Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Phase: PHASE3
Conditions: Limited Stage Lung Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
Sponsor: National Cancer Institute (NCI)

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
3URWRFRO$JHQW
$JHQW
6XSSO\
16&
,1'
,1'6SRQVRU
&LVSODWLQ
&RPPHUFLDO






'&7'1&,
&DUERSODWLQ
&RPPHUFLDO

(WRSRVLGH
&RPPHUFLDO

$WH]ROL]XPDE
03'/$
1&,30%


3DUWLFLSDWLQJ6LWHV)(%
86
&DQDGD
-DSDQ

'RFXPHQW+LVWRU\

9HUVLRQ'DWH
$PHQGPHQW
-XO\
$PHQGPHQW
'HFHPEHU
$PHQGPHQW
1RYHPEHU
$PHQGPHQW
2FWREHU
$PHQGPHQW
1RYHPEHU
$PHQGPHQW
$XJXVW
$PHQGPHQW
2FWREHU
$PHQGPHQW
-XQH
$PHQGPHQW
0DUFK
$PHQGPHQW
)HEUXDU\
$PHQGPHQW
6HSWHPEHU
$PHQGPHQW
1RYHPEHU
$PHQGPHQW
2FWREHU
,QLWLDO
0DUFK

















7KLVSURWRFROZDVGHVLJQHGDQGGHYHORSHGE\15*2QFRORJ\,WLVLQWHQGHG
WREHXVHGRQO\LQFRQMXQFWLRQZLWKLQVWLWXWLRQVSHFLILF,5%DSSURYDOIRU
VWXG\HQWU\1RRWKHUXVHRUUHSURGXFWLRQLVDXWKRUL]HGE\15*2QFRORJ\
QRUGRHV15*2QFRORJ\DVVXPHDQ\UHVSRQVLELOLW\IRUXQDXWKRUL]HGXVHRI
WKLVSURWRFRO
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
15*21&2/2*<DQG
7+($//,$1&()25&/,1,&$/75,$/6,121&2/2*<
15*/8
(ClinicalTrials.gov NCT #03811002) 

/,0,7('67$*(60$//&(///81*&$1&(5/66&/&$3+$6(,,,
5$1'20,=('678'<2)&+(025$',$7,219(5686
&+(025$',$7,213/86$7(=2/,=80$%

&768&217$&7,1)250$7,212&7
)RUUHJXODWRU\UHTXLUHPHQWV
)RUSDWLHQWHQUROOPHQWV
)RUGDWDVXEPLVVLRQ
5HJXODWRU\GRFXPHQWDWLRQPXVWEH
VXEPLWWHGWRWKH&DQFHU7ULDOV
6XSSRUW8QLW&768YLDWKH
5HJXODWRU\6XEPLVVLRQ3RUWDO6LJQ
LQDWKWWSVZZZFWVXRUJDQGVHOHFW
5HJXODWRU\!5HJXODWRU\
6XEPLVVLRQ

,QVWLWXWLRQVZLWKSDWLHQWVZDLWLQJWKDW
DUHXQDEOHWRXVHWKH3RUWDOVKRXOG
DOHUWWKH&7685HJXODWRU\2IILFH
LPPHGLDWHO\E\SKRQHRUHPDLO
&768RU
&7685HJ+HOS#FRFFJRUJWRUHFHLYH
IXUWKHULQVWUXFWLRQDQGVXSSRUW

&RQWDFWWKH&7685HJXODWRU\+HOS
'HVNDW&768RU
&7685HJ+HOS#FRFFJRUJIRU
UHJXODWRU\DVVLVWDQFH
5HIHUWRWKHSDWLHQW
HQUROOPHQWVHFWLRQRIWKH
SURWRFROIRULQVWUXFWLRQVRQ
XVLQJWKH2QFRORJ\3DWLHQW
(QUROOPHQW1HWZRUN23(1
23(1LVDFFHVVHGDW
KWWSVZZZFWVXRUJ23(1B
6<67(0RU
KWWSV23(1FWVXRUJ

&RQWDFWWKH&768+HOS'HVN
ZLWKDQ\23(1UHODWHG
TXHVWLRQVE\SKRQHRUHPDLO
RU
FWVXFRQWDFW#ZHVWDWFRP
'DWDFROOHFWLRQIRUWKLV
VWXG\ZLOOEHGRQH
H[FOXVLYHO\WKURXJK
0HGLGDWD5DYH5HIHU
WRWKHGDWDVXEPLVVLRQ
VHFWLRQRIWKHSURWRFRO
IRUIXUWKHULQVWUXFWLRQV

7KHPRVWFXUUHQWYHUVLRQRIWKHVWXG\SURWRFRODQGDOOVXSSRUWLQJGRFXPHQWVPXVWEH
GRZQORDGHGIURPWKHSURWRFROVSHFLILFSDJHORFDWHGRQWKH&768PHPEHUV¶ZHEVLWH
KWWSVZZZFWVXRUJ

3HUPLVVLRQWRYLHZDQGGRZQORDGWKLVSURWRFRODQGLWVVXSSRUWLQJGRFXPHQWVLVUHVWULFWHGDQGLV
EDVHGRQSHUVRQDQGVLWHURVWHUDVVLJQPHQWKRXVHGLQWKH5RVWHU0DLQWHQDQFHDSSOLFDWLRQDQGLQ
PRVWFDVHVYLHZDEOHDQGPDQDJHDEOHYLDWKH5RVWHU8SGDWH0DQDJHPHQW6\VWHP5806RQ
WKH&768PHPEHUV¶ZHEVLWH

)RUFOLQLFDOTXHVWLRQVLHSDWLHQWHOLJLELOLW\RUWUHDWPHQWUHODWHG&RQWDFWWKHVWXG\GDWD
PDQDJHUOLVWHGRQWKH15*2QFRORJ\FRQWDFWLQIRUPDWLRQWDEOHRQWKHSURWRFROFRYHUSDJH
)RUQRQFOLQLFDOTXHVWLRQVLHXQUHODWHGWRSDWLHQWHOLJLELOLW\WUHDWPHQWRUFOLQLFDOGDWD
VXEPLVVLRQ&RQWDFWWKH&768+HOS'HVNE\SKRQHRUHPDLO&768*HQHUDO,QIRUPDWLRQ
/LQH±RUFWVXFRQWDFW#ZHVWDWFRP$OOFDOOVDQGFRUUHVSRQGHQFHZLOOEH
WULDJHGWRWKHDSSURSULDWH&768UHSUHVHQWDWLYH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
)RULPDJLQJGDWDVXEPLVVLRQTXHVWLRQV
,52&LPDJHDUFKLYH#DFURUJSOHDVHLQFOXGHWULDOQXPEHULQWKHHPDLOVXEMHFWOLQH

)RU75,$'DFFHVVDQGLQVWDOODWLRQVXSSRUW
75,$'6XSSRUW#DFURUJ
7ULDGKHOSDFURUJ

75,$'6RIWZDUH,QVWDOODWLRQ
KWWSVWULDGLQVWDOODFURUJWULDGFOLHQW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
15*/8
7$%/(2)&217(176
6&+(0$
2%-(&7,9(6
3ULPDU\2EMHFWLYH
6HFRQGDU\2EMHFWLYHV
([SORUDWRU\2EMHFWLYHV
%$&.*5281'
5DWLRQDOH
6WXG\6LJQLILFDQFH
&RQWH[WIRU&KHPRUDGLDWLRQLQ/66&/&LQ&RPELQDWLRQZLWK
,PPXQRWKHUDS\
4XDOLW\RI/LIH
3$7,(176(/(&7,21(/,*,%,/,7<$1',1(/,*,%,/,7<&5,7(5,$

3DWLHQW6HOHFWLRQ*XLGHOLQHV

(OLJLELOLW\&ULWHULD

,QHOLJLELOLW\&ULWHULD
5(48,5(0(176)25678'<(175<75($70(17$1')2//2:83
75($70(173/$15(*,0(1'(6&5,37,21

6\VWHPLF7UHDWPHQW

5DGLDWLRQ7KHUDS\

*HQHUDO&RQFRPLWDQW0HGLFDWLRQDQG6XSSRUWLYH&DUH*XLGHOLQHV

'XUDWLRQRI7KHUDS\
75($70(1702',),&$7,2160$1$*(0(17
0DQDJHPHQWRI$WH]ROL]XPDE5HODWHG7R[LFLW\
'RVH0RGLILFDWLRQV'XULQJ&RQFXUUHQW&KHPRUDGLRWKHUDS\:LWK&LVSODWLQ
DQG(WRSRVLGH
'RVH0RGLILFDWLRQVIRU'XULQJ&RQFXUUHQW&KHPRUDGLRWKHUDS\:LWK
&DUERSODWLQDQG(WRSRVLGH
$'9(56((9(1765(3257,1*5(48,5(0(176
3URWRFRO$JHQWV
$GYHUVH(YHQWVDQG6HULRXV$GYHUVH(YHQWV

&RPSUHKHQVLYH$GYHUVH(YHQWVDQG3RWHQWLDO5LVNV&$(35/LVWIRU
,QYHVWLJDWLRQDO6WXG\$JHQW$WH]ROL]XPDE03'/$
$GYHUVH(YHQWVRI6SHFLDO,QWHUHVWIRU$WH]ROL]XPDE
$GYHUVH(YHQWVIRU&LVSODWLQ
$GYHUVH(YHQWVIRU&DUERSODWLQ
$GYHUVH(YHQWVIRU(WRSRVLGH
$GYHUVH(YHQWVDQG352&7&$(
([SHGLWHG5HSRUWLQJRI$GYHUVH(YHQWV
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

5(*,675$7,21$1'678'<(175<352&('85(6
&DQFHU7ULDOV6XSSRUW8QLW5HJLVWUDWLRQ5HTXLUHPHQWV
$GGLWLRQDO3UH5HJLVWUDWLRQ5HTXLUHPHQWV)RU&DQDGLDQ,QVWLWXWLRQV
576SHFLILF3UH5HJLVWUDWLRQ5HTXLUHPHQWV

'LJLWDO5DGLDWLRQ7KHUDS\'DWD6XEPLVVLRQ8VLQJ7UDQVIHURI,PDJHVDQG
'DWD
3DWLHQW(QUROOPHQW
'58*,1)250$7,21

,QYHVWLJDWLRQDO6WXG\$JHQW$WH]ROL]XPDE

&RPPHUFLDO$JHQW&LVSODWLQ

&RPPHUFLDO$JHQW&DUERSODWLQ

&RPPHUFLDO$JHQW(WRSRVLGH
3$7+2/2*<%,263(&,0(16
&HQWUDO3DWKRORJ\5HYLHZ*XLGHOLQHV

%LRVSHFLPHQ6XEPLVVLRQ7DEOHV
63(&,$/678',(61217,668(
4XDOLW\RI/LIH42/DQG3DWLHQW5HSRUWHG2XWFRPHV352V
$VVHVVPHQWV
$GPLQLVWUDWLRQRI15*/83DWLHQW&RPSOHWHG4XHVWLRQQDLUHV
3DWLHQW3RSXODWLRQ
$GGLWLRQDO7R[LFLW\0RQLWRULQJZLWK352&7&$(
$GPLQLVWUDWLRQRI352&7&$(
352&7&$(3DWLHQW3RSXODWLRQ
02'$/,7<5(9,(:6
5DGLDWLRQ7KHUDS\4XDOLW\$VVXUDQFH5HYLHZV
0HGLFDO2QFRORJ\0RGDOLW\4XDOLW\$VVXUDQFH5HYLHZV
'$7$$1'5(&25'6
'DWD0DQDJHPHQW&ROOHFWLRQ
'DWD4XDOLW\3RUWDO
5DYH&7(3$(56,QWHJUDWLRQ
6XPPDU\RI'DWD6XEPLVVLRQ
(QKDQFHG&HQWUDOL]HG'DWD0RQLWRULQJ
*OREDO5HSRUWLQJ0RQLWRULQJ
67$7,67,&$/&216,'(5$7,216

6WXG\'HVLJQ

6WXG\(QGSRLQWV

3ULPDU\2EMHFWLYHV6WXG\'HVLJQ

6WXG\0RQLWRULQJRI3ULPDU\2EMHFWLYHV
$FFUXDO6WXG\'XUDWLRQ&RQVLGHUDWLRQV
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

6HFRQGDU\RU([SORUDWRU\(QGSRLQWV

'HILQLWLRQVRI6HFRQGDU\(QGSRLQWVDQG+RZ7KHVH:LOO%H$QDO\]HG

([SORUDWRU\+\SRWKHVLVDQG(QGSRLQWV
2WKHU3UHVSHFLILHG2XWFRPHV1,+5HTXLUHG$QDO\VHVIRU7ULDOVZLWK
3KDVH,,,&RPSRQHQWV
 6H[(WKQLFLW\5DFH'LVWULEXWLRQ
5()(5(1&(6
$33(1',;,
3(5)250$1&(67$786&5,7(5,$
$33(1',;,,
$33(1',;,,,
$33(1',;,9
$33(1',;9&/,1,&$/%/22'6$03/(6+,30(1735(3$5$7,21


8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
15*/8
6&+(0$$8*

3$7,(173238/$7,21
/LPLWHGVWDJH7[7710VPDOOFHOOOXQJFDQFHU/66&/&

675$7,),&$7,21
x 5DGLDWLRQVFKHGXOH%,'ZHHNVYVGDLO\ZHHNV
x &KHPRWKHUDS\FLVSODWLQYVFDUERSODWLQ
x 6H[PDOHYVIHPDOH
x (&2*3HUIRUPDQFH6WDWXVYV

5$1'20,=(



$UP
3ODWLQXPHWRSRVLGHTZHHNV[F\FOHV

7KRUDFLF57*\ELGRU*\GDLO\
EHJLQQLQJZLWKF\FOHRIFKHPRWKHUDS\


$UP
3ODWLQXPHWRSRVLGHTZHHNV[F\FOHV

7KRUDFLF57*\ELGRU*\GDLO\
EHJLQQLQJZLWKF\FOHRIFKHPRWKHUDS\

$WH]ROL]XPDETZHHNV[\HDU
GRVHVEHJLQQLQJZLWKF\FOHRI
FKHPRWKHUDS\


5DQGRPL]DWLRQLV
)LUVWF\FOHRIFKHPRWKHUDS\PXVWEHJLYHQSULRUWRVWXG\HQWU\IRUDWRWDORIF\FOHVJLYHQ
RQVWXG\&KHPRWKHUDS\GRXEOHWVGHOLYHUHGFRQFXUUHQWO\FLVSODWLQHWRSRVLGHRU
FDUERSODWLQHWRSRVLGHLVUHTXLUHG7KHVLWHLQYHVWLJDWRUPXVWGHFODUHWKHFKHPRWKHUDS\
UHJLPHQWKDWWKHSDWLHQWZLOOUHFHLYHSULRUWRWKHSDWLHQW¶VUDQGRPL]DWLRQ3DWLHQWVZKRGHYHORS
DFRQWUDLQGLFDWLRQWRFLVSODWLQDIWHUEHJLQQLQJWKHUDS\PD\UHFHLYHFDUERSODWLQLQVXEVHTXHQW
F\FOHV6HH6HFWLRQDQGIRUGHWDLOV
$OOSDWLHQWVZLWKDFRPSOHWHRUQHDUFRPSOHWHUHVSRQVHDUHVWURQJO\UHFRPPHQGHGWRUHFHLYH
SURSK\ODFWLFFUDQLDOLUUDGLDWLRQ3&,SODQQHGZLWKLQZHHNVIURPFRPSOHWLRQRI
FKHPRUDGLRWKHUDS\6LJQLILFDQWFKHPRUDGLRWKHUDS\WR[LFLWLHVVKRXOGEHUHVROYHGWRJUDGH
RUOHVVEHIRUHEHJLQQLQJ3&,3DWLHQWVRQ$UPZKRUHFHLYH3&,ZLOOUHFHLYHLWFRQFXUUHQW
ZLWKDWH]ROL]XPDE
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
2%-(&7,9(6
3ULPDU\2EMHFWLYH-81(
7RFRPSDUHRYHUDOOVXUYLYDO26IRUSDWLHQWVZLWK/66&/&WUHDWHGZLWK
FKHPRUDGLDWLRQDWH]ROL]XPDE

6HFRQGDU\2EMHFWLYHV-8/
x 7RFRPSDUHSURJUHVVLRQIUHHVXUYLYDO3)6IRUSDWLHQWVZLWKOLPLWHGVWDJHVPDOOFHOO
OXQJFDQFHU/66&/&WUHDWHGZLWKFKHPRUDGLDWLRQDWH]ROL]XPDE
x 7RGHWHUPLQHRYHUDOOUHVSRQVHUDWH255UDWHVRIORFDOFRQWURODQGGLVWDQW
PHWDVWDVHVIUHHVXUYLYDOZLWKFKHPRUDGLDWLRQDWH]ROL]XPDE
x 7RFKDUDFWHUL]HLPPXQHPHGLDWHGDQGQRQLPPXQHPHGLDWHGWR[LFLW\IURP
FKHPRUDGLRWKHUDS\SOXVDWH]ROL]XPDE
x 7RFRPSDUHTXDOLW\RIOLIHDVPHDVXUHGE\WKH)$&772,IRUSDWLHQWVXQGHUJRLQJ
FKHPRUDGLDWLRQDWH]ROL]XPDE
x 7RHYDOXDWHWKHTXDOLW\DGMXVWHGVXUYLYDOXVLQJVFRUHVIURPWKH(4'/RI
FKHPRUDGLDWLRQDWH]ROL]XPDEIRUSDWLHQWVZLWK/66&/&
x 7RFKDUDFWHUL]HIDWLJXHDVPHDVXUHGE\WKH3520,6IROORZLQJFKHPRUDGLDWLRQ
DWH]ROL]XPDE
x 7RGHWHUPLQHWKHDVVRFLDWLRQRI6&/&PROHFXODUVXEW\SHVZLWKFOLQLFDORXWFRPHV

([SORUDWRU\2EMHFWLYHV-8/
x 7RFROOHFWELRVSHFLPHQVDWEDVHOLQH'D\DQGPRQWKVDIWHUWKHHQGRI
FKHPRUDGLRWKHUDS\WRDOORZIRUIXWXUHDQDO\VHV
x7RFKDUDFWHUL]HSDWLHQWUHSRUWHGV\PSWRPDWLFWR[LFLWLHVPHDVXUHGE\WKH352
&7&$(
x 7RFKDUDFWHUL]HWKHFRQFRUGDQFHEHWZHHQWXPRUDQGFI'1$GHWHUPLQHGPROHFXODU
VXEW\SHV

%$&.*5281'
5DWLRQDOH
3DWLHQWVZLWK/66&/&UHVSRQGWRFKHPRUDGLRWKHUDS\ZLWKVXEVWDQWLDOGHFUHDVHLQWXPRU
EXUGHQWKHYDVWPDMRULW\RIWKHWLPHEXWUHODSVHRFFXUVHDUO\DQGRIWHQOLPLWLQJORQJWHUP
VXUYLYDOWRDERXWRIWKH/66&/&SRSXODWLRQ:HK\SRWKHVL]HWKDWWKHXQPDVNLQJRI
KLGGHQWXPRUDQWLJHQVDQGFUHDWLRQRILPPXQRORJLFVSDFHGXULQJDQGDIWHU
FKHPRUDGLRWKHUDS\ZLOOHQKDQFHLPPXQHVWLPXODWLRQE\DWH]ROL]XPDEWKXVLQFUHDVLQJ
HIILFDF\RIWKHUDS\GXUDWLRQRIUHVSRQVHDQGRYHUDOOVXUYLYDO

,PPXQRWKHUDS\LVDOUHDG\HVWDEOLVKHGLQH[WHQVLYHVWDJH(66&/&,QWKHSKDVH
&KHFNPDWHWULDO$QWRQLDHWDOKWWSVFOLQLFDOWULDOVJRYFWVKRZ
1&7UHVSRQVHUDWHVZHUHIRUQLYROXPDEDQGIRUQLYROXPDESOXV
LSLOLPXPDELQGHSHQGHQWRI3'/H[SUHVVLRQDQGZLWKJUDGHDGYHUVHHYHQWVRFFXUULQJ
LQDSSUR[LPDWHO\1LYROXPDERUQLYROXPDESOXVLSLOLPXPDEDUHQRZFRPSHQGLD
OLVWHGIRUUHODSVHG6&/&DQGDUHLQFOXGHGLQWKH1DWLRQDO&RPSUHKHQVLYH&DQFHU
1HWZRUNJXLGHOLQHVIRUSDWLHQWVZKRKDYHSURJUHVVLYHGLVHDVHZLWKLQPRQWKVRI
FRPSOHWLRQRILQLWLDOFKHPRWKHUDS\)XUWKHUWKH,0SRZHUVWXG\+RUQHWDO
KWWSVFOLQLFDOWULDOVJRYFWVKRZ1&7DSKDVH,,,GRXEOHEOLQGHGSODFHER
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
FRQWUROOHGVWXG\RIFDUERSODWLQHWRSRVLGHDWH]ROL]XPDELQFKHPRWKHUDS\QDwYH
H[WHQVLYHVWDJHVPDOOFHOOOXQJFDQFHUUHFHQWO\UHSRUWHGLPSURYHG3)6DQG26LQSDWLHQWV
UHFHLYLQJDWH]ROL]XPDEFRQFXUUHQWO\ZLWKFKHPRWKHUDS\

,Q/66&/&WKH(XURSHDQ7KRUDFLF2QFRORJ\3ODWIRUPSKDVH,,UDQGRPL]HGVWXG\
FRPSDUHVFKHPRUDGLDWLRQZLWKSODWLQXPHWRSRVLGHDQG3&,DORQHRUIROORZHGE\DGMXYDQW
QLYROXPDEDQGLSLOLPXPDEKWWSVFOLQLFDOWULDOVJRYFWVKRZ1&715*
/8GLIIHUVLQDJHQWXVHGDVZHOODVLQWLPLQJRILPPXQRWKHUDS\ZKLFKEHJLQV
FRQFXUUHQWZLWKFKHPRUDGLRWKHUDS\WRWDNHDGYDQWDJHRIWKHVDOXWDU\HIIHFWVRIUDGLDWLRQ
RQERWKWXPRUDQWLJHQH[SRVXUHDQGUHGXFWLRQLQLPPXQRVXSSUHVVLYH7FHOOV


15*/8ZLOOUDQGRPO\DVVLJQSDWLHQWVWRVWDQGDUGHWRSRVLGHDQGSODWLQXP
FKHPRWKHUDS\SOXVWKRUDFLFUDGLDWLRQDORQHRUZLWKFRQFXUUHQWDQGDGMXYDQWDWH]ROL]XPDE
7KHK\SRWKHVLVWKDWFKHPRUDGLRWKHUDS\SOXVDWH]ROL]XPDEZLOOEHVXSHULRUWR
FKHPRUDGLRWKHUDS\DORQHLVEDVHGRQNQRZQFKHPRWKHUDS\DQGUDGLDWLRQHIIHFWVRQERWK
WXPRUFHOOVDQGKRVWLPPXQHV\VWHP$GGLQJFRQFXUUHQWFKHFNSRLQWLQKLELWRUVWRUDGLDWLRQ
ZDVV\QHUJLVWLFLQ[HQRJUDIWPRGHOVRISDQFUHDWLFFRORQDQGEUHDVWFDQFHU%ODQTXLFHWWHW
DO'HQJHWDO5DGLDWLRQXSUHJXODWHV3'/H[SUHVVLRQRQWXPRUDQG
VWURPDOFHOOV%RWKFKHPRWKHUDS\DQGUDGLDWLRQDIIHFWLPPXQHUHVSRQVHWRFDQFHUE\
GHFUHDVLQJ7UHJXODWRU\FHOOVDQGE\LQFUHDVLQJH[SUHVVLRQRIKLGGHQWXPRUQHRDQWLJHQV
GXULQJLPPXQHUHFRQVWLWXWLRQDIWHUWUHDWPHQW5DGLDWLRQWRDSULPDU\WXPRUOHDGVWR
WXPRUDQWLJHQUHOHDVHDQGDWXPRUVSHFLILFDGDSWLYHLPPXQHUHVSRQVHZKLFKLVHQKDQFHG
E\LPPXQHVWLPXODWLQJDJHQWV7KXVZKLOHUDGLDWLRQLQGXFHVDORFDOWXPRUUHVSRQVHDW
WKHVLWHRIUDGLDWLRQLWPD\DOVROHDGWRUHJUHVVLRQRIPLFURPHWDVWDWLFGLVHDVHWKH
DEVFRSDOHIIHFW7DQJHWDO

'RYHGLHWDOUHSRUWHGWKDWORZGRVHVRIIUDFWLRQDWHGUDGLDWLRQJLYHQFRQFXUUHQWO\ZLWKDQWL
3'DQWLERGLHVHQKDQFHGORFDOWXPRUFRQWURODQGHOLFLWHGRXWRIILHOGUHVSRQVHVLQD
PRXVHPRGHORIFRORQFDQFHUZLWKD!FRPSOHWHUHVSRQVHUDWH6HTXHQWLDOGHOLYHU\
RIFKHFNSRLQWLQKLELWRUVGLGQRWLPSURYHUHVSRQVHWRUDGLRWKHUDS\DWORFDORUGLVWDQWVLWHV
1H[WJHQHUDWLRQVHTXHQFLQJRI7FHOOUHFHSWRUVVKRZHGWKDWZKLOHUDGLDWLRQLQFUHDVHG7
FHOOLQILOWUDWLRQDWWKHLUUDGLDWHGWXPRURQO\UDGLDWLRQDQWL3'LQFUHDVHG7FHOO
LQILOWUDWLRQH[SDQVLRQDWERWKLUUDGLDWHGDQGRXWRIILHOGWXPRUV$GGLWLRQDOO\UDGLDWLRQ
DQWL3'LQFUHDVHG7FHOOUHFHSWRUGLYHUVLW\PRUHWKDQUDGLDWLRQRUDQWL3'DORQH
'RYHGLHWDO

5HSRUWVIURPWKHSKDVH,,,3$&,),&WULDOLQ16&/&VKRZHGVXEVWDQWLDOLPSURYHPHQWVLQ
3)6RQHRIWKHFRSULPDU\HQGSRLQWVZLWKFRQVROLGDWLYHGXUYDOXPDEDIWHUFRQFXUUHQW
FKHPRUDGLDWLRQ$QWRQLDHWDOKWWSVFOLQLFDOWULDOVJRYFWVKRZ1&7
$QXQSODQQHGVXEVHWDQDO\VLVVXJJHVWHGEHWWHU3)6IRUSDWLHQWVZKREHJDQGXUYDOXPDE
ZLWKLQGD\VDIWHUWKHODVWUDGLDWLRQWUHDWPHQWFRPSDUHGZLWKWKRVHUDQGRPL]HGODWHU
7KLVILQGLQJVXSSRUWVWKHK\SRWKHVLVWKDWFRQFXUUHQWRUHDUO\DGMXYDQWLPPXQRWKHUDS\
PD\DXJPHQWUDGLDWLRQUHVSRQVH

,QFRUSRUDWLQJFRQFXUUHQWDQGFRQVROLGDWLYHLPPXQRWKHUDS\LQWKHGHILQLWLYHVHWWLQJDV
VWXGLHGKHUHLVDUDWLRQDODSSURDFKJLYHQWKHSUHFOLQLFDOHYLGHQFHIRUV\QHUJ\RI
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
FKHFNSRLQWLQKLELWRUVZLWKUDGLDWLRQDQGFKHPRWKHUDS\DQGFOLQLFDOHYLGHQFHIURPVLPLODU
SDWLHQWSRSXODWLRQVZLWK16&/&7KLVVWXG\LQFRUSRUDWHVHDUO\FKHFNSRLQWLQKLELWRU
WKHUDS\ZLWKVWDQGDUGFXUDWLYHLQWHQWFKHPRUDGLRWKHUDS\WRHQKDQFHWKHV\VWHPLF
SRO\FORQDO7FHOOUHVSRQVHDQGDGGUHVVV\VWHPLFPLFURPHWDVWDWLFGLVHDVHDVHDUO\DV
SRVVLEOHGXULQJWKHWUHDWPHQWFRXUVH

6WXG\6LJQLILFDQFH
6&/&DFFRXQWVIRUDSSUR[LPDWHO\RIOXQJFDQFHUFDVHVLQWKH86LQPHQDQG
LQZRPHQDQGKDVDSRRUSURJQRVLVGHVSLWHUDSLGDQGVLJQLILFDQWLQLWLDOUHVSRQVHWR
FKHPRUDGLRWKHUDS\6WDQGDUGFKHPRUDGLRWKHUDS\IRU/66&/&FXUHVVRPHSDWLHQWVEXW
DWOHDVWZLOOUHODSVHZLWKLQ\HDUVZLWKQRDYDLODEOHFXUDWLYHVWUDWHJ\DWSURJUHVVLRQ
7KHXQPHWQHHGLQ/66&/&±WKHDELOLW\WRFXUHPRUHWKDQDVPDOOIUDFWLRQRIWKHVHHDUO\
VWDJHSDWLHQWV±KDVQRWFKDQJHGLQGHFDGHVRIFKHPRUDGLRWKHUDS\DQGWDUJHWHGWKHUDS\
WULDOV7KHPHGLDQRYHUDOOVXUYLYDOUHSRUWHGLQWKHPRVWFRQWHPSRUDU\SKDVH,,,WULDOLQ
OLPLWHGVWDJHVPDOOFHOOOXQJFDQFHUWHVWLQJRQFHGDLO\FRPSDUHGWRWZLFHGDLO\UDGLDWLRQ
WKHUDS\ZDVDQGPRQWKVUHVSHFWLYHO\DQGWKHPHGLDQSURJUHVVLRQIUHHVXUYLYDO
ZDVDQGPRQWKVUHVSHFWLYHO\)DLYUH)LQQHWDO
KWWSVFOLQLFDOWULDOVJRYFWVKRZ1&7

&KHFNSRLQWLQKLELWRUVUHSUHVHQWDQRSSRUWXQLW\WRLPSURYHFXUHUDWHVE\HVWDEOLVKLQJ
LPPXQRORJLFFRQWURORYHUORFDODQGGLVVHPLQDWHGUHVLGXDOFDQFHUDIWHU
FKHPRUDGLRWKHUDS\(WRSRVLGHSODWLQXPSOXVWKRUDFLFUDGLDWLRQLVWKHVWDQGDUGRIFDUHLQ
WKHVHSDWLHQWVDQGFXUHVWRRISDWLHQWV7KXVWKLVEDFNERQHSURYLGHVDSODWIRUP
XSRQZKLFKWRDGGQRYHODJHQWVVXFKDVLPPXQRWKHUDS\7KHH[SRVXUHRIKLGGHQDQWLJHQV
DQGWKHGHSOHWLRQRILPPXQHFHOOVHVSHFLDOO\7UHJVE\FKHPRWKHUDS\DQGUDGLDWLRQ
DOORZVEURDGHUDQWLJHQH[SRVXUHWRUHSRSXODWHHIIHFWRU7FHOOVDQG1.FHOOV:KLOH
WR[LFLW\LVDFRQFHUQZKHQFRPELQLQJUDGLRWKHUDS\WRWKHFKHVWDQGRUEUDLQSDUWLFXODUO\
ZLWKFKHFNSRLQWLQKLELWRUVH[FHVVLYHWR[LFLW\KDVQRWEHHQUHSRUWHGLQRQJRLQJWULDOVLQ
ZKLFKSDWLHQWVKDYHUHFHLYHGUDGLDWLRQDQGLPPXQRWKHUDS\FRQFXUUHQWO\(YHQVR
FRPSDUDWLYHO\IHZSDWLHQWVKDYHEHHQWUHDWHGWKXVIDUVR15*/8LVGHVLJQHGZLWK
UHDOWLPHPRQLWRULQJIRUVDIHW\HVSHFLDOO\IRUSRWHQWLDOO\VLJQLILFDQWLPPXQHUHODWHG
SQHXPRQLWLVHVRSKDJLWLVQHXURWR[LFLW\DQGP\RFDUGLWLV

,QWHJUDWLYHELRPDUNHUVWXGLHVZLOOKHOSWRGHYHORSWRROVWRLGHQWLI\SDWLHQWVZKRPD\
EHQHILWPRVWIURPLPPXQRWKHUDS\7KLVVWXG\KDVWKHSRWHQWLDOWRFUHDWHDQHZWUHDWPHQW
SDUDGLJPIRUDGHDGO\GLVHDVH

7KLVVWXG\ZLOOUDQGRPL]HSDWLHQWVWRFKHPRUDGLDWLRQDWH]ROL]XPDEJLYHQ
FRQFXUUHQWO\DQGLQWKHFRQVROLGDWLYHVHWWLQJIRUPRQWKVWRWDO3DWLHQWVZLOOEHVWUDWLILHG
E\VH[SHUIRUPDQFHVWDWXV36	YVUDGLDWLRQIUDFWLRQDWLRQVFKHPDRQFHYVWZLFH
GDLO\IUDFWLRQDWLRQDQGFLVSODWLQYVFDUERSODWLQFKHPRWKHUDS\)RUOLPLWHGVWDJHVPDOO
FHOOOXQJFDQFHU/66&/&WKHVWURQJHVWSURJQRVWLFIDFWRUVLQFOXGHJRRGSHUIRUPDQFH
VWDWXVDQGIHPDOHVH[7KHVHYDULDEOHVKDYHEHHQVKRZQWREHKLJKO\SURJQRVWLFLQ/6
6&/&EDVHGXSRQDQDQDO\VLVRIRYHUSDWLHQWVWUHDWHGRQ6RXWKZHVW2QFRORJ\
*URXSFOLQLFDOWULDOV$OEDLQHWDO-&OLQ2QFRO6HS5DGLDWLRQ
IUDFWLRQDWLRQDQGFDUERSODWLQYVFLVSODWLQZLOODOVREHVWUDWLILFDWLRQIDFWRUVLQRUGHUWR
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
DYRLGDQ\SRWHQWLDOWUHDWPHQWLPEDODQFHVEHWZHHQWKHVWXG\DUPV

&RQWH[WIRU&KHPRUDGLDWLRQLQ/66&/&LQ&RPELQDWLRQZLWK,PPXQRWKHUDS\
5DGLDWLRQGRVHDQGVFKHGXOHIRU/66&/&KDYHEHHQSUHYLRXVO\VWXGLHG7KH
&219(57WULDO)DLYUH)LQQHWDOKWWSVFOLQLFDOWULDOVJRYFWVKRZ
1&7VKRZHGQRVWDWLVWLFDOO\VLJQLILFDQWGLIIHUHQFHLQRYHUDOOVXUYLYDOEHWZHHQ
*\WZLFHGDLO\RU*\GDLO\,QSDWLHQWVDVVHVVHGIRUUDGLRWKHUDS\WR[LFLW\WKHUDWHV
RIJUDGHRUHVRSKDJLWLVDQGUDGLDWLRQSQHXPRQLWLVZHUHVLPLODU7KHFRQFXUUHQW
UDGLDWLRQVFKHGXOHLQWKLVWULDOZLOOWKHUHIRUHDOORZHLWKHU*\WZLFHGDLO\RU*\
GDLO\DQGZLOOVWUDWLI\IRUUDGLDWLRQRSWLRQ3&,ZLOOEHHQFRXUDJHGIRUSDWLHQWVZKR
DFKLHYHDFRPSOHWHRUQHDUFRPSOHWHUHVSRQVH

3UHOLPLQDU\VDIHW\GDWDIURPFRPELQHGLPPXQRWKHUDS\DQGUDGLDWLRQWULDOVLVUHDVVXULQJ
+ZDQJHWDOUHSRUWHGFOLQLFDOO\VLJQLILFDQWSQHXPRQLWLVLQRISDWLHQWVWUHDWHG
ZLWKWKRUDFLFUDGLDWLRQEHIRUHGXULQJRUDIWHUFKHFNSRLQWLQKLELWRUV+XEEHOLQJHWDO
UHSRUWHGQRGLIIHUHQFHLQWR[LFLW\RIEUDLQUDGLDWLRQZKHWKHURUQRWSDWLHQWVUHFHLYHG
LPPXQRWKHUDS\QRUGLGWKHWLPLQJRILPPXQRWKHUDS\DQGEUDLQUDGLDWLRQLQIOXHQFHVLGH
HIIHFWV$GGLWLRQDOO\WKH,0SRZHUVWXG\RIFDUERSODWLQHWRSRVLGHDWH]ROL]XPDEDV
ILUVWOLQHWUHDWPHQWRIH[WHQVLYHVWDJHVPDOOFHOOOXQJFDQFHUDOORZHG3&,DQGWKHUHZDVQR
LQFUHDVHLQQHXURORJLFWR[LFLWLHVLQSDWLHQWVUHFHLYLQJDWH]ROL]XPDE+RUQHWDO

$SKDVH,,,0'$QGHUVRQWULDOXWLOL]LQJ0.SHPEUROL]XPDEDQWL3'0HUFN
FRQFXUUHQWO\ZLWKFKHPRUDGLDWLRQ&57DQGIRUPRQWKVIROORZLQJ&57LQ/66&/&
UHSRUWHGWROHUDEOHWR[LFLW\SURILOHV3DWLHQWVUHFHLYHG3&,LQWKLVVWXG\DWWKHGLVFUHWLRQRI
WKHWUHDWLQJSK\VLFLDQ7DEOHEHORZVXPPDUL]HVVWHURLGXVHDQGQXPEHURISDWLHQWVZLWK
JUDGHDQGKLJKHUDGYHUVHHYHQWVLQWKLVVWXG\KWWSVFOLQLFDOWULDOVJRYFWVKRZ
1&7

7DEOH6XPPDU\RI,PPXQHPHGLDWHG*UDGHDQG+LJKHU$(V0'$3KDVH,6WXG\
RISDWLHQWV
*UDGH	$(V
6WHURLG8VH

3HULFDUGLWLV


5HVSLUDWRU\SQHXPRQLWLV
SQHXPRQLDK\SR[LD


1HXURORJLFFRJQLWLYH
GHFOLQHHQFHSKDOLWLV
1RWDSSOLFDEOH

7KH0'$QGHUVRQLQYHVWLJDWRUVIRXQGWKDWJUDGHDQGKLJKHUDGYHUVHHYHQWVZHUH
PDQDJHDEOHDQGQRWH[FHVVLYH)RXUSDWLHQWVGHYHORSHGJUDGHDQGKLJKHU
UHVSLUDWRU\WR[LFLWLHVWKDWZHUHSRVVLEO\DWWULEXWHGWRSURWRFROWUHDWPHQWDQGZHUHWUHDWHG
ZLWKVWHURLGVZKLOHSDWLHQWVUHPDLQHGRQVWXG\2IWKHVHSDWLHQWVKDGWR[LFLW\WKDW
UHVROYHGZLWKLQZHHNVIURPRQVHW2QHSDWLHQWGHYHORSHGJUDGHIDWLJXH1RSDWLHQWV
GHYHORSHGJUDGHRUKLJKHUHVRSKDJLWLV1RSDWLHQWVGHYHORSHGHQFHSKDOLWLVRURWKHU
JUDGHRUKLJKHUQHXURORJLFWR[LFLWLHVSRVVLEO\DWWULEXWDEOHWRLPPXQRWKHUDS\LQWKH
VHWWLQJRI3&,RIZKLFKRISDWLHQWVUHFHLYHG3&,XQSXEOLVKHGGDWDSHUVRQDO
FRPPXQLFDWLRQIURP'U


8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$SKDVH,VWXG\RIFKHPRUDGLDWLRQSHPEUROL]XPDEIRUVWDJH,,,QRQVPDOOFHOOOXQJ
FDQFHULVXQGHUZD\DW5XWJHUV8QLYHUVLW\KWWSVFOLQLFDOWULDOVJRYFWVKRZ
1&77KLVVWXG\GHOLYHUV*\WKRUDFLFUDGLDWLRQZLWKZHHNO\
FDUERSODWLQSDFOLWD[HOSHPEUROL]XPDELQWURGXFHGDWYDU\LQJWLPHSRLQWVRI
FKHPRUDGLDWLRQGHSHQGHQWXSRQWKHVSHFLILFGRVHFRKRUW2QHJUDGHSQHXPRQLWLVKDV
EHHQUHSRUWHGDWWULEXWHGWRSHPEUROL]XPDEZLWKQRJUDGHRUWR[LFLWLHVUHODWHGWR
LPPXQRWKHUDS\7KLVWULDOLVRQJRLQJXQSXEOLVKHGGDWDSHUVRQDOFRPPXQLFDWLRQIURP
'U


4XDOLW\RI/LIH
+HDOWKUHODWHGTXDOLW\RIOLIH42/LVDQLPSRUWDQWHQGSRLQWLQFOLQLFDOWULDOVWRDVVHVV
WKHRYHUDOOGLVHDVHEXUGHQDQGWUHDWPHQWHIIHFWIURPWKHSDWLHQW¶VSHUVSHFWLYHXVLQJ
SDWLHQWUHSRUWHGRXWFRPHV352V,IWKHDWH]ROL]XPDEDUPVKRZVVXSHULRU26DQHZ
VWDQGDUGRIFDUHZLOOEHGHILQHGIRUOLPLWHGVWDJH6&/&

7KHHIIHFWVRIDWH]ROL]XPDELPPXQRWKHUDS\RQ&57LQOXQJFDQFHURQ42/DUHFXUUHQWO\
XQNQRZQ+HQFHWKLVVWXG\ZLOOSURYLGHDXQLTXHRSSRUWXQLW\WRFKDUDFWHUL]HWKHHIIHFWV
RIWKLVQRYHOWUHDWPHQWRQ42/,WLVDQWLFLSDWHGWKDWFRQFXUUHQWDQGFRQVROLGDWLYH
DWH]ROL]XPDEZLOOLPSURYH26ZLWKPLQLPDORYHUODSSLQJDFXWHWR[LFLWLHVRIDWH]ROL]XPDE
DQG&572EWDLQLQJ42/GDWDDWEDVHOLQHGXULQJWUHDWPHQWDQGIROORZXSDIWHU
WUHDWPHQWSURYLGHVEDVHOLQHSURJQRVWLFGDWDDVZHOODVUHSRUWLQJWKHHIIHFWRIWUHDWPHQWRQ
+542/IURPWKHSDWLHQW¶VSHUVSHFWLYH%DVHOLQH42/GDWDZDVIRXQGWREHDSURJQRVWLF
YDULDEOHLQDGGLWLRQWRFOLQLFDOIDFWRUVLQSUHGLFWLQJVXUYLYDOLQFDQFHUSDWLHQWV4XLQWHQ
8UEDLQDSRROHGDQDO\VLVRIFDQFHUSDWLHQWVHQWHUHGRQUDQGRPL]HG
WULDOV7KHVHGDWDVXJJHVWWKDWREWDLQLQJEDVHOLQH42/GDWDDUHRIVXSHULRUSURJQRVWLF
VLJQLILFDQFHWKDQREWDLQLQJSK\VLFLDQJUDGHGSHUIRUPDQFHVFDOHVFRUHVVXFKDV.DUQRIVN\
SHUIRUPDQFHVFDOHVRU(&2*VFDOHVSULRUWRLQLWLDWLRQRIWUHDWPHQW

3$7,(176(/(&7,21(/,*,%,/,7<$1',1(/,*,%,/,7<&5,7(5,$

1RWH3HU1&,JXLGHOLQHVH[FHSWLRQVWRLQFOXVLRQDQGH[FOXVLRQFULWHULDDUHQRW
SHUPLWWHG)RUTXHVWLRQVFRQFHUQLQJHOLJLELOLW\SOHDVHFRQWDFWWKH%LRVWDWLVWLFDO'DWD
0DQDJHPHQW&HQWHUVHHSURWRFROFRYHUSDJH)RUUDGLDWLRQWKHUDS\UHODWHGHOLJLELOLW\
TXHVWLRQVSOHDVHFRQWDFW574$VHHSURWRFROFRYHUSDJH


3DWLHQW6HOHFWLRQ*XLGHOLQHV129
$OWKRXJKWKHJXLGHOLQHVSURYLGHGEHORZDUHQRWLQFOXVLRQH[FOXVLRQFULWHULDLQYHVWLJDWRUV
VKRXOGFRQVLGHUWKHVHIDFWRUVZKHQVHOHFWLQJSDWLHQWVIRUWKLVWULDO,QYHVWLJDWRUVDOVR
VKRXOGFRQVLGHUDOORWKHUUHOHYDQWIDFWRUVPHGLFDODQGQRQPHGLFDODVZHOODVWKHULVNV
DQGEHQHILWVRIWKHVWXG\WKHUDS\ZKHQGHFLGLQJLIDSDWLHQWLVDQDSSURSULDWHFDQGLGDWH
IRUWKLVWULDO
 3DWLHQWVPXVWKDYHWKHSV\FKRORJLFDODELOLW\DQGJHQHUDOKHDOWKWKDWSHUPLWVFRPSOHWLRQRI
WKHVWXG\UHTXLUHPHQWVDQGUHTXLUHGIROORZXS
 $GPLQLVWUDWLRQRIDWH]ROL]XPDESODWLQXPHWRSRVLGHFKHPRWKHUDS\DQGH[WHUQDOEHDP
UDGLDWLRQPD\KDYHDQDGYHUVHHIIHFWRQSUHJQDQF\DQGSRVHVDULVNWRWKHKXPDQIHWXV
LQFOXGLQJHPEU\ROHWKDOLW\:RPHQRIFKLOGEHDULQJSRWHQWLDODQGPHQPXVWDJUHHWRXVH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
DGHTXDWHFRQWUDFHSWLRQKRUPRQDORUEDUULHUPHWKRGRIELUWKFRQWURODEVWLQHQFHSULRUWR
VWXG\HQWU\IRUWKHGXUDWLRQRIVWXG\WUHDWPHQWDQGIRUPRQWKVGD\VDIWHUWKHODVW
GRVHRIVWXG\DJHQWRUIRUSDWLHQWVRQDUPDIWHUFRPSOHWLRQRIFKHPRUDGLDWLRQ6KRXOG
DZRPDQEHFRPHSUHJQDQWRUVXVSHFWVKHLVSUHJQDQWZKLOHVKHRUKHUSDUWQHULV
SDUWLFLSDWLQJLQWKLVVWXG\VKHVKRXOGLQIRUPKHUWUHDWLQJSK\VLFLDQLPPHGLDWHO\
 6XEPLVVLRQRIDQ+	(VWDLQHGVOLGHIURPSULPDU\WXPRULVUHTXLUHGIRUDOOSDWLHQWV
,QYHVWLJDWRUVVKRXOGFKHFNZLWKWKHLUVLWH3DWKRORJ\GHSDUWPHQWUHJDUGLQJUHOHDVHRI
ELRVSHFLPHQVEHIRUHDSSURDFKLQJSDWLHQWVDERXWSDUWLFLSDWLRQLQWKHWULDO6HH6HFWLRQ
IRUGHWDLOV


(OLJLELOLW\&ULWHULD2&7
$SDWLHQWFDQQRWEHFRQVLGHUHGHOLJLEOHIRUWKLVVWXG\XQOHVV$//RIWKHIROORZLQJ
FRQGLWLRQVDUHPHW
 3DWKRORJLFDOO\KLVWRORJLFDOO\RUF\WRORJLFDOO\SURYHQGLDJQRVLVRIOLPLWHGVWDJHVPDOOFHOO
OXQJFDQFHU6WDJH7[7710$-&&6WDJLQJWK(GZLWKLQGD\VSULRUWR
UHJLVWUDWLRQ
3DWLHQWVPXVWKDYHUHFHLYHGRQHF\FOHRISODWLQXPHWRSRVLGHFKHPRWKHUDS\SUH
UHJLVWUDWLRQSULRUWRVWXG\HQWU\6WXG\UHJLVWUDWLRQPXVWEHZLWKLQGD\VIURPGD\
RIWKHSUHUHJLVWUDWLRQF\FOHRIFKHPRWKHUDS\
3DWLHQWVPXVWKDYHKDGPHDVXUDEOHGLVHDVHSHU5(&,67YHUVLRQSULRUWRWKH
UHTXLUHGSUHUHJLVWUDWLRQF\FOHRISODWLQXPHWRSRVLGHFKHPRWKHUDS\
0LQLPDOVWDJLQJUHTXLUHPHQWVLQFOXGH
x +LVWRU\SK\VLFDOH[DPLQDWLRQZLWKLQGD\VSULRUWRUHJLVWUDWLRQ
x 3(7&7VFDQIRUVWDJLQJZLWKLQGD\VSULRUWRUHJLVWUDWLRQ
x &7FKHVWDQG&7DEGRPHQZLWK,9FRQWUDVWXQOHVVFRQWUDLQGLFDWHGEDVHGRQNLGQH\
IXQFWLRQZLWKLQGD\VSULRUWRUHJLVWUDWLRQ05,DEGRPHQZLWK,9FRQWUDVW
DOORZHGLQSODFHRI&7DEGRPHQ
1RWH,IFRQWUDVWDOOHUJ\H[LVWVSUHPHGLFDWLRQSHULQVWLWXWLRQDOJXLGHOLQHVVKRXOGEH
SHUIRUPHGSULRUWRREWDLQLQJ&7ZLWKFRQWUDVW7KHRQO\H[FHSWLRQWRWKLVLVD
GRFXPHQWHGOLIHWKUHDWHQLQJDOOHUJ\
x 05,VFDQRIWKHEUDLQZLWKFRQWUDVWSUHIHUUHGRU&7VFDQRIWKHEUDLQZLWKFRQWUDVW
DOORZDEOHLIWKHUHLVDFRQWUDLQGLFDWLRQZLWK05,ZLWKFRQWUDVWZLWKLQGD\VSULRU
WRUHJLVWUDWLRQ
 $JH   
 (&2*3HUIRUPDQFH6WDWXVRIZLWKLQGD\VSULRUWRUHJLVWUDWLRQ
 5HTXLUHG,QLWLDO/DERUDWRU\9DOXHVSULRUWRSUHUHJLVWUDWLRQF\FOH
$1&
FHOOVPP
3ODWHOHW&RXQW
FHOOVPP
+HPRJORELQ
JG/
7RWDO%LOLUXELQ
 [ 8/1
$676*27DQG$/76*37
[8/1
$GHTXDWHUHQDOIXQFWLRQZLWKLQGD\VSULRUWRUHJLVWUDWLRQGHILQHGDVIROORZV
&UHDWLQLQHFOHDUDQFH  P/PLQE\WKH&RFNFURIW*DXOW&*HTXDWLRQ
&U&OP/PLQ  >±DJH\HDUV@[ZHLJKWNJ ^[IRUIHPDOHSDWLHQWV`
[VHUXPFUHDWLQLQHPJG/
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

 3DWLHQWVSUHVHQWLQJZLWKDSOHXUDOHIIXVLRQZLOOEHHOLJLEOHLIWKRUDFHQWHVLVLVF\WRORJLFDOO\
QHJDWLYHDQGQRQEORRG\RULISOHXUDOIOXLGLVWRRVPDOODYROXPHWRHIIHFWLYHO\VDPSOHE\
WKRUDFHQWHVLVDQGGRHVQRWVKRZLQFUHDVHGPHWDEROLFDFWLYLW\RQ&73(7LPDJLQJ
1HJDWLYHVHUXPSUHJQDQF\WHVWZLWKLQGD\VRIUHJLVWUDWLRQIRUSUHPHQRSDXVDOZRPHQ
RIFKLOGEHDULQJSRWHQWLDO
7KHSDWLHQWRUDOHJDOO\DXWKRUL]HGUHSUHVHQWDWLYHPXVWSURYLGHVWXG\VSHFLILFLQIRUPHG
FRQVHQWSULRUWRVWXG\HQWU\
+HSDWLWLV%&WHVWLQJSULRUWRHQUROOPHQWIRUSDWLHQWVWKDWKDYHQRWEHHQWHVWHGEHIRUH
1RWH7KLVLVUHTXLUHGHYHQLIWKHSDWLHQWKDVQHYHUVKRZQRUKDGV\PSWRPVRIKHSDWLWLV
+,9LQIHFWHGSDWLHQWVRQHIIHFWLYHDQWLUHWURYLUDOWKHUDS\ZLWKXQGHWHFWDEOHYLUDOORDG
ZLWKLQPRQWKVDUHHOLJLEOHIRUWKLVWULDO


,QHOLJLELOLW\&ULWHULD129
Patients with any of the following conditions are NOT eligible for this study. 
 'HILQLWLYHFOLQLFDORUUDGLRORJLFHYLGHQFHRIPHWDVWDWLFGLVHDVH
'HILQLWLYHVXUJLFDOUHVHFWLRQRIVPDOOFHOOOXQJFDQFHU
3ULRULQYDVLYHPDOLJQDQF\H[FHSWQRQPHODQRPDWRXVVNLQFDQFHUORFDOL]HGSURVWDWH
FDQFHURUDQ\HDUO\VWDJHFDQFHUWUHDWHGZLWKFXUDWLYHLQWHQWUHVHFWLRQXQOHVVGLVHDVHIUHH
IRUDPLQLPXPRI\HDUVFDUFLQRPDLQVLWXRIWKHEUHDVWRUDOFDYLW\RUFHUYL[DUHDOO
SHUPLVVLEOH
 0RUHWKDQF\FOHRISULRUSODWLQXPEDVHGFKHPRWKHUDS\IRU6&/&SULRUWRHQUROOPHQW
QRWHWKDWSULRUFKHPRWKHUDS\IRUDGLIIHUHQWFDQFHULVDOORZDEOH
$Q\SULRU$WH]ROL]XPDERURWKHULPPXQRWKHUDS\DJHQW
 3ULRUUDGLRWKHUDS\WRWKHOXQJVRUPHGLDVWLQXPWKDWZRXOGUHVXOWLQFOLQLFDOO\VLJQLILFDQW
RYHUODSRIUDGLDWLRQWKHUDS\ILHOGVSULRUWDQJHQWILHOGVIRUEUHDVWFDQFHUZLWKPLQLPDO
RYHUODSZLWKWDUJHWYROXPHVDUHDOORZHGSHUDSSURYDORIVWXG\3,V
3DWLHQWVZLWKF\WRORJLFDOO\SRVLWLYHSOHXUDORUSHULFDUGLDOIOXLGDUHQRWHOLJLEOH
$QDFWLYHNQRZQRUVXVSHFWHGDXWRLPPXQHGLVHDVH3DWLHQWVDUHSHUPLWWHGWRHQUROOLI
WKH\KDYHYLWLOLJRW\SH,GLDEHWHVPHOOLWXVUHVLGXDOK\SRWK\URLGLVPGXHWRDXWRLPPXQH
FRQGLWLRQRQO\UHTXLULQJKRUPRQHUHSODFHPHQWSVRULDVLVQRWUHTXLULQJV\VWHPLF
WUHDWPHQWRUFRQGLWLRQVQRWH[SHFWHGWRUHFXULQWKHDEVHQFHRIDQH[WHUQDOWULJJHU
$FWLYHRUSULRUGRFXPHQWHGLQIODPPDWRU\ERZHOGLVHDVHHJ&URKQ¶VGLVHDVHXOFHUDWLYH
FROLWLV
+LVWRU\RIDOORJHQHLFRUJDQWUDQVSODQW
+LVWRU\RISULPDU\LPPXQRGHILFLHQF\
 6HYHUHDFWLYHFRPRUELGLW\GHILQHGDVIROORZV
x .QRZQFOLQLFDOO\VLJQLILFDQWOLYHUGLVHDVHLQFOXGLQJDFWLYHYLUDODOFRKROLFRURWKHU
KHSDWLWLVFLUUKRVLVIDWW\OLYHUDQGLQKHULWHGOLYHUGLVHDVH
x $Q\RWKHUGLVHDVHVPHWDEROLFG\VIXQFWLRQSK\VLFDOH[DPLQDWLRQILQGLQJRUFOLQLFDO
ODERUDWRU\ILQGLQJJLYLQJUHDVRQDEOHVXVSLFLRQRIDGLVHDVHRUFRQGLWLRQWKDW
FRQWUDLQGLFDWHVWKHXVHRIDQLQYHVWLJDWLRQDOGUXJRUWKDWPD\DIIHFWWKHLQWHUSUHWDWLRQ
RIWKHUHVXOWVRUUHQGHUWKHSDWLHQWDWKLJKULVNIURPWUHDWPHQWFRPSOLFDWLRQV
x $FWLYHWXEHUFXORVLV
x $FWLYHKHSDWLWLV%FKURQLFRUDFXWHRUKHSDWLWLV&LQIHFWLRQ1RWHWKDWLIKHSDWLWLV
VWDWXVLVXQNQRZQKHSDWLWLV%&WHVWLQJLVUHTXLUHG
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
o 3DWLHQWVZLWKSDVWRUUHVROYHGKHSDWLWLV%LQIHFWLRQGHILQHGDVKDYLQJD
QHJDWLYHKHSDWLWLV%VXUIDFHDQWLJHQ+%V$JWHVWDSRVLWLYHDQWL+%F
>DQWLERG\WRKHSDWLWLV%FRUHDQWLJHQ@DQGDQHJDWLYHYLUDO'1$WHVWRQO\
REWDLQHGLI+%V$JLVIRXQGSRVLWLYHDUHHOLJLEOH
o 3DWLHQWVSRVLWLYHIRU+&9DQWLERG\DUHHOLJLEOHRQO\LISRO\PHUDVHFKDLQ
UHDFWLRQ3&5LVQHJDWLYHIRU+&951$7KH+&951$WHVWPXVWEH
SHUIRUPHGIRUSDWLHQWVZKRKDYHDSRVLWLYH+&9DQWLERG\WHVW
x .QRZQLPPXQRVXSSUHVVLYHGLVHDVHIRUH[DPSOHKLVWRU\RIERQHPDUURZWUDQVSODQW
RU&//
x &23'UHTXLULQJFKURQLFRUDOVWHURLGWKHUDS\RI!PJSUHGQLVRQHGDLO\RU
HTXLYDOHQWDWWKHWLPHRIUHJLVWUDWLRQ,QKDOHGFRUWLFRVWHURLGVDUHQRWH[FOXVLRQDU\
x 8QVWDEOHDQJLQDDQGRUFRQJHVWLYHKHDUWIDLOXUHUHTXLULQJKRVSLWDOL]DWLRQZLWKLQWKH
ODVWPRQWKV
x 7UDQVPXUDOP\RFDUGLDOLQIDUFWLRQZLWKLQWKHODVWPRQWKV
x &OLQLFDOO\VLJQLILFDQWLQWHUVWLWLDOOXQJGLVHDVH
 $FRQGLWLRQUHTXLULQJV\VWHPLFWUHDWPHQWZLWKHLWKHUFRUWLFRVWHURLGV!PJGDLO\
SUHGQLVRQHHTXLYDOHQWVRURWKHULPPXQRVXSSUHVVLYHPHGLFDWLRQVZLWKLQGD\VRIVWXG\
GUXJDGPLQLVWUDWLRQ,QKDOHGRUWRSLFDOVWHURLGVDQGDGUHQDOUHSODFHPHQWGRVHV!PJ
GDLO\SUHGQLVRQHHTXLYDOHQWVDUHSHUPLWWHGLQWKHDEVHQFHRIDFWLYHDXWRLPPXQHGLVHDVH
3UHJQDQF\RUZRPHQRIFKLOGEHDULQJSRWHQWLDODQGPHQZKRDUHVH[XDOO\DFWLYHDQGQRW
ZLOOLQJDEOHWRXVHPHGLFDOO\DFFHSWDEOHIRUPVRIFRQWUDFHSWLRQIRUWKHGXUDWLRQRIVWXG\
WUHDWPHQWDQGIRUGD\VDIWHUWKHODVWGRVHRIVWXG\GUXJ$UPWKLVH[FOXVLRQLV
QHFHVVDU\EHFDXVHWKHWUHDWPHQWLQYROYHGLQWKLVVWXG\PD\EHVLJQLILFDQWO\WHUDWRJHQLF
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
 5(48,5(0(176)25678'<(175<75($70(17$1')2//2:83
-8/

35(75($70(17$66(660(176
Timepoint
Procedure/test
Notes
GD\V3ULRUWR
5HJLVWUDWLRQ
 3DWKRORJLFSURRIRI6&/&
 3(7&7IRUVWDJLQJLQFOXGLQJWXPRU
PHDVXUHPHQWV
 &7FKHVWDQGDEGRPHQZLWK,9FRQWUDVW05,
DEGRPHQZLWK,9FRQWUDVWDOORZHGLQSODFHRI
&7DEGRPHQ
5DGLRJUDSKLFWXPRUPHDVXUHPHQWV
VKRXOGEHREWDLQHGYLD&KHVW&7
6HH5(&,67
KWWSVFWHSFDQFHUJRY
SURWRFRO'HYHORSPHQWGRFVUHFLVWB
JXLGHOLQHSGI$SSHQGL[,,IRU
DOORZDEOHLPDJLQJPRGDOLWLHVXVHGWR
DVVHVVGLVHDVHDWEDVHOLQHDQG
VXEVHTXHQWYLVLWV

$OOGLDJQRVWLFLPDJLQJLVWREH
VXEPLWWHGWR75,$'127(
6XEPLVVLRQRILPDJLQJYLD
75,$'LVQRWSRVVLEOHXQWLO
SDWLHQWLVHQUROOHG
GD\V3ULRUWR
5HJLVWUDWLRQ
 %UDLQ05,ZLWKFRQWUDVWRU%UDLQ&7ZLWK
FRQWUDVWDOORZDEOHLIWKHUHLVDFRQWUDLQGLFDWLRQ
WR05,ZLWKFRQWUDVW
 0HGLFDOKLVWRU\
 3K\VLFDO([DP
 (&2*3HUIRUPDQFH6WDWXV
 9LWDOVLJQV
7RLQFOXGHKHDUWUDWHEORRGSUHVVXUH
SXOVH2[DQGZHLJKWDGGLWLRQDO
EDVHOLQHFDUGLDFPRQLWRULQJHJ
(&*WURSRQLQDVFOLQLFDOO\
LQGLFDWHG
3ULRUWR3UH
UHJLVWUDWLRQ&\FOH
 &03DQG&%&ZLWKGLIIHUHQWLDO
 6HUXP3UHJQDQF\7HVWLIDSSOLFDEOH
)RUFKHPRWKHUDS\F\FOHSULRUWR
VWXG\HQUROOPHQW
:LWKLQGD\VRI
5HJLVWUDWLRQ
 6HUXP3UHJQDQF\7HVWLIDSSOLFDEOH
5HTXLUHGRQO\LIWHVWDERYHLV!
GD\VSULRUWR5HJLVWUDWLRQ
GD\V3ULRUWR
3URWRFRO7UHDWPHQW
 3XOPRQDU\)XQFWLRQ7HVWV)(9DQG'/&2

:LWKLQGD\V3ULRU
WR3URWRFRO
7UHDWPHQW
 )$&772,
 3520,6IDWLJXHVKRUWIRUP
 (4'/
 352&7&$(
7KHVWXG\VSHFLILF352&7&$(
LWHPVFDQEHIRXQGRQWKHIRUPV
VHFWLRQRIWKH&768SURWRFRO
ZHESDJHDQGLVWLWOHG³15*/8
1&,352&7&$(,WHP/LEUDU\´
3UHWUHDWPHQWSULRU
WRHQUROOPHQW
 +HSDWLWLV%&WHVWLQJ
5HTXLUHGRQO\LIKHSDWLWLVVWDWXVLV
XQNQRZQ6HHVHFWLRQVDQG
IRU+HSDWLWLVWHVWLQJ
UHTXLUHPHQWV7KH+&951$WHVW
PXVWEHSHUIRUPHGIRUSDWLHQWVZKR
KDYHDSRVLWLYH+&9DQWLERG\WHVW
3UHWUHDWPHQWSULRU
WRSURWRFRO
WUHDWPHQW
 0DQGDWRU\+	(VWDLQHGVOLGHVXEPLVVLRQ
 2SWLRQDOVSHFLPHQVXEPLVVLRQV)RUSDWLHQWV
ZKRFRQVHQWWRELREDQNLQJ
6HH6HFWLRQ


8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$66(660(176'85,1*75($70(17
x
&\FOHLVWKHILUVWF\FOHRIFKHPRWKHUDS\IROORZLQJVWXG\HQWU\
x
3UHPHGLFDWLRQVPXVWEHDGPLQLVWHUHGSHULQVWLWXWLRQDOJXLGHOLQHV
x
6WDQGDUGLQWUDYHQRXVK\GUDWLRQPXVWEHDGPLQLVWHUHGLQFRQMXQFWLRQZLWKFLVSODWLQ
x
5RXWLQHSUHPHGLFDWLRQVDUHQRWDOORZHGIRUVWF\FOHRIDWH]ROL]XPDEEXWPD\EHDGGHGSHUVWDQGDUG
LQVWLWXWLRQDOSURWRFROVLILQGLFDWHGIRUVXEVHTXHQWF\FOHV
x
'RVHPRGLILFDWLRQVIRXQGLQ6HFWLRQRISURWRFRO
x
$WH]ROL]XPDEPXVWEHDGPLQLVWHUHGZLWKLQKRXUVRISUHSDUDWLRQ
x
5DGLDWLRQZLOOEHDGPLQLVWHUHGDW*\ELGLQIUDFWLRQVRU*\GDLO\LQIUDFWLRQV6HH6HFWLRQ
Timepoint 
Procedure/test/treatment 
Notes 

&\FOHV
&\FOHVGD\WKHVWDUW
RIWKHF\FOHKDVD
ZLQGRZRIGD\V
EXWRQFHWKHF\FOHVWDUWV
(WRSRVLGHPXVWEHJLYHQ
FRQVHFXWLYHO\

+LVWRU\3K\VLFDOH[DP
(&2*3HUIRUPDQFH6WDWXV
9LWDOVVLJQV
&03
&%&ZLWKGLIIHUHQWLDO
76+
$GYHUVHHYHQWHYDOXDWLRQ
&LVSODWLQPJPDQG(WRSRVLGH
PJPG
25
&DUERSODWLQ$8& PJPLQP/DQG
(WRSRVLGHPJPG
$WH]ROL]XPDEPJ$UP2QO\
96WRLQFOXGHKHDUWUDWHEORRG
SUHVVXUHSXOVH2[DQGZHLJKW
DGGLWLRQDOFDUGLDFPRQLWRULQJHJ
(&*WURSRQLQDVFOLQLFDOO\LQGLFDWHG

&03WRLQFOXGHFUHDWLQLQHFOHDUDQFH
$67$/7DQGELOLUXELQ

&%&WRLQFOXGH$1&SODWHOHWV
KHPRJORELQ

76+ZLWKUHIOH[WR7WKHQ7DV
FOLQLFDOO\LQGLFDWHG$UPRQO\

$VVHVVPHQWVFDQEHSHUIRUPHGXSWR
GD\VSULRUWRGD\RI&\FOH
$WH]ROL]XPDEPD\EHJLYHQRQGD\
RURIWKHF\FOH
&\FOHVGD\V
(WRSRVLGHRUPJPG
(WRSRVLGHPXVWEHJLYHQRYHU
FRQVHFXWLYHGD\V
&\FOHVGD\V	
GD\V
+LVWRU\3K\VLFDOH[DP
(&2*3HUIRUPDQFH6WDWXV
9LWDOVVLJQV
&03
&%&ZLWKGLIIHUHQWLDO
$GYHUVHHYHQWHYDOXDWLRQ
352&7&$(
96WRLQFOXGHKHDUWUDWHEORRG
SUHVVXUHSXOVH2[DQGZHLJKW
DGGLWLRQDOFDUGLDFPRQLWRULQJHJ
(&*WURSRQLQDVFOLQLFDOO\LQGLFDWHG

&03WRLQFOXGHFUHDWLQLQHFOHDUDQFH
$67$/7DQGELOLUXELQ

&%&WRLQFOXGH$1&SODWHOHWV
KHPRJORELQ
&\FOH&RQVROLGDWLYH,PPXQRWKHUDS\$UPRQO\

(YHU\ZHHNVGD\V
+LVWRU\3K\VLFDOH[DP
(&2*3HUIRUPDQFH6WDWXV
9LWDO6LJQV
96WRLQFOXGHKHDUWUDWHEORRG
SUHVVXUHSXOVH2[DQGZHLJKW
DGGLWLRQDOFDUGLDFPRQLWRULQJHJ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$GYHUVHHYHQWHYDOXDWLRQ
&03
&%&ZLWKGLIIHUHQWLDO
76+



(&*WURSRQLQDVFOLQLFDOO\LQGLFDWHG

&03WRLQFOXGHFUHDWLQLQHFOHDUDQFH
$67$/7DQGELOLUXELQ

&%&WRLQFOXGH$1&SODWHOHWV
KHPRJORELQ

76+ZLWKUHIOH[WR7WKHQ7LI
FOLQLFDOO\LQGLFDWHG
&\FOHRISURWRFROWUHDWPHQWFRUUHVSRQGVWRF\FOHVRISODWLQXPHWRSRVLGHJLYHQLQWRWDO
WKHILUVWF\FOHRIFKHPRWKHUDS\LVJLYHQEHIRUHSURWRFROWUHDWPHQW


$66(660(176,1)2//2:83
)ROORZXS$VVHVVPHQWVIURP(QGRI&57GHILQHGDVWKHHQGRIWKHODVWF\FOHRIFKHPRWKHUDS\HJ
GD\F\FOHRISODWLQXPHWRSRVLGHSURWRFROLQIXVLRQ
Timepoint 
Procedure/test/treatment 
Notes 
(QGRI&57ZHHN
 7XPRUPHDVXUHPHQWV
 &7VFDQFKHVWWKURXJKDGUHQDOVZLWK
FRQWUDVW
 )$&772,
 3520,6IDWLJXHVKRUWIRUP
 (4'/
 352&7&$(
 2SWLRQDO6SHFLPHQVXEPLVVLRQ
8QOHVVFRQWUDLQGLFDWHG

42/DVVHVVPHQWVPXVWEHGRQHDW
HDFKWLPHSRLQWLQGLFDWHGLQWKLVWDEOH

2SWLRQDOVSHFLPHQVGD\DIWHU
FRPSOHWLRQRI&57
4PRV[\HDUV
ZHHNV
 +LVWRU\DQG3K\VLFDO([DP
 (&2*3HUIRUPDQFHVWDWXV
 9LWDO6LJQV
 $GYHUVH(YHQWHYDOXDWLRQ
 &7VFDQRIFKHVWWKURXJKDGUHQDOV&7
DEGRPHQZLWKFRQWUDVWXQOHVV
FRQWUDLQGLFDWHG
 %UDLQ05,ZLWKDQGZLWKRXWFRQWUDVWRU
EUDLQ&7ZLWKFRQWUDVWDOORZDEOHLIWKHUH
LVDFRQWUDLQGLFDWLRQWR05,
 7XPRUPHDVXUHPHQWVLIDSSOLFDEOH
 &03LIFOLQLFDOO\LQGLFDWHG
 &%&ZLWKGLIIHUHQWLDOLIFOLQLFDOO\
LQGLFDWHG
 76+
 )$&772,
 3520,6IDWLJXHVKRUWIRUP
 (4'/
 352&7&$(

 2SWLRQDO6SHFLPHQVXEPLVVLRQ

9LWDOVLJQVLQFOXGHKHDUWUDWHEORRG
SUHVVXUHSXOVH2[DQGZHLJKW
DGGLWLRQDOFDUGLDFPRQLWRULQJHJ
(&*WURSRQLQDVFOLQLFDOO\LQGLFDWHG

%UDLQ05,LQIROORZXS±4PRV
LQ\HDU4PRVLQ\HDU7KHQDV
FOLQLFDOO\LQGLFDWHG

$OOGLDJQRVWLFLPDJLQJLVWREH
VXEPLWWHGWR75,$'

76+XQWLOUHWXUQVWREDVHOLQHDQGWKHQ
DVFOLQLFDOO\LQGLFDWHG$UPRQO\
76+ZLWKUHIOH[WR7WKHQ7LI
FOLQLFDOO\LQGLFDWHG

4XDOLW\RI/LIHDVVHVVPHQWVDWDQG
PRQWKVZHHNVDQGDQG
PRQWKVZHHNVDIWHUFRPSOHWLRQ
RI&57WKHQHYHU\RWKHU\HDU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
352&7&$(DWPRQWKV
ZHHNVDQGPRQWKVZHHNV
DIWHUFRPSOHWLRQRI&57

2SWLRQDOVSHFLPHQVDW'D\DIWHU
FRPSOHWLRQRI&57DQGPRQWKV
DIWHUFRPSOHWLRQRI&57
4PRVLQ\HDU
ZHHNV
 +LVWRU\DQG3K\VLFDO([DP
 (&2*3HUIRUPDQFHVWDWXV
 9LWDO6LJQV
 $GYHUVH(YHQWHYDOXDWLRQ
 &7VFDQRIFKHVWWKURXJKDGUHQDOV&7
DEGRPHQZLWKFRQWUDVW
 %UDLQ05,ZLWKDQGZLWKRXWFRQWUDVWLI
FOLQLFDOO\LQGLFDWHGRUEUDLQ&7ZLWK
FRQWUDVWDOORZDEOHLIWKHUHLVD
FRQWUDGLFWLRQWR05,
 7XPRUPHDVXUHPHQWVLIDSSOLFDEOH
 &03LIFOLQLFDOO\LQGLFDWHG
 &%&ZLWKGLIIHUHQWLDOLIFOLQLFDOO\
LQGLFDWHG


7KHQDQQXDOO\
ZHHNVXQOHVVRWKHUZLVH
LQGLFDWHG
 +LVWRU\DQG3K\VLFDO([DP
 (&2*3HUIRUPDQFHVWDWXV
 9LWDO6LJQV
 $GYHUVH(YHQWHYDOXDWLRQ
 &7VFDQRIFKHVWWKURXJKDGUHQDOV&7
DEGRPHQZLWKFRQWUDVW
 %UDLQ05,ZLWKDQGZLWKRXWFRQWUDVWLI
FOLQLFDOO\LQGLFDWHGRUEUDLQ&7ZLWK
FRQWUDVWDOORZDEOHLIWKHUHLVD
FRQWUDLQGLFDWLRQWR05,
 7XPRUPHDVXUHPHQWVLIDSSOLFDEOH
 &03LIFOLQLFDOO\LQGLFDWHG
 &%&ZLWKGLIIHUHQWLDOLIFOLQLFDOO\
LQGLFDWHG


7KLVVWXG\XVHV0HGLGDWD3DWLHQW&ORXGH352H352LVQRWDYDLODEOHLQ-DSDQHVH
5HPHPEHUWRUHJLVWHUWKHSDWLHQWWRWKH3DWLHQW&ORXGH352)RULQVWUXFWLRQVRQUHJLVWHULQJ
WKHSDWLHQWVSOHDVHUHIHUWR$SSHQGL[,,,7KHVWXG\VSHFLILF352&7&$(LWHPVIRUWKLV
SURWRFROFDQEHIRXQGRQWKH&,5%WDERIWKH&768SURWRFROZHESDJHDQGLVWLWOHG³15*
/83DUWLFLSDQW4XHVWLRQQDLUH352&7&$(´

3OHDVHQRWHWKDWWKHHQGRI&57GHILQHGE\WKHHQGRIWKHWKF\FOHRIFKHPRWKHUDS\ZDV
FKRVHQWRVWDQGDUGL]HWKLVWLPHSRLQWIRUDOOSDWLHQWVDVUDGLDWLRQVFKHGXOHZLOOYDU\GHSHQGLQJ
RQZKHWKHUSDWLHQWVUHFHLYHGGDLO\RUWZLFHGDLO\UDGLDWLRQ$GGLWLRQDOO\SOHDVHQRWHWKDW
IROORZXSDVVHVVPHQWVLQFOXGLQJ42/352PHDVXUHPHQWVRFFXUULQJDWPRQWKVDIWHUWKH
HQGRI&57ZLOOEHGXULQJLPPXQRWKHUDS\IRUSDWLHQWVUDQGRPL]HGWRWKHH[SHULPHQWDODUP

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
'HILQLWLRQRI'LVHDVH$VVHVVPHQWV
5HVSRQVHDQGSURJUHVVLRQZLOOEHHYDOXDWHGLQWKLVVWXG\XVLQJWKHQHZLQWHUQDWLRQDOFULWHULD
SURSRVHGE\WKHUHYLVHG5HVSRQVH(YDOXDWLRQ&ULWHULDLQ6ROLG7XPRUV5(&,67JXLGHOLQH
YHUVLRQ>(LVHQKDXHU@&KDQJHVLQWKHODUJHVWGLDPHWHUXQLGLPHQVLRQDO
PHDVXUHPHQWRIWKHWXPRUOHVLRQVDQGWKHVKRUWHVWGLDPHWHULQWKHFDVHRIPDOLJQDQWO\PSK
QRGHVDUHXVHGLQWKH5(&,67FULWHULD

 75($70(173/$15(*,0(1'(6&5,37,21$8*
7KLVUDQGRPL]HGSKDVH,,,WULDOZLOOFRPSDUHHWRSRVLGHDQGSODWLQXPFKHPRWKHUDS\SOXV
VWDQGDUGWKRUDFLFUDGLDWLRQZLWKRUZLWKRXWFRQFXUUHQWDQGDGMXYDQWDWH]ROL]XPDE7KHILUVW
F\FOHRIFKHPRWKHUDS\PXVWEHJLYHQSULRUWRVWXG\HQWU\LHSUHUHJLVWUDWLRQF\FOH
3DUWLFLSDQWVZLOOUHFHLYHWKUHHF\FOHVLH&\FOHVRIFKHPRWKHUDS\RQVWXG\IRUDWRWDORI
IRXUF\FOHV3URWRFROWUHDWPHQWEHJLQVZLWKFRQFXUUHQWFKHPRWKHUDS\DQGUDGLDWLRQ

3DUWLFLSDQWVUDQGRPL]HGWR$UPZLOOUHFHLYH6WDQGDUG&57*\ELGRU*\GDLO\SOXV
SODWLQXPHWRSRVLGHFKHPRWKHUDS\FLVSODWLQSUHIHUUHGJLYHQHYHU\ZHHNVIRUF\FOHVIRU
DWRWDORIF\FOHVRIFKHPRWKHUDS\WKDWLQFOXGHVWKHF\FOHJLYHQSULRUWRUHJLVWUDWLRQ
5DGLDWLRQPXVWVWDUWZLWKLQEXVLQHVVGD\VRISURWRFROFKHPRWKHUDS\

3DUWLFLSDQWVUDQGRPL]HGWR$UPZLOOUHFHLYH6WDQGDUG&57*\ELGRU*\GDLO\SOXV
SODWLQXPHWRSRVLGHFKHPRWKHUDS\FLVSODWLQSUHIHUUHGJLYHQHYHU\ZHHNVIRUF\FOHVIRU
DWRWDORIF\FOHVRIFKHPRWKHUDS\WKDWLQFOXGHVWKHF\FOHJLYHQSULRUWRUHJLVWUDWLRQSOXV
FRQFXUUHQWDWH]ROL]XPDEPJ,9HYHU\ZHHNV[\HDUGRVHV5DGLDWLRQPXVW
VWDUWZLWKLQEXVLQHVVGD\VRISURWRFROFKHPRWKHUDS\

1RWH3&,LVVWURQJO\UHFRPPHQGHGDIWHUFRPSOHWLRQRIFKHPRWKHUDS\IRUSDWLHQWVZKRKDYH
DFRPSOHWHRUQHDUFRPSOHWHUHVSRQVH*\LQIUDFWLRQVSODQQHGZLWKLQZHHNVIURP
FRPSOHWLRQRIFKHPRUDGLRWKHUDS\7R[LFLWLHVIURPFKHPRUDGLRWKHUDS\VKRXOGEHUHVROYHGWR
JUDGHRUOHVVEHIRUHLQLWLDWLRQRI3&,3DWLHQWVRQ$UPZKRUHFHLYH3&,ZLOOUHFHLYHLW
FRQFXUUHQWZLWKDWH]ROL]XPDE

127(5DGLDWLRQWKHUDS\SURWRFROWUHDWPHQW*\ELGRU*\GDLO\PXVWEHJLQ
ZLWKLQEXVLQHVVGD\VRISURWRFROSODWLQXPHWRSRVLGHFKHPRWKHUDS\,WLVSUHIHUUHG
IRUUDGLDWLRQWRVWDUWLQWKHHDUO\SDUWRIWKHZHHN0RQGD\:HGQHVGD\


7UHDWPHQW:HHN

3UHVWXG\
UHJLVWUDWLRQ






:HHNV

57*\ELGRU
*\GDLO\Ƈ











Ƈ
Ƈ
Ƈ
Ƈ
Ƈ
Ƈ
ƇZHHN
SODWLQXPHWRSRVLGH
FLVSODWLQ
PJPRQGD\
ZLWKHWRSRVLGH
PJPRQGD\V
25FDUERSODWLQ
;

;


;


;ZHHN
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
>$8& @RQGD\
ZLWKHWRSRVLGH
PJPRQ
GD\V
$UP2QO\
DWH]ROL]XPDE
PJ,9TZHHNV[
\HDUGRVHV


;


;


;TZHHNV[
F\FOHV
WRWDO
7KHSUHUHJLVWUDWLRQF\FOHRIFKHPRWKHUDS\LVJLYHQSULRUWRVWXG\HQWU\2QVWXG\
SURWRFROWUHDWPHQWEHJLQVZLWKFRQFXUUHQWFKHPR57DWH]ROL]XPDE


6\VWHPLF7UHDWPHQW$8*
3ODWLQXPHWRSRVLGH

$SODWLQXPHWRSRVLGHGRXEOHWZLOOEHDGPLQLVWHUHGDVIROORZV&LVSODWLQZLOOEHGRVHGDW
PJPGD\ZLWKHWRSRVLGHPJPGD\VRIHDFKGD\F\FOH,IXVLQJ
FDUERSODWLQFDUERSODWLQZLOOEHGRVHGDW$8& GD\ZLWKHWRSRVLGHPJPGD\V
IRUHDFKRIIRXUGD\F\FOHV9DULDWLRQVLQGRVLQJLQWKHSUHUHJLVWUDWLRQF\FOH
LQLWLDWHGSULRUWRVWXG\HQWU\DUHDFFHSWDEOHSURYLGHGWKH\DUHZLWKLQWKHVWDQGDUGRIFDUH
IRUSODWLQXPHWRSRVLGHDGPLQLVWUDWLRQ$QWLHPHWLFSUHPHGLFDWLRQVLQFOXGLQJVWDQGDUG
GH[DPHWKDVRQHVKRXOGEHDGPLQLVWHUHGSHULQVWLWXWLRQDOVWDQGDUGV(LWKHUWKH
FLVSODWLQHWRSRVLGHRUFDUERSODWLQHWRSRVLGHGRXEOHWLVDOORZHGSHUWKHWUHDWLQJ
SK\VLFLDQ¶VGLVFUHWLRQZLWKFLVSODWLQSUHIHUUHGXQOHVVFRQWUDLQGLFDWHG,ID
FRQWUDLQGLFDWLRQWRFLVSODWLQGHYHORSVGXULQJWKHUDS\FDUERSODWLQPD\EHVXEVWLWXWHGLI
WKHSDWLHQWUHPDLQVRWKHUZLVHHOLJLEOHWRFRQWLQXHWUHDWPHQW

3URWRFROWUHDWPHQWLVGHVLJQHGWREHJLQGD\VDIWHULQLWLDWLRQRISUHUHJLVWUDWLRQF\FOH
KRZHYHULISDWLHQWKDVQRWUHFRYHUHGIURPSUHUHJLVWUDWLRQF\FOHFKHPRWKHUDS\WR[LFLWLHV
WKHQDQDGGLWLRQDOGD\VLVSHUPLWWHGIURPVWDUWRIWUHDWPHQW

2QHRIWKHIROORZLQJUHFRJQL]HGVWDQGDUGSURWRFRODOORZHGUHJLPHQVPXVWEHJLYHQZLWK
UDGLDWLRQWKHUDS\

7+,65(*,0(135()(55('
&LVSODWLQPJPGLQWUDYHQRXVRQGD\DQG
(WRSRVLGHPJPGLQWUDYHQRXVRQGD\VWR

6WDQGDUGDQWLHPHWLFSUHPHGLFDWLRQVPXVWEHDGPLQLVWHUHGSHULQGLYLGXDO
LQVWLWXWLRQDOJXLGHOLQHV6WDQGDUGLQWUDYHQRXVK\GUDWLRQPXVWEHDGPLQLVWHUHGLQ
FRQMXQFWLRQZLWKFLVSODWLQ

25


&DUERSODWLQ$8& PJPLQP/LQWUDYHQRXVGD\DQG
(WRSRVLGHPJPGLQWUDYHQRXVRQGD\VWR

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
6WDQGDUGSUHPHGLFDWLRQVPXVWEHDGPLQLVWHUHGSHULQGLYLGXDOLQVWLWXWLRQDO
JXLGHOLQHV

$WH]ROL]XPDE
$WH]ROL]XPDEPJZLOOEHDGPLQLVWHUHG,9RYHUPLQXWHVILUVWGRVHRU
PLQXWHVVXEVHTXHQWGRVHVRQGD\RURIHDFKFKHPRWKHUDS\F\FOHDQGFRQWLQXHG
HYHU\ZHHNVIRURQH\HDURUXQWLOORVVRIFOLQLFDOEHQHILWGHILQHGDVGLVHDVH
SURJUHVVLRQRUH[FHVVLYHWR[LFLW\UHTXLULQJVWRSSLQJRIVWXG\GUXJVHH6HFWLRQ
ZKLFKHYHULVHDUOLHU

$GPLQLVWUDWLRQRIDWH]ROL]XPDEZLOOEHSHUIRUPHGLQDVHWWLQJZLWKHPHUJHQF\PHGLFDO
IDFLOLWLHVDQGVWDIIZKRDUHWUDLQHGWRPRQLWRUIRUDQGUHVSRQGWRPHGLFDOHPHUJHQFLHV

7KHLQLWLDOGRVHRIDWH]ROL]XPDEZLOOEHGHOLYHUHGRYHUPLQXWHV,IWKHILUVW
LQIXVLRQLVWROHUDWHGZLWKRXWLQIXVLRQDVVRFLDWHG$(VWKHVHFRQGLQIXVLRQPD\EH
GHOLYHUHGRYHUPLQXWHV,IWKHPLQXWHLQIXVLRQLVZHOOWROHUDWHGDOO
VXEVHTXHQWLQIXVLRQVPD\EHGHOLYHUHGRYHUPLQXWHV)RUWKHILUVWLQIXVLRQWKH
SDWLHQW¶VYLWDOVLJQVKHDUWUDWHUHVSLUDWRU\UDWHEORRGSUHVVXUHDQGWHPSHUDWXUHVKRXOG
EHGHWHUPLQHGZLWKLQPLQXWHVEHIRUHWKHLQIXVLRQ,IFOLQLFDOO\LQGLFDWHGYLWDOVVKRXOG
EHPHDVXUHGHYHU\>@PLQXWHVDQGPLQXWHVDIWHUWKHLQIXVLRQ)RU
VXEVHTXHQWLQIXVLRQVYLWDOVLJQVZLOOEHFROOHFWHGZLWKLQPLQXWHVEHIRUHWKHLQIXVLRQ
,ISDWLHQWH[SHULHQFHGDQLQIXVLRQUHODWHGUHDFWLRQZLWKSUHYLRXVLQIXVLRQRULIFOLQLFDOO\
LQGLFDWHGYLWDOVLJQVVKRXOGEHPHDVXUHGGXULQJWKHLQIXVLRQDQGDWPLQXWHV
DIWHUWKHLQIXVLRQ

3UHPHGLFDWLRQLVQRWSHUPLWWHGIRUWKHILUVWGRVHRIDWH]ROL]XPDE3UHPHGLFDWLRQZLWK
DQWLKLVWDPLQHVRUDQWLS\UHWLFVDQDOJHVLFVHJDFHWDPLQRSKHQPD\EHDGPLQLVWHUHGIRU
VXEVHTXHQWLQIXVLRQVDWWKHGLVFUHWLRQRIWKHWUHDWLQJSK\VLFLDQ6HH6HFWLRQIRUWKH
PDQDJHPHQWRI,QIXVLRQ5HODWHG5HDFWLRQV

2QWKHGD\RILQIXVLRQWKHUHLVQRWDVSHFLILHGVHTXHQFHRIDGPLQLVWUDWLRQRI
FKHPRWKHUDS\DQGDWH]ROL]XPDEWKLVFDQEHSHUIRUPHGSHULQVWLWXWLRQDOSUHIHUHQFH


5DGLDWLRQ7KHUDS\
127(6)257+,6678'<(,7+(5,05725'&57,65(48,5(',*57,6
5(48,5('

35(75($70(17 5(9,(: LV UHTXLUHG IRU WKH ILUVW  SDWLHQWV HQUROOHG IURP HDFK
LQVWLWXWLRQ 35,25 72 '(/,9(5< RI UDGLDWLRQ WUHDWPHQW 7KH SDWLHQW FDQQRW VWDUW
WUHDWPHQWXQWLOWKH\KDYHUHFHLYHGDSSURYDOIURPWKH,PDJLQJDQG5DGLDWLRQ2QFRORJ\
&RUH,52&3KLODGHOSKLD577KH3UH7UHDWPHQW5HYLHZSURFHVVUHTXLUHVEXVLQHVV
GD\VIURPWKHUHFHLSWRIFRPSOHWHGDWDYLD75,$'

 7UHDWPHQW7HFKQRORJ\5HTXLUHPHQWV
7KUHHGLPHQVLRQDOFRQIRUPDOUDGLDWLRQWKHUDS\'&57RU,QWHQVLW\0RGXODWHG
5DGLDWLRQ7KHUDS\,057LVUHTXLUHG3URWRQ%HDP7KHUDS\LVQRWDOORZHG,057
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WHFKQLTXHVGHOLYHUHGIURPHTXLSPHQWXVLQJ7RPRWKHUDS\9LHZ5D\DQG90$7DUH
DOORZHG)RUSKRWRQVEHDPHQHUJ\RI09ZLOOEHXVHG9LHZ5D\ZLWK&REDOW
VRXUFHDQG9LHZ5D\05,GLDQDUHSHUPLWWHG'DLO\LPDJHJXLGHGUDGLDWLRQWKHUDS\
,*57XVLQJRUWKRJRQDO;UD\FRQHEHDP&7&7RQUDLOVRU05JXLGDQFHPXVWEH
XVHGIRUDOOSDWLHQWVUHJDUGOHVVRIUDGLDWLRQWHFKQLTXHV0XOWLOHDIFROOLPDWLRQZLOOEH
XVHGWRVSDUHQRUPDOWLVVXHVRXWVLGHRIWKHWDUJHWYROXPH'&7LVUHTXLUHG8VHRI
3(7&7IRUWUHDWPHQWSODQQLQJLVVWURQJO\HQFRXUDJHG

 ,PPRELOL]DWLRQDQG6LPXODWLRQ
,PPRELOL]DWLRQ
3URSHULPPRELOL]DWLRQLVFULWLFDOIRUWKLVSURWRFRO3DWLHQWVHWXSUHSURGXFLELOLW\PXVWEH
DFKLHYHGXVLQJDSSURSULDWHFOLQLFDOGHYLFHV$OSKD&UDGOHVRU9DFORNGHYLFHVDUHXVHG
IRUVKRXOGHULPPRELOL]DWLRQ$UPVDUHDEGXFWHGELODWHUDOO\ZLWKKDQGVDERYHWKHKHDG
SUHIHUDEO\LQDOOFDVHVXQOHVVSDWLHQWVDUHLQFDSDEOHRIGRLQJVREXWVHWXSPXVWEH
UHSURGXFLEOHGDLO\DQGWUHDWPHQWSODQQLQJZLOODFFRPPRGDWHIRUWKHGHYLDWLRQ

6LPXODWLRQ,PDJLQJ
6LPXODWLRQ&7VVKRXOGEH&7VOLFHVRIPPVOLFHWKLFNQHVVVWDUWLQJIURPWKHOHYHORI
WKHFULFRLGFDUWLODJHRUIXUWKHUFUDQLDOO\DQGH[WHQGLQJLQIHULRUO\WKURXJKWKHHQWLUHOLYHU
RUIXUWKHUFDXGDGYROXPH$GPLQLVWUDWLRQRILQWUDYHQRXV,9FRQWUDVWGXULQJ
VLPXODWLRQ&7LVRSWLRQDOSURYLGHGDGLDJQRVWLF&7ZLWKFRQWUDVWKDVEHHQGRQHWRKHOS
GHOLQHDWHWKHPDMRUEORRGYHVVHOV,IVXFKGLDJQRVWLF&7LVQRWDYDLODEOH,9FRQWUDVW
VKRXOGEHJLYHQGXULQJWKHWUHDWPHQWSODQQLQJ&77KHVLPXODWLRQVKRXOGEHSHUIRUPHG
DIWHUWKHILUVWF\FOHRIFKHPRWKHUDS\WRDFFRXQWIRUDQ\VLJQLILFDQWVKULQNDJHRIWKH
SULPDU\WXPRU

0RWLRQ0DQDJHPHQW7HFKQLTXH
7KHXVHRIIRXUGLPHQVLRQDOUDGLDWLRQWUHDWPHQWSODQQLQJLVUHTXLUHGWRDVVHVVIRU
UHVSLUDWRU\PRWLRQLQWKHWUHDWPHQWSODQQLQJSURFHVV8VHRID0,3LPDJHLVDFFHSWDEOH
WRDLGLQFRQWRXULQJWKH,*79EXWFDUHVKRXOGEHWDNHQLQDUHDVRIXQLIRUPGHQVLW\VXFK
DVPHGLDVWLQXPFKHVWZDOODQGGLDSKUDJP,IQRUPDOWLVVXHWROHUDQFHVDUHH[FHHGHGRU
0/&LQWHUSOD\HIIHFWVDUHRIFRQFHUQPRWLRQOLPLWLQJWHFKQLTXHVPD\EHFRQVLGHUHG
3HUPLWWHGPHWKRGVLQFOXGHDFWLYHEUHDWKKROGJDWHGWUHDWPHQWDQGDEGRPLQDO
FRPSUHVVLRQ

 ,PDJLQJIRU6WUXFWXUH'HILQLWLRQDQG,PDJH5HJLVWUDWLRQ
$YROXPHWULFWUHDWPHQWSODQQLQJ&7VWXG\DVGHVFULEHGDERYHXQGHU6LPXODWLRQ,PDJLQJ
ZLOOEHUHTXLUHGWRGHILQHJURVVWXPRUYROXPH,*79FOLQLFDOWDUJHWYROXPH&79DQG
SODQQLQJWDUJHWYROXPH379VHHGHILQLWLRQVEHORZ7KH,*79&79DQG379DQG
FULWLFDOVWUXFWXUHVZLOOEHRXWOLQHGRQDOODSSURSULDWH&7VOLFHV$WUHDWPHQWSODQQLQJ
)'*3(7&7VFDQRU)'*3(7DORQHZLWKWKHSDWLHQWLQWKHWUHDWPHQWSRVLWLRQLV
HQFRXUDJHGIRUWUHDWPHQWSODQQLQJ,QWKHFDVHZKHUHWKH3(7&7LVREWDLQHGLQWKH
WUHDWPHQWSRVLWLRQWKH&7IURPWKLVVWXG\PD\EHXVHGDVWKHSODQQLQJ&7VFDQ
2WKHUZLVHDGLDJQRVWLF3(7&7XVHGIRUVWDJLQJFRXOGEHXVHGIRUWDUJHWGHOLQHDWLRQ
ZLWKLPDJHFRUHJLVWUDWLRQZLWKWKHSODQQLQJ&7

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
 'HILQLWLRQRI7DUJHW9ROXPHVDQG0DUJLQV
1RWH$OOVWUXFWXUHVPXVWEHQDPHGIRUGLJLWDO57GDWDVXEPLVVLRQDVOLVWHGLQWKHWDEOH
EHORZ7KHVWUXFWXUHVPDUNHGDV³5HTXLUHG´LQWKHWDEOHPXVWEHFRQWRXUHGDQG
VXEPLWWHGZLWKWKHWUHDWPHQWSODQ6WUXFWXUHVPDUNHGDV³5HTXLUHGZKHQDSSOLFDEOH´
PXVWEHFRQWRXUHGDQGVXEPLWWHGZKHQDSSOLFDEOH5HVXEPLVVLRQRIGDWDPD\EH
UHTXLUHGLIODEHOLQJRIVWUXFWXUHVGRHVQRWFRQIRUPWRWKHVWDQGDUG',&20QDPHOLVWHG
&DSLWDOOHWWHUVVSDFLQJDQGXVHRIXQGHUVFRUHVPXVWEHDSSOLHGH[DFWO\DVLQGLFDWHG

2QFH3HU'D\572SWLRQ*\[IUDFWLRQV *\
',&206WDQGDUG1DPH
'HVFULSWLRQ
9DOLGDWLRQ
5HTXLUHG5HTXLUHGZKHQ
DSSOLFDEOH
,*79B

*79WRUHFHLYH*\


5HTXLUHG

&79B

&79WRUHFHLYH*\

5HTXLUHG
379B
379WRUHFHLYH*\
5HTXLUHG
%,'572SWLRQ*\%,'[IUDFWLRQV *\
',&206WDQGDUG1DPH
'HVFULSWLRQ
9DOLGDWLRQ
5HTXLUHG5HTXLUHGZKHQ
DSSOLFDEOH
,*79B

,*79WRUHFHLYH*\


5HTXLUHG

&79B

&79WRUHFHLYH*\

5HTXLUHG
379B
379WRUHFHLYH*\
5HTXLUHG

'HWDLOHG6SHFLILFDWLRQV
7DUJHWYROXPHV7KHGHILQLWLRQVRIYROXPHVZLOOEHLQDFFRUGDQFHZLWKWKHICRU 50 
(1999) for 3DCRT and ICRU 83 (2010) for IMRT. 

,*79BRU,*79B7KHSULPDU\WXPRUDQGFOLQLFDOO\SRVLWLYHO\PSKQRGHV
VHHQHLWKHURQWKHSODQQLQJ&7
!FPVKRUWD[LVGLDPHWHURUSUHWUHDWPHQW3(7VFDQ689!ZLOOFRQVWLWXWHWKH
,*797KLVYROXPHVPD\EHGLVMRLQWHG,IWKHSULPDU\WXPRUO\PSKQRGHVKDYH
FKDQJHGVLJQLILFDQWO\DIWHUWKHILUVWF\FOHRIFKHPRWKHUDS\WKH,*79VKRXOGUHIOHFWWKH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WXPRUVHHQRQSODQQLQJ&7DQGQRWDODUJHUSUHFKHPRWKHUDS\YROXPH,QWKHHYHQWRID
FROODSVHGOREHRUOXQJVHJPHQWWKHXVHRI3(7WRGLVWLQJXLVKWXPRUIURPIOXLGDWHOHFWDVLV
LVHQFRXUDJHG
&79BRU&79B7KH&79LVGHILQHGWREHWKH,*79SOXVDFPPDUJLQDV
DSSURSULDWHWRDFFRXQWIRUPLFURVFRSLFWXPRUH[WHQVLRQ7KH&79VKRXOGEHDGMXVWHGWR
QRWH[SDQGLQWRRWKHURUJDQVVXFKDVHVRSKDJXVKHDUWPDMRUEORRGYHVVHOVRUERQH
XQOHVVFOLQLFDOO\LQGLFDWHG
379BRU379B7KH379ZLOOEHHTXDOWRWKH&79FPVHWXSPDUJLQ
60LQDOOGLUHFWLRQV

'HILQLWLRQRI&ULWLFDO6WUXFWXUHVDQG0DUJLQV
1RWH$OOVWUXFWXUHVPXVWEHQDPHGIRUGLJLWDO57GDWDVXEPLVVLRQDVOLVWHGLQWKHWDEOH
EHORZ7KHVWUXFWXUHVPDUNHGDV³5HTXLUHG´LQWKHWDEOHPXVWEHFRQWRXUHGDQG
VXEPLWWHGZLWKWKHWUHDWPHQWSODQ6WUXFWXUHVPDUNHGDV³5HTXLUHGZKHQDSSOLFDEOH´
PXVWEHFRQWRXUHGDQGVXEPLWWHGZKHQDSSOLFDEOH

5HVXEPLVVLRQRIGDWDPD\EHUHTXLUHGLIODEHOLQJRIVWUXFWXUHVGRHVQRWFRQIRUPWRWKH
VWDQGDUG',&20QDPHOLVWHG&DSLWDOOHWWHUVVSDFLQJDQGXVHRIXQGHUVFRUHVPXVWEH
DSSOLHGH[DFWO\DVLQGLFDWHG

6WDQGDUG1DPH

'HVFULSWLRQ

9DOLGDWLRQ
5HTXLUHG5HTXLUHGZKHQ
DSSOLFDEOH
6SLQDO&RUG
6SLQDO&RUG

5HTXLUHG
/XQJV,*79
&RPELQHGOXQJVPLQXV
,*79
5HTXLUHG
(VRSKDJXV
(VRSKDJXV
5HTXLUHG
+HDUW
+HDUW
5HTXLUHG
%UDFKLDO3OH[XV
%UDFKLDO3OH[XV
5HTXLUHGIRUXSSHUOREHWXPRUV
RUKLJKPHGLDVWLQDOQRGDO
LQYROYHPHQW

'HWDLOHG6SHFLILFDWLRQV

6SLQDO&RUG%RXQGDULHV&UDQLDOVWVOLFHRI&7&DXGDOODVWVOLFHRI&7

(VRSKDJXV%RXQGDULHV&UDQLDO%RWWRPRIFULFRLG&DXGDO*(MXQFWLRQ

/XQJV,*79%RXQGDULHV&UDQLDO)URPDSH[ELODWHUDOO\&DXGDOWRERWWRPRI/
5LJKW/HIW/XQJ&RPELQHGEXWH[FOXGLQJ,*79
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

+HDUW%RXQGDULHV%DVH%RWWRPRIWKHDRUWLFDUFK,QIHULRU$SLFDOPRVWRIWKH
YHQWULFOH

%UDFKLDO3OH[XV&&&&7QHUYHURRWVDQGFRUGH[WHQVLRQV

 'RVH3UHVFULSWLRQ
 *\LQZHHNV
3DWLHQWV ZLOO UHFHLYH WUHDWPHQW  GD\V SHU ZHHN LQ RQFH GDLO\IUDFWLRQV  *\ SHU
IUDFWLRQ7KHWRWDOGRVHZLOOEH*\LQIUDFWLRQV5DGLDWLRQZLOOEHJLQFRQFXUUHQWO\
ZLWKWKHVHFRQGF\FOHRIFKHPRWKHUDS\

 *\LQZHHNVSUHIHUUHG
3DWLHQWVZLOOUHFHLYHWUHDWPHQWGD\VSHUZHHNLQWZLFHGDLO\IUDFWLRQV*\SHU
IUDFWLRQ7KHWRWDOGRVHZLOOEH*\LQIUDFWLRQV)RU,057WKHVDPHWUHDWPHQW
SODQZLOOEHGHOLYHUHGIRUHDFKWUHDWPHQW7KHUHZLOOEHDPLQLPXPRIKRXUVEHWZHHQ
WKHPRUQLQJDQGDIWHUQRRQIUDFWLRQV5DGLDWLRQZLOOEHJLQFRQFXUUHQWO\ZLWKWKHVHFRQG
F\FOHRIFKHPRWKHUDS\

)RUSDWLHQWVZLWKDFRPSOHWHRUQHDUFRPSOHWHUHVSRQVHWRWKHUDS\3&,LVUHFRPPHQGHG
7KHGRVHZLOOEH*\GHOLYHUHGDW*\SHUIUDFWLRQIRUIUDFWLRQVWREHVWDUWHG
ZHHNV IURP FRPSOHWLRQ RI &57  3DWLHQWV RQ $UP  ZKR UHFHLYH 3&, ZLOO UHFHLYHLW
FRQFXUUHQWZLWKDWH]ROL]XPDE

2QFH'DLO\57*\[IUDFWLRQV *\
7DUJHW
6WDQGDUG1DPH
'RVH*\
)UDFWLRQ
6L]H*\
RI
IUDFWLRQV
)UHTXHQF\
'RVHVSHFLILFDWLRQWHFKQLTXH

379B






'DLO\
IUDFWLRQ
SHUGD\
&RYHULQJDWOHDVWRI379


%,'57*\[IUDFWLRQV *\
7DUJHW
6WDQGDUG1DPH
'RVH*\
)UDFWLRQ
6L]H*\
RI
IUDFWLRQV
)UHTXHQF\
'RVHVSHFLILFDWLRQWHFKQLTXH

379B







%,'
! KRXUV
DSDUW

&RYHULQJDWOHDVWRI379

 &RPSOLDQFH&ULWHULD
7KHFRPSOLDQFHFULWHULDOLVWHGKHUHZLOOEHXVHGWRVFRUHHDFKFDVH*LYHQWKHOLPLWDWLRQV
LQKHUHQW LQ WKH WUHDWPHQW SODQQLQJ SURFHVV WKH QXPEHUV JLYHQ LQ WKLV VHFWLRQ FDQ EH
GLIIHUHQWWKDQWKHSUHVFULSWLRQWDEOH7KH3HU3URWRFRODQG9DULDWLRQ$FFHSWDEOHFDWHJRULHV
DUHERWKFRQVLGHUHGWREHDFFHSWDEOH7KH3HU3URWRFROFDVHVFDQEHYLHZHGDVLGHDOSODQV
DQGWKH9DULDWLRQ$FFHSWDEOHFDWHJRU\FDQLQFOXGHPRUHFKDOOHQJLQJSODQVWKDWGRQRWIDOO
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
DWRUQHDUWKHLGHDOUHVXOWV$ILQDOFDWHJRU\FDOOHG'HYLDWLRQ8QDFFHSWDEOHUHVXOWVZKHQ
FDVHVGRQRWPHHWWKHUHTXLUHPHQWVIRUHLWKHU3HU3URWRFRORU9DULDWLRQ$FFHSWDEOH3ODQV
IDOOLQJLQWKLVFDWHJRU\DUHFRQVLGHUHGWREHVXERSWLPDODQGDGGLWLRQDOWUHDWPHQWSODQQLQJ
RSWLPL]DWLRQLVUHFRPPHQGHG

1RUPDOL]DWLRQRI'RVH7KHSODQLVQRUPDOL]HGVXFKWKDWRIWKH379YROXPH
UHFHLYHVSUHVFULSWLRQGRVH

2QFH'DLO\57*\7DUJHW9ROXPH&RQVWUDLQWVDQG&RPSOLDQFH&ULWHULD
2QFH'DLO\57*\[)UDFWLRQV *\
1DPHRI
6WUXFWXUH
'RVLPHWULF
3DUDPHWHU
3HU
3URWRFRO
9DULDWLRQ
$FFHSWDEOH
379B
'>*\@

WR
H[FOXGLQJ*\

'FF>*\@
 
 

2QFH'DLO\57*\1RUPDO6WUXFWXUH&RQVWUDLQWVDQG&RPSOLDQFH&ULWHULD
1DPHRI6WUXFWXUH
'RVLPHWULF
3DUDPHWHU
3HU
3URWRFRO
9DULDWLRQ
$FFHSWDEOH
/XQJV,*79
9>@
 
 

9>@
 
 

0HDQ>*\@
 
 
6SLQDO&RUG
'FF>*\@
 
 
(VRSKDJXV
'FF>*\@
 
 

0HDQ>*\@
 
 
%UDFKLDO3OH[XV
'FF>*\@
 
 
+HDUW
9>@
 
 

'FF>*\@
 
 

0HDQ>*\@
 
 
3HU3URWRFROUDQJHLVH[FOXGHGIURP9DULDWLRQ$FFHSWDEOHUDQJH
'HYLDWLRQ8QDFFHSWDEOHRFFXUVZKHQGRVHOLPLWVIRU9DULDWLRQ$FFHSWDEOHDUHQRWPHW

2QFH'DLO\57*\'HOLYHU\&RPSOLDQFH&ULWHULD

3HU3URWRFRO
9DULDWLRQ
$FFHSWDEOH
6WDUW'DWHZLWK&\FOH
SODWLQXPHWRSRVLGH

 GD\V
 GD\V
2YHUDOO7UHDWPHQW7LPH
 GD\V
 GD\V
,QWHUUXSWLRQVRWKHUWKDQ
KROLGD\V
QRQH
 GD\V


%,'57*\7DUJHW9ROXPH&RQVWUDLQWVDQG&RPSOLDQFH&ULWHULD
%,'57*\[)UDFWLRQV *\
1DPHRI
6WUXFWXUH
'RVLPHWULF
3DUDPHWHU
3HU
3URWRFRO
9DULDWLRQ
$FFHSWDEOH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
379B
'>*\@

WRH[FOXGLQJ
*\

'FF>*\@
 
 

%,'57*\1RUPDO6WUXFWXUH&RQVWUDLQWVDQG&RPSOLDQFH&ULWHULD
1DPHRI6WUXFWXUH
'RVLPHWULF
3DUDPHWHU
3HU
3URWRFRO
9DULDWLRQ
$FFHSWDEOH
/XQJV,*79
9>@
 
 

9>@
 
 

0HDQ>*\@
 
 
6SLQDO&RUG
'FF>*\@
 
QRQH
(VRSKDJXV
'FF>*\@
 
 

0HDQ>*\@
 
 
%UDFKLDO3OH[XV
'FF>*\@
 
 
+HDUW
9>@
 
 

'FF>*\@
 
 

0HDQ>*\@
 
 
3HU3URWRFROUDQJHLVH[FOXGHGIURP9DULDWLRQ$FFHSWDEOHUDQJH
'HYLDWLRQ8QDFFHSWDEOHRFFXUVZKHQGRVHOLPLWVIRU9DULDWLRQ$FFHSWDEOHDUHQRWPHW

%,'57*\'HOLYHU\&RPSOLDQFH&ULWHULD

3HU3URWRFRO
9DULDWLRQ
$FFHSWDEOH
6WDUW'DWHZLWK&\FOH
SODWLQXPHWRSRVLGH

 GD\V
 GD\V
2YHUDOO7UHDWPHQW7LPH
 GD\V
 GD\V
,QWHUUXSWLRQVRWKHUWKDQ
KROLGD\V
QRQH
 GD\V

7UHDWPHQW3ODQQLQJ3ULRULWLHVDQG,QVWUXFWLRQV
 6SLQDO&RUG
 379
 /XQJV
 +HDUW
(VRSKDJXV
 %UDFKLDO3OH[XV

5HTXLUHGDOJRULWKPV
$FFHSWDEOHFKRLFHVRIDOJRULWKPDUHOLVWHGDWKWWSLURFKRXVWRQPGDQGHUVRQRUJ$Q\
DOJRULWKPXVHGIRUWKLVVWXG\PXVWEHFUHGHQWLDOHGE\,52&+RXVWRQ

)RU&RQYROXWLRQ6XSHUSRVLWLRQW\SHDOJRULWKPVGRVHVKRXOGEHUHSRUWHGDVFRPSXWHG
LQKHUHQWO\E\WKHJLYHQDOJRULWKP)RU0RQWH&DUORRU*ULG%DVHG%ROW]PDQQ6ROYHU
DOJRULWKPVFRQYHUVLRQRI'PGRVHWRPHGLXPWR'ZGRVHWRZDWHUVKRXOGEH
DYRLGHG'PFRPSXWHGLQKHUHQWO\E\WKHVHDOJRULWKPVVKRXOGEHUHSRUWHG7KHVH
SULQFLSOHVKROGIRU3HQFLO%HDPW\SHDOJRULWKPVDQGIRUKRPRJHQHRXVGRVHFDOFXODWLRQV
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
ZKHQDOORZHGIRUDFOLQLFDOWULDOHJFRQLFDOFROOLPDWRUVLQVWHUHRWDFWLFUDGLRVXUJHU\

3ULPDU\GDWDVHWIRUGRVHFDOFXODWLRQ
7KHSULPDU\GDWDVHWIRUGRVHFDOFXODWLRQPXVWEHDQDYHUDJHLQWHQVLW\SL[HO&7$YH,3
JHQHUDWHGIURPWKH'&7RUWKHEUHDWKKROGJDWHG&70D[LPXP,QWHQVLW\3L[HO0,3
JHQHUDWHGLPDJHVIURP'&7VPD\QRWEHXVHGDVWKHSULPDU\GRVHFDOFXODWLRQGDWDVHW

'RVHPDWUL[UHVROXWLRQ
'RVH JULG VL]H VKRXOG EH   PP LQ DOO GLUHFWLRQV

 3DWLHQWVSHFLILF4$
$Q\SDWLHQWVSHFLILF4$WKDWQHHGVWREHDFTXLUHGVKRXOGIROORZLQVWLWXWLRQDOJXLGHOLQHV
DQG$$30WDVNJURXSUHSRUWUHFRPPHQGDWLRQV,05790$7SDWLHQWVSHFLILF4$LV
KLJKO\UHFRPPHQGHG

'DLO\7UHDWPHQW/RFDOL]DWLRQ,*57
,PDJHJXLGHGUDGLDWLRQWKHUDS\,*57LVUDGLDWLRQWKHUDS\XVLQJLPDJLQJWRIDFLOLWDWH
DFFXUDF\DQGSUHFLVLRQWKURXJKRXWLWVHQWLUHSURFHVVIURPWDUJHWDQGQRUPDOWLVVXH
GHOLQHDWLRQWRUDGLDWLRQGHOLYHU\WRDGDSWDWLRQRIWKHUDS\WRDQDWRPLFDQGELRORJLFDO
FKDQJHVRYHUWLPHLQLQGLYLGXDOSDWLHQWV,QWKLVVHFWLRQZHXVHWKHWHUPLQRORJ\,*57WR
IRFXVRQLPDJHJXLGDQFHDWWKHWLPHRIUDGLDWLRQGHOLYHU\WRHQVXUHLWVDGKHUHQFHWRWKH
SODQQHGWUHDWPHQW

'DLO\LPDJHJXLGDQFHWKDWDOORZVIRU'VKLIWVLVWKHPLQLPXPUHTXLUHPHQWIRUWKLVWULDO
0RVWDGYDQFHGLPDJLQJWHFKQLTXHVFDQEHXWLOL]HGDVORQJDVWKH\DOVRDOORZIRU'
VKLIWV7KHVHWXSPDUJLQLQWKLVWULDOLVWLHGWRWKHXVHRIGDLO\LPDJHJXLGDQFH:KHQ
DEOHWRORFDOL]HXVLQJVRIWWLVVXHWKHWDUJHWZLOOEHPRVWHIIHFWLYHIRUORFDOL]DWLRQ2WKHU
VRIWWLVVXHVLQWKHOXQJVXFKDVWKHFDULQDFDQKHOSIRUPHGLDVWLQDODOLJQPHQW)LGXFLDO
PDUNHUVFDQEHXVHGIRUORFDOL]DWLRQDVQHHGHG$Q\OLQHDUVKLIWVVHHQWKDWDUH PP
VKRXOGEHDSSOLHGSULRUWRWUHDWPHQW

0LQLPDO,*57UHTXLUHPHQWV
/RFDWLRQ
1R)LGXFLDOV
:LWK)LGXFLDOV
/XQJ
,PDJLQJWKDWDOORZVIRU'
VKLIWV
,PDJLQJWKDWDOORZVIRU'
VKLIWV
5HJLVWUDWLRQXVLQJDVRIWWLVVXHVXUURJDWHIRUWKHWXPRULVUHFRPPHQGHG)UHHEUHDWKLQJ
&7VDUHQRWWREHXVHGDVUHIHUHQFHLPDJHVIRU'&%&7,*57SURFHVV
&OHDUO\YLVLEOHDQDWRPLFDOPDUNHUVDUHDFFHSWDEOHDVILGXFLDOVHJLQVHUWHGUDGLR
RSDTXHPDUNHUV


*HQHUDO&RQFRPLWDQW0HGLFDWLRQDQG6XSSRUWLYH&DUH*XLGHOLQHV)(%
 3HUPLWWHG6XSSRUWLYH$QFLOODU\&DUHDQG&RQFRPLWDQW0HGLFDWLRQV

&RQFRPLWDQWWKHUDS\LQFOXGHVDQ\SUHVFULSWLRQPHGLFDWLRQVRURYHUWKHFRXQWHU
SUHSDUDWLRQVXVHGE\DSDWLHQWEHWZHHQWKHGD\VSUHFHGLQJWKHVFUHHQLQJHYDOXDWLRQDQG
WKHWUHDWPHQWGLVFRQWLQXDWLRQYLVLW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
3DWLHQWVZKRH[SHULHQFHLQIXVLRQDVVRFLDWHGV\PSWRPVPD\EHWUHDWHGV\PSWRPDWLFDOO\
ZLWKDFHWDPLQRSKHQLEXSURIHQGLSKHQK\GUDPLQHDQGRUFLPHWLGLQHRUDQRWKHU+
UHFHSWRUDQWDJRQLVWDVSHUVWDQGDUGSUDFWLFHIRUVLWHVRXWVLGHWKH8QLWHG6WDWHV
HTXLYDOHQWPHGLFDWLRQVPD\EHVXEVWLWXWHGSHUORFDOSUDFWLFH6HULRXVLQIXVLRQ
DVVRFLDWHGHYHQWVPDQLIHVWHGE\G\VSQHDK\SRWHQVLRQZKHH]LQJEURQFKRVSDVP
WDFK\FDUGLDUHGXFHGR[\JHQVDWXUDWLRQRUUHVSLUDWRU\GLVWUHVVVKRXOGEHPDQDJHGZLWK
VXSSRUWLYHWKHUDSLHVDVFOLQLFDOO\LQGLFDWHGHJVXSSOHPHQWDOR[\JHQDQGDGUHQHUJLF
DJRQLVWVVHH6HFWLRQ

6\VWHPLFFRUWLFRVWHURLGVDQG71)ĮLQKLELWRUVPD\DWWHQXDWHSRWHQWLDOEHQHILFLDO
LPPXQRORJLFHIIHFWVRIWUHDWPHQWZLWKDWH]ROL]XPDEEXWPD\EHDGPLQLVWHUHGDWWKH
GLVFUHWLRQRIWKHWUHDWLQJSK\VLFLDQ,IIHDVLEOHDOWHUQDWLYHVWRFRUWLFRVWHURLGVVKRXOGEH
FRQVLGHUHG3UHPHGLFDWLRQPD\EHDGPLQLVWHUHGIRUDWH]ROL]XPDE&\FOHV  DW WKH
GLVFUHWLRQRIWKHWUHDWLQJSK\VLFLDQ7KHXVHRILQKDOHGFRUWLFRVWHURLGVDQG
PLQHUDORFRUWLFRLGVHJIOXGURFRUWLVRQHIRUSDWLHQWVZLWKRUWKRVWDWLFK\SRWHQVLRQRU
DGUHQRFRUWLFDOLQVXIILFLHQF\LVDOORZHG0HJHVWURODGPLQLVWHUHGDVDSSHWLWHVWLPXODQWLV
DFFHSWDEOHZKLOHWKHSDWLHQWLVHQUROOHGLQWKHVWXG\

3DWLHQWVZKRXVHRUDOFRQWUDFHSWLYHVKRUPRQHUHSODFHPHQWWKHUDS\SURSK\ODFWLFRU
WKHUDSHXWLFDQWLFRDJXODWLRQWKHUDS\VXFKDVORZPROHFXODUZHLJKWKHSDULQRUZDUIDULQDW
DVWDEOHGRVHOHYHOVKRXOGFRQWLQXHWKHLUXVH0DOHVDQGIHPDOHVRIUHSURGXFWLYH
SRWHQWLDOVKRXOGXVHKLJKO\HIIHFWLYHPHDQVRIFRQWUDFHSWLRQ

 3URKLELWHG7KHUDSLHV
$Q\FRQFRPLWDQWWKHUDS\LQWHQGHGIRUWKHWUHDWPHQWRIFDQFHUZKHWKHUKHDOWKDXWKRULW\
DSSURYHGRUH[SHULPHQWDOLVSURKLELWHGXQOHVVLWLVVSHFLILFDOO\LQFOXGHGLQWKHWUHDWPHQW
UHJLPHQGHVFULEHGLQWKLVSURWRFRO7KLVLQFOXGHVEXWLVQRWOLPLWHGWRWKHIROORZLQJ
x &KHPRWKHUDS\KRUPRQDOWKHUDS\LPPXQRWKHUDS\UDGLRWKHUDS\RULQYHVWLJDWLRQDO
DJHQWVH[FHSWIRUPDLQWHQDQFHWKHUDSLHVRXWOLQHGLQ6HFWLRQ
o $IWHU&\FOHFHUWDLQIRUPVRIUDGLRWKHUDS\PD\EHFRQVLGHUHGIRUSDLQ
SDOOLDWLRQLISDWLHQWVDUHGHULYLQJEHQHILWHJWUHDWPHQWRINQRZQERQ\
PHWDVWDVHVDWH]ROL]XPDEDGPLQLVWUDWLRQPD\EHVXVSHQGHGGXULQJ
UDGLRWKHUDS\ 

,QLWLDWLRQRULQFUHDVHGGRVHRIJUDQXORF\WHFRORQ\VWLPXODWLQJIDFWRUVHJJUDQXORF\WH
FRORQ\VWLPXODWLQJIDFWRUJUDQXORF\WHPDFURSKDJHFRORQ\VWLPXODWLQJIDFWRUDQGRU
SHJILOJUDVWLPLVSURKLELWHGGXULQJUDGLRWKHUDS\IRUWKLVWULDO

3DWLHQWVDUHQRWDOORZHGWRUHFHLYHLPPXQRVWLPXODWRU\DJHQWVLQFOXGLQJEXWQRWOLPLWHG
WR,)1Į,)1ȖRU,/GXULQJWKHHQWLUHVWXG\7KHVHDJHQWVLQFRPELQDWLRQZLWK
DWH]ROL]XPDEFRXOGSRWHQWLDOO\LQFUHDVHWKHULVNIRUDXWRLPPXQHFRQGLWLRQV

3DWLHQWVVKRXOGDOVRQRWEHUHFHLYLQJLPPXQRVXSSUHVVLYHPHGLFDWLRQVLQFOXGLQJEXWQRW
OLPLWHGWRF\FORSKRVSKDPLGHD]DWKLRSULQHPHWKRWUH[DWHDQGWKDOLGRPLGH7KHVHDJHQWV
FRXOGSRWHQWLDOO\DOWHUWKHDFWLYLW\DQGWKHVDIHW\RIDWH]ROL]XPDE6\VWHPLF
FRUWLFRVWHURLGVDQGDQWL71)ĮDJHQWVPD\DWWHQXDWHSRWHQWLDOEHQHILFLDOLPPXQRORJLF
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
HIIHFWVRIWUHDWPHQWZLWKDWH]ROL]XPDEEXWPD\EHDGPLQLVWHUHGDWWKHGLVFUHWLRQRIWKH
WUHDWLQJSK\VLFLDQ,IIHDVLEOHDOWHUQDWLYHVWRWKHVHDJHQWVVKRXOGEHFRQVLGHUHG

+HUEDODQG1XWULWLRQDO6XSSOHPHQWV
7KHFRQFRPLWDQWXVHRIKHUEDOWKHUDSLHVLVQRWUHFRPPHQGHGDVWKHLUSKDUPDFRNLQHWLFV
VDIHW\SURILOHVDQGSRWHQWLDOGUXJGUXJLQWHUDFWLRQVDUHJHQHUDOO\XQNQRZQ+RZHYHUWKH
XVHRIJHQHUDOQXWULWLRQDOIRXQGDWLRQVXSSOHPHQWVZLOOEHDOORZHGLQFOXGLQJFDOFLXP
ZLWKYLWDPLQ'DQGRUPLQHUDOV2PHJD¶VILVKRLO9LWDPLQ%9LWDPLQ%DEDVLF
PXOWLYLWDPLQ/JOXWDPLQHRUSURELRWLFRUDOVXSSOHPHQWVDVORQJDVWKHVXSSOHPHQWVLV
DWRUEHORZWKH)'$DSSURYHGUHFRPPHQGHGGRVHDOORZDQFH5'$E\DKHDOWKFDUH
SURYLGHU+HUEDOEDVHGPXOWLYLWDPLQVDUHQRWDOORZHG$Q\DGGLWLRQDOVXSSOHPHQWVZLOO
QHHGSULRUUHYLHZDQGDSSURYDOE\6WXG\&KDLU

 3DUWLFLSDWLRQLQ2WKHU7ULDOV
x 3DWLHQWVDUHQRWWRSDUWLFLSDWHLQRWKHUWKHUDSHXWLFWULDOV+RZHYHUWULDOVWKDWGRQRW
DGGH[SHULPHQWDODJHQWVDUHDOORZHGHJLPDJLQJWULDOVTXDOLW\RIOLIHELREDQNLQJ
HWF

'XUDWLRQRI7KHUDS\
,QWKHDEVHQFHRIWUHDWPHQWGHOD\VGXHWRDGYHUVHHYHQWVWUHDWPHQWPD\FRQWLQXHDV
VSHFLILHGLQWKHDERYHWUHDWPHQWPRGDOLW\VHFWLRQVRUIRUDWRWDORIRQH\HDURUXQWLORQHRI
WKHIROORZLQJFULWHULDDSSOLHV

'LVHDVHSURJUHVVLRQ

,QWHUFXUUHQWLOOQHVVWKDWSUHYHQWVIXUWKHUDGPLQLVWUDWLRQRIWUHDWPHQW

8QDFFHSWDEOHDGYHUVHHYHQWVDVGHVFULEHGLQ6HFWLRQ

3DWLHQWGHFLGHVWRZLWKGUDZFRQVHQWIRUWUHDWPHQWRUSDUWLFLSDWLRQLQWKHVWXG\RU

*HQHUDORUVSHFLILFFKDQJHVLQWKHSDWLHQW
VFRQGLWLRQUHQGHUWKHSDWLHQWXQDFFHSWDEOH
IRUIXUWKHUWUHDWPHQWLQWKHMXGJPHQWRIWKHLQYHVWLJDWRU

75($70(1702',),&$7,2160$1$*(0(17
&KHPRWKHUDS\GRVHVDQGVFKHGXOHVPD\EHPRGLILHGSHUVWDQGDUGLQVWLWXWLRQDOSURWRFROVGXH
WRWR[LFLW\

:KHQV\VWHPLFWKHUDS\UHODWHGWR[LFLW\LVREVHUYHGGRVHGHOD\VDQGRUUHGXFWLRQVLQGUXJ
DGPLQLVWUDWLRQDUHDOORZHGSHUSDFNDJHLQVHUWDQGLQVWLWXWLRQDOVWDQGDUGVDVGHVFULEHGEHORZ
3OHDVHQRWHWKDWWKHWDEOHEHORZVKRZVVXJJHVWHGVWDUWLQJGRVLQJWKRXJKWUHDWPHQWGRVLQJ
DQGGRVHPRGLILFDWLRQLVSHUPLWWHGLQDFFRUGDQFHZLWKORFDOLQVWLWXWLRQDOJXLGHOLQHV'RVH
URXQGLQJLVDOVRSHUPLWWHGSHUORFDOLQVWLWXWLRQDOSUDFWLFH:HLJKWRU%6$FKDQJHVRI!
ZRXOGUHTXLUHUHFDOFXODWLRQRIGRVHV,QJHQHUDOLIDVXEMHFWPLVVHVDWUHDWPHQWWKHQH[W
GRVHVKRXOGEHDGPLQLVWHUHGDWWKHQH[WVFKHGXOHGWLPHHJQRPRUHWKDQGRVHUHGXFWLRQV
ZLOOEHSHUPLWWHGIRUDQ\SDWLHQW

0DQDJHPHQWRI$WH]ROL]XPDE5HODWHG7R[LFLW\2&7
)RUDQDSK\OD[LVSUHFDXWLRQVVHHWKHPDQDJHPHQWJXLGHOLQHV$WH]ROL]XPDELQIXVLRQV
ZLOOEHDGPLQLVWHUHGSHUWKHLQVWUXFWLRQVRXWOLQHGLQ7DEOHEHORZ

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$GPLQLVWUDWLRQRI)LUVWDQG6XEVHTXHQW$WH]ROL]XPDE,QIXVLRQV
)LUVW,QIXVLRQ
6XEVHTXHQW,QIXVLRQV
x 1RSUHPHGLFDWLRQLVSHUPLWWHGSULRUWRWKH
DWH]ROL]XPDELQIXVLRQ
x 9LWDOVLJQVSXOVHUDWHUHVSLUDWRU\UDWH
EORRGSUHVVXUHDQGWHPSHUDWXUHVKRXOGEH
PHDVXUHGZLWKLQPLQXWHVSULRUWRWKH
LQIXVLRQ
x $WH]ROL]XPDEVKRXOGEHLQIXVHGRYHU
rPLQXWHV
x ,IFOLQLFDOO\LQGLFDWHGYLWDOVLJQVVKRXOGEH
PHDVXUHGHYHU\rPLQXWHVGXULQJWKH
LQIXVLRQDQGDWrPLQXWHVDIWHUWKH
LQIXVLRQ
x 3DWLHQWVVKRXOGEHLQIRUPHGDERXWWKH
SRVVLELOLW\RIGHOD\HGSRVWLQIXVLRQ
V\PSWRPVDQGLQVWUXFWHGWRFRQWDFWWKHLU
VWXG\SK\VLFLDQLIWKH\GHYHORSVXFK
V\PSWRPV
x ,IWKHSDWLHQWH[SHULHQFHGDQLQIXVLRQ
UHODWHGUHDFWLRQZLWKDQ\SUHYLRXV
LQIXVLRQSUHPHGLFDWLRQZLWK
DQWLKLVWDPLQHVDQWLS\UHWLFVDQGRU
DQDOJHVLFVPD\EHDGPLQLVWHUHGIRU
VXEVHTXHQWGRVHVDWWKHGLVFUHWLRQRIWKH
LQYHVWLJDWRU
x 9LWDOVLJQVVKRXOGEHPHDVXUHGZLWKLQ
PLQXWHVSULRUWRWKHLQIXVLRQ
x $WH]ROL]XPDEVKRXOGEHLQIXVHGRYHU
rPLQXWHVLIWKHSUHYLRXVLQIXVLRQ
ZDVWROHUDWHGZLWKRXWDQLQIXVLRQUHODWHG
UHDFWLRQRUrPLQXWHVLIWKH
SDWLHQWH[SHULHQFHGDQLQIXVLRQUHODWHG
UHDFWLRQZLWKWKHSUHYLRXVLQIXVLRQ
x ,IWKHSDWLHQWH[SHULHQFHGDQLQIXVLRQ
UHODWHGUHDFWLRQZLWKWKHSUHYLRXVLQIXVLRQ
RULIFOLQLFDOO\LQGLFDWHGYLWDOVLJQV
VKRXOGEHPHDVXUHGGXULQJWKHLQIXVLRQ
DQGDWrPLQXWHVDIWHUWKH
LQIXVLRQ

)RUDQDSK\OD[LVSUHFDXWLRQVXVHWKHIROORZLQJSURFHGXUH

(TXLSPHQW1HHGHG

Ɣ 0RQLWRULQJGHYLFHV(&*PRQLWRUEORRGSUHVVXUHPRQLWRUR[\JHQVDWXUDWLRQ
PRQLWRUDQGWKHUPRPHWHU
Ɣ 2[\JHQ
Ɣ (SLQHSKULQHIRUVXEFXWDQHRXVLQWUDYHQRXVDQGRUHQGRWUDFKHDOXVHLQDFFRUGDQFH
ZLWKVWDQGDUGSUDFWLFH
Ɣ $QWLKLVWDPLQHV
Ɣ &RUWLFRVWHURLGV
Ɣ ,9LQIXVLRQVROXWLRQVWXELQJFDWKHWHUVDQGWDSH

3URFHGXUHV

,QWKHHYHQWRIDVXVSHFWHGDQDSK\ODFWLFUHDFWLRQGXULQJDWH]ROL]XPDELQIXVLRQWKH
IROORZLQJSURFHGXUHVVKRXOGEHSHUIRUPHG

 6WRSWKHVWXG\GUXJLQIXVLRQ
 &DOOIRUDGGLWLRQDOPHGLFDODVVLVWDQFH
 (QVXUHWKDWDSSURSULDWHPRQLWRULQJLVLQSODFHZLWKFRQWLQXRXV(&*DQGSXOVH
R[LPHWU\PRQLWRULQJLISRVVLEOH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
 $GPLQLVWHUDQWLKLVWDPLQHVHSLQHSKULQHRURWKHUPHGLFDWLRQVDVUHTXLUHGE\
SDWLHQWVWDWXVDQGGLUHFWHGE\WKHSK\VLFLDQLQFKDUJH
 &RQWLQXHWRREVHUYHWKHSDWLHQWDQGGRFXPHQWREVHUYDWLRQ
 'UDZVHUXPSODVPDVDPSOHVIRULPPXQRJHQLFLW\WHVWLQJ
 $VNSDUWLFLSDQWWRUHWXUQIRUZDVKRXWLPPXQRJHQLFLW\VDPSOHLIDSSURSULDWH

*HQHUDO$(0DQDJHPHQWDQG'RVH0RGLILFDWLRQ*XLGHOLQHV
7KHUHZLOOEHQRGRVHUHGXFWLRQIRUDWH]ROL]XPDELQWKLVVWXG\

3DWLHQWVPD\WHPSRUDULO\VXVSHQGVWXG\WUHDWPHQWIRUXSWRGD\VZHHNVEH\RQG
WKHVFKHGXOHGGDWHRIGHOD\HGLQIXVLRQLIVWXG\GUXJUHODWHGWR[LFLW\UHTXLULQJGRVH
VXVSHQVLRQLVH[SHULHQFHG,IDWH]ROL]XPDELVKHOGEHFDXVHRI$(VIRU!GD\VEH\RQG
WKHVFKHGXOHGGDWHRILQIXVLRQWKHSDWLHQWZLOOEHGLVFRQWLQXHGIURPDWH]ROL]XPDEDQG
ZLOOEHIROORZHGIRUVDIHW\DQGHIILFDF\DVVSHFLILHGLQWKLVSURWRFRO,IWKH$(UHVROYHV
ZLWKLQGD\VDQGWKHSDWLHQWLVUHFHLYLQJFRUWLFRVWHURLGWKHUDS\IRUWKHHYHQW
DWH]ROL]XPDEPD\EHKHOGIRUORQJHUWKDQGD\VXSWRZHHNVLQRUGHUWRDOORZ
WDSHULQJ RI WKH VWHURLG GRVH WR PJRUDOSUHGQLVRQHRUHTXLYDOHQW

'RVHLQWHUUXSWLRQVIRUUHDVRQVRWKHUWKDQWR[LFLW\VXFKDVVXUJLFDOSURFHGXUHVPD\EH
DOORZHG7KHDFFHSWDEOHOHQJWKRILQWHUUXSWLRQZLOOEHDWWKHGLVFUHWLRQRIWKHVWXG\3,LQ
FRQVXOWDWLRQZLWK&7(3

7KHSULPDU\DSSURDFKWRJUDGHWRLU$(VLVVXSSRUWLYHDQGV\PSWRPDWLFFDUHZLWK
FRQWLQXHGWUHDWPHQWZLWKDWH]ROL]XPDEIRUKLJKHUJUDGHLU$(VDWH]ROL]XPDEVKRXOGEH
ZLWKKHOGDQGRUDODQGRUSDUHQWHUDOVWHURLGVDGPLQLVWHUHG5HFXUUHQWJUDGHLU$(VPD\
DOVRPDQGDWHZLWKKROGLQJDWH]ROL]XPDERUWKHXVHRIVWHURLGV$VVHVVPHQWRIWKHEHQHILW
ULVNEDODQFHVKRXOGEHPDGHE\WKHLQYHVWLJDWRUZLWKFRQVLGHUDWLRQRIWKHWRWDOLW\RI
LQIRUPDWLRQDVLWSHUWDLQVWRWKHQDWXUHRIWKHWR[LFLW\DQGWKHGHJUHHRIFOLQLFDOEHQHILWD
JLYHQSDWLHQWPD\EHH[SHULHQFLQJSULRUWRIXUWKHUDGPLQLVWUDWLRQRIDWH]ROL]XPDE
$WH]ROL]XPDEVKRXOGEHSHUPDQHQWO\GLVFRQWLQXHGLQSDWLHQWVZLWKOLIHWKUHDWHQLQJLU$(V

0DQDJHPHQWRI6SHFLILF$(V
0DQDJHPHQWRIFHUWDLQ$(VRIFRQFHUQLQFOXGLQJLPPXQHUHODWHGSQHXPRQLWLVKHSDWLWLV
FROLWLVHQGRFULQRSDWKLHVSDQFUHDWLWLVQHXURSDWKLHVPHQLQJRHQFHSKDOLWLVDQGSRWHQWLDO
RFXODUWR[LFLWLHVDUHSUHVHQWHGLQWKH$WH]ROL]XPDE,QYHVWLJDWRU¶V%URFKXUH6HHWKH
$JHQW$GPLQLVWUDWLRQ*XLGHOLQHVLQWKLVGRFXPHQWLQFOXGLQJWKH³$GPLQLVWUDWLRQRI
)LUVWDQG6XEVHTXHQW$WH]ROL]XPDE,QIXVLRQV´WDEOHIRUJXLGHOLQHVIRUWKH
PDQDJHPHQWRI,QIXVLRQ5HODWHG5HDFWLRQVDQG$QDSK\OD[LV

$WH]ROL]XPDEKDVEHHQDVVRFLDWHGZLWKULVNVVXFKDVWKHIROORZLQJ,55VDQG
LPPXQHUHODWHGKHSDWLWLVSQHXPRQLWLVFROLWLVSDQFUHDWLWLVGLDEHWHVPHOOLWXV
K\SRWK\URLGLVPK\SHUWK\URLGLVPDGUHQDOLQVXIILFLHQF\K\SRSK\VLWLV*XLOODLQ%DUUp
V\QGURPHP\DVWKHQLFV\QGURPHRUP\DVWKHQLDJUDYLVPHQLQJRHQFHSKDOLWLV
P\RFDUGLWLVQHSKULWLVP\RVLWLVDQGVHYHUHFXWDQHRXVDGYHUVHUHDFWLRQV,PPXQH
PHGLDWHGUHDFWLRQVPD\LQYROYHDQ\RUJDQV\VWHPDQGPD\OHDGWRKHPRSKDJRF\WLF
O\PSKRKLVWLRF\WRVLVDQGPDFURSKDJHDFWLYDWLRQV\QGURPH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

3OHXUDODQGSHULFDUGLDOHIIXVLRQ
3DWLHQWVH[SHULHQFLQJG\VSQHDFKHVWSDLQRUXQH[SODLQHGWDFK\FDUGLDVKRXOGEH
HYDOXDWHGIRUWKHSUHVHQFHRIDSHULFDUGLDOHIIXVLRQ3DWLHQWVZLWKSUHH[LVWLQJSHULFDUGLDO
HIIXVLRQVKRXOGEHIROORZHGFORVHO\IRUSHULFDUGLDOIOXLGYROXPHPHDVXUHPHQWVDQG
LPSDFWRQFDUGLDFIXQFWLRQ:KHQLQWHUYHQWLRQLVUHTXLUHGIRUSHULFDUGLDORUSOHXUDO
HIIXVLRQVDWH]ROL]XPDEVKRXOGEHKHOGDQGDSSURSULDWHZRUNXSLQFOXGHVF\WRORJ\
ODFWDWHGHK\GURJHQDVH/'+JOXFRVHFKROHVWHUROSURWHLQFRQFHQWUDWLRQVZLWKSOHXUDO
HIIXVLRQVDQGFHOOFRXQW

3XOPRQDU\HYHQWV
'\VSQHDFRXJKIDWLJXHK\SR[LDSQHXPRQLWLVDQGSXOPRQDU\LQILOWUDWHVKDYHEHHQ
DVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE3DWLHQWVZLOOEHDVVHVVHGIRU
SXOPRQDU\VLJQVDQGV\PSWRPVWKURXJKRXWWKHVWXG\DQGZLOOKDYHFRPSXWHG
WRPRJUDSK\&7VFDQVRIWKHFKHVWSHUIRUPHGDWHYHU\WXPRUDVVHVVPHQW

$OOSXOPRQDU\HYHQWVVKRXOGEHWKRURXJKO\HYDOXDWHGIRURWKHUFRPPRQO\UHSRUWHG
HWLRORJLHVVXFKDVSQHXPRQLDRURWKHULQIHFWLRQO\PSKDQJLWLFFDUFLQRPDWRVLVSXOPRQDU\
HPEROLVPKHDUWIDLOXUHFKURQLFREVWUXFWLYHSXOPRQDU\GLVHDVHRUSXOPRQDU\
K\SHUWHQVLRQ0DQDJHPHQWJXLGHOLQHVIRUSXOPRQDU\HYHQWVDUHSURYLGHGLQWKHWDEOH
EHORZ

(YHQW
0DQDJHPHQW
3XOPRQDU\HYHQW
*UDGH
Ɣ &RQWLQXHDWH]ROL]XPDEDQGPRQLWRUFORVHO\
Ɣ 5HHYDOXDWHRQVHULDOLPDJLQJ
Ɣ &RQVLGHUSDWLHQWUHIHUUDOWRSXOPRQDU\VSHFLDOLVW
3XOPRQDU\HYHQW
*UDGH
Ɣ :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
Ɣ 5HIHUSDWLHQWWRSXOPRQDU\DQGLQIHFWLRXVGLVHDVHVSHFLDOLVWVDQG
FRQVLGHUEURQFKRVFRS\RU%$/
Ɣ ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\RUDO
SUHGQLVRQH
Ɣ ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
Ɣ ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
Ɣ )RUUHFXUUHQWHYHQWVWUHDWDVD*UDGHRUHYHQW
3XOPRQDU\HYHQW
*UDGHRU
Ɣ 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
Ɣ %URQFKRVFRS\RU%$/LVUHFRPPHQGHG
Ɣ ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\RUDO
SUHGQLVRQH
Ɣ ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
Ɣ ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHU
PRQWK
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
%$/ EURQFKRVFRSLFDOYHRODUODYDJH
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
PJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
GHWHUPLQHGE\WKHLQYHVWLJDWRUDQGWKH0HGLFDO0RQLWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

+HSDWLFHYHQWV
,PPXQHPHGLDWHGKHSDWLWLVKDVEHHQDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE
(OLJLEOHSDWLHQWVPXVWKDYHDGHTXDWHOLYHUIXQFWLRQDVPDQLIHVWHGE\PHDVXUHPHQWVRIWRWDO
ELOLUXELQDQGKHSDWLFWUDQVDPLQDVHVDQGOLYHUIXQFWLRQZLOOEHPRQLWRUHGWKURXJKRXWVWXG\
WUHDWPHQW0DQDJHPHQWJXLGHOLQHVIRUKHSDWLFHYHQWVDUHSURYLGHGLQWKHWDEOHEHORZ

3DWLHQWVZLWKULJKWXSSHUTXDGUDQWDEGRPLQDOSDLQDQGRUXQH[SODLQHGQDXVHDRUYRPLWLQJVKRXOG
KDYHOLYHUIXQFWLRQWHVWV/)7VSHUIRUPHGLPPHGLDWHO\DQGUHYLHZHGEHIRUHDGPLQLVWUDWLRQRI
WKHQH[WGRVHRIVWXG\GUXJ

)RUSDWLHQWVZLWKHOHYDWHG/)7VFRQFXUUHQWPHGLFDWLRQYLUDOKHSDWLWLVDQGWR[LFRUQHRSODVWLF
HWLRORJLHVVKRXOGEHFRQVLGHUHGDQGDGGUHVVHGDVDSSURSULDWH

(YHQW
0DQDJHPHQW
+HSDWLFHYHQW
*UDGH
x &RQWLQXHDWH]ROL]XPDE
x 0RQLWRU/)7VXQWLOYDOXHVUHVROYHWRZLWKLQQRUPDOOLPLWVRUWR
EDVHOLQHYDOXHV
+HSDWLFHYHQW
*UDGH
$OOHYHQWV
x 0RQLWRU/)7VPRUHIUHTXHQWO\XQWLOUHWXUQWREDVHOLQHYDOXHV
(YHQWVRI!GD\V¶GXUDWLRQ
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\
RUDOSUHGQLVRQH
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
+HSDWLFHYHQW
*UDGHRU
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x &RQVLGHUSDWLHQWUHIHUUDOWRJDVWURLQWHVWLQDOVSHFLDOLVWIRUHYDOXDWLRQ
DQGOLYHUELRSV\WRHVWDEOLVKHWLRORJ\RIKHSDWLFLQMXU\
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\
RUDOSUHGQLVRQH
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHUt
PRQWK
/)7 OLYHUIXQFWLRQWHVW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
GHWHUPLQHGE\WKHLQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

*DVWURLQWHVWLQDOHYHQWV
,PPXQHPHGLDWHGFROLWLVKDVEHHQDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE
0DQDJHPHQWJXLGHOLQHVIRUGLDUUKHDRUFROLWLVDUHSURYLGHGLQWKHWDEOHEHORZ

$OOHYHQWVRIGLDUUKHDRUFROLWLVVKRXOGEHWKRURXJKO\HYDOXDWHGIRURWKHUPRUHFRPPRQ
HWLRORJLHV)RUHYHQWVRIVLJQLILFDQWGXUDWLRQRUPDJQLWXGHRUDVVRFLDWHGZLWKVLJQVRIV\VWHPLF
LQIODPPDWLRQRUDFXWHSKDVHUHDFWDQWVe.gLQFUHDVHG&UHDFWLYHSURWHLQSODWHOHWFRXQWRU
EDQGHPLD3HUIRUPVLJPRLGRVFRS\RUFRORQRVFRS\LIDSSURSULDWHZLWKFRORQLFELRSV\ZLWK
WKUHHWRILYHVSHFLPHQVIRUVWDQGDUGSDUDIILQEORFNWRFKHFNIRULQIODPPDWLRQDQGO\PSKRF\WLF
LQILOWUDWHVWRFRQILUPFROLWLVGLDJQRVLV

(YHQW
0DQDJHPHQW
'LDUUKHDRU
FROLWLV*UDGH
x &RQWLQXHDWH]ROL]XPDE
x ,QLWLDWHV\PSWRPDWLFWUHDWPHQW
x (QGRVFRS\LVUHFRPPHQGHGLIV\PSWRPVSHUVLVWIRU!GD\V
x 0RQLWRUFORVHO\
'LDUUKHDRU
FROLWLV*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x ,QLWLDWHV\PSWRPDWLFWUHDWPHQW
x 3DWLHQWUHIHUUDOWR*,VSHFLDOLVWLVUHFRPPHQGHG
x )RUUHFXUUHQWHYHQWVRUHYHQWVWKDWSHUVLVW!GD\VLQLWLDWHWUHDWPHQW
ZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\RUDOSUHGQLVRQH
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
'LDUUKHDRU
FROLWLV*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x 5HIHUSDWLHQWWR*,VSHFLDOLVWIRUHYDOXDWLRQDQGFRQILUPDWRU\ELRSV\
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\,9
PHWK\OSUHGQLVRORQHDQGFRQYHUWWRPJNJGD\RUDOSUHGQLVRQHRU
HTXLYDOHQWXSRQLPSURYHPHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
'LDUUKHDRU
FROLWLV*UDGH
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWR*,VSHFLDOLVWIRUHYDOXDWLRQDQGFRQILUPDWLRQELRSV\
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\,9
PHWK\OSUHGQLVRORQHDQGFRQYHUWWRPJNJGD\RUDOSUHGQLVRQHRU
HTXLYDOHQWXSRQLPSURYHPHQW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHU
tPRQWK
*, JDVWURLQWHVWLQDO
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
GHWHUPLQHGE\WKHLQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

(QGRFULQHGLVRUGHUV
7K\URLGGLVRUGHUVDGUHQDOLQVXIILFLHQF\GLDEHWHVPHOOLWXVDQGSLWXLWDU\GLVRUGHUVKDYHEHHQ
DVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE0DQDJHPHQWJXLGHOLQHVIRUHQGRFULQH
HYHQWVDUHSURYLGHGLQWKHWDEOHEHORZ

3DWLHQWVH[SHULHQFLQJRQHRUPRUHXQH[SODLQHG$(VSRVVLEO\LQGLFDWLYHRIHQGRFULQHG\VIXQFWLRQ
LQFOXGLQJKHDGDFKHIDWLJXHP\DOJLDVLPSRWHQFHPHQWDOVWDWXVFKDQJHVDQGFRQVWLSDWLRQ
VKRXOGEHLQYHVWLJDWHGIRUWKHSUHVHQFHRIWK\URLGSLWXLWDU\RUDGUHQDOHQGRFULQRSDWKLHV7KH
SDWLHQWVKRXOGEHUHIHUUHGWRDQHQGRFULQRORJLVWLIDQHQGRFULQRSDWK\LVVXVSHFWHG7K\URLG
VWLPXODWLQJKRUPRQH76+DQGIUHH7DQG7OHYHOVVKRXOGEHPHDVXUHGWRGHWHUPLQHZKHWKHU
WK\URLGDEQRUPDOLWLHVDUHSUHVHQW3LWXLWDU\KRUPRQHOHYHOVDQGIXQFWLRQWHVWV>e.g.76+JURZWK
KRUPRQHOXWHLQL]LQJKRUPRQHIROOLFOHVWLPXODWLQJKRUPRQHWHVWRVWHURQHSURODFWLQ
DGUHQRFRUWLFRWURSLFKRUPRQH$&7+OHYHOVDQG$&7+VWLPXODWLRQWHVW@DQG05,RIWKHEUDLQ
ZLWKGHWDLOHGSLWXLWDU\VHFWLRQVPD\KHOSWRGLIIHUHQWLDWHSULPDU\SLWXLWDU\LQVXIILFLHQF\IURP
SULPDU\DGUHQDOLQVXIILFLHQF\7KHWDEOHEHORZGHVFULEHVGRVHPDQDJHPHQWJXLGHOLQHVIRU
K\SHUWK\URLGLVPK\SRWK\URLGLVPV\PSWRPDWLFDGUHQDOLQVXIILFLHQF\DQGK\SHUJO\FHPLD

(YHQW
0DQDJHPHQW
$V\PSWRPDWLF
K\SRWK\URLGLVP
x &RQWLQXHDWH]ROL]XPDE
x ,QLWLDWHWUHDWPHQWZLWKWK\URLGUHSODFHPHQWKRUPRQH
x 0RQLWRU76+ZHHNO\
6\PSWRPDWLF
K\SRWK\URLGLVP
x :LWKKROGDWH]ROL]XPDE
x ,QLWLDWHWUHDWPHQWZLWKWK\URLGUHSODFHPHQWKRUPRQH
x 0RQLWRU76+ZHHNO\
x &RQVLGHUSDWLHQWUHIHUUDOWRHQGRFULQRORJLVW
x 5HVXPHDWH]ROL]XPDEZKHQV\PSWRPVDUHFRQWUROOHGDQG
WK\URLGIXQFWLRQLVLPSURYLQJ
$V\PSWRPDWLF
K\SHUWK\URLGLVP
76+tP8/DQGP8/
x &RQWLQXHDWH]ROL]XPDE
x 0RQLWRU76+HYHU\ZHHNV
76+P8/
x )ROORZJXLGHOLQHVIRUV\PSWRPDWLFK\SHUWK\URLGLVP
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
6\PSWRPDWLF
K\SHUWK\URLGLVP
x :LWKKROGDWH]ROL]XPDE
x ,QLWLDWHWUHDWPHQWZLWKDQWLWK\URLGGUXJVXFKDVPHWKLPD]ROHRU
FDUELPD]ROHDVQHHGHG
x &RQVLGHUSDWLHQWUHIHUUDOWRHQGRFULQRORJLVW
x 5HVXPHDWH]ROL]XPDEZKHQV\PSWRPVDUHFRQWUROOHGDQG
WK\URLGIXQFWLRQLVLPSURYLQJ
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
6\PSWRPDWLFDGUHQDO
LQVXIILFLHQF\*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x 5HIHUSDWLHQWWRHQGRFULQRORJLVW
x 3HUIRUPDSSURSULDWHLPDJLQJ
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWR
PJNJGD\RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQ
LPSURYHPHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUDQGSDWLHQWLVVWDEOHRQ
UHSODFHPHQWWKHUDS\UHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHURUSDWLHQWLVQRW
VWDEOHRQUHSODFHPHQWWKHUDS\ZKLOHZLWKKROGLQJDWH]ROL]XPDE
SHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
+\SHUJO\FHPLD*UDGH
RU
x &RQWLQXHDWH]ROL]XPDE
x ,QYHVWLJDWHIRUGLDEHWHV,ISDWLHQWKDV7\SHGLDEHWHVWUHDWDVD
*UDGHHYHQW,ISDWLHQWGRHVQRWKDYH7\SHGLDEHWHVWUHDWDV
SHULQVWLWXWLRQDOJXLGHOLQHV
x 0RQLWRUIRUJOXFRVHFRQWURO
+\SHUJO\FHPLD*UDGH
RU
x :LWKKROGDWH]ROL]XPDE
x ,QLWLDWHWUHDWPHQWZLWKLQVXOLQ
x 0RQLWRUIRUJOXFRVHFRQWURO
x &RQVLGHUUHIHUUDOWRHQGRFULQRORJLVWSDUWLFXODUO\LISDWLHQWLV
GHHPHGWRKDYHDWH]ROL]XPDELQGXFHGGLDEHWHVLIVRREWDLQ&
SHSWLGHOHYHOSDLUHGZLWKJOXFRVHDXWRDQWLERG\OHYHOVHJ
*$'LVOHWFHOODXWRDQWLERGLHVDQGKHPRJORELQ$&OHYHO
x ,ISDWLHQWLVIRXQGWRKDYHGLDEHWLFNHWRDFLGRVLVRU
K\SHUJO\FHPLFK\SHURVPRODUV\QGURPHWUHDWDVSHULQVWLWXWLRQDO
JXLGHOLQHVZLWKDSSURSULDWHPDQDJHPHQWDQGODERUDWRU\YDOXHV
egDQLRQJDSNHWRQHVEORRGS+etcUHSRUWHG
x 5HVXPHDWH]ROL]XPDEZKHQV\PSWRPVUHVROYHDQGJOXFRVH
OHYHOVDUHVWDEOH
+\SRSK\VLWLVSDQ
K\SRSLWXLWDULVP*UDGH
RU
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x 5HIHUSDWLHQWWRHQGRFULQRORJLVW
x 3HUIRUPEUDLQ05,SLWXLWDU\SURWRFRO
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWR
PJNJGD\RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQ
LPSURYHPHQW
x ,QLWLDWHKRUPRQHUHSODFHPHQWLIFOLQLFDOO\LQGLFDWHG
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x )RUUHFXUUHQWK\SRSK\VLWLVWUHDWDVD*UDGHHYHQW
+\SRSK\VLWLVSDQ
K\SRSLWXLWDULVP*UDGH

x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRHQGRFULQRORJLVW
x 3HUIRUPEUDLQ05,SLWXLWDU\SURWRFRO
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWR
PJNJGD\RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQ
LPSURYHPHQW
x ,QLWLDWHKRUPRQHUHSODFHPHQWLIFOLQLFDOO\LQGLFDWHG
05, PDJQHWLFUHVRQDQFHLPDJLQJ76+ WK\URLGVWLPXODWLQJKRUPRQH
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
GHWHUPLQHGE\WKHLQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

2FXODUHYHQWV
$QRSKWKDOPRORJLVWVKRXOGHYDOXDWHYLVXDOFRPSODLQWVegXYHLWLVUHWLQDOHYHQWV
0DQDJHPHQWJXLGHOLQHVIRURFXODUHYHQWVDUHSURYLGHGLQWKHWDEOHEHORZ

(YHQW
0DQDJHPHQW
2FXODUHYHQW
*UDGH
x &RQWLQXHDWH]ROL]XPDE
x 3DWLHQWUHIHUUDOWRRSKWKDOPRORJLVWLVVWURQJO\UHFRPPHQGHG
x ,QLWLDWHWUHDWPHQWZLWKWRSLFDOFRUWLFRVWHURLGH\HGURSVDQGWRSLFDO
LPPXQRVXSSUHVVLYHWKHUDS\
x ,IV\PSWRPVSHUVLVWWUHDWDVD*UDGHHYHQW
2FXODUHYHQW
*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x 3DWLHQWUHIHUUDOWRRSKWKDOPRORJLVWLVVWURQJO\UHFRPPHQGHG
x ,QLWLDWHWUHDWPHQWZLWKWRSLFDOFRUWLFRVWHURLGH\HGURSVDQGWRSLFDO
LPPXQRVXSSUHVVLYHWKHUDS\
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
2FXODUHYHQW
*UDGHRU
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRRSKWKDOPRORJLVW
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\
RUDOSUHGQLVRQH
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHU
tPRQWK
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVW
EHGHWHUPLQHGE\WKHLQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKH
HTXLYDOHQWRIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

,PPXQHPHGLDWHGP\RFDUGLWLVDQGSHULFDUGLWLVKDYHEHHQDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRI
DWH]ROL]XPDE0DQDJHPHQWJXLGHOLQHVIRUFDUGLDFHYHQWVDUHSURYLGHGLQWKHWDEOHEHORZ

,PPXQHPHGLDWHG0\RFDUGLWLV
,PPXQHPHGLDWHGP\RFDUGLWLVKDVEHHQDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE
,PPXQHPHGLDWHGP\RFDUGLWLVVKRXOGEHVXVSHFWHGLQDQ\SDWLHQWSUHVHQWLQJZLWKVLJQVRU
V\PSWRPVVXJJHVWLYHRIP\RFDUGLWLVLQFOXGLQJEXWQRWOLPLWHGWRODERUDWRU\eg%13>%
1DWULXUHWLF3HSWLGH@RUFDUGLDFLPDJLQJDEQRUPDOLWLHVG\VSQHDFKHVWSDLQSDOSLWDWLRQVIDWLJXH
GHFUHDVHGH[HUFLVHWROHUDQFHRUV\QFRSH0\RFDUGLWLVPD\DOVREHDFOLQLFDOPDQLIHVWDWLRQRI
P\RVLWLVRUDVVRFLDWHGZLWKSHULFDUGLWLVVHHVHFWLRQRQSHULFDUGLDOGLVRUGHUVEHORZDQGVKRXOG
EHPDQDJHGDFFRUGLQJO\

,PPXQHPHGLDWHGP\RFDUGLWLVQHHGVWREHGLVWLQJXLVKHGIURPP\RFDUGLWLVUHVXOWLQJIURP
LQIHFWLRQFRPPRQO\YLUDOegLQDSDWLHQWZKRUHSRUWVDUHFHQWKLVWRU\RIJDVWURLQWHVWLQDO
LOOQHVVLVFKHPLFHYHQWVXQGHUO\LQJDUUK\WKPLDVH[DFHUEDWLRQRISUHH[LVWLQJFDUGLDFFRQGLWLRQV
RUSURJUHVVLRQRIPDOLJQDQF\$OOSDWLHQWVZLWKSRVVLEOHP\RFDUGLWLVVKRXOGEHXUJHQWO\
HYDOXDWHGE\SHUIRUPLQJFDUGLDFHQ]\PHDVVHVVPHQWDQHOHFWURFDUGLRJUDP(&*DFKHVW;UD\
DQHFKRFDUGLRJUDPDQGDFDUGLDF05,DVDSSURSULDWHSHULQVWLWXWLRQDOJXLGHOLQHV$FDUGLRORJLVW
VKRXOGEHFRQVXOWHG$QHQGRP\RFDUGLDOELRSV\PD\EHFRQVLGHUHGWRHQDEOHDGHILQLWLYH
GLDJQRVLVDQGDSSURSULDWHWUHDWPHQWLIFOLQLFDOO\LQGLFDWHG

3DWLHQWVZLWKVLJQVDQGV\PSWRPVRIP\RFDUGLWLVLQWKHDEVHQFHRIDQLGHQWLILHGDOWHUQDWH
HWLRORJ\VKRXOGEHWUHDWHGDFFRUGLQJWRWKHJXLGHOLQHVLQWKHWDEOHEHORZ

,PPXQHPHGLDWHG3HULFDUGLDO'LVRUGHUV
,PPXQHPHGLDWHGSHULFDUGLWLVVKRXOGEHVXVSHFWHGLQDQ\SDWLHQWSUHVHQWLQJZLWKFKHVWSDLQDQG
PD\EHDVVRFLDWHGZLWKLPPXQHPHGLDWHGP\RFDUGLWLVVHHVHFWLRQRQP\RFDUGLWLVDERYH

,PPXQHPHGLDWHGSHULFDUGLDOHIIXVLRQDQGFDUGLDFWDPSRQDGHVKRXOGEHVXVSHFWHGLQDQ\SDWLHQW
SUHVHQWLQJZLWKFKHVWSDLQDVVRFLDWHGZLWKG\VSQHDRUKHPRG\QDPLFLQVWDELOLW\

3DWLHQWVVKRXOGEHHYDOXDWHGIRURWKHUFDXVHVRISHULFDUGLDOGLVRUGHUVVXFKDVLQIHFWLRQ
FRPPRQO\YLUDOFDQFHUUHODWHGPHWDVWDWLFGLVHDVHRUFKHVWUDGLRWKHUDS\FDUGLDFLQMXU\UHODWHG
SRVWP\RFDUGLDOLQIDUFWLRQRULDWURJHQLFDQGDXWRLPPXQHGLVRUGHUVDQGVKRXOGEHPDQDJHG
DFFRUGLQJO\

$OOSDWLHQWVZLWKVXVSHFWHGSHULFDUGLDOGLVRUGHUVVKRXOGEHXUJHQWO\HYDOXDWHGE\SHUIRUPLQJDQ
(&*FKHVW;UD\WUDQVWKRUDFLFHFKRFDUGLRJUDPDQGFDUGLDF05,DVDSSURSULDWHSHU
LQVWLWXWLRQDOJXLGHOLQHV$FDUGLRORJLVWVKRXOGEHFRQVXOWHG3HULFDUGLRFHQWHVLVVKRXOGEH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
FRQVLGHUHGIRUGLDJQRVWLFRUWKHUDSHXWLFSXUSRVHVLIFOLQLFDOO\LQGLFDWHG

3DWLHQWVZLWKVLJQVDQGV\PSWRPVRISHULFDUGLWLVSHULFDUGLDOHIIXVLRQRUFDUGLDFWDPSRQDGHLQ
WKHDEVHQFHRIDQLGHQWLILHGDOWHUQDWHHWLRORJ\VKRXOGEHWUHDWHGDFFRUGLQJWRWKHJXLGHOLQHVLQ
WKHWDEOHEHORZ:LWKKROGWUHDWPHQWZLWKDWH]ROL]XPDEIRU*UDGHSHULFDUGLWLVDQGFRQGXFWD
GHWDLOHGFDUGLDFHYDOXDWLRQWRGHWHUPLQHWKHHWLRORJ\DQGPDQDJHDFFRUGLQJO\


(YHQW
0DQDJHPHQW

x 
,PPXQHPHGLDWHG
P\RFDUGLWLV*UDGH


,PPXQHPHGLDWHG
SHULFDUGLDOGLVRUGHUV
*UDGH

x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRFDUGLRORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHVDQGFRQVLGHU
DQWLDUUK\WKPLFGUXJVWHPSRUDU\SDFHPDNHU(&02RU9$'DV
DSSURSULDWH
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWRPJNJGD\
RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQLPSURYHPHQW
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
x ,IV\PSWRPVUHVROYHWREHORZ*UDGHWDSHUFRUWLFRVWHURLGV
RYHUtPRQWK
(&02 H[WUDFRUSRUHDOPHPEUDQHR[\JHQDWLRQ9$' YHQWULFXODUDVVLVWGHYLFH


,QIXVLRQ5HODWHG5HDFWLRQVDQG&\WRNLQH5HOHDVH6\QGURPH
1RSUHPHGLFDWLRQLVLQGLFDWHGIRUWKHDGPLQLVWUDWLRQRI&\FOHRIDWH]ROL]XPDE+RZHYHU
SDWLHQWVZKRH[SHULHQFHDQLQIXVLRQUHODWHGUHDFWLRQ,55RUF\WRNLQHUHOHDVHV\QGURPH&56
ZLWKDWH]ROL]XPDEPD\UHFHLYHSUHPHGLFDWLRQZLWKDQWLKLVWDPLQHVDQWLS\UHWLFVDQGRU
DQDOJHVLFVegDFHWDPLQRSKHQIRUVXEVHTXHQWLQIXVLRQV0HWDPL]ROHGLS\URQHLVSURKLELWHG
LQWUHDWLQJDWH]ROL]XPDEDVVRFLDWHG,55VEHFDXVHRILWVSRWHQWLDOIRUFDXVLQJDJUDQXORF\WRVLV

,55VDUHNQRZQWRRFFXUZLWKWKHDGPLQLVWUDWLRQRIPRQRFORQDODQWLERGLHVDQGKDYHEHHQ
UHSRUWHGZLWKDWH]ROL]XPDE7KHVHUHDFWLRQVZKLFKDUHWKRXJKWWREHGXHWRUHOHDVHRIF\WRNLQHV
DQGRURWKHUFKHPLFDOPHGLDWRUVRFFXUZLWKLQKRXUVRIDWH]ROL]XPDEDGPLQLVWUDWLRQDQGDUH
JHQHUDOO\PLOGWRPRGHUDWHLQVHYHULW\

&56LVGHILQHGDVDVXSUDSK\VLRORJLFUHVSRQVHIROORZLQJDGPLQLVWUDWLRQRIDQ\LPPXQHWKHUDS\
WKDWUHVXOWVLQDFWLYDWLRQRUHQJDJHPHQWRIHQGRJHQRXVRULQIXVHG7FHOOVDQGRURWKHULPPXQH
HIIHFWRUFHOOV6\PSWRPVFDQEHSURJUHVVLYHDOZD\VLQFOXGHIHYHUDWWKHRQVHWDQGPD\LQFOXGH
K\SRWHQVLRQFDSLOODU\OHDNK\SR[LDDQGHQGRUJDQG\VIXQFWLRQ/HHet al&56KDV
EHHQZHOOGRFXPHQWHGZLWKFKLPHULFDQWLJHQUHFHSWRU7FHOOWKHUDSLHVDQGELVSHFLILF7FHOO
HQJDJHUDQWLERG\WKHUDSLHVEXWKDVDOVREHHQUHSRUWHGZLWKLPPXQRWKHUDSLHVWKDWWDUJHW3'RU
3'/5RW]et al$GDVKHNDQG)HOGPDQLQFOXGLQJDWH]ROL]XPDE

7KHUHPD\EHVLJQLILFDQWRYHUODSLQVLJQVDQGV\PSWRPVRI,55VDQG&56DQGLQUHFRJQLWLRQRI
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WKHFKDOOHQJHVLQFOLQLFDOO\GLVWLQJXLVKLQJEHWZHHQWKHWZRFRQVROLGDWHGJXLGHOLQHVIRUPHGLFDO
PDQDJHPHQWRI,55VDQG&56DUHSURYLGHGLQWKHWDEOHEHORZ

0DQDJHPHQW*XLGHOLQHVIRU,QIXVLRQ5HODWHG5HDFWLRQVDQG&\WRNLQH5HOHDVH6\QGURPH

(YHQW
0DQDJHPHQW
*UDGHD
)HYHUEZLWKRU
ZLWKRXW
FRQVWLWXWLRQDO
V\PSWRPV
Ɣ ,PPHGLDWHO\LQWHUUXSWLQIXVLRQ
Ɣ 8SRQV\PSWRPUHVROXWLRQZDLWPLQXWHVDQGWKHQUHVWDUWLQIXVLRQDW
KDOIWKHUDWHEHLQJJLYHQDWWKHWLPHRIHYHQWRQVHW
Ɣ ,IWKHLQIXVLRQLVWROHUDWHGDWWKHUHGXFHGUDWHIRUPLQXWHVWKHLQIXVLRQ
UDWHPD\EHLQFUHDVHGWRWKHRULJLQDOUDWH
Ɣ ,IV\PSWRPVUHFXUGLVFRQWLQXHLQIXVLRQRIWKLVGRVH
Ɣ $GPLQLVWHUV\PSWRPDWLFWUHDWPHQWFLQFOXGLQJPDLQWHQDQFHRI,9IOXLGV
IRUK\GUDWLRQ
Ɣ ,QFDVHRIUDSLGGHFOLQHRUSURORQJHG&56!GD\VRULQSDWLHQWVZLWK
VLJQLILFDQWV\PSWRPVDQGRUFRPRUELGLWLHVFRQVLGHUPDQDJLQJDVSHU
*UDGH
Ɣ )RUVXEVHTXHQWLQIXVLRQVFRQVLGHUDGPLQLVWUDWLRQRIRUDOSUHPHGLFDWLRQ
ZLWKDQWLKLVWDPLQHVDQWLS\UHWLFVDQGRUDQDOJHVLFVDQGPRQLWRUFORVHO\
IRU,55VDQGRU&56
*UDGHD
)HYHUEZLWK
K\SRWHQVLRQQRW
UHTXLULQJ
YDVRSUHVVRUV
DQGRU
+\SR[LD
UHTXLULQJORZ
IORZR[\JHQG
E\QDVDOFDQQXOD
RUEORZE\
Ɣ ,PPHGLDWHO\LQWHUUXSWDWH]ROL]XPDELQIXVLRQ
Ɣ 8SRQV\PSWRPUHVROXWLRQZDLWIRUPLQXWHVDQGWKHQUHVWDUWLQIXVLRQDW
KDOIWKHUDWHEHLQJJLYHQDWWKHWLPHRIHYHQWRQVHW
Ɣ ,IV\PSWRPVUHFXUGLVFRQWLQXHLQIXVLRQRIWKLVGRVH
Ɣ $GPLQLVWHUV\PSWRPDWLFWUHDWPHQWF
Ɣ )RUK\SRWHQVLRQDGPLQLVWHU,9IOXLGEROXVDVQHHGHG
Ɣ 0RQLWRUFDUGLRSXOPRQDU\DQGRWKHURUJDQIXQFWLRQFORVHO\LQWKH,&8LI
DSSURSULDWH$GPLQLVWHU,9IOXLGVDVFOLQLFDOO\LQGLFDWHGDQGPDQDJH
FRQVWLWXWLRQDOV\PSWRPVDQGRUJDQWR[LFLWLHVDVSHULQVWLWXWLRQDOSUDFWLFH
Ɣ 5XOHRXWRWKHULQIODPPDWRU\FRQGLWLRQVWKDWFDQPLPLF&56egVHSVLV
,IQRLPSURYHPHQWZLWKLQKRXUVLQLWLDWHZRUNXSDQGDVVHVVIRUVLJQV
DQGV\PSWRPVRI+/+RU0$6
Ɣ &RQVLGHU,9FRUWLFRVWHURLGVegPHWK\OSUHGQLVRORQHPJNJGD\RU
GH[DPHWKDVRQHPJHYHU\KRXUV
Ɣ &RQVLGHUDQWLF\WRNLQHWKHUDS\H
Ɣ &RQVLGHUKRVSLWDOL]DWLRQXQWLOFRPSOHWHUHVROXWLRQRIV\PSWRPV,IQR
LPSURYHPHQWZLWKLQKRXUVPDQDJHDVSHU*UDGHWKDWLVKRVSLWDOL]H
SDWLHQWPRQLWRULQJLQWKH,&8LVUHFRPPHQGHGSHUPDQHQWO\GLVFRQWLQXH
DWH]ROL]XPDE
Ɣ ,IV\PSWRPVUHVROYHWR*UDGHRUEHWWHUIRUFRQVHFXWLYHGD\VWKHQH[W
GRVHRIDWH]ROL]XPDEPD\EHDGPLQLVWHUHG)RUVXEVHTXHQWLQIXVLRQV
FRQVLGHUDGPLQLVWUDWLRQRIRUDOSUHPHGLFDWLRQZLWKDQWLKLVWDPLQHVDQWL
S\UHWLFVDQGRUDQDOJHVLFVDQGPRQLWRUFORVHO\IRU,55VDQGRU&56
Ɣ ,IV\PSWRPVGRQRWUHVROYHWR*UDGHRUEHWWHUIRUFRQVHFXWLYHGD\V
FRQWDFWWKH3ULQFLSDO,QYHVWLJDWRU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
*UDGHD
)HYHUEZLWK
K\SRWHQVLRQ
UHTXLULQJD
YDVRSUHVVRU
ZLWKRUZLWKRXW
YDVRSUHVVLQ
DQGRU
+\SR[LD
UHTXLULQJKLJK
IORZR[\JHQG
E\QDVDO
FDQQXODIDFH
PDVNQRQ
UHEUHDWKHUPDVN
RUYHQWXULPDVN
Ɣ 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
Ɣ $GPLQLVWHUV\PSWRPDWLFWUHDWPHQWF
Ɣ )RUK\SRWHQVLRQDGPLQLVWHU,9IOXLGEROXVDQGYDVRSUHVVRUDVQHHGHG
Ɣ 0RQLWRUFDUGLRSXOPRQDU\DQGRWKHURUJDQIXQFWLRQFORVHO\PRQLWRULQJLQ
WKH,&8LVUHFRPPHQGHG$GPLQLVWHU,9IOXLGVDVFOLQLFDOO\LQGLFDWHGDQG
PDQDJHFRQVWLWXWLRQDOV\PSWRPVDQGRUJDQWR[LFLWLHVDVSHULQVWLWXWLRQDO
SUDFWLFH
Ɣ 5XOHRXWRWKHULQIODPPDWRU\FRQGLWLRQVWKDWFDQPLPLF&56egVHSVLV
,IQRLPSURYHPHQWZLWKLQKRXUVLQLWLDWHZRUNXSDQGDVVHVVIRUVLJQV
DQGV\PSWRPVRI+/+RU0$6
Ɣ $GPLQLVWHU,9FRUWLFRVWHURLGVegPHWK\OSUHGQLVRORQHPJNJGD\RU
GH[DPHWKDVRQHPJHYHU\KRXUV
Ɣ &RQVLGHUDQWLF\WRNLQHWKHUDS\H
Ɣ +RVSLWDOL]HSDWLHQWXQWLOFRPSOHWHUHVROXWLRQRIV\PSWRPV,IQR
LPSURYHPHQWZLWKLQKRXUVPDQDJHDVSHU*UDGHWKDWLVDGPLW
SDWLHQWWR,&8DQGLQLWLDWHKHPRG\QDPLFPRQLWRULQJPHFKDQLFDO
YHQWLODWLRQDQGRU,9IOXLGVDQGYDVRSUHVVRUVDVQHHGHGIRUSDWLHQWVZKR
DUHUHIUDFWRU\WRDQWLF\WRNLQHWKHUDS\H[SHULPHQWDOWUHDWPHQWVPD\EH
FRQVLGHUHGDWWKHGLVFUHWLRQRIWKHLQYHVWLJDWRU
*UDGHD
)HYHUEZLWK
K\SRWHQVLRQ
UHTXLULQJ
PXOWLSOH
YDVRSUHVVRUV
H[FOXGLQJ
YDVRSUHVVLQ
DQGRU
+\SR[LD
UHTXLULQJ
R[\JHQE\
SRVLWLYHSUHVVXUH
eg&3$3
%L3$3
LQWXEDWLRQDQG
PHFKDQLFDO
YHQWLODWLRQ
Ɣ 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
Ɣ $GPLQLVWHUV\PSWRPDWLFWUHDWPHQWF
Ɣ $GPLWSDWLHQWWR,&8DQGLQLWLDWHKHPRG\QDPLFPRQLWRULQJPHFKDQLFDO
YHQWLODWLRQDQGRU,9IOXLGVDQGYDVRSUHVVRUVDVQHHGHG0RQLWRURWKHU
RUJDQIXQFWLRQFORVHO\0DQDJHFRQVWLWXWLRQDOV\PSWRPVDQGRUJDQ
WR[LFLWLHVDVSHULQVWLWXWLRQDOSUDFWLFH
Ɣ 5XOHRXWRWKHULQIODPPDWRU\FRQGLWLRQVWKDWFDQPLPLF&56egVHSVLV
,IQRLPSURYHPHQWZLWKLQKRXUVLQLWLDWHZRUNXSDQGDVVHVVIRUVLJQV
DQGV\PSWRPVRI+/+RU0$6
Ɣ $GPLQLVWHU,9FRUWLFRVWHURLGVegPHWK\OSUHGQLVRORQHPJNJGD\RU
GH[DPHWKDVRQHPJHYHU\KRXUV
Ɣ &RQVLGHUDQWLF\WRNLQHWKHUDS\H)RUSDWLHQWVZKRDUHUHIUDFWRU\WRDQWL
F\WRNLQHWKHUDS\H[SHULPHQWDOWUHDWPHQWVIPD\EHFRQVLGHUHGDWWKH
GLVFUHWLRQRIWKHLQYHVWLJDWRU
Ɣ +RVSLWDOL]HSDWLHQWXQWLOFRPSOHWHUHVROXWLRQRIV\PSWRPV
$67&7 $PHULFDQ6RFLHW\IRU7UDQVSODQWDWLRQDQG&HOOXODU7KHUDS\%L3$3 ELOHYHOSRVLWLYHDLUZD\
SUHVVXUH&$5 FKLPHULFDQWLJHQUHFHSWRU&3$3 FRQWLQXRXVSRVLWLYHDLUZD\SUHVVXUH
&56 F\WRNLQHUHOHDVHV\QGURPH+/+ KHPRSKDJRF\WLFO\PSKRKLVWLRF\WRVLV,55 LQIXVLRQUHODWHG
UHDFWLRQ0$6 PDFURSKDJHDFWLYDWLRQV\QGURPH
1RWH7KHPDQDJHPHQWJXLGHOLQHVKDYHEHHQDGDSWHGIURP1&&1JXLGHOLQHVIRUPDQDJHPHQWRI
&$57FHOOUHODWHGWR[LFLWLHV9HUVLRQ
D *UDGLQJV\VWHPIRUPDQDJHPHQWJXLGHOLQHVLVEDVHGRQ$67&7FRQVHQVXVJUDGLQJIRU&56
1&,&7&$(YHUVLRQDVVSHFLILHGLQWKHSURWRFROVKRXOGEHXVHGZKHQUHSRUWLQJVHYHULW\
RI,55V&56RURUJDQWR[LFLWLHVDVVRFLDWHGZLWK&56RQWKH$GYHUVH(YHQWH&5)2UJDQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WR[LFLWLHVDVVRFLDWHGZLWK&56VKRXOGQRWLQIOXHQFHRYHUDOO&56JUDGLQJ
E )HYHU LV GHILQHG DV WHPSHUDWXUH & QRW DWWULEXWDEOH WR DQ\ RWKHU FDXVH ,Q SDWLHQWV ZKR
GHYHORS&56DQGWKHQUHFHLYHDQWLS\UHWLFDQWLF\WRNLQHRUFRUWLFRVWHURLGWKHUDS\IHYHULV
QRORQJHUUHTXLUHGZKHQVXEVHTXHQWO\GHWHUPLQLQJHYHQWVHYHULW\JUDGH,QWKLVFDVHWKH
JUDGHLVGULYHQE\WKHSUHVHQFHRIK\SRWHQVLRQDQGRUK\SR[LD
F 6\PSWRPDWLFWUHDWPHQWPD\LQFOXGHRUDORU,9DQWLKLVWDPLQHVDQWLS\UHWLFVDQDOJHVLFV
EURQFKRGLODWRUVDQGRUR[\JHQ)RUEURQFKRVSDVPXUWLFDULDRUG\VSQHDDGGLWLRQDO
WUHDWPHQWPD\EHDGPLQLVWHUHGDVSHULQVWLWXWLRQDOSUDFWLFH
G /RZ IORZ LV GHILQHG DV R[\JHQ GHOLYHUHG DW  /PLQ DQG KLJK IORZ LV GHILQHG DV R[\JHQ
GHOLYHUHGDW!/PLQ
H 7KHUHDUHFDVHUHSRUWVZKHUHDQWLF\WRNLQHWKHUDS\KDVEHHQXVHGIRUWUHDWPHQWRI&56ZLWK
LPPXQHFKHFNSRLQWLQKLELWRUV5RW]et al$GDVKHNDQG)HOGPDQEXWGDWDDUH
OLPLWHGDQGWKHUROHRIVXFKWUHDWPHQWLQWKHVHWWLQJRIDQWLERG\DVVRFLDWHG&56KDVQRW
EHHQHVWDEOLVKHG
I 5HIHUWR5LHJOHUet alIRULQIRUPDWLRQRQH[SHULPHQWDOWUHDWPHQWVIRU&56

3DQFUHDWLFHYHQWV
6\PSWRPVRIDEGRPLQDOSDLQDVVRFLDWHGZLWKHOHYDWLRQVRIDP\ODVHDQGOLSDVHVXJJHVWLYHRI
SDQFUHDWLWLVKDYHEHHQDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE7KHGLIIHUHQWLDO
GLDJQRVLVRIDFXWHDEGRPLQDOSDLQVKRXOGLQFOXGHSDQFUHDWLWLV$SSURSULDWHZRUNXSVKRXOG
LQFOXGHDQHYDOXDWLRQIRUGXFWDOREVWUXFWLRQDVZHOODVVHUXPDP\ODVHDQGOLSDVHWHVWV
0DQDJHPHQWJXLGHOLQHVIRUSDQFUHDWLFHYHQWVLQFOXGLQJSDQFUHDWLWLVDUHSURYLGHGLQWKHWDEOH
EHORZ

(YHQW
0DQDJHPHQW
$P\ODVHDQGRUOLSDVH
HOHYDWLRQ*UDGH
$P\ODVHDQGRUOLSDVH!u8/1
x &RQWLQXHDWH]ROL]XPDE
x 0RQLWRUDP\ODVHDQGOLSDVHZHHNO\
x )RUSURORQJHGHOHYDWLRQeg!ZHHNVFRQVLGHUWUHDWPHQW
ZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJGD\RUDOSUHGQLVRQH
$V\PSWRPDWLFZLWKDP\ODVHDQGRUOLSDVH!u8/1
x 7UHDWDVD*UDGHHYHQW
$P\ODVHDQGRUOLSDVH
HOHYDWLRQ*UDGHRU
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x 5HIHUSDWLHQWWR*,VSHFLDOLVW
x 0RQLWRUDP\ODVHDQGOLSDVHHYHU\RWKHUGD\
x ,IQRLPSURYHPHQWFRQVLGHUWUHDWPHQWZLWKFRUWLFRVWHURLGV
HTXLYDOHQWWRPJNJGD\RUDOSUHGQLVRQH
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOH
ZLWKKROGLQJDWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXH
DWH]ROL]XPDEF
x )RUUHFXUUHQWHYHQWVSHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
,PPXQHUHODWHG
SDQFUHDWLWLV*UDGHRU

x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x 5HIHUSDWLHQWWR*,VSHFLDOLVW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWR
PJNJGD\RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQ
LPSURYHPHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOH
ZLWKKROGLQJDWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXH
DWH]ROL]XPDE
x )RUUHFXUUHQWHYHQWVSHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
,PPXQHUHODWHG
SDQFUHDWLWLV*UDGH
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWR*,VSHFLDOLVW
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWR
PJNJGD\RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQ
LPSURYHPHQW
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYH
DJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGV
RYHUtPRQWK
*, JDVWURLQWHVWLQDO
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
GHWHUPLQHGE\WKHLQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

'HUPDWRORJLFHYHQWV
7UHDWPHQWHPHUJHQWUDVKKDVEHHQDVVRFLDWHGZLWKDWH]ROL]XPDE7KHPDMRULW\RIFDVHVRIUDVK
ZHUHPLOGLQVHYHULW\DQGVHOIOLPLWHGZLWKRUZLWKRXWSUXULWXV$GHUPDWRORJLVWVKRXOGHYDOXDWH
SHUVLVWHQWDQGRUVHYHUHUDVKRUSUXULWXV$OWKRXJKXQFRPPRQFDVHVRIVHYHUHFXWDQHRXV
DGYHUVHUHDFWLRQVVXFKDV6WHYHQV-RKQVRQV\QGURPHDQGWR[LFHSLGHUPDOQHFURO\VLVKDYHEHHQ
UHSRUWHGZLWKDWH]ROL]XPDE$ELRSV\VKRXOGEHFRQVLGHUHGXQOHVVFRQWUDLQGLFDWHG
0DQDJHPHQWJXLGHOLQHVIRUGHUPDWRORJLFHYHQWVDUHSURYLGHGLQWKHWDEOHEHORZ


(YHQW
0DQDJHPHQW
'HUPDWRORJLF
HYHQW*UDGH
Ɣ &RQWLQXHDWH]ROL]XPDE
Ɣ &RQVLGHUWUHDWPHQWZLWKWRSLFDOFRUWLFRVWHURLGVDQGRURWKHU
V\PSWRPDWLFWKHUDS\egDQWLKLVWDPLQHV
'HUPDWRORJLF
HYHQW*UDGH
Ɣ &RQWLQXHDWH]ROL]XPDE
Ɣ &RQVLGHUSDWLHQWUHIHUUDOWRGHUPDWRORJLVWIRUHYDOXDWLRQDQGLI
LQGLFDWHGELRSV\
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
Ɣ ,QLWLDWHWUHDWPHQWZLWKWRSLFDOFRUWLFRVWHURLGV
Ɣ &RQVLGHUWUHDWPHQWZLWKKLJKHUSRWHQF\WRSLFDOFRUWLFRVWHURLGVLIHYHQW
GRHVQRWLPSURYH
'HUPDWRORJLF
HYHQW*UDGH
Ɣ :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
Ɣ 5HIHUSDWLHQWWRGHUPDWRORJLVWIRUHYDOXDWLRQDQGLILQGLFDWHGELRSV\
Ɣ ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJGD\RUDO
SUHGQLVRQHLQFUHDVLQJGRVHWRPJNJGD\LIHYHQWGRHVQRW
LPSURYHZLWKLQKRXUV
Ɣ ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
Ɣ ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
'HUPDWRORJLF
HYHQW*UDGH
Ɣ 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
6WHYHQV-RKQVRQ
V\QGURPHRUWR[LF
HSLGHUPDO
QHFURO\VLVDQ\
JUDGH
$GGLWLRQDOJXLGDQFHIRU6WHYHQV-RKQVRQV\QGURPHRUWR[LF
HSLGHUPDOQHFURO\VLV
x :LWKKROGDWH]ROL]XPDEIRUVXVSHFWHG6WHYHQV-RKQVRQV\QGURPHRU
WR[LFHSLGHUPDOQHFURO\VLV
x &RQILUPGLDJQRVLVE\UHIHUULQJSDWLHQWWRDVSHFLDOLVWGHUPDWRORJLVW
RSKWKDOPRORJLVWRUXURORJLVWDVUHOHYDQWIRUHYDOXDWLRQDQGLI
LQGLFDWHGELRSV\
x )ROORZWKHDSSOLFDEOHWUHDWPHQWDQGPDQDJHPHQWJXLGHOLQHVDERYH
Ɣ ,I6WHYHQV-RKQVRQV\QGURPHRUWR[LFHSLGHUPDOQHFURO\VLVLV
FRQILUPHGSHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
$WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQWRQVHWWR
DOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRIdPJGD\RUDO
SUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEHGHWHUPLQHGE\WKH
LQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

1HXURORJLFGLVRUGHUV
0\DVWKHQLDJUDYLVDQG*XLOODLQ%DUUpV\QGURPHKDYHEHHQREVHUYHGZLWKVLQJOHDJHQW
DWH]ROL]XPDE3DWLHQWVPD\SUHVHQWZLWKVLJQVDQGV\PSWRPVRIVHQVRU\DQGRUPRWRU
QHXURSDWK\'LDJQRVWLFZRUNXSLVHVVHQWLDOIRUDQDFFXUDWHFKDUDFWHUL]DWLRQWRGLIIHUHQWLDWH
EHWZHHQDOWHUQDWLYHHWLRORJLHV0DQDJHPHQWJXLGHOLQHVIRUQHXURORJLFGLVRUGHUVDQGVSHFLILF
JXLGHOLQHVIRUP\HOLWLVDUHSURYLGHGLQWKHWDEOHEHORZ







8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
,PPXQHUHODWHG
QHXURSDWK\*UDGH

x &RQWLQXHDWH]ROL]XPDE
x ,QYHVWLJDWHHWLRORJ\
x $Q\FUDQLDOQHUYHGLVRUGHULQFOXGLQJIDFLDOSDUHVLVVKRXOGEH
PDQDJHGDVSHU*UDGHPDQDJHPHQWJXLGHOLQHVEHORZ
,PPXQHUHODWHG
QHXURSDWK\
LQFOXGLQJIDFLDO
SDUHVLV*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x ,QYHVWLJDWHHWLRORJ\DQGUHIHUSDWLHQWWRQHXURORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV
x )RUJHQHUDOLPPXQHPHGLDWHGQHXURSDWK\
x ,IV\PSWRPVUHVROYHWREHORZ*UDGHUHVXPHDWH]ROL]XPDEE
x ,IV\PSWRPVGRQRWUHVROYHWREHORZ*UDGHZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x )RUIDFLDOSDUHVLV
x ,IHYHQWUHVROYHVIXOO\UHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHIXOO\ZKLOHZLWKKROGLQJDWH]ROL]XPDE
SHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDEF
,PPXQHUHODWHG
QHXURSDWK\
LQFOXGLQJIDFLDO
SDUHVLV*UDGHRU

x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRQHXURORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV
0\DVWKHQLDJUDYLV
DQG*XLOODLQ%DUUp
V\QGURPHDQ\
JUDGH
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRQHXURORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV
x &RQVLGHULQLWLDWLRQRIFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\RUDO
RU,9SUHGQLVRQH
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
GHWHUPLQHGE\WKHLQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

(YHQW
0DQDJHPHQW
,PPXQHPHGLDWHGP\HOLWLV
*UDGH
x
&RQWLQXHDWH]ROL]XPDEXQOHVVV\PSWRPVZRUVHQRUGRQRW
LPSURYH
x
,QYHVWLJDWHHWLRORJ\DQGUHIHUSDWLHQWWRDQHXURORJLVW
,PPXQHPHGLDWHGP\HOLWLV
*UDGH
x
3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x
,QYHVWLJDWHHWLRORJ\DQGUHIHUSDWLHQWWRDQHXURORJLVW
x
5XOHRXWLQIHFWLRQ
x
,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\RUDOSUHGQLVRQH
,PPXQHPHGLDWHGP\HOLWLV
*UDGHRU
x
3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x
5HIHUSDWLHQWWRDQHXURORJLVW
x
,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
,PPXQH0HGLDWHG0HQLQJRHQFHSKDOLWLV
,PPXQHPHGLDWHGPHQLQJRHQFHSKDOLWLVLVDQLGHQWLILHGULVNDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRI
DWH]ROL]XPDE,PPXQHPHGLDWHGPHQLQJRHQFHSKDOLWLVVKRXOGEHVXVSHFWHGLQDQ\SDWLHQW
SUHVHQWLQJZLWKVLJQVRUV\PSWRPVVXJJHVWLYHRIPHQLQJLWLVRUHQFHSKDOLWLVLQFOXGLQJEXWQRW
OLPLWHGWRKHDGDFKHQHFNSDLQFRQIXVLRQVHL]XUHPRWRURUVHQVRU\G\VIXQFWLRQDQGDOWHUHGRU
GHSUHVVHGOHYHORIFRQVFLRXVQHVV(QFHSKDORSDWK\IURPPHWDEROLFRUHOHFWURO\WHLPEDODQFHV
QHHGVWREHGLVWLQJXLVKHGIURPSRWHQWLDOPHQLQJRHQFHSKDOLWLVUHVXOWLQJIURPLQIHFWLRQEDFWHULDO
YLUDORUIXQJDORUSURJUHVVLRQRIPDOLJQDQF\RUVHFRQGDU\WRDSDUDQHRSODVWLFSURFHVV

$OOSDWLHQWVEHLQJFRQVLGHUHGIRUPHQLQJRHQFHSKDOLWLVVKRXOGEHXUJHQWO\HYDOXDWHGZLWKD&7
VFDQDQGRU05,VFDQRIWKHEUDLQWRHYDOXDWHIRUPHWDVWDVLVLQIODPPDWLRQRUHGHPD,IGHHPHG
VDIHE\WKHWUHDWLQJSK\VLFLDQDOXPEDUSXQFWXUHVKRXOGEHSHUIRUPHGDQGDQHXURORJLVWVKRXOG
EHFRQVXOWHG

3DWLHQWVZLWKVLJQVDQGV\PSWRPVRIPHQLQJRHQFHSKDOLWLVLQWKHDEVHQFHRIDQLGHQWLILHG
DOWHUQDWHHWLRORJ\VKRXOGEHWUHDWHGDFFRUGLQJWRWKHJXLGHOLQHVLQWKHWDEOHEHORZ

(YHQW
0DQDJHPHQW
,PPXQHUHODWHG
PHQLQJRHQFHSKDOLWLV
DOOJUDGHV
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRQHXURORJLVW
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWR
PJNJGD\,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWR
PJNJGD\RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQ
LPSURYHPHQW
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHU
tPRQWK

5HQDOHYHQWV
,PPXQHPHGLDWHGQHSKULWLVKDVEHHQDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE
(OLJLEOHSDWLHQWVPXVWKDYHDGHTXDWHUHQDOIXQFWLRQ5HQDOIXQFWLRQLQFOXGLQJVHUXPFUHDWLQLQH
VKRXOGEHPRQLWRUHGWKURXJKRXWVWXG\WUHDWPHQW3DWLHQWVZLWKDEQRUPDOUHQDOIXQFWLRQVKRXOG
EHHYDOXDWHGDQGWUHDWHGIRURWKHUPRUHFRPPRQHWLRORJLHVLQFOXGLQJSUHUHQDODQGSRVWUHQDO
FDXVHVDQGFRQFRPLWDQWPHGLFDWLRQVVXFKDVQRQVWHURLGDODQWLLQIODPPDWRU\GUXJV5HIHUWKH
SDWLHQWWRDUHQDOVSHFLDOLVWLIFOLQLFDOO\LQGLFDWHG$UHQDOELRSV\PD\EHUHTXLUHGWRHQDEOHD
GHILQLWLYHGLDJQRVLVDQGDSSURSULDWHWUHDWPHQW

3DWLHQWVZLWKVLJQVDQGV\PSWRPVRIQHSKULWLVLQWKHDEVHQFHRIDQLGHQWLILHGDOWHUQDWHHWLRORJ\
VKRXOGEHWUHDWHGDFFRUGLQJWRWKHJXLGHOLQHVLQWKHWDEOHEHORZ

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
5HQDOHYHQW
*UDGH
x &RQWLQXHDWH]ROL]XPDE
x 0RQLWRUNLGQH\IXQFWLRQLQFOXGLQJFUHDWLQLQHFORVHO\XQWLOYDOXHV
UHVROYHWRZLWKLQQRUPDOOLPLWVRUWREDVHOLQHYDOXHV
5HQDOHYHQW
*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWD
x 5HIHUSDWLHQWWRUHQDOVSHFLDOLVW
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\
RUDOSUHGQLVRQH
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
5HQDOHYHQW
*UDGHRU
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRUHQDOVSHFLDOLVWDQGFRQVLGHUUHQDOELRSV\
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\
RUDOSUHGQLVRQH
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHUt
PRQWK
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
GHWHUPLQHGE\WKHLQYHVWLJDWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

,PPXQH0HGLDWHG0\RVLWLV
,PPXQHPHGLDWHGP\RVLWLVKDVEHHQDVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRIDWH]ROL]XPDE
0\RVLWLVRULQIODPPDWRU\P\RSDWKLHVDUHDJURXSRIGLVRUGHUVVKDULQJWKHFRPPRQIHDWXUHRI
LQIODPPDWRU\PXVFOHLQMXU\GHUPDWRP\RVLWLVDQGSRO\P\RVLWLVDUHDPRQJWKHPRVWFRPPRQ
GLVRUGHUV,QLWLDOGLDJQRVLVLVEDVHGRQFOLQLFDOPXVFOHZHDNQHVVPXVFOHSDLQVNLQUDVKLQ
GHUPDWRP\RVLWLVELRFKHPLFDOVHUXPFUHDWLQHNLQDVHLQFUHDVHDQGLPDJLQJ
HOHFWURP\RJUDSK\05,IHDWXUHVDQGLVFRQILUPHGZLWKDPXVFOHELRSV\

3DWLHQWVZLWKVLJQVDQGV\PSWRPVRIP\RVLWLVLQWKHDEVHQFHRIDQLGHQWLILHGDOWHUQDWHHWLRORJ\
VKRXOGEHWUHDWHGDFFRUGLQJWRWKHJXLGHOLQHVLQWDEOHEHORZ

(YHQW
0DQDJHPHQW
,PPXQHPHGLDWHG
P\RVLWLV*UDGH
x &RQWLQXHDWH]ROL]XPDE
x 5HIHUSDWLHQWWRUKHXPDWRORJLVWRUQHXURORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV
,PPXQHPHGLDWHG
P\RVLWLV*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWDDQG
FRQWDFW0HGLFDO0RQLWRU
x 5HIHUSDWLHQWWRUKHXPDWRORJLVWRUQHXURORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
x &RQVLGHUWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\
,9PHWK\OSUHGQLVRORQHDQGFRQYHUWWRPJNJGD\RUDOSUHGQLVRQH
RUHTXLYDOHQWXSRQLPSURYHPHQW
x ,IFRUWLFRVWHURLGVDUHLQLWLDWHGDQGHYHQWGRHVQRWLPSURYHZLWKLQ
KRXUVDIWHULQLWLDWLQJFRUWLFRVWHURLGVFRQVLGHUDGGLQJDQ
LPPXQRVXSSUHVVLYHDJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDEDQGFRQWDFW
0HGLFDO0RQLWRU
,PPXQHPHGLDWHG
P\RVLWLV*UDGH
x :LWKKROGDWH]ROL]XPDEIRUXSWRZHHNVDIWHUHYHQWRQVHWDDQG
FRQWDFW0HGLFDO0RQLWRU
x 5HIHUSDWLHQWWRUKHXPDWRORJLVWRUQHXURORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV
x 5HVSLUDWRU\VXSSRUWPD\EHUHTXLUHGLQPRUHVHYHUHFDVHV
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\,9
PHWK\OSUHGQLVRORQHRUKLJKHUGRVHEROXVLISDWLHQWLVVHYHUHO\
FRPSURPLVHGegFDUGLDFRUUHVSLUDWRU\V\PSWRPVG\VSKDJLDRU
ZHDNQHVVWKDWVHYHUHO\OLPLWVPRELOLW\FRQYHUWWRPJNJGD\
RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQLPSURYHPHQW
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUUHVXPHDWH]ROL]XPDEE
x ,IHYHQWGRHVQRWUHVROYHWR*UDGHRUEHWWHUZKLOHZLWKKROGLQJ
DWH]ROL]XPDESHUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDEDQGFRQWDFW
0HGLFDO0RQLWRU
x )RUUHFXUUHQWHYHQWVWUHDWDVD*UDGHHYHQW
,PPXQHPHGLDWHG
P\RVLWLV*UDGH
x 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDEDQGFRQWDFW0HGLFDO0RQLWRU
x 5HIHUSDWLHQWWRUKHXPDWRORJLVWRUQHXURORJLVW
x ,QLWLDWHWUHDWPHQWDVSHULQVWLWXWLRQDOJXLGHOLQHV
x 5HVSLUDWRU\VXSSRUWPD\EHUHTXLUHGLQPRUHVHYHUHFDVHV
x ,QLWLDWHWUHDWPHQWZLWKFRUWLFRVWHURLGVHTXLYDOHQWWRPJNJGD\,9
PHWK\OSUHGQLVRORQHRUKLJKHUGRVHEROXVLISDWLHQWLVVHYHUHO\
FRPSURPLVHGegFDUGLDFRUUHVSLUDWRU\V\PSWRPVG\VSKDJLDRU
ZHDNQHVVWKDWVHYHUHO\OLPLWVPRELOLW\FRQYHUWWRPJNJGD\
RUDOSUHGQLVRQHRUHTXLYDOHQWXSRQLPSURYHPHQW
x ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
x ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHU
tPRQWK
D $WH]ROL]XPDEPD\EHZLWKKHOGIRUDORQJHUSHULRGRIWLPHie!ZHHNVDIWHUHYHQW
RQVHWWRDOORZIRUFRUWLFRVWHURLGVLILQLWLDWHGWREHUHGXFHGWRWKHHTXLYDOHQWRI
dPJGD\RUDOSUHGQLVRQH7KHDFFHSWDEOHOHQJWKRIWKHH[WHQGHGSHULRGRIWLPHPXVWEH
DJUHHGXSRQE\WKHLQYHVWLJDWRUDQGWKH0HGLFDO0RQLWRU
E ,IFRUWLFRVWHURLGVKDYHEHHQLQLWLDWHGWKH\PXVWEHWDSHUHGRYHUtPRQWKWRWKHHTXLYDOHQW
RIdPJGD\RUDOSUHGQLVRQHEHIRUHDWH]ROL]XPDEFDQEHUHVXPHG

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
x
+HPRSKDJRF\WLF/\PSKRKLVWLRF\WRVLVDQG0DFURSKDJH$FWLYDWLRQ6\QGURPH

,PPXQHPHGLDWHGUHDFWLRQVPD\LQYROYHDQ\RUJDQV\VWHPDQGPD\OHDGWRKHPRSKDJRF\WLF
O\PSKRKLVWLRF\WRVLV+/+DQGPDFURSKDJHDFWLYDWLRQV\QGURPH0$6

3DWLHQWVZLWKVXVSHFWHG+/+VKRXOGEHGLDJQRVHGDFFRUGLQJWRSXEOLVKHGFULWHULDE\0F&ODLQ
DQG(FNVWHLQ$SDWLHQWVKRXOGEHFODVVLILHGDVKDYLQJ+/+LIILYHRIWKHIROORZLQJHLJKW
FULWHULDDUHPHW

Ɣ
)HYHU&
Ɣ
6SOHQRPHJDO\
Ɣ
3HULSKHUDOEORRGF\WRSHQLDFRQVLVWLQJRIDWOHDVWWZRRIWKHIROORZLQJ
±
+HPRJORELQJ/JG/J/>JG/@IRULQIDQWVZHHNVROG
±
3ODWHOHWFRXQWî/PF/
±
$1&î/PF/
Ɣ
)DVWLQJWULJO\FHULGHV!PPRO/PJG/DQGRUILEULQRJHQJ/
PJG/
Ɣ
+HPRSKDJRF\WRVLVLQERQHPDUURZVSOHHQO\PSKQRGHRUOLYHU
Ɣ
/RZRUDEVHQWQDWXUDONLOOHUFHOODFWLYLW\
Ɣ
)HUULWLQ!PJ/QJP/
Ɣ
6ROXEOHLQWHUOHXNLQ,/UHFHSWRUVROXEOH&'HOHYDWHGVWDQGDUG
GHYLDWLRQVDERYHDJHDGMXVWHGODERUDWRU\VSHFLILFQRUPV

3DWLHQWVZLWKVXVSHFWHG0$6VKRXOGEHGLDJQRVHGDFFRUGLQJWRSXEOLVKHGFULWHULDIRUV\VWHPLF
MXYHQLOHLGLRSDWKLFDUWKULWLVE\5DYHOOLet al$IHEULOHSDWLHQWVKRXOGEHFODVVLILHGDV
KDYLQJ0$6LIWKHIROORZLQJFULWHULDDUHPHW
Ɣ
)HUULWLQ!PJ/QJP/
Ɣ
$WOHDVWWZRRIWKHIROORZLQJ
±
3ODWHOHWFRXQWî/PF/
±
$678/
±
7ULJO\FHULGHV!PPRO/PJG/
±
)LEULQRJHQJ/PJG/

3DWLHQWVZLWKVXVSHFWHG+/+RU0$6VKRXOGEHWUHDWHGDFFRUGLQJWRWKHJXLGHOLQHVEHORZ

(YHQW
0DQDJHPHQW
6XVSHFWHG+/+
RU0$6
Ɣ 3HUPDQHQWO\GLVFRQWLQXHDWH]ROL]XPDEDQGFRQWDFW0HGLFDO
0RQLWRU
Ɣ &RQVLGHUSDWLHQWUHIHUUDOWRKHPDWRORJLVW
Ɣ ,QLWLDWHVXSSRUWLYHFDUHLQFOXGLQJLQWHQVLYHFDUHPRQLWRULQJLI
LQGLFDWHGSHULQVWLWXWLRQDOJXLGHOLQHV
Ɣ &RQVLGHULQLWLDWLRQRI,9FRUWLFRVWHURLGVDQGRUDQ
LPPXQRVXSSUHVVLYHDJHQW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
(YHQW
0DQDJHPHQW
Ɣ ,IHYHQWGRHVQRWLPSURYHZLWKLQKRXUVDIWHULQLWLDWLQJ
FRUWLFRVWHURLGVFRQVLGHUDGGLQJDQLPPXQRVXSSUHVVLYHDJHQW
Ɣ ,IHYHQWUHVROYHVWR*UDGHRUEHWWHUWDSHUFRUWLFRVWHURLGVRYHU
PRQWK
+/+ KHPRSKDJRF\WLFO\PSKRKLVWLRF\WRVLV0$6 PDFURSKDJHDFWLYDWLRQV\QGURPH

'RVH0RGLILFDWLRQV'XULQJ&RQFXUUHQW&KHPRUDGLRWKHUDS\:LWK&LVSODWLQDQG
(WRSRVLGH
3OHDVHQRWHWKDWLQVWLWXWLRQVDUHSHUPLWWHGWRIROORZWKHLUORFDOLQVWLWXWLRQDOVWDQGDUGVIRUGRVH
PRGLILFDWLRQVDVVWDQGDUGRIFDUHDQGLQDFFRUGDQFHZLWKSDFNDJHLQVHUWJXLGHOLQHVIRUWKHVH
DJHQWV

,IFLVSODWLQRUHWRSRVLGHGRVHVDUHUHGXFHGDOOIXWXUHGRVHVDUHUHGXFHG

'RVH0RGLILFDWLRQVIRU'XULQJ&RQFXUUHQW&KHPRUDGLRWKHUDS\:LWK&DUERSODWLQ
DQG(WRSRVLGH
3OHDVHQRWHWKDWLQVWLWXWLRQVDUHSHUPLWWHGWRIROORZWKHLUORFDOLQVWLWXWLRQDOVWDQGDUGVIRU
GRVHPRGLILFDWLRQVDVVWDQGDUGRIFDUHDQGLQDFFRUGDQFHZLWKSDFNDJHLQVHUWJXLGHOLQHV
IRUWKHVHDJHQWV

,IFDUERSODWLQRUHWRSRVLGHGRVHVDUHUHGXFHGDOOIXWXUHGRVHVDUHUHGXFHG

 $'9(56((9(1765(3257,1*5(48,5(0(176
3URWRFRO$JHQWV
,QYHVWLJDWLRQDO$JHQWV
7KHLQYHVWLJDWLRQDODJHQWDGPLQLVWHUHGLQ15*/8DWH]ROL]XPDE16&
03'/$LVEHLQJPDGHDYDLODEOHXQGHUDQ,1'VSRQVRUHGE\'&7'1&,)RU
DWH]ROL]XPDEGHWHUPLQDWLRQRIZKHWKHUDQDGYHUVHHYHQWPHHWVH[SHGLWHGUHSRUWLQJ
FULWHULDVHHWKHUHSRUWLQJWDEOHLQ6HFWLRQ$UPRIWKHSURWRFRO
&RPPHUFLDO$JHQWV
7KHFRPPHUFLDODJHQWVLQ15*/8DUHFLVSODWLQHWRSRVLGHDQGFDUERSODWLQ


$GYHUVH(YHQWVDQG6HULRXV$GYHUVH(YHQWV
7KLVVWXG\ZLOOXWLOL]HWKH1&,&RPPRQ7HUPLQRORJ\&ULWHULDIRU$GYHUVH(YHQWV
&7&$(YHUVLRQIRU&7(3$(56&7(3$GYHUVH(YHQW5HSRUWLQJ6\VWHP&$(5V
UHSRUWLQJRIDGYHUVHHYHQWV$(VORFDWHGRQWKH&7(3ZHEVLWH
KWWSFWHSFDQFHUJRYSURWRFRO'HYHORSPHQWHOHFWURQLFBDSSOLFDWLRQVFWFKWP$OO
DSSURSULDWHWUHDWPHQWDUHDVVKRXOGKDYHDFFHVVWRDFRS\RIWKH&7&$(YHUVLRQ

352&7&$(LVQRWLQWHQGHGIRUH[SHGLWHGUHSRUWLQJUHDOWLPHUHYLHZRUVDIHW\
UHSRUWLQJ

 'HILQLWLRQRIDQ$GYHUVH(YHQW$(
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$Q\XQWRZDUGPHGLFDORFFXUUHQFHDVVRFLDWHGZLWKWKHXVHRIDGUXJLQKXPDQVZKHWKHU
RUQRWFRQVLGHUHGGUXJUHODWHG7KHUHIRUHDQ$(FDQEHDQ\XQIDYRUDEOHDQGXQLQWHQGHG
VLJQLQFOXGLQJDQDEQRUPDOODERUDWRU\ILQGLQJV\PSWRPRUGLVHDVHWHPSRUDOO\
DVVRFLDWHGZLWKWKHXVHRIDPHGLFLQDOLQYHVWLJDWLRQDOSURGXFWZKHWKHURUQRW
FRQVLGHUHGUHODWHGWRWKHPHGLFLQDOLQYHVWLJDWLRQDOSURGXFWDWWULEXWLRQRIXQUHODWHG
XQOLNHO\SRVVLEOHSUREDEOHRUGHILQLWH,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQLVDWLRQ
>,&+@($(

)RUPXOWLPRGDOLW\WULDOVDGYHUVHHYHQWUHSRUWLQJHQFRPSDVVHVDOODVSHFWVRISURWRFRO
WUHDWPHQWLQFOXGLQJUDGLDWLRQWKHUDS\VXUJHU\GHYLFHDQGGUXJ

'XHWRWKHULVNRILQWUDXWHULQHH[SRVXUHRIDIHWXVWRSRWHQWLDOO\WHUDWRJHQLFDJHQWVWKH
SUHJQDQF\RIDVWXG\SDUWLFLSDQWPXVWEHUHSRUWHGYLD&7(3$(56LQDQH[SHGLWHG
PDQQHU

&OLQLFLDQJUDGHG&7&$(LVWKH$(DGYHUVHHYHQWVDIHW\VWDQGDUG352&7&$(LWHPV
DUHWRFRPSOHPHQW&7&$(UHSRUWLQJ3DWLHQWVZLOOUHVSRQGWR352&7&$(LWHPVEXW
QRGLUHFWHGDFWLRQZLOOEHWDNHQ3DWLHQWUHVSRQVHVWRWKH352&7&$(PD\OHDGWR
DGGLWLRQDODVVHVVPHQWE\WKHFOLQLFLDQWKHUHVSRQVHVVKRXOGEHUHYLHZHG7KHVSHFLILF
352&7&$(LWHPVIRUWKLVSURWRFROFDQEHIRXQGRQWKHIRUPVVHFWLRQRIWKH&768
SURWRFROZHESDJHDQGLVWLWOHG³15*/81&,352&7&$(,WHP/LEUDU\´352
&7&$(LVQRWLQWHQGHGIRUH[SHGLWHGUHSRUWLQJUHDOWLPHUHYLHZRUVDIHW\UHSRUWLQJ
352&7&$(GDWDDUHH[SORUDWRU\DQGQRWFXUUHQWO\LQWHQGHGIRUXVHLQGDWDVDIHW\
PRQLWRULQJRUDGYHUVHHYHQWVWRSSLQJUXOHV
127(  352&7&$( GDWD VKRXOG QRW EH XVHG IRU GHWHUPLQLQJ GRVH GHOD\V RU GRVH
PRGLILFDWLRQVRUDQ\RWKHUSURWRFROGLUHFWHGDFWLRQ352&7&$(PD\OHDGWRDGGLWLRQDO
HYDOXDWLRQE\WKHFOLQLFLDQWKHLUUHVSRQVHVKRXOGQRWEHRYHUORRNHG


&RPSUHKHQVLYH$GYHUVH(YHQWVDQG3RWHQWLDO5LVNV&$(35/LVWIRU
,QYHVWLJDWLRQDO6WXG\$JHQW$WH]ROL]XPDE03'/$2&7

)RUDWH]ROL]XPDEH[SHFWHGQHVVRIDGYHUVHHYHQWVLVEDVHGRQWKHFXUUHQW1&,6SHFLILF
3URWRFRO([FHSWLRQVWR([SHGLWHG5HSRUWLQJ63((5

&RPSUHKHQVLYH$GYHUVH(YHQWVDQG3RWHQWLDO5LVNVOLVW&$(35
IRU
$WH]ROL]XPDE03'/$16&

7KH&RPSUHKHQVLYH$GYHUVH(YHQWVDQG3RWHQWLDO5LVNVOLVW&$(35SURYLGHVDVLQJOH
OLVWRIUHSRUWHGDQGRUSRWHQWLDODGYHUVHHYHQWV$(DVVRFLDWHGZLWKDQDJHQWXVLQJD
XQLIRUPSUHVHQWDWLRQRIHYHQWVE\ERG\V\VWHP,QDGGLWLRQWRWKHFRPSUHKHQVLYHOLVWD
VXEVHWWKH6SHFLILF3URWRFRO([FHSWLRQVWR([SHGLWHG5HSRUWLQJ63((5DSSHDUVLQD
VHSDUDWHFROXPQDQGLVLGHQWLILHGZLWKEROGDQGLWDOLFL]HGWH[W7KLVVXEVHWRI$(V
63((5LVDOLVWRIHYHQWVWKDWDUHSURWRFROVSHFLILFH[FHSWLRQVWRH[SHGLWHGUHSRUWLQJWR
1&,H[FHSWDVQRWHGEHORZ5HIHUWRWKH
&7(31&,*XLGHOLQHV$GYHUVH(YHQW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
+(3$72%,/,$5<',625'(563RUWDOYHLQWKURPERVLV
,19(67,*$7,216/\PSKRF\WHFRXQWGHFUHDVHG1HXWURSKLOFRXQWGHFUHDVHG
:HLJKWORVV:KLWHEORRGFHOOGHFUHDVHG
0(7$%2/,60$1'1875,7,21',625'(56+\SRSKRVSKDWHPLD7XPRUO\VLV
V\QGURPH
086&8/26.(/(7$/$1'&211(&7,9(7,668(',625'(56%RQHSDLQ
0XVFOHFUDPS3DLQLQH[WUHPLW\
1(592866<67(0',625'(56+HDGDFKH
36<&+,$75,&',625'(56&RQIXVLRQ,QVRPQLD6XLFLGHDWWHPSW
5(352'8&7,9(6<67(0$1'%5($67',625'(56%UHDVWSDLQ
5(63,5$725<7+25$&,&$1'0(',$67,1$/',625'(56
%URQFKRSXOPRQDU\KHPRUUKDJH3XOPRQDU\K\SHUWHQVLRQ5HVSLUDWRU\IDLOXUH
6.,1$1'68%&87$1(2867,668(',625'(56$ORSHFLD'U\VNLQ
+\SHUKLGURVLV
9$6&8/$5',625'(56+\SHUWHQVLRQ+\SRWHQVLRQ7KURPERHPEROLFHYHQW

1RWH$WH]ROL]XPDE03'/$LQFRPELQDWLRQZLWKRWKHUDJHQWVFRXOGFDXVHDQ
H[DFHUEDWLRQRIDQ\DGYHUVHHYHQWFXUUHQWO\NQRZQWREHFDXVHGE\WKHRWKHUDJHQWRUWKH
FRPELQDWLRQPD\UHVXOWLQHYHQWVQHYHUSUHYLRXVO\DVVRFLDWHGZLWKHLWKHUDJHQW

$GYHUVH(YHQWVRI6SHFLDO,QWHUHVWIRU$WH]ROL]XPDE6(37
$GYHUVHHYHQWVRIVSHFLDOLQWHUHVW$(6,VLQFOXGLQJSRWHQWLDOGUXJLQGXFHGOLYHULQMXU\
DQGVXVSHFWHGWUDQVPLVVLRQRIDQLQIHFWLRXVDJHQWE\WKHVWXG\GUXJPXVWEHUHSRUWHG
H[SHGLWLRXVO\ZLWKLQKRXUVUHJDUGOHVVRIJUDGH5HSRUWDOOLQVWDQFHVRI$(6,VGXULQJ
SURWRFROWUHDWPHQWDQGIRUGD\VIURPODVWGRVHRIDWH]ROL]XPDE

'UXJ,QGXFHG/LYHU,QMXU\
&DVHVRISRWHQWLDOGUXJLQGXFHGOLYHULQMXU\WKDWLQFOXGHDQHOHYDWHG$/7RU$67LQ
FRPELQDWLRQZLWKHLWKHUDQHOHYDWHGELOLUXELQRUFOLQLFDOMDXQGLFHDVGHILQHGE\+\¶VODZ
x 7UHDWPHQWHPHUJHQW$/7RU$67![8/1LQFRPELQDWLRQZLWKWRWDOELOLUXELQ
![8/1
x 7UHDWPHQWHPHUJHQW$/7RU$67![8/1LQFRPELQDWLRQZLWKFOLQLFDO
MDXQGLFH

6XVSHFWHGWUDQVPLVVLRQRIDQLQIHFWLRXVDJHQWE\WKHVWXG\GUXJ
$Q\RUJDQLVPYLUXVRULQIHFWLRXVSDUWLFOHHJSULRQSURWHLQWUDQVPLWWLQJWUDQVPLVVLEOH
VSRQJLIRUPHQFHSKDORSDWK\SDWKRJHQLFRUQRQSDWKRJHQLFLVFRQVLGHUHGDQLQIHFWLRXV
DJHQW$WUDQVPLVVLRQRIDQLQIHFWLRXVDJHQWPD\EHVXVSHFWHGIURPFOLQLFDOV\PSWRPVRU
ODERUDWRU\ILQGLQJVWKDWLQGLFDWHDQLQIHFWLRQLQDSDWLHQWH[SRVHGWRDPHGLFLQDOSURGXFW
7KLVWHUPDSSOLHVRQO\ZKHQDFRQWDPLQDWLRQRIWKHVWXG\GUXJLVVXVSHFWHG

$GGLWLRQDO$GYHUVH(YHQWVRI6SHFLDO,QWHUHVW
x 6\VWHPLFOXSXVHU\WKHPDWRVXV
x (YHQWVVXJJHVWLYHRIK\SHUVHQVLWLYLW\LQIXVLRQUHODWHGUHDFWLRQVF\WRNLQHUHOHDVH
V\QGURPHPDFURSKDJHDFWLYDWLQJV\QGURPHKHPRSKDJRF\WLFO\PSKRKLVWLRF\WRVLV
x 1HSKULWLV
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
x 2FXODUWR[LFLWLHVHJXYHLWLVUHWLQLWLVRSWLFQHXULWLV
x *UDGH   FDUGLDF GLVRUGHUV HJ DWULDO ILEULOODWLRQ P\RFDUGLWLV SHULFDUGLWLV
x 9DVFXOLWLV
x $XWRLPPXQHKHPRO\WLFDQHPLD
x 6HYHUHFXWDQHRXVUHDFWLRQVHJ6WHYHQV-RKQVRQV\QGURPHGHUPDWLWLVEXOORXVWR[LF
HSLGHUPDOQHFURO\VLV

$GYHUVH(YHQWVIRU&LVSODWLQ
5HIHUWRWKHSDFNDJHLQVHUWIRUGHWDLOHGSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ

$GYHUVH(YHQWVIRU&DUERSODWLQ
5HIHUWRWKHSDFNDJHLQVHUWIRUGHWDLOHGSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ

$GYHUVH(YHQWVIRU(WRSRVLGH
5HIHUWRWKHSDFNDJHLQVHUWIRUGHWDLOHGSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ

$GYHUVH(YHQWVDQG352&7&$()(%
352&7&$(
7KH352&7&$(LQVWUXPHQWZLOOEHXVHGWRDVVHVVSDWLHQWUHSRUWHGWR[LFLW\RXWFRPHV

352&7&$(LVDYDOLGDWHGLQVWUXPHQWGHYHORSHGE\WKH1DWLRQDO&DQFHU,QVWLWXWHWRDVVHVV
FOLQLFDOWULDOWR[LFLW\RXWFRPHVE\SDWLHQWUHSRUWLWFRPSOHPHQWVLQIRUPDWLRQFROOHFWHGE\
SK\VLFLDQUHSRUWHG&7&$(352&7&$(LVDYDLODEOHLQ(QJOLVK)UHQFKDQG6SDQLVKIRU
WKLVVWXG\7KH352&7&$(DVVHVVPHQWFDQEHFRPSOHWHGRQSDSHURUXVLQJDQHOHFWURQLF
GHYLFHEXWSDWLHQWVSDUWLFLSDWLQJLQWKHHOHFWURQLFSDWLHQWUHSRUWHGRXWFRPHVDVVHVVPHQW
0HGLGDWD3DWLHQW&ORXGH352ZLOORQO\KDYHWKHRSWLRQWRFRPSOHWHWKH(QJOLVKDQG
6SDQLVKODQJXDJH352&7&$()UHQFKDQG-DSDQHVHODQJXDJH352&7&$(LVQRW
FXUUHQWO\DYDLODEOHRQH352)UHQFKDQG-DSDQHVHVSHDNLQJSDWLHQWVZLOOKDYHWRFRPSOHWH
WKH352&7&$(RQSDSHU

$VVHVVPHQWVZLOOEHFROOHFWHGEHIRUHGXULQJDQGDWWKHHQGRIWUHDWPHQWDQGLQIROORZXS
DVVSHFLILHGLQWKH6HFWLRQDVVHVVPHQWWDEOHV

7KHSDWLHQWUHSRUWHG$(VWKDWZLOOEHDVVHVVHGXVLQJ352&7&$(DUHOLVWHGLQWKHWDEOH
EHORZ7KHVHDGYHUVHHYHQWVDUHFRQVLGHUHGH[SHFWHGDQGLIUHSRUWHGVKRXOGDOVREH
FOLQLFLDQJUDGHGXVLQJWKH&7&$(Y
&7&$(Y
352&7&$(,WHPV:LWK$WWULEXWHV
(VRSKDJLWLV
'\VSKDJLD
'LIILFXOW\VZDOORZLQJ6HYHULW\
$QRUH[LD
'HFUHDVHGDSSHWLWH6HYHULW\
1DXVHD
1DXVHD6HYHULW\
9RPLWLQJ
9RPLWLQJ6HYHULW\
&RQVWLSDWLRQ
&RQVWLSDWLRQ6HYHULW\
&ROLWLV
'LDUUKHD)UHTXHQF\
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
'LDUUKHD
'\VSQHD
6KRUWQHVVRIEUHDWK6HYHULW\	,QWHUIHUHQFH
&RXJK
&RXJK6HYHULW\
3DOSLWDWLRQV
+HDUWSDOSLWDWLRQV6HYHULW\
5DVKDFQHLIRUP
5DVKPDFXORSDSXODU
5DVK3UHVHQFH
3UXULWXV
,WFKLQJ6HYHULW\
'HUPDWLWLVUDGLDWLRQ
5DGLDWLRQVNLQUHDFWLRQ6HYHULW\
3HULSKHUDOVHQVRU\QHXURSDWK\
1XPEQHVV	WLQJOLQJ6HYHULW\
'L]]LQHVV
'L]]LQHVV6HYHULW\
%OXUUHGYLVLRQ
%OXUUHGYLVLRQ6HYHULW\
7LQQLWXV
5LQJLQJLQHDUV6HYHULW\
&RQFHQWUDWLRQLPSDLUPHQW
&RQFHQWUDWLRQ6HYHULW\
0HPRU\,PSDLUPHQW
0HPRU\6HYHULW\
+HDGDFKH
+HDGDFKH6HYHULW\
)DWLJXH
)DWLJXH6HYHULW\
,QVRPQLD
,QVRPQLD6HYHULW\

([SHGLWHG5HSRUWLQJRI$GYHUVH(YHQWV
$OODGYHUVHHYHQWV$(VDUHVXEPLWWHGIRUH[SHGLWHGUHSRUWLQJSURWRFROVSHFLILFUXOHV
HYDOXDWLRQXVLQJWKH0HGLGDWD5DYHGDWDPDQDJHPHQWV\VWHP$OO$(VZLOOEHHYDOXDWHG
E\WKH&DQFHU7KHUDS\(YDOXDWLRQ3URJUDP$GYHUVH(YHQW5HSRUWLQJ6\VWHP&7(3
$(56WRGHWHUPLQHZKHWKHUH[SHGLWHGUHSRUWLQJLVUHFRPPHQGHGEDVHGRQDVHWRI
SURJUDPPHGH[SHGLWHGUHSRUWLQJUXOHV$(VLGHQWLILHGDVPHHWLQJWKHSURJUDPPHG
H[SHGLWHGUHSRUWLQJUHTXLUHPHQWVFDQWKHQEHVXEPLWWHGLQ&7(3$(56$GHHSOLQNLQ
5DYHZLOOWDNHWKHXVHUGLUHFWO\WR&7(3$(56ZKHUHWKHH[SHGLWHGUHSRUWPD\EH
FRPSOHWHGDQGVXEPLWWHGYLD&7(3$(56

$OOVHULRXVDGYHUVHHYHQWVWKDWPHHWH[SHGLWHGUHSRUWLQJFULWHULDGHILQHGLQWKHUHSRUWLQJ
WDEOHEHORZZLOOEHUHSRUWHGYLDWKH&7(3$GYHUVH(YHQW5HSRUWLQJ6\VWHP&7(3
$(56DFFHVVHGYLDWKHOLQNLQ5$9(&7(3$(56LVDOVRDFFHVVHGYLDWKH&7(3ZHE
VLWHEXWDOOH[SHGLWHGUHSRUWVPXVWEHLQLWLDWHGLQ5$9(
KWWSVHDSSVFWHSQFLQLKJRYFWHSDHUVSDJHVWDVN"UDQG 

,QWKHUDUHHYHQWZKHQ,QWHUQHWFRQQHFWLYLW\LVGLVUXSWHGDKRXUQRWLILFDWLRQPXVWEH
PDGHWR&7(3E\WHOHSKRQHDWDQG15*2QFRORJ\E\SKRQHDW
$QHOHFWURQLFUHSRUWPXVWEHVXEPLWWHGLPPHGLDWHO\XSRQUHHVWDEOLVKPHQWRI
WKH,QWHUQHWFRQQHFWLRQ

 ([SHGLWHG5HSRUWLQJ0HWKRGV
x 3HU&7(31&,*XLGHOLQHVIRU$GYHUVH(YHQWV5HSRUWLQJD&7(3$(56KRXU
QRWLILFDWLRQPXVWEHVXEPLWWHGZLWKLQKRXUVRIOHDUQLQJRIWKHDGYHUVHHYHQW(DFK
&7(3$(56+RXU1RWLILFDWLRQPXVWEHIROORZHGE\DFRPSOHWHUHSRUWZLWKLQ
GD\V
x 6XSSRUWLQJVRXUFHGRFXPHQWDWLRQLVUHTXHVWHGE\&7(3DVWKH,1'VSRQVRUIRUWKLV
VWXG\DQG15*DVQHHGHGWRFRPSOHWHDGYHUVHHYHQWUHYLHZ6XSSRUWLQJVRXUFH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
([SHGLWHG$(UHSRUWLQJWLPHOLQHVDUHGHILQHGDV
o³+RXU&DOHQGDU'D\V´7KH$(PXVWLQLWLDOO\EHUHSRUWHGYLD&7(3$(56ZLWKLQKRXUVRIOHDUQLQJRI
WKH$(IROORZHGE\DFRPSOHWHH[SHGLWHGUHSRUWZLWKLQFDOHQGDUGD\VRIWKHLQLWLDOKRXUUHSRUW
o ³&DOHQGDU'D\V´$FRPSOHWHH[SHGLWHGUHSRUWRQWKH$(PXVWEHVXEPLWWHGZLWKLQFDOHQGDUGD\VRI
OHDUQLQJRIWKH$(
6HULRXVDGYHUVHHYHQWVWKDWRFFXUPRUHWKDQGD\VDIWHUWKHODVWDGPLQLVWUDWLRQRILQYHVWLJDWLRQDODJHQWLQWHUYHQWLRQ
DQGKDYHDQDWWULEXWLRQRISRVVLEOHSUREDEOHRUGHILQLWHUHTXLUHUHSRUWLQJDVIROORZV
([SHGLWHGKRXUQRWLILFDWLRQIROORZHGE\FRPSOHWHUHSRUWZLWKLQFDOHQGDUGD\VIRU
x
8QH[SHFWHG*UDGHDQGDOO*UDGH$(V


&OLQLFLDQJUDGHG&7&$(LVWKH$(VDIHW\VWDQGDUG352&7&$(LWHPVDUHWRFRPSOHPHQW
&7&$(UHSRUWLQJ3DWLHQWVZLOOUHVSRQGWR352&7&$(LWHPVEXWQRSURWRFROGLUHFWHG
DFWLRQZLOOEHWDNHQ7KHVWXG\VSHFLILF352&7&$(LWHPVIRUWKLVSURWRFROFDQEHIRXQG
RQWKHIRUPVVHFWLRQRIWKH&768SURWRFROZHESDJHDQGLVWLWOHG³15*/81&,352
&7&$(,WHP/LEUDU\´
 5HSRUWLQJWRWKH6LWH,5%5(%
,QYHVWLJDWRUVZLOOUHSRUWVHULRXVDGYHUVHHYHQWVWRWKHORFDO,QVWLWXWLRQDO5HYLHZ%RDUG
,5%RU5HVHDUFK(WKLFV%RDUG5(%UHVSRQVLEOHIRURYHUVLJKWRIWKHSDWLHQWDFFRUGLQJ
WRLQVWLWXWLRQDOSROLF\
 6HFRQGDU\0DOLJQDQF\2&7
$VHFRQGDU\PDOLJQDQF\LVDFDQFHUFDXVHGE\WUHDWPHQWIRUDSUHYLRXVPDOLJQDQF\HJ
WUHDWPHQWZLWKLQYHVWLJDWLRQDODJHQWLQWHUYHQWLRQUDGLDWLRQRUFKHPRWKHUDS\$
VHFRQGDU\PDOLJQDQF\LVQRWFRQVLGHUHGDPHWDVWDVLVRIWKHLQLWLDOQHRSODVP

&7(3UHTXLUHVDOOVHFRQGDU\PDOLJQDQFLHVWKDWRFFXUGXULQJRUVXEVHTXHQWWR WUHDWPHQW
ZLWKDQDJHQWXQGHUDQ1&,,1','(EHUHSRUWHGYLD&7(3$(56.,QDGGLWLRQ
VHFRQGDU\PDOLJQDQFLHVIROORZLQJUDGLDWLRQWKHUDS\PXVWEHUHSRUWHGYLD&7(3$(56
7KUHHRSWLRQVDUHDYDLODEOHWRGHVFULEHWKHHYHQW
x
/HXNHPLDVHFRQGDU\WRRQFRORJ\FKHPRWKHUDS\HJDFXWHP\HORF\WLFOHXNHPLD
>$0/@
x
0\HORG\VSODVWLFV\QGURPH0'6
x
7UHDWPHQWUHODWHGVHFRQGDU\PDOLJQDQF\
$Q\PDOLJQDQF\SRVVLEO\UHODWHGWRFDQFHUWUHDWPHQWLQFOXGLQJ$0/0'6VKRXOGDOVR
EHUHSRUWHGYLDWKHURXWLQHUHSRUWLQJPHFKDQLVPVRXWOLQHGLQHDFKSURWRFRO

6HFRQG0DOLJQDQF\
$VHFRQGPDOLJQDQF\LVRQHXQUHODWHGWRWKHWUHDWPHQWRIDSULRUPDOLJQDQF\DQGLV127
DPHWDVWDVLVIURPWKHLQLWLDOPDOLJQDQF\6HFRQGPDOLJQDQFLHVUHTXLUH21/<URXWLQH
$(UHSRUWLQJXQOHVVRWKHUZLVHVSHFLILHG


5RXWLQH5HSRUWLQJ5HTXLUHPHQWVIRU$GYHUVH(YHQWV2&7
$UPDWH]ROL]XPDE$(5HSRUWLQJ5HTXLUHPHQWV
x 5HSRUWDOODGYHUVHHYHQWVUHJDUGOHVVRIUHODWLRQVKLSWRSURWRFROWUHDWPHQWVWDUWLQJ
DWLQLWLDWLRQRISURWRFROWUHDWPHQW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
x 5HSRUWDOORWKHU$(VIRUGD\VDIWHUHQGRIWUHDWPHQWUHJDUGOHVVRIUHODWLRQVKLS
WRSURWRFROWUHDWPHQWWKHQRQO\UHSRUW$(VUHDVRQDEO\UHODWHGWRSURWRFRO
WUHDWPHQW

$UP$(5HSRUWLQJ5HTXLUHPHQWVUHSRUWDOODGYHUVHHYHQWVUHJDUGOHVVRI
UHODWLRQVKLSWRSURWRFROWUHDWPHQWVWDUWLQJDWLQLWLDWLRQRISURWRFROWUHDWPHQWDQGIRU
GD\VDIWHUHQGRIWUHDWPHQWWKHQRQO\UHSRUW$(VUHDVRQDEO\UHODWHGWRSURWRFRO
WUHDWPHQW

$OO$GYHUVH(YHQWVPXVWEHUHSRUWHGLQURXWLQHVWXG\GDWDVXEPLVVLRQV

 5HSRUWLQJ352&7&$(
6\PSWRPDWLF$GYHUVH(YHQWVUHSRUWHGE\SDWLHQWVWKURXJK352&7&$(DUHQRWVDIHW\
UHSRUWLQJDQGVKRXOGDOVREHFOLQLFLDQJUDGHGXVLQJWKH&7&$(YDQGUHSRUWHGDV
URXWLQH$(GDWD


3UHJQDQF\129
$OWKRXJKQRWDQDGYHUVHHYHQWLQDQGRILWVHOISUHJQDQF\DVZHOODVLWVRXWFRPHPXVWEH
GRFXPHQWHGYLD&7(3$(56,QDGGLWLRQWKHPregnancy Information FormLQFOXGHG
ZLWKLQWKH1&,*XLGHOLQHVIRU$GYHUVH(YHQW5HSRUWLQJ5HTXLUHPHQWVPXVWEH
FRPSOHWHGDQGVXEPLWWHGWR&7(3$Q\SUHJQDQF\RFFXUULQJLQDSDWLHQWRUSDWLHQW¶V
SDUWQHUIURPWKHWLPHRIFRQVHQWWRPRQWKVDIWHUWKHODVWGRVHRIVWXG\GUXJPXVWEH
UHSRUWHGDQGWKHQIROORZHGIRURXWFRPH1HZERUQLQIDQWVVKRXOGEHIROORZHGXQWLO
GD\VROG3OHDVHVHHWKH³1&,*XLGHOLQHVIRU,QYHVWLJDWRUV$GYHUVH(YHQW5HSRUWLQJ
5HTXLUHPHQWVIRU'&7'&7(3DQG&,3DQG'&3,1'VDQG,'(V´DW
KWWSFWHSFDQFHUJRYSURWRFRO'HYHORSPHQWDGYHUVHBHIIHFWVKWPIRUPRUHGHWDLOVRQ
KRZWRUHSRUWSUHJQDQF\DQGLWVRXWFRPHWR&7(3

5(*,675$7,21$1'678'<(175<352&('85(6-8/
)RRGDQG'UXJ$GPLQLVWUDWLRQ)'$UHJXODWLRQVUHTXLUHVSRQVRUVWRVHOHFWTXDOLILHG
LQYHVWLJDWRUV1DWLRQDO&DQFHU,QVWLWXWH1&,SROLF\UHTXLUHVDOOLQGLYLGXDOVFRQWULEXWLQJ
WR1&,VSRQVRUHGWULDOVWRUHJLVWHUZLWKWKHLUTXDOLILFDWLRQVDQGFUHGHQWLDOVDQGWRUHQHZ
WKHLUUHJLVWUDWLRQDQQXDOO\7RUHJLVWHUDOOLQGLYLGXDOVPXVWREWDLQ&DQFHU7KHUDS\
(YDOXDWLRQ3URJUDP&7(3FUHGHQWLDOVQHFHVVDU\WRDFFHVVVHFXUH1&,&OLQLFDO
2QFRORJ\5HVHDUFK(QWHUSULVH&25(V\VWHPV,QYHVWLJDWRUVDQGFOLQLFDOVLWHVWDIIZKR
DUHVLJQLILFDQWFRQWULEXWRUVWRUHVHDUFKPXVWUHJLVWHULQWKH5HJLVWUDWLRQDQG&UHGHQWLDO
5HSRVLWRU\5&57KH5&5LVDVHOIVHUYLFHRQOLQHSHUVRQUHJLVWUDWLRQDSSOLFDWLRQZLWK
HOHFWURQLFVLJQDWXUHDQGGRFXPHQWVXEPLVVLRQFDSDELOLW\
5&5XWLOL]HVILYHSHUVRQUHJLVWUDWLRQW\SHV
x ,QYHVWLJDWRU,95²0''2RULQWHUQDWLRQDOHTXLYDOHQW
x 1RQ3K\VLFLDQ,QYHVWLJDWRU13,95²DGYDQFHGSUDFWLFHSURYLGHUVHJ13RU3$
RUJUDGXDWHOHYHOUHVHDUFKHUVHJ3K'
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
,5%$SSURYDO
$VRI0DUFKDOO86EDVHGVLWHVPXVWEHPHPEHUVRIWKH1&,&HQWUDO
,QVWLWXWLRQDO5HYLHZ%RDUG1&,&,5%LQRUGHUWRSDUWLFLSDWHLQ&DQFHU7KHUDS\
(YDOXDWLRQ3URJUDP&7(3DQG'LYLVLRQRI&DQFHU3UHYHQWLRQ'&3VWXGLHVRSHQWR
WKH1DWLRQDO&OLQLFDO7ULDOV1HWZRUN1&71DQG1&,&RPPXQLW\2QFRORJ\5HVHDUFK
3URJUDP1&2535HVHDUFK%DVHV,QDGGLWLRQ86EDVHGVLWHVPXVWDFFHSWWKH1&,
&,5%UHYLHZWRDFWLYDWHQHZVWXGLHVDWWKHVLWHDIWHU0DUFK/RFDO,5%UHYLHZ
ZLOOFRQWLQXHWREHDFFHSWHGIRUVWXGLHVWKDWDUHQRWUHYLHZHGE\WKH&,5%RULIWKHVWXG\
ZDVSUHYLRXVO\RSHQDWWKHVLWHXQGHUWKHORFDO,5%,QWHUQDWLRQDOVLWHVVKRXOGFRQWLQXHWR
VXEPLW5HVHDUFK(WKLFV%RDUG5(%DSSURYDOWRWKH&7685HJXODWRU\2IILFHIROORZLQJ
FRXQWU\VSHFLILFUHJXODWLRQV
6LWHVSDUWLFLSDWLQJWKURXJKWKH1&,&,5%PXVWVXEPLWWKH6WXG\6SHFLILF:RUNVKHHW
66:IRU/RFDO&RQWH[WWRWKH&,5%XVLQJ,5%0DQDJHUWRLQGLFDWHWKHLULQWHQWWRRSHQ
WKHVWXG\ORFDOO\7KH1&,&,5%¶VDSSURYDORIWKH66:LVDXWRPDWLFDOO\FRPPXQLFDWHG
WRWKH&7685HJXODWRU\2IILFHEXWVLWHVDUHUHTXLUHGWRFRQWDFWWKH&7685HJXODWRU\
2IILFHDW&7685HJ3UHI#FWVXFRFFJRUJWRHVWDEOLVKVLWHSUHIHUHQFHVIRUDSSO\LQJ1&,
&,5%DSSURYDOVDFURVVWKHLU6LJQDWRU\1HWZRUN6LWHSUHIHUHQFHVFDQEHVHWDWWKH
QHWZRUNRUSURWRFROOHYHO4XHVWLRQVDERXWHVWDEOLVKLQJVLWHSUHIHUHQFHVFDQEHDGGUHVVHG
WRWKH&7685HJXODWRU\2IILFHE\HPDLO&7685HJ3UHI#FWVXFRFFJRUJRUE\FDOOLQJ
&768
6LWHVXVLQJWKHLUORFDO,5%RU5(%PXVWVXEPLWWKHLUDSSURYDOWRWKH&7685HJXODWRU\
2IILFHXVLQJWKH5HJXODWRU\6XEPLVVLRQ3RUWDOORFDWHGLQWKH5HJXODWRU\VHFWLRQRIWKH
&768ZHEVLWH$FFHSWDEOHGRFXPHQWDWLRQRIORFDO,5%5(%DSSURYDOLQFOXGHV
x /RFDO,5%GRFXPHQWDWLRQ
x ,5%VLJQHG&768,5%&HUWLILFDWLRQ)RUPDQGRU
x 3URWRFRORI+XPDQ6XEMHFWV$VVXUDQFH,GHQWLILFDWLRQ,5%
&HUWLILFDWLRQ'HFODUDWLRQRI([HPSWLRQ)RUP
,QDGGLWLRQWKH6LWH3URWRFRO3ULQFLSDO,QYHVWLJDWRU3,LHWKHLQYHVWLJDWRURQWKH
,5%5(%DSSURYDOPXVWPHHWWKHIROORZLQJFULWHULDIRUWKHVLWHWREHDEOHWRKDYHDQ
$SSURYHGVWDWXVIROORZLQJSURFHVVLQJRIWKH,5%5(%DSSURYDOUHFRUG
x +DYHDQDFWLYH&7(3VWDWXV
x +DYHDQDFWLYHVWDWXVDWWKHVLWHVRQWKH,5%5(%DSSURYDORQDWOHDVWRQH
SDUWLFLSDWLQJRUJDQL]DWLRQ¶VURVWHU
x ,IXVLQJ1&,&,5%EHDFWLYHRQWKH1&,&,5%URVWHUXQGHUWKHDSSOLFDEOH&,5%
6LJQDWRU\,QVWLWXWLRQVUHFRUG
x ,QFOXGHWKH,5%QXPEHURIWKH,5%SURYLGLQJDSSURYDOLQWKH)RUP)'$LQ
WKH5&5SURILOH
x /LVWDOOVLWHVRQWKH,5%5(%DSSURYDODV3UDFWLFH6LWHVLQWKH)RUP)'$LQ
WKH5&5SURILOHDQG
x +DYHWKHDSSURSULDWH&7(3UHJLVWUDWLRQW\SHIRUWKHSURWRFRO

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$GGLWLRQDO5HTXLUHPHQWV
$GGLWLRQDOVLWHUHTXLUHPHQWVWRREWDLQDQDSSURYHGVLWHUHJLVWUDWLRQVWDWXVLQFOXGH
x $QDFWLYH)HGHUDO:LGH$VVXUDQFH):$QXPEHU
x $QDFWLYHURVWHUDIILOLDWLRQZLWKWKH/HDG3URWRFRO2UJDQL]DWLRQ/32RUD
3DUWLFLSDWLQJ2UJDQL]DWLRQ32
x $QDFWLYHURVWHUDIILOLDWLRQZLWKWKH1&,&,5%URVWHUXQGHUDWOHDVWRQH&,5%
6LJQDWRU\,QVWLWXWLRQ86VLWHVRQO\
x 'HOHJDWLRQDQG7DVN/RJ'7/
x &RPSOLDQFHZLWKDOODSSOLFDEOHSURWRFROVSHFLILFUHTXLUHPHQWV365V

57,3URYLGHU
7KLVLVDVWXG\ZLWKDUDGLDWLRQDQGRULPDJLQJ57,FRPSRQHQWDQGWKHHQUROOLQJVLWH
PXVWEHDOLJQHGWRDQ57,SURYLGHU7RPDQDJHSURYLGHUDVVRFLDWLRQVDFFHVVWKH3URYLGHU
$VVRFLDWLRQSDJHIURPWKH5HJXODWRU\VHFWLRQRQWKH&768PHPEHUV¶ZHEVLWHDW
KWWSVZZZFWVXRUJ56657)3URYLGHU$VVRFLDWLRQ6LWHVPXVWEHOLQNHGWRDWOHDVWRQH
,PDJLQJDQG5DGLDWLRQ2QFRORJ\&RUH,52&SURYLGHUWRSDUWLFLSDWHRQWULDOVZLWKDQ
57,FRPSRQHQW(QUROOLQJVLWHVDUHUHVSRQVLEOHIRUHQVXULQJWKDWWKHDSSURSULDWH
DJUHHPHQWVDQG,5%DSSURYDOVDUHLQSODFHZLWKWKHLU57,SURYLGHU2QO\DQLQGLYLGXDO
ZLWKDSULPDU\UROHRQDWUHDWLQJVLWHURVWHUFDQXSGDWHWKHSURYLGHUDVVRFLDWLRQVWKRXJK
DOOLQGLYLGXDOVDWDVLWHPD\YLHZSURYLGHUDVVRFLDWLRQV7RILQGZKRKROGVSULPDU\UROHV
DW\RXUVLWHYLHZWKH3HUVRQ5RVWHU%URZVHUXQGHUWKH5806VHFWLRQRQWKH&768
PHPEHUV¶ZHEVLWH
,52&&UHGHQWLDOLQJ6WDWXV,QTXLU\&6,)RUP±WKLVIRUPLVVXEPLWWHGWR,52&+RXVWRQ
WRYHULI\FUHGHQWLDOLQJVWDWXVRUWREHJLQDQHZPRGDOLW\FUHGHQWLDOLQJSURFHVV
7RFRPSOHWHSURWRFROVSHFLILFFUHGHQWLDOLQJWKH57,SURYLGHURUHQUROOLQJVLWHVKRXOG
IROORZLQVWUXFWLRQVLQWKHSURWRFROWRVXEPLWGRFXPHQWDWLRQRURWKHUPDWHULDOVWRWKH
GHVLJQDWHG,52&4XDOLW\$VVXUDQFH4$FHQWHU8SRQWKH,52&4$FHQWHUDSSURYLQJ
WKH57,SURYLGHUIRUWKHVWXG\PRGDOLW\,52&ZLOODXWRPDWLFDOO\VHQGWKHDSSURYDOWR
WKH5HJXODWRU\DQG5RVWHU0DLQWHQDQFHDSSOLFDWLRQVWRFRPSO\ZLWKWKHSURWRFROVSHFLILF
UHTXLUHPHQWXQOHVVRWKHUZLVHQRWHGDWWKHERWWRPRIWKH,52&&UHGHQWLDOLQJ$SSURYDO
QRWLILFDWLRQ,52&ZLOOFRQWLQXHWRFRS\WKHSURYLGHUDQGRUHQUROOLQJVLWHRQPRGDOLW\
DSSURYDOV8SRQVLWHUHJLVWUDWLRQDSSURYDOLQWKH5HJXODWRU\DSSOLFDWLRQWKHHQUROOLQJVLWH
PD\DFFHVV2QFRORJ\3DWLHQW(QUROOPHQW1HWZRUN23(1WRFRPSOHWHHQUROOPHQWV,I
WKHVWXG\LVXVLQJWKH,52&LQWHJUDWLRQVXLWHWKHHQUROOLQJVLWHZLOOVHOHFWWKHLU
FUHGHQWLDOHGSURYLGHUWUHDWLQJWKHVXEMHFWLQWKH23(1FUHGHQWLDOLQJVFUHHQDQGPD\QHHG
WRDQVZHUDGGLWLRQDOTXHVWLRQVUHODWHGWRWUHDWPHQWLQWKHHOLJLELOLW\FKHFNOLVW

'RZQORDGLQJ6LWH5HJLVWUDWLRQ'RFXPHQWV
'RZQORDGWKHVLWHUHJLVWUDWLRQIRUPVIURPWKH15*/8SURWRFROSDJHORFDWHGRQ
WKH&768PHPEHUV¶ZHEVLWH3HUPLVVLRQWRYLHZDQGGRZQORDGWKLVSURWRFRODQGLWV
VXSSRUWLQJGRFXPHQWVLVUHVWULFWHGWRLQVWLWXWLRQVDQGLWDVVRFLDWHGLQYHVWLJDWRUVDQG
VWDIIRQDSDUWLFLSDWLQJURVWHU7RYLHZGRZQORDGVLWHUHJLVWUDWLRQIRUPV
x /RJLQWRWKH&768PHPEHUV¶ZHEVLWHKWWSVZZZFWVXRUJ
x &OLFNRQProtocolsLQWKHXSSHUOHIWRIWKHVFUHHQ
o (QWHUWKHSURWRFROLQWKHVHDUFKILHOGDWWKHWRSRIWKHSURWRFROWUHHRU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
o &OLFNRQWKH%\/HDG2UJDQL]DWLRQIROGHUWRH[SDQGWKHQVHOHFWNRGDQG
SURWRFRO# NRG-LU005
x &OLFNRQDocumentsProtocol Related DocumentsDQGXVHWKHDocument Type
ILOWHUDQGVHOHFWSite RegistrationWRGRZQORDGDQGFRPSOHWHWKHIRUPVSURYLGHG
1RWH)RUVLWHVXQGHUWKH&,5%,5%GDWDZLOOORDGDXWRPDWLFDOO\WRWKH&768
6XEPLWWLQJ5HJXODWRU\'RFXPHQWV
6XEPLWUHTXLUHGIRUPVDQGGRFXPHQWVWRWKH&7685HJXODWRU\2IILFHXVLQJWKH
5HJXODWRU\6XEPLVVLRQ3RUWDORQWKH&768PHPEHUV¶ZHEVLWH

7RDFFHVVWKH5HJXODWRU\6XEPLVVLRQ3RUWDOORJLQWRWKH&768PHPEHUV¶ZHEVLWHJRWR
WKH5HJXODWRU\VHFWLRQDQGVHOHFW5HJXODWRU\6XEPLVVLRQ

,QVWLWXWLRQVZLWKSDWLHQWVZDLWLQJWKDWDUHXQDEOHWRXVHWKH5HJXODWRU\6XEPLVVLRQ3RUWDO
VKRXOGDOHUWWKH&7685HJXODWRU\2IILFHLPPHGLDWHO\E\SKRQHRUHPDLO
&768RU&7685HJ+HOS#FRFFJRUJWRUHFHLYHIXUWKHULQVWUXFWLRQDQGVXSSRUW
&KHFNLQJ<RXU6LWH¶V5HJLVWUDWLRQ6WDWXV
6LWHUHJLVWUDWLRQVWDWXVPD\EHYHULILHGRQWKH&768PHPEHUV¶ZHEVLWH
x &OLFNRQRegulatoryDWWKHWRSRIWKHVFUHHQ
x &OLFNRQSite RegistrationDQG
x (QWHUWKHVLWH¶VFKDUDFWHU&7(3,QVWLWXWLRQ&RGHDQGFOLFNRQ*R
o $GGLWLRQDOILOWHUVDUHDYDLODEOHWRVRUWE\3URWRFRO5HJLVWUDWLRQ6WDWXV
3URWRFRO6WDWXVDQGRU,5%7\SH

1RWH7KHVWDWXVVKRZQRQO\UHIOHFWVLQVWLWXWLRQDOFRPSOLDQFHZLWKVLWHUHJLVWUDWLRQ
UHTXLUHPHQWVDVRXWOLQHGZLWKLQWKHSURWRFRO,WGRHVQRWUHIOHFWFRPSOLDQFHZLWKSURWRFRO
UHTXLUHPHQWVIRULQGLYLGXDOVSDUWLFLSDWLQJRQWKHSURWRFRORUWKHHQUROOLQJLQYHVWLJDWRU¶V
VWDWXVZLWKWKH1&,RUWKHLUDIILOLDWHGQHWZRUNV

'HOHJDWLRQRI7DVNV/RJ'7/
(DFKVLWHPXVWFRPSOHWHDSURWRFROVSHFLILF'HOHJDWLRQRI7DVNV/RJ'7/XVLQJWKH
'7/DSSOLFDWLRQLQWKH'HOHJDWLRQ/RJVHFWLRQRQWKH&768PHPEHUV¶ZHEVLWH7KH
&OLQLFDO,QYHVWLJDWRU&,LVUHTXLUHGWRUHYLHZDQGHOHFWURQLFDOO\VLJQWKH'7/SULRUWRWKH
VLWHUHFHLYLQJDQDSSURYHGVLWHUHJLVWUDWLRQVWDWXVDQGHQUROOLQJSDWLHQWVWRWKHVWXG\7R
PDLQWDLQDQDSSURYHGVLWHUHJLVWUDWLRQVWDWXVWKH&,PXVWUHVLJQWKH'7/DWOHDVWDQQXDOO\
DQGZKHQDQHZYHUVLRQRIWKH'7/LVUHOHDVHGDQGWRDFWLYDWHQHZWDVNDVVLJQPHQWV
UHTXLULQJ&,VLJQRII$Q\LQGLYLGXDODWWKHHQUROOLQJVLWHRQDSDUWLFLSDWLQJURVWHUPD\
LQLWLDWHWKHVLWH'7/2QFHWKH'7/LVVXEPLWWHGIRU&,DSSURYDORQO\WKHGHVLJQDWHG'7/
$GPLQLVWUDWRUVRUWKH&,PD\XSGDWHWKH'7/,QVWUXFWLRQVRQFRPSOHWLQJWKH'7/DUH
DYDLODEOHLQWKH+HOS7RSLFVEXWWRQLQWKH'7/DSSOLFDWLRQDQGGHVFULEH'7/WDVN
DVVLJQPHQWV&,VLJQDWXUHDQG&7(3UHJLVWUDWLRQUHTXLUHPHQWVDVZHOODVLQFOXGHD0DVWHU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
7DVN/LVW

$GGLWLRQDO3UH5HJLVWUDWLRQ5HTXLUHPHQWV)25&$1$',$1,167,787,216
2&7
3ULRUWRFOLQLFDOWULDOFRPPHQFHPHQW&DQDGLDQLQVWLWXWLRQVPXVWDOVRFRPSOHWHDQGVXEPLW
YLDWKH5HJXODWRU\6XEPLVVLRQSRUWDORQWKH&768ZHEVLWH
x &OLQLFDO7ULDO6LWH,QIRUPDWLRQ)RUP
x 4XDOLILHG,QYHVWLJDWRU8QGHUWDNLQJ)RUP
x 5HVHDUFK(WKLFV%RDUG$WWHVWDWLRQ)RUP
x ,5%5(%DSSURYHGFRQVHQW(QJOLVKDQGQDWLYHODQJXDJHYHUVLRQV
1RWH&DQDGLDQ,QVWLWXWLRQVPXVWVXEPLWWKHLUFRQVHQWIRUPWR15*5HJXODWRU\
UHJXODWRU\SKO#15*2QFRORJ\RUJSULRUWR,5%VXEPLVVLRQLQLWLDODQG
DPHQGPHQWV&HUWLILFDWLRQYHULILFDWLRQRI,5%5(%FRQVHQWWUDQVODWLRQLVDOVR
UHTXLUHGGHVFULEHGEHORZ
x 3URWRFRO6LJQDWXUH)RUP
x ,QYHVWLJDWRU%URFKXUH6LJQDWXUH)RUP
x /LVWRI/DERUDWRULHV

7KHIROORZLQJLWHPVDUHFROOHFWHGE\15*2QFRORJ\5HJXODWRU\RQD\HDUO\RUEL\HDUO\
EDVLV
x ,5%5(%0HPEHUVKLS5RVWHU
x /DERUDWRU\&HUWLILFDWHVDQG1RUPDO9DOXHV
x &9VIRU4XDOLILHG,QYHVWLJDWRUDQG6XE,QYHVWLJDWRUVQRWHGRQWKH'7/ORJ
x 
 $GGLWLRQDO3UH5HJLVWUDWLRQ5HTXLUHPHQWV)25,17(51$7,21$/,167,787,216
x ,5%5(%DSSURYHGFRQVHQW(QJOLVKDQGQDWLYHODQJXDJHYHUVLRQV(QJOLVK
YHUVLRQPXVWEHVXEPLWWHGWR15*5HJXODWRU\UHJXODWRU\
SKO#15*2QFRORJ\RUJIRUUHYLHZSULRUWR,5%5(%,(&VXEPLVVLRQ
1RWH,QWHUQDWLRQDO,QVWLWXWLRQVPXVWSURYLGHFHUWLILFDWLRQYHULILFDWLRQRI,5%5(%,(&FRQVHQWWUDQVODWLRQ
WR15*2QFRORJ\GHVFULEHGEHORZ

1RQ(QJOLVK6SHDNLQJ&DQDGLDQDQG,QWHUQDWLRQDO,QVWLWXWLRQV
7UDQVODWLRQRIGRFXPHQWVLVFULWLFDO7KHLQVWLWXWLRQLVUHVSRQVLEOHIRUDOOWUDQVODWLRQFRVWV
$OOUHJXODWRU\GRFXPHQWVLQFOXGLQJWKH,5%5(%DSSURYHGFRQVHQWPXVWEHSURYLGHGLQ
(QJOLVKDQGLQWKHQDWLYHODQJXDJH&HUWLILFDWLRQRIWKHWUDQVODWLRQLVRSWLPDOEXWGXHWR
WKHSURKLELWLYHFRVWVLQYROYHG15*ZLOODFFHSWDWDPLQLPXPDYHULILHGWUDQVODWLRQ$
YHULILHGWUDQVODWLRQFRQVLVWVRIWKHDFWXDO5(%DSSURYHGFRQVHQWGRFXPHQWLQ(QJOLVKDQG
LQWKHQDWLYHODQJXDJHDORQJZLWKDFRYHUOHWWHURQRUJDQL]DWLRQDOOHWWHUKHDGVWDWLRQHU\
WKDWLQFOXGHVWKHSURIHVVLRQDOWLWOHFUHGHQWLDOVDQGVLJQDWXUHRIWKHWUDQVODWRUDVZHOODV
VLJQHGGRFXPHQWDWLRQRIWKHUHYLHZDQGYHULILFDWLRQRIWKHWUDQVODWLRQE\DQHXWUDOWKLUG
SDUW\7KHSURIHVVLRQDOWLWOHDQGFUHGHQWLDOVRIWKHQHXWUDOWKLUGSDUW\WUDQVODWRUPXVWEH
VSHFLILHGDVZHOO

x 7KLVLVDVWXG\ZLWKDUDGLDWLRQDQGRULPDJLQJ57,FRPSRQHQWDQGWKHHQUROOLQJ
VLWHPXVWEHDOLJQHGWRDQ57,SURYLGHU7RPDQDJHSURYLGHUDVVRFLDWLRQVRUWR
DGGRUUHPRYHDVVRFLDWHGSURYLGHUVDFFHVVWKH3URYLGHU$VVRFLDWLRQSDJHIURP
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WKH5HJXODWRU\VHFWLRQRIWKH&768PHPEHUV¶ZHEVLWHDW
KWWSVZZZFWVXRUJ56657)3URYLGHU$VVRFLDWLRQ6LWHPXVWEHOLQNHGWRDW
OHDVWRQH,PDJLQJDQG5DGLDWLRQ2QFRORJ\&RUH,52&SURYLGHUWRSDUWLFLSDWH
RQWULDOVZLWKDQ57,FRPSRQHQW(QUROOLQJVLWHVDUHUHVSRQVLEOHIRUHQVXULQJWKDW
WKHDSSURSULDWHDJUHHPHQWVDQG,5%DSSURYDOVDUHLQSODFHZLWKWKHLU57,
SURYLGHU$QLQGLYLGXDOZLWKDSULPDU\UROHRQDWUHDWLQJVLWHURVWHUFDQXSGDWHWKH
SURYLGHUDVVRFLDWLRQVWKRXJKDOOLQGLYLGXDOVDWDVLWHPD\YLHZSURYLGHU
DVVRFLDWLRQV7RILQGZKRKROGVSULPDU\UROHVDW\RXUVLWHYLHZWKH3HUVRQ5RVWHU
%URZVHUXQGHUWKH5806VHFWLRQRQWKH&768PHPEHUV¶ZHEVLWH
x ,52&&UHGHQWLDOLQJ6WDWXV,QTXLU\&6,)RUP±WKLVIRUPLVVXEPLWWHGWR,52&
+RXVWRQWRYHULI\FUHGHQWLDOLQJVWDWXVRUWREHJLQDQHZPRGDOLW\FUHGHQWLDOLQJ
SURFHVV

576SHFLILF3UH5HJLVWUDWLRQ5HTXLUHPHQWV2&7
)RUGHWDLOHGLQIRUPDWLRQRQWKHVSHFLILFWHFKQRORJ\UHTXLUHPHQWUHTXLUHGIRUWKLVVWXG\
SOHDVHUHIHUWRWKHWDEOHEHORZDQGXWLOL]HWKHZHEOLQNSURYLGHGIRUGHWDLOHGLQVWUXFWLRQV
7KH FKHFN PDUNV XQGHU WKH WUHDWPHQW PRGDOLW\ FROXPQVLQGLFDWH ZKHWKHU WKDW VSHFLILF
FUHGHQWLDOLQJ UHTXLUHPHQW LVUHTXLUHG IRUWKLV VWXG\ 6SHFLILFFUHGHQWLDOLQJFRPSRQHQWV
PD\UHTXLUH\RXWRZRUNZLWKYDULRXV4$FHQWHUVKRZHYHU,52&+RXVWRQZLOOQRWLI\
\RXULQVWLWXWLRQZKHQDOOFUHGHQWLDOLQJUHTXLUHPHQWVKDYHEHHQPHWDQGWKHLQVWLWXWLRQLV
57 FUHGHQWLDOHG WR HQWHU SDWLHQWV RQWR WKLV VWXG\  ,52& ZLOO DXWRPDWLFDOO\ VHQG WKH
DSSURYDOWRWKH5HJXODWRU\6XSSRUW6\VWHP566WRFRPSO\ZLWKWKHSURWRFROVSHFLILF
UHTXLUHPHQWXQOHVVRWKHUZLVHQRWHGDWWKHERWWRPRIWKH,52&&UHGHQWLDOLQJ$SSURYDO
QRWLILFDWLRQ


8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

57
&UHGHQWLDOLQJ
5HTXLUHPHQWV
:HE/LQNIRU&UHGHQWLDOLQJ3URFHGXUHVDQG,QVWUXFWLRQV
KWWSLURFKRXVWRQPGDQGHUVRQRUJ
7UHDWPHQW0RGDOLW\

3KRWRQ
.H\,QIRUPDWLRQ
&UHGHQWLDOLQJ
6WDWXV
,QTXLU\)RUP
[
7RGHWHUPLQHLI\RXULQVWLWXWLRQKDVFRPSOHWHGWKH
UHTXLUHPHQWVDERYHSOHDVHFRPSOHWHD
³&UHGHQWLDOLQJ6WDWXV,QTXLU\)RUP´IRXQGXQGHU
&UHGHQWLDOLQJRQWKH,52&+RXVWRQ4$&HQWHU
ZHEVLWHKWWSLURFKRXVWRQPGDQGHUVRQRUJ
)DFLOLW\
4XHVWLRQQDLUH
[
7KH,52&+RXVWRQHOHFWURQLFIDFLOLW\TXHVWLRQQDLUH
)4VKRXOGEHFRPSOHWHGRUXSGDWHGZLWKWKHPRVW
UHFHQWLQIRUPDWLRQDERXW\RXULQVWLWXWLRQ7RDFFHVV
WKLV)4HPDLOLURFKRXVWRQ#PGDQGHUVRQRUJWR
UHFHLYH\RXU)4OLQN
3KDQWRP
,UUDGLDWLRQ
[
$7KRUD[SKDQWRPVWXG\SURYLGHGE\WKH,52&
+RXVWRQ4$&HQWHUPXVWEHVXFFHVVIXOO\FRPSOHWHG
,QVWUXFWLRQVIRUUHTXHVWLQJDQGLUUDGLDWLQJWKH
SKDQWRPDUHIRXQGRQWKH,52&+RXVWRQZHEVLWH
KWWSLURFKRXVWRQPGDQGHUVRQRUJ
&UHGHQWLDOLQJ1RWLILFDWLRQ,VVXHGWR
,QVWLWXWLRQ
[
,QVWLWXWLRQZLOOEHFUHGHQWLDOHGIRUWKHWUHDWPHQW
PRGDOLW\WKDWWKH\LQWHQGWRXVHRQDOOSDWLHQWV
,52&+RXVWRQ4$&HQWHUZLOOQRWLI\WKHLQVWLWXWLRQ
DQG15*+HDGTXDUWHUVWKDWDOOGHVLUHGFUHGHQWLDOLQJ
UHTXLUHPHQWVKDYHEHHQPHW


'LJLWDO5DGLDWLRQ7KHUDS\'DWD6XEPLVVLRQ8VLQJ7UDQVIHURI,PDJHVDQG'DWD
2&7
7UDQVIHURI,PDJHVDQG'DWD75,$'LVWKH$PHULFDQ&ROOHJHRI5DGLRORJ\¶V
$&5LPDJHH[FKDQJHDSSOLFDWLRQ75,$'SURYLGHVVLWHVSDUWLFLSDWLQJLQFOLQLFDO
WULDOVDVHFXUHPHWKRGWRWUDQVPLWLPDJHV75,$'DQRQ\PL]HVDQGYDOLGDWHVWKH
LPDJHVDVWKH\DUHWUDQVIHUUHG

75,$'$FFHVV5HTXLUHPHQWV
x $FWLYH&7(3UHJLVWUDWLRQZLWKWKHFUHGHQWLDOVQHFHVVDU\WRDFFHVVVHFXUH
1&,&768,7V\VWHPV
x 5HJLVWUDWLRQW\SHRI$VVRFLDWH$$VVRFLDWH3OXV$31RQ3K\VLFLDQ
,QYHVWLJDWRU13,95RU,QYHVWLJDWRU,955HIHUWRWKH&7(35HJLVWUDWLRQ
3URFHGXUHVVHFWLRQIRULQVWUXFWLRQVRQKRZWRUHTXHVWD&7(3,$0DFFRXQWDQG
FRPSOHWHUHJLVWUDWLRQLQ5&5
x 75,$'6LWH8VHUUROHRQDQ1&71(7&71RURWKHUUHOHYDQWURVWHU

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$OOLQGLYLGXDOVRQWKH,PDJLQJDQG5DGLDWLRQ2QFRORJ\&RUHSURYLGHUURVWHUKDYHDFFHVVWR
75,$'DQGPD\VXEPLWLPDJHVIRUFUHGHQWLDOLQJSXUSRVHVRUIRUHQUROOPHQWVWRZKLFKWKH
SURYLGHULVOLQNHGLQ23(1

75,$',QVWDOODWLRQ
7RVXEPLWLPDJHVWKHLQGLYLGXDOKROGLQJWKH75,$'6LWH8VHUUROHZLOOQHHGWR
LQVWDOOWKH75,$'DSSOLFDWLRQRQWKHLUZRUNVWDWLRQ75,$'LQVWDOODWLRQ
GRFXPHQWDWLRQLVDYDLODEOHDWKWWSVWULDGLQVWDOODFURUJWULDGFOLHQW

7KLVSURFHVVFDQEHGRQHLQSDUDOOHOWRREWDLQLQJ\RXU&7(3,$0DFFRXQWDQG
5&5UHJLVWUDWLRQ
)RUTXHVWLRQVFRQWDFW75,$'7HFKQLFDO6XSSRUWVWDIIYLDHPDLO75,$'
6XSSRUW#DFURUJRU

3DWLHQW(QUROOPHQW-8/
3DWLHQWUHJLVWUDWLRQFDQRFFXURQO\DIWHUHYDOXDWLRQIRUHOLJLELOLW\LVFRPSOHWHHOLJLELOLW\
FULWHULDKDYHEHHQPHWLQIRUPHGFRQVHQWLVREWDLQHGDQGWKHVWXG\VLWHLVOLVWHGDV
µDSSURYHG¶LQWKH&768566
3DWLHQWVPXVWKDYHVLJQHGDQGGDWHGDOODSSOLFDEOHFRQVHQWVDQGDXWKRUL]DWLRQIRUPV

,QIRUPHG&RQVHQW3DWLHQWVPXVWEHDZDUHRIWKHQHRSODVWLFQDWXUHRIWKHLUGLVHDVHDQG
LQIRUPHGRIWKHSURFHGXUHVWREHIROORZHGWKHH[SHULPHQWDOQDWXUHRIWKHWKHUDS\
DOWHUQDWLYHVSRWHQWLDOEHQHILWVVLGHHIIHFWVULVNVDQGGLVFRPIRUWVSULRUWRVLJQLQJWKH
LQIRUPHGFRQVHQWLQDFFRUGDQFHZLWKLQVWLWXWLRQDODQGIHGHUDOJXLGHOLQHV&XUUHQW
,5%5(%5(&DSSURYDORIWKLVSURWRFRODQGDFRQVHQWIRUPLVUHTXLUHGSULRUWRSDWLHQW
FRQVHQWDQGUHJLVWUDWLRQ7KHPRGHOFRQVHQWIRUPFUHDWHGIRUWKLVVWXG\DGKHUHVWRWKH
1&,LQIRUPHGFRQVHQWWHPSODWHUHTXLUHPHQWV

 2QFRORJ\3DWLHQW(QUROOPHQW1HWZRUN23(1
7KH2QFRORJ\3DWLHQW(QUROOPHQW1HWZRUN23(1LVDZHEEDVHGUHJLVWUDWLRQV\VWHP
DYDLODEOHRQDEDVLV23(1LVLQWHJUDWHGZLWK&768UHJXODWRU\DQGURVWHUGDWDDQG
ZLWKWKH/32VUHJLVWUDWLRQUDQGRPL]DWLRQV\VWHPVRU7KHUDGH[,QWHUDFWLYH:HE5HVSRQVH
6\VWHP,:56IRUUHWULHYDORISDWLHQWUHJLVWUDWLRQUDQGRPL]DWLRQDVVLJQPHQW23(1ZLOO
SRSXODWHWKHSDWLHQWHQUROOPHQWGDWDLQ1&,¶VFOLQLFDOGDWDPDQDJHPHQWV\VWHP0HGLGDWD
5DYH

5HTXLUHPHQWVIRU23(1DFFHVV
x $FWLYH&7(3UHJLVWUDWLRQZLWKWKHFUHGHQWLDOVQHFHVVDU\WRDFFHVVVHFXUH1&,&768
,7V\VWHPV
x 7RSHUIRUPHQUROOPHQWVRUUHTXHVWVORWUHVHUYDWLRQV0XVWEHRQDQ/32URVWHU
(7&71FRUUHVSRQGLQJURVWHURUSDUWLFLSDWLQJRUJDQL]DWLRQURVWHUZLWKWKHUROHRI
5HJLVWUDU5HJLVWUDUVPXVWKROGDPLQLPXPRIDQ$VVRFLDWH3OXV$3UHJLVWUDWLRQ
W\SH
x $'HOHJDWLRQRI7DVNV/RJ'7/LVUHTXLUHGIRUWKHVWXG\WKHUHJLVWUDUVPXVWKROG
WKH23(15HJLVWUDUWDVNRQWKH'7/IRUWKHVLWHDQG
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
x
+DYHDQDSSURYHGVLWHUHJLVWUDWLRQIRUDSURWRFROSULRUWRSDWLHQWHQUROOPHQW

7RDVVLJQDQ,QYHVWLJDWRU,95RU1RQ3K\VLFLDQ,QYHVWLJDWRU13,95DVWKH
WUHDWLQJFUHGLWLQJFRQVHQWLQJRUUHFHLYLQJLQYHVWLJDWRUIRUDSDWLHQWWUDQVIHULQ23(1
WKH,95RU13,95PXVWOLVWWKH,QVWLWXWLRQDO5HYLHZ%RDUG,5%QXPEHUXVHGRQWKH
VLWH¶V,5%DSSURYDORQWKHLU)RUP)RRGDQG'UXJ$GPLQLVWUDWLRQ)'$LQWKH
5HJLVWUDWLRQDQG&UHGHQWLDO5HSRVLWRU\5&5,ID'7/LVUHTXLUHGIRUWKHVWXG\WKH
,95RU13,95PXVWEHDVVLJQHGWKHDSSURSULDWH23(1UHODWHGWDVNVRQWKH'7/

3ULRUWRDFFHVVLQJ23(1VLWHVWDIIVKRXOGYHULI\WKHIROORZLQJ
x 3DWLHQWKDVPHWDOOHOLJLELOLW\FULWHULDZLWKLQWKHSURWRFROVWDWHGWLPHIUDPHVDQG
x $OOSDWLHQWVKDYHVLJQHGDQDSSURSULDWHFRQVHQWIRUPDQG+HDOWK,QVXUDQFH
3RUWDELOLW\DQG$FFRXQWDELOLW\$FW+,3$$DXWKRUL]DWLRQIRUPLIDSSOLFDEOH

1RWH7KH23(1V\VWHPZLOOSURYLGHWKHVLWHZLWKDSULQWDEOHFRQILUPDWLRQRI
UHJLVWUDWLRQDQGWUHDWPHQWLQIRUPDWLRQ<RXPD\SULQWWKLVFRQILUPDWLRQIRU\RXUUHFRUGV

$FFHVV23(1DWKWWSVRSHQFWVXRUJRUIURPWKH23(1OLQNRQWKH&768PHPEHUV¶
ZHEVLWH)XUWKHULQVWUXFWLRQDOLQIRUPDWLRQLVLQWKH23(1VHFWLRQRIWKH&768ZHEVLWHDW
KWWSVZZZFWVXRUJRUDWKWWSVRSHQFWVXRUJ)RUDQ\DGGLWLRQDOTXHVWLRQVFRQWDFWWKH
&768+HOS'HVNDWRUFWVXFRQWDFW#ZHVWDWFRP

,QWKHHYHQWWKDWWKH23(1V\VWHPLVQRWDFFHVVLEOHSDUWLFLSDWLQJVLWHVFDQFRQWDFW15*
ZHEVXSSRUWIRUDVVLVWDQFHZLWKZHEUHJLVWUDWLRQZHEVXSSRUW#DFURUJRUFDOOWKH15*
5HJLVWUDWLRQ'HVNDW0RQGD\WKURXJK)ULGD\DPWRSP(7
7KHUHJLVWUDUZLOODVNWKHVLWHWRID[LQWKHHOLJLELOLW\FKHFNOLVWDQGZLOOQHHGWKHUHJLVWHULQJ
LQGLYLGXDO¶VHPDLODGGUHVVDQGRUUHWXUQID[QXPEHU7KLVLQIRUPDWLRQLVUHTXLUHGWRDVVXUH
WKDW PHFKDQLVPV XVXDOO\ WULJJHUHG E\ WKH 23(1 ZHE UHJLVWUDWLRQ V\VWHP HJ GUXJ
VKLSPHQWDQGFRQILUPDWLRQRIUHJLVWUDWLRQZLOORFFXU

0HGLGDWD3DWLHQW&ORXGH3525HJLVWUDWLRQ
7KLVVWXG\LQFOXGHVWKHXVHRI0HGLGDWD3DWLHQW&ORXGH352HOHFWURQLFSDWLHQWUHSRUWHG
RXWFRPHVH352LVQRWDYDLODEOHLQ-DSDQHVH$IWHUWKHSDWLHQWLVUHJLVWHUHGWRWKHWULDO
YLD23(1DQGLIWKHSDWLHQWFDQUHDGRUXQGHUVWDQG(QJOLVK)UHQFKRU6SDQLVKDQGLV
ZLOOLQJWRSDUWLFLSDWHLQHOHFWURQLFGDWDFROOHFWLRQWKHVLWHVWDIIZLOOWKHQFRPSOHWHD
UHJLVWUDWLRQIRUWKHSDWLHQWWRWKH3DWLHQW&ORXGH352WKURXJKL0HGLGDWD1RWH6LWHVWDII
PXVWKDYHDOUHDG\FRPSOHWHGUHTXLUHGH/HDUQLQJIRUWKH3DWLHQW&ORXGH352DSSOLFDWLRQ
WRUHJLVWHUDSDWLHQWDQGLQIRUPDWLRQDERXWWKHWUDLQLQJLVLQWKHH352$SSHQGL[7KH
UHJLVWUDWLRQWRWKH3DWLHQW&ORXGH352ZLOOFUHDWHDXQLTXHSDWLHQWUHJLVWUDWLRQFRGHWKDW
WKHVLWHVWDIIZLOOSURYLGHWRWKHSDWLHQW7KHSDWLHQWZLWKDVVLVWDQFHIURPWKHVLWHVWDII
VKRXOGEHLQVWUXFWHGWRGRZQORDGWKH3DWLHQW&ORXGH352DSSRQWRKLVKHURZQGHYLFH
,26$QGURLGSKRQHRUWDEOHWDQGXVHWKHXQLTXHSDWLHQWUHJLVWUDWLRQFRGHWRFUHDWHDQ
DFFRXQW2QFHWKHSDWLHQW
VDFFRXQWLVVHWXSWKHSDWLHQWZLOOEHDEOHWRFRPSOHWHWKH
VXEPLVVLRQRISDWLHQWUHSRUWHGRXWFRPHVHOHFWURQLFDOO\IRUWKHWULDO7KHUHDUHPXOWLSOH
YHUVLRQVRIWKHDSSDYDLODEOH7KH3DWLHQW&ORXG$SSWKHYHUVLRQZLWKWKHFORXGORJR
ZLOOEHXVHGRQWKLVVWXG\(QVXUHWKDWWKHSDWLHQWGRZQORDGVWKHFRUUHFWYHUVLRQRIWKH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
H352DSS1RWHRQO\YHUVLRQRIWKHDSSLVDFWLYHSHUSURWRFRO

)RUVLWHVSURYLGLQJDVKDUHGLQVWLWXWLRQDOGHYLFHIRUXVHE\PXOWLSOHSDWLHQWVRQVLWH
x 7KHVLWHVWDIIVKRXOGDVVLVWWKHSDWLHQWZLWKDFFHVVDQGUHJLVWUDWLRQWRWKH3DWLHQW
&ORXGH352DSSDQGWKHSDWLHQWFDQWKHQFRPSOHWHWKHHOHFWURQLFGDWDVXEPLVVLRQ
LQGHSHQGHQWO\6LWHVWDIIPD\QHHGWRDVVLVWSDWLHQWVZLWKORJJLQJRQWRWKHGHYLFHDW
HDFKYLVLW
 &5$3DWLHQW5HJLVWUDWLRQ,QVWUXFWLRQVIRUH352
3OHDVHYLVLWWKH&768ZHEVLWHIRUUHIHUHQFHLQIRUPDWLRQRQ3DWLHQW&ORXGH352IRU
&5$V
x 7KHVXEMHFWUHJLVWUDWLRQSURFHVVVWDUWVLQL0HGLGDWD%HJLQE\VHOHFWLQJWKH3DWLHQW
&ORXGH3525HJLVWUDWLRQOLQNIRU\RXUVWXG\
x 7KHSDWLHQWPDQDJHPHQWDSSZLOOGLVSOD\VHOHFW\RXU678'<DQG6,7(IURPWKH
GURSGRZQVDQGFOLFN/DXQFK
x 1RZ\RXFDQUHJLVWHU\RXUILUVWSDWLHQW&UHDWHDVXEMHFW,'DQGVHOHFWD&RXQWU\
/DQJXDJHIURPWKHGURSGRZQWKHVHDUHWKHRQO\UHTXLUHGGDWDILHOGV7KHVXEMHFW
LQLWLDOVDUHRSWLRQDOEXWDUHKHOSIXOLQLGHQWLI\LQJZKLFKVXEMHFW,'PDSVZLWKZKLFK
DFWLYDWLRQFRGH:KHQILQLVKHGFOLFN$GG
x 7KHVXEMHFWDGGHGDQGZLOOLQFOXGHWKHGDWHWKHSDWLHQWZDVDGGHGWKHVXEMHFW,'
VXEMHFWLQLWLDOVLILQFOXGHGDQGDXQLTXHDXWRJHQHUDWHGDFWLYDWLRQFRGH7KH
DFWLYDWLRQFRGHLVXQLTXHIRUHDFKSDWLHQWDQGOLQNHGWRWKHVXEMHFW,'LWLVQRW
LQWHUFKDQJHDEOH,QDGGLWLRQWKHUHLVDVWDWXVVHFWLRQZKLFKLQGLFDWHVLIWKHSDWLHQW
KDVUHJLVWHUHG:KHQWKHSDWLHQWKDVUHJLVWHUHGWKHVWDWXVZLOOFKDQJHIURPLQYLWHG
WRUHJLVWHUHG

5HPLQGHUVLWHVWDIIPXVWKDYHDOUHDG\FRPSOHWHGWKH0HGLGDWD3DWLHQW&ORXGWUDLQLQJLQ
RUGHUWRUHJLVWHUVWXG\SDUWLFLSDQWV3OHDVHYLVLWWKH0HGLGDWD/HDUQLQJ7RROIRUUHIHUHQFH
LQIRUPDWLRQRQ3DWLHQW&ORXGH352IRU&5$VKWWSVOHDUQPGVROFRPSDWLHQW
FORXGHQYLGHROLEUDU\IRUSURYLGHUVKWPO

'58*,1)250$7,21


,QYHVWLJDWLRQDO6WXG\$JHQW$WH]ROL]XPDE,1'
16&-8/


2WKHU1DPHV7HFHQWULT03'/$

&ODVVLILFDWLRQPRQRFORQDODQWLERG\

0:.'

0RGHRI$FWLRQDQWL3'/

'HVFULSWLRQ
$WH]ROL]XPDELVDKXPDQL]HG,J*PRQRFORQDODQWLERG\FRQVLVWLQJRIWZRKHDY\FKDLQV
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
DPLQRDFLGVDQGWZROLJKWFKDLQVDPLQRDFLGV$WH]ROL]XPDEWDUJHWVKXPDQ
3'/DQGLQKLELWVLWVLQWHUDFWLRQZLWKLWVUHFHSWRU3'$WH]ROL]XPDEDOVREORFNVWKH
ELQGLQJRI3'/WR%DQLQWHUDFWLRQWKDWLVUHSRUWHGWRSURYLGHDGGLWLRQDOLQKLELWRU\
VLJQDOVWR7FHOOV%XWWHHWDO

+RZ6XSSOLHG
$WH]ROL]XPDELVSURYLGHGE\*HQHQWHFK)+RIIPDQQ/D5RFKH/7'DQGGLVWULEXWHGE\
WKH3KDUPDFHXWLFDO0DQDJHPHQW%UDQFK&7(31&,7KHDJHQWLVVXSSOLHGLQDVLQJOH
XVHP/JODVVYLDODVDFRORUOHVVWRVOLJKWO\\HOORZVWHULOHSUHVHUYDWLYHIUHHFOHDU
OLTXLGVROXWLRQLQWHQGHGIRU,9DGPLQLVWUDWLRQ(DFKP/YLDOFRQWDLQVPJRI
DWH]ROL]XPDEDQGLVIRUPXODWHGLQJODFLDODFHWLFDFLGPJ/KLVWLGLQHPJ
SRO\VRUEDWHPJDQGVXFURVHPJZLWKDS+RI7KHYLDOLVGHVLJQHGWR
GHOLYHUP/PJRIDWH]ROL]XPDEVROXWLRQEXWPD\FRQWDLQPRUHWKDQWKHVWDWHG
YROXPHWRHQDEOHGHOLYHU\RIWKHHQWLUHP/YROXPH

3UHSDUDWLRQ
7KHSUHVFULEHGGRVHRIDWH]ROL]XPDEVKRXOGEHGLOXWHGLQ1D&OWRDFRQFHQWUDWLRQ
EHWZHHQPJP/DQGPJP/DQGLQIXVHGZLWKRUZLWKRXWDORZSURWHLQELQGLQJ
RUPLFURPHWHULQOLQHILOWHU7KH,9EDJPD\EHFRQVWUXFWHGRISRO\YLQ\O
FKORULGH39&SRO\ROHILQ32RUSRO\HWK\OHQH3(7KHSUHSDUHGVROXWLRQPD\EH
VWRUHG DW && IRU XS WR  KRXUV RU DW DPELHQW  & ) IRU  KRXUV IURP WKH
WLPHRISUHSDUDWLRQ,IWKHGRVHVROXWLRQLVVWRUHGDW&±&)±) LW VKRXOG EH
UHPRYHGIURPUHIULJHUDWLRQDQGDOORZHGWRUHDFKURRPWHPSHUDWXUHSULRUWR
DGPLQLVWUDWLRQ7KHVHWLPHVLQFOXGHWKHVWRUDJHDQGDGPLQLVWUDWLRQWLPHVIRUWKHLQIXVLRQ
'RQRWVKDNHRUIUHH]HLQIXVLRQEDJVFRQWDLQLQJWKHGRVHVROXWLRQ

6WRUDJH && )) 9LDO FRQWHQWV VKRXOG QRW EH IUR]HQ RU VKDNHQ DQG VKRXOG
EHSURWHFWHGIURPGLUHFWVXQOLJKW

,I D VWRUDJH WHPSHUDWXUH H[FXUVLRQ LV LGHQWLILHG SURPSWO\ UHWXUQ DWH]ROL]XPDE WR &&
)) DQG TXDUDQWLQH WKH VXSSOLHV 3URYLGH D GHWDLOHG UHSRUW RI WKH H[FXUVLRQ
LQFOXGLQJGRFXPHQWDWLRQRIWHPSHUDWXUHPRQLWRULQJDQGGXUDWLRQRIWKHH[FXUVLRQWR
30%$IWHU+RXUV#PDLOQLKJRYIRUGHWHUPLQDWLRQRIVXLWDELOLW\

6WDELOLW\6WDELOLW\VWXGLHVDUHRQJRLQJ

&$87,211RSUHVHUYDWLYHLVXVHGLQDWH]ROL]XPDEWKHUHIRUHWKHYLDOLVLQWHQGHGIRU
VLQJOHXVHRQO\'LVFDUGDQ\XQXVHGSRUWLRQRIGUXJUHPDLQLQJLQDYLDO

5RXWHRI$GPLQLVWUDWLRQ,9LQIXVLRQ

0HWKRGRI$GPLQLVWUDWLRQ
$WH]ROL]XPDELVDGPLQLVWHUHGDVDQLQWUDYHQRXVLQIXVLRQRYHUPLQXWHV,IWKHILUVW
LQIXVLRQLVWROHUDWHGDOOVXEVHTXHQWLQIXVLRQVPD\EHGHOLYHUHGRYHUPLQXWHV'RQRW
DGPLQLVWHUDWH]ROL]XPDEDVDQLQWUDYHQRXVSXVKRUEROXV1RSUHPHGLFDWLRQLVLQGLFDWHG
IRUDGPLQLVWUDWLRQRI&\FOHRIDWH]ROL]XPDE3DWLHQWVZKRH[SHULHQFHDQLQIXVLRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
UHODWHGUHDFWLRQZLWK&\FOHRIDWH]ROL]XPDEPD\UHFHLYHSUHPHGLFDWLRQVZLWK
VXEVHTXHQWLQIXVLRQV

3RWHQWLDO'UXJ,QWHUDFWLRQV
&\WRFKURPH3HQ]\PHVDVZHOODVFRQMXJDWLRQJOXFXURQLGDWLRQUHDFWLRQVDUHQRW
LQYROYHGLQWKHPHWDEROLVPRIDWH]ROL]XPDE1RGUXJLQWHUDFWLRQVWXGLHVIRUDWH]ROL]XPDE
KDYHEHHQFRQGXFWHGRUDUHSODQQHG7KHUHDUHQRNQRZQLQWHUDFWLRQVZLWKRWKHU
PHGLFLQDOSURGXFWVRURWKHUIRUPRILQWHUDFWLRQV

3DWLHQW&DUH,PSOLFDWLRQV
)HPDOHSDWLHQWVRIFKLOGEHDULQJSRWHQWLDOVKRXOGXWLOL]HFRQWUDFHSWLRQDQGWDNHDFWLYH
PHDVXUHVWRDYRLGSUHJQDQF\ZKLOHXQGHUJRLQJDWH]ROL]XPDEWUHDWPHQWDQGIRUDWOHDVW
GD\VDIWHUWKHODVWGRVHRIDWH]ROL]XPDE
 $JHQW2UGHULQJDQG$JHQW$FFRXQWDELOLW\
1&,VXSSOLHGDJHQWVPD\EHUHTXHVWHGE\HOLJLEOHSDUWLFLSDWLQJ,QYHVWLJDWRUVRUWKHLU
DXWKRUL]HGGHVLJQHHDWHDFKSDUWLFLSDWLQJLQVWLWXWLRQ7KH&7(3DVVLJQHGSURWRFRO
QXPEHUPXVWEHXVHGIRURUGHULQJDOO&7(3VXSSOLHGLQYHVWLJDWLRQDODJHQWV7KHHOLJLEOH
SDUWLFLSDWLQJLQYHVWLJDWRUVDWHDFKSDUWLFLSDWLQJLQVWLWXWLRQPXVWEHUHJLVWHUHGZLWK&7(3
'&7'WKURXJKDQDQQXDOVXEPLVVLRQRI)'$)RUP6WDWHPHQWRI,QYHVWLJDWRU
1&,%LRVNHWFK$JHQW6KLSPHQW)RUPDQG)LQDQFLDO'LVFORVXUH)RUP)'),IWKHUH
DUHVHYHUDOSDUWLFLSDWLQJLQYHVWLJDWRUVDWRQHLQVWLWXWLRQ&7(3VXSSOLHGLQYHVWLJDWLRQDO
DJHQWVIRUWKHVWXG\VKRXOGEHRUGHUHGXQGHUWKHQDPHRIRQHOHDGSDUWLFLSDWLQJ
LQYHVWLJDWRUDWWKDWLQVWLWXWLRQ

6LWHVPD\RUGHUVXSSOLHVRIDWH]ROL]XPDERQFHWKH\KDYHDSDWLHQWLQVFUHHQLQJ

6XEPLWDJHQWUHTXHVWVWKURXJKWKH30%$JHQW,QYHQWRU\0DQDJHPHQW6\VWHP
$8525$DSSOLFDWLRQ$FFHVVWR$8525$UHTXLUHVWKHHVWDEOLVKPHQWRID&7(3
,GHQWLW\DQG$FFHVV0DQDJHPHQW,$0DFFRXQWDQGWKHPDLQWHQDQFHRIDQ³DFWLYH´
DFFRXQWVWDWXVD³FXUUHQW´SDVVZRUGDQGDFWLYHSHUVRQUHJLVWUDWLRQVWDWXV)RUTXHVWLRQV
DERXWGUXJRUGHUVWUDQVIHUVUHWXUQVRUDFFRXQWDELOLW\FDOORUHPDLO30%DQ\WLPH
5HIHUWRWKH30%¶VZHEVLWHIRUVSHFLILFSROLFLHVDQGJXLGHOLQHVUHODWHGWRDJHQW
PDQDJHPHQW 

$JHQW,QYHQWRU\5HFRUGV
7KHLQYHVWLJDWRURUDUHVSRQVLEOHSDUW\GHVLJQDWHGE\WKHLQYHVWLJDWRUPXVWPDLQWDLQD
FDUHIXOUHFRUGRIWKHUHFHLSWGLVSHQVLQJDQGILQDOGLVSRVLWLRQRIDOODJHQWVUHFHLYHGIURP
WKH30%XVLQJWKHDSSURSULDWH1&,,QYHVWLJDWLRQDO$JHQW'UXJ$FFRXQWDELOLW\5HFRUG
'$5)DYDLODEOHRQWKH&7(3IRUPVSDJH6WRUHDQGPDLQWDLQVHSDUDWH1&,
,QYHVWLJDWLRQDO$JHQW$FFRXQWDELOLW\5HFRUGVIRUHDFKDJHQWVWUHQJWKIRUPXODWLRQDQG
RUGHULQJLQYHVWLJDWRURQWKLVSURWRFRO

,QYHVWLJDWRU%URFKXUH$YDLODELOLW\
7KHFXUUHQWYHUVLRQVRIWKH,%VIRUWKHDJHQWVZLOOEHDFFHVVLEOHWRVLWHLQYHVWLJDWRUVDQG
UHVHDUFKVWDIIWKURXJKWKH30%$8525$$FFHVVWR$8525$UHTXLUHVWKH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
HVWDEOLVKPHQWRID&7(3,$0DFFRXQWDQGWKHPDLQWHQDQFHRIDQ³DFWLYH´DFFRXQWVWDWXV
D³FXUUHQW´SDVVZRUGDQGDFWLYHSHUVRQUHJLVWUDWLRQVWDWXV4XHVWLRQVDERXW,%DFFHVV
PD\EHGLUHFWHGWRWKH30%,%&RRUGLQDWRUYLDHPDLO

8VHIXO/LQNVDQG&RQWDFWV
x &7(3)RUPV7HPSODWHV'RFXPHQWVKWWSFWHSFDQFHUJRYIRUPV
x 1&,&7(3,QYHVWLJDWRU5HJLVWUDWLRQ5&5+HOS'HVN#QLKJRY
x 30%SROLFLHVDQGJXLGHOLQHV
KWWSFWHSFDQFHUJRYEUDQFKHVSPEDJHQW PDQDJHPHQWKWP
x
30%Agent Inventory Management System (AURORA) application: 
https://ctepcore.nci.nih.gov/aurora
x &7(3,GHQWLW\DQG$FFHVV0DQDJHPHQW,$0DFFRXQWKWWSVFWHSFRUHQFLQLKJRYLDP
x &7(3,$0DFFRXQWKHOSFWHSUHJKHOS#FWHSQFLQLKJRY
x ,%&RRUGLQDWRU,%&RRUGLQDWRU#PDLOQLKJRY
x 30%HPDLO30%$IWHU+RXUV#PDLOQLKJRY
x 30%SKRQHDQGKRXUVRIVHUYLFH0RQGD\WKURXJK)ULGD\EHWZHHQ
DPDQGSP(7


&RPPHUFLDO$JHQW&LVSODWLQ)(%
6LWHVLQWKH86DQG-DSDQPXVWUHIHUWRWKHSDFNDJHLQVHUWDQGVLWHVSHFLILFSKDUPDF\IRU
GHWDLOHGSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ6LWHVLQ&DQDGDPXVWUHIHUWRWKHSURGXFW
PRQRJUDSKIRUSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ

 $GYHUVH(YHQWV
6LWHVLQWKH86DQG-DSDQSOHDVHUHIHUWRWKHSDFNDJHLQVHUW6LWHVLQ&DQDGDUHIHUWRWKH
SURGXFWPRQRJUDSK

 $YDLODELOLW\6XSSO\

3OHDVHVHH6HFWLRQIRUDGPLQLVWUDWLRQLQVWUXFWLRQV86VLWHVSOHDVHUHIHUWRWKHFXUUHQW
)'$DSSURYHGSDFNDJHLQVHUWSURYLGHGZLWKHDFKGUXJDQGWKHVLWHVSHFLILFSKDUPDF\IRU
WR[LFLW\LQIRUPDWLRQDQGLQVWUXFWLRQVIRUGUXJSUHSDUDWLRQKDQGOLQJDQGVWRUDJH6LWHVLQ
&DQDGDPXVWUHIHUWRWKHSURGXFWPRQRJUDSKIRUWKLVLQIRUPDWLRQ


&RPPHUFLDO$JHQW&DUERSODWLQ)(%

6LWHVLQWKH86DQG-DSDQPXVWUHIHUWRWKHSDFNDJHLQVHUWDQGVLWHVSHFLILFSKDUPDF\IRU
GHWDLOHGSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ6LWHVLQ&DQDGDPXVWUHIHUWRWKHSURGXFW
PRQRJUDSKIRUSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ

 $GYHUVH(YHQWV
6LWHVLQWKH86DQG-DSDQSOHDVHUHIHUWRWKHSDFNDJHLQVHUW6LWHVLQ&DQDGDUHIHUWRWKH
SURGXFWPRQRJUDSK

 $YDLODELOLW\6XSSO\

3OHDVHVHH6HFWLRQIRUDGPLQLVWUDWLRQLQVWUXFWLRQV86VLWHVSOHDVHUHIHUWRWKHFXUUHQW
)'$DSSURYHGSDFNDJHLQVHUWSURYLGHGZLWKHDFKGUXJDQGWKHVLWHVSHFLILFSKDUPDF\IRU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WR[LFLW\LQIRUPDWLRQDQGLQVWUXFWLRQVIRUGUXJSUHSDUDWLRQKDQGOLQJDQGVWRUDJH6LWHVLQ
&DQDGDPXVWUHIHUWRWKHSURGXFWPRQRJUDSKIRUWKLVLQIRUPDWLRQ


&RPPHUFLDO$JHQW(WRSRVLGH)(%
6LWHVLQWKH86DQG-DSDQPXVWUHIHUWRWKHSDFNDJHLQVHUWDQGVLWHVSHFLILFSKDUPDF\IRU
GHWDLOHGSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ6LWHVLQ&DQDGDPXVWUHIHUWRWKHSURGXFW
PRQRJUDSKIRUSKDUPDFRORJLFDQGVDIHW\LQIRUPDWLRQ

 $GYHUVH(YHQWV
6LWHVLQWKH86DQG-DSDQSOHDVHUHIHUWRWKHSDFNDJHLQVHUW6LWHVLQ&DQDGDUHIHUWRWKH
SURGXFWPRQRJUDSK

 $YDLODELOLW\6XSSO\

3OHDVHVHH6HFWLRQIRUDGPLQLVWUDWLRQLQVWUXFWLRQV86VLWHVSOHDVHUHIHUWRWKHFXUUHQW
)'$DSSURYHGSDFNDJHLQVHUWSURYLGHGZLWKHDFKGUXJDQGWKHVLWHVSHFLILFSKDUPDF\IRU
WR[LFLW\LQIRUPDWLRQDQGLQVWUXFWLRQVIRUGUXJSUHSDUDWLRQKDQGOLQJDQGVWRUDJH6LWHVLQ
&DQDGDPXVWUHIHUWRWKHSURGXFWPRQRJUDSKIRUWKLVLQIRUPDWLRQ

3$7+2/2*<%,263(&,0(16
&HQWUDO3DWKRORJ\5HYLHZ*XLGHOLQHV2&7

,QWKLVVWXG\UHWURVSHFWLYHFHQWUDOUHYLHZIRUFRQILUPDWLRQRIQRQPHWDVWDWLFVPDOOFHOO
OXQJFDQFHU6WDJH7[7710ZLOOEHSHUIRUPHGE\WKH15*2QFRORJ\
%LRVSHFLPHQ%DQN±6DQ)UDQFLVFR15*%%6)XWLOL]LQJVWDQGDUGSDWKRORJLFFULWHULD
7KHSULPDU\UHYLHZHURIHDFKFDVHZLOOEHWKH3DWKRORJ\&R&KDLU'U

6XEPLVVLRQRIELRVSHFLPHQVIRUWKLVUHYLHZLVPDQGDWRU\IRUDOOSDWLHQWV6HH6HFWLRQ
IRUVSHFLPHQFROOHFWLRQDQGVKLSSLQJGHWDLOV

%LRVSHFLPHQ6HOHFWLRQIRU,QWHJUDWHG0DUNHU7HVWLQJ-8/
7XPRUPROHFXODUVXEW\SLQJ
,QDUHFHQWSXEOLFDWLRQE\*D\HWDOLQYHVWLJDWRUVXVHGWXPRUH[SUHVVLRQGDWDDQGD
ELRLQIRUPDWLFVDSSURDFKWRGHPRQVWUDWHWKDW6&/&LVDJURXSRIKHWHURJHQHRXV
PROHFXODUVXEW\SHV7KH\LGHQWLILHGVXEW\SHVODUJHO\EDVHGRQWUDQVFULSWLRQIDFWRUV
LQFOXGLQJ6&/&$6&/&16&/&3DQG6&/&,6&/&$RFFXUULQJLQDERXW
RIFDVHVDQG6&/&1RFFXUULQJLQDERXWRIFDVHVDUHQHXURHQGRFULQH
VXEW\SHVDQGVKDUHKLJKFKURPRJUDQLQDQGV\QDSWRSK\VLQVWDLQLQJ6&/&$LV
FKDUDFWHUL]HGE\$6&/H[SUHVVLRQKLJK77)DQGLVPRUHHSLWKHOLDO6&/&1LV
PRUHQHXURHQGRFULQHGULYHQE\1(852'EXWODFNV77)ZKLOH6&/&3LVGULYHQ
E\328)6&/&,LVDVXEW\SHFKDUDFWHUL]HGE\PRUHPHVHQFK\PDOIHDWXUHV
KLJKHUYLPHQWLQ$;/ORZHU(FDGKHULQDQGRFFXUULQJLQDERXWRIFDVHV
,QWHUHVWLQJO\6&/&,LVFKDUDFWHUL]HGE\KLJKHU&'H[SUHVVLRQDQGLPPXQHFHOO
LQILOWUDWHLQFOXGLQJ7FHOOV1.FHOOVDQGPDFURSKDJHV,QDGGLWLRQ6&/&,
GHPRQVWUDWHVDKLJKHU7FHOOJHQHH[SUHVVLRQVLJQDWXUHVFRUHKLJKHU67,1*SDWKZD\
JHQHH[SUHVVLRQIHDWXUHVDQGKLJKHULPPXQHFKHFNSRLQWV&','27,*,7
9,67$,&26/$*VXJJHVWLQJWKLVVXEW\SHLVDQLPPXQHLQIODPHGVXEW\SH7KLV
WUDQVFULSWLRQDOVXEW\SHDQDO\VLVZDVSHUIRUPHGXWLOL]LQJDQRQQHJDWLYHPDWUL[
IDFWRUL]DWLRQ6NRXOLGLVHWDO30,'WRSUHYLRXVO\SXEOLVKHG51$VHT
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
GDWDIURPVXUJLFDOO\UHVHFWHGOLPLWHGVWDJH6&/&VDPSOHV*HRUJHHWDO
&RQFRUGDQWZLWKWKHDERYHILQGLQJV6&/&,H[SHULHQFHVWKHJUHDWHVWEHQHILWIURPWKH
DGGLWLRQRIDQWL3'/WKHUDS\WRFKHPRWKHUDS\LQ,03RZHUFRPSDULQJILUVWOLQH
DWH]ROL]XPDESOXVFKHPRWKHUDS\YVFKHPRWKHUDS\DORQHIRUH[WHQVLYHVWDJH6&/&
6&/&,SDWLHQWVKDGDPHGLDQRYHUDOOVXUYLYDORIPRQWKVZLWKDWH]ROL]XPDEDQG
FKHPRWKHUDS\FRPSDUHGWRPRQWKVIRUWKHRWKHUVXEW\SHV(LJKWHHQ
SHUFHQWRISDWLHQWVZHUHFODVVLILHGDV6&/&,LQWKLVDQDO\VLV*D\HWDO30,'
7KHVHUHVXOWVVXJJHVWPROHFXODUVXEW\SLQJFDQLGHQWLI\SDWLHQWVPRVWOLNHO\
WRUHVSRQGWRDWH]ROL]XPDEDQGFKHPRWKHUDS\

51$6HTLVDQH[WJHQHUDWLRQVHTXHQFLQJSODWIRUPWKDWPHDVXUHVYDULRXVOHYHOVRI
51$WUDQVFULSWVDQGSURYLGHVVHTXHQFLQJLQIRUPDWLRQ:HZLOOSHUIRUP51$6HTRQ
DYDLODEOHEDVHOLQHDUFKLYDOWXPRUWLVVXHIURPWKH15*%%6)$IWHUH[WUDFWLQJ51$
ZHZLOOSHUIRUP51$6HTRQWXPRUWLVVXHVDPSOHVDQGSHUIRUPELRLQIRUPDWLFV
DQDO\VLVWRVXEW\SHWXPRUVIURPSDWLHQWVHQUROOHGRQ15*/8LQWRWKHVXEW\SHV
6&/&$6&/&16&/&3DQG6&/&,7KLVWHVWLQJZLOOEHGRQHDWD*HQHQWHFK
GHVLJQDWHGWKLUGSDUW\YHQGRUODERUDWRU\([SUHVVLRQ$QDO\VLVD46ROXWLRQV
ODERUDWRU\:HK\SRWKHVL]HWKDWSDWLHQWVEHDULQJWXPRUVZLWKWKH³LQIODPHG´6&/&,
VLJQDWXUHZLOOKDYHWKHKLJKHVWUHVSRQVHWRDWH]ROL]XPDEDQGFKHPRUDGLDWLRQWKHUDS\
OHDGLQJWRLPSURYHG3)6FRPSDUHGWRWKHRWKHUVXEW\SHVRUDJURXSLQJRIDOO
VXEW\SHV6&/&$6&/&1DQG6&/&3

6&/&VXEW\SHVLGHQWLILHGIURPSXEOLFGDWD*D\HWDO&DQFHU&HOODQG
,0SRZHU1DEHWHWDO&DQFHU&HOOZLOOEHDVVLJQHGIURPEXON51$VHTGDWD
IURP15*/8$SUHYLRXVO\GHYHORSHGDQGORFNHGELRLQIRUPDWLFSURWRFROZLOOEH
XVHGIRUWKLVDSSURDFKDVGHVFULEHG0RW]HUHWDO&DQFHU&HOO$UDQGRPIRUHVW
PDFKLQHOHDUQLQJDOJRULWKPZDVWUDLQHGRQGDWDIURP,0SRZHUWRGHYHORSD
FODVVLILHUWRSUHGLFWHDFKRIWKHVXEW\SHVLQSURVSHFWLYHO\FROOHFWHGGDWD$VLQSXWWKH
FODVVLILHUXVHVJHQHH[SUHVVLRQRIWKHPRVWYDULDEOHJHQHVLGHQWLILHGLQ,0SRZHUWR
SUHGLFWFODVVHVLQVXEVHTXHQWGDWD,QSXWGDWDDUHILUVWQRUPDOL]HG]VFRUH
WUDQVIRUPHGWRHQVXUHVLPLODUVFDOHDVWKHWUDLQLQJGDWD,0SRZHUDQGWKH
FODVVLILHUDVVLJQVHDFKQHZVDPSOH15*/8DSUREDELOLW\RIHDFK6&/&
VXEW\SH7KH6&/&VXEW\SHZLWKWKHPD[LPXPSUREDELOLW\LVWKHQDVVLJQHGWRWKH
VDPSOH7KLVDOJRULWKPKDVEHHQSUHYLRXVO\WUDLQHGRQ,0SRZHUDQGWHVWHGRQ
6.<6&5$3(5DQG6.<6&5$3(5&DQGLVIXOO\ORFNHGIRUGHSOR\PHQWRQ
DGGLWLRQDOGDWD

%ORRG6&/&PROHFXODUVXEW\SLQJ
'XHWRWKHFKDOOHQJHVLQREWDLQLQJWXPRUELRSVLHVIRUPROHFXODUSURILOLQJWKHUHLVDQ
XUJHQWQHHGWRGHYHORSQRQLQYDVLYHGLDJQRVWLFPHWKRGVWKDWFDQLGHQWLI\SDWLHQWVZKR
DUHPRUHOLNHO\WREHQHILWIURPDQWL3'/WKHUDSLHV5HFHQWO\&KHPLDQGFROOHDJXHV
UHSRUWHGRQDJHQRPHZLGH'1$PHWK\ODWLRQSURILOLQJPHWKRGWRGHWHFWWKHGLIIHUHQW
WUDQVFULSWLRQIDFWRUPROHFXODUVXEW\SHVYLDOLTXLGELRSV\HJSODVPD7KH\IRXQG
WKDWWKHLUFI'1$PHWK\ODWLRQPHWKRGGLVFULPLQDWHGEHWZHHQWUDQVFULSWLRQIDFWRU
6&/&VXEW\SHV

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
:HZLOOWHVWWKHLUPHWK\ORPHSURILOLQJDVVD\E\SHUIRUPLQJXQVXSHUYLVHG'1$
PHWK\ODWLRQDQDO\VLVIURPFI'1$LVRODWHGIURPSDWLHQWSODVPDVWRUHGDW)RXQGDWLRQ
0HGLFLQH%DWFKHIIHFWUHPRYDOSUHSURFHVVLQJXVLQJWKHOLPPD5SDFNDJHRU
VLPLODUVRIWZDUHZLOOEHSHUIRUPHGEHIRUHFHQWHULQJEHWDYDOXHVDQGDSSO\LQJ3&$
7KHQELRLQIRUPDWLFVDQDO\VLVZLOOEHFRPSOHWHGWRDVVLJQ6&/&VXEW\SHVWRHDFK
SDWLHQW¶VSODVPDHJ$6&/1(852'328)VXEW\SHV:HK\SRWKHVL]HWKDW
WKH$6&/6&/&$1(852'6&/&1DQG328)6&/&3VXEW\SHVZLOO
EHQHILWOHVVIURPDWH]ROL]XPDEDQGFKHPRUDGLDWLRQFRPSDUHGWR6&/&,RU³WULSOH
QHJDWLYH´PROHFXODUVXEW\SHE\GHPRQVWUDWLQJORZHU3)6

6&/&VXEW\SHVZLOOEHDVVLJQHGXVLQJDFHOOIUHH'1$PHWK\ODWLRQEDVHGDVVD\IURP
SODVPDVDPSOHVIURP15*/87KHILQDODVVD\DQGELRLQIRUPDWLFSLSHOLQHZLOOEH
IXOO\WUDLQHGDQGWHVWHGXVLQJVDPSOHVIURP,0SRZHUXVLQJWKH51$VHTEDVHG
VXEW\SHDVVLJQPHQWDVJURXQGWUXWKSULRUWRDSSOLFDWLRQWRVDPSOHVIURP15*/8
$VSUHYLRXVO\GHPRQVWUDWHGE\VHYHUDOJURXSVFHOOIUHH'1$DVVD\VFDQDFFXUDWHO\
LGHQWLI\6&/&VXEW\SHVIURPSODVPD+HHNHHWDO&DQFHU&HOO&KHPLHWDO
1DWXUH&DQFHU:HDUHFXUUHQWO\WUDLQLQJDQGWHVWLQJDQDSSURDFKWKDWXVHVEXW
LVQRWOLPLWHGWRFI'1$PHWK\ODWLRQWRSUHGLFW6&/&VXEW\SHVQRQLQYDVLYHO\
FI'1$LVHQ]\PDWLFDOO\FRQYHUWHGWRLGHQWLI\PHWK\ODWHGUHJLRQVDQGGLIIHUHQWLDOO\
PHWK\ODWHGJHQRPLFUHJLRQVEHWZHHQ6&/&VXEW\SHVDUHXVHGWRGHYHORSDPDFKLQH
OHDUQLQJEDVHGFODVVLILHUWRSURVSHFWLYHO\DVVLJQVDPSOHV$GGLWLRQDODQDO\WHVIURPWKH
VDPHSODVPDVDPSOHVWKDWPD\ERRVWFODVVLILFDWLRQSHUIRUPDQFHDUHDOVREHLQJ
DVVHVVHGVXFKDVFI'1$ZKROHJHQRPHVHTXHQFLQJWRLGHQWLI\GLIIHUHQWLDOO\
IUDJPHQWHGJHQRPLFUHJLRQVDVZHOODVFLUFXODWLQJSURWHRPLFV8VLQJPDWFKWLVVXHDQG
SODVPDVDPSOHVIURP,0SRZHUDVXLWHRIPDFKLQHOHDUQLQJDOJRULWKPV/$662
UDQGRPIRUHVWULGJHUHJUHVVLRQHODVWLFQHWDUHEHLQJWHVWHGWRDVVHVVFODVVLILFDWLRQ
SHUIRUPDQFHXVLQJWKHFI'1$PHWK\ODWLRQEDVHGDVVD\2QFHDQRSWLPDOFODVVLILHUKDV
EHHQGHYHORSHGWKLVDOJRULWKPZLOOEHORFNHGIRUGHSOR\PHQWRQVXEVHTXHQWVDPSOHV
15*/815*/8VDPSOHVZLWKPDWFKHGWLVVXHDQGSODVPDVDPSOHVZLOOEH
WKHILUVWYDOLGDWLRQRIWKLVDSSURDFK

7KHFXUUHQWSODQLVWRSHUIRUPWKHPHWK\ORPHDVVD\DW)UHHQRPH6DQ)UDQFLVFR&$
7KLVWHVWLQJZLOOUHTXLUHEORRGVDPSOHVWKDWVLWHVZLOOFROOHFWDQGVKLSDPELHQW
RYHUQLJKW7KHSODVPDZLOOEHLVRODWHGDQGVWRUHGWHPSRUDULO\DW3UHFLVLRQIRU
0HGLFLQHXQWLOWKHSULPDU\DQDO\VLV

&RUUHODWLRQDQGGHJUHHRIDJUHHPHQWEHWZHHQWXPRU51$6HTDQGEORRG
PHWK\ORPHPROHFXODUVXEW\SLQJZLOODOVREHGHWHUPLQHG


%LRVSHFLPHQ6XEPLVVLRQ7DEOHV-8/
0DQGDWRU\6SHFLPHQ6XEPLVVLRQV
7KLVVWXG\LQFOXGHVPDQGDWRU\FROOHFWLRQRIELRVSHFLPHQVIRUIXWXUHLQWHJUDWHGDQDO\VHV
$QDPHQGPHQWIRUDQ\FRUUHODWLYHVFLHQFHVWXGLHVWREHSHUIRUPHGRQELRORJLFDOVDPSOHV
ZLOOEHVXEPLWWHGWR&7(31&,IRUUHYLHZDQGDSSURYDODFFRUGLQJWR1&71JXLGHOLQHV
RUYLDWKH1DYLJDWRUSRUWDODIWHUWKHWULDOKDVEHHQUHSRUWHG$PHQGPHQWVWRWKHSURWRFRO
DQGRUSURSRVDOVIRUXVHRIEDQNHGWLVVXHRUEORRGVDPSOHVZLOOLQFOXGHWKHDSSURSULDWH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
EDFNJURXQGH[SHULPHQWDOSODQVZLWKDVVD\GHWDLOVDQGDGHWDLOHGVWDWLVWLFDOVHFWLRQ
6DPSOHVIRUWHVWLQJZLOOQRWEHUHOHDVHGIRUWHVWLQJXQWLOWKHDSSURSULDWH1&,DSSURYDOV
KDYHEHHQREWDLQHG

6HHGHWDLOHGVSHFLPHQFROOHFWLRQSURFHVVLQJVKLSSLQJLQVWUXFWLRQVRQWKHSURWRFRO
VSHFLILFSDJHRIWKH&768ZHEVLWH

0DQGDWRU\6SHFLPHQ&ROOHFWLRQ&HQWUDO&RQILUPDWLRQRI7XPRUDQGLQWHJUDWHG
FRUUHODWLYHVWXGLHVRQWLVVXH$IWHUFHQWUDOUHYLHZRIWXPRUWLVVXHLVSHUIRUPHGIRU
SDWLHQWVZKRFRQVHQWWRWLVVXHEDQNLQJWKHIROORZLQJDVVD\VPD\EHSHUIRUPHGXVLQJ
DYDLODEOHUHPDLQLQJ))3(WLVVXH51$VHTXHQFLQJILUVWSDWLHQWVRQO\IRUWLVVXH
PROHFXODUVXEW\SLQJ

x +	(VWDLQHGVOLGHZLWKWXPRUPXVWEHVXEPLWWHGDQGZLOOEHXVHGWRUHWURVSHFWLYHO\
FRQILUPWKHGLDJQRVLVRIVPDOOFHOOFDUFLQRPDDVZHOODVEHXVHGIRUFRUUHODWLYHWLVVXH
VWXGLHV
x ,IUHYLHZRIVXEPLWWHG+	(VOLGHLVLQDGHTXDWHDQHZ+	(VOLGHPD\EHUHTXHVWHG
IURPWKHFRUUHVSRQGLQJWLVVXHEORFNDQGLPPXQRKLVWRFKHPLFDOVWDLQVPD\QHHGWREH
SHUIRUPHGLQFOXGLQJXVHRIVWDQGDUGQHXURHQGRFULQHPDUNHUVWRFRQILUPDGLDJQRVLV
RIVPDOOFHOOOXQJFDQFHU
x ,IVHQGLQJDQ))3(EORFNWXPRUFHOOFRQWHQWVKRXOGEH!DQGDWOHDVWWXPRU
FHOOVLQWKHVSHFLPHQDVDVVHVVHGE\DFRUUHVSRQGLQJ+	(VOLGHFXWIURPWKHEORFN
,ISXQFKFRUHVDUHVHQWLQVWHDGSOHDVHHQVXUHWKDWWKHVHFRUHVDUHWDNHQIURPYLDEOH
QRQQHFURWLFSRUWLRQVRIWXPRUVDVDVVHVVHGZLWKDFRUUHVSRQGLQJ+	(VOLGHFXWIURP
WKHEORFN
x 5HTXLUHG)RUPV67IRUPDQGSDWKRORJ\UHSRUWVZLWKVWXG\DQGFDVHQXPEHUGDWHRI
SURFHGXUHSDWKRORJ\DFFHVVLRQQXPEHUDQ\RWKHUSHUVRQDOKHDOWKLQIRUPDWLRQ3+,
VKRXOGEHUHGDFWHGE\VLWHVEHIRUHVHQGLQJ
x 6KLSSLQJFRVWV6XEPLWWLQJVLWHSD\VFRVWRIVKLSSLQJ))3(VDPSOHVDQGSD\VIRU
UHWXUQV6LWHVFDQVKLS))3(PDWHULDO0RQGD\)ULGD\
x 5HVLGXDO0DWHULDO+	(VOLGHVDQGEORFNVZLOOEHUHWDLQHGDWWKHEDQNXQOHVVQHHGHG
IRULPPHGLDWHSDWLHQWFDUH

6KLSDOO))3(ELRVSHFLPHQVIRUFHQWUDOUHYLHZIRUWKLVWULDOWR
15*2QFRORJ\%LRVSHFLPHQ%DQN±6DQ)UDQFLVFR
8QLYHUVLW\RI&DOLIRUQLD6DQ)UDQFLVFR
6XWWHU6WUHHW5RRP6
6DQ)UDQFLVFR&$

)$;
15*%%#XFVIHGX

48(67,216&DOORUHPDLOWKH15*%%6)
0DQGDWRU\6SHFLPHQ
7\SH
&ROOHFWLRQ7LPH
3RLQWV
&ROOHFWLRQ
,QIRUPDWLRQDQG
6KLSSLQJ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
5HTXLUHPHQWV
2QH+	(VOLGHIURP
SULPDU\WXPRUFDQEH
IURPDO\PSKQRGHRUDQ
)1$RQO\LID
FRUUHVSRQGLQJ))3(
EORFNLVDYDLODEOH
3UHWUHDWPHQW
+	(6OLGHVFDQEH
GLDJQRVWLFRUGXSOLFDWH
FXWVOLGHV%DQNUHWDLQV
DOOVOLGHVXQOHVV
RWKHUZLVHUHTXHVWHGIRU
SDWLHQWFDUH
6OLGHVVKLSSHG
DPELHQW
WHPSHUDWXUHWR
15*%%6)
))3(%ORFNUHTXLUHG
RQO\IRUSDWLHQWVZKR
FRQVHQWWREDQNLQJ
3UHWUHDWPHQW
&RUUHVSRQGLQJ))3(
%ORFNUHFRPPHQGHG

,IVLWHLVXQDEOHWR
VXEPLWD%ORFNWKHQ
WKHIROORZLQJ
DOWHUQDWLYHLV
DFFHSWDEOH7ZRRU
WKUHHPPRUPP
SXQFKHVWXPRUVL]H
GHSHQGHQWHPEHGGHG
LQSDUDIILQZLWKD
FRUUHVSRQGLQJ+	(
SXQFKNLWVDYDLODEOH
IURP15*%%6DQ
)UDQFLVFR

8QVWDLQHGVOLGHVDUH
QRWDFFHSWDEOH
6KLSE\RYHUQLJKW
FDUULHUWR15*%%
6)XVHFROGSDFNV
GXULQJZDUP
ZHDWKHU
)RUVLWHVZLWKWKHFDSDELOLW\WRGRVRWKHWZRWRWKUHHPPSXQFKELRSVLHVVKRXOGEHHPEHGGHG
LQWRRQHQHZSDUDIILQEORFNIURPZKLFKDQ+	(VOLGHVKRXOGEHREWDLQHG7KHFRQVWUXFWHGEORFN
FRQWDLQLQJWKHSXQFKDQGWKH+	(VOLGHPXVWWKHQEHVXEPLWWHGWRWKH15*%%6)DORQJZLWK
WKHRULJLQDO+	(VOLGH$OWHUQDWLYHO\VLWHVFDQHLWKHUVHQGWKHEORFNWRWKH%LRVSHFLPHQ%DQN
DQGWKHEDQNZLOOSXQFKDQGHPEHGWKHEORFNVIRUWKHVLWHVEHIRUHUHWXUQLQJWKHPRUVHQGWKH
WZRWRWKUHHSXQFKHVWRWKHEDQNWREHHPEHGGHGE\WKH%LRVSHFLPHQ%DQN

0DQGDWRU\6SHFLPHQ&ROOHFWLRQ)RULQWHJUDWHGEORRGPROHFXODUVXEW\SLQJDQG
IUR]HQZKROHEORRGIRUVHTXHQFLQJFRQWURO
x 6SHFLPHQP/EORRGLQ%&7WXEHVPXVWEHFROOHFWHGPLQLPXPP/DQG
VHQWZLWKLQKRXUVRIFROOHFWLRQWR3UHFLVLRQIRU0HGLFLQH30VHH$SSHQGL[9
EHORZIRUGHWDLOV3ODVPDZLOOEHLVRODWHGVWRUHGWHPSRUDULO\DW30DQGVKLSSHG
EDFNWRWKH15*ELRVSHFLPHQEDQNIRUDOOSDWLHQWV6SHFLPHQVZLOOEHXVHGWR
LGHQWLI\ZKHWKHUWXPRUPROHFXODUVXEW\SLQJIURPEORRGFI'1$PHWK\ORPH
SURILOLQJFDQSUHGLFWUHVSRQVHWRDWH]ROL]XPDE
x 6SHFLPHQP/ZKROHEORRGDVDFRQWUROZLOOQHHGWREHFROOHFWHGLQ.('7$
WXEHVDOLTXRWHGLQWRFU\RYLDOVRQWKHVDPHGD\DVFROOHFWLRQDQGVWRUHGIUR]HQ
)UR]HQZKROHEORRGZLOOEHVKLSSHGWRWKH15*%%6)LQEDWFKHV
x 5HTXLUHG)RUPV6WXG\VSHFLILF67IRUPIRU6SHFLPHQUHJXODU15*67IRUPIRU
6SHFLPHQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
x 0DWHULDOV)RU6SHFLPHQ%&7WXEHVDQGNLWVDQGVKLSSLQJODEHOVFDQEHUHTXHVWHG
IURP30)RU6SHFLPHQZKROHEORRGNLWVFDQEHUHTXHVWHGIURPWKH15*%%6)
DW15*%%#XFVIHGX$OORZEXVLQHVVGD\VIRUPDWHULDOVWRDUULYH6LWHVPXVW
KDYH,5%DSSURYDOEHIRUHUHTXHVWLQJPDWHULDOV86DQG&DQDGLDQVLWHVZLOOUHFHLYH
RQHSUHSDLGUHWXUQODEHOSURYLGHGIRUHDFKFDVHIRUEDWFKVKLSSLQJRIIUR]HQ
ELRVSHFLPHQVRQO\6LWHVLQ-DSDQDUHWRSURYLGHWKHLURZQVKLSSLQJFRQWDLQHUVDQG
VKRXOGVWRUH6SHFLPHQDW& DQG WKHQ EDWFK VKLS VDPSOHV IURP PXOWLSOH
SDWLHQWV
x 6KLSSLQJFRVWV1RQH*HQHQWHFKFRYHUVDOOVKLSSLQJFRVWV
6KLS6SHFLPHQSHULQVWUXFWLRQVLQ$SSHQGL[9EHORZWR

866LWHV
$771

3UHFLVLRQIRU0HGLFLQH30
3UHFLVLRQ:D\
)UHGHULFN0'
5HSRVLWRU\6HUYLFHV0DLOER[#SUHFLVLRQIRUPHGLFLQHFRP

6LWHVLQ-DSDQ
1DWLRQDO8QLYHUVLW\+RVSLWDO63WH/WG
FR18+7LVVXH5HSRVLWRU\
/RZHU.HQW5LGJH5RDG
0DLQ%XLOGLQJ/HYHO
6LQJDSRUH
3UHFLVLRQ$3$&#SUHFLVLRQIRUPHGLFLQHFRP

6DPSOHVFDQEHVKLSSHGWR3UHFLVLRQIRU0HGLFLQHRQ)ULGD\IRU6DWXUGD\'HOLYHU\
3OHDVHGRQRWVKLSVDPSOHVRQ6DWXUGD\6XQGD\RUWKHGD\EHIRUHDQDWLRQDOO\
UHFRJQL]HGKROLGD\

6KLS6SHFLPHQWR
15*2QFRORJ\%LRVSHFLPHQ%DQN±6DQ)UDQFLVFR
8QLYHUVLW\RI&DOLIRUQLD6DQ)UDQFLVFR
6XWWHU6WUHHW5RRP6
6DQ)UDQFLVFR&$
)$;
15*%%#XFVIHGX

127(6KLSZKROHEORRGVSHFLPHQWR15*%LREDQNRQ0RQGD\WR:HGQHVGD\
'R127VKLSGD\VEHIRUHDQDWLRQDOO\UHFRJQL]HGKROLGD\&KHFN15*EURDGFDVWVIRU
RWKHUFORVXUHV

0DQGDWRU\6SHFLPHQ
7\SH
&ROOHFWLRQ
7LPH3RLQWV
&ROOHFWLRQ,QIRUPDWLRQ
DQG5HTXLUHPHQWV
6KLSSLQJ
:+2/(%/22'
6SHFLPHQP/RI
3UHWUHDWPHQW

)RUPV6WXG\VSHFLILF67
IRUP
866LWHV
6KLSDPELHQWE\
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
IUHVKEORRGWR\LHOGa
P/RISODVPDDIWHU
SURFHVVLQJE\3UHFLVLRQ
IRU0HGLFLQHLQ%&7
WXEHVDQGVKLSSHGZLWKLQ
KUVRIFROOHFWLRQ




.LWVUHTXHVWIURP30

6KLSSLQJ
866LWHV
2QHSUHSDLG)HG([ODEHO
SURYLGHGE\30&DQEH
VKLSSHGZLWKRSWLRQDO
VSHFLPHQVLQ
6LWHVLQ-DSDQ
,QVWUXFWLRQVIRUVKLSSLQJ
YLD4XLFN6WDWWREH
LQFOXGHGLQ3UHFLVLRQIRU
0HGLFLQHODEPDQXDO/DE
PDQXDOZLOOEHSURYLGHG
HOHFWURQLFDOO\WRWKHVLWHV
&DQEHVKLSSHGZLWK
RSWLRQDOVSHFLPHQVLQ

3ULRULW\2YHUQLJKW
&RXULHUWR3UHFLVLRQ
IRU0HGLFLQHIRU
GHWDLOVVHH
$SSHQGL[9EHORZ
6LWHVLQ-DSDQ
6KLSDPELHQWE\
4XLFN6WDWWR
1DWLRQDO8QLYHUVLW\
+RVSLWDOIRUGHWDLOV
VHH$SSHQGL[9
EHORZ
:+2/(%/22'
6SHFLPHQP/RI
DQWLFRDJXODWHGZKROH
EORRGLQ.('7$WXEHV
3UHWUHDWPHQW

)RUPV67)RUP
6SHFLPHQV:KROHEORRG
VDPSOHVFRQWDLQLQJD
PLQLPXPRIP/SHU
DOLTXRWLQWKUHHP/
FU\RYLDOVIUR]HQDQG
VWRUHGDW&&DQEH
EDWFKVKLSSHGWR15*%%
6)
$OOVLWHV6KLS
IUR]HQRQGU\LFHE\
3ULRULW\2YHUQLJKW
&RXULHUWR15*%%
6)

6LWHVLQ-DSDQ
%DWFKVKLSVDPSOHV
IURPPXOWLSOH
SDWLHQWV

2SWLRQDO6SHFLPHQ6XEPLVVLRQV
3DWLHQWVPXVWEHRIIHUHGWKHRSSRUWXQLW\WRFRQVHQWWRRSWLRQDOVSHFLPHQFROOHFWLRQ,IWKH
SDWLHQWFRQVHQWVWRSDUWLFLSDWHWKHVLWHLVUHTXLUHGWRVXEPLWWKHSDWLHQW¶VVSHFLPHQVDV
VSHFLILHGSHUSURWRFRO6LWHVDUHQRWSHUPLWWHGWRGHOHWHWKHVSHFLPHQFRPSRQHQWIURPWKH
SURWRFRORUIURPWKHVDPSOHFRQVHQW

7KLVVWXG\LQFOXGHVRSWLRQDOFROOHFWLRQRIELRVSHFLPHQVIRUIXWXUHDQDO\VHVIRUH[DPSOH
WRDVVHVVELRPDUNHUVLQDVVRFLDWLRQZLWKWUHDWPHQWFRPSOLFDWLRQV$QDPHQGPHQWIRUDQ\
FRUUHODWLYHVFLHQFHVWXGLHVWREHSHUIRUPHGRQELRORJLFDOVDPSOHVZLOOEHVXEPLWWHGWR
&7(31&,IRUUHYLHZDQGDSSURYDODFFRUGLQJWR1&71JXLGHOLQHVRUYLDWKH1DYLJDWRU
SRUWDODIWHUWKHWULDOKDVEHHQUHSRUWHG$PHQGPHQWVWRWKHSURWRFRODQGRUSURSRVDOVIRU
XVHRIEDQNHGWLVVXHRUEORRGVDPSOHVZLOOLQFOXGHWKHDSSURSULDWHEDFNJURXQG
H[SHULPHQWDOSODQVZLWKDVVD\GHWDLOVDQGDGHWDLOHGVWDWLVWLFDOVHFWLRQ6DPSOHVIRU
WHVWLQJZLOOQRWEHUHOHDVHGIRUWHVWLQJXQWLOWKHDSSURSULDWH1&,DSSURYDOVKDYHEHHQ
REWDLQHG

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
6HHGHWDLOHGVSHFLPHQFROOHFWLRQSURFHVVLQJVKLSSLQJLQVWUXFWLRQVDWRQWKHSURWRFRO
VSHFLILFSDJHRIWKH&768ZHEVLWH

2SWLRQDO6SHFLPHQ&ROOHFWLRQIRU7LVVXH%LREDQNLQJIRU3RWHQWLDO)XWXUH5HVHDUFK
)RUPV67)RUPSDWKRORJ\UHSRUWZLWKDFFHVVLRQQXPEHUDQGGDWHRISURFHGXUHYLVLEOH$OO
RWKHU3+,LQIRUPDWLRQVKRXOGEHUHGDFWHG

x )RUSDWLHQWVZKRFRQVHQWWREDQNLQJWKHWXPRUEORFNWKDWFRUUHVSRQGVWRWKHPDQGDWRU\
+	(VWDLQHGVOLGHO\PSKQRGHEORFNRU)1$FHOOEORFNLVUHTXLUHGDQGFDQEHUHWXUQHG
XSRQUHTXHVWIRULPPHGLDWHSDWLHQWFDUH
x 7ZRWRWKUHHSXQFKELRSVLHVPPLQVL]HRIWKHSDUDIILQEORFNPD\EHVXEVWLWXWHGLQ
SODFHRIWKH))3(EORFN7KHSXQFKHVVKRXOGEHHPEHGGHGLQWRDQHZEORFNDQG
VXEPLWWHGZLWKDQHZ+	(2ULJLQDO+	(PXVWVWLOOEHVXEPLWWHGIRUFHQWUDOUHYLHZ
x $Q))3(FHOOEORFNIURPILQHQHHGOHDVSLUDWLRQRIWKHSULPDU\WXPRURUIURPO\PSKQRGH
WLVVXHPD\EHVXEPLWWHGLQVWHDGRISULPDU\WXPRUEORFNLIVXIILFLHQWWXPRUFHOOVDUH
SUHVHQW

))3(3XQFK.LWVFDQEHUHTXHVWHGDWWKHVDPHWLPHDVEORRGNLWVIURPWKH15*%%6)DW
15*%%#XFVIHGX$OORZEXVLQHVVGD\VIRUNLWV6LWHVPXVWKDYH,5%DSSURYDOEHIRUH
UHTXHVWLQJNLWV
6KLSSLQJ6LWHVSD\IRU))3(VKLSPHQWV6LWHVFDQVKLS))3(VDPSOHV0RQGD\)ULGD\

6KLSVSHFLPHQVWR
15*2QFRORJ\%LRVSHFLPHQ%DQN±6DQ)UDQFLVFR
8&6)±'HSWRI5DGLDWLRQ2QFRORJ\
6XWWHU6WUHHW5RRP6
6DQ)UDQFLVFR&$

)RUTXHVWLRQVSOHDVHFRQWDFWWKH6DQ)UDQFLVFR%DQNDW
(PDLO15*%%#XFVIHGX
)D[
6SHFLPHQ7\SH
&ROOHFWLRQ7LPH
3RLQWV
&ROOHFWLRQ,QIRUPDWLRQ
DQG5HTXLUHPHQWV
,QVWUXFWLRQVIRU6LWH
6KLSSLQJ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
+	(VOLGHVRI
SULPDU\WXPRU

3UHWUHDWPHQW


&DQEHVDPHPDWHULDODVIRU
FHQWUDOUHYLHZLQ6HFWLRQ

6KLSDPELHQW
WHPSHUDWXUHWR
15*%%6)E\
RYHUQLJKWFRXULHU
))3(%ORFNRI
SULPDU\WXPRU
VDPHDV+	(

3UHWUHDWPHQW

6LWHVKRXOGPDNHHYHU\
HIIRUWWRVXEPLWWKHEORFN
IRUWKLVVWXG\&DQEHVDPH
PDWHULDODVIRUFHQWUDO
UHYLHZLQ6HFWLRQ,I
VLWHLVXQDEOHWRVXEPLWD
%ORFNWKHQWKHIROORZLQJ
DOWHUQDWLYHLVDFFHSWDEOH
7ZRRUWKUHHPPRU
PPSXQFKHVWXPRUVL]H
GHSHQGHQWHPEHGGHGLQ
SDUDIILQZLWKD
FRUUHVSRQGLQJ+	(SXQFK
NLWVDYDLODEOHIURP15*
%%6DQ)UDQFLVFR

1RWH8QVWDLQHGVOLGHVDUH
QRWDFFHSWDEOH
6KLSDPELHQW
WHPSHUDWXUHE\
RYHUQLJKWFDUULHUWR
15*%%6)
XVHFROGSDFNV
GXULQJZDUPZHDWKHU
7KH15*%%6)FDQHPEHGWKHSXQFKHVIRUVLWHVZLWKRXWWKHIDFLOLWLHVWRHPEHGSXQFKHVLQWR
EORFNV

2SWLRQDO6SHFLPHQ&ROOHFWLRQIRU3ODVPDDQG3%0&%LREDQNLQJIRU3RWHQWLDO)XWXUH
5HVHDUFK

6DPSOH6L]H7HVWLQJZLOOEHSHUIRUPHGRQPDWHULDOVIURPSDWLHQWVZKRFRQWULEXWHVDPSOHVDW
DOOWKUHHWLPHSRLQWVEDVHOLQHGD\RQHDIWHU&57DQGDWWKUHHPRQWKVSRVW&577RHQVXUHWKDW
ZHKDYHSDWLHQWVZLWKVXEPLVVLRQVDWDOOWKUHHWLPHSRLQWVZHZLOOFROOHFWVSHFLPHQVIURPWKH
ILUVWSDWLHQWVWKDWFRQVHQWWRSDUWLFLSDWHLQWKLVRSWLRQDOFROOHFWLRQ

)RUPV6WXG\VSHFLILF67IRUP

.LWVDQG6KLSSLQJ$OOQHFHVVDU\PDWHULDOVIRUVKLSSLQJLQFOXGLQJEORRGFROOHFWLRQWXEHVDQG
SUHSDLG)HG([ODEHOVFDQEHREWDLQHGIURP3UHFLVLRQIRU0HGLFLQH3OHDVHFRQWDFW

WRDUUDQJHIRUGHOLYHU\RIPDWHULDOV6LWHVPXVWKDYH
,5%DSSURYDOSULRUWRUHTXHVWLQJNLWV

6KLSVDPSOHVSHULQVWUXFWLRQVLQ$SSHQGL[9EHORZWR

866LWHV
$771

3UHFLVLRQIRU0HGLFLQH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
3UHFLVLRQ:D\
)UHGHULFN0'
5HSRVLWRU\6HUYLFHV0DLOER[#SUHFLVLRQIRUPHGLFLQHFRP

6LWHVLQ-DSDQ
1DWLRQDO8QLYHUVLW\+RVSLWDO63WH/WG
FR18+7LVVXH5HSRVLWRU\
/RZHU.HQW5LGJH5RDG
0DLQ%XLOGLQJ/HYHO
6LQJDSRUH
3UHFLVLRQ$3$&#SUHFLVLRQIRUPHGLFLQHFRP

)RUTXHVWLRQVSOHDVHFRQWDFW3UHFLVLRQIRU0HGLFLQHDWWKHHPDLODERYH

6DPSOHVFDQEHVKLSSHGRQ)ULGD\IRU6DWXUGD\'HOLYHU\3OHDVHGRQRWVKLSVDPSOHVRQ
6DWXUGD\6XQGD\RUWKHGD\EHIRUHDQDWLRQDOO\UHFRJQL]HGKROLGD\
6SHFLPHQ7\SH
&ROOHFWLRQ7LPH
3RLQWV
&ROOHFWLRQ,QIRUPDWLRQ
DQG5HTXLUHPHQWV
,QVWUXFWLRQVIRU6LWH
6KLSSLQJ
:+2/(
%/22')25
3/$60$
,62/$7,21

$SSUR[LPDWHO\
P/LQ%&7
WXEHVDQG
VKLSSHGZLWKLQ
KUVRI
FROOHFWLRQ

3UHWUHDWPHQW

'D\DIWHU
FRPSOHWLRQRI&57

PRQWKVDIWHUHQGRI
&57


)RUPV6WXG\VSHFLILF67
IRUP

.LWVUHTXHVWIURP30

6KLSSLQJ
866LWHV
2QHSUHSDLG)HG([ODEHO
SURYLGHGE\30
6LWHVLQ-DSDQ
,QVWUXFWLRQVIRUVKLSSLQJYLD
4XLFN6WDWWREHLQFOXGHGLQ
3UHFLVLRQIRU0HGLFLQHODE
PDQXDO/DEPDQXDOZLOOEH
SURYLGHGHOHFWURQLFDOO\WR
WKHVLWHV
866LWHV
6KLSDPELHQWE\
3ULRULW\2YHUQLJKW
&RXULHUWR3UHFLVLRQ
IRU0HGLFLQHIRU
GHWDLOVVHH$SSHQGL[
9EHORZ
6LWHVLQ-DSDQ
6KLSDPELHQWE\
4XLFN6WDWWR1DWLRQDO
8QLYHUVLW\+RVSLWDO
IRUGHWDLOVVHH
$SSHQGL[9EHORZ

:+2/(
%/22')25
3%0&
,62/$7,21
aP/RIZKROH
EORRGLQ.
('7$WXEHVDQG
VKLSSHGZLWKLQ
KUVRI
FROOHFWLRQ

3UHWUHDWPHQW



'D\DIWHU
FRPSOHWLRQRI&57

PRQWKVDIWHUHQGRI
&57


)RUPV6WXG\VSHFLILF67
IRUP

.LWVUHTXHVWIURP30

6KLSSLQJ
866LWHV
2QHSUHSDLG)HG([ODEHO
SURYLGHGE\30&DQEH
VKLSSHGZLWKRSWLRQDO
VSHFLPHQVLQ
866LWHV
6KLSDPELHQWE\
3ULRULW\2YHUQLJKW
&RXULHUWR30)RU
GHWDLOVVHH$SSHQGL[
9EHORZ
6LWHVLQ-DSDQ
6KLSDPELHQWE\
4XLFN6WDWWR1DWLRQDO
8QLYHUVLW\+RVSLWDO
IRUGHWDLOVVHH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

6LWHVLQ-DSDQ
,QVWUXFWLRQVIRUVKLSSLQJYLD
4XLFN6WDWWREHLQFOXGHGLQ
3UHFLVLRQIRU0HGLFLQHODE
PDQXDO/DEPDQXDOZLOOEH
SURYLGHGHOHFWURQLFDOO\WR
WKHVLWHV
$SSHQGL[9EHORZ
&RPSOHWLRQRI&57GHILQHGDVWKHHQGRIWKHODVWF\FOHRIFKHPRWKHUDS\HJGD\F\FOH
RISODWLQXPHWRSRVLGHSURWRFROLQIXVLRQ127(GRQRWFROOHFWVXEPLWVDPSOHVIURPSDWLHQWV
ZKRGRQRWKDYHDEDVHOLQHVDPSOH

63(&,$/678',(61217,668(
4XDOLW\RI/LIH42/DQG3DWLHQW5HSRUWHG2XWFRPHV352V
%DFNJURXQG
+HDOWKUHODWHG42/LVDQLPSRUWDQWHQGSRLQWLQFOLQLFDOWULDOVWRDVVHVVWUHDWPHQWHIIHFW
IURPWKHSDWLHQW¶VSHUVSHFWLYHXVLQJ352V,QWKLVVWXG\DWH]ROL]XPDEZLOOEHJLYHQ
FRQFXUUHQWO\ZLWKFKHPRUDGLDWLRQDQGZLOOFRQWLQXHIRUDIXOO\HDU,IWKHDWH]ROL]XPDE
DUPVKRZVVXSHULRU26DQHZVWDQGDUGRIFDUHZLOOEHGHILQHGIRUOLPLWHGVWDJHVPDOO
FHOOOXQJFDQFHU7KHHIIHFWVRIDWH]ROL]XPDEFRPELQHGZLWK&57RQ42/DUHFXUUHQWO\
XQNQRZQ7KLVVWXG\SURYLGHVDXQLTXHRSSRUWXQLW\WRVWXG\WKHHIIHFWVRI
LPPXQRWKHUDS\RQ42/,WLVDQWLFLSDWHGWKDWDWH]ROL]XPDEZLOOLPSURYH26ZKLOH
PDLQWDLQLQJDUHDVRQDEOHWR[LFLW\SURILOH*LYHQWKHKLJKGHJUHHRIV\PSWRPEXUGHQRI
VPDOOFHOOOXQJFDQFHUFKDUDFWHUL]HGE\FHQWUDODQGRIWHQREVWUXFWLQJSULPDU\WXPRUV
LPSURYHPHQWVLQ3)6DQG26ZLWKLPPXQRWKHUDS\DUHOLNHO\WRFRUUHODWHZLWK42/
ZLWKOHVVFDQFHUUHODWHGV\PSWRPDWRORJ\7KHK\SRWKHVLVIRUWKLVVWXG\LVWKDWORQJ
WHUP42/XVLQJ)$&772,DWPRQWKVIURPWKHHQGRI&57aPRQWKVIURP
FRPSOHWLRQRILPPXQRWKHUDS\IRUSDWLHQWVUHFHLYLQJDWH]ROL]XPDEZLOOEHVXSHULRULQ
WKH&57SOXVDWH]ROL]XPDEDUPFRPSDUHGWRWKH&57DORQHDUPDVWKHDGGLWLRQRI
DWH]ROL]XPDELVH[SHFWHGWRLPSURYHWXPRUUHVSRQVHWR&57DQGWKHUHE\LPSURYH42/


$VVHVVPHQWV2&7
)$&772,
,QRUGHUWRDQDO\]HWKHGLIIHUHQFHLQ42/EHWZHHQDOODUPVZHSODQWRXVHDEULHI
YDOLGDWHGLQVWUXPHQWWKDWLVXVHUIULHQGO\DQGKDVFOLQLFDOUHOHYDQFH)$&772,LVD
PHDVXUHRILWHPVWKDWVXPVWKHIXQFWLRQDOZHOOEHLQJ):%SK\VLFDOZHOOEHLQJ
3:%DQGWKHOXQJFDQFHUVXEVFDOH/&6RIWKH)XQFWLRQDO$VVHVVPHQWRI&DQFHU
7KHUDS\±/XQJ)$&7/42/LQVWUXPHQWZKLFKKDVEHHQH[WHQVLYHO\XVHGIRU
PHDVXULQJ42/LQSDWLHQWVZLWKOXQJFDQFHU,QDUHYLHZRIOLWHUDWXUHUHSRUWHGWKDWWKH
)$&7/VFDOHKDVEHHQXVHGLQPRUHWKDQSDWLHQWVDQGKDVEHHQIRXQGWREH
VHQVLWLYHWRFKDQJHVLQSHUIRUPDQFHVWDWXVWUHDWPHQWUHVSRQVH)$&7KDVEHHQ
WUDQVODWHGLQWRPDQ\ODQJXDJHVDQGLVDYDLODEOHIUHHRIFKDUJHWRLQVWLWXWLRQVZLWKWKH
FRPSOHWLRQRIDQDJUHHPHQWWRVKDUHGDWDDFFHVVLEOHDW
KWWSZZZIDFLWRUJWUDQVODWLRQOLFHQVXUHDVS[7KLVLQVWUXPHQWKDVQRWRQO\EHHQ
VKRZQWREHSURJQRVWLFIRUVXUYLYDOEXWDOVRVHQVLWLYHWRFKDQJHVLQ42/RQVHULDO
HYDOXDWLRQVWKURXJKRXWWUHDWPHQW,PSRUWDQWO\WKH)$&772,KDVEHHQDVVRFLDWHGZLWK
FOLQLFDOO\PHDQLQJIXOFKDQJHVLQSDWLHQWVZLWKOXQJFDQFHU7KHOXQJFDQFHUVXEVFDOH
/&6FRQVLVWVRILWHPVLQYROYLQJOXQJFDQFHUVSHFLILFV\PSWRPV$OOLWHPVDUHUDWHG
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
RQDLWHPSRLQW/LNHUW6FDOHIURPQRWDWDOOWRYHU\PXFK,WKDVEHHQ
GHWHUPLQHGWKDWDSRLQWGLIIHUHQFHRQWKH)$&772,LVDVVRFLDWHGZLWKDPHDQLQJIXO
GLIIHUHQFHLQFOLQLFDODQGVXEMHFWLYHLQGLFDWRUV7KXVDGLIIHUHQFHRISRLQWVZLOOEH
FRQVLGHUHGFOLQLFDOO\VLJQLILFDQW+DQGOLQJRIPLVVLQJGDWDZLOOEHLQDFFRUGDQFHZLWK
WKH)$&,7$GPLQLVWUDWLRQDQG6FRULQJ*XLGHOLQHVGHVFULEHGDWZZZIDFLWRUJ

7KHIXOO)$&7/TXHVWLRQQDLUHFDQEHFRPSOHWHGLQOHVVWKDQPLQXWHV3DWLHQWVZLOO
FRPSOHWHWKH)$&772,DWWKHWLPHSRLQWVGHVFULEHGLQ6HFWLRQ

)DWLJXHLQ16&/&SDWLHQWVUHFHLYLQJ&57DQGLPPXQRWKHUDS\
,QFOLQLFDOVWXGLHVLQYHVWLJDWLQJLPPXQRWKHUDS\WKHPRVWFRPPRQWR[LFLW\GHVFULEHGLV
IDWLJXH2WKHUWR[LFLWLHVLQFOXGHGHUPDWRORJLFWR[LFLW\JDVWURLQWHVWLQDOV\PSWRPV
GLDUUKHDFROLWLVGHFUHDVHGDSSHWLWH5DUHLPPXQRORJLFPHGLDWHGWR[LFLWLHVIURP
LPPXQRWKHUDS\KDYHEHHQGHVFULEHGDQGLQFOXGHSQHXPRQLWLVDQGHQGRFULQRSDWKLHV
SLWXLWDU\K\SRWKDODPXVWK\URLGDQGDGUHQDOGLVHDVH7KHVHLPPXQHPHGLDWHG
WR[LFLWLHVPD\SUHVHQWZLWKQRQVSHFLILFV\PSWRPVVXFKDVIDWLJXHKHDGDFKHPHQWDO
VWDWXVFKDQJHVDEGRPLQDOSDLQFKDQJHLQERZHOKDELWVRUK\SRWHQVLRQ,QOXQJFDQFHU
IDWLJXHLVRQHRIWKHPRVWFRPPRQDQGGLVWUHVVLQJV\PSWRPVDIIHFWLQJXSWRRI
SDWLHQWV:LWKFRQFXUUHQWFKHPRUDGLDWLRQWKHPDMRULW\RISDWLHQWVH[SHULHQFHIDWLJXH
XVXDOO\SHDNLQJGXULQJWKHILUVWDQGVHFRQGZHHNVDIWHUFRPSOHWLRQRI&57ZKLFKFDQ
UHPDLQKLJKHUWKDQEDVHOLQHLQDSSUR[LPDWHO\KDOIRISDWLHQWVORQJWHUP%HFDXVH
DSSUR[LPDWHO\RISDWLHQWVXQGHUJRLQJLPPXQRWKHUDS\DORQHH[SHULHQFHIDWLJXHWKH
HIIHFWRILPPXQRWKHUDS\ZLWK&57RQSDWLHQWUHSRUWHGIDWLJXHZDUUDQWVVWXG\

+HQFHDVHFRQGDU\REMHFWLYHLVWRHYDOXDWHSDWLHQWUHSRUWHGIDWLJXHXVLQJWKH3520,6
IDWLJXHVKRUWIRUPLQSDWLHQWVUHFHLYLQJDWH]ROL]XPDEFRQFXUUHQWO\DQGIROORZLQJ
FKHPRUDGLDWLRQIRUOXQJFDQFHU:HDFNQRZOHGJHWKDWWKHGDWDDURXQGIDWLJXHLQ
SDWLHQWVXQGHUJRLQJFKHPRUDGLDWLRQSOXVLPPXQRWKHUDS\LVPLQLPDODQGZHEHOLHYH
PHDVXULQJIDWLJXHLQDV\VWHPDWLFZD\ZLOOLQIRUPIXWXUHWULDOVWKDWVWXG\
FKHPRUDGLDWLRQDQGLPPXQRWKHUDS\FRPELQDWLRQV

3520,6)DWLJXH$1RYHO6KRUW)RUP)DWLJXH6FDOH
7KH1DWLRQDO,QVWLWXWHVRI+HDOWK1,+3DWLHQW5HSRUWHG2XWFRPHV0HDVXUHPHQW
,QIRUPDWLRQ6\VWHP3520,65RDGPDSLQLWLDWLYHZZZQLKSURPLVRUJZDVLQLWLDWHG
3520,6LVD\HDUFRRSHUDWLYHJURXSSURJUDPRIUHVHDUFKGHVLJQHGWRGHYHORS
YDOLGDWHDQGVWDQGDUGL]HLWHPEDQNVWRPHDVXUHSDWLHQWUHSRUWHGRXWFRPHV352V
UHOHYDQWDFURVVFRPPRQPHGLFDOFRQGLWLRQVLQFOXGLQJFDQFHU>&HOOD*DUFLD
@,QWHJUDOWRWKHZRUNRIWKLVJURXSLVWKHFUHDWLRQRID3520,6GHULYHGIDWLJXH
VKRUWIRUPXVLQJOLPLWHGTXHVWLRQVWRPLQLPL]HSDWLHQWEXUGHQWKDWZDVGHYHORSHGIRU
HDVHRIXVHLQRQFRORJ\SRSXODWLRQV:KLOHWKHSV\FKRPHWULFSURSHUWLHVRIWKLV
TXHVWLRQVKRUWIDWLJXHVFDOHKDYHEHHQYDOLGDWHGLQWKHJHQHUDOSRSXODWLRQ>*DUFLD
/DL@YDOLGDWLRQLQSDWLHQWVZLWKFDQFHULVRQJRLQJ$³FURVVZDON´KDVEHHQ
VXFFHVVIXOO\GHYHORSHGEHWZHHQWKH3520,6IDWLJXHLWHPEDQNDQGWKH3520,6
&DQFHUIDWLJXHLWHPEDQNWKDWSURGXFHGWKHVKRUWIRUPPHDVXUH7KHVHWZRLWHPEDQNV
VKDULQJFRPPRQLWHPVZHUHOLQNHGE\HTXDWLQJLWHPSDUDPHWHUVXVLQJLWHPVWKDW
KHOGVWDEOHSV\FKRPHWULFSURSHUWLHVEHWZHHQWKHFDQFHUDQGJHQHUDOSRSXODWLRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
SRSXODWLRQVLQZKLFKWKH\ZHUHWHVWHG5HVXOWVVKRZHGWKDWFDQFHUSDWLHQWVUHSRUWHG
PRUHVHYHUHIDWLJXHVWDQGDUGGHYLDWLRQPRUHVHYHUHEXWWKHVDPHVFDOH
FKDUDFWHULVWLFFXUYHVORSHWKDQWKHJHQHUDOSRSXODWLRQZKLFKPDWFKHVFOLQLFDO
H[SHFWDWLRQV>&HOOD@

7KLVTXHVWLRQVKRUWIDWLJXHVFDOHFDQEHFRPSOHWHGLQDIHZPLQXWHV7KH3520,6
IDWLJXHZLOOEHFRPSOHWHGDWWKHWLPHSRLQWVGHVFULEHGLQ6HFWLRQ

(XUR4RO(4'/
7KH(XUR4RO(4'LVDZHOODFFHSWHGLQVWUXPHQWWRPHDVXUHJHQHULFKHDOWKVWDWXV
DQG42/DQGKDVEHHQXVHGZLGHO\IRUHFRQRPLFHYDOXDWLRQWKDWFRPSDUHVWKHFRVWDQG
EHQHILWRIKHDOWKFDUHLQWHUYHQWLRQV3LFNDUG7KH(4'/ZLOOEHXVHGWR
DVVHVVTXDOLW\DGMXVWHGOLIH\HDU4$/<DQGSRWHQWLDOO\IRUIXWXUHFRVWXWLOLW\DQDO\VLV
IRUWKLVVWXG\7KH(4'/LVDWZRSDUWTXHVWLRQQDLUHDQGKDVEHHQWUDQVODWHGLQWR
PXOWLSOHODQJXDJHV7KHILUVWSDUWLVWKHGHVFULSWLYHV\VWHPDQGFRQVLVWVRILWHPV
FRYHULQJGLPHQVLRQVLQFOXGLQJPRELOLW\VHOIFDUHXVXDODFWLYLWLHVSDLQGLVFRPIRUW
DQGDQ[LHW\GHSUHVVLRQ(DFKGLPHQVLRQFDQEHJUDGHGRQOHYHOVLQFOXGLQJQR
SUREOHPPRGHUDWHSUREOHPVDQGH[WUHPHSUREOHPV7KHVFRUHIURPWKHGHVFULSWLYH
V\VWHPZLOOEHFRQYHUWHGLQWRDVLQJOHLQGH[YDOXHWRFRPSDUHWKHKHDOWKVWDWXV7KH
VHFRQGSDUWLVDYLVXDODQDORJXHVFDOH9$6YDOXLQJFXUUHQWKHDOWKVWDWHPHDVXUHGRQD
FPSRLQWLQWHUYDOVFDOH(LWKHUWKHLQGH[VFRUHRUWKH9$6VFRUHFDQEHXVHGLQ
WKH4$/<DQDO\VLVWKDWZLOOLQIRUPHFRQRPLFHYDOXDWLRQRILQWHUYHQWLRQV:X
$GGLWLRQDOO\WKHEHQHILWRIXVLQJ4$/<LVWKDWWKH4$/<FDQEHFRPSDUHGWRWKH
RXWFRPHVRIRWKHULQWHUYHQWLRQVDFURVVGLVHDVHVLWHVDQGFDQEHXVHGE\KHDOWKSROLF\
PDNHUVWRUDQNLQWHUYHQWLRQV

3URWRFROHOLJLEOHSDWLHQWVZLOOEHLQFOXGHGLQWKHTXDOLW\DGMXVWHGVXUYLYDODQDO\VLVRQO\
LIWKH\KDYHSURYLGHGEDVHOLQHDQGDWOHDVWVXEVHTXHQWPHDVXUHPHQW

7KH(4'/FDQEHFRPSOHWHGLQPLQXWHV6FKXO]3DWLHQWVZLOOFRPSOHWHWKH
(4'/YHUVLRQDWWKHWLPHSRLQWVGHVFULEHGLQ6HFWLRQ

)RUP42/VKRXOGEHDGPLQLVWHUHGGXULQJDQRIILFHYLVLWLIDWDOOSRVVLEOHSUHIHUDEO\
ZKLOHWKHSDWLHQWLVZDLWLQJWREHVHHQ2QFHWKHTXHVWLRQQDLUHVDUHFRPSOHWHGE\WKH
SDWLHQWWKHVWDIIPHPEHUVKRXOGUHYLHZLWWRHQVXUHWKDWQRLWHPVZHUHXQLQWHQWLRQDOO\
OHIWEODQN:KHQDEVROXWHO\QHFHVVDU\LWPD\DOVREHDGPLQLVWHUHGE\PDLORUSKRQH
8SORDGWKHFRPSOHWHGIRUPRQWRWKH4XDOLW\RI/LIH&RPSOHWLRQ)RUPLQ0HGLGDWD
5DYH


4XDOLW\RI/LIH42/DQG3DWLHQW5HSRUWHG2XWFRPHLQVWUXPHQWVZLOOEHDVVHVVHGDW
WLPHSRLQWVGHVFULEHGLQ6HFWLRQ1RWHWKHEDVHOLQHDVVHVVPHQWLQWKHFRQWH[WRI
42/352FRPSRQHQWLVGHILQHGDVSULRUWRVWXG\HQWU\RFFXUULQJZLWKLQGD\VSULRUWR
LQLWLDWLRQRISURWRFROWUHDWPHQW

$GPLQLVWUDWLRQRI15*/83DWLHQW&RPSOHWHG4XHVWLRQQDLUHV
7LPH3RLQWVIRU$GPLQLVWUDWLRQ6HH6HFWLRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

3DWLHQW3RSXODWLRQ)(%
$OOSDWLHQWVHQUROOHGLQ15*/8ZKRUHDG(QJOLVK)UHQFK6SDQLVKRU-DSDQHVHDQG
ZKRKDYHFRPSOHWHGWKHEDVHOLQHTXHVWLRQQDLUHZLOOEHUHTXLUHGWRSDUWLFLSDWHLQWKH
42/VWXG\

$GGLWLRQDO7R[LFLW\0RQLWRULQJZLWK352&7&$($8*
3DWLHQWUHSRUWHGV\PSWRPDWLF$(VZLOOEHHYDOXDWHGXVLQJVHOHFW352&7&$(LWHPV
7ZHQW\RQH352&7&$(LWHPVKDYHEHHQVHOHFWHGEDVHGRQOLWHUDWXUHLQFOXGLQJWKH
PRVWFRPPRQVLGHHIIHFWVRIFRQFXUUHQWFKHPRUDGLDWLRQIRUOXQJFDQFHUSDWLHQWV
.RPLQJHWDO9HUPDHWDOWKHPRVWFRPPRQDQGSRWHQWLDOVLGHHIIHFWVRI
$WH]ROL]XPDE5DPRV(VTXLYHOHWDDQGDFRUHVHWRIV\PSWRPVUHFRPPHQGHG
E\WKH1&,¶V6\PSWRP0DQDJHPHQWDQG+HDOWK5HODWHG4XDOLW\RI/LIH6WHHULQJ
&RPPLWWHHIRUDGXOWFDQFHUSDWLHQWV5HHYHHWDO3OHDVHUHIHUWRWKH6HFWLRQ
IRUWKHOLVWRIWKH352&7&$(LWHPV

$GPLQLVWUDWLRQRI352&7&$(
7LPHSRLQWVIRU$GPLQLVWUDWLRQ
3DWLHQWVZLOOFRPSOHWHWKH352&7&$(DWWKHWLPHSRLQWVGHVFULEHGLQ6HFWLRQ

5HFDOOSHULRG
$ZHHNUHFDOOSHULRGWLPHSHULRGRYHUZKLFKSDWLHQWUHFDOOVVSHFLILFV\PSWRPVZLOOEH
XVHGIRUDOO352&7&$(GDWDFROOHFWHG

352&7&$(3DWLHQW3RSXODWLRQ)(%
$OOSDWLHQWV HQUROOHGLQ15*/8ZKRUHDG(QJOLVK)UHQFK6SDQLVKRU-DSDQHVHDQG
ZKRKDYHFRPSOHWHGWKHEDVHOLQH352&7&$(TXHVWLRQQDLUHZLOOEHUHTXLUHGWR
SDUWLFLSDWHLQWKH352&7&$(VWXG\$IWHUUHVSRQGLQJWRWKHLQLWLDOEDVHOLQHTXHVWLRQV
SDWLHQWVZLOOKDYHWKHRSWLRQWRFRPSOHWHWKHUHPDLQGHURIWKHVXUYH\E\SDSHURU
HOHFWURQLFGHYLFHH[FHSWSDWLHQWVZKRUHDG)UHQFKRU-DSDQHVHZKRPXVWFRPSOHWHWKH
352&7&$(RQSDSHU

02'$/,7<5(9,(:6
5DGLDWLRQ7KHUDS\4XDOLW\$VVXUDQFH5HYLHZV6(37
7KH3ULQFLSDO,QYHVWLJDWRU.ULVWLQ+LJJLQV0'RU5DGLDWLRQ2QFRORJ\&R&KDLUV
0'RU
0'3K'ZLOOSHUIRUPDQ574XDOLW\5HYLHZV

3UHWUHDWPHQWUHYLHZVRIWKHILUVWSDWLHQWVHQUROOHGIURPHDFKLQVWLWXWLRQDUH
UHTXLUHG35,2572'(/,9(5<RIUDGLDWLRQWUHDWPHQW7KHSDWLHQWFDQQRWVWDUW
WUHDWPHQWXQWLOWKHVLWHKDVUHFHLYHGDSSURYDOIURPWKH,PDJLQJDQG5DGLDWLRQ2QFRORJ\
&RUH,52&3KLODGHOSKLD577KH3UH7UHDWPHQW5HYLHZSURFHVVUHTXLUHVEXVLQHVV
GD\VIURPWKHUHFHLSWRIFRPSOHWHGDWDYLD75,$'

7KH3ULQFLSDO,QYHVWLJDWRURU5DGLDWLRQ2QFRORJ\&R&KDLUVZLOOSHUIRUPDQ574XDOLW\
$VVXUDQFH5HYLHZRQDQRQJRLQJEDVLVRQFHFRPSOHWH57GDWDLVUHFHLYHGDW15*
+HDGTXDUWHUVIRUWKHUHPDLQGHURIHQUROOHGFDVHV

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
0HGLFDO2QFRORJ\0RGDOLW\4XDOLW\$VVXUDQFH5HYLHZV6(37
7KH0HGLFDO2QFRORJ\&R&KDLUV
0'DQG
0'3K'ZLOOSHUIRUPD0RGDOLW\4XDOLW\$VVXUDQFH5HYLHZRIDOOSDWLHQWVZKRUHFHLYH
RUDUHWRUHFHLYHV\VWHPLFWUHDWPHQWLQWKLVWULDO7KHJRDORIWKHUHYLHZLVWRHYDOXDWH
SURWRFROFRPSOLDQFH7KHUHYLHZSURFHVVLVFRQWLQJHQWRQWLPHO\VXEPLVVLRQRIV\VWHPLF
WUHDWPHQWGDWD7KHVFRULQJPHFKDQLVPLV3HU3URWRFRO$FFHSWDEOH9DULDWLRQ
8QDFFHSWDEOH'HYLDWLRQDQG1RW(YDOXDEOH

'UV
ZLOOSHUIRUPD4XDOLW\$VVXUDQFH5HYLHZDIWHU15*
+HDGTXDUWHUVKDVUHFHLYHGFRPSOHWHGDWDIRUWKHILUVWFDVHVHQUROOHG'U

DQG
ZLOOSHUIRUPWKHQH[WUHYLHZDIWHU15*+HDGTXDUWHUVKDVUHFHLYHG
FRPSOHWHGDWDIRUWKHQH[WFDVHVHQUROOHG7KHILQDOFDVHVZLOOEHUHYLHZHGZLWKLQ
PRQWKVDIWHUWKLVVWXG\KDVUHDFKHGWKHWDUJHWDFFUXDORUDVVRRQDV15*+HDGTXDUWHUV
KDVUHFHLYHGFRPSOHWHGDWDIRUDOOFDVHVHQUROOHGZKLFKHYHURFFXUVILUVW

'$7$$1'5(&25'6

'DWD0DQDJHPHQW&ROOHFWLRQ-8/
0HGLGDWD5DYHLVDFOLQLFDOGDWDPDQDJHPHQWV\VWHPEHLQJXVHGIRUGDWDFROOHFWLRQIRU
WKLVWULDOVWXG\$FFHVVWRWKHWULDOLQ5DYHLVFRQWUROOHGWKURXJKWKH&7(3,$0V\VWHP
DQGUROHDVVLJQPHQWV
5HTXLUHPHQWVWRDFFHVV5DYHYLDL0HGLGDWD
x
$FWLYH&7(3UHJLVWUDWLRQZLWKWKHFUHGHQWLDOVQHFHVVDU\WRDFFHVVVHFXUH
1&,&768,7V\VWHPVDQG
x
$VVLJQHGD5DYHUROHRQWKH/32RU32URVWHUDWWKHHQUROOLQJVLWHRI5DYH&5$
5DYH5HDG2QO\5DYH&5$/DE$GPLQ5DYH6/$RU5DYH,QYHVWLJDWRU

5DYHUROHUHTXLUHPHQWV
x 5DYH&5$RU5DYH&5$/DE$GPLQUROHPXVWKDYHDPLQLPXPRIDQ$VVRFLDWH
3OXV$3UHJLVWUDWLRQW\SH
x 5DYH,QYHVWLJDWRUUROHPXVWEHUHJLVWHUHGDVD1RQ3K\VLFLDQ,QYHVWLJDWRU
13,95RU,QYHVWLJDWRU,95DQG
x 5DYH5HDG2QO\UROHPXVWKDYHDWDPLQLPXPDQ$VVRFLDWHV$UHJLVWUDWLRQW\SH

5HIHUWRKWWSVFWHSFDQFHUJRYLQYHVWLJDWRU5HVRXUFHVGHIDXOWKWPIRUUHJLVWUDWLRQW\SHV
DQGGRFXPHQWDWLRQUHTXLUHG

7KLVVWXG\KDVD'HOHJDWLRQRI7DVNV/RJ'7/7KHUHIRUHWKRVHLQGLYLGXDOVUHTXLULQJ
ZULWHDFFHVVWR5DYHPXVWDOVREHDVVLJQHGWKHDSSURSULDWH5DYHWDVNVRQWKH'7/

8SRQLQLWLDOVLWHUHJLVWUDWLRQDSSURYDOIRUWKHVWXG\LQWKH5HJXODWRU\DSSOLFDWLRQDOO
SHUVRQVZLWK5DYHUROHVDVVLJQHGRQWKHDSSURSULDWHURVWHUZLOOEHVHQWDVWXG\LQYLWDWLRQ
HPDLOIURPL0HGLGDWD1RDFWLRQZLOOEHUHTXLUHGHDFKVWXG\LQYLWDWLRQZLOOEH
DXWRPDWLFDOO\DFFHSWHGDQGVWXG\DFFHVVLQ5DYHZLOOEHDXWRPDWLFDOO\JUDQWHG6LWHVWDII
ZLOOQRWEHDEOHWRDFFHVVWKHVWXG\LQ5DYHXQWLODOOUHTXLUHG0HGLGDWDDQGVWXG\VSHFLILF
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WUDLQLQJVDUHFRPSOHWHG7UDLQLQJVZLOOEHLQWKHIRUPRIHOHFWURQLFOHDUQLQJVH/HDUQLQJV
DQGFDQEHDFFHVVHGE\FOLFNLQJRQWKHH/HDUQLQJOLQNLQWKHTasksSDQHORFDWHGLQWKH
XSSHUULJKWFRUQHURIWKHL0HGLGDWDVFUHHQ,IDQH/HDUQLQJLVUHTXLUHGIRUDVWXG\DQGKDV
QRW\HWEHHQWDNHQWKHOLQNWRWKHH/HDUQLQJZLOODSSHDUXQGHUWKHVWXG\QDPHLQWKH
Studies SDQHORFDWHGLQWKHFHQWHURIWKHL0HGLGDWDVFUHHQRQFHWKHVXFFHVVIXO
FRPSOHWLRQRIWKHH/HDUQLQJKDVEHHQUHFRUGHGDFFHVVWRWKHVWXG\LQ5DYHZLOOEH
JUDQWHGDQGDRave EDCOLQNZLOOUHSODFHWKHH/HDUQLQJOLQNXQGHUWKHVWXG\QDPH
1RDFWLRQZLOOEHUHTXLUHGE\VLWHVWDIIWRDFWLYDWHWKHLUDFFRXQWZKRKDYHQRW
SUHYLRXVO\DFWLYDWHGWKHLUL0HGLGDWD5DYHDFFRXQWDWWKHWLPHRILQLWLDOVLWHUHJLVWUDWLRQ
DSSURYDOIRUWKHVWXG\LQWKH5HJXODWRU\DSSOLFDWLRQ3HQGLQJVWXG\LQYLWDWLRQV
SUHYLRXVO\VHQWEXWQRWDFFHSWHGRUGHFOLQHGE\DVLWHXVHUZLOOEHDXWRPDWLFDOO\
DFFHSWHGDQGVWXG\DFFHVVLQ5DYHZLOOEHDXWRPDWLFDOO\JUDQWHGIRUWKHVLWHXVHU
$FFRXQWDFWLYDWLRQLQVWUXFWLRQVDUHORFDWHGRQWKH&768ZHEVLWHLQWKHData
ManagementVHFWLRQXQGHUWKH'DWD0DQDJHPHQW+HOS7RSLFV!5DYHUHVRXUFHPDWHULDOV
Medidata Account Activation and Study Invitation$GGLWLRQDOLQIRUPDWLRQRQ
L0HGLGDWD5DYHLVDYDLODEOHRQWKH&768PHPEHUV¶ZHEVLWHLQWKHData Management!
RaveVHFWLRQRUE\FRQWDFWLQJWKH&768+HOS'HVNDWRUE\HPDLODW
FWVXFRQWDFW#ZHVWDWFRP

352&7&$(LWHPVZLOOEHFROOHFWHGXVLQJH352IRUSDWLHQWVZKRUHDG(QJOLVKRU
6SDQLVK7KHSDWLHQWZLOOXVHSHUVRQDOKDQGKHOGGHYLFHVRUWDEOHWV2QFHDSDWLHQW
VXEPLWVWKHUHVSRQVHVWKHGDWDJRHVGLUHFWO\IURPWKHGHYLFHLQWRWKH5DYHGDWDEDVH
7KHUHDUHQRGRFXPHQWVWRDXGLW7KHHOHFWURQLFUHVSRQVHVDUHWKHVRXUFHGRFXPHQWDWLRQ
3DWLHQWVZKRUHDG)UHQFKRU-DSDQHVHZLOOFRPSOHWHWKH352&7&$(RQSDSHU

'DWD4XDOLW\3RUWDO129
7KH'DWD4XDOLW\3RUWDO'43SURYLGHVDFHQWUDOORFDWLRQIRUVLWHVWDIIWRPDQDJH
XQDQVZHUHGTXHULHVDQGIRUPGHOLQTXHQFLHVPRQLWRUGDWDTXDOLW\DQGWLPHOLQHVV
JHQHUDWHUHSRUWVDQGUHYLHZPHWULFV
7KH'43LVORFDWHGRQWKH&768PHPEHUV¶ZHEVLWHXQGHU'DWD0DQDJHPHQW
7KH5DYH+RPHVHFWLRQGLVSOD\VDWDEOHSURYLGLQJVXPPDU\FRXQWVRI7RWDO
'HOLQTXHQFLHVDQG7RWDO4XHULHV'434XHULHV'43'HOLQTXHQW)RUPV'43
)RUP6WDWXVDQGWKH'435HSRUWVPRGXOHVDUHDYDLODEOHWRDFFHVVGHWDLOVDQG
UHSRUWVRIXQDQVZHUHGTXHULHVGHOLQTXHQWIRUPVIRUPVZLWKFXUUHQWVWDWXVDQG
WLPHOLQHVVUHSRUWV5HYLHZWKH'43PRGXOHVRQDUHJXODUEDVLVWRPDQDJH
VSHFLILHGTXHULHVDQGGHOLQTXHQWIRUPV
7KH'43LVDFFHVVLEOHE\VLWHVWDIIZKRDUHURVWHUHGWRDVLWHDQGKDYHDFFHVVWR
WKH&768ZHEVLWH6WDIIZKRKDYH5DYHVWXG\DFFHVVFDQDFFHVVWKH5DYHVWXG\
GDWDXVLQJYLDGLUHFWOLQNVDYDLODEOHLQWKH'43PRGXOHV
&768'HOLQTXHQF\1RWLILFDWLRQHPDLOVDUHVHQWWRSULPDU\FRQWDFWVDWVLWHVWZLFH
DPRQWK7KHVHQRWLILFDWLRQVVHUYHDVDOHUWVWKDWTXHULHVDQGRUGHOLQTXHQWIRUPV
UHTXLUHVLWHUHYLHZSURYLGLQJDVXPPDU\FRXQWRITXHULHVDQGGHOLQTXHQWIRUPV
IRUHDFK5DYHVWXG\WKDWDVLWHLVSDUWLFLSDWLQJLQ$GGLWLRQDOVLWHVWDIIFDQ
VXEVFULEHDQGXQVXEVFULEHWRWKHVHQRWLILFDWLRQVXVLQJWKH&7685HSRUWDQG
,QIRUPDWLRQ6XEVFULSWLRQ3RUWDORQWKH&768PHPEHUV¶ZHEVLWH
7ROHDUQPRUHDERXW'43XVHDQGDFFHVVFOLFNRQWKH+HOS7RSLFVEXWWRQGLVSOD\HGRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WKH5DYH+RPH'434XHULHV'43'HOLQTXHQW)RUPV'43)RUP6WDWXVDQG'43
5HSRUWVPRGXOHV

5DYH&7(3$(56,QWHJUDWLRQ129
7KH5DYH&DQFHU7KHUDS\(YDOXDWLRQ3URJUDP$GYHUVH(YHQW5HSRUWLQJ6\VWHP
&7(3$(56,QWHJUDWLRQHQDEOHVHYDOXDWLRQRI$GYHUVH(YHQWV$(HQWHUHGLQ
5DYHWRGHWHUPLQHZKHWKHUWKH\UHTXLUHH[SHGLWHGUHSRUWLQJDQGIDFLOLWDWHVHQWU\
LQ&7(3$(56IRUWKRVH$(VUHTXLULQJH[SHGLWHGUHSRUWLQJ6LWHVPXVWLQLWLDWH
DOO$(VIRUWKLVVWXG\LQ0HGLGDWD5DYH

3UHH[LVWLQJPHGLFDOFRQGLWLRQVIRUPHUO\UHIHUUHGWRDVEDVHOLQH$(VLGHQWLILHG
GXULQJEDVHOLQHDVVHVVPHQWDUHQRWFRQVLGHUHG$(VDQGWKHUHIRUHVKRXOGQRWEH
UHSRUWHGRQWKH$GYHUVH(YHQWIRUP,IWKHVHSUHH[LVWLQJFRQGLWLRQVZRUVHQLQ
VHYHULW\WKHLQYHVWLJDWRUPXVWUHDVVHVVWKHHYHQWWRGHWHUPLQHLIDQH[SHGLWHG
UHSRUWLVUHTXLUHG:KHWKHURUQRWDQH[SHGLWHGUHSRUWLVUHTXLUHGWKHZRUVHQHG
HYHQWVKRXOGEHUHSRUWHGDVDURXWLQH$(

7UHDWPHQWHPHUJHQW$(V$OO$(VWKDWRFFXUDIWHUVWDUWRIWUHDWPHQWDUHFROOHFWHG
LQ0HGLGDWD5DYHXVLQJWKH$GYHUVH(YHQWIRUPZKLFKLVDYDLODEOHIRUHQWU\DW
HDFKWUHDWPHQWFRXUVHRUUHSRUWLQJSHULRGDQGLVXVHGWRFROOHFW$(VWKDWVWDUW
GXULQJWKHSHULRGRUSHUVLVWIURPWKHSUHYLRXVUHSRUWLQJSHULRG$(VWKDWRFFXU
GD\VDIWHUWKH/DVW$GPLQLVWUDWLRQRI,QYHVWLJDWLRQDO$JHQW,QWHUYHQWLRQDUH
FROOHFWHGXVLQJWKH/DWH$GYHUVH(YHQWIRUP

3ULRUWRVHQGLQJ$(VWKURXJKWKHUXOHVHYDOXDWLRQSURFHVVVLWHVWDIIVKRXOGYHULI\
WKHIROORZLQJRQWKH$GYHUVH(YHQWIRUPLQ5DYH
x 7KHUHSRUWLQJSHULRGFRXUVHF\FOHLVFRUUHFWDQG
x $(VDUHUHFRUGHGDQGFRPSOHWHQRPLVVLQJILHOGVDQGWKHIRUPLVTXHU\IUHH
7KH&5$UHSRUWV$(VLQ5DYHDWWKHWLPHWKH,QYHVWLJDWRUOHDUQVRIWKHHYHQW,I
WKH&5$PRGLILHVDQ$(LWPXVWEHUHVXEPLWWHGIRUUXOHVHYDOXDWLRQ

8SRQFRPSOHWLRQRI$(HQWU\LQ0HGLGDWD5DYHWKH&5$VXEPLWVWKH$(IRU
UXOHVHYDOXDWLRQE\FRPSOHWLQJWKH([SHGLWHG5HSRUWLQJ(YDOXDWLRQIRUP%RWK
1&,DQGSURWRFROVSHFLILFUHSRUWLQJUXOHVHYDOXDWHWKH$(VVXEPLWWHGIRU
H[SHGLWHGUHSRUWLQJ$UHSRUWLVLQLWLDWHGLQ&7(3$(56XVLQJLQIRUPDWLRQ
HQWHUHGLQ0HGLGDWD5DYHIRU$(VWKDWPHHWUHSRUWLQJUHTXLUHPHQWV7KH&5$
FRPSOHWHVWKHUHSRUWE\DFFHVVLQJ&7(3$(56YLDDGLUHFWOLQNRQWKH0HGLGDWD
5DYH([SHGLWHG5HSRUWLQJ(YDOXDWLRQIRUP&RQWDFWWKH&768+HOS'HVNDW
RUE\HPDLODWFWVXFRQWDFW#ZHVWDWFRPLI\RXKDYHDQ\LVVXHV
VXEPLWWLQJDQH[SHGLWHGUHSRUWLQ&7(3$(56

,QWKHUDUHRFFXUUHQFHWKDWLQWHUQHWFRQQHFWLYLW\LVORVWDKRXUQRWLILFDWLRQLVWR
EHPDGHWR&7(3E\WHOHSKRQHDW2QFHLQWHUQHWFRQQHFWLYLW\LV
UHVWRUHGWKHKRXUQRWLILFDWLRQWKDWZDVSKRQHGLQPXVWEHHQWHUHGLPPHGLDWHO\
LQWR&7(3$(56XVLQJWKHGLUHFWOLQNIURP0HGLGDWD5DYH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

$GGLWLRQDOLQIRUPDWLRQDERXWWKH&7(3$(56LQWHJUDWLRQLVDYDLODEOHRQWKH
&768PHPEHUV¶ZHEVLWH
x 6WXG\VSHFLILFGRFXPHQWVProtocols!Documents !Protocol Related 
Documents !Adverse Event ReportingDQG
x $GGLWLRQDOUHVRXUFHVResources!CTSU Operations Information!User
Guides & Help Topics

1&,UHTXLUHPHQWVIRU6$(UHSRUWLQJDUHDYDLODEOHRQWKH&7(3ZHEVLWH
x
1&,*XLGHOLQHVIRU,QYHVWLJDWRUV$GYHUVH(YHQW5HSRUWLQJ5HTXLUHPHQWVLV
DYDLODEOHDW
KWWSVFWHSFDQFHUJRYSURWRFRO'HYHORSPHQWHOHFWURQLFBDSSOLFDWLRQVGRFVDHJ
XLGHOLQHVSGI

6XPPDU\RI'DWD6XEPLVVLRQ)(%
$GYHUVHHYHQWGDWDFROOHFWLRQDQGUHSRUWLQJZKLFKDUHUHTXLUHGDVSDUWRIHYHU\FOLQLFDO
WULDODUHGRQHWRHQVXUHWKHVDIHW\RISDWLHQWVHQUROOHGLQWKHVWXGLHVDVZHOODVWKRVHZKR
ZLOOHQUROOLQIXWXUHVWXGLHVXVLQJVLPLODUDJHQWV$GYHUVHHYHQWVDUHUHSRUWHGLQDURXWLQH
PDQQHUDWVFKHGXOHGWLPHVGXULQJWKHWULDOXVLQJ0HGLGDWD5DYH$GGLWLRQDOO\FHUWDLQ
DGYHUVHHYHQWVPXVWEHUHSRUWHGLQDQH[SHGLWHGPDQQHUIRUPRUHWLPHO\PRQLWRULQJRI
SDWLHQWVDIHW\DQGFDUH6HH6HFWLRQVDQGIRULQIRUPDWLRQDERXWH[SHGLWHGDQG
URXWLQHUHSRUWLQJ352&7&$(LVQRWLQWHQGHGIRUH[SHGLWHGUHSRUWLQJUHDOWLPHUHYLHZ
RUVDIHW\UHSRUWLQJ352&7&$(GDWDDUHH[SORUDWRU\DQGQRWFXUUHQWO\LQWHQGHGIRUXVH
LQGDWDVDIHW\PRQLWRULQJRUDGYHUVHHYHQWVWRSSLQJUXOHV

6XPPDU\RI'DWD6XEPLVVLRQ5HIHUWRWKH&768ZHEVLWH

6HH6HFWLRQIRU75,$'DFFRXQWDFFHVVDQGLQVWDOODWLRQLQVWUXFWLRQV6HHWDEOHEHORZ
IRU57GDWDVXEPLVVLRQGHWDLOV

',&20ILOHVWRH[SRUWIURP
7UHDWPHQW3ODQQLQJ6\VWHPWR
75,$'

',&203ODQQLQJ&7

',&20%DVHOLQH3(7RU
3(7&7XVHGIRUWXPRU
YROXPHGHOLQHDWLRQ

',&20576WUXFWXUH

',&2057'RVH

',&20573ODQ
'XH:LWKLQZHHNRIVWDUW
RI57XQOHVVSUHWUHDWPHQW
UHYLHZLVUHTXLUHGIRUILUVW
FDVHVHQUROOHG

75,$'7LPH3RLQW
RT Digital Plan
$OOUHTXLUHGVWUXFWXUHVPXVWEHODEHOHGSHUWKHWDEOHVLQ6HFWLRQVDQG
8SRQVXEPLVVLRQRIWKH57GLJLWDOGDWDYLD75,$'FRPSOHWHDQRQOLQH'LJLWDO'DWD6XEPLVVLRQ
,QIRUPDWLRQ)RUP''6,
KWWSVZZZLURFTDRUJ5HVRXUFHV75,$'
127($//6,08/$7,21$1'3257$/,0$*(6:,//%(.(37%<7+(,167,787,21
$1'21/<68%0,77(',)5(48(67('
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

6HH'LDJQRVWLF,PDJLQJVXEPLVVLRQWDEOHIRU75,$'EHORZ
$OO'LDJQRVWLF,PDJLQJ6XEPLVVLRQVUHTXLUH&OLQLFDO,PDJH6XEPLVVLRQ)RUP&,6)
FRPSOHWLRQLQL0HGLGDWD5$9(IRUFRUUHVSRQGLQJWLPHSRLQWV

',&20ILOHVWR
H[SRUWWR75,$'

3UH7UHDWPHQW$VVHVVPHQW
,PDJLQJ
75,$'7LPH3RLQW
x 3(7&7IRUVWDJLQJLQFOXGLQJ
WXPRUPHDVXUHPHQWV
x &7&KHVW&7$EGRPHQZLWK
,9FRQWUDVW
x %UDLQ05,ZLWKFRQWUDVW
SUHIHUUHGRU%UDLQ&7ZLWK
FRQWUDVWDOORZDEOHLIWKHUHLVD
FRQWUDLQGLFDWLRQWR05,
x %DVHOLQH
(QGRI&57,PDJLQJ

&7&KHVWZLWK,9&RQWUDVW
WKURXJKDGUHQDOV
x (QGRI&57
)8,PDJLQJ

x &7FKHVWWKURXJKDGUHQDOV
&7DEGRPHQZLWKFRQWUDVW
x %UDLQ05,ZLWKDQGZLWKRXW
FRQWUDVWRUEUDLQ&7ZLWK
FRQWUDVWDOORZDEOHLIWKHUHLV
DFRQWUDLQGLFDWLRQWR05,
x 3RVW&57
o 0RQWKVRU<HDUV
)ROORZ8S,PDJLQJ4PRV[\HDUVZHHNVWKHQ4PRVLQ\HDU
ZHHNV7KHQDQQXDOO\ZHHNVXQOHVVRWKHUZLVHLQGLFDWHG3OHDVHUHIHUWRVHFWLRQ
%UDLQ05,LQIROORZXS±<HDU4PRV<HDU4PRV7KHQDVFOLQLFDOO\
LQGLFDWHG


Note:3OHDVHUHIUDLQIURPDQRQ\PL]LQJWKH',&20KHDGHURIDQ\H[DPSULRUWR
XSORDGLQJLQWRWKH75,$'DSSOLFDWLRQ&XVWRP',&20HGLWLQJFDQH[FOXGHDQH[DP
IURPILQDODQDO\VLVGXHWRWKHRPLVVLRQRIWHFKQLFDOGDWDHOHPHQWV7KHVHHOHPHQWV
LQFOXGHEXWDUHQRWOLPLWHGWRVWXG\VHULHVQDPHVWXG\GDWHXQLWVWDWLRQQDPHXQLWVHULDO
QXPEHUDQGDOOLPDJHDFTXLVLWLRQSDUDPHWHUV75,$'KDVEHHQXQLTXHO\FRQILJXUHGWR
ORFDWHDQGGHLGHQWLI\DOO3+,IURPWKH15*/8',&20KHDGHUVSULRUWRWKHLPDJH
WUDQVIHUWRHQVXUHWKHDQRQ\PLW\RIRXUWULDOSDWLHQWV

(QKDQFHG&HQWUDOL]HG'DWD0RQLWRULQJ)(%
,QDGGLWLRQWRWKH1&,JXLGHOLQHVIRUDXGLWLQJFOLQLFDOWULDOVIRUWKH1DWLRQDO&OLQLFDO
7ULDOV1HWZRUN1&713URJUDP15*ZLOOSHUIRUPHQKDQFHGFHQWUDOL]HGPRQLWRULQJRI
WKHFRPSRQHQWVOLVWHGEHORZ

4XDOLW\$VVXUDQFH(QKDQFHPHQWV
x Site Initiation Visit 
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
7KHVWXG\LQLWLDWLRQZLOOEHFRQGXFWHGYLDYLGHRZHELQDU7KHOLQNWRDVHFXUHZHE
VLWHLVSRVWHGRQWKH&768ZHEVLWHDQGDYDLODEOHIRUDOO1&710HPEHU,QVWLWXWLRQV
,WLVPDQGDWRU\WKDWWKH3ULQFLSDO,QYHVWLJDWRU3,WKH3,RQWKH,5%GRFXPHQWDWLRQ
DQGDWOHDVWRQHUHVHDUFKDVVRFLDWH5$YLHZWKHLQLWLDWLRQYLGHR

'XULQJWKHVLWHLQLWLDWLRQYLGHRDWDPLQLPXPWKHIROORZLQJDFWLYLWLHVDUHLQFOXGHG
 $QLQGHSWKUHYLHZRIWKHSURWRFROXVLQJDOHFWXUHIRUPDW
 3UHVHQWDWLRQRIVWXG\UHTXLUHPHQWVDQGSURFHGXUHVLQFOXGLQJEXWQRWOLPLWHGWR
VWXG\REMHFWLYHVVWXG\GHVLJQHOLJLELOLW\FULWHULDHQUROOPHQWSURFHGXUHVVFKHGXOH
RIHYDOXDWLRQVFULWHULDIRUSDWLHQWGLVFRQWLQXDWLRQDGYHUVHHYHQWUHSRUWLQJ
GHILQLWLRQV6$(UHSRUWLQJSURFHGXUHVVWXG\GUXJDGPLQLVWUDWLRQVWXG\WLPH
IUDPHGUXJRUGHULQJEORRGDQGWXPRUVDPSOHVXEPLVVLRQUHTXLUHPHQWVLI
DSSOLFDEOHDQGODERUDWRU\SURFHGXUHV
 'LVFXVVLRQRIWKHVWUXFWXUHRIWKHDXGLWLQJPRQLWRULQJSURFHVVIRUWKH6WXG\
 'LVFXVVLRQRIWKHSDWLHQWHQUROOPHQWSURFHGXUHV
 'LVFXVVLRQRIWKHLPSRUWDQFHRIPDLQWDLQLQJDGHTXDWHVRXUFHDQGUHJXODWRU\
GRFXPHQWV
 5HYLHZRI(OHFWURQLF&DVH5HSRUW)RUPVDQGFRPSOHWLRQJXLGHOLQHVLQFOXGLQJ
YLVLWVSHFLILFSDJHVFRUUHFWLRQSURFHGXUHSDWLHQWLGHQWLILFDWLRQQXPEHUVDQGWKH
GDWDTXHU\UHVROXWLRQSURFHVV
 5HYLHZRIWKH15*2QFRORJ\FRQWDFWOLVW
 'LVFXVVLRQRIWKH'UXJ$FFRXQWDELOLW\/RJUHTXLUHPHQWV
 'RFXPHQWDWLRQRIDOODWWHQGHHVE\REWDLQLQJDVLJQHGFRQILUPDWLRQRIFRPSOHWLRQ
IURPWKHDWWHQGHHV
&HQWUDOL]HG0RQLWRULQJ&0
&HQWUDO0RQLWRULQJ&05HYLHZLVUHTXLUHGIRUWKLVSURWRFRO&0DOORZV/HDG3URWRFRO
2UJDQL]DWLRQV/32VWRUHPRWHO\FRPSDUHGDWDHQWHUHGLQ5DYHWRVRXUFHGRFXPHQWDWLRQ
WRHQVXUHWKDWVLWHVDUHDGKHULQJWRWKHSURWRFRODQGFHQWUDOPRQLWRULQJSODQDVZHOODV
DFFXUDWHO\WUDQVFULELQJGDWDIURPSDWLHQWV¶FKDUWVLHVRXUFHGDWDYHULILFDWLRQ

6LWHVFDQXSORDGVRXUFHGRFXPHQWVUHTXLUHGIRU&05HYLHZDVGRFXPHQWHGLQWKHFHQWUDO
PRQLWRULQJSODQXVLQJWKH6RXUFH'RFXPHQW3RUWDO6'3$OOVRXUFHGRFXPHQWVPXVW
EHSURYLGHGLQ(QJOLVK7KLVDSSOLFDWLRQLVDYDLODEOHRQWKH&768PHPEHUV¶ZHEVLWH
XQGHU$XGLWLQJ	0RQLWRULQJDQGPD\DOVREHDFFHVVHGXVLQJDGLUHFWOLQNZLWKLQ5DYH
RQWKH&0$OHUWIRUP6LWHVWDIIZLWKWKH&5$RU,QYHVWLJDWRUUROHVLQ5DYHFDQYLHZDQG
XSORDGVRXUFHGRFXPHQWV3ULRUWRVDYLQJVRXUFHGRFXPHQWVRQWKH6'3HDFKVLWHLV
UHVSRQVLEOHIRUUHPRYLQJRUUHGDFWLQJDQ\3HUVRQDOO\,GHQWLILDEOH,QIRUPDWLRQ3,,QRWH
WKDWIXQFWLRQDOLW\WRGRWKLVUHGDFWLRQH[LVWVZLWKLQWKH6'3LWVHOI'HVLJQDWHG/32VWDII
ZLOOUHYLHZHDFKGRFXPHQWDIWHULWKDVEHHQORDGHGRQWKH6'3WRHQVXUHWKHDSSURSULDWH
GRFXPHQWVKDYHEHHQXSORDGHGDQGWRHQVXUH3,,LVUHGDFWHG

$GGLWLRQDOLQIRUPDWLRQRQWKH6'3LVDYDLODEOHRQWKH&768PHPEHUV¶ZHEVLWHXQGHU
$XGLWLQJ	0RQLWRULQJ!6RXUFH'RFXPHQW3RUWDOLQWKH+HOS7RSLFVEXWWRQRUE\
FRQWDFWLQJWKH&768+HOS'HVNRUFWVXFRQWDFW#ZHVWDWFRP

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
Eligibility 
7KHVRXUFHUHFRUGVZKLFKGRFXPHQWWKHHOLJLELOLW\IRUWKHILUVWWZRSDWLHQWVUDQGRPL]HGWR
HDFKDUPHJ$UPDQG$UPWKHQHYHU\WKSDWLHQWUDQGRPL]HGWRHDFKDUP
HQUROOHGIURPHDFKVLWHDVLGHQWLILHGE\DXQLTXH1&,LGHQWLILHUZLOOEHUHYLHZHGIRU
FRPSOHWHQHVVDQGFRQVLVWHQF\ZLWKWKHHOLJLELOLW\FULWHULDWKHGDWDUHSRUWHGGXULQJ
WKHHQUROOPHQWSURFHVVDQGWKHGDWDUHSRUWHGRQWKHFDVHUHSRUWIRUPV&5)V
'RFXPHQWVDUHWREHVXEPLWWHGZLWKLQWZRZHHNVRIVXEMHFWHQUROOPHQW

,QWKHHYHQWWKDWWKLVPRQLWRULQJLGHQWLILHVXQDFFHSWDEOHHQUROOPHQWSURFHGXUHVRU
VLJQLILFDQWGHYLDWLRQVIURPHOLJLELOLW\FULWHULDWKHQWKHVLWHZLOOQHHGWRVXEPLWD
FRUUHFWLYHDFWLRQSODQZLWKLQWZRZHHNVRIEHLQJQRWLILHGRIWKHILQGLQJVRIWKH
FHQWUDOL]HGPRQLWRULQJ7KHVRXUFHUHFRUGVIRUWKHHOLJLELOLW\DQGWUHDWPHQWIRUWKHQH[W
LQGLYLGXDOHQUROOHGWRWKHVWXG\IURPWKHVLWHDUHDJDLQWREHVXEPLWWHGDQGUHYLHZHG,Q
WKHHYHQWRIVLJQLILFDQWUHSHDWHGGHYLDWLRQVIURPWKHSURWRFRODFFUXDODWWKHVLWHPD\EH
VXVSHQGHGSHUGLVFUHWLRQRIWKHRYHUDOO6WXG\&KDLU

7KHSUHWUHDWPHQWGRFXPHQWVWREHUHYLHZHGLQFOXGH
 3DWKRORJ\5HSRUWWRGRFXPHQWWKHVWDJHDQGKLVWRORJ\RIWKHSULPDU\WXPRU
 'RFXPHQWDWLRQRIGDWHVDQGDJHQWVDGPLQLVWHUHGIRUWKHILUVWF\FOHRIFKHPRWKHUDS\
SUHVWXG\UHJLVWUDWLRQ
 'RFXPHQWDWLRQRIEDVHOLQHWXPRUPHDVXUHPHQWVSHU5(&,67
 $OO%DVHOLQHLPDJLQJUHSRUWVWRFRQILUPWKHSUHVHQFHRI5(&,67PHDVXUDEOHGLVHDVH
 0HGLFDOKLVWRU\WRLQFOXGHKLVWRU\RISULRUPDOLJQDQF\SULRUUDGLRWKHUDS\WROXQJV
PHGLDVWLQXPSULRUFRUWLFRVWHURLGXVHDQGRWKHUFKURQLFDFXWHFRQGLWLRQVDQGRU
FRPRUELGLWLHVSK\VLFDOH[DPLQDWLRQVUHFRUGVDQGODERUDWRU\UHVXOWVLQFOXGLQJDOO
EORRGDQGXULQHWHVWV
 'RFXPHQWDWLRQSOHXUDOHIIXVLRQDEVHQFHSUHVHQFHZLWKF\WRORJLFDOILQGLQJVLISUHVHQW
 6LJQHGDQGGDWHGLQIRUPHGFRQVHQWIRUP,QDGGLWLRQWRUHYLHZRIVLJQDWXUHVYHUVLRQ
DQGSDWLHQWUHVSRQVHVWRFRQVHQWIRUPTXHVWLRQVWKHILUVWFRQVHQWIRUPIRUHDFKVLWH
ZLOOEHUHYLHZHGIRUFRQWHQW,IDQHZYHUVLRQRIWKHSURWRFROUHVXOWVLQPRGLILFDWLRQV
WRWKHFRQVHQWIRUPWKHQWKHILUVWFRQVHQWIRUPIRUDSDWLHQWHQUROOHGXQGHUWKHQHZ
YHUVLRQZLOODOVREHUHYLHZHGIRUFRQWHQW
Drug Accountability, Drug-Dose Compliance and Adverse Events  
$VLQWKHHOLJLELOLW\UHYLHZWKHVRXUFHUHFRUGVDQGDGYHUVHHYHQWV$(VGXULQJthe first
two cyclesRIWUHDWPHQWIRUWKHSDWLHQWVHQUROOHGIURPHDFKVLWHDVLGHQWLILHGE\DXQLTXH
1&,LGHQWLILHUZLOOEHUHYLHZHGIRUFRPSOLDQFHZLWKWKHSURWRFROFRPSOHWHQHVVDQG
FRQVLVWHQF\ZLWKWKHGDWDUHSRUWHGRQWKHFDVHUHSRUWIRUPVDQGGUXJDFFRXQWDELOLW\
UHFRUGV7KHGRFXPHQWVOLVWHGEHORZVKRXOGEHVXEPLWWHGDWWZRWLPHSRLQWVZLWKLQ
WZRZHHNVRIEHJLQQLQJWKHVHFRQGF\FOHRIWUHDWPHQWIRUUHFRUGVDQG$(VGXULQJWKH
ILUVWF\FOHRIWUHDWPHQWDQGZLWKLQWZRZHHNVRIEHJLQQLQJWKHWKLUGF\FOHRI
WUHDWPHQWIRUUHFRUGVDQG$(VGXULQJWKHVHFRQGF\FOHRIWUHDWPHQW

,QWKHHYHQWWKDWWKLVPRQLWRULQJLGHQWLILHVXQDFFHSWDEOHSURFHGXUHVRUVLJQLILFDQW
GHYLDWLRQVIURPSURWRFROSURFHGXUHVWKHQWKHVLWHZLOOQHHGWRVXEPLWDFRUUHFWLYHDFWLRQ
SODQZLWKLQWZRZHHNV7KHVRXUFHUHFRUGVIRUWKHILUVWWZRF\FOHVRIWUHDWPHQWIRUWKH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
QH[WLQGLYLGXDOHQUROOHGWRWKHVWXG\IURPWKHVLWHVKRXOGWKHQDJDLQEHVXEPLWWHGDQG
UHYLHZHG,QWKHHYHQWRIVLJQLILFDQWUHSHDWHGGHYLDWLRQVIURPWKHSURWRFRODFFUXDODWWKH
VLWHPD\EHVXVSHQGHGSHUGLVFUHWLRQRIWKHRYHUDOO6WXG\&KDLU
7KHGRFXPHQWVWREHUHYLHZHGLQFOXGH
 6WXG\GUXJRUGHUVWUHDWPHQWGRVHFDOFXODWLRQVDQGDGPLQLVWUDWLRQUHFRUGV
 5HSRUWVIURPSURWRFROGLUHFWHGODERUDWRU\VWXGLHV
 5HSRUWVIURPDQ\DGGLWLRQDOWHVWVSHUIRUPHGWRGRFXPHQWDQDGYHUVHHYHQW
 $OOSURJUHVVQRWHVUHODWLQJWR$(DVVHVVPHQWV
 3KDUPDF\GUXJDFFRXQWDELOLW\UHFRUGV
 6XPPDULHVRIKRVSLWDODGPLVVLRQVDQGGLVFKDUJHIRUKRVSLWDOL]DWLRQV


(QKDQFHG&RQVHQW)RUP5HYLHZ2&7
&HQWUDOUHYLHZRIWKHFRQVHQWIRUPIRUWKHHVVHQWLDOHOHPHQWVRILQIRUPHGFRQVHQWDV
GHILQHGE\WKH'HSDUWPHQWRI+HDOWKDQG+XPDQ6HUYLFHV2IILFHIRU+XPDQ
5HVHDUFK3URWHFWLRQIRUWKHILUVWVLJQHGFRQVHQWIRUPDQGVLJQHGDPHQGHGFRQVHQW
IRUPVZKHQUHTXLUHGE\SURWRFRODPHQGPHQWVXEPLWWHGIURPHDFKVLWHDVLGHQWLILHG
E\DXQLTXH1&,LGHQWLILHUZLOOEHSHUIRUPHGLQUHDOWLPHDIWHUILUVWSDWLHQWHQWU\


(QKDQFHG5HFRUG5HYLHZ$XGLW9LVLWV2&7
7KHHQKDQFHGUHFRUGUHYLHZZLOOEHFRQGXFWHGE\WKH15*6'0&DWDQ\1&71
LQVWLWXWLRQZKLFKHQUROOHGDSDWLHQWRQWKH6WXG\


Time of Site Visit Audits 
'XULQJWKHDXGLWYLVLWVWKDWRFFXUXQGHUWKH&7(3DXGLWSURFHGXUHVDGGLWLRQDOFDVHV
ZLOOEHUHYLHZHGWRHQVXUHWKDWDOOVLWHVWKDWHQUROOHGSDWLHQWVWRWKH6WXG\ZLOOEH
VHOHFWHGIRUUHYLHZ


Additional On-Site Audit  
,QDGGLWLRQWRWKHUHJXODUO\VFKHGXOHGDXGLWSHU&70%JXLGHOLQHVDQDGGLWLRQDODXGLW
ZLOOEHFRQGXFWHGZLWKLQWZR\HDUVRIWKHDQWLFLSDWHGGDWHZKHQWKHVWXG\LVH[SHFWHG
WRPDWXUHIRUWKHILQDODQDO\VLV6LWHVWKDWHQUROOHGIHZHUWKDQHLJKWVXEMHFWVPD\EH
DXGLWHGUHPRWHO\
*OREDO5HSRUWLQJ0RQLWRULQJ2&7
7KLVVWXG\ZLOOEHPRQLWRUHGE\WKH&OLQLFDO'DWD8SGDWH6\VWHP&'869HUVLRQ
&XPXODWLYHSURWRFRODQGSDWLHQWVSHFLILF&'86GDWDZLOOEHVXEPLWWHGHOHFWURQLFDOO\WR
&7(3RQDTXDUWHUO\EDVLVE\)73EXUVWRIGDWD5HSRUWVDUHGXH-DQXDU\$SULO
-XO\DQG2FWREHU,QVWUXFWLRQVIRUVXEPLWWLQJGDWDXVLQJWKH&'86FDQEHIRXQG
RQWKH&7(3ZHEVLWHKWWSFWHSFDQFHUJRYUHSRUWLQJFGXVKWPO
7KLVVWXG\KDVEHHQDVVLJQHGWR&'86$EEUHYLDWHGUHSRUWLQJQRDGYHUVHHYHQWUHSRUWLQJ
URXWLQHRUH[SHGLWHGLVUHTXLUHGWREHUHSRUWHGYLD&'86EXWH[SHGLWHGDGYHUVHHYHQWV
DUHVWLOOUHTXLUHGWREHVXEPLWWHGYLD&7(3$(56

67$7,67,&$/&216,'(5$7,216

6WXG\'HVLJQ129
7KHVWXG\LVDQRSHQODEHOUDQGRPL]HGSKDVH,,,WULDOWRHYDOXDWHWKHDGGLWLRQRI
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
DWH]ROL]XPDEWRVWDQGDUGFKHPRUDGLDWLRQIRUOLPLWHGVWDJHVPDOOFHOOOXQJFDQFHU
5DQGRPL]DWLRQZLOORFFXULQDUDWLRWKURXJKXVHRIDSHUPXWHGEORFNUDQGRPL]DWLRQ
PHWKRG3DWLHQWVZLOOEHUDQGRPO\DVVLJQHGWRRQHRIWZRWUHDWPHQWDUPVFKHPRUDGLDWLRQ
DORQH$UPRUFKHPRUDGLDWLRQSOXVDWH]ROL]XPDE$UP7KHUDQGRPL]DWLRQVFKHPH
LVGHVLJQHGWRHQVXUHWKDWDQDSSUR[LPDWHO\HTXDOQXPEHURISDWLHQWVZLOOEHHQUROOHGLQ
HDFKWUHDWPHQWDUPZLWKLQWKHEDVHOLQHFKDUDFWHULVWLFVRIWKHIROORZLQJVWUDWLILFDWLRQ
IDFWRUV

5DGLDWLRQVFKHGXOH%,'ZHHNVYVGDLO\ZHHNV

&KHPRWKHUDS\FLVSODWLQYVFDUERSODWLQ

6H[PDOHYVIHPDOH

(&2*3HUIRUPDQFH6WDWXVYV


6WXG\(QGSRLQWV-8/
3ULPDU\(QGSRLQW
7KHSULPDU\HQGSRLQWLVRYHUDOOVXUYLYDO26ZKLFKLVGHILQHGDVWKHWLPHIURP
UDQGRPL]DWLRQWRWKHGDWHRIGHDWKGXHWRDQ\FDXVH

6HFRQGDU\(QGSRLQWV
x 3URJUHVVLRQIUHHVXUYLYDO
x 7R[LFLWLHVDVPHDVXUHGE\WKH&7&$(Y
x 2EMHFWLYHUHVSRQVHUDWH
x /RFDOFRQWURO
x 'LVWDQWPHWDVWDVHVIUHHVXUYLYDO
x 4XDOLW\RIOLIHDVPHDVXUHGE\WKH)$&772,
x 4XDOLW\DGMXVWHGVXUYLYDOXVLQJVFRUHVIURPWKH(4'/
x )DWLJXHDVPHDVXUHGE\WKH3520,6
0ROHFXODUVXEW\SLQJDVLQWHJUDWHGPDUNHUV
([SORUDWRU\(QGSRLQWV
x 3DWLHQWUHSRUWHGV\PSWRPDWLFWR[LFLWLHV352&7&$(


3ULPDU\2EMHFWLYHV6WXG\'HVLJQ$8*
 3ULPDU\+\SRWKHVLVDQG(QGSRLQWV
7KHSULPDU\REMHFWLYHRIWKLVUDQGRPL]HGSKDVH,,,WULDOLVWRGHWHUPLQHZKHWKHUDGGLWLRQ
RIDWH]ROL]XPDEWRFRQFXUUHQWFKHPRUDGLRWKHUDS\ZLOOLPSURYH26FRPSDUHGWRVWDQGDUG
FKHPRUDGLRWKHUDS\IRUSDWLHQWVZLWK/66&/&
%DVHGRQWKH&219(57WULDO)DLYUH)LQQHWDODQGWKHPRVWUHFHQWGDWDIRU
FRPELQHGPRGDOLW\WKHUDS\RXWFRPHVZHDVVXPHWKHPHGLDQ26LQWKHFRQWURODUPZLOO
EHPRQWKV,QUHJDUGVWRWKHHIIHFWVL]HDKD]DUGUDWLR+5RILVK\SRWKHVL]HGIRU
26DSSUR[LPDWHO\HTXLYDOHQWWRLPSURYLQJWKHPHGLDQ26IURPPRQWKVWRPRQWKV
>+@:HEHOLHYHWKHHIIHFWVL]HIRU26LVVXSSRUWHGE\SULRULPPXQRWKHUDS\VWXGLHV
XWLOL]LQJDWH]ROL]XPDELQ16&/&7KHSKDVH,,,2$.VWXG\ZKLFKFRPSDUHG
DWH]ROL]XPDEYHUVXVGRFHWD[HOLQSDWLHQWVZLWKVWDJH,,,%RU,916&/&ZLWKGLVHDVH
SURJUHVVLRQDIWHUSODWLQXPEDVHGWKHUDS\DQGZKLFKHVWDEOLVKHGWKHUROHRIDWH]ROL]XPDE
LQVWDJH,916&/&GHPRQVWUDWHGDQLPSURYHPHQWLQ26ZLWKDWH]ROL]XPDEFRPSDUHG
ZLWKGRFHWD[HOZLWKD+5RI&,S 
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

 +RZ3ULPDU\(QGSRLQWV:LOO%H$QDO\]HG
26LVGHILQHGDVWKHWLPHIURPUDQGRPL]DWLRQWRGHDWKGXHWRDQ\FDXVH3DWLHQWVZLWKRXW
GRFXPHQWHGGHDWKDWWKHWLPHRIDQDO\VLVZLOOEHFHQVRUHGDWWKHGDWHRIODVWNQRZQ
FRQWDFW7KHSULPDU\DQDO\VLVIRU26ZLOOEHSHUIRUPHGRQDQLQWHQWWRWUHDW,77EDVLV
VXFKWKDWDOOUDQGRPL]HGFDVHVZLOOEHLQFOXGHGLQWKHWUHDWPHQWDUPWRZKLFKWKH\ZHUH
UDQGRPL]HGUHJDUGOHVVRIZKDWWUHDWPHQWWKHSDWLHQWVDFWXDOO\UHFHLYHG7KLVLVWKH
SULPDU\GDWDVHWIRUDQDO\VHVRIGHPRJUDSK\SURWRFROGHYLDWLRQVEDVHOLQHFKDUDFWHULVWLFV
DQGHIILFDF\RXWFRPHUHVHDUFK


7KHGHILQLWLYHSKDVH,,,DQDO\VLVRI26ZLOORFFXUZKHQDWOHDVWGHDWKVDUHDYDLODEOH
DQGWKHVWXG\ZLOOEHFRQVLGHUHGDVSRVLWLYHLIWKHORJUDQNWHVWVWDWLVWLFV=YDOXH!S
ZKLFKLVWKHWKUHVKROGDGMXVWHGIRUW\SHHUURUXVLQJJURXSVHTXHQWLDOPHWKRGV


7KHVXUYLYDOUDWHVDWYDULRXVWLPHSRLQWVHJHYHU\PRQWKVDIWHUUDQGRPL]DWLRQDQG
PHGLDQ26IRUHDFKDUPZLOOEHHVWLPDWHGXVLQJWKH.DSODQ0HLHUPHWKRG7KH
DVVRFLDWHGFRQILGHQFHLQWHUYDO&,ZLOOEHFDOFXODWHGXVLQJ*UHHQZRRG¶VIRUPXOD
DQGEDVHGRQDORJORJWUDQVIRUPDWLRQDSSOLHGRQWKHVXUYLYDOIXQFWLRQ,QDGGLWLRQWKH
WUHDWPHQWKD]DUGUDWLRZLOOEHHVWLPDWHGXVLQJDVWUDWLILHG&R[UHJUHVVLRQPRGHO
VWUDWLI\LQJIRUUDQGRPL]DWLRQVWUDWLILFDWLRQIDFWRUV,IRQHVWUDWXPKDVOHVVWKDQ
HYHQWVWKHVWUDWLILFDWLRQIDFWRUZKLFKFRQWDLQVWKHOHYHOZLWKWKHVPDOOHVWQXPEHURI
SDWLHQWVZLOOEHUHPRYHGIURPWKHVWUDWLILHGDQDO\VHV5HVXOWVIURPDQXQVWUDWLILHG
DQDO\VLVZLOODOVREHSURYLGHG

 6DPSOH6L]HDQG3RZHU&DOFXODWLRQV
7KHILQDODQDO\VLVIRU26ZLOORFFXUZKHQDWOHDVWGHDWKVIXOO26LQIRUPDWLRQKDYH
EHHQREVHUYHG7KHVWXG\ZLOOSURYLGHDWOHDVWSRZHUWRGHWHFWDKD]DUGUDWLRRI
DWDVLGHGVLJQLILFDQFHOHYHORI$VVXPLQJH[SRQHQWLDOO\GLVWULEXWHG26DQGD
PRQWKO\DFFUXDOUDWHRIHOLJLEOHSDWLHQWVSHUPRQWKVHH6HFWLRQEHORZDVWXG\
WKDWHQUROOVDWRWDORIHOLJLEOHSDWLHQWVXQLIRUPO\RYHUPRQWKVZLWKDQDGGLWLRQDO
IROORZXSRIPRQWKVDIWHUWKHODVWSDWLHQWDFFUXDOZLOOKDYHaSRZHUWRGHWHFWDQ
LPSURYHPHQWLQPHGLDQ26RIPRQWKVLQWKHFRQWURODUPWRPRQWKVLQWKH
H[SHULPHQWDODUPXVLQJDVLGHGOHYHOORJUDQNWHVW$VRI-XQHWKH
VWXG\LVFORVHGWRDFFUXDOIRUVLWHVLQWKH86DQG&DQDGDDQGRQO\RSHQWRDFFUXDOIRU
VLWHVLQ-DSDQ7KHWULDOZLOOHQUROODWRWDORISDWLHQWVDIWHUDFFRXQWLQJIRULQHOLJLELOLW\
RUODFNRIGDWDDVZHOODVUHJXODWRU\UHTXLUHPHQWVLQ-DSDQ


6WXG\0RQLWRULQJRI3ULPDU\2EMHFWLYHV$8*
7KH15*2QFRORJ\'DWD0RQLWRULQJ&RPPLWWHH'0&ZLOOUHYLHZWKHVWXG\WZLFHD
\HDUZLWKUHVSHFWWRSDWLHQWDFFUXDODQGPRUELGLW\$QLQWHULPVWXG\VXPPDU\UHSRUWZLOO
EHSUHSDUHGDWHDFKPHHWLQJDFFRUGLQJO\XQWLOWKHLQLWLDOVWXG\UHVXOWVKDYHEHHQUHOHDVHG
,QJHQHUDOWKHLQWHULPUHSRUWVZLOOFRQWDLQLQIRUPDWLRQDERXWSDWLHQWDFFUXDOUDWHD
SURMHFWHGFRPSOHWLRQGDWHIRUWKHDFFUXDOSKDVHGLVWULEXWLRQVRISUHWUHDWPHQW
FKDUDFWHULVWLFVDQGLPSRUWDQWSURJQRVWLFEDVHOLQHYDULDEOHVDQGWKHIUHTXHQFLHVDQG
VHYHULW\RIDGYHUVHHYHQWV7KHLQWHULPUHSRUWVZLOOQRWFRQWDLQWKHUHVXOWVIURPWKH
WUHDWPHQWFRPSDULVRQVZLWKUHVSHFWWRWKHSULPDU\RUDQ\VHFRQGDU\HQGSRLQWVZLWKWKH
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
H[FHSWLRQRIUHSRUWLQJRIDGYHUVHHYHQWV7KH'0&DOVRZLOOUHYLHZWKHVWXG\RQDQ³DV
QHHGHG´EDVLV

7RDOORZDGHTXDWHSURWHFWLRQRIWKHSDWLHQWVLQWKHH[SHULPHQWDODUPLQWKHHYHQWWKDWWKH
H[SHULPHQWDOUHJLPHLVFOHDUO\KDUPIXODQHDUO\³KDUP´ORRNZLOOEHFRQGXFWHGDWRI
WKHIXOO26LQIRUPDWLRQFRUUHVSRQGLQJWRWKHWLPHZKHQDWRWDORI26HYHQWVKDYH
EHHQREVHUYHG)UHLGOLQ.RUQDQG*UD\6SHFLILFDOO\DWWKLVWLPHZHFRQVLGHU
WKHH[SHULPHQWDOUHJLPHQLVOLNHO\WREHVDIHZLWKUHVSHFWWR26LIWKHORJUDQNWHVW
VWDWLVWLFV=YDOXH!ZKHQDWOHDVWGHDWKVDUHDYDLODEOH,QRWKHUZRUGVWKHWULDO
ZLOOVWRSZKHQWKHQXOOK\SRWKHVLVFDQEHUHMHFWHGLQIDYRURIVXSHULRUHIILFDF\RIWKH
controlDUPDWWKHRQHVLGHGOHYHO

7ZRLQWHULPDQDO\VHVIRUERWKHIILFDF\DQGIXWLOLW\RI26ZLOORFFXUZKHQDSSUR[LPDWHO\
DQGGHDWKVDUHDYDLODEOHFRUUHVSRQGLQJWRDQGLQIRUPDWLRQ7KH
HIILFDF\HDUO\VWRSSLQJERXQGDU\LVEDVHGRQWKH/DQ'H0HWVLPSOHPHQWDWLRQRI
2¶%ULHQ)OHPLQJERXQGDU\DQGWKHIXWLOLW\HDUO\VWRSSLQJERXQGDU\LVEDVHGRQ)UHLGOLQ
HWDOXVLQJWKH/,%FULWHULRQ7KHWDEOHEHORZVXPPDUL]HVWKHDQDO\VHVWREH
FRQGXFWHGDQGWKHFULWHULDIRUSRVVLEOHHDUO\VWRSSLQJIRUHIILFDF\RUIXWLOLW\IRUWKH
SULPDU\HQGSRLQW

$QDO\VLV
,QIRUPDWLRQ
)UDFWLRQ
&XPXODWLYH
26(YHQWV
%RWK
$UPV
(IILFDF\
%RXQGDU\
)XWLOLW\
%RXQGDU\
3URMHFWHG
DQDO\VLV
WLPHIURP
VWXG\
DFWLYDWLRQ
PRQWKV
=!
3
=
3!
,QWHULP







,QWHULP







)LQDO







RQHVLGHGSYDOXH

,IWKHUHDUHDQ\GHYLDWLRQVIURPWKHDVVXPSWLRQVJURXSVHTXHQWLDOPHWKRGVZLOOEHXVHG
WRSURSHUO\DGMXVWIRUWKHVWRSSLQJERXQGDU\EDVHGRQFXPXODWLYHLQIRUPDWLRQ8QOHVVWKH
VWXG\LVWHUPLQDWHGSULRUWRWKHILQDODQDO\VLVWKHLQWHULPDQDO\VHVUHVXOWVZLOOQRWEH
DYDLODEOHWRWKHLQYHVWLJDWRUVVSRQVRURULQGXVWU\FROODERUDWRUQRUXVHGWRPRGLI\WKH
VWXG\GHVLJQRUVDPSOHVL]H7KHUHVXOWVRIWKLVDQDO\VLVZLOOEHUHSRUWHGWRWKH15*
'0&IRUUHYLHZ

$FFUXDO6WXG\'XUDWLRQ&RQVLGHUDWLRQV-81(
'XULQJWKHILUVWPRQWKVIROORZLQJDFWLYDWLRQOLWWOHDFFUXDOLVDQWLFLSDWHGZKLOHWKHWULDO
LVEHLQJDSSURYHGE\LQVWLWXWLRQDOUHYLHZERDUGV,5%V:HDVVXPHDXQLIRUPPRQWKO\
DFFUXDOUDWHRISDWLHQWVHOLJLEOHSDWLHQWVWREHUDQGRPL]HGDQGPLQLPDODFFUXDO
LQWKHILUVWPRQWKVIRUUDPSXS$FFUXDOUDWHVDUHEDVHGRQREVHUYHGHQUROOPHQW
SDWWHUQVLQFRPSOHWHGDQGRQJRLQJ572*15*DQG$OOLDQFHWULDOVLQWKLVGLVHDVHVHWWLQJ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
,QWKHRQJRLQJ$OOLDQFH&$/*%572*DSKDVH,,,UDQGRPL]HGWULDOIRU
OLPLWHGVWDJHVPDOOFHOOOXQJFDQFHUWKHDYHUDJHPRQWKO\DFFUXDOLVDSSUR[LPDWHO\
SDWLHQWV,QWKHFORVHG572*DSKDVH,,,,,UDQGRPL]HGWULDOIRUOLPLWHGVWDJHVPDOO
FHOOOXQJFDQFHUIRFXVLQJWKHXVHRISURSK\ODFWLFFUDQLDOLUUDGLDWLRQWKHPRQWKO\DFFUXDO
ZDVDSSUR[LPDWHO\SDWLHQWV7KHUHIRUHZLWKWKHFROOHFWLYHHIIRUWVIURPERWK15*
2QFRORJ\DQG$OOLDQFHWKH1&71DFFUXDOLQIUDVWUXFWXUHDVZHOODVSDWLHQWFDUHJLYHU
GHVLUHVIRUDFFHVVWRLPPXQRWKHUDS\ZHEHOLHYHDPRQWKO\DFFUXDORISDWLHQWVLVD
UHDVRQDEOHSURMHFWLRQ

8QGHUWKHDOWHUQDWLYHK\SRWKHVLV+WKHHQWLUHVWXG\LVSURMHFWHGWRWDNHDSSUR[LPDWHO\
PRQWKV PRQWKVUDPSXSPRQWKVDFFUXDOPRQWKVIROORZXS a
\HDUVIURPVWXG\LQLWLDWLRQWRUHDFKWKHUHTXLUHGGHDWKV

7KHDERYHSURMHFWHGVWXG\GXUDWLRQLVEDVHGRQWKHK\SRWKHVL]HGGHVLJQSDUDPHWHUV,I
WKHDFWXDOVWXG\SDUDPHWHUVGHYLDWHIURPWKHK\SRWKHVL]HGRQHVWKHDFWXDOVWXG\GXUDWLRQ
PD\EHGLIIHUHQWIURPWKHSURMHFWLRQ)RUH[DPSOHIURPWKHUHVXOWVRIWKH&219(57
WULDOZLWKDPHGLDQIROORZXSRIPRQWKVLWDSSHDUHGWKDWWKHUHPD\EHSODWHDXVLQ
WKH26FXUYHEH\RQG\HDUV6KRXOGVXFKSKHQRPHQRQRFFXUWKHUHTXLUHGQXPEHURI
26HYHQWVIRUWKHILQDODQDO\VLVZLOOQRWFKDQJHEXWWKHSURMHFWHGVWXG\GXUDWLRQPD\EH
ORQJHUWKDQFXUUHQWO\DQWLFLSDWHG7RDFFRXQWIRUWKLVSRVVLELOLW\\HWHQVXULQJVXIILFLHQW
26IROORZXSWKHILQDO26DQDO\VLVZLOORFFXUDIWHUREVHUYLQJDWOHDVWGHDWKVRU
\HDUVDIWHUDFFUXDOFRPSOHWLRQZKLFKHYHURFFXUVILUVW


6HFRQGDU\RU([SORUDWRU\(QGSRLQWV-8/
6HFRQGDU\+\SRWKHVHVDQG(QGSRLQWV
x 3URJUHVVLRQIUHHVXUYLYDO
x 7R[LFLWLHVDVPHDVXUHGE\WKH&7&$(Y
x 2EMHFWLYHUHVSRQVHUDWH
x /RFDOFRQWURO
x 'LVWDQWPHWDVWDVHVIUHHVXUYLYDO
x 4XDOLW\RIOLIHDVPHDVXUHGE\WKH)$&772,
x 4XDOLW\DGMXVWHGVXUYLYDOXVLQJVFRUHVIURPWKH(4'/
x )DWLJXHDVPHDVXUHGE\3520,6
x 0ROHFXODUVXEW\SLQJDVLQWHJUDWHGPDUNHUV

 ([SORUDWRU\(QGSRLQWV
x 3DWLHQWUHSRUWHGV\PSWRPDWLFWR[LFLWLHV352&7&$(&RQFRUGDQFHEHWZHHQWXPRU
DQGFI'1$PROHFXODUVXEW\SHV


'HILQLWLRQVRI6HFRQGDU\(QGSRLQWVDQG+RZ7KHVH:LOO%H$QDO\]HG-8/


 6WDWLVWLFDO$QDO\VLV3ODQ7R[LFLW\
7KH$V7UHDWHG$7SDWLHQWSRSXODWLRQZLOOEHXVHGIRUWKHDQDO\VLVRIVDIHW\GDWDLQWKLV
VWXG\7KH$7SRSXODWLRQFRQVLVWVRIDOOUDQGRPL]HGVXEMHFWVEDVHGRQWKHWUHDWPHQWWKH\
DFWXDOO\UHFHLYHGSDWLHQWVZKRGRQRWUHFHLYHDQ\SURWRFROWUHDWPHQWZLOOQRWEHLQFOXGHG
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
LQWKHVHDQDO\VHV

)RUHDFKSDWLHQWWKHPD[LPXPVHYHULW\UHSRUWHGIRUERWKLPPXQHPHGLDWHGDQGQRQ
LPPXQHPHGLDWHGDGYHUVHHYHQWVZLOOEHXVHGLQWKHVXPPDULHV$GYHUVHHYHQWVZLOOEH
VXPPDUL]HGUHJDUGOHVVRIUHODWLRQVKLSWRSURWRFROWUHDWPHQWDVDVVHVVHGE\WKH
LQYHVWLJDWRU$OODGYHUVHHYHQWVDGYHUVHHYHQWVOHDGLQJWRZLWKGUDZDOLQWHUUXSWLRQRU
PRGLILFDWLRQRISURWRFROWUHDWPHQW *UDGH   DGYHUVH HYHQWV DQG VHULRXV DGYHUVH HYHQWV
ZLOOEHVXPPDUL]HG'HDWKVDQGFDXVHRIGHDWKZLOOEHVXPPDUL]HG7KHUDWHRI
WUHDWPHQWUHODWHGDGYHUVHHYHQWVXVLQJ1&,&RPPRQ7HUPLQRORJ\&ULWHULDIRU$GYHUVH
(YHQWV&7&$(YZLOOEHUHSRUWHGZLWKWKHIUHTXHQF\DQGVHYHULW\HJW\SH
JUDGHDQGDWWULEXWLRQE\DUPWKHDQDO\VLVZLOOEHSHUIRUPHGDWWKHWLPHRIWKHSULPDU\
HQGSRLQWDQDO\VHV$OODGYHUVHHYHQWVZLOOEHFODVVLILHGDVHLWKHULPPXQHRUQRQLPPXQH
PHGLDWHG

 6WDWLVWLFDO$QDO\VLV3ODQ3URJUHVVLRQIUHHVXUYLYDO'LVWDQWPHWDVWDVHVIUHHVXUYLYDO
/RFDOFRQWURO2EMHFWLYHUHVSRQVHUDWH
7KHDQDO\VHVIRUDOOHIILFDF\VHFRQGDU\HQGSRLQWVZLOOEHSHUIRUPHGRQDQLQWHQWWRWUHDW
,77EDVLVDQGFRQGXFWHGDWWKHWLPHRISULPDU\DQDO\VLVDIWHUVWXG\FORVXUH7KH
SULPDU\DQDO\VLVRFFXUVZKHQ26PHHWVLWVILQDODQDO\VLVJRDOHJDWOHDVWGHDWKV
REVHUYHGLIQRWWHUPLQDWHGHDUO\RU26HIILFDF\ERXQGDU\LVFURVVHGDQGWKHWULDOVWRSV
HDUO\DWRQHRIWKHSODQQHGLQWHULPDQDO\VLV

3URJUHVVLRQIUHHVXUYLYDO3)6LVGHILQHGDVWKHWLPHEHWZHHQWKHGDWHRIUDQGRPL]DWLRQ
DQGWKHILUVWGDWHRIGRFXPHQWHGSURJUHVVLRQDVGHWHUPLQHGE\WKHLQYHVWLJDWRUDFFRUGLQJ
WR5(&,67YUHJDUGOHVVRIGLVFRQWLQXDWLRQRIVWXG\GUXJRUGHDWKGXHWRDQ\FDXVH
ZKLFKHYHURFFXUVILUVW6XEMHFWVZKRGLHZLWKRXWDUHSRUWHGSURJUHVVLRQZLOOEH
FRQVLGHUHGWRKDYHWKH3)6HYHQWRQWKHGDWHRIWKHLUGHDWK6XEMHFWVZKRGRQRW
SURJUHVVRUGLHZLOOEHFHQVRUHGRQWKHGDWHRIWKHLUODVWHYDOXDEOHWXPRUDVVHVVPHQWDV
GHWHUPLQHGZLWKUDGLRJUDSKLFHYLGHQFH6XEMHFWVZKRGRQRWKDYHDQ\RQVWXG\WXPRU
DVVHVVPHQWVDQGGRQRWGLHZLOOEHFHQVRUHGRQWKHVHFRQGGD\RIWKHLUGDWHRI
UDQGRPL]DWLRQ7KHUDWHVDWYDULRXVWLPHSRLQWVHJHYHU\PRQWKVDIWHUUDQGRPL]DWLRQ
DQGPHGLDQVRI3)6IRUHDFKDUPZLOOEHHVWLPDWHGXVLQJWKH.DSODQ0HLHUPHWKRG
7KHDVVRFLDWHGFRQILGHQFHLQWHUYDO&,ZLOOEHFDOFXODWHGXVLQJ
*UHHQZRRG¶VIRUPXODDQGEDVHGRQDORJORJWUDQVIRUPDWLRQDSSOLHGRQWKHVXUYLYDO
IXQFWLRQ6WUDWLILHGORJUDQNWHVWZLOOEHXVHGWRFRPSDUH3)6EHWZHHQWKHWUHDWPHQW
DUPV&R[SURSRUWLRQDOKD]DUGVPRGHOVWUDWLILHGE\WKHSURWRFROGHILQHGVWUDWLILFDWLRQ
IDFWRUVZLOOEHXVHGWRHVWLPDWHWKH+5EHWZHHQWKHWZRWUHDWPHQWDUPVDQGLWV
FRQILGHQFHLQWHUYDO&,5HVXOWVIURPDQXQVWUDWLILHGDQDO\VLVZLOODOVREHSURYLGHGDV
VHQVLWLYLW\DQDO\VLV,I!RISDWLHQWVUHFHLYHSDOOLDWLYHORFDOWKHUDS\RULQLWLDWH
V\VWHPDWLFDQWLFDQFHUWKHUDS\DNDQHZWKHUDS\ZLWKRXWDSULRUUHSRUWHGSURJUHVVLRQ
FRQILUPHGE\5(&,67DVHQVLWLYLW\DQDO\VLVZLOOEHFRQGXFWHGE\FHQVRULQJWKHVH
SDWLHQWVRQWKHGDWHRIWKHLUODVWWXPRUDVVHVVPHQWDVGHWHUPLQHGZLWKUDGLRJUDSKLF
HYLGHQFHSULRUWRWKHSHUPDQHQWGLVFRQWLQXDWLRQRIWUHDWPHQWRUWKHLQLWLDWLRQRI
VXEVHTXHQWDQWLFDQFHUWKHUDS\RUSDOOLDWLYHORFDOWKHUDS\

'LVWDQWPHWDVWDVHVIUHHVXUYLYDO'0)6LVGHILQHGDVWKHWLPHEHWZHHQWKHGDWHRI
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
UDQGRPL]DWLRQDQGWKHILUVWGDWHRIGRFXPHQWHGGLVWDQWPHWDVWDVHVRUIDLOXUHVLQD
GLIIHUHQWOXQJOREHRUGHDWKGXHWRDQ\FDXVHZKLFKHYHURFFXUVILUVW3DWLHQWVZLWKQR
SRVWEDVHOLQHWXPRUDVVHVVPHQWDQGGRQRWGLHZLOOEHFHQVRUHGRQWKHGDWHRI
UDQGRPL]DWLRQ/RFDOSURJUHVVLRQRFFXUUHGSULRUWRGLVWDQWPHWDVWDVHVZLOOEHFHQVRUHGRQ
WKHGDWHRIORFDOSURJUHVVLRQ7KHUDWHVDWYDULRXVWLPHSRLQWVHJHYHU\PRQWKVDIWHU
UDQGRPL]DWLRQDQGPHGLDQVRI'0)6IRUHDFKDUPZLOOEHHVWLPDWHGXVLQJWKH.DSODQ
0HLHUPHWKRG7KHDVVRFLDWHGFRQILGHQFHLQWHUYDO&,ZLOOEHFDOFXODWHG
XVLQJ*UHHQZRRG¶VIRUPXODDQGEDVHGRQDORJORJWUDQVIRUPDWLRQDSSOLHGRQWKH
VXUYLYDOIXQFWLRQ6WUDWLILHGORJUDQNWHVWZLOOEHXVHGWRFRPSDUH'0)6EHWZHHQWKH
WUHDWPHQWDUPV&R[SURSRUWLRQDOKD]DUGVPRGHOVWUDWLILHGE\WKHSURWRFROGHILQHG
VWUDWLILFDWLRQIDFWRUVZLOOEHXVHGWRHVWLPDWHWKH+5EHWZHHQWKHWZRWUHDWPHQWDUPVDQG
LWVFRQILGHQFHLQWHUYDO&,5HVXOWVIURPDQXQVWUDWLILHGDQDO\VLVZLOODOVREH
SURYLGHG3DWLHQWVZKRKDYHQRWH[SHULHQFHGGLVWDQWPHWDVWDVHVRUIDLOXUHVLQDGLIIHUHQW
OXQJOREHDQGKDYHQRWGLHGE\WKHGDWDFXWRIIGDWHZLOOEHFHQVRUHGDWWKHGDWHRIWKHODVW
WXPRUDVVHVVPHQWDVGHWHUPLQHGZLWKUDGLRJUDSKLFHYLGHQFH/RFDOFRQWUROLVDQDO\]HG
EDVHGRQWLPHWRORFDOSURJUHVVLRQGHILQHGDVWKHWLPHIURPUDQGRPL]DWLRQWRILUVWGDWHRI
GRFXPHQWHGORFDOSURJUHVVLRQLQZKLFKDIDLOXUHLVGHILQHGDVLQWUDWKRUDFLFWXPRU
SURJUHVVLRQIDLOXUHLQWKHOREHRIWKHSULPDU\WXPRURUPHGLDVWLQDOO\PSKQRGHVE\
5(&,67FULWHULDGHWHUPLQHGE\WKHLQYHVWLJDWRU7LPHWRORFDOSURJUHVVLRQLV
DQDO\]HGDVWLPHWRHYHQWFRPSHWLQJULVNVGDWDZKHUHERWKQRQORFDOSURJUHVVLRQLH
GLVWDQWPHWDVWDVLVRUIDLOXUHLQDGLIIHUHQWOXQJDQGGHDWKZLWKRXWORFDO
SURJUHVVLRQIDLOXUHZLOOEHFRQVLGHUHGDV³FRPSHWLQJULVNV´7KHSUREDELOLW\RIORFDO
SURJUHVVLRQZLOOEHHVWLPDWHGE\WUHDWPHQWXVLQJ$DOHQ-RKDQVHQHVWLPDWRURIFXPXODWLYH
LQFLGHQFHIXQFWLRQ7KHUDWHVDWYDULRXVWLPHSRLQWVHJHYHU\PRQWKVDIWHU
UDQGRPL]DWLRQIRUHDFKDUPZLOOEHHVWLPDWHG7RDFFRXQWIRUWKHFRPSHWLQJULVNV
LQKHUHQWLQWKHFRPSDULVRQRIWLPHWRORFDOSURJUHVVLRQEHWZHHQWUHDWPHQWDUPVD
VWUDWLILHGORJUDQNWHVWZLOOEHFRPSXWHGEDVHGRQDFDXVHVSHFLILFKD]DUGIXQFWLRQ+5
DQG&,EDVHGRQVWUDWLILHGFDXVHVSHFLILF&R[UHJUHVVLRQPRGHOZLOODOVREH
HVWLPDWHG

2EMHFWLYHUHVSRQVHUDWH255LVGHILQHGDVWKHSURSRUWLRQRIDOOUDQGRPL]HGVXEMHFWV
ZKRVHEHVWRYHUDOOUHVSRQVH%25LVDFRQILUPHGREMHFWLYHUHVSRQVHLH&RPSOHWH
5HVSRQVHRU3DUWLDO5HVSRQVHRQ WZR FRQVHFXWLYH RFFDVLRQV  ZHHNV DSDUWDV
GHWHUPLQHGE\WKHLQYHVWLJDWRUDFFRUGLQJWR5(&,67Y255ZLOOEHFRPSDUHGXVLQJD
WZRVLGHGOHYHO&RFKUDQ0DQWHO+DHQV]HO&0+WHVWVWUDWLILHGE\WKHVDPH
VWUDWLILFDWLRQIDFWRUVXVHGIRUUDQGRPL]DWLRQ7KH&,IRUWKHGLIIHUHQFHLQFRQILUPHG
255VEHWZHHQWKHWZRWUHDWPHQWDUPVZLOOEHFRPSXWHGXVLQJWKHQRUPDODSSUR[LPDWLRQ
WRWKHELQRPLDOGLVWULEXWLRQ7KH&,RIWKHFRQILUPHG255ZLOOEHFDOFXODWHGIRU
HDFKWUHDWPHQWDUPXVLQJWKH&ORSSHU3HDUVRQPHWKRG



,IRQHVWUDWXPKDVOHVVWKDQHYHQWVWKHVWUDWLILFDWLRQIDFWRUZKLFKFRQWDLQVWKHOHYHO
ZLWKWKHVPDOOHVWQXPEHURISDWLHQWVZLOOEHUHPRYHGIURPWKHVWUDWLILHGDQDO\VHV

 0XOWLSOLFLW\6WUDWHJ\IRU3ULPDU\(QGSRLQWDQG6HFRQGDU\(QGSRLQWV

 7RPHHWUHJXODWRU\UHTXLUHPHQWVDPXOWLSOHWHVWLQJVWUDWHJ\ZLOOEHLPSOHPHQWHGWR
FRQWUROWKHIDPLO\ZLVHW\SHHUURUDOSKDIRUWKHHQWLUHWULDO6SHFLILFDOO\XSRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
DFKLHYLQJVWDWLVWLFDOVLJQLILFDQFHRQWKHSULPDU\HQGSRLQW26WHVWLQJRIHDFKRIWKH
VHFRQGDU\HQGSRLQWVLQWKHIROORZLQJRUGHUVHTXHQWLDOO\SURJUHVVLRQIUHHVXUYLYDO
3)6REMHFWLYHUHVSRQVHUDWH255ORFDOFRQWURO/&GLVWDQWPHWDVWDVHVIUHH
VXUYLYDO'0)6

 
 ,QWHULP$QDO\VLVIRU7R[LFLW\
,QDGGLWLRQWRPRQLWRULQJVHYHUHDGYHUVHHYHQWVDQGXQH[SHFWHGDGYHUVHHYHQWVFORVHO\
DQGKDYLQJWKHPUHYLHZHGDWWKHVHPLDQQXDO'0&PHHWLQJVDVSDUWRIURXWLQHVWXG\
PRQLWRULQJHIIRUWWKHIROORZLQJDGYHUVHHYHQWVRILQWHUHVWZLOOEHFORVHO\PRQLWRUHGE\
WKHVWXG\WHDPSQHXPRQLWLVSHULFDUGLWLVHVRSKDJLWLVDQGHQFHSKDOLWLV)RUWKHILUVW
HOLJLEOHSDWLHQWVUDQGRPL]HGWR$UPZKRUHFHLYHDWOHDVWRQHF\FOHRIDWH]ROL]XPDEWKH
IUHTXHQF\RIJUDGHRUKLJKHUSQHXPRQLWLVSHULFDUGLWLVHVRSKDJLWLVDQGHQFHSKDOLWLV
ZLOOEHFRQWLQXRXVO\PRQLWRUHGGXULQJWKHVDIHW\HYDOXDWLRQ
6SHFLDOVDIHW\LQWHULPDQDO\VHVRIJUDGHRUKLJKHUSQHXPRQLWLVSHULFDUGLWLVHVRSKDJLWLV
DQGHQFHSKDOLWLVWKDWUHPDLQXQUHVROYHGIRUPRUHWKDQZHHNVZLOOEHFRQGXFWHGZKHQ
DQGSDWLHQWVEHFRPHDQDO\]DEOHHJSDWLHQWVZKRKDYHEHHQWUHDWHGZLWK
DWH]ROL]XPDEDQGKDYHEHHQREVHUYHGIRUDWOHDVWZHHNV%DVHGRQWKHIROORZLQJ
%D\HVLDQWR[LFLW\PRQLWRULQJUXOHLIWKHUDWHLVFRQVLGHUHGDVFRQFHUQLQJWKHVWXG\WHDP
DQGJURXSOHDGHUVZLOOGLVFXVVZLWK&7(3DERXWWKHPRVWDSSURSULDWHDFWLRQVWRPLWLJDWH
WKHSRWHQWLDOULVNVLQFOXGLQJDSRVVLEOHPDMRUPRGLILFDWLRQWRVWXG\GHVLJQRUDFFUXDO
VXVSHQVLRQ:HDVVXPHDSULRULWKDW$UPKDVDQDYHUDJHWR[LFLW\UDWHRIDSSUR[LPDWHO\
DQGWKDWWKHUHLVDQDSSUR[LPDWHO\FKDQFHWKDWWKHULVNZLOOEHRUKLJKHU
ZKLFKFRUUHVSRQGVWRD%HWDSULRUGLVWULEXWLRQ:HWKHQFRQVLGHUWKHUDWHRI
WR[LFLW\WREHFRQFHUQLQJLIWKHSRVWHULRUSUREDELOLW\RIWKHWR[LFLW\UDWHLVPRUH
WKDQ7DEOHVXPPDUL]HVWKH%D\HVLDQPRQLWRULQJUXOHZKHQWKHWKWKWK
DQGWKSDWLHQWVEHFRPHDQDO\]DEOH
7DEOH%D\HVLDQ7R[LFLW\0RQLWRULQJ5XOH
7RWDORIDQDO\]DEOHSDWLHQWV




SDWLHQWVZLWK$(RILQWHUHVW




7DEOHVXPPDUL]HVWKHRSHUDWLQJFKDUDFWHULVWLFVEDVHGRQVLPXODWLRQVZLWK
SDWLHQWVLQWHUPVRIKRZIUHTXHQW$UPPD\EHFRQVLGHUHG³DODUPLQJ´IRUDFFUXDO
VXVSHQVLRQ
7DEOH2SHUDWLQJFKDUDFWHULVWLFVRIWKHPRQLWRULQJUXOH
8QGHUO\LQJULVN






RIWLPHVWRSSLQJFRQVLGHUHG







 3RZHU&DOFXODWLRQVIRU4XDOLW\RI/LIH42/5HVHDUFK%DVHGRQ([SHFWHG6DPSOH6L]HV
7KHSULPDU\42/HQGSRLQWLVZKHWKHUDSDWLHQWH[SHULHQFHVDFOLQLFDOO\PHDQLQJIXO
GHWHULRUDWLRQRI)$&772,GHILQHGDVDGHFOLQHRISRLQWVRUPRUHIURPEDVHOLQHDW
PRQWKVDIWHUWKHHQGRIWKHWKF\FOHRIFKHPRWKHUDS\HJDELQDU\HQGSRLQW7KH
SULPDU\42/K\SRWKHVLVLVWKDWWKHSURSRUWLRQRISDWLHQWVLQWKHH[SHULPHQWDODUPZLOO
H[SHULHQFHFOLQLFDOO\PHDQLQJIXOGHWHULRUDWLRQ&0'DWPRQWKVDIWHUFRPSOHWLRQRI
&57SLVVPDOOHUWKDQWKDWLQWKHFRQWURODUPSHJSS%DVHGRQ6HFWLRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WKLVK\SRWKHVLVZLOOEHWHVWHGLIDQGRQO\LIWKHVLGHGW\SHHUURURIDUH
SDVVHGRYHUIURPRWKHUVHFRQGDU\HQGSRLQWVZLWKKLJKHUUDQN,QWKLVFDVH)LVKHU¶VH[DFW
WHVWZLOOEHXVHGWRFRPSDUHWKHSURSRUWLRQVRISDWLHQWVH[SHULHQFLQJ&0'EHWZHHQWKH
WZRDUPV


%\GHILQLWLRQRQO\SDUWLFLSDQWVZKRDUHDOLYHDWPRQWKVDIWHUFRPSOHWLRQRI&57
DSSUR[LPDWHO\PRQWKVDIWHUUDQGRPL]DWLRQFRXOGSRWHQWLDOO\EHDQDO\]DEOHIRU
)$&772,DQDO\VLV%DVHGRQWKHSULPDU\K\SRWKHVLVRI26WKHVXUYLYDOUDWHDW
PRQWKVDIWHUFRPSOHWLRQRIWKHWKF\FOHRIFKHPRWKHUDS\DSSUR[LPDWHO\PRQWKV
DIWHUUDQGRPL]DWLRQLVDSSUR[LPDWHO\XQGHU+DQGXQGHU+:HGHILQH
SDWLHQWVDUHDQDO\]DEOHLIWKH\DUHUDQGRPL]HGDQGKDYHDVVHVVPHQWVDWERWKWLPHSRLQWV
EDVHOLQHDQGPRQWKVDIWHU&57FRPSOHWLRQ:KLOHJUHDWHIIRUWVZLOOEHPDGHWR
PLQLPL]HSDWLHQWV¶DWWULWLRQVXFKWKDWWKHQXPEHURIDQDO\]DEOHFDVHVFDQEHPD[LPL]HG
LWLVZHOODFNQRZOHGJHGWKDWXQFHUWDLQW\VWLOOH[LVWVLQWKHWRWDOQXPEHURIDQDO\]DEOH
FDVHV)XUWKHUPRUHWRRXUEHVWNQRZOHGJHWKHUHDUHQRH[LVWLQJGDWDDYDLODEOHLQ/6
6&/&WKDWFDQEHXVHGIRUWKHFRQWUROJURXSQRUDZLGHO\DFFHSWHGGLIIHUHQFHLQSDWLHQWV
H[SHULHQFLQJ&0'7KHUHIRUHZHDUJXHWKHVDPSOHVL]HRIWKH42/FRPSRQHQWVKRXOG
QRWEHGHWHUPLQHGE\GHWHFWLQJDIL[HGGLIIHUHQFHEHWZHHQSDWLHQWV¶SURSRUWLRQVRI
H[SHULHQFLQJ&0',QVWHDGZHGHPRQVWUDWHWKDWXQGHUUHDVRQDEOHDVVXPSWLRQVLWLV
UHDVRQDEOHDQGMXVWLILDEOHWRRIIHU42/WRDOOSDWLHQWVDQGWKHHQWLUHVWXG\ZLOOSURYLGH
UHDVRQDEO\JRRGSRZHUWRGHWHFWQRQWULYLDOGLIIHUHQFHVLQSURSRUWLRQVRISDWLHQWV
H[SHULHQFLQJ&0'7KHIROORZLQJWDEOHDVVXPHVSDWLHQWVDUHDQDO\]DEOH:KHQWKH
DWWULWLRQUDWHLVORZHUHJVPDOOHUWKDQJUHDWHUSRZHUVDUHH[SHFWHGWRGHWHFWVDPH
GLIIHUHQFHVLQ&0'SURSRUWLRQV

7DEOH3RZHURI&RPSDULQJ)$&772,'HWHULRUDWLRQ
([SHULHQFHG
&0'LQ$UPS
([SHULHQFHG&0'
LQ$UPS
3RZHU8QGHU+
IRU26
3RZHU8QGHU+
IRU26

































6WDWLVWLFDO$QDO\VLV3ODQ4XDOLW\RI/LIHDQG)DWLJXH
7KH42/DQDO\VHVIRUDQ\FKDQJHVEHWZHHQWZRWLPHSRLQWVZLOOEHSHUIRUPHGEDVHGRQ
DOOUDQGRPL]HGSDWLHQWVZLWKDVVHVVPHQWVDWERWKWLPHSRLQWVVHFWLRQ

7KHSULPDU\42/HQGSRLQW)$&772,GHWHULRUDWLRQUDWHDWPRQWKVDIWHUWKHHQGRI
WKHWKF\FOHRIFKHPRWKHUDS\LVGHILQHGDVWKHSURSRUWLRQRIUDQGRPL]HGVXEMHFWVZKR
KDYHDSRLQWRUJUHDWHUGHFUHDVHIURPEDVHOLQHLQ)$&772,DWPRQWKVDIWHU
FKHPRWKHUDS\FRPSOHWLRQ)$&772,GHWHULRUDWLRQUDWHVDQGDVVRFLDWHGFRQILGHQFH
LQWHUYDOZLOOEHFDOFXODWHGIRUHDFKWUHDWPHQWJURXSEDVHGRQDOOUDQGRPL]HGVXEMHFWV
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
&ORSSHU3HDUVRQPHWKRGZLOOEHXVHGIRUFDOFXODWLQJ&,7KHGHWHULRUDWLRQUDWHVRI
HDFKDUPZLOODOVREHFRPSDUHGXVLQJ)LVKHU¶VH[DFW7HVW

)$&772,FRPSOHWLRQUDWHVZLOOEHVXPPDUL]HGDWHDFKDVVHVVPHQWSRLQWDVWKH
SURSRUWLRQRIDVVHVVPHQWVDFWXDOO\UHFHLYHGRXWRIWKHH[SHFWHGQXPEHULHWKHQXPEHU
RIVXEMHFWVVWLOOLQIROORZXS

)$&772,DWEDVHOLQHQRWHWKLVWLPHSRLQWLVGHILQHGDVSULRUWRVWXG\HQWU\RFFXUULQJ
ZLWKLQGD\VSULRUWRLQLWLDWLRQRISURWRFROWUHDWPHQWDQGDWHDFKVXEVHTXHQWDVVHVVPHQW
DVZHOODVWKHLUFKDQJHIURPEDVHOLQHZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYHVWDWLVWLFVE\
WUHDWPHQWJURXSDVUDQGRPL]HG7KHVXPPDU\DWEDVHOLQHDQGDWHDFKWLPHSRLQWLVEDVHG
RQDOOUDQGRPL]HGVXEMHFWVZLWKDPHDVXUHPHQWDWUHVSHFWLYHWLPHSRLQW7KHFKDQJHIURP
EDVHOLQHDQDO\VLVZLOORQO\LQFOXGHVXEMHFWVZKRKDYHDQDVVHVVPHQWDWEDVHOLQHDQGDWWKH
VXEVHTXHQWWLPHSRLQW

7KHVFRUHVDWEDVHOLQHDQGVXEVHTXHQWWLPHSRLQWVDVZHOOWKHFKDQJHVIURPEDVHOLQHDW
HDFKWLPHSRLQWIRUHDFKWUHDWPHQWJURXSZLOOEHFRPSDUHGXVLQJWKHWZRVDPSOHWWHVW,I
WKHSDUDPHWULFDVVXPSWLRQVDUHQRWPHWWKHQWKH0DQQ:KLWQH\WHVWZLOOEHXVHG(IIHFW
VL]HRI)$&772,FKDQJHVDWGLIIHUHQWWLPHSRLQWVZLOOEHFDOFXODWHGEDVHGRQ&RKHQ¶VG
LHGLYLGLQJWKHGLIIHUHQFHEHWZHHQDUPVLQPHDQVFRUHFKDQJHVE\WKHSRROHGVWDQGDUG
GHYLDWLRQRIWKHEDVHOLQHVFRUHPHDQV,WLVQRWHGWKDWSDWLHQWVLQWKLVVWXG\ZLOOUHFHLYH
HLWKHUWZLFHGDLO\RUGDLO\UDGLDWLRQZKLFKLVDVWUDWLILHGYDULDEOH*LYHQWKHK\SRWKHVLV
IRUWKHTXDOLW\RIOLIHDQDO\VLVDGGUHVVHVTXDOLW\RIOLIHDWPRQWKVDIWHU&57
FRPSOHWLRQZKLFKFRUUHVSRQGVWRPRQWKVDIWHUFRQVROLGDWLYHLPPXQRWKHUDS\KDV
HQGHGLWLVIHOWWKDWWKHUDGLDWLRQVFKHPDZLOOQRWLPSDFWWKHTXDOLW\RIOLIHDQDO\VLV

%DVHOLQHDQG3520,6DWHDFKVXEVHTXHQWDVVHVVPHQWDVZHOODVWKHLUFKDQJHIURP
EDVHOLQHZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYHVWDWLVWLFVE\WUHDWPHQWJURXSDV
UDQGRPL]HG7KHVXPPDU\DWEDVHOLQHDQGDWHDFKWLPHSRLQWLVEDVHGRQDOOUDQGRPL]HG
VXEMHFWVZLWKDPHDVXUHPHQWDWUHVSHFWLYHWLPHSRLQW7KHFKDQJHIURPEDVHOLQHDQDO\VLV
ZLOORQO\LQFOXGHVXEMHFWVZKRKDYHDQDVVHVVPHQWDWEDVHOLQHDQGDWWKHVXEVHTXHQWWLPH
SRLQW7KHFKDQJHIURPEDVHOLQHWRVXEVHTXHQWWLPHSRLQWVPD\EHFRPSDUHGEHWZHHQ
WUHDWPHQWDUPVXVLQJDWWHVWRU:LOFR[RQWHVWLIWKHGDWDLVQRQQRUPDO

$ORQJLWXGLQDODQDO\VLVZLOODOVREHFRQGXFWHGZLWKDIRFXVRQWKHSDWWHUQVRIVFRUHVRYHU
WLPHSRLQWVRI)$&772,DQG3520,6)ROORZLQJWKHGHVFULSWLYHVWDWLVWLFVRQ
DVVHVVPHQWVDOLQHDUPL[HGPRGHOZLOODOVREHXVHGWRDQDO\]HWKH42/352RXWFRPHV
FROOHFWHGRYHUWLPHXVLQJDOODYDLODEOHGDWDZKLOHDGMXVWLQJIRUVWUDWLILFDWLRQYDULDEOHVDQG
RWKHUEDVHOLQHFKDUDFWHULVWLFV0L[HGPRGHOVDUHDJHQHUDOFODVVRIPRGHOVIRUDQDO\]LQJ
UHSHDWHGPHDVXUHVGDWDZKLFKDOORZPRGHOLQJRIWKHFRYDULDQFHDPRQJWKHUHSHDWHG
PHDVXUHVDVZHOODVUDQGRPHIIHFWVVXFKDVSDWLHQWVSHFLILFLQWHUFHSWVDQGVORSHVDQGFDQ
LQFRUSRUDWHIL[HGDQGWLPHYDU\LQJFRYDULDWHV)L[HGHIIHFWVZLOOFRQVLVWRIVWUDWLILFDWLRQ
IDFWRUVDQGSRWHQWLDOO\RWKHUEDVHOLQHFRYDULDWHVWKDWPD\EHSURJQRVWLFWR42/352RU
HIILFDF\6LQFHPLVVLQJGDWDLVH[SHFWHGSDWLHQWVZLWKPLVVLQJGDWDZLOOEHFRPSDUHGWR
SDWLHQWVZLWKFRPSOHWHGDWDDWHDFKIROORZXSWLPHZLWKUHVSHFWWREDVHOLQH
FKDUDFWHULVWLFV,IDQ\RIWKHVHFKDUDFWHULVWLFVDUHIRXQGWREHVLJQLILFDQWO\GLIIHUHQWWKHQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WKH\ZLOOEHLQFRUSRUDWHGLQWRWKHPL[HGHIIHFWVPRGHO

&RPSOHWLRQRIDOOVFKHGXOHGDVVHVVPHQWVLVSDUWRIWKHURXWLQHGHOLQTXHQF\DVVHVVPHQWIRU
LQVWLWXWLRQVZLWKSDWLHQWVSDUWLFLSDWLQJ15*6'0&VWDWLVWLFLDQVZLOOPRQLWRUWKH
SURSRUWLRQVRIPLVVLQJTXDOLW\RIOLIHLQIRUPDWLRQLQHDFKWUHDWPHQWDUPDWGLIIHUHQW
DVVHVVPHQWSRLQWV,QVSLWHRIWKHVHHIIRUWVPLVVLQJGDWDLVWRDFHUWDLQH[WHQWH[SHFWHG
7KHLQIRUPDWLRQIURPSDWLHQWVZLWKPLVVLQJGDWDZLOOEHUHYLHZHGWRGHWHUPLQHZKHWKHU
WKHGDWDDQDO\VHVZLOOEHELDVHG3DWLHQWVZLWKPLVVLQJGDWDZLOOEHUHYLHZHGIRUWKH
GLVWULEXWLRQVRIWUHDWPHQWDUPVDQGSDWLHQWFKDUDFWHULVWLFVSDWLHQWH[FOXVLRQLVQRW
FRQVLGHUHGDVPLVVLQJQHVV0HDQVFRUHVE\DVVHVVPHQWWLPHIRUFRKRUWVVWUDWLILHGE\
EDVHOLQHVFRUHTXDUWLOHZLOODOVREHFRPSDUHGWRLQYHVWLJDWHLIWKHPLVVLQJQHVVLV
FRQVLVWHQWZLWKDQLJQRUDEOHPLVVLQJGDWDSURFHVVPLVVLQJDWUDQGRP,IDPLVVLQJDW
UDQGRP0$5PHFKDQLVPLVUHDVRQDEOHWKHGDWDZLOOEHDQDO\]HGZLWKDSSURSULDWH
OLNHOLKRRGEDVHGDQDO\VLVPHWKRGVVXFKDVOLQHDUPL[HGHIIHFWPRGHOV,IDPLVVLQJDW
UDQGRP0$5PHFKDQLVPLVVXVSHFWHGPXOWLSOHLPSXWDWLRQVIRUPLVVLQJYDOXHVDQG
VHQVLWLYLW\DQDO\VHVZLOOEHFRQGXFWHGWRFRQWUROIRUWKHSRWHQWLDOELDV7KHSRVVLEOH
VWUDWHJLHVIRULPSXWDWLRQDQGDQDO\VHVZLOOGHSHQGRQWKHVHYHULW\RIWKHPLVVLQJGDWD
SUREOHPDQGPD\LQFOXGHZRUVHFDVHVFHQDULRXVHRIPHDQUHVSRQVHIRULQGLYLGXDOVZKR
ZLWKGUDZIURPWKHWULDOIURPHLWKHUDOORUVLPLODUPDWFKHGSDWLHQWVUHPDLQLQJLQWKHWULDO
ODVWREVHUYDWLRQFDUULHGIRUZDUGRUPXOWLSOHLPSXWDWLRQV$MRLQWPRGHOWKDWDOORZVD
VKDUHGSDUDPHWHUEHWZHHQWKHUHSHDWHGPHDVXUHPHQWVDQGWLPHWRGHDWKRUGURSRXWFDQ
EHXVHGLIFRQVLGHUHG01$5GXHWRWKHKLJKQXPEHURISDWLHQWGHDWKVRUGURSRXWV
5L]RSRXORV2WKHURSWLRQVIRU01$5GDWDDUHSDWWHUQPL[WXUHDQGVHOHFWLRQ
PRGHOV)DLUFORXJK/LWWOH6HQVLWLYLW\DQDO\VHVZLOOEHSHUIRUPHGWR
FRPSDUHWKHUHVXOWVRIGLIIHUHQWDQDO\WLFVWUDWHJLHV)DLUFORXJK

(4'/FRQVLVWVRIWKHGHVFULSWLYHV\VWHPDQGWKHYLVXDODQDORJXHVFDOH(49$6
7KH(4'/GHVFULSWLYHV\VWHPFRPSULVHVWKHIROORZLQJGLPHQVLRQVPRELOLW\VHOI
FDUHXVXDODFWLYLWLHVSDLQGLVFRPIRUWDQGDQ[LHW\GHSUHVVLRQ(DFKGLPHQVLRQKDV
OHYHOVQRSUREOHPVVOLJKWSUREOHPVPRGHUDWHSUREOHPVVHYHUHSUREOHPVDQGH[WUHPH
SUREOHPV7KH9$6UHFRUGVWKHVXEMHFW¶VVHOIUDWHGKHDOWKVWDWHRQDSRLQWYHUWLFDO
YLVXDODQDORJXHVFDOH ZRUVWLPDJLQDEOHKHDOWKVWDWH EHVWLPDJLQDEOHKHDOWK
VWDWH

6XEMHFWV¶RYHUDOOKHDOWKVWDWHRQDYLVXDODQDORJVFDOH9$6DWHDFKDVVHVVPHQWWLPH
SRLQWZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYHVWDWLVWLFVE\WUHDWPHQWJURXSDVUDQGRPL]HG
3URSRUWLRQRIVXEMHFWVUHSRUWLQJSUREOHPVIRUWKHILYH(4'/GLPHQVLRQVDWHDFK
DVVHVVPHQWWLPHSRLQWZLOOEHVXPPDUL]HGE\OHYHORISUREOHPDQGE\WUHDWPHQWJURXSDV
UDQGRPL]HG3HUFHQWDJHVZLOOEHEDVHGRQQXPEHUVXEMHFWVDVVHVVHGDWDVVHVVPHQWWLPH
SRLQW

4XDOLW\DGMXVWHGVXUYLYDOFDQEHGHILQHGE\WKHZHLJKWHGVXPRIGLIIHUHQWWLPHHSLVRGHV
DGGHGXSWRDWRWDOTXDOLW\DGMXVWHGOLIH\HDU>8 VXPRITXDOLW\TLRIKHDOWKVWDWHV.
WLPHVWKHGXUDWLRQVLVSHQWLQHDFKKHDOWKVWDWH@*ODV]LRX

¦
 
 
.

L
L
LV
T


8

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

7KHDUHDXQGHUWKH(4'FXUYH\LHOGVSUHGLFWHG4XDOLW\$GMXVWHG/LIH<HDUV4$/<V
*OLFN4$/<GLIIHUHQFHVRIDUHFRQVLGHUHGLPSRUWDQWDQG4$/<GLIIHUHQFHV
RIDVOLWWOHDVDUHFRQVLGHUHGSRWHQWLDOO\PHDQLQJIXODQGLPSRUWDQWIRUVHYHUDOSUHYDOHQW
GLVHDVHVLQFOXGLQJFDQFHUGLDEHWHVDQGKHDUWGLVHDVH6DPVD:DOWHUV:H
ZLOOXVH*ODV]LRX¶VPXOWLSOHKHDOWKVWDWH47ZL67PRGHOVWRXVHWKHUHSHDWHGPHDVXUHV
RI(4'%HFDXVH*ODV]LRX¶VPHWKRGLQFRUSRUDWHVORQJLWXGLQDO42/GDWDLQWRDQDQDO\VLV
RITXDOLW\DGMXVWHGVXUYLYDOWKHKHDOWKVWDWHPRGHOPXVWEHFRQVWUXFWHGRQWKHIROORZLQJ
DVVXPSWLRQV

$42/LVLQGHSHQGHQWIURPWUHDWPHQW
$$KHDOWKVWDWHLVLQGHSHQGHQWIURPSUHYLRXVVWDWHV
$3URSRUWLRQDOLW\RITXDOLW\DGMXVWHGGXUDWLRQDQGGXUDWLRQRIWKHDFWXDOVWDWHRIKHDOWK

$VVXPSWLRQ$FDQEHFKHFNHGE\SORWWLQJ42/VFRUHVRYHUWLPHDFFRUGLQJWRWUHDWPHQW
DQG WKH WWHVW FDQ EH XVHG WR FRPSDUH WKH PHDQ 42/ VFRUHV RI HDFK WUHDWPHQW DUP
$VVXPSWLRQ$FDQEHFKHFNHGE\FRPSDULQJWKH42/VFRUHVIRUSDWLHQWJURXSVLQDJLYHQ
KHDOWKVWDWHZKHUHWKHJURXSVDUHGHILQHGE\GXUDWLRQRISUHYLRXVKHDOWKVWDWHH[SHULHQFH
XVLQJDUHJUHVVLRQPRGHO$VXLWDEOHFKHFNIRUDVVXPSWLRQ$DWDPLQLPXPZRXOGEHD
VLPSOHSORW,IGDWDGRQRWVXSSRUWWKHVHDVVXPSWLRQVZHZLOOXVHDPHWKRGWKDWXVHVWKH
ORQJLWXGLQDO42/GDWDGLUHFWO\7KHUHPDLQLQJWLPHSRLQWVDWZKLFKWKH(4'LVFROOHFWHG
ZLOODOVREHDVVHVVHGXVLQJVLPLODUORQJLWXGLQDODQDO\VLVWHFKQLTXHVDVGHVFULEHGIRUWKH
RWKHU42/HQGSRLQWV

6WDWLVWLFDO&RQVLGHUDWLRQV7XPRUDQGFI'1$0ROHFXODU6XEW\SLQJDV,QWHJUDWHG0DUNHUV
$OO WUDQVODWLRQDO UHVHDUFK WKDW FRUUHODWH ELRPDUNHUV DQG FOLQLFDO RXWFRPHV ZLOO RFFXU
FRQFXUUHQWO\ZLWKRUDIWHUWKHILQDODQDO\VLVDVVSHFLILHGLQ6HFWLRQ7XPRUDQG
FI'1$PROHFXODUVXEW\SLQJZLOOEHGHWHUPLQHGSHUSURWRFROVHFWLRQDQGUHIHUHQFH
ZLWKLQ:HK\SRWKHVL]HWKDWSDWLHQWVEHDULQJWXPRUVZLWKWKH³LQIODPHG´6&/&,VLJQDWXUH
ZLOOKDYHLPSURYHG3)6FRPSDUHGWRWKHRWKHUVXEW\SHVRUDJURXSLQJRIDOOVXEW\SHV
6&/&$6&/&1DQG6&/&3ZKHQWUHDWHGZLWKDWH]ROL]XPDE,Q*D\HWDO6&/&,
VXEW\SHEDVHGRQWXPRURFFXUUHGLQDERXWRIFDVHV

)RUFI'1$PROHFXODUVXEW\SLQJDQDO\VLVXVLQJPHWK\ODWLRQDQDO\VLVZHSURMHFWWKHUH
ZLOOEHDWOHDVW3)6HYHQWVIURPERWKDUPVDQG3)6HYHQWVIURPDWH]ROL]XPDE
DUPXQGHU+DYDLODEOHDWWKHWLPHRIFI'1$PROHFXODUVXEW\SLQJ$VVXPLQJ6&/&,
VXEW\SHSUHYDOHQFHZLOOEHDWOHDVWWKHIROORZLQJWDEOHVXPPDUL]HVWKHPLQLPDO+5
ZKLFKFDQEHGHWHFWHGDWDVLGHGVLJQLILFDQFHOHYHORIZLWKDWOHDVWSRZHU

7DEOH0LQLPXP(IIHFW6L]H+5WRGHWHFWFI'1$6&/&,VXEW\SHDVDSURJQRVWLF
IDFWRU
3RSXODWLRQ
RI3)6HYHQWV
3UHYDOHQFH
0LQ
3)6
+5
$WH]ROL]XPDE
DUP





8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

%DVHGRQWKLVWDEOHSDWLHQWVWUHDWHGZLWK$WH]ROL]XPDEDORQHZLOOKDYHDUHDVRQDEO\JRRG
SRZHUDWOHDVWWRGHWHFWFI'1$6&/&,VXEW\SHDVDSURJQRVWLFIDFWRU+5!
ZLWKUHVSHFWWR3)6ZKHQWKHSUHYDOHQFHLV,IWKHSUHYDOHQFHLVKLJKHUWKDQRU
REVHUYLQJPRUHWKDQ3)6HYHQWVZHZLOOKDYHDQHYHQJUHDWHUSRZHUWRGHWHFWVXFKD
UHODWLRQVKLSIRUSDWLHQWVWUHDWHGZLWKDWH]ROL]XPDEDORQH

,IZHREVHUYHDVWDWLVWLFDOO\VLJQLILFDQWDQGFOLQLFDOO\PHDQLQJIXOSURJQRVWLFHIIHFWRI
FI'1$6&/&,VXEW\SHIRUSDWLHQWVWUHDWHGZLWKDWH]ROL]XPDEZHZLOOWKHQHYDOXDWHLI
FI'1$6&/&,VXEW\SHLVDSUHGLFWLYHELRPDUNHUE\XVLQJSDWLHQWVIURPERWKDUPV
%DVHGRQWKHGHVLJQSDUDPHWHUVDQGWKHPHWKRGSURSRVHGE\3HWHUVRQDQG*HRUJH
>3HWHUVRQ@ZHVXPPDUL]HWKHVWDWLVWLFDOSRZHUWRGHWHFWLQWHUDFWLRQHIIHFWVUDWLRRI
KD]DUGUDWLRVRIZKHQWKHPDUNHUSRVLWLYHSUHYDOHQFHLVDWVLGHG
VLJQLILFDQFH OHYHO RI  :H GHQRWH PRQWKO\ KD]DUG UDWHV DV Ȝ H[SHFWHG QXPEHU RI
HYHQWVRIUHVSHFWLYHVXEJURXSVDV(>1@DQGWKHKD]DUGUDWLREHWZHHQPDUNHUDQGDV
ǻ 7KH VXEVFULSWV LQGLFDWH WKH FRUUHVSRQGLQJ WUHDWPHQW DUPV 7KH DVVXPHG PRQWKO\
KD]DUGUDWHVDQGDVVRFLDWHGH[SHFWHGQXPEHURIHYHQWVDUHOLVWHGLQWKHIROORZLQJ7DEOH
DFFRUGLQJO\:KHQWKHSUHYDOHQFHRIFI'1$6&/&,VXEW\SHLVODUJHUWKDQWKH
SRZHUWRGHWHFWVXFKLQWHUDFWLRQSUHGLFWLYHPDUNHUZLOOEHHYHQODUJHU
7DEOH3RZHU$QDO\VLVIRUFI'1$6&/&,VXEW\SHDV3UHGLFWLYH0DUNHU
3UHYDOHQFH
RI0DUNHU


$UP
$UP
,QWHUDFWLRQ


0DUNHU
0DUNHU
ǻ
0DUNHU
0DUNHU
ǻ
ǻ 
ǻ
ǻ
3RZHU

Ȝ





 


(>1@





Ȝ









(>1@





Ȝ





 


(>1@





)RUWXPRUPROHFXODUVXEW\SLQJDQDO\VLVZHDQWLFLSDWHURXJKO\RIFDVHVZLOOKDYH
VXIILFLHQWWXPRUWLVVXHVWRFRQGXFWWKLVDQDO\VLV:HSURMHFWWKHUHZLOOEHDWOHDVW3)6
HYHQWVIURPDWH]ROL]XPDEDUPXQGHU+DQGDWOHDVW3)6HYHQWVDYDLODEOHIURPERWK
DUPDWWKHWLPHRIWXPRUPROHFXODUVXEW\SLQJDQDO\VLV7KHWXPRU6&/&,VXEW\SH
DQDO\VLVZLOOEHGHVFULSWLYHLQQDWXUHDQGVKRXOGEHLQWHUSUHWHGFROOHFWLYHO\ZLWKFI'1$
DQDO\VLV,QWKHIROORZLQJZHVKRZWKHPLQLPDOHIIHFWVL]HZHPD\EHDEOHWRGHWHFW
XVLQJWXPRUWLVVXHDORQH$VVXPLQJWXPRU6&/&,VXEW\SHSUHYDOHQFHZLOOEHDWOHDVW
WKHIROORZLQJWDEOHVXPPDUL]HVWKHPLQLPDO+5ZKLFKFDQEHGHWHFWHGDWDVLGHG
VLJQLILFDQFHOHYHORIZLWKDWOHDVWSRZHU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
7DEOH0LQLPXP(IIHFW6L]H+5WRGHWHFWWXPRU6&/&,VXEW\SHDVDSURJQRVWLF
IDFWRU

3RSXODWLRQ
RI3)6HYHQWV
3UHYDOHQFH
0LQ
3)6
+5
$OOSDWLHQWV





$WH]ROL]XPDE
DUP







6&/&,VXEW\SLQJEDVHGRQFI'1$DQGWXPRUDQDO\VLVZLOOEHDOVRFRUUHODWHGZLWKRWKHU
FOLQLFDORXWFRPHVVXFKDVRYHUDOOVXUYLYDO
7KHDIRUHPHQWLRQHGDQDO\VLVZLOOEHSHUIRUPHGEDVHGRQWKHWUHDWPHQWSDWLHQWVDFWXDOO\
UHFHLYH7KHUDWHVRI263)6DWYDULRXVWLPHSRLQWVHJHYHU\PRQWKVDIWHU
UDQGRPL]DWLRQDQGPHGLDQ263)6IRUHDFK6&/&,VXEW\SHZLOOEHHVWLPDWHGXVLQJWKH
.DSODQ0HLHUPHWKRG7KHDVVRFLDWHGFRQILGHQFHLQWHUYDO&,ZLOOEH
FDOFXODWHGXVLQJ*UHHQZRRG¶VIRUPXODDQGEDVHGRQDORJORJWUDQVIRUPDWLRQDSSOLHGRQ
WKHVXUYLYDOIXQFWLRQ7KHSURJQRVWLFYDOXHRI6&/&,VXEW\SHEDVHGRQHLWKHUFI'1$
RUWXPRUDQDO\VLVZLOOEHHYDOXDWHGXVLQJD&R[UHJUHVVLRQPRGHO,IDSSOLFDEOHWKH
SUHGLFWLYHYDOXHRI6&/&,VXEW\SHZLOOEHHYDOXDWHGXVLQJD&R[UHJUHVVLRQPRGHO
LQFOXGLQJWKHVWDWXVRI6&/&,VXEW\SHWUHDWPHQWUHFHLYHGDQGWKHLULQWHUDFWLRQ,Q
DGGLWLRQWKHWUHDWPHQWKD]DUGUDWLRV&,IRUHDFK6&/&VXEW\SHLHVXEJURXS
DQDO\VLVE\6&/&VXEW\SHVZLOOEHHVWLPDWHGXVLQJDQXQVWUDWLILHG&R[UHJUHVVLRQ
PRGHO

([SORUDWRU\+\SRWKHVLVDQG(QGSRLQWV-8/
 ([SORUDWRU\(QGSRLQWV
x 3DWLHQWUHSRUWHGV\PSWRPDWLFWR[LFLWLHV352&7&$(
x &RQFRUGDQFHEHWZHHQWXPRUDQGFI'1$PROHFXODUVXEW\SHV

6WDWLVWLFDO$QDO\VLV3ODQ352&7&$(
$GYHUVHHYHQWVZLOODOVREHDVVHVVHGXVLQJ352&7&$(LWHPV7KH352&7&$(LVD
SDWLHQWUHSRUWHGRXWFRPHPHDVXUHPHQWV\VWHPGHYHORSHGWRFKDUDFWHUL]HWKHIUHTXHQF\
VHYHULW\DQGLQWHUIHUHQFHRIV\PSWRPDWLFWUHDWPHQWWR[LFLWLHV%DVFKHWDO,WHPV
DUHVFRUHGRQD/LNHUWVFDOHHJIRUVHYHULW\ QRQH PLOG PRGHUDWH VHYHUH
DQG YHU\VHYHUH7KHVSHFLILFV\PSWRPVWREHHYDOXDWHGIRUWKLVVWXG\DUHOLVWHGLQ
6HFWLRQDERYH$VVHVVPHQWVZLOOEHFROOHFWHGDVVSHFLILHGLQWKH6HFWLRQDVVHVVPHQW
WDEOHV)RUHDFKV\PSWRPDQGHDFKGRPDLQLHIUHTXHQF\VHYHULW\DQGLQWHUIHUHQFH
FRXQWVDQGIUHTXHQFLHVZLOOEHVXPPDUL]HGIRUWKHZRUVWVFRUHH[SHULHQFHGE\WKHSDWLHQW
E\WUHDWPHQWDUP

&RQFRUGDQFH%HWZHHQ7XPRUDQGFI'1$0ROHFXODU6XEW\SHV
7KHFRQFRUGDQFHEHWZHHQPROHFXODUVXEW\SHV6&/&$6&/&16&/&3DQG6&/&,
REWDLQHGYLD51$VHTRQWXPRUWLVVXHDQGPHWK\ODWLRQDQDO\VLVRQFI'1$ZLOOEHDVVHVVHG
DPRQJSDWLHQWVZKRKDYHERWKHYDOXDEOH51$VHTDQGPHWK\ODWLRQUHVXOWVZKHUH&RKHQ¶V
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
5()(5(1&(6-8/

$DURQVRQ1.$KPHG]DL6%HUJPDQ%HWDO7KH(XURSHDQ2UJDQL]DWLRQIRU5HVHDUFKDQG
7UHDWPHQWRI&DQFHU4/4&DTXDOLW\RIOLIHLQVWUXPHQWIRUXVHLQLQWHUQDWLRQDOFOLQLFDOWULDOV
LQRQFRORJ\-RXUQDORIWKH1DWLRQDO&DQFHU,QVWLWXWH

$GDVKHN0/)HOGPDQ0&\WRNLQHUHOHDVHV\QGURPHUHVXOWLQJIURPDQWLSURJUDPPHG
GHDWKDQWLERG\UDLVLQJDZDUHQHVVDPRQJFRPPXQLW\RQFRORJLVW-2QFRO
3UDFWLFH í

$JXLDU31-U3HUU\/$3HQQ\'LPUL-%DELNHU+7DGRNRUR+GH0HOOR5$	
/RSHV*/-U7KHHIIHFWRI3'/WHVWLQJRQWKHFRVWHIIHFWLYHQHVVDQGHFRQRPLF
LPSDFWRILPPXQHFKHFNSRLQWLQKLELWRUVIRUWKHVHFRQGOLQHWUHDWPHQWRI16&/&$QQ2QFRO


$QWRQLD6-/RSH]0DUWLQ-$%HQGHOO-HWDO1LYROXPDEDORQHDQGQLYROXPDESOXVLSLOLPXPDE
LQUHFXUUHQWVPDOOFHOOOXQJFDQFHU&KHFN0DWHDPXOWLFHQWUHRSHQODEHOSKDVHWULDO
/DQFHW2QFRO-XO(SXE-XQ

$QWRQLD6-9LOOHJDV$'DQLHO'9LFHQWH'0XUDNDPL6+XL5<RNRL7&KLDSSRUL$/HH
.+GH:LW0&KR%&%RXUKDED04XDQWLQ;7RNLWR70HNKDLO73ODQFKDUG'.LP<&
.DUDSHWLV&6+LUHW62VWRURV*.XERWD.*UD\-(3D]$UHV/GH&DVWUR&DUSHxR-
:DGVZRUWK & 0HOLOOR * -LDQJ + +XDQJ < 'HQQLV 3$ g]JUR÷OX 0 3$&,),& ,QYHVWLJDWRUV 
'XUYDOXPDEDIWHU&KHPRUDGLRWKHUDS\LQ6WDJH,,,1RQ6PDOO&HOO/XQJ&DQFHU1(QJO-0HG
6HS

%DVFK(5HHYH%%0LWFKHOO6$HWDO'HYHORSPHQWRIWKH1DWLRQDO&DQFHU,QVWLWXWH
VSDWLHQW
UHSRUWHGRXWFRPHVYHUVLRQRIWKHFRPPRQWHUPLQRORJ\FULWHULDIRUDGYHUVHHYHQWV352
&7&$(-1DWO&DQFHU,QVW.

%ODQTXLFHWW&6DLI0:%XFKVEDXP'-(ORXEHLGL09LFNHUV60&KLHQJ'&
&DUSHQWHU0'6HOOHUV-&5XVVR6'LDVLR5%HWDO$QWLWXPRUHIILFDF\RI
FDSHFLWDELQHDQGFHOHFR[LELQLUUDGLDWHGDQGOHDGVKLHOGHGFRQWUDODWHUDOKXPDQ%[3&
SDQFUHDWLFFDQFHU[HQRJUDIWVFOLQLFDOLPSOLFDWLRQVRIDEVFRSDOHIIHFWV&OLQ&DQFHU5HVHDUFK


&HOOD'<RXQW65RWKURFN1HWDO3520,6&RRSHUDWLYH*URXS7KH3DWLHQW5HSRUWHG
2XWFRPHV0HDVXUHPHQW,QIRUPDWLRQ6\VWHP3520,63URJUHVVRIDQ1,+5RDGPDS
FRRSHUDWLYHJURXSGXULQJLWVILUVWWZR\HDUV0HG&DUH6XSSO66


&HOOD'/DL-*DUFLD6)HWDO7KH3DWLHQW5HSRUWHG2XWFRPHV0HDVXUHPHQW,QIRUPDWLRQ
6\VWHP&DQFHU3520,6&D&DQFHUVSHFLILFDSSOLFDWLRQRIDJHQHULFIDWLJXHPHDVXUH
>$EVWUDFW@-&OLQ2QFRO

&KHPL)3HDUFH63&OLSVRQ$HWDOFI'1$PHWK\ORPHSURILOLQJIRUGHWHFWLRQDQGVXEW\SLQJ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
RIVPDOOFHOOOXQJFDQFHUV1DW&DQFHU

&ODDVVHQV/YDQ0HHUEHHFN-&RHQV&HWDO+HDOWKUHODWHGTXDOLW\RIOLIHLQQRQVPDOOFHOO
OXQJFDQFHUDQXSGDWHRIDV\VWHPDWLFUHYLHZRQPHWKRGRORJLFLVVXHVLQUDQGRPL]HGFRQWUROOHG
WULDOV-RXUQDORIFOLQLFDORQFRORJ\RIILFLDOMRXUQDORIWKH$PHULFDQ6RFLHW\RI&OLQLFDO
2QFRORJ\

&RX]LQ)UDQNHO-%UHDNWKURXJKRIWKH\HDU&DQFHULPPXQRWKHUDS\6FLHQFH


'HQJ//LDQJ+%XUQHWWH%%HFNHWW0'DUJD7:HLFKVHOEDXP55DQG)X<;
D,UUDGLDWLRQDQGDQWL3'/WUHDWPHQWV\QHUJLVWLFDOO\SURPRWHDQWLWXPRULPPXQLW\LQ
PLFH-&OLQ,QYHVW

'HQJ//LDQJ+%XUQHWWH%:HLFKVHOEDXP55DQG)X<;E5DGLDWLRQDQG
DQWL3'/DQWLERG\FRPELQDWRULDOWKHUDS\LQGXFHV7FHOOPHGLDWHGGHSOHWLRQRIP\HORLG
GHULYHGVXSSUHVVRUFHOOVDQGWXPRUUHJUHVVLRQ2QFRLPPXQRORJ\H

'RYHGL6-&KHDGOH(-3RSSOH$/3RRQ(0RUURZ06WHZDUW5<XVNR(&6DQGHUV&0
9LJQDOL0(PHUVRQ525RELQV+6:LONLQVRQ5:+RQH\FKXUFK-,OOLGJH70)UDFWLRQDWHG
5DGLDWLRQ7KHUDS\6WLPXODWHV$QWLWXPRU,PPXQLW\0HGLDWHGE\%RWK5HVLGHQWDQG,QILOWUDWLQJ
3RO\FORQDO7FHOO3RSXODWLRQVZKHQ&RPELQHGZLWK3'%ORFNDGH&OLQ&DQFHU5HV6HS


'L*LDFRPR$00%LDJLROL00DLR7KHHPHUJLQJWR[LFLW\SURILOHVRIDQWL&7/$
DQWLERGLHVDFURVVFOLQLFDOLQGLFDWLRQV6HPLQ2QFRO

(LVHQKDXHU($7KHUDVVH3%RJDHUWV-HWDO1HZUHVSRQVHHYDOXDWLRQFULWHULDLQVROLGWXPRXUV
UHYLVHG5(&,67JXLGHOLQHYHUVLRQ(XU-&D-DQ
)DEUL]LRHWDODEVWUDFW3
)DLUFORXJK'/'HVLJQDQGDQDO\VLVRITXDOLW\RIOLIHVWXGLHVLQFOLQLFDOWULDOV&KDSPDQDQG
+DOO&5&
)DLYUH)LQQ&6QHH0$VKFURIW/HWDO&RQFXUUHQWRQFHGDLO\YHUVXVWZLFHGDLO\
FKHPRUDGLRWKHUDS\LQSDWLHQWVZLWKOLPLWHGVWDJHVPDOOFHOOOXQJFDQFHU&219(57DQRSHQ
ODEHOSKDVHUDQGRPL]HGVXSHULRULW\WULDO/DQFHW2QFRO$XJ

)HKUHQEDFKHU/6SLUD$%DOOLQJHU0.RZDQHW]09DQVWHHQNLVWH-0D]LHUHV-3DUN.6PLWK
'$UWDO&RUWHV$/HZDQVNL&%UDLWHK):DWHUNDPS'+H3=RX:&KHQ'6<L-6DQGOHU
$5LWWPH\HU$323/$56WXG\*URXS$WH]ROL]XPDEYHUVXVGRFHWD[HOIRUSDWLHQWVZLWK
SUHYLRXVO\WUHDWHGQRQVPDOOFHOOOXQJFDQFHU323/$5DPXOWLFHQWUHRSHQODEHOSKDVH
UDQGRPLVHGFRQWUROOHGWULDO/DQFHW$SU

)UDPSWRQ*0)LFKWHQKROW]$2WWR*$HWDO'HYHORSPHQWDQGYDOLGDWLRQRIDFOLQLFDOFDQFHU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
JHQRPLFSURILOLQJWHVWEDVHGRQPDVVLYHO\SDUDOOHO'1$VHTXHQFLQJ1DW%LRWHFKQRO
1RY

)UHLGOLQ%.RUQ(/*UD\5$JHQHUDOLQHIILFDF\LQWHULPPRQLWRULQJUXOHIRUUDQGRPL]HG
FOLQLFDOWULDOV&OLQLFDO7ULDOV-XQ

*DQGDUD'53DXO60.RZDQHW]06FKOHLIPDQ(=RX:/L<5LWWPH\HU$)HKUHQEDFKHU/
2WWR*0DOERHXI&/LHEHU'6/LSVRQ'6LOWHUUD-$POHU/5LHKO7&XPPLQJV&$+HJGH
366DQGOHU$%DOOLQJHU0)DEUL]LR'0RN7	6KDPHV'6%ORRGEDVHGWXPRUPXWDWLRQDO
EXUGHQDVDSUHGLFWRURIFOLQLFDOEHQHILWLQQRQVPDOOFHOOOXQJFDQFHUSDWLHQWVWUHDWHGZLWK
DWH]ROL]XPDE1DW0HGYROSDJHV±

*DUFLD6)&HOOD'&ODXVHU6%HWDO6WDQGDUGL]LQJSDWLHQWUHSRUWHGRXWFRPHVDVVHVVPHQWLQ
FDQFHUFOLQLFDOWULDOVDSDWLHQWUHSRUWHGRXWFRPHVPHDVXUHPHQWLQIRUPDWLRQV\VWHPLQLWLDWLYH-
&OLQ2QFRO5HYLHZ(UUDWXPLQ-&OLQ2QFRO

*D\&06WHZDUW&$3DUN(0HWDO3DWWHUQVRIWUDQVFULSWLRQIDFWRUSURJUDPVDQGLPPXQH
SDWKZD\DFWLYDWLRQGHILQHIRXUPDMRUVXEW\SHVRI6&/&ZLWKGLVWLQFWWKHUDSHXWLF
YXOQHUDELOLWLHV&DQFHU&HOOH

*HRUJH-/LP-6-DQJ6-HWDO&RPSUHKHQVLYHJHQRPLFSURILOHVRIVPDOOFHOOOXQJ
FDQFHU1DWXUH

*ODV]LRX336LPHV5-*HOEHU5'4XDOLW\DGMXVWHGVXUYLYDODQDO\VLV6WDWLVWLFVLQPHGLFLQH
1RY

+HHNH6*D\&0(VWHFLR05HWDO7XPRUDQGFLUFXODWLQJIUHH'1$PHWK\ODWLRQLGHQWLILHV
FOLQLFDOO\UHOHYDQWVPDOOFHOOOXQJFDQFHUVXEW\SHV&DQFHU&HOO

+HOOPDQQ0'&DOODKDQ0.$ZDG00HWDO7XPRU0XWDWLRQDO%XUGHQDQG(IILFDF\RI
1LYROXPDE0RQRWKHUDS\DQGLQ&RPELQDWLRQZLWK,SLOLPXPDELQ6PDOO&HOO/XQJ&DQFHU
&DQFHU&HOO0D\H

+HOOPDQQ0'&LXOHDQX7(3OX]DQVNL$HWDO1LYROXPDESOXV,SLOLPXPDELQ/XQJ&DQFHU
ZLWKD+LJK7XPRU0XWDWLRQDO%XUGHQ1(-0

+RUQ / 0DQVILHOG $6 6]F]ĊVQD $ HW DO )LUVW/LQH$WH]ROL]XPDESOXV&KHPRWKHUDS\LQ
([WHQVLYH6WDJH6PDOO&HOO/XQJ&DQFHU1(QJO-0HG6HSGRL
1(-0RD>(SXEDKHDGRISULQW@
+XEEHOLQJ+*6FKDSLUD()+RULFN1.*RRGZLQ.(+/LQ--2K.66KDZ$70HKDQ:$
6KLK+$*DLQRU-)-7KRUDF2QFRO$SU
+XQVEHUJHU6=KDR<6LPRQ5$&RPSDULVRQRI3KDVH,,6WXG\6WUDWHJLHV&OLQ&DQFHU5HV
2FW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
.RZDQHW]0=RX:6KDPHV'HWDO7XPRU0XWDWLRQ%XUGHQ70%LVDVVRFLDWHGZLWK
LPSURYHGHIILFDF\RIDWH]ROL]XPDELQ/DQG/16&/&SDWLHQWV-7KRUDF2QFRO
66

.RQLQJ&&:RXWHUVH6-'DDPV-*8LWWHUKRHYH//YDQGHQ+HXYHO00	
%HOGHUERV-67R[LFLW\RIFRQFXUUHQWUDGLRFKHPRWKHUDS\IRUORFDOO\DGYDQFHGQRQ
VPDOOFHOOOXQJFDQFHUDV\VWHPDWLFUHYLHZRIWKHOLWHUDWXUH&OLQ/XQJ&DQFHU

/DL-6&HOOD'&KRL6:HWDO'HYHORSLQJDIDWLJXHLWHPEDQNIURPWKHSDWLHQWUHSRUWHG
RXWFRPHVPHDVXUHPHQWLQIRUPDWLRQV\VWHP3520,6),%YHUVLRQ3UHVHQWHGDWWKH
,QWHUQDWLRQDO&RQIHUHQFHRQ6XUYH\0HWKRGVLQ0XOWLQDWLRQDO0XOWLUHJLRQDODQG0XOWLFXOWXUDO
&RQWH[WV0&-XQH

/HH':6DQWRPDVVR%'/RFNH)/HWDO$67&7&RQVHQVXV*UDGLQJIRU&\WRNLQH
5HOHDVH6\QGURPHDQG1HXURORJLF7R[LFLW\$VVRFLDWHGZLWK,PPXQH(IIHFWRU&HOOV
%LRO%ORRG0DUURZ7UDQVSODQW$SU

/LWWOH5-5XELQ'%6WDWLVWLFDODQDO\VLVZLWKPLVVLQJGDWD-RKQ:LOH\	6RQV

0F&ODLQ./(FNVWHLQ2&OLQLFDOIHDWXUHVDQGGLDJQRVLVRIKHPRSKDJRF\WLF
O\PSKRKLVWLRF\WRVLV8SWR'DWH>UHVRXUFHRQWKH,QWHUQHW@>XSGDWHG
2FWREHUFLWHG0D\@$YDLODEOHIURP
KWWSVZZZXSWRGDWHFRPFRQWHQWVFOLQLFDOIHDWXUHVDQGGLDJQRVLVRIKHPRSKDJRF\WLF
O\PSKRKLVWLRF\WRVLV

0RW]HU 5- %DQFKHUHDX 5 +DPLGL + HW DO 0ROHFXODU 6XEVHWV LQ 5HQDO &DQFHU 'HWHUPLQH
2XWFRPHWR&KHFNSRLQWDQG$QJLRJHQHVLV%ORFNDGH&DQFHU&HOO

1DEHW %< +DPLGL + /HH 0& HW DO ,PPXQH KHWHURJHQHLW\ LQ VPDOOFHOO OXQJ FDQFHU DQG
YXOQHUDELOLW\WRLPPXQHFKHFNSRLQWEORFNDGH&DQFHU&HOO

3HWHUVRQ%	*HRUJH6/6DPSOHVL]HUHTXLUHPHQWVDQGOHQJWKRIVWXG\IRUWHVWLQJ
LQWHUDFWLRQLQDîNIDFWRULDOGHVLJQZKHQWLPHWRIDLOXUHLVWKHRXWFRPH&RQWUROOHGFOLQLFDOWULDOV


3LFNDUG$6HWDO+HDOWKXWLOLWLHVXVLQJWKH(4'LQVWXGLHVRIFDQFHU3KDUPDFRHFRQRPLFV


4XLQWHQ&0DUWLQHOOL)&RHQV&HWDO$JOREDODQDO\VLVRIPXOWLWULDOGDWDLQYHVWLJDWLQJTXDOLW\
RIOLIHDQGV\PSWRPVDVSURJQRVWLFIDFWRUVIRUVXUYLYDOLQGLIIHUHQWWXPRUVLWHV&DQFHU


5DPRV(VTXLYHO$YDQGHU/DDW$5RMDV9LJRWW5-XiUH]0	&RUUDOHV5RGUtJXH]/
$QWL3'DQWL3'/LPPXQRWKHUDS\YHUVXVGRFHWD[HOIRUSUHYLRXVO\WUHDWHGDGYDQFHG
QRQVPDOOFHOOOXQJFDQFHUDV\VWHPDWLFUHYLHZDQGPHWDDQDO\VLVRIUDQGRPLVHGFOLQLFDOWULDOV
ESMO Open, 2H
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

5DYHOOL$0LQRLD)'DYL6HWDOFODVVLILFDWLRQFULWHULDIRUPDFURSKDJHDFWLYDWLRQ
V\QGURPHFRPSOLFDWLQJV\VWHPLFMXYHQLOHLGLRSDWKLFDUWKULWLVD(XURSHDQ/HDJXH
$JDLQVW5KHXPDWLVP$PHULFDQ&ROOHJHRI5KHXPDWRORJ\3DHGLDWULF5KHXPDWRORJ\
,QWHUQDWLRQDO7ULDOV2UJDQLVDWLRQ&ROODERUDWLYH,QLWLDWLYH$QQ5KHXP'LV
í

5HHYH%%0LWFKHOO6$'XHFN$&%DVFK(&HOOD'5HLOO\&0%UXQHU':
5HFRPPHQGHGSDWLHQWUHSRUWHGFRUHVHWRIV\PSWRPVWRPHDVXUHLQDGXOWFDQFHUWUHDWPHQW
WULDOV-1DWO&DQFHU,QVW

5LHJOHU//-RQHV*3/HH':&XUUHQWDSSURDFKHVLQWKHJUDGLQJDQGPDQDJHPHQWRI
F\WRNLQHUHOHDVHV\QGURPHDIWHUFKLPHULFDQWLJHQUHFHSWRU7FHOOWKHUDS\7KHU&OLQ
5LVN 0DQDJ í

5LWWPH\HU$%DUOHVL):DWHUNDPS'3DUN.&LDUGLHOOR)YRQ3DZHO-*DGJHHO60+LGD7
.RZDOVNL'0'ROV0&&RUWLQRYLV'//HDFK-3ROLNRII-%DUULRV&.DEELQDYDU))URQWHUD
2$'H0DULQLV)7XUQD+/HH-6%DOOLQJHU0.RZDQHW]0+H3&KHQ'66DQGOHU$
*DQGDUD'52$.6WXG\*URXS$WH]ROL]XPDEYHUVXVGRFHWD[HOLQSDWLHQWVZLWKSUHYLRXVO\
WUHDWHGQRQVPDOOFHOOOXQJFDQFHU2$.DSKDVHRSHQODEHOPXOWLFHQWUHUDQGRPLVHG
FRQWUROOHGWULDO/DQFHW-DQ
5L]RSRXORV'-RLQWPRGHOVIRUORQJLWXGLQDODQGWLPHWRHYHQWGDWD:LWKDSSOLFDWLRQVLQ5
&KDSPDQDQG+DOO&5&

5RW]6-/HLQR'6]DER6HWDO6HYHUHF\WRNLQHUHOHDVHV\QGURPHLQDSDWLHQW
UHFHLYLQJ3'GLUHFWHGWKHUDS\3HGLDWU%ORRG&DQFHUH

5XELQVWHLQ/9.RUQ(/)UHLGOLQ%HWDO'HVLJQLVVXHVRIUDQGRPL]HGSKDVH,,WULDOVDQGD
SURSRVDOIRUSKDVH,,VFUHHQLQJWULDOV-&OLQ2QFRO2FW

6FKXO]0:HWDO$FRPSDULVRQRIWHFKQLTXHVIRUHOLFLWLQJSDWLHQWSUHIHUHQFHVLQSDWLHQWVZLWK
EHQLJQSURVWDWLFK\SHUSODVLD-8URO

6NRXOLGLV)%\HUV/$'LDR/HWDO&RRFFXUULQJJHQRPLFDOWHUDWLRQVGHILQHPDMRUVXEVHWVRI
.5$6PXWDQW OXQJ DGHQRFDUFLQRPD ZLWK GLVWLQFW ELRORJ\ LPPXQH SURILOHV DQG WKHUDSHXWLF
YXOQHUDELOLWLHV&DQFHU'LVFRY

7DQJ&:DQJ;6RK+6H\HGLQ6&RUWH]0$.ULVKQDQ60DVVDUHOOL(+RQJ'1DLQJ$
'LDE$*RPH]'<H++H\PDFK-.RPDNL5$OOLVRQ-36KDUPD3:HOVK-:
&RPELQLQJUDGLDWLRQDQGLPPXQRWKHUDS\DQHZV\VWHPLFWKHUDS\IRUVROLGWXPRUV"&DQFHU
,PPXQRO5HV

8UED6*DW]-6KHQ:HWDO4XDOLW\RIOLIHVFRUHVDVSURJQRVWLFIDFWRUVRIRYHUDOOVXUYLYDOLQ
DGYDQFHGKHDGDQGQHFNFDQFHUDQDO\VLVRIDSKDVH,,,UDQGRPL]HGWULDORISHPHWUH[HGSOXV
FLVSODWLQYHUVXVFLVSODWLQPRQRWKHUDS\2UDO2QFRO
MRUDORQFRORJ\(SXE0DU
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

9HUPD96LPRQH&%	:HUQHU:DVLN0$FXWHDQG/DWH7R[LFLWLHVRI&RQFXUUHQW
&KHPRUDGLRWKHUDS\IRU/RFDOO\$GYDQFHG1RQ6PDOO&HOO/XQJ&DQFHU&DQFHUV
GRLFDQFHUV

:X$:-DFREVRQ.')ULFN'/HWDO9DOLGLW\DQGUHVSRQVLYHQHVVRIWKH(4'DVDPHDVXUH
RIKHDOWKUHODWHGTXDOLW\RIOLIHLQSHRSOHHQUROOHGLQDQ$,'6FOLQLFDOWULDO4XDO/LIH5HV


=LNRV(*KLVODLQ,&RHQV&HWDO+HDOWKUHODWHGTXDOLW\RIOLIHLQVPDOOFHOOOXQJFDQFHUD
V\VWHPDWLFUHYLHZRQUHSRUWLQJRIPHWKRGVDQGFOLQLFDOLVVXHVLQUDQGRPLVHGFRQWUROOHGWULDOV
7KH/DQFHW2QFRORJ\H
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$33(1',;,
3(5)250$1&(67$786&5,7(5,$

(&2*3HUIRUPDQFH6WDWXV6FDOH
.DUQRIVN\3HUIRUPDQFH6FDOH
*UDGH
'HVFULSWLRQV
3HUFHQW
'HVFULSWLRQ

1RUPDODFWLYLW\)XOO\DFWLYHDEOH
WRFDUU\RQDOOSUHGLVHDVH
SHUIRUPDQFHZLWKRXWUHVWULFWLRQ

1RUPDOQRFRPSODLQWVQRHYLGHQFH
RIGLVHDVH

$EOHWRFDUU\RQQRUPDODFWLYLW\
PLQRUVLJQVRUV\PSWRPVRIGLVHDVH

6\PSWRPVEXWDPEXODWRU\
5HVWULFWHGLQSK\VLFDOO\VWUHQXRXV
DFWLYLW\EXWDPEXODWRU\DQGDEOH
WRFDUU\RXWZRUNRIDOLJKWRU
VHGHQWDU\QDWXUHe.g.OLJKW
KRXVHZRUNRIILFHZRUN

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

,QEHGRIWKHWLPH
$PEXODWRU\DQGFDSDEOHRIDOO
VHOIFDUHEXWXQDEOHWRFDUU\RXW
DQ\ZRUNDFWLYLWLHV8SDQGDERXW
PRUHWKDQRIZDNLQJKRXUV

5HTXLUHVRFFDVLRQDODVVLVWDQFHEXW
LVDEOHWRFDUHIRUPRVWRIKLVKHU
QHHGV

5HTXLUHVFRQVLGHUDEOHDVVLVWDQFHDQG
IUHTXHQWPHGLFDOFDUH

,QEHG!RIWKHWLPH&DSDEOH
RIRQO\OLPLWHGVHOIFDUHFRQILQHG
WREHGRUFKDLUPRUHWKDQRI
ZDNLQJKRXUV

'LVDEOHGUHTXLUHVVSHFLDOFDUHDQG
DVVLVWDQFH

6HYHUHO\GLVDEOHGKRVSLWDOL]DWLRQ
LQGLFDWHG'HDWKQRWLPPLQHQW

EHGULGGHQ&RPSOHWHO\
GLVDEOHG&DQQRWFDUU\RQDQ\
VHOIFDUH7RWDOO\FRQILQHGWREHG
RUFKDLU

9HU\VLFNKRVSLWDOL]DWLRQLQGLFDWHG
'HDWKQRWLPPLQHQW

0RULEXQGIDWDOSURFHVVHV
SURJUHVVLQJUDSLGO\

'HDG

'HDG

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$33(1',;,,
&ROODERUDWLYH$JUHHPHQWV/DQJXDJH

3URWRFROVWKDWLQYROYHDJHQWVFRYHUHGE\DFROODERUDWLYHDJUHHPHQWZLWKDELRWHFKSKDUPD
FRPSDQ\LHVPXVWLQFRUSRUDWHWKH1&,'&7'&ROODERUDWLYH$JUHHPHQW/DQJXDJHVKRZQ
EHORZ

7KHDJHQWVVXSSOLHGE\&7(3'&7'1&,XVHGLQWKLVSURWRFROLVDUHSURYLGHGWRWKH1&,
XQGHUD&ROODERUDWLYH$JUHHPHQW&5$'$&7$&6$EHWZHHQWKH3KDUPDFHXWLFDO
&RPSDQ\LHVKHUHLQDIWHUUHIHUUHGWRDV³&ROODERUDWRUV´DQGWKH1&,'LYLVLRQRI&DQFHU
7UHDWPHQWDQG'LDJQRVLV7KHUHIRUHWKHIROORZLQJREOLJDWLRQVJXLGHOLQHVLQDGGLWLRQWRWKH
SURYLVLRQVLQWKH³,QWHOOHFWXDO3URSHUW\2SWLRQWR&ROODERUDWRU´
KWWSFWHSFDQFHUJRYLQGXVWU\&ROODERUDWLRQVLQWHOOHFWXDOBSURSHUW\KWPFRQWDLQHGZLWKLQ
WKHWHUPVRIDZDUGDSSO\WRWKHXVHRIWKH$JHQWVLQWKLVVWXG\

$JHQWVPD\QRWEHXVHGIRUDQ\SXUSRVHRXWVLGHWKHVFRSHRIWKLVSURWRFROQRU
FDQ$JHQWVEHWUDQVIHUUHGRUOLFHQVHGWRDQ\SDUW\QRWSDUWLFLSDWLQJLQWKH
FOLQLFDOVWXG\&ROODERUDWRUVGDWDIRU$JHQWVDUHFRQILGHQWLDODQGSURSULHWDU\
WR&ROODERUDWRUVDQGVKDOOEHPDLQWDLQHGDVVXFKE\WKHLQYHVWLJDWRUV7KH
SURWRFROGRFXPHQWVIRUVWXGLHVXWLOL]LQJ$JHQWVFRQWDLQFRQILGHQWLDOLQIRUPDWLRQ
DQGVKRXOGQRWEHVKDUHGRUGLVWULEXWHGZLWKRXWWKHSHUPLVVLRQRIWKH1&,,ID
FRS\RIWKLVSURWRFROLVUHTXHVWHGE\DSDWLHQWRUSDWLHQW¶VIDPLO\PHPEHU
SDUWLFLSDWLQJRQWKHVWXG\WKHLQGLYLGXDOVKRXOGVLJQDFRQILGHQWLDOLW\DJUHHPHQW
$VXLWDEOHPRGHODJUHHPHQWFDQEHGRZQORDGHGIURPKWWSFWHSFDQFHUJRY

)RUDFOLQLFDOSURWRFROZKHUHWKHUHLVDQLQYHVWLJDWLRQDO$JHQWXVHGLQ
FRPELQDWLRQZLWKDQRWKHU$JHQWVHDFKWKHVXEMHFWRIGLIIHUHQW&ROODERUDWLYH
$JUHHPHQWVWKHDFFHVVWRDQGXVHRIGDWDE\HDFK&ROODERUDWRUVKDOOEHDVIROORZV
GDWDSHUWDLQLQJWRVXFKFRPELQDWLRQXVHVKDOOKHUHLQDIWHUEHUHIHUUHGWRDV³0XOWL
3DUW\'DWD´

D1&,ZLOOSURYLGHDOO&ROODERUDWRUVZLWKSULRUZULWWHQQRWLFHUHJDUGLQJWKH
H[LVWHQFHDQGQDWXUHRIDQ\DJUHHPHQWVJRYHUQLQJWKHLUFROODERUDWLRQZLWK
1&,WKHGHVLJQRIWKHSURSRVHGFRPELQDWLRQSURWRFRODQGWKHH[LVWHQFHRI
DQ\REOLJDWLRQVWKDWZRXOGWHQGWRUHVWULFW1&,
VSDUWLFLSDWLRQLQWKHSURSRVHG
FRPELQDWLRQSURWRFRO

E(DFK&ROODERUDWRUVKDOODJUHHWRSHUPLWXVHRIWKH0XOWL3DUW\'DWDIURPWKH
FOLQLFDOWULDOE\DQ\RWKHU&ROODERUDWRUVROHO\WRWKHH[WHQWQHFHVVDU\WRDOORZ
VDLGRWKHU&ROODERUDWRUWRGHYHORSREWDLQUHJXODWRU\DSSURYDORU
FRPPHUFLDOL]HLWVRZQ$JHQW

F$Q\&ROODERUDWRUKDYLQJWKHULJKWWRXVHWKH0XOWL3DUW\'DWDIURPWKHVHWULDOV
PXVWDJUHHLQZULWLQJSULRUWRWKHFRPPHQFHPHQWRIWKHWULDOVWKDWLWZLOOXVH
WKH0XOWL3DUW\'DWDVROHO\IRUGHYHORSPHQWUHJXODWRU\DSSURYDODQG
FRPPHUFLDOL]DWLRQRILWVRZQ$JHQW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\

&OLQLFDO7ULDO'DWDDQG5HVXOWVDQG5DZ'DWDGHYHORSHGXQGHUD&ROODERUDWLYH
$JUHHPHQWZLOOEHPDGHDYDLODEOHWR&ROODERUDWRUVWKH1&,DQGWKH)'$DV
DSSURSULDWHDQGXQOHVVDGGLWLRQDOGLVFORVXUHLVUHTXLUHGE\ODZRUFRXUWRUGHUDV
GHVFULEHGLQWKH,32SWLRQWR&ROODERUDWRU
KWWSFWHSFDQFHUJRYLQGXVWU\&ROODERUDWLRQVLQWHOOHFWXDOBSURSHUW\KWP
$GGLWLRQDOO\DOO&OLQLFDO'DWDDQG5HVXOWVDQG5DZ'DWDZLOOEHFROOHFWHGXVHG
DQGGLVFORVHGFRQVLVWHQWZLWKDOODSSOLFDEOHIHGHUDOVWDWXWHVDQGUHJXODWLRQVIRUWKH
SURWHFWLRQRIKXPDQVXEMHFWVLQFOXGLQJLIDSSOLFDEOHWKHStandards for Privacy 
of Individually Identifiable Health InformationVHWIRUWKLQ&)53DUW

:KHQD&ROODERUDWRUZLVKHVWRLQLWLDWHDGDWDUHTXHVWWKHUHTXHVWVKRXOGILUVWEH
VHQWWRWKH1&,ZKRZLOOWKHQQRWLI\WKHDSSURSULDWHLQYHVWLJDWRUV*URXS&KDLU
IRU&RRSHUDWLYH*URXSVWXGLHVRU3,IRURWKHUVWXGLHVRI&ROODERUDWRU
VZLVKWR
FRQWDFWWKHP

$Q\GDWDSURYLGHGWR&ROODERUDWRUVIRU3KDVHVWXGLHVPXVWEHLQDFFRUGDQFH
ZLWKWKHJXLGHOLQHVDQGSROLFLHVRIWKHUHVSRQVLEOH'DWD0RQLWRULQJ&RPPLWWHH
'0&LIWKHUHLVD'0&IRUWKLVFOLQLFDOWULDO

$Q\PDQXVFULSWVUHSRUWLQJWKHUHVXOWVRIWKLVFOLQLFDOWULDOPXVWEHSURYLGHGWR
&7(3E\WKH*URXSRIILFHIRU&RRSHUDWLYH*URXSVWXGLHVRUE\WKHSULQFLSDO
LQYHVWLJDWRUIRUQRQ&RRSHUDWLYH*URXSVWXGLHVIRULPPHGLDWHGHOLYHU\WR
&ROODERUDWRUVIRUDGYLVRU\UHYLHZDQGFRPPHQWSULRUWRVXEPLVVLRQIRU
SXEOLFDWLRQ&ROODERUDWRUVZLOOKDYHGD\VIURPWKHGDWHRIUHFHLSWIRUUHYLHZ
&ROODERUDWRUVKDOOKDYHWKHULJKWWRUHTXHVWWKDWSXEOLFDWLRQEHGHOD\HGIRUXSWR
DQDGGLWLRQDOGD\VLQRUGHUWRHQVXUHWKDW&ROODERUDWRU¶VFRQILGHQWLDODQG
SURSULHWDU\GDWDLQDGGLWLRQWR&ROODERUDWRUV¶VLQWHOOHFWXDOSURSHUW\ULJKWVDUH
SURWHFWHG&RSLHVRIDEVWUDFWVPXVWEHSURYLGHGWR&7(3IRUIRUZDUGLQJWR
&ROODERUDWRUVIRUFRXUWHV\UHYLHZDVVRRQDVSRVVLEOHDQGSUHIHUDEO\DWOHDVW
WKUHHGD\VSULRUWRVXEPLVVLRQEXWLQDQ\FDVHSULRUWRSUHVHQWDWLRQDWWKH
PHHWLQJRUSXEOLFDWLRQLQWKHSURFHHGLQJV3UHVVUHOHDVHVDQGRWKHUPHGLD
SUHVHQWDWLRQVPXVWDOVREHIRUZDUGHGWR&7(3SULRUWRUHOHDVH&RSLHVRIDQ\
PDQXVFULSWDEVWUDFWDQGRUSUHVVUHOHDVHPHGLDSUHVHQWDWLRQVKRXOGEHVHQWWR

(PDLOQFLFWHSSXEV#PDLOQLKJRY

7KH5HJXODWRU\$IIDLUV%UDQFKZLOOWKHQGLVWULEXWHWKHPWR&ROODERUDWRUV1R
SXEOLFDWLRQPDQXVFULSWRURWKHUIRUPRISXEOLFGLVFORVXUHVKDOOFRQWDLQDQ\RI
&ROODERUDWRU¶VFRQILGHQWLDOSURSULHWDU\LQIRUPDWLRQ




8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$33(1',;,,,6(37
0HGLGDWD3DWLHQW&ORXGH3522SHUDWLRQDO,QVWUXFWLRQV

,QWURGXFWLRQ

(OHFWURQLFFROOHFWLRQRISDWLHQWUHSRUWHGRXWFRPHVH352WKURXJK0HGLGDWD3DWLHQW&ORXG
H352LVSUHIHUUHGEXWQRWPDQGDWRU\7UDGLWLRQDOSDSHUVXEPLVVLRQLVWKHRWKHURSWLRQ3DWLHQWV
ZKRZLOOEHVXEPLWWLQJ352GDWDYLD3DWLHQW&ORXGH352PXVWEHUHJLVWHUHGWR3DWLHQW&ORXG
H352E\DQDXWKRUL]HGVLWHXVHUDIWHUWKHSDWLHQWKDVEHHQUHJLVWHUHGWRWKHVWXG\3DWLHQWVPD\
XVHWKHLURZQGHYLFHRURQHSURYLVLRQHGE\WKHVLWH

6LWHVFDQXVHDVLWHVSHFLILFWDEOHWIRUPXOWLSOHVWXG\SDUWLFLSDQWV,IDVLWHVSHFLILFWDEOHWLVXVHG
&5$VQHHGWRVHWXSWKHWDEOHWIRUPXOWLSOHXVHUV0XOWLXVHUPRGHOHWVPXOWLSOHVWXG\
SDUWLFLSDQWVORJLQWR3DWLHQW&ORXGH352ZLWKWKHLUSDVVZRUGVRUWKHLU3,1FRGHVRQWKHVDPH
GHYLFH

&5$6LWH8VHUV

6LWHXVHUVRI3DWLHQW&ORXGH352UHTXLUHWKHVDPHDFFHVVDV5DYH$FFHVVWRWKHWULDOLQWKH
3DWLHQW&ORXGH352LVJUDQWHGWKURXJKWKHL0HGLGDWD6LWHXVHUVZLOOUHFHLYHDQLQYLWDWLRQWR
3DWLHQW&ORXGH352DQGWKHVLWHXVHUPXVWDFFHSWWKHLQYLWDWLRQWREHJLQSDWLHQWUHJLVWUDWLRQ
8VHUVZKRKDYHQRWSUHYLRXVO\DFWLYDWHGWKHLUL0HGLGDWD5DYHDFFRXQWDWWKHWLPHRILQLWLDO
DSSURYDORIVLWHUHJLVWUDWLRQZLOODOVRUHFHLYHDVHSDUDWHLQYLWDWLRQIURPL0HGLGDWDWRDFWLYDWH
WKHLUDFFRXQW$FFRXQWDFWLYDWLRQLQVWUXFWLRQVDUHORFDWHGRQWKH&768ZHEVLWH5DYHWDEXQGHU
WKH5DYHUHVRXUFHPDWHULDOV0HGLGDWD$FFRXQW$FWLYDWLRQDQG6WXG\,QYLWDWLRQ$FFHSWDQFH
3OHDVHQRWHVLWHXVHUVZLOOQRWEHDEOHWRDFFHVVWKHVWXG\LQWKH3DWLHQW&ORXGH352XQWLODOO
UHTXLUHG5DYHDQGVWXG\VSHFLILFWUDLQLQJVDUHFRPSOHWHG

$GGLWLRQDOLQIRUPDWLRQRQL0HGLGDWD5DYHLVDYDLODEOHRQWKH&768PHPEHUV¶ZHEVLWHXQGHUWKH
5DYHWDEDWRUE\FRQWDFWLQJWKH&768+HOS'HVNDWRUE\HPDLO

&5$,QVWUXFWLRQVIRU6HWWLQJWKH3DWLHQW&ORXGH352$SSWR0XOWL8VHU0RGH

6LWHVFRQGXFWLQJVWXGLHVHQWLUHO\RQSUHPLVHZKHUHSDUWLFLSDQWVWUDYHOWRWKHVLWHVWRILOORXW
TXHVWLRQQDLUHVFDQXVHPXOWLXVHUPRGH0XOWLXVHUPRGHOHWVPXOWLSOHVWXG\SDUWLFLSDQWVORJLQ
WR3DWLHQW&ORXGZLWKWKHLUSDVVZRUGVRUWKHLU3,1FRGHVRQWKHVDPHGHYLFH,ISDWLHQWVZLOOEH
XVLQJGHYLFHVVXSSOLHGE\WKHLQVWLWXWLRQVLWHVWDIIZLOOQHHGWRKHOSWKHSDWLHQWWRDFFHVVWKH
GHYLFHLIWKHGHYLFHLVORFNHG

7KHVWXG\SURYLGHUZLOOGRZQORDGWKH3DWLHQW&ORXGH352DSSWRWKHGHYLFHDQGVHWWKH3DWLHQW
&ORXGH352$SSWRPXOWLXVHUPRGHLIDSSOLFDEOH
7RVZLWFKIURPSHUVRQDOPRGHGHIDXOWVHWWLQJWRPXOWLXVHUPRGH
7DS$ERXWDWWKHERWWRPRIWKHORJLQVFUHHQ
6FUROOWRWKHERWWRPDQGWDS$GYDQFHG8VHU
7DS0RGHWKHQVHOHFW0XOWL8VHU
7DS<HVWRFRQILUP
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
7DSWKHEDFNDUURZVWRUHWXUQWRWKHORJLQVFUHHQ
1RWH,IHQDEOLQJPXOWLXVHUPRGHRQDGHYLFHLWLVKLJKO\UHFRPPHQGHGWKDWFRPSOHWLRQ
UHPLQGHUVDUHWXUQHGRIIRQWKDWGHYLFH

)RUDYLGHRGHPRQVWUDWLRQVHH6KRZ0H+RZWR6ZLWFKWR0XOWL8VHU0RGH

3DWLHQW8VHUV

7RXVHWKH3DWLHQW&ORXGH352SDWLHQWVZLOOQHHGWRXVHWKHLURZQGHYLFH,26$QGURLGSKRQH
RUWDEOHW6KRUWWHUPGDWDZLOORQO\DSSHDURQWKHSDWLHQW¶VGHYLFHXQWLOUHVSRQVHVDUHFRPSOHWHG
DQGVXEPLWWHG7KHSDWLHQWGDWDZLOOLPSRUWGLUHFWO\LQWRWKHGDWDEDVHRQFHWKHSDWLHQWVHOHFWVWKH
³6XEPLW´EXWWRQDQGZLOOQRORQJHUEHYLVLEOHRQWKHSDWLHQW
VGHYLFH

6LWHVFDQSURYLGHDVLWHVSHFLILFWDEOHWIRUPXOWLSOHVWXG\SDUWLFLSDQWXVHRQVLWH,IDVLWHVSHFLILF
WDEOHWLVXVHGVWXG\VWDIIQHHGWRVHWXSWKHWDEOHWIRUPXOWLSOHXVHUV0XOWLXVHUPRGHOHWV
PXOWLSOHVWXG\SDUWLFLSDQWVORJLQWR3DWLHQW&ORXGH352ZLWKWKHLUSDVVZRUGVRUWKHLU3,1FRGHV
RQWKHVDPHGHYLFH5HIHUWR$SSHQGL[(RQ6HWWLQJWKH3DWLHQW&ORXGH352$SSWR0XOWL
8VHU0RGH

3DWLHQW,QVWUXFWLRQVIRU$FFHVVLQJWKH3DWLHQW&ORXG8VLQJ<RXU3HUVRQDO'HYLFH

Downloading the Patient Cloud ePRO App 
,I\RXDUHXVLQJ\RXUSHUVRQDOGHYLFHDQG\RXGRQRWKDYHWKH3DWLHQW&ORXGH352DSSXVHWKH
IROORZLQJLQVWUXFWLRQV:KHQGRZQORDGLQJWKHDSS\RXPXVWXVHWKH$SSOH,'RU*RRJOH
DFFRXQWDVVRFLDWHGZLWKWKHGHYLFH,IWKH3DWLHQW&ORXGH352DSSLVDOUHDG\RQWKHGHYLFHRULI
\RXDUHXVLQJDSURYLGHU
VGHYLFH\RXFDQVNLSWKLVVHFWLRQ

<RXZLOOQHHGDQHPDLODGGUHVVWKDW\RXDJUHHWRXVHIRUWKLVSXUSRVH7KHHPDLODGGUHVVLV
QHHGHGWRLGHQWLI\\RXRQWKH3DWLHQW&ORXG$SSOLFDWLRQDQGIRU\RXWRUHFHLYHQRWLILFDWLRQVWROHW
\RXNQRZZKHQIRUPVDUHGXH<RXUHPDLODGGUHVVZLOORQO\EHXVHGIRUWKLVVXUYH\VWXG\DQG
ZLOOQRWEHXVHGIRUPDLORUPDUNHWLQJSXUSRVHV

,I\RXGHFLGHWRXVHWKHHOHFWURQLFPHWKRGWRFRPSOHWHWKHTXHVWLRQQDLUHVDQGGRQRWKDYHDQH
PDLODGGUHVV\RXPD\VLJQXSIRURQHDWQRFKDUJHDWPDQ\GLIIHUHQWZHEVLWHV$IHZVLWHVWKDW
DUHFRPPRQO\XVHGDQGZLOODOORZ\RXWRFUHDWHDQHPDLODGGUHVVYHU\HDVLO\DUH<DKRR*PDLO
DQG2XWORRN

)RUL26

 $Q$SSOH,'LVUHTXLUHGIRUGRZQORDGLQJWKH3DWLHQW&ORXGH352DSS
 7DSWKHApp StoreLFRQ
 6HDUFKIRUMedidata Patient CloudDQGIROORZWKHLQVWDOODWLRQLQVWUXFWLRQV
1RWH3DWLHQW&ORXGH352LVOLVWHGDVDQL3KRQH$SSLQWKH$SSVWRUH:KHQXVLQJDQL3DG
SOHDVHYLHZWKHVHDUFKUHVXOWVXQGHUL3KRQHDSSV

)RU$QGURLG
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
 $*RRJOHDFFRXQWLVUHTXLUHGIRUGRZQORDGLQJWKH3DWLHQW&ORXGH352
DSS
 7DSWKHPlay StoreLFRQ
 6HDUFKIRUMedidata Patient CloudDQGIROORZWKHLQVWDOODWLRQLQVWUXFWLRQV
Registering
<RXPXVWUHJLVWHULQRUGHUWRFRPSOHWHDQGVXEPLW\RXUVWXG\IRUPV:KHQ\RXUHJLVWHU\RXZLOO
FUHDWHDXVHUQDPHZKLFKLV\RXUHPDLODGGUHVVDQGDSDVVZRUGWKDWDOORZV\RXWRORJLQWRWKH
3DWLHQW&ORXGH352DSS

1RWH<RXPXVWKDYHDQDFWLYDWLRQFRGHWREHJLQWKLVSURFHVV,I\RXGRQRWKDYHDQDFWLYDWLRQ
FRGHSOHDVHFRQWDFW\RXUSURYLGHU
7KHUHDUHWZRSRVVLEOHZD\VWRUHJLVWHU<RXUSURYLGHUPD\KDYHVHQW\RXDOLQNWRDZHEDGGUHVV
ZKHUH\RXPD\UHJLVWHUIURPDQ\ZHEEURZVHULQFOXGLQJWKHRQHRQ\RXUGHYLFH7KHRWKHUZD\
WRUHJLVWHULVRQWKH3DWLHQW&ORXGH352DSS
 ,IUHJLVWHULQJIURPWKH3DWLHQW&ORXGDSSWDS5HJLVWHURQWKHERWWRPRIWKH
ORJLQSDJH,IUHJLVWHULQJRQWKHZHERSHQWKH85/VKLHOGLPHGLGDWDFRP
RQDZHEEURZVHU
 (QWHU\RXUDFWLYDWLRQFRGHDQGWDS$FWLYDWH
 2QWKHQH[WSDJHUHDGWKHLQVWUXFWLRQVDQGWDS1H[W
 5HDGWKHSULYDF\QRWLFHDQGWDS,DJUHH7KHQWDS2.WRFRQILUP
 (QWHUDQGFRQILUP\RXUHPDLODGGUHVV7DS1H[W
 (QWHUDQGFRQILUP\RXUSDVVZRUG7DS1H[W
 &KRRVHDVHFXULW\TXHVWLRQE\VFUROOLQJWKURXJKWKHGURSGRZQPHQXWR
GLVSOD\WKHTXHVWLRQRI\RXUFKRLFH
 (QWHU\RXUVHFXULW\TXHVWLRQUHVSRQVH
 7DS&UHDWHP\DFFRXQWWRFRPSOHWH\RXUUHJLVWUDWLRQ
,I\RXUHJLVWHUHGRQWKH3DWLHQW&ORXGH352DSSLWDXWRPDWLFDOO\ORJV\RXRXW,I\RXUHJLVWHUHG
RQWKHZHE\RXDUHSUHVHQWHGZLWKWKHRSWLRQWRGRZQORDGWKH3DWLHQW&ORXGH352DSS<RXFDQ
WKHQSURFHHGWRORJLQZLWKWKHFUHGHQWLDOV\RXFUHDWHG

Logging in to the App 
 (QWHU\RXU(PDLODQG3DVVZRUGWKDW\RXFUHDWHGGXULQJWKHUHJLVWUDWLRQ
SURFHVV,I\RXSUHYLRXVO\VHWD3,1FRGHMXVWHQWHU\RXUIRXUGLJLW3,1
 7DS/RJLQ
1RWH,I\RXGRQRWUHPHPEHU\RXUSDVVZRUGWDS)RUJRW3DVVZRUGDQGIROORZ
WKHLQVWUXFWLRQVSURYLGHG
Setting a PIN Code 
7KHILUVWWLPH\RXORJLQWRWKH3DWLHQW&ORXGH352DSS\RXDUHJLYHQWKHRSWLRQWRFUHDWHD3,1
FRGH$3,1FRGHDOORZV\RXWRE\SDVVWKHVWHSRIHQWHULQJ\RXUHPDLODQGSDVVZRUGHYHU\WLPH
\RXQHHGWRORJLQWRWKH3DWLHQW&ORXGH352DSS,QVWHDG\RXFDQHQWHUDIRXUGLJLW3,1
 ,I\RXZLVKWRVHWD3,1FRGHWKHILUVWWLPH\RXORJLQWDS<HVZKHQ
SURPSWHG
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
 1RWH<RXFDQDOVRVHW\RXU3,1DWDODWHUWLPHE\WDSSLQJWKHRSWLRQV
PHQXRQWKHWRSOHIWRIPRVWSDJHVDQGVHOHFWLQJ6HW3,1
 (QWHUDIRXUGLJLW3,1
 5HHQWHUWKHIRXUGLJLW3,1WRFRQILUP
,I\RXIRUJHW\RXU3,1FRGHWDS)RUJRW3,1DQG\RXFDQDFFHVVWKHDSSXVLQJ\RXUHPDLODQG
SDVVZRUG<RXPD\UHVHW\RXU3,1E\WDSSLQJWKHRSWLRQVPHQXRQWKHWRSOHIWRIPRVWSDJHV
DQGVHOHFWLQJ 6HW3,1
Resetting Your Password
<RXFDQUHVHW\RXUSDVVZRUGE\XVLQJWKHRSWLRQVPHQXDWWKHWRSOHIWRIPRVWSDJHV
 7DSWKHRSWLRQVPHQXLFRQ
 7DS 5HVHW3DVVZRUG
 )ROORZWKHLQVWUXFWLRQVWRUHVHW\RXUSDVVZRUG
Completing and Submitting Forms 
2QFHORJJHGLQIRUPVUHODWHGWR\RXUVWXG\GLVSOD\RQWKH7DVNVSDJH,I\RXDUHHQUROOHGLQ
PXOWLSOHVWXGLHVVHOHFWWKHDSSURSULDWHVWXG\ILUVWDQGWKHQVHOHFWDIRUP1HZIRUPVFDQDSSHDU
RQWKH7DVNVSDJHDWDQ\WLPHGHSHQGLQJRQKRZWKHVWXG\LVGHVLJQHG
7KHUHDUHWZRW\SHVRIIRUPVGLVSOD\HGRQWKH7DVN/LVWSDJH
x
Scheduled Forms ZLWKD
LFRQ7KHVHIRUPVKDYHD'XH'DWHLQGLFDWRU
LQWKHPVR\RXDUHDZDUHRIWKHODVWGD\E\ZKLFK\RXZLOOQHHGWRFRPSOHWH
WKHIRUP,IWKHIRUPLVGXHLQOHVVWKDQRQHGD\\RXZLOOVHHWKHGXHWLPHLQ
KRXUV
x
Anytime Forms ZLWKD
LFRQ7KHVHIRUPVKDYH/DVW&RPSOHWHG7LPH
LQGLFDWRURQWKHPZKLFKWHOOVWKHPRVWUHFHQWGDWHRUWLPHZKHQ\RX
FRPSOHWHGWKHIRUP,I\RXVWDUWDIRUPEXWGRQRWFRPSOHWHLW\RXZLOOVHHDQ

,QFRPSOHWHVWDWXVEHQHDWKWKHIRUPQDPHDORQJZLWKDKDOIPRRQLFRQ
 6HOHFWWKHDSSURSULDWHIRUP
 )ROORZWKHRQVFUHHQLQVWUXFWLRQVXQWLO\RXUHDFKWKHHQGRIWKHIRUP
ZKHUH\RXDUHJLYHQWKHRSSRUWXQLW\WRUHYLHZDQGFKDQJH\RXUUHVSRQVHV
SULRUWRVXEPLWWLQJ
 5HYLHZ\RXUUHVSRQVHVE\VFUROOLQJGRZQWKHOLVW
 ,I\RXQHHGWRFKDQJHDQDQVZHUWDSWKHTXHVWLRQWRJREDFNDQGFKDQJH
WKHDQVZHU
 :KHQ\RXDUHUHDG\WRVXEPLWWDS6XEPLW<RXU'DWD
1RWH2QFHDIRUPLVVXEPLWWHG\RXZLOOEHXQDEOHWRHGLWDQ\RI\RXUUHVSRQVHV,QVRPHFDVHV
\RXPD\EHDVNHGWRDFNQRZOHGJH\RXUVXEPLVVLRQE\HQWHULQJ\RXUSDVVZRUG
3DWLHQW&RPSOLDQFH
7KHSDWLHQWGDWDLPSRUWVGLUHFWO\IURPDGHYLFHLQWRWKH5DYHGDWDEDVH7KHUHDUHQRGRFXPHQWV
WRDXGLW7KHSDWLHQWVXEPLWWHGHOHFWURQLFUHVSRQVHVDUHWKHVRXUFHGRFXPHQWDWLRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
6HFXULW\

$OOGDWDLVHQFU\SWHGRQWKHGHYLFHELWHQFU\SWLRQDQG+\SHU7H[W7UDQVIHU3URWRFRO6HFXUH
>KWWSV@DQGWKHDSSUHTXLUHVHDFKXVHUWRKDYHDXQLTXHXVHUQDPHDQGSDVVZRUGIRUDFFHVV,I
WKHXVHULVLGOHIRUWRRORQJPLQXWHVLQDFWLYLW\WLPHWKHDSSZLOOWLPHRXWDQGWKHXVHUZLOO
QHHGWRORJLQDJDLQ

7KHGDWDZLOORQO\UHVLGHRQWKHGHYLFHIRUDVKRUWSHULRGRIWLPH2QFHWKHXVHUFOLFNV³6XEPLW´
WKHGDWDLVVHFXUHO\WUDQVIHUUHGRYHU+7736EHWZHHQWKHGHYLFHDQGLQWHUQDOUHOD\WRWKH5DYH
GDWDEDVH([FHSWIRUWKHSDWLHQW
VHPDLODGGUHVVQRLGHQWLI\LQJLQIRUPDWLRQLVVWRUHGLQ
L0HGLGDWD7KHHPDLODGGUHVVLVVWRUHGIRUZKDWSXUSRVH"7KHSDWLHQW¶VHPDLOOLQNVWKHGHYLFH
XVHGDQGH352DFFRXQWWRZKHUHWKHGDWDLVVWRUHG7KHSDWLHQW¶VHPDLOLVQRWYLVLEOHWR
DQ\RQHLQWKHV\VWHP

7KH3DWLHQWLQIRUPDWLRQHPDLOSDVVZRUGGRHVQRWUHVLGHLQ0HGLGDWD5DYH('&DQGWKHSDWLHQW
DFFRXQWVDUHKLGGHQLQL0HGLGDWDIURPVLWHVDQG/32V

7KH3DWLHQW&ORXGH352DSSOLFDWLRQLV&)53DUWFRPSOLDQWDQGDFWVDVDJDWHZD\EHWZHHQ
WKHGHYLFHDQG0HGLGDWD&OLQLFDO&ORXG0&&

0HVVDJHVDQGLQIRUPDWLRQFRPPXQLFDWHGWRDQGIURPWKH3DWLHQW&ORXGH352DUHHQFU\SWHGDQG
WKHUHIRUHWKLVLQIRUPDWLRQFDQQRWEHUHDGLILQWHUFHSWHGZKLOHLQWUDQVLW

6LWHFKHFNOLVWIRUDFWLYLWLHVSULRUWRFRQVHQWLQJDSDWLHQW

 6LWHVWDIIPXVWKDYHDOUHDG\FRPSOHWHGUHTXLUHGH/HDUQLQJIRUWKH3DWLHQW&ORXGH352
DSSOLFDWLRQ6HHODVWEXOOHWZLWKK\SHUOLQNWRWUDLQLQJYLGHROLEUDU\&RQWDFWWKH/32WR
UHTXHVWDSSURSULDWH5DYHDFFHVVWRUHJLVWHUSDWLHQWVLQ3DWLHQW&ORXGH352
 $FFHSWVWXG\LQYLWDWLRQDWL0HGLGDWDFRP
o 1RWH\RXPXVWEHURVWHUHGLQ566DQGKDYHUHFHLYHGDQLQYLWDWLRQWR3DWLHQW&ORXG
H352
 9HULI\WKH,26RU$QGURLGRSHUDWLQJV\VWHPLVXVLQJWKHPRVWFXUUHQWYHUVLRQ
 9HULI\3DWLHQW&ORXGH352DSSLVXVLQJWKHPRVWFXUUHQWYHUVLRQ
 ,IXVLQJLQVWLWXWLRQDOVKDUHGGHYLFHVILUVWSDWLHQWRQO\9HULI\3DWLHQW&ORXGH352DSSLVLQ
0XOWL8VHUPRGH
 5HIHUWR5HYLHZ4XLFN5HIHUHQFH*XLGHVIRUYLGHRVDQGRWKHUSURFHGXUDOLQIRUPDWLRQ
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$33(1',;,92&7
352326('(;3/25$725<&255(/$7,9(678',(6

)ORZF\WRPHWU\LPPXQRSKHQRW\SLQJ
&HOOXODUFKDUDFWHUL]DWLRQE\PXOWLFRORUIORZF\WRPHWULFDQDO\VLVLVDQDQDO\WLFDO
F\WRPHWU\PHWKRGWRGHWHFWGLIIHUHQWSRSXODWLRQVRILPPXQHFHOOVLQSHULSKHUDOEORRG
7KHPDLQREMHFWLYHRIIORZEDVHGDQDO\VLVIRUWKLVVWXG\LVWRXQGHUVWDQGWKHEDVDO
FRPSRVLWLRQDQGVWDWXVRIWKHLPPXQHFHOOUHSHUWRLUHDQGPRVWLPSRUWDQWO\FKDQJHVLQWKH
FRPSRVLWLRQDQGVWDWXVRIWKHUHSHUWRLUHLQGXFHGE\WKHUDS\%RWKWKHEDVDOVWDWHDQG
SHUWXUEHGVWDWHRIWKHLPPXQHFHOOUHSHUWRLUHFDQEHPHDVXUHGE\FRPSUHKHQVLYH
HYDOXDWLRQRISHULSKHUDOEORRGVXEVHWV6XFKDQDO\VLVVKRXOGLQFOXGHQRWRQO\FHOOW\SH
HJKHOSHUVXSSUHVVRUUHJXODWRU\7FHOOVQDWXUDONLOOHUDOSKDEHWDJDPPDGHOWD
GHQGULWLFFHOOVP\HORLGGHULYHGVXSSUHVVRUFHOOVEXWDOVRWKHLUPDWXULW\QDwYHQDwYHLQ
WUDQVLWLRQPHPRU\TXLHVFHQWPHPRU\DFWLYDWHGPHPRU\VHQHVFHQWHWFWKHLU
DFWLYDWLRQVWDWXVHDUO\PLGPLGODWHODWHDQGYHU\ODWHDFWLYDWLRQDQGGHJUDQXODWLRQ
VWDWXV

2XUXQGHUO\LQJUHVHDUFKK\SRWKHVHVRIWKLVVWXG\DUHWKDWWKHFRPSRVLWLRQDQGVWDWXVRI
WKHLPPXQHFHOOUHSHUWRLUHDWEDVHOLQHFRUUHODWHVZLWKFOLQLFDOFKDUDFWHULVWLFVLQFOXGLQJ
KLVWRORJLFDOJUDGHWXPRUPXWDWLRQDOORDGSUHGLFWHGQHRDQWLJHQORDGSDWLHQWFOLQLFDO
710VWDJHSDWLHQWDJHSDWLHQWJHQGHUVPRNLQJVWDWXVHWFEXWDOVRZLWKUHVSRQVHWR
WKHUDS\DQGFOLQLFDORXWFRPHV,QDGGLWLRQFKDQJHVDQGGHJUHHRIFKDQJHVLQLPPXQH
FHOOUHSHUWRLUHFRPSRVLWLRQDQGVWDWXVLQGXFHGE\WKHUDS\E\FRPSDULQJEDVHOLQHDQG
VHULDOGXULQJWKHUDS\VDPSOHVZLOODOORZXVWRGHWHUPLQHZKLFKVXEVHWRIFHOOVDUHPRVW
LPSRUWDQWLQSRVLWLYHDQGQHJDWLYHUHVSRQVHWRWKHUDS\

3HULSKHUDOEORRGVDPSOHVZLOOEHFROOHFWHGLQ.('7$WXEHVDWYDULRXVWLPHSRLQWVDQG
3%0&VZLOOEHSURFHVVHGLQUHDOWLPHE\3UHFLVLRQIRU0HGLFLQH8SRQFRQFOXVLRQRI
WKLVFOLQLFDOWULDOWKHIUR]HQ3%0&VZLOOEHVHQWWRDSDUWQHULQJODEIRUDQDO\VLV&KDQJHV
LQWKHLPPXQHFHOOUHSHUWRLUHZLOOEHGHWHFWHGIURPEORRGVDPSOHV

7KLVWHVWLQJZLOOPHDVXUHFKDQJHVLQLPPXQHFHOOVXEVHWVLQSDWLHQWVFRQWURODUP
H[SHULPHQWDODUP

7LVVXH%ORRG6HOHFWLRQIRU)XWXUH5HVHDUFKH[SORUDWRU\HQGSRLQWVXVLQJEDQNHG
EORRGDQGWLVVXH
If sufficient tissue/blood remains after integrated analyses are complete (or optional 
biospecimen submission), other potential exploratory correlative assessments (not  
integrated) may include, but are not limited to: 

:KROHH[RPHVHTXHQFLQJ:(6LQSDWLHQWVZLWKSURJUHVVLRQWXPRU$VPHQWLRQHG
DERYHZHSODQWRSHUIRUPZKROHH[RPHVHTXHQFLQJRQDUFKLYDOWXPRUVDPSOHVIURP
SDWLHQWV,QDGGLWLRQZHZLOOSHUIRUP:(6RQWXPRUWLVVXHRQRIWKHVHSDWLHQWV
aSDWLHQWVZKRGHYHORSSURJUHVVLYHGLVHDVH7KLVZLOOVHUYHDVDQH[SORUDWRU\
DQDO\VLVWRLGHQWLI\SRWHQWLDOPHFKDQLVPVRIUHVLVWDQFHRUSURJUHVVLRQFRPSDUHGWR:(6
GDWDIURPEDVHOLQHWXPRUWLVVXH,ISDWLHQWVFRQVHQWWRRSWLRQDOELREDQNLQJWLVVXHIURP
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
DUFKLYDORUDIUHVKWXPRUELRSV\DWSURJUHVVLRQZLOOEHUHTXHVWHGIRUWKLVDQDO\VLV
6LPLODUWRWKH:(6DWEDVHOLQHHLWKHUDQ))3(EORFNRUSXQFKFRUHVHDFKFRUH
PPWKLFNIURPDQ))3(EORFNVKRXOGEHVHQWWRWKH15*ELREDQNIRUWKLVIXWXUH
DQDO\VLV

&LUFXODWLQJWXPRU'1$FW'1$&LUFXODWLQJWXPRU'1$FW'1$LVDVHQVLWLYHDQG
VSHFLILFZD\WRPHDVXUHSUHVHQFHRIWXPRU'1$LQWKHEORRGDQGFW'1$FRUUHODWHVZLWK
SURJQRVLVDQGUHVSRQVHWRWUHDWPHQWDQGWKHUHIRUHPD\EHDSUHGLFWLYHELRPDUNHU0DQ\
VWXGLHVVKRZWKDWFKDQJHVLQFW'1$FDQSUHGDWHFKDQJHVLQLPDJLQJ:HZLOODFFHVV
FW'1$IURPSHULSKHUDOEORRG:HK\SRWKHVL]HWKDWZHFDQLGHQWLI\SUHVHQFHRIFW'1$
PXWDWLRQVLQFLUFXODWLQJIUHH'1$RISHULSKHUDOEORRGDQGWKDWFKDQJHVLQFW'1$
GXULQJDIWHUWKHUDS\ZLOOVHUYHDVDQHDUO\SUHGLFWRURIWUHDWPHQWRXWFRPHVHJ
SURJUHVVLRQIUHHDQGRYHUDOOVXUYLYDO

3'/LPPXQRKLVWRFKHPLVWU\3'/SURJUDPPHGGHDWKOLJDQGRU%+LVD
WUDQVPHPEUDQHSURWHLQWKDWSOD\VDUROHLQVXSSUHVVLQJWKHLPPXQHV\VWHP7KURXJK
ELQGLQJRI3'/RQWXPRUFHOOVWR3'RQ7FHOOVDQLQKLELWRU\VLJQDOLVWUDQVPLWWHGWR
7FHOOV7KHUHLVGDWDVXJJHVWLQJWKDWKLJK3'/H[SUHVVLRQPD\SUHGLFWEHQHILWLQWKH
VHWWLQJRILPPXQRWKHUDS\IRU16&/&+RZHYHUWKHUROHIRU3'/DVDSUHGLFWLYH
ELRPDUNHULQ6&/&WRFKHFNSRLQWLQKLELWRUVLQ6&/&KDVQRWGHPRQVWUDWHGWKHVDPH
SUHGLFWLYHSRZHU)URPDYDLODEOHUHPDLQLQJWXPRUWLVVXHVXEPLWWHGIRUZKROHH[RPH
VHTXHQFLQJLQWHJUDWHGDQDO\VLVZHPD\SHUIRUP3'/LPPXQRKLVWRFKHPLVWU\DQG
TXDQWLI\WXPRU3'/H[SUHVVLRQSDWWHUQV:HK\SRWKHVL]HWKDWKLJK3'/H[SUHVVLRQ
LQWXPRUFHOOVZLOOSUHGLFWEHQHILWIURPSURWRFROWKHUDS\

7FHOOUHFHSWRU7&5VHTXHQFLQJSKHQRW\SLQJ+LJKWKURXJKSXWVHTXHQFLQJRI7FHOO
UHFHSWRUVKDVQRZSURYLGHGWKHRSSRUWXQLW\IRUDFFXUDWHLGHQWLILFDWLRQDQGTXDQWLILFDWLRQ
RIHYHU\GLVWLQFW7FHOOFORQH,WDOORZVWKHDVVHVVPHQWRIWKHGLYHUVLW\RIWKH7&5
UHSHUWRLUHDQGWKHNLQHWLFVRIHDFKDQWLJHQVSHFLILF7FHOOFORQHRYHUWLPH:HPD\
SHUIRUP7&5VHTXHQFLQJRQJHQRPLF51$LVRODWHGIURP3%0&VIURPSHULSKHUDOEORRG
DQGWXPRUXVLQJ51$6HTLQRUGHUWRGHWHUPLQHKRZSURWRFROWKHUDS\DOWHUV7&5
UHSHUWRLUHGLYHUVLW\DQGFORQHVRIQHRDQWLJHQVSHFLILF7FHOOV:HK\SRWKHVL]HWKDWWKH
DGGLWLRQRILPPXQRWKHUDS\WRVWDQGDUGFKHPRUDGLDWLRQZLOOUHVXOWLQFKDQJHVLQ7FHOO
UHFHSWRUUHSHUWRLUHDQGFORQDOGLYHUVLW\

&\WRNLQHDVVD\V:HZLOOSHUIRUPPXOWLSOH[HQ]\PHOLQNHGLPPXQRDGVRUEHQWDVVD\VWR
PHDVXUHF\WRNLQHVFKHPRNLQHVRULQIODPPDWRU\PDUNHUVLQEORRGVDPSOHV:H
K\SRWKHVL]HWKDWWKHDGGLWLRQRILPPXQRWKHUDS\WRVWDQGDUGFKHPRUDGLDWLRQWKHUDS\ZLOO
DOWHUF\WRNLQHLQIODPPDWRU\PDUNHUOHYHOVDQGWKDWUHSURGXFLEOHFKDQJHVLQF\WRNLQH
OHYHOVZLOOFRUUHODWHZLWKLPSURYHGUHVSRQVHIURPWKHSURWRFROWKHUDS\

51$6HTWXPRU51$6HTLVDQH[WJHQHUDWLRQVHTXHQFLQJSODWIRUPWKDWPHDVXUHV
YDULRXVOHYHOVRI51$WUDQVFULSWVDQGSURYLGHVVHTXHQFLQJLQIRUPDWLRQLQFOXGLQJ7FHOO
UHFHSWRU7&5VHTXHQFHV3UHOLPLQDU\GDWDVXJJHVWWKDWDQ51$VLJQDWXUHPHDVXULQJ
OHYHOVRI7FHOOHIIHFWRUSUHVHQFHDFWLYLW\PD\SUHGLFWUHVSRQVHWRLPPXQRWKHUDS\:H
K\SRWKHVL]HWKDWDKLJK7FHOOHIIHFWRUVLJQDWXUHZLOOFRUUHODWHZLWKUHVSRQVHWRSURWRFRO
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
WKHUDS\:HZLOOSHUIRUP51$6HTRQDYDLODEOHWXPRUWLVVXHUHPDLQLQJDIWHUWKHZKROH
H[RPHVHTXHQFLQJLQWHJUDWHGDQDO\VLVDERYH

51$6HTEORRG3UHOLPLQDU\GDWDVXJJHVWWKDWWUDQVFULSWVSDUWLFXODUWKRVHUHOHYDQWWR
LQIODPPDWRU\DQGDQWLYLUDOVLJQDOLQJSDWKZD\VPD\EHDVVRFLDWHGZLWKWKHGHYHORSPHQW
RIFDQFHUUHODWHGIDWLJXH:HPD\SHUIRUP51$6HTRQ51$LVRODWHGIURP3%0&V
IURPDYDLODEOHEORRGUHPDLQLQJLQWKHELREDQN7&5VHTXHQFHVZLOODOVREHGHULYHGIURP
51$6HTGDWDREWDLQHGIURPEORRGDQGSRWHQWLDOO\FRUUHODWHGWRWXPRUUHVSRQVHWR
LPPXQRWKHUDS\:HK\SRWKHVL]HWKDWWUDQVFULSWVJHQHUDWHGIURP51$6HTZLOOEH
DVVRFLDWHGZLWKIDWLJXHOHYHOVRYHUWKHFRXUVHRILPPXQRWKHUDS\

'1$PHWK\ODWLRQEORRG3UHOLPLQDU\GDWDLQGLFDWHWKDW'1$PHWK\ODWLRQFKDQJHV
VHFRQGDU\WRFDQFHUWUHDWPHQWPD\EHDVVRFLDWHGZLWKWKHGHYHORSPHQWRIFDQFHUUHODWHG
IDWLJXH:HK\SRWKHVL]H'1$PHWK\ODWLRQFKDQJHVZLOOEHDVVRFLDWHGZLWKIDWLJXHOHYHOV
RYHUWKHFRXUVHRILPPXQRWKHUDS\:HPD\SHUIRUP'1$PHWK\ODWLRQRQ'1$LVRODWHG
IURP3%0&VIURPDYDLODEOHEORRGUHPDLQLQJLQWKHELREDQN






























8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
1DWLRQDO8QLYHUVLW\+RVSLWDO63WH/WG
FR18+7LVVXH5HSRVLWRU\
/RZHU.HQW5LGJH5RDG
0DLQ%XLOGLQJ/HYHO
6LQJDSRUH
3UHFLVLRQ$3$&#SUHFLVLRQIRUPHGLFLQHFRP


8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
$33(1',;9,&$5%23/$7,1'26(&$/&8/$7,21,16758&7,216

7KH&RFNFURIW*DXOWIRUPXODZLOOEHXVHGLQ15*2QFRORJ\WULDOV

'RVLQJRI&DUERSODWLQ
 7KHFDUERSODWLQGRVHZLOOEHFDOFXODWHGWRUHDFKDWDUJHWDUHDXQGHUWKHFXUYH$8&
DFFRUGLQJWRWKH&DOYHUWIRUPXODXVLQJFUHDWLQLQHFOHDUDQFHP/PLQIURPWKH&RFNFURIW
*DXOWIRUPXOD

 ,QSDWLHQWVZLWKDQDEQRUPDOO\ORZVHUXPFUHDWLQLQHOHVVWKDQPJGOWKHFUHDWLQLQH
FOHDUDQFHVKRXOGEHHVWLPDWHGXVLQJDPLQLPXPYDOXHRIPJG/

 7KHLQLWLDOGRVHRIFDUERSODWLQPXVWEHFDOFXODWHGXVLQJ*)5,QWKHDEVHQFHRIUHQDOWR[LFLW\
JUHDWHUWKDQRUHTXDOWR&7&$(*UDGHVHUXPFUHDWLQLQH![8/1RUWR[LFLW\UHTXLULQJ
GRVHPRGLILFDWLRQWKHGRVHRIFDUERSODWLQZLOOQRWQHHGWREHUHFDOFXODWHGIRUVXEVHTXHQW
F\FOHVEXWZLOOEHVXEMHFWWRGRVHPRGLILFDWLRQIRUWR[LFLW\DVQRWHGLQWKHSURWRFRO

 &DUERSODWLQGRVHVDUHUHTXLUHGWREHUHFDOFXODWHGLIWKHSDWLHQWKDVDZHLJKWFKDQJHRIJUHDWHU
WKDQRUHTXDOWR3DWLHQWVDUHSHUPLWWHGWRKDYHFKHPRWKHUDS\GRVHVUHFDOFXODWHGIRU
ZHLJKWFKDQJHV

 $WWKHWLPHRIGRVHPRGLILFDWLRQLIWKHSDWLHQW¶VDJHKDGFKDQJHGWKHSDWLHQWKDVKDGD
ELUWKGD\WKHVLWHFDQXVHWKHFXUUHQWDJH

&$/9(57)2508/$
&DUERSODWLQGRVHPJ WDUJHW$8&[*)5>RUHVWLPDWHG&U&O@

127(WKH*)5XVHGLQWKH&DOYHUWIRUPXODVKRXOGQRWH[FHHGPOPLQ
0D[LPXPFDUERSODWLQGRVHPJ WDUJHW$8&PJPO[PLQ[POPLQ

7KHPD[LPXPDOORZHGGRVHVRIFDUERSODWLQDUH
$8& PJ
$8& PJ
$8& PJ

)RUWKHSXUSRVHVRIWKLVSURWRFROWKH*)5LVFRQVLGHUHGWREHHTXLYDOHQWWRWKHHVWLPDWHG
FUHDWLQLQHFOHDUDQFH7KHHVWLPDWHGFUHDWLQLQHFOHDUDQFHP/PLQLVFDOFXODWHGE\WKHPHWKRGRI
&RFNFURIW*DXOWXVLQJWKHIROORZLQJIRUPXOD

&UHDWLQLQH&OHDUDQFHP/PLQ >$JH\UV@[DFWXDOERG\:HLJKWNJ^[if
female`

[VHUXPFUHDWLQLQHPJGO

1RWHV
:HLJKWLQNLORJUDPVNJ
D%RG\0DVV,QGH[%0,VKRXOGEHFDOFXODWHGIRUHDFKSDWLHQW
8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW

15*/8

9HUVLRQ'DWH-XO\
E$FWXDOZHLJKWVKRXOGEHXVHGIRUHVWLPDWLRQRI*)5IRUSDWLHQWVZLWK%0,RIOHVVWKDQ
F$GMXVWHGZHLJKWVKRXOGEHXVHGIRUHVWLPDWLRQRI*)5IRUSDWLHQWVZLWK%0,RIJUHDWHU
WKDQRUHTXDOWR

G$GMXVWHGZHLJKWFDOFXODWLRQ
,GHDOZHLJKWNJ +HLJKWFP±[IHPDOHVRUIRUPHQ
$GMXVWHGZHLJKWNJ $FWXDOZHLJKW±,GHDOZHLJKW[,GHDOZHLJKW

$WWKHWLPHRIDGRVHPRGLILFDWLRQIRUWR[LFLW\
,IWKHFUHDWLQLQHDWWKHWLPHRIDGRVHPRGLILFDWLRQLVORZHUWKDQWKHFUHDWLQLQHXVHGWR
FDOFXODWHWKHSUHYLRXVGRVHXVHWKHSUHYLRXVKLJKHUFUHDWLQLQHLIWKHFUHDWLQLQHDWWKHWLPH
RIDGRVHPRGLILFDWLRQLVKLJKHUWKDQWKHFUHDWLQLQHXVHGWRFDOFXODWHWKHSUHYLRXVGRVHXVH
WKHFXUUHQWKLJKHUFUHDWLQLQH7KLVZLOOHQVXUHWKDWWKHSDWLHQWLVDFWXDOO\UHFHLYLQJDGRVH
UHGXFWLRQ



8VHRIWKLVGRFXPHQWLVJRYHUQHGE\WKHWHUPVRIXVHRQWKHILUVWSDJHRIWKLVGRFXPHQW