKRXOG EH WUHDWHG ZLWK DQ DJJUHVVLYH DQWLHPHWLF SURJUDP DV UHFRPPHQGHG LQ $SSHQGL[
0DQDJHPHQWRI1DXVHDDQG9RPLWLQJ
,QFDVHRIQDXVHDDQGRUYRPLWLQJ&7&$(JUDGHDSSURSULDWHK\GUDWLRQ/PGD\SOXV
K\GUDWLRQGHILFLWPXVWEHHQVXUHG

3XOPRQDU\
8QH[SODLQHGG\VSQHDHLWKHUQHZRUSURJUHVVLYHVKRXOGEHDJJUHVVLYHO\HYDOXDWHG&DUHIXO
DVVHVVPHQW RI DOO SDWLHQWV ZLWK DQ DFXWH RQVHW DQGRU XQH[SODLQHG ZRUVHQLQJ RI SXOPRQDU\
V\PSWRPV G\VSQHD FRXJK IHYHU VKRXOG EH SHUIRUPHG WR H[FOXGH ,/' %RWK DIDWLQLE DQG
GDVDWLQLE VKRXOG EH LQWHUUXSWHG SHQGLQJ LQYHVWLJDWLRQ RI WKHVH V\PSWRPV ,I LQWHUVWLWLDO OXQJ
GLVHDVH LV GLDJQRVHG VWXG\ GUXJ VKRXOG EH SHUPDQHQWO\ GLVFRQWLQXHG DQG DSSURSULDWH
WUHDWPHQWLQVWLWXWHGLQFOXGLQJYHUEDOGLVFXVVLRQZLWKDQGUHIHUUDOWRDSXOPRQRORJLVW
,IGRVHVKDYHWREHKHOGWKRVHGRVHVZLOOEHVNLSSHGDQGZLOOUHPDLQRQVFKHGXOH$Q\GRVHV
WKDWDUHLQDGYHUWHQWO\VNLSSHGZLOOQRWEHUHSODFHGDQGWKHSDWLHQWZLOOUHPDLQRQVFKHGXOH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

)OXLG,PEDODQFH
'DVDWLQLEKDVEHHQUHSRUWHGWRFDXVHWUDQVXGDWLYHSOHXUDOHIIXVLRQVLQSDWLHQWVZLWKFDQFHU
)RU QHZ RU ZRUVHQLQJ SOHXUDO HIIXVLRQV LQ SDWLHQWV GLXUHWLFV DQGRU D EULHI FRXUVH RI
FRUWLFRVWHURLGVVKRXOGEHLQVWLWXWHGDFFRUGLQJWKHUHFRPPHQGHGJXLGHOLQHV6HH³$SSHQGL[
0DQDJHPHQW RI /RFDOL]HG (GHPD´  )RU HIIXVLRQ WKDW FRQWLQXH RU ZRUVHQ GHVSLWH XVH RI
GLXUHWLFVFRUWLFRVWHURLGV WKRUDFHQWHVLV VKRXOG EH SHUIRUPHG WR FRQILUP WKH QDWXUH RI WKH
HIIXVLRQLQFOXGLQJ/'+DQGSURWHLQOHYHOVDQGF\WRORJ\VKRXOGEHHYDOXDWHGWRFRQILUPWKDWWKH
HIIXVLRQLVQRWPDOLJQDQW)RUV\PSWRPDWLFHIIXVLRQVWKDWUHFXUDIWHUWKRUDFHQWHVLVSDWLHQWV
VKRXOGEHFRQVLGHUHGIRUHLWKHULSOHXURGHVLVZLWKWDOFRUEHWDGLQHRULLLQGZHOOLQJFKHVWWXEH
7KLVGHFLVLRQZLOOEHOHIWWRWKHGLVFUHWLRQRIWKHWUHDWLQJSK\VLFLDQ3DWLHQWVZKRGHYHORSJUDGH
SOHXUDOHIIXVLRQVV\PSWRPDWLFDQGVXSSOHPHQWDOR[\JHQ!WKHUDSHXWLFWKRUDFHQWHVLVWXEH
GUDLQDJHRUSOHXURGHVLVVKRXOGKDYHGDVDWLQLEKHOGIRUXSWRGD\VDQGWKHQPD\UHVWDUW
GDVDWLQLE DW WKH QH[W ORZHU GRVH  3DWLHQWV ZKR WKHQ UHGHYHORS JUDGH  SOHXUDO HIIXVLRQV
VKRXOGEHGLVFRQWLQXHGIURPGDVDWLQLEDQGDIDWLQLEDQG'/7UHJLVWHUHG

*HQHUDO'RVH0RGLILFDWLRQV%H\RQG&\FOH
*LYHQ WKH FKURQLF QDWXUH RI WKHVH PHGLFDWLRQV DQG WKH SRVVLELOLW\ RI GHYHORSLQJ '/7 RU
LQWROHUDEOH WR[LFLWLHV EH\RQG F\FOH  DOORZDQFHV DUH PDGH IRU GRVH PRGLILFDWLRQV EH\RQG
WKRVHGLVFXVVHGDERYHIRUDIDWLQLEDQGRUGDVDWLQLE,IDSDWLHQWGHYHORSVD'/7RULQWROHUDEOH
JUDGH  RU  QRQKHPDWRORJLF WR[LFLW\ DIWHU F\FOH  GRVH PRGLILFDWLRQV RI DIDWLQLE DQGRU
GDVDWLQLE DUH DOORZDEOH DW WKH WUHDWLQJ SK\VLFLDQ¶V GLVFUHWLRQ 7UHDWPHQW ZLWK DIDWLQLE DQGRU
GDVDWLQLEFDQEHZLWKKHOGXQWLOWR[LFLW\UHVROYHVWROHVVWKDQRUHTXDOWRJUDGHIRUSDWLHQWV
ZLWK GRFXPHQWHG '/7 RU ZKHQ WKH SDWLHQW¶V LQWROHUDEOH WR[LFLW\ UHVROYHV 7KH GRVH RI WKH
ZLWKKHOG FRPSRXQGV FDQ WKHQ EH PRGLILHG DW WKH WUHDWLQJ SK\VLFLDQ¶V GLVFUHWLRQ  6HH
$SSHQGL[7R[LFLW\7DEOHVIRUJHQHUDOUHFRPPHQGDWLRQV)RUGRVHLQWHUUXSWLRQRIDIDWLQLEUH
WUHDWPHQWFDQHLWKHUEHDWWKHVDPHGRVHRUUHGXFHGRQHOHYHOYL]IURPPJGDLO\WRPJ
GDLO\)RUGRVHLQWHUUXSWLRQRIGDVDWLQLEUHWUHDWPHQWFDQEHDWWKHVDPHGRVHRUUHGXFHGRQH
OHYHO YL] IURP  PJ GDLO\ WR  PJ GDLO\  3DWLHQWV ZKR IDLO WR UHFRYHU WR JUDGH  RU
WROHUDEOHJUDGHIURPDWUHDWPHQWUHODWHG$(ZLWKLQGD\VRUWKRVHZKRUHTXLUHDWKLUGGRVH
UHGXFWLRQVKRXOGGLVFRQWLQXHWKHUDS\



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

2%6(59$7,216

0HWKRGRORJ\

3ODVPD&ROOHFWLRQDQG3URFHVVLQJ
%ORRGVDPSOHVDUHWREHFROOHFWHGIURPDQLQGZHOOLQJFDWKHWHURUE\GLUHFWYHQLSXQFWXUH,ID
FDWKHWHULVXVHGIRUEORRGFROOHFWLRQWKHQDSSUR[LPDWHO\P/RIEORRGVKRXOGEHZLWKGUDZQ
LQLWLDOO\DQGGLVFDUGHG

&RUUHODWLYH6FLHQFH

6WRUHG3ODVPD6DPSOHV
3UHYLRXVVWXGLHVKDYHLQGLFDWHGWKDW65&LQKLELWRUVFDQUHGXFHWXPRUSURGXFWLRQRIS65&
9(*)DQG,/WKDWDUHLPSRUWDQWIDFWRUVIRUWXPRUDQJLRJHQHVLV%ORRGZLOOEHFROOHFWHGDW
WKHWLPHRIVFUHHQLQJRUGD\DQGDJDLQRQGD\WRDVVHVVIRUIXWXUHFRUUHODWLYHPDUNHUV
ZLWK D SXUSOHWRS ('7$ WXEH  7KHVH VDPSOHV ZLOO EH SURFHVVHG DQG DQDO\]HG IRU SODVPD
EDVHG PROHFXODU PDUNHUV 6HUXP3ODVPD ZLOO EH FHQWULIXJHG IRU  PLQXWH DW  USP WR
SHOOHW DQ\ IORDWLQJ GHEULVFHOOV DQG WKHQ WUDQVIHUUHG WR D IUHVK PLFURFHQWULIXJH WXEH DQG
LPPHGLDWHO\IUR]HQDQGVWRUHGDW±&
7KHVH VDPSOHV ZLOO EH SURFHVVHG DQG DQDO\]HG IRU SODVPDEDVHG PROHFXODU PDUNHUV
6SHFLILFDOO\SODVPDLVH[WUDFWHGDQGDVVHVVHGIRUHSLGHUPDOJURZWKIDFWRUUHFHSWRU(*)5
PXWDWLRQW\SHDQGFRS\QXPEHU7KLVWHVWLQJLVGRQHXVLQJGLJLWDOGURSOHW3&5ZLWKVSHFLILFV
SULPHUVIRU(*)5/5([RQGHODQG707KLVWHVWLQJLVSHUIRUPHGE\FROODERUDWRU
%LRGHVL[ XVLQJ DQ HVWDEOLVKHG DQG H[HFXWHG PDWHULDO WUDQVIHU DJUHHPHQW %LRGHVL[0RIILWW
&RGHGSODVPDDOLTXRWVDPSOHVDUHVKLSSHGWRFROODERUDWRUE\0RIILWW7LVVXH&RUH
DQGFRGHGFVYILOHFRQWDLQLQJWKHQXPEHURIUHOHYDQWUHDGVSHUSRROHGDOLTXRWLVWKHQVHQW
EDFNWRWKHLQYHVWLJDWRUE\WKHFROODERUDWRU


5DGLRPLF$QDO\VLVIRU,PDJLQJ3UHGLFWLYH0DUNHUV
7KHDLPLVWRXVHVWDWHRIWKHDUWLPDJHDFTXLVLWLRQDQGIHDWXUHH[WUDFWLRQDQDO\VLVWRREWDLQD
UDGLRPLFSURILOHWKDWSUHGLFWVWKHFOLQLFDODFWLYLW\RIGXDOW\URVLQHNLQDVHLQKLELWRUVLQSDWLHQWV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
ZLWK16&/&$OO5DGLRPLFVDQDO\VLVZLOOEHSHUIRUPHGUHWURVSHFWLYHO\7ULDOSDUWLFLSDQWVZLOO
QRWEHVXEMHFWWRDQ\DGGLWLRQDOGLUHFWWHVWLQJLPDJLQJRUFKDUJHVDVSDUWRIWKLVFRPSRQHQWRI
WKHFRUUHODWLYHVFLHQFH2QO\LPDJLQJGDWDDYDLODEOHYLD0RIILWW3$&6V\VWHPZLOOEHDQDO\]HG
DV SDUW RI WKLV FRUUHODWLYH HQGSRLQW 3DUWLFLSDQWV DUH HQFRXUDJHG WR KDYH EDVHOLQH DQG
VXUYHLOODQFHLPDJLQJSHUIRUPHGDWWKH&DQFHU&HQWHU

$VVHVVPHQW
7XPRUUDGLRPLFVLQYROYHVWKHKLJKWKURXJKSXWVHJPHQWDWLRQRIWXPRUYROXPHVIURPDQDWRPLF
LPDJHVWKHH[WUDFWLRQRITXDQWLWDWLYHIHDWXUHVIURPUHQGHUHGYROXPHVZKLFKDUHXVHGWRZULWH
DUHSRUW6HJPHQWDWLRQLVSURYLGHGE\DUHVHDUFKVFLHQWLVW'U9.XPDULQFRQVXOWDWLRQZLWKD
UDGLRORJLVW'U(2XWZDWHUDQGRU'U'.OLSSHQVWHLQDQGDFRPSXWHUH[SHUW'U<XKXD*X
6HJPHQWDWLRQLVDFKLHYHGWKURXJKDRQHFOLFNUHJLRQJURZLQJURXWLQH%HFDXVHWKLVRIWHQIDLOV
WR VHJPHQW WKH WXPRU RQ ILUVW SDVV PXOWLSOH RSHUDWRU LQSXWV DUH UHTXLUHG 7R PLQLPL]H WKH
RSHUDWRULQSXWVDQGRSWLPL]HWKHVHJPHQWDWLRQZHGHYHORSHGDQDOJRULWKPWKDWSHUIRUPVWKH
UHJLRQJURZLQJIROORZHGE\UHJLRQVKULQNLQJ,QWKLVVKUXQNHQYROXPHGLIIHUHQWVHHGSRLQWV
DUHLQVHUWHGRQD&DUWHVLDQJULGDQGWKHVHDUHXVHGVLPXOWDQHRXVO\DVVHHGSRLQWV7KLVKDV
EHHQ UHSHDWHG  GLIIHUHQW WLPHV HDFK IRU  GLIIHUHQW SDWLHQWV 7KHVH UHVXOWV KDYH EHHQ
FRPSDUHGWRWKHVDPHOHVLRQVLQGHSHQGHQWO\VHJPHQWHGE\GLIIHUHQWUDGLDWLRQRQFRORJLVWV
ZLWKDOLQHDUFRUUHODWLRQFRHIILFLHQWRI:RUNLVRQJRLQJWRLPSURYHWKHPXOWLVHHGSRLQW
VHJPHQWDWLRQ )RU WKH FXUUHQW VWXG\ VHJPHQWHG YROXPHV DUH RYHUUHDG E\ WKRUDFLF
UDGLRORJLVWV2YHUIHDWXUHVDUHH[WUDFWHGLQWKHUHSRUW
5HFRQVWUXFWHGGDWDZLOOEHXVHGWRGHWHUPLQH5(&,67UHVSRQVHLIDYDLODEOH&RGHGDQG
UHFRQVWUXFWHGGDWDZLOOEHVHQWWR0RIILWWIRUFHQWUDOUHYLHZZLWKDQQRWDWHGPDUNXSRIOHVLRQV
XVHGLQ5(&,67YPHDVXUHV,ISRVVLEOHZHZLOOHQGHDYRUWRREWDLQUDZXQUHFRQVWUXFWHG
GDWDIRUDUFKLYDOVWRUDJHDOWKRXJKWKHORJLVWLFVKDYH\HWWREHZRUNHGRXWDQGWKXVLVQRWD
FRPSRQHQWRIWKHSURWRFRO
)RU WKH SXUSRVH RI WKH 5DGLRPLF DQDO\VLV RQO\ WKH GLDJQRVWLF &(&7V REWDLQHG SULRU WR
WKHUDS\ DQG DW WKH WLPH RI GLVHDVH SURJUHVVLRQ ZLOO EH XWLOL]HG $GGLWLRQDO &(&7V ZLOO EH
REWDLQHG DV GHVFULEHG LQ WKH VWXG\ FDOHQGDU IRU WKH GHWHUPLQDWLRQ RI WKH SULPDU\ DQG
VHFRQGDU\SURWRFROREMHFWLYHV

'DWD5HFRUGLQJ
',&20 GDWD ZLOO EH WUDQVIHUUHG WR 0&& YLD &'V RU VHFXUH )73 DQG WKH UHVHDUFK WHDP
KHDGHGE\(ULF.2XWZDWHU0'ZLOOSURFHHGWRVHJPHQW+HZLOORYHUUHDGWKHVHVHJPHQWHG
YROXPHV WR HQVXUH FRPSOLDQFH ZLWK VWDQGDUG SUDFWLFH )URP WKHVH VHJPHQWHG OHVLRQV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
YROXPHV ZLOO EH UHQGHUHG DQG UHSRUWV JHQHUDWHG RQ DOO  TXDQWLWDWLYH IHDWXUHV $ VHFRQG
OHYHORI4XDOLW\$VVXUDQFHZLOOLQYROYHFRPSDULVRQRIWKH5(&,67YPHWULFVJHQHUDWHGE\
DXWRPDWHGIHDWXUHH[WUDFWLRQWRWKHYDOXHVSURYLGHGE\LQGLYLGXDOUDGLRORJLVWVDWWKHLQLWLDWLQJ
VLWH$WWKH0&&WKHVHGDWDZLOOEHSDUVHGWRDQVZHUWKHIROORZLQJTXHVWLRQV
,VWKHUDQJHRIYDOXHVIRU6&/&IHDWXUHVVLPLODURUGLIIHUHQWWRWKDWREVHUYHGIRU16&/&"
&DQSUHWKHUDS\IHDWXUHVEHXVHGWRSUHGLFWUHVSRQVHWR7.,V"
&DQFKDQJHVLQIHDWXUHVIROORZLQJWKHUDS\EHXVHGWRSUHGLFWRXWFRPHWR7.,V"
'RDQ\&7IHDWXUHVFRUUHODWHZLWKPROHFXODUELRPDUNHUVEHLQJFROOHFWHGLQWKLVVWXG\"
'RELRPDUNHUVDGGWRWKHGLDJQRVWLFRUSUHGLFWLYHDFFXUDF\RIWKHLPDJHIHDWXUHV"
$UHDQ\IHDWXUHVPRUHUHSURGXFLEO\FKDQJHGFRPSDUHGWR5(&,67"
'DWDJHQHUDWHGIURPWKHVHPHWKRGVZLOOEHHQWHUHGLQWRDQDVFHQW&D%,*FRPSODLQWGDWDEDVH
WKDWZLOOEHPDGHDFFHVVLEOHE\WKHWULDOVWDWLVWLFLDQ

$VVHVVPHQWRI6DIHW\

6DIHW\(YDOXDWLRQ2YHUYLHZ
3DWLHQWVDUHVHHQDWVFUHHQLQJ&'&'IRUWKHILUVWF\FOHLQ3KDVH,$IRUHYDOXDWLQJRI
WR[LFLW\  7KLV LQFOXGHV D FRPSOHWH KLVWRU\ DQG SK\VLFDO H[DP LQFOXGLQJ ZHLJKW YLWDO VLJQV
DVVHVVPHQW RI SHUIRUPDQFH VWDWXV DQG ODERUDWRU\ HYDOXDWLRQ LQFOXGLQJ FRPSOHWH &%& ZLWK
GLIIHUHQWLDOSODWHOHWFRXQWDQG&03
)RU SXUSRVHV RI GRVH HVFDODWLRQ RQO\ '/7V FROOHFWHG GXULQJ WKH ILUVW  GD\ F\FOH ZLOO EH
FROOHFWHGDQGDQDO\]HG+RZHYHUGXULQJF\FOHDQGIRUWUHDWPHQWEH\RQGF\FOH'/7VZLOO
FRQWLQXH WR EH FROOHFWHG GXULQJ WKH YLVLWV WR WKH WUHDWLQJ SK\VLFLDQ VHH 7DEOH  'RVH
(VFDODWLRQ :KLOH WKHUH LV QR IRUPDO SURFHVV IRU DQDO\]LQJ WKHVH GDWD WKHVH GDWD ZLOO EH
SHULRGLFDOO\UHYLHZHGE\WKHVWXG\3,WRDVVHVVWKHSRWHQWLDORIGHOD\HGWR[LFLWLHVRIWKHUDS\
6HH 6HFWLRQ '/7 GHILQLWLRQ IRU GHILQLWLRQ RI '/7 ,Q FDVHV LQ ZKLFK D *UDGH  WR[LFLW\ LV
DZDLWLQJUHVROXWLRQ ZLWKVXSSRUWLYHFDUHIRU'/7GHWHUPLQDWLRQWKHGRVHHVFDODWLRQGHFLVLRQ
ZLOOEHSRVWSRQHGXQWLOWKHHYDOXDWLRQWLPHIRU'/7GHWHUPLQDWLRQKDVHODSVHG
7R[LFLW\LVJUDGHGDFFRUGLQJWRWKH1DWLRQDO&DQFHU,QVWLWXWH&RPPRQ7HUPLQRORJ\&ULWHULDIRU
$GYHUVH(YHQWV1&,&7&$(YHUVLRQ
KWWSFWHSFDQFHUJRYIRUPV&7&$(YSGI



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

$GYHUVH(YHQWV
'XULQJ WKH VFUHHQLQJ SKDVH RI WKH WULDO WKH SDWLHQW¶V FRQGLWLRQ ZLOO EH DVVHVVHG HJ
GRFXPHQWDWLRQ RI KLVWRU\  FRQFRPLWDQW GLDJQRVHV DQG GLVHDVHV DQG VXEVHTXHQWO\ DOO
UHOHYDQWFKDQJHVIURPEDVHOLQHZLOOEHQRWHG
7KHGHILQLWLRQRIDGYHUVHHYHQWV$(VDQGVHULRXVDGYHUVHHYHQWV6$(VFDQEHIRXQGLQ
VHFWLRQ³'HILQLWLRQRI$GYHUVH(YHQWV´7KHPRVWFRPPRQDGYHUVHHYHQWVDUHH[SHFWHGWR
EHJDVWURLQWHVWLQDOGLDUUKHDQDXVHDYRPLWLQJSDSXORSXVWXODUVNLQUDVKDQGIOXLGUHWHQWLRQ
7KHPDQDJHPHQWRIWKHVHWR[LFLWLHVLVRXWOLQHGLQ$SSHQGL[7R[LFLW\7DEOHV
3DWLHQWV ZLOO EH UHTXLUHG WR UHSRUW VSRQWDQHRXVO\ DQ\ DGYHUVH HYHQWV $(V DV ZHOO DV WKH
GDWHVRIRQVHWDQGHQGRIWKHVHHYHQWV6SHFLILFTXHVWLRQVZLOOEHDVNHGZKHUHYHUUHTXLUHGRU
XVHIXOWRPRUHSUHFLVHO\GHVFULEHDQ$(DQGWRDOORZDJUDGLQJDFFRUGLQJWR&7&$(9HUVLRQ
$FDUHIXOO\ZULWWHQUHFRUGRIDOO$(VVKDOOEHNHSWE\WKHLQYHVWLJDWRULQFKDUJHRIWKHWULDO
5HFRUGVRI$(VVKDOOLQFOXGHGDWDRQWKHGDWHRIRQVHWHQGGDWHDQG&7&$(JUDGLQJRIWKH
HYHQWDVZHOODVDQ\WUHDWPHQWRUDFWLRQUHTXLUHGIRUWKHHYHQWDQGLWVRXWFRPH5HJXODUDQG
FRQWLQXLQJDVVHVVPHQWRIVDIHW\ZLOOEHSHUIRUPHGDWOHDVWRQFHSHUFRXUVHGXULQJWKHILUVWVL[
FRXUVHVDQGHYHU\WKUHHZHHNVWKHUHDIWHU'RVHUHGXFWLRQVFKHPHVDUHSURYLGHGLQVSHFLILHG
WDEOHV6HH0DQDJHPHQWRI$GYHUVH(YHQWVIRUSDWLHQWVZKRH[SHULHQFHVSHFLILHGDGYHUVH
HYHQWV DQG ZKR DW WKH GLVFUHWLRQ RI WKH LQYHVWLJDWRU FRXOG GHULYH EHQHILW IURP FRQWLQXLQJ
WUHDWPHQWRQWKHSURWRFRO
x
$GYHUVH HYHQWV ZKLFK DUH QRW \HW UHFRYHUHG DW WKH (QG RI 7UHDWPHQW YLVLW ZLOO EH
IROORZHGXS XQWLOUHFRYHU\RULQFDVHRISHUVLVWHQFHVXIILFLHQWFKDUDFWHUL]DWLRQRIWKH
WR[LFHIIHFWVKDVEHHQDFKLHYHGWKHQ%ULVWRO0\HUV6TXLEEDQG%RHKULQJHU,QJHOKHLP
*PE+PD\DJUHHQRWWRSXUVXHWKHPIXUWKHU
x
$GYHUVHHYHQWVWKDWRFFXUEHWZHHQFHVVDWLRQRIWUHDWPHQWDQG(QGRI7UHDWPHQWYLVLW
ZLOORQO\EHUHSRUWHGLIWKH\DUHFRQVLGHUHGUHODWHGWRWULDOPHGLFDWLRQRUSURFHGXUHVE\
WKH ,QYHVWLJDWRU 7RWDO REVHUYDWLRQDO SHULRG  IRU $( UHSRUWLQJ LV  GD\V DIWHU
GLVFRQWLQXDWLRQRIVWXG\GUXJ
x
$GYHUVH HYHQWV RFFXUULQJ DIWHU WKH (QG RI 7UHDWPHQW YLVLW ZLOO EH UHSRUWHG RQO\ LI
FRQVLGHUHGVHULRXV6$(VDQGUHODWHGWRWULDOPHGLFDWLRQRUSURFHGXUHV
'DWD UHJDUGLQJ GHDWKV ZKLFK DUH QRW UHODWHG WR WULDO PHGLFDWLRQ ZLOO EH FROOHFWHG IRU WKH
SXUSRVHVRIDVVHVVLQJWKHRYHUDOOVXUYLYDOHQGSRLQWEXWWKHVHGHDWKVZLOOQRWEHUHSRUWHGDV
6$(V



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

7LPH3HULRG5HSRUWLQJ5HTXLUHPHQWV
x
%HJLQQLQJRI7UHDWPHQWWR(QGRI7UHDWPHQWYLVLW5HSRUWDOO$(VDQG6$(VUHJDUGOHVV
RIUHODWHGQHVV7KLVLQFOXGHVDOOGHDWKV
x
(QGRI7UHDWPHQWYLVLWWRILQDOREVHUYDWLRQ5HSRUW$(VDQG6$(VZKLFKDUHFRQVLGHUHG
UHODWHGWRVWXG\WUHDWPHQWRUSURFHGXUHV
'HDWK VKRXOG QRW EH UHSRUWHG DV DQ 6$( XQOHVV FRQVLGHUHG UHODWHG WR VWXG\ WUHDWPHQW RU
SURFHGXUHVEHFDXVHGHDWKLVDQHQGSRLQWDQGZLOOEHIROORZHGXSVHSDUDWHO\6HH6HFWLRQ
6HFWLRQ$GYHUVH(YHQW5HSRUWLQJ3HULRGIRUFRPSUHKHQVLYHUHYLHZRIUHSRUWLQJSURFHGXUHV
'HILQLWLRQV DQG UHTXLUHPHQWV IRU GRFXPHQWDWLRQ DQG UHSRUWLQJ RI $(V DQG VHULRXV DGYHUVH
HYHQWV6$(VGXULQJDWULDOLQ2Q&RUHDUHSURYLGHGLQ³'HILQLWLRQRI$GYHUVH(YHQWV´

+RVSLWDOL]DWLRQ
3DWLHQWV PD\ EH KRVSLWDOL]HG IRU DGPLQLVWUDWLYH UHDVRQV GXULQJ WKH WULDO 7KHVH DQG RWKHU
KRVSLWDOL]DWLRQVSODQQHGDWWKHEHJLQQLQJRIWKHWULDOQHHGQRWEHUHSRUWHGDV6$(VLIWKH\KDYH
EHHQGRFXPHQWHGDWWKHVFUHHQLQJYLVLWDQGKDYHEHHQSHUIRUPHGDVSODQQHG
&KDQJHV REVHUYHG LQ VDIHW\ WHVWV LQFOXGLQJ EORRG SUHVVXUH SXOVH UDWH HOHFWURFDUGLRJUDP
(.*DQGODERUDWRU\WHVWVZLOOEHUHFRUGHGDV$(VDQGJUDGHGDFFRUGLQJWR&7&$(LIWKH\
DUHQRWDVVRFLDWHGZLWKDQDOUHDG\UHSRUWHG$(V\PSWRPRUGLDJQRVLVDQGPHHWDWOHDVWRQH
RIWKHIROORZLQJFULWHULD
x
$FWLRQ LV UHTXLUHG DQG WDNHQ ZLWK WKH LQYHVWLJDWLRQDO GUXJ LH GRVH UHGXFWLRQ RU
WUHDWPHQWGLVFRQWLQXDWLRQ
x
7UHDWPHQWLVUHTXLUHGLHDFRQFRPLWDQWPHGLFDWLRQLVDGGHGRUFKDQJHG

:RUVHQLQJRISUHH[LVWLQJFRQGLWLRQV
([SHFWHGIOXFWXDWLRQVRUH[SHFWHGGHWHULRUDWLRQRIWKHXQGHUO\LQJGLVHDVHZLOOQRWEHUHFRUGHG
DVDQ$(,ISURJUHVVLYHGLVHDVHRFFXUVDQGLVDVVRFLDWHGZLWKV\PSWRPVRUPHHWVRQHRIWKH
VHULRXVQHVVFULWHULDWKHVLJQVDQGV\PSWRPVRISURJUHVVLYHGLVHDVH ZLOOEHUHSRUWHGDVDQ
DGYHUVHHYHQWRUDVHULRXV$(LIDSSOLFDEOH
7KHRQO\H[FHSWLRQWRWKHDERYHLVLQWKHHYHQWRIDGHDWKZKLFKLVDWWULEXWHGWRSURJUHVVLYH
GLVHDVHEXWZKHUHWKHVLJQVDQGV\PSWRPVDUHQRWDYDLODEOH,QWKLVVLWXDWLRQLWLVDFFHSWDEOH
WRUHSRUWWKHSURJUHVVLYHGLVHDVHDVWKHVHULRXV$(



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
$SUHH[LVWLQJFRQGLWLRQSUHVHQWDWEDVHOLQHZKLFKUHPDLQVXQFKDQJHGGXULQJWKHWULDOGRHV
QRW QHHG WR EH UHFRUGHG DV DGYHUVH HYHQW +RZHYHU DQ\ ZRUVHQLQJ RI DQ\ SUHH[LVWLQJ
EDVHOLQH FRQGLWLRQ VKRXOG EH UHSRUWHG DV DQ DGYHUVH HYHQW ([DPSOHV RI ZRUVHQLQJ RI D
SUHH[LVWLQJFRQGLWLRQWKDWVKRXOGEHUHFRUGHGDVDQ$(DUHJLYHQEHORZ
x
:RUVHQLQJRIFRQGLWLRQPHHWVWKHFULWHULDIRUDQ6$(
x
$FWLRQ LV WDNHQ ZLWK WKH LQYHVWLJDWLRQDO GUXJ LH GRVH LV UHGXFHG RU WUHDWPHQW LV
GLVFRQWLQXHG
x
7UHDWPHQWLVUHTXLUHGFRQFRPLWDQWPHGLFDWLRQLVDGGHGRUFKDQJHG
x
7KH LQYHVWLJDWRU EHOLHYHV D SDWLHQW KDV VKRZQ D FOHDU GHWHULRUDWLRQ IURP EDVHOLQH
V\PSWRPV

$VVHVVPHQWRIKHDOWKFDUHUHVRXUFHXVH
,ISDWLHQWVDUHKRVSLWDOL]HGGXHWRDGYHUVHHYHQWVWKHUHDVRQIRUKRVSLWDOL]DWLRQWKHGXUDWLRQ
RI KRVSLWDO VWD\ HPHUJHQF\ URRP DGPLVVLRQ DQG WLPH LQ WKH LQWHQVLYH FDUH XQLW ZLOO EH
GRFXPHQWHGLQ2Q&RUH$GYHUVHHYHQWUHODWHGRXWSDWLHQWYLVLWVDQGLQWHUYHQWLRQVZLOODOVREH
GRFXPHQWHG LQ 2Q&RUH ,QIRUPDWLRQ RQ FDUHJLYHU VXSSRUW KRPH FDUH KRVSLWDO DQG
RXWSDWLHQW YLVLWV RWKHU WKDQ VFKHGXOHG YLVLWV FROOHFWHG LQ WKH 2Q&RUH ZLOO LQIRUP RQ
KHDOWKFDUH UHVRXUFH XVH UHTXLUHG WR WUHDW WKH WULDO LQGLFDWLRQ DQG DGYHUVH HYHQWV REVHUYHG
GXULQJWKHWULDO

/DERUDWRU\LQYHVWLJDWLRQV
%ORRG VDPSOHV ZLOO EH FROOHFWHG DW WKH WLPH SRLQWV VSHFLILHG LQ WKH 6WXG\ &DOHQGDU DQG
DQDO\]HG LQ D ODERUDWRU\ IDFLOLW\ DW RU FORVH WR WKH LQYHVWLJDWLRQDO VLWH 6DIHW\ ODERUDWRU\
H[DPLQDWLRQV LQFOXGH KHPDWRORJ\ DQG ELRFKHPLVWU\ ,Q FDVH RI QHXWURSHQLD EORRG ZLOO EH
H[DPLQHGDVFOLQLFDOO\LQGLFDWHGDWWKHGLVFUHWLRQRIWKHLQYHVWLJDWRUXQWLOUHFRYHU\
)RU SDWLHQWV UHFHLYLQJ VWXG\ GUXJ WKH GHFLVLRQ WR FRQWLQXH WUHDWPHQW ZLOO EH EDVHG RQ
DVVHVVPHQWRIODERUDWRU\SDUDPHWHUV7KHUHIRUHWKHUHVXOWVRIWKHVHDVVHVVPHQWVVKRXOGEH
DYDLODEOHDQGDVVHVVHGRQWKHGD\RIWUHDWPHQWSULRUWRFRPPHQFLQJWUHDWPHQW
6DIHW\ODERUDWRU\DVVHVVPHQWZLOOLQFOXGHDWOHDVWWKHIROORZLQJSDUDPHWHUV
x
+HPDWRORJ\5HGEORRGFHOOFRXQW5%&QHXWURSKLOVKHPRJORELQKHPDWRFULWZKLWH
EORRGFHOOFRXQW:%&DQGGLIIHUHQWLDOSODWHOHWV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
x
%LRFKHPLVWU\ *OXFRVH VRGLXP SRWDVVLXP FDOFLXP FUHDWLQLQH DVSDUWDWH DPLQR
WUDQVIHUDVH $67 DODQLQH DPLQR WUDQVIHUDVH $/7 DONDOLQH SKRVSKDWDVH WRWDO
ELOLUXELQXUHDPDJQHVLXP
x
3UHJQDQF\ WHVW $W VFUHHQLQJ ȕ+&* WHVWLQJ LQ XULQH RU VHUXP ZLOO EH SHUIRUPHG LQ
ZRPHQRIFKLOGEHDULQJSRWHQWLDO

3K\VLFDOH[DPLQDWLRQDQGSHUIRUPDQFHVFRUH
$SK\VLFDOH[DPLQDWLRQZLOOEHSHUIRUPHGDWVFUHHQLQJDQGDWWKHWLPHSRLQWVVSHFLILHGLQWKH
6WXG\&DOHQGDU
$ IXOO SK\VLFDO H[DP VHUYHV DV D FOLQLFDO WXPRU DVVHVVPHQW DQG VKRXOG LQFOXGH D
FDUGLRSXOPRQDU\ H[DPLQDWLRQ H[DPLQDWLRQ RI WKH UHJLRQDO O\PSK QRGHV H[DPLQDWLRQ RI WKH
DEGRPHQDQGDQDVVHVVPHQWRIWKHPHQWDODQGQHXURORJLFDOVWDWXV$GGLWLRQDOV\PSWRPVWKDW
KDYHQRWEHHQUHSRUWHGGXULQJDSUHYLRXVH[DPLQDWLRQVKRXOGEHFODULILHG:KHUHYHUSRVVLEOH
WKHVDPHLQYHVWLJDWRUVKRXOGSHUIRUPWKLVH[DPLQDWLRQ
0HDVXUHPHQW RI KHLJKW LQ FP DQG ERG\ ZHLJKW LQ NJ DQG WKH HYDOXDWLRQ RI WKH (&2*
SHUIRUPDQFHVFRUHZLOOEHSHUIRUPHGDWWKHWLPHSRLQWVVSHFLILHGLQWKH6WXG\&DOHQGDU

9LWDOVLJQV
9LWDO VLJQV EORRG SUHVVXUH SXOVH DQG UHVSLUDWRU\ UDWH DIWHU  PLQXWHV VXSLQH UHVW DQG
WHPSHUDWXUHZLOOEHUHFRUGHGDWWKHVFUHHQLQJYLVLWDQGDWWKHWLPHSRLQWVVSHFLILHGZLWKWKH
SK\VLFDOH[DPLQDWLRQ

(.*
$OHDGUHVWLQJ(.*ZLOOEHSHUIRUPHGDWWKHWLPHSRLQWVVSHFLILHGLQWKH6WXG\&DOHQGDU
(.*VZLOOEHSHUIRUPHGXVLQJDGLJLWDO(.*PDFKLQH
7KHLQYHVWLJDWRUVKRXOGUHYLHZWKH(.*GDWDDWWKHWLPHRIWKHYLVLWDQGWKLVZLOOEHXVHGWR
PDNHGHFLVLRQVRQHOLJLELOLW\IRUWKHVWXG\DQGWUHDWPHQW

/HIWYHQWULFXODUIXQFWLRQDVVHVVPHQW
/HIW9HQWULFXODU(MHFWLRQ)UDFWLRQ/9()DVPHDVXUHGE\HFKRFDUGLRJUDSK\RU08*$VFDQ
ZLOO EH DVVHVVHG DW WLPH SRLQWV VSHFLILHG LQ WKH 6WXG\ &DOHQGDU 7KH VDPH PHWKRG RI
PHDVXUHPHQWVKRXOGEHXVHGWKURXJKRXWWKHVWXG\



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
x
08*$6FDQ7KH0XOWLSOH*DWHG$FTXLVLWLRQVFDQ08*$LVUHFRPPHQGHGDVDQRQ
LQYDVLYHPHWKRGIRUWKHDVVHVVPHQWRIGLVHDVHVRIWKHKHDUWPXVFOH,WLVXVHGIRUWKH
PRQLWRULQJRIWKHHMHFWLRQIUDFWLRQRIWKHFDUGLDFYHQWULFOHVHVSHFLDOO\WKHOHIWYHQWULFXODU
HMHFWLRQIUDFWLRQ/9()
x
(FKRFDUGLRJUDSK\(&+2(FKRFDUGLRJUDSK\ZLOOEHSHUIRUPHGWRDVVHVVWKH/9()
DFFRUGLQJ WR WKH VWDQGDUG JXLGHOLQHV RI WKH $PHULFDQ 6RFLHW\ RI (FKRFDUGLRJUDSK\
$6(KWWSDVHFKRRUJ*XLGHOLQHVSKS

'DWDDQG6DIHW\0RQLWRULQJ&RPPLWWHH'06&
$ 'DWD DQG 6DIHW\ 0RQLWRULQJ &RPPLWWHH '60& ZLOO EH VHW XS IRU WKLV VWXG\ LQ RUGHU WR
HQVXUHLWVRQJRLQJVDIHW\6DIHW\UHYLHZPHHWLQJVZLOOEHKHOGDFFRUGLQJWRWKH'0&FKDUWHU
DSSUR[LPDWHO\HYHU\PRQWKVGHSHQGLQJRQWKHUDWHRIHQUROPHQWDQGDWWKHWLPHRIGDWD
UHYLHZ
,QFOXVLRQ RI SDWLHQWV LQ WKH VWXG\ ZLOO FRQWLQXH GXULQJ WKH VFKHGXOHG PHHWLQJV RI WKH '0&
'HFLVLRQVRQWULDOWHUPLQDWLRQDPHQGPHQWRUFHVVDWLRQRISDWLHQWUHFUXLWPHQWEDVHGRQVDIHW\
RURXWFRPHILQGLQJVZLOOEHPDGHDIWHUUHFRPPHQGDWLRQVIURPWKH'0&KDYHEHHQDVVHVVHG
E\ WKH VSRQVRU )RU FRPSUHKHQVLYH GHVFULSWLRQ RI '60& SURFHGXUHV VHH 'DWD 6DIHW\
0RQLWRULQJ%RDUG

$VVHVVPHQWRI(IILFDF\

(YDOXDWLRQRI5HVSRQVH
7XPRUVL]HLVDVVHVVHGYLDFRPSXWHGWRPRJUDSK\DWGD\rGD\VDQGHYHU\GD\Vr
GD\VWKHUHDIWHU0DJQHWLFUHVRQDQFHLPDJLQJPD\EHXVHGRQO\LQWKRVHVHOHFWFDVHVLQZKLFK
VXFKLPDJLQJLVSUHIHUDEOHIRUVSHFLILFPHWDVWDVHVVXFKDVWKHEUDLQRUSHOYLV$WLQYHVWLJDWRU
GLVFUHWLRQ :KROH %RG\ 3(7&7 VFDQ PD\ EH VXEVWLWXWHG IRU &7 VFDQ IRU HYDOXDWLRQ RI
UHVSRQVHV
7KH 3KDVH ,$ JURXS ZLOO LQFOXGH SDUWLFLSDQWV ZLWK DQ\ HYDOXDEOH GLVHDVH LQFOXGLQJ VPDOO
OHVLRQVORQJHVWGLDPHWHUPPRUO\WLFERQHPHWDVWDVHVOHSWRPHQLQJHDOGLVHDVHDVFLWHV
SOHXUDOSHULFDUGLDO HIIXVLRQ LQIODPPDWRU\ VNLQ PHWDVWDVLV O\PSKDQJLWLV SXOPRQLV DQG F\VWLF
OHVLRQV7KHVHGLVHDVHHOHPHQWVDUHQRWQHFHVVDULO\LQFOXGHGLQIRUPDO5(&,67FULWHULD6LQFH
WKHUHPD\EHFDVHVLQZKLFKWKHUHVSRQVHW\SHLVUDGLRJUDSKLFDOO\RUFOLQLFDOO\LQFRQFOXVLYHLW
LV WKH UHVSRQVLELOLW\ RI WKH FOLQLFLDQ ZLWK VKDUHG LQSXW IURP SULQFLSOH LQYHVWLJDWRU WR GHFLGH
XSRQFRQWLQXDWLRQRIVWXG\GUXJ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
)RUWKH3KDVH,%H[WHQVLRQFRKRUWRQO\0RGLILHG5HVSRQVH(YDOXDWLRQ&ULWHULDLQ6ROLG7XPRUV
5(&,67 Y  DUH XVHG WR GHWHUPLQH WXPRU UHVSRQVH DQG GLVHDVH SURJUHVVLRQ 6HH
5HVSRQVHFULWHULD

5HVSRQVH&ULWHULDIRU3KDVH,$

%DVHOLQHFULWHULD
0HDVXULQJRIWXPRUOHVLRQVDWEDVHOLQH7KH3KDVH,$SRUWLRQRIWKHWULDOUHTXLUHVWKHSUHVHQFH
RIPHDVXUDEOHOHVLRQVDWEDVHOLQH
'HILQLWLRQRI³0HDVXUDEOH/HVLRQV´
x
/HVLRQVWKDWFDQEHDFFXUDWHO\PHDVXUHGLQDWOHDVWRQHGLPHQVLRQORQJHVWGLDPHWHUWR
EH UHFRUGHG DV t  PP E\ &7 VFDQ DQG 05, QR OHVV WKDQ GRXEOH WKH VOLFH
WKLFNQHVVPPFDOLSHUPHDVXUHPHQWE\FOLQLFDOH[DPZKHQVXSHUILFLDO
x
/\WLFERQHOHVLRQVZLWKDQLGHQWLILDEOHVRIWWLVVXHFRPSRQHQWHYDOXDWHGE\&7RU05,
FDQEHFRQVLGHUHGDVPHDVXUDEOHOHVLRQVLIWKHVRIWWLVVXHFRPSRQHQWRWKHUZLVHPHHWV
WKHGHILQLWLRQRIPHDVXUDELOLW\SUHYLRXVO\GHVFULEHG
x
&\VWLF /HVLRQV WKRXJKW WR EH F\VWLF PHWDVWDVHV FDQ EH FRQVLGHUHG DV PHDVXUDEOH
OHVLRQVLIWKH\PHHWWKHGHILQLWLRQRIPHDVXUDELOLW\+RZHYHULIQRQF\VWLFOHVLRQVDUH
SUHVHQWLQWKHVDPHSDWLHQWWKHVHVKRXOGEHSUHIHUDEO\VHOHFWHGIRUDVVHVVPHQW
x
7XPRUOHVLRQVVLWXDWHGLQDSUHYLRXVO\LUUDGLDWHGDUHDRULQDQDUHDVXEMHFWHGWRRWKHU
ORFRUHJLRQDO WKHUDS\ DUH XVXDOO\ QRW FRQVLGHUHG PHDVXUDEOH XQOHVV WKHUH KDV EHHQ
GHPRQVWUDWHGSURJUHVVLRQLQWKHOHVLRQ
x
$OORWKHUOHVLRQVZLOOEHMXGJHGDV³QRQPHDVXUDEOH´LQFOXGLQJOHVLRQVPPRQVSLUDO
&7
$OOPHDVXUHPHQWVZLOOEHUHFRUGHGLQPHWULFQRWDWLRQXVLQJDUXOHURUFDOLSHUV$OOEDVHOLQH
HYDOXDWLRQVZLOOEHSHUIRUPHGDVFORVHDVSRVVLEOHWRWKHWUHDWPHQWVWDUWDQGQHYHUPRUHWKDQ
ZHHNVEHIRUHWKHEHJLQQLQJRIWKHWUHDWPHQW

6SHFLILFDWLRQVE\PHWKRGVRIPHDVXUHPHQWV
7KHVDPHPHWKRGRIDVVHVVPHQWDQGWKHVDPHWHFKQLTXHZLOOEHXVHGWRFKDUDFWHUL]HHDFK
LGHQWLILHGDQGUHSRUWHGOHVLRQDWEDVHOLQHDQGGXULQJIROORZXS,PDJLQJEDVHGHYDOXDWLRQLV
SUHIHUUHGWRHYDOXDWLRQE\FOLQLFDOH[DPLQDWLRQZKHQERWKPHWKRGVKDYHEHHQXVHGWRDVVHVV
WKHDQWLWXPRUHIIHFWRIDWUHDWPHQW6SLUDO&7RIWKHFKHVWDQGDEGRPHQZLOOEHXVHGIRUWKH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
LQLWLDO DVVHVVPHQW IRU DVVHVVPHQW RI GLVHDVH UHVSRQVH DQG ZKHQHYHU SRVVLEOH IRU WKH
GRFXPHQWDWLRQRIUHFXUUHQWDQGRUSURJUHVVLYHGLVHDVH
&7DQG05,&7DSSOLHVRQO\IRUUHFXUUHQWSURJUHVVLYHGLVHDVHPLJKWEHWKHEHVWFXUUHQWO\
DYDLODEOH DQG UHSURGXFLEOH PHWKRGV WR PHDVXUH WDUJHW OHVLRQV VHOHFWHG IRU UHVSRQVH
DVVHVVPHQW  &RQYHQWLRQDO &7 VKRXOG EH SHUIRUPHG ZLWK FXWV RI  PP RU OHVV LQ VOLFH
WKLFNQHVV FRQWLJXRXVO\ 6SLUDO &7 VKRXOG EH SHUIRUPHG XVLQJ D  PP FRQWLJXRXV
UHFRQVWUXFWLRQ DOJRULWKP 7KLV DSSOLHV WR WKH FKHVW DQG DEGRPHQ  +HDG 	 QHFN DQG
H[WUHPLWLHVXVXDOO\UHTXLUHVSHFLILFSURWRFROV7KHVHVFDQVZLOOEHUHDGE\WKRUDFLFUDGLRORJLVWV
WUDLQHGLQ5(&,67YFULWHULDDWWKHWUHDWLQJFDQFHUFHQWHU
&OLQLFDO OHVLRQV DSSOLHV RQO\ IRU UHFXUUHQWSURJUHVVLYH GLVHDVH &OLQLFDO OHVLRQV ZLOO RQO\ EH
FRQVLGHUHGPHDVXUDEOHZKHQWKH\DUHVXSHUILFLDOHJVNLQQRGXOHVSDOSDEOHO\PSKQRGHV
)RUWKHFDVHRIVNLQOHVLRQVGRFXPHQWDWLRQE\FRORUSKRWRJUDSK\LQFOXGLQJDUXOHUWRHVWLPDWH
WKHVL]HRIWKHOHVLRQLVUHFRPPHQGHG
&KHVW ;UD\ DSSOLHV RQO\ IRU UHFXUUHQWSURJUHVVLYH GLVHDVH /HVLRQV RQ FKHVW ;UD\ DUH
DFFHSWDEOH DV PHDVXUDEOH OHVLRQV RQO\ ZKHQ WKH\ DUH FOHDUO\ GHILQHG DQG VXUURXQGHG E\
DHUDWHG OXQJ  +RZHYHU &7 LV UHFRPPHQGHG DQG SUHIHUUHG DV WKH WRRO IRU UHVSRQVH
PHDVXUHPHQWLQWKLVVWXG\&KHVW[UD\ZLOOEHXVHGIRULQWHULPVXUYHLOODQFHIRUSOHXUDOHIIXVLRQ
DNQRZQGDVDWLQLEDVVRFLDWHGWR[LFLW\
8OWUDVRXQGDSSOLHVRQO\IRUUHFXUUHQWSURJUHVVLYHGLVHDVH:KHQWKHSULPDU\HQGSRLQWRIWKH
VWXG\LVREMHFWLYHUHVSRQVHHYDOXDWLRQXOWUDVRXQG86VKRXOGQRWEHXVHGWRPHDVXUHWXPRU
OHVLRQV WKDW DUH FOLQLFDOO\ QRW HDVLO\ DFFHVVLEOH  ,W LV D SRVVLEOH DOWHUQDWLYH WR FOLQLFDO
PHDVXUHPHQWVIRUVXSHUILFLDOSDOSDEOHQRGHVVXEFXWDQHRXVOHVLRQVDQGWK\URLGQRGXOHV86
PLJKW DOVR EH XVHIXO WR FRQILUP WKH FRPSOHWH GLVDSSHDUDQFH RI VXSHUILFLDO OHVLRQV XVXDOO\
DVVHVVHGE\FOLQLFDOH[DPLQDWLRQ

7XPRUUHVSRQVHHYDOXDWLRQ
7RDVVHVVREMHFWLYHUHVSRQVHLWLVQHFHVVDU\WRHVWLPDWHWKHRYHUDOOWXPRUEXUGHQDWEDVHOLQH
DQGXVHWKLVDVDFRPSDUDWRUIRUVXEVHTXHQWPHDVXUHPHQWV3DWLHQWVZLWKDQ\FOLQLFDOO\RU
UDGLRORJLFDOO\HYDOXDEOHGLVHDVHZLOOEHLQFOXGHGRQ3KDVH,$RIWKLVSURWRFRO+RZHYHURQO\
SDWLHQWVZLWKPHDVXUDEOHGLVHDVHE\5(&,67YFULWHULDZLOOEHLQFOXGHGLQWKH3KDVH,%
H[WHQVLRQ2EMHFWLYHWXPRUUHVSRQVHLQWKLV,%JURXSLVDVHFRQGDU\HQGSRLQW0HDVXUDEOH
GLVHDVHLVGHILQHGE\WKHSUHVHQFHRIDWOHDVWRQHPHDVXUDEOHOHVLRQDVGHILQHGDERYH,IWKH
PHDVXUDEOHGLVHDVHLVUHVWULFWHGWRDVROLWDU\OHVLRQLWVQHRSODVWLFQDWXUHPXVWEHFRQILUPHGE\
KLVWRORJ\IRUSDUWLFLSDWLRQLQWKLVVWXG\(YDOXDWLRQVKRXOGIROORZ7DEOH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
)RUSDUWLFLSDQWVZLWKPHDVXUDEOHGLVHDVHXSWROHVLRQVUHSUHVHQWDWLYHRIDOOLQYROYHG
RUJDQV VKRXOG EH LGHQWLILHG DV WDUJHW OHVLRQV DQG ZLOO EH UHFRUGHG DQG PHDVXUHG DW
EDVHOLQH7DUJHWOHVLRQVVKRXOGEHVHOHFWHGRQWKHEDVLVRIWKHLUVL]HOHVLRQVZLWKWKHORQJHVW
GLDPHWHU DQG WKHLU VXLWDELOLW\ IRU DFFXUDWH UHSHWLWLYH PHDVXUHPHQWV HLWKHU E\ LPDJLQJ
WHFKQLTXHV RU FOLQLFDOO\  $ VXP RI WKH ORQJHVW GLDPHWHU /' IRU DOO WDUJHW OHVLRQV ZLOO EH
FDOFXODWHG DQG UHSRUWHG DV WKH EDVHOLQH VXP /'  7KH EDVHOLQH VXP /' ZLOO EH XVHG DV
UHIHUHQFHWRIXUWKHUFKDUDFWHUL]HWKHREMHFWLYHWXPRUUHVSRQVHRIWKHPHDVXUDEOHGLPHQVLRQRI
WKHGLVHDVH
$OORWKHUOHVLRQVRUVLWHVRIGLVHDVHVKRXOGEHLGHQWLILHGDVQRQWDUJHWOHVLRQVDQGVKRXOGDOVR
EHUHFRUGHGDWEDVHOLQH0HDVXUHPHQWVDUHQRWUHTXLUHGDQGWKHVHOHVLRQVVKRXOGEHIROORZHG
DVµSUHVHQW¶RUµDEVHQW¶

5HVSRQVH&ULWHULDIRU3KDVH,%

5(&,67YFULWHULD
(YDOXDWLRQRI7DUJHWOHVLRQV
5HVSRQVH
&ULWHULD
IRU
3KDVH
,%
ZLOO
IROORZ
5(&,67
Y
SRVWHG
DW
KWWSZZZUHFLVWFRPUHFLVWLQSUDFWLFHKWPO7KHFULWHULDDUHSURYLGHGEHORZIRUUHIHUHQFH
SXUSRVHV RQO\ ,Q WKH DGYHQW RI DQ\ LQFRQFOXVLYH RU GLVFRUGDQW ILQGLQJ WKH PRVW XSGDWHG
5(&,67YFULWHULDZLOOKROGSUHFHGHQFH,QWKHDGYHQWRIDQ\LQFUHPHQWDOGHYHORSPHQWRID
QHZHU 5(&,67 YHUVLRQ D SURWRFRO DPHQGPHQW ZLOO EH UHTXLUHG WR FKDQJH IURP 5(&,67
YHUVLRQ
&RPSOHWH5HVSRQVH&5LVGHILQHGDVGLVDSSHDUDQFHRIDOOWDUJHWOHVLRQV
3DUWLDO5HVSRQVH35LVGHILQHGDVDWOHDVWDGHFUHDVHLQWKHVXPRI/'RIWDUJHWOHVLRQV
WDNLQJDVUHIHUHQFHWKHEDVHOLQHVXP/'
3URJUHVVLYH'LVHDVH3'LVGHILQHGDVDWOHDVWDLQFUHDVHLQWKHVXPRI/'RIWDUJHW
OHVLRQVWDNLQJDVUHIHUHQFHVWKHVPDOOHVWVXP/'UHFRUGHGVLQFHWKHWUHDWPHQWVWDUWHGRUWKH
DSSHDUDQFHRIRQHRUPRUHQHZOHVLRQV
6WDEOH'LVHDVH6'LVGHILQHGDVQHLWKHUVXIILFLHQWVKULQNDJHWRTXDOLI\IRU35QRUVXIILFLHQW
LQFUHDVH WR TXDOLI\ IRU 3' WDNLQJ DV UHIHUHQFHV WKH VPDOOHVW VXP /' VLQFH WKH WUHDWPHQW
VWDUWHG
(YDOXDWLRQRI1RQ7DUJHWOHVLRQV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
&RPSOHWH 5HVSRQVH &5 'LVDSSHDUDQFH RI DOO QRQWDUJHW OHVLRQV WXPRU PDUNHUV DUH QRW
DSSOLFDEOH
1RQ&RPSOHWH 5HVSRQVH QRQ&5 3HUVLVWHQFH RI RQH RU PRUH QRQWDUJHW OHVLRQ WXPRU
PDUNHUVDUHQRW1RQ3URJUHVVLRQQRQ3'
3URJUHVVLRQ 3' $SSHDUDQFH RI RQH RU PRUH QHZ OHVLRQV  8QHTXLYRFDO SURJUHVVLRQ RI
H[LVWLQJ QRQ WDUJHW OHVLRQV DOWKRXJK D FOHDU SURJUHVVLRQ RI QRQ WDUJHW OHVLRQV RQO\ LV
H[FHSWLRQDOLQVXFKFLUFXPVWDQFHVWKHRSLQLRQRIWKHWUHDWLQJSK\VLFLDQVKRXOGSUHYDLODQGWKH
SURJUHVVLRQVWDWXVVKRXOGEHFRQILUPHGODWHURQE\WKHUHYLHZSDQHORUVWXG\FKDLU
(YDOXDWLRQRI%HVW2YHUDOO5HVSRQVH
7KHEHVWRYHUDOOUHVSRQVHLVWKHEHVWUHVSRQVHUHFRUGHGIURPWKHVWDUWRIWKHWUHDWPHQWXQWLO
GLVHDVH SURJUHVVLRQUHFXUUHQFH WDNLQJ DV UHIHUHQFH IRU SURJUHVVLYH GLVHDVH WKH VPDOOHVW
PHDVXUHPHQWVUHFRUGHGVLQFHWKHWUHDWPHQWVWDUWHG,QJHQHUDOWKHSDWLHQW
VEHVWUHVSRQVH
DVVLJQPHQWZLOOGHSHQGRQWKHDFKLHYHPHQWRIERWKPHDVXUHPHQWDQGFRQILUPDWLRQFULWHULD

7DEOH%HVWUHVSRQVH
7DUJHW/HVLRQ
1RQ7DUJHW/HVLRQ
1HZ/HVLRQ
2YHUDOO5HVSRQVH
&5
&5
1R
&5
&5
1RQ&51RQ3'
1R
35
35
1RQ3'
1R
35
6'
1RQ3'
1R
6'
3'
$Q\
<HVRU1R
3'
$Q\
3'
<HVRU1R
3'
$Q\
$Q\
<HV
3'
1RWH
3DWLHQWV ZLWK D JOREDO GHWHULRUDWLRQ RI KHDOWK VWDWXV UHTXLULQJ GLVFRQWLQXDWLRQ RI WUHDWPHQW
ZLWKRXWREMHFWLYHHYLGHQFHRIGLVHDVHSURJUHVVLRQDWWKDWWLPHZLOOEHUHSRUWHGDV³V\PSWRPDWLF



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
GHWHULRUDWLRQ´(YHU\HIIRUWVKRXOGEHPDGHWRGRFXPHQWWKHREMHFWLYHSURJUHVVLRQHYHQDIWHU
GLVFRQWLQXDWLRQRIWUHDWPHQW
&RQGLWLRQV WKDW PD\ GHILQH HDUO\ SURJUHVVLRQ HDUO\ GHDWK DQG LQHYDOXDELOLW\ DUH VWXG\
VSHFLILF DQG VKRXOG EH FOHDUO\ GHILQHG LQ HDFK SURWRFRO GHSHQGLQJ RQ WUHDWPHQW GXUDWLRQ
WUHDWPHQWSHULRGLFLW\)RUWKHSXUSRVHRIWKLVSURWRFROGLVHDVHHYDOXDWLRQIRUUHVSRQVHDQG
VXUYLYDOZLOOVWDUWIURPGD\RIWKHUDS\3DWLHQWVQRWUHFHLYLQJWKHLUILUVWGRVHRIWKHUDS\ZLOOEH
FHQVRUHG
,QVRPHFLUFXPVWDQFHVLWPD\EHGLIILFXOWWRGLVWLQJXLVKUHVLGXDOGLVHDVHIURPQRUPDOWLVVXH
:KHQ WKH HYDOXDWLRQ RI FRPSOHWH UHVSRQVH GHSHQGV XSRQ WKLV GHWHUPLQDWLRQ LW LV
UHFRPPHQGHG WKDW WKH UHVLGXDO OHVLRQ EH LQYHVWLJDWHG ILQH QHHGOH DVSLUDWHELRSV\ EHIRUH
FRQILUPLQJWKHFRPSOHWHUHVSRQVHVWDWXV
 'HILQLWLRQRI(YDOXDEOH3DUWLFLSDQWV
3DUWLFLSDQWV DUH FRQVLGHUHG HYDOXDEOH ZKR UHFHLYH WKHLU ILUVW GRVH RI WKHUDS\ 1RQHYDOXDEOH
SDUWLFLSDQWV
DUH
WKRVH
ZKR
GR
QRW
UHFHLYH
WKH
ILUVW
GRVH
RI
WKHUDS\
3DUWLFLSDQWV ZKR ZLWKGUDZ FRQVHQW RU GLVFRQWLQXHG GXH WR SURWRFRO YLRODWLRQV SULRU WR WKH ILUVW
HYDOXDWLRQDUHQRWFRQVLGHUHGHYDOXDEOHIRUHIILFDF\
)RURWKHUGHILQLWLRQVVHH6HFWLRQ³3URJUHVVLRQ'HILQLWLRQV´

&RQILUPDWRU\PHDVXUHPHQWGXUDWLRQRIUHVSRQVH
&RQILUPDWLRQ&RQILUPDWLRQRIUHVSRQVHLVQRWUHTXLUHGIRUWKLVVWXG\
'XUDWLRQRIRYHUDOOUHVSRQVHRI3URJUHVVLRQ)UHH6XUYLYDO7KHGXUDWLRQRIRYHUDOOUHVSRQVHLV
PHDVXUHG IURP WKH WLPH PHDVXUHPHQW FULWHULD DUH PHW IRU &5356' ZKLFKHYHU LV ILUVW
UHFRUGHGXQWLOWKHILUVWGDWHWKDWUHFXUUHQWRUSURJUHVVLYHGLVHDVHLVREMHFWLYHO\GRFXPHQWHG
WDNLQJDVUHIHUHQFHIRUSURJUHVVLYHGLVHDVHWKHVPDOOHVWPHDVXUHPHQWVUHFRUGHGVLQFHWKH
WUHDWPHQW VWDUWHG  7KH GXUDWLRQ RI RYHUDOO FRPSOHWH UHVSRQVH LV PHDVXUHG IURP WKH WLPH
PHDVXUHPHQWFULWHULDDUHILUVWPHWIRU&5XQWLOWKHILUVWGDWHWKDWUHFXUUHQWGLVHDVHLVREMHFWLYHO\
GRFXPHQWHG
'XUDWLRQRIVWDEOHGLVHDVH6WDEOHGLVHDVHLVPHDVXUHGIURPWKHVWDUWRIWKHWUHDWPHQWXQWLOWKH
FULWHULD IRU SURJUHVVLRQ DUH PHW WDNLQJ DV UHIHUHQFH WKH VPDOOHVW PHDVXUHPHQWV UHFRUGHG
VLQFHWKHWUHDWPHQWVWDUWHG6WDEOHGLVHDVHZLOOEHDVVHVVHGIRULQGXFWLRQFKHPRWKHUDS\DQG
GHILQHGDVWKHWLPHLQWHUYDOEHWZHHQWKHLQLWLDO&7ZHHNV±WR±DQGWKHILUVWIROORZXS&7
ZHHN



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
5HVSRQVH UHYLHZ 5HVSRQVH LV WKH VHFRQGDU\ HQGSRLQW LQ WKLV VWXG\  :H ZLOO SHULRGLFDOO\
DSSUR[LPDWHO\HYHU\PRQWKVUHYLHZDOOVWXGLHVDQGFKDUWVRQWKHSDWLHQWVLQWKHVWXG\DQG
UHYLHZ WKH PHDVXUHPHQWV DQG GDWD REWDLQHG 0HDVXUHPHQWV DUH SHUIRUPHG DW D
SLFWXUHDUFKLYHFRPPXQLFDWLRQV\VWHP3$&6ZRUNVWDWLRQXVLQJVWDQGDUGOXQJ:/±
 DQG VRIW WLVVXH :  /  ZLQGRZ DQG OHYHO VHWWLQJV 7KLV V\VWHP DOORZV IRU D
FRPSXWHUL]HGPHDVXUHPHQWRIWDUJHWOHVLRQV
3DWLHQWV ZLOO EH FHQVRUHG DW WKH GDWH RI ODVW FRQWDFW LI WKH LQYHVWLJDWRU LV QR ORQJHU DEOH WR
FRQWDFWDSDWLHQWRUFDUHJLYHUDQGYLWDOVWDWXVFDQQRWRWKHUZLVHEHGHWHUPLQHGSURYLGHGWKDW
QRRWKHULQIRUPDWLRQLQGLFDWHVWKDWWKHSDWLHQWZDVQHDUGHDWKDWWKDWSRLQW
3URJUHVVLRQ'HILQLWLRQV
6LWXDWLRQ2XWFRPH
'HFLVLRQ
'DWHRI3)6RUFHQVRULQJ
1REDVHOLQHWXPRUDVVHVVPHQW
FHQVRUHG
'DWHRIWUHDWPHQW
3URJUHVVHGQRPLVVHGUDGLRORJLFDO
DVVHVVPHQWV
HYHQW
'DWHRI3'
1RQ3'GHDWKEHIRUHQH[WVFKHGXOHG
DVVHVVPHQW
HYHQW
'DWHRIGHDWK
1RQ3'DQGRQHPLVVHGDVVHVVPHQWGHDWKRU
SURJUHVVLRQDIWHUGDWHRIPLVVHGDVVHVVPHQW
EXWEHIRUHDVHFRQGVFKHGXOHGDVVHVVPHQW
HYHQW
'DWHRI3'RUGHDWK
1RQ3' PRUH WKDQ RQH FRQVHFXWLYH PLVVHG
DVVHVVPHQWGHDWKRUSURJUHVVLRQDIWHUGDWHRI
VHFRQGPLVVHGDVVHVVPHQW
FHQVRUHG
'DWH RI ODVW LPDJLQJ EHIRUH
PLVVHGDVVHVVPHQW
1HZDQWLFDQFHUPHGLFDWLRQEHIRUHSURJUHVVLRQ
RUGHDWK
FHQVRUHG
'DWHRIODVWLPDJLQJEHIRUH
QHZPHGLFDWLRQ
'HDWK EHIRUH WKH VFKHGXOHG GDWH RI ILUVW
LPDJLQJHYHQW
HYHQW
'DWHRIGHDWK
1R LPDJLQJ SHUIRUPHG SRVWEDVHOLQH SDWLHQW
GLHV EHWZHHQ ILUVW DQG VHFRQG VFKHGXOHG
HYHQW
'DWHRIGHDWK



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
DVVHVVPHQWV
1R LPDJLQJ SHUIRUPHG SRVWEDVHOLQH SDWLHQW
GLHVDIWHUVHFRQGVFKHGXOHGDVVHVVPHQW
FHQVRUHG
'D\RIWUHDWPHQW
1R LPDJLQJ SHUIRUPHG SRVWEDVHOLQH YLWDO
VWDWXV LV XQNQRZQ RU SDWLHQW LV NQRZQ WR EH
DOLYHFHQVRUHG
FHQVRUHG
'D\RIWUHDWPHQW
$OLYH DQG QRW SURJUHVVHG DFFRUGLQJ WR FHQWUDO
UHYLHZQRPLVVHGUDGLRORJLFDODVVHVVPHQWV
FHQVRUHG
'DWHRIODVWLPDJLQJ

5HSRUWLQJRI5HVXOWV
(YHU\UHSRUWZLOOFRQWDLQDOOSDWLHQWVLQFOXGHGLQWKHVWXG\)RUWKHUHVSRQVHFDOFXODWLRQWKH
UHSRUWZLOOFRQWDLQDVHFWLRQZLWKDOOHOLJLEOHSDWLHQWV$QRWKHUVHFWLRQRIWKHUHSRUWPD\GHWDLO
WKHUHVSRQVHUDWHIRUHYDOXDEOHSDWLHQWVRQO\+RZHYHUDUHVSRQVHUDWHDQDO\VLVEDVHGRQD
VXEVHW RI SDWLHQWV ZLOO H[SODLQ ZKLFK SDWLHQWV ZHUH H[FOXGHG DQG IRU ZKLFK UHDVRQV
&RQILGHQFHOLPLWVZLOOEHJLYHQZKHQHYHUSRVVLEOH

678'<'58*663(&,),&$7,216

3URGXFW,GHQWLILFDWLRQ

'DVDWLQLE
7KH IROORZLQJ LQYHVWLJDWLRQDO SURGXFW %06 GDVDWLQLE ZLOO EH VXSSOLHG E\
%ULVWRO0\HUV6TXLEE3KDUPDFHXWLFDO5HVHDUFK,QVWLWXWHLQWZRGLIIHUHQWVWUHQJWKV
%06
PJILOPFRDWHGWDEOHWVELFRQYH[URXQGZKLWHWRRIIZKLWHLQ
DSSHDUDQFHZLWK³´GHERVVHGRQRQHVLGH
%06
PJILOPFRDWHGWDEOHWVELFRQYH[URXQGZKLWHWRRIIZKLWHLQ
DSSHDUDQFHZLWK³´GHERVVHGRQRQHVLGH

$IDWLQLE
7KH IROORZLQJ LQYHVWLJDWLRQDO SURGXFW %,%:  DIDWLQLE ZLOO EH VXSSOLHG E\ %RHKULQJHU
,QJHOKHLP3KDUPD*PE+LQWKUHHGLIIHUHQWVWUHQJWKV



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
%,%:
PJILOPFRDWHGWDEOHWOLJKWEOXHDQGRIURXQGELFRQYH[EHYHOHGJHGZLWK³´
GHERVVHGRQRQHVLGH
%,%:PJILOPFRDWHGWDEOHWELFRQYH[EHYHOHGJHGRYDODQGGDUNEOXH ZLWK³´
GHERVVHGRQRQHVLGH
%,%:  PJ ILOPFRDWHG WDEOHW ELFRQYH[ EHYHOHGJHG RYDO DQG OLJKW EOXH ZLWK ³´
GHERVVHGRQRQHVLGH

3DFNDJLQJDQG/DEHOLQJ
'DVDWLQLE ZLOOEHODEHOHGLQRSHQODEHOIDVKLRQ(DFKERWWOH ZLOO EHODEHOHG ZLWKDWZRSDQHO
ODEHO 'HVFULSWLRQ RI WKH FRQWHQWV EDWFK QXPEHU FRQWDLQHU QXPEHU VWRUDJH FRQGLWLRQV DQG
FDXWLRQVWDWHPHQWVUHTXLUHGE\FRXQWU\UHJXODWLRQVZLOOEHRQWKHODEHO7KHVHFRQGSDQHOZLOO
KDYHEDWFKQXPEHUFRQWDLQHUQXPEHU
$IDWLQLEZLOOEHODEHOHGLQRSHQODEHOIDVKLRQ(DFKERWWOHZLOOEHODEHOHGZLWKDWZRSDQHOODEHO
'HVFULSWLRQRIWKHFRQWHQWVEDWFKQXPEHUFRQWDLQHUQXPEHUVWRUDJHFRQGLWLRQVDQGFDXWLRQ
VWDWHPHQWVUHTXLUHGE\FRXQWU\UHJXODWLRQVZLOOEHRQWKHODEHO7KHVHFRQGSDQHOZLOOKDYH
EDWFKQXPEHUFRQWDLQHUQXPEHU

+DQGOLQJDQG'LVSHQVLQJRI,QYHVWLJDWLRQDO3URGXFW
,QYHVWLJDWLRQDOSURGXFWVVKRXOGEHVWRUHGLQDVHFXUHDUHDDFFRUGLQJWRORFDOUHJXODWLRQV,WLV
WKHUHVSRQVLELOLW\RIWKH,QYHVWLJDWRUWRHQVXUHWKDWLQYHVWLJDWLRQDOSURGXFWLVRQO\GLVSHQVHGWR
VWXG\VXEMHFWV7KHLQYHVWLJDWLRQDOSURGXFWVPXVWEHGLVSHQVHGRQO\IURPRIILFLDOVWXG\VLWHV
E\DXWKRUL]HGSHUVRQQHODFFRUGLQJWRORFDOUHJXODWLRQV
,WLVUHFRPPHQGHGWKDWLQYHVWLJDWLRQDOSURGXFWVVKRXOGRQO\EHKDQGOHGE\WKHVXEMHFW:KLOH
WKH ULVN IRU GHUPDO H[SRVXUH LV FRQVLGHUHG PLQLPDO LW LV UHFRPPHQGHG WKDW RQO\ WKH VWXG\
VXEMHFW KDQGOH WKH VWXG\ PHGLFDWLRQ  ,Q SDUWLFXODU SUHJQDQW ZRPHQ RU ZRPHQ ZKR DUH
EUHDVWIHHGLQJVKRXOGQRWKDQGOHWKHVWXG\GUXJ$OVRFKLOGUHQZKRDUHQRWVWXG\SDUWLFLSDQWV
VKRXOGQRWKDQGOHWKHGUXJ,IFDUHJLYHUVPXVWKDQGOHRUFRPHLQFRQWDFWZLWKWKHGUXJLWLV
DGYLVHGWKDWSURWHFWLYHJORYHVEHZRUQ
'DVDWLQLEDQGDIDWLQLEVKRXOGEHDGPLQLVWHUHGDVDQRUDOGRVHDVSHUWKHSURWRFRO6XEMHFWVGR
QRW UHTXLUH IDVWLQJ DW WKH WLPH RI GDVDWLQLE FRQVXPSWLRQ $IDWLQLE VKRXOG EH WDNHQ RQH KRXU
EHIRUHRUWZRKRXUVDIWHUDPHDO*UDSHIUXLWMXLFHVKRXOGQRWEHFRQVXPHGGXULQJVWXG\GUXJ
WKHUDS\DV3HQ]\PHLQKLELWLRQPD\LQFUHDVHGUXJH[SRVXUH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
%ULVWRO0\HUV 6TXLEE ZLOO EH UHVSRQVLEOH IRU DVVXULQJ WKDW WKH TXDOLW\ RI %06 LV
DGHTXDWHIRUWKHGXUDWLRQRIWKHWULDO%RHKULQJHU,QJHOKHLP3KDUPD*PE+ZLOOEHUHVSRQVLEOH
IRUDVVXULQJWKDWWKHTXDOLW\RI%,%:LVDGHTXDWHIRUWKHGXUDWLRQRIWKHWULDO
,QYHVWLJDWLRQDOSURGXFWVKRXOGEHVWRUHGLQDVHFXUHDUHDDW)WR)&WR&
7KH ,QYHVWLJDWRU RU DVVLJQHG GHVLJQHH LH VWXG\ SKDUPDFLVW ZLOO GLVSHQVH WKH SURSHU
QXPEHURIHDFKVWUHQJWKWDEOHWWRWKHVXEMHFWWRVDWLVI\GRVLQJUHTXLUHPHQWVIRUWKHVWXG\7KH
FRQWDLQHUVSURYLGHGWRWKHVXEMHFWVKRXOGEHODEHOHGZLWKSURSHULQVWUXFWLRQVIRUXVH6XEMHFWV
VKRXOGEHLQVWUXFWHGWRUHWXUQDOOXQXVHGGUXJWRWKHVLWHLQWKHVDPHFRQWDLQHU5HVXSSOLHV
FDQEHREWDLQHGE\FRPSOHWLQJWKH65&UHVXSSO\UHTXHVWIRUP5HVXSSO\UHTXHVWVQHHGWR
EHVXEPLWWHGDWOHDVWZHHNVEHIRUHWKHH[SHFWHGGHOLYHU\GDWH
7KHORWQXPEHUVGRVLQJVWDUWGDWHVDQGWKHQXPEHURIWDEOHWVIRUHDFKGRVDJHVWUHQJWKPXVW
EH UHFRUGHG RQ WKH GUXJ DFFRXQWDELOLW\ SDJHV RI UHFRUG IRU WKH VLWH 7KH VXEMHFW PXVW EH
LQVWUXFWHG WR UHWXUQ DOO XQXVHG VWXG\ PHGLFDWLRQV LQ WKH SURYLGHG SDFNDJLQJ DW HDFK
VXEVHTXHQWYLVLW
7KH,QYHVWLJDWRUPXVWEHVDWLVILHGWKHVXEMHFWUHWXUQHGRUDFFRXQWHGIRUDOOXQXVHGPHGLFDWLRQ
EHIRUH DGGLWLRQDO PHGLFDWLRQ LV GLVSHQVHG ,I WKH QXPEHU RI WDEOHWV XVHG LV VXEVWDQWLDOO\
GLIIHUHQWIURPWKHQXPEHURIWDEOHWVGLVSHQVHGWKHVXEMHFWPXVWEHFRXQVHOHGRQKRZVWXG\
WKHUDS\ VKRXOG EH WDNHQ  ,I VXFK GHYLDWLRQV SHUVLVW WKH ,QYHVWLJDWRU PD\ FRQVLGHU
GLVFRQWLQXLQJWKHVXEMHFWIRUQRQFRPSOLDQFH
,QYHVWLJDWLRQDOSURGXFWVKRXOGEHVWRUHGLQDVHFXUHDUHDDFFRUGLQJWRORFDOUHJXODWLRQV,WLV
WKHUHVSRQVLELOLW\RIWKH,QYHVWLJDWRUWRHQVXUHWKDWLQYHVWLJDWLRQDOSURGXFWLVRQO\GLVSHQVHGWR
VWXG\VXEMHFWV7KHLQYHVWLJDWLRQDOSURGXFWPXVWEHGLVSHQVHGRQO\IURPRIILFLDOVWXG\VLWHVE\
DXWKRUL]HGSHUVRQQHODFFRUGLQJWRORFDOUHJXODWLRQV
7KH,QYHVWLJDWRUVKRXOGHQVXUHWKDWWKHLQYHVWLJDWLRQDOSURGXFWLVVWRUHGLQDFFRUGDQFHZLWKWKH
HQYLURQPHQWDOFRQGLWLRQVWHPSHUDWXUHOLJKWDQGKXPLGLW\DVGHWHUPLQHGE\WKH6SRQVRUDQG
GHILQHGLQWKH,QYHVWLJDWRU%URFKXUHRU6P3&UHIHUHQFHODEHO

,QYHVWLJDWLRQDO3URGXFW5HFRUGVDW,QYHVWLJDWLRQDO6LWHV
,W LV WKH UHVSRQVLELOLW\ RI WKH ,QYHVWLJDWRU WR HQVXUH WKDW D FXUUHQW UHFRUG RI LQYHVWLJDWLRQDO
SURGXFW GLVSRVLWLRQ LV PDLQWDLQHG DW HDFK VWXG\ VLWH ZKHUH LQYHVWLJDWLRQDO SURGXFW LV
LQYHQWRULHG DQG GLVSRVHG  5HFRUGV RU ORJV PXVW FRPSO\ ZLWK DSSOLFDEOH UHJXODWLRQV DQG
JXLGHOLQHVDQGVKRXOGLQFOXGH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
x
$PRXQWUHFHLYHGDQGSODFHGLQVWRUDJHDUHD
x
$PRXQWFXUUHQWO\LQVWRUDJHDUHD
x
/DEHO,'QXPEHURUEDWFKQXPEHUDQGXVHGDWHRUH[SLU\GDWH
x
'DWHVDQGLQLWLDOVRISHUVRQUHVSRQVLEOHIRUHDFKLQYHVWLJDWLRQDOSURGXFWLQYHQWRU\
HQWU\PRYHPHQW
x
$PRXQWGLVSHQVHGWRDQGUHWXUQHGE\HDFKVXEMHFWLQFOXGLQJXQLTXHVXEMHFWLGHQWLILHUV
x
$PRXQWWUDQVIHUUHGWRDQRWKHUDUHDVLWHIRUGLVSHQVLQJRUVWRUDJH
x
1RQVWXG\GLVSRVLWLRQHJORVWZDVWHGEURNHQ
x
$PRXQWUHWXUQHGWR6SRQVRU
x
$PRXQWGHVWUR\HGDWVWXG\VLWHLIDSSOLFDEOH
x
5HWDLQVDPSOHVVHQWWRWKLUGSDUW\IRUELRDYDLODELOLW\ELRHTXLYDOHQFHLIDSSOLFDEOH
,QYHVWLJDWLRQDO SURGXFW GLVSHQVLQJ UHFRUGLQYHQWRU\ ORJV DQG FRSLHV RI VLJQHG SDFNLQJ OLVWV
PXVWEHPDLQWDLQHGDWWKHLQYHVWLJDWLRQDOVLWH%DWFKQXPEHUVIRUDIDWLQLEDQGGDVDWLQLEPXVW
EHUHFRUGHGLQWKHGUXJDFFRXQWDELOLW\UHFRUGV

5HWXUQDQG'HVWUXFWLRQRI,QYHVWLJDWLRQDO3URGXFW

5HWXUQRI,QYHVWLJDWLRQDO3URGXFW
8SRQFRPSOHWLRQRUWHUPLQDWLRQRIWKHVWXG\DOOXQXVHGDQGRUSDUWLDOO\XVHGLQYHVWLJDWLRQDO
SURGXFWPXVWEHUHWXUQHGWR%,RU%06LIQRWDXWKRUL]HGE\%,RU%06WREHGHVWUR\HGDWWKH
VLWH
$OOLQYHVWLJDWLRQDOSURGXFWVUHWXUQHGPXVWEHDFFRPSDQLHGE\WKHDSSURSULDWHGRFXPHQWDWLRQ
DQGEHFOHDUO\LGHQWLILHGE\SURWRFROQXPEHUDQGVWXG\VLWHQXPEHURQWKHRXWHUPRVWVKLSSLQJ
FRQWDLQHU5HWXUQHGVXSSOLHVVKRXOGEHLQWKHRULJLQDOFRQWDLQHUV(PSW\FRQWDLQHUVVKRXOG
QRW EH UHWXUQHG  ,W LV WKH ,QYHVWLJDWRU¶V UHVSRQVLELOLW\ WR DUUDQJH IRU GLVSRVDO RI DOO HPSW\
FRQWDLQHUVSURYLGHGWKDWSURFHGXUHVIRUSURSHUGLVSRVDOKDYHEHHQHVWDEOLVKHGDFFRUGLQJWR
DSSOLFDEOHIHGHUDOVWDWHORFDODQGLQVWLWXWLRQDOJXLGHOLQHVDQGSURFHGXUHVDQGSURYLGHGWKDW
DSSURSULDWH UHFRUGV RI GLVSRVDO DUH NHSW  7KH UHWXUQ RI XQXVHG LQYHVWLJDWLRQDO SURGXFWV
VKRXOGEHDUUDQJHGE\WKHUHVSRQVLEOH,QYHVWLJDWRUDWWKHVLWH

'HVWUXFWLRQRI,QYHVWLJDWLRQDO3URGXFW
,ILQYHVWLJDWLRQDOSURGXFWVDUHWREHGHVWUR\HGRQVLWHLWLVWKH,QYHVWLJDWRU¶VUHVSRQVLELOLW\WR
HQVXUHWKDWDUUDQJHPHQWVKDYHEHHQPDGHIRUGLVSRVDODQG ZULWWHQDXWKRUL]DWLRQKDVEHHQ
JUDQWHG E\ %06 RU %, DQG WKDW SURFHGXUHV IRU SURSHU GLVSRVDO KDYH EHHQ HVWDEOLVKHG



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
DFFRUGLQJ WR DSSOLFDEOH UHJXODWLRQV JXLGHOLQHV DQG LQVWLWXWLRQDO SURFHGXUHV  $SSURSULDWH
UHFRUGVRIWKHGLVSRVDOPXVWEHPDLQWDLQHG7KHXQXVHGLQYHVWLJDWLRQDOSURGXFWVFDQRQO\EH
GHVWUR\HGDIWHUDSSURSULDWHLQVWUXFWLRQE\%06RU%RHKULQJHU,QJHOKHLP

$'9(56((9(176	'$7$6$)(7<021,725,1*
&200,77(('60&
7KH VDIHW\ RI GDVDWLQLE DQG DIDWLQLE ZLOO EH DVVHVVHG WKURXJK FROOHFWLRQ DQG DQDO\VHV RI
DGYHUVHHYHQWV$(VDQGODERUDWRU\WHVWV

6SHFLILFDWLRQRI6DIHW\9DULDEOHV
6DIHW\DVVHVVPHQWVZLOOFRQVLVWRIPRQLWRULQJDQGUHFRUGLQJSURWRFROGHILQHGDGYHUVHHYHQWV
$(V DQG VHULRXV DGYHUVH HYHQWV 6$(V PHDVXUHPHQW RI SURWRFROVSHFLILHG KHPDWRORJ\
FOLQLFDOFKHPLVWU\DQGXULQDO\VLVYDULDEOHVPHDVXUHPHQWRISURWRFROVSHFLILHGYLWDOVLJQVDQG
RWKHU SURWRFROVSHFLILHG WHVWV WKDW DUH GHHPHG FULWLFDO WR WKH VDIHW\ HYDOXDWLRQ RI WKH VWXG\
GUXJV
'HDWKDVDUHVXOWRIGLVHDVHSURJUHVVLRQLVRQO\WREHDVVHVVHGDVHIILFDF\PHDVXUHVDQGQRW
DV$(VRU6$(V

'HILQLWLRQRI$GYHUVH(YHQWV
$Q$(LVDQ\XQIDYRUDEOHDQGXQLQWHQGHGVLJQV\PSWRPRUGLVHDVHWHPSRUDOO\DVVRFLDWHG
ZLWKWKHXVHRIDQLQYHVWLJDWLRQDOPHGLFLQDOSURGXFWRURWKHUSURWRFROLPSRVHGLQWHUYHQWLRQ
UHJDUGOHVVRIDWWULEXWLRQ
7KLVLQFOXGHVWKHIROORZLQJ
x
$(VQRWSUHYLRXVO\REVHUYHGLQWKHSDWLHQWWKDWHPHUJHGXULQJWKHSURWRFROVSHFLILHG
$(UHSRUWLQJSHULRGLQFOXGLQJVLJQVRUV\PSWRPVDVVRFLDWHGZLWK16&/&WKDWZHUH
QRWSUHVHQWSULRUWRWKH$(UHSRUWLQJSHULRG
x
&RPSOLFDWLRQVWKDWRFFXUDVDUHVXOWRISURWRFROPDQGDWHGLQWHUYHQWLRQV
HJLQYDVLYHSURFHGXUHVVXFKDVELRSVLHV
x
,IDSSOLFDEOH$(VWKDWRFFXUSULRUWRDVVLJQPHQWRIVWXG\WUHDWPHQWDVVRFLDWHGZLWK
PHGLFDWLRQZDVKRXWQRWUHDWPHQWUXQLQRURWKHUSURWRFROPDQGDWHGLQWHUYHQWLRQ
x
3UHH[LVWLQJPHGLFDOFRQGLWLRQVRWKHUWKDQWKHFRQGLWLRQEHLQJVWXGLHGMXGJHGE\
WKHLQYHVWLJDWRUWRKDYHZRUVHQHGLQVHYHULW\RUIUHTXHQF\RUFKDQJHGLQFKDUDFWHU
GXULQJWKHSURWRFROVSHFLILHG$(UHSRUWLQJSHULRG



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
x
'LDJQRVHVDQGRUV\PSWRPVDVVRFLDWHGZLWK16&/&VKRXOGEHUHSRUWHGDV$(VLI
WKH\ZRUVHQRUFKDQJHLQFKDUDFWHU&OLQLFDOSURJUHVVLRQRI16&/&VKRXOGQRWEH
UHSRUWHGDVDQ$(
x
:RUVHQLQJRIWKHXQGHUO\LQJGLVHDVHRURIRWKHUSUHH[LVWLQJFRQGLWLRQVZLOOEH
UHFRUGHGDVDQ$(LQWKH&5)
x
6HOHFWHYHQWVUHJDUGOHVVRIJUDGHZLOOEHUHFRUGHGDVDQ$(GLDUUKHDVNLQUDVK
WKURPERF\WRSHQLDQHXWURSHQLDDQG$67$/7ELOLUXELQRUFUHDWLQLQHHOHYDWLRQ
x
2WKHUFKDQJHVLQYLWDOVLJQV(&*SK\VLFDOH[DPLQDWLRQDQGODERUDWRU\WHVWUHVXOWV
ZLOOQRWEHUHFRUGHGDVDQ$(LQWKH&5)
R XQOHVVWKHUHDUHFOLQLFDOVLJQVRUV\PSWRPVRU
R WKH\UHTXLUHGFOLQLFDOLQWHUYHQWLRQRUWUHDWPHQW

 3URWRFRO6SHFLILHG6LJQLILFDQW(YHQWV
3URWRFROVSHFLILHGVLJQLILFDQWHYHQWVDUHWREHUHSRUWHGLQDQH[SHGLWHGPDQQHUWR%,VLPLODUWR
6HULRXV$GYHUVH(YHQWVHYHQLIWKH\GRQRWPHHWDQ\RIWKHVHULRXVQHVVFULWHULD7KHIROORZLQJ
HYHQWVDUHFRQVLGHUHGDVDIDWLQLESURWRFROVSHFLILHGVLJQLILFDQWHYHQWV

+HSDWLFLQMXU\GHILQHGE\WKHIROORZLQJDOWHUDWLRQVRIOLYHUSDUDPHWHUVPHDVXUHGLQWKHVDPH
EORRGGUDZVDPSOH
x
)RUSDWLHQWVZLWKQRUPDO$67$/7DQGWRWDOELOLUXELQDWEDVHOLQHDQHOHYDWLRQRI$67
DQGRU$/7DERYH!IROG8/1FRPELQHGZLWKDQHOHYDWLRQRIWRWDOELOLUXELQDERYH!
IROG8/1
x
)RUSDWLHQWVZLWKEDVHOLQHDEQRUPDO$67$/7DQHOHYDWLRQRI$67DQGRU$/7DERYH
!IROG8/1FRPELQHGZLWKDQHOHYDWLRQRIWRWDOELOLUXELQDERYH!IROG8/1
3DWLHQWVVKRZLQJWKHVHODEDEQRUPDOLWLHVQHHGWREHIROORZHGXSDSSURSULDWHO\

6HULRXV$GYHUVH(YHQWV
$VHULRXV$(LVDQ\XQWRZDUGPHGLFDORFFXUUHQFHWKDWDWDQ\GRVH
x
UHVXOWVLQGHDWK
x
LVOLIHWKUHDWHQLQJGHILQHGDVDQHYHQWLQZKLFKWKHSDWLHQWZDVDWULVNRIGHDWKDWWKHWLPH
RIWKHHYHQWLWGRHVQRWUHIHUWRDQHYHQWZKLFKK\SRWKHWLFDOO\PLJKWKDYHFDXVHGGHDWKLILW
ZHUHPRUHVHYHUH
x
UHTXLUHVLQSDWLHQWKRVSLWDOL]DWLRQRUFDXVHVSURORQJDWLRQRIH[LVWLQJKRVSLWDOL]DWLRQ
x
UHVXOWVLQSHUVLVWHQWRUVLJQLILFDQWGLVDELOLW\LQFDSDFLW\
x
LVDFRQJHQLWDODQRPDO\ELUWKGHIHFW
x
UHVXOWVLQWKHGHYHORSPHQWRIGUXJGHSHQGHQF\RUGUXJDEXVH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
x
LVDQLPSRUWDQWPHGLFDOHYHQWGHILQHGDVDPHGLFDOHYHQWVWKDWPD\QRWEHLPPHGLDWHO\
OLIHWKUHDWHQLQJRUUHVXOWLQGHDWKRUKRVSLWDOL]DWLRQEXWEDVHGXSRQDSSURSULDWHPHGLFDO
DQGVFLHQWLILFMXGJPHQWPD\MHRSDUGL]HWKHSDWLHQWRUPD\UHTXLUHLQWHUYHQWLRQHJ
PHGLFDOVXUJLFDOWRSUHYHQWRQHRIWKHRWKHUVHULRXVRXWFRPHVOLVWHGLQWKHGHILQLWLRQ
DERYH([DPSOHVRIVXFKHYHQWVLQFOXGHEXWDUHQRWOLPLWHGWRLQWHQVLYHWUHDWPHQWLQDQ
HPHUJHQF\URRPRUDWKRPHIRUDOOHUJLFEURQFKRVSDVPEORRGG\VFUDVLDVRUFRQYXOVLRQV
WKDWGRQRWUHVXOWLQKRVSLWDOL]DWLRQ)RUUHSRUWLQJSXUSRVHVDOVRFRQVLGHUWKH
RFFXUUHQFHVRISUHJQDQF\RURYHUGRVHUHJDUGOHVVRIDGYHUVHRXWFRPHDVHYHQWV
ZKLFKPXVWEHUHSRUWHGDVLPSRUWDQWPHGLFDOHYHQWV
x
$QRYHUGRVHLVGHILQHGDVWKHDFFLGHQWDORULQWHQWLRQDOLQJHVWLRQRIDQ\GRVHRIDSURGXFW
WKDWLVFRQVLGHUHGERWKH[FHVVLYHDQGPHGLFDOO\LPSRUWDQW)RUUHSRUWLQJSXUSRVHV%ULVWRO
0\HUV6TXLEEDQG%RHKULQJHU,QJHOKHLPFRQVLGHUDQRYHUGRVHUHJDUGOHVVRIDGYHUVH
RXWFRPHDVDQLPSRUWDQWPHGLFDOHYHQWVHH6HULRXV$GYHUVH(YHQWV
$OO$(VWKDWGRQRWPHHWDQ\RIWKHFULWHULDIRUVHULRXVVKRXOGEHUHJDUGHGDVQRQVHULRXV$(V
7KH WHUPV ³VHYHUH´ DQG ³VHULRXV´ DUH QRW V\QRQ\PRXV  6HYHULW\ RU LQWHQVLW\ UHIHUV WR WKH
JUDGH RI D VSHFLILF $( HJ PLOG *UDGH  PRGHUDWH *UDGH  RU VHYHUH *UDGH 
P\RFDUGLDO LQIDUFWLRQ VHH 6HFWLRQ   ³6HULRXV´ LV D UHJXODWRU\ GHILQLWLRQ VHH SUHYLRXV
GHILQLWLRQDQGLVEDVHGRQSDWLHQWRUHYHQWRXWFRPHRUDFWLRQFULWHULDXVXDOO\DVVRFLDWHGZLWK
HYHQWVWKDWSRVHDWKUHDWWRDSDWLHQW¶VOLIHRUIXQFWLRQLQJ6HULRXVQHVVQRWVHYHULW\VHUYHVDV
WKHJXLGHIRUGHILQLQJUHJXODWRU\UHSRUWLQJREOLJDWLRQVIURPWKH6SRQVRUWRDSSOLFDEOHUHJXODWRU\
DXWKRULWLHV
6HYHULW\DQGVHULRXVQHVVVKRXOGEHLQGHSHQGHQWO\DVVHVVHGZKHQUHFRUGLQJ$(VDQG6$(V
RQWKH&5)$OOVHULRXV$(VZKHWKHUUHODWHGRUXQUHODWHGWRLQYHVWLJDWLRQDOSURGXFWPXVWEH
LPPHGLDWHO\ UHSRUWHG WR %ULVWRO0\HUV 6TXLEE RU GHVLJQHH DQG %RHKULQJHU,QJHOKHLP E\
FRQILUPHG IDFVLPLOH WUDQVPLVVLRQ WR FRPSO\ ZLWK UHJXODWRU\ UHTXLUHPHQWV  ,I RQO\ OLPLWHG
LQIRUPDWLRQLVLQLWLDOO\DYDLODEOHIROORZXSUHSRUWVDUHUHTXLUHG7KHRULJLQDO6$(IRUPPXVWEH
NHSWRQILOHDWWKHVWXG\VLWH

0HWKRGVDQG7LPLQJIRU$VVHVVLQJ$1'5HFRUGLQJ6DIHW\YDULDEOHV
7KH LQYHVWLJDWRU LV UHVSRQVLEOH IRU HQVXULQJ WKDW DOO $(V DQG 6$(V WKDW DUH REVHUYHG RU
UHSRUWHG GXULQJ WKH VWXG\ DUH UHFRUGHG RQ WKH &5) DQG UHSRUWHG WR WKH 6SRQVRU LQ
DFFRUGDQFHZLWKSURWRFROLQVWUXFWLRQV
'HDWK DV D UHVXOW RI GLVHDVH SURJUHVVLRQ HQGSRLQWV DUH RQO\ WR EH DVVHVVHG DV HIILFDF\
PHDVXUHVDQGQRWDV$(VRU6$(V



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

$GYHUVH(YHQW5HSRUWLQJ3HULRG
7KH VWXG\ SHULRG GXULQJ ZKLFK DOO $(V DQG 6$(V PXVW EH UHSRUWHG EHJLQV DIWHU LQIRUPHG
FRQVHQWLVREWDLQHGDQGHQGVGD\VIROORZLQJWKHODVWDGPLQLVWUDWLRQRIVWXG\WUHDWPHQWRU
VWXG\ GLVFRQWLQXDWLRQWHUPLQDWLRQ ZKLFKHYHU LV HDUOLHU  ,Q DGGLWLRQ WKH LQYHVWLJDWRU VKRXOG
QRWLI\%RHKULQJHUDQG%06RIDQ\6$(WKDWPD\RFFXUDIWHUWKLVWLPHSHULRGZKLFKWKH\EHOLHYH
WREHFHUWDLQO\SUREDEO\RUSRVVLEO\UHODWHGWRLQYHVWLJDWLRQDOSURGXFW
6$(VWKDWDUHREVHUYHGRUUHSRUWHGSULRUWRLQLWLDWLRQRIVWXG\WUHDWPHQWVKRXOGEHUHFRUGHGDV
6$(VRQWKH&5)LIWKH\DUHDVVRFLDWHGZLWKSURWRFROPDQGDWHGLQWHUYHQWLRQVHJLQYDVLYH
SURFHGXUHVVXFKDVELRSVLHVPHGLFDWLRQZDVKRXWRUQRWUHDWPHQWUXQLQ

$VVHVVPHQWRI$GYHUVH(YHQWV
,QYHVWLJDWRUVZLOODVVHVVWKHRFFXUUHQFHRI$(VDQG6$(VDWDOOSDWLHQWHYDOXDWLRQWLPHSRLQWV
GXULQJWKHVWXG\$OO$(VDQG6$(VZKHWKHUYROXQWHHUHGE\WKHSDWLHQWGLVFRYHUHGE\VWXG\
SHUVRQQHO GXULQJ TXHVWLRQLQJ RU GHWHFWHG WKURXJK SK\VLFDO H[DPLQDWLRQ ODERUDWRU\ WHVW RU
RWKHUPHDQVZLOOEHUHFRUGHGLQWKHSDWLHQW¶VPHGLFDOUHFRUGDQGRQWKHDSSURSULDWH$(RU6$(
&5)SDJH
(DFKUHFRUGHG$(RU6$(ZLOOEHGHVFULEHGE\LWVGXUDWLRQLHVWDUWDQGHQGGDWHVVHYHULW\
VHH 7DEOH  UHJXODWRU\ VHULRXVQHVV FULWHULD LI DSSOLFDEOH VXVSHFWHG UHODWLRQVKLS WR WKH
LQYHVWLJDWLRQDOSURGXFWVHHIROORZLQJJXLGDQFHDQGDFWLRQVWDNHQ
7KH$(JUDGLQJVHYHULW\VFDOHIRXQGLQWKH1DWLRQDO&DQFHU,QVWLWXWH&RPPRQ7HUPLQRORJ\
&ULWHULDIRU$GYHUVH(YHQWV1&,&7&$(9HUVLRQZLOOEHXVHGIRU$(UHSRUWLQJ7KHWDEOH
EHORZLVSURYLGHGIRUUHIHUHQFHSXUSRVHVRQO\,QWKHDGYHQWRIDQ\LQFRQFOXVLYHRUGLVFRUGDQW
ILQGLQJVWKHFXUUHQW&7&$(9HUVLRQKROGVSUHFHGHQFH
7DEOH$GYHUVH(YHQW*UDGLQJ6HYHULW\6FDOH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
*UDGH
6HYHULW\
$OWHUQDWH'HVFULSWLRQD

0LOGDSSO\HYHQWVSHFLILF
1&,&7&$(JUDGLQJFULWHULD
7UDQVLHQWRUPLOGGLVFRPIRUWKRXUVQR
LQWHUIHUHQFHZLWKWKHSDWLHQW¶VGDLO\DFWLYLWLHV
QRPHGLFDOLQWHUYHQWLRQWKHUDS\UHTXLUHG

0RGHUDWHDSSO\HYHQWVSHFLILF
1&,&7&$(JUDGLQJFULWHULD
0LOGWRPRGHUDWHLQWHUIHUHQFHZLWKWKH
SDWLHQW¶VGDLO\DFWLYLWLHVQRRUPLQLPDO
PHGLFDOLQWHUYHQWLRQWKHUDS\UHTXLUHG

6HYHUHDSSO\HYHQWVSHFLILF
1&,&7&$(JUDGLQJFULWHULD
&RQVLGHUDEOHLQWHUIHUHQFHZLWKWKHSDWLHQW¶V
GDLO\DFWLYLWLHVPHGLFDOLQWHUYHQWLRQWKHUDS\
UHTXLUHGKRVSLWDOL]DWLRQSRVVLEOH

9HU\VHYHUHOLIHWKUHDWHQLQJ
RUGLVDEOLQJDSSO\HYHQWVSHFLILF
1&,&7&$(JUDGLQJFULWHULD
([WUHPHOLPLWDWLRQLQDFWLYLW\VLJQLILFDQW
PHGLFDOLQWHUYHQWLRQWKHUDS\UHTXLUHG
KRVSLWDOL]DWLRQSUREDEOH

'HDWKUHODWHGWR$(

1RWH5HJDUGOHVVRIVHYHULW\VRPHHYHQWVPD\DOVRPHHWUHJXODWRU\VHULRXVFULWHULD5HIHUWR
GHILQLWLRQVRIDQ6$(VHH6HFWLRQ
D 8VHWKHVHDOWHUQDWLYHGHILQLWLRQVIRU*UDGHDQGHYHQWVZKHQWKHREVHUYHGRU
UHSRUWHG$(LVQRWLQWKH1&,&7&$(OLVWLQJ
7RHQVXUHFRQVLVWHQF\RI$(DQG6$(FDXVDOLW\DVVHVVPHQWVLQYHVWLJDWRUVVKRXOGDSSO\WKH
IROORZLQJJHQHUDOJXLGHOLQH
x
<(6
7KHUHLVDSODXVLEOHWHPSRUDOUHODWLRQVKLSEHWZHHQWKHRQVHWRIWKH$(DQG
DGPLQLVWUDWLRQRIWKHLQYHVWLJDWLRQDOSURGXFWDQGWKH$(FDQQRWEHUHDGLO\H[SODLQHGE\
WKHSDWLHQW¶VFOLQLFDOVWDWHLQWHUFXUUHQWLOOQHVVRUFRQFRPLWDQWWKHUDSLHVDQGRUWKH$(
IROORZVDNQRZQSDWWHUQRIUHVSRQVHWRWKHLQYHVWLJDWLRQDOSURGXFWDQGRUWKH$(
DEDWHVRUUHVROYHVXSRQGLVFRQWLQXDWLRQRIWKHLQYHVWLJDWLRQDOSURGXFWRUGRVHUHGXFWLRQ
DQGLIDSSOLFDEOHUHDSSHDUVXSRQUHFKDOOHQJH
x
12
(YLGHQFHH[LVWVWKDWWKH$(KDVDQHWLRORJ\RWKHUWKDQWKHLQYHVWLJDWLRQDOSURGXFWHJ
SUHH[LVWLQJPHGLFDOFRQGLWLRQXQGHUO\LQJGLVHDVHLQWHUFXUUHQWLOOQHVVRUFRQFRPLWDQW
PHGLFDWLRQDQGRUWKH$(KDVQRSODXVLEOHWHPSRUDOUHODWLRQVKLSWRDGPLQLVWUDWLRQRI
WKHLQYHVWLJDWLRQDOSURGXFWHJFDQFHUGLDJQRVHGGD\VDIWHUILUVWGRVHRIVWXG\
GUXJ



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

'DWD6DIHW\DQG0RQLWRULQJ%RDUG
7KH GHVLJQDWHG FDQFHU FHQWHU 'DWD 6DIHW\ DQG 0RQLWRULQJ &RPPLWWHH '60& ZLOO SHUIRUP
UHYLHZVRIUHSRUWHGDGYHUVHHYHQWVDQGLQYHVWLJDWRUFRPSOLDQFHZLWKDGYHUVHHYHQWWUDFNLQJ
7KH'60&LQFOXGHVSK\VLFLDQUHSUHVHQWDWLRQIURPHDFKSURJUDPDUHDDQGDELRVWDWLVWLFLDQ
7KH'60&LVDXWKRUL]HGWRVXVSHQGDWULDOIRUQRQFRPSOLDQFHRUDVDUHVXOWRIDXGLWILQGLQJV
GHHPHGXQDFFHSWDEOH7KH'60&ZLOOUHSRUWVLJQLILFDQWILQGLQJVWRWKH,5%WKHVSRQVRUDQG
WKHDSSOLFDEOHUHJXODWRU\ERG\,QWHULPPHHWLQJVDUHVFKHGXOHGWRDGGUHVVVSHFLILFLVVXHVWKDW
UHTXLUHLPPHGLDWHDWWHQWLRQWRHQVXUHVDIHW\RIUHVHDUFKSDUWLFLSDQWV

$GYHUVH(YHQW5HSRUWLQJ*XLGHOLQHV

0HG:DWFK$5HSRUWLQJIRU*RRG&OLQLFDO3UDFWLFH
8QH[SHFWHGGUXJUHODWHG6$(VVKRXOGEHUHSRUWHGRQWKH0HG:DWFK)RUP$ZKLFKFDQ
EHDFFHVVHGDW
KWWSZZZDFFHVVGDWDIGDJRYVFULSWV0HG:DWFK
0HG:DWFKIRUPVVKRXOGEHVHQWWRWKH)'$RQOLQHDWWKHDERYHLQWHUQHWDGGUHVVRUDW
0(':$7&+
)LVKHUV/DQH
5RFNYLOOH0'
)D[)'$
 5HVSRQVLELOLWLHVIRU6$(UHSRUWLQJWR&ROODERUDWRUV
$OO6$(VVKRXOGVLPXOWDQHRXVO\EHID[HGWR%ULVWRO0\HUV6TXLEEDQG%RHKULQJHU,QJHOKHLPDW
*OREDO3KDUPDFRYLJLODQFH
%ULVWRO0\HUV6TXLEE&RPSDQ\
)D[1XPEHU
%RHKULQJHU,QJHOKHLP6DIHW\UHSRUWLQJ
6$(IRUPVKRXOGEHID[HGWR%,GUXJVDIHW\XQLTXHHQWU\SRLQW
%RHKULQJHU,QJOHKLHP3KDUPDFHXWLFDOV,QF
%RHKULQJHU,QJHOKHLP3KDUPDFHXWLFDOV,QF
5LGJHEXU\5RDG
5LGJHILHOG&7



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
)D[
(PDLOFDVHILOHUGJ#ERHKULQJHULQJHOKHLPFRP
,IQRFRQILUPDWLRQRIUHFHLSWUHFHLYHGIURP%,ZLWKLQZRUNLQJGD\WKHLQYHVWLJDWRUPXVW
UHVHQG6$(UHSRUW

7KHLQYHVWLJDWRUVKDOOUHSRUWDOO6$(VDQGQRQVHULRXV$(VRFFXUULQJDWWKHVDPHWLPHZKLFK
DUHPHGLFDOO\UHODWHGWRWKH6$(E\ID[RURWKHUVHFXUHPHWKRGWRWKH%,8QLTXH(QWU\3RLQWLQ
DFFRUGDQFHZLWKWKHIROORZLQJWLPHOLQHV
x
ZLWKLQILYHFDOHQGDUGD\VXSRQUHFHLSWRILQLWLDODQGIROORZXS6$(VFRQWDLQLQJDW
OHDVWRQHIDWDORULPPHGLDWHO\OLIHWKUHDWHQLQJHYHQW
x
ZLWKLQWHQFDOHQGDUGD\VXSRQUHFHLSWRIDQ\RWKHULQLWLDODQGIROORZXS6$(V

(DFKLQLWLDODQGIROORZXS6$(UHSRUWIRUPVKDOOEHSURYLGHGZLWKDFRYHUVKHHWIRUPSURYLGHG
E\%,7KHFRYHUVKHHWIRUPVKDOOEHFRPSOHWHO\ILOOHGRXWDQGLQGLFDWHZKHWKHURUQRWWKH
UHSRUWHG6$(VTXDOLILHVIRUH[SHGLWHGVXEPLVVLRQWRWKHFRPSHWHQWUHJXODWRU\DXWKRULWLHV
,5%,(&VDQGRULQYHVWLJDWRUVLIDSSOLFDEOH
7KH6$(UHSRUWIRUPVKDOOLQFOXGHDOO6$(VDQGQRQVHULRXV$(VRFFXUULQJLQWKHVDPHWLPH
ZKLFKDUHPHGLFDOO\UHODWHGDQGLQSDUWLFXODUWKHIROORZLQJLQIRUPDWLRQ
5HOHYDQFHRIWKHUHSRUWHGHYHQWVEDVHGRQ%,,QYHVWLJDWRU¶V%URFKXUHIRUWKH6WXG\'UXJ
6SRQVRU¶VFDXVDODVVHVVPHQWDVWRZKHWKHUWKHHYHQWVLVDUHUHODWHGWRWKHXVHRIWKH6WXG\
'UXJDQGWKHVHULRXVQHVVRIHDFK$(
2FFDVLRQDOO\ %ULVWRO0\HUV 6TXLEE RU %RHKULQJHU,QJHOKHLP PD\ FRQWDFW WKH UHSRUWHU IRU
DGGLWLRQDOLQIRUPDWLRQFODULILFDWLRQRUFXUUHQWVWDWXVRIWKHVXEMHFWIRUZKRPDQDGYHUVHHYHQW
ZDVUHSRUWHG


3URFHGXUHVIRU(OLFLWLQJ5HFRUGLQJDQG5HSRUWLQJ$GYHUVH(YHQWV
(OLFLWLQJ$GYHUVH(YHQWV
x
$FRQVLVWHQWPHWKRGRORJ\RIQRQGLUHFWLYHTXHVWLRQLQJIRUHOLFLWLQJ$(VDWDOO
SDWLHQWHYDOXDWLRQWLPHSRLQWVVKRXOGEHDGRSWHG([DPSOHVRIQRQGLUHFWLYH
TXHVWLRQVLQFOXGH
x
³+RZKDYH\RXIHOWVLQFH\RXUODVWFOLQLFDOYLVLW"´
x
³7HOOPHDERXWDQ\QHZRUFKDQJHGKHDOWKSUREOHPVVLQFH\RXZHUHODVWKHUH"´



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

([SHGLWHG5HSRUWLQJ5HTXLUHPHQWVIRU6HULRXV$GYHUVH(YHQWV
,QYHVWLJDWRUVZLOOVXEPLWZULWWHQUHSRUWVRIDOO6$(VUHJDUGOHVVRIDWWULEXWLRQWR+/HH0RIILWW
,QWHUQDO0RQLWRULQJ&RPPLWHH'60&ZLWKLQKRXUVUHVSHFWLYHO\RIOHDUQLQJRIWKHHYHQWV
YLD2Q&RUH)RULQLWLDO6$(UHSRUWVLQYHVWLJDWRUVVKRXOGUHFRUGDOOFDVHGHWDLOVWKDWFDQEH
JDWKHUHGZLWKLQKRXUVRQDQ6$(&5)SDJH


7\SHDQG'XUDWLRQRI)ROORZXSRI3DWLHQWVDIWHU$GYHUVH(YHQWV
&ROOHFWLRQRIFRPSOHWHLQIRUPDWLRQFRQFHUQLQJ$(VDQG6$(VLVH[WUHPHO\LPSRUWDQW$OO$(V
DQG6$(VWKDWDUHHQFRXQWHUHGGXULQJWKHSURWRFROVSHFLILHG$(UHSRUWLQJSHULRGVKRXOGEH
IROORZHGWRWKHLUUHVROXWLRQVRUXQWLOWKHLQYHVWLJDWRUDVVHVVHVWKHPDVVWDEOHRUWKHSDWLHQWLV
ORVW WR IROORZXS  5HVROXWLRQ RI $(V DQG 6$(V ZLWK GDWHV VKRXOG EH GRFXPHQWHG RQ WKH
DSSURSULDWH$(RU6$(&5)SDJHLQ2Q&RUHDQGLQWKHSDWLHQW¶VPHGLFDOUHFRUGWRIDFLOLWDWH
VRXUFHGDWDYHULILFDWLRQ
)RUVRPH6$(VWKH6SRQVRURULWVGHVLJQHHPD\IROORZXSE\WHOHSKRQHID[HOHFWURQLFPDLO
DQGRUDPRQLWRULQJYLVLWWRREWDLQDGGLWLRQDOFDVHGHWDLOVGHHPHGQHFHVVDU\WRDSSURSULDWHO\
HYDOXDWH WKH 6$( UHSRUW HJ KRVSLWDO GLVFKDUJH VXPPDU\ FRQVXOWDQW UHSRUW RU DXWRSV\
UHSRUW



















3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK







































3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK































$'0,1,675$7,9(6(&7,21
3URWHFWLRQRI+XPDQ6XEMHFWVIURP5HVHDUFK5LVN



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

5LVNWR6XEMHFWV
7KHULVNWRVXEMHFWVZLOOEHRXWOLQHGFOHDUO\DQGLQGHWDLOLQWKHLQIRUPHGFRQVHQW7KHFROOHFWLRQ
RI SHULSKHUDO YHQRXV EORRG IRU VWXG\ SXUSRVHV LV QRW DVVRFLDWHG ZLWK DQ DGGLWLRQDO ULVN WR
SDUWLFLSDQWV VLQFH LW ZLOO EH FROOHFWHG GXULQJ URXWLQH SKOHERWRP\ ZKLFK LV UHTXLUHG IRU
PRQLWRULQJEHIRUHDQGZKLOHRQFKHPRWKHUDS\

$GHTXDF\RI3URWHFWLRQ$JDLQVW5LVN
7R SURWHFW SDUWLFLSDQWV IURP H[FHVV ULVN WKH DERYHPHQWLRQHG VWXG\ SURFHGXUHV DQG GRVH
HVFDODWLRQVFKHPH ZHUHLQVWLWXWHG$GGLWLRQDO SURWHFWLRQ LVSURYLGHGWKURXJKWKHGDWDVDIHW\
DQGPRQLWRULQJSODQGHVFULEHGEHORZ

,PSRUWDQFHRIWKH.QRZOHGJHWREH*DLQHG
7KH GHYHORSPHQW RI DZHOOWROHUDWHG DQG HIIHFWLYH UHJLPHQ LQ D GLVHDVH FRXOG SRWHQWLDOO\ DW
ZRUVWDGGWRWKHDUPDPHQWDULXPRIDYDLODEOHUHJLPHQVDQGDWEHVWFKDQJHVWDQGDUGRIFDUH
6SHFLILFVWUDWHJLHVWRLPSURYHWKHFDUHRISDWLHQWVUHODSVLQJIROORZLQJFKHPRWKHUDS\IRUOXQJ
FDQFHUDUHGLUHO\QHHGHG

'DWD6DIHW\DQG0RQLWRULQJ3ODQ
7KH 'DWD 6DIHW\ 	 0RQLWRULQJ 3ODQ '603 ZLOO HQVXUH WKDW WKLV WULDO LV ZHOO GHVLJQHG
UHVSRQVLEO\ PDQDJHG DSSURSULDWHO\ UHSRUWHG DQG WKDW LW SURWHFWV WKH ULJKWV DQG ZHOIDUH RI
SDWLHQWV  7KH IROORZLQJ LQWHUQDO DQG H[WHUQDO UHYLHZ DQG PRQLWRULQJ SURFHVVHV SURYLGH
RYHUVLJKWDQGDFWLYHPRQLWRULQJRIWKLVWULDO
7KH3ULQFLSDO,QYHVWLJDWRUV3,
7KH&OLQLFDO7ULDOV2IILFH&72
7KH6FLHQWLILF5HYLHZ&RPPLWWHH65&
7KH3URWRFRO5HYLHZDQG0RQLWRULQJ&RPPLWWHH350&DND'60&
7KH5HVHDUFK&RPSOLDQFH'LYLVLRQ5&'RIWKH&DQFHU&HQWHU
V&RPSOLDQFH2IILFH
7KH8QLYHUVLW\RI6RXWK)ORULGD,QVWLWXWLRQDO5HYLHZ%RDUG86),5%
7KH SURWRFRO LQFOXGHV D VHFWLRQ WKDW VSHFLILHV WKH IROORZLQJ ZLWK UHVSHFW WR $GYHUVH (YHQW
UHSRUWLQJ ZKDW FRQVWLWXWHV DQ DGYHUVH HYHQW YHUVXV ZKDW LV D VHULRXV DGYHUVH HYHQW WKH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
HQWLWLHV WR ZKLFK DGYHUVH HYHQWV VKRXOG EH UHSRUWHG WKH WLPLQJ RI WKLV UHSRUWLQJ DQG WKH
SHUVRQ RU SHUVRQV UHVSRQVLEOH IRU UHSRUWLQJ  7KLV LQFOXGHV SURPSW ZLWKLQ RQH GD\ RI
NQRZOHGJHRIWKHHYHQWUHSRUWLQJWRWKH,5%IRUXQDQWLFLSDWHGULVNVWRVXEMHFWVDQGUHSRUWLQJLQ
ZULWLQJZLWKLQILYHZRUNLQJGD\VWRWKH,5%DQGVSRQVRU

,QLWLDODQG2QJRLQJ0RQLWRULQJDQG5HYLHZ
3ULQFLSDO ,QYHVWLJDWRU 7KH 3, RI WKH VWXG\ KDV SULPDU\ UHVSRQVLELOLW\ IRU HQVXULQJ WKDW WKH
SURWRFROLVFRQGXFWHG DVDSSURYHGE\WKH350&DQGWKH,5%7KH3, ZLOOHQVXUHWKDWWKH
PRQLWRULQJ SODQ LV IROORZHG WKDW DOO GDWD UHTXLUHG IRU RYHUVLJKW RIPRQLWRULQJ DUH DFFXUDWHO\
UHSRUWHG WR WKH 6FLHQWLILF 5HYLHZ &RPPLWWHH 65& 3URWRFRO 5HYLHZ DQG 0RQLWRULQJ
&RPPLWWHH 350& DQG ,5% DV UHTXLUHG DQG WKDW DOO DGYHUVH HYHQWV DUH DSSURSULDWHO\
UHSRUWHG
&OLQLFDO7ULDOV2IILFH7KH&72ZLOOSURYLGHVXSSRUWIRUWKHPRQLWRULQJRIWKLVWULDODQGWKHVH
IXQFWLRQVFRQVLVWRIWKHIROORZLQJ
D'DWDPDQDJHPHQWE\DUHVHDUFKFRRUGLQDWRUZKRVHSULPDU\IXQFWLRQVLQFOXGH

6XSSRUWLQJWKH3,LQVFUHHQLQJDQGHQUROOLQJSDWLHQWVRQWRWKHWULDO

3URYLGLQJGDWDPDQDJHPHQWVXSSRUW

3URYLGLQJVWDIIHGXFDWLRQDQGWUDLQLQJ

&RRUGLQDWLQJDQGLPSOHPHQWLQJSURWRFROUHODWHGRUGHUVIRUVWXG\SDWLHQWV
3UHSDULQJPHGLFDOFKDUWVIRUDXGLWV

E5HJXODWRU\VXSSRUWE\VSHFLDOLVWVWUDLQHGLQERWKWKH)HGHUDOUHJXODWLRQVDQG86)
,QVWLWXWLRQDO5HYLHZ%RDUGSROLFLHV7KHVSHFLDOLVWV
SULPDU\IXQFWLRQVLQFOXGH

$VVLVWDQFHLQWKHSUHSDUDWLRQDQGZULWLQJRIWKHFOLQLFDOSURWRFRO

$VVLVWDQFHLQZULWLQJRIWKHLQIRUPHGFRQVHQW

&RRUGLQDWLRQDQGIDFLOLWDWLRQRIFRPPXQLFDWLRQWRUHVHDUFKRYHUVLJKWFRPPLWWHHV

$VVLVWDQFHLQVXEPLVVLRQRIUHJXODWRU\GRFXPHQWVVXFKDV)'$V1,+$QQXDO
5HSRUWLQJDGYHUVHHYHQWUHSRUWVDQGDFFUXDOUHSRUWV

&RRUGLQDWLRQRIFOLQLFDOWULDODFWLYDWLRQDQGFORVXUH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

0DLQWHQDQFHRILQVWLWXWLRQDOFOLQLFDOUHVHDUFKUHJXODWRU\GRFXPHQWV
7KH6FLHQWLILF5HYLHZ&RPPLWWHH
7KH&DQFHU&HQWHU
VLQWHUQDO6FLHQWLILF5HYLHZ&RPPLWWHH65&SURYLGHVIRUDIRUPDOLQWHUQDO
SHHUUHYLHZRIDOOSURWRFROVDQGJHQHUDOVFLHQWLILFRYHUVLJKWRILQWHUYHQWLRQDOFOLQLFDOUHVHDUFK
7KH&RPPLWWHHKDVDGHILQHGPHPEHUVKLSUHSUHVHQWLQJDOORIWKHPDMRUUHVHDUFKGLYLVLRQVRI
WKH&DQFHU&HQWHULQFOXGLQJELRVWDWLVWLFLDQV$OOQHZSURWRFROVXEPLVVLRQVPXVWFRQWDLQWKH
UHTXLUHG HOHPHQWV RI WKH SURWRFRO DQG PXVW LQFOXGH D '603 SULRU WR DSSURYDO E\ WKH
&RPPLWWHH7KHSODQKDVWREHDSSURSULDWHIRUWKHSKDVHDQGULVNRIWKHSURSRVHGVWXG\7ZR
IRUPDOUHYLHZHUVDUHSUHDVVLJQHGWROHDGGLVFXVVLRQRIWKHSURWRFRO7KHFRPPLWWHH¶VYRWH
LQGLFDWHVDSSURYDOFRQGLWLRQDODSSURYDORUGLVDSSURYDO$SSURYDOE\PDMRULW\YRWHLVUHTXLUHG
0HPEHUV DIILOLDWHG ZLWK WKH SURWRFRO PXVW OHDYH WKH URRP GXULQJ WKH GLVFXVVLRQ DQG YRWLQJ
SURFHVV65&DSSURYDOLVUHTXLUHGEHIRUHWKHSURWRFROFDQEHVXEPLWWHGWRWKH,5%
7KH3URWRFRO5HYLHZDQG0RQLWRULQJ&RPPLWWHH
7KH 3URWRFRO 5HYLHZ DQG 0RQLWRULQJ &RPPLWWHH 350& ZLOO PRQLWRU WKLV WULDO IRU VDIHW\
SURJUHVV SURWRFRO FRPSOLDQFH DFFUXDO DGYHUVH HYHQW UHSRUWLQJ DQG GDWD LQWHJULW\  7KH
PHPEHUVKLSRIWKH350&LQFOXGHVSK\VLFLDQUHSUHVHQWDWLRQIURPHDFKSURJUDPDUHDDQGD
ELRVWDWLVWLFLDQ,QDGGLWLRQWRWKHH[LVWLQJVWRSSLQJUXOHVWKH350&LVDXWKRUL]HGWRVXVSHQGD
WULDOIRUQRQFRPSOLDQFHZLWKD'603RUDVDUHVXOWRIDXGLWILQGLQJVGHHPHGXQDFFHSWDEOH
7KH350&ZLOOUHSRUWVLJQLILFDQWILQGLQJVWRWKH,5%WKHVSRQVRUDQGWKHDSSOLFDEOHUHJXODWRU\
ERG\  ,QWHULP PHHWLQJV DUH VFKHGXOHG WR DGGUHVV VSHFLILF LVVXHV WKDW UHTXLUH LPPHGLDWH
DWWHQWLRQWRHQVXUHVDIHW\RIUHVHDUFKSDUWLFLSDQWV
,QWHUQDO0RQLWRULQJ
'DWDZLOOEHFDSWXUHGLQ2QFRUH0RIILWW¶V&OLQLFDO7ULDOV'DWDEDVH7KH&DVH5HSRUW)RUPVZLOO
EHUHYLHZHGE\0RIILWW¶V,QWHUQDO0RQLWRUVSHULRGLFDOO\WKURXJKRXWWKHFRQGXFWRIWKHWULDO7KH
PRQLWRULQJZLOOLQFOXGHVRXUFHGDWDYHULILFDWLRQXWLOL]LQJUHVHDUFKVXEMHFWV¶PHGLFDOUHFRUGV7KH
5HVHDUFK&RPSOLDQFH'LYLVLRQRIWKH&DQFHU&HQWHU¶V&RPSOLDQFH2IILFH
7KH &DQFHU &HQWHU KDV HVWDEOLVKHG WKH 5HVHDUFK &RPSOLDQFH 'LYLVLRQ 5&' DV WKH
FRRUGLQDWLQJRIILFHIRULQWHUQDODXGLWVRIDOOFOLQLFDOWULDOVFRQGXFWHGDWWKH&DQFHU&HQWHUDQGLWV
DIILOLDWHV
7KHSXUSRVHRIWKHLQWHUQDODXGLWSURJUDPLVWR

$VVXUHSDWLHQWVDIHW\E\PRQLWRULQJFRPSOLDQFH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

$VVXUHUHJXODWRU\FRPSOLDQFHE\UHYLHZLQJFRQVHQWDQGDGYHUVHHYHQWUHSRUWLQJ

$VVXUHVFLHQWLILFYDOXHE\PRQLWRULQJDFFXUDF\DQGFRPSOHWHQHVVRIGDWDFROOHFWLRQ

0RQLWRUDQGFRRUGLQDWHUHVHDUFKFRPSOLDQFHDFWLYLWLHVDVVRFLDWHGZLWKLQVWLWXWLRQDODQG
LQGLYLGXDOFRQIOLFWRILQWHUHVW

0DNHUHFRPPHQGDWLRQVIRUPRGLILFDWLRQRIUHVHDUFKSUDFWLFHVDVQHFHVVDU\DQG
SURYLGHHGXFDWLRQRQLVVXHVWKDWDUHFULWLFDOWRJRRGUHVHDUFKSUDFWLFHV
$XGLWV ZLOO EH FRQGXFWHG E\ WKH 5&' LQ DFFRUGDQFH ZLWK DSSOLFDEOH UHJXODWRU\ VWDQGDUGV
,QYHVWLJDWRU LQLWLDWHG WULDOV VXFK DV WKH RQH SURSRVHG KHUH UHFHLYH WKH KLJKHVW SULRULW\ IRU
DXGLW7KH5&'ZLOOFRQGXFWDQGUHSRUWWKHILQGLQJVRIDXGLWVWRWKH30&LQDFFRUGDQFHZLWKD
SURWRFRO
VDQQXDOUHYLHZ7KH350&ZLOOGHWHUPLQHWKHILQGLQJVWREHDFFHSWDEOHZLWKPLQRU
GHYLDWLRQVDFFHSWDEOHZLWKFRUUHFWLYHDFWLRQRUXQDFFHSWDEOHZLWKVXVSHQVLRQRUFORVXUH7KH
350& &KDLUSHUVRQ ZLOO QRWLI\ WKH ,5% RI WKH DXGLW ILQGLQJV  7KH 5&' ZLOO IROORZXS WR
DVFHUWDLQZKHWKHUFRUUHFWLYHDFWLRQVZKLFKKDYHEHHQDJUHHGWRDUHDFKLHYLQJWKHGHVLUHG
UHVXOWV 7KH 350& ZLOO EH LQIRUPHG RI DOO VLJQLILFDQW RSHQ IROORZXS LWHPV )RU WKRVH
REVHUYDWLRQVZKHUHQRDFWLRQKDVEHHQWDNHQWKH5HVHDUFK&RPSOLDQFH2IILFHZLOOLQIRUPWKH
350&DQGPD\FRQGXFWDIRFXVHGDXGLW
7KH8QLYHUVLW\RI6RXWK)ORULGD,QVWLWXWLRQDO5HYLHZ%RDUG
7KH8QLYHUVLW\RI6RXWK)ORULGD,QVWLWXWLRQDO5HYLHZ%RDUG86),5%WKH,5%FRQWUDFWHGE\
7KH&DQFHU&HQWHUPXVWUHYLHZDQGDSSURYHDOOFOLQLFDOUHVHDUFKSURWRFROVSULRUWRDFWLYDWLRQ
7KH'603FRQVWLWXWHVDVLJQLILFDQWHOHPHQWRIWKLVUHYLHZ

*RRG&OLQLFDO3UDFWLFH
7KLVVWXG\ZLOOEHFRQGXFWHGLQDFFRUGDQFHZLWK*RRG&OLQLFDO3UDFWLFH*&3DVGHILQHGE\
WKH ,QWHUQDWLRQDO &RQIHUHQFH RQ +DUPRQLVDWLRQ ,&+ DQG LQ DFFRUGDQFH ZLWK WKH HWKLFDO
SULQFLSOHV XQGHUO\LQJ (XURSHDQ 8QLRQ 'LUHFWLYH (& DQG WKH 8QLWHG 6WDWHV &RGH RI
)HGHUDO5HJXODWLRQV7LWOH3DUW&)5

7KHVWXG\ZLOOEHFRQGXFWHGLQFRPSOLDQFHZLWKWKHSURWRFRO7KHSURWRFRODQ\DPHQGPHQWV
DQGWKHVXEMHFWLQIRUPHGFRQVHQWZLOOUHFHLYH,QVWLWXWLRQDO5HYLHZ%RDUG,QGHSHQGHQW(WKLFV
&RPPLWWHH,5%,(&DSSURYDOIDYRUDEOHRSLQLRQEHIRUHLQLWLDWLRQRIWKHVWXG\
$OOSRWHQWLDOVHULRXVEUHDFKHVPXVWEHUHSRUWHGWR%RHKULQJHU,QJHOKHLP%,DQG%ULVWRO0\HUV
6TXLEE%06LPPHGLDWHO\$VHULRXVEUHDFKLVDEUHDFKRIWKHFRQGLWLRQVDQGSULQFLSOHVRI
*&3 LQ FRQQHFWLRQ ZLWK WKH VWXG\ RU WKH SURWRFRO ZKLFK LV OLNHO\ WR DIIHFW WR D VLJQLILFDQW



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
GHJUHHWKHVDIHW\RUSK\VLFDORUPHQWDOLQWHJULW\RIWKHVXEMHFWVRIWKHVWXG\RUWKHVFLHQWLILF
YDOXHRIWKHVWXG\

6WXG\SHUVRQQHOLQYROYHGLQFRQGXFWLQJWKLVVWXG\ZLOOEHTXDOLILHGE\HGXFDWLRQWUDLQLQJDQG
H[SHULHQFH WR SHUIRUP WKHLU UHVSHFWLYH WDVNV 7KLV VWXG\ ZLOO QRW XVH WKH VHUYLFHV RI VWXG\
SHUVRQQHOZKHUHVDQFWLRQVKDYHEHHQLQYRNHGRUZKHUHWKHUHKDVEHHQVFLHQWLILFPLVFRQGXFW
RUIUDXGHJORVVRIPHGLFDOOLFHQVXUHGHEDUPHQW6\VWHPVZLWKSURFHGXUHVWKDWHQVXUHWKH
TXDOLW\RIHYHU\DVSHFWRIWKHVWXG\ZLOOEHLPSOHPHQWHG

6XVSHQVLRQDQG7HUPLQDWLRQ
7KH350&DQGRUWKH,5%PD\YRWHWRVXVSHQGRUWHUPLQDWHDSSURYDORIWKLVWULDOLIRQUHYLHZLW
LVGHWHUPLQHGWKDWWKHWULDOLVQRWEHLQJFRQGXFWHGLQDFFRUGDQFHZLWKWKH,5%&DQFHU&HQWHU
DQGRU UHJXODWRU\ UHTXLUHPHQWV RUWKDW LW KDV EHHQ DVVRFLDWHG ZLWK XQH[SHFWHG SUREOHPV RU
VHULRXVKDUPWRVXEMHFWV7KH350&,5%ZLOOQRWLI\WKH3,LQZULWLQJRIVXFKVXVSHQVLRQVRU
WHUPLQDWLRQV,WLVWKHUHVSRQVLELOLW\RIWKH350&,5%FKDLUSHUVRQWRHQVXUHSURPSWZULWWHQ
QRWLILFDWLRQRIDQ\VXVSHQVLRQVRUWHUPLQDWLRQRI350&,5%DSSURYDOWRWKHUHOHYDQW)HGHUDO
$JHQFLHVLQFOXGLQJ2+53)'$DQGWKHVWXG\VSRQVRUIXQGLQJVRXUFH

,QVWLWXWLRQDODQG,QGLYLGXDO&RQIOLFWVRI,QWHUHVW
&RQIOLFWRILQWHUHVW&2,LVGHILQHGDVDQ\VLWXDWLRQLQZKLFKILQDQFLDORUSHUVRQDOREOLJDWLRQV
PD\ FRPSURPLVH RU SUHVHQW WKH DSSHDUDQFH RI FRPSURPLVLQJ DQ LQGLYLGXDO
V RU JURXS
V
SURIHVVLRQDOMXGJPHQWLQFRQGXFWLQJUHYLHZLQJRUUHSRUWLQJUHVHDUFK7KLVLQFOXGHVUHVHDUFK
SHUVRQQHO,5%PHPEHUVUHVHDUFKDGPLQLVWUDWLRQRIILFLDOVWKH&DQFHU&HQWHUWKH8QLYHUVLW\
RI6RXWK)ORULGDDQGUHVHDUFKVSRQVRUV
7KH SURFHVVHV IRU PDQDJLQJ LQGLYLGXDO DQG LQVWLWXWLRQDO &2, ZLOO IRFXV RQ GLVFORVXUH RI WKH
FRQIOLFWPDQDJLQJWKHFRQIOLFWDQGSURKLELWLQJWKHDFWLYLW\ZKHQQHFHVVDU\WRSURWHFWWKHSXEOLF
LQWHUHVWRUWKHLQWHUHVWRIWKH&DQFHU&HQWHU
3ULRUWRWKHDFWLYDWLRQRIWKLVWULDODQGRQJRLQJWKHUHDIWHULQGLYLGXDOVZKRDUHLQYROYHGLQWKH
GHVLJQFRQGXFWDQGUHSRUWLQJZLOOEHUHTXLUHGWRGLVFORVHWRWKH65&DQ\DQGDOOILQDQFLDORU
RWKHULQWHUHVWVWKDWDUHRUPD\SHUFHLYHGWREHUHODWHGWRWKHWULDOLQZKLFKWKH\DUHDFWLYHO\
LQYROYHG LQ  7KH 65& ZLOO GHWHUPLQH LI D FRQIOLFW H[LVWV DQG LI VR DVVXUH WKDW WKH &2, LV
PDQDJHG UHGXFHG RU HOLPLQDWHG  7KLV LQIRUPDWLRQ ZLOO DFFRPSDQ\ D SURWRFRO ZKHQ LW LV
SUHVHQWHGWRWKH,5%7KH,5%ZLOOUHWDLQWKHKLJKHVWDXWKRULW\IRUGHWHUPLQLQJWKDWWKHFRQIOLFW
RI LQWHUHVW KDV EHHQ SURSHUO\ GLVFORVHG PDQDJHG RU HOLPLQDWHG  7KH 350& ZLOO HQVXUH
RQJRLQJ PRQLWRULQJ RI FRQIOLFW RI LQWHUHVW WKURXJK PRQWKO\ UHYLHZ RI FRQIOLFW RI LQWHUHVW
GLVFORVXUHV,ID&2,H[LVWVWKH30&ZLOOHQVXUHWKDWDSODQWRPDQDJHUHGXFHRUHOLPLQDWH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
WKH &2, LV GHYHORSHG DQG VXEPLWWHG WR WKH ,5% IRU DSSURYDO DQG WKH SURWRFRO LV DPHQGHG
DFFRUGLQJO\7KH5&'ZLOOEHUHVSRQVLEOHIRUPDLQWDLQLQJDVHFXUHGDWDV\VWHPIRUWUDFNLQJ
DQGWLPHO\UHSRUWLQJRIGLVFORVXUHLQIRUPDWLRQWRWKH65&RU350&IRUUHYLHZDVDSSURSULDWH
7KH5&'ZLOOEHUHVSRQVLEOHIRUHQVXULQJFRRUGLQDWLRQDQGFRPPXQLFDWLRQRI&2,EHWZHHQWKH
&DQFHU&HQWHUDQGWKH,5%7KH,5%KDVWKHILQDODXWKRULW\WRGHWHUPLQHWKDWWKH&2,KDV
EHHQPDQDJHGVXIILFLHQWO\WRDVVXUHWKHSURWHFWLRQRIKXPDQSDUWLFLSDQWV

5HFRUGV5HWHQWLRQ
86)'$UHJXODWLRQV&)5>F@UHTXLUHWKDWUHFRUGVDQGGRFXPHQWVSHUWDLQLQJWR
WKHFRQGXFWRIWKLVVWXG\DQGWKHGLVWULEXWLRQRILQYHVWLJDWLRQDOGUXJLQFOXGLQJ&5)VFRQVHQW
IRUPV ODERUDWRU\ WHVW UHVXOWV DQG PHGLFDWLRQ LQYHQWRU\ UHFRUGV PXVW EH UHWDLQHG E\ WKH
3ULQFLSDO,QYHVWLJDWRUIRU\HDUVDIWHUPDUNHWLQJDSSOLFDWLRQDSSURYDO,IQRDSSOLFDWLRQLVILOHG
WKHVHUHFRUGVPXVWEHNHSW\HDUVDIWHUWKHVWXG\LVGLVFRQWLQXHGDQGWKH86)'$DQGWKH
DSSOLFDEOHQDWLRQDODQGORFDOKHDOWKDXWKRULWLHVDUHQRWLILHG

&RQWULEXWLRQV
'U7DNHVKL<RVKLGDDSRVWGRFWRUDOIHOORZLQWKH+DXUD/DEKDVFRQWULEXWHGWRWKLVSURWRFRO
E\KHOSLQJWRZULWHWKHEDFNJURXQGSRUWLRQRIWKH,QWURGXFWLRQDQGFRQWULEXWLRQWRSUHFOLQLFDO
VWXGLHV
'UV3DWULFLD/R5XVVR*DU\0&ODUNDQG0LJXHO9LOODORQDKDYHFRQWULEXWHGWRWKLVSURWRFROE\
UHYLVLRQDQGHGLWLQJ
%DUEDUD/H6WDJHDSDWLHQWDGYRFDWHKDVFRQWULEXWHGWRWKLVSURWRFROLQGHVLJQDQGHGLWLQJ
$QJHOD5HDJDQKDVFRQWULEXWHGWRUHYLVLRQDQGHGLWLQJRIWKLVSURWRFRO
5DVD+DPLOWRQKDVFRQWULEXWHGWRHGLWLQJRIWKLVSURWRFRO
0RIILWW/$77(/XQJ$QG7KRUDFLF7XPRUV(GXFDWLRQ$GYRFDWHDGYLVRU\SDQHOKDV
FRQWULEXWHGWRWKHGHVLJQDQGUHYLHZRIWKLVSURWRFRO



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK














 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
   
 
 
 
 
 
 
  
 
 
 
 
 
 
 


Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
 
 
   
 
 
105 


3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK




















































Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
 
 
107 


Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
108 


Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
109 


Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
110 


Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
 
111 


3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK



Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
113 


Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
114 


Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
115 


3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK


/,672)$%%5(9,$7,216
$(
$GYHUVHHYHQW
$1&
$EVROXWH1HXWURSKLO&RXQW
%,'
7ZLFHD'D\
%,
%RHKULQJHU,QJHOKHLP&RPSDQ\
%06
%ULVWRO0\HUV6TXLEE&RPSDQ\
&$7RU&7VFDQ
&RPSXWHG$[LDO7RPRJUDSK\
&%&
&RPSOHWH%ORRG&RXQW
&5
&RPSOHWH5HVSRQVH
&7&$(
&RPPRQ7HUPLQRORJ\&ULWHULDIRU$GYHUVH(YHQWV
'/7
'RVH/LPLWLQJ7R[LFLW\
'60&
'DWD6DIHW\0RQLWRULQJ&RPPLWWHH
(&2*36
(DVWHUQ&RRSHUDWLYH2QFRORJ\*URXS3HUIRUPDQFH6WDWXV
(.*
(OHFWURFDUGLRJUDP
(*)5
(SLGHUPDO*URZWK)DFWRU5HFHSWRU
)'$
)RRGDQG'UXJ$GPLQLVWUDWLRQ
)6+
)ROOLFOH6WLPXODWLQJ+RUPRQH
*&3
*RRG&OLQLFDO3UDFWLFH



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK
+&*
+XPDQ&KRULRQLF*RQDGRWURSLQ
+57
+RUPRQH5HSODFHPHQW7KHUDS\
,%
,QYHVWLJDWRUV¶%URFKXUH
,&+
,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQLVDWLRQ
,1'
,QYHVWLJDWLRQDO1HZ'UXJ$SSOLFDWLRQ
,5%
,QVWLWXWLRQDO5HYLHZ%RDUG
,,6
,QYHVWLJDWRU,QLWLDWHG7ULDO
07'
0D[LPXP7ROHUDWHG'RVH
0$'
0D[LPXP$GPLQLVWHUHG'RVH
05,
0DJQHWLF5HVRQDQFH,PDJLQJ
3'
3URJUHVVLYH'LVHDVH
3)6
3URJUHVVLRQ)UHH6XUYLYDO
32
%\0RXWK
350&
3URWRFRO5HYLHZ	0RQLWRULQJ&RPPLWWHH
35
3DUWLDO5HVSRQVH
4'
2QFH'DLO\
4R/
4XDOLW\2I/LIH
5(&,67
5HVSRQVH(YDOXDWLRQ&ULWHULD,Q6ROLG7XPRUV
6$(
6HULRXV$GYHUVH(YHQW
6'
6WDEOH'LVHDVH
686$5
6XVSHFWHG8QH[SHFWHG6HULRXV$GYHUVH5HDFWLRQ
7106WDJLQJ
7XPRU1RGHDQG0HWDVWDVLV6WDJLQJ
8/1
8SSHU/LPLWRI1RUPDO
:%&
:KLWH%ORRG&RXQW
:2&%3
:RPHQRI&KLOG%HDULQJ3RWHQWLDO


5()(5(1&(6

&URZQ-3HWDO3RROHGDQDO\VLVRIGLDUUKHDHYHQWVLQSDWLHQWVZLWKFDQFHUWUHDWHGZLWK
ODSDWLQLE%UHDVWFDQFHUUHVHDUFKDQGWUHDWPHQWS

0DVLHOOR'**RURVSHUGDQG$6<DQJ7KHRFFXUUHQFHDQGPDQDJHPHQWRIIOXLG
UHWHQWLRQDVVRFLDWHGZLWK7.,WKHUDS\LQ&0/ZLWKDIRFXVRQGDVDWLQLE-RXUQDORI
KHPDWRORJ\	RQFRORJ\S



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

-RUGDQ.&6LSSHODQG+-6FKPROO*XLGHOLQHVIRUDQWLHPHWLFWUHDWPHQWRIFKHPRWKHUDS\
LQGXFHGQDXVHDDQGYRPLWLQJSDVWSUHVHQWDQGIXWXUHUHFRPPHQGDWLRQV7KHRQFRORJLVW
S

-RHQVXX+-&7UHQWDQG35HLFKDUGW3UDFWLFDOPDQDJHPHQWRIW\URVLQHNLQDVHLQKLELWRU
DVVRFLDWHGVLGHHIIHFWVLQ*,67&DQFHUWUHDWPHQWUHYLHZVS

%DODJXOD<HWDO&OLQLFDOSUHVHQWDWLRQDQGPDQDJHPHQWRIGHUPDWRORJLFDOWR[LFLWLHVRI
HSLGHUPDOJURZWKIDFWRUUHFHSWRULQKLELWRUV,QWHUQDWLRQDOMRXUQDORIGHUPDWRORJ\
S

:X3$HWDO3URSK\OD[LVDQGWUHDWPHQWRIGHUPDWRORJLFDGYHUVHHYHQWVIURPHSLGHUPDO
JURZWKIDFWRUUHFHSWRULQKLELWRUV&XUUHQWRSLQLRQLQRQFRORJ\S

&KDIW-(HWDO'LVHDVH)ODUHDIWHU7\URVLQH.LQDVH,QKLELWRU'LVFRQWLQXDWLRQLQ3DWLHQWV
ZLWK(*)50XWDQW/XQJ&DQFHUDQG$FTXLUHG5HVLVWDQFHWR(UORWLQLERU*HILWLQLE
,PSOLFDWLRQVIRU&OLQLFDO7ULDO'HVLJQ&OLQLFDO&DQFHU5HVHDUFKS

-HPDO$HWDO&DQFHUVWDWLVWLFV&$DFDQFHUMRXUQDOIRUFOLQLFLDQVS


6((5KWWSZZZVHHUFDQFHUJRY

-HPDO$HWDO&DQFHUVWDWLVWLFV&$&DQFHU-&OLQS

1RQVPDOO&HOO/XQJ&DQFHU&ROODERUDWLYH*URXS&KHPRWKHUDS\LQQRQVPDOOFHOOOXQJ
FDQFHUDPHWDDQDO\VLVXVLQJXSGDWHGGDWDRQLQGLYLGXDOSDWLHQWVIURPUDQGRPLVHGFOLQLFDO
WULDOV%0-S

3ILVWHU'*HWDO$PHULFDQ6RFLHW\RI&OLQLFDO2QFRORJ\WUHDWPHQWRIXQUHVHFWDEOHQRQ
VPDOOFHOOOXQJFDQFHUJXLGHOLQHXSGDWH-&OLQ2QFROS

6RFLQVNL0$HWDO7UHDWPHQWRIQRQVPDOOFHOOOXQJFDQFHUVWDJH,9$&&3HYLGHQFH
EDVHGFOLQLFDOSUDFWLFHJXLGHOLQHVQGHGLWLRQ&KHVW6XSSOS66

*URXS10$&&KHPRWKHUDS\LQDGGLWLRQWRVXSSRUWLYHFDUHLPSURYHVVXUYLYDOLQ
DGYDQFHGQRQVPDOOFHOOOXQJFDQFHUDV\VWHPDWLFUHYLHZDQGPHWDDQDO\VLVRILQGLYLGXDO
SDWLHQWGDWDIURPUDQGRPL]HGFRQWUROOHGWULDOV-&OLQ2QFROS

6KHSKHUG)$HWDO3URVSHFWLYHUDQGRPL]HGWULDORIGRFHWD[HOYHUVXVEHVWVXSSRUWLYHFDUHLQ
SDWLHQWVZLWKQRQVPDOOFHOOOXQJFDQFHUSUHYLRXVO\WUHDWHGZLWKSODWLQXPEDVHGFKHPRWKHUDS\
-&OLQ2QFROS

1REOH-HWDO6HFRQGOLQHRUVXEVHTXHQWV\VWHPLFWKHUDS\IRUUHFXUUHQWRUSURJUHVVLYHQRQ
VPDOOFHOOOXQJFDQFHUDV\VWHPDWLFUHYLHZDQGSUDFWLFHJXLGHOLQH-7KRUDF2QFRO
S

+LUVFK)5HWDO(SLGHUPDOJURZWKIDFWRUUHFHSWRULQQRQVPDOOFHOOOXQJFDUFLQRPDV
FRUUHODWLRQEHWZHHQJHQHFRS\QXPEHUDQGSURWHLQH[SUHVVLRQDQGLPSDFWRQSURJQRVLV-&OLQ
2QFROS

6X]XNL6HWDO3URWHLQRYHUH[SUHVVLRQDQGJHQHDPSOLILFDWLRQRIHSLGHUPDOJURZWKIDFWRU
UHFHSWRULQQRQVPDOOFHOOOXQJFDUFLQRPDV$QLPPXQRKLVWRFKHPLFDODQGIOXRUHVFHQFHLQVLWX
K\EULGL]DWLRQVWXG\&DQFHUS



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

&DUSHQWHU*5HFHSWRUVIRUHSLGHUPDOJURZWKIDFWRUDQGRWKHUSRO\SHSWLGHPLWRJHQV$QQX
5HY%LRFKHPS

5LHVH'-QGDQG')6WHUQ6SHFLILFLW\ZLWKLQWKH(*)IDPLO\(UE%UHFHSWRUIDPLO\
VLJQDOLQJQHWZRUN%LRHVVD\VS

2JLVR+HWDO&U\VWDOVWUXFWXUHRIWKHFRPSOH[RIKXPDQHSLGHUPDOJURZWKIDFWRUDQG
UHFHSWRUH[WUDFHOOXODUGRPDLQV&HOOS

6FKOHVVLQJHU-/LJDQGLQGXFHGUHFHSWRUPHGLDWHGGLPHUL]DWLRQDQGDFWLYDWLRQRI(*)
UHFHSWRU&HOOS

'L0DUFR(HWDO$XWRFULQHLQWHUDFWLRQEHWZHHQ7*)DOSKDDQGWKH(*)UHFHSWRU
TXDQWLWDWLYHUHTXLUHPHQWVIRULQGXFWLRQRIWKHPDOLJQDQWSKHQRW\SH2QFRJHQHS


.ODSSHU/1HWDO%LRFKHPLFDODQGFOLQLFDOLPSOLFDWLRQVRIWKH(UE%+(5VLJQDOLQJQHWZRUN
RIJURZWKIDFWRUUHFHSWRUV$GY&DQFHU5HVS

1RUPDQQR1HWDO(SLGHUPDOJURZWKIDFWRUUHFHSWRU(*)5VLJQDOLQJLQFDQFHU*HQH
S

6FDOWULWL0DQG-%DVHOJD7KHHSLGHUPDOJURZWKIDFWRUUHFHSWRUSDWKZD\DPRGHOIRU
WDUJHWHGWKHUDS\&OLQ&DQFHU5HVS

9LHLUD$9&/DPD]HDQG6/6FKPLG&RQWURORI(*)UHFHSWRUVLJQDOLQJE\FODWKULQ
PHGLDWHGHQGRF\WRVLV6FLHQFHS

6RUNLQ$,QWHUQDOL]DWLRQRIWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRUUROHLQVLJQDOOLQJ%LRFKHP
6RF7UDQV3WS

:DQJ<HWDO(QGRVRPDOVLJQDOLQJRIHSLGHUPDOJURZWKIDFWRUUHFHSWRUVWLPXODWHVVLJQDO
WUDQVGXFWLRQSDWKZD\VOHDGLQJWRFHOOVXUYLYDO0RO&HOO%LROS

<XQ&+HWDO6WUXFWXUHVRIOXQJFDQFHUGHULYHG(*)5PXWDQWVDQGLQKLELWRUFRPSOH[HV
PHFKDQLVPRIDFWLYDWLRQDQGLQVLJKWVLQWRGLIIHUHQWLDOLQKLELWRUVHQVLWLYLW\&DQFHU&HOO
S

.XPDU$HWDO6WUXFWXUHDQGFOLQLFDOUHOHYDQFHRIWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRULQ
KXPDQFDQFHU-&OLQ2QFROS

)XNXRND0HWDO0XOWLLQVWLWXWLRQDOUDQGRPL]HGSKDVH,,WULDORIJHILWLQLEIRUSUHYLRXVO\
WUHDWHGSDWLHQWVZLWKDGYDQFHGQRQVPDOOFHOOOXQJFDQFHU7KH,'($/7ULDO>FRUUHFWHG@ -
&OLQ2QFROS

.ULV0*HWDO(IILFDF\RIJHILWLQLEDQLQKLELWRURIWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRU
W\URVLQHNLQDVHLQV\PSWRPDWLFSDWLHQWVZLWKQRQVPDOOFHOOOXQJFDQFHUDUDQGRPL]HGWULDO
-$0$S

6KHSKHUG)$HWDO(UORWLQLELQSUHYLRXVO\WUHDWHGQRQVPDOOFHOOOXQJFDQFHU1(QJO-
0HGS



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

:KHDWOH\3ULFH3HWDO(UORWLQLEIRUDGYDQFHGQRQVPDOOFHOOOXQJFDQFHULQWKHHOGHUO\DQ
DQDO\VLVRIWKH1DWLRQDO&DQFHU,QVWLWXWHRI&DQDGD&OLQLFDO7ULDOV*URXS6WXG\%5-&OLQ
2QFROS

/\QFK7-HWDO$FWLYDWLQJPXWDWLRQVLQWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRUXQGHUO\LQJ
UHVSRQVLYHQHVVRIQRQVPDOOFHOOOXQJFDQFHUWRJHILWLQLE1(QJO-0HGS


3DH]-*HWDO(*)5PXWDWLRQVLQOXQJFDQFHUFRUUHODWLRQZLWKFOLQLFDOUHVSRQVHWR
JHILWLQLEWKHUDS\6FLHQFHS

3DR:HWDO(*)UHFHSWRUJHQHPXWDWLRQVDUHFRPPRQLQOXQJFDQFHUVIURPQHYHU
VPRNHUVDQGDUHDVVRFLDWHGZLWKVHQVLWLYLW\RIWXPRUVWRJHILWLQLEDQGHUORWLQLE3URF1DWO
$FDG6FL86$S

0XUUD\6HWDO6RPDWLFPXWDWLRQVRIWKHW\URVLQHNLQDVHGRPDLQRIHSLGHUPDOJURZWKIDFWRU
UHFHSWRUDQGW\URVLQHNLQDVHLQKLELWRUUHVSRQVHWR7.,VLQQRQVPDOOFHOOOXQJFDQFHUDQ
DQDO\WLFDOGDWDEDVH-7KRUDF2QFROS

5RVHOO5HWDO6FUHHQLQJIRUHSLGHUPDOJURZWKIDFWRUUHFHSWRUPXWDWLRQVLQOXQJFDQFHU1
(QJO-0HGS

7DQDND7HWDO)UHTXHQF\RIDQGYDULDEOHVDVVRFLDWHGZLWKWKH(*)5PXWDWLRQDQGLWV
VXEW\SHV,QW-&DQFHUS

0XOOR\5HWDO(SLGHUPDOJURZWKIDFWRUUHFHSWRUPXWDQWVIURPKXPDQOXQJFDQFHUVH[KLELW
HQKDQFHGFDWDO\WLFDFWLYLW\DQGLQFUHDVHGVHQVLWLYLW\WRJHILWLQLE&DQFHU5HVS


2NDEH7HWDO'LIIHUHQWLDOFRQVWLWXWLYHDFWLYDWLRQRIWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRULQ
QRQVPDOOFHOOOXQJFDQFHUFHOOVEHDULQJ(*)5JHQHPXWDWLRQDQGDPSOLILFDWLRQ&DQFHU5HV
S

&KRL6+-00HQGURODDQG0$/HPPRQ(*)LQGHSHQGHQWDFWLYDWLRQRIFHOOVXUIDFH
(*)UHFHSWRUVKDUERULQJPXWDWLRQVIRXQGLQJHILWLQLEVHQVLWLYHOXQJFDQFHU2QFRJHQH
S

&KHQ<5HWDO'LVWLQFWLYHDFWLYDWLRQSDWWHUQVLQFRQVWLWXWLYHO\DFWLYHDQGJHILWLQLEVHQVLWLYH
(*)5PXWDQWV2QFRJHQHS

0LWVXGRPL7HWDO*HILWLQLEYHUVXVFLVSODWLQSOXVGRFHWD[HOLQSDWLHQWVZLWKQRQVPDOOFHOO
OXQJFDQFHUKDUERXULQJPXWDWLRQVRIWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRU:-72*DQ
RSHQODEHOUDQGRPLVHGSKDVHWULDO/DQFHW2QFRO

,QRXH$HWDO/%$$UDQGRPL]HGSKDVH,,,VWXG\FRPSDULQJJHILWLQLEZLWKFDUERSODWLQ
&%'&$SOXVSDFOLWD[HO7;/IRUWKHILUVWOLQHWUHDWPHQWRIQRQVPDOOFHOOOXQJFDQFHU
16&/&ZLWKVHQVLWLYH(*)5PXWDWLRQV1(-VWXG\(XURSHDQ-RXUQDORI&DQFHU
6XSSOHPHQWVS

0RN76HWDO*HILWLQLERUFDUERSODWLQSDFOLWD[HOLQSXOPRQDU\DGHQRFDUFLQRPD1(QJO-
0HGS



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

)XNXRND0HWDO%LRPDUNHUDQDO\VHVIURPDSKDVH,,,UDQGRPL]HGRSHQODEHOILUVWOLQH
VWXG\RIJHILWLQLE*YHUVXVFDUERSODWLQSDFOLWD[HO&3LQFOLQLFDOO\VHOHFWHGSDWLHQWVSWV
ZLWKDGYDQFHGQRQVPDOOFHOOOXQJFDQFHU16&/&LQ$VLD,3$66-&OLQ2QFRO0HHWLQJ
$EVWUDFWV6S

.RED\DVKL6HWDO(*)5PXWDWLRQDQGUHVLVWDQFHRIQRQVPDOOFHOOOXQJFDQFHUWRJHILWLQLE
1(QJO-0HGS

3DR:HWDO$FTXLUHGUHVLVWDQFHRIOXQJDGHQRFDUFLQRPDVWRJHILWLQLERUHUORWLQLELV
DVVRFLDWHGZLWKDVHFRQGPXWDWLRQLQWKH(*)5NLQDVHGRPDLQ3/R60HGSH

%DODN01HWDO1RYHO'<DQGFRPPRQVHFRQGDU\70PXWDWLRQVLQHSLGHUPDO
JURZWKIDFWRUUHFHSWRUPXWDQWOXQJDGHQRFDUFLQRPDVZLWKDFTXLUHGUHVLVWDQFHWRNLQDVH
LQKLELWRUV&OLQ&DQFHU5HVS

.RVDND7HWDO$QDO\VLVRIHSLGHUPDOJURZWKIDFWRUUHFHSWRUJHQHPXWDWLRQLQSDWLHQWVZLWK
QRQVPDOOFHOOOXQJFDQFHUDQGDFTXLUHGUHVLVWDQFHWRJHILWLQLE&OLQ&DQFHU5HV
S

6WDPRV-0;6OLZNRZVNLDQG&(LJHQEURW6WUXFWXUHRIWKHHSLGHUPDOJURZWKIDFWRU
UHFHSWRUNLQDVHGRPDLQDORQHDQGLQFRPSOH[ZLWKDDQLOLQRTXLQD]ROLQHLQKLELWRU-%LRO
&KHPS

&ODUN--&RROVDQG'**LOOLODQG(*)5LQKLELWLRQLQQRQVPDOOFHOOOXQJFDQFHU
UHVLVWDQFHRQFHDJDLQUHDUVLWVXJO\KHDG3/R60HGSH

*RGLQ+H\PDQQ1HWDO2QFRJHQLFDFWLYLW\RIHSLGHUPDOJURZWKIDFWRUUHFHSWRUNLQDVH
PXWDQWDOOHOHVLVHQKDQFHGE\WKH70GUXJUHVLVWDQFHPXWDWLRQ&DQFHU5HV
S

<XQ&+HWDO7KH70PXWDWLRQLQ(*)5NLQDVHFDXVHVGUXJUHVLVWDQFHE\LQFUHDVLQJ
WKHDIILQLW\IRU$733URF1DWO$FDG6FL86$S

.RED\DVKL6HWDO$QDOWHUQDWLYHLQKLELWRURYHUFRPHVUHVLVWDQFHFDXVHGE\DPXWDWLRQRIWKH
HSLGHUPDOJURZWKIDFWRUUHFHSWRU&DQFHU5HVS

(QJHOPDQ-$HWDO$OOHOLFGLOXWLRQREVFXUHVGHWHFWLRQRIDELRORJLFDOO\VLJQLILFDQWUHVLVWDQFH
PXWDWLRQLQ(*)5DPSOLILHGOXQJFDQFHU-&OLQ,QYHVWS

(QJHOPDQ-$HWDO3)DQLUUHYHUVLEOHSDQ(5%%LQKLELWRULVHIIHFWLYHLQOXQJ
FDQFHUPRGHOVZLWK(*)5DQG(5%%PXWDWLRQVWKDWDUHUHVLVWDQWWRJHILWLQLE&DQFHU5HV
S

*RQ]DOHV$-HWDO$QWLWXPRUDFWLYLW\DQGSKDUPDFRNLQHWLFSURSHUWLHVRI3)D
VHFRQGJHQHUDWLRQLUUHYHUVLEOHSDQHUE%UHFHSWRUW\URVLQHNLQDVHLQKLELWRU0RO&DQFHU7KHU
S

/L'HWDO%,%:DQLUUHYHUVLEOH(*)5+(5LQKLELWRUKLJKO\HIIHFWLYHLQSUHFOLQLFDO
OXQJFDQFHUPRGHOV2QFRJHQHS

.ZDN(/HWDO,UUHYHUVLEOHLQKLELWRUVRIWKH(*)UHFHSWRUPD\FLUFXPYHQWDFTXLUHG
UHVLVWDQFHWRJHILWLQLE3URF1DWO$FDG6FL86$S



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

6RV0/HWDO&KHPRJHQRPLF3URILOLQJ3URYLGHV,QVLJKWVLQWRWKH/LPLWHG$FWLYLW\RI
,UUHYHUVLEOH(*)5,QKLELWRUVLQ7XPRU&HOOV([SUHVVLQJWKH70(*)55HVLVWDQFH
0XWDWLRQ&DQFHU5HVS

<X=HWDO5HVLVWDQFHWRDQLUUHYHUVLEOHHSLGHUPDOJURZWKIDFWRUUHFHSWRU(*)5LQKLELWRU
LQ(*)5PXWDQWOXQJFDQFHUUHYHDOVQRYHOWUHDWPHQWVWUDWHJLHV&DQFHU5HVS


*RGLQ+H\PDQQ1HWDO7KH70JDWHNHHSHUPXWDWLRQLQ(*)5PHGLDWHVUHVLVWDQFHWR
ORZFRQFHQWUDWLRQVRIDQLUUHYHUVLEOH(*)5LQKLELWRU0RO&DQFHU7KHUS

6KLPDPXUD7HWDO+VSLQKLELWLRQVXSSUHVVHVPXWDQW(*)570VLJQDOLQJDQG
RYHUFRPHVNLQDVHLQKLELWRUUHVLVWDQFH&DQFHU5HVS

<DPDGD7HWDO+HSDWRF\WHJURZWKIDFWRUUHGXFHVVXVFHSWLELOLW\WRDQLUUHYHUVLEOHHSLGHUPDO
JURZWKIDFWRUUHFHSWRULQKLELWRULQ(*)570PXWDQWOXQJFDQFHU&OLQ&DQFHU5HV
S

(UFDQ'HWDO$PSOLILFDWLRQRI(*)570FDXVHVUHVLVWDQFHWRDQLUUHYHUVLEOH(*)5
LQKLELWRU2QFRJHQHS

0HWUR*DQG/&ULQR7KH/8;/XQJFOLQLFDOWULDOSURJUDPRIDIDWLQLEIRUQRQVPDOOFHOO
OXQJFDQFHU([SHUW5HY$QWLFDQFHU7KHUS

5HJDOHV/HWDO'XDOWDUJHWLQJRI(*)5FDQRYHUFRPHDPDMRUGUXJUHVLVWDQFHPXWDWLRQLQ
PRXVHPRGHOVRI(*)5PXWDQWOXQJFDQFHU-&OLQ,QYHVWS

/L'HWDO%URQFKLDODQGSHULSKHUDOPXULQHOXQJFDUFLQRPDVLQGXFHGE\70/5
PXWDQW(*)5UHVSRQGWR+.,DQGUDSDP\FLQFRPELQDWLRQWKHUDS\&DQFHU&HOO
S

(QJHOPDQ-$HWDO0(7DPSOLILFDWLRQOHDGVWRJHILWLQLEUHVLVWDQFHLQOXQJFDQFHUE\
DFWLYDWLQJ(5%%VLJQDOLQJ6FLHQFHS

)DEHU$&HWDO'LIIHUHQWLDOLQGXFWLRQRIDSRSWRVLVLQ+(5DQG(*)5DGGLFWHGFDQFHUV
IROORZLQJ3,.LQKLELWLRQ3URF1DWO$FDG6FL86$S

0RUJLOOR)HWDO+HWHURGLPHUL]DWLRQRILQVXOLQOLNHJURZWKIDFWRUUHFHSWRUHSLGHUPDOJURZWK
IDFWRUUHFHSWRUDQGLQGXFWLRQRIVXUYLYLQH[SUHVVLRQFRXQWHUDFWWKHDQWLWXPRUDFWLRQRI
HUORWLQLE&DQFHU5HVS

0RUJLOOR)HWDO,PSOLFDWLRQRIWKHLQVXOLQOLNHJURZWKIDFWRU,5SDWKZD\LQWKHUHVLVWDQFHRI
QRQVPDOOFHOOOXQJFDQFHUFHOOVWRWUHDWPHQWZLWKJHILWLQLE&OLQ&DQFHU5HVS


*XL[0HWDO$FTXLUHGUHVLVWDQFHWR(*)5W\URVLQHNLQDVHLQKLELWRUVLQFDQFHUFHOOVLV
PHGLDWHGE\ORVVRI,*)ELQGLQJSURWHLQV-&OLQ,QYHVWS

6RV0/HWDO37(1ORVVFRQWULEXWHVWRHUORWLQLEUHVLVWDQFHLQ(*)5PXWDQWOXQJFDQFHUE\
DFWLYDWLRQRI$NWDQG(*)5&DQFHU5HVS

<DPDVDNL)HWDO$FTXLUHGUHVLVWDQFHWRHUORWLQLELQ$HSLGHUPRLGFDQFHUFHOOVUHTXLUHV
GRZQUHJXODWLRQRI00$&37(1DQGXSUHJXODWLRQRISKRVSKRU\ODWHG$NW&DQFHU5HV
S



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

<DQR6HWDO+HSDWRF\WHJURZWKIDFWRULQGXFHVJHILWLQLEUHVLVWDQFHRIOXQJDGHQRFDUFLQRPD
ZLWKHSLGHUPDOJURZWKIDFWRUUHFHSWRUDFWLYDWLQJPXWDWLRQV&DQFHU5HVS


<DXFK5/HWDO(SLWKHOLDOYHUVXVPHVHQFK\PDOSKHQRW\SHGHWHUPLQHVLQYLWURVHQVLWLYLW\DQG
SUHGLFWVFOLQLFDODFWLYLW\RIHUORWLQLELQOXQJFDQFHUSDWLHQWV&OLQ&DQFHU5HV3W
S

7KRPVRQ6HWDO(SLWKHOLDOWRPHVHQFK\PDOWUDQVLWLRQLVDGHWHUPLQDQWRIVHQVLWLYLW\RIQRQ
VPDOOFHOOOXQJFDUFLQRPDFHOOOLQHVDQG[HQRJUDIWVWRHSLGHUPDOJURZWKIDFWRUUHFHSWRU
LQKLELWLRQ&DQFHU5HVS

8UDPRWR+HWDO([SUHVVLRQRIVHOHFWHGJHQHIRUDFTXLUHGGUXJUHVLVWDQFHWR(*)57.,LQ
OXQJDGHQRFDUFLQRPD/XQJ&DQFHUDKHDGRISULQW

<DR=HWDO7*)EHWD,/D[LVPHGLDWHVVHOHFWLYHDQGDGDSWLYHPHFKDQLVPVRIUHVLVWDQFHWR
PROHFXODUWDUJHWHGWKHUDS\LQOXQJFDQFHU3URF1DWO$FDG6FL86$S


6XGD.HWDO(SLWKHOLDOWR0HVHQFK\PDO7UDQVLWLRQLQDQ(SLGHUPDO*URZWK)DFWRU
5HFHSWRU0XWDQW/XQJ&DQFHU&HOO/LQHZLWK$FTXLUHG5HVLVWDQFHWR(UORWLQLE-7KRUDF
2QFRODKHDGRISULQW

.LP/&/6RQJDQG(%+DXUD6UFNLQDVHVDVWKHUDSHXWLFWDUJHWVIRUFDQFHU1DW5HY
&OLQ2QFROS

=KDQJ-HWDO65&IDPLO\NLQDVHVDUHDFWLYDWHGLQQRQVPDOOFHOOOXQJFDQFHUDQGSURPRWH
WKHVXUYLYDORIHSLGHUPDOJURZWKIDFWRUUHFHSWRUGHSHQGHQWFHOOOLQHV$P-3DWKRO
S

6RQJ/HWDO'DVDWLQLE%06VHOHFWLYHO\LQGXFHVDSRSWRVLVLQOXQJFDQFHUFHOOV
GHSHQGHQWRQHSLGHUPDOJURZWKIDFWRUUHFHSWRUVLJQDOLQJIRUVXUYLYDO&DQFHU5HV
S

/L-HWDO$FKHPLFDODQGSKRVSKRSURWHRPLFFKDUDFWHUL]DWLRQRIGDVDWLQLEDFWLRQLQOXQJ
FDQFHU1DW&KHP%LROS

-RKQVRQ)0HWDO3KDVH,,VWXG\RIGDVDWLQLELQSDWLHQWVZLWKDGYDQFHGQRQVPDOOFHOOOXQJ
FDQFHU-&OLQ2QFROS

+DXUD(%HWDO3KDVH,,,VWXG\RIWKH6UFLQKLELWRUGDVDWLQLELQFRPELQDWLRQZLWKHUORWLQLE
LQDGYDQFHGQRQVPDOOFHOOOXQJFDQFHU-&OLQ2QFROS

+HLJHQHU')DQG05HFN0XWDWLRQVLQWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRUJHQHLQQRQ
VPDOOFHOOOXQJFDQFHU,PSDFWRQWUHDWPHQWEH\RQGJHILWLQLEDQGHUORWLQLE$GYDQFHVLQ
7KHUDS\S

3DUVRQV6-DQG-73DUVRQV6UFIDPLO\NLQDVHVNH\UHJXODWRUVRIVLJQDOWUDQVGXFWLRQ
2QFRJHQHS

,VKL]DZDU5DQG6-3DUVRQVF6UFDQGFRRSHUDWLQJSDUWQHUVLQKXPDQFDQFHU&DQFHU&HOO
S



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

6LQLEDOGL'HWDO,QGXFWLRQRIS:$)&,3DQGF\FOLQ'H[SUHVVLRQE\WKH6UF
RQFRSURWHLQLQPRXVHILEUREODVWVUROHRIDFWLYDWHG67$7VLJQDOLQJ2QFRJHQH
S

0RUJDQ'2HWDO0LWRVLVVSHFLILFSKRVSKRU\ODWLRQRISFVUFE\SFGFDVVRFLDWHG
SURWHLQNLQDVH&HOOS

<HDWPDQ7-$UHQDLVVDQFHIRU65&1DW5HY&DQFHUS

(OOLV/0HWDO'RZQUHJXODWLRQRIYDVFXODUHQGRWKHOLDOJURZWKIDFWRULQDKXPDQFRORQ
FDUFLQRPDFHOOOLQHWUDQVIHFWHGZLWKDQDQWLVHQVHH[SUHVVLRQYHFWRUVSHFLILFIRUFVUF-%LRO
&KHPS

0XNKRSDGK\D\'HWDO+\SR[LFLQGXFWLRQRIKXPDQYDVFXODUHQGRWKHOLDOJURZWKIDFWRU
H[SUHVVLRQWKURXJKF6UFDFWLYDWLRQ1DWXUHS

/DLUG$'HWDO6UFIDPLO\NLQDVHDFWLYLW\LVUHTXLUHGIRUVLJQDOWUDQGXFHUDQGDFWLYDWRURI
WUDQVFULSWLRQDQGIRFDODGKHVLRQNLQDVHSKRVSKRU\ODWLRQDQGYDVFXODUHQGRWKHOLDOJURZWK
IDFWRUVLJQDOLQJLQYLYRDQGIRUDQFKRUDJHGHSHQGHQWDQGLQGHSHQGHQWJURZWKRIKXPDQWXPRU
FHOOV0RO&DQFHU7KHUS

*UD\0-HWDO+,)DOSKD67$7&%3SDQG5HI$3(DUHFRPSRQHQWVRID
WUDQVFULSWLRQDOFRPSOH[WKDWUHJXODWHV6UFGHSHQGHQWK\SR[LDLQGXFHGH[SUHVVLRQRI9(*)LQ
SDQFUHDWLFDQGSURVWDWHFDUFLQRPDV2QFRJHQHS

-LDQJ%+HWDO965&LQGXFHVH[SUHVVLRQRIK\SR[LDLQGXFLEOHIDFWRU+,)DQG
WUDQVFULSWLRQRIJHQHVHQFRGLQJYDVFXODUHQGRWKHOLDOJURZWKIDFWRUDQGHQRODVHLQYROYHPHQW
RI+,)LQWXPRUSURJUHVVLRQ&DQFHU5HVS

,UE\5%DQG7-<HDWPDQ5ROHRIVUFH[SUHVVLRQDQGDFWLYDWLRQLQKXPDQFDQFHU
2QFRJHQHS

0DVDNL7HWDOSSFVUFDFWLYDWLRQLQOXQJDGHQRFDUFLQRPD(XU-&DQFHUS


6RQJ/HWDO$FWLYDWLRQRI6WDWE\UHFHSWRUW\URVLQHNLQDVHVDQGF\WRNLQHVUHJXODWHV
VXUYLYDOLQKXPDQQRQVPDOOFHOOFDUFLQRPDFHOOV2QFRJHQHS

:HL/HWDO$OWHUHGUHJXODWLRQRI6UFXSRQFHOOGHWDFKPHQWSURWHFWVKXPDQOXQJ
DGHQRFDUFLQRPDFHOOVIURPDQRLNLV2QFRJHQHS

-RKQVRQ)0HWDO'DVDWLQLE%067\URVLQH.LQDVH,QKLELWRU6XSSUHVVHV,QYDVLRQ
DQG,QGXFHV&HOO&\FOH$UUHVWDQG$SRSWRVLVRI+HDGDQG1HFN6TXDPRXV&HOO&DUFLQRPDDQG
1RQ6PDOO&HOO/XQJ&DQFHU&HOOV&OLQ&DQFHU5HVS

<RVKLGD7HWDO(IIHFWVRI6UFLQKLELWRUVRQFHOOJURZWKDQGHSLGHUPDOJURZWKIDFWRU
UHFHSWRUDQG0(7VLJQDOLQJLQJHILWLQLEUHVLVWDQWQRQVPDOOFHOOOXQJFDQFHUFHOOVZLWK
DFTXLUHG0(7DPSOLILFDWLRQ&DQFHU6FLS

&DUUHWHUR-HWDO,QWHJUDWLYHJHQRPLFDQGSURWHRPLFDQDO\VHVLGHQWLI\WDUJHWVIRU/NE
GHILFLHQWPHWDVWDWLFOXQJWXPRUV&DQFHU&HOOS



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

-RKQVRQ0/HWDO3KDVH,,7ULDORI'DVDWLQLEIRU3DWLHQWVZLWK$FTXLUHG5HVLVWDQFHWR
7UHDWPHQWZLWKWKH(SLGHUPDO*URZWK)DFWRU5HFHSWRU7\URVLQH.LQDVH,QKLELWRUV(UORWLQLERU
*HILWLQLE-7KRUDF2QFROS

+HUROG&,HWDO3KDVH,,7ULDORI'DVDWLQLELQ3DWLHQWVZLWK0HWDVWDWLF%UHDVW&DQFHU8VLQJ
5HDO7LPH3KDUPDFRG\QDPLF7LVVXH%LRPDUNHUVRI6UF,QKLELWLRQWR(VFDODWH'RVLQJ&OLQLFDO
&DQFHU5HVHDUFKS

<X(<HWDO3KDVH,,VWXG\RIGDVDWLQLELQSDWLHQWVZLWKPHWDVWDWLFFDVWUDWLRQUHVLVWDQW
SURVWDWHFDQFHU&OLQLFDO&DQFHU5HVHDUFKS

$UDXMR-HWDO'DVDWLQLEDQGGRFHWD[HOFRPELQDWLRQWUHDWPHQWIRUSDWLHQWVZLWKFDVWUDWLRQ
UHVLVWDQWSURJUHVVLYHSURVWDWHFDQFHUDSKDVH,,,VWXG\&$-&OLQ2QFRO
VXSSOSV

<X(HWDO$SKDVH,,VWXG\RIRQFHGDLO\GDVDWLQLEIRUSDWLHQWVZLWKFDVWUDWLRQUHVLVWDQW
SURVWDWHFDQFHU&$-&OLQ2QFROS66

0F,QW\UH--&DVWDQHUDQG0%D\HV'DVDWLQLEWUHDWPHQWRIOHXNHPLDWUHDWPHQWRIVROLG
WXPRUV%FU$EODQG6UFNLQDVHLQKLELWRU'UXJVRIWKH)XWXUHS

$UDXMR-DQG&/RJRWKHWLV'DVDWLQLEDSRWHQW65&LQKLELWRULQFOLQLFDOGHYHORSPHQWIRUWKH
WUHDWPHQWRIVROLGWXPRUV&DQFHUWUHDWPHQWUHYLHZV

.LP/&85L[DQG(%+DXUD'DVDWLQLELQVROLGWXPRUV([SHUW2SLQLRQRQ
,QYHVWLJDWLRQDO'UXJVS

/XR)HWDO'DVDWLQLE%06SKDUPDFRNLQHWLFVFRUUHODWHZLWKS65&
SKDUPDFRG\QDPLFVLQSKDVH,VWXGLHVRISDWLHQWVZLWKFDQFHU&$&$-RXUQDO
RI&OLQLFDO2QFRORJ\BVXSSOS

-RKQVRQ)0HWDO3KDVHSKDUPDFRNLQHWLFDQGGUXJ-LQWHUDFWLRQVWXG\RIGDVDWLQLELQ
SDWLHQWVZLWKDGYDQFHGVROLGWXPRUV&DQFHUS

'HPHWUL*'HWDO3KDVH,GRVHHVFDODWLRQDQGSKDUPDFRNLQHWLFVWXG\RIGDVDWLQLELQ
SDWLHQWVZLWKDGYDQFHGVROLGWXPRUV&OLQLFDO&DQFHU5HVHDUFKS

&KULVWRSKHU/-HWDO0HWDEROLVPDQGGLVSRVLWLRQRIGDVDWLQLEDIWHURUDODGPLQLVWUDWLRQWR
KXPDQV'UXJ0HWDEROLVPDQG'LVSRVLWLRQS

:DQJ;HWDO'DVDWLQLESKDUPDFRNLQHWLFVDQGH[SRVXUHUHVSRQVH(5UHODWLRQVKLSWR
VDIHW\DQGHIILFDF\LQSDWLHQWVSWVZLWKFKURQLFP\HORLGOHXNHPLD&0/-&OLQ2QFRO
SV

/LOO\0%HWDO'DVDWLQLEPJRQFHGDLO\YHUVXVPJWZLFHGDLO\LQSDWLHQWVZLWK3K
SRVLWLYHDFXWHO\PSKREODVWLFOHXNHPLDZKRIDLOHGLPDWLQLE5HVXOWVIURPDSKDVHVWXG\
$PHULFDQMRXUQDORIKHPDWRORJ\S

6KDK13HWDO,QWHUPLWWHQWWDUJHWLQKLELWLRQZLWKGDVDWLQLEPJRQFHGDLO\SUHVHUYHV
HIILFDF\DQGLPSURYHVWROHUDELOLW\LQLPDWLQLEUHVLVWDQWDQGLQWROHUDQWFKURQLFSKDVHFKURQLF
P\HORLGOHXNHPLD-RXUQDORI&OLQLFDO2QFRORJ\S



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

6DQWRV(HWDO/RFDOL]DWLRQRIKXPDQSURVWDWHFDQFHUWKURXJK3(7LPDJLQJXVLQJDQRYHO
GDVDWLQLEDQDORJLQPLFH-18&/0('0((7,1*$%675$&76
0HHWLQJ$EVWUDFWVBS3E

.DQWDUMLDQ+HWDO3KDVHVWXG\RIGDVDWLQLEPJRQFHGDLO\YHUVXVPJWZLFHGDLO\LQ
SDWLHQWVZLWKFKURQLFP\HORLGOHXNHPLDLQDFFHOHUDWHGSKDVHUHVLVWDQWRULQWROHUDQWWRLPDWLQLE
PRQWKPHGLDQIROORZXS%ORRGS

4XLQWiV&DUGDPD$HWDO3OHXUDOHIIXVLRQLQSDWLHQWVZLWKFKURQLFP\HORJHQRXVOHXNHPLD
WUHDWHGZLWKGDVDWLQLEDIWHULPDWLQLEIDLOXUH-RXUQDORI&OLQLFDO2QFRORJ\S


-RKQVRQ0/HWDO3KDVH,,7ULDORI'DVDWLQLEIRU3DWLHQWVZLWK$FTXLUHG5HVLVWDQFHWR
7UHDWPHQWZLWKWKH(SLGHUPDO*URZWK)DFWRU5HFHSWRU7\URVLQH.LQDVH,QKLELWRUV(UORWLQLERU
*HILWLQLE-RXUQDORI7KRUDFLF2QFRORJ\S

-RKQVRQ)0HWDO3KDVH,,6WXG\RI'DVDWLQLELQ3DWLHQWV:LWK$GYDQFHG1RQ±6PDOO&HOO
/XQJ&DQFHU-RXUQDORI&OLQLFDO2QFRORJ\S

+DXUD(%HWDO3KDVH,,,VWXG\RIWKH6UFLQKLELWRUGDVDWLQLELQFRPELQDWLRQZLWKHUORWLQLE
LQDGYDQFHGQRQ±VPDOOFHOOOXQJFDQFHU-RXUQDORI&OLQLFDO2QFRORJ\S

/L'HWDO%,%:DQLUUHYHUVLEOH(*)5+(5LQKLELWRUKLJKO\HIIHFWLYHLQSUHFOLQLFDO
OXQJFDQFHUPRGHOV2QFRJHQHS

3HUHUD6$HWDO+(5<90$GULYHVUDSLGGHYHORSPHQWRIDGHQRVTXDPRXVOXQJWXPRUVLQ
PLFHWKDWDUHVHQVLWLYHWR%,%:DQGUDSDP\FLQFRPELQDWLRQWKHUDS\3URFHHGLQJVRIWKH
1DWLRQDO$FDGHP\RI6FLHQFHVS

6KLPDPXUD7HWDO(IILFDF\RI%,%:DSRWHQWLUUHYHUVLEOHLQKLELWRURI(*)5DQG
+(5LQKXPDQ16&/&[HQRJUDIWVDQGLQDWUDQVJHQLFPRXVHOXQJFDQFHUPRGHO&
-RXUQDORI7KRUDFLF2QFRORJ\S6

(VNHQV)HWDO$SKDVH,GRVHHVFDODWLRQVWXG\RI%,%:DQLUUHYHUVLEOHGXDOLQKLELWRU
RIHSLGHUPDOJURZWKIDFWRUUHFHSWRU(*)5DQG+(5W\URVLQHNLQDVHLQDZHHNRQ
ZHHNRIIVFKHGXOHLQSDWLHQWVZLWKDGYDQFHGVROLGWXPRXUV%ULWLVKMRXUQDORIFDQFHU
S

/HZLV1HWDO$SKDVH,GRVHHVFDODWLRQVWXG\RI%,%:DQLUUHYHUVLEOHGXDO
(*)5+(5UHFHSWRUW\URVLQHNLQDVHLQKLELWRULQDZHHNRQZHHNRIIVFKHGXOHLQSDWLHQWV
ZLWKDGYDQFHGVROLGWXPRUV-RXUQDORI&OLQLFDO2QFRORJ\BVXSSOS

<DS7$HWDO3KDVH,WULDORIWKHLUUHYHUVLEOH(*)5DQG+(5NLQDVHLQKLELWRU%,%:
LQSDWLHQWVZLWKDGYDQFHGVROLGWXPRUV-RXUQDORI&OLQLFDO2QFRORJ\S

$JXV'HWDO$SKDVH,GRVHHVFDODWLRQVWXG\RI%,%:DQLUUHYHUVLEOHGXDO
(*)5+(5UHFHSWRUW\URVLQHNLQDVHLQKLELWRULQDFRQWLQXRXVVFKHGXOHLQSDWLHQWVZLWK
DGYDQFHGVROLGWXPRXUV-RXUQDORI&OLQLFDO2QFRORJ\BVXSSOS

0DUVKDOO-HWDO$3KDVH,GRVHHVFDODWLRQWULDORI%,%:DQLUUHYHUVLEOH(*)5+(5
NLQDVHLQKLELWRUIRUDQGGD\VLQFRPELQDWLRQZLWKGRFHWD[HOHYHU\GD\V$QQ2QFRO
S



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

$ZDGD$HWDO$SKDVH,GRVHILQGLQJVWXG\RIWKHGD\DGPLQLVWUDWLRQRI%,%:DQ
LUUHYHUVLEOHGXDO(*)5+(5LQKLELWRULQFRPELQDWLRQZLWKWKUHHZHHNO\GRFHWD[HOLQ
SDWLHQWVZLWKDGYDQFHGVROLGWXPRUV-&OLQ2QFROS

(VFKULFK6HWDO6\VWHPVELRORJ\PRGHOLQJRIWKHUDGLDWLRQVHQVLWLYLW\QHWZRUNDELRPDUNHU
GLVFRYHU\SODWIRUP,QW-5DGLDW2QFRO%LRO3K\VS

'H*UHYH-HWDO&OLQLFDODFWLYLW\RI%,%:DQLUUHYHUVLEOHLQKLELWRURI(*)5DQG
+(5LQDGHQRFDUFLQRPDRIWKHOXQJZLWKPXWDWLRQVLQWKHNLQDVHGRPDLQRI+(5QHX-
7KRUDF2QFROS6

+LUVK9$IDWLQLE%,%:GHYHORSPHQWLQQRQVPDOOFHOOOXQJFDQFHU)XWXUH2QFRORJ\
S

0LOOHU99+LUVKDQG-&DGUDQHO3KDVH,,%,,,GRXEOHEOLQGUDQGRPL]HGWULDORIDIDWLQLE
%,%:DQLUUHYHUVLEOHLQKLELWRURI(*)5+(5DQG+(5SOXVEHVWVXSSRUWLYHFDUH
%6&YHUVXVSODFHERSOXV%6&LQSDWLHQWVZLWK16&/&IDLOLQJ±OLQHVRIFKHPRWKHUDS\DQG
HUORWLQLERUJHILWLQLE/8;/XQJ>DEVWUDFW/%$@$QQ2QFRO

0LOOHU99+LUVFKDQG-&DGUDQHO6XEJURXSDQDO\VLVRI/8;/XQJDUDQGRPL]HG3KDVH
,,,WULDORIDIDWLQLE%,%:EHVWVXSSRUWLYHFDUH%6&YHUVXVSODFHER%6&LQSDWLHQWV
ZLWK16&/&IDLOLQJ±OLQHVRIFKHPRWKHUDS\DQGHUORWLQLERUJHILWLQLE

<DPDPRWR177DPXUDDQG77DNDKDVKL3KDVH,RSHQODEHOWULDORIFRQWLQXRXVGRVHRI
%,%:LQSDWLHQWVZLWKDGYDQFHGQRQVPDOOFHOOOXQJFDQFHUIDLOLQJFKHPRWKHUDS\DQGRU
HUORWLQLEDQGRUJHILWLQLE/8;/XQJ>DEVWUDFW@-7KRUDF2QFROS

<DQJ&HWDO$3KDVH,,VWXG\RI%,%:LQSDWLHQWVZLWKDGHQRFDUFLQRPDRIWKHOXQJ
DQGDFWLYDWLQJ(*)5PXWDWLRQV/8;/XQJ-&OLQ2QFROS6

6WRSIHU3HWDO3KDUPDFRNLQHWLFV3.RI>&@%,%:DIWHUDGPLQLVWUDWLRQRIDVLQJOH
GRVHRIPJ>&@%,%:RUDOVROXWLRQLQKHDOWK\PDOHYROXQWHHUV-&OLQ2QFRO
S

'UHZ%-HWDO3UHYHQWLRQRI7RUVDGHGH3RLQWHVLQKRVSLWDOVHWWLQJVDVFLHQWLILFVWDWHPHQW
IURPWKH$PHULFDQ+HDUW$VVRFLDWLRQDQGWKH$PHULFDQ&ROOHJHRI&DUGLRORJ\)RXQGDWLRQ
HQGRUVHGE\WKH$PHULFDQ$VVRFLDWLRQRI&ULWLFDO&DUH1XUVHVDQGWKH,QWHUQDWLRQDO6RFLHW\
IRU&RPSXWHUL]HG(OHFWURFDUGLRORJ\-RXUQDORIWKH$PHULFDQ&ROOHJHRI&DUGLRORJ\
S

6RQJ/0RUULV0%DJXL7/HH)-RYH5DQG+DXUD(%'DVDWLQLE%06
VHOHFWLYHO\LQGXFHVDSRSWRVLVLQOXQJFDQFHUFHOOVGHSHQGHQWRQHSLGHUPDOJURZWKIDFWRU
UHFHSWRUVLJQDOLQJIRUVXUYLYDO&DQFHU5HV,Q3UHVV

:DFNHU%HWDO&RUUHODWLRQEHWZHHQGHYHORSPHQWRIUDVKDQGHIILFDF\LQSDWLHQWVWUHDWHG
ZLWKWKHHSLGHUPDOJURZWKIDFWRUUHFHSWRUW\URVLQHNLQDVHLQKLELWRUHUORWLQLELQWZRODUJHSKDVH
,,,VWXGLHV&OLQLFDOFDQFHUUHVHDUFKS

'UHZ%-HWDO3UHYHQWLRQRI7RUVDGHGH3RLQWHVLQ+RVSLWDO6HWWLQJV&LUFXODWLRQ
S

6PLWK$-0HGLFDWLRQ,QGXFHG47,QWHUYDO3URORQJDWLRQDQG7RUVDGHVGH3RLQWHV86
3KDUPS



3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ0DUFK

&KHQ<HWDO3JO\FRSURWHLQDQGEUHDVWFDQFHUUHVLVWDQFHSURWHLQLQIOXHQFHEUDLQ
GLVWULEXWLRQRIGDVDWLQLE-RXUQDORI3KDUPDFRORJ\DQG([SHULPHQWDO7KHUDSHXWLFV
S

%DODJXOD<0(/DFRXWXUHDQG-$&RWOLDU'HUPDWRORJLFWR[LFLWLHVRIWDUJHWHGDQWLFDQFHU
WKHUDSLHV-6XSSRUW2QFROS

0LOOHU-U5*:KDW3ULFH.DSODQ0HLHU"%LRPHWULFVS

0HLHU3HWDO7KH3ULFHRI.DSODQ0HLHU-RXUQDORIWKH$PHULFDQ6WDWLVWLFDO$VVRFLDWLRQ
S


 635<&(/ GDVDWLQLE 7DEOHWV 3UHVFULELQJ ,QIRUPDWLRQ %ULVWRO0\HUV 6TXLEE &RPSDQ\
3ULQFHWRQ1--XQH
635<&(/GDVDWLQLE%06%ULVWRO0\HUV6TXLEE,QYHVWLJDWRU%URFKXUH9HUVLRQ

635<&(/GDVDWLQLE%06%ULVWRO0\HUV6TXLEE,QYHVWLJDWRU%URFKXUH9HUVLRQ




3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ$XJXVW'HFHPEHU0DUFK
7,7/(3$*(
3KDVH,7ULDO(YDOXDWLQJ6DIHW\DQG7ROHUDELOLW\RIWKH,UUHYHUVLEOH
(SLGHUPDO*URZWK)DFWRU5HFHSWRU,QKLELWRU$IDWLQLE%,%:LQ
&RPELQDWLRQZLWKWKH65&.LQDVH,QKLELWRU'DVDWLQLEIRU3DWLHQWVZLWK
1RQVPDOO&HOO/XQJ&DQFHU16&/&
%,3URWRFRO1XPEHU
%063URWRFRO1XPEHU&$
0&&3URWRFRO1XPEHU0&&
/LEHUW\&KHVDSHDNH,5%3URWRFRO1XPEHU3UR
3ULQFLSDO,QYHVWLJDWRU
%HQ&UHHODQ0'06
7KRUDFLF2QFRORJ\3URJUDP
+/HH0RIILWW&DQFHU&HQWHU	5HVHDUFK,QVWLWXWH
0DJQROLD'ULYH7DPSD)/
3KRQH
)D[
EHQFUHHODQ#PRIILWWRUJ
9HUVLRQ'HFHPEHU0DUFK
,QLWLDO0RIILWW65&DSSURYDOGDWHY$XJXVW
,QLWLDO/LEHUW\,5%DSSURYDOGDWHY6HSWHPEHU
0RIILWW65&DSSURYDOGDWHY6HSWHPEHU
/LEHUW\,5%DSSURYDOGDWHY6HSWHPEHU
0RIILWW65&DSSURYDOGDWHY-XQH
/LEHUW\,5%DSSURYDOGDWHY-XO\
)RUPDWWHG)RQW'HIDXOW$ULDOSW%ROG


3URWRFRO3KDVH,'DVDWLQLE$IDWLQLELQ16&/&
9HUVLRQ$XJXVW'HFHPEHU0DUFK

2%6(59$7,216

0HWKRGRORJ\

3ODVPD&ROOHFWLRQDQG3URFHVVLQJ
%ORRGVDPSOHVDUHWREHFROOHFWHGIURPDQLQGZHOOLQJFDWKHWHURUE\GLUHFWYHQLSXQFWXUH,ID
FDWKHWHULVXVHGIRUEORRGFROOHFWLRQWKHQDSSUR[LPDWHO\P/RIEORRGVKRXOGEHZLWKGUDZQ
LQLWLDOO\DQGGLVFDUGHG

&RUUHODWLYH6FLHQFH

6WRUHG3ODVPD6DPSOHV9(*)
3UHYLRXVVWXGLHVKDYHLQGLFDWHGWKDW65&LQKLELWRUVFDQUHGXFHWXPRUSURGXFWLRQRIS65&
9(*)DQG,/WKDWDUHLPSRUWDQWIDFWRUVIRUWXPRUDQJLRJHQHVLV%ORRGZLOOEHFROOHFWHGDW
WKHWLPHRIVFUHHQLQJRUGD\DQGDJDLQRQGD\WRDVVHVVIRUIXWXUHFRUUHODWLYHPDUNHUV
ZLWK D SXUSOHWRS ('7$ WXEH  7KHVH VDPSOHV ZLOO EH SURFHVVHG DQG DQDO\]HG IRU SODVPD
EDVHG PROHFXODU PDUNHUV $Q\ VWXG\ RQ WKHVH EORRG VDPSOHV ZRXOG EH SHUIRUPHG
UHWURVSHFWLYHO\ XQGHU D VHSDUDWH SURWRFROV RU DPHQGPHQW ZLWK VHSDUDWH ,5% DSSURYDO
6HUXP3ODVPDZLOOEHFHQWULIXJHGIRUPLQXWHDWUSPWRSHOOHWDQ\IORDWLQJGHEULVFHOOV
DQGWKHQWUDQVIHUUHGWRDIUHVKPLFURFHQWULIXJHWXEHDQGLPPHGLDWHO\IUR]HQDQGVWRUHGDW±
&7KHVHEORRGVDPSOHVZLOOQRWEHXVHGIRUDQ\VWXGLHVZLWKRXWDVSHFLILFVWXG\SURWRFRO
ZKLFKKDVDQH[SOLFLW,5%DSSURYDOIRUWKDWSXUSRVH
7KHVH VDPSOHV ZLOO EH SURFHVVHG DQG DQDO\]HG IRU SODVPDEDVHG PROHFXODU PDUNHUV
6SHFLILFDOO\SODVPDLVH[WUDFWHGDQGDVVHVVHGIRUHSLGHUPDOJURZWKIDFWRUUHFHSWRU(*)5
PXWDWLRQW\SHDQGFRS\QXPEHU7KLVWHVWLQJLVGRQHXVLQJGLJLWDOGURSOHW3&5ZLWKVSHFLILFV
SULPHUVIRU(*)5/5([RQGHODQG707KLVWHVWLQJLVSHUIRUPHGE\FROODERUDWRU
%LRGHVL[ XVLQJ DQ HVWDEOLVKHG DQG H[HFXWHG PDWHULDO WUDQVIHU DJUHHPHQW %LRGHVL[0RIILWW
&RGHGSODVPDDOLTXRWVDPSOHVDUHVKLSSHGWRFROODERUDWRUE\0RIILWW7LVVXH&RUH
DQGFRGHGFVYILOHFRQWDLQLQJWKHQXPEHURIUHOHYDQWUHDGVSHUSRROHGDOLTXRWLVWKHQVHQW
EDFNWRWKHLQYHVWLJDWRUE\WKHFROODERUDWRU
)RUPDWWHG)RQW'HIDXOW$ULDOSW
)RUPDWWHG-XVWLILHG,QGHQW/HIW6SDFH
%HIRUHSW$IWHUSW/LQHVSDFLQJ
0XOWLSOHOL



Summary of Changes – MCC17176 
V2.0 
Section 
Description of Changes 
Rationale 
Title page; Table of Contents 
Updated to version 2.0; added information 
on v1.7 and v1.8 approvals; formatting 
changes; co-investigator list removed; 
CTC removed; page numbers revised 
Updated information applicable to 
amendment. Removed staff lists as they 
are not needed and have changed 
throughout study. Page numbers revised 
according to revisions. 
Protocol Synopsis 
Afatinib lowercase 
Formatting change 
Protocol Synopsis 
Inclusion and Exclusion Criteria deleted 
Inclusion and Exclusion Criteria deleted in 
order to eliminate inconsistency with main 
section.  
Protocol Synopsis 
Deleted “An elective patient decline 
questionnaire will be included after 
screening to guide corrective action.” 
Questionnaire was never developed. 
Study Calendar – Phase IA 
Afatinib uppercase 
Formatting change 
1.1.6  Significance of the Src-TKI 
Dasatinib in NSCLC 
SRC capitalized 
Formatting change 
Table 1: Drugs that may overcome EGFR 
resistance 
Recept deleted 
Formatting change 
4.1 Overview 
Name of IRB deleted 
This information is subject to change and 
was removed.  
5.2 Exclusion Criteria 
Criteria #3 now specifies that only women 
of childbearing potential must have a 
negative pregnancy test.  
Clarify that women who are not of child 
bearing potential should not be subjected 
to a pregnancy test.  
5.2 Exclusion Criteria 
Criteria #17 edited to explain that trace 
pericardial or pleural effusion is acceptable 
among subjects at baseline. 
Clarify that not all pericardial and pleural 
effusion not allowed on study.  
5.2 Exclusion Criteria 
Criteria #19 added azithromycin to the list 
of P-gp inhibitors that are not allowed.  
Modified per guidance on P-gp inhibitors.  
5.2 Exclusion Criteria 
ANC <1000 is exclusion cut off instead of 
1500. 
Revised per letter to IRB that was 
previously approved.  
6.1 Study Calendar 
Pregnancy test for women of child-bearing 
potential. 
Edited to conform with wording used in 
Exclusion criteria. 


6.2.1 Screening Evaluation, 6.3.2 
Definition of DLT; 7.3 Assessment of 
Safety 
NCI-CTCAE spelling  
Typographical error 
6.2.2 Cycle 1 
Dosing for Phase 1B explained. 
Revised for consistency with other 
sections 
6.2.2 Cycle 1 
C1D15 description 
This applies to both Phase 1A and Phase 
1B. Requirement to take study drug in 
clinic removed. 
6.4.1.1 Prohibited Therapies 
Carvedilol and quinidine removed from 
prohibited P-Glycoprotein 
List revised 
6.6 Patient Withdrawl Criteria 
Remove description of subject visit. 
All subjects already assessed for new 
related 21 calendar days; however 30 day 
patient visit is not feasible so removed. 
6.11 Management of Adverse Events 
SPF changed; number of weeks of 
minocycline treatment;   
 
 


Liberty protocol 12.09.006 (MCC 17176) 
 
Cover Letter 
Submission Type: ICF Update 
Liberty IRB, Inc 
1450 S Woodland Blvd  DeLand, FL 32720 
June 9, 2014 
Re: Liberty trial protocol 12.09.0006 
Dear Staff of Liberty Institutional Review Board, 
I am writing to notify your office of an amendment to protocol for Liberty 12.09.0006, (BI 
1200.166, MCC 17176), “Phase I Trial Evaluating Safety and Tolerability of the Irreversible 
Epidermal Growth Factor Receptor Inhibitor Afatinib (BIBW 2992) in Combination with the SRC 
Kinase Inhibitor Dasatinib for Patients with Non-small Cell Lung Cancer (NSCLC)”.  
We have received helpful commentary from the Boehringer-Ingelheim office. On the basis of 
this feedback, we have further refined the clinical trial protocol. Included is the trial protocol 
word document with tracked changes. These changes primarily focused on refining the DLT 
definition and clarifying discrepancies present in the prior version. 
Enclosed in this submission is an updated protocol with tracked changes.  
Also attached is the summary of changes on pages 2 and 3. 
 
 
Thank you for your time and consideration.  
 
Sincerely, 
 
Ben Creelan, MD, MS 
Thoracic Oncology 
12902 Magnolia Dr 
FOB-1, THOR 
1.813.745.3328 
ben.creelan@moffitt.org  
 
 
 


Liberty protocol 12.09.006 (MCC 17176) 
 
Summary of changes: 
1. Changed eligibility so that erlotinib may be continued until up to 3 days of C1D1. The 
mean terminal half-life of erlotinib (OSI-774) is 7 hours in healthy subjects, and closer to 
24 hours at steady-state in cancer subjects. The overall rationale for this amendment is 
to avoid flare phenomenon from erlotinib withdrawal.  
2. Changed dasatinib tablet specification to reflect actual dasatinib tablets received (50 mg 
and 20 mg tablets) 
3. Included the 20 mg afatinib tablet supply received in Product Specifications section 
4. Clarified imaging schedule as first evaluation at day 50, and then every 8 weeks 
thereafter. 
5. Removed mandatory pelvis CT from imaging schedule (this was SOC and does not affect 
budget) 
6. Made screening period tests uniformly within 28 days prior to C1D1. (some areas had 
said 30 days). 
7. Specified purple-top tube for plasma samples On page 10 and page 53 
8.  Inclusion Criteria #5, and Core guidance for Afatinib ALT & AST < 2.5 ULN, not < 3 ULN 
as in exclusion criteria. The exclusion criteria has been amended to < 2.5. 
9. Removed inclusion criteria #5, since it redundant with exclusion criteria #23 
10. Specified that afatinib should be taken 1 hour before/ 2 hours after meals. 
11. Specified a flexibility of +/- 3 days for C1D8 and C1D15. 
12. On page 12 and page 55, Exclusion Criteria # 19, and  Additional pgp inhibitor drugs in 
the BI core protocol have been added to this exclusion criterion, and also page 61, under 
Section 6.4.1.1.  
13. On pages 31, 32 & 33, Section 2.3.1 Table 2 has footnotes have been defined. 
14. On page 50, Section 3.5, add “light” to blue color. 
15. On page 52, Section 4.1, value of 50 days changed to 56 days to align with timeframe in 
study schema. 
16. On page 60, under Section 6.3.2, for clarification: Page 67 of protocol stated “In the 
event of CTCAE Grade > 3 rash, treatment with afatinib and dasatinib should be paused 
until recovery to CTCAE Grade <  1.  Treatment should be resumed at a reduced dose 
per Appendix, “Papulopustular Skin Rash”.”   
Pursuant to this, 6.11.1 section was revised to distinguish between routine CTCAE grade 
3 skin rash, and “severe” skin rash. This definition of severity and management 
algorithm is based upon expert opinion. Lacouture et al, Expert Rev. Anticancer Ther 
13(6) 2013. 
On the basis of above, CTC grade 2 and routine grade 3 skin rash will be managed 
identically, with a separate management plan for “severe grade 3 skin rash”.  Only 
severe grade 3 skin rash will be considered a DLT, as the amendment language now 
states. See tracked changes. 
Along these lines, Section 6.3.2 has been amended to include “severe grade 3 rash 
refractory to optimal supportive care” under DLT definition. 


Liberty protocol 12.09.006 (MCC 17176) 
17. On page 87, under Section 8.1.2, added  “light” to blue color. 
18. Amended Section 9.3 to reflect voluntary reporting to MedWatch under GCP only for 
unexpected drug-related SAEs. Note the reporting responsibilities to Boehringer using BI 
CRF forms remain unchanged. 
19. Removed Section 9.4, 9.5. Based upon feedback from our regulatory specialist, this 
section was redundant and non-applicable, because this particular trial is IND exempt. 
The AE reporting plan and guidelines are already outlined in Section 9.3. 
20. Amended Section 9.1.1: Adverse events section. Based upon feedback from our internal 
monitors, clarified reporting plan for adverse events to specify: “Select events, 
regardless of grade, will be recorded as an AE: diarrhea, skin rash, thrombocytopenia,  
neutropenia, and AST/ALT, bilirubin or creatinine elevation. Other changes in vital signs, 
ECG, physical examination and laboratory test results will not be recorded as an AE in 
the CRF, unless there are clinical signs or symptoms, or they required clinical 
intervention or treatment.” 
21. Amended Section 6.1, 6.2.1: Amended screening procedure window to be consistent 
and uniform 28 days prior to C1D1, instead of 30 days. 
 
 
 
 


Re: MCC 17176 
September 9, 2013 
 
Summary of changes for SRC  
 
Title Page:  updated Principal investigator based upon mutual agreement with Dr Haura and Dr 
Creelan. 
 
Title Page: updated clinical trial coordinator and contact information 
 
Title Page, and onwards: Updated relevant nomenclature throughout protocol, from 
investigational drug name (BIBW 2992) to current generic drug name (afatinib). 
 
Page 44 : updated clinical experience based on most recent investigator’s brochure from Jan 15 
2013, including the FDA approval of afatinib on July 12, 2013. 
 
Page 46:  updated information regarding the clinical trial experience leading to FDA approval of 
afatinib for advanced NSCLC 
 
Page 49:  updated Table 7 to reflect status of ongoing trials 
 
Page 120: Included two new appendices, Appendix 2 and Appendix 3. These independent 
appendices were stipulated to be included in the trial protocol based upon contractual 
agreement with the sponsor, Boehringer‐Ingelheim. 
Sincerely, 
Ben Creelan, MD