Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL
Phase: PHASE3
Conditions: Leukemia, Acute Lymphoblastic
Sponsor: Amgen

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH7ULDOWR,QYHVWLJDWHWKH(IILFDF\
6DIHW\DQG7ROHUDELOLW\RIWKH%L7($QWLERG\%OLQDWXPRPDEDV&RQVROLGDWLRQ
7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV
:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU$FXWH/\PSKREODVWLF/HXNHPLD$//
$PJHQ3URWRFRO1XPEHU
(XGUD&7QXPEHU
1&71XPEHU
&OLQLFDO6WXG\6SRQVRU
$PJHQ,QF
2QH$PJHQ&HQWHU'ULYH
7KRXVDQG2DNV&DOLIRUQLD
8QLWHG6WDWHV
3KRQH
)D[
.H\6SRQVRU&RQWDFWV

&OLQLFDO5HVHDUFK0HGLFDO'LUHFWRU
3KRQH
(PDLO



&OLQLFDO5HVHDUFK0HGLFDO'LUHFWRU
3KRQH
(PDLO

 

*OREDO6WXG\0DQDJHPHQW
3KRQH

(PDLO

'DWH
-DQXDU\
$PHQGPHQW'DWH 
$SULO
$PHQGPHQW'DWH
6HSWHPEHU
$PHQGPHQW'DWH
$SULO
$PHQGPHQW'DWH
-XO\
$PHQGPHQW'DWH
'HFHPEHU
$PHQGPHQW'DWH
1RYHPEHU
$PHQGPHQW'DWH
'HFHPEHU
$PHQGPHQW'DWH
$XJXVW

7KLVSURWRFROZDVGHYHORSHGUHYLHZHGDQGDSSURYHGLQDFFRUGDQFHZLWK$PJHQ¶V
VWDQGDUGRSHUDWLQJSURFHGXUHV


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


&RQILGHQWLDOLW\1RWLFH
7KLVGRFXPHQWFRQWDLQVFRQILGHQWLDOLQIRUPDWLRQRI$PJHQ,QF
7KLVGRFXPHQWPXVWQRWEHGLVFORVHGWRDQ\RQHRWKHUWKDQWKHVLWHVWXG\VWDIIDQGPHPEHUVRIWKH
LQVWLWXWLRQDOUHYLHZERDUGLQGHSHQGHQWHWKLFVFRPPLWWHHLQVWLWXWLRQDOVFLHQWLILFUHYLHZERDUGRUHTXLYDOHQW
7KHLQIRUPDWLRQLQWKLVGRFXPHQWFDQQRWEHXVHGIRUDQ\SXUSRVHRWKHUWKDQWKHHYDOXDWLRQRUFRQGXFWRIWKH
FOLQLFDOLQYHVWLJDWLRQZLWKRXWWKHSULRUZULWWHQFRQVHQWRI$PJHQ,QF 
,I\RXKDYHTXHVWLRQVUHJDUGLQJKRZWKLVGRFXPHQWPD\EHXVHGRUVKDUHGFDOOWKH$PJHQ0HGLFDO
,QIRUPDWLRQQXPEHU$OOFRXQWULHVSOHDVHFDOOWKHORFDOWROOIUHH0HGLFDO,QIRUPDWLRQQXPEHUSURYLGHGE\
\RXUPRQLWRURU$PJHQ¶VJHQHUDOQXPEHULQWKH86)RUDOORWKHUVWXG\UHODWHGTXHVWLRQV
FRQWDFWWKH.H\6SRQVRU&RQWDFWV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


,QYHVWLJDWRU¶V$JUHHPHQW
,KDYHUHDGWKHDWWDFKHGSURWRFROHQWLWOHG³$5DQGRPL]HG2SHQODEHO&RQWUROOHG
3KDVH7ULDOWR,QYHVWLJDWHWKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7($QWLERG\
%OLQDWXPRPDEDV&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ
&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU$FXWH
/\PSKREODVWLF/HXNHPLD$//´GDWHG$XJXVWDQGDJUHHWRDELGHE\DOO
SURYLVLRQVVHWIRUWKWKHUHLQ
,DJUHHWRFRPSO\ZLWKWKH,QWHUQDWLRQDO&RXQFLOIRU+DUPRQLVDWLRQ,&+7ULSDUWLWH
*XLGHOLQHRQ*RRG&OLQLFDO3UDFWLFH*&3DQGDSSOLFDEOHQDWLRQDORUUHJLRQDO
UHJXODWLRQVJXLGHOLQHV
,DJUHHWRHQVXUHWKDW)LQDQFLDO'LVFORVXUH6WDWHPHQWVZLOOEHFRPSOHWHGE\

PHLQFOXGLQJLIDSSOLFDEOHP\VSRXVH>RUOHJDOSDUWQHU@DQGGHSHQGHQWFKLOGUHQ

P\VXELQYHVWLJDWRUVLQFOXGLQJLIDSSOLFDEOHWKHLUVSRXVHV>RUOHJDOSDUWQHUV@DQG
GHSHQGHQWFKLOGUHQ
DWWKHVWDUWRIWKHVWXG\DQGIRUXSWRRQH\HDUDIWHUWKHVWXG\LVFRPSOHWHGLIWKHUHDUH
FKDQJHVWKDWDIIHFWP\ILQDQFLDOGLVFORVXUHVWDWXV
,DJUHHWRHQVXUHWKDWWKHFRQILGHQWLDOLQIRUPDWLRQFRQWDLQHGLQWKLVGRFXPHQWZLOOQRWEH
XVHGIRUDQ\SXUSRVHRWKHUWKDQWKHHYDOXDWLRQRUFRQGXFWRIWKHFOLQLFDOLQYHVWLJDWLRQ
ZLWKRXWWKHSULRUZULWWHQFRQVHQWRI$PJHQ,QF 



6LJQDWXUH


1DPHRI,QYHVWLJDWRU

'DWH''0RQWK<<<<

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


3URWRFRO6\QRSVLV
7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH7ULDOWR,QYHVWLJDWHWKH(IILFDF\6DIHW\
DQG7ROHUDELOLW\RIWKH%L7($QWLERG\%OLQDWXPRPDEDV&RQVROLGDWLRQ7KHUDS\9HUVXV
&RQYHQWLRQDO&RQVROLGDWLRQ&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH
%SUHFXUVRU$FXWH/\PSKREODVWLF/HXNHPLD$//
6WXG\3KDVH
,QGLFDWLRQ3HGLDWULFVXEMHFWVLHXQGHUWKHDJHRIZLWKKLJKULVN+5ILUVWUHODSVH
%SUHFXUVRU$//
3ULPDU\2EMHFWLYH 

7RHYDOXDWHHYHQWIUHHVXUYLYDO()6DIWHUEOLQDWXPRPDEZKHQFRPSDUHGWRVWDQGDUGRI
FDUH62&FKHPRWKHUDS\C
6HFRQGDU\2EMHFWLYHV

7RHYDOXDWHWKHHIIHFWRIEOLQDWXPRPDERQRYHUDOOVXUYLYDO26ZKHQFRPSDUHGWR62&
FKHPRWKHUDS\

7RHYDOXDWHUHGXFWLRQLQPLQLPDOUHVLGXDOGLVHDVH05'DIWHUEOLQDWXPRPDEZKHQ
FRPSDUHGWR62&FKHPRWKHUDS\

7RHYDOXDWHWKHVDIHW\RIEOLQDWXPRPDEZKHQFRPSDUHGWR62&FKHPRWKHUDS\

7RHYDOXDWHWKHVDIHW\RIDOORJHQHLFKHPDWRSRLHWLFVWHPFHOOWUDQVSODQWDWLRQDOOR+6&7
DIWHUEOLQDWXPRPDEZKHQFRPSDUHGWRDOOR+6&7DIWHU62&FKHPRWKHUDS\

7RHYDOXDWHWKHSKDUPDFRNLQHWLFV3.RIEOLQDWXPRPDE
+\SRWKHVLV 
%OLQDWXPRPDEZLOOGHPRQVWUDWHDUHGXFWLRQLQWKHULVNRIHYHQWVUHODSVHRU0PDUURZDIWHU
KDYLQJDFKLHYHGDFRPSOHWHUHPLVVLRQ&5IDLOXUHWRDFKLHYHD&5DWWKHHQGRIWUHDWPHQW
VHFRQGPDOLJQDQF\RUGHDWKGXHWRDQ\FDXVHLQWKLVSHGLDWULFKLJKULVNILUVWUHODSVH$//
SRSXODWLRQ,WLVDQWLFLSDWHGWKDWWKHULVNUHGXFWLRQRIHYHQWVZLOOEHLQQRQFXUHGVXEMHFWV
DQGDFXUHUDWHLQFUHDVHIURPWRFXUHLVGHILQHGDVDVXEMHFWKDYLQJQR()6HYHQW
DIWHUPRQWKVRQVWXG\
3ULPDU\(QGSRLQW 

()6
6HFRQGDU\(QGSRLQWV 

26

05'UHVSRQVHGHILQHGDV05'OHYHODWWKHHQGRIWUHDWPHQWZLWKLQYHVWLJDWLRQDO
SURGXFWV

&XPXODWLYHLQFLGHQFHRIUHODSVH

,QFLGHQFHRIDGYHUVHHYHQWVERWKVHULRXVDQGQRQVHULRXVWUHDWPHQWUHODWHGDGYHUVH
HYHQWVDGYHUVHHYHQWVRILQWHUHVWFOLQLFDOO\VLJQLILFDQWFKDQJHVLQODERUDWRU\YDOXHV

6XUYLYDOVWDWXVDWGD\VIROORZLQJDOOR+6&7

,QFLGHQFHRIDQWLEOLQDWXPRPDEDQWLERG\IRUPDWLRQEOLQDWXPRPDEDUPRQO\

3KDUPDFRNLQHWLFVDPSOLQJIRUEOLQDWXPRPDEFRQFHQWUDWLRQVIRUSRSXODWLRQ3.DQDO\VLV

%OLQDWXPRPDEVWHDG\VWDWHFRQFHQWUDWLRQV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


6WXG\'HVLJQ 
$IWHULQGXFWLRQWKHUDS\DQGF\FOHVRIKLJKULVNFRQVROLGDWLRQDQG+&DQG+&
FKHPRWKHUDS\VXEMHFWVZLOOEHUDQGRPL]HGLQDUDWLRWRUHFHLYHDWKLUGFRQVROLGDWLRQFRXUVH
FRQVLVWLQJRIHLWKHUEOLQDWXPRPDE$UP$RUVWDQGDUGKLJKULVNFRQVROLGDWLRQ+&
FKHPRWKHUDS\$UP$0RVWVXEMHFWVZKRDUHLQRUDFKLHYHF\WRPRUSKRORJLFDO&5
0PDUURZDIWHUFRPSOHWLQJFRQVROLGDWLRQWKHUDS\LQDQ\WUHDWPHQWDUPZLOOXQGHUJRDOOR+6&7
)ROORZLQJDOOR+6&7VXEMHFWVZLOOEHIROORZHGIRUGLVHDVHDQGVXUYLYDOVWDWXVXQWLOWKHODVWVXEMHFW
RQVWXG\LVPRQWKVIROORZLQJDOOR+6&7RUKDVGLHGZKLFKHYHULVILUVW
6DPSOH6L]HVXEMHFWV
6XPPDU\RI6XEMHFW(OLJLELOLW\&ULWHULD 
7KLVVWXG\VHHNVSHGLDWULFVXEMHFWVDJHGGD\VDQG\HDUVZLWKKLJKULVNILUVWUHODSVH
%SUHFXUVRU$//DVGHILQHGE\,QWHUQDWLRQDO%HUOLQ)UDQNIXUW0XHQVWHUVWXG\JURXS
>,%)06*@,QW5H$//FULWHULD6XEMHFWVZLOOKDYH0RU0PDUURZDWWKHWLPHRIUDQGRPL]DWLRQ
6XEMHFWVZLWKFOLQLFDOO\UHOHYDQWFHQWUDOQHUYRXVV\VWHP&16SDWKRORJ\UHTXLULQJWUHDWPHQWVXFK
DVXQVWDEOHHSLOHSV\ZLOOEHH[FOXGHG
)RUDIXOOOLVWRIHOLJLELOLW\FULWHULDSOHDVHUHIHUWR6HFWLRQ
,QYHVWLJDWLRQDO3URGXFW
$PJHQ,QYHVWLJDWLRQDO3URGXFW'RVDJHDQG$GPLQLVWUDWLRQ
%OLQDWXPRPDELVDGPLQLVWHUHGDVDFRQWLQXRXVLQWUDYHQRXVLQIXVLRQ&,9,2QHF\FOHRI
EOLQDWXPRPDEWUHDWPHQWLQFOXGHVZHHNVRI&,9,RIEOLQDWXPRPDE$OOR+6&7FDQEHFRQGXFWHG
DQ\WLPHDIWHUFRPSOHWLRQRIWKHEOLQDWXPRPDELQIXVLRQ
6XEMHFWVUDQGRPL]HGWRWKHEOLQDWXPRPDEDUPZLOOEHGRVHGDWȝJPGD\
)RUGHWDLOHGLQIRUPDWLRQUHJDUGLQJGRVHDQGVFKHGXOHSOHDVHVHH 6HFWLRQ
1RQ$PJHQ,QYHVWLJDWLRQDO3URGXFW'RVDJHDQG$GPLQLVWUDWLRQ
+&LVWKHVWDQGDUGLQWHQVLYHFRQVROLGDWLRQFKHPRWKHUDS\FRXUVHEDVHGRQPRGLILFDWLRQVWRWKH
$//$VVRFLD]RQH,WDOLDQD(PDWRORJLFD2QFRORJLD3HGLDWULFD%HUOLQ)UDQNOLQ0XQVWHU
$,(23%)0+5FRXUVH+&ZLOOEHFRQVLGHUHGQRQ$PJHQLQYHVWLJDWLRQDOSURGXFW
)RUGHWDLOHGLQIRUPDWLRQUHJDUGLQJGRVHDQGVFKHGXOHRIWKHVHWUHDWPHQWRSWLRQVSOHDVHVHH 
6HFWLRQ
3URFHGXUHV 
)RUDIXOOOLVWRIVWXG\SURFHGXUHVLQFOXGLQJWKHWLPLQJRIHDFKSURFHGXUHSOHDVHUHIHUWR
6HFWLRQDQGWKH6FKHGXOHRI$VVHVVPHQWV7DEOH
6WDWLVWLFDO&RQVLGHUDWLRQV
*HQHUDO$SSURDFK
7KHSULPDU\DQDO\VLVRIHIILFDF\ZLOOEHSHUIRUPHGRQDOOUDQGRPL]HGVXEMHFWVDQDO\]HGDFFRUGLQJ
WRWKHLUUDQGRPL]HGWUHDWPHQWDVVLJQPHQWWKH)XOO$QDO\VLV6HW7KHSULPDU\DQDO\VLVRIVDIHW\
ZLOOEHSHUIRUPHGRQWKH6DIHW\$QDO\VLV6HWZKLFKZLOOLQFOXGHDOOVXEMHFWVZKRUHFHLYHGDQ\
SURWRFROVSHFLILHGWKHUDS\DQDO\]HGDFFRUGLQJWRWKHWUHDWPHQWWKH\UHFHLYHG
6DPSOH6L]H&RQVLGHUDWLRQV
,IWKHVWXG\REVHUYHVHYHQWVLQWKH)XOO$QDO\VLV6HWLWZLOOEHSRZHUHGDWDSSUR[LPDWHO\
IRUDVLGHGORJUDQNWHVWZLWKDQRYHUDOODOSKDRIXQGHUDUDQGRPL]DWLRQUDWLRD
FRQWUROWUXHFXUHUDWHRIDFRQWUROWUXHPHGLDQ()6RIPRQWKVDPRQJQRQFXUHGVXEMHFWV
DWUXHWUHDWPHQWFXUHUDWHRIDQGDWUXHWUHDWPHQWPHGLDQ()6RIPRQWKVDPRQJ
QRQFXUHGVXEMHFWVDQRQFXUHGKD]DUGUDWLRRI7RREVHUYHHYHQWVWKHVWXG\ZLOO
UDQGRPL]HDSSUR[LPDWHO\VXEMHFWVGXULQJDQDSSUR[LPDWHPRQWKHQUROOPHQWSHULRGZLWK

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


HDFKVXEMHFWIROORZHGXQWLOWKHODVWVXEMHFWRQVWXG\LVPRQWKVIROORZLQJDOOR+6&7RUXQWLO
GHDWKZKLFKHYHURFFXUVILUVW
$QDO\VLVRI3ULPDU\(QGSRLQW
$VLGHGVWUDWLILHGORJUDQNWHVWVWUDWLILHGE\WKHUDQGRPL]DWLRQIDFWRUVZLOOEHXVHGWRGHWHUPLQH
LI()6LVVXSHULRULQWKHEOLQDWXPRPDEJURXSFRPSDUHGWRWKH62&FKHPRWKHUDS\JURXS
$GGLWLRQDODQDO\VHVZLOOLQFOXGHHVWLPDWLQJDKD]DUGUDWLRZLWKFRQILGHQFHLQWHUYDOIURPD
VWUDWLILHG&R[UHJUHVVLRQPRGHODQGHVWLPDWLQJ.DSODQ0HLHUFXUYHVDQGTXDUWLOHVE\JURXS
,QWHULP$QDO\VHV
7KLVVWXG\KDVLQWHULPDQDO\VHVSODQQHGWRDVVHVVEHQHILWZKHQDSSUR[LPDWHO\DQGRI
WKHWRWDOQXPEHURI()6HYHQWVKDYHEHHQREVHUYHG6WRSSLQJIRUEHQHILWZLOOEHEDVHGRQWKH
2¶%ULHQ)OHPLQJPHPEHURIWKHIDPLO\RI/DQ'H0HWVDOSKDVSHQGLQJIXQFWLRQV
WKHFULWLFDOSYDOXHVFRUUHVSRQGLQJWRWKLVVSHQGLQJIXQFWLRQDUHIRUWKHLQWHULP
DQDO\VLVIRUWKHLQWHULPDQDO\VLVDQGIRUWKHSULPDU\DQDO\VLVLIWKHLQWHULP
DQDO\VHVRFFXUSUHFLVHO\DWDQGHYHQWV$QLQGHSHQGHQW'0&H[WHUQDOWR
$PJHQZLOORYHUVHHWKHLQWHULPDQDO\VHVDQGDOVRDVVHVVVDIHW\DWUHJXODULQWHUYDOVGXULQJWKH
FRXUVHRIWKHVWXG\
)RUDIXOOGHVFULSWLRQRIVWDWLVWLFDODQDO\VLVPHWKRGVSOHDVHUHIHUWR6HFWLRQ
6SRQVRU$PJHQ,QF
'DWD(OHPHQW6WDQGDUGV
9HUVLRQV'DWHV
9HUVLRQ2FWREHU


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


6WXG\'HVLJQDQG7UHDWPHQW6FKHPD


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


6WXG\*ORVVDU\
$EEUHYLDWLRQRU7HUP
'HILQLWLRQ([SODQDWLRQ
$,(23%)0
$VVRFLD]RQH,WDOLDQD(PDWRORJLFD2QFRORJLD
3HGLDWULFD%HUOLQ)UDQNOLQ0XQVWHU
$1&
DEVROXWHQHXWURSKLOFRXQW
$//
DFXWHO\PSKREODVWLFOHXNHPLD
DOOR+6&7
DOORJHQHLFKHPDWRSRLHWLFVWHPFHOOWUDQVSODQWDWLRQ
$/7
DODQLQHDPLQRWUDQVIHUDVH
$65
DQQXDOVDIHW\UHSRUW
$67
DVSDUWDWHDPLQRWUDQVIHUDVH
%$//
%SUHFXUVRUDFXWHO\PSKREODVWLFOHXNHPLD
%L7(
%LVSHFLILF7FHOOHQJDJHUV
%6$
ERG\VXUIDFHDUHD
&&5
FRQWLQXRXVFRPSOHWHUHPLVVLRQ
&,9,
FRQWLQXRXVLQWUDYHQRXVLQIXVLRQ
&16
FHQWUDOQHUYRXVV\VWHP
&2*
&KLOGUHQ¶V2QFRORJ\*URXS
&5
FRPSOHWHUHPLVVLRQ
&5K
FRPSOHWHUHPLVVLRQZLWKSDUWLDOKHPDWRORJLFDOUHFRYHU\
&56
F\WRNLQHUHOHDVHV\QGURPH
&6)
FHUHEURVSLQDOIOXLG
&VV
VWHDG\VWDWHVHUXPFRQFHQWUDWLRQ
&7&$(
FRPPRQWHUPLQRORJ\FULWHULDIRUDGYHUVHHYHQWV
',/,
GUXJLQGXFHGOLYHULQMXU\
'/7
GRVHOLPLWLQJWR[LFLW\
'0&
GDWDPRQLWRULQJFRPPLWWHH
'685
GHYHORSPHQWVDIHW\XSGDWHUHSRUW
H&5)
HOHFWURQLFFDVHUHSRUWIRUP
('&
HOHFWURQLFGDWDFDSWXUH
()6
HYHQWIUHHVXUYLYDO
(0$
(XURSHDQ0HGLFLQHV$JHQF\
HQGRIVWXG\IRULQGLYLGXDO
VXEMHFW
GHILQHGDVWKHODVWGD\WKDWSURWRFROVSHFLILHGDVVHVVPHQWVDUH
FRQGXFWHGIRUDQLQGLYLGXDOVXEMHFW
HQGRIWUHDWPHQWSKDVH
GHILQHGDVWKHODVWDVVHVVPHQWIRUWKHSURWRFROVSHFLILHGWUHDWPHQW
SKDVHRIWKHVWXG\IRUDQLQGLYLGXDOVXEMHFW
HQGRIVWXG\SULPDU\
FRPSOHWLRQ
GHILQHGDVZKHQWKHODVWVXEMHFWLVDVVHVVHGRUUHFHLYHVDQ
LQWHUYHQWLRQIRUWKHSXUSRVHVRIILQDOFROOHFWLRQRIGDWDIRUWKHSULPDU\
HQGSRLQW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$EEUHYLDWLRQRU7HUP
'HILQLWLRQ([SODQDWLRQ
HQGRIVWXG\HQGRIWULDO GHILQHGDVZKHQWKHODVWVXEMHFWLVDVVHVVHGRUUHFHLYHVDQ
LQWHUYHQWLRQIRUHYDOXDWLRQLQWKHVWXG\LQFOXGLQJIROORZXS
DVVHVVPHQWV
H6$(
HOHFWURQLFVHULRXVDGYHUVHHYHQW
*&6)
JUDQXORF\WHFRORQ\VWLPXODWLQJIDFWRU
*0$//
*HUPDQ0XOWLFHQWHU*URXSIRU$GXOW$FXWH/\PSKREODVWLF/HXNHPLD
*Y+'
JUDIWYHUVXVKRVWGLVHDVH
+&
KLJKULVNFRQVROLGDWLRQ
+&
KLJKULVNFRQVROLGDWLRQ
+&
KLJKULVNFRQVROLGDWLRQ
+5
KLJKULVN
,%)0
,QWHUQDWLRQDO%HUOLQ)UDQNIXUW0XHQVWHUVWXG\JURXS
,&)
LQIRUPHGFRQVHQWIRUP
,&+*&3
,QWHUQDWLRQDO&RXQFLOIRU+DUPRQL]DWLRQ*XLGHOLQHIRU*RRG&OLQLFDO
3UDFWLFH
,*
LPPXQRJOREXOLQ
,3,0
LQYHVWLJDWLRQDOSURGXFWLQVWUXFWLRQPDQXDO
,9
LQWUDYHQRXV
,9,*
,QWUDYHQRXVLPPXQRJOREXOLQ
,956
,QWHJUDWHG9RLFH5HVSRQVH6\VWHP
,5%,(&
LQVWLWXWLRQDOUHYLHZERDUGLQGHSHQGHQWHWKLFVFRPPLWWHH
.0
.DSODQ0HLHU
.63
NH\VDIHW\SDUDPHWHUV
0
%RQHPDUURZEODVWSHUFHQWDJH
0
%RQHPDUURZEODVWSHUFHQWDJHDQG

05'
PLQLPDOUHVLGXDOGLVHDVH
07'
PD[LPXPWROHUDWHGGRVH
07;
PHWKRWUH[DWH
1+/
QRQ+RGJNLQVO\PSKRPD
26
RYHUDOOVXUYLYDO
3&5
SRO\PHUDVHFKDLQUHDFWLRQ
3K
3KLODGHOSKLDFKURPRVRPHQHJDWLYH
3K
3KLODGHOSKLDFKURPRVRPHSRVLWLYH
3.
SKDUPDFRNLQHWLF
3URWRFROUHTXLUHGWKHUDS\ PHGLFDWLRQVLQFOXGLQJSUHSKDVHWKHUDSLHVUHTXLUHGWREH
DGPLQLVWHUHGSHUSURWRFRO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$EEUHYLDWLRQRU7HUP
'HILQLWLRQ([SODQDWLRQ
3URWRFROVSHFLILHG
WKHUDS\
WUHDWPHQWDVVLJQHGE\UDQGRPL]DWLRQSULRUWRVWXG\GD\
HJEOLQDWXPRPDERUVWDQGDUGRIFDUHFKHPRWKHUDS\
55
UHODSVHGUHIUDFWRU\
6RXUFH'DWD
,QIRUPDWLRQIURPDQRULJLQDOUHFRUGRUFHUWLILHGFRS\RIWKHRULJLQDO
UHFRUGFRQWDLQLQJSDWLHQWLQIRUPDWLRQIRUXVHLQFOLQLFDO
UHVHDUFK7KHLQIRUPDWLRQPD\LQFOXGHEXWLVQRWOLPLWHGWRFOLQLFDO
ILQGLQJVREVHUYDWLRQVRURWKHUDFWLYLWLHVLQDFOLQLFDOWULDOQHFHVVDU\
IRUWKHUHFRQVWUXFWLRQDQGHYDOXDWLRQRIWKHWULDO6RXUFHGDWDDUH
FRQWDLQHGLQVRXUFHGRFXPHQWVRULJLQDOUHFRUGVRUFHUWLILHGFRSLHV
,&+*XLGHOLQH(([DPSOHVRIVRXUFHGDWDLQFOXGH6XEMHFW
LGHQWLILFDWLRQ5DQGRPL]DWLRQLGHQWLILFDWLRQDQG6WUDWLILFDWLRQ9DOXH
62&
VWDQGDUGRIFDUH
65
VWDQGDUGULVN
VWXG\GD\
GHILQHGDVWKHILUVWGD\WKDWSURWRFROVSHFLILHGWKHUDS\LV
DGPLQLVWHUHGWRWKHVXEMHFW
7%/
WRWDOELOLUXELQ
7&5
7FHOOUHFHSWRU
7.,
W\URVLQHNLQDVHLQKLELWRU
:%&
ZKLWHEORRGFHOO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7$%/(2)&217(176
3URWRFRO6\QRSVLV 
6WXG\'HVLJQDQG7UHDWPHQW6FKHPD 
6WXG\*ORVVDU\ 
 
2%-(&7,9(6 
 
3ULPDU\ 
 
6HFRQGDU\ 
 
([SORUDWRU\ 
 
%$&.*5281'$1'5$7,21$/( 
 
'LVHDVH 
 
3URJQRVWLF)DFWRUV 
 
7UHDWPHQW 
 
5HVXOWVRI&XUUHQW7UHDWPHQW5HJLPHQVDQG8QPHW
0HGLFDO1HHGV 
 
4XDQWLILFDWLRQRI0LQLPDO5HVLGXDO'LVHDVH 
 
6FKHGXOHIRU05'4XDQWLILFDWLRQRI05' 
 
05'4XDQWLILFDWLRQE\3&5 
 
05'4XDQWLILFDWLRQE\0XOWLFRORU)ORZ&\WRPHWU\ 
 
%OLQDWXPRPDE%DFNJURXQG 
 
%OLQDWXPRPDE&OLQLFDO6WXGLHV 
 
$GXOWV 
 
3HGLDWULF 
 
5DWLRQDOHIRU%OLQDWXPRPDE'RVH6HOHFWLRQ 
 
,QGXFWLRQDQG&RQVROLGDWLRQ+LJKULVN3URWRFROV 
 
3HGLDWULF5LVN$VVHVVPHQW 
 
5DWLRQDOH 
 
&OLQLFDO+\SRWKHVHV 
 
(;3(5,0(17$/3/$1 
 
6WXG\'HVLJQ 
 
1XPEHURI6LWHV 
 
1XPEHURI6XEMHFWV 
 
5HSODFHPHQWRI6XEMHFWV 
 
(VWLPDWHG6WXG\'XUDWLRQ 
 
6WXG\'XUDWLRQIRU6XEMHFWV 
 
(QGRI6WXG\ 
 
68%-(&7(/,*,%,/,7< 
 
,QFOXVLRQ&ULWHULD 
 
([FOXVLRQ&ULWHULD 
 
68%-(&7(152//0(17 

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


 
75($70(17352&('85(6 
 
&ODVVLILFDWLRQRI3URGXFWVDQGRU0HGLFDO'HYLFHV 
 
%OLQDWXPRPDE 
 
'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH 
 
%OLQDWXPRPDE,QSDWLHQW'RVLQJ 
 
%OLQDWXPRPDE2XWSDWLHQW'RVLQJ 
 
'RVDJH$GMXVWPHQWV'HOD\V5XOHVIRU:LWKKROGLQJRU
5HVWDUWLQJ3HUPDQHQW'LVFRQWLQXDWLRQRI
%OLQDWXPRPDE 
 
,QIXVLRQ,QWHUUXSWLRQ'RVH0RGLILFDWLRQRI
%OLQDWXPRPDEGXHWR$GYHUVH(YHQWV 
 
,QIXVLRQ,QWHUUXSWLRQ'RVH0RGLILFDWLRQRI
%OLQDWXPRPDEGXHWR1HXURORJLF(YHQWV 
 
&ULWHULDIRU'LVFRQWLQXDWLRQRI
%OLQDWXPRPDE 
 
6WDQGDUGRI&DUH&KHPRWKHUDS\ 
 
'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH 
 
'RVDJH$GMXVWPHQWV'HOD\V5XOHVIRU:LWKKROGLQJRU
5HVWDUWLQJ3HUPDQHQW'LVFRQWLQXDWLRQRI6WDQGDUGRI
&DUH 
 
&ULWHULDIRU'LVFRQWLQXDWLRQRI6WDQGDUGRI&DUH 
 
&RQFRPLWDQW7KHUDS\ 
 
2EOLJDWRU\3UHPHGLFDWLRQ3ULRUWR7UHDWPHQW 
 
,QWUDWKHFDO&KHPRWKHUDS\3ULRUWR
%OLQDWXPRPDEDQG6WDQGDUGRI&DUH
+& 
 
'H[DPHWKDVRQH3UHPHGLFDWLRQIRU
%OLQDWXPRPDE 
 
,QWUDWKHFDO&KHPRWKHUDS\DW'D\ 
 
6XSSRUWLYH&DUH*XLGHOLQHV 
 
6XSSRUWLYH&DUH*XLGHOLQHVIRU
%OLQDWXPRPDE 
 
6XSSRUWLYH&DUH*XLGHOLQHVIRU6WDQGDUG
RI&DUH 
 
0HGLFDO'HYLFHV 
 
3URGXFW&RPSODLQWV 
 
([FOXGHG7UHDWPHQWVDQGRU3URFHGXUHV'XULQJ6WXG\3HULRG 
 
678'<352&('85(6 
 
6FKHGXOHRI$VVHVVPHQWV 
 
*HQHUDO6WXG\3URFHGXUHV 
 
6FUHHQLQJ3UH3KDVH 
 
5DQGRPL]DWLRQ 
 
7UHDWPHQW 
 
6DIHW\)ROORZXS9LVLW 

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


 
6KRUWWHUP(IILFDF\)ROORZXS 
 
/RQJWHUP)ROORZXS 
 
/DQVN\.DUQRIVN\3HUIRUPDQFH6WDWXV 
 
3K\VLFDO([DPLQDWLRQ 
 
9LWDO6LJQV 
 
1HXURORJLFDO([DPLQDWLRQ 
 
%RQH0DUURZ%LRSV\$VSLUDWLRQ 
 
.H\6DIHW\3DUDPHWHUV 
 
'LVHDVH6XUYLYDO6WDWXV 
 
/DERUDWRU\$VVHVVPHQWV 
 
$QWLERG\7HVWLQJ3URFHGXUHV 
 
3KDUPDFRNLQHWLF$VVHVVPHQWV 
 
6DPSOH6WRUDJHDQG'HVWUXFWLRQ 
 
:,7+'5$:$/)52075($70(17352&('85(6$1'678'< 
 
6XEMHFWV¶'HFLVLRQWR:LWKGUDZ 
 
,QYHVWLJDWRURU6SRQVRU'HFLVLRQWR:LWKGUDZRU7HUPLQDWH
6XEMHFWV¶3DUWLFLSDWLRQ3ULRUWR6WXG\&RPSOHWLRQ 
 
5HDVRQVIRU5HPRYDO)URP7UHDWPHQW 
 
5HDVRQVIRU5HPRYDO)URP6WXG\ 
 
6$)(7<'$7$&2//(&7,215(&25',1*$1'5(3257,1* 
 
$GYHUVH(YHQWV 
 
'HILQLWLRQRI$GYHUVH(YHQWV 
 
(YHQWV0HHWLQJWKH$GYHUVH(YHQW
'HILQLWLRQ 
 
(YHQWV1270HHWLQJWKH$GYHUVH(YHQW
'HILQLWLRQ 
 
'HILQLWLRQRI6HULRXV$GYHUVH(YHQWV 
 
5HSRUWLQJRI$GYHUVH(YHQWV 
 
5HSRUWLQJ3URFHGXUHVIRU$GYHUVH(YHQWV7KDWGRQRW
0HHW6HULRXV&ULWHULD 
 
5HSRUWLQJ3URFHGXUHVIRU6HULRXV$GYHUVH(YHQWV 
 
6HULRXV$GYHUVH(YHQWV$IWHUWKH3URWRFROUHTXLUHG
5HSRUWLQJ3HULRG 
 
5HSRUWLQJD6DIHW\(QGSRLQWDVD6WXG\(QGSRLQW 
 
0HWKRGRI'HWHFWLQJ$GYHUVH(YHQWVDQG6HULRXV
$GYHUVH(YHQWV 
 
)ROORZXSRI$GYHUVH(YHQWVDQG6HULRXV$GYHUVH
(YHQWV 
 
5HJXODWRU\5HSRUWLQJ5HTXLUHPHQWVIRU6HULRXV
$GYHUVH(YHQWV 
 
6DIHW\0RQLWRULQJ3ODQ 
 
3UHJQDQF\DQG/DFWDWLRQ5HSRUWLQJ 

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


 
67$7,67,&$/&216,'(5$7,216 
 
6WXG\(QGSRLQWV$QDO\VLV6HWVDQG&RYDULDWHV 
 
6WXG\(QGSRLQWV 
 
3ULPDU\(QGSRLQW 
 
6HFRQGDU\(QGSRLQWV 
 
([SORUDWRU\(QGSRLQW 
 
$QDO\VLV6HWV 
 
&RYDULDWHVDQG6XEJURXSV 
 
6DPSOH6L]H&RQVLGHUDWLRQV 
 
3ODQQHG$QDO\VHV 
 
,QWHULP$QDO\VHV 
 
'DWD0RQLWRULQJ&RPPLWWHH 
 
3ULPDU\$QDO\VLV 
 
)LQDO$QDO\VLV 
 
3ODQQHG0HWKRGVRI$QDO\VLV 
 
*HQHUDO&RQVLGHUDWLRQV 
 
3ULPDU\(IILFDF\(QGSRLQW 
 
6HFRQGDU\(IILFDF\(QGSRLQWV 
 
3KDUPDFRNLQHWLF(QGSRLQWV 
 
6DIHW\(QGSRLQWV 
 
5(*8/$725<2%/,*$7,216 
 
,QIRUPHG&RQVHQW 
 
,QVWLWXWLRQDO5HYLHZ%RDUG,QGHSHQGHQW(WKLFV&RPPLWWHH 
 
6XEMHFW&RQILGHQWLDOLW\ 
 
,QYHVWLJDWRU6LJQDWRU\2EOLJDWLRQV 
 
$'0,1,675$7,9($1'/(*$/2%/,*$7,216 
 
3URWRFRO$PHQGPHQWVDQG6WXG\7HUPLQDWLRQ 
 
6WXG\'RFXPHQWDWLRQDQG$UFKLYH 
 
6WXG\0RQLWRULQJDQG'DWD&ROOHFWLRQ 
 
,QYHVWLJDWRU5HVSRQVLELOLWLHVIRU'DWD&ROOHFWLRQ 
 
/DQJXDJH 
 
3XEOLFDWLRQ3ROLF\ 
 
&RPSHQVDWLRQ 
 
5()(5(1&(6 
 
$33(1',&(6 

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


/LVWRI7DEOHV
7DEOH(0$$SSURYHG'UXJVIRUWKH7UHDWPHQWRI$// 
7DEOH'HILQLWLRQRI7LPH3RLQWRI5HODSVH,QW5H$//*URXS 
7DEOH'HILQLWLRQRI6LWHRI5HODSVH,QW5H$//*URXS 
7DEOH'HILQLWLRQRI,QW5H$//65+55LVN*URXSV,QW5H$//
*URXS 
7DEOH6\VWHPLF&KHPRWKHUDS\&RPSRQHQWVRI+&+&DQG+& 
7DEOH2EOLJDWRU\7ULSOH,QWUDWKHFDO&KHPRWKHUDS\3ULRUWR7UHDWPHQW 
7DEOH5HFRPPHQGHG)HYHU0DQDJHPHQW0LWLJDWLRQV 
7DEOH5HFRPPHQGHG$QWLIXQJDO3URSK\OD[LVIRU6WDQGDUGRI&DUH 
7DEOH6FKHGXOHRI$VVHVVPHQWV 
7DEOH7LPLQJRI()6(YHQW 
7DEOH/DERUDWRU\$QDO\WH/LVWLQJ 
/LVWRI)LJXUHV
)LJXUH0RGHRI$FWLRQRI%OLQDWXPRPDE 
)LJXUH,QW5H$//+5+&&RXUVH0RGLILHG%)0+5 
)LJXUH,QW5H$//+5+&&RXUVH0RGLILHG%)0+5 
)LJXUH,QW5H$//+5+&&RXUVH0RGLILHG%)0+5 
)LJXUH%OLQDWXPRPDE7UHDWPHQW&\FOH 
)LJXUH+&'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH 
/LVWRI$SSHQGLFHV
$SSHQGL[$$GGLWLRQDO6DIHW\$VVHVVPHQW,QIRUPDWLRQ 
$SSHQGL[%6DPSOH(OHFWURQLF6HULRXV$GYHUVH(YHQW&RQWLQJHQF\5HSRUW
)RUPSDSHUEDVHGIRUP 
$SSHQGL[&3UHJQDQF\1RWLILFDWLRQ)RUP 
$SSHQGL['/DFWDWLRQ1RWLILFDWLRQ)RUP 
$SSHQGL[(3UHJQDQF\DQG&RQWUDFHSWLYH*XLGHOLQHV 
$SSHQGL[).DUQRIVN\DQG/DQVN\3HUIRUPDQFH6WDWXV6FDOHV 
$SSHQGL[*&ULWHULDDQG'HILQLWLRQVIRU'LVHDVH6WDWXV$VVHVVPHQW 
$SSHQGL[+&OLQLFDOO\5HOHYDQW1HXURORJLF(YHQWVE\+LJKOHYHO*URXS7HUP
+/*7 

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



2%-(&7,9(6

3ULPDU\
7RHYDOXDWHHYHQWIUHHVXUYLYDO()6DIWHUEOLQDWXPRPDEZKHQFRPSDUHGWRVWDQGDUGRI
FDUH62&FKHPRWKHUDS\ 

6HFRQGDU\

7RHYDOXDWHWKHHIIHFWRIEOLQDWXPRPDERQRYHUDOOVXUYLYDO26ZKHQFRPSDUHG
WR62&FKHPRWKHUDS\

7RHYDOXDWHUHGXFWLRQLQPLQLPDOUHVLGXDOGLVHDVH05'DIWHUEOLQDWXPRPDE
ZKHQFRPSDUHGWR62&FKHPRWKHUDS\ 

7RHYDOXDWHWKHVDIHW\RIEOLQDWXPRPDEZKHQFRPSDUHGWR62&FKHPRWKHUDS\ 

7RHYDOXDWHWKHVDIHW\RIDOORJHQHLFKHPDWRSRLHWLFVWHPFHOOWUDQVSODQWDWLRQ
DOOR+6&7DIWHUEOLQDWXPRPDEZKHQFRPSDUHGWRDOOR+6&7DIWHU62&
FKHPRWKHUDS\ 

7RHYDOXDWHWKHSKDUPDFRNLQHWLFV3.RIEOLQDWXPRPDE 

([SORUDWRU\
$UHWURVSHFWLYHUHYLHZRI&'VWDWXVDWUHODSVH

%$&.*5281'$1'5$7,21$/(

'LVHDVH
3HGLDWULFDFXWHO\PSKREODVWLFOHXNHPLD$//LVDKHWHURJHQHRXVKHPDWRORJLF
PDOLJQDQF\FKDUDFWHUL]HGE\WKHSUROLIHUDWLRQRILPPDWXUHDQGDEQRUPDOO\PSKRLGFHOOV
LQWKHERQHPDUURZDQGSHULSKHUDOEORRG1RUPDOEORRGFHOOGHYHORSPHQWLQWKHPDUURZ
LVWKHUHIRUHLPSDLUHGDQGUHSODFHGZLWKDEQRUPDOO\PSKREODVWV7KHSUROLIHUDWLRQRI
WKHVHLPPDWXUHDEQRUPDOO\PSKRLGFHOOVLQWKHERQHPDUURZVXEVHTXHQWO\SUHYDLOVRYHU
WKHSURGXFWLRQRIQRUPDOERQHPDUURZHOHPHQWVXOWLPDWHO\UHVXOWLQJLQGHFUHDVHGUHG
EORRGFHOOVZKLWHEORRGFHOOV:%&VDQGSODWHOHWFRXQWV1&&1&OLQLFDO3UDFWLFH
*XLGHOLQHV
$//LVWKHPRVWFRPPRQFDQFHUGLDJQRVHGLQFKLOGUHQZLWKDQLQFLGHQFHRIDERXW
SHUFKLOGUHQSHU\HDU,QWHUQDWLRQDO%HUOLQ)UDQNIXUW0XHQVWHUVWXG\JURXS
>,%)06*@7KHUHKDVEHHQDJUDGXDOLQFUHDVHLQWKHLQFLGHQFHRISHGLDWULF$//
LQWKHSDVW\HDUV$VKDUSSHDNLQ$//LQFLGHQFHLVREVHUYHGDPRQJFKLOGUHQDJHG
WR\HDUVSHUPLOOLRQSHU\HDUZLWKUDWHVGHFUHDVLQJWRSHUPLOOLRQIRU
FKLOGUHQDJHVWR\HDUV7KHLQFLGHQFHRI$//DPRQJFKLOGUHQDJHGWR\HDUVLV
DSSUR[LPDWHO\IRXUIROGJUHDWHUWKDQIRULQIDQWVDQGLVQHDUO\WHQIROGJUHDWHUWKDQWKDWIRU
DGROHVFHQWVDJHGWR\HDUV(DUO\H[SRVXUHWRFKLOGKRRGLQIHFWLRQVPD\SOD\DUROH
IRUWKLVLQFUHDVHLQLQFLGHQFHUDWHV0F1DOO\DQG(GHQEXWODFNRIGHILQLWLYHGDWD

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


UHQGHUVWKHUHDVRQRIWKLVFRQFHQWUDWLRQRIFDVHVEHWZHHQDQG\HDUVODUJHO\
XQNQRZQ6LQFHRIFKLOGUHQGLHIURPWKHGLVHDVH$//LVWKHPRVWIUHTXHQWFDXVHRI
GHDWKLQFKLOGKRRGPDOLJQDQFLHV*D\QRQ

3URJQRVWLF)DFWRUV
&XUUHQWWUHDWPHQWUHJLPHQVIRUSHGLDWULF$//ZHUHGHYHORSHGE\QDWLRQDODQG
LQWHUQDWLRQDOUHVHDUFKJURXSVLQ(XURSH1RUWK$PHULFDDQG-DSDQ7KHUDS\LVXVXDOO\
VWUDWLILHGDFFRUGLQJWRULVNFKDUDFWHULVWLFVLQRUGHUWRHQVXUHWKDWDSSURSULDWHLQWHQVLW\RI
WUHDWPHQWEHDGPLQLVWHUHGWRSDWLHQWVZLWKKLJKULVNRIUHODSVHZKLOHDYRLGLQJ
XQQHFHVVDU\WR[LFLW\LQSDWLHQWVDWORZHUULVN6FKUDSSHDQG6WDQXOOD
0|ULFNHHWDO
7KHFODVVLFSURJQRVWLFIHDWXUHVIRU%SUHFXUVRU$//DUHDJHDWGLDJQRVLVDQGWKH
OHXNRF\WHFRXQWZKLFKZHUHFRPELQHGWRFUHDWHWKH8QLIRUP5LVN&ODVVLILFDWLRQWR
SUHGLFWWKHULVNRIUHODSVH&KLOGUHQDJHG\HDUVKDYHDEHWWHURXWFRPHWKDQLQIDQWV
DGROHVFHQWVRUDGXOWV&RQWHUHWDO3XLDQG(YDQV3XLE
1DWLRQDO&DQFHU,QVWLWXWHZKLOHLQFUHDVLQJOHXNRF\WHFRXQWSUHGLFWVDSRRUHU
RXWFRPHPRVWFODVVLILFDWLRQVFKHPHVGLVWLQJXLVKEHWZHHQSDWLHQWVZLWK
:%&[/IDYRUDEOHDQG:%&
[/XQIDYRUDEOH,WVKRXOGEH
QRWHGWKDWWKH8QLIRUP5LVN&ODVVLILFDWLRQLVDSSOLFDEOHRQO\WR%FHOOGLVHDVHIDLOVWR
SUHGLFWUHODSVHLQDWKLUGRIVWDQGDUGULVNFDVHVDQGGRHVQRWGLVWLQJXLVKEHWZHHQ
KLJKULVNDQGYHU\KLJKULVNGLVHDVHPDNLQJIXUWKHUUHILQHPHQWVQHFHVVDU\3XLD
:KLOHFOLQLFDOIHDWXUHVWRJHWKHUZLWKF\WRJHQHWLFFKDUDFWHULVWLFVVXFKDV
WUDQVORFDWLRQWLGHQWLI\LQJSRRUULVNSDWLHQWVRUWUDQVORFDWLRQWFKDUDFWHULVWLF
RIORZULVNSDWLHQWVDUHLQLWLDOO\XVHGWRVWUDWLI\SDWLHQWVLQWRGLIIHUHQWULVNJURXSV
SURJQRVLVLVIXUWKHUDVVHVVHGDIWHULQGXFWLRQWUHDWPHQWEDVHGRQ05'WKHSUHVHQFHRI
DORZQXPEHURIOHXNHPLFFHOOVWKDWDUHQRWGHWHFWDEOHE\OLJKWPLFURVFRS\7KH
GHWHFWLRQRI05'DIWHUWUHDWPHQWKDVEHHQVKRZQWRSRUWHQGDKLJKHUSURJQRVWLFYDOXH
WKDQYDULDEOHVLGHQWLILHGDWGLDJQRVLVDQGJXLGHSK\VLFLDQVWRVHOHFWWKHPRVWIDYRUDEOH
FRQVROLGDWLRQWUHDWPHQWRSWLRQLHDGGLWLRQDOFKHPRWKHUDS\RUDOOR+6&7
%DVVDQDQG+RHO]HU,QSDUWLFXODUWKHGHWHFWLRQRI05'DIWHULQGXFWLRQWKHUDS\
DQGRUFRQVROLGDWLRQWKHUDS\LVDQLQGHSHQGHQWSURJQRVWLFIDFWRUIRUSRRURXWFRPHRI
$//3DWLHQWVKLJKO\UHVSRQVLYHWRFKHPRWKHUDS\ZLWKDQ05'OHYHOEHORZLQGXFHG
E\LQGXFWLRQWUHDWPHQWKDYHDIDYRUDEOHSURJQRVLV3DWLHQWVZKRVH05'SHUVLVWV
GXULQJLQGXFWLRQDQGFRQVROLGDWLRQRIIURQWOLQHWUHDWPHQWRUZKREHFRPH05'SRVLWLYH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


IROORZLQJWUHDWPHQWKDYHDSRRUSUREDELOLW\RIEHLQJDOLYHDQGGLVHDVHIUHHLQWKH
ORQJWHUP

7UHDWPHQW
,QJHQHUDOSHGLDWULFWUHDWPHQWUHJLPHQVDUHPRUHLQWHQVHWKDQWKRVHHPSOR\HGLQDGXOWV
DQGLQFOXGHFRXUVHVRIFRPELQDWLRQFKHPRWKHUDS\DQGIRUSDWLHQWVDWULVNIRURUZLWK
FHQWUDOQHUYRXVV\VWHP&16LQYROYHPHQWVSHFLILFORFDOWKHUDS\HJLQWUDWKHFDO
FKHPRWKHUDS\ZLWKRUZLWKRXWFUDQLDOUDGLDWLRQ*XLGHOLQHVIRUWUHDWPHQWRIKLJKULVNILUVW
UHODSVHIRUHVHHSKDVHVLQGXFWLRQFRQVROLGDWLRQDQGDOOR+6&7$OOWUHDWPHQW
UHJLPHQVVKRXOGDOVRLQFOXGH&16SURSK\OD[LVDQGRUWUHDWPHQWZKHQHYHUDSSURSULDWH
$QRXWOLQHIRUWKHJRDORIHDFKSKDVHRIWKHUDS\LVSUHVHQWHGEHORZ
,QGXFWLRQ7KHUDS\
7KHJRDORILQGXFWLRQWKHUDS\LVWRUHGXFHWXPRUEXUGHQE\FOHDULQJDVPDQ\OHXNHPLF
FHOOVDVSRVVLEOHIURPWKHERQHPDUURZ,QGXFWLRQUHJLPHQVDUHW\SLFDOO\EDVHGRQD
VWDQGDUGEDFNERQHRIWKHUDS\FRQVLVWLQJRIDFRPELQDWLRQRIGUXJVLQFOXGLQJEXWQRW
OLPLWHGWRFRUWLFRVWHURLGVYLQFULVWLQHDQGDQWKUDF\FOLQHVZLWKRUZLWKRXW/DVSDUDJLQDVH
DQGRUF\FORSKRVSKDPLGHPHUFDSWRSXULQHDQGF\WRVLQHDUDELQRVLGH
&RQVROLGDWLRQ
7KHLQWHQWRISRVWLQGXFWLRQFRQVROLGDWLRQLVWRHOLPLQDWHSRWHQWLDOOHXNHPLFFHOOVWKDW
UHPDLQDIWHULQGXFWLRQWKHUDS\WKLVSHUPLWWLQJIXUWKHUHUDGLFDWLRQRIUHVLGXDOGLVHDVH
7KHFRPELQDWLRQRIGUXJVDQGGXUDWLRQRIWKHUDS\IRUFRQVROLGDWLRQUHJLPHQVYDU\
EHWZHHQVWXGLHVDQGSDWLHQWSRSXODWLRQV
$OOR+6&7
3DWLHQWVZLWKSRRURXWFRPHDQGKLJKUDWHVRIVXEVHTXHQWUHODSVHDIWHUFRQYHQWLRQDO
LQWHQVLYHFKHPRWKHUDS\KDYHDQLQGLFDWLRQIRUDOOR+6&7IURPDPDWFKHGGRQRURULQ
FDVHRIYHU\KLJKULVNDOVRIURP+/$GLVSDUDWHGRQRU)RUDVXFFHVVIXODOOR+6&7WKH
UHPLVVLRQTXDOLW\VKRXOGEHJRRGZKLFKPD\EHWKHFDVHDIWHULQGXFWLRQDQGHDUO\
FRQVROLGDWLRQWKHUDS\$ORZ05'YDOXHEHIRUHDOOR+6&7SUHGLFWVDEHWWHURXWFRPH
DIWHUWKHDOORJUDIW%DGHUHWDO
&163URSK\OD[LVDQG7UHDWPHQW
)RUSDWLHQWVDWULVNIRURUZLWKGHWHFWLRQRI&16LQYROYHPHQWDWGLDJQRVLVVSHFLILFORFDO
WKHUDS\HJLQWUDWKHFDOFKHPRWKHUDS\ZLWKRUZLWKRXWFUDQLDOUDGLDWLRQLVDGPLQLVWHUHG
7KHDLPRI&16SURSK\OD[LVDQGRUWUHDWPHQWLVWRFOHDUOHXNHPLFFHOOVIURPVLWHVWKDW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


FDQQRWEHUHDGLO\UHDFKHGE\V\VWHPLFFKHPRWKHUDS\GXHWRWKHEORRGEUDLQEDUULHUZLWK
WKHRYHUDOOJRDORISUHYHQWLQJ&16GLVHDVHRUUHODSVH&16VSHFLILFWKHUDS\PD\
LQFOXGHFUDQLDOLUUDGLDWLRQDQGLQWUDWKHFDOFKHPRWKHUDS\HJPHWKRWUH[DWH>07;@HLWKHU
DGPLQLVWHUHGDORQHRULQFRPELQDWLRQZLWKF\WDUDELQHDQGVWHURLGV&16SURSK\OD[LVLV
W\SLFDOO\JLYHQWKURXJKRXWWKHFRXUVHRI$//WKHUDS\VWDUWLQJIURPLQGXFWLRQDQG
FRQWLQXLQJWKURXJKFRQVROLGDWLRQ
6HYHUDOGUXJVKDYHEHHQDSSURYHGIRUWKHWUHDWPHQWRI$//E\WKH8QLWHG6WDWHV)RRG
DQG'UXJ$GPLQLVWUDWLRQDQGRU(XURSHDQ0HGLFLQHV$JHQF\(0$$VXPPDU\RI
FXUUHQWO\DSSURYHGGUXJVIRUWKHWUHDWPHQWRI$//E\WKH(0$LVVKRZQLQ7DEOH
7DEOH(0$$SSURYHG'UXJVIRUWKH7UHDWPHQWRI$//
$SSURYDO7\SH
'UXJ
,QGLFDWLRQ
5HJXODU$SSURYDO
$VSDUDJLQDVH
7UHDWPHQWRI$//
'DXQRUXELFLQ
5HPLVVLRQLQGXFWLRQLQ$//LQDGXOWVDQG
FKLOGUHQ
0HUFDSWRSXULQH
5HPLVVLRQLQGXFWLRQDQGPDLQWHQDQFHRI
$//
(WRSRVLGH
,QGXFWLRQWKHUDS\LQUHFXUUHQW$//LQ
FKLOGUHQ
9LQFULVWLQH
7UHDWPHQWRI$//
&\WDUDELQH
7UHDWPHQWRI$//
0HWKRWUH[DWH
7UHDWPHQWRI$//
$FFHOHUDWHG$SSURYDO
([FHSWLRQDO
&LUFXPVWDQFHV
&ORIDUDELQH
7UHDWPHQWRISHGLDWULFSDWLHQWVWR\HDUV
ROGZLWKUHODSVHGRUUHIUDFWRU\DFXWH
O\PSKREODVWLFOHXNHPLDDIWHUDWOHDVWWZR
SULRUUHJLPHQV
5HIHUWRWKHUHJLRQDOPDQXIDFWXUHUSDFNDJHLQVHUWIRUDGGLWLRQDOLQIRUPDWLRQUHJDUGLQJ
WKHVHWKHUDSLHV

5HVXOWVRI&XUUHQW7UHDWPHQW5HJLPHQVDQG8QPHW0HGLFDO1HHGV
$PRQJSHGLDWULFSDWLHQWVZLWK$//PRUHWKDQDFKLHYHDILUVW&5&5ZLWK
WUHDWPHQWDQGWRUHPDLQGLVHDVHIUHH\HDUVDIWHUWKHLQLWLDOGLDJQRVLV
&XUUHQWO\DERXWRISDWLHQWVVXIIHUDUHODSVHRI$//6FKUDSSHHWDO
7KHSURJQRVLVIRUDSDWLHQWZLWKUHODSVHG$//PDLQO\GHSHQGVRQWKHWLPHHODSVLQJIURP
GLDJQRVLVWRUHODSVHVLWHRIUHODSVHDVZHOODVF\WRJHQHWLFVDQGLPPXQRSKHQRW\SH
&KHVVHOOVHWDO8GHU]RHWDO0DOHPSDWLHWDO7KHULVNJURXS
VWUDWLILFDWLRQRIFKLOGUHQZLWKUHODSVHG$//VWDQGDUGULVN>65@YHUVXVKLJKULVN>+5@VHH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7DEOHGHSHQGVRQWLPHHODSVLQJIURPGLDJQRVLVWRUHODSVHDVGHILQHGLQ7DEOH
WKHVLWHRIUHODSVHDVGHILQHGLQ7DEOHDQGWKHLPPXQRSKHQRW\SH
/RFDWHOOLHWDO
7DEOH'HILQLWLRQRI7LPH3RLQWRI5HODSVH,QW5H$//*URXS
7LPHSRLQW
$IWHUSULPDU\GLDJQRVLV
$IWHUFRPSOHWLRQRISULPDU\WKHUDS\
9HU\HDUO\
PRQWKV


(DUO\

PRQWKV
DQG
PRQWKV
/DWH



PRQWKV
7DEOH'HILQLWLRQRI6LWHRI5HODSVH,QW5H$//*URXS
%RQHPDUURZ
0EODVWV
0
DQG
EODVWVD
0
EODVWV
([WUDPHGXOODU\
UHODSVH
1R
1R$//UHODSVH
5HTXLUHVIROORZXS
FRQWURO
,VRODWHGERQH
PDUURZUHODSVH
<HV
,VRODWHG
H[WUDPHGXOODU\
UHODSVH
&RPELQHGERQHPDUURZH[WUDPHGXOODU\
UHODSVH
7KHLPPXQRSKHQRW\SHLVGHILQHGDFFRUGLQJWR(*,/FULWHULD
DVXEMHFWVDUHFRQVLGHUHGKLJKULVNLIOHVVWKDQ0LVRODWHGERQHPDUURZUHODSVHEXWEODVWVDUH
FRQILUPHGE\IORZRUSRO\PHUDVHFKDLQUHDFWLRQ3&5WREHUHODSVHDQGQRWHDUO\UHJHQHUDWLQJQRUPDOFHOOV
DQGWKHLQYHVWLJDWRUFRQVLGHUHGWKHVXEMHFWKLJKULVNDQGWUHDWHGZLWKDKLJKULVNUHJLPHQ
7DEOH'HILQLWLRQRI,QW5H$//65+55LVN*URXSV,QW5H$//*URXS

,PPXQRSKHQRW\SH%FHOOSUHFXUVRU
,PPXQRSKHQRW\SHSUH7
6LWH

7LPHSRLQW
([WUDPHG
,VRODWHG
%RQHPDUURZ
FRPELQHGD
%RQH
PDUURZ
LVRODWHGE
([WUDPHG
LVRODWHG
%RQH
PDUURZ
FRPELQHG
%RQH
PDUURZ
LVRODWHG
9HU\HDUO\
+5
+5
+5
+5
+5
+5
(DUO\
65
65
+5
65
+5
+5
/DWH
65
65
65
65
+5
+5
DVXEMHFWVZLWKHDUO\FRPELQHGUHODSVHDUHDOVRFRQVLGHUHGKLJKULVNLIWKHLQYHVWLJDWRUFRQVLGHUHG
WKHVXEMHFWKLJKULVNDQGWUHDWHGZLWKDKLJKULVNUHJLPHQ
EVXEMHFWVDUHFRQVLGHUHGKLJKULVNLIOHVVWKDQ0LVRODWHGERQHPDUURZUHODSVHEXWEODVWVDUH
FRQILUPHGE\IORZRU3&5WREHUHODSVHDQGQRWHDUO\UHJHQHUDWLQJQRUPDOFHOOVDQGWKHLQYHVWLJDWRU
FRQVLGHUHGWKHVXEMHFWKLJKULVNDQGWUHDWHGZLWKDKLJKULVNUHJLPHQ
26UDWHVDIWHUPDUURZUHODSVHUDQJHIURPOHVVWKDQIRUSDWLHQWVZLWKPDUURZ
UHODSVHVRFFXUULQJZLWKLQPRQWKVIURPGLDJQRVLVWRWRIRUWKRVHZKRVH
UHODSVHVRFFXUPRUHWKDQPRQWKVIURPGLDJQRVLV(LQVLHGHOHWDO
1JX\HQHWDO)RUSDWLHQWVZLWKLVRODWHG&16UHODSVHVWKH26UDWHVIRUHDUO\
UHODSVHPRQWKVIURPGLDJQRVLVDUHWRZKLOHWKH\DUHWRIRU

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


FKLOGUHQZLWKODWHUHODSVHVPRQWKVIURPGLDJQRVLV1JX\HQHWDO
%DUUHGRHWDO7KHUHLVQRHYLGHQFHWKDWHDUO\GHWHFWLRQRIUHODSVHE\IUHTXHQW
VXUYHLOODQFHFRPSOHWHEORRGFRXQWVRUERQHPDUURZWHVWVLQRIIWKHUDS\SDWLHQWV
LPSURYHVRXWFRPH5XEQLW]HWDO1HZGDWDIURPWKH&DQFHU5HVHDUFK8QLWHG
.LQJGRP&KLOGUHQ¶V&DQFHU*URXSVKRZWKDWDSSUR[LPDWHO\RISDWLHQWVZLWK
KLJKULVNILUVWUHODSVHWKHVWXG\SRSXODWLRQWKDWWKLVVWXG\LQWHQGVWRWUHDWKDYHD
VHFRQGUHODSVHZLWKLQ\HDUV3DUNHUHWDO
$SSUR[LPDWHO\RISHGLDWULFSDWLHQWVZLWKVHFRQGPDUURZUHODSVHDQGRIWKRVH
ZLWKWKLUGPDUURZUHODSVHDFKLHYHDVXEVHTXHQWFRPSOHWHUHPLVVLRQ&5)LYH\HDU
GLVHDVHIUHHVXUYLYDOUDWHLQ&5ZDVUHSRUWHGWREH.RHWDO
)LIWHHQWRRIFKLOGUHQZLWK$//GLHIURPWUHDWPHQWUHVLVWDQWRUUHFXUUHQW$//RUIURP
WKHDFXWHDQGRUORQJWHUPDGYHUVHHIIHFWVRIWKHUDS\3XLDQG(YDQV
6WDU\HWDO7ZRSHUFHQWRIFKLOGUHQ3XLDZLWK$//ZKRGRQRWDFKLHYHD
UHPLVVLRQDUHFODVVLILHGDVKDYLQJUHIUDFWRU\GLVHDVHDQGRIWHQVXIIHUDQHYHQZRUVH
SURJQRVLVFRPSDUHGWRSDWLHQWVZLWKUHODSVHG$//6FKUDSSHHWDO
,QVXPPDU\%SUHFXUVRU$//LVDQDJJUHVVLYHPDOLJQDQWGLVHDVH%DVHGRQWKHIDFW
WKDWPRVWWKHUDSHXWLFDJHQWVDUHDVVRFLDWHGZLWKFRQVLGHUDEOHWR[LFLW\DQGWKHODFNRI
QRYHOWUHDWPHQWRSWLRQVIRUVXEMHFWVZKRUHODSVHRUDUHUHIUDFWRU\WRWUHDWPHQW
DGGLWLRQDODQGLQQRYDWLYHWKHUDSHXWLFDSSURDFKHVDUHXUJHQWO\QHHGHG

4XDQWLILFDWLRQRI0LQLPDO5HVLGXDO'LVHDVH
05'TXDQWLILFDWLRQHDUO\DQGHIILFLHQWO\GLIIHUHQWLDWHVSDWLHQWVZKREHQHILWIURP
FRQYHQWLRQDOWUHDWPHQWLQFOXGLQJDOOR+6&7IURPWKRVHQHHGLQJLQQRYDWLYH
H[SHULPHQWDOWKHUDSLHV(FNHUWHWDO3DJDQLQHWDO
05'TXDQWLILFDWLRQRQWKHJHQRPLFOHYHOE\'1$EDVHG5HDO7LPH4XDQWLWDWLYH54
3RO\PHUDVH&KDLQ5HDFWLRQ3&5XVLQJFORQDO7FHOOUHFHSWRU7&5LPPXQRJOREXOLQ
,*JHQHUHDUUDQJHPHQWVLVFRQVLGHUHGWKHJROGVWDQGDUG7KLVPHWKRGKDVEHHQ
YDOLGDWHGE\WKHSHGLDWULFDQGDGXOW$//VWXG\JURXSV%UJJHPDQQHWDO
%UJJHPDQQHWDO
)ORZF\WRPHWU\LVXVHGLI3&5EDVHG05'TXDQWLILFDWLRQFDQQRWEHSHUIRUPHGEHFDXVH
FULWHULDIRUDUHOLDEOHDQGUHSURGXFLEOHVHQVLWLYHTXDQWLILFDWLRQDUHQRWIXOILOOHG
3URVSHFWLYHFRPSDULVRQVRI05'UHVXOWVPHDVXUHGE\3&5DQGIORZF\WRPHWU\DUH
FXUUHQWO\SHUIRUPHGLQVHYHUDOFRXQWULHVDSSO\LQJWKH$//5(=%)0RU$//
5SURWRFRO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


0XOWLFRORUIORZF\WRPHWU\ZLOOEHGRQHLQSDUDOOHOZLWK3&5LQRUGHUWRJDLQDGGLWLRQDO
LPSRUWDQWLQIRUPDWLRQRQDQWLJHQH[SUHVVLRQLQUHVLGXDOOHXNHPLFFHOOVGXULQJGLIIHUHQW
WUHDWPHQWSKDVHVDQGLQIRUPDWLRQRIO\PSKRLGDQGP\HORLGUHJHQHUDWLRQ

6FKHGXOHIRU05'4XDQWLILFDWLRQRI05'
05'LVPHDVXUHGE\ERWKPHWKRGVDWGLDJQRVLVWRHVWDEOLVKWKHFORQDOPDUNHUVIRU3&5
DQGWKHFORQHVSHFLILFDQWLJHQSURILOHIRUIORZF\WRPHWU\05'E\3&5DQGIORZ
F\WRPHWU\DUHDOZD\VGRQHLQSDUDOOHOXQOHVVPDWHULDOLVOLPLWHGLQZKLFKFDVH3&5LV
WKHSUHIHUHQWLDOPHWKRG)ROORZXSDQDO\VHVDUHSHUIRUPHGDWWKHVDPHWLPHSRLQWVDV
WKHERQHPDUURZF\WRORJ\

05'4XDQWLILFDWLRQE\3&5
7FHOOUHFHSWRULPPXQRJOREXOLQ7&5,*JHQHUHDUUDQJHPHQWVFDQEHXVHGDVD
µILQJHUSULQW¶WRLGHQWLI\FORQDOO\PSKREODVWLFSRSXODWLRQVDWDKLJKO\VHQVLWLYH05'OHYHO
DWGLDJQRVLVDQGGXULQJWUHDWPHQWRI$//,QWKHFRQWH[WRIUHODSVHG$//LWLVVWURQJO\
UHFRPPHQGHGWRSHUIRUPVFUHHQLQJIRUFORQDO7&5,*JHQHUHDUUDQJHPHQWVDWUHODSVH
GLDJQRVLVLQRUGHUWRLGHQWLI\PDUNHUVVSHFLILFIRUFORQDOUHODSVHGSRSXODWLRQV7KHVH
PDUNHUVZLOOEHVHOHFWHGDFFRUGLQJWRWKHLUVHQVLWLYLW\IRU05'TXDQWLILFDWLRQ,WLV
UHFRPPHQGHGWRXVHDWOHDVWWZRPDUNHUVIRUTXDQWLILFDWLRQRIDERQHPDUURZWDNHQDWD
WLPHSRLQWUHOHYDQWIRUWUHDWPHQWVWUDWLILFDWLRQ,IRQO\RQHPDUNHULVDYDLODEOHLWLV
DFFHSWDEOHIRUVWUDWLILFDWLRQ&RQWHUHWDO$OO05'GDWDPHDVXUHGLQWKHSURWRFRO
KDYHEHHQDVVHVVHGDFFRUGLQJWRWKHJXLGHOLQHVRIWKH(XUR05'JURXSIRUPHUQDPH
(XURSHDQ6WXG\*URXSRQ05'GHWHFWLRQLQ$//YDQGHU9HOGHQHWDO$OO05'
DQDO\VHVE\3&5ZLOOEHSHUIRUPHGE\DQDWLRQDOO\DFFUHGLWHGFHQWUDOODERUDWRU\ZLWKLQ
WKLVQHWZRUNVHOHFWHGE\$PJHQXVLQJVWDQGDUGL]HGDVVD\V
0RQRQXFOHDUFHOOVDUHLVRODWHGIURPERQHPDUURZVDPSOHVDQG'1$H[WUDFWHGXVLQJWKH
1XFOHR6SLQ7LVVXHNLW0DFKHUH\1DJHO*PE+	&R.**HUPDQ\
&ORQDO7FHOOUHFHSWRUGHOWDJDPPDEHWDDQGLPPXQRJOREXOLQKHDY\DQGOLJKWFKDLQ
JHQHUHDUUDQJHPHQWVDUHLGHQWLILHGDQGVHTXHQFHGDVSUHYLRXVO\GHVFULEHG
/DQJHUDNHWDO3RQJHUV:LOOHPVHHWDO6]F]HSDQVNLHWDO
6]F]HSDQVNLHWDO%UJJHPDQQHWDO05'TXDQWLILFDWLRQRIERQH
PDUURZVDPSOHVDIWHULQGXFWLRQZLOOEHSHUIRUPHGXVLQJ543&5ZLWKJHUPOLQH
K\GUROL]DWLRQ7DT0DQSUREHVDQGFORQHVSHFLILFSULPHUVDVSUHYLRXVO\GHVFULEHG
(FNHUWDQG/DQGWYDQGHU9HOGHQHWDO$LPLQJDUHOLDEOHVHQVLWLYH
DVVHVVPHQWRI05'UHVSRQVHDWOHDVW05'PDUNHUVZLWKDPLQLPXPTXDQWLWDWLYH
UDQJHRIOHXNHPLFFHOOLQQRUPDOFHOOVVKRXOGEHXVHG543&5GDWDZLOOEH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


DQDO\]HGDFFRUGLQJWRWKHJXLGHOLQHVRIWKH(XUR05'&RQVRUWLXP
KWWSZZZHXURPUGRUJ7KLVODERUDWRU\WDNHVSDUWLQTXDOLW\FRQWUROSURJUDPV
RUJDQL]HGZLWKLQWKH(XUR05'&RQVRUWLXPWZLFHSHU\HDU

05'4XDQWLILFDWLRQE\0XOWLFRORU)ORZ&\WRPHWU\
'HWHFWLRQRI05'E\IORZF\WRPHWU\LVEDVHGRQWKHLGHQWLILFDWLRQRIDEHUUDQWRUVSHFLILF
H[SUHVVLRQRIDQWLJHQVRQOHXNHPLFFHOOVFRPSDUHGWRQRUPDOKHPDWRSRLHWLFFHOOV
%HVLGHVVHQVLWLYHGHWHFWLRQRI05'WKHPHWKRGLVDSSOLHGWRDVVHVVDQWLJHQH[SUHVVLRQ
VXFKDV&'DQG&'DQGDGGLWLRQDOLQWHUHVWLQJSURWHLQVZKLFKPLJKWEHLPSRUWDQWIRU
WDUJHWHGWKHUDS\)XUWKHUPRUHWKHPHWKRGLVLPSRUWDQWWRGHVFULEHDQGILQGD
TXDQWLWDWLYHGLPHQVLRQIRUUHJHQHUDWLRQGXULQJWUHDWPHQW
6WDQGDUGL]DWLRQDQGTXDOLW\FRQWUROIRUIORZF\WRPHWU\EDVHG05'TXDQWLILFDWLRQKDYH
EHHQHVWDEOLVKHGE\VHYHUDOLQWHUQDWLRQDODQGQDWLRQDOJURXSVDVZHOODVFHQWUDO
ODERUDWRULHV05'DQDO\VHVE\IORZF\WRPHWU\ZLOOEHSHUIRUPHGE\QDWLRQDOO\DFFUHGLWHG
FHQWUDOODERUDWRULHVZLWKLQWKLVQHWZRUNORFDWHGLQ(XURSH$XVWUDOLDDQG$PHULFDDOO
XVLQJVWDQGDUGL]HGDVVD\V

%OLQDWXPRPDE%DFNJURXQG
%OLQDWXPRPDELVDPXULQHUHFRPELQDQWVLQJOHFKDLQDQWLERG\FRQVWUXFWFRPELQLQJERWK
WKHELQGLQJVSHFLILFLW\IRUWKHSDQ%FHOODQWLJHQ&'DQGWKHHSVLORQFKDLQRIWKH7FHOO
UHFHSWRU&'FRPSOH[RQRQHSRO\SHSWLGHFKDLQ,WLVPRQRPHULFQRWJO\FRV\ODWHGDQG
ZHLJKVDSSUR[LPDWHO\N'D
,WEHORQJVWRDQHZFODVVRIELVSHFLILFDQWLERG\FRQVWUXFWVFDOOHGELVSHFLILF7FHOO
HQJDJHUV%,7(%LVSHFLILF7FHOOHQJDJHUVKDYHEHHQGHVLJQHGWRGLUHFW7HIIHFWRU
PHPRU\FHOOVWRZDUGVWDUJHWFHOOV7KHSUR[LPLW\LQGXFHGE\WKH%,7(WULJJHUVWDUJHW
FHOOVSHFLILFF\WRWR[LFLW\ZKLFKFORVHO\UHVHPEOHVVWDQGDUGF\WRWR[LF7O\PSKRF\WH&7/
DFWLYDWLRQ7KLV7FHOO±PHGLDWHGWDUJHWVSHFLILFNLOOLQJLVWKHWKHUDSHXWLFPHFKDQLVPRI
DFWLRQRIEOLQDWXPRPDE/|IIOHUHWDO:ROIHWDO
%OLQDWXPRPDEVSHFLILFDOO\WDUJHWVFHOOVWKDWH[SUHVV&'DPDUNHUVROHO\H[SUHVVHGE\
%FHOOVLQFOXGLQJ%SUHFXUVRU$//FHOOVZLWKDQDIILQLW\RI[0%OLQDWXPRPDE
UHFUXLWVDQGDFWLYDWHV7FHOOVYLDDORZHUDIILQLW\LQWHUDFWLRQZLWK&'[0
7KHVHDFWLYDWHG7FHOOVWKHQLQGXFHDKDOIPD[LPDOWDUJHWFHOOO\VLVUDQJLQJLQYLWUR
EHWZHHQWRSJP/VKRZLQJEOLQDWXPRPDEWREHDQH[WUHPHO\SRWHQWPROHFXOH
'UHLHUHWDO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW 
3DJH RI
&21),'(17,$/
)LJXUH0RGHRI$FWLRQRI%OLQDWXPRPDE
'XHWRLWVXQLTXHDELOLW\WRUHGLUHFW7FHOOVYLD&'WRZDUGVD&' WXPRUFHOOO\VLV
EOLQDWXPRPDE FDQHOLFLWUHSHDWHGWDUJHWFHOOHOLPLQDWLRQE\F\WRWR[LF7FHOOVDQGD
SRO\FORQDOUHVSRQVHRISUHYLRXVO\SULPHG&' DQG& 7FHOOV 7KHDQWLWXPRUDFWLYLW\LV
HIIHFWLYHZLWKLQDZLGHUDQJHRIHIIHFWRUWRWDUJHW(7UDWLRV
,QWKHDEVHQFHRI&' WDUJHWFHOOVQHLWKHUF\WRWR[LFLW\QRUUHOHDVHRIF\WRNLQHVZLOO
RFFXU %OLQDWXPRPDE DFWVVWULFWO\LQDWDUJHWFHOOVSHFLILFDQGGHSHQGHQWPDQQHUZLWK
UHJDUGWRF\WRWR[LFDFWLRQ 7KHSUHVHQFHRIERWK&' WDUJHWFHOOVDQG7FHOOVDUH
UHTXLUHGIRULWVF\WRWR[LFDFWLYLW\
5HIHUWRWKH%OLQDWXPRPDE ,QYHVWLJDWRU¶V%URFKXUH IRUDGGLWLRQDOLQIRUPDWLRQ

%OLQDWXPRPDE&OLQLFDO6WXGLHV

$GXOWV
6WXG\07LVDQDFWLYHEXWQRORQJHUUHFUXLWLQJRSHQODEHOPXOWLFHQWHUVLQJOH
DUPH[SORUDWRU\3KDVH VWXG\LQDGXOWVXEMHFWVZLWKUHODSVHGUHIUDFWRU\55 $//
%OLQDWXPRPDELVDGPLQLVWHUHGE\FRQWLQXRXVLQWUDYHQRXVLQIXVLRQ&,9,IRUGD\V
IROORZHGE\DGD\WUHDWPHQWIUHHLQWHUYDOSHUF\FOH 7KHSULPDU\HQGSRLQWLVWKH
KHPDWRORJLFFRPSOHWHUHPLVVLRQUDWHZLWKLQF\FOHVRIWUHDWPHQWZLWKEOLQDWXPRPDE $
KHPDWRORJLFFRPSOHWHUHPLVVLRQLVGHILQHGDVDFRPSOHWHUHPLVVLRQ&5RUDFRPSOHWH
UHPLVVLRQZLWKRQO\SDUWLDOKHPDWRORJLFDOUHFRYHU\&5KZLWKLQF\FOHVRI
EOLQDWXPRPDEWUHDWPHQW &5LVGHILQHGDV OHVVWKDQRUHTXDOWR EODVWVLQWKHERQH
PDUURZQRHYLGHQFHRIGLVHDVHDQGIXOOUHFRYHU\RISHULSKHUDOEORRGFRXQWV
SODWHOHWV  ȝ/+E
 JG/DQGDEVROXWHQHXWURSKLOFRXQW>$1&@  ȝ/
&5KLVGHILQHGDV OHVVWKDQRUHTXDOWR EODVWVLQWKHERQHPDUURZQRRWKHU
6LJQDO
$QWL&'$QWLERG\
$QWL&'$QWLERG\
%L7(
07
9+
9+
9/
9/
%&HOO
&\WRWR[LF7&HOO
5HGLUHFWHG &HOO /\VLV
&'
&'
&'
&'
$FWLYDWLRQ
3UROLIHUDWLRQ
$SRSWRWLF &HOO
'HDWK
$
%
6LJQDO
6LJQDO
$QWL&'$QWLERG\
$QWL&'$QWLERG\
%L7(
07
9+
9+
9/
9/
%&HOO
&\WRWR[LF7&HOO
5HGLUHFWHG &HOO /\VLV
&'
&'
&'
&'
$FWLYDWLRQ
3UROLIHUDWLRQ
$SRSWRWLF &HOO
'HDWK
$
%

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


HYLGHQFHRIGLVHDVHDQGSDUWLDOUHFRYHU\RISHULSKHUDOEORRGFRXQWV
SODWHOHWVȝ/+E
JG/DQG$1&ȝ/
7KLUW\VL[VXEMHFWVZLWK55%SUHFXUVRU$//ZHUHWUHDWHGLQWKLVVWXG\VXEMHFWVLQ
GRVHFRKRUWȝJPðGD\VXEMHFWVLQGRVHFRKRUWDȝJPðGD\VXEMHFWV
LQGRVHFRKRUWEȝJPðGD\DQGVXEMHFWVLQGRVH
FRKRUWȝJPðGD\7KHRYHUDOOPHGLDQDJHZDV\HDUVUDQJH\HDUV
ZHUHIHPDOHDQGZHUHPDOH7KLUW\WKUHHVXEMHFWVLQWKLVVWXG\KDG
UHODSVHG$//ZLWKVXEMHFWVLQVHFRQGRUODWHUUHODSVH7KUHHVXEMHFWVKDGUHIUDFWRU\
GLVHDVH7ZRVXEMHFWVZHUH3KLODGHOSKLDFKURPRVRPHSRVLWLYH3KDQG
VXEMHFWVKDGDWWUDQVORFDWLRQ)LIWHHQVXEMHFWVKDGXQGHUJRQHSULRU
DOOR+6&77ZHQW\VXEMHFWVKDGDERQHPDUURZEODVWFRXQWRIVXEMHFWV
KDGDERQHPDUURZEODVWFRXQWRIWRDQGVXEMHFWVKDGD
ERQHPDUURZEODVWFRXQWRI
7ZHQW\ILYHRIVXEMHFWVUHVSRQGHGWRWUHDWPHQW)LIWHHQVXEMHFWVDQG
VXEMHFWVVKRZHGD&5DQG&5KUHVSHFWLYHO\ZLWKLQF\FOHVRIEOLQDWXPRPDE
WUHDWPHQW$WWKHVHOHFWHGEOLQDWXPRPDEGRVHOHYHORIȝJPFRKRUWVDDQG
VXEMHFWVUHVSRQGHGWRWUHDWPHQW(OHYHQVXEMHFWVGHPRQVWUDWHGD
&5DQGVXEMHFWVKDGD&5K$OOEXWVXEMHFWVZLWKKHPDWRORJLFFRPSOHWH
UHVSRQVHVDOVRKDGFRPSOHWH05'UHVSRQVHVGHILQHGDV05'3&5GD\7KH
PRVWFRPPRQDGYHUVHHYHQWVZHUHS\UH[LDDQGIDWLJXHDOOPDLQO\JUDGHRU7KH
PRVWFOLQLFDOO\UHOHYDQWDGYHUVHHYHQWVZHUHFOLQLFDOO\UHYHUVLEOHQHXURORJLFHYHQWV
VXEMHFWVDQGF\WRNLQHUHOHDVHV\QGURPHVXEMHFWV)LYHVXEMHFWV
GLHGRIDGYHUVHHYHQWVFODVVLILHGLQWKHLQIHFWLRQVDQGLQIHVWDWLRQVV\VWHPRUJDQFODVV
LQFOXGLQJLQIHFWLRQSQHXPRQLDSQHXPRQLDIXQJDOSXOPRQDU\VHSVLV&16LQIHFWLRQ
VHSVLVDQGFDQGLGDVHSVLV&16LQIHFWLRQZDVFRQVLGHUHGE\WKHLQYHVWLJDWRUWREH
SRVVLEO\UHODWHGWREOLQDWXPRPDE
5HIHUWRWKH%OLQDWXPRPDE,QYHVWLJDWRU¶V%URFKXUHIRUDGGLWLRQDOLQIRUPDWLRQ

3HGLDWULF
&OLQLFDODFWLYLW\RIEOLQDWXPRPDEKDVEHHQUHSRUWHGLQSHGLDWULFSDWLHQWVZLWKUHODSVHG
%SUHFXUVRU$//+DQGJUHWLQJHUHWDO6FKOHJHOHWDO
1LQHSHGLDWULFVXEMHFWVZLWK55$//IROORZLQJDQDOOR+6&7ZHUHWUHDWHGLQD³QDPHG
SDWLHQWXVH´VHWWLQJZLWK&,9,LQIXVLRQRIEOLQDWXPRPDEDWDGRVHRIRU
ȝJPðGD\IRUDWOHDVWZHHNV)RXUVXEMHFWVVKRZHGKHPDWRORJLFDODQGPROHFXODU

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


&5ZLWKLQWKHILUVWF\FOHRIEOLQDWXPRPDEZKLOHVXEMHFWVDFKLHYHGUHPLVVLRQE\WKH
VHFRQGF\FOHRIWUHDWPHQW
,QWKHVHUHVSRQGHUVEOLQDWXPRPDEZDVZHOOWROHUDWHGDQGUDSLGO\LQGXFHG
05'QHJDWLYH&5VDIWHUPXOWLSOHUHODSVHVDQGDOOR+6&7,WLVQRWHZRUWK\WKDWQRQHRI
WKHVXEMHFWVVKRZHGDQ\VLJQVRIJUDIWYHUVXVKRVWGLVHDVHGHVSLWHWKHHQJDJHPHQWRI
GRQRUGHULYHG+/$PDWFKHGSDUWLDOO\PDWFKHGRUWKUHHORFLPLVPDWFKHGKDSORLGHQWLFDO
7O\PSKRF\WHV7KHPRVWFRPPRQWR[LFLWLHVLQGHSHQGHQWRIFDXVHZHUHGHFUHDVHG
QHXWURSKLODQGO\PSKRF\WHFRXQWDQHPLDDQGORZSODWHOHWFRXQW%OLQDWXPRPDEZDV
DVVRFLDWHGZLWKPLOGWUDQVLHQWDQGIXOO\UHYHUVLEOHDGYHUVHHYHQWVLQFOXGLQJPLOGDWD[LD
WUHPRUDQGVRPQROHQFHLQWKHVXEMHFWV2QHVXEMHFWH[SHULHQFHGJHQHUDOL]HG
FHUHEUDOVHL]XUHVDQGZDVDEOHWRFRQWLQXHEOLQDWXPRPDEWUHDWPHQWZLWKDQWLFRQYXOVDQW
WUHDWPHQWDQGQRVXEVHTXHQWUHFXUUHQFH1REOLQDWXPRPDEUHODWHGGHDWKVZHUH
REVHUYHG
7KHLQYHVWLJDWLRQRIEOLQDWXPRPDELVIXUWKHUVWUHQJWKHQHGE\DUHFHQWGDWDPRQLWRULQJ
FRPPLWWHH'0&UHFRPPHQGDWLRQLQWKHRQJRLQJSHGLDWULF07VWXG\7KH
ILUVWSDUWRIWKH07VWXG\LVGHVLJQHGWREHDGRVHILQGLQJVWXG\3KDVHWR
LQYHVWLJDWHWKHSKDUPDFRNLQHWLFVVDIHW\DQGFOLQLFDODFWLYLW\RIHVFDODWLQJGRVHOHYHOVRI
EOLQDWXPRPDELQSHGLDWULFVXEMHFWVZLWK%SUHFXUVRU$//LQVHFRQGRUODWHUERQHPDUURZ
UHODSVHLQDQ\PDUURZUHODSVHDIWHUDOOR+6&7RULQSHGLDWULFVXEMHFWVUHIUDFWRU\WRRWKHU
WUHDWPHQWV)RXUGLIIHUHQWGRVHOHYHOVRIEOLQDWXPRPDEZHUHHYDOXDWHG7KHGRVH
ȝJPðGD\IRUF\FOHZHHNDQGDGRVHRIȝJPðGD\IRUF\FOHZHHNVDQGDOO
VXEVHTXHQWDGGLWLRQDOF\FOHVKDVEHHQVHOHFWHGLQWKH3KDVHSDUWRIWKHVWXG\
ȝJPðGD\7KH3KDVHSDUWDVVHVVHGWKHVDIHW\DQGHIILFDF\RIWKHVHOHFWHG
DQG'0&UHFRPPHQGHGGRVHRIȝJPðGD\
,QWHULPGDWDIURP07KDYHVKRZQSURPLVLQJUHVXOWV6WDFNHOEHUJHWDO
8VLQJERG\VXUIDFHDUHDGRVLQJEOLQDWXPRPDEVKRZHGOLQHDUSKDUPDFRNLQHWLFVLQ
SHGLDWULFVXEMHFWVZLWK$//%OLQDWXPRPDEVWHDG\VWDWHFRQFHQWUDWLRQVLQWKHVHUXP
ZHUHFRPSDUDEOHDFURVVSHGLDWULFDJHJURXSVDQGVLPLODUWRWKRVHUHSRUWHGIRUDGXOW
VXEMHFWVZLWK$//,QWKH3KDVHSDUWRIWKLVVWXG\GRVHOLPLWLQJWR[LFLWLHV'/7VZHUH
F\WRNLQHUHOHDVHV\QGURPHV&56DIXUWKHULPSRUWDQWILQGLQJZDVQHXURORJLFHYHQWVLQ
LQGLYLGXDOVXEMHFWV%DVHGRQ'/7VWKH3KDVHSDUWRIWKHVWXG\HVWDEOLVKHGD
PD[LPXPWROHUDWHGGRVH07'DQGUHFRPPHQGHGGRVHRIȝJPðGD\IRU3KDVH
LQSHGLDWULFVXEMHFWVZLWK$//2XWRIWKHVXEMHFWVWUHDWHGVXEMHFWV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


DFKLHYHG&5(LJKWRIWKHVHUHVSRQGHUVDOVRUHDFKHG05'QHJDWLYLW\(QUROOPHQWLQ
WKH3KDVHSDUWRIWKHVWXG\LVFRPSOHWHDQGUHVXOWVDUHQRW\HWDYDLODEOH

5DWLRQDOHIRU%OLQDWXPRPDE'RVH6HOHFWLRQ
7KHIROORZLQJVHWVRIGDWDVXSSRUWWKHQRWLRQWKDWWKHSURSRVHGGRVHȝJPðGD\
VKRXOGEHVDIHDQGHIIHFWLYHLQWUHDWLQJSHGLDWULFVXEMHFWVZLWKUHODSVHG$//ZLWKD
UHGXFHGWXPRUEXUGHQRIEODVWVLQWKHERQHPDUURZ0PDUURZ
 $KLJKGHJUHHRIFOHDUDQFHRIERQHPDUURZGLVHDVHLQDGXOWVXEMHFWVZLWK
UHODSVHGQRQ+RGJNLQVO\PSKRPD1+/ZDVREVHUYHGDWDGRVHRI
ȝJPðGD\WULDO077KH07'IRUVXEMHFWVZLWK1+/ZDVUHDFKHGDW
ȝJPðGD\
 ,QDSKDVHVWXG\LQDGXOWSDWLHQWVZLWK05'SRVLWLYH$//ȝJPðGD\ZDV
VHOHFWHGDVWKHRSWLPDOGRVH$KLJK05'UHVSRQVHUDWHLQDGXOWVXEMHFWVZDV
REVHUYHGDWWKLVGRVHWULDO077KHȝJPðGD\GRVHZDVIXUWKHU
WHVWHGLQDQRQJRLQJFRQILUPDWRU\VWXG\WULDO07
 ,QSHGLDWULF55$//WKH07'ZDVJPGD\7KHUHFRPPHQGHGGRVHIRUWKH
ILUVWF\FOHRIWUHDWPHQWZDVDVWDUWLQJGRVHRIȝJPðGD\ZLWKHVFDODWLRQWR
ȝJPðGD\DIWHURQHZHHNWRDYRLG&56DVVRFLDWHGZLWKKLJKWXPRUEXUGHQ
,QSHGLDWULF55$//D0PDUURZ
ZDVWKHLQFOXVLRQFULWHULRQZLWKUHJDUG
WRWXPRUEXUGHQ:KHQVXEMHFWVUHDFKHGD&5RU0PDUURZWKHWUHDWPHQWZDV
FRQGXFWHGZLWKDFRQVWDQWGRVHRIJPGD\IRUZHHNVIRUDOOIXUWKHUF\FOHV
 ,QDSUHYLRXV³QDPHGSDWLHQWXVH´VWXG\SHGLDWULFVXEMHFWVZLWK55$//
IROORZLQJDQDOOR+6&7ZHUHWUHDWHGZLWKEOLQDWXPRPDEDWDGRVHRI
ȝJPðGD\IRUDWOHDVWZHHNVDQGVKRZHGKHPDWRORJLFDODQG&5
+DQGJUHWLQJHUHWDO
 ,QWKLVWULDOLQGXFWLRQWUHDWPHQWLVDGPLQLVWHUHGE\FKHPRWKHUDS\QRWE\
EOLQDWXPRPDEDQGRQO\VXEMHFWVZLWK&50PDUURZRU0PDUURZZLOOEH
UDQGRPL]HG7KHUHIRUHWKHGRVHZLOOEHJPGD\

,QGXFWLRQDQG&RQVROLGDWLRQ+LJKULVN3URWRFROV
2QO\LQGXFWLRQDQGFRQVROLGDWLRQUHJLPHQVEDVHGRQ,QW5H$//JXLGHOLQHV,QW5H$//
KLJKULVNSURWRFRO$//5(=%)0$//5&2235$//$,(23$//5(&
35272&2/DUHSHUPLWWHG,QWKH,QW5H$//+5SURWRFROWKHVWDQGDUGLQGXFWLRQ
WKHUDS\ZLOOEHDGPLQLVWHUHGEDVHGRQWKH8.$//5SURWRFRO3DUNHUHWDO
IROORZHGE\KLJKULVNFRQVROLGDWLRQFRXUVHVVXFKDV

+LJKULVNFRQVROLGDWLRQ+&LVDVWDQGDUGLQWHQVLYHFRQVROLGDWLRQ
FKHPRWKHUDS\FRXUVHEDVHGRQPRGLILFDWLRQVWRWKH$//$VVRFLD]RQH,WDOLDQD
(PDWRORJLFD2QFRORJLD3HGLDWULFD%HUOLQ)UDQNOLQ0XQVWHU$,(23%)0+5
FRXUVH&RQWHUHWDO  

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



+LJKULVNFRQVROLGDWLRQ+&LVDVWDQGDUGLQWHQVLYHFRQVROLGDWLRQ
FKHPRWKHUDS\FRXUVHEDVHGRQPRGLILFDWLRQVWRWKH$//$,(23%)0+5
FRXUVH&RQWHUHWDO 

+LJKULVNFRQVROLGDWLRQ+&LVDVWDQGDUGLQWHQVLYHFRQVROLGDWLRQ
FKHPRWKHUDS\FRXUVHEDVHGRQPRGLILFDWLRQVWRWKH$//$,(23%)0+5
FRXUVH&RQWHUHWDO
)LJXUH,QW5H$//+5+&&RXUVH0RGLILHG%)0+5

,QFDVHRIDOOHUJLFUHDFWLRQFKDQJHWR(UZLQLDDVSDUDJLQDVHXQLWVPHYHU\KRXUVIRUDWRWDORI
GRVHV
$JHGHSHQGHQWGRVDJHV
)LJXUH,QW5H$//+5+&&RXUVH0RGLILHG%)0+5

,QFDVHRIDOOHUJLFUHDFWLRQFKDQJHWR(UZLQLDDVSDUDJLQDVHXQLWVPHYHU\KRXUVIRUDWRWDORI
GRVHV
$JHGHSHQGHQWGRVDJHV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


)LJXUH,QW5H$//+5+&&RXUVH0RGLILHG%)0+5

,QFDVHRIDOOHUJLFUHDFWLRQFKDQJHWR(UZLQLDDVSDUDJLQDVHXQLWVPHYHU\KRXUVIRUDWRWDORI
GRVHV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7DEOH6\VWHPLF&KHPRWKHUDS\&RPSRQHQWVRI+&+&DQG+&
6\VWHPLF&KHPRWKHUDS\&RPSRQHQWV
+& +& +&
'H[DPHWKDVRQH
PJPðGGLYLGHGLQWRWZRGDLO\GRVHVRQGD\VWRSOHDVHQRWHWKDWZKLOHLQ+&
DQG+&GH[DPHWKDVRQHLVJLYHQRUDOO\IRUVWXG\LQ+&GH[DPHWKDVRQHLV
JLYHQLQWUDYHQRXVO\VHHDOVR6HFWLRQDQG)LJXUH
;
;
;
9LQFULVWLQH
PJPðPD[LPXPVLQJOHGRVHPJDVDPLQXWHVKRUWLQIXVLRQRUDVDQ
LQWUDYHQRXV,9EROXVQRWRQWKHVDPHGD\DVLQWUDWKHFDOWKHUDS\RQGD\VDQG
;

;
'DXQRUXELFLQ
PJPDVDKRXULQWUDYHQRXVLQIXVLRQRQGD\


;
0HWKRWUH[DWH07;
JP,9RYHUKRXUVVWDUWLQJRQGD\LVJLYHQDVDPLQXWHEROXVDQGWKH
UHPDLQLQJDVDFRQWLQXRXVLQIXVLRQRYHUKRXUV
&RQFRPLWDQWDONDOLQHK\GUDWLRQZLWKP/PKRXUVLVJLYHQRQGD\DQG
6HUXP07;OHYHOVDUHPHDVXUHGDWKRXUVDQGKRXUVDIWHUVWDUWRI07;LQIXVLRQ
&RQFRPLWDQWUHVFXHZLWKIROLQLFDFLGDWPJPLVJLYHQDWDQGKRXUVDIWHUVWDUW
RI07;7KHGRVHVKRXOGEHDGDSWHGWRHOHYDWHG07;VHUXPOHYHOV$ONDOLQH
K\GUDWLRQDQGIROLQLFDFLGDUHFRQVLGHUHGQRQLQYHVWLJDWLRQDOSURWRFROUHTXLUHGWKHUDSLHV
VHH6HFWLRQ
;

;
,IRVIDPLGH
PJPGRVHDVDKRXULQWUDYHQRXVLQIXVLRQHYHU\KRXUVRQGD\VWRWRWDO
RIGRVHV0HVQDDWDGRVHRIPJPLVJLYHQEHIRUHVWDUWRILQIXVLRQDQGDW
DQGKRXUVDIWHUVWDUWRILQIXVLRQ+\GUDWLRQZLWKP/PGRQGD\VWR
0HVQDDQGFRQFRPLWDQWK\GUDWLRQDUHFRQVLGHUHGQRQLQYHVWLJDWLRQDOSURWRFROUHTXLUHG
WKHUDSLHVVHH6HFWLRQ


;
3(*$VSDUDJLQDVH
XQLWVPðHLWKHUDVDQLQWUDYHQRXVLQIXVLRQRULQWUDPXVFXODUO\RQGD\7KH
LQIXVLRQRI/DVSDUDJLQDVHVKRXOGEHVWDUWHGDWDUHGXFHGUDWHDQGLQFUHDVHGVWHSZLVH
LIDSSOLFDEOH,WLVUHFRPPHQGHGWRTXDQWLI\/DVSDUDJLQDVHDFWLYLW\DQGDQWLERGLHVLQ
WKHVHUXPDQGGD\VDIWHUDGPLQLVWUDWLRQRI3(*DVSDUDJLQDVH,QFDVHRIRYHUW
DOOHUJLFUHDFWLRQRQHGRVHRI3(*DVSDUDJLQDVHZLOOEHUHSODFHGE\
(UZLQLDDVSDUDJLQDVHDWDGRVHRIXQLWVPð,9RU,0HYHU\KRXUVIRUDWRWDORI
GRVHV,WLVUHFRPPHQGHGWRTXDQWLI\(UZLQLDDVSDUDJLQDVHDFWLYLW\DQGDQWLERGLHVLQ
WKHVHUXPEHIRUHHYHU\DGPLQLVWUDWLRQDVZHOODVGD\VDIWHUWKHODVWGRVH
;
;
;
&\FORSKRVSKDPLGH
PJPGRVHDVDKRXULQWUDYHQRXVLQIXVLRQHYHU\KRXUVRQGD\VWRWRWDO
RIGRVHV0HVQDLVDGPLQLVWHUHGDWPJPGRVHEHIRUHDQGDWDQGKRXUVDIWHU
VWDUWRIHDFKF\FORSKRVSKDPLGHLQIXVLRQ+\GUDWLRQZLWKP/PLVDGPLQLVWHUHG
IURPVWDUWRIF\FORSKRVSKDPLGHXQWLOGD\0HVQDDQGFRQFRPLWDQWK\GUDWLRQDUH
FRQVLGHUHGQRQLQYHVWLJDWLRQDOSURWRFROUHTXLUHGWKHUDSLHVVHH6HFWLRQ
;


$5$&+LJK'RVH&\WDUDELQH
JPGRVHDVDKRXULQWUDYHQRXVLQIXVLRQHYHU\KRXUVRQGD\RIZHHNIRU
+&WRWDORIGRVHVDQGRQGD\V±RIZHHNRI+&WRWDORIGRVHV
3URSK\OD[LVRIFRQMXQFWLYLWLVZLWKH\HGURSVHYHU\KRXUVGXULQJDGPLQLVWUDWLRQDQGRI
QHXURSDWK\ZLWKYLWDPLQ%DWDGRVHRIPJP,9SULRUWRHDFKF\WDUDELQHGRVHLV
UHFRPPHQGHG$5$&+LJK'RVH&\WDUDELQHSURSK\OD[LVPHGLFDWLRQVDUH
FRQVLGHUHGQRQLQYHVWLJDWLRQDOSURWRFROUHTXLUHGWKHUDSLHVVHH6HFWLRQ
;
;

(WRSRVLGH
PJPGRVHDVDKRXULQWUDYHQRXVLQIXVLRQHYHU\KRXUVRQGD\VWRWRWDO
RIGRVHV

;

+&KLJKULVNFRQVROLGDWLRQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



3HGLDWULF5LVN$VVHVVPHQW
6XUYLYDOIRUILUVWUHODSVHRI%SUHFXUVRUDFXWHO\PSKREODVWLFOHXNHPLD%$//LV
VXERSWLPDO%OLQDWXPRPDELVDSURPLVLQJQRYHODJHQWIRUWKHWUHDWPHQWRI%OLQHDJH
O\PSKRLGPDOLJQDQFLHV,QD3KDVHWULDORIDGXOW%$//SDWLHQWVZLWK05'SHUVLVWHQFH
RUUHODSVHDIWHULQGXFWLRQDQGFRQVROLGDWLRQWKHUDS\UHFHLYHGEOLQDWXPRPDEDVDZHHN
&,9,DWDGRVHRIȝJPGD\2IWUHDWHGSDWLHQWVSDWLHQWVEHFDPH05'
QHJDWLYHDVDVVHVVHGE\TXDQWLWDWLYH3&5IRUHLWKHUUHDUUDQJHPHQWVRILPPXQRJOREXOLQ
RU7FHOOUHFHSWRUJHQHVRUVSHFLILFJHQHWLFDEHUUDWLRQV$PRQJWKHUHVSRQGHUV
SDWLHQWVKDGEHHQPROHFXODUO\UHIUDFWRU\WRSUHYLRXVFKHPRWKHUDS\3UREDELOLW\IRU
UHODSVHIUHHVXUYLYDOZDVDWDPHGLDQIROORZXSRIGD\V7RSSHWDO
7RSSHWDOD7RSSHWDOE%OLQDWXPRPDEZDVVLPLODUO\HIIHFWLYHDQG
ZHOOWROHUDWHGLQDQDQHFGRWDOUHSRUWRIDVPDOOVHULHVRISHGLDWULFFDVHV
+DQGJUHWLQJHUHWDO6FKOHJHOHWDO
%OLQDWXPRPDELVSUHVHQWO\EHLQJHYDOXDWHGLQFKLOGUHQZLWK55$//LQDQ
$PJHQVSRQVRUHG3KDVHVWXG\07EHLQJFRQGXFWHGLQFROODERUDWLRQZLWK
WKH&KLOGUHQ¶V2QFRORJ\*URXS&2*DQGWKH,%)0(XURSHDQFKLOGKRRGOHXNHPLD
FRRSHUDWLYHJURXSZLWKSURPLVLQJHDUO\UHVXOWV$VRI6HSWHPEHUSDWLHQWVKDYH
EHHQWUHDWHGLQWKH3KDVHSRUWLRQ$FURVVDOOGRVHOHYHOVSDWLHQWVKDG&5
*RUHHWDO6WDFNHOEHUJHWDO7KH3KDVHSRUWLRQRIWKHVWXG\LVEHLQJ
FRQGXFWHGDW&2*DQG(XURSHDQLQVWLWXWLRQVDQGFORVHGDFFUXDOLQ0D\
7KHOHYHORIVLQJOHDJHQWDFWLYLW\VHHQZLWKEOLQDWXPRPDEKDVQRWEHHQVHHQLQUHFHQW
3KDVH$//VWXGLHVRXWVLGHWKHXVHRIW\URVLQHNLQDVHLQKLELWRUV7.,LQSDWLHQWVZLWK
3K$//WKXVVXSSRUWLQJD3KDVHUDQGRPL]HGFOLQLFDOWULDOZLWK()6HQGSRLQWV7KLV
VWXG\XVHVDQDSSURDFKWRWHVWZKHWKHULQFRUSRUDWLQJEOLQDWXPRPDELQWRWUHDWPHQWRI
KLJKULVNILUVWUHODSVH%$//ZLOOUHGXFHUDWHVRIVHFRQGUHODSVHDQGLPSURYH()6
$GGLWLRQDOO\VXFFHVVLQUHODSVHG%$//ZLOOSURYLGHDGGLWLRQDOUDWLRQDOHWRWHVW
EOLQDWXPRPDELQQHZO\GLDJQRVHG%$//SDWLHQWVLQRUGHUWRUHGXFHUDWHVRIILUVW
UHODSVH
$VH[SHULHQFHZLWKEOLQDWXPRPDEUHPDLQVUHODWLYHO\OLPLWHGWKLVVWXG\ZLOOLQFOXGHFORVH
HDUO\VWRSSLQJUXOHVIRUPHGLFDOO\LPSRUWDQWDGYHUVHHYHQWVVXFKDVUHOHYDQWQHXURORJLF
HYHQWVLQVXEMHFWVUHFHLYLQJEOLQDWXPRPDE,QDGGLWLRQWKHSRWHQWLDOIRUDGYHUVHHIIHFWV
IURPORQJWHUPGHSOHWLRQRI&'QRUPDOO\PSKRF\WHVZLWKGHFUHDVHLQLPPXQH
JOREXOLQVIROORZLQJEOLQDWXPRPDEWUHDWPHQWLVXQNQRZQDQGVRPRQLWRULQJIRULPPXQH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


JOREXOLQUHFRYHU\DQGIRUSRWHQWLDODGYHUVHHIIHFWVUHODWHGWRGHOD\HGUHFRYHU\DUH
LQFOXGHG
1HXURORJLFHYHQWVKDYHEHHQGHVFULEHGZLWKEOLQDWXPRPDEPDLQO\LQDGXOWSDWLHQWVEXW
VWLOOZLOOEHFORVHO\PRQLWRUHGRQWKLVVWXG\2QHSRWHQWLDOFRQFHUQUHJDUGVWKHVDIHW\RI
FRPELQLQJEOLQDWXPRPDEZLWKLQWUDWKHFDOFKHPRWKHUDS\,QWKHFXUUHQW3KDVH
SHGLDWULFVWXG\FLWHGDERYHLQWUDWKHFDO07;RULQWUDWKHFDOWULSOHVDUHLQFOXGHGSULRU
WR&\FOHDW'D\RI&\FOHDQGDW'D\RIHDFKF\FOH1RXQXVXDORU
LQFUHDVHG&16VLGHHIIHFWVKDYHEHHQVHHQLQWKLVVHWWLQJ*RUHHWDO
6WDFNHOEHUJHWDO
&56KDVDOVREHHQGHVFULEHG7KLVLVPRUHSUHYDOHQWLQSDWLHQWVZLWKKLJKHUOHXNHPLD
EXUGHQ3UHPHGLFDWLRQZLWKGH[DPHWKDVRQHLPPHGLDWHO\EHIRUHWUHDWPHQWVWDUWLQ
RUGHUWRPLWLJDWHILUVWGRVHHIIHFWVLVPDQGDWHGLQWKHSURWRFRO$QDQWL,/PRQRFORQDO
DQWLERG\LHWRFLOL]XPDEZDVVKRZQWREHHIIHFWLYHLQRQHSDWLHQWLQUHYHUWLQJRYHUWDQG
OLIHWKUHDWHQLQJ&567HDFKH\HWDO2WKHUFRPPRQWUDQVLHQWDGYHUVHHYHQWV
DVVRFLDWHGZLWKF\WRNLQHUHOHDVHDUHS\UH[LDKHDGDFKHDQGHOHYDWLRQLQOLYHUHQ]\PHV
ZKLFKKDYHQRWOHGWRWUHDWPHQWGLVFRQWLQXDWLRQ
7KXVWKHSRWHQWLDOEHQHILWUHSRUWHGWRGDWHIRUEOLQDWXPRPDERXWZHLJKVWKHSRWHQWLDO
ULVN

5DWLRQDOH
7KLVVWXG\ZLOOSURYLGHDQRSSRUWXQLW\WRFRQILUP3KDVHVDIHW\DQGHIILFDF\GDWDLQWKH
55SHGLDWULF$//SRSXODWLRQE\JHQHUDWLQJGDWDLQD3KDVHUDQGRPL]HGFRQWUROOHG
VWXG\HQUROOLQJSHGLDWULFVXEMHFWVZLWKKLJKULVNILUVWUHODSVH%SUHFXUVRU$//
7KLVLVD3KDVHUDQGRPL]HGRSHQODEHOFRQWUROOHGPXOWLFHQWHUVWXG\LQYHVWLJDWLQJWKH
HIILFDF\DQGVDIHW\SURILOHRIEOLQDWXPRPDEYHUVXVLQWHQVLYHVWDQGDUGODWHFRQVROLGDWLRQ
FKHPRWKHUDS\3HGLDWULFVXEMHFWVZLWKKLJKULVNILUVWUHODSVH%SUHFXUVRU$//ZLWKDQ
0RUDQ0PDUURZZLOOEHUDQGRPL]HGWRUHFHLYHHLWKHURQHF\FOHRIEOLQDWXPRPDE
JPGD\RU+&FKHPRWKHUDS\
7KHUDWLRQDOHIRUWKLVGHVLJQLVEDVHGRQWKHUHVXOWVRISUHYLRXVVWXGLHVE\WKHSHGLDWULF
VWXG\JURXSVLQWKLVSDWLHQWJURXSVKRZLQJKLJKUDWHVRIVXEVHTXHQWUHODSVHVLQSDWLHQWV
WUDQVSODQWHGLQ&57KLVUDWHGHSHQGVRQWKHSHUVLVWLQJ05'XQWLODOOR+6&7ZLWK
KLJKHUUHODSVHUDWHVLQSDWLHQWVZLWKKLJK05'OHYHOV%DGHUHWDO
3DWLHQWVZLWKQHJDWLYH05'OHYHOVDWDOOR+6&7DOVRVXIIHUUHOHYDQWUDWHVRIVXEVHTXHQW
UHODSVHV%DGHUHWDO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


6LQFHEOLQDWXPRPDEKDVVKRZQWKHFDSDFLW\WRLQGXFH05'QHJDWLYHUHPLVVLRQVLQ55
DQG05'SRVLWLYH$//ZLWKDFRPSOHWHO\GLIIHUHQWPHFKDQLVPRIDFWLRQFRPSDUHGWR
FRQYHQWLRQDOFKHPRWKHUDS\ZHK\SRWKHVL]HWKDWEOLQDWXPRPDEZLOOLPSURYH05'
QHJDWLYLW\XQWLODOOR+6&7LQ0RU05'SRVLWLYHVXEMHFWVDQGIXUWKHUPRUHZLOOUHGXFH
VXEVHTXHQWUHODSVHUDWHVSRVWDOOR+6&7LQ05'QHJDWLYHVXEMHFWVWKXVOHDGLQJWR
KLJKHU()6DQG26UDWHV
)XUWKHUPRUHOHVVWR[LFLW\LVH[SHFWHGGXULQJWUHDWPHQWZLWKEOLQDWXPRPDELQFRPSDULVRQ
WRFKHPRWKHUDS\DQGWKXVEHWWHUJHQHUDOVWDWXVDWDOOR+6&7OHDGLQJWROHVVWR[LFLW\DQG
PRUWDOLW\ZLWKWKLVWR[LFSURFHGXUH
$VGHVFULEHGEOLQDWXPRPDEKDVJHQHUDWHGSRVLWLYHGDWDLQWKHDGXOWSRSXODWLRQLQ
05'±SRVLWLYH$//DIWHUWKHLQGXFWLRQDQGFRQVROLGDWLRQRIIURQWOLQHWKHUDS\ZLWKLQWKH
SURWRFROVRIWKH*HUPDQ0XOWLFHQWHU6WXG\*URXSIRU$GXOW$FXWH/\PSKREODVWLF
/HXNHPLD*0$//(LJKW\SHUFHQWRXWRIRIWKHVXEMHFWVHYDOXDEOHIRU05'
DVVHVVPHQWDFKLHYHGDQ05'UHVSRQVH7RSSHWDO$IWHUDPHGLDQIROORZXSRI
PRQWKVWKHKHPDWRORJLFDOUHODSVHIUHHVXUYLYDOZDVE\.DSODQ0HLHUHVWLPDWH
7RSSHWDOD7RSSHWDOE$VDUHVXOWWKHUHLVHYLGHQFHWKDWWKLVVWXG\ZLOO
GHPRQVWUDWHHIIHFWLYHQHVVLQWKHSURSRVHGSHGLDWULFKLJKULVNILUVWUHODSVH%SUHFXUVRU
$//FRQVROLGDWLRQVHWWLQJ
7KHORQJWHUPIROORZXSSHULRGRIIHUVWKHRSSRUWXQLW\WRHYDOXDWHEOLQDWXPRPDEHIIHFWV
ZLWKUHJDUGWRHIILFDF\DQGWR[LFLW\UHODWLYHWRFKHPRWKHUDS\7KHPRVWLPSRUWDQWWLPH
SRLQWVIRUDVVHVVPHQWRIVDIHW\IROORZXSDUHWLPHEHIRUHDOOR+6&7DQGWKHHQGRI
IROORZXS%HFDXVHDOOR+6&7LVDWKHUDSHXWLFPHDVXUHZKLFKPD\KDYHDVHULRXV
LPSDFWRQVXEMHFWV¶SHUIRUPDQFHLWLVLPSRUWDQWWKDWWKHSHUIRUPDQFHVWDWXVRIVXEMHFWV
EHIRUHWUDQVSODQWDWLRQLVDVRSWLPDODVSRVVLEOH,WLVDOVRLPSRUWDQWWKDWWKHUHLVQR
ORQJWHUPLPSDFWRQVXEMHFWV¶SHUIRUPDQFHVWDWXVWKHUHIRUHWKLVZLOOEHDOVRDVVHVVHGDW
WKHHQGRIIROORZXS
7KHPDMRUWR[LFLWLHVRIEOLQDWXPRPDEDUH&56QHXURORJLFHYHQWVDQGLQIHFWLRQV
&56KDVEHHQREVHUYHGLQWKH55$//LQGLFDWLRQLQVXEMHFWVZLWKKLJKWXPRUEXUGHQDW
WKHVWDUWRIEOLQDWXPRPDEWUHDWPHQW&56LVJHQHUDOO\DQLPPHGLDWHHYHQWRFFXUULQJ
XSRQLQLWLDWLQJ7FHOOWKHUDS\$FURVVWKHDGXOW55$//SURJUDPWKHPHGLDQWLPHWR
RQVHWRI&56ZDVGD\V7KHWLPHDWZKLFKVXEMHFWVH[SHULHQFHGWKHJUHDWHVWULVNRI
GHYHORSLQJ&56ZDVRQGD\RIWUHDWPHQWZLWKEOLQDWXPRPDE7KHUHIRUHEDVHGRQ
WKHWLPLQJRIRFFXUUHQFHRI&56HYHQWVORQJWHUPIROORZXSIRU&56ZLOOOLNHO\QRW
SURYLGHIXUWKHUXVHIXOLQIRUPDWLRQ&ORVHPRQLWRULQJGXULQJWKHLQLWLDWLRQRI

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


EOLQDWXPRPDEWUHDWPHQWORZHULQLWLDOEOLQDWXPRPDEGRVHLQWKHILUVWZHHNRIWUHDWPHQW
DQGSUHSKDVHWUHDWPHQWZLWKGH[DPHWKDVRQHLQSDWLHQWVZLWKKLJKWXPRUEXUGHQKDV
EHHQVXFFHVVIXOLQPLWLJDWLQJWKLVULVN
1HXURORJLFHYHQWVDUHPRVWIUHTXHQWO\REVHUYHGDWWKHEHJLQQLQJRIWUHDWPHQWDQGPRVW
FOLQLFDOO\UHVROYH)HZFDVHVZLWKZKLWHPDWWHUPDJQHWLFUHVRQDQFHLPDJLQJFKDQJHV
OHXNRHQFHSKDORSDWK\KDYHEHHQQRWHGEXWWKHVHFDVHVDUHFRQIRXQGHGE\SDVW
KLVWRU\RIKLJKGRVH07;F\WDUDELQHDQGZKROHERG\LUUDGLDWLRQ7%,7KHUHIRUHD
FDXVDOUHODWLRQVKLSWREOLQDWXPRPDEFDQQRWEHHQWLUHO\UXOHGRXW$QHXURORJLFDO
DVVHVVPHQWXVHGLQSUHYLRXVEOLQDWXPRPDESURWRFROVZLOOEHSHUIRUPHGDWVFUHHQLQJ
DQGGXULQJWUHDWPHQWRQWKLVVWXG\EHIRUHDOOR+6&7DQGDWWKHHQGRIIROORZXS
&OLQLFDOO\UHOHYDQWQHXURORJLFHYHQWVPRVWIUHTXHQWO\REVHUYHGGXULQJWUHDWPHQWZLWK
EOLQDWXPRPDEDUHOLVWHGLQ$SSHQGL[+
%OLQDWXPRPDELVDVVRFLDWHGZLWKDQLQFUHDVHGULVNRILQIHFWLRQVGXULQJWUHDWPHQWEXW
WKLVULVNLVQRORQJHUUHOHYDQWDIWHUDOOR+6&7+RZHYHUVLQFHDOOR+6&7LQFUHDVHVWKH
ULVNRILQIHFWLRQLQFLGHQFHDQGVHYHULW\RILQIHFWLRQVZLOOEHFROOHFWHGGXULQJIROORZXS

&OLQLFDO+\SRWKHVHV
%OLQDWXPRPDEZLOOGHPRQVWUDWHDUHGXFWLRQLQWKHULVNRIHYHQWVUHODSVHRU0PDUURZ
DIWHUKDYLQJDFKLHYHGD&5IDLOXUHWRDFKLHYHD&5DWWKHHQGRIWUHDWPHQWVHFRQG
PDOLJQDQF\RUGHDWKGXHWRDQ\FDXVHLQWKLVSHGLDWULFKLJKULVNILUVWUHODSVH$//
SRSXODWLRQ,WLVDQWLFLSDWHGWKDWWKHULVNUHGXFWLRQRIHYHQWVZLOOEHLQQRQFXUHG
VXEMHFWVDQGDFXUHUDWHLQFUHDVHIURPWRFXUHLVGHILQHGDVDVXEMHFW
KDYLQJQR()6HYHQWDIWHUPRQWKVRQVWXG\ 

(;3(5,0(17$/3/$1

6WXG\'HVLJQ
7KLVLVD3KDVHUDQGRPL]HGRSHQODEHOFRQWUROOHGPXOWLFHQWHUVWXG\LQYHVWLJDWLQJWKH
HIILFDF\DQGVDIHW\SURILOHRIEOLQDWXPRPDEYHUVXVLQWHQVLYHVWDQGDUGODWHFRQVROLGDWLRQ
FKHPRWKHUDS\$IWHULQGXFWLRQWKHUDS\DQGEORFNVRIKLJKULVNFRQVROLGDWLRQ
FKHPRWKHUDS\SHGLDWULFVXEMHFWVZLWKKLJKULVNILUVWUHODSVH%SUHFXUVRU$//ZLOOEH
UDQGRPL]HGLQDUDWLRWRHLWKHUEOLQDWXPRPDERUDWKLUGEORFNRIVWDQGDUG+&
FKHPRWKHUDS\

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


5DQGRPL]DWLRQZLOOEHVWUDWLILHGE\DJHPDUURZVWDWXVGHWHUPLQHGDWWKHHQGRI+&
DQG05'VWDWXVGHWHUPLQHGDWWKHHQGRILQGXFWLRQ6L[VWUDWDZLOOEHIRUPHGIURPWKH
IROORZLQJDJHFDWHJRULHVDQGPDUURZ05'FDWHJRULHV

$JH\HDUVDQGRWKHU\HDUDQG\HDUV

0DUURZ05'0ZLWK05'OHYHO
0ZLWK05'OHYHODQG0
$IWHUDVFUHHQLQJSHULRGRIXSWRZHHNVHOLJLEOHVXEMHFWVZLOOEHHQUROOHGDQG
UDQGRPL]HGWRRQHRIWKHIROORZLQJWZRWUHDWPHQWDUPV

$UP$2QHFRQVROLGDWLRQF\FOHRIEOLQDWXPRPDEJPGD\GHILQHG
DVDZHHN&,9,RIEOLQDWXPRPDERU

$UP$2QHFRQVROLGDWLRQF\FOHRI+&
0RVWVXEMHFWVZKRDUHLQRUDFKLHYHF\WRPRUSKRORJLFDO&50PDUURZDIWHU
FRPSOHWLQJFRQVROLGDWLRQWKHUDS\LQDQ\WUHDWPHQWDUPZLOOXQGHUJRDOOR+6&7
7KHIROORZLQJYLVLWW\SHVZLOOEHSHUIRUPHG

'XULQJVFUHHQLQJDVVHVVPHQWVZLOOEHSHUIRUPHGWRHYDOXDWHHOLJLELOLW\RIWKH
VXEMHFW

'XULQJWKHWUHDWPHQWSHULRGYLVLWVZLOOEHSHUIRUPHGRQ'D\'D\(QGRI
7UHDWPHQW7KH'D\YLVLWZLOOKDYHDZLQGRZRI	GD\V

$VDIHW\IROORZXSYLVLWZLOOEHUHTXLUHGZLWKLQGD\VSULRUWRDOOR+6&7

6XEMHFWVZLOOEHIROORZHGGXULQJDVKRUWWHUPHIILFDF\IROORZXSSHULRGRI
PRQWKVIROORZLQJDOOR+6&7IROORZHGE\DORQJWHUPIROORZXSSHULRGWKDWODVWV
XQWLOWKHODVWVXEMHFWRQVWXG\LVPRQWKVIROORZLQJDOOR+6&7RUXQWLOGHDWK
ZKLFKHYHULVILUVW$IWHUUHDFKLQJWKHSULPDU\HQGSRLQWVXEMHFWVZLOOEHGLUHFWO\
IROORZHGE\WKHORQJWHUPIROORZXSSHULRG
o 'XULQJWKHVKRUWWHUPHIILFDF\IROORZXSSHULRGYLVLWVZLOOEHSHUIRUPHGDW
GD\VGD\VPRQWKVPRQWKVDQGPRQWKVIROORZLQJ
DOOR+6&7
o 'XULQJWKHORQJWHUPIROORZXSSHULRGWHOHSKRQHDQGRUHPDLOFRQWDFWZLOO
EHPDGHWRDVVHVVGLVHDVHDQGVXUYLYDOVWDWXVHYHU\PRQWKV
	ZHHNVXQWLOWKHODVWVXEMHFWRQVWXG\LVPRQWKVIROORZLQJ
DOOR+6&7RUXQWLOGHDWKZKLFKHYHURFFXUVILUVW
7KHRYHUDOOVWXG\GHVLJQLVGHVFULEHGE\DVWXG\VFKHPDDWWKHHQGRIWKH
SURWRFROV\QRSVLVVHFWLRQ3URFHGXUHVWREHSHUIRUPHGDWHDFKYLVLWDUHGHVFULEHGLQWKH
6FKHGXOHRI$VVHVVPHQWV7DEOHDQGWKURXJKRXW6HFWLRQ
7KHVWXG\HQGSRLQWVDUHGHILQHGLQ6HFWLRQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



1XPEHURI6LWHV
$SSUR[LPDWHO\FHQWHUVORFDWHGLQEXWQRWOLPLWHGWR(XURSH,VUDHO/DWLQ$PHULFD
DQG$XVWUDOLDZLOOSDUWLFLSDWHLQWKLVVWXG\'XULQJWKHFRQGXFWRIWKHVWXG\DGGLWLRQDO
UHJLRQVFRXQWULHVRUVLWHVPD\EHDGGHGDVQHFHVVDU\
6LWHVWKDWGRQRWHQUROOVXEMHFWVZLWKLQPRQWKVRIVLWHLQLWLDWLRQPD\EHFRQVLGHUHGIRU
FORVXUHWRIXUWKHUSDUWLFLSDWLRQLQWKHWULDO

1XPEHURI6XEMHFWV
3DUWLFLSDQWVLQWKLVFOLQLFDOLQYHVWLJDWLRQVKDOOEHUHIHUUHGWRDV³VXEMHFWV´,WLV
DQWLFLSDWHGWKDWXSWRSHGLDWULFVXEMHFWVZLOOEHHQUROOHGLQWRWKLVVWXG\
3OHDVHUHIHUWR6HFWLRQIRUVDPSOHVL]HFRQVLGHUDWLRQV 

5HSODFHPHQWRI6XEMHFWV
6XEMHFWVZLOOQRWEHUHSODFHGDIWHUUDQGRPL]DWLRQ

(VWLPDWHG6WXG\'XUDWLRQ

6WXG\'XUDWLRQIRU6XEMHFWV
)RUDQLQGLYLGXDOVXEMHFWWKHOHQJWKRISDUWLFLSDWLRQLQFOXGHVDZHHNVFUHHQLQJSHULRG
DZHHNWUHDWPHQWSHULRGIROORZHGE\DZHHNVDIHW\IROORZXSSHULRGDQGDPRQWK
VKRUWWHUPHIILFDF\IROORZXSDQGDORQJWHUPIROORZXSWKDWFRQWLQXHVXQWLOWKHODVW
VXEMHFWRQVWXG\LVPRQWKVIROORZLQJDOOR+6&7RUXQWLOGHDWKZKLFKHYHULVILUVW

(QGRI6WXG\
3ULPDU\&RPSOHWLRQ7KHSULPDU\FRPSOHWLRQGDWHLVGHILQHGDVWKHGDWHZKHQWKHODVW
VXEMHFWLVDVVHVVHGRUUHFHLYHVDQLQWHUYHQWLRQIRUWKHILQDOFROOHFWLRQRIGDWDIRUWKH
SULPDU\HQGSRLQWZKHWKHUWKHVWXG\FRQFOXGHGDVSODQQHGLQWKHSURWRFRORUZDV
WHUPLQDWHGHDUO\
8QOHVVWKHVWXG\LVVWRSSHGSUHPDWXUHO\WKHSULPDU\DQDO\VLVZLOOEHWULJJHUHGZKHQ
()6HYHQWVDUHUHSRUWHGLQWKHFOLQLFDOWULDOGDWDEDVH
,IWKHVWXG\FRQFOXGHVSULRUWRWKHSULPDU\FRPSOHWLRQGDWHRULJLQDOO\SODQQHGLQWKH
SURWRFROLHHDUO\WHUPLQDWLRQRIWKHVWXG\WKHQWKHSULPDU\FRPSOHWLRQZLOOEHWKHGDWH
ZKHQWKHODVWVXEMHFWLVDVVHVVHGRUUHFHLYHVDQLQWHUYHQWLRQIRUHYDOXDWLRQLQWKHVWXG\
LHODVWVXEMHFWODVWYLVLW
(QGRI6WXG\7KHHQGRIVWXG\GDWHLVGHILQHGDVWKHGDWHZKHQWKHODVWVXEMHFWDFURVV
DOOVLWHVLVDVVHVVHGRUUHFHLYHVDQLQWHUYHQWLRQIRUHYDOXDWLRQLQWKHVWXG\LHODVW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


VXEMHFWODVWYLVLWIROORZLQJDQ\DGGLWLRQDOSDUWVLQWKHVWXG\HJORQJWHUPIROORZXSDV
DSSOLFDEOH

68%-(&7(/,*,%,/,7<
,QYHVWLJDWRUVZLOOEHH[SHFWHGWRPDLQWDLQDVFUHHQLQJORJRIDOOSRWHQWLDOVWXG\
FDQGLGDWHVWKDWLQFOXGHVOLPLWHGLQIRUPDWLRQDERXWWKHSRWHQWLDOFDQGLGDWHHJGDWHRI
VFUHHQLQJ
%HIRUHDQ\VWXG\VSHFLILFDFWLYLW\SURFHGXUHWKHDSSURSULDWHZULWWHQLQIRUPHGFRQVHQW
DQGDVVHQWPXVWEHREWDLQHG6HFWLRQ,QDGGLWLRQWRZULWWHQLQIRUPHGFRQVHQW
IURPDOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHWKHDVVHQWRIWKHFKLOGPXVWEHREWDLQHGDV
DSSURSULDWHWRWKHDJHRIWKHVXEMHFWDQGRUEDVHGRQORFDOUHJXODWLRQV

,QFOXVLRQ&ULWHULD

6XEMHFWVZLWK3KLODGHOSKLDFKURPRVRPHQHJDWLYH3KKLJKULVN+5ILUVW
UHODSVH%SUHFXUVRU$//DVGHILQHGE\,%)06*,QW5H$//FULWHULDDIWHU
VHFRQGFRQVROLGDWLRQDIWHULQGXFWLRQDFFRUGLQJWR,QW5H$//WUHDWPHQWJXLGHOLQHV 

6XEMHFWVZLWK0RU0DWWKHWLPHRIUDQGRPL]DWLRQ 

$JHGD\VDQG\HDUVDWWKHWLPHRILQIRUPHGFRQVHQWDVVHQW

6XEMHFW¶VOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHKDVSURYLGHGLQIRUPHGFRQVHQWZKHQ
WKHVXEMHFWLVOHJDOO\WRR\RXQJWRSURYLGHLQIRUPHGFRQVHQWDQGWKHVXEMHFWKDV
SURYLGHGZULWWHQDVVHQWEDVHGRQORFDOUHJXODWLRQVDQGRUJXLGHOLQHVSULRUWRDQ\
VWXG\VSHFLILFDFWLYLWLHVSURFHGXUHVEHLQJLQLWLDWHG 

$YDLODELOLW\RIWKHIROORZLQJPDWHULDOIURPUHODSVHGLDJQRVLVIRUFHQWUDODQDO\VLVRI
05'E\3&5FORQHVSHFLILFSULPHUVDQGUHIHUHQFH'1$DVZHOODVSULPHU
VHTXHQFHVDQGDQDO\]HGVHTXHQFHVRIFORQDOUHDUUDQJHPHQWVFDVHVZLWK
LVRODWHGH[WUDPHGXOODU\UHODSVHRUFDVHVZLWKWHFKQLFDODQGRUORJLVWLFKXUGOHVWR
REWDLQDQGSURFHVVERQHPDUURZPDWHULDODUHH[HPSWIURPSURYLGLQJWKLV
PDWHULDO,QWKHVHFDVHVFHQWUDO05'DQDO\VLVRQO\E\)ORZLVSHUPLWWHG 

([FOXVLRQ&ULWHULD

&OLQLFDOO\UHOHYDQW&16SDWKRORJ\UHTXLULQJWUHDWPHQWHJXQVWDEOHHSLOHSV\
(YLGHQFHRIFXUUHQW&16&16&16LQYROYHPHQWE\$//6XEMHFWVZLWK
&16UHODSVHDWWKHWLPHRIUHODSVHDUHHOLJLEOHLI&16LVVXFFHVVIXOO\WUHDWHGSULRU
WRHQUROOPHQW

3HULSKHUDOQHXWURSKLOV/SULRUWRVWDUWRIWUHDWPHQW

3HULSKHUDOSODWHOHWV/SULRUWRVWDUWRIWUHDWPHQW

&XUUHQWO\UHFHLYLQJWUHDWPHQWLQDQRWKHULQYHVWLJDWLRQDOGHYLFHRUGUXJVWXG\RU
OHVVWKDQZHHNVVLQFHHQGLQJWUHDWPHQWRQDQRWKHULQYHVWLJDWLRQDOGHYLFHRU
GUXJVWXG\V3URFHGXUHVUHTXLUHGE\,QW5H$//+5JXLGHOLQHVDUHDOORZHG

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



6\PSWRPVDQGRUFOLQLFDOVLJQVDQGRUUDGLRORJLFDODQGRUVRQRJUDSKLFVLJQVWKDW
LQGLFDWHDQDFXWHRUXQFRQWUROOHGFKURQLFLQIHFWLRQDQ\RWKHUFRQFXUUHQWGLVHDVH
RUPHGLFDOFRQGLWLRQWKDWFRXOGEHH[DFHUEDWHGE\WKHWUHDWPHQWRUZRXOG
VHULRXVO\FRPSOLFDWHFRPSOLDQFHZLWKWKHSURWRFRO

6XEMHFWOLNHO\WRQRWEHDYDLODEOHWRFRPSOHWHDOOSURWRFROUHTXLUHGVWXG\YLVLWVRU
SURFHGXUHVLQFOXGLQJIROORZXSYLVLWVDQGRUWRFRPSO\ZLWKDOOUHTXLUHGVWXG\
SURFHGXUHVWRWKHEHVWRIWKHVXEMHFW¶VDQGLQYHVWLJDWRU¶VNQRZOHGJH

+LVWRU\RUHYLGHQFHRIDQ\RWKHUFOLQLFDOO\VLJQLILFDQWGLVRUGHUFRQGLWLRQRU
GLVHDVHZLWKWKHH[FHSWLRQRIWKRVHRXWOLQHGDERYHWKDWLQWKHRSLQLRQRIWKH
LQYHVWLJDWRURU$PJHQSK\VLFLDQLIFRQVXOWHGZRXOGSRVHDULVNWRVXEMHFWVDIHW\
RULQWHUIHUHZLWKWKHVWXG\HYDOXDWLRQSURFHGXUHVRUFRPSOHWLRQ

3ODFHGLQWRDQLQVWLWXWLRQGXHWRMXULGLFDORUUHJXODWRU\UXOLQJ

$EQRUPDOUHQDORUKHSDWLFIXQFWLRQSULRUWRVWDUWRIWUHDWPHQWGD\DVGHILQHG
EHORZ
D
$EQRUPDOVHUXPFUHDWLQLQHEDVHGRQDJHJHQGHU
E
7RWDOELOLUXELQPJG/SULRUWRVWDUWRIWUHDWPHQWXQOHVVUHODWHGWR
*LOEHUW¶VRU0HXOHQJUDFKWGLVHDVH 

&KHPRWKHUDS\UHODWHGWR[LFLWLHVWKDWKDYHQRWUHVROYHGWRJUDGHH[FHSWIRU
SDUDPHWHUVGHILQHGLQ([FOXVLRQ&ULWHULDDQG

'RFXPHQWHGLQIHFWLRQZLWKKXPDQLPPXQRGHILFLHQF\YLUXV+,9

.QRZQK\SHUVHQVLWLYLW\WRLPPXQRJOREXOLQVRUDQ\RIWKHSURGXFWVRUFRPSRQHQWV
WREHDGPLQLVWHUHGGXULQJGRVLQJH[FOXGLQJDVSDUDJLQDVH

3RVWPHQDUFKDOIHPDOHVXEMHFWZKRLVSUHJQDQWRUEUHDVWIHHGLQJRULVSODQQLQJ
WREHFRPHSUHJQDQWRUEUHDVWIHHGZKLOHUHFHLYLQJSURWRFROVSHFLILHGWKHUDS\DQG
IRUDWOHDVWPRQWKVDIWHUWKHODVWGRVHRIFKHPRWKHUDS\

3RVWPHQDUFKDOIHPDOHVXEMHFWZKRLVQRWZLOOLQJWRSUDFWLFHWUXHVH[XDO
DEVWLQHQFHRUXVHDKLJKO\HIIHFWLYHIRUPRIFRQWUDFHSWLRQZKLOHUHFHLYLQJ
SURWRFROVSHFLILHGWKHUDS\DQGIRUDWOHDVWPRQWKVDIWHUWKHODVWGRVHRI
FKHPRWKHUDS\VHH$SSHQGL[(

6H[XDOO\PDWXUHPDOHVXEMHFWZKRLVQRWZLOOLQJWRSUDFWLFHWUXHVH[XDO
DEVWLQHQFHRUXVHDFRQGRPZLWKVSHUPLFLGHZKLOHUHFHLYLQJSURWRFROVSHFLILHG
WKHUDS\DQGIRUDWOHDVWPRQWKVDIWHUODVWGRVHRIFKHPRWKHUDS\,QFRXQWULHV
ZKHUHVSHUPLFLGHLVQRWDYDLODEOHDFRQGRPZLWKRXWVSHUPLFLGHLVDFFHSWDEOH
VHH$SSHQGL[(

6H[XDOO\PDWXUHPDOHVXEMHFWZKRLVQRWZLOOLQJWRDEVWDLQIURPVSHUPGRQDWLRQ
ZKLOHUHFHLYLQJSURWRFROVSHFLILHGWKHUDS\DQGIRUDWOHDVWPRQWKVDIWHUODVW
GRVHRIFKHPRWKHUDS\

68%-(&7(152//0(17
%HIRUHVXEMHFWVEHJLQSDUWLFLSDWLRQLQDQ\VWXG\VSHFLILFDFWLYLWLHVSURFHGXUHV$PJHQ
UHTXLUHVDFRS\RIWKHVLWH¶VZULWWHQ,QVWLWXWLRQDO5HYLHZ%RDUG,QGHSHQGHQW(WKLFV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


&RPPLWWHH,5%,(&DSSURYDORIWKHSURWRFROLQIRUPHGFRQVHQWIRUP,&)DQGDVVHQW
IRUPDQGDOORWKHUVXEMHFWLQIRUPDWLRQDQGRUUHFUXLWPHQWPDWHULDOLIDSSOLFDEOHVHH
6HFWLRQ
$OOVXEMHFWVDQGRUOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHVPXVWSHUVRQDOO\VLJQDQGGDWHWKH
$PJHQDSSURYHGFRQVHQWIRUPDQGRUDVVHQWIRUPEHIRUHFRPPHQFHPHQWRI
VWXG\VSHFLILFSURFHGXUHV
$VXEMHFWLVFRQVLGHUHGHQUROOHGZKHQWKHLQYHVWLJDWRUGHFLGHVWKDWWKHVXEMHFWKDVPHW
DOOHOLJLELOLW\FULWHULDDQGWKHVXEMHFWKDVEHHQUDQGRPL]HG7KHLQYHVWLJDWRULVWR
GRFXPHQWWKLVGHFLVLRQDQGGDWHLQWKHVXEMHFW¶VPHGLFDOUHFRUGDQGLQRQWKH
HQUROOPHQWFDVHUHSRUWIRUP&5)DQGWRHQWHUWKHSDWLHQWLQWKH,QWHJUDWHG9RLFH
5HVSRQVH6\VWHP,956
(DFKVXEMHFWZKRHQWHUVLQWRWKHVFUHHQLQJSHULRGIRUWKHVWXG\HJDWWKHWLPHLQIRUPHG
FRQVHQWDQGRUDVVHQWLVDUHVLJQHGUHFHLYHVDXQLTXHVXEMHFWLGHQWLILFDWLRQQXPEHU
EHIRUHDQ\VWXG\UHODWHGDFWLYLWLHVSURFHGXUHVDUHSHUIRUPHG7KHVXEMHFWLGHQWLILFDWLRQ
QXPEHUZLOOEHDVVLJQHGE\WKH,9567KLVQXPEHUZLOOEHXVHGWRLGHQWLI\WKHVXEMHFW
WKURXJKRXWWKHFOLQLFDOVWXG\DQGPXVWEHXVHGRQDOOVWXG\GRFXPHQWDWLRQUHODWHGWRWKDW
VXEMHFW5HVFUHHQLQJLVQRWSHUPLWWHGKRZHYHUVFUHHQLQJPD\EHH[WHQGHGE\XSWR
GD\VIRUERQHPDUURZFRXQWUHFRYHU\DQGRUVFKHGXOLQJRIERQHPDUURZFROOHFWLRQ
RQO\
5DQGRPL]DWLRQ
2QFHHOLJLELOLW\KDVEHHQFRQILUPHGVXEMHFWVZLOOEHUDQGRPL]HGLQDUDWLRWRUHFHLYH
EOLQDWXPRPDERU62&FKHPRWKHUDS\DVDVVLJQHGE\WKH,956
7RUDQGRPL]HDVXEMHFWDQDXWKRUL]HGVLWHUHSUHVHQWDWLYHZLOOPDNHWKHUDQGRPL]DWLRQ
FDOOWRWKH,956WRDVVLJQDUDQGRPL]DWLRQQXPEHUWRWKHVXEMHFW7KHUDQGRPL]DWLRQ
FDOOWRWKH,956LVDFFRPSOLVKHGE\HQWHULQJWKHSHUWLQHQWLQIRUPDWLRQGHWDLOHGLQWKH
,956XVHUPDQXDO5DQGRPL]DWLRQZLOOEHVWUDWLILHGE\DJHPDUURZVWDWXVDQG05'
VWDWXVDVGHVFULEHGLQ6HFWLRQ
2QFHGDWDKDYHEHHQHQWHUHGLQWRWKH,956DFRQILUPDWLRQID[RUHPDLOZLOOEHVHQWWR
WKHVLWHWRYHULI\WKDWWKHFRUUHFWLQIRUPDWLRQKDVEHHQHQWHUHG7KHVLWHUHSUHVHQWDWLYH
ZLOOUHFHLYHDVLQJOHXQLTXHUDQGRPL]DWLRQQXPEHUIRUHDFKVXEMHFWDQGWKH
UDQGRPL]DWLRQWUHDWPHQWDVVLJQHG$VXEMHFWZLOOEHFRQVLGHUHGHQUROOHGDQG
UDQGRPL]HGLQWRWKHVWXG\ZKHQDUDQGRPL]DWLRQQXPEHULVDVVLJQHG

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7KHUDQGRPL]DWLRQGDWHLVWREHGRFXPHQWHGLQWKHVXEMHFW¶VPHGLFDOUHFRUGDQGRQWKH
HQUROOPHQW&5)
6XEMHFWVVKRXOGFRPPHQFHSURWRFROUHTXLUHGWKHUDS\ZLWKLQGD\VRIUDQGRPL]DWLRQ 

75($70(17352&('85(6

&ODVVLILFDWLRQRI3URGXFWVDQGRU0HGLFDO'HYLFHV
7KH$PJHQLQYHVWLJDWLRQDOSURGXFWIRUWKLVVWXG\LVEOLQDWXPRPDE%OLQDWXPRPDEZLOOEH
PDQXIDFWXUHGDQGSDFNDJHGE\$PJHQ,QF.DQGGLVWULEXWHGXVLQJ$PJHQFOLQLFDOVWXG\
GUXJGLVWULEXWLRQSURFHGXUHV
7KHQRQ$PJHQLQYHVWLJDWLRQDOSURGXFWIRUWKLVVWXG\LVWKH62&UHJLPHQ+&$OO
FRPSRQHQWVRIWKH62&UHJLPHQ+&ZLOOEHSURYLGHGE\WKHVSRQVRU
RUUHLPEXUVHGFRPSHQVDWHGLQFDVHRIORFDOVXSSO\
7KH,QYHVWLJDWLRQDO3URGXFW,QVWUXFWLRQ0DQXDO,3,0DGRFXPHQWH[WHUQDOWRWKLV
SURWRFROFRQWDLQVGHWDLOHGLQIRUPDWLRQUHJDUGLQJWKHSUHVHQWDWLRQVWRUDJHSUHSDUDWLRQ
DQGDGPLQLVWUDWLRQRIEOLQDWXPRPDEDQG62&$VRXWOLQHGLQWKH,3,0EOLQDWXPRPDE
LQIXVLRQEDJVVKRXOGEHFKDQJHGLQDFFRUGDQFHZLWKORFDOSKDUPDF\VWDQGDUGVIRU
LQIXVLRQRIFRPSRXQGHGVWHULOHSURGXFWVEXWDWOHDVWHYHU\GD\V
7KHWHUP³SURWRFROVSHFLILHGWKHUDSLHV´XVHGWKURXJKRXWWKHSURWRFROUHIHUVWRERWK
EOLQDWXPRPDEDQG62&FKHPRWKHUDS\
7KHWHUP³SURWRFROUHTXLUHGWKHUDSLHV´XVHGWKURXJKRXWWKHSURWRFROUHIHUVWRRWKHU
SURWRFROPDQGDWHGPHGLFDWLRQHJSUHSKDVHZLWKGH[DPHWKDVRQHLQWUDWKHFDO
SURSK\OD[LVFRQFRPLWDQWPHGLFDWLRQVUHTXLUHGWRVXSSRUW62&UHJLPHQV
3URWRFROUHTXLUHGWKHUDSLHVDUHFRPPHUFLDOO\DYDLODEOHDQGDUHQRWSURYLGHGRU
UHLPEXUVHGE\$PJHQH[FHSWLIUHTXLUHGE\ORFDOUHJXODWLRQ7KHLQYHVWLJDWRUZLOOEH
UHVSRQVLEOHIRUREWDLQLQJVXSSOLHVRIWKHVHSURWRFROUHTXLUHGWKHUDSLHV

%OLQDWXPRPDE
%OLQDWXPRPDEZLOOEHVXSSOLHGDVVLQJOHXVHJODVVLQMHFWLRQYLDOVFRQWDLQLQJDVWHULOH
SUHVHUYDWLYHIUHHZKLWHWRRIIZKLWHO\RSKLOL]HGSRZGHUIRULQWUDYHQRXV,9
DGPLQLVWUDWLRQIROORZLQJUHFRQVWLWXWLRQZLWKVWHULOHZDWHUIRULQMHFWLRQ6WHULOHZDWHUIRU
LQMHFWLRQDQGVXSSOLHVUHTXLUHGIRUUHFRQVWLWXWLRQDQGLQMHFWLRQRIEOLQDWXPRPDEZLOOQRW
EHSURYLGHGWRFOLQLFDOVLWHV
)RULQIRUPDWLRQVXUURXQGLQJWKHXVHRIDFRQWLQXRXVLQIXVLRQSXPSUHIHUWR6HFWLRQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH
%OLQDWXPRPDEZLOOEHDGPLQLVWHUHGDV&,9,DWDFRQVWDQWGDLO\IORZUDWHRIJPGD\
RYHUZHHNVPD[LPXPGDLO\GRVHQRWWRH[FHHGJGD\DVGHSLFWHGLQ)LJXUH
)LJXUH%OLQDWXPRPDE7UHDWPHQW&\FOH

6XEMHFWVUDQGRPL]HGWR$UP$ZLOOUHFHLYHF\FOHRIEOLQDWXPRPDE
7KHILQDOVROXWLRQIRULQIXVLRQVKRXOGEHDGPLQLVWHUHGWKURXJKDVWHULOHȝPLQOLQH
ILOWHU
7KHGUXJDGPLQLVWUDWLRQVKRXOGQRWEHLQWHUUXSWHGLISRVVLEOH,QFDVHRILQIXVLRQ
LQWHUUXSWLRQGXHWRWHFKQLFDORUORJLVWLFDOLQWHUUXSWLRQHJGLDJQRVWLFPHDVXUHPHQWWKH
LQWHUUXSWLRQVKRXOGEHDVVKRUWDVSRVVLEOHDQGWKHLQIXVLRQFRQWLQXHGDWWKHHDUOLHVWWLPH
SRVVLEOH(YHU\LQWHUUXSWLRQORQJHUWKDQKRXUVKRXOGEHGRFXPHQWHG,IWKH
LQWHUUXSWLRQLVORQJHUWKDQKRXUVUHVWDUWRIWKHLQIXVLRQVKRXOGEHSHUIRUPHGLQWKH
KRVSLWDOXQGHUWKHVXSHUYLVLRQRIWKHLQYHVWLJDWRU7KHVXEMHFWVKRXOGEHREVHUYHG
RYHUQLJKWIRUSRVVLEOHVLGHHIIHFWVDIWHUWKHUHVWDUWHLWKHULQWKHKRVSLWDORULQWKH
RXWSDWLHQWVHWWLQJDVDSSOLFDEOH$GPLQLVWUDWLRQRIGH[DPHWKDVRQHSUHPHGLFDWLRQDV
GHVFULEHGLQ6HFWLRQLVUHFRPPHQGHG,ISRVVLEOHWKHLQIXVLRQGXUDWLRQEHIRUH
DQGDIWHUDQLQWHUUXSWLRQVKRXOGWRWDOGD\VSHUWUHDWPHQWF\FOH
7KHGDLO\EOLQDWXPRPDEGRVHPD\EHXSWRORZHURUKLJKHULQRUGHUWRDFFRXQWIRU
SRVVLEOHSXPSLQDFFXUDFLHV)RUGRVHPRGLILFDWLRQVLQFDVHRIDGYHUVHHYHQWVVHH
6HFWLRQ
$GRVHRIXSWRKLJKHUWKDQWKHLQWHQGHGEOLQDWXPRPDEGRVHZLOOQRWUHTXLUH
VSHFLILFLQWHUYHQWLRQ,QFDVHRIRYHUGRVHRUPHGLFDWLRQHUURUWKHLQIXVLRQVKRXOGEH
VWRSSHGLPPHGLDWHO\5RXWLQHVXSSRUWLYHDQGV\PSWRPDWLFFDUHDFFRUGLQJWRVWDQGDUG
PHGLFDOSUDFWLFHLVUHFRPPHQGHG2QFHWKHVXEMHFWLVVWDELOL]HGDQGQRFOLQLFDOO\
UHOHYDQWVDIHW\ILQGLQJVGXHWREOLQDWXPRPDEDUHREVHUYHGUHVXPSWLRQRIEOLQDWXPRPDE
DWDFRUUHFWGRVHFDQEHFRQVLGHUHGDIWHUFRQVXOWDWLRQZLWKWKH$PJHQPHGLFDOPRQLWRU

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$GRVHRIKLJKHUWKDQWKHLQWHQGHGEOLQDWXPRPDEGRVHZLOOEHFRQVLGHUHGDQ
RYHUGRVHDQGFODVVLILHGDVDVHULRXVDGYHUVHHYHQWXQGHUWKHFULWHULRQRI³RWKHU
PHGLFDOO\LPSRUWDQWVHULRXVHYHQW´SHU6HFWLRQ,IWKHRYHUGRVHUHVXOWVLQ
DGGLWLRQDODGYHUVHHYHQWVWKHVXEMHFWVKRXOGEHIROORZHGFDUHIXOO\XQWLODOOVLJQVRI
WR[LFLW\DUHUHVROYHGDQGWKHDGYHUVHHYHQWVVKRXOGEHUHFRUGHGUHSRUWHGSHU6HFWLRQ
RIWKHSURWRFRO
7KHGRVHVWDUWDQGVWRSGDWHWLPHDQGORWQXPEHURISURWRFROVSHFLILHGWKHUDS\LVWREH
UHFRUGHGRQHDFKVXEMHFW¶V&5)7KHGDWHDQGWLPHRILQIXVLRQEDJFKDQJHVDOO
LQIXVLRQVWDUWDQGVWRSWLPHVDQGDQ\GRVHPRGLILFDWLRQVVKRXOGDOVREHUHFRUGHG
DFFXUDWHO\

%OLQDWXPRPDE,QSDWLHQW'RVLQJ
7KHILUVWVXEMHFWVHQUROOHGZHUHWUHDWHGDVLQSDWLHQWIRUWKHILUVWGD\VRI
EOLQDWXPRPDEWUHDWPHQW)ROORZLQJ'0&UHYLHZVXEVHTXHQWO\HQUROOHGVXEMHFWVVKRXOG
EHWUHDWHGDVLQSDWLHQWIRUWKHILUVWGD\V7KHUHPDLQLQJWUHDWPHQWFDQFRQWLQXHLQDQ
RXWSDWLHQWVHWWLQJ7KHKRVSLWDOL]DWLRQWLPHGHSHQGVRQLQYHVWLJDWRU¶VMXGJPHQWDVZHOO
DVVDIHW\DQGWROHUDELOLW\RIEOLQDWXPRPDE
7KHLQIXVLRQEDJVZLOOEHFKDQJHGE\VLWHQXUVLQJSHUVRQQHOWUDLQHGRQWKHSURWRFRODQG
RQWKHSURSHUDGPLQLVWUDWLRQRIEOLQDWXPRPDE&ORVHPRQLWRULQJGXULQJWKHILUVWKRXUV
RIWUHDWPHQWZLOOEHLQGLFDWHGEHFDXVHRIWKHSRWHQWLDODGYHUVHHYHQWVDVVRFLDWHGZLWK
7FHOOUHGLVWULEXWLRQDQGSRWHQWLDOF\WRNLQHUHOHDVHHIIHFWVWULJJHUHGE\WKHDGPLQLVWUDWLRQ
RIEOLQDWXPRPDE1XUVHVSK\VLFLDQVWUDLQHGLQHPHUJHQF\PHGLFLQHVKRXOGEHDYDLODEOH
IRULPPHGLDWHLQWHUYHQWLRQLQFDVHRIFRPSOLFDWLRQV3DUWLFXODUDWWHQWLRQVKRXOGEHSDLG
WRVXEMHFW¶VPHQWDOVWDWXVDQGQHXURORJLFIXQFWLRQ

%OLQDWXPRPDE2XWSDWLHQW'RVLQJ
$IWHUDVXEMHFWPHHWVWKHPLQLPXPFULWHULDIRULQSDWLHQWDGPLQLVWUDWLRQDQGPRQLWRULQJDV
GHVFULEHGLQWKHDERYHVHFWLRQDQGLIDVXEMHFWLVGHHPHGVWDEOHE\WKHLQYHVWLJDWRU
FRQWLQXDWLRQRIEOLQDWXPRPDELQIXVLRQPD\FRQWLQXHDVDQRXWSDWLHQWKRXU
HPHUJHQF\RQFDOOVHUYLFHPXVWEHHQVXUHGLQWKHRXWSDWLHQWVHWWLQJ
,QWKHRXWSDWLHQWVHWWLQJHLWKHUWKHVXEMHFWZLOOUHWXUQWRWKHVWXG\VLWHIRUFKDQJHVRI
LQIXVLRQEDJVRUWKHVXEMHFWZLOOEHYLVLWHGE\DQDPEXODQWKRPHFDUHVHUYLFHSURYLGHUDW
VSHFLILFLQWHUYDOVWRFKDQJHWKHLQIXVLRQEDJ7KHVXEMHFWDQGWKHDPEXODQWKRPHFDUH
SURYLGHUZLOOEHWUDLQHGDQGZLOOUHFHLYHZULWWHQLQVWUXFWLRQVIRUVWRUDJHRIWKH,9EDJV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


)RUWKHDPEXODQWKRPHFDUHSURYLGHUWUDLQLQJRIERWKVWXG\VSHFLILFUHTXLUHPHQWVDQG
UHFRUGLQJRIVRXUFHGRFXPHQWDWLRQPXVWEHFRPSOHWHGEHIRUHDQ\VWXG\UHODWHGWDVNV
DUHVWDUWHG$FRPSUHKHQVLYHOLVWRIDOOKRPHFDUHVHUYLFHVLQFOXGLQJEXWQRWOLPLWHGWR
WKHVWRUDJHKDQGOLQJDQGDGPLQLVWUDWLRQRIEOLQDWXPRPDEDVZHOODVPDQGDWRU\
SURFHGXUDODQGGDWDFROOHFWLRQUHTXLUHPHQWVZLOOEHSURYLGHGVHSDUDWHO\LQDKRPHKHDOWK
FDUHPDQXDO)ROORZLQJHDFKYLVLWWKLVLQIRUPDWLRQZLOOEHGRFXPHQWHGRQWKH
$PEXODQW+RPH&DUH6HUYLFHVYLVLWZRUNVKHHWDQGIRUZDUGHGWRWKHLQYHVWLJDWRU$Q\
XQH[SHFWHGRUXQXVXDOHYHQWVDVZHOODVDQ\GHYLDWLRQVZLOOEHFRPPXQLFDWHGSURPSWO\
WRWKHLQYHVWLJDWRU7KHDPEXODQWKRPHFDUHSURIHVVLRQDOVSURYLGHKRXUHPHUJHQF\
RQFDOOVHUYLFH,QDGGLWLRQWKHVXEMHFWZLOOYLVLWWKHVWXG\VLWHIRUWKHH[DPLQDWLRQV
DFFRUGLQJWRWKH6FKHGXOHRI$VVHVVPHQWVLQ7DEOH
,QWKHHYHQWRIGUXJLQWHUUXSWLRQVRIKRXUVWKHUHVWDUWRIWKHLQIXVLRQVKRXOGEH
SHUIRUPHGLQWKHFOLQLFKRVSLWDOXQGHUWKHVXSHUYLVLRQRIWKHLQYHVWLJDWRU
,QFDVHRIDQ\DGYHUVHHYHQWLQWKHRXWSDWLHQWVHWWLQJWKHDPEXODQWKRPHFDUHSURYLGHU
VKRXOGGLUHFWO\FRQWDFWWKHLQYHVWLJDWRUDWWKHVWXG\FHQWHUDQGWKHVXEMHFWVKRXOGFRQWDFW
WKHLQYHVWLJDWRULPPHGLDWHO\IRUIXUWKHULQVWUXFWLRQRQPDQDJHPHQWDQGDVVHVVPHQWRI
DGYHUVHHYHQWVE\WKHLQYHVWLJDWRU

'RVDJH$GMXVWPHQWV'HOD\V5XOHVIRU:LWKKROGLQJRU5HVWDUWLQJ
3HUPDQHQW'LVFRQWLQXDWLRQRI%OLQDWXPRPDE

,QIXVLRQ,QWHUUXSWLRQ'RVH0RGLILFDWLRQRI%OLQDWXPRPDEGXHWR
$GYHUVH(YHQWV
7UHDWPHQWZLOOEHLQWHUUXSWHGLQFDVHRI

&OLQLFDOO\UHOHYDQWQHXURORJLFHYHQWDVGHILQHGLQ$SSHQGL[+
JUDGHUHODWHG
WREOLQDWXPRPDEJUDGHDQGJUDGHUHVXOWVLQSHUPDQHQWGLVFRQWLQXDWLRQRI
EOLQDWXPRPDE

&56
JUDGHUHODWHGWREOLQDWXPRPDE

$Q\FOLQLFDOO\UHOHYDQWDGYHUVHHYHQW
JUDGHUHODWHGWREOLQDWXPRPDE
,IDQDGYHUVHHYHQWKDVUHVROYHGWR&RPPRQ7HUPLQRORJ\&ULWHULDIRU$GYHUVH(YHQWV
&7&$(JUDGHZLWKLQZHHNDIWHUWKHLQIXVLRQLVVWRSSHGWKHLQIXVLRQPD\EH
UHVXPHGWRFRPSOHWHWKHGD\LQIXVLRQQRWFRXQWLQJWKHGXUDWLRQRIWUHDWPHQW
LQWHUUXSWLRQDWDUHGXFHGGRVHRIJPðGD\7KLVUHGXFHGGRVHVKRXOGEH
DGPLQLVWHUHGIRUDWOHDVWGD\VEHIRUHLWFDQEHDJDLQLQFUHDVHGH[FHSWIRUFOLQLFDOO\
UHOHYDQWQHXURORJLFHYHQWVGHILQHGLQ$SSHQGL[+7KHPD[LPXPGRVHDGPLQLVWHUHG
PXVWQRWEHKLJKHUWKDQȝJPGD\PD[LPXPGDLO\GRVHRIJGD\

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7KHUHVWDUWRIWKHLQIXVLRQVKRXOGEHSHUIRUPHGLQWKHKRVSLWDOXQGHUVXSHUYLVLRQRIWKH
LQYHVWLJDWRU

,QIXVLRQ,QWHUUXSWLRQ'RVH0RGLILFDWLRQRI%OLQDWXPRPDEGXHWR
1HXURORJLF(YHQWV
,QFDVHRIFOLQLFDOO\UHOHYDQWQHXURORJLFHYHQWVGHILQHGLQ$SSHQGL[+GH[DPHWKDVRQH
VKRXOGEHDGPLQLVWHUHGDWDWRWDOGDLO\GRVHRIDWOHDVWPJNJGD\SUHIHUDEO\
,9PD[LPXPPJSHUGD\GLYLGHGLQWRGRVHVSHUGD\IRUXSWRGD\V7KHGRVH
ZLOOWKHQEHUHGXFHGVWHSZLVHE\DWOHDVWSHUGD\RYHUXSWRGD\V
0RVWQHXURORJLFHYHQWVVWDUWZLWKDSURGURPDOSKDVHRINLQHWLFWUHPRU$GDLO\ZULWLQJ
WHVWRUILQJHUQRVHWHVWLVUHFRPPHQGHG,QFDVHRIDSDWKRORJLFDOWHVWWKHVWDUWRI
GH[DPHWKDVRQHLVUHFRPPHQGHG
,IDQHXURORJLFHYHQWKDVUHVROYHGWRJUDGHZLWKLQZHHNDIWHUWKHLQIXVLRQLV
VWRSSHGWKHWUHDWPHQWF\FOHPD\EHUHVXPHGDWWKHUHGXFHGGRVHRIJPðGD\7KH
GRVHPXVWQRWEHHVFDODWHGDQ\PRUH7KHLQWHUUXSWLRQRIWUHDWPHQWVKRXOGODVWDWOHDVW
ZHHN
,IWKHQHXURORJLFHYHQWZDVDVHL]XUHDSSURSULDWHSURSK\ODFWLFDQWLFRQYXOVDQWWUHDWPHQW
ZLWKDWKHUDSHXWLFGRVHRIHJSKHQ\WRLQRUOHYHWLUDFHWDPZLOOEHDGPLQLVWHUHGEHIRUH
UHVXPSWLRQRIWKHF\FOHIRUWKHUHPDLQLQJWUHDWPHQWSHULRGRIWKHF\FOH
'LDJQRVWLFPHDVXUHVWRH[FOXGHSRWHQWLDOLQIHFWLRXVFDXVHVVKRXOGEHFRQGXFWHGDIWHU
QHXURORJLFHYHQWV

&ULWHULDIRU'LVFRQWLQXDWLRQRI%OLQDWXPRPDE

6XEMHFWUHODSVH

6XEMHFWH[SHULHQFHVDGYHUVHHYHQWVUHTXLULQJGRVHLQWHUUXSWLRQDWWKH
ȝJPGD\GRVH

&OLQLFDOO\UHOHYDQWWR[LFLWLHVWKDWE\LQYHVWLJDWRU¶VYLHZLPSRVHDQXQDFFHSWDEOH
VDIHW\ULVNWRWKHVXEMHFW

&OLQLFDOO\UHOHYDQWQHXURORJLFHYHQWVUHODWHGWREOLQDWXPRPDEGHILQHGLQ
$SSHQGL[+
o 7KDWQHHGPRUHWKDQZHHNWRUHVROYHWRJUDGH
o 7KDWDUHJUDGHRU
o 7KDWRFFXUDIWHUUHVWDUWRIWUHDWPHQW

$QDGYHUVHHYHQWDVOLVWHGLQ6HFWLRQWKDWKDVQRWUHVROYHGWR&7&$(
*UDGHZLWKLQZHHNRUPRUHWKDQLQWHUUXSWLRQVSHUF\FOHGXHWRDGYHUVH
HYHQW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



0HGLFDOFRQGLWLRQZKLFKLQWKHYLHZRIWKHLQYHVWLJDWRUGRHVQRWLQGLFDWHDEHQHILW
RIEOLQDWXPRPDEIRUWKHVXEMHFW

:LWKGUDZDORIVXEMHFW¶VFRQVHQWWRVWXG\WUHDWPHQW

6WDQGDUGRI&DUH&KHPRWKHUDS\

'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH
+&ZLOOEHDGPLQLVWHUHGSHUWKH,QW5H$//SURWRFROVXPPDUL]HGLQ)LJXUH7KH
GRVDJHVIRUHDFKFRPSRXQGURXWHDQGVFKHGXOHRIDGPLQLVWUDWLRQDUHGHVFULEHGLQ
GHWDLOLQ7DEOHZLWKWKHH[FHSWLRQRIGH[DPHWKDVRQHZKLFKZLOOEHDGPLQLVWHUHG
LQWUDYHQRXVO\DVZHOODVLQWKH,3,0DQG,QW5H$//ZRUNLQJSURFHGXUHV
)LJXUH+&'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH


D'H[DPHWKDVRQHGDLO\GRVHRIPJPGLVGLYLGHGLQWRGRVHVRIPJP
E,QFDVHRIDOOHUJLFUHDFWLRQFKDQJHWR(UZLQLDDVSDUDJLQDVHXQLWVPHYHU\KRXUVIRUDWRWDORI
GRVHV
,IDQRYHUGRVHGRVHGHOLYHUHGKLJKHUWKDQWKHLQWHQGHGGRVHRFFXUVDQGLVDVVRFLDWHG
ZLWKDGGLWLRQDODGYHUVHHYHQWVWKHVXEMHFWVVKRXOGEHIROORZHGFDUHIXOO\XQWLODOOVLJQVRI
WR[LFLW\DUHUHVROYHGDQGWKHDGYHUVHHYHQWVVKRXOGEHUHFRUGHGUHSRUWHGSHU6HFWLRQ
RIWKHSURWRFRO

'RVDJH$GMXVWPHQWV'HOD\V5XOHVIRU:LWKKROGLQJRU5HVWDUWLQJ
3HUPDQHQW'LVFRQWLQXDWLRQRI6WDQGDUGRI&DUH
'RVHUHGXFWLRQVRIFKHPRWKHUDSHXWLFUHJLPHQVDUHDQH[FHSWLRQLQFDVHRI
XQDFFHSWDEOHWR[LFLW\RUVXEVWDQWLDOWUHDWPHQWGHOD\VGXHWRLQWROHUDQFHRIWUHDWPHQW
7KHQHHGIRUGRVHUHGXFWLRQVKRXOGEHUHDVVHVVHGFDUHIXOO\SULRUWRHYHU\WUHDWPHQW
HOHPHQW,QJHQHUDORQHRUVHYHUDOF\WRWR[LFGUXJVPD\EHUHGXFHGWRRIWKH
VFKHGXOHGSURWRFROGRVDJH,QFDVHRIVHYHUH07;DVVRFLDWHGWR[LFLW\VXFKDV
PXFRVLWLVOLYHUWR[LFLW\UHQDOLQVXIILFLHQF\DQGHOLPLQDWLRQIDLOXUHKLJKGRVH07;PD\
EHJLYHQDWDVKRUWHULQIXVLRQGXUDWLRQRIKRXUVDWDORZHUGRVHRIPJPðDQGRU

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


ZLWKHDUOLHUOHXFRYRULQUHVFXHHYHQWXDOO\DWKLJKHUHJGRXEOHGRVHV,QFDVHRI
FRUWLFRVWHURLGDVVRFLDWHGGLDEHWHVWKHGH[DPHWKDVRQHGRVHVKRXOGEHUHGXFHGDQGD
JOXFRVHIUHHLQIXVLRQVKRXOGEHJLYHQ,QFDVHRIDVSDUDJLQDVHDVVRFLDWHG
FRPSOLFDWLRQVVXFKDVWKURPERVLVDOOHUJLFUHDFWLRQVRUSDQFUHDWLWLVWKHDVSDUDJLQDVH
DGPLQLVWUDWLRQPD\EHSRVWSRQHGRUFDQFHOOHG
,QFDVHRISURORQJHGWUHDWPHQWGHOD\VGRVHUHGXFWLRQVDFFRUGLQJWRJXLGHOLQHVKDYHWR
EHFRQVLGHUHG
%RG\ZHLJKWEHORZNJ
,QWKHUDUHFDVHRIERG\ZHLJKWEHORZNJDWUHODSVHWKHGUXJGRVHVDUHFDOFXODWHG
DFFRUGLQJWRERG\ZHLJKWLQVWHDGRIERG\VXUIDFHDUHD%6$XVLQJWKHIROORZLQJ
IRUPXOD

'RVHVFKHGXOHGGRVHP%6$[ERG\ZHLJKW>NJ@
6XEMHFWVZLWK'RZQ6\QGURPH
3DWLHQWVZLWK'RZQV\QGURPHDQG$//UHODSVHWROHUDWHWUHDWPHQWOHVVWKDQRWKHUV
DQGLQSDUWLFXODUDKLJKLQGXFWLRQGHDWKUDWHDQGPRUWDOLW\UDWHLQ&5RFFXU
%XLWHQNDPSHWDO7UHDWPHQWVFKHGXOHRI07;VKRXOGEHDGDSWHGDFFRUGLQJWR
WKHH[SHULHQFHRISULRUWUHDWPHQWDQGSK\VLFLDQGHFLVLRQ
,PSDLUHGHOLPLQDWLRQRI07;
7KHVHUXP07;OHYHOKRXUVDIWHUWKHVWDUWRI07;LQIXVLRQLVJHQHUDOO\EHORZ
PRO/2WKHUZLVHIROLQLFDFLGUHVFXHLVH[WHQGHGDWKRXUO\LQWHUYDOVEH\RQGWKH
VFKHGXOHGGRVHVDWDQGKRXUVXQWLOWKH07;VHUXPOHYHOIDOOVEHORZPRO/
7KHGRVHRIIROLQLFDFLGGHSHQGVRQWKH07;VHUXPOHYHODQGLVFDOFXODWHGDVPJPð
DQWDJRQL]LQJXSWRPRO/VHUXP07;,IWKH07;VHUXPOHYHODWKRXUV
LVPRO/DONDOLQHGLXUHVLVZLWKWR/PLVXVHGLQDGGLWLRQ,IWKH07;VHUXP
OHYHODWKRXULVPRO/RULQFDVHVRIPDUNHGLQWROHUDQFHZLWKVHYHUHYRPLWLQJ
GLDUUKHDDQGQHXURORJLFDOV\PSWRPVWKHXVHRIFDUER[\SHSWLGDVHVKRXOGEHFRQVLGHUHG
&DUER[\SHSWLGDVHUHVXOWVLQHQ]\PDWLFFOHDYDJHRI07;,QWKLVFDVHFRQWDFWWKH
QDWLRQDORULQWHUQDWLRQDOVWXG\FRRUGLQDWRU
,IGHFUHDVHGHOLPLQDWLRQRI07;LVDSSDUHQWDWKRXUV07;VHUXPOHYHOPRO/
DUHSHDW07;VHUXPOHYHODWKRXUVLVUHFRPPHQGHG,QWKLVFDVHWKHDGPLQLVWUDWLRQ
RIOHXFRYRULQVKRXOGEHDGMXVWHGWRDGRVHHTXLYDOHQWWRWKDWUHFRPPHQGHGE\WKH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


UHVFXHVFKHPHDWKRXUVPJPðDQWDJRQL]LQJXSWRPRO/VHUXP07;,IWKH
YDOXHLVPRO/WKHGRVHRIIROLQLFDFLGLVFDOFXODWHGXVLQJWKHIROORZLQJIRUPXOD

/HXFRYRULQPJ07;DWKPRO/[ERG\ZHLJKWNJ
0HDVXUHVLQFDVHRIH[WUDYDVDWLRQRIDQWKUDF\FOLQHVRUYLQFDDONDORLGV
,QFDVHRIH[WUDYDVDWLRQRIDQDQWKUDF\FOLQHWKHH[WUDYDVDWHDVZHOODVWKHWLVVXHIOXLG
DQGEORRGVKRXOGILUVWEHDVSLUDWHGXVLQJWKHH[LVWLQJYHQRXVDFFHVVDQGLISRVVLEOH
GLOXWHGE\LQVWLOOLQJQRUPDOVDOLQHEHIRUHUHPRYLQJWKHYDVFXODUOLQH7RSLFDODSSOLFDWLRQ
RIGLPHWK\OVXOIR[LGH'062IRXUGURSVSHUFPVNLQWKUHHWLPHVDGD\IRU
VHYHUDOGD\VPD\DPHOLRUDWHWKHFRXUVH7KHORFDODUHDRIVNLQVKRXOGEHNHSWFRROIRU
VHYHUDOGD\V
,QFDVHRIH[WUDYDVDWLRQRIDYLQFDDONDORLGWKHH[WUDYDVDWHDVZHOODVWLVVXHIOXLGDQG
EORRGVKRXOGEHDVSLUDWHGXVLQJWKHH[LVWLQJYHQRXVDFFHVV7KHQK\DOXURQLGDVH
XQLWVP/1D&OVKRXOGEHLQMHFWHGLQWRWKDWDUHDXVLQJWKHH[LVWLQJYHQRXV
DFFHVVEHIRUHLWLVUHPRYHG6XEVHTXHQWO\WKHDIIHFWHGWLVVXHFDQEHLQILOWUDWHG
VXEFXWDQHRXVO\ZLWKVHYHUDOVPDOOLQMHFWLRQVRIK\DOXURQLGDVH7KHORFDODUHDVKRXOGEH
NHSWZDUPLQFRQWUDVWWRWKHFRROLQJUHFRPPHQGHGIRUDQWKUDF\FOLQHH[WUDYDVDWLRQV
,IQHFURVLVGHYHORSVGHVSLWHWKHVHORFDOPHDVXUHVHDUO\VXUJLFDOUHYLVLRQVKRXOGEH
FRQVLGHUHG 

&ULWHULDIRU'LVFRQWLQXDWLRQRI6WDQGDUGRI&DUH
7UHDWPHQWZLWK62&FKHPRWKHUDS\VKRXOGEHGLVFRQWLQXHGLQWKHHYHQWRIDQ\RIWKH
IROORZLQJ

6XEMHFWUHODSVH

6XEMHFWPHHWVFULWHULDIRUGLVFRQWLQXDWLRQRI62&FKHPRWKHUDS\EDVHGRQWKH
LQYHVWLJDWRU¶VRSLQLRQORFDOWUHDWPHQWVWDQGDUGV

2FFXUUHQFHRIDQDGYHUVHHYHQWZKLFKPDNHVGLVFRQWLQXDWLRQIURPWUHDWPHQW
QHFHVVDU\GXHWRSURWRFROVSHFLILHGVDIHW\FULWHULDRUGHVLUDEOHLQWKHLQYHVWLJDWRU¶V
DQGRUWKHVXEMHFW¶VRSLQLRQ

,QYHVWLJDWRU¶VGHFLVLRQWKDWDFKDQJHRIWKHUDS\LQFOXGLQJLPPHGLDWHDOOR+6&7LVLQ
WKHVXEMHFW¶VEHVWLQWHUHVW

,QYHVWLJDWRU¶VGHFLVLRQWKDWDVXEMHFWGRHVQRWEHQHILWIURPWUHDWPHQWDQ\PRUH
HJQRQUHVSRQVHRUGHYHORSPHQWRISURJUHVVLYHGLVHDVH

,QWHUFXUUHQWPHGLFDOFRQGLWLRQZKLFKLQWKHRSLQLRQRIWKHLQYHVWLJDWRURUWKHVXEMHFW
SUHFOXGHVIXUWKHUWUHDWPHQWRIWKHVXEMHFW

:LWKGUDZDORIVXEMHFW¶VFRQVHQWWRVWXG\WUHDWPHQW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



&RQFRPLWDQW7KHUDS\
)URPVLJQLQJRIWKHFRQVHQWIRUPXQWLOWKHVDIHW\IROORZXSYLVLWDOOFRQFRPLWDQW
PHGLFDWLRQLQWUDWKHFDOSURSK\OD[LVDQGWKHUDSLHVLQFOXGLQJWUDQVIXVLRQRIDOOEORRG
SURGXFWVVKRXOGEHUHFRUGHGLQWKHHOHFWURQLFFDVHUHSRUWIRUPH&5),IUHTXLUHG
VXSSRUWLYHWKHUDS\VKRXOGEHDGPLQLVWHUHGDVPHGLFDOO\QHHGHGLQDFFRUGDQFHZLWK
VWDQGDUGSUDFWLFH2QO\FRQGLWLRQLQJUHJLPHQVGRQRUW\SH*Y+'SURSK\OD[LVDQG
PHGLFDWLRQVWDNHQIRUWKHWUHDWPHQWRI$//DUHWREHFROOHFWHGGXULQJWKHVKRUWWHUP
HIILFDF\IROORZXSSHULRGXQWLOGD\VDIWHUDOOR+6&7'XULQJWKHUHPDLQGHURIWKH
VKRUWWHUPHIILFDF\IROORZXSSHULRGDIWHUGD\DQGWKHORQJWHUPIROORZXSSHULRG
RQO\PHGLFDWLRQVWDNHQIRUWKHWUHDWPHQWRI$//ZLOOEHFROOHFWHG
&RQFRPLWDQWPHGLFDWLRQVJLYHQWRVXSSRUW62&UHJLPHQVDSSURSULDWHDQWLELRWLFVEORRG
SURGXFWVDQWLHPHWLFVIOXLGVHOHFWURO\WHVDQGJHQHUDOVXSSRUWLYHFDUHLQFOXGLQJSDLQ
PDQDJHPHQWDUHWREHXVHGDVQHFHVVDU\
)RUFRQFRPLWDQWWKHUDSLHVEHLQJWDNHQIRUWKHWUHDWPHQWRUVXSSRUWRI$//WKHWKHUDS\
QDPHLQGLFDWLRQGRVHXQLWIUHTXHQF\VWDUWGDWHDQGVWRSGDWHDWDPLQLPXPZLOOEH
FROOHFWHG)RUDOORWKHUFRQFRPLWDQWWKHUDSLHVWKHWKHUDS\QDPHLQGLFDWLRQVWDUWGDWH
DQGVWRSGDWHDWDPLQLPXPZLOOEHFROOHFWHG
$OOYLVLEOHILHOGVLQWKHH&5)DUHUHTXLUHGWREHFRPSOHWHG&RQFRPLWDQWPHGLFDWLRQ
FROOHFWLRQUHTXLUHPHQWVDQGLQVWUXFWLRQVDUHLQFOXGHGLQWKHH&5)FRPSOHWLRQJXLGHOLQHV

2EOLJDWRU\3UHPHGLFDWLRQ3ULRUWR7UHDWPHQW

,QWUDWKHFDO&KHPRWKHUDS\3ULRUWR%OLQDWXPRPDEDQG6WDQGDUGRI
&DUH+&
$JHDGDSWHGGRVHV7DEOHRILQWUDWKHFDO07;F\WDUDELQHDQGSUHGQLVRORQH
RUHTXLYDOHQWGRVHRIK\GURFRUWLVRQHPXVWEHDGPLQLVWHUHGZLWKLQGD\VSULRUWR
WUHDWPHQWVWDUWRIEOLQDWXPRPDE,QWUDWKHFDOFKHPRWKHUDS\FDQEHDGPLQLVWHUHGDVSDUW
RI62&SULRUWRLQIRUPHGFRQVHQWEXWZLWKLQGD\VSULRUWRWUHDWPHQWVWDUW,QWKHFRQWURO
DUP+&LQWUDWKHFDOWKHUDS\FDQEHDGPLQLVWHUHGHLWKHUZLWKLQGD\VSULRUWRVWDUWLQJ
WUHDWPHQWRUEHJLYHQRQGD\$GLDJQRVWLFOXPEDUSXQFWXUHPXVWEHFRQGXFWHG
EHIRUHUDQGRPL]DWLRQLQRUGHUWRH[FOXGHHYLGHQFHRIFXUUHQW&16&16&16
LQYROYHPHQWE\$//
7DEOH2EOLJDWRU\7ULSOH,QWUDWKHFDO&KHPRWKHUDS\3ULRUWR7UHDWPHQW
$JH
\HDUV
07;
PJ
&\WDUDELQH
PJ
3UHGQLVRORQHD
PJ
1D&O
P/

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/























D2UHTXLYDOHQWGRVHK\GURFRUWLVRQH

'H[DPHWKDVRQH3UHPHGLFDWLRQIRU%OLQDWXPRPDE
,PPHGLDWHO\EHIRUHWKHVWDUWRIWKHUDS\ZLWKEOLQDWXPRPDEGH[DPHWKDVRQHPJPZLOO
EHDGPLQLVWHUHGHLWKHURUDOO\RU,9WRVXEMHFWVRQGD\

,QWUDWKHFDO&KHPRWKHUDS\DW'D\
'D\LQWUDWKHFDOFKHPRWKHUDS\LVDGPLQLVWHUHGSHUGRVHVLQ7DEOH

6XSSRUWLYH&DUH*XLGHOLQHV

6XSSRUWLYH&DUH*XLGHOLQHVIRU%OLQDWXPRPDE
5HFRPPHQGHGPDQDJHPHQWEDVHGRQUHJLRQDOGLIIHUHQFHVLQDSSURYHGPHGLFDWLRQVRI
EOLQDWXPRPDELQGXFHGGUXJIHYHULQSDWLHQWVZKRGRQRWKDYHVLJQVRILQIHFWLRQLV
SURYLGHGLQ7DEOH1RQVWHURLGDODQWLLQIODPPDWRU\GUXJV16$,'VDUHUHVWULFWHG
EHFDXVHWKH\DUHDSRWHQWLDOFDXVHRIHQGRWKHOLDOVWUHVV
7DEOH5HFRPPHQGHG)HYHU0DQDJHPHQW0LWLJDWLRQV
6\PSWRP
5HFRPPHQGHG0LWLJDWLRQ
)HYHU
&
8SWRJSDUDFHWDPRODVVKRUWWHUPLQIXVLRQDQGRUXSWR
JPHWDPL]ROHDVVKRUWWHUPLQIXVLRQ
)HYHUSHUVLVWHQW
KUVDQGRU
8SWRJPHWDPL]ROHRYHUKUVDQGRU
)HYHU
&
8SWR[PJ'H[DPHWKDVRQHDVVKRUWWHUPLQIXVLRQ
&KLOOV
8SWRPJSHWKLGLQH,9
%HFDXVHEOLQDWXPRPDELVDQDQWL&'DQWLERG\GHFUHDVHVLQLPPXQRJOREXOLQVKDYH
EHHQREVHUYHG,9LPPXQRJOREXOLQ,9,*PD\EHDGPLQLVWHUHGDWWKHLQYHVWLJDWRU¶V
GLVFUHWLRQ,PPXQRJOREXOLQVDQGEOLQDWXPRPDEPXVWQRWEHDGPLQLVWHUHGWKURXJKWKH
VDPHOLQH
,QSDWLHQWVWUHDWHGZLWKEOLQDWXPRPDEWUDQVLHQWQHXWURSHQLDKDVEHHQREVHUYHG7KH
DGPLQLVWUDWLRQRI*&6)FDQEHGRQHDWWKHLQYHVWLJDWRU¶VGLVFUHWLRQ
,QWKHILUVWGD\VRIWUHDWPHQWZLWKEOLQDWXPRPDEDUDSLGWUDQVLHQWGURSLQSODWHOHWVDQGRU
KHPRJORELQPD\EHREVHUYHG7KHVHHIIHFWVDUHQRWQHFHVVDULO\F\WRNLQHPHGLDWHG
3ODWHOHWVDQGKHPRJORELQUHFRYHUWREDVHOLQHGXULQJWUHDWPHQW7KHLQYHVWLJDWRUVKRXOG

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


WDNHDSSURSULDWHPHDVXUHVE\KRVSLWDOVWDQGDUGVWRPDQDJHGHFUHDVHVLQSODWHOHWV
DQGRUKHPRJORELQ
,QWKHILUVWGD\VRIWUHDWPHQWZLWKEOLQDWXPRPDEWUDQVLHQWLQFUHDVHVLQWUDQVDPLQDVHV
$/7$67XSWRRYHU8/PD\GHYHORS,QSUHYLRXVVWXGLHVWKHVHKDYHJHQHUDOO\
UHWXUQHGWREDVHOLQHE\WKHHQGRIWKHILUVWZHHNRIWUHDWPHQW

6XSSRUWLYH&DUH*XLGHOLQHVIRU6WDQGDUGRI&DUH
6XSSRUWLYHFDUHJXLGHOLQHVIRU62&DUHUHFRPPHQGDWLRQVDQGFDQEHDGDSWHGWRORFDO
VFKHPHVDQGUHTXLUHPHQWV5HIHUEDFNWR7DEOHIRUDGGLWLRQDOGHWDLOVRQ
FRQFRPLWDQWPHGLFDWLRQVDGPLQLVWHUHGDVSDUWRI62&
$QWLLQIHFWLRXVSURSK\OD[LV
)URPWKHEHJLQQLQJRIVWXG\WUHDWPHQWXQWLODOOR+6&7WKHIROORZLQJPHDVXUHVDUH
UHFRPPHQGHG

3QHXPRF\VWLVFDULQLLSURSK\OD[LV&RWULPR[D]ROHWRPJNJWULPHWKRSULP
PJNJVXOIDPHWKR[D]ROH%,'IRUGD\VSHUZHHNHJ6DWXUGD\DQG
6XQGD\7KHGUXJVKRXOGQRWEHJLYHQWKHVDPHGD\DV07;&RWULPR[D]ROH
PD\FDXVHSURORQJHGF\WRSHQLDV,IWKLVLVVXVSHFWHGWKHGUXJVKRXOGEH
LQWHUUXSWHGRUGLVFRQWLQXHG$VDQDOWHUQDWLYHLQKDODWLRQZLWKSHQWDPLGLQH
PJPRQWKO\RUGDSVRQHPJNJZHHNO\PD\EHFRQVLGHUHG

$QWLIXQJDOSURSK\OD[LV
7DEOH5HFRPPHQGHG$QWLIXQJDO3URSK\OD[LVIRU6WDQGDUGRI&DUH
$JH\HDUV
$PSKRWHULFLQ%VXVSHQVLRQP/G

[
±
[


[
7KHDPSKRWHULFLQVXVSHQVLRQLVFDUHIXOO\VSUHDGRYHUWKHHQWLUHRUDOPXFRVDDQGWKHQ
VZDOORZHG,ISURSK\OD[LVZLWKDPSKRWHULFLQVXVSHQVLRQLVQRWIHDVLEOHRULIWKUXVK
EHFRPHVDSSDUHQWGHVSLWHSURSK\OD[LVIOXFRQD]ROHPJNJGD\LVUHFRPPHQGHG
+HSDWLFWR[LFLW\DQGSRVVLEOHGUXJUHVLVWDQFHVKRXOGEHFRQVLGHUHG

*HQHUDOV\VWHPLFDQWLP\FRWLFSURSK\OD[LV,QFDVHRISURORQJHGDSODVLD
V\VWHPLFDQWLIXQJDOSURSK\OD[LVDFFRUGLQJWRSUHIHUHQFHVDWWKHGLIIHUHQWFHQWHUV
PD\EHDSSOLHG6FKHPHVVXFKDVGDLO\RUDOYRULFRQD]ROHRULQWHUPLWWHQW
DPELVRPHWLPHVZHHNKDYHEHHQDSSOLHG
$QWLHPHWLFWUHDWPHQW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


2QGDQVHWURQWZRGRVHVRIPJPGD\LVXVHGIRUKLJKO\HPHWRJHQLFWUHDWPHQW
HOHPHQWVVXFKDVKLJKGRVH$5$&LIRVIDPLGHDQGF\FORSKRVSKDPLGH$GGLWLRQDO
WUHDWPHQWZLWKDSUHSLWDQWRUGLPHQK\GULQDWHPD\EHUHTXLUHGLIRQGDQVHWURQLV
LQVXIILFLHQWSDUWLFXODUO\LQDGROHVFHQWV0DQ\WUHDWPHQWHOHPHQWVDOUHDG\LQFOXGHWKH
DGPLQLVWUDWLRQRIGH[DPHWKDVRQHVRWKDWQRIXUWKHUDQWLHPHWLFHIIHFWFDQEHH[SHFWHG
IURPWKLVDJHQW
0XFRVDOOHVLRQV
&DUHIRURUDOPXFRVDOOHVLRQVRUDOULQVHVHJZLWKFKDPRPLOHVROXWLRQDWOHDVWWLPHV
DGD\ORFDOXVHRIDVWULQJHQWVHJDTXHRXVVROXWLRQVRIPHWK\OHQHEOXHRQRSHQVRUHV
DWOHDVWRQFHGDLO\
8VXDOO\VHYHUHODUJHXOFHUDWLRQVDUHQRWOLPLWHGWRWKHPRXWKEXWFDQDOVRDIIHFWWKH
HQWLUHJDVWURLQWHVWLQDOWUDFW7KHVHUHTXLUHFORVHPRQLWRULQJDQGDFRQVLVWHQWDQGHDUO\
UHSODFHPHQWRISURWHLQDQGHOHFWURO\WHORVVHV,QDGGLWLRQVXIILFLHQWDQDOJHVLDVKRXOGEH
JLYHQLQFOXGLQJRSLDWHV
,QJHQHUDOWKHPXFRVDODUHDXQGHUWKHWRQJXHLVUHSUHVHQWDWLYHRIWKHVWDWXVRIWKH
HQWLUHJDVWURLQWHVWLQDOWUDFW,WXVXDOO\UHPDLQVDFFHVVLEOHWRLQVSHFWLRQDQGDVVHVVPHQW
HYHQLQFDVHVZLWKPDUNHGVZHOOLQJDQGSDLQ
)HEULOH1HXWURSHQLD
,QFDVHRIDQHXWURSKLOFRXQWEHORZ[/DQGIHYHUJUHDWHUWKDQ&V\VWHPDWLF
DQWLELRWLFDQGSRVVLEO\DQWLIXQJDOWUHDWPHQWVKRXOGEHDGPLQLVWHUHG3DUWLFXODUO\
VXEMHFWVZLWKDKLJKWKHUDSHXWLFULVNHJVXEMHFWVZLWKYHU\HDUO\UHODSVHGXULQJLQLWLDO
WUHDWPHQWRUIHYHUDWWKHEHJLQQLQJRIF\WRSHQLDUHTXLUHUDSLGHVFDODWLRQRIDQWLELRWLFVWR
EHDEOHWRFRQWUROVHYHUHLQIHFWLRQVXQWLOWKHUHJHQHUDWLRQRIFHOOV7KHIROORZLQJLVDQ
H[DPSOHRIVXFKDQHVFDODWLRQZLWK,9DQWLELRWLFFRPELQDWLRQV
Start with: 
Cefotaxime or ceftriaxone and gentamicin 
If still febrile 48h later: 
Add vancomycin or teicoplanin 
If still febrile 48h later: 
Replace cephalosporine/gentamicin with meropenem 
If still febrile 48h later: 
Add liposomal amphotericin B or voriconazole 
7KLVDSSURDFKLVDQH[DPSOHWKDWVKRXOGEHVXSSOHPHQWHGE\FOLQLFDOILQGLQJVDQG
PLFURELRORJLFDOUHVXOWVDQGUHTXLUHVPRGLILFDWLRQDFFRUGLQJWRWKHH[SHULHQFHRIWKH
WUHDWLQJSK\VLFLDQ'HOD\VLQWKHUHYLVLRQRIDQWLELRWLFPHGLFDWLRQVPD\SURYLGHDQ
LUUHWULHYDEOHDGYDQWDJHRIPDMRUWKUHDWVVXFKDVSVHXGRPRQDVFRDJXODVHQHJDWLYH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


VWDSK\ORFRFFLRUDVSHUJLOOXV,IWKHUHLVFOLQLFDOHYLGHQFHRIDQLQIHFWLRQZLWK
SVHXGRPRQDVDVWURQJDQWLPLFURELDOPHGLFDWLRQVXFKDVDPLNDFLQDQGFHIWD]LGLP
VKRXOGEHDGGHG,IDQDW\SLFDOSQHXPRQLDLVVXVSHFWHGWKHFRPELQDWLRQRIDQWLELRWLFV
VKRXOGLQFOXGHDPDFUROLGHDQWLELRWLFVXFKDVHU\WKURP\FLQ
,QFDVHRISURORQJHGDQGRUUHSHDWHGQHXWURSHQLD*&6)FDQEHDSSOLHGDWWKH
GLVFUHWLRQRIWKHWUHDWLQJSK\VLFLDQ
7UDQVIXVLRQRI%ORRG3URGXFWV
)RUUHGFHOODQGSODWHOHWWUDQVIXVLRQVRQO\OHXNRF\WHGHSOHWHGLUUDGLDWHG*\DQG
ILOWHUHGFRQFHQWUDWHVVKRXOGEHXVHG+/$FRPSDWLEOHSODWHOHWFRQFHQWUDWHVVKRXOGEH
FRQVLGHUHGZKHQDQWLERGLHVDUHGHWHFWHG*UDQXORF\WHFRQFHQWUDWHVDUHWREHXVHG
RQO\LQUDUHDQGH[FHSWLRQDOFLUFXPVWDQFHVHJXQFRQWUROODEOHIXQJDOLQIHFWLRQVGXULQJ
SHULRGVRISURORQJHGDSODVLD 

0HGLFDO'HYLFHV
%OLQDWXPRPDEPXVWEHDGPLQLVWHUHGLQERWKWKHLQSDWLHQWDQGRXWSDWLHQWVHWWLQJXVLQJ
LQIXVLRQSXPSVDSSURYHGIRUXVHE\WKHDSSURSULDWHUHJXODWRU\DXWKRULWLHVIRUWKHFRXQWU\
LQZKLFKWKHVWXG\LVEHLQJFRQGXFWHG
%OLQDWXPRPDEVROXWLRQIRULQIXVLRQZLOOEHSUHSDUHGLQEDJVIRU,9LQIXVLRQDQGGHOLYHUHG
WKURXJKLQIXVLRQOLQHVWKDWDUHFRPSDWLEOHZLWKWKHLQYHVWLJDWLRQDOSURGXFWDVGHVFULEHGLQ
WKH,3,07KHEOLQDWXPRPDEILQDOVROXWLRQIRULQIXVLRQVKRXOGQRWFRPHLQWRFRQWDFWZLWK
WKHSXPSDWDQ\WLPH
$GGLWLRQDOGHWDLOVIRUWKHXVHRIWKHDERYHPHQWLRQHGPHGLFDOGHYLFHVDUHSURYLGHGLQWKH
,3,0.
,QIXVLRQSXPSV,9EDJVDQGWXELQJDQGDGGLWLRQDOPHGLFDOGHYLFHVHJV\ULQJHVVWHULOH
QHHGOHVDOFRKROSUHSSDGVWKDWDUHFRPPHUFLDOO\DYDLODEOHDUHQRWSURYLGHGRU
UHLPEXUVHGE\$PJHQH[FHSWLIUHTXLUHGE\ORFDOUHJXODWLRQ,QIXVLRQSXPSVDQG
WXELQJPD\EHDYDLODEOHLQOLPLWHGTXDQWLWLHVIRUSURYLVLRQE\$PJHQZKHUHSURYLVLRQLV
UHTXLUHGE\ORFDOUHJXODWLRQ7KHLQYHVWLJDWRURYHUVHHLQJWKHFRQGXFWRIWKHVWXG\DW
HDFKUHVSHFWLYHLQVWLWXWLRQZLOOEHUHVSRQVLEOHIRUREWDLQLQJWKHVHVXSSOLHV

3URGXFW&RPSODLQWV
$SURGXFWFRPSODLQWLVDQ\ZULWWHQHOHFWURQLFRURUDOFRPPXQLFDWLRQWKDWDOOHJHV
GHILFLHQFLHVUHODWHGWRWKHLGHQWLW\TXDOLW\GXUDELOLW\UHOLDELOLW\VDIHW\HIIHFWLYHQHVVRU
SHUIRUPDQFHRIDQ\GUXJFRPELQDWLRQSURGXFWRUGHYLFHDIWHULWLVUHOHDVHGIRU
GLVWULEXWLRQWRPDUNHWRUFOLQLFE\HLWKHU$PJHQRUGLVWULEXWRUVDQGSDUWQHUVIRU

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


ZKRP$PJHQPDQXIDFWXUHVWKHPDWHULDO7KLVLQFOXGHVDOOFRPSRQHQWVGLVWULEXWHGZLWK
WKHGUXJVXFKDVSDFNDJLQJGUXJFRQWDLQHUVGHOLYHU\V\VWHPVODEHOLQJDQGLQVHUWV
7KLVLQFOXGHVDQ\LQYHVWLJDWLRQDOQRQLQYHVWLJDWLRQDOSURGXFWVGHYLFHVRUFRPELQDWLRQ
SURGXFWVSURYLVLRQHGDQGRUUHSDFNDJHGPRGLILHGE\$PJHQ
$Q\SURGXFWFRPSODLQWVDVVRFLDWHGZLWKDQLQYHVWLJDWLRQDOSURGXFWVRUGHYLFHV
VXSSOLHGE\$PJHQDUHWREHUHSRUWHGDFFRUGLQJWRWKHLQVWUXFWLRQVSURYLGHGLQWKH,3,0

([FOXGHG7UHDWPHQWVDQGRU3URFHGXUHV'XULQJ6WXG\3HULRG
:KLOHVXEMHFWVUHPDLQHQUROOHGRQSURWRFROWUHDWPHQWWKHIROORZLQJPHGLFDWLRQVDQG
WKHUDSLHVZLOOEHSURKLELWHGGXULQJWKHWUHDWPHQWSKDVHRIWKHVWXG\

$Q\DQWLWXPRUWKHUDS\RWKHUWKDQSURWRFROVSHFLILHGWKHUDS\HJEOLQDWXPRPDE
RU62&LQFOXGLQJ
o &\WRWR[LFDQGRUF\WRVWDWLFGUXJV
o 5DGLDWLRQWKHUDS\
o ,PPXQRWKHUDS\

$Q\RWKHULQYHVWLJDWLRQDODJHQW

$Q\RWKHULPPXQRVXSSUHVVLYHWKHUDSLHVH[FHSWIRUWUDQVLHQWXVHRI
FRUWLFRVWHURLGV

7.,V 
)URPHQGRISURWRFROVSHFLILHGWUHDWPHQWF\FOH+&RUEOLQDWXPRPDEXQWLOVXEMHFWV
KDYHUHDFKHGWKHLUSULPDU\HQGSRLQWWKHIROORZLQJPHGLFDWLRQVUHJLPHQVZLOOEH
SURKLELWHG

%OLQDWXPRPDE

+&
3URFHGXUHVUHTXLUHGE\,QW5H$//+5JXLGHOLQHVDUHDOORZHG 

678'<352&('85(6

6FKHGXOHRI$VVHVVPHQWV


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7DEOH6FKHGXOHRI$VVHVVPHQWV
([DPLQDWLRQ
6FUHHQLQJ
7UHDWPHQW3HULRG(DFK&\FOH
RI3URWRFROVSHFLILHG7KHUDS\
6DIHW\
)ROORZXS
9LVLW
6KRUW7HUP(IILFDF\)ROORZXS
/RQJ7HUP
)ROORZXS$
'D\'
'WR'
'
'
	GD\V
'%
	GD\V
:LWKLQGD\V
SULRUWR
DOOR+6&7
GD\V
SRVWDOOR+6&7
	ZHHN
GD\V
SRVWDOOR+6&7
	ZHHN
PRQWKV
PRQWKV
PRQWKV
SRVWDOOR+6&7
	ZHHN
4PRQWKV
	ZHHNV
,QIRUPHG&RQVHQW	$VVHQW
)RUP
;








,QFOXVLRQ([FOXVLRQ
&ULWHULD5DQGRPL]DWLRQ
;








0HGLFDO
+LVWRU\'HPRJUDSKLFV
;








.DUQRIVN\RU/DQVN\
3HUIRUPDQFH6WDWXV
;



;

;

;&
&RPSOHWH1HXURORJLFDO
([DPLQDWLRQ
;



;

;

;&
3K\VLFDO([DPLQDWLRQ
;



;
;
;
;

+HLJKW	:HLJKW'
;
;
;






9LWDO6LJQV	7HPSHUDWXUH
;
;
;
;
;
;
;
;

/XPEDU3XQFWXUH
;(


;





,QWUDWKHFDO3URSK\OD[LV
;(

;





%RQH0DUURZ$VSLUDWH%LRSV\
05')
;(

;*
;

;
;
;

&KHPLVWU\
;
;+
;
;

;
;
;

+HPDWRORJ\ZLWK'LIIHUHQWLDO
;
;+
;
;

;
;
;

&RDJXODWLRQ
;
;+
;
;

;
;
;

8ULQDO\VLV
;
;
;
;

;
;
;

6HUXP&UHDWLQLQH
;
;+
;
;

;
;
;

3UHJQDQF\7HVW,
;








+XPDQ,PPXQRGHILFLHQF\
9LUXV+,97HVWLQJ
;








4XDQWLWDWLYH,PPXQH
*OREXOLQV-

;+

;





3DJHRI
)RRWQRWHVGHILQHGRQODVWSDJHRIWKHWDEOH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7DEOH6FKHGXOHRI$VVHVVPHQWV
([DPLQDWLRQ
6FUHHQLQJ
7UHDWPHQW3HULRG(DFK&\FOH
RI3URWRFROVSHFLILHG7KHUDS\
6DIHW\
)ROORZXS
9LVLW
6KRUW7HUP(IILFDF\)ROORZXS
/RQJ7HUP
)ROORZXS%
'D\'
'WR'
'
'
	GD\V
'&
	GD\V
:LWKLQGD\V
SULRUWR
DOOR+6&7
GD\V
SRVWDOOR+6&7
	ZHHN
GD\V
SRVWDOOR+6&7
	ZHHN
PRQWKV
PRQWKV
PRQWKV
SRVWDOOR+6&7
	ZHHN
4PRQWKV
	ZHHNV
$QWLEOLQDWXPRPDE$QWLERG\*

;+

;





3KDUPDFRNLQHWLFV*.

;
;






.H\6DIHW\3DUDPHWHUV/

&RQWLQXRXVO\WKURXJKVWXG\/
'LVHDVH6XUYLYDO6WDWXV0

&RQWLQXRXVO\WKURXJKVWXG\
3URWRFROVSHFLILHG7KHUDS\

&RQWLQXRXVO\WKURXJKWUHDWPHQW
SHULRG





&RQFRPLWDQW0HGLFDWLRQ
&RQWLQXRXVO\IURPLQIRUPHGFRQVHQWWKURXJKSURWRFROGHILQHG
UHSRUWLQJSHULRG
;12
;12
;
;
$GYHUVH(YHQW$VVHVVPHQW
&RQWLQXRXVO\WKURXJKSURWRFROGHILQHGUHSRUWLQJSHULRGV3
;3
6HULRXV$GYHUVH(YHQW
$VVHVVPHQW
&RQWLQXRXVO\IURPLQIRUPHGFRQVHQWWKURXJKSURWRFROGHILQHGUHSRUWLQJSHULRG'XULQJ/7)86$(VVXVSHFWHGWREHUHODWHGWR,3ZLOOEH
UHSRUWHGWR$PJHQLPPHGLDWHO\DQGQRODWHUWKDQKRXUVRIDZDUHQHVV4
3DJHRI
$EEUHYLDWLRQV'GD\+,9KXPDQ,PPXQRGHILFLHQF\9LUXV,3LQYHVWLJDWLRQDOSURGXFW.63NH\VDIHW\SDUDPHWHUV/7)8ORQJWHUPIROORZXS05'PLQLPDOUHVLGXDO
GLVHDVH6$(VHULRXVDGYHUVHHYHQW
$/RQJWHUPIROORZXSZLOOEHSHUIRUPHGYLDWHOHSKRQHRUHPDLOFRQWDFWDWDOOWLPHSRLQWVXQWLOWKHODVWVXEMHFWHQUROOHGRQVWXG\LVPRQWKVDIWHUDOOR+6&7$FOLQLFYLVLWZLOOEH
SHUIRUPHGDWWKHWLPHSRLQWPRQWKVDIWHUDOOR+6&7
%(QGRIF\FOHERQHPDUURZDVSLUDWHELRSV\DQGDVVHVVPHQWVVKRXOGEHFRPSOHWHGRQ'	GD\VDQGSULRUWRDOOR+6&77KHGD\ZLQGRZLVDOORZHGIRUDGPLQLVWUDWLYH
VFKHGXOLQJDURXQGZHHNHQGVDQGKROLGD\VEXWDOODVVHVVPHQWVVKRXOGEHSHUIRUPHGRQWKHVDPHGD\
&5HTXLUHGDWFOLQLFYLVLWPRQWKVDIWHUDOOR+6&7
'+HLJKWFROOHFWHGDWVFUHHQLQJRQO\:HLJKWFROOHFWHGDWVFUHHQLQJ'DQG'
(6FUHHQLQJOXPEDUSXQFWXUHDQGERQHPDUURZDVSLUDWHELRSV\WREHSHUIRUPHGSULRUWRUDQGRPL]DWLRQLQWUDWKHFDOSURSK\OD[LVWREHSHUIRUPHGZLWKLQGD\VRIWUHDWPHQWVWDUW,I
WKHLQWUDWKHFDOFKHPRWKHUDS\ZLOOEHDGPLQLVWHUHGDIWHUUDQGRPL]DWLRQWKHQDQDGGLWLRQDOGLDJQRVWLFOXPEDUSXQFWXUHLVUHTXLUHGEHIRUHUDQGRPL]DWLRQLQRUGHUWRH[FOXGH
HYLGHQFHRIFXUUHQW&16&16&16LQYROYHPHQWE\$//6FUHHQLQJERQHPDUURZUHVXOWVVKRXOGUHYHDODUHSUHVHQWDWLYH0RU0E\ORFDODVVHVVPHQWDWUDQGRPL]DWLRQ
LQRUGHUWRVWDUWWUHDWPHQW,QFDVHRIDQRQUHSUHVHQWDWLYHRUDQDSODVWLFPDUURZWKHDQDO\VLVVKRXOGEHUHSHDWHGDQGWKHVWDUWRIVWXG\WUHDWPHQWSRVWSRQHGDFFRUGLQJO\
)6OLGHVIRUF\WRPRUSKRORJ\DVVHVVPHQWDQGVDPSOHVIRU05'3&5DQGIORZF\WRPHWU\QHHGWREHVHQWWRWKHFHQWUDOODEDWVFUHHQLQJGD\EOLQDWXPRPDEDUPRQO\DQG
GD\/RFDOF\WRPRUSKRORJ\DQG05'DVVHVVPHQWLIDYDLODEOHVKRXOGEHUHSRUWHGDWVFUHHQLQJGD\EOLQDWXPRPDEDUPRQO\DQGGD\'XULQJVKRUWWHUPHIILFDF\
IROORZXSSHULRGVOLGHVIRUF\WRPRUSKRORJ\DVVHVVPHQWQHHGWREHVHQWWRWKHFHQWUDOODE7KHORFDOODEGXULQJWKHVKRUWWHUPHIILFDF\IROORZXSSHULRGQHHGVWRUHSRUW
F\WRPRUSKRORJ\DQG05'DVVHVVPHQWLIDYDLODEOH
*%OLQDWXPRPDEDUPRQO\)RUDQWLEOLQDWXPRPDEDQWLERGLHVZLWKDSRVLWLYHWHVWUHVXOWUHIHUWR6HFWLRQ
+'VDPSOHWREHFROOHFWHGSULRUWRLQIXVLRQVWDUW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


,3UHJQDQF\WHVWQHHGVWREHFRQGXFWHGRQO\RQIHPDOHVZKRDUHRIFKLOGEHDULQJSRWHQWLDO$GGLWLRQDOSUHJQDQF\WHVWVPD\EHSHUIRUPHGDWWKHGLVFUHWLRQRIWKHLQYHVWLJDWRURU
SHUORFDOUXOHVDQGUHJXODWLRQV
-4XDQWLWDWLYHLPPXQHJOREXOLQVZLOOEHFKHFNHGDWKRVSLWDOODERUDWRULHVWRGHWHFWK\SRJDPPDJOREXOLQHPLDRULPPXQRORJLFDOFKDQJHV
.7ZRSKDUPDFRNLQHWLFVDPSOHVZLOOEHFROOHFWHGIURPDVLWHGLVWDOIURPWKHVLWHRIEOLQDWXPRPDEDGPLQLVWUDWLRQ'DWOHDVWKRXUVDIWHULQIXVLRQVWDUWDQGXSWRKRXUV
'DWWKHVDPHWLPHDVWKHRWKHUEORRGVDPSOHVVFKHGXOHGIRUWKDWGD\
/.H\VDIHW\SDUDPHWHUVGHILQHGLQ6HFWLRQ$GYHUVHHYHQWVDVVRFLDWHGZLWK.63VKRXOGEHUHSRUWHGIRUWKHGXUDWLRQRIWKHVWXG\ZLWKWKHH[FHSWLRQWKDWWKRVHUHODWHGWR
RWKHUDQWLFDQFHUWKHUDSLHVRFFXUULQJSRVWEOLQDWXPRPDEWUHDWPHQWPD\EHH[FOXGHG
0'LVHDVH6XUYLYDOVWDWXVGDWDGHILQHGLQ6HFWLRQDQG$SSHQGL[*
1'XULQJVKRUWWHUPHIILFDF\IROORZXSXQWLOGD\VDIWHUDOOR+6&7RQO\WKHFRQGLWLRQLQJUHJLPHQVWKHGRQRUW\SHDQG*Y+'SURSK\OD[LVZLOOEHFROOHFWHGDVFRQFRPLWDQW
PHGLFDWLRQ'XULQJWKHUHPDLQGHURIWKHVKRUWWHUPHIILFDF\IROORZXSDIWHUGD\RQO\DQWLFDQFHUWKHUDS\IRUFXUUHQWPDOLJQDQF\ZLOOEHFROOHFWHG,IDFKHPRWKHUDS\LV
DGPLQLVWHUHGLQEHWZHHQHQGRIVWXG\WUHDWPHQWDQGDOOR+6&7ZKLFKLVQRWUHFRPPHQGHGWKLVUHJLPHQZLOOEHUHFRUGHGDVFRQFRPLWDQWPHGLFDWLRQDVZHOO
2$QWLFDQFHUWKHUDS\IRUFXUUHQWPDOLJQDQF\
3$OODGYHUVHHYHQWVWKDWRFFXUGXULQJSURWRFROUHTXLUHGUHSRUWLQJSHULRGDUHUHSRUWHG$GYHUVHHYHQWVDVVRFLDWHGZLWK.63VKRXOGEHUHSRUWHGIRUWKHGXUDWLRQRIWKHVWXG\ZLWK
WKHH[FHSWLRQWKDWWKRVHUHODWHGWRRWKHUDQWLFDQFHUWKHUDSLHVRFFXUULQJSRVWEOLQDWXPRPDEWUHDWPHQWPD\EHH[FOXGHG
4$OOVHULRXVDGYHUVHHYHQWVWKDWRFFXUGXULQJSURWRFROUHTXLUHGUHSRUWLQJSHULRGDUHUHSRUWHG'XULQJWKH/RQJWHUPIROORZXSSKDVHVHULRXVDGYHUVHHYHQWVVXVSHFWHGWREH
UHODWHGWRLQYHVWLJDWLRQDOSURGXFWVWKDWWKHLQYHVWLJDWRUEHFRPHVDZDUHRIZLOOEHUHSRUWHGWR$PJHQLPPHGLDWHO\DQGQRODWHUWKDQKRXUVRIDZDUHQHVV3URWRFROUHTXLUHG
UHSRUWLQJSHULRGLQWKLVVWXG\LVGHILQHGDVWKHWLPHLQWHUYDODIWHUVLJQLQJRILQIRUPHGFRQVHQWDQGDVVHQWWKURXJKGD\VDIWHUWKHODVWGRVHRIVWXG\WUHDWPHQWLQFDVHVZKHUH
WKHVXEMHFWZLOOQRWUHFHLYH+6&7RUGD\VDIWHUDOOR+6&7,ILQYHVWLJDWRUEHFRPHVDZDUHRIVXEMHFWGHDWKWKLVVKRXOGDOZD\VEHUHSRUWHGDVDVHULRXVDGYHUVHHYHQW
$IWHUHQGRIVWXG\VHULRXVDGYHUVHHYHQWVVXVSHFWHGWREHUHODWHGWRLQYHVWLJDWLRQDOSURGXFWVZLOOEHUHSRUWHGWR$PJHQLPPHGLDWHO\DQGQRODWHUWKDQZLWKLQ
KRXUVRIDZDUHQHVV3OHDVHUHIHUWR6HFWLRQIRUDGGLWLRQDOGHWDLOV


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



*HQHUDO6WXG\3URFHGXUHV
$GHVFULSWLRQIRUHDFKSKDVHRIWKHVWXG\LVSURYLGHGLQWKLVVHFWLRQ5HIHUWRWKHH&5)
FRPSOHWLRQJXLGHOLQHVIRUGDWDFROOHFWLRQUHTXLUHPHQWVDQGGRFXPHQWDWLRQRIVWXG\
DVVHVVPHQWVSURFHGXUHV
&RQILUPDWLRQWKDWWKHPRVWFXUUHQW,5%,(&DSSURYHG,&)DQGDVVHQWIRUPKDYHEHHQ
VLJQHGVKRXOGRFFXUEHIRUHDQ\VWXG\VSHFLILFSURFHGXUHVDUHSHUIRUPHG$OOVXEMHFWV
ZKRDUHHQUROOHGDQGUHFHLYHSURWRFROUHTXLUHGWKHUDS\RUXQGHUJRVWXG\VSHFLILF
SURFHGXUHVVKRXOGEHUHFRQVHQWHGZLWKDQ\XSGDWHG,5%,(&DSSURYHG,&)VDQGDVVHQW
IRUPVGXULQJVWXG\SDUWLFLSDWLRQDVDSSOLFDEOHDQGSHULQVWLWXWLRQDOJXLGHOLQHV
'HPRJUDSKLFGDWDWKDWZLOOEHFROOHFWHGLQFOXGHVH[GDWHRIELUWKDQGRUDJHUDFHDQG
HWKQLFLW\WRVWXG\WKHLUSRVVLEOHDVVRFLDWLRQZLWKVXEMHFWVDIHW\DQGWUHDWPHQW
HIIHFWLYHQHVV$GGLWLRQDOO\GHPRJUDSKLFGDWDZLOOEHXVHGWRVWXG\WKHLPSDFWRQ
SKDUPDFRNLQHWLFVRIEOLQDWXPRPDE
5HOHYDQWPHGLFDOKLVWRU\UHODWHGWRWKHVXEMHFW¶VGLDJQRVLVRI$//HJULVNVWUDWLILFDWLRQ
LPPXQRSKHQRW\SHLQIRUPDWLRQRQSULRUDQWLWXPRUWKHUDSLHVDOOR+6&7GDWDUHODSVH
VWDWXVZLOOEHFROOHFWHGDQGPXVWGDWHEDFNWRWKHRULJLQDOGLDJQRVLV)RUVXEMHFWVZKR
DUHEHLQJUHIHUUHGWRWKHUHVHDUFKFHQWHUFRSLHVRIWKHVXEMHFW¶VFKDUWIURPWKHUHIHUULQJ
SK\VLFLDQVKRXOGEHREWDLQHG

6FUHHQLQJ3UH3KDVH
7KHVFUHHQLQJSURFHVVEHJLQVRQWKHGDWHWKHVXEMHFWVLJQVWKH,5%,(&DSSURYHG,&)
DQGDVVHQWIRUPDQGFRQWLQXHVXQWLOUDQGRPL]DWLRQ,QIRUPHGFRQVHQWDQGDVVHQWPXVW
EHREWDLQHGEHIRUHFRPSOHWLQJDQ\VWXG\VSHFLILFSURFHGXUHV:LWKWKHH[FHSWLRQRI
ERQHPDUURZDVSLUDWHELRSV\SURFHGXUHVWKDWDUHSDUWRI62&DUHQRWFRQVLGHUHG
VWXG\VSHFLILFSURFHGXUHVDQGPD\EHSHUIRUPHGSULRUWRLQIRUPHGFRQVHQWDQGXVHGWR
GHWHUPLQHHOLJLELOLW\EXWPXVWEHGRQHZLWKLQGD\VSULRUWRWUHDWPHQWVWDUWXQOHVV
VSHFLILHGRWKHUZLVH
$IWHUZULWWHQLQIRUPHGFRQVHQWDQGDVVHQWKDYHEHHQREWDLQHGVXEMHFWVZLOOEHVFUHHQHG
WRDVVHVVHOLJLELOLW\IRUVWXG\SDUWLFLSDWLRQ2QO\HOLJLEOHVXEMHFWVZKRPHHWWKH
LQFOXVLRQH[FOXVLRQFULWHULDOLVWHGLQ6HFWLRQZLOOEHHQUROOHGLQWKHVWXG\7KHWRWDO
VFUHHQLQJZLQGRZLVXSWRGD\V,IDVXEMHFWKDVQRWPHWDOOHOLJLELOLW\FULWHULDDWWKH
HQGRIWKHGD\ZLQGRZWKHVXEMHFWZLOOEHFODVVLILHGDVDVFUHHQIDLOXUH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7KHIROORZLQJSURFHGXUHVDUHWREHFRPSOHWHGGXULQJWKHGD\VFUHHQLQJSHULRGDW
WLPHSRLQWVGHVLJQDWHGLQWKH6FKHGXOHRI$VVHVVPHQWV7DEOH

&RQILUPDWLRQWKDWWKH,&)DQGDVVHQWIRUPKDYHEHHQVLJQHG

5HYLHZRILQFOXVLRQH[FOXVLRQFULWHULD

5HOHYDQWPHGLFDOKLVWRU\

'HPRJUDSKLFGDWD

.DUQRIVN\RU/DQVN\3HUIRUPDQFH6WDWXV$SSHQGL[)

&RPSOHWHQHXURORJLFDOH[DPLQDWLRQ

3K\VLFDOH[DPLQDWLRQLQFOXGLQJKHLJKWDQGZHLJKW

9LWDOVLJQVHJEORRGSUHVVXUHKHDUWUDWHDQGWHPSHUDWXUH

/XPEDUSXQFWXUHZLWKLQGD\VRIWUHDWPHQWVWDUWEXWSULRUWRUDQGRPL]DWLRQ

,QWUDWKHFDOSURSK\OD[LVZLWKLQGD\VRIWUHDWPHQWVWDUWVHH6HFWLRQ

&HQWUDOODERUDWRU\DVVHVVPHQWVLQFOXGLQJ
ż %RQHPDUURZDVSLUDWHELRSV\ZLWKLQGD\VRIWUHDWPHQWVWDUWSULRUWR
UDQGRPL]DWLRQIRUEODVWFRXQWDQG05'DVVHVVPHQW

/RFDOODERUDWRU\DVVHVVPHQWVLQFOXGLQJ
ż &KHPLVWU\LQFOXGLQJWRWDOELOLUXELQVHUXPFUHDWLQLQHIRUHOLJLELOLW\
ż +HPDWRORJ\ZLWKGLIIHUHQWLDOLQFOXGLQJSHULSKHUDOQHXWURSKLOVSHULSKHUDOSODWHOHWV
IRUHOLJLELOLW\
ż &RDJXODWLRQ
ż 8ULQDO\VLV
ż 8ULQHRUVHUXPSUHJQDQF\WHVWSRVWPHQDUFKDOIHPDOHVXEMHFWVRQO\
ż +XPDQLPPXQRGHILFLHQF\YLUXVWHVWLQJ

'RFXPHQWDWLRQRIFRQFRPLWDQWPHGLFDWLRQV

6HULRXV$GYHUVH(YHQWUHSRUWLQJIURPVLJQLQJRILQIRUPHGFRQVHQW

5HJLVWHUVFUHHQHGVXEMHFWLQWKH,956

5DQGRPL]DWLRQ
2QFHHOLJLELOLW\LQWRWKHVWXG\KDVEHHQFRQILUPHGDVLWHUHSUHVHQWDWLYHZLOOPDNHWKH
UDQGRPL]DWLRQFDOOWRWKH,956WRDVVLJQDUDQGRPL]DWLRQQXPEHUWRWKHVXEMHFW7KH
UDQGRPL]DWLRQFDOOWRWKH,956LVDFFRPSOLVKHGE\HQWHULQJWKHIROORZLQJLQIRUPDWLRQ
DJHERQHPDUURZVWDWXVDWVFUHHQLQJORFDOUHVXOWLIWKHFHQWUDOUHVXOWLVQRW\HWDYDLODEOH
DWWKHWLPHRIUDQGRPL]DWLRQLQFDVHRI0ERQHPDUURZVWDWXVDWVFUHHQLQJ05'OHYHO
DIWHULQGXFWLRQORFDOUHVXOW$FRQILUPDWLRQID[RUHPDLOZLOOEHVHQWWRWKHVLWHWRYHULI\
WKDWWKHFRUUHFWLQIRUPDWLRQKDVEHHQHQWHUHGDQGWRFRQILUPWKHUDQGRPL]DWLRQ
DVVLJQHG$VXEMHFWZLOOEHFRQVLGHUHGHQUROOHGDQGUDQGRPL]HGLQWRWKHVWXG\ZKHQD
UDQGRPL]DWLRQQXPEHULVDVVLJQHG

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


(DFKVXEMHFWVKRXOGEHGRVHGZLWKLQGD\VRIUDQGRPL]DWLRQDVGHVFULEHGLQ6HFWLRQ

7UHDWPHQW
'XULQJWKHWUHDWPHQWSHULRGDVVHVVPHQWVZLOOEHSHUIRUPHGRQGD\VDQGRUDW
WKHWLPHSRLQWVVSHFLILHGLQWKH6FKHGXOHRI$VVHVVPHQWV7DEOH   
)RUDVVHVVPHQWVSHUIRUPHGDWF\FOHGD\DOOVWXG\SURFHGXUHVVKRXOGEHFRPSOHWHG
SULRUWRWKHLQLWLDWLRQRISURWRFROVSHFLILHGWKHUDS\

:HLJKW

9LWDOVLJQVHJEORRGSUHVVXUHKHDUWUDWHDQGWHPSHUDWXUH

/XPEDUSXQFWXUHGD\

,QWUDWKHFDOSURSK\OD[LVGD\>LIDSSOLFDEOHVHH6HFWLRQ@DQGGD\

&HQWUDOODERUDWRU\DVVHVVPHQWVLQFOXGLQJ
ż %RQHPDUURZDVSLUDWHELRSV\GD\ERQHPDUURZDVVHVVPHQWLVUHTXLUHGIRU
WKHEOLQDWXPRPDEDUPRQO\WRHYDOXDWHF\WRPRUSKRORJ\DQG05'E\IORZ
F\WRPHWU\DQG3&5

/RFDOODERUDWRU\DVVHVVPHQWVLQFOXGLQJ
ż %RQHPDUURZDVSLUDWHELRSV\WRHYDOXDWHF\WRPRUSKRORJ\UHSRUW05'LI
DYDLODEOH
ż &KHPLVWU\
ż +HPDWRORJ\ZLWKGLIIHUHQWLDO
ż &RDJXODWLRQ
ż 8ULQDO\VLV
ż 6HUXPFUHDWLQLQH
ż 4XDQWLWDWLYHLPPXQRJOREXOLQV,J*,J$,J0,J(

&HQWUDOODERUDWRU\DVVHVVPHQWVEOLQDWXPRPDEDUPRQO\LQFOXGLQJ
ż ,PPXQRJHQLFLW\VDPSOHDQWLEOLQDWXPRPDEDQWLERG\
ż 3.VDPSOHVVHH6HFWLRQ

.H\VDIHW\SDUDPHWHUVVHH6HFWLRQ

'LVHDVH6XUYLYDOVWDWXVVHH6HFWLRQDQG$SSHQGL[*

$GPLQLVWUDWLRQRISURWRFROVSHFLILHGWKHUDS\

'RFXPHQWDWLRQRIFRQFRPLWDQWPHGLFDWLRQV

$GYHUVHHYHQWUHSRUWLQJ

6HULRXVDGYHUVHHYHQWUHSRUWLQJ
)RUVXEMHFWVZKRZLWKGUDZIURPWUHDWPHQWSULRUWRWKHGD\YLVLWHYHU\HIIRUWVKRXOGEH
PDGHWRFRPSOHWHGD\DQGWKHVDIHW\IROORZXSYLVLWDVVHVVPHQWVDVGHVFULEHGLQ
6HFWLRQRQWKHGD\RIGLVFRQWLQXDWLRQ,QFDVHVZKHUHDVXEMHFWUHDFKHVWKH
SULPDU\HQGSRLQWWKHVXEMHFWLVLQGLVHDVHVXUYLYDOIROORZXS

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



6DIHW\)ROORZXS9LVLW
$OOVXEMHFWVZLOOFRPSOHWHDVDIHW\IROORZXSYLVLWZLWKLQGD\VSULRUWRDOOR+6&7RU
DQWLFDQFHUWKHUDS\IRUFXUUHQWPDOLJQDQF\QRWPDQGDWHGE\WKHSURWRFROZKLFKHYHU
FRPHVILUVW,QWKHHYHQWDOOR+6&7LVSODQQHGWRWDNHSODFHZLWKLQGD\VDIWHUWKH
GD\YLVLWWKHVDIHW\IROORZXSYLVLWVKRXOGDOVREHFRPSOHWHGRQGD\	GD\V,Q
WKHXQOLNHO\HYHQWDVXEMHFWGRHVQRWXQGHUJRDOOR+6&7WKHVDIHW\IROORZXSYLVLW
DVVHVVPHQWVVKRXOGEHFRPSOHWHGDWWKHGD\YLVLW,QFDVHVZKHUHDVXEMHFWUHDFKHV
WKHSULPDU\HQGSRLQWWKHVXEMHFWLVLQGLVHDVHVXUYLYDOIROORZXSVHH7DEOH
7DEOH7LPLQJRI()6(YHQW
()6
HYHQW
E\
'"
7UHDWPHQW
IROORZLQJ
+&,3
7LPLQJRI
6)83
&DOFXODWLRQ
RI
IROORZXS
7\SHRI
IROORZXS
()6HYHQW
GXULQJ67)8
SHULRG"
1R
$OOR+6&7
7UDQVSODQW
8SWR
GD\V
35,25WR
7UDQVSODQWD
)URPGDWH
RI
WUDQVSODQW
6KRUWWHUP
HIILFDF\)8
&RQWLQXHWR
VXUYLYDO)8
ORQJWHUP
IROORZXS
>FRXQWIURP
GDWHRI()6
HYHQW@E
1R
$OWHUQDWLYH
DQWLFDQFHU
WUHDWPHQW
IROORZHGE\
DOOR+6&7
WUDQVSODQW
8SWR
GD\V
35,25WR
7UHDWPHQW
)URPGDWH
RI
WUDQVSODQW
1R
12DOOR+6&7
>$OWHUQDWLYH
WUHDWPHQW@
'
	GD\V
)URP
6)83'
<(6
6XEMHFWUHDFKHV
SULPDU\HQGSRLQW
()6HYHQWE\
'
'
	GD\V
)URP
6)83'
6XUYLYDO
ORQJWHUP
IROORZXSF

DOOR+6&7DOORJHQHLFKHPDWRSRLHWLFVWHPFHOOWUDQVSODQWDWLRQ%0ERQHPDUURZ()6HYHQW
IUHHVXUYLYDO+&KLJKULVNFRQVROLGDWLRQ,3LQYHVWLJDWLRQDOSURGXFW6)83VDIHW\IROORZ
XS67)8VKRUWWHUPHIILFDF\IROORZXS
D,IDOOR+6&7DOWHUQDWLYHDQWLFDQFHUWUHDWPHQWLVSODQQHGZLWKLQGRI'FRPSOHWH6)83RQ'
	GD\V
E6XEPLW%0DVSLUDWHWRFHQWUDOODEIURPYLVLWVKRZLQJ()6HYHQW6XEVHTXHQWYLVLWVRIRULJLQDO67)8
SHULRG%0DVSLUDWHQRWUHTXLUHG
&%0DVSLUDWHQRWUHTXLUHG
7KHIROORZLQJSURFHGXUHVZLOOEHFRPSOHWHGDWWKHYLVLW

.DUQRIVN\RU/DQVN\3HUIRUPDQFH6WDWXV$SSHQGL[)

&RPSOHWHQHXURORJLFDOH[DPLQDWLRQ

3K\VLFDOH[DPLQDWLRQ

9LWDOVLJQVHJEORRGSUHVVXUHKHDUWUDWHDQGWHPSHUDWXUH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



.H\VDIHW\SDUDPHWHUVVHH6HFWLRQ

'LVHDVH6XUYLYDOVWDWXVVHH6HFWLRQDQG$SSHQGL[*

'RFXPHQWDWLRQRIFRQFRPLWDQWPHGLFDWLRQV

$GYHUVHHYHQWUHSRUWLQJ

6HULRXVDGYHUVHHYHQWUHSRUWLQJ

6KRUWWHUP(IILFDF\)ROORZXS
6XEMHFWYLVLWVZLOOEHSHUIRUPHGGXULQJWKHVKRUWWHUPHIILFDF\IROORZXSSHULRGRIWKH
VWXG\DWGD\VGD\VPRQWKVPRQWKVDQGPRQWKV	ZHHNIROORZLQJ
DOOR+6&7$OODVVHVVPHQWVVKRXOGEHSHUIRUPHGRQWKHVDPHGD\,QWKHXQOLNHO\HYHQW
DVXEMHFWGRHVQRWXQGHUJRDOOR+6&7WKHWLPLQJRIVKRUWWHUPHIILFDF\IROORZXSYLVLWV
VKRXOGEHVFKHGXOHGZLWKUHVSHFWWRWKHGD\VDIHW\IROORZXSFRPELQHGYLVLW
7KHIROORZLQJSURFHGXUHVZLOOEHFRPSOHWHGDWWKHWLPHSRLQWVVSHFLILHGLQWKH6FKHGXOH
RI$VVHVVPHQWV7DEOH

.DUQRIVN\RU/DQVN\3HUIRUPDQFH6WDWXV$SSHQGL[)

&RPSOHWHQHXURORJLFDOH[DPLQDWLRQ

3K\VLFDOH[DPLQDWLRQ

9LWDOVLJQVHJEORRGSUHVVXUHKHDUWUDWHDQGWHPSHUDWXUH

&HQWUDOODERUDWRU\DVVHVVPHQWVLQFOXGLQJ
ż %RQHPDUURZDVSLUDWHELRSV\WRHYDOXDWHF\WRPRUSKRORJ\

/RFDOODERUDWRU\DVVHVVPHQWVLQFOXGLQJ
ż %RQHPDUURZDVSLUDWHELRSV\WRHYDOXDWHF\WRPRUSKRORJ\UHSRUW05'LI
DYDLODEOH
ż &KHPLVWU\
ż +HPDWRORJ\ZLWKGLIIHUHQWLDO
ż &RDJXODWLRQ
o 8ULQDO\VLV
o 6HUXPFUHDWLQLQH

.H\VDIHW\SDUDPHWHUVVHH6HFWLRQ

'LVHDVH6XUYLYDOVWDWXVVHH6HFWLRQDQG$SSHQGL[*

'RFXPHQWDWLRQRIFRQFRPLWDQWPHGLFDWLRQVXQWLOGD\VDIWHUDOOR+6&7UHIHUWR
WKH6FKHGXOHRI$VVHVVPHQWVIRRWQRWH1

$GYHUVHHYHQWUHSRUWLQJXQWLOGD\VDIWHUDOOR+6&7

$GYHUVHHYHQWVUHODWHGWRNH\VDIHW\SDUDPHWHUVVKRXOGEHUHFRUGHGIRUWKH
GXUDWLRQRIWKHVWXG\

6HULRXVDGYHUVHHYHQWUHSRUWLQJXQWLOGD\VDIWHUDOOR+6&7

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



6HULRXVDGYHUVHHYHQWUHSRUWLQJLVFRQWLQXRXVIRUWKHGXUDWLRQRIWKHVWXG\DFWLYH
PRQLWRULQJXQWLOGD\VDIWHUDOOR+&67
6XEMHFWVZKRZLWKGUDZIURPWUHDWPHQWRURWKHUVWXG\SURFHGXUHVEXWVWLOOFRQVHQWWREH
IROORZHGIRUGLVHDVHVXUYLYDOVWDWXVZLOOEHFRQWDFWHGYLDWHOHSKRQHRUHPDLOHYHU\
PRQWKV,QFDVHVZKHUHDVXEMHFWUHDFKHVWKHSULPDU\HQGSRLQWWKHVXEMHFWLVLQ
GLVHDVHVXUYLYDOIROORZXSRQO\()6NH\VDIHW\SDUDPHWHUV>.63@UHTXLUHG

/RQJWHUP)ROORZXS
$OOVXEMHFWVZLOOEHIROORZHGLQWKHORQJWHUPIROORZXSSRUWLRQRIWKHVWXG\IRUGLVHDVH
DQGVXUYLYDOVWDWXV)ROORZLQJWKHVKRUWWHUPHIILFDF\IROORZXSSHULRGVXEMHFWYLVLWVZLOO
RFFXUHYHU\PRQWKV	ZHHNVYLDWHOHSKRQHHPDLORUFOLQLFYLVLWDVVSHFLILHGEHORZ
XQWLOWKHODVWVXEMHFWHQUROOHGRQVWXG\LVPRQWKVIROORZLQJDOOR+6&7RUXQWLOGHDWK
ZKLFKHYHURFFXUVILUVW,IWKHODVWVXEMHFWHQUROOHGRQVWXG\GLHVRULVORVWWRIROORZXS
EHIRUHWKHPRQWKVIROORZLQJDOOR+6&7WKHUHPDLQGHURIWKHVXEMHFWVRQVWXG\ZLOO
FRQWLQXHWREHIROORZHGXQWLODOOVXEMHFWVRQVWXG\KDYHUHDFKHGPRQWKVIROORZLQJ
DOOR+6&7XQWLOGHDWKRUORVWWRIROORZXS
$VXEMHFWZLOOEHFRQVLGHUHGORVWWRIROORZXSLIKHRUVKHUHSHDWHGO\IDLOVWRUHWXUQIRU
VFKHGXOHGYLVLWVDQGLVXQDEOHWREHFRQWDFWHGE\WKHVWXG\VLWH
7KHIROORZLQJDFWLRQVPXVWEHWDNHQLIDVXEMHFWIDLOVWRUHWXUQWRWKHFOLQLFIRUDUHTXLUHG
VWXG\YLVLW

7KHVLWHPXVWDWWHPSWWRFRQWDFWWKHVXEMHFWDQGUHVFKHGXOHWKHPLVVHGYLVLWDVVRRQ
DVSRVVLEOHDQGFRXQVHOWKHVXEMHFWRQWKHLPSRUWDQFHRIPDLQWDLQLQJWKHDVVLJQHG
YLVLWVFKHGXOHDQGDVFHUWDLQZKHWKHURUQRWWKHVXEMHFWZLVKHVWRDQGRULVDEOHWR
FRQWLQXHLQWKHVWXG\

,QFDVHVLQZKLFKWKHVXEMHFWLVGHHPHGORVWWRIROORZXSWKHLQYHVWLJDWRURU
GHVLJQHHPXVWPDNHHYHU\HIIRUWWRUHJDLQFRQWDFWZLWKWKHVXEMHFWZKHUHSRVVLEOH
WHOHSKRQHFDOOVDQGLIQHFHVVDU\DFHUWLILHGOHWWHUWRWKHVXEMHFW¶VODVWNQRZQ
PDLOLQJDGGUHVVRUORFDOHTXLYDOHQWPHWKRGV7KHVHFRQWDFWDWWHPSWVDUHWREH
GRFXPHQWHGLQWKHVXEMHFW¶VPHGLFDOUHFRUG

,IWKHVXEMHFWFRQWLQXHVWREHXQUHDFKDEOHKHVKHZLOOEHFRQVLGHUHGWRKDYH
ZLWKGUDZQIURPWKHVWXG\ZLWKDSULPDU\UHDVRQRIORVWWRIROORZXS

)RUVXEMHFWVZKRDUHORVWWRIROORZXSWKHLQYHVWLJDWRUVKRXOGVHDUFKSXEOLFO\
DYDLODEOHUHFRUGVZKHUHSHUPLWWHGWRDVFHUWDLQVXUYLYDOVWDWXV7KLVHQVXUHVWKDWWKH
GDWDVHWVSURGXFHGDVDQRXWFRPHRIWKHVWXG\LVDUHDVFRPSUHKHQVLYHDV
SRVVLEOH
7KHIROORZLQJSURFHGXUHVZLOOEHFRPSOHWHGDWWKHWLPHSRLQWVVSHFLILHGLQWKH6FKHGXOH
RI$VVHVVPHQWV7DEOH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


9LDWHOHSKRQHRUHPDLOFRQWDFWDWHYHU\PRQWKVXQWLOWKHODVWVXEMHFWHQUROOHGRQVWXG\
LVPRQWKVIROORZLQJDOOR+6&7RUXQWLOGHDWKZKLFKHYHURFFXUVILUVW

.H\VDIHW\SDUDPHWHUVVHH6HFWLRQ

'LVHDVH6XUYLYDOVWDWXVVHH6HFWLRQDQG$SSHQGL[*
(DFKVXEMHFWVKRXOGFRPHWRDFOLQLFYLVLWDWPRQWKVDIWHUDOOR+6&7

.DUQRIVN\RU/DQVN\3HUIRUPDQFH6WDWXV$SSHQGL[)

&RPSOHWHQHXURORJLFDOH[DPLQDWLRQ

.H\VDIHW\SDUDPHWHUVVHH6HFWLRQ

'LVHDVH6XUYLYDOVWDWXVVHH6HFWLRQDQG$SSHQGL[*
6XEMHFWVZKRZLWKGUDZIURPWUHDWPHQWRURWKHUVWXG\SURFHGXUHVEXWVWLOOFRQVHQWWREH
IROORZHGIRUGLVHDVHVXUYLYDOVWDWXVZLOOEHFRQWDFWHGYLDWHOHSKRQHRUHPDLOHYHU\
PRQWKV

/DQVN\.DUQRIVN\3HUIRUPDQFH6WDWXV
7KHSDWLHQW¶VSHUIRUPDQFHVWDWXVZLOOEHDVVHVVHGDVRXWOLQHGLQWKH6FKHGXOHRI
$VVHVVPHQWV7DEOHXVLQJWKH/DQVN\3HUIRUPDQFHVFRUHIRULQIDQWVWRGGOHUVDQG
FKLOGUHQEHORZ\HDUVRIDJHDQGWKH.DUQRIVN\VFRUHIRUFKLOGUHQDJHG\HDUVDQG
DERYH$SSHQGL[)

3K\VLFDO([DPLQDWLRQ
7KHEDVHOLQHSK\VLFDOH[DPLQDWLRQZLOOEHDFRPSOHWHSK\VLFDOH[DPLQDWLRQ7KH
SK\VLFDOH[DPLQDWLRQDWVXEVHTXHQWVWXG\YLVLWVZLOOFRQVLVWRIDQLQWHULPH[DPLQDWLRQWR
PRQLWRUIRUDQ\FKDQJHVIURPWKHEDVHOLQHSK\VLFDOH[DPLQDWLRQ
+HLJKWZLOOEHFROOHFWHGDWVFUHHQLQJZLWKRXWVKRHV:HLJKWVKRXOGEHPHDVXUHGZLWKRXW
VKRHV

9LWDO6LJQV
7KHIROORZLQJPHDVXUHPHQWVPXVWEHSHUIRUPHGDVRXWOLQHGLQWKH6FKHGXOHRI
$VVHVVPHQWV7DEOHV\VWROLFGLDVWROLFEORRGSUHVVXUHSXOVHUDWHUHVSLUDWLRQVDQG
WHPSHUDWXUHLQLQWHUYDOV6XEMHFWPXVWEHLQDVXSLQHSRVLWLRQLQDUHVWHGDQGFDOPVWDWH
IRUDWOHDVWPLQXWHVEHIRUHEORRGSUHVVXUHDVVHVVPHQWVDUHFRQGXFWHG,IWKHVXEMHFW
LVXQDEOHWREHLQWKHVXSLQHSRVLWLRQWKHVXEMHFWVKRXOGEHLQWKHPRVWUHFXPEHQW
SRVLWLRQDVSRVVLEOH7KHSRVLWLRQVHOHFWHGIRUDVXEMHFWVKRXOGEHWKHVDPHWKDWLVXVHG
WKURXJKRXWWKHVWXG\DQGVKRXOGEHGRFXPHQWHGRQWKH9LWDO6LJQVH&5)
5HFRUGDOOPHDVXUHPHQWVRQWKH9LWDO6LJQVH&5)
7KHWHPSHUDWXUHORFDWLRQVHOHFWHGIRUDVXEMHFWVKRXOGEHWKHVDPHWKDWLVXVHG
WKURXJKRXWWKHVWXG\DQGGRFXPHQWHGRQWKHDSSURSULDWHH&5)

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



1HXURORJLFDO([DPLQDWLRQ
$QDJHDSSURSULDWHQHXURORJLFDOH[DPLQDWLRQZLOOEHSHUIRUPHGSHULQVWLWXWLRQDO
JXLGHOLQHVDWWKHWLPHSRLQWVVSHFLILHGLQWKH6FKHGXOHRI$VVHVVPHQWV7DEOH7KH
IROORZLQJZLOOEHHYDOXDWHGOHYHORIFRQVFLRXVQHVVRULHQWDWLRQYLVLRQFUDQLDOQHUYHV
DQGEUDLQVWHPIXQFWLRQVS\UDPLGDODQGH[WUDS\UDPLGDOPRWRUV\VWHPUHIOH[HVPXVFOH
WRQHDQGWURSKLFILQGLQJVFRRUGLQDWLRQVHQVRU\V\VWHPQHXURSV\FKRORJLFDOILQGLQJV
HJVSHHFKFRJQLWLRQDQGHPRWLRQ,WLVUHFRPPHQGHGWKDWVXEMHFWVEHTXHULHGIRU
QHXURORJLFDOV\PSWRPVLQWKHLQWHUYDOVLQFHWKHODVWH[WHQGHGQHXURORJLFDOH[DPLQDWLRQ
)LQJHUQRVHRUZULWLQJWHVWVDUHUHFRPPHQGHGDVDSSURSULDWHIRUDJH

%RQH0DUURZ%LRSV\$VSLUDWLRQ
%RQHPDUURZVDPSOHVZLOOEHXVHGIRUKHPDWRORJLFDODVVHVVPHQWDQGHYDOXDWLRQRI
05'E\3&5DQGE\IORZF\WRPHWU\7KHIROORZLQJVDPSOHVZLOOEHREWDLQHGIRU
F\WRPRUSKRORJLFDODVVHVVPHQWDQG05'PHDVXUHPHQWDWWLPHSRLQWVVSHFLILHGLQWKH
6FKHGXOHRI$VVHVVPHQWV7DEOH

&\WRPRUSKRORJ\%RQHPDUURZVPHDUVVOLGHVZLOOEHFROOHFWHG,QFDVH
DVSLUDWLRQFDQQRWEHSHUIRUPHGRULITXDOLW\RIWKHDVSLUDWLRQPDWHULDOLV
LQVXIILFLHQWDFRUHELRSV\VKRXOGEHSHUIRUPHG$OOF\WRORJLFDODVVHVVPHQWVRI
ERQHPDUURZFROOHFWHGGXULQJVFUHHQLQJXQWLOHQGRIVKRUWWHUPIROORZXSZLOOEH
FHQWUDOO\UHYLHZHGE\DODERUDWRU\GHILQHGE\WKHVSRQVRU

05'$OLTXRWVIRU3&5LQGLYLGXDOUHDUUDQJHPHQWVZLOOEHFROOHFWHG7KH
VDPSOHVFROOHFWHGDWVFUHHQLQJ'D\EOLQDWXPRPDEDUPRQO\DQGDW'D\
ZLOOEHDQDO\]HGDWDFHQWUDOODEGHILQHGE\WKHVSRQVRUXVLQJFORQHVSHFLILF
SULPHUVHVWDEOLVKHGDWWKHQDWLRQDO05'ODEDQGUHIHUHQFH'1$IURPUHODSVHRU
LQLWLDOGLDJQRVLV,I'1$IURPLQLWLDOGLDJQRVLVZLOOEHSURYLGHGVWDELOLW\RI
FORQHVSHFLILF7&5O*UHDUUDQJHPHQWVDWUHODSVHPXVWEHSURYHQ,IWKH
FORQHVSHFLILFSULPHUVRIWKHQDWLRQDO05'ODEZRXOGQRWVXIILFLHQWO\ZRUNDWWKH
FHQWUDOODEVHTXHQFHVRISURYLGHGFORQHVSHFLILFSULPHUVDQGDQDO\]HG
VHTXHQFHVRIDOOFORQDOUHDUUDQJHPHQWVIURPUHODSVHGLDJQRVLVZLOOEHXVHGLQ
RUGHUWRGHVLJQQHZFORQHVSHFLILFSULPHUVDQGRUVHOHFWRWKHU7&5O*
UHDUUDQJHPHQWDV05'PDUNHU05'VDPSOHVLIFROOHFWHGGXULQJVKRUWWHUP
IROORZXSZLOOEHDQDO\]HGORFDOO\DQGVKRXOGEHGRFXPHQWHGLIDYDLODEOH

05'$OLTXRWVIRUIORZF\WRPHWU\ZLOOEHFROOHFWHG7KHVDPSOHVFROOHFWHGDW
VFUHHQLQJ'D\EOLQDWXPRPDEDUPRQO\DQGDW'D\ZLOOEHDQDO\]HGDWD
FHQWUDOODEGHILQHGE\WKHVSRQVRU05'VDPSOHVLIFROOHFWHGGXULQJVKRUWWHUP
IROORZXSZLOOEHDQDO\]HGORFDOO\DQGVKRXOGEHGRFXPHQWHGLIDYDLODEOH$OO
VDPSOHVVKRZLQJ05'0RU0ZLOOEHDQDO\]HGIRU&'H[SUHVVLRQ
7KHGHJUHHRIERQHPDUURZLQILOWUDWLRQGHILQHGE\WKHSHUFHQWDJHRIOHXNHPLFEODVWVLQ
ERQHPDUURZZLOOEHHYDOXDWHGE\ORFDOODERUDWRULHVDVSHUF\WRORJLFDODVVHVVPHQW,Q
DGGLWLRQWKHERQHPDUURZVOLGHVZLOOEHSURYLGHGWRWKHGHVLJQDWHGFHQWUDOODERUDWRULHV
IRUF\WRORJLFDODVVHVVPHQW,QFDVHRI0RUUHODSVHWKH%SUHFXUVRUSKHQRW\SHZLOOEH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


FRQILUPHGE\WKHORFDOODERUDWRU\E\LPPXQRSKHQRW\SLQJ$OOVDPSOHVZLOOEHDQDO\]HG
IRU&'H[SUHVVLRQ
6FUHHQLQJERQHPDUURZUHVXOWVVKRXOGUHYHDODUHSUHVHQWDWLYH0RU0E\ORFDO
DVVHVVPHQWDWUDQGRPL]DWLRQLQRUGHUWRVWDUWWUHDWPHQW,QFDVHRIDQRQUHSUHVHQWDWLYH
RUDQDSODVWLFPDUURZWKHDQDO\VLVVKRXOGEHUHSHDWHGDQGWKHVWDUWRIVWXG\WUHDWPHQW
SRVWSRQHGDFFRUGLQJO\
7KHUHVXOWVRIWKHORFDOODERUDWRU\DUHDSSOLFDEOHIRULQFOXVLRQLQWRWKHVWXG\DQGIRUWKH
GHFLVLRQZKHWKHUVWXG\WUHDWPHQWVKRXOGEHVWDUWHGLIWKHUHVXOWVRIWKHFHQWUDOODERUDWRU\
DUHQRW\HWDYDLODEOHDWWKHWLPHWKHVHGHFLVLRQVDUHUHTXLUHG7KURXJKRXWWKHVWXG\LQ
FDVHVZKHUHWKHUHLVDGLVFUHSDQF\EHWZHHQFHQWUDODQGORFDOODEUHVXOWVWKHFHQWUDO
ODERUDWRU\UHVXOWVZLOOEHXVHGIRUDQDO\VLVLQWKHVWXG\
.QRZQF\WRJHQHWLFDQGPROHFXODUDEHUUDWLRQVVKRXOGEHGRFXPHQWHGLQWKH&5)

.H\6DIHW\3DUDPHWHUV
7KHIROORZLQJNH\VDIHW\SDUDPHWHUVZLOOEHDVVHVVHGDWVSHFLILHGWLPHSRLQWVGHVLJQDWHG
LQWKH6FKHGXOHRI$VVHVVPHQWV7DEOH

,QFLGHQFHRILQIHFWLRQVDQGVHYHULW\RILQIHFWLRQVHJKRVSLWDOL]DWLRQVGXULQJIROORZXS
SHULRGWUHDWPHQWZLWK,9DQWLELRWLFV,9,J*&6)HWFWRWUHDWLQIHFWLRQV 

(QJUDIWPHQWGHILQHGE\SODWHOHWDQGQHXWURSKLOUHFRYHU\GHILQHGDV
WUDQVIXVLRQLQGHSHQGHQWSODWHOHWFRXQWJUHDWHUWKDQ[/DQGDQ$1&JUHDWHU
WKDQ[/DIWHUDOOR+6&7DIWHUUDQGRPL]DWLRQ

$FXWHDQGFKURQLF*Y+'DIWHUDOOR+6&7DIWHUUDQGRPL]DWLRQLQRUGHUWRH[FOXGHDQ\
HIIHFWRIEOLQDWXPRPDERQWKHVHLPPXQHPHGLDWHGFRPSOLFDWLRQVRFFXUULQJLQD
SURSRUWLRQRIVXEMHFWVJLYHQDQDOORJUDIW
7KHXQGHUO\LQJDGYHUVHHYHQWVDQGDVVRFLDWHGODEDVVHVVPHQWVVKRXOGEHUHSRUWHGRQ
WKHDSSURSULDWHH&5)XQWLOWKHHQGRIWKHVWXG\LIWKHLQIRUPDWLRQLVDYDLODEOH

'LVHDVH6XUYLYDO6WDWXV
7KHIROORZLQJGLVHDVHDQGVXUYLYDOVWDWXVGDWDZLOOEHFROOHFWHGDWWKHWLPHSRLQWV
VSHFLILHGLQWKH6FKHGXOHRI$VVHVVPHQWV7DEOH

5HODSVH

&RQWLQXRXVFRPSOHWHUHPLVVLRQ&&5

6HFRQGDU\PDOLJQDQF\

'HDWKDQGFDXVHRIGHDWKHJGHDWKLQUHPLVVLRQWUHDWPHQWUHODWHGGHDWK
&ULWHULDDQGGHILQLWLRQVIRUGLVHDVHVWDWXVDVVHVVPHQWDUHGHILQHGLQ$SSHQGL[*

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



/DERUDWRU\$VVHVVPHQWV
9ROXPHVRIEORRGZLWKGUDZQIRUDQDO\VLVZLOOEHPLQLPL]HGDVDSSURSULDWHIRUWKLV
SHGLDWULFSRSXODWLRQ:KHUHSRVVLEOHWKHFHQWUDOODERUDWRU\ZLOOXWLOL]HPLFURYROXPHV
DQGPLFURDVVD\VWRIXUWKHUPLQLPL]HWKHYROXPHRIEORRGEHLQJZLWKGUDZQIRU
DQDO\VLV$GGLWLRQDOGHWDLOVUHJDUGLQJWKHSUHSDUDWLRQRIVDPSOHVWREHVHQWWRWKH
FHQWUDOODERUDWRU\PD\EHIRXQGLQWKHODERUDWRU\PDQXDO
0HDVXUHVWRSUHYHQWDQGRUPLQLPL]HSDLQDQGGLVFRPIRUWVKRXOGEHXVHGIRUDOOEORRG
GUDZVDFFRUGLQJWRWKHVWDQGDUGRIFDUHDWWKHLQGLYLGXDOVLWH
$OOVFUHHQLQJDQGRQVWXG\ODERUDWRU\VDPSOHVZLOOEHFROOHFWHGDQGSURFHVVHGDWWKH
LQYHVWLJDWRUVORFDOODERUDWRU\DQGDQDO\]HGORFDOO\RUFHQWUDOO\&KHPLVWU\FRDJXODWLRQ
WHVWVKHPDWRORJ\XULQDO\VLVLPPXQRJOREXOLQVDQGSUHJQDQF\FRQILUPDWLRQZLOOEH
SHUIRUPHGORFDOO\,WLVUHFRPPHQGHGWKDWFRDJXODWLRQSDUDPHWHUVDUHPRQLWRUHGDW
OHDVWGDLO\GXULQJWKHILUVWGD\VRILQLWLDWLRQRIEOLQDWXPRPDE$QWLEOLQDWXPRPDE
DQWLERG\VDPSOHVDQG3.VDPSOHVZLOOEHHYDOXDWHGFHQWUDOO\%RQHPDUURZVDPSOHV
IRUKHPDWRORJLFDODQG05'DVVHVVPHQWVZLOODOVREHHYDOXDWHGE\WKHFHQWUDOODERUDWRU\
DVGHVFULEHGLQ6HFWLRQ
$PJHQRUWKHFHQWUDOODERUDWRULHVZLOOVXSSO\FRQWDLQHUVIRUVDPSOHFROOHFWLRQ
SUHSDUDWLRQSDFNDJLQJDQGVKLSSLQJ'HWDLOHGLQVWUXFWLRQVIRUVDPSOHFROOHFWLRQ
SURFHVVLQJDQGVKLSSLQJDUHSURYLGHGLQWKHFHQWUDOODERUDWRU\PDQXDODQGRU
$PJHQSURYLGHGWUDLQLQJPDWHULDOV7KHGDWHDQGWLPHRIVDPSOHFROOHFWLRQZLOOEH
UHFRUGHGLQWKHVRXUFHGRFXPHQWVDWWKHVLWH
%ORRGGUDZVVKRXOGQRWEHGRQHYLDWKHFHQWUDOYHQRXVDFFHVV([FHSWLRQ,ID
SHUPDQHQWFHQWUDOOLQHZLWKPRUHWKDQRQHOXPHQLVXVHGEORRGGUDZVFDQEHGRQHYLD
WKHOXPHQWKDWLVQRWXVHGIRUGUXJDGPLQLVWUDWLRQ
7DEOHRXWOLQHVWKHVSHFLILFDQDO\WHVWKDWZLOOEHDVVHVVHGGXULQJWKHVWXG\DWWLPH
SRLQWVRXWOLQHGLQWKH6FKHGXOHRI$VVHVVPHQWV7DEOH$GGLWLRQDODQDO\WHWHVW
UHVXOWVPD\EHUHSRUWHGE\WKHORFDORUFHQWUDOODERUDWRU\LQDFFRUGDQFHZLWKVWDQGDUG
ODERUDWRU\SURFHGXUHVHJFRPSRQHQWVRIDKHPDWRORJ\SDQHO



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


7DEOH/DERUDWRU\$QDO\WH/LVWLQJ
&KHPLVWU\
&RDJXODWLRQ
+HPDWRORJ\
6RGLXP
377
+HPRJORELQ
3RWDVVLXP
,15
+HPDWRFULW
&KORULGH

5HWLFXORF\WHV
7RWDOSURWHLQ
8ULQDO\VLV
3ODWHOHWV
$OEXPLQ
%ORRG
:%&
&DOFLXP
3URWHLQ
5%&
0DJQHVLXP
*OXFRVH
'LIIHUHQWLDO
3KRVSKRUXV

 1HXWURSKLOV
*OXFRVH
2WKHU/DEV
 (RVLQRSKLOV
%81RU8UHD
$QWLEOLQDWXPRPDEDQWLERGLHV
 %DVRSKLOV
6HUXP&UHDWLQLQH
4XDQWLWDWLYHLPPXQHJOREXOLQV
 /HXFHPLF/\PSKREODVWV
8ULFDFLG
 ,J*
 /\PSKRF\WHV
$ONSKRV
 ,J$
 0RQRF\WHV
/'+
 ,J0

$676*27
 ,J(

$/76*37
3KDUPDFRNLQHWLF3.

**7
&6)DQDO\WHVSURWHLQJOXFRVH
:%&DQG
F\WRVSLQF\WRPRUSKRORJ\&'
E\IORZRSWLRQDO

&UHDFWLYHSURWHLQ
+XPDQLPPXQRGHILFLHQF\YLUXV
+,9

$P\ODVH


/LSDVH


%LOLUXELQ
GLUHFWLQGLUHFWDQGWRWDO



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



$QWLERG\7HVWLQJ3URFHGXUHV
$OOVXEMHFWVUHFHLYLQJEOLQDWXPRPDEZLOOKDYHVDPSOHVDQDO\]HGIRUELQGLQJDQGSRVLWLYH
QHXWUDOL]LQJDQWLERGLHV%ORRGVDPSOHVZLOOEHFROOHFWHGDWWLPHSRLQWVDVRXWOLQHGLQ
WKH6FKHGXOHRI$VVHVVPHQWV7DEOHIRUWKHPHDVXUHPHQWRIDQWLEOLQDWXPRPDE
ELQGLQJDQWLERGLHV6DPSOHVWHVWLQJSRVLWLYHIRUELQGLQJDQWLERGLHVZLOODOVREHWHVWHGIRU
QHXWUDOL]LQJDQWLERGLHVDQGPD\EHIXUWKHUFKDUDFWHUL]HGIRUTXDQWLW\WLWHULVRW\SHDIILQLW\
DQGSUHVHQFHRILPPXQHFRPSOH[HV$GGLWLRQDOEORRGVDPSOHVPD\EHREWDLQHGWRUXOH
RXWDQWLEOLQDWXPRPDEDQWLERGLHVGXULQJWKHVWXG\
6LWHVWDIIZLOOEHQRWLILHGRIDQ\SRVLWLYHQHXWUDOL]LQJDQWLERG\UHVXOWVWREOLQDWXPRPDE,I
UHVXOWVDUHQRWSURYLGHGQRQHXWUDOL]LQJDQWLERGLHVWREOLQDWXPRPDEKDYHEHHQ
GHWHFWHG
6XEMHFWVZKRWHVWSRVLWLYHIRUQHXWUDOL]LQJDQWLERGLHVWREOLQDWXPRPDEDWWKHILQDO
VFKHGXOHGVWXG\YLVLWZLOOEHDVNHGWRUHWXUQIRUDGGLWLRQDOIROORZXSWHVWLQJ7KLVWHVWLQJ
LVWRRFFXUDSSUR[LPDWHO\HYHU\PRQWKVVWDUWLQJIURPZKHQWKHVLWHKDVEHHQQRWLILHGRI
WKHSRVLWLYHUHVXOWXQWLOQHXWUDOL]LQJDQWLERGLHVDUHQRORQJHUGHWHFWDEOHRUWKH
VXEMHFWKDVEHHQIROORZHGIRUDSHULRGRIDWOHDVW\HDU	ZHHNVSRVWDGPLQLVWUDWLRQ
RIEOLQDWXPRPDE$OOIROORZXSUHVXOWVERWKSRVLWLYHDQGQHJDWLYHZLOOEHFRPPXQLFDWHG
WRWKHVLWHV0RUHIUHTXHQWWHVWLQJHJHYHU\PRQWKRUWHVWLQJIRUDORQJHUSHULRGRI
WLPHPD\EHUHTXHVWHGLQWKHHYHQWRIVDIHW\UHODWHGFRQFHUQV)ROORZXSWHVWLQJLVQRW
UHTXLUHGZKHUHLWLVHVWDEOLVKHGWKDWWKHVXEMHFWGLGQRWUHFHLYHEOLQDWXPRPDE.
6XEMHFWVZKRWHVWSRVLWLYHIRUELQGLQJQRQQHXWUDOL]LQJDQWLERGLHVDQGKDYHFOLQLFDO
VHTXHODHWKDWDUHFRQVLGHUHGSRWHQWLDOO\UHODWHGWRDQDQWLEOLQDWXPRPDEDQWLERG\
UHVSRQVHPD\DOVREHDVNHGWRUHWXUQIRUDGGLWLRQDOIROORZXSWHVWLQJ

3KDUPDFRNLQHWLF$VVHVVPHQWV
6HUXPVDPSOHVZLOOEHFROOHFWHGWRPHDVXUHEOLQDWXPRPDEVHUXPFRQFHQWUDWLRQLQDOO
VXEMHFWVZKRUHFHLYHEOLQDWXPRPDEGXULQJWKHVWXG\7ZRVDPSOHVZLOOEHFROOHFWHG
RQGD\DWOHDVWKRXUVDIWHUWKHVWDUWRIWKHLQIXVLRQXSWRKRXUVDIWHUVWDUWRI
WKHLQIXVLRQDQGRQGD\DWDQ\WLPHHJZKHQVDPSOLQJIRUEORRGFKHPLVWU\DV
GHVFULEHGLQWKH6FKHGXOHRI$VVHVVPHQWV7DEOH7KHEOLQDWXPRPDE3.VDPSOHV
ZLOOEHPHDVXUHGZLWKDYDOLGDWHGELRDVVD\
%ORRGIRU3.DVVHVVPHQWPXVWEHGUDZQDYRLGLQJFRQWDPLQDWLRQRIWKH3.VDPSOHV
3.VDPSOHVVKRXOGEHGUDZQIURPDVLWHWKDWLVGLVWDOWRWKHVLWHZKHUHWKH
LQYHVWLJDWLRQDOSURGXFWKDVEHHQDGPLQLVWHUHG,IEORRGFDQQRWEHGUDZQIURPDGLVWDO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


VLWHWKHQEORRGPD\EHGUDZQIURPWKHFHQWUDOOLQH,IEORRGLVGUDZQIURPWKHFHQWUDO
OLQHWKHOXPHQPXVWEHVHSDUDWHGIURPWKHOXPHQIRUEOLQDWXPRPDELQIXVLRQDQGLWPXVW
QRWKDYHEHHQXVHGIRUEOLQDWXPRPDELQIXVLRQ,QDGGLWLRQEOLQDWXPRPDELQIXVLRQPXVW
EHSDXVHGGXULQJWKHEORRGGUDZ

6DPSOH6WRUDJHDQG'HVWUXFWLRQ
$Q\EORRGVDPSOHHJ3.FROOHFWHGDFFRUGLQJWRWKH6FKHGXOHRI$VVHVVPHQWV
7DEOHFDQEHDQDO\]HGIRUDQ\RIWKHWHVWVRXWOLQHGLQWKHSURWRFRODQGIRUDQ\WHVWV
QHFHVVDU\WRPLQLPL]HULVNVWRVWXG\VXEMHFWV7KLVLQFOXGHVWHVWLQJWRHQVXUHDQDO\WLFDO
PHWKRGVSURGXFHUHOLDEOHDQGYDOLGGDWDWKURXJKRXWWKHFRXUVHRIWKHVWXG\7KLVFDQ
DOVRLQFOXGHEXWLVQRWOLPLWHGWRLQYHVWLJDWLRQRIXQH[SHFWHGUHVXOWVLQFXUUHGVDPSOH
UHDQDO\VLVDQGDQDO\VHVIRUPHWKRGWUDQVIHUDQGFRPSDUDELOLW\
$OOVDPSOHVDQGDVVRFLDWHGUHVXOWVZLOOEHFRGHGSULRUWREHLQJVKLSSHGIURPWKHVLWHIRU
DQDO\VLVRUVWRUDJH6DPSOHVZLOOEHWUDFNHGXVLQJDXQLTXHLGHQWLILHUWKDWLVDVVLJQHGWR
WKHVDPSOHVIRUWKHVWXG\5HVXOWVDUHVWRUHGLQDVHFXUHGDWDEDVHWRHQVXUH
FRQILGHQWLDOLW\
,ILQIRUPHGFRQVHQWLVSURYLGHGE\WKHVXEMHFW$PJHQFDQGRDGGLWLRQDOWHVWLQJRQ
UHPDLQLQJVDPSOHVLHUHVLGXDODQGEDFNXSWRLQYHVWLJDWHDQGEHWWHUXQGHUVWDQGWKH
GLVHDVHXQGHUVWXG\$//WKHGRVHUHVSRQVHDQGRUSUHGLFWLRQRIUHVSRQVHWR
EOLQDWXPRPDEFKDUDFWHUL]HDQWLERG\UHVSRQVHDQGFKDUDFWHUL]HDVSHFWVRIWKH
PROHFXOHHJPHFKDQLVPRIDFWLRQWDUJHWPHWDEROLWHV5HVXOWVIURPWKLVDQDO\VLVDUH
WREHGRFXPHQWHGDQGPDLQWDLQHGEXWDUHQRWQHFHVVDULO\UHSRUWHGDVSDUWRIWKLVVWXG\
6DPSOHVFDQEHUHWDLQHGIRUXSWR\HDUV
6LQFHWKHHYDOXDWLRQVDUHQRWH[SHFWHGWREHQHILWWKHVXEMHFWGLUHFWO\RUWRDOWHUWKH
WUHDWPHQWFRXUVHWKHUHVXOWVRIDQ\H[SORUDWRU\VWXGLHVDUHQRWSODFHGLQWKHVXEMHFW¶V
PHGLFDOUHFRUGDQGDUHQRWWREHPDGHDYDLODEOHWRWKHVXEMHFWPHPEHUVRIWKHIDPLO\
WKHSHUVRQDOSK\VLFLDQRURWKHUWKLUGSDUWLHVH[FHSWDVVSHFLILHGLQWKHLQIRUPHG
FRQVHQW
7KHVXEMHFWUHWDLQVWKHULJKWWRUHTXHVWWKDWWKHVDPSOHPDWHULDOEHGHVWUR\HGE\
FRQWDFWLQJWKHLQYHVWLJDWRU)ROORZLQJWKHUHTXHVWIURPWKHVXEMHFWWKHLQYHVWLJDWRULVWR
SURYLGHWKHVSRQVRUZLWKWKHUHTXLUHGVWXG\DQGVXEMHFWQXPEHUVRWKDWDQ\UHPDLQLQJ
EORRG VDPSOHVDQGDQ\RWKHUFRPSRQHQWVIURPWKHFHOOVFDQEHORFDWHGDQGGHVWUR\HG
6DPSOHVZLOOEHGHVWUR\HGRQFHDOOSURWRFROGHILQHGSURFHGXUHVDUHFRPSOHWHG

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


+RZHYHULQIRUPDWLRQFROOHFWHGIURPVDPSOHVSULRUWRWKHUHTXHVWIRUGHVWUXFWLRQZLOOEH
UHWDLQHGE\$PJHQ
7KHVSRQVRULVWKHH[FOXVLYHRZQHURIDQ\GDWDGLVFRYHULHVRUGHULYDWLYHPDWHULDOVIURP
WKHVDPSOHPDWHULDOVDQGLVUHVSRQVLEOHIRUWKHGHVWUXFWLRQRIWKHVDPSOHVDWWKH
UHTXHVWRIWKHVXEMHFWWKURXJKWKHLQYHVWLJDWRUDWWKHHQGRIWKHVWRUDJHSHULRGRUDV
DSSURSULDWHHJWKHVFLHQWLILFUDWLRQDOHIRUH[SHULPHQWDWLRQZLWKDFHUWDLQVDPSOHW\SHQR
ORQJHUMXVWLILHVNHHSLQJWKHVDPSOH,IDFRPPHUFLDOSURGXFWLVGHYHORSHGIURPWKLV
UHVHDUFKSURMHFWWKHVSRQVRURZQVWKHFRPPHUFLDOSURGXFW7KHVXEMHFWKDVQR
FRPPHUFLDOULJKWVWRVXFKSURGXFWDQGKDVQRFRPPHUFLDOULJKWVWRWKHGDWDLQIRUPDWLRQ
GLVFRYHULHVRUGHULYDWLYHPDWHULDOVJDLQHGRUSURGXFHGIURPWKHVDPSOH6HH
6HFWLRQIRUVXEMHFWFRQILGHQWLDOLW\

:,7+'5$:$/)52075($70(17352&('85(6$1'678'<

6XEMHFWV¶'HFLVLRQWR:LWKGUDZ
6XEMHFWVKDYHWKHULJKWWRZLWKGUDZIURPWKHVWXG\DWDQ\WLPHDQGIRUDQ\UHDVRQ
ZLWKRXWSUHMXGLFHWRWKHLUIXWXUHPHGLFDOFDUHE\WKHSK\VLFLDQRUDWWKHLQVWLWXWLRQ
6XEMHFWVRUDOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHFDQGHFOLQHWRFRQWLQXHUHFHLYLQJ
LQYHVWLJDWLRQDOSURGXFWDQGRURWKHUSURWRFROUHTXLUHGWKHUDSLHVRUSURFHGXUHVDWDQ\
WLPHGXULQJWKHVWXG\EXWFRQWLQXHSDUWLFLSDWLRQLQWKHVWXG\,IWKLVRFFXUVWKH
LQYHVWLJDWRULVWRGLVFXVVZLWKWKHVXEMHFWWKHDSSURSULDWHSURFHVVHVIRUGLVFRQWLQXDWLRQ
IURPLQYHVWLJDWLRQDOSURGXFWRURWKHUSURWRFROUHTXLUHGWKHUDSLHVDQGPXVWGLVFXVVZLWK
WKHVXEMHFWWKHRSWLRQVIRUFRQWLQXDWLRQRIWKH6FKHGXOHRI$VVHVVPHQWV7DEOHDQG
FROOHFWLRQRIGDWDLQFOXGLQJHQGSRLQWVDQGDGYHUVHHYHQWV7KHLQYHVWLJDWRUPXVW
GRFXPHQWWKHFKDQJHWRWKH6FKHGXOHRI$VVHVVPHQWV7DEOHDQGWKHOHYHORI
IROORZXSWKDWLVDJUHHGWRE\WKHVXEMHFWHJLQSHUVRQE\WHOHSKRQHPDLOWKURXJK
IDPLO\IULHQGVLQFRUUHVSRQGHQFHFRPPXQLFDWLRQZLWKRWKHUSK\VLFLDQVIURPUHYLHZRI
WKHPHGLFDOUHFRUGV
:LWKGUDZDORIFRQVHQWIRUDVWXG\PHDQVWKDWWKHVXEMHFWGRHVQRWZLVKWRUHFHLYH
IXUWKHUSURWRFROUHTXLUHGWKHUDSLHVRUSURFHGXUHVDQGWKHVXEMHFWGRHVQRWZLVKWRRULV
XQDEOHWRFRQWLQXHIXUWKHUVWXG\SDUWLFLSDWLRQ6XEMHFWGDWDXSWRZLWKGUDZDORIFRQVHQW
ZLOOEHLQFOXGHGLQWKHDQDO\VLVRIWKHVWXG\DQGZKHUHSHUPLWWHGSXEOLFDOO\DYDLODEOH
GDWDFDQEHLQFOXGHGDIWHUZLWKGUDZDORIFRQVHQW7KHLQYHVWLJDWRULVWRGLVFXVVZLWKWKH
VXEMHFWDSSURSULDWHSURFHGXUHVIRUZLWKGUDZDOIURPWKHVWXG\

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



,QYHVWLJDWRURU6SRQVRU'HFLVLRQWR:LWKGUDZRU7HUPLQDWH
6XEMHFWV¶3DUWLFLSDWLRQ3ULRUWR6WXG\&RPSOHWLRQ
7KHLQYHVWLJDWRUDQGRUVSRQVRUFDQGHFLGHWRZLWKGUDZDVXEMHFWVIURPLQYHVWLJDWLRQDO
SURGXFWDQGRURWKHUSURWRFROUHTXLUHGWKHUDSLHVSURWRFROSURFHGXUHVRUWKHVWXG\DVD
ZKROHDWDQ\WLPHSULRUWRVWXG\FRPSOHWLRQ
6XEMHFWVPD\EHHOLJLEOHIRUFRQWLQXHGWUHDWPHQWZLWK$PJHQLQYHVWLJDWLRQDOSURGXFWV
DQGRURWKHUSURWRFROUHTXLUHGWKHUDSLHVE\DVHSDUDWHSURWRFRORUDVSURYLGHGIRUE\WKH
ORFDOFRXQWU\¶VUHJXODWRU\PHFKDQLVPEDVHGRQSDUDPHWHUVFRQVLVWHQWZLWK6HFWLRQ

5HDVRQVIRU5HPRYDO)URP7UHDWPHQW 
5HDVRQVIRUUHPRYDOIURPSURWRFROVSHFLILHGLQYHVWLJDWLRQDOSURGXFWVRUSURFHGXUDO
DVVHVVPHQWVLQFOXGHDQ\RIWKHIROORZLQJ

3URWRFROVSHFLILHGFULWHULD
 $OOFULWHULDGHILQHGLQ6HFWLRQDQG6HFWLRQ
 $Q\UHODSVHGXULQJWUHDWPHQWRUUHIUDFWRU\0DWWKHHQGRIWUHDWPHQW
 0ERQHPDUURZDWGD\LQVXEMHFWVWUHDWHGZLWKEOLQDWXPRPDE
 ,QYHVWLJDWRUGHFLVLRQWKDWDFKDQJHHJVWRSRIWKHUDS\LVLQWKHVXEMHFW¶VEHVW
LQWHUHVW

6XEMHFWUHTXHVW

6DIHW\FRQFHUQHJGXHWRDQDGYHUVHHYHQWSURWRFROGHYLDWLRQQRQFRPSOLDQFH
UHTXLUHPHQWIRUDOWHUQDWLYHWKHUDS\SUHJQDQF\

'HDWK

/RVWWRIROORZXS

'HFLVLRQE\VSRQVRURWKHUWKDQVXEMHFWUHTXHVWVDIHW\FRQFHUQORVWWRIROORZXS

5HDVRQVIRU5HPRYDO)URP6WXG\
5HDVRQVIRUUHPRYDORIDVXEMHFWIURPWKHVWXG\DUH

'HFLVLRQE\VSRQVRU

:LWKGUDZDORIFRQVHQWIURPVWXG\

'HDWK

/RVWWRIROORZXS
$VSDUWRIWKHVWXG\VLWHVPD\EHDVNHGWRFRQGXFWVHDUFKHVRISXEOLFUHFRUGVVXFKDV
WKRVHHVWDEOLVKLQJVXUYLYDOVWDWXVLIDYDLODEOHWRREWDLQVXUYLYDOGDWDIRUDQ\VXEMHFWIRU
ZKRPWKHVXUYLYDOVWDWXVLVQRWNQRZQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



6$)(7<'$7$&2//(&7,215(&25',1*$1'5(3257,1*

$GYHUVH(YHQWV

'HILQLWLRQRI$GYHUVH(YHQWV
$QDGYHUVHHYHQWLVGHILQHGDVDQ\XQWRZDUGPHGLFDORFFXUUHQFHLQDFOLQLFDOWULDO
VXEMHFW7KHHYHQWGRHVQRWQHFHVVDULO\KDYHDFDXVDOUHODWLRQVKLSZLWKVWXG\WUHDWPHQW
$QDGYHUVHHYHQWFDQWKHUHIRUHEHDQ\XQIDYRUDEOHDQGXQLQWHQGHGVLJQLQFOXGLQJDQ
DEQRUPDOODERUDWRU\ILQGLQJV\PSWRPRUGLVHDVHQHZRUH[DFHUEDWHGWHPSRUDOO\
DVVRFLDWHGZLWKWKHXVHRIDWUHDWPHQWFRPELQDWLRQSURGXFWPHGLFDOGHYLFHRU
SURFHGXUH
7UHDWPHQWHPHUJHQWDGYHUVHHYHQWVZLOOEHGHILQHGLQWKH6$3

(YHQWV0HHWLQJWKH$GYHUVH(YHQW'HILQLWLRQ

$Q\DEQRUPDOODERUDWRU\WHVWUHVXOWVKHPDWRORJ\FOLQLFDOFKHPLVWU\RU
XULQDO\VLVRURWKHUVDIHW\DVVHVVPHQWVHJHOHFWURFDUGLRJUDPUDGLRORJLFDO
VFDQVYLWDOVLJQVPHDVXUHPHQWVLQFOXGLQJWKRVHWKDWZRUVHQIURPEDVHOLQH
WKDWDUHFRQVLGHUHGFOLQLFDOO\VLJQLILFDQWLQWKHPHGLFDODQGVFLHQWLILFMXGJHPHQW
RIWKHLQYHVWLJDWRULHQRWUHODWHGWRGLVHDVHSURJUHVVLRQRIXQGHUO\LQJGLVHDVH

([DFHUEDWLRQRIDFKURQLFRULQWHUPLWWHQWSUHH[LVWLQJFRQGLWLRQLQFOXGLQJHLWKHU
DQLQFUHDVHLQIUHTXHQF\DQGRULQWHQVLW\RIWKHFRQGLWLRQ

1HZFRQGLWLRQVGHWHFWHGRUGLDJQRVHGDIWHUVWXG\WUHDWPHQWDGPLQLVWUDWLRQHYHQ
WKRXJKLWPD\KDYHEHHQSUHVHQWEHIRUHWKHVWDUWRIWKHVWXG\

6LJQVV\PSWRPVRUWKHFOLQLFDOVHTXHODHRIDVXVSHFWHGRYHUGRVHRIHLWKHU
VWXG\WUHDWPHQWRUFRQFRPLWDQWPHGLFDWLRQ)RUWKH+&FKHPRWKHUDS\RU
FRQFRPLWDQWPHGLFDWLRQVRYHUGRVHSHUVHZLOOQRWEHUHSRUWHGDVDQDGYHUVH
HYHQWVHULRXVDGYHUVHHYHQWXQOHVVLWLVDQLQWHQWLRQDORYHUGRVHWDNHQZLWK
SRVVLEOHVXLFLGDOVHOIKDUPLQJLQWHQW6XFKRYHUGRVHVDUHWREHUHSRUWHG
UHJDUGOHVVRIVHTXHODH
)RUVLWXDWLRQVZKHQDQDGYHUVHHYHQWRUVHULRXVDGYHUVHHYHQWLVGXHWR$//UHSRUWDOO
NQRZQVLJQVDQGV\PSWRPV'HDWKGXHWRGLVHDVHSURJUHVVLRQLQWKHDEVHQFHRIVLJQV
DQGV\PSWRPVVKRXOGEHUHSRUWHGDVWKHSULPDU\WXPRUW\SHHJ55%SUHFXUVRU$//
1RWH7KHWHUP³GLVHDVHSURJUHVVLRQ´VKRXOGQRWEHXVHGWRGHVFULEHWKHDGYHUVHHYHQW
³/DFNRIHIILFDF\´RU³IDLOXUHRIH[SHFWHGSKDUPDFRORJLFDODFWLRQ´SHUVHZLOOQRWEH
UHSRUWHGDVDQDGYHUVHHYHQWRUVHULRXVDGYHUVHHYHQW6XFKLQVWDQFHVZLOOEHFDSWXUHG
LQWKHHIILFDF\DVVHVVPHQWV+RZHYHUWKHVLJQVV\PSWRPVDQGRUFOLQLFDOVHTXHODH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


IURPODFNRIHIILFDF\ZLOOEHUHSRUWHGDVDGYHUVHHYHQWRUVHULRXVDGYHUVHHYHQWLIWKH\
IXOILOOWKHGHILQLWLRQRIDQDGYHUVHHYHQWRUVHULRXVDGYHUVHHYHQW

(YHQWV1270HHWLQJWKH$GYHUVH(YHQW'HILQLWLRQ

0HGLFDORUVXUJLFDOSURFHGXUHHJHQGRVFRS\DSSHQGHFWRP\WKHFRQGLWLRQ
WKDWOHDGVWRWKHSURFHGXUHLVWKHDGYHUVHHYHQW

6LWXDWLRQVLQZKLFKDQXQWRZDUGPHGLFDORFFXUUHQFHGLGQRWRFFXUVRFLDODQGRU
FRQYHQLHQFHDGPLVVLRQWRDKRVSLWDO

$QWLFLSDWHGGD\WRGD\IOXFWXDWLRQVRISUHH[LVWLQJGLVHDVHVRUFRQGLWLRQV
SUHVHQWRUGHWHFWHGDWWKHVWDUWRIWKHVWXG\WKDWGRQRWZRUVHQ
,IWKHVHYHULW\RIDQDGYHUVHHYHQWFKDQJHVIURPWKHGDWHRIRQVHWWRWKHGDWHRI
UHVROXWLRQUHFRUGDVDVLQJOHHYHQWZLWKWKHZRUVWVHYHULW\RQWKH$GYHUVH(YHQW
6XPPDU\&5)
7KHLQYHVWLJDWRU¶VFOLQLFDOMXGJPHQWLVXVHGWRGHWHUPLQHZKHWKHUDVXEMHFWLVWREH
UHPRYHGIURPWUHDWPHQWGXHWRDQDGYHUVHHYHQW,QWKHHYHQWDVXEMHFWRUVXEMHFW¶V
OHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHUHTXHVWVWRZLWKGUDZIURPSURWRFROUHTXLUHGWKHUDSLHV
RUWKHVWXG\GXHWRDQDGYHUVHHYHQWUHIHUWR6HFWLRQIRUDGGLWLRQDOLQVWUXFWLRQVRQWKH
SURFHGXUHVUHFRPPHQGHGIRUVDIHZLWKGUDZDOIURPSURWRFROUHTXLUHGWKHUDSLHVRUWKH
VWXG\

'HILQLWLRQRI6HULRXV$GYHUVH(YHQWV
$VHULRXVDGYHUVHHYHQWLVGHILQHGDVDQXQWRZDUGPHGLFDORFFXUUHQFHWKDWPHHWVDW
OHDVWRIWKHIROORZLQJVHULRXVFULWHULD

5HVXOWVLQGHDWKIDWDO

/LIHWKUHDWHQLQJSODFHVWKHVXEMHFWDWLPPHGLDWHULVNRIGHDWK

7KHWHUP³OLIHWKUHDWHQLQJ´LQWKHGHILQLWLRQRI³VHULRXV´UHIHUVWRDQHYHQWLQZKLFK
WKHVXEMHFWZDVDWULVNRIGHDWKDWWKHWLPHRIWKHHYHQW,WGRHVQRWUHIHUWRDQ
HYHQWZKLFKK\SRWKHWLFDOO\PLJKWKDYHFDXVHGGHDWKLILWZHUHPRUHVHYHUH

5HTXLUHVLQSDWLHQWKRVSLWDOL]DWLRQRUSURORQJDWLRQRIH[LVWLQJKRVSLWDOL]DWLRQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



,QJHQHUDOKRVSLWDOL]DWLRQVLJQLILHVWKDWWKHVXEMHFWZDVGHWDLQHGXVXDOO\
LQYROYLQJDWOHDVWDQRYHUQLJKWVWD\DWWKHKRVSLWDORUHPHUJHQF\ZDUGIRU
REVHUYDWLRQDQGRUWUHDWPHQWWKDWZRXOGQRWKDYHEHHQDSSURSULDWHLQWKH
SK\VLFLDQ¶VRIILFHRURXWSDWLHQWVHWWLQJ&RPSOLFDWLRQVWKDWRFFXUGXULQJWKH
KRVSLWDOL]DWLRQDUHDQDGYHUVHHYHQW,IDFRPSOLFDWLRQSURORQJVKRVSLWDOL]DWLRQRU
IXOILOOVDQ\RWKHUVHULRXVFULWHULDWKHHYHQWLVVHULRXV:KHQLQGRXEWDVZKHWKHU
³KRVSLWDOL]DWLRQ´RFFXUUHGRUZDVQHFHVVDU\WKHDGYHUVHHYHQWLVWREH
FRQVLGHUHGVHULRXV+RVSLWDOL]DWLRQVIRUHOHFWLYHWUHDWPHQWRUSUHH[LVWLQJ
FRQGLWLRQWKDWGLGQRWZRUVHQIURPEDVHOLQHLVQRWFRQVLGHUHGDQDGYHUVHHYHQW

5HVXOWVLQSHUVLVWHQWRUVLJQLILFDQWGLVDELOLW\LQFDSDFLW\

7KHWHUPGLVDELOLW\PHDQVDVXEVWDQWLDOGLVUXSWLRQRIDSHUVRQ¶VDELOLW\WRFRQGXFW
QRUPDOOLIHIXQFWLRQV7KLVGHILQLWLRQLVQRWLQWHQGHGWRLQFOXGHH[SHULHQFHVRI
UHODWLYHO\PLQRUPHGLFDOVLJQLILFDQFHVXFKDVXQFRPSOLFDWHGKHDGDFKHQDXVHD
YRPLWLQJGLDUUKHDLQIOXHQ]DDQGDFFLGHQWDOWUDXPDHJVSUDLQHGDQNOHZKLFK
PD\LQWHUIHUHZLWKRUSUHYHQWHYHU\GD\IXQFWLRQVEXWGRQRWFRQVWLWXWHD
VXEVWDQWLDOGLVUXSWLRQ

&RQJHQLWDODQRPDO\ELUWKGHIHFW 

2WKHUPHGLFDOO\LPSRUWDQWVHULRXVHYHQW 

0HGLFDORUVFLHQWLILFMXGJPHQWLVWREHH[HUFLVHGLQGHFLGLQJZKHWKHUVHULRXV
DGYHUVHHYHQWUHSRUWLQJLVDSSURSULDWHLQRWKHUVLWXDWLRQVVXFKDVLPSRUWDQW
PHGLFDOHYHQWVWKDWPD\QRWEHLPPHGLDWHO\OLIHWKUHDWHQLQJRUUHVXOWLQGHDWKRU
KRVSLWDOL]DWLRQEXWPD\MHRSDUGL]HWKHVXEMHFWRUPD\UHTXLUHPHGLFDORUVXUJLFDO
LQWHUYHQWLRQWRSUHYHQWRIWKHRWKHURXWFRPHVOLVWHGLQWKHDERYHGHILQLWLRQ
7KHVHHYHQWVDUHW\SLFDOO\WREHFRQVLGHUHGVHULRXV
([DPSOHVRIVXFKHYHQWVLQFOXGHLQYDVLYHRUPDOLJQDQWFDQFHUVLQWHQVLYH
WUHDWPHQWLQDQHPHUJHQF\URRPRUDWKRPHIRUDOOHUJLFEURQFKRVSDVPEORRG
G\VFUDVLDVRUFRQYXOVLRQVWKDWGRQRWUHVXOWLQKRVSLWDOL]DWLRQRUGHYHORSPHQWRI
GUXJGHSHQGHQF\RUGUXJDEXVH2YHUGRVHEOLQDWXPRPDEGRVHZLOOEH
FODVVLILHGDVVXFK2WKHUH[DPSOHVRIVXFKHYHQWVFRXOGLQFOXGHDOOHUJLF
EURQFKRVSDVPFRQYXOVLRQVEORRGG\VFUDVLDV
GUXJLQGXFHGOLYHULQMXU\',/,RUHYHQWVWKDWQHFHVVLWDWHDQHPHUJHQF\URRP
YLVLWRXWSDWLHQWVXUJHU\RUXUJHQWLQWHUYHQWLRQ

5HSRUWLQJRI$GYHUVH(YHQWV
:KHQDQDGYHUVHHYHQWRUVHULRXVDGYHUVHHYHQWRFFXUVLWLVWKHUHVSRQVLELOLW\RIWKH
LQYHVWLJDWRUWRUHYLHZDOOGRFXPHQWDWLRQHJKRVSLWDOSURJUHVVQRWHVODERUDWRU\DQG
GLDJQRVWLFVUHSRUWVUHODWHGWRWKHHYHQW
7KHLQYHVWLJDWRUZLOOWKHQUHFRUGDOOUHOHYDQWDGYHUVHHYHQWVHULRXVDGYHUVHHYHQW
LQIRUPDWLRQLQWKH(YHQWVH&5)
7KHLQYHVWLJDWRUPXVWDVVLJQWKHIROORZLQJDGYHUVHHYHQWDWWULEXWHV

$GYHUVHHYHQWGLDJQRVLVRUV\QGURPHVLINQRZQLIQRWNQRZQVLJQVRU
V\PSWRPV

'DWHVRIRQVHWDQGUHVROXWLRQLIUHVROYHG

6HYHULW\DQGRUWR[LFLW\SHUSURWRFRO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



$VVHVVPHQWRIUHODWHGQHVVWRLQYHVWLJDWLRQDOSURGXFWRURWKHUSURWRFROUHTXLUHG
WKHUDSLHVDQGRUVWXG\PDQGDWHGDFWLYLW\DQGRUSURFHGXUHV

$FWLRQWDNHQ
)RUHDFKDGYHUVHHYHQWVHULRXVDGYHUVHHYHQWWKHLQYHVWLJDWRUPXVWGRFXPHQWLQ
WKHPHGLFDOQRWHVWKDWWKH\KDYHUHYLHZHGWKHDGYHUVHHYHQWVHULRXVDGYHUVH
HYHQWDQGKDVSURYLGHGDQDVVHVVPHQWRIFDXVDOLW\)RUVLWHVUHSRUWLQJVHULRXV
DGYHUVHHYHQWVYLDHOHFWURQLFGDWDFDSWXUH('&WKHLQYHVWLJDWRURU
VXELQYHVWLJDWRUPXVWFRQILUPFDXVDOLW\LQ('&ZLWKLQKRXUVRIWKHVHULRXV
DGYHUVHHYHQWEHLQJHQWHUHGRQWKH(YHQWV&5)
7KHUHPD\EHVLWXDWLRQVLQZKLFKDVHULRXVDGYHUVHHYHQWKDVRFFXUUHGDQGWKH
LQYHVWLJDWRUKDVPLQLPDOLQIRUPDWLRQWRLQFOXGHLQWKHLQLWLDOUHSRUW+RZHYHULWLV
YHU\LPSRUWDQWWKDWWKHLQYHVWLJDWRUDOZD\VPDNHDQDVVHVVPHQWRIFDXVDOLW\IRU
HYHU\HYHQWEHIRUHWKHLQLWLDOWUDQVPLVVLRQRIWKHVHULRXVDGYHUVHHYHQWGDWD
7KHLQYHVWLJDWRUPD\FKDQJHKLVKHURSLQLRQRIFDXVDOLW\LQOLJKWRIIROORZXS
LQIRUPDWLRQDQGVHQGDVHULRXVDGYHUVHHYHQWIROORZXSUHSRUWZLWKWKHXSGDWHG
FDXVDOLW\DVVHVVPHQW,QWKLVFDVHIRUVLWHVUHSRUWLQJVHULRXVDGYHUVHHYHQWVYLD
('&WKHLQYHVWLJDWRURUVXELQYHVWLJDWRUPXVWUHFRQILUPFDXVDOLW\LQWKH('&
V\VWHPZLWKLQKRXUVRIWKHVHULRXVDGYHUVHHYHQWEHLQJHQWHUHGRQWKH(YHQWV
&5)
,WLVQRWDFFHSWDEOHIRUWKHLQYHVWLJDWRUWRVHQGSKRWRFRSLHVRIWKHVXEMHFW¶VPHGLFDO
UHFRUGVWRVSRQVRULQOLHXRIFRPSOHWLRQRIWKH(YHQWVH&5)
,IVSHFLILFDOO\UHTXHVWHGWKHLQYHVWLJDWRUPD\QHHGWRSURYLGHDGGLWLRQDOIROORZXS
LQIRUPDWLRQVXFKDVGLVFKDUJHVXPPDULHVPHGLFDOUHFRUGVRUH[WUDFWVIURPWKHPHGLFDO
UHFRUGV,QWKLVFDVHDOOVXEMHFWLGHQWLILHUVZLWKWKHH[FHSWLRQRIWKHVXEMHFWQXPEHUZLOO
EHEOLQGHGRQWKHFRSLHVRIWKHPHGLFDOUHFRUGVEHIRUHVXEPLVVLRQWR$PJHQ
7KHLQYHVWLJDWRUZLOODWWHPSWWRHVWDEOLVKDGLDJQRVLVRIWKHHYHQWEDVHGRQVLJQV
V\PSWRPVDQGRURWKHUFOLQLFDOLQIRUPDWLRQ,QVXFKFDVHVWKHGLDJQRVLVQRWWKH
LQGLYLGXDOVLJQVV\PSWRPVZLOOEHGRFXPHQWHGDVWKHDGYHUVHHYHQWVHULRXVDGYHUVH
HYHQW
7KHLQYHVWLJDWRUZLOOPDNHDQDVVHVVPHQWRIWKHVHYHULW\RIHDFKDGYHUVHHYHQWDQG
VHULRXVDGYHUVHHYHQWUHSRUWHGGXULQJWKHVWXG\7KH&7&$(YJUDGLQJVFDOHXVHG
LQWKLVVWXG\LVGHVFULEHGLQ$SSHQGL[$

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



5HSRUWLQJ3URFHGXUHVIRU$GYHUVH(YHQWV7KDWGRQRW0HHW6HULRXV
&ULWHULD
7KHLQYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJWKDWDOODGYHUVHHYHQWVREVHUYHGE\WKH
LQYHVWLJDWRURUUHSRUWHGE\WKHVXEMHFWWKDWRFFXUDIWHUHQUROOPHQWWKURXJKGD\VDIWHU
WKHODVWGRVHRIVWXG\WUHDWPHQWLQFDVHVZKHUHWKHVXEMHFWZLOOQRWUHFHLYH+6&7RU
GD\VDIWHUDOOR+6&7UHJDUGOHVVRIFDXVDOLW\DUHUHSRUWHGXVLQJWKH(YHQWVH&5)
HJ$GYHUVH(YHQW6XPPDU\$GYHUVHHYHQWVDVVRFLDWHGZLWK.63GHILQHGLQ
6HFWLRQVKRXOGEHUHSRUWHGIRUWKHGXUDWLRQRIWKHVWXG\ZLWKWKHH[FHSWLRQWKDW
WKRVHUHODWHGWRRWKHUDQWLFDQFHUWKHUDSLHVRFFXUULQJSRVWEOLQDWXPRPDEWUHDWPHQWPD\
EHH[FOXGHG
7KHLQYHVWLJDWRUPXVWDVVHVVZKHWKHUWKHDGYHUVHHYHQWLVSRVVLEO\UHODWHGWRWKH
LQYHVWLJDWLRQDOSURGXFW7KLVUHODWLRQVKLSLVLQGLFDWHGE\D³\HV´RU³QR´UHVSRQVHWRWKH
TXHVWLRQ,VWKHUHDUHDVRQDEOHSRVVLELOLW\WKDWWKHHYHQWPD\KDYHEHHQFDXVHGE\
EOLQDWXPRPDERURWKHUSURWRFROVSHFLILHGWKHUDSLHV"´
7KHLQYHVWLJDWRUPXVWDVVHVVZKHWKHUWKHDGYHUVHHYHQWLVSRVVLEO\UHODWHGWRDQ\
VWXG\PDQGDWHGDFWLYLW\HJDGPLQLVWUDWLRQRILQYHVWLJDWLRQDOSURGXFWSURWRFROUHTXLUHG
WKHUDSLHVGHYLFHVDQGRUSURFHGXUHLQFOXGLQJDQ\VFUHHQLQJSURFHGXUH>V@7KLV
UHODWLRQVKLSLVLQGLFDWHGE\D³\HV´RU³QR´UHVSRQVHWRWKHTXHVWLRQ³,VWKHUHD
UHDVRQDEOHSRVVLELOLW\WKDWWKHHYHQWPD\KDYHEHHQFDXVHGE\DVWXG\DFWLYLW\
HJDGPLQLVWUDWLRQRILQYHVWLJDWLRQDOSURGXFWSURWRFROUHTXLUHGWKHUDSLHVGHYLFH>V@
DQGRUSURFHGXUH"´
7KHLQYHVWLJDWRULVUHVSRQVLEOHIRUUHYLHZLQJODERUDWRU\WHVWUHVXOWVDQGGHWHUPLQLQJ
ZKHWKHUDQDEQRUPDOYDOXHLQDQLQGLYLGXDOVWXG\VXEMHFWUHSUHVHQWVDFOLQLFDOO\
VLJQLILFDQWFKDQJHIURPWKHVXEMHFW¶VEDVHOLQHYDOXHV,QJHQHUDODEQRUPDOODERUDWRU\
ILQGLQJVZLWKRXWFOLQLFDOVLJQLILFDQFHEDVHGRQWKHLQYHVWLJDWRU
VMXGJPHQWDUHQRWWREH
UHFRUGHGDVDGYHUVHHYHQWV+RZHYHUODERUDWRU\YDOXHFKDQJHVWKDWUHTXLUHWUHDWPHQW
RUDGMXVWPHQWLQFXUUHQWWKHUDS\DUHFRQVLGHUHGDGYHUVHHYHQWV:KHUHDSSOLFDEOH
FOLQLFDOVHTXHODHQRWWKHODERUDWRU\DEQRUPDOLW\DUHWREHUHFRUGHGDVWKHDGYHUVH
HYHQW
7KHLQYHVWLJDWRULVH[SHFWHGWRIROORZUHSRUWHGDGYHUVHHYHQWVXQWLOVWDELOL]DWLRQRU
UHYHUVLELOLW\

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



5HSRUWLQJ3URFHGXUHVIRU6HULRXV$GYHUVH(YHQWV
3URWRFROUHTXLUHGUHSRUWLQJSHULRGLQWKLVVWXG\LVGHILQHDVWKHWLPHLQWHUYDODIWHUVLJQLQJ
RILQIRUPHGFRQVHQWDQGDVVHQWWKURXJKGD\VDIWHUWKHODVWGRVHRIVWXG\WUHDWPHQWLQ
FDVHVZKHUHWKHVXEMHFWZLOOQRWUHFHLYH+6&7RUGD\VDIWHUDOOR+6&77KH
LQYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJWKDWDOOVHULRXVDGYHUVHHYHQWVREVHUYHGE\WKH
LQYHVWLJDWRURUUHSRUWHGE\WKHVXEMHFWWKDWRFFXUGXULQJWKHSURWRFROUHTXLUHGUHSRUWLQJ
SHULRGDUHUHSRUWHGXVLQJWKH(YHQWVH&5)
,IWKHLQYHVWLJDWRUEHFRPHVDZDUHRIVHULRXVDGYHUVHHYHQWVVXVSHFWHGWREHUHODWHGWR
LQYHVWLJDWLRQDOSURGXFWRFFXUULQJDIWHUWKHSURWRFROUHTXLUHGUHSRUWLQJSHULRGLVFRPSOHWH
WKHQWKHVHVHULRXVDGYHUVHHYHQWVZLOOEHUHSRUWHGRQWKHHYHQWH&5)V$OOVHULRXV
DGYHUVHHYHQWVZLOOEHFROOHFWHGUHFRUGHGDQGUHSRUWHGWRWKHVSRQVRURUGHVLJQHH
LPPHGLDWHO\DQGQRODWHUWKDQKRXUVRIWKHLQYHVWLJDWRU¶VNQRZOHGJHRIWKHHYHQW
DVLQGLFDWHGLQ6HFWLRQ7KHFULWHULDIRUJUDGHLQWKH&7&$(JUDGLQJVFDOHGLIIHUV
IURPWKHUHJXODWRU\FULWHULDIRUVHULRXVDGYHUVHHYHQWV,WLVOHIWWRLQYHVWLJDWRU¶V
MXGJHPHQWWRUHSRUWWKHVHJUDGHDEQRUPDOLWLHVDVVHULRXVDGYHUVHHYHQWV
$VRYHUDOOVXUYLYDOLVDQHQGSRLQWRIWKHVWXG\WKHLQYHVWLJDWRUVKRXOGDOVRFROOHFWUHSRUW
IDWDOVHULRXVDGYHUVHHYHQWVUHJDUGOHVVRIFDXVDOLW\WR$PJHQLPPHGLDWHO\DQGQR
ODWHUWKDQKRXUVRIDZDUHQHVV
7KHSULPDU\PHFKDQLVPIRUUHSRUWLQJVHULRXVDGYHUVHHYHQWZLOOEHWKH('&V\VWHP
,IWKH('&V\VWHPLVXQDYDLODEOHIRUPRUHWKDQKRXUVWKHQWKHVLWHZLOOUHSRUWWKH
LQIRUPDWLRQWR$PJHQXVLQJDSDSHUEDVHG6HULRXV$GYHUVH(YHQW&RQWLQJHQF\5HSRUW
)RUPDOVRUHIHUUHGWRDVWKHHOHFWURQLF6HULRXV$GYHUVH(YHQW>H6$(@&RQWLQJHQF\
5HSRUW)RUPVHH$SSHQGL[%LPPHGLDWHO\DQGQRODWHUWKDQKRXUVRIWKH
LQYHVWLJDWRU¶VDZDUHQHVVRIWKHHYHQW
7KHVLWHZLOOHQWHUWKHVHULRXVDGYHUVHHYHQWGDWDLQWRWKHHOHFWURQLFV\VWHPDVVRRQDVLW
EHFRPHVDYDLODEOH
$IWHUWKHVWXG\LVFRPSOHWHGDWDJLYHQVLWHWKH('&V\VWHPZLOOEHWDNHQRIIOLQHWR
SUHYHQWWKHHQWU\RIQHZGDWDRUFKDQJHVWRH[LVWLQJGDWD
,IDVLWHUHFHLYHVDUHSRUWRIDQHZVHULRXVDGYHUVHHYHQWIURPDVWXG\VXEMHFWRU
UHFHLYHVXSGDWHGGDWDRQDSUHYLRXVO\UHSRUWHGVHULRXVDGYHUVHHYHQWDIWHUWKH('&
V\VWHPKDVEHHQWDNHQRIIOLQHWKHQWKHVLWHFDQUHSRUWWKLVLQIRUPDWLRQRQWKHSDSHU
EDVHG6HULRXV$GYHUVH(YHQW&RQWLQJHQF\5HSRUW)RUPVHH$SSHQGL[%

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



6HULRXV$GYHUVH(YHQWV$IWHUWKH3URWRFROUHTXLUHG5HSRUWLQJ
3HULRG
,IWKHLQYHVWLJDWRUEHFRPHVDZDUHRIVHULRXVDGYHUVHHYHQWVVXVSHFWHGWREHUHODWHGWR
LQYHVWLJDWLRQDOSURGXFWEOLQDWXPRPDEDIWHUWKHSURWRFROUHTXLUHGUHSRUWLQJSHULRGDV
GHILQHGLQ6HFWLRQLVFRPSOHWHWKHVHVHULRXVDGYHUVHHYHQWVZLOOEHUHSRUWHGWR
$PJHQ7KHLQYHVWLJDWRUZLOOUHSRUWVHULRXVDGYHUVHHYHQWVWR$PJHQLPPHGLDWHO\
DQGQRODWHUWKDQKRXUVIROORZLQJWKHLQYHVWLJDWRU¶VNQRZOHGJHRIWKHHYHQWRQWKH
(YHQWVH&5)
$IWHUWKHHQGRIVWXG\WKHUHLVQRUHTXLUHPHQWWRDFWLYHO\PRQLWRUVWXG\VXEMHFWVDIWHUWKH
VWXG\KDVHQGHGZLWKUHJDUGVWRVWXG\VXEMHFWVWUHDWHGE\WKHLQYHVWLJDWRU +RZHYHU LI
WKHLQYHVWLJDWRUEHFRPHVDZDUHRIVHULRXVDGYHUVHHYHQWVVXVSHFWHGWREHUHODWHGWR
LQYHVWLJDWLRQDOSURGXFWEOLQDWXPRPDEWKHQWKHVHVHULRXVDGYHUVHHYHQWVZLOOEH
UHSRUWHGWR$PJHQLPPHGLDWHO\DQGQRODWHUWKDQKRXUVIROORZLQJWKHLQYHVWLJDWRU¶V
NQRZOHGJHRIWKHHYHQW7KHLQYHVWLJDWRUVKRXOGXVHWKHSDSHUEDVHG6HULRXV
$GYHUVH(YHQW&RQWLQJHQF\5HSRUW)RUPWRUHSRUWWKHHYHQW
$VRYHUDOOVXUYLYDOLVDVWXG\HQGSRLQWWKHVLWHZLOODOVRQHHGWRFROOHFWUHSRUWIDWDO
VHULRXVDGYHUVHHYHQWVUHJDUGOHVVRIFDXVDOLW\WR$PJHQLPPHGLDWHO\DQGQRODWHU
WKDQKRXUVRIDZDUHQHVV
6HULRXVDGYHUVHHYHQWVUHSRUWHGRXWVLGHRIWKHSURWRFROUHTXLUHGUHSRUWLQJSHULRGZLOOEH
FDSWXUHGZLWKLQWKHVDIHW\GDWDEDVHDVFOLQLFDOWULDOFDVHVDQGKDQGOHGDFFRUGLQJO\EDVHG
RQUHODWLRQVKLSWRLQYHVWLJDWLRQDOSURGXFW
,IIXUWKHUVDIHW\UHODWHGGDWDLVQHHGHGWRIXOILOODQ\UHJXODWRU\UHSRUWLQJ
UHTXLUHPHQWVIRUDUHSRUWDEOHHYHQWWKHQDGGLWLRQDOLQIRUPDWLRQPD\QHHGWREH
FROOHFWHGIURPWKHVXEMHFW¶VUHFRUGVDIWHUWKHVXEMHFWHQGVWKHVWXG\

5HSRUWLQJD6DIHW\(QGSRLQWDVD6WXG\(QGSRLQW
6DIHW\HQGSRLQWVRYHUDOOVXUYLYDOWKDWDUHVWXG\HQGSRLQWVDUHUHSRUWHGRQWKH(YHQW
H&5)$OOHQGSRLQWVWKDWDOVRPHHWWKHFULWHULDRIVHULRXVDGYHUVHHYHQWPXVWDOVREH
WUDQVPLWWHGWRVDIHW\LPPHGLDWHO\DQGQRODWHUWKDQKRXUVRIWKHLQYHVWLJDWRU¶V
NQRZOHGJHRIWKHHYHQW6HFWLRQ

0HWKRGRI'HWHFWLQJ$GYHUVH(YHQWVDQG6HULRXV$GYHUVH(YHQWV
&DUHZLOOEHWDNHQQRWWRLQWURGXFHELDVZKHQGHWHFWLQJDGYHUVHHYHQWVDQGRUVHULRXV
DGYHUVHHYHQWV2SHQHQGHGDQGQRQOHDGLQJYHUEDOTXHVWLRQLQJRIWKHVXEMHFWLVWKH
SUHIHUUHGPHWKRGWRLQTXLUHDERXWDGYHUVHHYHQWRFFXUUHQFH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



)ROORZXSRI$GYHUVH(YHQWVDQG6HULRXV$GYHUVH(YHQWV
$IWHUWKHLQLWLDODGYHUVHHYHQWVHULRXVDGYHUVHHYHQWUHSRUWWKHLQYHVWLJDWRULVUHTXLUHGWR
SURDFWLYHO\IROORZHDFKVXEMHFWDWVXEVHTXHQWYLVLWVFRQWDFWV$OODGYHUVHHYHQWVDQG
VHULRXVDGYHUVHHYHQWVZLOOEHIROORZHGXQWLOUHVROXWLRQVWDELOL]DWLRQXQWLOWKHHYHQWLV
RWKHUZLVHH[SODLQHGRUWKHVXEMHFWLVORVWWRIROORZXS)XUWKHULQIRUPDWLRQRQIROORZXS
SURFHGXUHVLVJLYHQLQ6HFWLRQ
$OOQHZLQIRUPDWLRQIRUSUHYLRXVO\UHSRUWHGVHULRXVDGYHUVHHYHQWVPXVWEHVHQWWR
$PJHQLPPHGLDWHO\DQGQRODWHUWKDQKRXUVIROORZLQJNQRZOHGJHRIWKHQHZ
LQIRUPDWLRQ,IVSHFLILFDOO\UHTXHVWHGWKHLQYHVWLJDWRUPD\EHDVNHGWRSURYLGHDGGLWLRQDO
IROORZXSLQIRUPDWLRQVXFKDVGLVFKDUJHVXPPDULHVPHGLFDOUHFRUGVRUH[WUDFWVIURP
WKHPHGLFDOUHFRUGV,QIRUPDWLRQSURYLGHGDERXWWKHVHULRXVDGYHUVHHYHQWPXVWEH
FRQVLVWHQWZLWKWKDWUHFRUGHGRQWKH(YHQWH&5)

5HJXODWRU\5HSRUWLQJ5HTXLUHPHQWVIRU6HULRXV$GYHUVH(YHQWV
,IDVXEMHFWLVSHUPDQHQWO\ZLWKGUDZQIURPSURWRFROUHTXLUHGWKHUDSLHVEHFDXVHRID
VHULRXVDGYHUVHHYHQWWKLVLQIRUPDWLRQPXVWEHVXEPLWWHGWR$PJHQ
3URPSWQRWLILFDWLRQE\WKHLQYHVWLJDWRUWRWKHVSRQVRURIVHULRXVDGYHUVHHYHQWVLV
HVVHQWLDOVRWKDWOHJDOREOLJDWLRQVDQGHWKLFDOUHVSRQVLELOLWLHVWRZDUGVWKHVDIHW\RI
VXEMHFWVDQGWKHVDIHW\RIDVWXG\WUHDWPHQWXQGHUFOLQLFDOLQYHVWLJDWLRQDUHPHW7KH
VSRQVRUKDVDOHJDOUHVSRQVLELOLW\WRQRWLI\ERWKWKHORFDOUHJXODWRU\DXWKRULW\DQGRWKHU
UHJXODWRU\DJHQFLHVDERXWWKHVDIHW\RIDVWXG\WUHDWPHQWXQGHUFOLQLFDOLQYHVWLJDWLRQ
7KHVSRQVRUZLOOFRPSO\ZLWKFRXQWU\VSHFLILFUHJXODWRU\UHTXLUHPHQWVUHODWLQJWRVDIHW\
UHSRUWLQJWRWKHUHJXODWRU\DXWKRULW\,5%,(&VDQGLQYHVWLJDWRUVLQVWLWXWLRQV
,QGLYLGXDOVDIHW\UHSRUWVPXVWEHSUHSDUHGIRUVXVSHFWHGXQH[SHFWHGVHULRXVDGYHUVH
UHDFWLRQVDFFRUGLQJWRORFDOUHJXODWRU\UHTXLUHPHQWVDQGVSRQVRUSROLF\DQGIRUZDUGHG
WRLQYHVWLJDWRUVDVQHFHVVDU\
$QLQYHVWLJDWRUZKRUHFHLYHVDQLQGLYLGXDOVDIHW\UHSRUWGHVFULELQJDVHULRXVDGYHUVH
HYHQWRURWKHUVSHFLILFVDIHW\LQIRUPDWLRQHJVXPPDU\RUOLVWLQJRIVHULRXVDGYHUVH
HYHQWVIURPWKHVSRQVRUZLOOILOHLWDORQJZLWKWKH,QYHVWLJDWRUV%URFKXUHDQGZLOOQRWLI\
WKH,5%,(&LIDSSURSULDWHDFFRUGLQJWRORFDOUHTXLUHPHQWV
$PJHQZLOOSUHSDUHDVLQJOH'HYHORSPHQW6DIHW\8SGDWH5HSRUW'685DOVR
UHIHUUHGWRDV$QQXDO6DIHW\5HSRUW>$65@LQWKH(XURSHDQ8QLRQIRUWKH$PJHQ
,QYHVWLJDWLRQDO3URGXFW,QRUGHUWRHQVXUHWKDWFRQVROLGDWHGVDIHW\LQIRUPDWLRQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


IRUWKHWULDOLVSURYLGHGWKLVVLQJOH'685ZLOODOVRLQFOXGHDSSURSULDWHLQIRUPDWLRQ
RQDQ\RWKHULQYHVWLJDWLRQDOSURGXFWVXVHGLQWKHFOLQLFDOWULDOLIDSSOLFDEOH

6DIHW\0RQLWRULQJ3ODQ
6XEMHFWVDIHW\ZLOOEHURXWLQHO\PRQLWRUHGDVGHILQHGLQ$PJHQ¶VVDIHW\VXUYHLOODQFHDQG
VLJQDOPDQDJHPHQWSURFHVVHV

3UHJQDQF\DQG/DFWDWLRQ5HSRUWLQJ
'HWDLOVRISUHJQDQFLHVDQGRUODFWDWLRQLQIHPDOHVXEMHFWVZLOOEHFROOHFWHGIURPWKHVWDUW
RIVWXG\WUHDWPHQWDQGXQWLOPRQWKVDIWHUWKHODVWGRVHRIFKHPRWKHUDS\'HWDLOVRI
SUHJQDQFLHVLQIHPDOHSDUWQHUVRIPDOHVXEMHFWVZLOOEHFROOHFWHGIURPWKHVWDUWRI
VWXG\WKURXJKPRQWKVDIWHUWKHODVWGRVHRIFKHPRWKHUDS\  
,IDSUHJQDQF\LVUHSRUWHGWKHLQYHVWLJDWRULVWRLQIRUP$PJHQLPPHGLDWHO\DQGQR
ODWHUWKDQKRXUVRIOHDUQLQJRIWKHSUHJQDQF\DQGRUODFWDWLRQ5HSRUWDSUHJQDQF\
RQWKH3UHJQDQF\1RWLILFDWLRQ)RUP$SSHQGL[&
$PJHQ*OREDO3DWLHQW6DIHW\ZLOOIROORZXSZLWKWKHLQYHVWLJDWRUUHJDUGLQJDGGLWLRQDO
LQIRUPDWLRQWKDWPD\EHUHTXHVWHG$EQRUPDOSUHJQDQF\RXWFRPHVHJVSRQWDQHRXV
DERUWLRQIHWDOGHDWKVWLOOELUWKFRQJHQLWDODQRPDOLHVHFWRSLFSUHJQDQF\DUHFRQVLGHUHG
VHULRXVDGYHUVHHYHQWV
$Q\ODFWDWLRQFDVHVKRXOGEHUHSRUWHGWR$PJHQ¶V*OREDO3DWLHQW6DIHW\3URJUDP
LPPHGLDWHO\DQGQRODWHUWKDQKRXUVRIWKHLQYHVWLJDWRU¶VNQRZOHGJHRIWKHHYHQW
5HSRUWDODFWDWLRQFDVHRQWKH/DFWDWLRQ1RWLILFDWLRQ)RUP$SSHQGL[' 

67$7,67,&$/&216,'(5$7,216

6WXG\(QGSRLQWV$QDO\VLV6HWVDQG&RYDULDWHV

6WXG\(QGSRLQWV

3ULPDU\(QGSRLQW

()6()6ZLOOEHFDOFXODWHGIURPWKHWLPHRIUDQGRPL]DWLRQXQWLOWKHGDWHRIUHODSVH
RU0PDUURZDIWHUKDYLQJDFKLHYHGD&5IDLOXUHWRDFKLHYHD&5DWWKHHQGRI
WUHDWPHQWVHFRQGPDOLJQDQF\RUGHDWKGXHWRDQ\FDXVHZKLFKHYHURFFXUVILUVW
6XEMHFWVZKRIDLOWRDFKLHYHD&5IROORZLQJWUHDWPHQWZLWKLQYHVWLJDWLRQDOSURGXFWRU
ZKRGLHGEHIRUHWKHGLVHDVHDVVHVVPHQWDWWKHHQGRIWUHDWPHQWZLOOEHFRQVLGHUHG
WUHDWPHQWIDLOXUHVDQGDVVLJQHGDQ()6GXUDWLRQRIGD\6XEMHFWVVWLOODOLYHDQG
HYHQWIUHHZLOOEHFHQVRUHGRQWKHLUODVWGLVHDVHDVVHVVPHQWGDWH,IWKHODVWGLVHDVH
DVVHVVPHQWGDWHLVDIWHUWKHGDWHWKDWWULJJHUVWKHDQDO\VLVWKHVXEMHFWZLOOEH
FHQVRUHGDWWKHDQDO\VLVWULJJHUGDWH

6HFRQGDU\(QGSRLQWV

2626ZLOOEHFDOFXODWHGIURPWLPHRIUDQGRPL]DWLRQXQWLOGHDWKGXHWRDQ\FDXVH
6XEMHFWVVWLOODOLYHZLOOEHFHQVRUHGDWWKHGDWHODVWNQRZQWREHDOLYH,IWKHGDWHODVW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


NQRZQWREHDOLYHLVDIWHUWKHGDWHWKDWWULJJHUVWKHDQDO\VLVWKHVXEMHFWZLOOEH
FHQVRUHGDWWKHDQDO\VLVWULJJHUGDWH

05'UHVSRQVHGHILQHGDV05'OHYHODWWKHHQGRIWUHDWPHQWZLWK
LQYHVWLJDWLRQDOSURGXFWV

&XPXODWLYHLQFLGHQFHRIUHODSVH

,QFLGHQFHRIDGYHUVHHYHQWVERWKVHULRXVDQGQRQVHULRXVWUHDWPHQWUHODWHG
DGYHUVHHYHQWVDGYHUVHHYHQWVRILQWHUHVWFOLQLFDOO\VLJQLILFDQWFKDQJHVLQODERUDWRU\
YDOXHV

6XUYLYDOVWDWXVDWGD\VIROORZLQJDOOR+6&7

,QFLGHQFHRIDQWLEOLQDWXPRPDEDQWLERG\IRUPDWLRQEOLQDWXPRPDEDUPRQO\

3KDUPDFRNLQHWLFVDPSOLQJIRUEOLQDWXPRPDEFRQFHQWUDWLRQVIRUSRSXODWLRQ3.
DQDO\VLV

%OLQDWXPRPDEVWHDG\VWDWHFRQFHQWUDWLRQV

([SORUDWRU\(QGSRLQW

&'VWDWXVDWUHODSVH

$QDO\VLV6HWV
7KHSULPDU\DQDO\VLVRIHIILFDF\ZLOOEHSHUIRUPHGRQDOOUDQGRPL]HGVXEMHFWVDQDO\]HG
DFFRUGLQJWRWKHLUUDQGRPL]HGWUHDWPHQWDVVLJQPHQWWKH)XOO$QDO\VLV6HW
7KHSULPDU\DQDO\VLVRIVDIHW\ZLOOEHSHUIRUPHGRQWKH6DIHW\$QDO\VLV6HWZKLFKZLOO
LQFOXGHDOOVXEMHFWVZKRUHFHLYHGLQYHVWLJDWLRQDOSURGXFWDQDO\]HGDFFRUGLQJWRWKH
WUHDWPHQWWKH\UHFHLYHG 

&RYDULDWHVDQG6XEJURXSV
7KHDQDO\VLVWRGHWHUPLQHLIEOLQDWXPRPDELVVXSHULRUWRWKHFKHPRWKHUDS\ZLWKUHVSHFW
WRWKHSULPDU\HQGSRLQWRI()6ZLOOEHVWUDWLILHGE\WKHVWUDWLILFDWLRQIDFWRUVDW
UDQGRPL]DWLRQDVGHVFULEHGLQ6HFWLRQ
([SORUDWRU\VXEJURXSDQDO\VHVZLOOEHSHUIRUPHGE\VWUDWLILFDWLRQFDWHJRU\VH[
UDFHHWKQLFLW\DQGRWKHUIDFWRUVGHVFULEHGLQWKH6$3

6DPSOH6L]H&RQVLGHUDWLRQV
7KHWDUJHWLVWRREVHUYH()6HYHQWVLQVXEMHFWVUDQGRPL]HGWKH)XOO$QDO\VLV
6HW7KHIROORZLQJRSHUDWLQJFKDUDFWHULVWLFVDUHEDVHGRQVLPXODWLRQVXVLQJD
VLGHGORJUDQNWHVWZLWKDQRYHUDOOW\SHHUURURIDUDQGRPL]DWLRQUDWLRDQG
H[SRQHQWLDOO\GLVWULEXWHG()6WLPHVIRUQRQFXUHGVXEMHFWVDQGDXQLIRUPHQUROOPHQW
SHULRGRIPRQWKV
,IWKHFRQWURODUP$UP$KDVDWUXHFXUHUDWHRIDQGPHGLDQ()6RIPRQWKV
DPRQJQRQFXUHGVXEMHFWVGDWDRQILOHDQGWKHWUHDWPHQWDUP$UP$KDVDWUXHFXUH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


UDWHRIDQGPHGLDQ()6RIPRQWKVDPRQJQRQFXUHGVXEMHFWVDQRQFXUHG
KD]DUGUDWLRRIWKHQDSSUR[LPDWHO\RIWKHVLPXODWLRQVSURGXFHDVWDWLVWLFDOO\
VLJQLILFDQWUHVXOWSRZHU
8QGHUWKHDVVXPSWLRQRIQRWUHDWPHQWHIIHFWFXUHUDWHDQGPHGLDQ()6RI
PRQWKVIRUDOODUPVWKHSUREDELOLW\GHWHFWLQJDVLJQLILFDQWUHVXOWLQIDYRURI
EOLQDWXPRPDE$UP$LVDSSUR[LPDWHO\ZKLFKLVVLPLODUWRWKHSODQQHGW\SH
HUURURI

3ODQQHG$QDO\VHV

,QWHULP$QDO\VHV
7KHVWXG\KDVLQWHULPDQDO\VHVSODQQHGWRDVVHVVEHQHILWZKHQDSSUR[LPDWHO\
DQGRIWKHWRWDOQXPEHURI()6HYHQWVKDYHEHHQREVHUYHG6WRSSLQJIRU
EHQHILWZLOOEHEDVHGRQWKH2¶%ULHQ)OHPLQJPHPEHURIWKHIDPLO\RI
/DQ'H0HWVDOSKDVSHQGLQJIXQFWLRQVWKHFULWLFDOSYDOXHVFRUUHVSRQGLQJWRWKLV
VSHQGLQJIXQFWLRQDUHIRUWKHLQWHULPDQDO\VLVIRUWKHLQWHULP
DQDO\VLVDQGIRUWKHSULPDU\DQDO\VLVLIWKHLQWHULPDQDO\VHVRFFXUSUHFLVHO\DW
DQGHYHQWV
$SSUR[LPDWHO\WRPRQWKVSULRUWRWKHFRPSOHWLRQRIWKHHQUROOPHQWSHULRGWKH
VSRQVRUPD\DVVHVVWKHHYHQWUDWHDJJUHJDWHGRYHUWUHDWPHQWJURXSVDQGPD\UHYLVH
WKHVDPSOHVL]HLQRUGHUWRHQVXUHWKHVWXG\FRPSOHWHVZLWKWKHVSHFLILHGQXPEHUVRI
HYHQWVZLWKLQDGHVLUHGWLPHIUDPH

'DWD0RQLWRULQJ&RPPLWWHH
$QLQGHSHQGHQW'0&H[WHUQDOWR$PJHQZLOORYHUVHHWKHLQWHULPDQDO\VHVGHVFULEHGLQ
6HFWLRQ,QDGGLWLRQWKH'0&ZLOODVVHVVVDIHW\DSSUR[LPDWHO\HYHU\PRQWKV
SURYLGHGDQDGHTXDWHHQUROOPHQWUDWH7KHWLPLQJRIVDIHW\UHYLHZVPD\EHDGMXVWHGWR
DGHJUHHLQRUGHUWRFRLQFLGHZLWKZKHQWKH'0&PHHWVWRUHYLHZWKHLQWHULP
DQDO\VHV2QWKHEDVLVRIWKHLUUHYLHZVWKH'0&ZLOOPDNHUHFRPPHQGDWLRQVWR$PJHQ
UHJDUGLQJWKHFRQWLQXDWLRQRIWKHVWXG\7KH'0&ZLOOFRQVLVWRIRUPRUHPHPEHUV
LQFOXGLQJRUPRUHFOLQLFLDQVZLWKUHOHYDQWVSHFLDOWLHVDQGRUPRUHVWDWLVWLFLDQV7KH
'0&ZLOOEHVXSSRUWHGE\DQH[WHUQDOLQGHSHQGHQWVWDWLVWLFLDQZKRLVUHVSRQVLEOHIRU
SUHSDULQJUHSRUWVWKDWGHVFULEHWKHRQJRLQJFOLQLFDOVWXG\GDWD'HWDLOVUHJDUGLQJWKH
UHVSRQVLELOLWLHVRIWKH'0&DQGWKHLQGHSHQGHQWVWDWLVWLFLDQZLOOEHGHVFULEHGLQWKH'0&
&KDUWHU

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



3ULPDU\$QDO\VLV
7KHSULPDU\DQDO\VLVZLOOWHVWZKHWKHU()6LVVXSHULRULQWKHEOLQDWXPRPDEDUP
$UP$FRPSDUHGWRWKHFKHPRWKHUDS\DUP$UP$8QOHVVWKHVWXG\LVVWRSSHG
SUHPDWXUHO\WKHSULPDU\DQDO\VLVZLOOEHWULJJHUHGZKHQ()6HYHQWVDUHUHSRUWHGLQ
WKHFOLQLFDOWULDOGDWDEDVH7KHVHFRQGDU\HQGSRLQWVZLOODOVREHVXPPDUL]HGGXULQJWKH
SULPDU\DQDO\VLV

)LQDO$QDO\VLV
7KHILQDODQDO\VLVZLOODVVHVVWKHSRWHQWLDOORQJWHUPHIIHFWRIEOLQDWXPRPDERQVDIHW\
7KHILQDODQDO\VLVZLOOEHWULJJHUHGZKHQWKHODVWVXEMHFWHQUROOHGLQORQJWHUPIROORZXS
LVPRQWKVIROORZLQJDOOR+6&7RUGLHGZKLFKHYHURFFXUVILUVW$WWKHILQDODQDO\VLV
WKH()6DQG26DQDO\VHVZLOODOVREHXSGDWHGZLWKDGGLWLRQDOIROORZXSGDWDWKHVH
DQDO\VHVZLOOEHFRQVLGHUHGGHVFULSWLYH,IWKHODVWVXEMHFWHQUROOHGRQVWXG\GLHVRULV
ORVWWRIROORZXSEHIRUHWKHPRQWKVIROORZLQJDOOR+6&7WKHUHPDLQGHURIWKHVXEMHFWV
RQVWXG\ZLOOFRQWLQXHWREHIROORZHGXQWLODOOVXEMHFWVRQVWXG\KDYHUHDFKHGPRQWKV
IROORZLQJDOOR+6&7XQWLOGHDWKRUORVWWRIROORZXSZKLFKZLOOWULJJHUWKHILQDODQDO\VLV

3ODQQHG0HWKRGVRI$QDO\VLV

*HQHUDO&RQVLGHUDWLRQV
&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGE\WKHQRQPLVVLQJVDPSOHVL]HQPHDQ
VWDQGDUGGHYLDWLRQPHGLDQILUVWDQGWKLUGTXDUWLOHVPLQLPXPDQGPD[LPXP
&DWHJRULFDOYDULDEOHVZLOOEHVXPPDUL]HGE\WKHQDQGSHUFHQWDJHLQHDFKFDWHJRU\
7LPHWRHYHQWHQGSRLQWVZLOOEHVXPPDUL]HGZLWKKD]DUGUDWLRV.DSODQ0HLHU.0
FXUYHV.0SURSRUWLRQVDWVHOHFWWLPHSRLQWV.0TXDUWLOHVZKHQHVWLPDEOHWKHQXPEHU
RIVXEMHFWVZLWKHYHQWVWKHQXPEHURIVXEMHFWVFHQVRUHGDQGWKHSDWWHUQRIFHQVRULQJ
3RLQWHVWLPDWHVIRUHIILFDF\HQGSRLQWVZLOOEHDFFRPSDQLHGE\VLGHGFRQILGHQFH
LQWHUYDOV
7KHVWXG\ZLOOKDYHDQRYHUDOODOSKDRIZLWKVLGHGWHVWLQJDQDOSKDRIDQG
IRUWKHDQGLQWHULPDQDO\VHVUHVSHFWLYHO\DQGIRUWKHSULPDU\
DQDO\VLVZLOOEHXVHGLIWKHHIILFDF\LQWHULPDQDO\VHVRFFXUVDWSUHFLVHO\DQGRI
WKHWRWDO()6HYHQWVXVLQJWKHVSHQGLQJIXQFWLRQGHVFULEHGLQ6HFWLRQ7HVWLQJ
RIVHFRQGDU\HQGSRLQWVZLOOEHFRQVLGHUHGGHVFULSWLYH

3ULPDU\(IILFDF\(QGSRLQW
$VLGHGVWUDWLILHGORJUDQNWHVWVWUDWLILHGE\WKHUDQGRPL]DWLRQIDFWRUVZLOOEHXVHGWR
GHWHUPLQHLI()6LVVXSHULRUZLWKEOLQDWXPRPDEFRPSDUHGWRFKHPRWKHUDS\,QDGGLWLRQ
DKD]DUGUDWLRZLWKDFRQILGHQFHLQWHUYDOZLOOEHHVWLPDWHGIURPDVWUDWLILHG&R[

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


UHJUHVVLRQPRGHO.0VXPPDULHVZLOOEHSHUIRUPHGE\WUHDWPHQWDUPLQFOXGLQJWKH
.0SURSRUWLRQDWPRQWKV7KHSULPDU\DQDO\VLVZLOOEHSHUIRUPHGRQWKH)XOO$QDO\VLV
6HW$VHQVLWLYLW\DQDO\VLVZLOODVVLJQWKHSODQQHGVWXG\GD\UDWKHUWKDQWKHDFWXDOVWXG\
GD\WR()6HYHQWVRWKHUWKDQGHDWKVWRDGGUHVVSRWHQWLDOHYDOXDWLRQWLPHELDVUHVXOWLQJ
IURPWKHGLIIHUHQWWUHDWPHQWOHQJWKVEHWZHHQVWXG\DUPV

6HFRQGDU\(IILFDF\(QGSRLQWV
/LNH()6DKD]DUGUDWLRDQG.0VXPPDULHVZLOODOVRVXPPDUL]H26E\WUHDWPHQWDUP
,QDGGLWLRQDVLGHGVWUDWLILHGORJUDQNWHVWZLOOEHXVHGWRGHVFULEHWKHGLIIHUHQFHLQ
26EHWZHHQWUHDWPHQWDUPV7KHSULPDU\DQDO\VLVZLOOEHSHUIRUPHGRQWKH)XOO
$QDO\VLV6HW
7KHSHUFHQWDJHRIVXEMHFWVLQHDFKWUHDWPHQWDUPZLWKDQ05'UHVSRQVHLH05'
OHYHOZLOOEHVXPPDUL]HGZLWKDQH[DFWELQRPLDOFRQILGHQFHLQWHUYDO,Q
DGGLWLRQDVLGHG&RFKUDQ0DQWHO+DHQV]HOWHVWZKLFKZLOODGMXVWIRUWKHVWUDWLILFDWLRQ
IDFWRUVDWUDQGRPL]DWLRQZLOOGHVFULEHWKHGLIIHUHQFHLQ05'UHVSRQVHEHWZHHQ
WUHDWPHQWDUPV6XEMHFWVPLVVLQJSRVWEDVHOLQHGLVHDVHDVVHVVPHQWVZLOOEH
FRQVLGHUHGQRWWRKDYHDFKLHYHGDUHVSRQVH7KHFXPXODWLYHLQFLGHQFHRIUHODSVHZLOO
EHDQDO\]HGDVSURSRVHGE\)LQHDQG*UD\¶VH[WHQVLRQRIWKH&R[UHJUHVVLRQ
PRGHOZKHUHE\GHDWKVSULRUWRUHODSVHWKDWDUHQRWFRQVLGHUHGUHODWHGWRDQRWKHUZLVH
XQGRFXPHQWHGUHODSVHZLOOEHWUHDWHGDVDFRPSHWLQJULVN7KHSULPDU\DQDO\VLVZLOOEH
SHUIRUPHGRQWKH)XOO$QDO\VLV6HW6HQVLWLYLW\DQDO\VHVZLOOEHSHUIRUPHGRQWKHVXEVHW
RIVXEMHFWVZKRUHFHLYHGLQYHVWLJDWLRQDOSURGXFWWKHVXEVHWRIVXEMHFWVZKRKDGDWOHDVW
RQHSRVWEDVHOLQHGLVHDVHDVVHVVPHQWDQGRQSURVSHFWLYHO\GHILQHGSHUSURWRFRO
DQDO\VLVVHW

3KDUPDFRNLQHWLF(QGSRLQWV
$OOVXEMHFWVZKRUHFHLYHGDQ\LQIXVLRQRIEOLQDWXPRPDEDQGKDGDWOHDVWRQH3.VDPSOH
FROOHFWHGZLOOEHLQFOXGHGLQWKH3.DQDO\VLVGDWDVHW7KHVHVXEMHFWVZLOOEHHYDOXDWHG
IRU3.XQOHVVVLJQLILFDQWSURWRFROGHYLDWLRQVDIIHFWWKHGDWDDQDO\VLVRULINH\GRVLQJ
GRVLQJLQWHUUXSWLRQRUVDPSOLQJLQIRUPDWLRQDUHPLVVLQJ,QGLYLGXDOVWHDG\VWDWHVHUXP
FRQFHQWUDWLRQV&VVZLOOEHVXPPDUL]HGE\GHVFULSWLYHVWDWLVWLFV1RQFRPSDUWPHQW
DQDO\VLVZLOOEHSHUIRUPHGWRHVWLPDWH3.SDUDPHWHUV
%OLQDWXPRPDE3.GDWDFROOHFWHGIURPWKLVVWXG\LQFRQMXQFWLRQZLWK3.GDWDIURPRWKHU
UHOHYDQWVWXGLHVZLOOEHXVHGLQDSRSXODWLRQ3.DQDO\VLV$VHSDUDWHGDWDDQDO\VLVSODQ
DQGDSRSXODWLRQ3.UHSRUWZLOOEHJHQHUDWHG

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



6DIHW\(QGSRLQWV
6DIHW\DQDO\VHVZLOOEHSHUIRUPHGXVLQJVXEMHFWVLQWKH6DIHW\$QDO\VLV6HW6XEMHFW
LQFLGHQFHRIDOOWUHDWPHQWHPHUJHQWDGYHUVHHYHQWVZLOOEHWDEXODWHGE\V\VWHPRUJDQ
FODVVDQGSUHIHUUHGWHUP7DEOHVRIIDWDODGYHUVHHYHQWVVHULRXVDGYHUVHHYHQWV
DGYHUVHHYHQWVOHDGLQJWRZLWKGUDZDOIURPLQYHVWLJDWLRQDOSURGXFWRURWKHU
SURWRFROVSHFLILHGWKHUDSLHVDQGVLJQLILFDQWWUHDWPHQWHPHUJHQWDGYHUVHHYHQWV
LQFOXGLQJDGYHUVHHYHQWVRILQWHUHVWZLOODOVREHSURYLGHG
7KHQXPEHUDQGSHUFHQWDJHRIVXEMHFWVZLWKDQWLERG\IRUPDWLRQWREOLQDWXPRPDEZLOO
DOVREHVXPPDUL]HG
,QDGGLWLRQFKDQJHVLQVHOHFWYLWDOVLJQDQGODERUDWRU\SDUDPHWHUVZLOOEHVXPPDUL]HG
7KHGD\PRUWDOLW\DIWHUDOOR+6&7ZLOOEHVXPPDUL]HGZLWKWKHGD\.0UDWHDQG
WKHDGGLWLRQDO.0VXPPDULHVGHVFULEHGLQ6HFWLRQE\WUHDWPHQWDUP)RUWKLV
HQGSRLQW26ZLOOEHPHDVXUHGVWDUWLQJIURPWKHGDWHRIDOOR+6&77KLVDQDO\VLVZLOOEH
SHUIRUPHGRQWKHVXEVHWRIVXEMHFWVLQWKH6DIHW\$QDO\VLV6HWZKRXQGHUJRDQ
DOOR+6&7

5(*8/$725<2%/,*$7,216

,QIRUPHG&RQVHQW
$QLQLWLDOVDPSOH,&)DQGDVVHQWIRUPDUHSURYLGHGIRUWKHLQYHVWLJDWRURUVSRQVRURQ
EHKDOIRIWKHLQYHVWLJDWRUWRSUHSDUHWKHLQIRUPHGFRQVHQWDQGDVVHQWGRFXPHQWVWREH
XVHGDWKLVRUKHUVLWH8SGDWHVWRWKHWHPSODWHVDUHWREHFRPPXQLFDWHGIRUPDOO\LQ
ZULWLQJIURPWKH$PJHQ&OLQLFDO6WXG\0DQDJHUWRWKHLQYHVWLJDWRU7KHZULWWHQLQIRUPHG
FRQVHQWDQGDVVHQWGRFXPHQWVDUHWREHSUHSDUHGLQWKHODQJXDJHVRIWKHSRWHQWLDO
SDWLHQWSRSXODWLRQ
%HIRUHDVXEMHFW¶VSDUWLFLSDWLRQLQWKHFOLQLFDOVWXG\WKHLQYHVWLJDWRULVUHVSRQVLEOHIRU
REWDLQLQJZULWWHQLQIRUPHGFRQVHQWIURPWKHVXEMHFWRUOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYH
DIWHUDGHTXDWHH[SODQDWLRQRIWKHDLPVPHWKRGVDQWLFLSDWHGEHQHILWVDQGSRWHQWLDO
KD]DUGVRIWKHVWXG\DQGEHIRUHDQ\SURWRFROVSHFLILFVFUHHQLQJSURFHGXUHVRUDQ\
LQYHVWLJDWLRQDOSURGXFWVLVDUHDGPLQLVWHUHG$OHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHLVDQ
LQGLYLGXDORURWKHUERG\DXWKRUL]HGXQGHUDSSOLFDEOHODZWRFRQVHQWRQEHKDOIRID
SURVSHFWLYHVXEMHFWWRWKHVXEMHFW¶VSDUWLFLSDWLRQLQWKHFOLQLFDOVWXG\
,QDGGLWLRQWRLQIRUPHGFRQVHQWIURPWKHSDUHQWVRUOHJDOO\DXWKRUL]HGUHSUHVHQWDWLYH
DVVHQWPXVWEHREWDLQHGIURPDOOSHGLDWULFVXEMHFWVH[FHSWLIWKHFKLOGLVDQLQIDQWD
WRGGOHURUYHU\\RXQJDVGHILQHGE\ORFDOODZ$FKLOGLVGHILQHGDVDSHUVRQZKRKDV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


QRWDWWDLQHGWKHOHJDODJHIRUFRQVHQWIRUWUHDWPHQWVRUSURFHGXUHVLQYROYHGLQFOLQLFDO
LQYHVWLJDWLRQVXQGHUWKHDSSOLFDEOHODZRIWKHMXULVGLFWLRQLQZKLFKWKHFOLQLFDO
LQYHVWLJDWLRQZLOOWDNHSODFH
7KHLQYHVWLJDWRULVDOVRUHVSRQVLEOHIRUDVNLQJWKHVXEMHFWLIWKHVXEMHFWKDVDSULPDU\
FDUHSK\VLFLDQDQGLIWKHVXEMHFWDJUHHVWRKDYHKLVKHUSULPDU\FDUHSK\VLFLDQLQIRUPHG
RIWKHVXEMHFW¶VSDUWLFLSDWLRQLQWKHFOLQLFDOVWXG\,IWKHVXEMHFWDJUHHVWRVXFK
QRWLILFDWLRQWKHLQYHVWLJDWRULVWRLQIRUPWKHVXEMHFW¶VSULPDU\FDUHSK\VLFLDQRIWKH
VXEMHFW¶VSDUWLFLSDWLRQLQWKHFOLQLFDOVWXG\,IWKHVXEMHFWGRHVQRWKDYHDSULPDU\FDUH
SK\VLFLDQDQGWKHLQYHVWLJDWRUZLOOEHDFWLQJLQWKDWFDSDFLW\WKHLQYHVWLJDWRULVWR
GRFXPHQWVXFKLQWKHVXEMHFW¶VPHGLFDOUHFRUG
7KHDFTXLVLWLRQRILQIRUPHGFRQVHQWDQGDVVHQWDQGWKHVXEMHFW¶VDJUHHPHQWRUUHIXVDO
RIKLVKHUQRWLILFDWLRQRIWKHSULPDU\FDUHSK\VLFLDQLVWREHGRFXPHQWHGLQWKHVXEMHFW¶V
PHGLFDOUHFRUGVDQGWKH,&)DQGDVVHQWIRUPDUHWR EHVLJQHGDQGSHUVRQDOO\GDWHGE\
WKHVXEMHFWRUDOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHDQGE\WKHSHUVRQZKRFRQGXFWHGWKH
LQIRUPHGFRQVHQWGLVFXVVLRQ7KHRULJLQDOVLJQHG,&)DQGDVVHQWIRUPDUHWREH
UHWDLQHGLQDFFRUGDQFHZLWKLQVWLWXWLRQDOSROLF\DQGDFRS\RIWKHVLJQHGFRQVHQWIRUP
DQGDVVHQWIRUPDUHWREHSURYLGHGWRWKHVXEMHFWRUOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYH
,IDSRWHQWLDOVXEMHFWLVLOOLWHUDWHRUYLVXDOO\LPSDLUHGDQGGRHVQRWKDYHDOHJDOO\
DFFHSWDEOHUHSUHVHQWDWLYHWKHLQYHVWLJDWRUPXVWSURYLGHDQLPSDUWLDOZLWQHVVWRUHDGWKH
,&)WRWKHVXEMHFWDQGPXVWDOORZIRUTXHVWLRQV7KHUHDIWHUERWKWKHVXEMHFWDQGWKH
ZLWQHVVPXVWVLJQWKH,&)DQGDVVHQWIRUPWRDWWHVWWKDWLQIRUPHGFRQVHQWDQGDVVHQW
ZHUHIUHHO\JLYHQDQGXQGHUVWRRG

,QVWLWXWLRQDO5HYLHZ%RDUG,QGHSHQGHQW(WKLFV&RPPLWWHH
$FRS\RIWKHSURWRFROSURSRVHG,&)DQGDVVHQWIRUPRWKHUZULWWHQVXEMHFWLQIRUPDWLRQ
DQGDQ\SURSRVHGDGYHUWLVLQJPDWHULDOPXVWEHVXEPLWWHGWRWKH,5%,(& IRUZULWWHQ
DSSURYDO$FRS\RIWKHZULWWHQDSSURYDORIWKHSURWRFRO,&)DQGDVVHQWIRUPPXVWEH
UHFHLYHGE\$PJHQEHIRUHUHFUXLWPHQWRIVXEMHFWVLQWRWKHVWXG\DQGVKLSPHQWRI$PJHQ
LQYHVWLJDWLRQDOSURGXFW
7KHLQYHVWLJDWRURUVSRQVRURQEHKDOIRIWKHLQYHVWLJDWRUPXVWVXEPLWDQGZKHUH
QHFHVVDU\REWDLQDSSURYDOIURPWKH,5%,(&IRUDOOVXEVHTXHQWSURWRFRODPHQGPHQWV
DQGFKDQJHVWRWKHLQIRUPHGFRQVHQWDQGDVVHQWGRFXPHQWV7KHLQYHVWLJDWRU
RUVSRQVRURQEHKDOIRIWKHLQYHVWLJDWRULVWRQRWLI\WKH,5%,(&RIGHYLDWLRQVIURPWKH

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


SURWRFRORUVHULRXVDGYHUVHHYHQWVRFFXUULQJDWWKHVLWHDQGRWKHUDGYHUVHHYHQWUHSRUWV
UHFHLYHGIURP$PJHQLQDFFRUGDQFHZLWKORFDOSURFHGXUHV
7KHLQYHVWLJDWRURUVSRQVRURQEHKDOIRIWKHLQYHVWLJDWRULVUHVSRQVLEOHIRUREWDLQLQJ
DQQXDO,5%,(&DSSURYDOUHQHZDOWKURXJKRXWWKHGXUDWLRQRIWKHVWXG\ZKHUHQHFHVVDU\
&RSLHVRIWKHLQYHVWLJDWRU¶VUHSRUWVDQGWKH,5%,(&FRQWLQXDQFHRIDSSURYDOPXVWEH
VHQWWR$PJHQ

6XEMHFW&RQILGHQWLDOLW\
7KHLQYHVWLJDWRUPXVWHQVXUHWKDWWKHVXEMHFW¶VFRQILGHQWLDOLW\LVPDLQWDLQHGIRU
GRFXPHQWVVXEPLWWHGWR$PJHQ

6XEMHFWVDUHWREHLGHQWLILHGE\DXQLTXHVXEMHFWLGHQWLILFDWLRQQXPEHU

:KHUHSHUPLWWHGGDWHRIELUWKLVWREHGRFXPHQWHGDQGIRUPDWWHGLQDFFRUGDQFHZLWK
ORFDOODZVDQGUHJXODWLRQV

2QWKH&5)GHPRJUDSKLFVSDJHLQDGGLWLRQWRWKHXQLTXHVXEMHFWLGHQWLILFDWLRQ
QXPEHULQFOXGHWKHDJHDWWLPHRIHQUROOPHQW

)RU6HULRXV$GYHUVH(YHQWVUHSRUWHGWR$PJHQVXEMHFWVDUHWREHLGHQWLILHGE\WKHLU
XQLTXHVXEMHFWLGHQWLILFDWLRQQXPEHULQLWLDOVIRUID[HGUHSRUWVLQDFFRUGDQFHZLWK
ORFDOODZVDQGUHJXODWLRQVDQGGDWHRIELUWKLQDFFRUGDQFHZLWKORFDOODZVDQG
UHJXODWLRQV

'RFXPHQWVWKDWDUHQRWVXEPLWWHGWR$PJHQHJVLJQHGLQIRUPHGFRQVHQWDQG
DVVHQWIRUPVDUHWREHNHSWLQFRQILGHQFHE\WKHLQYHVWLJDWRUH[FHSWDVGHVFULEHG
EHORZ
,QFRPSOLDQFHZLWK)HGHUDOUHJXODWLRQV,&+*&3*XLGHOLQHVLWLVUHTXLUHGWKDWWKH
LQYHVWLJDWRUDQGLQVWLWXWLRQSHUPLWDXWKRUL]HGUHSUHVHQWDWLYHVRIWKHFRPSDQ\RIWKH
UHJXODWRU\DJHQF\VDQGWKH,5%,(&GLUHFWDFFHVVWRUHYLHZWKHVXEMHFW¶VRULJLQDO
PHGLFDOUHFRUGVIRUYHULILFDWLRQRIVWXG\UHODWHGSURFHGXUHVDQGGDWD'LUHFWDFFHVV
LQFOXGHVH[DPLQLQJDQDO\]LQJYHULI\LQJDQGUHSURGXFLQJDQ\UHFRUGVDQGUHSRUWVWKDW
DUHLPSRUWDQWWRWKHHYDOXDWLRQRIWKHVWXG\7KHLQYHVWLJDWRULVREOLJDWHGWRLQIRUPDQG
REWDLQWKHFRQVHQWRIWKHVXEMHFWWRSHUPLWVXFKLQGLYLGXDOVWRKDYHDFFHVVWRKLVKHU
VWXG\UHODWHGUHFRUGVLQFOXGLQJSHUVRQDOLQIRUPDWLRQ

,QYHVWLJDWRU6LJQDWRU\2EOLJDWLRQV
(DFKFOLQLFDOVWXG\UHSRUWLVWREHVLJQHGE\WKHLQYHVWLJDWRURULQWKHFDVHRI
PXOWLFHQWHUVWXGLHVWKHFRRUGLQDWLQJLQYHVWLJDWRU
7KHFRRUGLQDWLQJLQYHVWLJDWRULGHQWLILHGE\$PJHQZLOOEHDQ\RUDOORIWKHIROORZLQJ

DUHFRJQL]HGH[SHUWLQWKHWKHUDSHXWLFDUHD

DQLQYHVWLJDWRUZKRSURYLGHGVLJQLILFDQWFRQWULEXWLRQVWRHLWKHUWKHGHVLJQRU
LQWHUSUHWDWLRQRIWKHVWXG\

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



DQLQYHVWLJDWRUFRQWULEXWLQJDKLJKQXPEHURIHOLJLEOHVXEMHFWV

$'0,1,675$7,9($1'/(*$/2%/,*$7,216

3URWRFRO$PHQGPHQWVDQG6WXG\7HUPLQDWLRQ
,I$PJHQDPHQGVWKHSURWRFRODJUHHPHQWIURPWKHLQYHVWLJDWRUPXVWEHREWDLQHG7KH
,5%,(&PXVWEHLQIRUPHGRIDOODPHQGPHQWVDQGJLYHDSSURYDOZKHUHDSSOLFDEOH7KH
LQYHVWLJDWRURUVSRQVRURQEHKDOIRIWKHLQYHVWLJDWRUPXVWVHQGDFRS\RIWKHDSSURYDO
OHWWHUIURPWKH,5%,(&WR$PJHQ
$PJHQUHVHUYHVWKHULJKWWRWHUPLQDWHWKHVWXG\DWDQ\WLPH%RWK$PJHQDQGWKH
LQYHVWLJDWRUUHVHUYHWKHULJKWWRWHUPLQDWHWKHLQYHVWLJDWRU¶VSDUWLFLSDWLRQLQWKHVWXG\
DFFRUGLQJWRWKHVWXG\FRQWUDFW7KHLQYHVWLJDWRURUVSRQVRURQEHKDOIRIWKH
LQYHVWLJDWRULVWR QRWLI\WKH,5%,(&LQZULWLQJRIWKHVWXG\¶VFRPSOHWLRQRUHDUO\
WHUPLQDWLRQDQGVHQGDFRS\RIWKHQRWLILFDWLRQWR$PJHQ
6XEMHFWVPD\EHHOLJLEOHIRUFRQWLQXHGWUHDWPHQWZLWK$PJHQLQYHVWLJDWLRQDOSURGXFWV
E\DQH[WHQVLRQSURWRFRORUDVSURYLGHGIRUE\WKHORFDOFRXQWU\¶VUHJXODWRU\PHFKDQLVP
+RZHYHU$PJHQUHVHUYHVWKHXQLODWHUDOULJKWDWLWVVROHGLVFUHWLRQWRGHWHUPLQH
ZKHWKHUWRVXSSO\$PJHQLQYHVWLJDWLRQDOSURGXFWVDQGE\ZKDWPHFKDQLVPDIWHU
WHUPLQDWLRQRIWKHVWXG\DQGEHIRUHWKHSURGXFWVLVDUHDYDLODEOHFRPPHUFLDOO\

6WXG\'RFXPHQWDWLRQDQG$UFKLYH
7KHLQYHVWLJDWRULVWRPDLQWDLQDOLVWRIDSSURSULDWHO\TXDOLILHGSHUVRQVWRZKRPKHVKH
KDVGHOHJDWHGVWXG\GXWLHV$OOSHUVRQVDXWKRUL]HGWRPDNHHQWULHVDQGRUFRUUHFWLRQV
RQ&5)VZLOOEHLQFOXGHGRQWKH$PJHQ'HOHJDWLRQRI$XWKRULW\)RUP
6RXUFHGRFXPHQWVDUHRULJLQDOGRFXPHQWVGDWDDQGUHFRUGVIURPZKLFKWKHVXEMHFW¶V
&5)GDWDDUHREWDLQHG7KHVHLQFOXGHEXWDUHQRWOLPLWHGWRKRVSLWDOUHFRUGVFOLQLFDO
DQGRIILFHFKDUWVODERUDWRU\DQGSKDUPDF\UHFRUGVGLDULHVPLFURILFKHVUDGLRJUDSKV
DQGFRUUHVSRQGHQFH
7KHLQYHVWLJDWRUDQGVWXG\VWDIIDUHUHVSRQVLEOHIRUPDLQWDLQLQJDFRPSUHKHQVLYHDQG
FHQWUDOL]HGILOLQJV\VWHPRIDOOVWXG\UHODWHGHVVHQWLDOGRFXPHQWDWLRQVXLWDEOHIRU
LQVSHFWLRQDWDQ\WLPHE\UHSUHVHQWDWLYHVIURP$PJHQDQGRUDSSOLFDEOHUHJXODWRU\
DXWKRULWLHV
(OHPHQWVWRLQFOXGH

6XEMHFWILOHVFRQWDLQLQJLQIRUPHGFRQVHQWDQGDVVHQWIRUPVDQGVXEMHFWLGHQWLILFDWLRQ
OLVW

6WXG\ILOHVFRQWDLQLQJWKHSURWRFROZLWKDOODPHQGPHQWV,QYHVWLJDWRU¶V%URFKXUH
FRSLHVRISUHVWXG\GRFXPHQWDWLRQDQGDOOFRUUHVSRQGHQFHWRDQGIURPWKH,5%,(&
DQG$PJHQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



,QYHVWLJDWLRQDOSURGXFWUHODWHGFRUUHVSRQGHQFHLQFOXGLQJ3URRIRI5HFHLSWV325
,QYHVWLJDWLRQDO3URGXFW$FFRXQWDELOLW\5HFRUGV5HWXUQRI,QYHVWLJDWLRQDO3URGXFW
IRU'HVWUXFWLRQ)RUPV)LQDO,QYHVWLJDWLRQDO3URGXFW5HFRQFLOLDWLRQ6WDWHPHQWDV
DSSOLFDEOH

1RQLQYHVWLJDWLRQDOSURGXFWVDQGRUPHGLFDOGHYLFHVGRFXPHQWDWLRQDV
DSSOLFDEOH
,QDGGLWLRQDOORULJLQDOVRXUFHGRFXPHQWVVXSSRUWLQJHQWULHVLQWKH&5)VPXVWEH
PDLQWDLQHGDQGEHUHDGLO\DYDLODEOH
5HWHQWLRQRIVWXG\GRFXPHQWVZLOOEHJRYHUQHGE\WKH&OLQLFDO7ULDO$JUHHPHQW

6WXG\0RQLWRULQJDQG'DWD&ROOHFWLRQ
7KH$PJHQUHSUHVHQWDWLYHVDQGUHJXODWRU\DXWKRULW\LQVSHFWRUVDUHUHVSRQVLEOHIRU
FRQWDFWLQJDQGYLVLWLQJWKHLQYHVWLJDWRUIRUWKHSXUSRVHRILQVSHFWLQJWKHIDFLOLWLHVDQG
XSRQUHTXHVWLQVSHFWLQJWKHYDULRXVUHFRUGVRIWKHFOLQLFDOVWXG\HJH&5)VDQGRWKHU
SHUWLQHQWGDWDSURYLGHGWKDWVXEMHFWFRQILGHQWLDOLW\LVUHVSHFWHG
7KH$PJHQ&OLQLFDO0RQLWRULVUHVSRQVLEOHIRUYHULI\LQJWKHH&5)VDWUHJXODULQWHUYDOV
WKURXJKRXWWKHVWXG\WRYHULI\DGKHUHQFHWRWKHSURWRFROFRPSOHWHQHVVDFFXUDF\DQG
FRQVLVWHQF\RIWKHGDWDDQGDGKHUHQFHWRORFDOUHJXODWLRQVRQWKHFRQGXFWRIFOLQLFDO
UHVHDUFK7KH&OLQLFDO0RQLWRULVWRKDYHDFFHVVWRVXEMHFWPHGLFDOUHFRUGVDQGRWKHU
VWXG\UHODWHGUHFRUGVQHHGHGWRYHULI\WKHHQWULHVRQWKHH&5)V
7KHLQYHVWLJDWRUDJUHHVWRFRRSHUDWHZLWKWKHFOLQLFDOPRQLWRUWRHQVXUHWKDWDQ\
SUREOHPVGHWHFWHGLQWKHFRXUVHRIWKHVHPRQLWRULQJYLVLWVLQFOXGLQJGHOD\VLQ
FRPSOHWLQJH&5)VDUHUHVROYHG
,QDFFRUGDQFHZLWK,&+*&3DQGWKHVSRQVRU¶VDXGLWSODQVWKLVVWXG\PD\EHVHOHFWHG
IRUDXGLWE\UHSUHVHQWDWLYHVIURP$PJHQ¶V*OREDO5	'&RPSOLDQFHDQG$XGLWIXQFWLRQ
RUGHVLJQHHV,QVSHFWLRQRIVLWHIDFLOLWLHVHJSKDUPDF\LQYHVWLJDWLRQDOSURGXFWV
DQGRUSURWRFROUHTXLUHGWKHUDS\VWRUDJHDUHDVODERUDWRULHVDQGUHYLHZRIVWXG\UHODWHG
UHFRUGVZLOORFFXUWRHYDOXDWHWKHVWXG\FRQGXFWDQGFRPSOLDQFHZLWKWKHSURWRFRO
,&+*&3DQGDSSOLFDEOHUHJXODWRU\UHTXLUHPHQWV
$OOVXEMHFWGDWDUHODWLQJWRWKHVWXG\ZLOOEHUHFRUGHGRQSULQWHGRUHOHFWURQLF&5)XQOHVV
WUDQVPLWWHGWRWKHVSRQVRURUGHVLJQHHHOHFWURQLFDOO\HJODERUDWRU\GDWDFHQWUDOO\RU
DGMXGLFDWHGGDWD7KHLQYHVWLJDWRULVUHVSRQVLEOHIRUYHULI\LQJWKDWGDWDHQWULHVDUH
DFFXUDWHDQGFRUUHFWE\SK\VLFDOO\RUHOHFWURQLFDOO\VLJQLQJWKH&5)
'DWDFDSWXUHIRUWKLVVWXG\LVSODQQHGWREHHOHFWURQLF

$OOVRXUFHGRFXPHQWDWLRQVXSSRUWLQJHQWULHVLQWRWKHH&5)VPXVWEHPDLQWDLQHGDQG
UHDGLO\DYDLODEOH

8SGDWHVWR&5)VZLOOEHDXWRPDWLFDOO\GRFXPHQWHGWKURXJKWKHVRIWZDUH¶V³DXGLW
WUDLO´

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



7RHQVXUHWKHTXDOLW\RIFOLQLFDOGDWDDFURVVDOOVXEMHFWVDQGVLWHVDFOLQLFDOGDWD
PDQDJHPHQWUHYLHZLVSHUIRUPHGRQVXEMHFWGDWDUHFHLYHGDW$PJHQ'XULQJWKLV
UHYLHZVXEMHFWGDWDDUHFKHFNHGIRUFRQVLVWHQF\RPLVVLRQVDQGDQ\DSSDUHQW
GLVFUHSDQFLHV,QDGGLWLRQWKHGDWDDUHUHYLHZHGIRUDGKHUHQFHWRWKHSURWRFRODQG
*&37RUHVROYHDQ\TXHVWLRQVDULVLQJIURPWKHFOLQLFDOGDWDPDQDJHPHQWUHYLHZ
SURFHVVGDWDTXHULHVDQGRUVLWHQRWLILFDWLRQVDUHFUHDWHGLQWKH('&V\VWHP
GDWDEDVHIRUVLWHUHVROXWLRQDQGVXEVHTXHQWO\FORVHGE\WKH('&V\VWHPRUE\DQ
$PJHQUHYLHZHU

7KHLQYHVWLJDWRUVLJQVRQO\WKH,QYHVWLJDWRU9HULILFDWLRQ)RUPIRUWKLVHOHFWURQLFGDWD
FDSWXUHVWXG\7KLVVLJQDWXUHLQGLFDWHVWKDWLQYHVWLJDWRULQVSHFWHGRUUHYLHZHGWKH
GDWDRQWKHH&5)WKHGDWDTXHULHVDQGWKHVLWHQRWLILFDWLRQVDQGDJUHHVZLWKWKH
FRQWHQW

,QYHVWLJDWRU5HVSRQVLELOLWLHVIRU'DWD&ROOHFWLRQ
7KHLQYHVWLJDWRULVUHVSRQVLEOHIRUFRPSO\LQJZLWKWKHUHTXLUHPHQWVIRUDOODVVHVVPHQWV
DQGGDWDFROOHFWLRQLQFOXGLQJVXEMHFWVQRWUHFHLYLQJLQYHVWLJDWLRQDOSURGXFWVDQGRU
SURWRFROUHTXLUHGWKHUDSLHVDVVWLSXODWHGLQWKHSURWRFROIRUHDFKVXEMHFWLQWKHVWXG\
)RUVXEMHFWVZKRZLWKGUDZSULRUWRFRPSOHWLRQRIDOOSURWRFROUHTXLUHGYLVLWVDQGDUH
XQDEOHRUXQZLOOLQJWRFRQWLQXHWKH6FKHGXOHRI$VVHVVPHQWV7DEOHWKH
LQYHVWLJDWRUFDQVHDUFKSXEOLFO\DYDLODEOHUHFRUGVZKHUHSHUPLWWHGWRDVFHUWDLQVXUYLYDO
VWDWXV7KLVHQVXUHVWKDWWKHGDWDVHWVSURGXFHGDVDQRXWFRPHRIWKHVWXG\LVDUHDV
FRPSUHKHQVLYHDVSRVVLEOH

/DQJXDJH
&5)VPXVWEHFRPSOHWHGLQ(QJOLVK75$'(1$0(6LIXVHGIRUFRQFRPLWDQW
PHGLFDWLRQVPD\EHHQWHUHGLQWKHORFDOODQJXDJH&RQVXOWWKHFRXQWU\VSHFLILF
ODQJXDJHUHTXLUHPHQWV
$OOZULWWHQLQIRUPDWLRQDQGRWKHUPDWHULDOWREHXVHGE\VXEMHFWVDQGLQYHVWLJDWLYHVWDII
PXVWXVHYRFDEXODU\DQGODQJXDJHWKDWDUHFOHDUO\XQGHUVWRRG

3XEOLFDWLRQ3ROLF\
7RFRRUGLQDWHGLVVHPLQDWLRQRIGDWDIURPWKLVVWXG\$PJHQHQFRXUDJHVWKHIRUPDWLRQRI
DSXEOLFDWLRQFRPPLWWHHFRQVLVWLQJRIVHYHUDOLQYHVWLJDWRUVDQGDSSURSULDWH$PJHQVWDII
WKHJRYHUQDQFHDQGUHVSRQVLELOLWLHVRIZKLFKDUHVHWIRUWKLQD3XEOLFDWLRQ&KDUWHU7KH
FRPPLWWHHLVH[SHFWHGWRVROLFLWLQSXWDQGDVVLVWDQFHIURPRWKHULQYHVWLJDWRUVDQGWR
FROODERUDWHZLWKDXWKRUVDQG$PJHQVWDIIDVDSSURSULDWHDVGHILQHGLQWKH3XEOLFDWLRQ
&KDUWHU0HPEHUVKLSRQWKHFRPPLWWHHERWKIRULQYHVWLJDWRUVDQG$PJHQVWDIIGRHV
QRWJXDUDQWHHDXWKRUVKLS7KHFULWHULDGHVFULEHGEHORZDUHWREHPHWIRUHYHU\
SXEOLFDWLRQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$XWKRUVKLSRIDQ\SXEOLFDWLRQVUHVXOWLQJIURPWKLVVWXG\ZLOOEHGHWHUPLQHGRQWKHEDVLV
RIWKH8QLIRUP5HTXLUHPHQWIRU0DQXVFULSWV6XEPLWWHGWR%LRPHGLFDO-RXUQDOV
,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUVZKLFKVWDWHV

$XWKRUVKLSFUHGLWVKRXOGEHEDVHGRQVXEVWDQWLDOFRQWULEXWLRQVWRFRQFHSWLRQDQG
GHVLJQDFTXLVLWLRQRIGDWDRUDQDO\VLVDQGLQWHUSUHWDWLRQRIGDWDGUDIWLQJWKH
DUWLFOHRUUHYLVLQJLWFULWLFDOO\IRULPSRUWDQWLQWHOOHFWXDOFRQWHQWILQDODSSURYDORIWKH
YHUVLRQWREHSXEOLVKHG$JUHHPHQWWREHDFFRXQWDEOHIRUDOODVSHFWVRIWKHZRUN
LQHQVXULQJWKDWTXHVWLRQVUHODWHGWRWKHDFFXUDF\RULQWHJULW\RIDQ\SDUWRIWKHZRUN
DUHDSSURSULDWHO\LQYHVWLJDWHGDQGUHVROYHG$XWKRUVVKRXOGPHHWFRQGLWLRQV
DQG

:KHQDODUJHPXOWLFHQWHUJURXSKDVFRQGXFWHGWKHZRUNWKHJURXSVKRXOGLGHQWLI\
WKHLQGLYLGXDOVZKRDFFHSWGLUHFWUHVSRQVLELOLW\IRUWKHPDQXVFULSW7KHVHLQGLYLGXDOV
VKRXOGIXOO\PHHWWKHFULWHULDIRUDXWKRUVKLSGHILQHGDERYH

$FTXLVLWLRQRIIXQGLQJFROOHFWLRQRIGDWDRUJHQHUDOVXSHUYLVLRQRIWKHUHVHDUFK
JURXSDORQHGRHVQRWMXVWLI\DXWKRUVKLS

$OOSHUVRQVGHVLJQDWHGDVDXWKRUVVKRXOG TXDOLI\IRUDXWKRUVKLSDQGDOOWKRVHZKR
TXDOLI\VKRXOGEHOLVWHG

(DFKDXWKRUVKRXOGKDYHSDUWLFLSDWHGVXIILFLHQWO\LQWKHZRUNWRWDNHSXEOLF
UHVSRQVLELOLW\IRUDSSURSULDWHSRUWLRQVRIWKHFRQWHQW
$OOSXEOLFDWLRQVHJPDQXVFULSWVDEVWUDFWVRUDOVOLGHSUHVHQWDWLRQVERRNFKDSWHUV
EDVHGRQWKLVVWXG\PXVWEHVXEPLWWHGWR$PJHQIRUUHYLHZ7KH&OLQLFDO7ULDO
$JUHHPHQWDPRQJWKHLQVWLWXWLRQLQYHVWLJDWRUDQG$PJHQZLOOGHWDLOWKHSURFHGXUHVIRU
DQGWLPLQJRI$PJHQ¶VUHYLHZRISXEOLFDWLRQV

&RPSHQVDWLRQ
$Q\DUUDQJHPHQWVIRUFRPSHQVDWLRQWRVXEMHFWVIRULQMXU\RULOOQHVVWKDWDULVHVLQWKH
VWXG\DUHGHVFULEHGLQWKH&RPSHQVDWLRQIRU,QMXU\VHFWLRQRIWKH,QIRUPHG&RQVHQWWKDW
LVDYDLODEOHDVDVHSDUDWHGRFXPHQW 

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



5()(5(1&(6
%DGHU3.UH\HQEHUJ++HQ]H*+HWDO3URJQRVWLFYDOXHRIPLQLPDOUHVLGXDOGLVHDVH
TXDQWLILFDWLRQEHIRUHDOORJHQHLFVWHPFHOOWUDQVSODQWDWLRQLQUHODSVHGFKLOGKRRGDFXWH
O\PSKREODVWLFOHXNHPLDWKH$//5(;%)06WXG\*URXSJ Clin Oncol

%DUUHGR-&'HYLGDV0/DXHU6-HWDO,VRODWHG&16UHODSVHRIDFXWHO\PSKREODVWLF
OHXNHPLDWUHDWHGZLWKLQWHQVLYHV\VWHPLFFKHPRWKHUDS\DQGGHOD\HG&16UDGLDWLRQD
SHGLDWULFRQFRORJ\JURXSVWXG\J Clin Oncol
%DVVDQ5+RHO]HU'0RGHUQWKHUDS\RIDFXWHO\PSKREODVWLFOHXNHPLDJ Clin Oncol

%OLQDWXPRPDE,QYHVWLJDWRU¶V%URFKXUH7KRXVDQG2DNV&$$PJHQ,QF
%UJJHPDQQ0*|NEXJHW1.QHED0$FXWHO\PSKREODVWLFOHXNHPLDPRQLWRULQJ
PLQLPDOUHVLGXDOGLVHDVHDVDWKHUDSHXWLFSULQFLSOHSemin Oncol
%UJJHPDQQ06FKUDXGHU$5DII7HWDO6WDQGDUGL]HG05'TXDQWLILFDWLRQLQ
(XURSHDQ$//WULDOVSURFHHGLQJVRIWKH6HFRQG,QWHUQDWLRQDO6\PSRVLXPRQ05'
DVVHVVPHQWLQ.LHO*HUPDQ\6HSWHPEHU.Leukemia
%UJJHPDQQ03RWW&5LWJHQ0.QHED06LJQLILFDQFHRIPLQLPDOUHVLGXDOGLVHDVHLQ
O\PSKRLGPDOLJQDQFLHVActa Haematol
%XLWHQNDPS7',]UDHOL6=LPPHUPDQQ0HWDO$FXWHO\PSKREODVWLFOHXNHPLDLQ
FKLOGUHQZLWK'RZQV\QGURPHDUHWURVSHFWLYHDQDO\VLVIURPWKH3RQWHGL/HJQRVWXG\
JURXSBlood
&KHVVHOOV-09H\V3.HPSVNL+HWDO/RQJWHUPIROORZXSRIUHODSVHG
FKLOGKRRGDFXWHO\PSKREODVWLFOHXNDHPLDBr J Haematol. 
&RQWHU9%DUWUDP&59DOVHFFKL0*HWDO0ROHFXODUUHVSRQVHWRWUHDWPHQWUHGHILQHV
DOOSURJQRVWLFIDFWRUVLQFKLOGUHQDQGDGROHVFHQWVZLWK%FHOOSUHFXUVRUDFXWH
O\PSKREODVWLFOHXNHPLDUHVXOWVLQSDWLHQWVRIWKH$,(23%)0$//VWXG\
Blood
&RQWHU95L]]DUL&6DOD$&KLHVD5&LWWHULR0%LRQGL$ $FXWHO\PSKREODVWLF
OHXNHPLD >2QOLQH@Orphanet Encyclopedia'HFHPEHU$YDLODEOH
KWWSZZZRUSKDQHWGDWDSDWKR*%XN$//SGI>$FFHVVHG6HSWHPEHU@
'UHLHU7/RUHQF]HZVNL*%UDQGO&HWDO([WUHPHO\SRWHQWUDSLGDQG
FRVWLPXODWLRQLQGHSHQGHQWF\WRWR[LF7FHOOUHVSRQVHDJDLQVWO\PSKRPDFHOOVFDWDO\]HG
E\DVLQJOHFKDLQELVSHFLILFDQWLERG\Int J Cancer.  
(FNHUW&/DQGW25HDOWLPH3&5WRGHWHFWPLQLPDOUHVLGXDOGLVHDVHLQFKLOGKRRG$//
Methods Mol Med
(FNHUW&%LRQGL$6HHJHU.HWDO3URJQRVWLFYDOXHRIPLQLPDOUHVLGXDOGLVHDVHLQ
UHODSVHGFKLOGKRRGDFXWHO\PSKREODVWLFOHXNHPLDLancet
(LQVLHGHO+*YRQ6WDFNHOEHUJ$+DUWPDQQ5HWDO/RQJWHUPRXWFRPHLQFKLOGUHQZLWK
UHODSVHG$//E\ULVNVWUDWLILHGVDOYDJHWKHUDS\UHVXOWVRIWULDODFXWHO\PSKREODVWLF
OHXNHPLDUHODSVHVWXG\RIWKH%HUOLQ)UDQNIXUW0QVWHU*URXSJ Clin Oncol. 

)LQH-3*UD\5-$SURSRUWLRQDOKD]DUGVPRGHOIRUWKHVXEGLVWULEXWLRQRIDFRPSHWLQJ
ULVNJ Am Stat Assoc.

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


*D\QRQ36&KLOGKRRGDFXWHO\PSKREODVWLFOHXNDHPLDDQGUHODSVHBr J Haematol

*RUH/=XJPDLHU*+DQGJUHWLQJHU5HWDO&\WRORJLFDODQGPROHFXODUUHPLVVLRQVZLWK
EOLQDWXPRPDEWUHDWPHQWLQVHFRQGRUODWHUERQHPDUURZUHODSVHLQSHGLDWULFDFXWH
O\PSKREODVWLFOHXNHPLD$//J Clin OncolVXSSODEVWU
+DQGJUHWLQJHU5=XJPDLHU*+HQ]H*.UH\HQEHUJ+/DQJ3YRQ6WDFNHOEHUJ$
&RPSOHWHUHPLVVLRQDIWHUEOLQDWXPRPDELQGXFHGGRQRU7FHOODFWLYDWLRQLQWKUHHSHGLDWULF
SDWLHQWVZLWKSRVWWUDQVSODQWUHODSVHGDFXWHO\PSKREODVWLFOHXNHPLDLeukemia.

,QWHUQDWLRQDO%HUOLQ)UDQNIXUW0XHQVWHU6WXG\*URXS,QW5H$//+5,QWHUQDWLRQDO
6WXG\IRU7UHDWPHQWRI+LJK5LVN&KLOGKRRG5HODSVHG$//
.R5+-L/%DUQHWWH3%RVWURP%HWDO2XWFRPHRISDWLHQWVWUHDWHGIRUUHODSVHGRU
UHIUDFWRU\DFXWHO\PSKREODVWLFOHXNHPLDD7KHUDSHXWLF$GYDQFHVLQ&KLOGKRRG
/HXNHPLD&RQVRUWLXPVWXG\J Clin Oncol.
/DQ..'H0HWV'/'LVFUHWHVHTXHQWLDOERXQGDULHVIRUFOLQLFDOWULDOVBiometrika

/DQJHUDN$:6]F]HSDQVNL7YDQGHU%XUJ0:ROYHUV7HWWHUR,/YDQ'RQJHQ--
+HWHURGXSOH[3&5DQDO\VLVRIUHDUUDQJHG7FHOOUHFHSWRUJHQHVIRUFORQDOLW\DVVHVVPHQW
LQVXVSHFW7FHOOSUROLIHUDWLRQVLeukemia.
/DQVN\6%/LVW0$/DQVN\//5LWWHU6WHUU&0LOOHU'57KHPHDVXUHPHQWRI
SHUIRUPDQFHLQFKLOGKRRGFDQFHUSDWLHQWVCancer.
/RFDWHOOL)6FKUDSSH0%HUQDUGR0(5XWHOOD6+RZ,WUHDWFKLOGKRRGDFXWH
O\PSKREODVWLFOHXNHPLDBlood
/|IIOHU$.XIHU3/XWWHUEVH5HWDO$UHFRPELQDQWELVSHFLILFVLQJOHFKDLQDQWLERG\
&'[&'LQGXFHVUDSLGDQGKLJKO\PSKRPDGLUHFWHGF\WRWR[LFLW\E\XQVWLPXODWHG7
O\PSKRF\WHVBlood.  
0DFKHUH\1DJHO*PE+	&R.**HUPDQ\1XFOHR6SLQ7LVVXHNLWXVHUPDQXDO
0DOHPSDWL6*D\QRQ366DWKHU+/D0.6WRUN/&&KLOGUHQ¶V2QFRORJ\*URXS
2XWFRPHDIWHUUHODSVHDPRQJFKLOGUHQZLWKVWDQGDUGULVNDFXWHO\PSKREODVWLFOHXNHPLD
&KLOGUHQ
V2QFRORJ\*URXSVWXG\&&*J Clin Oncol.
0F1DOO\5-(GHQ72$QLQIHFWLRXVDHWLRORJ\IRUFKLOGKRRGDFXWHOHXNDHPLDDUHYLHZRI
WKHHYLGHQFHBr J Haematol.
0|ULFNH$5HLWHU$=LPPHUPDQQ0HWDO5LVNDGMXVWHGWKHUDS\RIDFXWHO\PSKREODVWLF
OHXNHPLDFDQGHFUHDVHWUHDWPHQWEXUGHQDQGLPSURYHVXUYLYDOWUHDWPHQWUHVXOWVRI
XQVHOHFWHGSHGLDWULFDQGDGROHVFHQWSDWLHQWVHQUROOHGLQWKHWULDO$//%)0
Blood. 
1DWLRQDO&DQFHU,QVWLWXWH3'4&KLOGKRRG$FXWH/\PSKREODVWLF/HXNHPLD7UHDWPHQW
>2QOLQH@0D\$YDLODEOHDW
KWWSFDQFHUJRYFDQFHUWRSLFVSGTWUHDWPHQWFKLOG$//+HDOWK3URIHVVLRQDO
1&&13UDFWLFH*XLGHOLQHVLQ2QFRORJ\$FXWH/\PSKREODVWLF/HXNHPLD1&&1RUJ
9HUVLRQ
1JX\HQ.'HYLGDV0&KHQJ6&HWDO)DFWRUVLQIOXHQFLQJVXUYLYDODIWHUUHODSVHIURP
DFXWHO\PSKREODVWLFOHXNHPLD$&KLOGUHQ¶V2QFRORJ\*URXSVWXG\Leukemia


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


2¶%ULHQ3&)OHPLQJ75$PXOWLSOHWHVWLQJSURFHGXUHIRUFOLQLFDOWULDOVBiometrics

3DJDQLQ0=HFFD0)DEEUL*HWDO0LQLPDOUHVLGXDOGLVHDVHLVDQLPSRUWDQWSUHGLFWLYH
IDFWRURIRXWFRPHLQFKLOGUHQZLWKUHODSVHGµKLJKULVN¶DFXWHO\PSKREODVWLFOHXNHPLD
Leukemia.
3DUNHU&:DWHUV5/HLJKWRQ&HWDO(IIHFWRIPLWR[DQWURQHRQRXWFRPHRIFKLOGUHQZLWK
ILUVWUHODSVHRIDFXWHO\PSKREODVWLFOHXNDHPLD$//5DQRSHQODEHOUDQGRPLVHGWULDO
Lancet
3RQJHUV:LOOHPVH0-6HULX76WRO])HWDO3ULPHUVDQGSURWRFROVIRUVWDQGDUGL]HG
GHWHFWLRQRIPLQLPDOUHVLGXDOGLVHDVHLQDFXWHO\PSKREODVWLFOHXNHPLDXVLQJ
LPPXQRJOREXOLQDQG7FHOOUHFHSWRUJHQHUHDUUDQJHPHQWVDQG7$/GHOHWLRQVDV3&5
WDUJHWVUHSRUWRIWKH%,20('&21&(57('$&7,21LQYHVWLJDWLRQRIPLQLPDO
UHVLGXDOGLVHDVHLQDFXWHOHXNHPLDLeukemia.
3XL&+$FXWH/\PSKREODVWLF/HXNHPLDIn:3XL&+HGChildhood Leukemias.
&DPEULGJH&DPEULGJH8QLYHUVLW\3UHVVD
3XL&+5RELVRQ///RRN$7$FXWHO\PSKREODVWLFOHXNDHPLDLancet. 
E
3XL&+(YDQV:(7UHDWPHQWRIDFXWHO\PSKREODVWLFOHXNHPLDN Engl J Med

5XEQLW]-(+LML\D1=KRX<+DQFRFN0/5LYHUD*.3XL&+/DFNRIEHQHILWRIHDUO\
GHWHFWLRQRIUHODSVHDIWHUFRPSOHWLRQRIWKHUDS\IRUDFXWHO\PSKREODVWLF
OHXNHPLDPediatr BloodCancer.
6FKDJ&&+HLQULFK5/*DQ]3$.DUQRIVN\SHUIRUPDQFHVWDWXVUHYLVLWHG5HOLDELOLW\
YDOLGLW\DQGJXLGHOLQHVJ Clin Oncol
6FKOHJHO3/DQJ3=XJPDLHU*HWDO3HGLDWULFSRVWWUDQVSODQWUHODSVHGUHIUDFWRU\
%SUHFXUVRUDFXWHO\PSKREODVWLFOHXNHPLDVKRZVGXUDEOHUHPLVVLRQE\WKHUDS\ZLWKWKH
7FHOOHQJDJLQJELVSHFLILFDQWLERG\EOLQDWXPRPDEHaematologica

6FKUDSSH06WDQXOOD07UHDWPHQWRIFKLOGKRRGDFXWHO\PSKREODVWLFOHXNHPLD,Q3XL
&+HG7UHDWPHQWRI$FXWH/HXNHPLDV1HZ'LUHFWLRQVIRU&OLQLFDO5HVHDUFK7RWRZD
1-+XPDQD3UHVV
6FKUDSSH00|ULFNH$5HLWHU$HWDO.H\WUHDWPHQWTXHVWLRQVLQFKLOGKRRGDFXWH
O\PSKREODVWLFOHXNHPLDUHVXOWVLQFRQVHFXWLYHWULDOVSHUIRUPHGE\WKH$//%)0VWXG\
JURXSIURPWRKlin Padiatr. 0D\6XSSO6
6WDFNHOEHUJ$=XJPDLHU*+DQGJUHWLQJHU5HWDO$SKDVHVWXG\RIEOLQDWXPRPDE
LQSHGLDWULFSDWLHQWVZLWKUHODSVHGUHIUDFWRU\%FHOOSUHFXUVRUDFXWHO\PSKREODVWLF
OHXNHPLDBlood.  
6WDU\-=LPPHUPDQ0&DPSEHOO0HWDO,QWHQVLYHFKHPRWKHUDS\IRUFKLOGKRRGDFXWH
O\PSKREODVWLFOHXNHPLDUHVXOWVRIWKHUDQGRPL]HGLQWHUFRQWLQHQWDOWULDO$//,&%)0
J Clin Oncol
6]F]HSDQVNL7YDQGHU9HOGHQ9++RRJHYHHQ3*HWDO9GHOWD-DOSKD
UHDUUDQJHPHQWVDUHIUHTXHQWLQSUHFXUVRU%DFXWHO\PSKREODVWLFOHXNHPLDEXWUDUHLQ
QRUPDOO\PSKRLGFHOOVBlood.

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


6]F]HSDQVNL7%HLVKXL]HQ$3RQJHUV:LOOHPVH0-HWDO&URVVOLQHDJH7FHOOUHFHSWRU
JHQHUHDUUDQJHPHQWVRFFXULQPRUHWKDQQLQHW\SHUFHQWRIFKLOGKRRGSUHFXUVRU%DFXWH
O\PSKREODVWLFOHXNHPLDVDOWHUQDWLYH3&5WDUJHWVIRUGHWHFWLRQRIPLQLPDOUHVLGXDO
GLVHDVHLeukemia
7HDFKH\'75KHLQJROG650DXGH6/HWDO&\WRNLQHUHOHDVHV\QGURPHDIWHU
EOLQDWXPRPDEWUHDWPHQWUHODWHGWRDEQRUPDOPDFURSKDJHDFWLYDWLRQDQGDPHOLRUDWHG
ZLWKF\WRNLQHGLUHFWHGWKHUDS\Blood.  
7RSS06*|NEXJHW1=XJPDLHU*HWDO$QWL&'%L7(EOLQDWXPRPDELQGXFHVKLJK
FRPSOHWHUHPLVVLRQUDWHDQGSURORQJVRYHUDOOVXUYLYDOLQDGXOWSDWLHQWVZLWK
UHODSVHGUHIUDFWRU\ESUHFXUVRUDFXWHO\PSKEODVWLFOHXNHPLD$//Blood;$PHULFDQ
6RFLHW\RI+HPDWRORJ\>$6+@$QQXDO0HHWLQJ$EVWUDFWVD$EVWUDFW
7RSS06*|NEXJHW1=XJPDLHU*HWDO/RQJWHUPIROORZXSRIKHPDWRORJLF
UHODSVHIUHHVXUYLYDOLQDSKDVHVWXG\RIEOLQDWXPRPDELQSDWLHQWVZLWK05'LQ
%OLQHDJH$//Blood.E
7RSS06.XIHU3*|NEXJHW1HWDO7DUJHWHGWKHUDS\ZLWKWKH7FHOOHQJDJLQJ
DQWLERG\EOLQDWXPRPDERIFKHPRWKHUDS\UHIUDFWRU\PLQLPDOUHVLGXDOGLVHDVHLQ
%OLQHDJHDFXWHO\PSKREODVWLFOHXNHPLDSDWLHQWVUHVXOWVLQKLJKUHVSRQVHUDWHDQG
SURORQJHGOHXNHPLDIUHHVXUYLYDOJ Clin Oncol.
8GHU]R&3LOORQ0&RUWL3HWDO,PSDFWRIFXPXODWLYHDQWKUDF\FOLQHGRVHSUHSDUDWLYH
UHJLPHQWDQGFKURQLFJUDIWYHUVXVKRVWGLVHDVHRQSXOPRQDU\DQGFDUGLDFIXQFWLRQLQ
FKLOGUHQ\HDUVDIWHUDOORJHQHLFKHPDWRSRHWLFVWHPFHOOWUDQVSODQWDWLRQDSURVSHFWLYH
HYDOXDWLRQRQEHKDOIRIWKH(%073HGLDWULF'LVHDVHVDQG/DWH(IIHFWV:RUNLQJ3DUWLHV
Bone Marrow Transplant.
YDQGHU9HOGHQ9+&D]]DQLJD*6FKUDXGHU$HWDO$QDO\VLVRIPLQLPDOUHVLGXDO
GLVHDVHE\,J7&5JHQHUHDUUDQJHPHQWVJXLGHOLQHVIRULQWHUSUHWDWLRQRIUHDOWLPH
TXDQWLWDWLYH3&5GDWDLeukemia
:ROI(+RIPHLVWHU5.XIHU36FKOHUHWK%%DHXHUOH3$%L7(VELVSHFLILFDQWLERG\
FRQVWUXFWVZLWKXQLTXHDQWLWXPRUDFWLYLW\Drug Discov Today.  

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



$33(1',&(6
$SSHQGL[$$GGLWLRQDO6DIHW\$VVHVVPHQW,QIRUPDWLRQ
5HIHUWRWKH1&,&RPPRQ7HUPLQRORJ\&ULWHULDIRU$GYHUVH(YHQWV&7&$(YHUVLRQ
IRU$(JUDGLQJDQGLQIRUPDWLRQ7KH&7&$(VFDOHLVDYDLODEOHDWWKHIROORZLQJORFDWLRQ
KWWSFWHSFDQFHUJRYSURWRFRO'HYHORSPHQWHOHFWURQLFBDSSOLFDWLRQVFWFKWP
'UXJLQGXFHG/LYHU,QMXU\5HSRUWLQJ	$GGLWLRQDO$VVHVVPHQWV5HSRUWLQJ
7RIDFLOLWDWHDSSURSULDWHPRQLWRULQJIRUVLJQDOVRI',/,FDVHVRIFRQFXUUHQW$67RU$/7
DQG7%/DQGRU,15HOHYDWLRQUHTXLUHWKHIROORZLQJ

7KHHYHQWLVWREHUHSRUWHGWR$PJHQDVDVHULRXVDGYHUVHHYHQWLPPHGLDWHO\DQG
QRODWHUWKDQKRXUVRIGLVFRYHU\RUQRWLILFDWLRQRIWKHHYHQWLHEHIRUHDGGLWLRQDO
HWLRORJLFLQYHVWLJDWLRQVKDYHEHHQFRQFOXGHG

7KHDSSURSULDWH&5)HJ$GYHUVH(YHQW&5)WKDWFDSWXUHVLQIRUPDWLRQQHFHVVDU\
WRIDFLOLWDWHWKHHYDOXDWLRQRIWUHDWPHQWHPHUJHQWOLYHUDEQRUPDOLWLHVLVWREH
FRPSOHWHGDQGVHQWWRWKH$PJHQ
2WKHUHYHQWVRIKHSDWRWR[LFLW\DQGSRWHQWLDO',/,DUHWREHUHSRUWHGDVVHULRXVDGYHUVH
HYHQWVLIWKH\PHHWWKHFULWHULDIRUDVHULRXVDGYHUVHHYHQWGHILQHGLQ6HFWLRQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$SSHQGL[%6DPSOH(OHFWURQLF6HULRXV$GYHUVH(YHQW&RQWLQJHQF\5HSRUW)RUP
SDSHUEDVHGIRUP


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/




3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$SSHQGL[&3UHJQDQF\1RWLILFDWLRQ)RUP


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$SSHQGL['/DFWDWLRQ1RWLILFDWLRQ)RUP


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$SSHQGL[(3UHJQDQF\DQG&RQWUDFHSWLYH*XLGHOLQHV
0DOHDQGIHPDOHVXEMHFWVZKRKDYHUHDFKHGSXEHUW\PXVWUHFHLYHSUHJQDQF\SUHYHQWLRQ
VH[XDOFRXQVHOLQJDQGEHDGYLVHGRIWKHULVNWRIHWXVLIWKH\EHFRPHSUHJQDQWRUIDWKHU
DFKLOGGXULQJWUHDWPHQWZLWKSURWRFROVSHFLILHGWKHUDSLHV
&RQWUDFHSWLYH5HTXLUHPHQWVIRU6XEMHFWV5HFHLYLQJ3URWRFROVSHFLILHG7KHUDSLHV
)HPDOH6XEMHFWV
)HPDOHVXEMHFWVZKRKDYHUHDFKHGPHQDUFKHPXVWDJUHHWRSUDFWLFHWUXHVH[XDO
DEVWLQHQFHUHIUDLQIURPKHWHURVH[XDOLQWHUFRXUVHRUXVHKLJKO\HIIHFWLYHPHWKRGVRI
FRQWUDFHSWLRQZKLOHUHFHLYLQJSURWRFROVSHFLILHGWKHUDS\DQGIRUDWOHDVWPRQWKVDIWHU
WKHODVWGRVHRIFKHPRWKHUDS\7KHUHOLDELOLW\RIVH[XDODEVWLQHQFHPXVWEHHYDOXDWHG
E\WKHLQYHVWLJDWRUDQGEHWKHSUHIHUUHGDQGXVXDOOLIHVW\OHRIWKHVXEMHFW
&RQWUDFHSWLYHPHWKRGVWKDWDFKLHYHDIDLOXUHUDWHRIOHVVWKDQSHU\HDUZKHQXVHG
FRQVLVWHQWO\DQGFRUUHFWO\DUHFRQVLGHUHGKLJKO\HIIHFWLYHDQGPD\LQFOXGH

&RPELQHGHVWURJHQDQGSURJHVWHURQHFRQWDLQLQJKRUPRQDOFRQWUDFHSWLRQ
DVVRFLDWLRQZLWKLQKLELWLRQRIRYXODWLRQ
o 2UDO
o ,QWUDYDJLQDO
o 7UDQVGHUPDO

3URJHVWHURQHRQO\KRUPRQDOFRQWUDFHSWLRQDVVRFLDWHGZLWKLQKLELWLRQRIRYXODWLRQ
o 2UDO
o ,QMHFWDEOH
o ,PSODQWDEOH

,QWUDXWHULQHGHYLFH,8'

,QWUDXWHULQHKRUPRQDOUHOHDVLQJV\VWHP,86
,IDIHPDOHVXEMHFWLVVXVSHFWHGRIEHLQJSUHJQDQWWKHSURWRFROVSHFLILHGWKHUDSLHVPXVW
EHVWRSSHGLPPHGLDWHO\DQGPD\QRWEHUHVXPHGXQWLODEVHQFHRISUHJQDQF\KDVEHHQ
PHGLFDOO\FRQILUPHG
)HPDOH3DUWQHUVRI0DOH6XEMHFWV
)HPDOHSDUWQHUVRIPDOHVXEMHFWVVKRXOGXVHFRQWUDFHSWLRQIRUPRQWKVSRVW
FKHPRWKHUDS\
0DOH6XEMHFWV
0DOHVXEMHFWVZKRKDYHUHDFKHGSXEHUW\PXVWDJUHHWRSUDFWLFHDEVWLQHQFHUHIUDLQIURP
KHWHURVH[XDOLQWHUFRXUVHGXULQJWUHDWPHQWDQGIRUDQDGGLWLRQDOPRQWKVDIWHUWKHODVW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


GRVHRISURWRFROVSHFLILHGWKHUDSLHV7KHUHOLDELOLW\RIVH[XDODEVWLQHQFHPXVWEH
HYDOXDWHGE\WKHLQYHVWLJDWRUDQGEHWKHSUHIHUUHGDQGXVXDOOLIHVW\OHRIWKHVXEMHFW
0DOHVXEMHFWVZKRDUHVH[XDOO\DFWLYHPXVWXVHDFRQGRPZLWKVSHUPLFLGHGXULQJ
WUHDWPHQWDQGIRUDQDGGLWLRQDOPRQWKVDIWHUWKHODVWGRVHRISURWRFROVSHFLILHG
WKHUDSLHV,QFRXQWULHVZKHUHVSHUPLFLGHLVQRWDYDLODEOHDFRQGRPZLWKRXWVSHUPLFLGH
LVDFFHSWDEOH,QDGGLWLRQLWLVUHFRPPHQGHGWKDWDQRQSUHJQDQWIHPDOHSDUWQHURI
UHSURGXFWLYHSRWHQWLDODOVRFRQVLGHUXVLQJFRQWUDFHSWLYH0DOHVXEMHFWVZLWKDSUHJQDQW
SDUWQHUPXVWXVHDFRQGRPGXULQJVH[XDOLQWHUFRXUVHWRDYRLGH[SRVLQJWKH
HPEU\RIHWXVWRSURWRFROVSHFLILHGWKHUDSLHVYLDVHPLQDOIOXLG0DOHVXEMHFWVZKRDUH
UDQGRPL]HGWRWKHEOLQDWXPRPDEDUPDQGUHFHLYHGFKHPRWKHUDS\SULRUWRVWXG\
HQWU\PXVWXVHFRQWUDFHSWLRQIRUPRQWKVDIWHUODVWGRVHRIFKHPRWKHUDS\
,QVFHQDULRVZKHUHDSRWHQWLDORYHUODSRIFRQWUDFHSWLYHGXUDWLRQUHTXLUHPHQWV
H[LVWVGXHWRGLIIHUHQWWUHDWPHQWVWKHPRVWFRQVHUYDWLYHFRQWUDFHSWLYHGXUDWLRQ
UHTXLUHPHQWVKRXOGEHIROORZHG

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$SSHQGL[).DUQRIVN\DQG/DQVN\3HUIRUPDQFH6WDWXV6FDOHV
.DUQRIVN\3HUIRUPDQFH6WDWXV6FDOH
*UDGH
'HVFULSWLRQV

1RUPDOQRFRPSODLQWVQRHYLGHQFHRIGLVHDVH

$EOHWRFDUU\RQQRUPDODFWLYLW\PLQRUVLJQVRUV\PSWRPVRIGLVHDVH

1RUPDODFWLYLW\ZLWKHIIRUWVRPHVLJQVRUV\PSWRPVRIGLVHDVH

&DUHVIRUVHOIXQDEOHWRFDUU\RQQRUPDODFWLYLW\RUWRGRDFWLYHZRUN

5HTXLUHVRFFDVLRQDODVVLVWDQFHEXWLVDEOHWRFDUHIRUPRVWRIKLVSHUVRQDO
QHHGV

5HTXLUHVFRQVLGHUDEOHDVVLVWDQFHDQGIUHTXHQWPHGLFDOFDUH

'LVDEOHGUHTXLUHVVSHFLDOFDUHDQGDVVLVWDQFH

6HYHUHO\GLVDEOHGKRVSLWDODGPLVVLRQLVLQGLFDWHGDOWKRXJKGHDWKQRWLPPLQHQW

9HU\VLFNKRVSLWDODGPLVVLRQQHFHVVDU\DFWLYHVXSSRUWLYHWUHDWPHQWQHFHVVDU\

0RULEXQGIDWDOSURFHVVHVSURJUHVVLQJUDSLGO\

'HDG
6RXUFH 6FKDJ+HLQULFK*DQ]
/DQVN\3HUIRUPDQFH6WDWXV6FDOH
*UDGH
'HVFULSWLRQV

)XOO\DFWLYHQRUPDO

0LQRUUHVWULFWLRQVLQVWUHQXRXVSK\VLFDODFWLYLW\

$FWLYHEXWWLUHGPRUHTXLFNO\

*UHDWHUUHVWULFWLRQRISOD\DQGOHVVWLPHVSHQWLQSOD\DFWLYLW\

8SDQGDURXQGEXWDFWLYHSOD\PLQLPDONHHSVEXV\E\EHLQJLQYROYHGLQTXLHWHU
DFWLYLWLHV

/\LQJDURXQGPXFKRIWKHGD\EXWJHWVGUHVVHGQRDFWLYHSOD\LQJSDUWLFLSDWHVLQ
DOOTXLHWSOD\DQGDFWLYLWLHV

0DLQO\LQEHGSDUWLFLSDWHVLQTXLHWDFWLYLWLHV

%HGERXQGQHHGLQJDVVLVWDQFHIRUHYHQTXLHWSOD\

6OHHSLQJRIWHQSOD\HQWLUHO\OLPLWHGWRYHU\SDVVLYHDFWLYLWLHV

'RHVQ¶WSOD\GRHVQRWJHWRXWRIWKHEHG

8QUHVSRQVLYH
6RXUFH/DQVN\/LVW/DQVN\5LWWHU6WHUU0LOOHU

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$SSHQGL[*&ULWHULDDQG'HILQLWLRQVIRU'LVHDVH6WDWXV$VVHVVPHQW
&\WRORJLFDO%RQH0DUURZ$VVHVVPHQW
0
5HSUHVHQWDWLYHERQHPDUURZDVSLUDWHRUELRSV\ZLWKEODVWVZLWKYHU\ORZ
FHOOXODULW\DQGZLWKQRUHJHQHUDWLQJKHPDWRSRLHVLV
0
5HSUHVHQWDWLYHERQHPDUURZDVSLUDWHRUELRSV\ZLWKEODVWVZLWKVDWLVIDFWRU\
FHOOXODULW\DQGZLWKUHJHQHUDWLQJKHPDWRSRLHVLV
0D
5HSUHVHQWDWLYHERQHPDUURZDVSLUDWHRUELRSV\ZLWKDWOHDVWDQG
EODVWV
0
5HSUHVHQWDWLYHERQHPDUURZDVSLUDWHRUELRSV\ZLWKDWOHDVWEODVWV
1RQUHSUHVHQWDWLYH
ERQHPDUURZ
1RWHYDOXDEOHERQHPDUURZ
5HODSVH&ULWHULD
,VRODWHGERQH
PDUURZUHODSVH
0PDUURZLQWKHDEVHQFHRIH[WUDPHGXOODU\LQYROYHPHQW
&RPELQHGERQH
PDUURZUHODSVH
0RU0PDUURZDQGDWOHDVWRQHH[WUDPHGXOODU\PDQLIHVWDWLRQRI$//
([WUDPHGXOODU\
UHODSVH
&16UHODSVH0RUSKRORJLFDOO\XQHTXLYRFDOOHXNHPLFO\PSKREODVWVLQWKH&6)DQG
DSOHRF\WRVLVRIȝOQXFOHDWHGFHOOV,IWKH&)6LVFRQWDPLQDWHGZLWKEORRGWKH
IROORZLQJSURFHGXUHLVUHFRPPHQGHGDIWHUFRQVXOWDWLRQZLWKWKHQDWLRQDOVWXG\
FHQWHU,IEODVWVDUHSUHVHQWLQWKH&6)EXWQRWLQWKHSHULSKHUDOEORRG&16
UHODSVHLVDVVXPHG,IWKHSURSRUWLRQRIEODVWVLQWKH&6)LVHTXLYDOHQWWRWKH
SURSRUWLRQRIEODVWVLQWKHSHULSKHUDOEORRGDQGWKHUHLVQRDGGLWLRQDOPRUSKRORJLF
HYLGHQFHWKDWWKHEODVWVSHUVLVWHGLQWKH&6)FRQWDPLQDWLRQLVDVVXPHG,Q
XQFOHDUVLWXDWLRQVDFDVHE\FDVHGHFLVLRQPD\EHQHFHVVDU\,QWKHSUHVHQFHRI
EODVWVWKHSDWLHQWZLOOUHFHLYHWKHLQWHQVLILHGLQWUDWKHFDOFKHPRWKHUDS\VLPLODUWR
SDWLHQWVZLWK&16LQYROYHPHQWEXWQRWWKHLQFUHDVHGGRVHRIFUDQLDOLUUDGLDWLRQ,Q
WKHSUHVHQFHRIFOLQLFDOVLJQVRI&16LQYROYHPHQWVXFKDVYLVXDOGLVWXUEDQFHV
SRO\SKDJLDFUDQLDOQHUYHSDOVLHVEXWZLWKRXW&6)SOHRF\WRVLVWKHSUHVHQFHRID
&16UHODSVHKDVWREHFRQILUPHGRUUXOHGRXWZLWKDOODYDLODEOHGLDJQRVWLFPHWKRGV
FUDQLDO&705,,IHYLGHQFHRIPHQLQJHDOLQILOWUDWLRQLVIRXQGE\LPDJLQJD
ELRSV\PD\KDYHWREHSHUIRUPHG

7HVWLFXODUUHODSVH8QLRUELODWHUDOSDLQOHVVWHVWLFXODUHQODUJHPHQWZLWKLQILOWUDWLRQ
RIOHXNHPLFO\PSKREODVWVFRQILUPHGE\ELRSV\LQFDVHRIDFOLQLFDOO\QRUPDO
FRQWUDODWHUDOWHVWLVDVXEFOLQLFDOLQYROYHPHQWKDVWREHUXOHGRXWE\ELRSV\

5HODSVHDWRWKHUVLWHV'HWHFWLRQRIOHXNHPLFLQILOWUDWLRQE\DSSURSULDWHLPDJLQJ
WHFKQLTXHVZLWKFRQILUPDWLRQE\ELRSV\
05'UHDSSHDUDQFH
$UHFRQYHUVLRQDIWHUPROHFXODUUHPLVVLRQWRUHSURGXFLEOH05'SRVLWLYLW\DWDOHYHO

LVFDOOHGPROHFXODUUHDSSHDUDQFH$UHFRQILUPDWLRQLVVWURQJO\
UHFRPPHQGHG7KLVILQGLQJGRHVQRWIXOILOWKHFRQGLWLRQVIRUWKHGHILQLWLRQRI
VXEVHTXHQWUHODSVHDQGLVQRWFRQVLGHUHGDVHYHQW
5HPLVVLRQ&ULWHULD
$SODVWLFERQH
PDUURZ
0PDUURZ
&RPSOHWH
UHPLVVLRQ&5

0PDUURZ

3HULSKHUDOEORRGZLWKRXWEODVWV

$EVHQFHRIH[WUDPHGXOODU\OHXNHPLFLQYROYHPHQW
1RQUHVSRQVH15
3HUVLVWLQJ0PDUURZDWWKHHQGRIWUHDWPHQWZLWKLQYHVWLJDWLRQDOSURGXFWV
0ROHFXODU
UHPLVVLRQ
05'YDOXHRI7KLVOHYHOLVDFFHSWHGDVWKHORZHUTXDQWLILDEOHPDUJLQIRU
3&5DQGRUIORZTXDQWLILFDWLRQRI05'
DVXEMHFWVDUHFRQVLGHUHGKLJKULVNLIOHVVWKDQ0LVRODWHGERQHPDUURZUHODSVHEXWEODVWVDUH
FRQILUPHGE\IORZRU3&5WREHUHODSVHDQGQRWHDUO\UHJHQHUDWLQJQRUPDOFHOOVDQGWKHLQYHVWLJDWRU
FRQVLGHUHGWKHVXEMHFWKLJKULVNDQGWUHDWHGZLWKDKLJKULVNUHJLPHQ

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW
3DJHRI
&21),'(17,$/


$SSHQGL[+&OLQLFDOO\5HOHYDQW1HXURORJLF(YHQWVE\+LJKOHYHO*URXS7HUP
+/*7
&UDQLDOQHUYHGLVRUGHUVH[FOXGLQJQHRSODVPV
'HP\HOLQDWLQJGLVRUGHUV
(QFHSKDORSDWKLHV
0HQWDOLPSDLUPHQWGLVRUGHUV
0RYHPHQWGLVRUGHUVLQFOXGLQJSDUNLQVRQLVP
1HXURORJLFDOGLVRUGHUV1(&
6HL]XUHVLQFOXGLQJVXEW\SHV
&RJQLWLYHDQGDWWHQWLRQGLVRUGHUVDQGGLVWXUEDQFHV
&RPPXQLFDWLRQGLVRUGHUVDQGGLVWXUEDQFHV
'HOLULDLQFOXGLQJFRQIXVLRQ
'HPHQWLDDQGDPQHVWLFFRQGLWLRQV
'LVWXUEDQFHVLQWKLQNLQJDQGSHUFHSWLRQ
3V\FKLDWULFGLVRUGHUV1(&
6FKL]RSKUHQLDDQGRWKHUSV\FKRWLFGLVRUGHUV


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$XJXVW3DJHRI
$PJHQ3URSULHWDU\&RQILGHQWLDO
)250(IIHFWLYH'DWH0DU9HUVLRQ
$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH7ULDOWR
,QYHVWLJDWHWKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7($QWLERG\
%OLQDWXPRPDEDV&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO
&RQVROLGDWLRQ&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW
5HODSVH%SUHFXUVRU$FXWH/\PSKREODVWLF/HXNHPLD$//

$PJHQ3URWRFRO1XPEHU%OLQDWXPRPDE
(XGUD&71XPEHU
1&71XPEHU

$PHQGPHQW'DWH
$XJXVW

5DWLRQDOH
7KHSURWRFROLVEHLQJDPHQGHG

7RXSGDWHFRQWUDFHSWLRQGXUDWLRQIRUVH[XDOO\PDWXUHIHPDOHVXEMHFWVIURPDW
OHDVWKRXUVDIWHUWKHODVWGRVHRIEOLQDWXPRPDEWRDWOHDVWPRQWKVDIWHU
WKHODVWGRVHRIFKHPRWKHUDS\WRDFFRXQWIRUVWDQGDUGRIFDUHFKHPRWKHUDS\
VXEMHFWVUHFHLYHGSULRUWRVWXG\HQUROOPHQW 

7RXSGDWHFRQWUDFHSWLRQGXUDWLRQIRUVH[XDOO\PDWXUHPDOHVXEMHFWVIURPDQ
DGGLWLRQDOKRXUVDIWHUUHFHLYLQJSURWRFROVSHFLILHGWKHUDS\WRDWOHDVW
PRQWKVDIWHUUHFHLYLQJODVWGRVHRIFKHPRWKHUDS\WRDFFRXQWIRUVWDQGDUGRI
FDUHFKHPRWKHUDS\VXEMHFWVUHFHLYHGSULRUWRVWXG\HQUROOPHQW

7RDGGDQRWHWKDWLQVFHQDULRVZKHUHDSRWHQWLDORYHUODSRIFRQWUDFHSWLYH
GXUDWLRQUHTXLUHPHQWVH[LVWVGXHWRGLIIHUHQWWUHDWPHQWVWKHPRVW
FRQVHUYDWLYHFRQWUDFHSWLYHGXUDWLRQUHTXLUHPHQWVKRXOGEHIROORZHG

7RXSGDWHRYHUGRVHODQJXDJHWRLQIRUPWKDWIRU+&FKHPRWKHUDS\RU
FRQFRPLWDQWPHGLFDWLRQVRYHUGRVHZLOOQRWEHUHSRUWHGDVDQDGYHUVH
HYHQWVHULRXVDGYHUVHHYHQWXQOHVVLWLVDQLQWHQWLRQDORYHUGRVH

7RXSGDWH,PSRUWDQW3URWRFRO'HYLDWLRQ,3'QXPEHULQJIURP
3URWRFROVSHFLILF,3'/LVWGRFXPHQWYHUVLRQGDWHG$XJXVW

7RXSGDWHVDIHW\UHSRUWUHTXLUHPHQWODQJXDJHVWKDWDUHGHHPHGPDQGDWRU\
IRUDOORQJRLQJ$PJHQVSRQVRUHGLQWHUYHQWLRQDOVWXGLHVWRDOLJQZLWKODWHVW
FOLQLFDOSURWRFROWHPSODWHYHUVLRQHIIHFWLYHGDWH0D\

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH'HFHPEHU
3DJHRI
$PJHQ3URSULHWDU\&RQILGHQWLDO
)250(IIHFWLYH'DWH0DU9HUVLRQ
$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH7ULDOWR,QYHVWLJDWH
WKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7($QWLERG\%OLQDWXPRPDEDV
&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ&KHPRWKHUDS\LQ
3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU$FXWH/\PSKREODVWLF
/HXNHPLD$//

$PJHQ3URWRFRO1XPEHU%OLQDWXPRPDE

$PHQGPHQW'DWH
'HFHPEHU

5DWLRQDOH
7KHPDLQSXUSRVHRIWKLVSURWRFRODPHQGPHQWLVWR

8SGDWHWKHNH\VSRQVRUFRQWDFWGHWDLOV

&ODULI\WKDWDGYHUVHHYHQWVDVVRFLDWHGZLWKNH\VDIHW\SDUDPHWHU.63VKRXOGEH
UHSRUWHGIRUWKHGXUDWLRQRIWKHVWXG\ZLWKWKHH[FHSWLRQWKDWWKRVHUHODWHGWRRWKHU
DQWLFDQFHUWKHUDSLHVRFFXUULQJSRVWEOLQDWXPRPDEWUHDWPHQWPD\EHH[FOXGHG
o 8SGDWHSURWRFROODQJXDJHSHUQHZWHPSODWHXSGDWHVFODULI\WKDWVHULRXV
DGYHUVHHYHQWVVXVSHFWHGWREHUHODWHGWREOLQDWXPRPDEWKDWWKHLQYHVWLJDWRU
EHFRPHVDZDUHRIZLOOEHUHSRUWHGWR$PJHQZLWKLQKRXUVRIDZDUHQHVV
GXULQJWKHORQJWHUPIROORZXSSKDVH
o &KDQJHWKHFRQWUDFHSWLRQSHULRGDYRLGDQFHRISUHJQDQF\EUHDVWIHHGLQJ
DQGVSHUPGRQDWLRQSHULRGIURPPRQWKVWRKRXUV7KHFKDQJHLQ
ZLQGRZIRUDYRLGDQFHRIEUHDVWIHHGLQJDQGSUHJQDQF\ZDVH[WHQGHGIURP
KRXUVWRKRXUVLQ)HEUXDU\KRZHYHUWKLVFKDQJHZDVQRWPDGHLQ
WKHSUHYLRXVSURWRFRODPHQGPHQWYHUVLRQ
o 8SGDWHWKHODQJXDJHIRUUHSRUWLQJSURFHGXUHVIRUDGYHUVHHYHQWVDQGVHULRXV
DGYHUVHHYHQWV
o &ODULI\WKDWRQO\DGYHUVHHYHQWVRUVHULRXVDGYHUVHHYHQWVZLOOEHUHSRUWHGLI
WKHUHZDVKDUPIURPRYHUGRVHDQGWRDOLJQZLWKRWKHUVHFWLRQVRIWKH
SURWRFRO

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH'HFHPEHU
3DJHRI
$PJHQ3URSULHWDU\&RQILGHQWLDO
)250(IIHFWLYH'DWH0DU9HUVLRQ
o 8SGDWHWKHVHULRXVDGYHUVHHYHQWUHSRUWLQJSUHJQDQF\DQGODFWDWLRQIRUPLQ
WKHDSSHQGLFHVRIWKHSURWRFRO

2WKHUPLQRUSURWRFROFODULILFDWLRQVDQGLQFRQVLVWHQFLHVZHUHXSGDWHGGXULQJWKLV
DPHQGPHQW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH1RYHPEHU
3DJHRI
&21),'(17,$/


$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH7ULDOWR,QYHVWLJDWH
WKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7(£$QWLERG\%OLQDWXPRPDEDV
&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ&KHPRWKHUDS\LQ
3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU$FXWH/\PSKREODVWLF
/HXNHPLD$//

$PJHQ3URWRFRO1XPEHU%OLQDWXPRPDE

$PHQGPHQW'DWH
1RYHPEHU

5DWLRQDOH
7KHPDLQSXUSRVHRIWKLVSURWRFRODPHQGPHQWLVWRFDSWXUH&'H[SUHVVLRQLQFDVHVRI
UHODSVHDQGWRXSGDWHDGYHUVHHYHQWJXLGDQFH
2WKHUPLQRUSURWRFROFODULILFDWLRQVDQGLQFRQVLVWHQFLHVZHUHXSGDWHGGXULQJWKLV
DPHQGPHQW

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH'HFHPEHU
3DJHRI
&21),'(17,$/


$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH7ULDOWR,QYHVWLJDWH
WKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7(£$QWLERG\%OLQDWXPRPDEDV
&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ&KHPRWKHUDS\LQ
3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU$FXWH/\PSKREODVWLF
/HXNHPLD$//

$PJHQ3URWRFRO1XPEHU
1&71XPEHU

$PHQGPHQW'DWH
'HFHPEHU

5DWLRQDOH
7KLVLVDPHQGPHQWIRUEOLQDWXPRPDEVWXG\7KHSULPDU\FKDQJHVLQFOXGHG
WKHIROORZLQJ
x
,QDOLJQPHQWZLWKWKHUHFHQWO\DSSURYHGUHTXHVWIRUPRGLILFDWLRQRIWKHEOLQDWXPRPDE
3HGLDWULF,QYHVWLJDWLRQ3ODQ3,3WKHRSWLRQIRUDGDSWDWLRQRIWKHVWXG\ZDVUHPRYHG
IURPWKHVWXG\GHVLJQ$PJHQKDGSURSRVHGUHPRYDORIWKHDGDSWDWLRQIRUWKH
IROORZLQJUHDVRQV7KHDGDSWHGVWXG\ZLOOPLVVWKHSULPDU\HQGSRLQWIRUWKH
RULJLQDOVWXG\GHVLJQ7KHDGDSWHGVWXG\LVXQOLNHO\WRPHHWWKH3,3WLPHOLQH
6WXG\FRQWLQXDWLRQZLWKRXWDGDSWDWLRQDOORZVHYDOXDWLRQRIWKHLPSDFWRI
EOLQDWXPRPDEXVHGXULQJFRQVROLGDWLRQWKHUDS\
x
([SODQDWLRQRIVXEMHFWVWKDWDUHH[HPSWIURPVXSSO\LQJPDWHULDOIURPUHODSVHIRU
3&5FHQWUDOODEDQDO\VLVZDVDGGHGWRLQFOXVLRQFULWHULRQ
x
$GGLWLRQWRSURKLELWHGWUHDWPHQWVZDVDGGHGWR6HFWLRQWRH[FOXGHVXEMHFWV
UHFHLYLQJDGGLWLRQDOF\FOHVRIWKHVWXG\GUXJVDIWHUWKHWUHDWPHQWF\FOHLVFRPSOHWHG
x
/RQJWHUPIROORZXSIRUVXEMHFWVZDVFKDQJHGIURPPRQWKVIROORZLQJDOOR+6&7WR
XQWLOWKHODVWVXEMHFWHQUROOHGRQWKHVWXG\LVPRQWKVIROORZLQJDOOR+6&7WRDOORZ
ORQJHUIROORZXSGDWDRQWKHVXEMHFWVWREHFROOHFWHGZKLOHWKHVWXG\LVRSHQ
x
3ULPDU\FRPSOHWLRQDQGHQGRIVWXG\ODQJXDJH6HFWLRQKDVEHHQXSGDWHGWR
DOLJQZLWKFXUUHQWSURWRFROWHPSODWHLQRUGHUWRFOHDUO\GHILQHWKHVHWHUPVDQGZKHQ
WKH\RFFXU
x
$GPLQLVWUDWLYHW\SRJUDSKLFDODQGIRUPDWWLQJFKDQJHVZHUHPDGHWKURXJKRXWWKH
SURWRFRO
$SSURYHG



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH-XO\
3DJHRI
&21),'(17,$/


$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH$GDSWLYH7ULDOWR
,QYHVWLJDWHWKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7(£$QWLERG\
%OLQDWXPRPDEDV&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ
&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU
$FXWH/\PSKREODVWLF/HXNHPLD$//

$PJHQ3URWRFRO1XPEHU

$PHQGPHQW'DWH
-XO\
5DWLRQDOH
7KLVSURWRFROLVEHLQJDPHQGHGKHOSFODULI\LVVXHVWKDWKDYHRFFXUUHGDVVXEMHFWVKDYH
EHHQHQUROOHG,QDGGLWLRQWKHUHKDVEHHQDFKDQJHLQWKHVKHOIOLIHRIDNH\VWDQGDUG
FKHPRWKHUDS\DJHQW3(*$VSDUDJLQDVHWKDWZDVVXSSOLHGE\$0*(13(*
$VSDUDJLQDVHZLOOQRZEHHLWKHUSURYLGHGRUUHLPEXUVHGFRPSHQVDWHGWRWKHVWXG\VLWH
VRWKHUHLVDYDLODELOLW\RIWKLVDJHQWIRUDOOVXEMHFWV0DMRUFKDQJHVLQFOXGH
x
$GG³(YDOXDWHSKDUPDFRNLQHWLFVRIEOLQDWXPRPDE´WRWKHVHFRQGDU\REMHFWLYHV
3UHYLRXVO\WKLVZDVDQHQGSRLQWEXWQRWOLVWHGDVDQREMHFWLYH
x
&RUUHFWWKDWQRWDOOVXEMHFWVZLOOSURFHHGWRWUDQVSODQWLI0PDUURZRFFXUVDIWHU
FRQVROLGDWLRQUHDVRQVQRWWRSURFHHGWRWUDQVSODQWPD\LQFOXGHLVVXHVVXFKDV
GRQRUQRWDYDLODEOHLQIHFWLRQRUJDQIXQFWLRQLVVXHV
x
&RUUHFWWKHQXPEHURIFHQWHUVSDUWLFLSDWLQJLQWKHVWXG\DVWKLVKDVLQFUHDVHG
x
3ULPDU\FRPSOHWLRQQRZDOVRLQFOXGHVLIWKHVWXG\LVVWRSSHGSUHPDWXUHO\
x
8SGDWHLQFOXVLRQFULWHULRQUHPRYHGWKHGHILQLWLRQRI0PDUURZVLQFHLWZDV
FRQIXVLQJWRLQYHVWLJDWRUVVLQFH0PDUURZVDUHDOVRDOORZHG
x
8SGDWHLQFOXVLRQFULWHULRQH[FOXGHG&16UHODSVHVXEMHFWVIURPKDYLQJWRVXSSO\
WKHPDWHULDOUHTXHVWHGIRUFHQWUDOODE05'DQDO\VLVDVLWLVGLIILFXOWWRSHUIRUPWKLV
DQDO\VLVRQ&6)VDPSOHV
x
8SGDWHGWKHH[FOXVLRQFULWHULRQFKDQJHGWRWRWDOELOLUXELQIURPGLUHFWELOLUXELQDV
WKDWLVWKHODEWHVWPRVWVLWHVXVHLQWKHLUFKHPLVWU\SDQHODQGLQFUHDVHGWKH
DFFHSWDEOHOHYHORIWRWDOELOLUXELQIRUVWXG\HQWU\WRDOLJQZLWKWKH86SURWRFRO
$$//LQRUGHUWRDYRLGVFUHHQLQJIDLOXUHV
x
8SGDWHGH[FOXVLRQFULWHULRQFKDQJHGWRLQGLFDWHWKDWH[FOXVLRQFULWHULD
DQGGRQRWKDYHWRUHVROYHWRJUDGHIRUVWXG\SDUWLFLSDWLRQ
x
8SGDWHGH[FOXVLRQFULWHULRQFKDQJHGNQRZQWRGRFXPHQWHGIRUFODULW\
x
8SGDWHGH[FOXVLRQFULWHULRQDGGHGFODULILFDWLRQWKDWDVSDUDJLQDVHUHDFWLRQVDUH
QRWDQH[FOXVLRQFULWHULRQ
$SSURYHG



3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH-XO\
3DJHRI
&21),'(17,$/


x
$GGHGWRUHVFUHHQLQJLVQRWSHUPLWWHGWKDWVFUHHQLQJSHULRGFDQEHH[WHQGHGGD\V
IRUERQHPDUURZFRXQWUHFRYHU\DQGRUVFKHGXOLQJRIERQHPDUURZFROOHFWLRQRQO\
x
$GGHGWKDWVWXG\GUXJPD\EHUHLPEXUVHGFRPSHQVDWHGWRHQVXUHWKDWLWZLOOEH
SURYLGHGVLQFHQHZVKHOIOLIHLVVXHVIRU3(*DVSDUDJLQDVHZLOOPDNHLWQHFHVVDU\WR
XVHKRVSLWDOVXSSO\DWVRPHFHQWHUVZLWKVXEVHTXHQWUHLPEXUVHPHQWWRWKHFHQWHU
x
&RUUHFWHGWKDWDQWLFRQYXOVDQWWUHDWPHQWQHHGVWREHVWDUWHGSULRUWRUHVXPSWLRQRI
WKHF\FOHDIWHUDVHL]XUHKDVLQWHUUXSWHGWKHEOLQDWXPRPDELQIXVLRQ
x
&ODULILHGWKDWWRGLVFRQWLQXHEOLQDWXPRPDEIRUUHOHYDQWQHXURORJLFHYHQWVWKDWWKH\
QHHGWREHUHODWHGWREOLQDWXPRPDE
x
$GGHGDOOHUJLFUHDFWLRQVDVDFRPSOLFDWLRQWKDWRFFXUVZLWKDVSDUDJLQDVH
x
&ODULILFDWLRQRIZKDWGDWDQHHGWREHFROOHFWHGIURPVLJQLQJWRVDIHW\YLVLWDQGGXULQJ
WKHVKRUWWHUPIROORZXSXQWLOGD\DIWHUDOOR+6&7
x
&ODULILFDWLRQRIWLPLQJRILQWUDWKHFDOFKHPRWKHUDS\DQGWKDWLWFDQEHDGPLQLVWHUHG
SULRUWRVLJQLQJFRQVHQWDVORQJDVLWLVDGPLQLVWHUHGZLWKLQGD\VSULRUWRWUHDWPHQW
VWDUW
x
&ODULILFDWLRQRI'D\LQWUDWKHFDOFKHPRWKHUDS\DGPLQLVWUDWLRQ
x
$GGHGFODULILFDWLRQLQVFKHGXOHRIDVVHVVPHQWVIRUIRRWQRWH*IRUWLPLQJRIERQH
PDUURZDQG05'VDPSOHVIRRWQRWH2DQG3WRFODULI\GDWDWRFROOHFWRQWKH
FRQFRPLWDQWPHGLFDWLRQH&5)GXULQJYDULRXVWLPHIUDPHVLQWKHSURWRFRO
x
&ODULILFDWLRQRIZKDWWHVWVDUHUHSRUWHGRQWKHERQHPDUURZE\FHQWUDOUHYLHZDQG
ORFDOODERUDWRU\
x
$GGHGWKDWVDIHW\IROORZXSDOVRRFFXUVSULRUWRDQ\DQWLOHXNHPLFWKHUDS\QRW
PDQGDWHGE\WKHSURWRFRO
x
&ODULILFDWLRQRQZKHQDVXEMHFWHQWHUVORQJWHUPIROORZXS
x
&ODULILFDWLRQWKDWFHQWUDOODERUDWRU\UHVXOWVZLOOEHXVHGLILQGLVFUHSDQF\ZLWKORFDO
HYDOXDWLRQ
x
&ODULILFDWLRQWKDW.H\6DIHW\3DUDPHWHUVDGYHUVHHYHQWVVKRXOGEHUHSRUWHGRQWKH
DSSURSULDWHH&5)
x
&ODULILFDWLRQRIWLPLQJRI$(H&5)UHSRUWLQJIRUWKRVHSURFHHGLQJDQGQRWSURFHHGLQJ
WRDOOR+6&7
x
$GPLQLVWUDWLYHDQGHGLWRULDOFKDQJHV
$SSURYHG



$SSURYHG


3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH$GDSWLYH7ULDOWR
,QYHVWLJDWHWKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7(£$QWLERG\
%OLQDWXPRPDEDV&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ
&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU
$FXWH/\PSKREODVWLF/HXNHPLD$//

$PJHQ3URWRFRO1XPEHU%OLQDWXPRPDE
(XGUD&7QXPEHU

$PHQGPHQW'DWH
$SULO

5DWLRQDOH
7KLVSURWRFROLVEHLQJDPHQGHGWR
x
$GG3RSXODWLRQ3.$QDO\VLVDVDVHFRQGDU\HQGSRLQW
x
&RUUHFWWLPHIUDPHIRUDGPLQLVWUDWLRQRI,7SURSK\OD[LVDVSUHPHGLFDWLRQLQ62&
DUP
x
&KDQJHWUHDWPHQWIUHHLQWHUYDOIURPZHHNVWRZHHNZKHQGHILQLQJDF\FOHLQ
WKHDGDSWLYHGHVLJQ
x
8SGDWHH[FOXVLRQFULWHULDWRHDVHWKHUHTXLUHPHQWVIRUELOLUXELQ
x
8SGDWHLQFOXVLRQFULWHULDWRDGGUHTXLUHPHQWRIKLVWRULFDOVDPSOHVIRUFHQWUDO
DQDO\VLVRI05'
x
8SGDWHH[FOXVLRQFULWHULDWRUHPRYHH[FOXVLRQRIRWKHULQYHVWLJDWLRQDOSURFHGXUHV
GXULQJVWXG\FRQWDFW
x
$GPLQLVWUDWLYHDQGHGLWRULDOFKDQJHV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH6HSWHPEHU
3DJHRI
&21),'(17,$/


$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH$GDSWLYH7ULDOWR
,QYHVWLJDWHWKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7(£$QWLERG\
%OLQDWXPRPDEDV&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ
&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU
$FXWH/\PSKREODVWLF/HXNHPLD$//

$PJHQ3URWRFRO1XPEHUEOLQDWXPRPDE
(XGUD&7

$PHQGPHQW'DWH
6HSWHPEHU

5DWLRQDOH
7KHSURWRFROLVEHLQJDPHQGHGWR
x
$GG,7SURSK\OD[LVK\GURFRUWLVRQHDVDQDOWHUQDWLYHWRSUHGQLVRORQHWRDOORZ8.
DQG$XVWUDOLDSDUWLFLSDWLRQLQWKHVWXG\
x
&KDQJHGLVWULEXWLRQRIVLWHVSDUWLFLSDWLQJLQWKHVWXG\
x
$GDSWWKHWLPHSHULRGIRUDGPLQLVWUDWLRQRI,7SURSK\OD[LVWRDOLJQZLWKEHVW
PHGLFDOSUDFWLFHIRUWKH62&DUP
x
$GGFXPXODWLYHLQFLGHQFHRIUHODSVHWRHQGSRLQWV
x
$GGFRDJXODWLRQDVVHVVPHQWWR6HFWLRQVFUHHQLQJSUHSKDVHSURFHGXUHVWR
DOLJQZLWK7DEOH6FKHGXOHRI$VVHVVPHQWV
x
8SGDWHSUHJQDQF\FRQWUDFHSWLRQDQGODFWDWLRQUHTXLUHPHQWVWRDOLJQZLWK
FXUUHQWULVNDQGGLVFRPIRUWVODQJXDJH
x
&ODULI\ODQJXDJHLQVHYHUDOVHFWLRQV

3URGXFW%OLQDWXPRPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$PHQGPHQW
3URWRFRO7LWOH$5DQGRPL]HG2SHQODEHO&RQWUROOHG3KDVH$GDSWLYH7ULDOWR
,QYHVWLJDWHWKH(IILFDF\6DIHW\DQG7ROHUDELOLW\RIWKH%L7(£ $QWLERG\
%OLQDWXPRPDEDV&RQVROLGDWLRQ7KHUDS\9HUVXV&RQYHQWLRQDO&RQVROLGDWLRQ
&KHPRWKHUDS\LQ3HGLDWULF6XEMHFWV:LWK+LJKULVN)LUVW5HODSVH%SUHFXUVRU
$FXWH/\PSKREODVWLF/HXNHPLD$//
$PJHQ3URWRFRO1XPEHU
'DWH
 -DQXDU\ 
$PHQGPHQW'DWH
$SULO
5DWLRQDOH
7KHSXUSRVHRIWKLVDPHQGPHQWLVWRFODULI\WKHIROORZLQJ
x
7KHDEQRUPDOVHUXPFUHDWLQLQHYDOXHUHTXLUHGIRUH[FOXVLRQIURPWKHFOLQLFDOWULDO
x
0HDVXUHVWRSUHYHQWPLQLPL]HSDLQDQGGLVFRPIRUWGXULQJEORRGVDPSOLQJ
x
0HDVXUHVWRPLQLPL]HWKHEORRGYROXPHVUHTXLUHGIRUVDPSOLQJGXULQJWKHWULDO