An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With DSXS in Patients With Atopic Dermatitis.
Phase: PHASE2
Conditions: Dermatitis, Atopic
Sponsor: Sun Pharmaceutical Industries, Inc.

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




7,7/(3$*(



7KLVGRFXPHQWLVDFRQILGHQWLDOFRPPXQLFDWLRQRI1RYXP3KDUPDFHXWLFDO5HVHDUFK6HUYLFHV5HFHLSWRI
WKLVGRFXPHQWFRQVWLWXWHVDQDJUHHPHQWE\WKHUHFLSLHQWWKDWQRXQSXEOLVKHGLQIRUPDWLRQFRQWDLQHGKHUHLQ
ZLOOEHGLVFORVHGZLWKRXW1RYXP
VZULWWHQDSSURYDO

'UXJ
'HVR[LPHWDVRQH7RSLFDO6SUD\

'HVLJQ
$QRSHQODEHOVDIHW\VWXG\WRDVVHVVWKHSRWHQWLDOIRUDGUHQDO
VXSSUHVVLRQIROORZLQJPD[LPDOXVHWUHDWPHQWZLWKGHVR[LPHWDVRQH
WRSLFDOVSUD\LQSDWLHQWVZLWKDWRSLFGHUPDWLWLV
3RSXODWLRQ
8SWRVHYHQW\SDWLHQWVZLWKDFRQILUPHGGLDJQRVLVRIDWRSLF
GHUPDWLWLVSDWLHQWVPRQWKV\HDUVRIDJHZLWK%6$
DIIHFWHGDQGSDWLHQWVDJH\HDUVRIDJHRUROGHUZLWK%6$
DIIHFWHG

3DWLHQWVZLOOEHHQUROOHGLQWKHIROORZLQJ&RKRUWV
·
&RKRUW±DJH\HDUVDQGROGHU
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±SDWLHQWVPRQWKV\HDUROG

6SRQVRU
7DUR3KDUPDFHXWLFDOV86$,QF
6N\OLQH'ULYH
+DZWKRUQH1<

3URWRFRO1XPEHU
'6;6

1RYXP6WXG\1XPEHU


,1'


3URWRFRO'DWH


 
NIIRB
September 13, 2016
APPROVED

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




.(<678'<3(56211(/$1')$&,/,7,(6

6SRQVRU

7DUR3KDUPDFHXWLFDOV86$,QF
6N\OLQH'ULYH
+DZWKRUQH1<


&52

1RYXP3KDUPDFHXWLFDO5HVHDUFK6HUYLFHV1RYXP
:6WDWLRQ6TXDUH'ULYH
3LWWVEXUJK3$


6SRQVRU¶V5HSUHVHQWDWLYH

1DWDOLH<DQWRYVNL\
6HQLRU'LUHFWRU&OLQLFDO5HVHDUFK
7DUR3KDUPDFHXWLFDOV86$,QF
6N\OLQH'ULYH
+DZWKRUQH1<
3KRQH([W
)D[
(PDLO1DWDOLH<DQWRYVNL\#7DURFRP


&52UHSUHVHQWDWLYH

*DLO*RQJDV
9LFH3UHVLGHQW&OLQLFDO7ULDOV
1RYXP3KDUPDFHXWLFDO5HVHDUFK6HUYLFHV
:6WDWLRQ6TXDUH'ULYH
3LWWVEXUJK3$
7HO[
)D[
(PDLOJGJRQJDV#QRYXPSUVFRP

0HGLFDO0RQLWRU

3DROR)DQ]LR0'
0HGLFDO0RQLWRU
1RYXP3KDUPDFHXWLFDO5HVHDUFK6HUYLFHV
:6WDWLRQ6TXDUH'ULYH
3LWWVEXUJK3$
7HO[
)D[
(PDLOSPIDQ]LR#QRYXPSUVFRP


%LRVWDWLVWLFLDQ

-LDQKXD/LX06F
6HQLRU%LRVWDWLVWLFLDQ
1RYXP3KDUPDFHXWLFDO5HVHDUFK6HUYLFHV
7HO
(PDLOMOLX#QRYXPSUVFRP





9/23/2016
27 Sep 2016

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



35,1&,3$/,19(67,*$725¶66,*1$785(



, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB DJUHH WR FRQGXFW SURWRFRO '6;6  5HY  LQ
DFFRUGDQFH ZLWK )'$ UHJXODWLRQV ,&+ JXLGHOLQHV DQG *RRG &OLQLFDO 3UDFWLFH , XQGHUVWDQG WKDW QR
GHYLDWLRQV IURP WKH SURWRFRO PD\ EH PDGH ZLWKRXW WKH SULRU SHUPLVVLRQ RI WKH 6SRQVRU 7DUR
3KDUPDFHXWLFDOV86$RU1RYXP3KDUPDFHXWLFDO5HVHDUFK6HUYLFHVWKHFRPSDQ\PDQDJLQJWKHVWXG\





BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB


BBBBBBBBBB
3ULQFLSDO,QYHVWLJDWRU






'DWH























&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI





7$%/(2)&217(176

 
7,7/(3$*( 
 
.(<678'<3(56211(/$1')$&,/,7,(6 
6,*1$785(3$*( 
 
7$%/(2)&217(176 
 
6<1236,6 
 
/,672)$%%5(9,$7,216$1'7(506 
 
,1752'8&7,21 
 
'LVHDVH%HLQJ7UHDWHG 
 
$YDLODELOLW\DQG(IILFDF\RI$OUHDG\$SSURYHG7KHUDSLHV 
 
6FLHQWLILFDQG6WDWLVWLFDO&RQVLGHUDWLRQV 
 
5LVNVDQG%HQHILWV 
 
678'<2%-(&7,9(6 
 
,19(67,*$7,21$/3/$1 
 
6WXG\'HVLJQDQG3ODQ'HVFULSWLRQ 
 
6HOHFWLRQRI6WXG\'HVLJQ 
 
6HOHFWLRQRI6WXG\3RSXODWLRQ 
 
,QFOXVLRQ&ULWHULD 
 
([FOXVLRQ&ULWHULD 
 
5HVWULFWLRQVGXULQJWKH6WXG\ 
 
5HPRYDORI3DWLHQWVIURPWKH6WXG\ 
 
7UHDWPHQWV 
 
7UHDWPHQWV$GPLQLVWUDWLRQ 
 
,GHQWLW\RI,QYHVWLJDWLRQDO3URGXFW 
 
0HWKRGRI$VVLJQLQJ3DWLHQWVWR7UHDWPHQW*URXSV 
 
3DFNDJLQJ 
 
$FFRXQWDELOLW\ 
 
&RPSOLDQFH 
 
6WXG\&RQGXFW 
 
9LVLW:LWKLQGD\VEHIRUHHQUROOPHQW6FUHHQLQJ%HIRUHSP 
 
9LVLW'D\(QUROOPHQW 

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



 
9LVLW'D\,QWHULP9LVLW 
9LVLW'D\(QGRI6WXG\RU(DUO\7HUPLQDWLRQ%HIRUHSP 
9LVLW'D\)ROORZXS3KRQH&DOO 
 
6WXG\3URFHGXUHV 
 
,QIRUPHG&RQVHQW 
 
'HPRJUDSKLFV 
 
0HGLFDO+LVWRU\ 
 
9LWDO6LJQV 
 
3K\VLFDO([DPDQG%RG\6XUIDFH$UHD%6$ 
 
'HUPDWRORJLFDO$VVHVVPHQW 
 
&RQFRPLWDQW0HGLFDWLRQ8VH 
 
3UHJQDQF\7HVW 
 
'LVSHQVLQJ6WXG\'UXJ 
 
&ROOHFWLQJ6WXG\'UXJ 
 
'RVLQJ,QVWUXFWLRQVDQG'LDU\ 
 
'RVLQJ&RPSOLDQFH 
 
6WDQGDUG6XQVFUHHQDQG3DWLHQW:ULVWEDQG 
 
/DERUDWRU\(YDOXDWLRQ 
 
&RUWLVRO5HVSRQVH7HVW 
 
$GYHUVH(YHQWV 
 
$GYHUVH(YHQW'HILQLWLRQV 
 
6HYHULW\RI$GYHUVH(YHQW 
 
5HODWLRQVKLSRI$GYHUVH(YHQW 
 
3DWLHQW¶V3DUWLFLSDWLRQ6WRSSLQJ&ULWHULD 
 
6HULRXV$GYHUVH(YHQWV 
 
'HILQLWLRQRID6HULRXV$GYHUVH(YHQW 
 
5HSRUWLQJ6HULRXV$GYHUVH(YHQWV 
 
67$7,67,&$/0(7+2'6 
 
6WDWLVWLFDO3ODQ 
 
'HWHUPLQDWLRQRI6DPSOH6L]H 
 
%DVHOLQH&RPSDUDELOLW\ 
 
6DIHW\$QDO\VLVRI3RWHQWLDO+3$$[LV6XSSUHVVLRQ 
 
6DIHW\$QDO\VLV 

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



 
5(*8/$725<2%/,*$7,216 
 
,QVWLWXWLRQDO5HYLHZ%RDUG 
 
6WXG\'RFXPHQWDWLRQ 
 
3URWRFRO 
 
,QIRUPHG&RQVHQW 
 
3URWRFRODQG,QIRUPHG&RQVHQW&KDQJHV 
 
6RXUFH'RFXPHQWVDQG&DVH5HSRUW)RUPV 
 
'UXJ$FFRXQWDELOLW\ 
 
'UXJ6WRUDJH 
 
3UHJQDQFLHV 
 
5HSRUWLQJ6DIHW\,QIRUPDWLRQWRWKH,5% 
 
5HFRUG5HWHQWLRQ 
6WXG\0RQLWRULQJDQG$XGLWLQJ 
(QGRIWKH7ULDO 
&OLQLFDO6WXG\5HSRUW 
 
5()(5(1&(6 
 
$33(1',&(6 
$33(1',;$%RG\6XUIDFH$UHD&DOFXODWLRQ 
$33(1',;%(F]HPD$UHDDQG6HYHULW\,QGH[6FRUH($6, 
$33(1',;&,QYHVWLJDWRU*OREDO$VVHVVPHQW,*$ 
$33(1',;'$SSOLFDWLRQ6LWH5HDFWLRQV 
$33(1',;(&RUWLVRO5HVSRQVH7HVW 
$33(1',;)(YDOXDWLRQRI+3$$[LV6XSSUHVVLRQ 
$33(1',;*&OLQLFDO/DERUDWRU\7HVWLQJ 
$33(1',;+&RUWURV\Q3DFNDJH,QVHUW 
$33(1',;,,QYHVWLJDWRU%URFKXUH'HVR[LPHWDVRQH7RSLFDO6SUD\ 
$33(1',;-$PHQGPHQWVWRWKH3URWRFRO 


&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




6<1236,6

3URWRFRO1XPEHU
'6;6
7LWOH
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ
)ROORZLQJ 0D[LPDO 8VH 7UHDWPHQW ZLWK 'HVR[LPHWDVRQH  7RSLFDO
6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV
2EMHFWLYHV
 7KHREMHFWLYHRIWKLVVWXG\LVWRHYDOXDWHWKHSRWHQWLDORIGHVR[LPHWDVRQH
WRSLFDOVSUD\WRVXSSUHVV+3$D[LVIXQFWLRQLQSDWLHQWVZLWK
PRGHUDWHWRVHYHUHDWRSLFGHUPDWLWLV
 7KHVHFRQGDU\REMHFWLYHVDUHWRHYDOXDWHWRHYDOXDWHWKHHIILFDF\
SDUDPHWHUVDQGDGYHUVHHYHQW$(SURILOHVRIGHVR[LPHWDVRQH
WRSLFDOVSUD\DGPLQLVWHUHGWRSDWLHQWVZLWKPRGHUDWHWRVHYHUHDWRSLF
GHUPDWLWLV
6SRQVRU
7DUR3KDUPDFHXWLFDOV86$,QF
1DPHRI7HVW
3URGXFW
'HVR[LPHWDVRQH7RSLFDO6SUD\
5RXWHRI
$GPLQLVWUDWLRQ
7RSLFDO
6WXG\'HVLJQ
$Q RSHQ ODEHO VDIHW\ VWXG\ WR DVVHVV WKH SRWHQWLDO IRU DGUHQDO VXSSUHVVLRQ
IROORZLQJPD[LPDOXVHWUHDWPHQWZLWKGHVR[LPHWDVRQHWRSLFDOVSUD\
DGPLQLQVWHUHG WZLFH GDLO\ IRU  GD\V LQ SDWLHQWV ZLWK PRGHUDWH WR VHYHUH
DWRSLFGHUPDWLWLV
6WXG\3RSXODWLRQ
8SWRVHYHQW\SDWLHQWVVWUDWLILHGE\DJHZLWKDFRQILUPHGGLDJQRVLVRI
PRGHUDWHWRVHYHUHDWRSLFGHUPDWLWLVZLWK
&RKRUW±SDWLHQWVDJH\HDUVDQGROGHUZLWKERG\VXUIDFH
DUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKERG\VXUIDFH
DUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD
%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKZLWKERG\VXUIDFH
DUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVPRQWKV\HDURIDJHZLWKERG\VXUIDFH
DUHD%6$DIIHFWHG

&RKRUWVZLOOEHHQUROOHGLQVHTXHQWLDORUGHU(DFKFRKRUWZLOOLQLWLDWH
HQUROOPHQWRQFHWKHSUHYLRXVFRKRUWKDVUHDFKHGWKHPLQLPXPQXPEHURI

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



SDWLHQWVDQGDVDIHW\DQDO\VLVKDVEHHQUHYLHZHG(DFKFRKRUWZLOOEH
HQUROOHGEDVHGRQWKHDYDLODELOLW\RISDWLHQWV

(DFKFRKRUWZLOOEHUHYLHZHGIRUWKHSRWHQWLDORI+3$D[LVVXSSUHVVLRQ,IDW
OHDVWRISDWLHQWVLQHDFK&RKRUWH[SHULHQFH+3$D[LVVXSSUHVVLRQRQFH
WKHPLQLPXPQXPEHURISDWLHQWVKDVEHHQHQUROOHGDQGFRPSOHWHGWKHFRKRUW
HQUROOPHQWIRUWKDWFRKRUWZLOOEHVWRSSHGDQGQRIXUWKHUFRKRUWVZLOOEH
LQLWLDWHG,IDWOHDVWRISDWLHQWVKDYHH[SHULHQFHG+3$D[LVVXSSUHVVLRQ
DFURVVFRKRUWVFRPELQHGGXULQJWKHVWXG\HQUROOPHQWZLOOEHGLVFRQWLQXHG
DQGQRRWKHUFRKRUWVZLOOEHLQLWLDWHG&RKRUWZLOOQRWEHJLQXQWLOVDIHW\
GDWDKDVEHHQUHYLHZHGIRU&RKRUW7KHVDPHSURFHVVZLOOEHIROORZHGIRU
HDFK&RKRUWXQWLOWKHVWXG\LVFRPSOHWH
6WXG\&RQGXFW
$OOSDWLHQWVZLOODWWHQGWKHFOLQLFIRUVFKHGXOHGYLVLWV
9LVLW6FUHHQLQJZLWKLQGD\VSULRUWRHQUROOPHQW
9LVLW(QUROOPHQW'D\
9LVLW,QWHULP9LVLW'D\
9LVLW(QGRI6WXG\'D\RU(DUO\7HUPLQDWLRQ
,QFOXVLRQ&ULWHULD
 0DOHRUQRQSUHJQDQWQRQODFWDWLQJIHPDOHV
·
&RKRUW±DJH\HDUVDQGROGHU
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±SDWLHQWVPRQWKV\HDURIDJH
 ,IIHPDOHDQGRIFKLOGEHDULQJSRWHQWLDOSUHSDUHGWRDEVWDLQIURPVH[XDO
LQWHUFRXUVH RU XVH D UHOLDEOH PHWKRG RI FRQWUDFHSWLRQ GXULQJ WKH VWXG\
HJ
FRQGRP
,8'
RUDO
WUDQVGHUPDO
RU
LQMHFWHG
KRUPRQDO
FRQWUDFHSWLYHV
 3DWLHQWV  DQG ROGHU RU SDUHQWOHJDO JXDUGLDQ KDV VLJQHG LQIRUPHG
FRQVHQWIRUPZKLFKPHHWVDOOFULWHULDRIFXUUHQW)'$UHJXODWLRQV
 %DVHG RQ WKH SDWLHQW¶V DJH   \HDUV ROG ZLOO UHDG DQG VLJQ DQ ,5%
DSSURYHGDVVHQWIRUP3DWLHQWVDJH\HDUVRIDJHZLOOSURYLGHYHUEDO
DVVHQWWRSDUWLFLSDWH
 3DWLHQWVZLWKDGHILQLWHFOLQLFDOGLDJQRVLVRIVWDEOHDWRSLFGHUPDWLWLVZLWK
LQYROYHPHQWRI
·
&RKRUW±DJH\HDUVDQGROGHUZLWKERG\VXUIDFHDUHD
%6$DIIHFWHGH[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
·
&RKRUW±DJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD
%6$DIIHFWHGH[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
·
&RKRUW±DJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD
%6$DIIHFWHGH[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
·
&RKRUW±DJH\HDUVRIDJHZLWKZLWKERG\VXUIDFHDUHD
%6$DIIHFWHGH[FOXGLQJIDFHD[LOODDQGJURLQDUHDV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



·
&RKRUW±PRQWKV\HDURIDJHZLWKERG\VXUIDFHDUHD
%6$DIIHFWHGH[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
 +DYHDQ(F]HPD$UHDDQG6HYHULW\,QGH[($6,VFRUHRIDWOHDVW
 +DYHDQ,QYHVWLJDWRU*OREDO$VVHVVPHQW6FDOH,*$RI0RGHUDWHRU
6HYHUH
 5HVXOWVIURPDFRUWLVROUHVSRQVHWHVWWKDWDUHFRQVLGHUHGQRUPDODQGVKRZ
QRHYLGHQFHRIDQ\DEQRUPDO+3$IXQFWLRQRUDGUHQDOUHVSRQVH6HH
$SSHQGL[(3DWLHQWVPXVWIXOILOODOORIWKHIROORZLQJVWLSXODWLRQV
D 7KHLUEDVDOSUH&RUWURV\QLQMHFWLRQFRUWLVROFRQFHQWUDWLRQLV
PFJP/
E 7KHLUPLQXWHSRVWLQMHFWLRQFRUWLVROOHYHOLVDWOHDVWPFJ
P/JUHDWHUWKDQWKHEDVDOOHYHOEDVDOYDOXH
F 7KHSRVWVWLPXODWLRQOHYHOLV!PFJP/
([FOXVLRQ&ULWHULD
 )HPDOHVZKRDUHSUHJQDQWQXUVLQJSODQQLQJWREHFRPHSUHJQDQWGXULQJ
WKH GXUDWLRQ RI WKH VWXG\ RU LI RI FKLOGEHDULQJ SRWHQWLDO DQG VH[XDOO\
DFWLYHDQGQRWSUHSDUHGWRXVHDSSURSULDWHFRQWUDFHSWLYHPHWKRGVWRDYRLG
SUHJQDQF\
 /DFNVVWDEOHGLDJQRVLVRIDWRSLFGHUPDWLWLVRUKDVEHHQGLDJQRVHGZLWK
PLOGDWRSLFGHUPDWLWLV
 +DYHDQ($6,VFRUHRI
 +DYHDQ,*$VFRUHRI
 $WRSLFGHUPDWLWLVZLWKD%6$LQYROYHPHQWRIIRU&RKRUWVRU
RUIRU&RKRUWVRU
 5HVXOWVIURPDFRUWLVROUHVSRQVHWHVWWKDWVKRZHYLGHQFHRIDQ\DEQRUPDO
+3$IXQFWLRQRUDGUHQDOUHVSRQVHVHH$SSHQGL[(
D 7KHLUEDVDOSUH&RUWURV\Q70LQMHFWLRQFRUWLVROFRQFHQWUDWLRQLV
PFJPO
E WKHLUPLQXWHSRVWLQMHFWLRQFRUWLVROOHYHOLVOHVVWKDQ
PFJPOJUHDWHUWKDQWKHEDVDOOHYHOEDVDOYDOXH
F WKHSRVWVWLPXODWLRQOHYHOLVPFJPO
 $FWLYH FXWDQHRXV EDFWHULDO RU YLUDO LQIHFWLRQ LQ DQ\ WUHDWPHQW DUHD DW
EDVHOLQHLHFOLQLFDOO\LQIHFWHGDWRSLFGHUPDWLWLV
 3DWLHQWKDVDKLVWRU\RIDWRSLFGHUPDWLWLVWKDWKDVEHHQXQUHVSRQVLYHWR
WRSLFDOFRUWLFRVWHURLGWKHUDS\
 $Q\ FRQGLWLRQ LH VXQEXUQ SVRULDVLV HWF WKDW LQ WKH ,QYHVWLJDWRU¶V
RSLQLRQ PD\ LQWHUIHUH ZLWK WKH FOLQLFDO DVVHVVPHQWV RI WKH VLJQV DQG
V\PSWRPVRIDWRSLFGHUPDWLWLV
6XEMHFWKDVDKLVWRU\RIDOOHUJ\RUVHQVLWLYLW\WRFRUWLFRVWHURLGVRUKLVWRU\
RIDQ\GUXJK\SHUVHQVLWLYLW\RULQWROHUDQFHZKLFKLQWKHRSLQLRQRIWKH
,QYHVWLJDWRUZRXOGFRPSURPLVHWKHVDIHW\RIWKHSDWLHQWRUWKHUHVXOWVRI
WKHVWXG\
3DWLHQWKDVDVLJQLILFDQWKLVWRU\RUFXUUHQWHYLGHQFHRIFKURQLFLQIHFWLRXV
GLVHDVHV\VWHPGLVRUGHURUJDQGLVRUGHURURWKHUPHGLFDOFRQGLWLRQWKDW
LQWKH,QYHVWLJDWRU¶VRSLQLRQZRXOGSODFHWKHVWXG\SDWLHQWDWXQGXHULVN

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



E\SDUWLFLSDWLRQLQWKHVWXG\
3DWLHQWLVFXUUHQWO\UHFHLYLQJRUKDVUHFHLYHGDQ\UDGLDWLRQWKHUDS\DQWL
QHRSODVWLF DJHQWV RU LPPXQRVXSSUHVVDQW PHGLFDWLRQ ZLWKLQ  ZHHNV
EHIRUHWKHILUVWGRVHRIVWXG\GUXJ
8VH ZLWKLQ RQH PRQWK EHIRUH EDVHOLQH RI  RUDO RU LQWUDYHQRXV
FRUWLFRVWHURLGV  89$89% WKHUDS\  389$ SVRUDOHQ SOXV
XOWUDYLROHW $ WKHUDS\  WDQQLQJ ERRWKV  QRQSUHVFULSWLRQ 89 OLJKW
VRXUFH  LPPXQRPRGXODWRUV RU LPPXQRVXSSUHVVLYH WKHUDSLHV 
LQWHUIHURQF\WRWR[LFGUXJVWDFUROLPXVRUSLPHFUROLPXV
8VH ZLWKLQ  GD\V EHIRUH EDVHOLQH RI  V\VWHPLF DQWLELRWLFV 
FDOFLSRWULHQHRURWKHU9LWDPLQ'SUHSDUDWLRQVRUUHWLQRLGV
3DWLHQWV ZKR KDYH XVHG WRSLFDO WUHDWPHQWV SUHVFULSWLRQ RU RYHU WKH
FRXQWHULQFOXGLQJ
D $Q\WRSLFDODWRSLFGHUPDWLWLVWKHUDSHXWLFDJHQWVRIDQ\NLQGZLWKLQ
WKHZHHNVEHIRUHILUVWXVHRIVWXG\GUXJ
E $Q\WRSLFDOFRUWLFRVWHURLGVZLWKLQWKHZHHNVEHIRUHWKHILUVWXVH
RIWKHVWXG\GUXJ
F $Q\DQWLEDFWHULDOPHGLFDWHGDQGRUDVWULQJHQWZDVKHVVRDSVSDGV
RUPRLVWXUL]HUVZLWKLQWKHGD\VEHIRUHWKHILUVWXVHRIVWXG\GUXJ
G +LJKVWUHQJWKRUDERYHDOSKDK\GUR[\DFLGRUDQ\NLQGRI
SHHO RU RWKHU SURFHGXUHV RQ WKH IDFH HJ ODVHU KDLU UHPRYDO
ZLWKLQGD\VRIWKHVWXG\VWDUW
H $Q\WRSLFDOSURGXFWVLHVXQVFUHHQVORWLRQVFUHDPVH[FHSWIRU
EODQGHPROOLHQWPRLVWXUL]HUZLWKLQKRXUEHIRUHEDVHOLQH
I 7RSLFDO DQWLELRWLFV LQ WKH WUHDWPHQW DUHD ZLWKLQ  GD\V EHIRUH
EDVHOLQH
3DWLHQWKDVEHHQWUHDWHGZLWKLQZHHNVRUILYHKDOIOLYHVZKLFKHYHULV
OHVVEHIRUHWKHILUVWGRVHRIVWXG\GUXJZLWKDQ\ELRORJLFDOWKHUDSLHVIRU
DWRSLFGHUPDWLWLV
8VH RI QRQVHGDWLQJ DQWLKLVWDPLQHV ZLWKLQ WKH  GD\V EHIRUH WKH ILUVW
GRVLQJGD\
7KHXVHRIVHGDWLQJDQWLKLVWDPLQHVVXFKDVGLSKHQK\GUDPLQHPD\EH
DFFHSWDEOHRQFRQGLWLRQWKHSDWLHQWKDVEHHQRQDVWDEOHGRVHIRUDWOHDVW
GD\VEHIRUHWKHVWXG\VWDUWDQGZLOOUHPDLQRQDVWDEOHGRVHWKURXJKRXW
WKHVWXG\
$Q\RUDOVWHURLGGUXJXVHZLWKWKHH[FHSWLRQFRQWUDFHSWLYHVZLWKLQ
GD\VRIWKHILUVWGRVLQJGD\RUGXULQJWKHVWXG\
D )HPDOHSDWLHQWVXVLQJKRUPRQDOFRQWUDFHSWLYHVVKRXOGKDYHEHHQ
RQ WKHVDPH SURGXFWGRVLQJ UHJLPHQ IRU DW OHDVW GD\V EHIRUH
DQGVKRXOGQRWFKDQJHWKLVUHJLPHQGXULQJWKHVWXG\
E 7KH XVH RI LQKDOHG RU LQWUDQDVDO FRUWLFRVWHURLGV LV DFFHSWDEOH DV
ORQJDVXVDJHKDVEHHQVWDEOHIRUDWOHDVWZHHNVEHIRUHWKHILUVW
GRVHRIVWXG\GUXJDQGZLOOEHFRQWLQXHGGXULQJWKHVWXG\
,QDELOLW\WRXQGHUVWDQGWKHSURWRFROUHTXLUHPHQWVLQVWUXFWLRQVDQGVWXG\
UHODWHGUHVWULFWLRQVWKHQDWXUHVFRSHDQGSRVVLEOHFRQVHTXHQFHVRIWKH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



FOLQLFDOVWXG\
8QOLNHO\ WR FRPSO\ ZLWK WKH SURWRFRO UHTXLUHPHQWV LQVWUXFWLRQV DQG
VWXG\UHODWHG UHVWULFWLRQV VXFK DV XQFRRSHUDWLYH DWWLWXGH LQDELOLW\ WR
UHWXUQIRUIROORZXSYLVLWVDQGLPSUREDELOLW\RIFRPSOHWLQJWKHFOLQLFDO
VWXG\
5HFHLSWRIDQ\GUXJDVSDUWRIDUHVHDUFKVWXG\ZLWKLQGD\VSULRUWR
ILUVWGRVLQJ
7KHSDWLHQWLVDPHPEHURIWKHLQYHVWLJDWLRQDOVWXG\VWDIIRUDPHPEHURI
WKHIDPLO\RIWKHLQYHVWLJDWLRQDOVWXG\VWDII
3UHYLRXVSDUWLFLSDWLRQLQWKLVVWXG\
&ULWHULDIRU
(YDOXDWLRQ
3ULPDU\2XWFRPH0HDVXUHV
+\SRWKDODPLF 3LWXLWDU\ $GUHQDO +3$ $[LV 5HVSRQVH WR &RV\QWURSLQ
GHPRQVWUDWLQJWKHDEVHQFHRUSUHVHQFHRIDGUHQDOVXSSUHVVLRQDWWKHHQGRI
WUHDWPHQW
6HFRQGDU\2XWFRPH0HDVXUHV
+\SRWKDODPLF 3LWXLWDU\ $GUHQDO +3$ $[LV 5HVSRQVH WR &RV\QWURSLQ
GHPRQVWUDWLQJWKHSUHVFHQVHRIDGUHQDOVXSSUHVVLRQDWWKHHQGRIWUHDWPHQW
ZLWK%6$DVDFRYDULDWH
+3$$[LV
(YDOXDWLRQ
:LWKLQGD\VSULRUWRWKHILUVWGRVHRIVWXG\GUXJDQGDWWKHHQGRIWKHVWXG\
'D\RUHDUO\WHUPLQDWLRQDOOSDWLHQWVZLOOKDYHDFRUWLVROUHVSRQVHWHVW
SHUIRUPHGXVLQJWKHSURFHGXUHRI:RRGHWDO6HH$SSHQGL[(2QO\WKRVH
SDWLHQWV ZLWK QRUPDO DGUHQDO IXQFWLRQ DW EDVHOLQH ZLOO EH HQUROOHG DQG
GLVSHQVHG VWXG\ GUXJ  ,I DW WKH HQG RIWKH VWXG\ WKH SDWLHQW KDVDFRUWLVRO
UHVSRQVH WHVW WKDW LV VXJJHVWLYH RI +3$ D[LV VXSSUHVVLRQ WKH\ ZLOO KDYH D
IROORZWHVWDWOHDVWHYHU\ZHHNVXQWLOVXFKWLPHDVWKH,QYHVWLJDWRUFRQVLGHUV
WKHDGUHQDOIXQFWLRQKDVWXUQHGWRQRUPDO
&RKRUWVZLOOEHHQUROOHGLQVHTXHQWLDORUGHU(DFKFRKRUWZLOOLQLWLDWH
HQUROOPHQWRQFHWKHSUHYLRXVFRKRUWKDVUHDFKHGWKHPLQLPXPQXPEHURI
SDWLHQWVDQGDVDIHW\DQDO\VLVKDVEHHQUHYLHZHG(DFKFRKRUWZLOOEH
HQUROOHGEDVHGRQWKHDYDLODELOLW\RISDWLHQWV

(DFKFRKRUWZLOOEHUHYLHZHGIRUWKHSRWHQWLDORI+3$D[LVVXSSUHVVLRQ,IDW
OHDVWRISDWLHQWVLQHDFK&RKRUWH[SHULHQFH+3$D[LVVXSSUHVVLRQRQFH
WKHPLQLPXPQXPEHURISDWLHQWVKDVEHHQHQUROOHGDQGFRPSOHWHGWKHFRKRUW
HQUROOPHQW IRU WKDW FRKRUW ZLOO EH VWRSSHG DQG QR IXUWKHU FRKRUWV ZLOO EH
LQLWLDWHG,IDWOHDVWRISDWLHQWVKDYHH[SHULHQFHG+3$D[LVVXSSUHVVLRQ
DFURVV FRKRUWV FRPELQHG GXULQJ WKH VWXG\ HQUROOPHQW ZLOO EH GLVFRQWLQXHG
DQGQRRWKHUFRKRUWVZLOOEHLQLWLDWHG&RKRUWZLOOQRWEHJLQXQWLOVDIHW\
GDWDKDVEHHQUHYLHZHGIRU&RKRUW7KHVDPHSURFHVVZLOOEHIROORZHGIRU
HDFK&RKRUWXQWLOWKHVWXG\LVFRPSOHWH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



3ULPDU\$QDO\VLV
3URSRUWLRQ RI SDWLHQWV LQ WKH VWXG\ ZLWK +3$ D[LV VXSSUHVVLRQ IROORZLQJ
WUHDWPHQWZLWKWKHVWXG\PHGLFDWLRQ
$ORJLVWLFUHJUHVVLRQRIWKHSURSRUWLRQRISDWLHQWVLQWKHVWXG\ZLWK+3$D[LV
VXSSUHVVLRQPD\EHSHUIRUPHGDVH[SORUDWRU\DQDO\VLVZLWK%6$DIIHFWHG
DVDFRYDULDWH 7KLV ZLOO GHSHQG RQ WKH GLVWULEXWLRQ RI WKH %6$ GDWD
FROOHFWHG
6DIHW\3DUDPHWHUV
$GYHUVH HYHQWV ZLOO EH FODVVLILHG XVLQJ VWDQGDUG 0HG'5$ WHUPLQRORJ\
9HUVLRQRUKLJKHUDQGVXPPDUL]HGE\WUHDWPHQWJURXS6XPPDU\WDEOHV
FRPSDULQJ WKH W\SH LQFLGHQFH VHYHULW\ DQG ,QYHVWLJDWRU¶V RSLQLRQ RI
UHODWLRQVKLSWRWKHVWXG\GUXJZLOOEHSUHSDUHGE\WUHDWPHQWJURXS6LJQVDQG
V\PSWRPVRIDWRSLFGHUPDWLWLVZLOOQRWEHFRQVLGHUHGDGYHUVHHYHQWVXQOHVV
LQ WKH ,QYHVWLJDWRU¶V RSLQLRQ WKH\ KDYH LQFUHDVHG LQ IUHTXHQF\ DQGRU
VHYHULW\WRVXFKDQH[WHQWWKDWWKH,QYHVWLJDWRUSDWLHQWFRQVLGHUVWKDWLWLVLQ
WKHSDWLHQW¶VEHVWLQWHUHVWWREHGURSSHGIURPFRQWLQXHGSDUWLFLSDWLRQLQWKH
VWXG\DQGJLYHQDOWHUQDWLYHWKHUDS\IRUWKHLUFRQGLWLRQ
,IVXIILFLHQWGDWDH[LVWDGYHUVHHYHQWIUHTXHQFLHVZLOOEHFRPSDUHGEHWZHHQ
WUHDWPHQWVXVLQJ)LVKHU¶VH[DFWWHVWRUDVLPLODUWHVW&RQFRPLWDQWPHGLFDWLRQ
XVHGXULQJWKHVWXG\ZLOOEHWDEXODWHGE\SDWLHQW
$GYHUVH HYHQWV UHSRUWHG GXULQJ WKH VWXG\ ZLOO EH WDEXODWHG LQ D VXPPDU\
WDEOHOLVWLQJWKHW\SHLQFLGHQFHVHYHULW\DQG,QYHVWLJDWRU¶VRSLQLRQWRGUXJ
UHODWLRQVKLS
6DPSOH6L]H
'HWHUPLQDWLRQ
7KHVDPSOHVL]HRISDWLHQWVVWUDWLILHGE\DJHDQG%6$LVEDVHGRQ
UHFRPPHQGDWLRQVSURYLGHGE\WKH)'$LQ,1'*XLGDQFH0HHWLQJ
 5HIHUHQFH ,'  DQG )'$ $GYLFH /HWWHU GDWHG
 5HIHUHQFH ,'  UHJDUGLQJ WKH VFRSH DQG GHVLJQ RI
VWXGLHVIRUGHVR[LPHWDVRQHVSUD\










&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




678'<6&+(0$7,&

9LVLW
9LVLW
9LVLW
9LVLW
9LVLW
'D\
WR




3URFHGXUHV
6FUHHQLQJ
ZLWKLQGD\V
EHIRUH
HQUROOPHQW
%HIRUHSP
(QUROOPHQW
,QWHULP
9LVLW
(QGRI
6WXG\(DUO\
7HUPLQDWLRQ
%HIRUHSP
7HOHSKRQH
)ROORZ8S
9LVLW
,QIRUPHG&RQVHQW
;




0HGLFDO+LVWRU\DQG
'HPRJUDSKLFV
;




9LWDO6LJQV
;
;
;
;

3UHJQDQF\7HVW
;
;
;
;

3K\VLFDO([DP
;


;

%6$$VVHVVPHQW
;
;
;
;

,*$6FRUH
;
;
;
;

($6,6FRUH
;
;
;
;

$SSOLFDWLRQ6LWH5HDFWLRQV
;
;
;
;

&RQFRPLWDQW0HGLFDWLRQ
;
;
;
;

/DERUDWRU\(YDOXDWLRQV
;


;

&RUWLVRO5HVSRQVH7HVW
;


;

&RQILUP
,QFOXVLRQ([FOXVLRQ
&ULWHULD
;
;



'LVSHQVH6XQVFUHHQDQG
:ULVWEDQG

;



:HLJKDQG'LVSHQVH
6WXG\'UXJ

;
;


&ROOHFWDQG:HLJK6WXG\
'UXJ


;
;

'LVSHQVH5HYLHZ3DWLHQW
'LDU\

;
;
;

$GYHUVH(YHQWV


;
;
;
(YDOXDWLRQRI3DWLHQW
&RPSOLDQFHWRWKH
3URWRFRO


;
;

3UHJQDQF\WHVWZLOOEHFDUULHGRXWIRUIHPDOHVRIFKLOGEHDULQJSRWHQWLDO


&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




/,672)$%%5(9,$7,216$1'7(506

$EEUHYLDWLRQ 7HUP
$'/
$FWLYLWLHVIRU'DLO\/LYLQJ
$'5
$GYHUVH'UXJ5HDFWLRQ
$(
$GYHUVH(YHQW
%3
%ORRG3UHVVXUH
&
&HOVLXV
&5)
&DVH5HSRUW)RUP
&52
&OLQLFDO5HVHDUFK2UJDQL]DWLRQ
H&7'
HOHFWURQLF&RPPRQ7HFKQLFDO'RFXPHQW
)'$
)RRGDQG'UXJ$GPLQLVWUDWLRQ
+5
+HDUW5DWH
+57
+RUPRQH5HSODFHPHQW7KHUDS\
,&)
,QIRUPHG&RQVHQW)RUP
,&+
,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQL]DWLRQ
,*$
,QYHVWLJDWRU¶V*OREDO$VVHVVPHQW
,1'
,QYHVWLJDWLRQDO1HZ'UXJ
,5%
,QVWLWXWLRQDO5HYLHZ%RDUG
,77
,QWHQWWR7UHDW
,8'
,QWUDXWHULQH'HYLFH
/2&)
/DVW2EVHUYDWLRQ&DUULHG)RUZDUG
PO
PLOOLOLWHU
P,77
0RGLILHG,QWHQWWR7UHDW
1'$
1HZ'UXJ$SSOLFDWLRQ
16$,'
1RQ6WHURLGDO$QWL,QIODPPDWRU\'UXJ
2+53
2IILFHRI+XPDQ5LJKWV3URWHFWLRQ
27&
2YHUWKH&RXQWHU
389$
3VRUDOHQDQG8OWUD9LROHW$
55
5HVSLUDWRU\5DWH
6$(
6HULRXV$GYHUVH(YHQW
6$3
6WDWLVWLFDO$QDO\VLV3ODQ
86$
8QLWHG6WDWHVRI$PHULFD




&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




,1752'8&7,21
7DUR 3KDUPDFHXWLFDOV 86$ ,QF 7DUR SODQV WR VXEPLW DQ ,QYHVWLJDWLRQDO 1HZ 'UXJ
$SSOLFDWLRQ ,1' IRU D QHZ IRUPXODWLRQ RI GHVR[LPHWDVRQH GHVR[LPHWDVRQH  WRSLFDO
VSUD\7KLVSURGXFWFRQWDLQVDSRWHQWFRUWLFRVWHURLGWREHLQGLFDWHGIRUWKHWUHDWPHQWRISDWLHQWV
ZLWKPRGHUDWHWRVHYHUHDWRSLFGHUPDWLWLV

'LVHDVH%HLQJ7UHDWHG
$WRSLFGHUPDWLWLV$'FRPPRQO\NQRZQDVHF]HPDLVDFKURQLFLQIODPPDWRU\VNLQFRQGLWLRQ
DIIHFWLQJDSSUR[LPDWHO\PLOOLRQSHRSOHLQWKH8QLWHG6WDWHV,WLVFKDUDFWHUL]HGE\LWFK\
HU\WKHPDWRXVDQGVFDO\VNLQOHVLRQVRIWHQORFDOL]HGWRWKHIOH[XUDOVXUIDFHVRIWKHERG\LQFOXGLQJ
QHFN H\HOLGV IRUHKHDG IDFH ZULVWV GRUVD RI WKH IHHW DQG KDQGV $' LV DOVR DVVRFLDWHG ZLWK
VHFRQGDU\VNLQLQIHFWLRQVZLWK6DXUHXVDQGKHUSHVVLPSOH[YLUXV+692QVHWRI$'W\SLFDOO\
RFFXUVDWDQHDUO\DJHDQGDVXUYH\RIFKLOGUHQLQWKH8QLWHG6WDWHVHVWLPDWHGDQRYHUDOO
SUHYDOHQFHRIDSSUR[LPDWHO\DQGDVKLJKDVLQVRPHVWDWHV,QWKH8QLWHG6WDWHVDORQH
LWLVHVWLPDWHGWKDWPRUHWKDQPLOOLRQSHU\HDULVVSHQWRQWKHWUHDWPHQWRIFKLOGKRRGDWRSLF
GHUPDWLWLV
$'FDQSUHVHQWLQWKUHHFOLQLFDOSKDVHVYL]DFXWHVXEDFXWHDQGFKURQLF,WFDQEHGLIIHUHQWLDOO\
GLDJQRVHGDVFRQWDFWGHUPDWLWLVFDQGLGLDVLVSVRULDVLVVFDELHVLPSHWLJRHWFGXHWRLWVDSSHDUDQFH
DQGSUHVHQWDWLRQRQVNLQ'LDJQRVLVRI$'LVEDVHGRQKLVWRU\DQGSK\VLFDOH[DPLQDWLRQ7KHUH
DUH PDQ\ SURSRVHG GLDJQRVWLF FULWHULD KRZHYHU D  V\VWHPDWLF UHYLHZ FRQFOXGHG WKDW WKH
8.:RUNLQJ3DUW\¶V'LDJQRVWLF&ULWHULDDUHWKHPRVWH[WHQVLYHO\YDOLGDWHG7KHPRVWLPSRUWDQW
IHDWXUHVFRQVLGHUHGIRU$'GLDJQRVLVDUHSUXULWXVHF]HPDERG\VXUIDFHDUHDLQYROYHPHQWDQG
SDWWHUQDORQJZLWKPHGLFDOKLVWRU\DQGDVVRFLDWHGIHDWXUHV$FRPPRQO\XVHGGLVHDVHVHYHULW\
VFDOH IRU FOLQLFDO VWXGLHV LQ $' LV WKH (F]HPD $UHD DQG 6HYHULW\ ,QGH[ ($6, ZKLFK XVHV
REMHFWLYH SK\VLFLDQ HVWLPDWHV RI GLVHDVH H[WHQW DQG VHYHULW\ 7KH ,QYHVWLJDWRU¶V *OREDO
$VVHVVPHQW,*$LVDOVRXVHGW\SLFDOO\DVDVWDWLFPHDVXUHWRVFRUHWKHVHYHULW\RIVLJQVDQG
V\PSWRPVRI$'
5HFHQW UHVHDUFK LQGLFDWHV WKDW VRPH RI WKH FDXVDWLYH IDFWRUV IRU $' LQFOXGH DQ LPSDLUHG VNLQ
EDUULHU DOOHUJLHV FRPSOH[ LPPXQH G\VUHJXODWLRQ DQG ,J(PHGLDWHG LQIODPPDWRU\ SDWKZD\V
*HQHWLF DVVRFLDWLRQV RI $' KDYH DOVR EHHQ LQGLFDWHG LQFOXGLQJ PXWDWLRQ RI WKH SURILODJJULQ
)/*JHQHUHVSRQVLEOHIRUDNH\VWUXFWXUDOSURWHLQRIWKHXSSHUHSLGHUPDOOD\HURIVNLQ

$YDLODELOLW\DQG(IILFDF\RI$OUHDG\$SSURYHG7KHUDSLHV
7KH-RLQW7DVN)RUFHRQ3UDFWLFH3DUDPHWHUVUHSUHVHQWLQJWKH$PHULFDQ$FDGHP\RI$OOHUJ\
$VWKPD 	 ,PPXQRORJ\ $$$$, WKH $PHULFDQ &ROOHJH RI $OOHUJ\ $VWKPD 	 ,PPXQRORJ\
$&$$,DQGWKH-RLQW&RXQFLORI$OOHUJ\$VWKPDDQG,PPXQRORJ\HVWDEOLVKHGJXLGHOLQHVIRU
$' WKHUDS\ LQ  $FFRUGLQJ WR WKHVH JXLGHOLQHV WKH ILUVW OLQH PDQDJHPHQW RI $' PXVW
LQFOXGHDFRPELQDWLRQRIVNLQK\GUDWLRQWRSLFDOFRUWLFRVWHURLGVFDOFLQHXULQLQKLELWRUVWDFUROLPXV
3URWRSLF(OLGHORYHUWKHFRXQWHU27&WDUSUHSDUDWLRQVDQWLKLVWDPLQHV9LWDPLQ'RUGLOXWH
EOHDFKEDWKV7RSLFDOFRUWLFRVWHURLGVFUHDPVJHOVHPXOVLRQVORWLRQVUHPDLQWKHILUVWFKRLFHRI
WKHUDS\ IRU PDQDJHPHQW RI PLOGVHYHUH IRUPV RI $' $QWLPLFURELDOV RUDO  WRSLFDO DUH
UHFRPPHQGHG WR WUHDW VHFRQGDU\ LQIHFWLRQV LQ $' ,PPXQRPRGXODWLQJ DJHQWV VXFK DV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



F\FORVSRULQHP\FRSKHQRODWHPRIHWLOD]DWKLRSULQH,)1JDQGFRUWLFRVWHURLGVKDYHEHHQVKRZQ
WRSURYLGHEHQHILWIRUSDWLHQWVZLWKVHYHUHUHIUDFWRU\$'KRZHYHUPDQ\RIWKHPDUHDVVRFLDWHG
SRWHQWLDOVHULRXVDGYHUVHHIIHFWV
$ QHZ IRUPXODWLRQ RI GHVR[LPHWDVRQH ± 'HVR[LPHWDVRQH WRSLFDO VSUD\  KDV EHHQ
GHYHORSHGE\7DUR3KDUPDFHXWLFDOV86$,QFDQGLVWKH7HVWSURGXFWXVHGLQWKLVVWXG\

6FLHQWLILFDQG6WDWLVWLFDO&RQVLGHUDWLRQV
,QVRPHLQVWDQFHVKLJKSRWHQF\VWHURLGVDSSOLHGWRSLFDOO\KDYHEHHQNQRZQWRFDXVHVXSSUHVVLRQ
RIWKHK\SRWKDODPLFSLWXLWDU\DGUHQDO+3$D[LV,QRUGHUWRDVVHVV+3$D[LVIXQFWLRQSODVPD
OHYHOVRIFRUWLVRODUHPHDVXUHGEHIRUHEDVDODQGDIWHUDEROXVDGPLQLVWUDWLRQRIV\QWKHWLFĮ
DGUHQRFRUWLFRWURSLFKRUPRQH$&7+,QWKLVVWXG\&RUWURV\Q70FRV\QWURSLQDV\QWKHWLF
VXEXQLW RI $&7+ $PSKVWDU 3KDUPDFHXWLFDOV ,QF ZLOO EH XVHG DFFRUGLQJ WR PDQXIDFWXUHU
LQVWUXFWLRQVWRDVVHVV+3$D[LVIXQFWLRQ6HH$SSHQGLFHV()5HFRYHU\IURPVWHURLGLQGXFHG
DGUHQDO LQVXIILFLHQF\ LV XVXDOO\ UDSLG DIWHU WKH WUHDWPHQW LV ZLWKGUDZQ 6HH $SSHQGL[ ( IRU
IXUWKHU H[SODQDWLRQ RI WKH HYDOXDWLRQ RI WKH UROH RI WRSLFDO FRUWLFRVWHURLGV LQ +3$ D[LV
VXSSUHVVLRQ
7DUR 3KDUPDFHXWLFDOV 86$ KDV UHFHQWO\ FRPSOHWHG DQ RSHQ ODEHO VDIHW\ DQG HIILFDF\ VWXG\ WR
DVVHVVDGUHQDOVXSSUHVVLRQLQDGXOWVZLWKPRGHUDWHWRVHYHUHSODTXHSVRULDVLVDIWHUZHHNVRI
WUHDWPHQWXQGHUPD[LPDOXVHFRQGLWLRQVZLWKWKHWHVWSURGXFWGHVR[LPHWDVRQHVSUD\2I
HYDOXDEOHVXEMHFWVDGUHQDOVXSSUHVVLRQZDVLGHQWLILHGLQRIVXEMHFWVKDYLQJLQYROYHPHQW
RIRIERG\VXUIDFHDUHD%6$DQGRIVXEMHFWVKDYLQJLQYROYHPHQWRI!RI%6$
DIWHUWUHDWPHQWZLWK7RSLFRUW7RSLFDO6SUD\WZLFHDGD\IRUGD\V$GUHQDOIXQFWLRQUHWXUQHG
WRQRUPDODWWKHILUVWIROORZXSYLVLWZKLFKZDVGD\VDIWHUWKHHQGRIWUHDWPHQWIRUDOORI
WKHVHSDWLHQWV
7KLVVWXG\GHVLJQLVEDVHGRQVLPLODUVWXGLHVSHUIRUPHGVXEPLWWHGDQGDFFHSWHGE\WKH)'$IRU
UHFHQWO\ DSSURYHG KLJK SRWHQF\ VSUD\ DQG IRDP WRSLFDO FRUWLFRVWHURLG IRUPXODWLRQV WRSLFDO
FRUWLFRVWHURLGWRSLFDOYLWDPLQ'DQDORJXHFRPELQDWLRQDJHQWVDQGUHFRPPHQGDWLRQVIURPWKH
)'$LQ,1'*XLGDQFH0HHWLQJWKDWWRRNSODFHRQDQGDQ)'$$GYLFH/HWWHU
GDWHG

5LVNVDQG%HQHILWV
.QRZQDGYHUVHUHDFWLRQVWRWRSLFDOFRUWLFRVWHURLGVLQFOXGHEXUQLQJLWFKLQJLUULWDWLRQGU\QHVV
IROOLFXOLWLVK\SHUWULFKRVLVDFQHLIRUPHUXSWLRQVK\SRSLJPHQWDWLRQSHULRUDOGHUPDWLWLVDOOHUJLF
FRQWDFW GHUPDWLWLV PDFHUDWLRQ RI WKH VNLQ VHFRQGDU\ LQIHFWLRQ VNLQ DWURSK\ VWULDH DQG
PLOOLDULD'RVLQJIRUH[WHQGHGSHULRGVRIWLPHPD\UHVXOWLQVXSSUHVVLRQRIDGUHQDOIXQFWLRQ
&RUWURV\Q70IRULQMHFWLRQLVLQWHQGHGGLDJQRVWLFDQGQRWWKHUDSHXWLFXVHDQGDGYHUVHUHDFWLRQV
RWKHU WKDQ D UDUH K\SHUVHQVLWLYLW\ UHDFWLRQ DUH QRW DQWLFLSDWHG  .QRZQ UHDFWLRQV DUH VOLJKW
ZKHDOLQJZLWKHU\WKHPDDWWKHVLWHRILQMHFWLRQ
7KHVXEMHFWPD\EHQHILWIURPFOHDULQJRIWKHOHVLRQVDQGLPSURYHPHQWRIWKHFRQGLWLRQRIWKH
GLVHDVH,IWKHGUXJLVDSSURYHGWKHQPDQ\FKLOGUHQPD\EHQHILWIURPLWVXVH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



7KH SRWHQWLDO ULVNV DQG EHQHILWV RI SDUWLFLSDWLRQ LQ WKH VWXG\ ZLOO EH H[SODLQHGWRWKHSDWLHQW
DQGSDUHQWRUOHJDOJXDUGLDQYHUEDOO\DQGZULWWHQLQWKHLQIRUPHGFRQVHQWIRUP
$OO SDWLHQWV HQUROOHG LQ WKLV VWXG\ ZLOO UHFHLYH WKH EHQHILW RI IUHH VSHFLDOL]HG PHGLFDO FDUH
EH\RQGVWDQGDUGPHGLFDOWUHDWPHQWWKDWZRXOGEHH[SHFWHGWKURXJKPRVWKHDOWKLQVXUDQFHSODQV
,Q DGGLWLRQ WKH SDWLHQW ZLOO UHFHLYH D VWLSHQG DV FRPSHQVDWLRQ IRU WLPH DQG LQFRQYHQLHQFH
UHODWHGWRVWXG\SDUWLFLSDWLRQLQFOXGLQJFRVWVDVVRFLDWHGZLWKWUDYHOWRDQGIURPWKHPHGLFDO
IDFLOLW\
(WKLFDOFRQVLGHUDWLRQUHODWHGWRWKLVSURWRFRODQGWKHXVHRIKXPDQSDWLHQWVZLOOEHUHYLHZHGE\
DQ,5%
678'<2%-(&7,9(6
 7KHSULPDU\REMHFWLYHRIWKLVVWXG\LVWRHYDOXDWHWKHSRWHQWLDORIGHVR[LPHWDVRQHWRSLFDO
VSUD\WRVXSSUHVV+3$D[LVIXQFWLRQLQSDWLHQWVZLWKPRGHUDWHWRVHYHUHDWRSLFGHUPDWLWLV
 7KHVHFRQGDU\REMHFWLYHVDUHWRHYDOXDWHWKHHIILFDF\SDUDPHWHUVDQGDGYHUVHHYHQW$(SURILOH
RIGHVR[LPHWDVRQHWRSLFDOVSUD\DGPLQLVWHUHGWRSDWLHQWVZLWKPRGHUDWHWRVHYHUHDWRSLF
GHUPDWLWLV


,19(67,*$7,21$/3/$1

6WXG\'HVLJQDQG3ODQ'HVFULSWLRQ
7KLVRSHQODEHOVDIHW\VWXG\LVGHVLJQHGWRHYDOXDWHWKHSRWHQWLDOIRUDGUHQDOVXSSUHVVLRQDIWHU
PD[LPDOXVHWUHDWPHQWZLWKGHVR[LPHWDVRQHWRSLFDOVSUD\7DUR3KDUPDFHXWLFDOV86$
IRUWKHWUHDWPHQWRIPRGHUDWHWRVHYHUHDWRSLFGHUPDWLWLV
8SWRHOLJLEOHSDWLHQWVZLWKDWRSLFGHUPDWLWLVWKDWVDWLVI\DOOHOLJLELOLW\FULWHULDZLOOEHHQUROOHG
LQWRWKHVWXG\DW9LVLW3DWLHQWVPXVWEHRYHUDOO LQJRRGKHDOWK7KH\VKRXOGKDYHDFXUUHQW
GLDJQRVLVRIPRGHUDWHWRVHYHUHDWRSLFGHUPDWLWLVZLWK,*$VFRUHRIDWOHDVWRU
8SWRVHYHQW\SDWLHQWVVWUDWLILHGE\DJHZLWKDFRQILUPHGGLDJQRVLVRIPRGHUDWHWRVHYHUH
DWRSLFGHUPDWLWLVZLWK
&RKRUW±SDWLHQWVDJH\HDUVDQGROGHUZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVPRQWKVWR\HDURIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG

&RKRUWVZLOOEHHQUROOHGLQVHTXHQWLDORUGHU(DFKFRKRUWZLOOLQLWLDWHHQUROOPHQWRQFHWKH
SUHYLRXVFRKRUWKDVUHDFKHGWKHPLQLPXPQXPEHURISDWLHQWVDQGDVDIHW\DQDO\VLVKDVEHHQ
UHYLHZHG(DFKFRKRUWZLOOEHHQUROOHGEDVHGRQWKHDYDLODELOLW\RISDWLHQWV

(DFKFRKRUWZLOOEHUHYLHZHGIRUWKHSRWHQWLDORI+3$D[LVVXSSUHVVLRQ,IDWOHDVWRISDWLHQWV
LQHDFK&RKRUWH[SHULHQFH+3$D[LVVXSSUHVVLRQRQFHWKHPLQLPXPQXPEHURISDWLHQWVKDVEHHQ
HQUROOHGDQGFRPSOHWHGWKHFRKRUWHQUROOPHQWIRUWKDWFRKRUWZLOOEHVWRSSHGDQGQRIXUWKHU
FRKRUWVZLOOEHLQLWLDWHG,IDWOHDVWRISDWLHQWVKDYHH[SHULHQFHG+3$D[LVVXSSUHVVLRQ

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



DFURVVFRKRUWVFRPELQHGGXULQJWKHVWXG\HQUROOPHQWZLOOEHGLVFRQWLQXHGDQGQRRWKHUFRKRUWV
ZLOOEHLQLWLDWHG&RKRUWZLOOQRWEHJLQXQWLOVDIHW\GDWDKDVEHHQUHYLHZHGIRU&RKRUW7KH
VDPHSURFHVVZLOOEHIROORZHGIRUHDFK&RKRUWXQWLOWKHVWXG\LVFRPSOHWH

3DWLHQWVHQUROOHGLQWKHVWXG\ZLOODSSO\SURGXFWWZLFHDGD\DFFRUGLQJWRSURYLGHGLQVWUXFWLRQV
IRUDWRWDORIGD\V
3DWLHQWVZLOODWWHQGDWRWDORI&OLQLF9LVLWVDVIROORZV
·
9LVLWZLWKLQGD\VSULRUWRHQUROOPHQW6FUHHQLQJ
·
9LVLW'D\(QUROOPHQW
·
9LVLW'D\,QWHULP9LVLW
·
9LVLW'D\(QGRI6WXG\RU(DUO\7HUPLQDWLRQ
7KH SULPDU\ HQGSRLQW LV WKH SURSRUWLRQ RI SDWLHQWV LQ WKH VWXG\ ZLWK +3$ D[LV VXSSUHVVLRQ
IROORZLQJWUHDWPHQWZLWKWKHVWXG\PHGLFDWLRQ
7KHVDIHW\SURILOHRIHDFKWUHDWPHQWJURXSZLOOEHHYDOXDWHGE\FRPSDULQJDGYHUVHHYHQWV
(WKLFDOFRQVLGHUDWLRQUHODWHGWRWKLVSURWRFRODQGWKHXVHRIKXPDQSDWLHQWVZLOOEHUHYLHZHGE\DQ
,5%

6HOHFWLRQRI6WXG\'HVLJQ
7KLVRSHQODEHOVDIHW\VWXG\WRDVVHVVWKHSRWHQWLDORIGHVR[LPHWDVRQHWRSLFDOVSUD\WR
VXSSUHVV+3$D[LVIXQFWLRQZDVEDVHGRQUHFRPPHQGDWLRQVSURYLGHGE\WKH)'$LQ,1'
*XLGDQFH0HHWLQJ5HIHUHQFH,'UHJDUGLQJWKHVFRSHDQGGHVLJQRI
VWXGLHVIRUGHVR[LPHWDVRQHVSUD\DQGDQ)'$$GYLFH/HWWHUGDWHG

6HOHFWLRQRI6WXG\3RSXODWLRQ

,QFOXVLRQ&ULWHULD
 0DOHRUQRQSUHJQDQWQRQODFWDWLQJIHPDOHV
·
&RKRUW±DJH\HDUVDQGROGHU
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±DJHV\HDUVRIDJH
·
&RKRUW±PRQWKV\HDURIDJH
 ,I IHPDOH DQG RI FKLOGEHDULQJ SRWHQWLDO SUHSDUHG WR DEVWDLQ IURP VH[XDO LQWHUFRXUVH RU XVH D
UHOLDEOH PHWKRG RI FRQWUDFHSWLRQ GXULQJ WKH VWXG\ HJ FRQGRP ,8' RUDO WUDQVGHUPDO RU
LQMHFWHGKRUPRQDOFRQWUDFHSWLYHV
 3DWLHQWVDQGROGHURUSDUHQWOHJDOJXDUGLDQKDVVLJQHGLQIRUPHGFRQVHQWIRUPZKLFKPHHWV
DOOFULWHULDRIFXUUHQW)'$UHJXODWLRQV
 %DVHG RQ WKH SDWLHQW¶V DJH   \HDUV ROG ZLOO UHDG DQG VLJQ DQ ,5% DSSURYHG DVVHQW IRUP
3DWLHQWVDJH\HDUVRIDJHZLOOSURYLGHYHUEDODVVHQWWRSDUWLFLSDWH
 3DWLHQWVZLWKDGHILQLWHFOLQLFDOGLDJQRVLVRIVWDEOHDWRSLFGHUPDWLWLVZLWKLQYROYHPHQWRI
·
&RKRUW±DJH\HDUVDQGROGHUZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
H[FOXGLQJIDFHD[LOODDQGJURLQDUHDV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



·
&RKRUW±DJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
H[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
·
&RKRUW±DJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
H[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
·
&RKRUW±DJH\HDUVRIDJHZLWKZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
H[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
·
&RKRUW±PRQWKV±\HDURIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
H[FOXGLQJIDFHD[LOODDQGJURLQDUHDV
 +DYHDQ(F]HPD$UHDDQG6HYHULW\,QGH[($6,VFRUHRIDWOHDVW
 +DYHDQ,QYHVWLJDWRU*OREDO$VVHVVPHQW6FDOH,*$RI0RGHUDWHRU6HYHUH
 5HVXOWVIURPDFRUWLVROUHVSRQVHWHVWWKDWDUHFRQVLGHUHGQRUPDODQGVKRZQRHYLGHQFHRIDQ\
DEQRUPDO+3$IXQFWLRQRUDGUHQDOUHVSRQVH6HH$SSHQGL[(3DWLHQWVPXVWIXOILOODOORIWKH
IROORZLQJVWLSXODWLRQV
D 7KHLUEDVDOSUH&RUWURV\QLQMHFWLRQFRUWLVROFRQFHQWUDWLRQLVPFJP/
E 7KHLUPLQXWHSRVWLQMHFWLRQFRUWLVROOHYHOLVDWOHDVWPFJP/JUHDWHUWKDQWKHEDVDO
OHYHOEDVDOYDOXH
F 7KHSRVWVWLPXODWLRQOHYHOLV!PFJP/

([FOXVLRQ&ULWHULD
 )HPDOHV ZKR DUH SUHJQDQW QXUVLQJ SODQQLQJ WR EHFRPH SUHJQDQW GXULQJ WKH GXUDWLRQ RI WKH
VWXG\ RU LI RI FKLOGEHDULQJ SRWHQWLDO DQG VH[XDOO\ DFWLYH DQG QRW SUHSDUHG WRXVH DSSURSULDWH
FRQWUDFHSWLYHPHWKRGVWRDYRLGSUHJQDQF\
 /DFNVVWDEOHGLDJQRVLVRIDWRSLFGHUPDWLWLVRUKDVEHHQGLDJQRVHGZLWKPLOGDWRSLFGHUPDWLWLV
 +DYHDQ($6,VFRUHRI
 +DYHDQ,*$VFRUHRI
 $WRSLFGHUPDWLWLVZLWKD%6$LQYROYHPHQWRIIRU&RKRUWVRURUIRU&RKRUWV
RU
 5HVXOWVIURPDFRUWLVROUHVSRQVHWHVWWKDWVKRZHYLGHQFHRIDQ\DEQRUPDO+3$IXQFWLRQRU
DGUHQDOUHVSRQVHVHH$SSHQGL[(
D 7KHLUEDVDOSUH&RUWURV\Q70LQMHFWLRQFRUWLVROFRQFHQWUDWLRQLVPFJPO
E WKHLUPLQXWHSRVWLQMHFWLRQFRUWLVROOHYHOLVOHVVWKDQPFJPOJUHDWHUWKDQ
WKHEDVDOOHYHOEDVDOYDOXH
F WKHSRVWVWLPXODWLRQOHYHOLVPFJPO
 $FWLYH FXWDQHRXV EDFWHULDO RU YLUDO LQIHFWLRQ LQ DQ\ WUHDWPHQW DUHD DW EDVHOLQH LH FOLQLFDOO\
LQIHFWHGDWRSLFGHUPDWLWLV
 3DWLHQW KDV D KLVWRU\ RI DWRSLF GHUPDWLWLV WKDW KDV EHHQ XQUHVSRQVLYH WR WRSLFDO FRUWLFRVWHURLG
WKHUDS\
 $Q\FRQGLWLRQLHVXQEXUQSVRULDVLVHWFWKDWLQWKH,QYHVWLJDWRU¶VRSLQLRQPD\LQWHUIHUHZLWK
WKHFOLQLFDODVVHVVPHQWVRIWKHVLJQVDQGV\PSWRPVRIDWRSLFGHUPDWLWLV
6XEMHFW KDV D KLVWRU\ RI DOOHUJ\ RU VHQVLWLYLW\ WR FRUWLFRVWHURLGV RU KLVWRU\ RI DQ\ GUXJ
K\SHUVHQVLWLYLW\RULQWROHUDQFHZKLFKLQWKHRSLQLRQRIWKH,QYHVWLJDWRUZRXOGFRPSURPLVHWKH
VDIHW\RIWKHSDWLHQWRUWKHUHVXOWVRIWKHVWXG\

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



3DWLHQWKDVDVLJQLILFDQWKLVWRU\RUFXUUHQWHYLGHQFHRIFKURQLFLQIHFWLRXVGLVHDVHV\VWHPGLVRUGHU
RUJDQ GLVRUGHU RU RWKHU PHGLFDO FRQGLWLRQ WKDW LQ WKH ,QYHVWLJDWRU¶V RSLQLRQ ZRXOG SODFH WKH
VWXG\SDWLHQWDWXQGXHULVNE\SDUWLFLSDWLRQLQWKHVWXG\
3DWLHQW LV FXUUHQWO\ UHFHLYLQJ RU KDV UHFHLYHG DQ\ UDGLDWLRQ WKHUDS\ DQWLQHRSODVWLF DJHQWV RU
LPPXQRVXSSUHVVDQWPHGLFDWLRQZLWKLQZHHNVEHIRUHWKHILUVWGRVHRIVWXG\GUXJ
8VHZLWKLQRQHPRQWK EHIRUHEDVHOLQHRIRUDORULQWUDYHQRXVFRUWLFRVWHURLGV89$89%
WKHUDS\389$SVRUDOHQSOXVXOWUDYLROHW$WKHUDS\WDQQLQJERRWKVQRQSUHVFULSWLRQ89
OLJKWVRXUFHLPPXQRPRGXODWRUVRULPPXQRVXSSUHVVLYHWKHUDSLHVLQWHUIHURQF\WRWR[LF
GUXJVWDFUROLPXVRUSLPHFUROLPXV
8VHZLWKLQGD\VEHIRUHEDVHOLQHRIV\VWHPLFDQWLELRWLFVFDOFLSRWULHQHRURWKHU9LWDPLQ'
SUHSDUDWLRQVRUUHWLQRLGV
3DWLHQWVZKRKDYHXVHGWRSLFDOWUHDWPHQWVSUHVFULSWLRQRURYHUWKHFRXQWHULQFOXGLQJ
D $Q\ WRSLFDO DWRSLF GHUPDWLWLV WKHUDSHXWLF DJHQWV RI DQ\ NLQG ZLWKLQ WKH  ZHHNV
EHIRUHILUVWXVHRIVWXG\GUXJ
E $Q\WRSLFDOFRUWLFRVWHURLGVZLWKLQWKHZHHNVEHIRUHWKHILUVWXVHRIWKHVWXG\GUXJ
F $Q\DQWLEDFWHULDOPHGLFDWHGDQGRUDVWULQJHQWZDVKHVVRDSVSDGVRUPRLVWXUL]HUV
ZLWKLQWKHGD\VEHIRUHWKHILUVWXVHRIVWXG\GUXJ
G +LJK VWUHQJWK  RU DERYH DOSKDK\GUR[\ DFLG RU DQ\ NLQG RI SHHO RU RWKHU
SURFHGXUHVRQWKHIDFHHJODVHUKDLUUHPRYDOZLWKLQGD\VRIWKHVWXG\VWDUW
H $Q\WRSLFDOSURGXFWVLHVXQVFUHHQVORWLRQVFUHDPVH[FHSWIRUEODQGHPROOLHQW
PRLVWXUL]HUZLWKLQKRXUEHIRUHEDVHOLQH
I 7RSLFDODQWLELRWLFVLQWKHWUHDWPHQWDUHDZLWKLQGD\VEHIRUHEDVHOLQH
3DWLHQWKDVEHHQWUHDWHGZLWKLQZHHNVRUILYHKDOIOLYHVZKLFKHYHULVOHVV EHIRUHWKHILUVW
GRVHRIVWXG\GUXJZLWKDQ\ELRORJLFDOWKHUDSLHVIRUDWRSLFGHUPDWLWLV
8VHRIQRQVHGDWLQJDQWLKLVWDPLQHVZLWKLQWKHGD\VEHIRUHWKHILUVWGRVLQJGD\
7KHXVHRIVHGDWLQJDQWLKLVWDPLQHVVXFKDVGLSKHQK\GUDPLQHPD\EHDFFHSWDEOHRQFRQGLWLRQ
WKHSDWLHQWKDVEHHQRQDVWDEOHGRVHIRUDWOHDVWGD\VEHIRUHWKHVWXG\VWDUWDQGZLOOUHPDLQRQ
DVWDEOHGRVHWKURXJKRXWWKHVWXG\
$Q\RUDOVWHURLGGUXJXVHZLWKWKHH[FHSWLRQFRQWUDFHSWLYHVZLWKLQGD\VRIWKHILUVWGRVLQJ
GD\RUGXULQJWKHVWXG\
D )HPDOH SDWLHQWV XVLQJ KRUPRQDO FRQWUDFHSWLYHV VKRXOG KDYH EHHQ RQ WKH VDPH
SURGXFWGRVLQJ UHJLPHQ IRU DW OHDVW  GD\V EHIRUH DQG VKRXOG QRW FKDQJH WKLV
UHJLPHQGXULQJWKHVWXG\
E 7KHXVHRILQKDOHGRULQWUDQDVDOFRUWLFRVWHURLGVLVDFFHSWDEOHDVORQJDVXVDJHKDV
EHHQ VWDEOH IRU DW OHDVW  ZHHNV EHIRUH WKH ILUVW GRVH RI VWXG\ GUXJ DQG ZLOO EH
FRQWLQXHGGXULQJWKHVWXG\
,QDELOLW\WRXQGHUVWDQGWKHSURWRFROUHTXLUHPHQWVLQVWUXFWLRQVDQGVWXG\UHODWHGUHVWULFWLRQVWKH
QDWXUHVFRSHDQGSRVVLEOHFRQVHTXHQFHVRIWKHFOLQLFDOVWXG\
8QOLNHO\WRFRPSO\ZLWKWKHSURWRFROUHTXLUHPHQWVLQVWUXFWLRQVDQGVWXG\UHODWHGUHVWULFWLRQV
VXFK DV XQFRRSHUDWLYH DWWLWXGH LQDELOLW\ WR UHWXUQ IRU IROORZXS YLVLWV DQG LPSUREDELOLW\ RI
FRPSOHWLQJWKHFOLQLFDOVWXG\
5HFHLSWRIDQ\GUXJDVSDUWRIDUHVHDUFKVWXG\ZLWKLQGD\VSULRUWRILUVWGRVLQJ

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



7KH SDWLHQW LV D PHPEHU RI WKH LQYHVWLJDWLRQDO VWXG\ VWDII RU D PHPEHU RI WKH IDPLO\ RI WKH
LQYHVWLJDWLRQDOVWXG\VWDII
3UHYLRXVSDUWLFLSDWLRQLQWKLVVWXG\

5HVWULFWLRQVGXULQJWKH6WXG\
7KHIROORZLQJFRQFRPLWDQWPHGLFDWLRQVZLOOQRWEHDOORZHGZKLOHHQUROOHGLQWKHVWXG\
·
$Q\SUHVFULSWLRQRURYHUWKHFRXQWHU27&WRSLFDOV\VWHPLFSKRWRWKHUDS\RUELRORJLFDO
PHGLFDWLRQVRUWUHDWPHQWVIRU$'
·
$Q\QRQVWHURLGDOLPPXQRVXSSUHVVDQWVE\DQ\URXWHRIDGPLQLVWUDWLRQ
·
8VHRIQRQVHGDWLQJDQWLKLVWDPLQHV
o 7KH XVH RI VHGDWLQJ DQWLKLVWDPLQHV VXFK DV GLSKHQK\GUDPLQH PD\ EH DFFHSWDEOH RQ
FRQGLWLRQWKHSDWLHQWKDVEHHQRQDVWDEOHGRVHIRUDWOHDVWGD\VEHIRUHHQUROOPHQWDQG
ZLOOUHPDLQRQDVWDEOHGRVHWKURXJKRXWWKHVWXG\
·
$Q\ RUDO WRSLFDO RU LQMHFWDEOH VWHURLG GUXJ XVH ZLWK WKH H[FHSWLRQ RI +57 DQG
FRQWUDFHSWLYHV
o )HPDOHSDWLHQWVXVLQJKRUPRQDOFRQWUDFHSWLYHVRU+57VKRXOGKDYHEHHQRQWKHVDPH
SURGXFWGRVLQJUHJLPHQIRUDWOHDVWZHHNVEHIRUHDQGVKRXOGQRWFKDQJHWKLVGXULQJWKH
VWXG\
·
1HZUHJLPHQVRILQKDOHGFRUWLFRVWHURLGV
o ,QKDOHGRULQWUDQDVDOFRUWLFRVWHURLGVDUHSHUPLVVLEOHSURYLGHGWKDWWKHSDWLHQWKDVEHHQRQ
DVWDEOHUHJLPHQIRUDWOHDVWZHHNVEHIRUHWKHILUVWGRVHRIVWXG\GUXJDQGZLOOFRQWLQXH
GXULQJWKHVWXG\
·
$Q\RWKHUWUHDWPHQWVSUHVFULSWLRQRURYHUWKHFRXQWHUSURGXFWVIRUWKHWUHDWPHQWRIDQ\
RWKHUGHUPDWRORJLFDOFRQGLWLRQLQFOXGLQJWRSLFDOFRUWLFRVWHURLGVDQWLEDFWHULDOPHGLFDWHG
DQGRUDVWULQJHQWZDVKHVVRDSVSDGVRUPRLVWXUL]HUVGXULQJWKHVWXG\
·
8VHRIKLJKVWUHQJWKRUDERYHDOSKDK\GUR[\ DFLGRUDQ\NLQGRISHHORURWKHU
SURFHGXUHVRQWKHWUHDWPHQWDUHDVODVHUKDLUUHPRYDOGXULQJWKHVWXG\
3DWLHQWV DQG SDUHQWVOHJDO JXDUGLDQV ZLOO EH DGYLVHG WR DYRLG HQYLURQPHQWDO FRQGLWLRQV WKDW PD\
H[DFHUEDWHWKHLUGLVHDVHVWDWH3DWLHQWVDQGSDUHQWVOHJDOJXDUGLDQVZLOOEHDGYLVHGWRDYRLGH[SRVXUH
WRVXQOLJKWRIDGXUDWLRQWKDWZRXOGUHTXLUHDSSOLFDWLRQRIVXQVFUHHQ
3DWLHQWV ZLOO EH LQVWUXFWHG QRW WR DSSO\ WKH PHGLFDWLRQ WR WKHIDFH JURLQ RU D[LOOD DQG QRW WR XVH
RFFOXVLYHGUHVVLQJVRQWKHWUHDWPHQWDUHD
3DWLHQWVDQGSDUHQWVOHJDOJXDUGLDQVZLOOEHTXHVWLRQHGDERXWDOOFRQFRPLWDQWSUHVFULSWLRQDQG27&
PHGLFDWLRQXVHDWHDFKVWXG\YLVLW$OOFRQFRPLWDQWPHGLFDWLRQVZLOOEHUHFRUGHGLQWKHSDWLHQW¶VVWXG\
FKDUW $Q\ SDWLHQW ZKR YLRODWHV DQ\ RI WKH OLVWHG UHVWULFWLRQV PD\ EH GURSSHG IURP FRQWLQXHG
SDUWLFLSDWLRQLQWKHVWXG\E\WKH,QYHVWLJDWRU


&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




5HPRYDORI3DWLHQWVIURPWKH6WXG\
3DWLHQWVZLOOEHDGYLVHGWKDWWKH\DUHIUHHWRZLWKGUDZIURPWKHVWXG\DWDQ\WLPHIRUDQ\UHDVRQRULI
QHFHVVDU\WKH,QYHVWLJDWRUPD\ZLWKGUDZDSDWLHQWIURPWKHVWXG\WRSURWHFWWKHKHDOWKRIWKDWSDWLHQW
$SDWLHQWPD\DOVREHZLWKGUDZQIRUQRWFRPSO\LQJZLWKVWXG\SURFHGXUHV7KHFOLQLFDOUHSRUWZLOO
LQFOXGHDOOUHDVRQVIRUHDUO\ZLWKGUDZDOV
$OOSDWLHQWVZKRDGPLQLVWHUDWOHDVWRQHGRVHRIUDQGRPL]HGVWXG\PHGLFDWLRQZLOOEHLQFOXGHGLQWKH
VDIHW\DQDO\VLV,IDSDWLHQWWHUPLQDWHVIURPWKHVWXG\HDUO\DOOHIIRUWVZLOOEHPDGHWRFRPSOHWHWKHLU
QH[W YLVLW VWXG\ SURFHGXUHV ,Q FDVH RI HDUO\ WHUPLQDWLRQ WKH ,QYHVWLJDWRU VKDOO IXOO\ GRFXPHQW WKH
UHDVRQIRUHDUO\WHUPLQDWLRQ5HDVRQVIRUHDUO\WHUPLQDWLRQPD\LQFOXGHWKHIROORZLQJ
·
3DWLHQWZLWKGUHZFRQVHQW
·
6LJQLILFDQW DGYHUVH HYHQW WKDW OHG WKH ,QYHVWLJDWRU RU SDWLHQW WR ZLWKGUDZ IRU VDIHW\
UHDVRQV
·
:RUVHQLQJVLJQVV\PSWRPVRI$'
·
'HYHORSPHQWRIDQLQWHUFXUUHQWFRQGLWLRQRUFRPSOLFDWLRQWKDWFRXOGDIIHFWWKHVDIHW\RI
WKH SDWLHQW RU WKH YDOLGLW\ RI WKH HYDOXDWLRQ RI WKH SDWLHQW¶V FOLQLFDO VWDWH WR DQ H[WHQW
FRQVLGHUHGVLJQLILFDQWE\WKH,QYHVWLJDWRU
·
6LJQVDQGV\PSWRPVRISRVVLEOH+3$D[LVVXSSUHVVLRQ
·
3URWRFROGHYLDWLRQVYLRODWLRQVWKDWLQWKH,QYHVWLJDWRU¶VRSLQLRQZDUUDQWGLVFRQWLQXDWLRQ
1RQFRPSOLDQFHZLWKGRVLQJQHHGQRWEHDUHDVRQIRUHDUO\WHUPLQDWLRQ3DWLHQWVZKRZLWKGUDZRUDUH
UHPRYHGIURPWKHVWXG\ZLOOQRWEHUHSODFHG,QWKHHYHQWDSDWLHQWZLWKGUDZVRULVGURSSHGIURPWKH
VWXG\IRUDQ\UHDVRQWKH,QYHVWLJDWRUZLOOUHTXHVWUHWXUQRIWKHXQXVHGSURGXFWDQGUHSRUWWKHUHDVRQ
IRUWKHGLVFRQWLQXHGSDUWLFLSDWLRQ
:KHQDSDWLHQWGLVFRQWLQXHVHDUO\IURPWKHVWXG\DOOVWXG\SURFHGXUHVUHTXLUHGIRUWKHHQGRIVWXG\
VKRXOG EH SHUIRUPHG DW WKHLU ODVW VWXG\ YLVLW 3DWLHQWV ZKR DUH GLVFRQWLQXHG IURP WKH VWXG\ DIWHU
HQUROOPHQWZLOOEHHYDOXDWHGIRUVDIHW\DQGZLOOEHJLYHQRUUHIHUUHGIRUDSSURSULDWHWUHDWPHQW

7UHDWPHQWV

7UHDWPHQWV$GPLQLVWUDWLRQ
7KHSDWLHQWRUSDUHQWOHJDOJXDUGLDQZLOOEHLQVWUXFWHGWRDSSO\DQGUXELQJHQWO\DWKLQILOPRIWKH
VWXG\GUXJWRWKHDIIHFWHGDUHDVWZLFHGDLO\PRUQLQJDQGHYHQLQJIRUGD\V7KHKDQGVVKRXOGEH
ZDVKHGDIWHUDSSO\LQJWKHGUXJ
7R HQVXUH FRPSOLDQFH ZLWK WKH GRVLQJ WHFKQLTXH WKH SDWLHQW RU SDUHQWOHJDO JXDUGLDQ ZLOO EH
LQVWUXFWHGWRDSSO\WKHILUVWGRVHRIPHGLFDWLRQXQGHUVWDIIVXSHUYLVLRQDWWKHWLPHRIHQUROOPHQWDQG
WKHQWZLFHGDLO\XQWLOWKHSDWLHQW¶VQH[WVFKHGXOHGYLVLW3DUHQWVOHJDOJXDUGLDQVZLOOEHLQVWUXFWHGQRW
WRDSSO\WKHVWXG\GUXJZLWKLQKRXUVRIWKHYLVLWZKLFKLQFOXGHVWKH&RUWLVRO5HVSRQVH7HVW7KH
SDWLHQWRUSDUHQWOHJDOJXDUGLDQZLOOEHLQVWUXFWHGQRWWRDSSO\WKHPHGLFDWLRQWRWKHIDFHD[LOODRU
JURLQDQGQRWWRXVHRFFOXVLYHGUHVVLQJVRQWKHWUHDWPHQWDUHD(DFKSDWLHQWRUSDUHQWOHJDOJXDUGLDQ
ZLOOEHSURYLGHGZLWKDGRVLQJGLDU\LQZKLFKWKH\ZLOOEHUHTXLUHGWRUHFRUGGRVLQJGDWHVDQGWLPHV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



7KHVHGLDULHVVKRXOGEHEURXJKWWRHDFKYLVLWLQRUGHUWKDWWKHVWXG\VWDIIPD\FKHFNFRPSOLDQFH$W
WKHHQGRIWKHVWXG\WKHGRVLQJGLDULHVZLOOEHUHWDLQHGLQWKHSDWLHQW¶VILOHDVVRXUFHGRFXPHQWDWLRQ
$W9LVLW(QUROOPHQWDQG9LVLW,QWHULP9LVLWTXDOLILHGVWXG\SDWLHQWVRUSDUHQWVOHJDOJXDUGLDQV
ZLOOEHSURYLGHGZLWKRQHPOERWWOHRIGHVR[LPHWDVRQHWRSLFDODORQJZLWKLQVWUXFWLRQVIRU
GRVLQJ 7KLV ERWWOH VKRXOG EH ZHLJKHG EHIRUH WR GLVSHQVLQJ DQG WKH ZHLJKW UHFRUGHG $W 9LVLW 
,QWHULP9LVLWWKHERWWOHVKRXOGEHFROOHFWHGDQGZHLJKHGDQGDQHZPOERWWOHRIVSUD\VKRXOGEH
ZHLJKHGDQGGLVSHQVHGDORQJZLWKGRVLQJLQVWUXFWLRQV7KLVERWWOHZLOOEHUHWXUQHGDQGZHLJKHGDW
9LVLW(QGRI6WXG\(QGRI7UHDWPHQW
7UHDWPHQWFRPSOLDQFHZLOOEHHQFRXUDJHGE\LQVWUXFWLQJWKHSDWLHQWRUSDUHQWOHJDOJXDUGLDQRQWKH
SURSHUGRVLQJWHFKQLTXHDQGE\WKHXVHRIWKHGDLO\GLDU\&RPSOLDQFHZLOOEHDVVHVVHGE\HYDOXDWLRQ
RIWKHGLDU\

,GHQWLW\RI,QYHVWLJDWLRQDO3URGXFW
$OOVWXG\GUXJVZLOOEHSURYLGHGE\7DUR3KDUPDFHXWLFDOV86$,QF(DFKSDWLHQWZLOOUHFHLYH[
P/ERWWOHVRIGHVR[LPHWDVRQHWRSLFDOVSUD\
7KHVWXG\PHGLFDWLRQZLOOEHVKLSSHGWRHDFK,QYHVWLJDWRU¶VVLWHIURPDFHQWUDOL]HGSKDUPDF\7KH
3ULQFLSDO,QYHVWLJDWRUDWHDFKVLWHLVUHVSRQVLEOHIRUHQVXULQJWKDWDOOVWXG\PHGLFDWLRQVDUHVWRUHGLQD
ORFNHGVHFXUHORFDWLRQZLWKDFFHVVOLPLWHGWRWKH,QYHVWLJDWRUDQGKLVKHUGHVLJQHHV$QDFFXUDWH
LQYHQWRU\RIWKHVWXG\PHGLFDWLRQZLOOEHPDLQWDLQHGLQDFFRUGDQFHZLWKIHGHUDOUHJXODWLRQV
2QFH WKH VLWH KDV EHHQ QRWLILHG WKDW WKH\ PD\ GR VR DOO XQXVHG VWXG\ PHGLFDWLRQ DQG HPSW\ RU
SDUWLDOO\XVHGERWWOHVRIVWXG\PHGLFDWLRQPD\EHUHWXUQHGWRWKH6SRQVRURUGHVLJQHH

0HWKRGRI$VVLJQLQJ3DWLHQWVWR7UHDWPHQW*URXSV
3DWLHQWVHOLJLEOHIRUHQUROOPHQWLQWRWKHVWXG\ZLOOIDOOLQWRRQHRIILYHFRKRUWV
&RKRUW±SDWLHQWVDJH\HDUVDQGROGHUZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVDJH\HDUVRIDJHZLWKZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
&RKRUW±SDWLHQWVPRQWKV\HDURIDJHZLWKERG\VXUIDFHDUHD%6$DIIHFWHG
$W9LVLWHOLJLEOHSDWLHQWVZLOOEHHQUROOHGWRWKHVWXG\DQGDVVLJQHGDSDWLHQWQXPEHU
&RKRUWVZLOOEHHQUROOHGLQVHTXHQWLDORUGHU(DFKFRKRUWZLOOLQLWLDWHHQUROOPHQWRQFHWKHSUHYLRXV
FRKRUWKDVUHDFKHGWKHPLQLPXPQXPEHURISDWLHQWVDQGDVDIHW\DQDO\VLVKDVEHHQUHYLHZHG(DFK
FRKRUWZLOOEHHQUROOHGEDVHGRQWKHDYDLODELOLW\RISDWLHQWV

(DFKFRKRUWZLOOEHUHYLHZHGIRUWKHSRWHQWLDORI+3$D[LVVXSSUHVVLRQ,IDWOHDVWRISDWLHQWVLQ
HDFK&RKRUWH[SHULHQFH+3$D[LVVXSSUHVVLRQRQFHWKHPLQLPXPQXPEHURISDWLHQWVKDVEHHQ
HQUROOHGDQGFRPSOHWHGWKHFRKRUWHQUROOPHQWIRUWKDWFRKRUWZLOOEHVWRSSHGDQGQRIXUWKHUFRKRUWV
ZLOOEHLQLWLDWHG,IDWOHDVWRISDWLHQWVKDYHH[SHULHQFHG+3$D[LVVXSSUHVVLRQDFURVVFRKRUWV
FRPELQHGGXULQJWKHVWXG\HQUROOPHQWZLOOEHGLVFRQWLQXHGDQGQRRWKHUFRKRUWVZLOOEHLQLWLDWHG
&RKRUWZLOOQRWEHJLQXQWLOVDIHW\GDWDKDVEHHQUHYLHZHGIRU&RKRUW7KHVDPHSURFHVVZLOOEH
IROORZHGIRUHDFK&RKRUWXQWLOWKHVWXG\LVFRPSOHWH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




3DFNDJLQJ
7KLVLVDQRSHQODEHOVWXG\7KHVWXG\GUXJZLOOFRQWDLQDODEHOZLWKWKHIROORZLQJLQIRUPDWLRQ
·
3URWRFROQXPEHU
·
%RWWOHQXPEHU
·
6SDFHIRUSDWLHQWQXPEHUSDWLHQW¶VLQLWLDOVDQGGLVSHQVHGGDWH
·
$QRWHWKDWWKHGUXJLVIRU,QYHVWLJDWLRQDO8VH2QO\

$FFRXQWDELOLW\
·
7KH,QYHVWLJDWRURUGHVLJQHHZLOOPDLQWDLQDQLQYHQWRU\RIDOOVWXG\GUXJVXSSOLHVUHFHLYHG
·
7KH,QYHVWLJDWRURUGHVLJQHHZLOOPDLQWDLQDORJRIDOOGUXJGLVSHQVHGWRDQGUHWXUQHGE\WKH
SDWLHQWVDQGQRWHWKHGDWHHDFKGUXJLVUHWXUQHGWRWKH6SRQVRU
·
7KH ZHLJKW RI WKH VWXG\ GUXJ ERWWOHV EHIRUH WR GLVSHQVLQJ DQG DIWHU FROOHFWLRQ ZLOO EH
UHFRUGHG
·
$OOVWXG\UXJZLOOEHVWRUHGDWFRQWUROOHGURRPWHPSHUDWXUHEHWZHHQ&WR&)WR
)H[FXUVLRQVSHUPLWWHGWR&WR&)WR)LQDVHFXUHSODFHZLWKDFFHVVWR
DXWKRUL]HGLQGLYLGXDOVRQO\
·
,QWKHHYHQWRIORVVRUDSSDUHQWVSRLODJHRIWKHWHVWSUHSDUDWLRQWKH,QYHVWLJDWRURU
GHVLJQHHPXVWLQIRUPWKHVWXG\PRQLWRU,IQHFHVVDU\DSURSHUO\ODEHOHGUHSODFHPHQWERWWOH
ZLOOEHLVVXHGWRWKHSDWLHQW

&RPSOLDQFH
3DWLHQWVZLOOEHSURYLGHGZLWKDGLDU\ZLWKLQVWUXFWLRQVWRUHFRUGWKHWLPHDQGGDWHRIGRVLQJ
3DWLHQWV ZLOO EH DVNHG WR DOVR UHFRUG DQ\ DGYHUVH HYHQWV DQG FRQFRPLWDQW PHGLFDWLRQV WDNHQ
GXULQJWKHVWXG\
3DWLHQWVZLOOGRVHWZLFHGDLO\IRUGD\V$OOSDWLHQWVZKRDUHHQUROOHGDQGXVHGDWOHDVW
RIVFKHGXOHGGRVHVRIWKHVWXG\GUXJDQGKDYHGDWDIURPDSRVWWUHDWPHQWFRUWLVROUHVSRQVH
WHVWZLOOEHLQFOXGHGLQWKHDQDO\VLV

6WXG\&RQGXFW
7KHFRUWLVROUHVSRQVHWHVWLVWREHGRQHLQWKHPRUQLQJDVWKHERG\¶VSHDNFRUWLVROOHYHOLVGLUHFWO\
UHODWHG WR WKH HYHQW RI DZDNHQLQJ 9LVLW  DQG 9LVLW  VKRXOG EH VFKHGXOHG EHIRUH QRRQ DQG
VXEMHFWVVKRXOGQRWDSSO\WKHVWXG\GUXJZLWKLQKRXUVRI9LVLW

 9LVLW:LWKLQGD\VEHIRUHHQUROOPHQW6FUHHQLQJ%HIRUHSP
 ,QIRUPHG&RQVHQW3DWLHQWVZKRDUHZLOOLQJWRFRPSO\ZLWKVWXG\SURFHGXUHVZLOOUHDGDQGVLJQ
WKHLQIRUPHGFRQVHQWIRUP)RUSDWLHQWVXQGHUWKHDJHRIPDMRULW\LQWKHVWDWHWKHVWXG\LVEHLQJ
FRQGXFWHG\HDUVLQPRVWVWDWHVWKHSDUHQWRUOHJDOJXDUGLDQVKRXOGVLJQWKHFRQVHQWIRUPDQG
WKHFKLOGDJH\HDUVROGZLOOEHUHTXLUHGWRVLJQDSDWLHQW³DVVHQW´IRUPWKDWZLOOEHZULWWHQ
LQVXFKDZD\DVWREHXQGHUVWDQGDEOHWRDFKLOG3DWLHQWVDJH\HDUVRIDJHZLOOSURYLGHYHUEDO
DVVHQWWRSDUWLFLSDWH
 0HGLFDO+LVWRU\DQG'HPRJUDSKLFV7KHSDWLHQW¶VGHPRJUDSKLFDQGDFRPSOHWHPHGLFDOKLVWRU\
ZLOOEHREWDLQHGIRUWKHSDWLHQW¶VFXUUHQWDQGSDVWPHGLFDOFRQGLWLRQV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



 3K\VLFDO([DPLQDWLRQDQG%6$$VVHVVPHQW$JHQHUDOSK\VLFDOH[DPZLOOEHFRQGXFWHG
7KH6XEMHFW¶VERG\ZHLJKWNJDQGKHLJKWFPZLOODOVREHPHDVXUHGZKLOHWKH6XEMHFWLVOLJKWO\
FORWKHGHJQRFRDWRUVKRHV%6$ZLOOEHDVVHVVHGXVLQJLQVWUXFWLRQVLQ$SSHQGL[$
 9LWDO6LJQV7KHSDWLHQW¶VYLWDOVLJQVZLOOEHUHFRUGHGSXOVHEORRGSUHVVXUHWHPSHUDWXUHDQG
UHVSLUDWLRQUDWH
 3UHJQDQF\7HVW$SUHJQDQF\WHVWZLOOEHUHTXLUHGRIDOOIHPDOHVRIFKLOGEHDULQJSRWHQWLDOSULRU
WRHQUROOPHQW
 'HUPDWRORJLFDO $VVHVVPHQW  &OLQLFDO VLJQV DQG V\PSWRPV RI $' ZLOO EH HYDOXDWHG E\ WKH
,QYHVWLJDWRUEDVHGRQWKHIROORZLQJ
·
($6,6FRUH$SSHQGL[%
·
,*$6FRUH$SSHQGL[&
·
$SSOLFDWLRQ6LWH5HDFWLRQV$SSHQGL['
 &RQFRPLWDQW0HGLFDWLRQ5HYLHZZLWKWKHSDWLHQWDQGSDUHQWOHJDOJXDUGLDQWKHSDWLHQW¶V
XVHRIFRQFRPLWDQWPHGLFDWLRQZLWKLQWKHODVWZHHNV
 &RQILUP ,QFOXVLRQ([FOXVLRQ 0HW &RQILUP WKH SDWLHQW PHHWV DOO LQFOXVLRQH[FOXVLRQ FULWHULD
SHQGLQJUHVXOWVRIWKH&RUWLVRO5HVSRQVH7HVW
 /DERUDWRU\ (YDOXDWLRQV  $ EORRG VDPSOH ZLOO EH FROOHFWHG IRU KHPDWRORJ\ DQG FOLQLFDO
FKHPLVWU\WHVWLQJ6HH$SSHQGL[*
&RUWLVRO5HVSRQVH7HVW$OOSDWLHQWVZLOOKDYHDFRUWLVROUHVSRQVHWHVWSHUIRUPHGDFFRUGLQJWR
WKHSURFHGXUHGHWDLOHGLQ$SSHQGL[(
6FKHGXOH9LVLW


9LVLW'D\(QUROOPHQW
 3UHJQDQF\7HVW$SUHJQDQF\WHVWZLOOEHUHTXLUHGRIDOO IHPDOHVRIFKLOGEHDULQJSRWHQWLDO
SULRUWRHQUROOPHQW 
 9LWDO6LJQV7KHSDWLHQW¶VYLWDOVLJQVZLOOEHUHFRUGHGSXOVHEORRGSUHVVXUHWHPSHUDWXUHDQG
UHVSLUDWLRQUDWH
%6$$VVHVVPHQW%6$FRYHUHGZLWKDWRSLFGHUPDWLWLVZLOOEHDVVHVVHGXVLQJLQVWUXFWLRQVLQ
$SSHQGL[$
  'HUPDWRORJLFDO $VVHVVPHQW  &OLQLFDO VLJQV DQG V\PSWRPV RI $' ZLOO EH HYDOXDWHG E\ WKH
,QYHVWLJDWRUEDVHGRQWKHIROORZLQJ
·
($6,6FRUH$SSHQGL[%
·
,*$6FRUH$SSHQGL[& 
·
$SSOLFDWLRQ6LWH5HDFWLRQV$SSHQGL['
 &RQFRPLWDQW0HGLFDWLRQ5HYLHZZLWKWKHSDWLHQWDQGSDUHQWOHJDOJXDUGLDQWKHSDWLHQW¶VXVH
RIQHZRUFKDQJHLQRQJRLQJFRQFRPLWDQWPHGLFDWLRQVLQFH9LVLW
 &RQILUP
,QFOXVLRQ([FOXVLRQ
0HW
&RQILUP
WKH
SDWLHQW
FRQWLQXHV
WR
PHHW
DOO
LQFOXVLRQH[FOXVLRQFULWHULDLQFOXGLQJUHVXOWVRIWKH&RUWLVRO5HVSRQVH7HVWDQGDQ\FKDQJHVLQ
KHDOWKVWDWXV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



 'LVSHQVH6WXG\GUXJ,ISDWLHQWLVHOLJLEOHWRHQUROOUHFRUGWKHZHLJKWRIRQHERWWOHRIVWXG\GUXJ
DQGGLVSHQVHZLWKLQVWUXFWLRQV
 $SSO\6WXG\0HGLFDWLRQ7KHILUVWGRVHRIVWXG\PHGLFDWLRQVKRXOGEHDGPLQLVWHUHGE\WKH
SDWLHQW\HDUVRIDJHRUSDUHQWOHJDOJXDUGLDQDWWKHVLWHXQGHUVWDIIVXSHUYLVLRQ
 3URYLGH'RVLQJ'LDU\3URYLGH'LDU\DQGLQVWUXFWSDUHQWOHJDOJXDUGLDQUHJDUGLQJKRZLWLVWREH
ILOOHGRXWDQGKRZVWXG\GUXJLVWREHXVHG
'LVSHQVH6XQVFUHHQ)RUXVHRQO\ZKHQVXQH[SRVXUHFDQQRWEHDYRLGHG
3URYLGH3DWLHQW:ULVWEDQG(DFKSDWLHQWZLOOUHFHLYHDZULVWEDQGWRLQGLFDWHWKDWWKHSDWLHQWLV
XVLQJDPHGLFDWLRQWKDWKDVWKHSRWHQWLDOWRFDXVH+3$D[LVVXSSUHVVLRQ
6FKHGXOH9LVLW 


9LVLW'D\,QWHULP9LVLW
  3UHJQDQF\7HVW$SUHJQDQF\WHVWZLOOEHUHTXLUHGRIDOOIHPDOHVRIFKLOGEHDULQJSRWHQWLDO
SULRUWRHQUROOPHQW 
 9LWDO6LJQV7KHSDWLHQW¶VYLWDOVLJQVZLOOEHUHFRUGHGSXOVHEORRGSUHVVXUHWHPSHUDWXUHDQG
UHVSLUDWLRQUDWH 
%6$$VVHVVPHQW%6$FRYHUHGZLWKDWRSLFGHUPDWLWLVZLOOEHDVVHVVHGXVLQJLQVWUXFWLRQVLQ
$SSHQGL[$
.   'HUPDWRORJLFDO $VVHVVPHQW  &OLQLFDO VLJQV DQG V\PSWRPV RI $' ZLOO EH HYDOXDWHG E\ WKH
,QYHVWLJDWRUEDVHGRQWKHIROORZLQJ
·
($6,6FRUH$SSHQGL[%
·
,*$6FRUH$SSHQGL[& 
·
$SSOLFDWLRQ6LWH5HDFWLRQV$SSHQGL['
&RQFRPLWDQW0HGLFDWLRQ5HYLHZZLWKWKHSDWLHQWDQGSDUHQWOHJDOJXDUGLDQWKHSDWLHQW¶VXVH
RIQHZRUFKDQJHLQRQJRLQJFRQFRPLWDQWPHGLFDWLRQVLQFH9LVLW
$GYHUVH(YHQWV3DWLHQWVZLOOEHTXHVWLRQHGDERXWDQ\KHDOWKVWDWXVFKDQJHVDGYHUVHHYHQWVVLQFH
ODVWYLVLW$OOHYHQWVZLOOEHUHFRUGHG
 (YDOXDWLRQRI3DWLHQW&RPSOLDQFHWRWKH3URWRFRO&ROOHFWDQGUHYLHZSDWLHQW¶VGRVLQJGLDU\IRU
FRPSOLDQFH DQG SURYLGH D QHZ GLDU\ 1RQFRPSOLDQFH ZLWK GRVLQJ GRHV QRW ZDUUDQW GLVPLVVDO
IURP WKH VWXG\ &RXQVHO QRQFRPSOLDQW SDWLHQWV DQG SDUHQWVOHJDO JXDUGLDQV RQ GRVLQJ
UHTXLUHPHQWVRIWKHVWXG\
 &ROOHFW6WXG\'UXJ7KHXVHGERWWOHRIVWXG\GUXJZLOOEHFROOHFWHGDQGWKHZHLJKWUHFRUGHG
 'LVSHQVH6WXG\GUXJ,ISDWLHQWFRQWLQXHVLQWKHVWXG\UHFRUGZHLJKWRIRQHERWWOHRIVWXG\
GUXJDQGGLVSHQVH
3URYLGH'RVLQJ'LDU\,ISDWLHQWFRQWLQXHVLQWKHVWXG\SURYLGHDQHZGRVLQJGLDU\,QVWUXFW
SDUHQWVOHJDOJXDUGLDQVQRWWRDSSO\GRVHWRSDWLHQWZLWKLQDSSUR[LPDWHO\KRXUVRI9LVLW


&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




9LVLW'D\(QGRI6WXG\RU(DUO\7HUPLQDWLRQ%HIRUHSP
 9LWDO6LJQV7KHSDWLHQW¶VYLWDOVLJQVZLOOEHUHFRUGHGSXOVHEORRGSUHVVXUHWHPSHUDWXUHDQG
UHVSLUDWLRQUDWH
 3UHJQDQF\7HVW$SUHJQDQF\WHVWZLOOEHUHTXLUHGRIDOOIHPDOHVRIFKLOGEHDULQJSRWHQWLDOSULRU
WRHQUROOPHQW
 3K\VLFDO([DP$JHQHUDOSK\VLFDOH[DPZLOOEHFRQGXFWHG
%6$$VVHVVPHQW%6$FRYHUHGZLWKDWRSLFGHUPDWLWLVZLOOEHDVVHVVHGXVLQJLQVWUXFWLRQVLQ
$SSHQGL[$
5.   'HUPDWRORJLFDO $VVHVVPHQW  &OLQLFDO VLJQV DQG V\PSWRPV RI $' ZLOO EH HYDOXDWHG E\ WKH
,QYHVWLJDWRUEDVHGRQWKHIROORZLQJ
·
($6,6FRUH$SSHQGL[%
·
,*$6FRUH$SSHQGL[& 
·
$SSOLFDWLRQ6LWH5HDFWLRQV$SSHQGL['
&RQFRPLWDQW0HGLFDWLRQ5HYLHZZLWKWKHSDWLHQWDQGSDUHQWOHJDOJXDUGLDQWKHSDWLHQW¶VXVH
RIQHZRUFKDQJHLQRQJRLQJFRQFRPLWDQWPHGLFDWLRQVLQFH9LVLW
$GYHUVH(YHQWV3DWLHQWVZLOOEHTXHVWLRQHGDERXWDQ\KHDOWKVWDWXVFKDQJHVDGYHUVHHYHQWVVLQFH
ODVWYLVLW$OOHYHQWVZLOOEHUHFRUGHG
 (YDOXDWLRQRI3DWLHQW&RPSOLDQFHWRWKH3URWRFRO&ROOHFWDQGUHYLHZSDWLHQW¶VGRVLQJGLDU\
IRUFRPSOLDQFH1RQFRPSOLDQFHZLWKGRVLQJGRHVQRWZDUUDQWGLVPLVVDOIURPWKHVWXG\
 &ROOHFW6WXG\'UXJ7KHXVHGERWWOHRIVWXG\GUXJZLOOEHFROOHFWHGDQGWKHZHLJKWUHFRUGHG
/DERUDWRU\ (YDOXDWLRQV  $ EORRG VDPSOH ZLOO EH FROOHFWHG IRU KHPDWRORJ\ DQG FOLQLFDO
FKHPLVWU\WHVWLQJ6HH$SSHQGL[*
&RUWLVRO5HVSRQVH7HVW$OOSDWLHQWVZLOOKDYHDFRUWLVROUHVSRQVHWHVWSHUIRUPHGDFFRUGLQJWR
WKHSURFHGXUHGHWDLOHGLQ$SSHQGL[(

9LVLW'D\)ROORZXS3KRQH&DOO
$ SKRQH FDOO ZLOO EH FRQGXFWHG DSSUR[LPDWHO\  GD\V DIWHU WKH VXEMHFW KDV FRPSOHWHG GRVLQJ WR
IROORZXSRQDQ\QHZDGYHUVHHYHQWVWKDWPD\KDYHRFFXUUHG

6WXG\3URFHGXUHV

,QIRUPHG&RQVHQW
1RSDWLHQWZLOOEHHQWHUHGLQWRWKHVWXG\ZLWKRXWUHDGLQJXQGHUVWDQGLQJDQGVLJQLQJDQLQIRUPHG
FRQVHQW )RU LOOLWHUDWH SDWLHQWV YHUEDO FRQVHQW VKRXOG EH REWDLQHG LQ WKH SUHVHQFH RI DQG EH
FRXQWHUVLJQHGE\DOLWHUDWHZLWQHVV,IDQ\RWKHUODQJXDJHLVUHTXLUHGWUDQVODWLRQZLOOEHSHUIRUPHGE\
DFHUWLILHGWUDQVODWRU)RUSDWLHQWVXQGHUWKHDJHRIPDMRULW\LQWKHVWDWHWKHVWXG\LVEHLQJFRQGXFWHG
\HDUVLQPRVWVWDWHVWKHSDUHQWRUOHJDOJXDUGLDQVKRXOGVLJQWKHFRQVHQWIRUPDQGIRUSDWLHQWV
\HDUVRIDJHRUROGHUDQDVVHQWIRUPZLOODOVREHUHTXLUHG7KHFKLOGZLOOEHUHTXLUHGWRVLJQDSDWLHQW
³DVVHQW´IRUPWKDWZLOOEHZULWWHQLQVXFKDZD\DVWREHXQGHUVWDQGDEOHWRDFKLOG3DWLHQWVDJH
\HDUVRIDJHZLOOSURYLGHYHUEDODVVHQWWRSDUWLFLSDWH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




'HPRJUDSKLFV
$WVFUHHQLQJHDFKSDWLHQWVKDOOEHUHTXLUHGWRSURYLGHEDVLFGHPRJUDSKLFLQIRUPDWLRQGDWHRIELUWK
JHQGHUHWKQLFLW\DQGUDFH

0HGLFDO+LVWRU\
$W9LVLWSDWLHQWVZLOOEHTXHVWLRQHGDERXWPHGLFDOKLVWRU\LQFOXGLQJDFXWHDQGFKURQLFPHGLFDO
KLVWRU\DQGPHGLFDOKLVWRU\UHOHYDQWWRWKHLUDWRSLFGHUPDWLWLVDVZHOODVDOOPHGLFDWLRQXVHZLWKLQWKH
SDVWZHHNV
 9LWDO6LJQV
7KHSDWLHQW¶VYLWDOVLJQVZLOOEHUHFRUGHGKHDUWUDWHEORRGSUHVVXUHWHPSHUDWXUHDQGUHVSLUDWLRQUDWH
DW9LVLWDQG

3K\VLFDO([DPDQG%RG\6XUIDFH$UHD%6$
$JHQHUDOSK\VLFDOH[DPZLOOEHFRQGXFWHGDW9LVLWDQG9LVLW$W9LVLWWKHSDWLHQW¶VKHLJKW
PHWHUVDQGZHLJKWNJZLOOEHPHDVXUHG7KHKHLJKWDQGZHLJKWZLOOEHUHFRUGHGDQGWKH%RG\
6XUIDFH$UHD%6$ZLOOEHFDOFXODWHGVHH$SSHQGL[$IRUFRQYHUVLRQVIURPLQFKHVDQGSRXQGVDV
DSSURSULDWH$W9LVLWDQGWKH%6$DIIHFWHGZLOOEHUHFRUGHGVHH$SSHQGL[$

'HUPDWRORJLFDO$VVHVVPHQW
$W9LVLWDYLVXDOLQVSHFWLRQWRFRQILUPDGLDJQRVLVRIPRGHUDWHWRVHYHUHDWRSLFGHUPDWLWLVZLOOEH
GRQH$WHDFKYLVLWDWRSLFGHUPDWLWLVZLOOEHDVVHVVHGDFFRUGLQJWRWKHIROORZLQJPHDVXUHV
·
,*$6FRUH$SSHQGL[&
·
6LJQVDQG6\PSWRPV$VVHVVPHQWVDQG($6,6FRUH$SSHQGL[%
·
$SSOLFDWLRQ6LWH5HDFWLRQV$SSHQGL['
3DWLHQWV ZLOO DOVR EH DVNHG WR UDWH WKH VHYHULW\ RI SUXULWXV RYHU WKH SUHYLRXV KRXUV XVLQJ VFDOH
SURYLGHGLQ$SSHQGL[%:KHQHYHUSRVVLEOHWKHVDPH,QYHVWLJDWRUVKRXOGSHUIRUPGHUPDWRORJLFDO
DVVHVVPHQWVIRUDJLYHQSDWLHQW

&RQFRPLWDQW0HGLFDWLRQ8VH
$W 9LVLWV  SDWLHQWV ZLOO EH TXHVWLRQHG DERXW FXUUHQW DQG FRQFRPLWDQW PHGLFDWLRQ XVH RYHU WKH
SUHYLRXV  ZHHNV  $W DOO ,QWHULP 9LVLWV SDWLHQWV ZLOO EH TXHVWLRQHG DERXW RQJRLQJ RU QHZ
FRQFRPLWDQWPHGLFDWLRQXVH

3UHJQDQF\7HVW
8ULQHSUHJQDQF\WHVWVRQIHPDOHVRIFKLOGEHDULQJSRWHQWLDOZLOOEHSHUIRUPHGDW9LVLWDQG
7KHWHVWPXVWEHQHJDWLYHIRUWKHSDWLHQWWREHHOLJLEOHIRULQFOXVLRQLQWKHVWXG\,IWKHSDWLHQWLVRI
QRQFKLOGEHDULQJSRWHQWLDOWKHVRXUFHGRFXPHQWPXVWOLVWWKHUHDVRQZK\VKHLVRIQRQFKLOGEHDULQJ
SRWHQWLDOHJSUHPHQDUFKDO
$Q\ SDWLHQW ZKR EHFRPHV SUHJQDQW GXULQJ WKH VWXG\ PXVW EH GLVFRQWLQXHG DQG (QG RI 6WXG\
SURFHGXUHVFRPSOHWHG7KHRXWFRPHRIWKHSUHJQDQF\ZLOOEHIROORZHGE\WKH,QYHVWLJDWRUWRELUWKRU
HDUO\WHUPLQDWLRQDVDSSURSULDWH7KHSUHJQDQF\ZLOOEHUHSRUWHGDVDQ$(

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




'LVSHQVLQJ6WXG\'UXJ
$W9LVLWSDWLHQWVWKDWVDWLVI\DOORIWKHLQFOXVLRQH[FOXVLRQFULWHULDZLOOEHGLVSHQVHGRQHERWWOHRIWKH
VWXG\GUXJDQGGRVLQJLQVWUXFWLRQV$W9LVLW'D\DQHZERWWOHRIVWXG\GUXJZLOOEHGLVSHQVHG
7KHZHLJKWRIWKHVWXG\GUXJSURGXFWVKRXOGEHUHFRUGHGEHIRUHGLVSHQVLQJ7KHSDWLHQWZLOOEH
LQVWUXFWHGWRDSSO\WKHILUVWGRVHRIVWXG\GUXJGXULQJ9LVLWXQGHUVWDIIVXSHUYLVLRQ
 &ROOHFWLQJ6WXG\'UXJ
6WXG\PHGLFDWLRQERWWOHVZLOOEHFROOHFWHGDQGZHLJKWHGDW9LVLWVDQG
 'RVLQJ,QVWUXFWLRQVDQG'LDU\
3DWLHQWV ZLOO EH SURYLGHG ZLWK D GLDU\ WR UHFRUG WKH WLPH DQG GDWH RI GRVLQJ RWKHU FRQFRPLWDQW
PHGLFDWLRQV DQG DGYHUVH HYHQWV  3DWLHQWV DSSO\LQJ IHZHU WKDQ  RU PRUH WKDQ  RI WKH
UHTXLUHG GRVHV ZLOO EH FRQVLGHUHG QRQFRPSOLDQW ZLWK GRVLQJ  &RPSOLDQFH ZLWK GRVLQJ ZLOO EH
YHULILHGE\WKHXVHRIWKHSDWLHQWGLDULHV
 'RVLQJ&RPSOLDQFH
'RVLQJFRPSOLDQFHZLOOEHFKHFNHGE\VLWHVWDIIDW9LVLWVDQG3DWLHQWVWDNLQJIHZHUWKDQRU
PRUHWKDQRIWKHVFKHGXOHGGRVHVZLOOEHFRQVLGHUHGQRQFRPSOLDQWZLWKGRVLQJ&RPSOLDQFH
ZLWKGRVLQJZLOOEHYHULILHGE\WKHXVHRIWKHSDWLHQWGLDULHV
 6WDQGDUG6XQVFUHHQDQG3DWLHQW:ULVWEDQG
$OOSDWLHQWVZLOOEHDGYLVHGWRDYRLGVXQH[SRVXUH$VWDQGDUGVXQVFUHHQZLOOEHSURYLGHGDW9LVLW
VKRXOGWKHXVHRIVXQVFUHHQEHZDUUDQWHG(DFKSDWLHQWZKRHQWHUVWKHVWXG\ZLOOEHSURYLGHGZLWKD
ZULVWEDQGDW9LVLWWRLGHQWLI\WKDWWKHSDWLHQWLVWDNLQJDPHGLFDWLRQWKDWFRXOGSRWHQWLDOO\FDXVH
+3$D[LVVXSSUHVVLRQ7KHSDWLHQWVKRXOGEHLQVWUXFWHGWRZHDUWKHZULVWEDQGIRUWKHGXUDWLRQRIWKH
VWXG\
 /DERUDWRU\(YDOXDWLRQ
$W9LVLWDQG9LVLWDEORRGVDPSOHZLOOEHFROOHFWHGIRUKHPDWRORJ\DQGFOLQLFDOFKHPLVWU\WHVWLQJ
6HH$SSHQGL[* 
 &RUWLVRO5HVSRQVH7HVW
$W 9LVLW  DQG 9LVLW  DOO SDWLHQWV ZLOO KDYH D FRUWLVRO UHVSRQVH WHVW SHUIRUPHG DFFRUGLQJ WR WKH
SURFHGXUH GHWDLOHG LQ $SSHQGL[ (  7KH UHVXOWLQJ EORRG VDPSOH VKRXOG EH VHQW WR $&0 *OREDO
/DERUDWRU\IRULPPHGLDWHWHVWLQJ
9LVLW7HVW
7KHUHVXOWVRIWKHFRUWLVROUHVSRQVHWHVWPXVWEHREWDLQHGEHIRUHVWXG\GUXJLVGLVSHQVHGDW9LVLW
2QO\SDWLHQWVZLWKQRUPDOEDVHOLQH9LVLWFRUWLVRODQGDGUHQDOIXQFWLRQ
VHH
FULWHULD
EHORZ
VKRXOGEHHQUROOHGLQWKHVWXG\
9LVLW7HVW
7KHWHVWDWWKH(QGRI6WXG\YLVLWVKRXOGQRWEHSHUIRUPHGLIWKHSDWLHQWGRVHGZLWKLQKRXUV
$SDWLHQWZLOOEHFRQVLGHUHGWRKDYHQRUPDOEDVDOFRUWLVROOHYHODQGDGUHQDOIXQFWLRQLIWKH\PHHWDOO
WKUHH FULWHULD OLVWHG EHORZ XQGHU 1RUPDO  )DLOXUH WR PHHW DQ\ RI WKHVH FULWHULD LV LQGLFDWLYH RI
DEQRUPDODGUHQDOIXQFWLRQRUSRWHQWLDO+3$D[LVVXSSUHVVLRQHYHQLQDEVHQFHRIUHODWHGV\PSWRPV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



HJQDXVHDKHDGDFKHP\DOJLDIDWLJXHRUORRVHVWRROLQFDVHRIDEQRUPDOUHVXOWVWKHSDWLHQWZLOOEH
PRQLWRUHGLQDFFRUGDQFHWRWKHIROORZXSVFKHGXOHEHORZ


&RUWLVRO5HVXOWV
1RUPDO
$EQRUPDO
%DVDO
SUH&RUWURV\Q70
LQMHFWLRQ
PFJPO
PFJPO
PLQXWHVSRVW
&RUWURV\Q70LQMHFWLRQ
EDVDOYDOXH
EDVDOYDOXH
!PFJPO
PFJPO

+3$$[LVVXSSUHVVLRQZLOOEHGHILQHGDVDPLQXWHSRVW&RUWURV\Q70LQMHFWLRQOHYHOFRUWLVROOHYHO
RIPFJPO$VWKHVWXG\WUHDWPHQWSHULRGZLOOEHRYHUDQ\SDWLHQWVZLWKUHVXOWVRI+3$D[LV
VXSSUHVVLRQZLOOEHDGYLVHGQRWWRLQLWLDWHDQ\QHZVWHURLGWKHUDS\WRSLFDORURWKHUZLVHDQGWRUHWXUQ
WRWKHVLWHLQGD\VDWZKLFKWLPHWKH\ZLOOEHDVVHVVHGIRU+3$D[LVVXSSUHVVLRQ
$Q\SDWLHQWSUHVHQWLQJZLWKV\PSWRPVRI+3$D[LVVXSSUHVVLRQVXFKDVQDXVHDKHDGDFKHP\DOJLD
IDWLJXH RU ORRVH VWRRO ZLOO EH UHIHUUHG WR DQ HQGRFULQRORJLVW $V DQ DGGLWLRQDO VDIHW\ SUHFDXWLRQ
ZULVWEDQGVLGHQWLI\LQJWKHSDWLHQWDVVRPHRQHVXIIHULQJIURPDGUHQDOVXSSUHVVLRQVHFRQGDU\WRVWHURLG
ZLWKGUDZDOZLOOEHSURYLGHGWRDOHUWPHGLFDOSHUVRQQHOVKRXOGDQ\HPHUJHQFLHVDULVHEHIRUHDGUHQDO
IXQFWLRQUHWXUQVWRQRUPDO
,I WKH UHVXOWV RI WKH FRUWLVRO UHVSRQVH WHVW VWLOO VKRZ VLJQV RI +3$ D[LV VXSSUHVVLRQ  GD\V DIWHU
GLVFRQWLQXLQJ WKHUDS\ WKH SDWLHQW ZLOO EH DVNHG WR UHWXUQ LQ  GD\V  GD\V DIWHU GLVFRQWLQXLQJ
VWHURLG WKHUDS\ IRU DQRWKHU IROORZXS WHVW ,I WKH SDWLHQW LV VWLOO VKRZLQJ VLJQV RI +3$ D[LV
VXSSUHVVLRQ  GD\V DIWHU GLVFRQWLQXLQJ VWHURLG WKHUDS\ DQG SUHVHQWV ZLWK UHODWHG V\PSWRPV WKH
SDWLHQWZLOOEHUHIHUUHGWRDQHQGRFULQRORJLVW
,I+3$D[LVVXSSUHVVLRQSHUVLVWVIRUGD\VDIWHUGLVFRQWLQXLQJVWHURLGWKHUDS\EXWWKHSDWLHQWKDVQR
V\PSWRPVWKH\ZLOOEHDVNHGWRUHWXUQLQGD\VGD\VDIWHUGLVFRQWLQXLQJVWHURLGWKHUDS\IRU
DQRWKHU IROORZXS WHVW ,I +3$ D[LV VXSSUHVVLRQ SHUVLVWV IRU  GD\V DIWHU GLVFRQWLQXLQJ VWHURLG
WKHUDS\WKHSDWLHQWZLOOEHUHIHUUHGWRDQHQGRFULQRORJLVWUHJDUGOHVVRIV\PSWRPV
3DWLHQWV VKRXOG QRW EH VXEMHFWHG WR &RUWURV\Q70 WHVWLQJ RU DQ\ RWKHU FKDOOHQJH WR WKHLU DGUHQDO
UHVSRQVHDQ\VRRQHUWKDQZHHNVIURPWKHLUODVW&RUWURV\Q70WHVW

)ROORZ8S6FKHGXOHIRU3DWLHQWVVKRZLQJVLJQVRI+3$$[LV6XSSUHVVLRQ
'D\V
DIWHUGF
+3$5HVXOWV
6\PSWRPV
3DWLHQW&RXUVH

1RUPDO
1$
6WXG\RYHU

$EQRUPDO
<HV
5HIHUWRHQGRFULQRORJLVW

$EQRUPDO
1R
5HSHDWWHVWLQGD\V

1RUPDO
1$
6WXG\RYHU

$EQRUPDO
<HV
5HIHUWRHQGRFULQRORJLVW

$EQRUPDO
1R
5HSHDWWHVWLQGD\V

1RUPDO
1$
6WXG\RYHU

$EQRUPDO
<HVRU1R
5HIHUWRDQHQGRFULQRORJLVW


&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




$GYHUVH(YHQWV
7KHSDWLHQWVZLOOEHPRQLWRUHGWKURXJKRXWWKHVWXG\IRUDQ\$GYHUVH(YHQWV$(VZLOOEHFROOHFWHG
WKURXJK ERWK VROLFLWHG DQG XQVROLFLWHG PHDQV DQG VXEVHTXHQWO\ FRGHG LQ WDEXODU IRUP XVLQJ WKH
0HG'5$9HUVLRQRUKLJKHU$GYHUVH(YHQW'LFWLRQDU\7KHSDWLHQWVZLOOEHHQFRXUDJHGWRUHSRUW
VLJQVV\PSWRPVDQGDQ\FKDQJHVLQKHDOWKWRWKHFOLQLFVWDII6HYHULW\RIHDFK$(ZLOOEHGHWHUPLQHG
E\ WKH VWDII EDVHG RQ REVHUYDWLRQ DQG TXHVWLRQLQJ RI WKH SDWLHQWV  7KH ,QYHVWLJDWRU ZLOO MXGJH WKH
UHODWLRQVKLSRIWKHHYHQWWRWKHVWXG\WUHDWPHQWV$GYHUVHHYHQWVVKRXOGEHIROORZHGXSXQWLOWKH\KDYH
UHVROYHGRUVWDELOL]HG

$GYHUVH(YHQW'HILQLWLRQV
$GYHUVH (YHQW $Q\ XQWRZDUG PHGLFDO RFFXUUHQFH LQ D SDWLHQW RU FOLQLFDO LQYHVWLJDWLRQ SDWLHQW
DGPLQLVWHUHGDSKDUPDFHXWLFDOSURGXFWDQGZKLFKGRHVQRWQHFHVVDULO\KDYHDFDXVDOUHODWLRQVKLSZLWK
WUHDWPHQW $Q $( FDQ WKHUHIRUH EH DQ\ XQIDYRUDEOH DQG XQLQWHQGHG VLJQ V\PSWRP RU GLVHDVH
WHPSRUDOO\DVVRFLDWHGZLWKWKHXVHRIDPHGLFLQDOLQYHVWLJDWLRQDOSURGXFWZKHWKHURUQRWUHODWHGWR
WKLVSURGXFW7KLVLQFOXGHVHYHQWVQRWVHHQDWEDVHOLQHRUZRUVHQHGHYHQLISUHVHQWDWEDVHOLQH
8QH[SHFWHG$GYHUVH(YHQW$QDGYHUVHHYHQWZKHUHWKHQDWXUHRUVHYHULW\RILVQRWFRQVLVWHQWZLWK
WKHDSSOLFDEOHSURGXFWLQIRUPDWLRQHJ,QYHVWLJDWRU¶V%URFKXUHIRUDQXQDSSURYHGLQYHVWLJDWLRQDO
SURGXFWRUSDFNDJHLQVHUWVXPPDU\RISURGXFWFKDUDFWHULVWLFVIRUDQDSSURYHGSURGXFW
$GYHUVH'UXJ5HDFWLRQ$OOQR[LRXVDQGXQLQWHQGHGUHVSRQVHVWRDPHGLFDOSURGXFWUHODWHGWRDQ\
GRVHVKRXOGEHFRQVLGHUHGDGYHUVHGUXJUHDFWLRQV7KHUHVSRQVHWRDµPHGLFDOSURGXFW¶PHDQVWKDWD
FDXVDO UHODWLRQVKLS EHWZHHQ D PHGLFLQDO SURGXFW DQG DQ DGYHUVH HYHQW LV DW OHDVW D UHDVRQDEOH
SRVVLELOLW\LHWKHUHODWLRQVKLSFDQQRWEHUXOHGRXW
 6HYHULW\RI$GYHUVH(YHQW
7KHVHYHULW\RIWKHDGYHUVHHYHQWZLOOEHJUDGHGE\WKH,QYHVWLJDWRUXVLQJWKHIROORZLQJFULWHULDDV
JXLGHOLQHV
·
0,/'$ZDUHQHVVRIV\PSWRPEXWGRHVQRWLQWHUIHUHZLWKURXWLQHDFWLYLWLHV
·
02'(5$7('LVFRPIRUWVXIILFLHQWWRLQWHUIHUHZLWKURXWLQHDFWLYLWLHV
·
6(9(5(,PSRVVLEOHWRSHUIRUPURXWLQHDFWLYLWLHV
 5HODWLRQVKLSRI$GYHUVH(YHQW
5HODWLRQVKLSWRWKH6WXG\3URGXFW
·
1275(/$7('$Q\$(WKDWLVFOHDUO\QRWUHODWHGWRXVHRIWKHVWXG\GUXJ
·
3266,%/( 7KH DVVRFLDWLRQ RI WKH $( ZLWK WKH VWXG\ GUXJ LV XQNQRZQ KRZHYHU D
UHODWLRQVKLSEHWZHHQWKHGUXJDQGHYHQWFDQQRWEHUXOHGRXW
·
352%$%/(7KHUHLVUHDVRQDEOHWHPSRUDOUHODWLRQVKLSEHWZHHQWKHXVHRIWKHVWXG\GUXJ
DQGWKH$(%DVHGXSRQWKH,QYHVWLJDWRU¶VFOLQLFDOH[SHULHQFHWKHDVVRFLDWLRQRIWKHHYHQW
ZLWKWKHVWXG\GUXJVHHPVOLNHO\
·
'(),1,7(7KH$(RFFXUVIROORZLQJWKHDSSOLFDWLRQRIWKHVWXG\GUXJDQGLWFDQQRWEH
UHDVRQDEO\ H[SODLQHG E\ DQ\ RWKHU NQRZQ FKDUDFWHULVWLFV RI WKH SDWLHQW¶V FOLQLFDO VWDWH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



HQYLURQPHQWDORUWR[LFIDFWRUVRURWKHUPRGHVRIWUHDWPHQWDGPLQLVWHUHGWRWKHSDWLHQW,W
GLVDSSHDUVRUGHFUHDVHVXSRQGLVFRQWLQXDWLRQRIWKHVWXG\PHGLFDWLRQDQGUHDSSHDUVRQD
UHFKDOOHQJHRIWKHVWXG\GUXJ
3DWLHQW¶V3DUWLFLSDWLRQ6WRSSLQJ&ULWHULD
,QWKHRSLQLRQRIWKH,QYHVWLJDWRULIWKHSDWLHQWVXIIHUVDQ$(WKDWZDUUDQWVGLVFRQWLQXDWLRQRIWKHVWXG\
GUXJ GXH WR LQWHUIHUHQFH ZLWK DJHDSSURSULDWH LQVWUXPHQWDO $'/ $FWLYLWLHV RI 'DLO\ /LYLQJ IRU
H[DPSOHSUHSDULQJIRUPHDOVKRSSLQJIRUJURFHULHVRUFORWKLQJXVLQJWKHWHOHSKRQHHWFWKHSDWLHQWZLOO
EHIROORZHGXQWLOWKH$(UHVROYHVRULVFRQVLGHUHGVWDEOH$Q\VXEMHFWWKDWGLVFRQWLQXHVWKHVWXG\GXHWR
DQDGYHUVHHYHQWZLOOEHIROORZHGXQWLOUHVROXWLRQRUVWDELOL]DWLRQRIWKHDGYHUVHHYHQW

6HULRXV$GYHUVH(YHQWV

'HILQLWLRQRID6HULRXV$GYHUVH(YHQW
$6HULRXV$GYHUVH(YHQW6$(LVDQ\XQWRZDUGPHGLFDORFFXUUHQFHWKDWDWDQ\GRVHVXJJHVWVD
PHGLFDOO\VLJQLILFDQWKD]DUGLQFOXGLQJDQ\HYHQWWKDW
·
5HVXOWVLQGHDWK±LQFOXGHVDOOGHDWKVHYHQWKRVHWKDWDSSHDUWREHFRPSOHWHO\XQUHODWHGWR
VWXG\WUHDWPHQWHJFDUDFFLGHQWZKHUHSDWLHQWLVDSDVVHQJHU
·
,VOLIH±WKUHDWHQLQJ±LQWKHYLHZRIWKH,QYHVWLJDWRUWKHSDWLHQWLVDWLPPHGLDWHULVNRIGHDWKDW
WKHWLPHRIWKHHYHQW
·
5HVXOWV LQ SHUVLVWHQW RU VLJQLILFDQW GLVDELOLW\ RU LQFDSDFLW\ VXEVWDQWLDO GLVUXSWLRQ RI RQH¶V
DELOLW\WRFRQGXFWQRUPDOOLIH
·
5HTXLUHVLQSDWLHQWKRVSLWDOL]DWLRQRUSURORQJDWLRQRIH[LVWLQJKRVSLWDOL]DWLRQ
·
&DXVHVFRQJHQLWDODQRPDO\RUELUWKGHIHFW
·
,VDQLPSRUWDQWPHGLFDOHYHQWWKDWPD\QRWEHLPPHGLDWHO\OLIHWKUHDWHQLQJRUUHVXOWLQGHDWK
RU KRVSLWDOL]DWLRQ EXW PD\ MHRSDUGL]H WKH SDWLHQW RU PD\ UHTXLUH PHGLFDO RU VXUJLFDO
LQWHUYHQWLRQWRSUHYHQWRQHRIWKHVHULRXVRXWFRPHVOLVWHGDERYHHJLQWHQVLYHWUHDWPHQWLQ
DQ HPHUJHQF\ URRP FRQYXOVLRQV WKDW GR QRW UHVXOW LQ KRVSLWDOL]DWLRQV (PHUJHQF\ 5RRP
YLVLWV WKDW UHTXLUH PHGLFDO RU VXUJLFDO LQWHUYHQWLRQ WR SUHYHQW RQH RI WKH RWKHU VHULRXV
RXWFRPHVOLVWHGDERYHDUHFRQVLGHUHGD6HULRXV$GYHUVH(YHQW
 5HSRUWLQJ6HULRXV$GYHUVH(YHQWV
,QYHVWLJDWRU5HSRUWLQJRI6$(V
$GYHUVHHYHQWVZKLFKDUHHYDOXDWHGE\WKH,QYHVWLJDWRUDV6HULRXVZLOOEHUHSRUWHGWRWKH6SRQVRU
DQG,5%ZLWKLQKRXUVRIQRWLFHZKHWKHURUQRWWKH\DUHFRQVLGHUHGH[SHFWHGRUGUXJUHODWHG$OO
6$(VZLOOEHUHSRUWHGDVSHUDSSOLFDEOHUHJXODWLRQV$OO6$(VHQFRXQWHUHGGXULQJWKHVWXG\ZLOOEH
UHSRUWHGRQWKHDSSURSULDWHIRUPDQGVXPPDUL]HGLQWKHILQDOUHSRUW
$Q\ VHULRXV RU XQH[SHFWHG DGYHUVH HYHQWV VKRXOG EH UHSRUWHG WR 1RYXP ZLWKLQ  KRXUV
)ROORZLQJLVWKHFRQWDFWLQIRUPDWLRQ
*DLO*RQJDV
9LFH3UHVLGHQW&OLQLFDO7ULDOV

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



&HOO3KRQH
3KRQH[
)D[
2U
3DROR)DQ]LR0'

0HGLFDO0RQLWRU

3KRQH[
)D[
1RYXPZLOOUHSRUWDQ\6HULRXV$GYHUVH(YHQWWR7DUR
'RFXPHQWDWLRQVKRXOGEHVHQWWR7DUR¶V6$(&RRUGLQDWRUDQG7DUR¶V'UXJ6DIHW\'HSDUWPHQWOLVWHG
EHORZ
7DUR6$(&RRUGLQDWRU
7DUR'UXJ6DIHW\
'DQLHOOH6LPSVRQ
&RRUGLQDWRU&OLQLFDO2SHUDWLRQ
7DUR3KDUPDFHXWLFDOV86$,QF
7HOH[W
(PDLOGDQLHOOHVLPSVRQ#WDURFRP
0DUJR:\DWW51%61
$VVRFLDWH'LUHFWRU'UXJ6DIHW\
7DUR3KDUPDFHXWLFDOV86$,QF
6N\OLQH'ULYH+DZWKRUQH1<
([W
(PDLO0DUJR:\DWW#WDURFRP
DQG7$523986#7$52FRP
,QYHVWLJDWRUVZLOOEHLQIRUPHGRIDQ\6$(VUHSRUWHGDWRWKHUVWXG\VLWHVZLWKLQGD\VIURPWKHLQLWLDO
UHSRUW

67$7,67,&$/0(7+2'6

6WDWLVWLFDO3ODQ
$6WDWLVWLFDO$QDO\VLV3ODQ6$3GHWDLOLQJWKHLQWHQGHGVWDWLVWLFDODQDO\VLVRIWKHVWXG\GDWDZLOOEH
SUHSDUHGDVDVHSDUDWHGRFXPHQWDQGILQDOL]HGSULRUWRGDWDEDVHORFN$Q\GHYLDWLRQIURPWKHRULJLQDO
VWDWLVWLFDOSODQZLOOEHGHVFULEHGDQGMXVWLILHGLQWKHILQDOUHSRUWDVDSSURSULDWH7KHSURFHGXUHIRU
DFFRXQWLQJIRUPLVVLQJXQXVHGDQGVSXULRXVGDWDZLOOEHLQFOXGHGLQWKH6WDWLVWLFDO$QDO\VLV3ODQ
$OOVWDWLVWLFDODQDO\VLVZLOOEHFRQGXFWHGXVLQJ6$69HUVLRQRUKLJKHU
 'HWHUPLQDWLRQRI6DPSOH6L]H
7KHVDPSOHVL]HRISDWLHQWVVWUDWLILHGE\DJHDQG%6$ZDVEDVHGRQUHFRPPHQGDWLRQVRIWKH
)'$LQ,1'*XLGDQFH0HHWLQJWKDWWRRNSODFHRQDQG)'$$GYLFH/HWWHUGDWHG
5HIHUHQFH,'
 %DVHOLQH&RPSDUDELOLW\
%DVHOLQHFRPSDUDELOLW\RIWKHWZRJURXSVZLOOEHDVVHVVHGXVLQJDSSURSULDWHVWDWLVWLFDOWHVWVHJRQH
ZD\ DQDO\VLV RI YDULDQFH)LVKHU¶V H[DFW WHVW &RFKUDQ0DQWHO+DHQV]HO WHVW 7KH JURXSV ZLOO EH
FRPSDUHG IRU EDVLF GHPRJUDSKLFV DJH JHQGHU HWKQLFLW\ DQG UDFH EDVHOLQH ,*$ EDVHOLQH ($6,
VFRUHDQGEDVHOLQHWRWDO%6$6XPPDU\WDEOHVE\JURXSZLOOEHSUHVHQWHG
 6DIHW\$QDO\VLVRI3RWHQWLDO+3$$[LV6XSSUHVVLRQ
'RVLQJZLOOEHWZLFHDGD\IRUGD\VH[FOXGLQJWKHGRVHVSULRUWRWKH&RUWLVRO5HVSRQVH7HVW
DSSOLFDWLRQV$OOSDWLHQWVZKRDUHHQUROOHGXVHDWOHDVWGRVHVRIWKHVWXG\GUXJDQGKDYHGDWD

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



IURPDSRVWWUHDWPHQWFRUWLVROUHVSRQVHWHVWZLOOEHLQFOXGHGLQWKHDQDO\VLV3DWLHQWVZKRKDYHQRW
XVHGGRVHVRIWKHVWXG\GUXJZLOOEHH[FOXGHGIURPWKHSULPDU\DQDO\VLVRI+3$D[LVVXSSUHVVLRQ

7KHSULPDU\DQDO\VLVRILQWHUHVWLVWKHSURSRUWLRQRISDWLHQWVLQHDFKJURXSZKRDUHFRQVLGHUHGWR
KDYHGHPRQVWUDWHGSRVVLEOH+3$D[LVVXSSUHVVLRQIROORZLQJWUHDWPHQWZLWKWKHVWXG\PHGLFDWLRQ
$ORJLVWLFUHJUHVVLRQRIWKHSURSRUWLRQRISDWLHQWVLQWKHVWXG\ZLWK+3$D[LVVXSSUHVVLRQPD\EH
SHUIRUPHGDVH[SORUDWRU\DQDO\VLVZLWK%6$DIIHFWHGDVDFRYDULDWH7KLVZLOOGHSHQGRQWKH
GLVWULEXWLRQRIWKH%6$GDWDFROOHFWHG6HH$SSHQGL[(IRUUHVXOWVIURPWKHFRUWLVROUHVSRQVHWHVW
FRQVLGHUHGLQGLFDWLYHRISRWHQWLDO+3$D[LVVXSSUHVVLRQ

7KHVWXG\ZLOOEHHQUROOHGE\&RKRUWVWDUWLQJZLWK&RKRUWDQGHDFKFRKRUWZLOOEHUHYLHZHGIRUWKH
SRWHQWLDORI+3$D[LVVXSSUHVVLRQ,IDWOHDVWRISDWLHQWVLQ&RKRUWH[SHULHQFH+3$D[LV
VXSSUHVVLRQRQFHWKHPLQLPXPQXPEHURISDWLHQWVKDVEHHQHQUROOHGDQGFRPSOHWHGWKHFRKRUW
HQUROOPHQWIRUWKDWFRKRUWZLOOEHVWRSSHGDQGQRIXUWKHUFRKRUWVZLOOEHLQLWLDWHG,IDWOHDVWRI
SDWLHQWVKDYHH[SHULHQFHG+3$D[LVVXSSUHVVLRQDFURVVFRKRUWVFRPELQHGGXULQJWKHVWXG\
HQUROOPHQWZLOOEHGLVFRQWLQXHGDQGQRRWKHUFRKRUWVZLOOEHLQLWLDWHG&RKRUWZLOOQRWEHJLQXQWLO
VDIHW\GDWDKDVEHHQUHYLHZHGIRU&RKRUW7KHVDPHSURFHVVZLOOEHIROORZHGIRUHDFK&RKRUWXQWLO
WKHVWXG\LVFRPSOHWH

)RUDOOSDWLHQWVWKHDFWXDODPRXQWRIGHVR[LPHWDVRQHPJDSSOLHGGXULQJWKHVWXG\ZLOOEH
FDOFXODWHGIURPUHFRUGHGERWWOHZHLJKWVDQGSUHVHQWHG


6DIHW\$QDO\VLV
6DIHW\DQDO\VLVZLOOEHFRQGXFWHGRQDOOSDWLHQWVZKRDSSOLHGDWOHDVWRQHGRVHRIVWXG\GUXJ
$GYHUVHPHGLFDOHYHQWVH[SHULHQFHGE\WKHSDWLHQWVZLOOEHWDEXODWHG7KHUHODWLRQVKLSRI$(VLI
DQ\WRWKHVWXG\GUXJZLOOEHDVVHVVHGE\WKH,QYHVWLJDWRU$GYHUVHHYHQWVDVVHVVHGDVGHILQLWH
SUREDEOH SRVVLEOH RU QRW UHODWHG WR WKH VWXG\ GUXJ ZLOO EH SUHVHQWHG 6KLIW DQDO\VLV XVLQJ WKH
FDWHJRULHVEHORZDERYHDQGZLWKLQWKHODERUDWRU\QRUPDOUDQJHZLOOEHSHUIRUPHGWRLGHQWLI\DQ\
VSHFLILFODERUDWRU\SDUDPHWHUWKDWVKRZVDWUHQGWRZDUGSRWHQWLDOO\FOLQLFDOO\VLJQLILFDQWFKDQJHV


5(*8/$725<2%/,*$7,216

,QVWLWXWLRQDO5HYLHZ%RDUG
7KH VWXG\ SURWRFRO LQIRUPHG FRQVHQWDVVHQW IRUP ,QYHVWLJDWRU
V %URFKXUH RU SDFNDJH LQVHUW DV
DSSOLFDEOH DQG DQ\ VSHFLILF DGYHUWLVLQJ ZLOO EH VXEPLWWHG WR DQG DSSURYHG E\ DQ ,QVWLWXWLRQDO
5HYLHZ %RDUG ,5% EHIRUH WKH VWDUW RI WKH VWXG\ $ IRUP PXVW EH VLJQHG E\ WKH FKDLUPDQ RU
GHVLJQHH RI WKH ,5% QRWLQJ WKH DSSURYDOV 7KLV QRWLILFDWLRQ RI WKHERDUG
V DSSURYDO DORQJ ZLWK D
GHVFULSWLRQE\SURIHVVLRQDQGJHQGHURIWKHERDUG
VFRPSRVLWLRQZLOOEHSURYLGHGWRWKH6SRQVRU

6WXG\'RFXPHQWDWLRQ
7KLVVWXG\ZLOOEHFRQGXFWHGLQFRPSOLDQFHZLWKWKHSURWRFRO*RRG&OLQLFDO3UDFWLFHV*&3VDQG
DOODSSOLFDEOHUHJXODWLRQVLQFOXGLQJWKH)HGHUDO)RRG'UXJDQG&RVPHWLFV$FW86DSSOLFDEOH&RGH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



RI)HGHUDO5HJXODWLRQVWLWOHSDUWVDQGDQ\,5%UHTXLUHPHQWVUHODWLYHWRFOLQLFDO
VWXGLHV DQG WKH 'HFODUDWLRQ RI +HOVLQNL -XQH  DV PRGLILHG E\ WKH WK :RUOG 0HGLFDO
$VVRFLDWLRQ*HQHUDO$VVHPEO\2FWREHU
7KH,QYHVWLJDWRUZLOOSHUPLWWULDOUHODWHGPRQLWRULQJDXGLWV,5%UHYLHZDQGUHJXODWRU\LQVSHFWLRQV
SURYLGLQJGLUHFWDFFHVVWRVRXUFHGDWDGRFXPHQWV
 3URWRFRO
7KH,QYHVWLJDWRULQGLFDWHGRQ)'$)RUPZLOODFWDVWKH3ULQFLSDO,QYHVWLJDWRUDWHDFKVWXG\
VLWH3URWRFROVZLOOEHQRWHGDVDSSURYHGE\SODFHPHQWRIWKH1RYXP5HSUHVHQWDWLYH¶VVLJQDWXUHRQ
WKH FRYHU SDJH 7KH 6SRQVRU RI WKH VWXG\ ZLOO DOVR DSSURYH WKH SURWRFRO E\ KDYLQJ D VWXG\
UHVSRQVLEOHLQGLYLGXDOVLJQWKHSURWRFROFRYHUSDJH
 ,QIRUPHG&RQVHQW
$Q,QIRUPHG&RQVHQW)RUP,&)WKDWLQFOXGHVDOORIWKHUHOHYDQWHOHPHQWVFXUUHQWO\UHTXLUHGE\
)'$DQGORFDO6WDWHUHJXODWLRQVZLOOEHSURYLGHGWRHDFKSURVSHFWLYHVWXG\SDWLHQWEHIRUHHQUROOPHQW
LQWRWKHVWXG\,QDGGLWLRQVXEMHFWV\HDUVRIDJHZLOOEHSUHVHQWHGZLWKDQ$VVHQW)RUP7KH
W\SH DQG PHWKRG RI VWXG\ WHVWV WR EH DGPLQLVWHUHG DQ\ SRWHQWLDO RU SRVVLEOH KD]DUGV DQG WKH
SDWLHQW
V ULJKW WR ZLWKGUDZ IURP WKH VWXG\ DW DQ\ WLPH ZLOO EH H[SODLQHG WR WKH SDWLHQWV E\ WKH
,QYHVWLJDWRURUGHVLJQHH2QFHWKH,QYHVWLJDWRURUGHVLJQHHLVDVVXUHGWKDWDQLQGLYLGXDOFDQGLGDWH
XQGHUVWDQGVWKHLPSOLFDWLRQVRISDUWLFLSDWLQJLQWKLVVWXG\WKHSDWLHQWZLOOEHDVNHGWRJLYHFRQVHQW
E\VLJQLQJDQGGDWLQJLQWKHDSSURSULDWHDUHDVRIWKH,&)RU$VVHQW7KH,QYHVWLJDWRURUGHVLJQHHZLOO
DOVRVLJQDQGGDWHWKHIRUPDORQJZLWKDVWDIIPHPEHUZKRZLOOVLJQWKH,&)DVDZLWQHVVWRYHULI\
WKDW WKH SDWLHQW KDV LQGHHG UHFHLYHG LQIRUPDWLRQ )RU LOOLWHUDWH SDWLHQWV YHUEDO FRQVHQW VKRXOG EH
REWDLQHG LQ WKH SUHVHQFH RI DQG EH FRXQWHUVLJQHG E\ D OLWHUDWH ZLWQHVV ,I DQ\ RWKHU ODQJXDJH LV
UHTXLUHGWUDQVODWLRQZLOOEHSHUIRUPHGE\DFHUWLILHGWUDQVODWRU$FRS\RIWKH,&)ZLOOEHSURYLGHG
WRWKHSDWLHQW
 3URWRFRODQG,QIRUPHG&RQVHQW&KDQJHV
5HYLVLRQVWRWKHRULJLQDOSURWRFROZLOOEHGRFXPHQWHGLQDPHQGPHQWVLQFRUSRUDWHGDVDSUHIDFHWR
WKHQHZYHUVLRQDQGDSSURYHGE\WKH,5%$Q\UHYLVLRQWKDWVXEVWDQWLDOO\DOWHUVWKHVWXG\GHVLJQRU
LQFUHDVHV SRWHQWLDO ULVN WR WKH SDWLHQW UHTXLUHV WKH SDWLHQW¶V FRQVHQW WR FRQWLQXH LQ WKH VWXG\
5HYLVLRQVWRWKHRULJLQDO,&)ZLOODOVREHDSSURYHGE\WKH,5%7KHDSSURYDOVZLOOEHSURFHVVHGLQ
DFFRUGDQFH ZLWK WKH HVWDEOLVKHG ,5% SURFHGXUHV &RSLHV RI DOO SURWRFRO DQG ,&)
DPHQGPHQWVUHYLVLRQVDORQJZLWKOHWWHUVQRWLQJ,5%DSSURYDOZLOOEHVXEPLWWHGWRWKH6SRQVRU
 6RXUFH'RFXPHQWVDQG&DVH5HSRUW)RUPV
$OO SDWLHQWV ZLOO EH LGHQWLILHG E\ LQLWLDOV GDWH RI ELUWK DQG D XQLTXH SDWLHQW QXPEHU 6RXUFH
GRFXPHQWVZLOOEHXVHGWRUHFRUGDOOVWXG\UHODWHGGDWD6RXUFHGRFXPHQWHQWULHVZLOOEHXVHGWR
FRPSOHWH&DVH5HSRUW)RUPV&5)V$VHWRI&5)VZLOOEHFRPSOHWHGIRUHDFKSDWLHQWHQUROOHGLQ
WKHVWXG\$OOGDWDDQG&5)VZLOOEHUHYLHZHGHYDOXDWHGDQGVLJQHGE\WKH,QYHVWLJDWRUDVUHTXLUHG
7KH RULJLQDO VRXUFH GRFXPHQWV DQG D FRS\ RI WKH FRUUHVSRQGLQJ &5)V ZLOO EH UHWDLQHG E\ WKH
,QYHVWLJDWRU 3DWLHQWV ZKR WHUPLQDWH HDUO\ IURP WKH VWXG\ ZLOO KDYH WKH HQG RI VWXG\ 9LVLW 
VRXUFH&5)FRPSOHWHG

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



 'UXJ$FFRXQWDELOLW\
$OO GUXJ UHFHLSW LQYHQWRU\ GLVSHQVLQJ GRVLQJ DQG UHFRQFLOLDWLRQ UHFRUGV ZLOO EH PDLQWDLQHG LQ
FRPSOLDQFHZLWK)HGHUDO5HJXODWLRQV7KHVWXG\GUXJZLOOEHGLVSHQVHGWRTXDOLILHGVWXG\SDWLHQWV
DFFRUGLQJWRHVWDEOLVKHGSURFHGXUHV$WWKHHQGRIWKHVWXG\DIWHUWKHGDWDEDVHKDVEHHQORFNHGDOO
XVHGDQGXQXVHGVWXG\GUXJZLOOEHUHWXUQHGWR1RYXP
 'UXJ6WRUDJH
$OOVWXG\GUXJZLOOEHVWRUHGDWFRQWUROOHGURRPWHPSHUDWXUH&)LQDVHFXUHSODFH
ZLWK DFFHVV E\ DXWKRUL]HG LQGLYLGXDOV RQO\ 7KH ,QYHVWLJDWRU ZLOO EH UHVSRQVLEOH IRU PDLQWDLQLQJ
DFFXUDWHUHFRUGVRIGUXJUHFHLSWGLVSHQVLQJDQGUHWXUQ$WWKHHQGRIWKHVWXG\DOOSDUWLDOO\XVHG
DQGXQXVHGVWXG\GUXJZLOOEHUHWXUQHGWR1RYXP
 3UHJQDQFLHV
3DWLHQWVZLWKDSRVLWLYHSUHJQDQF\WHVWGXULQJVFUHHQLQJZLOOQRWEHHQUROOHGLQWKHVWXG\3DWLHQWV
ZKRUHSRUWWKDWWKH\KDYHEHFRPHSUHJQDQWGXULQJWKHVWXG\RUKDYHDSRVLWLYHSUHJQDQF\WHVWDWDQ\
FOLQLFYLVLWZLOOEHIROORZHGWRFRPSOHWLRQRIWKHSUHJQDQF\7KHSUHJQDQF\ZLOOEHUHSRUWHGDVDQ
$(
)HPDOHSDWLHQWVRIFKLOGEHDULQJSRWHQWLDOPXVWKDYHEHHQXVLQJDQGPXVWDJUHHWRFRQWLQXHWRXVH
DFFHSWHGPHWKRGVRIELUWKFRQWUROWKURXJKRXWWKHVWXG\$OOIHPDOHSDWLHQWVDUHFRQVLGHUHGWREHRI
FKLOGEHDULQJ SRWHQWLDO XQOHVV WKH\ DUH SUHPHQDUFKDOKDYH EHHQ VXUJLFDOO\ VWHULOL]HG RU KDYH EHHQ
SRVWPHQRSDXVDOIRUDWOHDVW\HDU$EVWLQHQFHLVDQDFFHSWHGPHWKRGRIELUWKFRQWURO$OWHUQDWLYHO\
DQ\ RI WKH IROORZLQJ PHWKRGV RI ELUWK FRQWURO DUH DFFHSWDEOH RUDO FRQWUDFHSWLYHV FRQWUDFHSWLYH
SDWFKHVLPSODQWV HJ 1RUSODQW 'HSR3URYHUD GRXEOH EDUULHU PHWKRGV HJ FRQGRP DQG
VSHUPLFLGHRU,8'3ULRUWRVWXG\HQUROOPHQWZRPHQRIFKLOGEHDULQJSRWHQWLDOPXVWEHDGYLVHGRI
WKHLPSRUWDQFHRIDYRLGLQJSUHJQDQF\GXULQJVWXG\SDUWLFLSDWLRQ
$QHJDWLYHUHVXOWRIDXULQHSUHJQDQF\WHVWKDYLQJDPLQLPXPVHQVLWLYLW\RIDWOHDVWP,8POIRU
K&*VKRXOGEHREWDLQHGSULRUWRVWXG\SDUWLFLSDWLRQ3UHJQDQF\WHVWLQJZLOOEHSHUIRUPHGDW9LVLWV
DQGDQGWKHUHVXOWVRIDOOSUHJQDQF\WHVWVSRVLWLYHRUQHJDWLYHZLOOEHGRFXPHQWHG
,I IROORZLQJ LQLWLDWLRQ RI VWXG\ WUHDWPHQW LW LV VXEVHTXHQWO\ GLVFRYHUHG WKDW D VWXG\ SDWLHQW LV
SUHJQDQW RU PD\ KDYH EHHQ SUHJQDQW DW WKH WLPH RI ,QYHVWLJDWLRQDO 3URGXFW H[SRVXUH WKH
,QYHVWLJDWLRQDO 3URGXFW ZLOO EH SHUPDQHQWO\ GLVFRQWLQXHG 7KH 3ULQFLSDO ,QYHVWLJDWRU PXVW
LPPHGLDWHO\QRWLI\WKH0HGLFDO0RQLWRURIWKLVHYHQW
3URWRFROUHTXLUHG SURFHGXUHV IRU VWXG\ GLVFRQWLQXDWLRQ DQG IROORZXS PXVW EH SHUIRUPHG RQ WKH
SDWLHQW 2WKHU DSSURSULDWH SUHJQDQF\ IROORZXS SURFHGXUHV VKRXOG EH FRQVLGHUHG LI LQGLFDWHG ,Q
DGGLWLRQWKH3ULQFLSDO,QYHVWLJDWRUPXVWUHSRUWWRWKHVSRQVRUIROORZXSLQIRUPDWLRQUHJDUGLQJWKH
FRXUVHRIWKHSUHJQDQF\LQFOXGLQJSHULQDWDODQGQHRQDWDORXWFRPH,QIDQWVVKRXOGEHIROORZHGIRUD
PLQLPXPRIHLJKWZHHNVDIWHUELUWK
 5HSRUWLQJ6DIHW\,QIRUPDWLRQWRWKH,5%
7KH,QYHVWLJDWRUPXVWSURPSWO\UHSRUWWRWKH,QYHVWLJDWRU¶V,5%DOOXQDQWLFLSDWHGSUREOHPVLQYROYLQJ
ULVNVWRSDWLHQWV7KLVLQFOXGHVGHDWKIURPDQ\FDXVHDQGDOOVHULRXVDGYHUVHHYHQWVRFFXUULQJGXULQJ
WKHVWXG\UHJDUGOHVVRIWKHDVVHVVHGFDXVDOLW\

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



 5HFRUG5HWHQWLRQ
$OO GUXJ DFFRXQWDELOLW\ UHFRUGV &5)V VRXUFH GDWD DQG UHODWHG UHJXODWRU\ GRFXPHQWV PXVW EH
UHWDLQHGIRUDWOHDVWWHQ\HDUVIROORZLQJFRPSOHWLRQRIWKHVWXG\RUIRUWZR\HDUVDIWHUWKHWHVWSURGXFW
KDVEHHQDSSURYHGIRUPDUNHWLQJE\WKH)RRGDQG'UXJ$GPLQLVWUDWLRQ
6WXG\0RQLWRULQJDQG$XGLWLQJ
1RYXP ZLOO EH UHVSRQVLEOH IRU PRQLWRULQJ WKH VWXG\ DFFRUGLQJ WR *RRG &OLQLFDO 3UDFWLFH DQG
DSSOLFDEOHUHJXODWLRQV0RQLWRULQJYLVLWVDUHIRUWKHSXUSRVHRIFRQILUPLQJDGKHUHQFHWRWKHSURWRFRO
DQGWRYHULI\FRPSOHWHDQGDFFXUDWHGDWDFROOHFWLRQ7KHFOLQLFDOVLWHZLOOPDNHDOOUHFRUGVDVVRFLDWHG
ZLWKWKHVWXG\DYDLODEOHWR1RYXP¶VUHSUHVHQWDWLYHGXULQJVXFKYLVLWVDQGDXGLWV
7KH VWXG\ PD\ EH VXEMHFW WR DXGLW E\ WKH 6SRQVRU 6SRQVRU 5HSUHVHQWDWLYH RU E\ UHJXODWRU\
DXWKRULWLHV,IVXFKDQDXGLWRFFXUVWKH,QYHVWLJDWRUPXVWDJUHHWRDOORZDFFHVVWRUHTXLUHGSDWLHQW
UHFRUGV%\VLJQLQJWKLVSURWRFROWKH,QYHVWLJDWRUJUDQWVSHUPLVVLRQWRSHUVRQQHOIURPWKH6SRQVRU
LWV UHSUHVHQWDWLYHV DQG DSSURSULDWH UHJXODWRU\ DXWKRULWLHV IRU RQVLWH PRQLWRULQJ RI DOO DSSURSULDWH
VWXG\GRFXPHQWDWLRQDVZHOODVRQVLWHUHYLHZRIVWXG\SURFHGXUHV
(QGRIWKH7ULDO
7KHHQGRIWKHWULDOLVGHILQHGDVWKHWLPHDWZKLFKWKHODVWSDWLHQWKDVFRPSOHWHGWKHLUODVWYLVLWLQWKH
VWXG\8SRQFRPSOHWLRQRIWKHVWXG\WKHVWXG\GUXJZLOOQRORQJHUEHDYDLODEOHWRWKHSDWLHQWEXWWKH
,QYHVWLJDWRUFDQDWWKHLUGLVFUHWLRQGLVFXVVDOWHUQDWLYHWUHDWPHQWVZLWKWKHSDWLHQW
&OLQLFDO6WXG\5HSRUW
$WWKHHQGRIWKHVWXG\DIXOOUHSRUWLQH&7'IRUPDWZLOOEHSUHSDUHGWKDWZLOOLQFOXGHDQDUUDWLYHRI
WKHFOLQLFDOFRQGXFWDQGUHVXOWVRIWKHVWXG\DVWDWLVWLFDOUHSRUWLQFOXGLQJDGHVFULSWLRQRIWKHDQDO\VLV
SHUIRUPHGDQGRWKHUGRFXPHQWDWLRQDVPD\EHDSSURSULDWH



&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



 5()(5(1&(6



%HUNH56LQJK$	*XUDOQLFN0$WRSLFGHUPDWLWLVDQRYHUYLHZ$PHULFDQIDPLO\
SK\VLFLDQ

2QJ3<	/HXQJ'<7KHLQIHFWLRXVDVSHFWVRIDWRSLFGHUPDWLWLV,PPXQRORJ\DQG
DOOHUJ\FOLQLFVRI1RUWK$PHULFDGRLMLDF

(LFKHQILHOG / ) HW DO *XLGHOLQHV RI FDUH IRU WKH PDQDJHPHQW RI DWRSLF GHUPDWLWLV
VHFWLRQ  'LDJQRVLV DQG DVVHVVPHQW RI DWRSLF GHUPDWLWLV -RXUQDO RI WKH $PHULFDQ
$FDGHP\RI'HUPDWRORJ\GRLMMDDG

%UHQQLQNPHLMHU ( ( 6FKUDP 0 ( /HHIODQJ 0 0 %RV - ' 	 6SXOV 3 ,
'LDJQRVWLF FULWHULD IRU DWRSLF GHUPDWLWLV D V\VWHPDWLF UHYLHZ 7KH %ULWLVK MRXUQDO RI
GHUPDWRORJ\GRLM[

6FKQHLGHU/HWDO$WRSLFGHUPDWLWLVDSUDFWLFHSDUDPHWHUXSGDWH7KH-RXUQDORI
DOOHUJ\DQGFOLQLFDOLPPXQRORJ\HGRLMMDFL


/HXQJ ' < 1HZ LQVLJKWV LQWR DWRSLF GHUPDWLWLV UROH RI VNLQ EDUULHU DQG LPPXQH
G\VUHJXODWLRQ $OOHUJRORJ\ LQWHUQDWLRQDO  RIILFLDO MRXUQDO RI WKH -DSDQHVH 6RFLHW\ RI
$OOHUJRORJ\GRLDOOHUJROLQW5$,

1RYDN 1 	 /HXQJ ' < $GYDQFHV LQ DWRSLF GHUPDWLWLV &XUUHQW RSLQLRQ LQ
LPPXQRORJ\GRLMFRL

(LFKHQILHOG / ) HW DO *XLGHOLQHV RI FDUH IRU WKH PDQDJHPHQW RI DWRSLF GHUPDWLWLV
VHFWLRQ0DQDJHPHQWDQGWUHDWPHQWRIDWRSLFGHUPDWLWLVZLWKWRSLFDOWKHUDSLHV-RXUQDO
RIWKH$PHULFDQ$FDGHP\RI'HUPDWRORJ\GRLMMDDG


1'$&RQQHWLFV)HEUXDU\

+HQJJH855X]LFDN76FKZDUW]5$&RUN0-$GYHUVHHIIHFWVRI7RSLFDO
*OXFRFRUWLFRVWHURLGV-$P$FDG'HUPDWRORJ\&RQWLQXLQJ0HGLFDO(GXFDWLRQ

3URGXFW/DEHOIRU723,&257GHVR[LPHWDVRQH7RSLFDO6SUD\$SULO

3URGXFW/DEHOIRU&RUWURV\Q70$PSKDVWDU3KDUPDFHXWLFDOV,QF$XJXVW

6XPPDU\%DVLVRI$SSURYDO2/8;FOREHWDVROIRDP1'$&RQQHWLFV
0D\

6XPPDU\%DVLVRI$SSURYDO/8;,4EHWDPHWKDVRQHIRDP

)'$&RUUHVSRQGHQFH0HHWLQJ0LQXWHV,1''HVR[LPHWDVRQH7RSLFDO6SUD\
'HSDUPHQWRI+HDOWKDQG+XPDQ6HUYLFHV)'$

0RVWHOOHU5%6LPSOLILHG&DOFXODWLRQRI%RG\6XUIDFH$UHD1(QJ-0HG2FW


)'$&RUUHVSRQGHQFH$GYLFH/HWWHU,1''HSDUWPHQWRI+HDOWKDQG+XPDQ
6HUYLFHV)'$





&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',&(6

$33(1',;$%RG\6XUIDFH$UHD&DOFXODWLRQ

7RWDO%RG\6XUIDFH$UHD&DOFXODWLRQ

7RFDOFXODWHWKH7RWDO%6$WKHIROORZLQJSURFHGXUH0RVWHOOHU)RUPXODVKRXOGEHIROORZHG

7RWDO%RG\6XUIDFH$UHD%6$LQPHWHUVVTXDUHG

P KHLJKWFP[ZHLJKWNJò

7KHSDWLHQW¶VKHLJKWDQGZHLJKWVKRXOGEHUHSRUWHGWRWKHQHDUHVWFPDQGQHDUHVWNJ7KH%6$VKRXOG
EHUHSRUWHGWRWKHQHDUHVWVHFRQGGHFLPDOSODFH

)RUH[DPSOHDSDWLHQWZKRLVLQFKHVWDOODQGZHLJKVOEVZLOOKDYHDUHSRUWHG%6$RI
LQ[ FP
OE[ NJ

%6$
 6457[
 Pð

%6$$IIHFWHG

7RHVWLPDWHWKH%6$$IIHFWHGWKH,QYHVWLJDWRUVKRXOGXVHWKHPHWKRGRIDSSUR[LPDWLRQ

7KH³5XOHRI1LQHV´SURYLGHVDJHQHUDOHVWLPDWLRQRIWRWDO%6$IRUVHYHUDODQDWRPLFDUHDVHDFK
DUP HDFKOHJ EDFN FKHVWDQGDEGRPHQ KHDG JURLQ 7KH
,QYHVWLJDWRUPD\WKHQYLVXDOO\HVWLPDWHWKHSURSRUWLRQRIWKHLQYROYHGVNLQZLWKLQHDFKDQDWRPLF
DUHDDQGFDOFXODWHWKHWRWDOSHUFHQWDJHRI%6$DIIHFWHG,QFKLOGUHQKLSVDQGOHJVDUHVPDOOHUDQG
WKHKHDGQHFNDQGVKRXOGHUVDUHODUJHUDVDUHVXOWDPRGLILHG³5XOHRI1LQHV´LVXVHGVHH
GLDJUDPEHORZ
·
LVWDNHQIURPWKHOHJVDQGDGGHGWRWKHKHDGRIDFKLOG\HDUROG)RUHDFK
VXEVHTXHQW\HDULVUHWXUQHGWRWKHOHJVXQWLO\HDUVROGDWZKLFKWLPHWKHKHDGLVLQ
SURSRUWLRQWRWKHDGXOW
·
%\\HDUVRIDJHWKHUHODWLYHSURSRUWLRQVDVVXPHWKHYDOXHVIRUDGXOW%6$DQGKHQFHWKH
DGXOWGLDJUDPFDQEHXVHGDVDUHIHUHQFHDWWKDWWLPH

,WLVSUHIHUDEOHWKDWWKHSDWLHQW¶VKHLJKWDQGZHLJKWEHPHDVXUHG
LQFPDQGNJKRZHYHULIQHHGHG

7RFRQYHUWLQFKHVLQWRFHQWLPHWHUVFPWKHIROORZLQJ
FRQYHUVLRQVKRXOGEHXVHG
LQFK FP

7RFRQYHUWSRXQGVOEVWRNLORJUDPVNJWKHIROORZLQJ
FRQYHUVLRQVKRXOGEHXVHG
OE NJ

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI






3DUW
\HDUFKLOG
ERG\
RIWRWDO
\HDUFKLOG
ERG\
RIWRWDO
\HDUFKLOGERG\
RIWRWDO
$GXOWERG\
RIWRWDO
$UP




+HDG




1HFN


/HJ




$QWHULRUWUXQN




3RVWHULRUWUXQN










&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',;%(F]HPD$UHDDQG6HYHULW\,QGH[6FRUH($6,
7KH($6,LVDFRPSRVLWHVFRUHEDVHGRQWKHVHYHULW\RIIRXUGLIIHUHQWVLJQVRIDWRSLF
GHUPDWLWLVLQIRXUGLIIHUHQWDUHDVRIWKHERG\PXOWLSOLHGE\WKHSHUFHQWRIWKDWVSHFLILFERG\
DUHDDIIHFWHGPXOWLSOLHGE\DZHLJKWLQJIDFWRU

(U\WKHPD
 &OHDU



1RHYLGHQFHRIHU\WKHPD
 0LOG



'HILQLWHOLJKWUHGFRORUDWLRQ
 0RGHUDWH



0RGHUDWHUHGQHVVEXWQRWGDUN
 6HYHUH



'DUNUHGFRORUDWLRQ

,QGXUDWLRQSDSXODWLRQHGHPD 

 &OHDU



1RHYLGHQFHRIDQ\LQGXUDWLRQSDSXODWLRQHGHPD
 0LOG



%DUHO\SHUFHSWLEOHHOHYDWLRQ
 0RGHUDWH



&OHDUO\SHUFHSWLEOHHOHYDWLRQ
 6HYHUH



0DUNHGDQGH[WHQVLYHHOHYDWLRQ

/LFKHQLILFDWLRQ
 &OHDU



1RHYLGHQFHRIOLFKHQLILFDWLRQ
 0LOG
6OLJKWWKLFNHQLQJRIVNLQGLVFHULEOHRQO\E\WRXFK
DQGZLWKVNLQPDUNLQJVPLQLPDOO\H[DJJHUDWHG
 0RGHUDWH
'HILQLWHWKLFNHQLQJRIVNLQZLWKVNLQPDUNLQJ
H[DJJHUDWHGVRWKDWWKH\IRUPDYLVLEOHFULVVFURVV
RUULGJHGSDWWHUQ
 6HYHUH
7KLFNHQHGVNLQZLWKVNLQPDUNLQJVYLVLEO\
SRUWUD\LQJDQH[DJJHUDWHGFULVVFURVVRUULGJHG
SDWWHUQ

([FRULDWLRQ
 &OHDU
1RHYLGHQFHRIH[FRULDWLRQ
 0LOG
6FDQWHYLGHQFHRIH[FRULDWLRQZLWKQRVLJQVRI
GHHSHUVVNLQGDPDJHDEVHQFHRIHURVLRQRU
FUXVWV
 0RGHUDWH
6HYHUDOOLQHDUPDUNVRIVNLQZLWKVRPHVKRZLQJ
HYLGHQFHRIGHHSHUVNLQLQMXU\HURVLRQFUXVW
YLVLEOH
 6HYHUH
0DQ\HURVLYHRUFUXVW\OHVLRQVSUHVHQW





7KHSDWLHQWZLOOEHUHTXLUHGWRUDWHWKHVHYHULW\RIWKHLUSUXULWLVLWFKLQJVFUDWFKLQJGLVFRPIRUWRYHUWKH

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



SUHYLRXVKRXUVXVLQJWKHIROORZLQJVFDOH

3UXULWLV
 1RQH
1RQH
 0LOG
2FFDVLRQDOVOLJKWLWFKLQJRUVFUDWFKLQJ
 0RGHUDWH&RQVWDQWRULQWHUPLWWHQW
LWFKLQJVFUDWFKLQJGLVFRPIRUWZKLFKLVQRW
GLVWXUELQJVOHHS
 6HYHUH
%RWKHUVRPHLWFKLQJVFUDWFKLQJGLVFRPIRUW
ZKLFKLVGLVWXUELQJVOHHS

(F]HPDLQGXUDWLRQH[FRULDWLRQDQGOLFKHQLILFDWLRQDUHSDUWRIWKH($6,VFRUHEXWSUXULWLVLVQRW

($6,6FRUH

7KH($6,VFRUHLVFDOFXODWHGDVIROORZV
+HDGQHFN
(,;/[$UHD[LQFKLOGUHQDJHV[
8SSHU/LPEV
(,;/[$UHD[
7UXQN 
(,;/[$UHD[
/RZHU/LPEV
(,;/[$UHD[LQFKLOGUHQDJHV[
($6,6&25( 6802)$%29(5(*,216

(
(U\WKHPD
,
,QGXUDWLRQSDSXODWLRQHGHPD
;
([FRULDWLRQ
/
/LFKHQLILFDWLRQ

6HYHULW\LVEDVHGRQWKH,QYHVWLJDWRU¶VDVVHVVPHQWRILQGLYLGXDOVLJQVDQGV\PSWRPV
 QRQH PLOG PRGHUDWH VHYHUHXVLQJWKHGHILQLWLRQVDERYH

7KHRIHDFKERG\UHJLRQDIIHFWHGLVVFRUHGDVWKHYDULDEOH$UHDDERYHLQWKH($6,
IRUPXOD)RUWKHERG\UHJLRQVKHDGQHFNXSSHUOLPEVWUXQNDQGORZHUOLPEVLIWKH

$UHD 
LIDIIHFWHGLV
$UHD 
LIDIIHFWHGLVWR
$UHD 
LIDIIHFWHGLVWR
$UHD 
LIDIIHFWHGLVWR
$UHD 
LIDIIHFWHGLVWR
$UHD 
LIDIIHFWHGLVWR
$UHD 
LIDIIHFWHGLVWR

($6,6FRUHFDQEHSUHVHQWHGWRWKHQHDUHVWZKROHQXPEHUQRGHFLPDOVDQGDOOQXPEHUV
VKRXOGEHURXQGHGVKRXOGEHURXQGHGXSWRWKHQHDUHVWZKROHQXPEHU


&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



7KHPLQLPXPVFRUHZRXOGEHDQGWKH0D[LPXP6FRUHZRXOGEH7REHHOLJLEOHIRU
SDUWLFLSDWLRQLQWKLVVWXG\DSDWLHQWPXVWKDYHDQ($6,RIDWOHDVWDWEDVHOLQH








&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI


$33(1',;&,QYHVWLJDWRU*OREDO$VVHVVPHQW,*$

7REHHOLJLEOHIRULQFOXVLRQLQWKHVWXG\WKH,*$PXVWEHRUDWEDVHOLQH7REH
FRQVLGHUHGD&OLQLFDO6XFFHVVWKHSDWLHQWPXVWVFRUHDDW9LVLW


&OHDU
0LQRUUHVLGXDOGLVFRORUDWLRQQRHU\WKHPDRULQGXUDWLRQSDSXODWLRQ
QRRR]LQJFUXVWLQJ

$OPRVW&OHDU
-XVWSHUFHSWLEOHHU\WKHPDZLWKDOPRVWQRLQGXUDWLRQSDSXODWLRQDQG
QRRR]LQJFUXVWLQJ

0LOG'LVHDVH
'HILQLWHSLQNHU\WKHPDZLWKPLOGLQGXUDWLRQSDSXODWLRQDQGQR
RR]LQJFUXVWLQJ

0RGHUDWH
'LVHDVH
5HGHU\WKHPDZLWKPRGHUDWHLQGXUDWLRQSDSXODWLRQDQGWKHUHPD\EH
VRPHRR]LQJFUXVWLQJ

6HYHUH'LVHDVH
'DUNEULJKWUHGHU\WKHPDZLWKVHYHUHLQGXUDWLRQSDSXODWLRQZLWK
RR]LQJFUXVWLQJ


&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',;'$SSOLFDWLRQ6LWH5HDFWLRQV

7KHIROORZLQJDSSOLFDWLRQVLWHUHDFWLRQVZLOOEHHYDOXDWHGDWHDFKYLVLWEDVHGRQWKHVFDOHSURYLGHGEHORZ
%XUQLQJ
(URVLRQ
(GHPD
3DLQ
,WFKLQJ
'U\QHVV

$EVHQW 

0LOG


VOLJKWEDUHO\SHUFHSWLEOH
0RGHUDWH

GLVWLQFWSUHVHQFH
6HYHUH 

PDUNHGLQWHQVH






















&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',;(&RUWLVRO5HVSRQVH7HVW

7KLVFRUWLVROUHOHDVHWHVWLVPRGLILHGIURPWKHSURFHGXUHRI:RRGHWDODVGHVFULEHGLQWKH3URGXFW/DEHO
IRU&RUWURV\Q70FRV\QWURSLQIRULQMHFWLRQ$PSKVWDU3KDUPDFHXWLFDOV,QF
7KHSURFHGXUHLVDVIROORZV
 $VLQJOHPOEORRGVDPSOHVKRXOGEHWDNHQDVWKHEDVDOVDPSOH
 PJDVLQJOHYLDORI&RUWURV\Q70FRV\QWURSLQVKRXOGEHUHFRQVWLWXWHGZLWKPORI
VRGLXP FKORULGH LQMHFWLRQ 863 LQMHFWHG LQWUDPXVFXODUO\ ,Q SDWLHQWV XQGHU  \HDUV RI DJH
PJRI&RUWURV\Q70ZLOOEHXVHG
 PLQXWHVDIWHUWKH,0LQMHFWLRQDVHFRQGPOEORRGVDPSOHVKRXOGEHREWDLQHG7KHUHVXOWLQJ
WZRVHUXPVDPSOHVDWOHDVWPORIVHUXPLQHDFKVKRXOGEHSURFHVVHGDQGODEHOHGDFFRUGLQJWR
WKHLQVWUXFWLRQVSURYLGHGDQGVHQWWKHVDPHGD\WR$&0*OREDO/DERUDWRU\IRUDQDO\VLVRIEDVDO
DQGSRVWVWLPXODWHGVHUXPFRUWLVROFRQFHQWUDWLRQ

7KHUHVXOWLQJEORRGVDPSOHVVKRXOGEHVHQWWR$&0*OREDO/DERUDWRU\IRULPPHGLDWHWHVWLQJ
9LVLW7HVW
7KHUHVXOWVRIWKHFRUWLVROUHVSRQVHWHVWPXVWEHREWDLQHGSULRUWRVWXG\GUXJEHLQJGLVSHQVHGDW9LVLW
2QO\SDWLHQWVZLWKQRUPDOEDVHOLQH9LVLWFRUWLVRODQGDGUHQDOIXQFWLRQVHH FULWHULD EHORZ VKRXOG EH
HQUROOHGLQWKHVWXG\
9LVLW7HVW
7KHWHVWDWWKH(QGRI6WXG\YLVLWVKRXOGQRWEHSHUIRUPHGLIWKHSDWLHQWGRVHGZLWKLQKRXUV
$SDWLHQWZLOOEHFRQVLGHUHGWRKDYHQRUPDOEDVDOFRUWLVROOHYHODQGDGUHQDOIXQFWLRQLIWKH\PHHWDOOWKUHH
FULWHULDOLVWHGEHORZXQGHU1RUPDO)DLOXUHWRPHHWDQ\RIWKHVHFULWHULDLVLQGLFDWLYHRIDEQRUPDODGUHQDO
IXQFWLRQRUSRWHQWLDO+3$D[LVVXSSUHVVLRQ


&RUWLVRO5HVXOWV
1RUPDO
$EQRUPDO
%DVDO
SUH&RUWURV\Q70
LQMHFWLRQ
PFJPO
PFJPO
PLQXWHVSRVW
&RUWURV\Q70LQMHFWLRQ
EDVDOYDOXH
EDVDOYDOXH
!PFJPO
PFJPO

+3$$[LVVXSSUHVVLRQZLOOEHGHILQHGDVDPLQXWHSRVW&RUWURV\Q70LQMHFWLRQOHYHOFRUWLVROOHYHO
RIPFJPO$VWKHVWXG\WUHDWPHQWSHULRGZLOOEHRYHUDQ\SDWLHQWVZLWKUHVXOWVRI+3$D[LV
VXSSUHVVLRQZLOOEHDGYLVHGQRWWRLQLWLDWHDQ\QHZVWHURLGWKHUDS\WRSLFDORURWKHUZLVHDQGWRUHWXUQ
WRWKHVLWHLQGD\VDWZKLFKWLPHWKH\ZLOOEHDVVHVVHGIRU+3$D[LVVXSSUHVVLRQ
$Q\SDWLHQWSUHVHQWLQJZLWKV\PSWRPVRI+3$D[LVVXSSUHVVLRQVXFKDVQDXVHDKHDGDFKHP\DOJLD
IDWLJXH RU ORRVH VWRRO ZLOO EH UHIHUUHG WR DQ HQGRFULQRORJLVW $V DQ DGGLWLRQDO VDIHW\ SUHFDXWLRQ
ZULVWEDQGVLGHQWLI\LQJWKHSDWLHQWDVVRPHRQHVXIIHULQJIURPDGUHQDOVXSSUHVVLRQVHFRQGDU\WRVWHURLG
ZLWKGUDZDOZLOOEHSURYLGHGWRDOHUWPHGLFDOSHUVRQQHOVKRXOGDQ\HPHUJHQFLHVDULVHEHIRUHDGUHQDO
IXQFWLRQUHWXUQVWRQRUPDO
,I WKH UHVXOWV RI WKH FRUWLVRO UHVSRQVH WHVW VWLOO VKRZ VLJQV RI +3$ D[LV VXSSUHVVLRQ  GD\V DIWHU
GLVFRQWLQXLQJ WKHUDS\ WKH\ ZLOO EHDVNHG WR UHWXUQ LQ  GD\V  GD\V DIWHU GLVFRQWLQXLQJ VWHURLG
WKHUDS\IRUDQRWKHUIROORZXSWHVW,IWKHSDWLHQWLVVWLOOVKRZLQJVLJQVRI+3$D[LVVXSSUHVVLRQ

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



GD\VDIWHUGLVFRQWLQXLQJVWHURLGWKHUDS\DQGSUHVHQWVZLWKUHODWHGV\PSWRPVWKH\ZLOOEHUHIHUUHGWR
DQHQGRFULQRORJLVW
,I+3$D[LVVXSSUHVVLRQSHUVLVWVIRUGD\VDIWHUGLVFRQWLQXLQJVWHURLGWKHUDS\EXWWKHSDWLHQWKDVQR
V\PSWRPVWKH\ZLOOEHDVNHGWRUHWXUQLQGD\VGD\VDIWHUGLVFRQWLQXLQJVWHURLGWKHUDS\IRU
DQRWKHU IROORZXS WHVW ,I +3$ D[LV VXSSUHVVLRQ SHUVLVWV IRU  GD\V DIWHU GLVFRQWLQXLQJ VWHURLG
WKHUDS\SDWLHQWVZLOOEHUHIHUUHGWRDQHQGRFULQRORJLVWUHJDUGOHVVRIV\PSWRPV
3DWLHQWV VKRXOG QRW EH VXEMHFWHG WR &RUWURV\Q70 WHVWLQJ RU DQ\ RWKHU FKDOOHQJH WR WKHLU DGUHQDO
UHVSRQVHDQ\VRRQHUWKDQZHHNVIURPWKHLUODVW&RUWURV\Q70WHVW

)ROORZ8S6FKHGXOHIRU3DWLHQWVVKRZLQJVLJQVRI+3$$[LV6XSSUHVVLRQ
'D\V
DIWHUGF
+3$5HVXOWV
6\PSWRP
V
3DWLHQW&RXUVH

1RUPDO
1$
6WXG\RYHU

$EQRUPDO
<HV
5HIHUWRHQGRFULQRORJLVW

$EQRUPDO
1R
5HSHDWWHVWLQGD\V

1RUPDO
1$
6WXG\RYHU

$EQRUPDO
<HV
5HIHUWRHQGRFULQRORJLVW

$EQRUPDO
1R
5HSHDWWHVWLQGD\V

1RUPDO
1$
6WXG\RYHU

$EQRUPDO
<HVRU1R
5HIHUWRDQHQGRFULQRORJLVW





&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI


$33(1',;)(YDOXDWLRQRI+3$$[LV6XSSUHVVLRQ
&RUWLFRVWHURLG(IIHFWRQ+3$$[LV)HHGEDFN/RRS



$VVHVVPHQWRI&RUWLFRVWHURLG(IIHFWRQ+3$$[LV)HHGEDFN/RRS




























7KH +\SRWKDODPXV VHFUHWHV &RUWLFRWURSKLQ
5HOHDVLQJ+RUPRQH&5+ZKLFKWULJJHUVWKH
DQWHULRU
SLWXLWDU\
WR
UHOHDVH
$GUHQRFRUWLFRWURSKLQ
+RUPRQH
$&7+
$&7+VWLPXODWHVWKHDGUHQDOFRUWH[WRUHOHDVH
JOXFRFRUWLFRVWHURLGV LQWR WKH EORRGVWUHDP
,QFUHDVHGOHYHOVRIFLUFXODWLQJJOXFRFRUWLFRLGV
LQ WKH EORRGVWUHDP VHQG D VLJQDO WR WKH
K\SRWKDODPXV WR GHFUHDVH WKH VHFUHWLRQ RI
&5+ DQG DOVR WR WKH DQWHULRU SLWXLWDU\ WR
GHFUHDVHWKHVHFUHWLRQRI$&7+UHVXOWLQJLQD
GHFUHDVH LQ FLUFXODWLQJ JOXFRFRUWLFRVWHURLGV
([RJHQRXV FRUWLFRVWHURLGV LQFOXGLQJ WKRVH
DEVRUEHGV\VWHPLFDOO\WKURXJKWKHVNLQPD\
DOVR LPSDUW D PHVVDJH WR WKH K\SRWKDODPXV
DQGDQWHULRUSLWXLWDU\WRGHFUHDVHVHFUHWLRQRI
KRUPRQHV  7KLV PD\ UHVXOW LQ GHFUHDVHG
FLUFXODWLQJ JOXFRFRUWLFRVWHURLGV DQG WKXV D
GHFUHDVHGUHVSRQVHWRJOXFRFRUWLFRVWHURLGV
/RZFLUFXODWLQJFRUWLVROOHYHOVRUDGHFUHDVHG
UHVSRQVH WR FRUWLVRO DUH LQGLFDWLYH RI
VXSSUHVVLRQ RIWKHDFWLYLW\ RI WKH +3$ D[LV
,QRUGHUWRHYDOXDWHWKH+3$D[LVIXQFWLRQRI
SDWLHQWVLQWKLVVWXG\EDVDOOHYHOVRIFRUWLVRO
LQ WKH EORRG ZLOO EH PHDVXUHG DW WKH HQG RI
WUHDWPHQW3DWLHQWVZLOOWKHQEHLQMHFWHGZLWK
&RUWRV\Q70 D V\QWKHWLF VXEXQLW RI $&7+
6\VWHPLF DGPLQLVWUDWLRQ RI D V\QWKHWLF
VXEXQLWRI$&7+VKRXOGVWLPXODWHWKH
$GUHQDO
&RUWH[
WR
UHOHDVH
JOXFRFRUWLFRVWHURLGVXQOHVVWKHSDWLHQWKDV
KDG   LQFUHDVHG   FLUFXODWLQJ OHYHOV RI
JOXFRFRUWLFRVWHURLGV IRU VRPH WLPH DQG WKH
+3$D[LVKDVEHHQVXSSUHVVHG$IWHU
 PLQXWHV KDYH  SDVVHG  EORRG  OHYHOV  RI
FRUWLVRO ZLOO EH PHDVXUHGDJDLQ /DFN RI RU
OLPLWHGUHOHDVHRIJOXFRFRUWLFRVWHURLGVLQWR
WKH EORRG VWUHDP LQ UHVSRQVH WR WKH
DGPLQLVWHUHG
&RUWRV\Q70
ZLOO
LQGLFDWH
VXSSUHVVLRQRI+3$D[LVIXQFWLRQ

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',;*&OLQLFDO/DERUDWRU\7HVWLQJ
$VSDUWRIWKH6FUHHQLQJ3URFHGXUHVDQGDW9LVLWRUHDUO\WHUPLQDWLRQIRUUDQGRPL]HGSDWLHQWVRQO\
SDWLHQWVZLOOKDYHDEORRGVDPSOHWDNHQIRUKHPDWRORJ\DQGFOLQLFDOFKHPLVWU\WHVWLQJ7KHWHVWLQJSDQHO
VKRXOGLQFOXGHDVDPLQLPXPWKHIROORZLQJWHVWV
+HPDWRORJ\
·
+HPDWRFULW
·
:KLWHEORRGFHOOFRXQW
·
3ODWHOHWV
·
+HPRJORELQ
·
5HGEORRGFHOOFRXQW
·
'LIIHUHQWLDOZKLWHFHOOFRXQW
&KHPLVWU\
·
$ONDOLQHSKRVSKDWDVH
·
7RWDOELOLUXELQ
·
$ODQLQHWUDQVDPLQDVH
·
&UHDWLQLQH
·
$VSDUWDWHWUDQVDPLQDVH
·
*OXFRVH
·
%ORRGXUHDQLWURJHQ
&OLQLFDO/DERUDWRU\7HVWLQJZLOOEHSHUIRUPHGDWD&HQWUDO/DERUDWRU\
$&00HGLFDO/DE,QF
(OPJURYH3DUN
5RFKHVWHU1<86$

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',;+&RUWURV\Q3DFNDJH,QVHUW
)25',$*1267,&86(21/<
&257526<1
70
(cosyntropin) for Injection
'(6&5,37,21
&257526<170 FRV\QWURSLQ IRU ,QMHFWLRQ LV D VWHULOH ,\RSKLOL]HG SRZGHU LQ YLDOV FRQWDLQLQJ  PJ RI &257526<170 DQG  PJ RI PDQQLWRO WR EH
UHFRQVWLWXWHGZLWKP/RI6RGLXP&KORULGH,QMHFWLRQ863$GPLQLVWUDWLRQLVE\LQWUDYHQRXVRULQWUDPXVFXODULQMHFWLRQ&RV\QWURSLQLVĮFRUWLFRWURSLQD
V\QWKHWLFVXEXQLWRI$&7+,WLVDQRSHQFKDLQSRO\SHSWLGHFRQWDLQLQJIURPWKH1WHUPLQXVWKHILUVWRIWKHDPLQRDFLGVRIQDWXUDO$&7+7KHVHTXHQFHRI
DPLQRDFLGVLQWKHFRPSRXQGLVDVIROORZV


&/,1,&$/3+$50$&2/2*<
&257526<170FRV\QWURSLQIRU,QMHFWLRQH[KLELWVWKHIXOOFRUWLFRVWHURLGRJHQLFDFWLYLW\RIQDWXUDO$&7+9DULRXVVWXGLHVKDYHVKRZQWKDWWKHELRORJLFDFWLYLW\RI
$&7+UHVLGHVLQWKH1WHUPLQDOSRUWLRQRIWKHPROHFXOHDQGWKDWWKHDPLQRDFLGUHVLGXHLVWKHPLQLPDOVHTXHQFHUHWDLQLQJIXOODFWLYLW\3DUWLDORUFRPSOHWH
ORVVRIDFWLYLW\LVQRWHGZLWKSURJUHVVLYHVKRUWHQLQJRIWKHFKDLQEH\RQGDPLQRDFLGUHVLGXHV)RUH[DPSOHWKHGHFUHPHQWIURPWRUHVXOWVLQDORVVRI
SRWHQF\
7KH SKDUPDFRORJLF SURILOH RI &257526<170 LV VLPLODU WR WKDW RI SXULILHG QDWXUDO $&7+ ,W KDV EHHQ HVWDEOLVKHG WKDW  PJ RI &257526<170 ZLOO
VWLPXODWHWKHDGUHQDOFRUWH[PD[LPDOO\DQGWRWKHVDPHH[WHQWDVXQLWVRIQDWXUDO$&7+7KLVGRVHRI&257526<170ZLOOSURGXFHPD[LPDOVHFUHWLRQRI
2+FRUWLFRVWHURLGVNHWRVWHURLGVDQGRUNHWRJHQLFVWHURLGV
7KH H[WUDDGUHQDO HIIHFWV ZKLFK QDWXUDO $&7+ DQG &257526<170 KDYH LQ FRPPRQ LQFOXGH LQFUHDVHG PHODQRWURSLF DFWLYLW\ LQFUHDVHG JURZWK KRUPRQH
VHFUHWLRQDQGDQDGLSRNLQHWLFHIIHFW7KHVHDUHFRQVLGHUHGWREHZLWKRXWSK\VLRORJLFDORUFOLQLFDOVLJQLILFDQFH
$QLPDOKXPDQDQGV\QWKHWLF$&7+ZKLFKDOOFRQWDLQDPLQRDFLGVH[KLELWVLPLODULPPXQRORJLFDFWLYLW\7KLVDFWLYLW\UHVLGHVLQWKH&WHUPLQDOSRUWLRQRIWKH
PROHFXOHDQGWKHDPLQRDFLGUHVLGXHVH[KLELWWKHJUHDWHVWGHJUHHRIDQWLJHQLFLW\,QFRQWUDVWV\QWKHWLFSRO\SHSWLGHVFRQWDLQLQJRUIHZHUDPLQRDFLGV
KDYHQRGHWHFWDEOHLPPXQRORJLFDFWLYLW\7KRVHFRQWDLQLQJRUDPLQRDFLGVKDYHYHU\OLWWOHLPPXQRORJLFDOWKRXJKIXOOELRORJLFDFWLYLW\7KLVSURSHUW\
RI&257526<170DVVXPHVDGGHGLPSRUWDQFHLQYLHZRIWKHNQRZQDQWLJHQLFLW\RIQDWXUDO$&7+

,1',&$7,216$1'86$*(
&257526<170FRV\QWURSLQIRU,QMHFWLRQLVLQWHQGHGIRUXVHDVDGLDJQRVWLFDJHQWLQWKHVFUHHQLQJRISDWLHQWVSUHVXPHGWRKDYHDGUHQRFRUWLFDOLQVXIILFLHQF\
%HFDXVHRILWVUDSLGHIIHFWRQWKHDGUHQDOFRUWH[LWPD\EHXWLOL]HGWRSHUIRUPDPLQXWHWHVWRIDGUHQDOIXQFWLRQSODVPDFRUWLVROUHVSRQVHDVDQRIILFHRU
RXWSDWLHQWSURFHGXUHXVLQJRQO\YHQLSXQFWXUHVVHH'26$*($1'$'0,1,675$7,21VHFWLRQ
6HYHUHK\SRIXQFWLRQRIWKHSLWXLWDU\DGUHQDOD[LVLVXVXDOO\DVVRFLDWHGZLWKVXEQRUPDOSODVPDFRUWLVROYDOXHVEXWDORZEDVDOOHYHOLVQRWSHUVHHYLGHQFHRI
DGUHQDOLQVXIILFLHQF\DQGGRHVQRWVXIILFHWRPDNHWKHGLDJQRVLV0DQ\SDWLHQWVZLWKSURYHQLQVXIILFLHQF\ZLOOKDYHQRUPDOEDVDOOHYHOVDQGZLOOGHYHORSVLJQVRI
LQVXIILFLHQF\RQO\ZKHQVWUHVVHG)RUWKLVUHDVRQDFULWHULRQZKLFKVKRXOGEHXVHGLQHVWDEOLVKLQJWKHGLDJQRVLVLVWKHIDLOXUHWRUHVSRQGWRDGHTXDWHFRUWLFRWURSLQ
VWLPXODWLRQ:KHQSUHVXPSWLYHDGUHQDOLQVXIILFLHQF\LVGLDJQRVHGE\DVXEQRUPDO&257526<170WHVWIXUWKHUVWXGLHVDUHLQGLFDWHGWRGHWHUPLQHLILWLVSULPDU\
RUVHFRQGDU\
3ULPDU\ DGUHQDO LQVXIILFLHQF\ $GGLVRQ¶V GLVHDVH LV WKH UHVXOW RI DQ LQWULQVLF GLVHDVH SURFHVV VXFK DV WXEHUFXORVLV ZLWKLQ WKH JODQG 7KH SURGXFWLRQ RI
DGUHQRFRUWLFDO KRUPRQHV LV GHILFLHQW GHVSLWH KLJK $&7+ OHYHOV IHHGEDFN PHFKDQLVP 6HFRQGDU\ RU UHODWLYH LQVXIILFLHQF\ DULVHV DV WKH UHVXOW RI GHIHFWLYH
SURGXFWLRQRI$&7+OHDGLQJLQWXUQWRGLVXVHDWURSK\RIWKHDGUHQDOFRUWH[,WLVFRPPRQO\VHHQIRUH[DPSOHDVUHVXOWRIFRUWLFRVWHURLGWKHUDS\6KHHKDQ¶V
V\QGURPHDQGSLWXLWDU\WXPRUVRUDEODWLRQ
7KHGLIIHUHQWLDWLRQRIERWKW\SHVLVEDVHGRQWKHSUHPLVHWKDWDSULPDULO\GHIHFWLYHJODQGFDQQRWEHVWLPXODWHGE\$&7+ZKHUHDVDVHFRQGDULO\GHIHFWLYHJODQGLV
SRWHQWLDOO\IXQFWLRQDODQGZLOOUHVSRQGWRDGHTXDWHVWLPXODWLRQZLWK$&7+3DWLHQWVVHOHFWHGIRUIXUWKHUVWXG\DVWKHUHVXOWRIDVXEQRUPDO&257526<170WHVW
VKRXOGEHJLYHQDRUGD\FRXUVHRIWUHDWPHQWZLWK5HSRVLWRU\&RUWLFRWURSLQ,QMHFWLRQ863DQGWKHQUHWHVWHG6XJJHVWHGGRVHVDUH863XQLWVWZLFHGDLO\IRU
GD\VRU863XQLWVWZLFHGDLO\IRUGD\V8QGHUWKHVHFRQGLWLRQVOLWWOHRUQRLQFUHDVHLQSODVPDFRUWLVROOHYHOVZLOOEHVHHQLQ$GGLVRQ¶VGLVHDVHZKHUHDV
KLJKHURUHYHQQRUPDOOHYHOVZLOOEHVHHQLQFDVHVZLWKVHFRQGDU\DGUHQDOLQVXIILFLHQF\
&2175$,1',&$7,21
7KHRQO\FRQWUDLQGLFDWLRQWR&257526<170FRV\QWURSLQIRU,QMHFWLRQLVDKLVWRU\RIDSUHYLRXVDGYHUVHUHDFWLRQWRLW

35(&$87,216

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI




*HQHUDO
&257526<170FRV\QWURSLQIRU,QMHFWLRQH[KLELWVVOLJKWLPPXQRORJLFDFWLYLW\GRHVQRWFRQWDLQDQLPDOSURWHLQDQGLVWKHUHIRUHOHVVULVN\WRXVHWKDQQDWXUDO
$&7+3DWLHQWVNQRZQWREHVHQVLWL]HGWRQDWXUDO$&7+ZLWKPDUNHGO\SRVLWLYHVNLQWHVWVZLOOZLWKIHZH[FHSWLRQVUHDFWQHJDWLYHO\ZKHQWHVWHGLQWUDGHUPDOO\ZLWK
&257526<170 0RVW SDWLHQWV ZLWK D KLVWRU\ RI D SUHYLRXV K\SHUVHQVLWLYLW\ UHDFWLRQ WR QDWXUDO $&7+ RU D SUHH[LVWLQJ DOOHUJLF GLVHDVH ZLOO WROHUDWH
&257526<170 'HVSLWH WKLV KRZHYHU &257526<170 LV QRW FRPSOHWHO\ GHYRLG RI LPPXQRORJLF DFWLYLW\ DQG K\SHUVHQVLWLYLW\ UHDFWLRQV LQFOXGLQJ UDUH
DQDSK\OD[LVDUHSRVVLEOH7KHUHIRUHWKHSK\VLFLDQVKRXOGEHSUHSDUHGSULRUWRLQMHFWLRQWRWUHDWDQ\SRVVLEOHDFXWHK\SHUVHQVLWLYLW\UHDFWLRQ

'UXJ,QWHUDFWLRQV
&RUWLFRWURSLQPD\DFFHQWXDWHWKHHOHFWURO\WHORVVDVVRFLDWHGZLWKGLXUHWLFWKHUDS\

&DUFLQRJHQHVLV0XWDJHQHVLV,PSDLUPHQWRI)HUWLOLW\
/RQJWHUPVWXGLHVLQDQLPDOVKDYHQRWEHHQSHUIRUPHGWRHYDOXDWHFDUFLQRJHQLFRUPXWDJHQLFSRWHQWLDORULPSDLUPHQWRIIHUWLOLW\$VWXG\LQUDWVQRWHGLQKLELWLRQRI
UHSURGXFWLYHIXQFWLRQOLNHQDWXUDO$&7+

3UHJQDQF\
3UHJQDQF\&DWHJRU\&$QLPDOUHSURGXFWLRQVWXGLHVKDYHQRWEHHQFRQGXFWHGZLWK&257526<170FRV\QWURSLQIRU,QMHFWLRQ,WLVDOVRQRWNQRZQZKHWKHU
&257526<170FDQFDXVHIHWDOKDUPZKHQDGPLQLVWHUHGWRDSUHJQDQWZRPDQRUFDQDIIHFWUHSURGXFWLRQFDSDFLW\&257526<170VKRXOGEHJLYHQWRD
SUHJQDQWZRPDQRQO\LIFOHDUO\QHHGHG

1XUVLQJ0RWKHUV
,W LV QRW NQRZQ ZKHWKHU WKLV GUXJ LV H[FUHWHG LQ KXPDQ PLON %HFDXVH PDQ\ GUXJV DUH H[FUHWHG LQ KXPDQ PLON FDXWLRQ VKRXOG EH H[HUFLVHG ZKHQ
&257526<170FRV\QWURSLQIRU,QMHFWLRQLVDGPLQLVWHUHGWRDQXUVLQJZRPDQ

3HGLDWULF8VH
6HH'26$*($1'$'0,1,675$7,21VHFWLRQ

$'9(56(5($&7,216
6LQFH &257526<170 FRV\QWURSLQ IRU ,QMHFWLRQ LV LQWHQGHG IRU GLDJQRVWLF DQG QRW WKHUDSHXWLF XVH DGYHUVH UHDFWLRQV RWKHU WKDQ D UDUH K\SHUVHQVLWLYLW\
UHDFWLRQDUHQRWDQWLFLSDWHG$UDUHK\SHUVHQVLWLYLW\UHDFWLRQXVXDOO\DVVRFLDWHGZLWKDSUHH[LVWLQJDOOHUJLFGLVHDVHDQGRUDSUHYLRXVUHDFWLRQWRQDWXUDO$&7+LV
SRVVLEOH6\PSWRPVPD\LQFOXGHVOLJKWZKHDOLQJZLWKVSORWFK\HU\WKHPDDWWKHLQMHFWLRQVLWH7KHUHKDYHEHHQUDUHUHSRUWVRIDQDSK\ODFWLFUHDFWLRQ7KHIROORZLQJ
DGYHUVHUHDFWLRQVKDYHEHHQUHSRUWHGLQSDWLHQWVDIWHUWKHDGPLQLVWUDWLRQRI&257526<170DQGWKHDVVRFLDWLRQKDVEHHQQHLWKHUFRQILUPHGQRUUHIXWHG
ƔEUDG\FDUGLD
ƔWDFK\FDUGLD
ƔK\SHUWHQVLRQ
ƔSHULSKHUDOHGHPD
ƔUDVK

'26$*($1'$'0,1,675$7,21
&257526<170FRV\QWURSLQIRU,QMHFWLRQPD\EHDGPLQLVWHUHGLQWUDPXVFXODUO\RUDVDGLUHFWLQWUDYHQRXVLQMHFWLRQZKHQXVHGDVDUDSLGVFUHHQLQJWHVWRI
DGUHQDO IXQFWLRQ ,W PD\ DOVR EH JLYHQ DV DQ LQWUDYHQRXV LQIXVLRQ RYHU D  WR  KRXU SHULRG WR SURYLGH D JUHDWHU VWLPXOXV WR WKH DGUHQDO JODQGV 'RVHV RI
&257526<170WRPJKDYHEHHQXVHGLQFOLQLFDOVWXGLHVDQGDPD[LPDOUHVSRQVHQRWHGZLWKWKHVPDOOHVWGRVH

$VXJJHVWHGPHWKRGIRUDUDSLGVFUHHQLQJWHVWRIDGUHQDOIXQFWLRQ KDVEHHQGHVFULEHGE\:RRGDQG$VVRFLDWHV$FRQWUROEORRGVDPSOHRIWRP/LV
FROOHFWHGLQDKHSDULQL]HGWXEH5HFRQVWLWXWHPJRI&257526<170ZLWKP/RI6RGLXP&KORULGH,QMHFWLRQ863DQGLQMHFWLQWUDPXVFXODUO\7KH
UHFRQVWLWXWHGGUXJSURGXFWVKRXOGEHLQVSHFWHGYLVXDOO\IRUSDUWLFXODWHPDWWHUDQGGLVFRORUDWLRQSULRUWRLQMHFWLRQ5HFRQVWLWXWHG&257526<170VKRXOGQRWEH
UHWDLQHG,QWKHSHGLDWULFSRSXODWLRQDJHG\HDUVRUOHVVDGRVHRIPJZLOORIWHQVXIILFH$VHFRQGEORRGVDPSOHLVFROOHFWHGH[DFWO\PLQXWHVODWHU%RWK
EORRGVDPSOHVVKRXOGEHUHIULJHUDWHGXQWLOVHQWWRWKHODERUDWRU\IRUGHWHUPLQDWLRQRIWKHSODVPDFRUWLVROUHVSRQVHE\VRPHDSSURSULDWHPHWKRG,ILWLVQRWSRVVLEOH
WRVHQGWKHPWRWKHODERUDWRU\RUSHUIRUPWKHIOXRULPHWULFSURFHGXUHZLWKLQKRXUVWKHQWKHSODVPDVKRXOGEHVHSDUDWHGDQGUHIULJHUDWHGRUIUR]HQDFFRUGLQJWR
QHHG

7ZRDOWHUQDWLYHPHWKRGVRIDGPLQLVWUDWLRQDUHLQWUDYHQRXVLQMHFWLRQDQGLQIXVLRQ&257526<170FDQEHLQMHFWHGLQWUDYHQRXVO\LQWRP/RIVDOLQHRYHUD
PLQXWH SHULRG :KHQ JLYHQ DV DQ LQWUDYHQRXV LQIXVLRQ &257526<170  PJ PD\ EH DGGHG WR JOXFRVH RU VDOLQH VROXWLRQV DQG JLYHQ DW WKH UDWH RI

&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



DSSUR[LPDWHO\PLFURJUDPVSHUKRXURYHUDKRXUSHULRG,WVKRXOGQRWEHDGGHGWREORRGRUSODVPDDVLWLVDSWWREHLQDFWLYDWHGE\HQ]\PHV$GUHQDOUHVSRQVH
PD\EHPHDVXUHGLQWKHXVXDOPDQQHUE\GHWHUPLQLQJXULQDU\VWHURLGH[FUHWLRQEHIRUHDQGDIWHUWUHDWPHQWRUE\PHDVXULQJSODVPDFRUWLVROOHYHOVEHIRUHDQGDWWKH
HQGRIWKHLQIXVLRQ7KHODWWHULVSUHIHUDEOHEHFDXVHWKHXULQDU\VWHURLGH[FUHWLRQGRHVQRWDOZD\VDFFXUDWHO\UHIOHFWWKHDGUHQDORUSODVPDFRUWLVROUHVSRQVHWR
$&7+

7KHXVXDOQRUPDOUHVSRQVHLQPRVWFDVHVLVDQDSSUR[LPDWHGRXEOLQJRIWKHEDVDOOHYHOSURYLGHGWKDWWKHEDVDOOHYHOGRHVQRWH[FHHGWKHQRUPDOUDQJH3DWLHQWV
UHFHLYLQJFRUWLVRQHK\GURFRUWLVRQHRUVSLURQRODFWRQHVKRXOGRPLWWKHLUSUHWHVWGRVHVRQWKHGD\VHOHFWHGIRUWHVWLQJ3DWLHQWVWDNLQJLQDGYHUWHQWGRVHVRIFRUWLVRQH
RUK\GURFRUWLVRQHRQWKHWHVWGD\DQGSDWLHQWVWDNLQJVSLURQRODFWRQHRUZRPHQWDNLQJGUXJVZKLFKFRQWDLQHVWURJHQPD\H[KLELWDEQRUPDOO\KLJKEDVDOSODVPD
FRUWLVROOHYHOV
$SDUDGR[LFDOUHVSRQVHPD\EHQRWHGLQWKHFRUWLVRQHRUK\GURFRUWLVRQHJURXSDVVHHQLQDGHFUHDVHLQSODVPDFRUWLVROYDOXHVIROORZLQJDVWLPXODWLQJGRVHRI
&257526<170
,QWKHVSLURQRODFWRQHRUHVWURJHQJURXS RQO\D QRUPDOLQFUHPHQWDOUHVSRQVHLVWREHH[SHFWHG0DQ\ SDWLHQWVZLWK QRUPDODGUHQDOIXQFWLRQ KRZHYHUGR QRW
UHVSRQGWRWKHH[SHFWHGGHJUHHVRWKDWWKHIROORZLQJFULWHULDKDYHEHHQHVWDEOLVKHGWRGHQRWHDQRUPDOUHVSRQVH

7KHFRQWUROSODVPDFRUWLVROOHYHOVKRXOGH[FHHGPLFURJUDPVP/
7KHPLQXWHOHYHOVKRXOGVKRZDQLQFUHPHQWRIDWOHDVWPLFURJUDPVP/DERYHWKHEDVDOOHYHO
7KHPLQXWHOHYHOVKRXOGH[FHHGPLFURJUDPVP/&RPSDUDEOHILJXUHVKDYHEHHQUHSRUWHGE\*UHLJDQGFRZRUNHUV

3ODVPDFRUWLVROOHYHOVXVXDOO\SHDNDERXWWRPLQXWHVDIWHUDQLQMHFWLRQRI&257526<170DQGVRPHSUHIHUWKHPLQXWHLQWHUYDOIRUWHVWLQJIRUWKLV
UHDVRQ:KLOHLWLVWUXHWKDWWKHPLQXWHYDOXHVDUHXVXDOO\KLJKHUWKDQWKHPLQXWHYDOXHVWKHGLIIHUHQFHPD\QRWEHVLJQLILFDQWHQRXJKLQPRVWFDVHVWR
RXWZHLJKWKHGLVDGYDQWDJHRIDORQJHUWHVWLQJSHULRG,IWKHPLQXWHWHVWSHULRGLVXVHGWKHFULWHULRQIRUDQRUPDOUHVSRQVHLVDQDSSUR[LPDWHGRXEOLQJRIWKH
EDVDOSODVPDFRUWLVROYDOXH

,QSDWLHQWVZLWKDUDLVHGSODVPDELOLUXELQRULQSDWLHQWVZKHUHWKHSODVPDFRQWDLQVIUHHKHPRJORELQIDOVHO\KLJKIOXRUHVFHQFHPHDVXUHPHQWVZLOOUHVXOW7KHWHVW
PD\EHSHUIRUPHGDWDQ\WLPHGXULQJWKHGD\EXWEHFDXVHRIWKHSK\VLRORJLFDOGLXUQDOYDULDWLRQRISODVPDFRUWLVROWKHFULWHULDOLVWHGE\:RRGFDQQRWDSSO\,WKDV
EHHQVKRZQWKDWEDVDOSODVPDFRUWLVROOHYHOVDQGWKHSRVW&257526<170LQFUHPHQWH[KLELWGLXUQDOFKDQJHV+RZHYHUWKHPLQXWHSODVPDFRUWLVROOHYHO
UHPDLQVXQFKDQJHGWKURXJKRXWWKHGD\VRWKDWRQO\WKLVVLQJOHFULWHULRQVKRXOGEHXVHG

3DUHQWHUDO GUXJ SURGXFWV VKRXOG EH LQVSHFWHG YLVXDOO\ IRU SDUWLFXODWH PDWWHU DQG GLVFRORUDWLRQ ZKHQHYHU VROXWLRQ DQG FRQWDLQHU SHUPLW 5HFRQVWLWXWHG
&257526<170VKRXOGQRWEHUHWDLQHG

+2:6833/,('
%R[RIYLDOVRI&257526<170FRV\QWURSLQIRU,QMHFWLRQPJ
1'&

6WRUDJH
6WRUHDW&)
&257526<170LVLQWHQGHGDVDVLQJOHGRVHLQMHFWLRQDQGFRQWDLQVQRDQWLPLFURELDOSUHVHUYDWLYH$Q\XQXVHGSRUWLRQVKRXOGEHGLVFDUGHG

5[RQO\

5()(5(1&(6
:RRG-%HWDO/$1&(7
*UHLJ:5HWDO-(1'2&5
0F*LOO3(HWDO$115+(80',6

$PSKDVWDU3KDUPDFHXWLFDOV,QF
5DQFKR&XFDPRQJD&$86$5(9





&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',;,,QYHVWLJDWRU%URFKXUH'HVR[LPHWDVRQH7RSLFDO6SUD\



&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



$33(1',;-$PHQGPHQWVWRWKH3URWRFRO

5HYLVLRQ
'DWH



7KHIROORZLQJUHYLVLRQVZHUHPDGHWRWKHSURWRFRO5HYLVLRQGDWHG
·
3DWLHQWHQUROOPHQWZDVFODULILHGWRLQFOXGH&RKRUWHQUROOPHQWVWDUWLQJZLWKWKHDGXOWSRSXODWLRQ
·
$PLQLPXPDJHJURXSRIPRQWKV±\HDURIDJHZDVDGGHGDV&RKRUW
·
7KHWRWDOSDWLHQWQXPEHUZDVXSGDWHGWRSDWLHQWVWRUHIOHFWWKHPD[LPXPDPRXQWRISDWLHQWV
WKDWFDQEHHQUROOHGLQHDFK&RKRUW
·
7KHUHTXLUHGFRPSOHWLRQDQGDQDO\VLVRIVHTXHQWLDOFRKRUWVZDVDGGUHVVHGWKURXJKRXWWKH
SURWRFRO
·
9LVLW)ROORZ8S3KRQH&DOOZDVDGGHGIRUDQDGGLWLRQDOVDIHW\FKHFNLQWKH6WXG\6FKHPDWLF
DQG6HFWLRQ
·
3ODVPDOHYHOEORRGDQDO\VLVGUDZVZHUHUHPRYHGIURPWKHSURWRFRO
·
$OOUHIHUHQFHWRSKDUPDFRNLQHWLFVZDVUHPRYHGIURPWKHSURWRFROLQFOXGLQJWKHWLWOH
·
6DIHW\ODEVLQFOXGLQJFOLQLFDOFKHPLVWU\DQGKHPDWRORJ\ZHUHDGGHGDW9LVLWDQG9LVLW6HH
$SSHQGL[(
·
5HPRYHG$SSOLFDWLRQRI0HGLFDWLRQRQ6LWHDW9LVLW
·
9LWDO6LJQVDQG3UHJQDQF\7HVWZHUHDGGHGWREHFRPSOHWHGDW9LVLWDQG
·
+3$$[LV6XSSUHVVLRQFULWHULDZDVGHILQHGLQ6HFWLRQ
·
&RPSOLDQFHGHILQLWLRQZDVXSGDWHG

5HYLVLRQ
'DWH



7KHIROORZLQJUHYLVLRQVZHUHPDGHWRWKHSURWRFRO5HYLVLRQGDWHG
·
7KHSRLQW,QYHVWLJDWRU6WDWLF*OREDO$VVHVVPHQW,6*$6FDOHZDVXSGDWHGWRDSRLQW
,QYHVWLJDWRU¶V*OREDO$VVHVVPHQW,*$6FDOH$SSHQGL[&
·
0LQRUFRUUHFWLRQVZHUHPDGHWRFODULI\$SSHQGL[HVLQWKHERG\RIWKHSURWRFRO

5HYLVLRQ
'DWH



7KHIROORZLQJUHYLVLRQVZHUHPDGHWRWKHSURWRFRO5HYLVLRQGDWHG
·
7KH9LVLWZLQGRZFKDQJHGIURPZLWKLQGD\VSULRUWRHQUROOPHQWWRZLWKLQGD\VSULRUWR
HQUROOPHQW


5HYLVLRQ
'DWH



7KHIROORZLQJUHYLVLRQVZHUHPDGHWRWKHSURWRFRO5HYLVLRQGDWHG
·
(UURUZDVFRUUHFWHGLQWKH6WXG\6FKHPDWLF
·
1RYXPDGGUHVVZDVXSGDWHG







&21),'(17,$/35272&2/
$Q2SHQ/DEHO6DIHW\6WXG\WR$VVHVVWKH3RWHQWLDOIRU$GUHQDO6XSSUHVVLRQ)ROORZLQJ0D[LPDO8VH7UHDWPHQW
ZLWK'HVR[LPHWDVRQH7RSLFDO6SUD\7DUR3KDUPDFHXWLFDOV86$,QFLQ3DWLHQWVZLWK$WRSLF'HUPDWLWLV


3URWRFRO'6;65HY¡6HSWHPEHU¡7DUR3KDUPDFHXWLFDOV86$,QF¡3DJHRI



5HYLVLRQ
'DWH



7KHIROORZLQJUHYLVLRQVZHUHPDGHWRWKHSURWRFRO5HYLVLRQGDWHG
·
8SGDWHGVDIHW\DQDO\VLVIRU+3$$[LVVXSSUHVVLRQZRUGLQJ
·
7DUR¶V6DIHW\&RQWDFWZDVXSGDWHG



5HYLVLRQ
'DWH



7KHIROORZLQJUHYLVLRQVZHUHPDGHWRWKHSURWRFRO5HYLVLRQGDWHG
·
$SSOLFDWLRQ6LWH5HDFWLRQV$SSHQGL['DGGHGWRWKHSURWRFRO
·
&OHULFDOFRUUHFWLRQVWKURXJKRXWWKHGRFXPHQW
·
3URWRFRO5HYLVLRQ$SSHQGL[-XSGDWHG
