A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides Difficile Infection (CDI)
Phase: PHASE3
Conditions: Recurrent C. Difficile Infection
Sponsor: Finch Research and Development LLC.

Official Study Title:  A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, 
and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides 
difficile Infection (PRISM4)
NCT#:  NCT 05153499
Document:  Protocol
Document Date:  04 May 2022

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
&/,1,&$/ 75,$/ 35272&2/
3URWRFRO 7LWOH
$ 5DQGRPL]HG 'RXEOH%OLQG 3ODFHER&RQWUROOHG 3KDVH 
7ULDO RI WKH (IILFDF\ 6DIHW\ DQG 7ROHUDELOLW\ RI D 6LQJOH 2UDO
$GPLQLVWUDWLRQ RI &3 IRU WKH 3UHYHQWLRQ RI 5HFXUUHQW
&ORVWULGLRLGHV GLIILFLOH ,QIHFWLRQ 35,60
7ULDO 1XPEHU
),1&',
9HUVLRQ 1XPEHU

$PHQGPHQW

5HYLVHG )LQDO
1RW DSSOLFDEOH
9HUVLRQ 'DWH
 0D\ 
&21),'(17,$/,7< 67$7(0(17
7KH LQIRUPDWLRQ LQ WKLV GRFXPHQW FRQWDLQV WUDGH VHFUHWV DQG FRPPHUFLDO LQIRUPDWLRQ WKDW DUH
SULYLOHJHG RU FRQILGHQWLDO DQG PD\ QRW EH GLVFORVHG XQOHVV VXFK GLVFORVXUH LV UHTXLUHG E\
DSSOLFDEOH ODZV DQG UHJXODWLRQV ,Q DQ\ HYHQW SHUVRQV WR ZKRP WKH LQIRUPDWLRQ LV GLVFORVHG
PXVW EH LQIRUPHG WKDW WKH LQIRUPDWLRQ LV SULYLOHJHG RU FRQILGHQWLDO DQG PD\ QRW EH IXUWKHU
GLVFORVHG E\ WKHP 7KHVH UHVWULFWLRQV RQ GLVFORVXUH ZLOO DSSO\ HTXDOO\ WR DOO IXWXUH
LQIRUPDWLRQ VXSSOLHG WR \RX ZKLFK LV LQGLFDWHG DV SULYLOHJHG RU FRQILGHQWLDO

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
6<1236,6
1$0( 2) &203$1<
)LQFK 5HVHDUFK DQG 'HYHORSPHQW
,QGLYLGXDO 7ULDO 7DEOH
5HIHUULQJ WR 3DUW RI WKH
'RVVLHU
9ROXPH
3DJH
)25 1$7,21$/ $87+25,7<
86( 21/<
1$0( 2) ),1,6+(' 352'8&7
&3
1$0( 2) $&7,9( ,1*5(',(17
)XOO 6SHFWUXP 0LFURELRWD
&RPSOHWH &RQVRUWLD
7,7/( 2) 75,$/ $ 5DQGRPL]HG 'RXEOH%OLQG 3ODFHER&RQWUROOHG 3KDVH  7ULDO RI WKH (IILFDF\
6DIHW\ DQG 7ROHUDELOLW\ RI D 6LQJOH 2UDO $GPLQLVWUDWLRQ RI &3 IRU WKH 3UHYHQWLRQ RI 5HFXUUHQW
&ORVWULGLRLGHV GLIILFLOH ,QIHFWLRQ 35,60
3URWRFRO 1XPEHU ),1&',
,QGLFDWLRQ 5HFXUUHQW &ORVWULGLRLGHV GLIILFLOH LQIHFWLRQ &',
75,$/ &(17(56 $SSUR[LPDWHO\  WULDO VLWHV JOREDOO\
38%/,&$7,21 5()(5(1&( 1RW DSSOLFDEOH
678',(' 3(5,2' $SSUR[LPDWHO\ ZHHN
6FUHHQLQJ VLQJOHGRVH WUHDWPHQW DQG ZHHN
)ROORZXS LQ 3DUW $
)RU HOLJLEOH SDUWLFLSDQWV VLQJOHGRVH RSHQODEHO
WUHDWPHQW DQG ZHHN )ROORZXS LQ 3DUW %
3+$6( 2) '(9(/230(17 
2%-(&7,9(6
7KH RYHUDOO REMHFWLYHV RI WKLV 3KDVH  WULDO DUH
x
7R HYDOXDWH WKH HIILFDF\ RI &3 WUHDWPHQW UHODWLYH WR SODFHER LQ DGXOWV ZLWK SUHYLRXVO\ WUHDWHG
UHFXUUHQW &',
x
7R HYDOXDWH WKH VDIHW\ DQG WROHUDELOLW\ RI &3 WUHDWPHQW FRPSDUHG WR SODFHER LQ DGXOWV ZLWK
SUHYLRXVO\ WUHDWHG UHFXUUHQW &',
6HH 7ULDO 2EMHFWLYHV IRU IXOO GHILQLWLRQ
75,$/ '(6,*1
7KLV 3KDVH  WULDO ZLOO EH FRQGXFWHG LQ  SDUWV D UDQGRPL]HG GRXEOHEOLQG SODFHERFRQWUROOHG WULDO DUP
3DUW $ DQG DQ RSWLRQDO RSHQODEHO WUHDWPHQW DUP 3DUW % 7KH WULDO LV GHVLJQHG WR HYDOXDWH WKH HIILFDF\
VDIHW\ DQG WROHUDELOLW\ RI D VLQJOH RUDO DGPLQLVWUDWLRQ RI &3 IRU WKH SUHYHQWLRQ RI UHFXUUHQW &', LQ DGXOW
SDUWLFLSDQWV $IWHU FRPSOHWLQJ VWDQGDUGRIFDUH 62& &', DQWLELRWLFV IRU WKHLU PRVW UHFHQW &', UHFXUUHQFH
SDUWLFLSDQWV ZKR PHHW DOO HOLJLELOLW\ UHTXLUHPHQWV ZLOO EH UDQGRPL]HG LQ D  UDWLR WR UHFHLYH HLWKHU &3 RU
SODFHER 3DUW $ 3DUWLFLSDQWV ZLOO EH HYDOXDWHG IRU &', UHFXUUHQFH DQG VDIHW\ IROORZXS WKURXJK :HHN  WKH
SULPDU\ HQGSRLQW DV ZHOO DV WKURXJK :HHN 
3DUWLFLSDQWV ZKR H[SHULHQFH DQ RQWULDO FHQWUDO ODERUDWRU\SRVLWLYH & GLIILFLOHUHODWHG GLDUUKHD VHH ,QFOXVLRQ
&ULWHULD 3DUW % IRU IXOO GHILQLWLRQ WKURXJK :HHN  DUH HOLJLEOH IRU RSHQODEHO WUHDWPHQW 2/7 ZLWK &3
3DUW % 3DUWLFLSDQWV LQ 3DUW % ZLOO EH HYDOXDWHG IRU &', UHFXUUHQFH DQG VDIHW\ IROORZXS WKURXJK :HHN  DV
ZHOO DV WKURXJK :HHN 

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
$EEUHYLDWLRQV &',  &ORVWULGLRLGHV GLIILFLOH LQIHFWLRQ 62&  VWDQGDUGRIFDUH
180%(5 2) 3$57,&,3$176 3/$11(' $SSUR[LPDWHO\  SDUWLFLSDQWV
3$57,&,3$17 3238/$7,21 $1' (/,*,%,/,7< &5,7(5,$
3RSXODWLRQ
3DUW $
x
5HFXUUHQW &', GHILQHG DV
o
3DUWLFLSDQWV ZLWK D KLVWRU\ RI   HSLVRGHV RI &', ZLWK  HSLVRGHV RFFXUULQJ ZLWKLQ WKH
SUHYLRXV  PRQWKV LQFOXVLYH RI WKH FXUUHQW HSLVRGH 25
o
3DUWLFLSDQWV ZLWK D KLVWRU\ RI  HSLVRGHV RI &', RFFXUULQJ ZLWKLQ WKH SUHYLRXV  PRQWKV
LQFOXVLYH RI WKH FXUUHQW HSLVRGH PD\ EH HOLJLEOH LI  \HDUV RI DJH RU ROGHU
3DUW %
x
3DUWLFLSDQWV ZKR KDYH DQ RQWULDO FHQWUDO ODERUDWRU\SRVLWLYH & GLIILFLOHUHODWHG GLDUUKHD ZLWKLQ 
ZHHNV DIWHU UHFHLYLQJ &3 RU SODFHER LQ 3DUW $ RI WKH WULDO DQG FRQVHQW WR KDYLQJ RSHQODEHO
DGPLQLVWUDWLRQ RI &3
(OLJLELOLW\ &ULWHULD
,QFOXVLRQ &ULWHULD 3DUW $ 6FUHHQLQJ

3DUWLFLSDQW RU OHJDO UHSUHVHQWDWLYH YROXQWDULO\ DJUHHG WR SDUWLFLSDWH E\ VLJQLQJ DQG GDWLQJ WKH ZULWWHQ
LQIRUPHG FRQVHQW IRUP DIWHU WULDO KDV EHHQ IXOO\ H[SODLQHG

3DUWLFLSDQW  \HDUV RI DJH RU ROGHU

+LVWRU\ RI UHFXUUHQW &', GHILQHG DV

  HSLVRGHV RI &', ZLWK  HSLVRGHV RFFXUULQJ ZLWKLQ WKH SUHYLRXV  PRQWKV
LQFOXVLYH RI WKH FXUUHQW HSLVRGH 25

3DUWLFLSDQWV ZLWK D KLVWRU\ RI  HSLVRGHV RI &', RFFXUULQJ ZLWKLQ WKH SUHYLRXV 
PRQWKV LQFOXVLYH RI WKH FXUUHQW HSLVRGH PD\ EH HOLJLEOH LI  \HDUV RI DJH RU
ROGHU

)RU WKH 4XDOLI\LQJ &', HSLVRGH WKH IROORZLQJ FULWHULD  PXVW EH VDWLVILHG

+LVWRU\ RI GLDUUKHD !  XQIRUPHG VWRROV SHU GD\ IRU  RU PRUH FRQVHFXWLYH GD\V
WKDW LV FOLQLFDOO\ FRQVLVWHQW ZLWK &',
$1'

'RFXPHQWHG SRVLWLYH VWRRO WHVW E\ ORFDO ODERUDWRU\ IRU WR[LJHQLF & GLIILFLOH WR[LQ
HQ]\PH LPPXQRDVVD\ >(,$@ RU SRO\PHUDVH FKDLQ UHDFWLRQ >3&5@EDVHG WHVWLQJ IRU
WKH FXUUHQW &', HSLVRGH DQG ZLWKLQ  GD\V SULRU WR 5DQGRPL]DWLRQ

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
$1'

5HFHLYHG D FRXUVH RI 62& &', DQWLELRWLFV IRU WKH PRVW UHFHQW &', HSLVRGH IRU 
WR  GD\V ZLWK H[DFW GXUDWLRQ DQWLELRWLF W\SH DQG GRVH DW WKH GLVFUHWLRQ RI WKH
,QYHVWLJDWRU
$1'

'HPRQVWUDWHG DQ DGHTXDWH FOLQLFDO UHVSRQVH GHILQHG DV   XQIRUPHG VWRROV LQ
 KRXUV IRU  RU PRUH FRQVHFXWLYH GD\V GXULQJ 62& &', DQWLELRWLFV SULRU WR
5DQGRPL]DWLRQ
127( $// TXDOLI\LQJ &', HSLVRGHV UHTXLUH &/,1,&$/ DQG /$%25$725< &21),50$7,21 RI HOLJLELOLW\
E\ 0HGLFDO 0RQLWRU

)HPDOHV DVVLJQHG DW ELUWK PXVW IXOILOO DW OHDVW  RI WKH IROORZLQJ FULWHULD

3RVWPHQRSDXVDO GHILQHG DV DPHQRUUKHD t  \HDU RU

6XUJLFDOO\ VWHULOH K\VWHUHFWRP\ ELODWHUDO RRSKRUHFWRP\ RU WXEDO OLJDWLRQ RU

$EVWLQHQW RU ZLOOLQJ WR XVH DGHTXDWH FRQWUDFHSWLRQ IURP 6FUHHQLQJ WKURXJK WKH
:HHN  YLVLW SHU 6HFWLRQ 

0DOHV DVVLJQHG DW ELUWK PXVW IXOILOO WKH IROORZLQJ FULWHULD $EVWLQHQW RU ZLOOLQJ WR XVH DGHTXDWH
FRQWUDFHSWLRQ IURP 6FUHHQLQJ WKURXJK WKH :HHN  YLVLW SHU 6HFWLRQ 
([FOXVLRQ &ULWHULD 3DUW $ 6FUHHQLQJ

.QRZQ VWRRO VDPSOH WHVWLQJ SRVLWLYH IRU HQWHULF SDWKRJHQV HJ 6DOPRQHOOD 6KLJHOOD
GLDUUKRHDJHQLF ( FROL &DPS\OREDFWHU *LDUGLD ZLWKLQ  GD\V SULRU WR 6FUHHQLQJ

,QDELOLW\ WR LQJHVW FDSVXOHV HJ VHYHUH QDXVHD YRPLWLQJ JDVWURSDUHVLV JDVWULF RXWOHW REVWUXFWLRQ
G\VSKDJLD DQGRU KLVWRU\ RI FKURQLF DVSLUDWLRQ

$FWLYH RU VXVSHFWHG LOHXV WR[LF PHJDFRORQ RU ERZHO REVWUXFWLRQ

+LVWRULFDO RU FXUUHQW GLDJQRVLV RI LQIODPPDWRU\ ERZHO GLVHDVH HJ &URKQ¶V GLVHDVH XOFHUDWLYH
FROLWLV LQGHWHUPLQDWH FROLWLV RU PLFURVFRSLF FROLWLV

5HFHQW GLDJQRVLV   PRQWKV SULRU WR 6FUHHQLQJ RI GLDUUKHDSUHGRPLQDQW LUULWDEOH ERZHO V\QGURPH
SRVWLQIHFWLRQ RU QRW UHODWHG WR DQ HQWHULF LQIHFWLRQ 3DUWLFLSDQWV ZLWK GLDUUKHDSUHGRPLQDQW
LUULWDEOH ERZHO V\QGURPH  PRQWKV SULRU WR 6FUHHQLQJ PD\ EH UDQGRPL]HG IROORZLQJ FRQILUPDWLRQ
RI HOLJLELOLW\

&XUUHQW GLDJQRVLV RI FKURQLF GLDUUKHDO LOOQHVV ZLWK SUH&', EDVHOLQH GLDUUKHD 7KLV LQFOXGHV EXW LV
QRW OLPLWHG WR FHOLDF GLVHDVH ELOH VDOW GLDUUKHD FKURQLF SDQFUHDWLWLV DQG VKRUW JXW V\QGURPH

3DVW DGPLQLVWUDWLRQ RI EH]ORWR[XPDE =LQSODYD RU SDVW HQUROOPHQW LQ D & GLIILFLOH YDFFLQH WULDO
ZKHUH SDUWLFLSDQW UHFHLYHG DFWLYH LQYHVWLJDWLRQDO SURGXFW ,3 ZLWKLQ  PRQWKV SULRU WR
5DQGRPL]DWLRQ 3DUWLFLSDQWV EOLQGHG WR WUHDWPHQW DVVLJQPHQW RU ZLWK XQNQRZQ VWDWXV DUH H[FOXGHG
3DUWLFLSDQWV ZKR RQO\ UHFHLYHG SODFHER ZRXOG QRW EH H[FOXGHG

3DUWLFLSDWLRQ LQ 35,60 &', RU 35,60(;7 &3&',( ZKHUH SDUWLFLSDQW UHFHLYHG
DFWLYH ,3 RU UHFHLYHG &3 DW DQ\ WLPH LQ WKH SDVW 3DUWLFLSDQWV ZKR RQO\ UHFHLYHG SODFHER ZRXOG
QRW EH H[FOXGHG

)HFDO WUDQVSODQW RU RWKHU OLYH PLFURELRPH WKHUDSHXWLFV IRU DQ\ FRQGLWLRQ UHJDUGOHVV RI URXWH RI
DGPLQLVWUDWLRQ ZLWKLQ  PRQWKV SULRU WR 5DQGRPL]DWLRQ

,QLWLDWLRQ RI DQ\ V\VWHPLF FDQFHU WUHDWPHQW HJ FKHPRWKHUDS\ UDGLRWKHUDS\ ELRORJLF
LPPXQRWKHUDS\ RWKHUV IRU DFWLYH PDOLJQDQF\ WKDW LV SODQQHG  ZHHNV SULRU WR 5DQGRPL]DWLRQ RU
GXULQJ WKH  ZHHNV IROORZLQJ 5DQGRPL]DWLRQ 3DUWLFLSDQWV RQ PDLQWHQDQFH WUHDWPHQW IRU PDOLJQDQF\
PD\ EH UDQGRPL]HG IROORZLQJ FRQILUPDWLRQ RI HOLJLELOLW\ 127( 3DUWLFLSDQWV RQ KRUPRQH WKHUDS\
DORQH DUH HOLJLEOH

.QRZQ SULPDU\ RU VHFRQGDU\ LPPXQRGHILFLHQF\ LQFOXGLQJ EXW QRW OLPLWHG WR ,J$ GHILFLHQF\
FRPPRQ YDULDEOH LPPXQRGHILFLHQF\ VHYHUH FRPELQHG LPPXQRGHILFLHQF\ RU KXPDQ
LPPXQRGHILFLHQF\ YLUXVDFTXLUHG LPPXQH GHILFLHQF\ V\QGURPH

+LVWRU\ RI VROLG RUJDQ WUDQVSODQWDWLRQ RU VWHP FHOO WUDQVSODQW

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
7$%/( 2) &217(176
6<1236,6 
/,67 2) $%%5(9,$7,216 $1' '(),1,7,21 2) 7(506 
 
%$&.*5281' ,1)250$7,21  
 
,QYHVWLJDWLRQDO 3URGXFW  
 
%DFNJURXQG  
 
(SLGHPLRORJ\ 
 
3DWKRSK\VLRORJ\  
 
/DFN RI &RORQL]DWLRQ 5HVLVWDQFH 'XH WR /RZ 0LFURELRPH 'LYHUVLW\ 
 
,PSDLUHG &RQYHUVLRQ RI 3ULPDU\ WR 6HFRQGDU\ %LOH $FLGV  
 
&OLQLFDO )LQGLQJV  
 
&3 D 0LFURELRPH 7KHUDSHXWLF IRU 3UHYHQWLRQ RI 5HFXUUHQW &
GLIILFLOH ,QIHFWLRQ  
 
6XPPDU\ RI 7ULDO 'HVLJQ 
 
5DWLRQDOH IRU 7ULDO  
 
5DWLRQDOH IRU 8VH RI &3 IRU WKH 3UHYHQWLRQ RI 5HFXUUHQW &', 
 
'DWD 6XSSRUWLQJ WKH 8VH RI &3 IRU WKH 3UHYHQWLRQ RI 5HFXUUHQW &',  
 
5DWLRQDOH IRU 'RVH DQG $GPLQLVWUDWLRQ 
 
'RVH IRU WKLV &OLQLFDO 7ULDO 
 
5LVN%HQHILW $QDO\VLV 
 
7ULDO 3RSXODWLRQ  
 
75,$/ 2%-(&7,9(6 
 
3ULPDU\ (IILFDF\ 2EMHFWLYH (QGSRLQW DQG (VWLPDQG 
 
6HFRQGDU\ 2EMHFWLYHV 
 
75,$/ '(6,*1 
 
2YHUDOO 7ULDO 'HVLJQ  
 
$GMXGLFDWLRQ %RDUG  
 
7ULDO (QGSRLQWV  
 
5DQGRPL]DWLRQ DQG %OLQGLQJ  
 
5DQGRPL]DWLRQ$OORFDWLRQ 
 
,QYHVWLJDWLRQDO 3URGXFW %OLQGLQJ 
 
,QYHVWLJDWLRQDO 3URGXFW 8QEOLQGLQJ 
 
7ULDO 7UHDWPHQW 
 
,QYHVWLJDWLRQDO 3URGXFWV 
 
&3  
 
3ODFHER  
 
,QYHVWLJDWLRQDO 3URGXFW $GPLQLVWUDWLRQ  
 
,QYHVWLJDWLRQDO 3URGXFW 3DFNDJLQJ DQG /DEHOLQJ 
 
6WRUDJH RI ,QYHVWLJDWLRQDO 3URGXFW 
 
7ULDO 'XUDWLRQ  
 
'LVFRQWLQXDWLRQ &ULWHULD 
 
&ULWHULD IRU 7ULDO 7HUPLQDWLRQ  
 
3DUWLFLSDQW :LWKGUDZDO 
 
&ROOHFWLRQ RI 'DWD IURP :LWKGUDZQ 3DUWLFLSDQWV 

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
 
3UHJQDQF\ 
 
9LWDO 6LJQV +HLJKW DQG :HLJKW 
 
3K\VLFDO ([DPLQDWLRQV 
 
(OHFWURFDUGLRJUDPV 
 
&OLQLFDO 6DIHW\ /DERUDWRU\ (YDOXDWLRQV 
 
8QVFKHGXOHG 9LVLW 
 
8QVFKHGXOHG 9LVLW IRU 1HZ 'LDUUKHD (SLVRGH 
 
8QVFKHGXOHG 9LVLW IRU $GYHUVH (YHQWV 
 
67$7,67,&$/ 0(7+2'6 $1' '$7$ $1$/<6,6 
 
7ULDO (QGSRLQWV  
 
2YHUYLHZ RI 6WDWLVWLFDO $QDO\VLV  
 
$QDO\VLV 3RSXODWLRQV 
 
(IILFDF\ $QDO\VLV 
 
3ULPDU\ (QGSRLQW 
 
6HFRQGDU\ (QGSRLQWV 
 
6DIHW\ $QDO\VLV  
 
&OLQLFDO /DERUDWRU\ (YDOXDWLRQV  
 
$GYHUVH (YHQWV 
 
6XPPDULHV RI %DVHOLQH &KDUDFWHULVWLFV 'HPRJUDSKLFV DQG 2WKHU
$QDO\VHV  
 
%LRPDUNHU $QDO\VLV  
 
6XEJURXS $QDO\VHV DQG (IIHFW RI %DVHOLQH )DFWRUV  
 
,QWHULP $QDO\VLV 
 
+DQGOLQJ RI 0LVVLQJ 'DWD 
 
'HWHUPLQDWLRQ RI 6DPSOH 6L]H 
 
5HSRUWLQJ 'HYLDWLRQV  
 
 
 
75,$/ 0$1$*(0(17 $1' '$7$ &2//(&7,21 
 
&RQILGHQWLDOLW\ 5HJDUGLQJ 7ULDO 3DUWLFLSDQWV  
 
6RXUFH 'RFXPHQWV 
 
&DVH 5HSRUW )RUPV  
 
5HFRUGV 5HWHQWLRQ 
 
'DWD 0DQDJHPHQW 
 
'DWD 0DQDJHPHQW 5HVSRQVLELOLWLHV  
 
'DWD (UURUV 
 
'DWD &ROOHFWLRQ DQG 5HWULHYDO 
 
75,$/ 021,725,1* $8',7,1* $1' ,163(&7,1*  
 
5LVN%DVHG 4XDOLW\ 0DQDJHPHQW 
 
7ULDO 6LWH 7UDLQLQJ  
 
0RQLWRULQJ 3URFHGXUHV 
 
$XGLW DQG ,QVSHFWLRQ 
 
(7+,&$/ &216,'(5$7,216 
 
(WKLFV DQG *RRG &OLQLFDO 3UDFWLFH 
 
 
 
)XWXUH 8VH RI 6WRUHG 6SHFLPHQV 

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
/,67 2) $%%5(9,$7,216 $1' '(),1,7,21 2) 7(506
7HUP
'HILQLWLRQ
$%
$GMXGLFDWLRQ %RDUG
$(
$GYHUVH HYHQW
%0,
%RG\ PDVV LQGH[
&%&
&RPSOHWH EORRG FRXQW
&'$'
&ORVWULGLRLGHV GLIILFLOHDVVRFLDWHG GLDUUKHD
&',
&ORVWULGLRLGHV GLIILFLOH LQIHFWLRQ
&5$
&OLQLFDO UHVHDUFK DVVRFLDWH
&5)
&DVH UHSRUW IRUP
&7&$(
&RPPRQ 7HUPLQRORJ\ &ULWHULD IRU $GYHUVH (YHQWV
(&*
(OHFWURFDUGLRJUDP
('&
(OHFWURQLF GDWD FDSWXUH
(,$
(Q]\PH LPPXQRDVVD\
)'$
)RRG DQG 'UXJ $GPLQLVWUDWLRQ
)07
)HFDO PLFURELRWD WUDQVSODQWDWLRQ
*&3
*RRG &OLQLFDO 3UDFWLFH
K&*
+XPDQ FKRULRQLF JRQDGRWURSLQ
,$
,QWHULP DQDO\VLV
,&)
,QIRUPHG FRQVHQW IRUP
,&+
,QWHUQDWLRQDO &RXQFLO IRU +DUPRQL]DWLRQ
,(&
,QGHSHQGHQW HWKLFV FRPPLWWHH
,3
,QYHVWLJDWLRQDO SURGXFW
,5%
,QVWLWXWLRQDO UHYLHZ ERDUG
,57
,QWHUDFWLYH UHVSRQVH WHFKQRORJ\
,77
,QWHQW WR WUHDW
0HG'5$
0HGLFDO 'LFWLRQDU\ IRU 5HJXODWRU\ $FWLYLWLHV

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

%$&.*5281' ,1)250$7,21

,QYHVWLJDWLRQDO 3URGXFW
&3 LV DQ LQYHVWLJDWLRQDO RUDO PLFURELRPH GUXJ GHVLJQHG WR GHOLYHU D FRPSOHWH DQG
IXQFWLRQDO PLFURELRPH WR GXUDEO\ UHSDLU LQWHVWLQDO G\VELRVLV DQG UHVWRUH PLFURELRPH
GLYHUVLW\ ZKLFK LV NQRZQ WR EH GLVUXSWHG LQ SDUWLFLSDQWV ZLWK UHFXUUHQW &ORVWULGLRLGHV
GLIILFLOH LQIHFWLRQ &', DQG NH\ LQ WKH SDWKRJHQHVLV RI &', UHFXUUHQFH

%DFNJURXQG
&ORVWULGLRLGHV GLIILFLOH IRUPHUO\ &ORVWULGLXP GLIILFLOH & GLIILFLOH LV D WR[LQSURGXFLQJ
VSRUHIRUPLQJ EDFWHULXP WKDW FDXVHV VHYHUH DQG SHUVLVWHQW GLDUUKHD LQ LQIHFWHG LQGLYLGXDOV
& GLIILFLOH H[SUHVVHV WR[LQV WKDW OHDG WR LQIODPPDWLRQ RI WKH FRORQ VHYHUH GLDUUKHD DQG
DEGRPLQDO SDLQ DV ZHOO DV SRWHQWLDOO\ PRUH VHULRXV FOLQLFDO RXWFRPHV LQFOXGLQJ WR[LF
PHJDFRORQ SHUIRUDWLRQ RI WKH FRORQ DQG GHDWK &RPPRQO\ SDWLHQWV ZLWK &', H[SHULHQFH
UHFXUUHQW &', DIWHU FRPSOHWLQJ D FRXUVH RI VWDQGDUGRIFDUH 62& &', DQWLELRWLFV
0F'RQDOG HW DO  &OLQLFDOO\ UHFXUUHQW &', LV RIWHQ DVVRFLDWHG ZLWK PRUH VHYHUH
V\PSWRPV DQG PRUH IUHTXHQW FRPSOLFDWLRQV DQG VHULRXV FRPSOLFDWLRQV RI UHFXUUHQW &', KDYH
LQFUHDVHG VLJQLILFDQWO\ RYHU WKH SDVW GHFDGH &RKHQ HW DO  .KDQQD HW DO 
5HFXUUHQW &', RFFXUV ZKHQ  FRQGLWLRQV DUH PHW LQ DQ LQGLYLGXDO  WKH FDXVDWLYH
PLFURRUJDQLVP & GLIILFLOH LV SUHVHQW DQG  WKHUH LV DQ DEQRUPDO PLFURELRPH RU G\VELRVLV
$V 62& DQWLELRWLFV H[DFHUEDWH G\VELRVLV WKHUH LV DQ XUJHQW QHHG IRU WKHUDSHXWLFV WKDW DGGUHVV
LQWHVWLQDO G\VELRVLV ZKLFK XQGHUOLHV WKH SDWKRJHQHVLV RI &', UHFXUUHQFH &3 LV DQ
LQYHVWLJDWLRQDO RUDO PLFURELRPH GUXJ GHVLJQHG WR GHOLYHU D FRPSOHWH DQG IXQFWLRQDO
PLFURELRPH WR GXUDEO\ UHSDLU LQWHVWLQDO G\VELRVLV ZKLFK LV EHLQJ HYDOXDWHG IRU WKH SUHYHQWLRQ
RI UHFXUUHQW &', 7KH SURSRVHG XVH RI &3 LV IRU SUHYHQWLRQ RI UHFXUUHQW &', LQ
LQGLYLGXDOV ZLWK UHFXUUHQW &',

(SLGHPLRORJ\
&', LV WKH PRVW FRPPRQ KHDOWKFDUHDVVRFLDWHG LQIHFWLRQ DQG LW LV UHFRJQL]HG E\ WKH 8QLWHG
6WDWHV &HQWHUV IRU 'LVHDVH &RQWURO DV RQH WKH PRVW XUJHQW DQWLELRWLFUHVLVWDQW EDFWHULDO WKUHDWV
LQ WKH 8QLWHG 6WDWHV 5HFXUUHQW &', UHSUHVHQWV D PDMRU XQPHW PHGLFDO QHHG ,Q WKH 8QLWHG
6WDWHV 'HVDL DQG FROOHDJXHV HVWLPDWH JUHDWHU WKDQ  HSLVRGHV RI UHFXUUHQW &', LQ 
'HVDL HW DO  'XH WR IHZ HIIHFWLYH WUHDWPHQWV DQG DQ DEVHQFH RI WKHUDSHXWLFV WKDW
DGGUHVV WKH XQGHUO\LQJ G\VELRVLV XQGHUSLQQLQJ WKH SDWKRJHQHVLV RI UHFXUUHQW &', WKHUH KDV
EHHQ D ULVH LQ PXOWLSO\ UHFXUUHQW &', 0D DQG FROOHDJXHV UHSRUW WKH LQFLGHQFH RI PXOWLSO\
UHFXUUHQW &', KDV GUDPDWLFDOO\ LQFUHDVHG ZLWK DQ  LQFUHDVH LQ DQQXDO LQFLGHQFH
EHWZHHQ  DQG  0D HW DO  2YHUDOO UHFXUUHQW &', LV D PDMRU XQPHW PHGLFDO
QHHG

3DWKRSK\VLRORJ\
7KH XQGHUO\LQJ SDWKRSK\VLRORJ\ RI UHFXUUHQW &', LV GLVWLQFW 5HFXUUHQW &', LV GULYHQ E\
LQWHVWLQDO G\VELRVLV FKDUDFWHUL]HG E\  D ODFN RI FRORQL]DWLRQ UHVLVWDQFH FRQIHUUHG E\ WKH
SUHVHQFH RI D KHDOWK\ DQG GLYHUVH JXW PLFURELRPH DQG  WKH GHILFLHQF\ RI
PLFURELRPHGHULYHG VHFRQGDU\ ELOH DFLGV ZKLFK SUHYHQW WKH JHUPLQDWLRQ RI & GLIILFLOH
VSRUHV LQWR WR[LQSURGXFLQJ YHJHWDWLYH & GLIILFLOH

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

5DWLRQDOH IRU 7ULDO

5DWLRQDOH IRU 8VH RI &3 IRU WKH 3UHYHQWLRQ RI 5HFXUUHQW &',
&3 LV DQ LQYHVWLJDWLRQDO RUDO PLFURELRPH GUXJ GHVLJQHG WR GHOLYHU D FRPSOHWH DQG
IXQFWLRQDO PLFURELRPH WR GXUDEO\ UHSDLU LQWHVWLQDO G\VELRVLV &3 LQFUHDVHV PLFURELRPH
GLYHUVLW\ UHHVWDEOLVKLQJ FRORQL]DWLRQ UHVLVWDQFH DQG LQFUHDVLQJ WKH SURWHFWLYH
PLFURELRPHGHULYHG VHFRQGDU\ ELOH DFLGV DGGUHVVLQJ WKH XQGHUO\LQJ ELRORJ\ RI UHFXUUHQW
&', &3 HIILFDF\ LQ UHFXUUHQW &', KDV EHHQ GHPRQVWUDWHG LQ 3KDVH E DQG WKH ILUVW
DGHTXDWH DQG ZHOOFRQWUROOHG WULDO 35,60 VWXGLHV 35,60 LV WKH VHFRQG DGHTXDWH DQG
ZHOOFRQWUROOHG SLYRWDO WULDO LQ WKH GUXJ GHYHORSPHQW SURFHVV IRU &3 DQG ZLOO HYDOXDWH WKH
HIILFDF\ DQG VDIHW\ RI &3 LQ WKH SUHYHQWLRQ RI UHFXUUHQW &',

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

7ULDO 3RSXODWLRQ
3RSXODWLRQ
7KLV WULDO LV D SDUW WULDO ZKLFK ZLOO HQUROO DGXOW SDUWLFLSDQWV ZLWK UHFXUUHQW &', LQIHFWLRQ
3DUW $
x
3DUWLFLSDQWV ZLWK UHFXUUHQW &', GHILQHG DV
o
$ KLVWRU\ RI   HSLVRGHV RI &', ZLWK  HSLVRGHV RFFXUULQJ ZLWKLQ WKH
SUHYLRXV  PRQWKV LQFOXVLYH RI WKH FXUUHQW HSLVRGH 25
o
$ KLVWRU\ RI  HSLVRGHV RI &', RFFXUULQJ ZLWKLQ WKH SUHYLRXV  PRQWKV
LQFOXVLYH RI WKH FXUUHQW HSLVRGH PD\ EH HOLJLEOH LI  \HDUV RI DJH RU ROGHU
3DUW %
x
3DUWLFLSDQWV ZKR KDYH DQ RQWULDO FHQWUDO ODERUDWRU\SRVLWLYH & GLIILFLOHUHODWHG
GLDUUKHD ZLWKLQ  ZHHNV DIWHU UHFHLYLQJ &3 RU SODFHER LQ 3DUW $ RI WKH WULDO DQG
FRQVHQW WR KDYLQJ RSHQODEHO DGPLQLVWUDWLRQ RI &3

75,$/ 2%-(&7,9(6
7KH RYHUDOO REMHFWLYHV RI WKLV 3KDVH  WULDO DUH
x
7R HYDOXDWH WKH HIILFDF\ RI &3 WUHDWPHQW UHODWLYH WR SODFHER LQ DGXOWV ZLWK
SUHYLRXVO\ WUHDWHG UHFXUUHQW &',
x
7R HYDOXDWH WKH VDIHW\ DQG WROHUDELOLW\ RI &3 WUHDWPHQW FRPSDUHG WR SODFHER LQ
DGXOWV ZLWK SUHYLRXVO\ WUHDWHG UHFXUUHQW &',
)XOO GHWDLOV RI WKH WULDO REMHFWLYHV DUH GHVFULEHG EHORZ

3ULPDU\ (IILFDF\ 2EMHFWLYH (QGSRLQW DQG (VWLPDQG
3ULPDU\ 2EMHFWLYH
3ULPDU\ (QGSRLQW
7R HYDOXDWH WKH HIILFDF\ RI D VLQJOH RUDO GRVH
RI &3 FRPSDUHG WR SODFHER IROORZLQJ
62& &', DQWLELRWLFV LQ SUHYHQWLQJ &',
UHFXUUHQFH LQ SDUWLFLSDQWV ZLWK UHFXUUHQW &',
3URSRUWLRQ RI SDUWLFLSDQWV H[SHULHQFLQJ D &',
UHFXUUHQFH WKURXJK :HHN  EDVHG RQ
DGMXGLFDWLRQ
7KH SULPDU\ FOLQLFDO TXHVWLRQ RI LQWHUHVW LV
:KDW LV WKH GLIIHUHQFH LQ WKH SURSRUWLRQV RI SDUWLFLSDQWV H[SHULHQFLQJ &', UHFXUUHQFH WKURXJK
 ZHHNV DIWHU UDQGRPL]DWLRQ WR &3 YV SODFHER LQ SDUWLFLSDQWV ZLWK UHFXUUHQW &',
UHJDUGOHVV RI GLVFRQWLQXDWLRQ RI LQYHVWLJDWLRQDO LQWHUYHQWLRQ IRU DQ\ UHDVRQ RU FKDQJH LQ
EDFNJURXQG PHGLFDWLRQ GRVH DQG SURGXFW"
7KH HVWLPDQG LV GHVFULEHG E\ WKH IROORZLQJ DWWULEXWHV
x
3RSXODWLRQ
$GXOW SDUWLFLSDQWV ZLWK UHFXUUHQW &', ZKR KDYH FRPSOHWHG 62& &', DQWLELRWLFV IRU
WKHLU TXDOLI\LQJ HSLVRGH
x
(QGSRLQW

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
&', UHFXUUHQFH WKURXJK  ZHHNV SRVW UDQGRPL]DWLRQ
x
7UHDWPHQW FRQGLWLRQ
&3 RU SODFHER RQ 'D\  ZLWK  ZHHN IROORZXS IRU UHFXUUHQFH UHJDUGOHVV RI
GLVFRQWLQXDWLRQ RI LQYHVWLJDWLRQDO LQWHUYHQWLRQ IRU DQ\ UHDVRQ RU FKDQJH LQ
EDFNJURXQG PHGLFDWLRQ WUHDWPHQW SROLF\ VWUDWHJ\
x
5HPDLQLQJ LQWHUFXUUHQW HYHQWV
7KH LQWHUFXUUHQW HYHQWV ³LQWHUYHQWLRQ GLVFRQWLQXDWLRQ IRU DQ\ UHDVRQ´ DQG FKDQJH LQ
EDFNJURXQG PHGLFDWLRQ GRVH DQG SURGXFW´ DUH DGGUHVVHG E\ WKH WUHDWPHQW FRQGLWLRQ
RI LQWHUHVW DWWULEXWH
7KH IROORZLQJ LQWHUFXUUHQW HYHQWV ZLOO UHVXOW LQ DQ RXWFRPH RI UHFXUUHQFH IRU WKH SULPDU\
HIILFDF\ DQDO\VLV
x
,QLWLDWLRQ RI UHVFXH PHGLFDWLRQ IRU &', IHFDO PLFURELRWD WUDQVSODQWDWLRQ >)07@ RU
IXOO FRXUVH RI 62& DQWLELRWLFV SULRU WR  ZHHNV SRVW UDQGRPL]DWLRQ
x
2FFXUUHQFH RI & GLIILFLOHUHODWHG GLDUUKHD SULRU WR  ZHHNV LQ D SDUWLFLSDQW ZKR GRHV
QRW TXDOLI\ IRU 3DUW % RI WKH VWXG\ SHU FHQWUDO ODE WHVWLQJ DOJRULWKP DQG GLVFRQWLQXHV
WKH VWXG\ IRU DQ\ UHDVRQ
x
3DUWLFLSDQWV ZKR HQWHU LQWR 3DUW % RI WKH VWXG\ KRZHYHU WKH & GLIILFLOHUHODWHG
GLDUUKHD HSLVRGH LV DGMXGLFDWHG DV QR UHFXUUHQFH E\ WKH $%
x
3DUWLFLSDQWV ZKR GLH RU H[SHULHQFH DQRWKHU GHELOLWDWLQJ HYHQW SULRU WR  ZHHNV ZKLFK
SUHFOXGHV FRQWLQXHG SDUWLFLSDWLRQ LQ WKH VWXG\
x
3DUWLFLSDQWV ZKR ZLWKGUDZ FRQVHQW SULRU WR  ZHHNV DIWHU UDQGRPL]DWLRQ
x
3DUWLFLSDQWV ZKR DUH ORVW WR IROORZXS SULRU WR  ZHHNV DIWHU UDQGRPL]DWLRQ
7KHUH DUH QR RWKHU LQWHUFXUUHQW HYHQWV DQWLFLSDWHG DW WKLV WLPH
x
3RSXODWLRQOHYHO VXPPDU\
'LIIHUHQFH LQ WKH SURSRUWLRQ RI SDUWLFLSDQWV H[SHULHQFLQJ D &', UHFXUUHQFH WKURXJK
:HHN  DIWHU UDQGRPL]DWLRQ EHWZHHQ &3 DQG 3ODFHER

6HFRQGDU\ 2EMHFWLYHV
.H\ 6HFRQGDU\ 2EMHFWLYH
x
7R GHWHUPLQH LI WUHDWPHQW ZLWK D VLQJOH RUDO GRVH RI &3 IROORZLQJ 62& &',
DQWLELRWLFV LQ SDUWLFLSDQWV ZLWK UHFXUUHQW &', LQFUHDVHV PLFURELDO GLYHUVLW\ DW :HHN 
DV GHWHUPLQHG E\ 6 ULERVRPDO ULERQXFOHLF DFLG U51$ JHQH DPSOLFRQ VHTXHQFLQJ
FRPSDUHG WR SODFHER
2WKHU 6HFRQGDU\ 2EMHFWLYHV
x
7R GHWHUPLQH LI WUHDWPHQW ZLWK D VLQJOH RUDO GRVH RI &3 IROORZLQJ 62& &',
DQWLELRWLFV LQ SDUWLFLSDQWV ZLWK UHFXUUHQW &', GHFUHDVHV WKH SURSRUWLRQ RI SDUWLFLSDQWV
ZLWK &', UHFXUUHQFH WKURXJK  ZHHNV DV GHWHUPLQHG E\ WR[LQ HQ]\PH LPPXQRDVVD\
(,$UHODWHG GLDUUKHD DV FRPSDUHG WR SODFHER

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
7DEOH 
7UHDWPHQW 3ODQ

,QYHVWLJDWLRQDO 3URGXFW %OLQGLQJ
7KH ,3 EOLQG ZLOO EH PDLQWDLQHG WKURXJK :HHN  3DUWLFLSDQWV WKH 6SRQVRU ,QYHVWLJDWRUV DQG
DOO WULDO VLWH SHUVRQQHO LQYROYHG ZLWK WKH WULDO FDUU\LQJ RXW WULDO SURFHGXUHV HYDOXDWLQJ
SDUWLFLSDQWV HQWHULQJ WULDO GDWD DQGRU HYDOXDWLQJ WULDO GDWD ZLOO UHPDLQ EOLQGHG WR WUHDWPHQW
DOORFDWLRQV XQWLO DOO SDUWLFLSDQWV KDYH FRPSOHWHG WKH :HHN  DVVHVVPHQWV DQG WKH GDWDEDVH KDV
EHHQ ORFNHG IRU WKH DQDO\VLV DW :HHN  7KH ,QYHVWLJDWRUV WULDO VLWH SHUVRQQHO DQG
SDUWLFLSDQWV ZLOO UHPDLQ EOLQGHG XQWLO :HHN 
$FWLYH DQG SODFHER SURGXFW ZLOO EH LGHQWLFDO ZLWK WKH H[FHSWLRQ RI D XQLTXH LGHQWLILFDWLRQ
QXPEHU RQ WKH ERWWOH ODEHO

,QYHVWLJDWLRQDO 3URGXFW 8QEOLQGLQJ
3DUW $
3DUW $ RI WKH WULDO ZLOO EH SHUIRUPHG LQ D GRXEOHEOLQG PDQQHU $OO GUXJV ZLOO EH VXSSOLHG LQ
LGHQWLFDO SDFNDJHV DQG ,3 NLWV 7KH ,3 FDSVXOHV ZLOO EH LGHQWLFDO LQ FRORU VPHOO WDVWH DQG
DSSHDUDQFH WKHUHE\ PDLQWDLQLQJ GRXEOHEOLQG FRQGLWLRQV
(OLJLEOH SDUWLFLSDQWV ZLOO EH UDQGRPO\ DVVLJQHG WR WUHDWPHQW LQ D  UDWLR WR UHFHLYH HLWKHU
DFWLYH GUXJ &3 RU SODFHER 3DUWLFLSDQW ZLOO QRW EH DZDUH RI WKHLU WUHDWPHQW DOORFDWLRQ
DQG DOO WULDO VWDII LQYROYHG LQ HIILFDF\ DQG VDIHW\ DVVHVVPHQWV ZLOO EH EOLQGHG WR WUHDWPHQW
DVVLJQPHQWV XQWLO DIWHU GDWDEDVH ORFN DQG UHOHDVH RI XQEOLQGLQJ UDQGRPL]DWLRQ FRGHV
,Q FDVH RI D PHGLFDO HPHUJHQF\ WKH ,QYHVWLJDWRU KDV WKH VROH UHVSRQVLELOLW\ IRU GHWHUPLQLQJ LI
XQEOLQGLQJ RI D SDUWLFLSDQW¶V PHGLFDWLRQ DVVLJQPHQW LV ZDUUDQWHG 3DUWLFLSDQW VDIHW\ PXVW
DOZD\V EH WKH ILUVW FRQVLGHUDWLRQ LQ PDNLQJ VXFK D GHWHUPLQDWLRQ ,I WKH ,QYHVWLJDWRU GHFLGHV
WKDW XQEOLQGLQJ LV ZDUUDQWHG WKH ,QYHVWLJDWRU VKRXOG PDNH HYHU\ HIIRUW WR FRQWDFW WKH 6SRQVRU
SULRU WR XQEOLQGLQJ XQOHVV WKLV FRXOG GHOD\ HPHUJHQF\ LQWHUYHQWLRQ RI WKH SDUWLFLSDQW 7KH

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

3DUWLFLSDQW :LWKGUDZDO
$ WULDO SDUWLFLSDQW RU OHJDO JXDUGLDQ DFWLQJ RQ EHKDOI RI WKH SDUWLFLSDQW LV IUHH WR ZLWKGUDZ
FRQVHQW DQG GLVFRQWLQXH SDUWLFLSDWLRQ LQ WKH WULDO DW DQ\ WLPH ZLWKRXW SUHMXGLFH WR IXUWKHU
WUHDWPHQW DFFRUGLQJ WR VWDQGDUG FOLQLFDO SUDFWLFH $ SDUWLFLSDQW
V SDUWLFLSDWLRQ LQ WKH WULDO PD\
EH GLVFRQWLQXHG DW DQ\ WLPH DW WKH GLVFUHWLRQ RI WKH ,QYHVWLJDWRU RU 6SRQVRU LI IRU H[DPSOH
x
7KH SDUWLFLSDQW LV QRQFRPSOLDQW ZLWK WKH WULDO UHVSRQVLELOLWLHV
x
3DUWLFLSDQW ZLWKGUDZV FRQVHQW DQG UHIXVHV WR FRQWLQXH SURFHGXUHVDVVHVVPHQWV
x
7KH 6SRQVRU WHUPLQDWHV WKH WULDO
x
7KH ,QYHVWLJDWRU GHWHUPLQHV LW LV QR ORQJHU LQ WKH SDUWLFLSDQW¶V EHVW LQWHUHVW WR
SDUWLFLSDWH LQ WKH WULDO
x
$IWHU DW OHDVW  UHDVRQDEOH DWWHPSWV WR PDNH FRQWDFW LQFOXGLQJ ILQDO FRQWDFW YLD
FHUWLILHG PDLO WKH SDUWLFLSDQW LV ORVW WR IROORZXS
3DUWLFLSDQWV ZKR KDYH GLVFRQWLQXHG ,3 E\ UHFHLYLQJ D SDUWLDO GRVH DV DSSOLFDEOH DUH
HQFRXUDJHG WR UHPDLQ LQ WKH WULDO DQG WR FRQWLQXH WR FRPSOHWH WULDO DVVHVVPHQWV WR WKH H[WHQW
SRVVLEOH ,I D SDUWLFLSDQW RU WKH SDUWLFLSDQW¶V OHJDO JXDUGLDQ DFWLQJ RQ EHKDOI RI WKH
SDUWLFLSDQW GLVFRQWLQXHV SDUWLFLSDWLRQ LQ WKH WULDO RU WKH SDUWLFLSDQW LV GLVFRQWLQXHG E\ WKH
,QYHVWLJDWRU RU 6SRQVRU WKH (DUO\ 7HUPLQDWLRQ &DVH 5HSRUW )RUP &5) GHVFULELQJ WKH
UHDVRQ IRU GLVFRQWLQXDWLRQ PXVW EH FRPSOHWHG

&ROOHFWLRQ RI 'DWD IURP :LWKGUDZQ 3DUWLFLSDQWV
:KHQHYHU SRVVLEOH ,QYHVWLJDWRUV VKRXOG DWWHPSW WR REWDLQ LQIRUPDWLRQ DERXW SDUWLFLSDQWV LQ
WKH FDVH RI ZLWKGUDZDO IURP WKH WULDO 5HVXOWV RI DQ\ HYDOXDWLRQV DQG REVHUYDWLRQV WRJHWKHU
ZLWK D QDUUDWLYH GHVFULELQJ WKH UHDVRQV IRU ZLWKGUDZDO IURP WKH WULDO PXVW EH UHFRUGHG LQ
WKH VRXUFH GRFXPHQWV 7KH &5) PXVW GRFXPHQW WKH SULPDU\ UHDVRQ IRU ZLWKGUDZDO IURP WKH
WULDO
,I WKH UHDVRQ IRU ZLWKGUDZDO IURP WKH WULDO LV DQ $( DQGRU FOLQLFDOO\ VLJQLILFDQW DEQRUPDO
ODERUDWRU\ WHVW UHVXOW WKH ,QYHVWLJDWRU ZLOO FRQWLQXH WR PRQLWRU WKH HYHQW XQWLO WKH HYHQW KDV
UHVROYHG RU VWDELOL]HG XQWLO WKH SDUWLFLSDQW LV UHIHUUHG WR WKH FDUH RI D KHDOWK FDUH SURIHVVLRQDO
RU XQWLO D GHWHUPLQDWLRQ RI D FDXVH XQUHODWHG WR WKH ,3 RU WULDO SURFHGXUH LV PDGH 7KH VSHFLILF
HYHQW RU WHVW UHVXOW LQFOXGLQJ UHSHDWHG WHVW UHVXOWV DV DSSOLFDEOH PXVW EH UHFRUGHG ERWK RQ
WKH VRXUFH GRFXPHQWDWLRQ DQG LQ WKH &5) ERWK WKH $( SDJH DQG WKH UHOHYDQW SDJH RI WKH
&5) ZLOO EH FRPSOHWHG DW WKDW WLPH $V VRRQ DV SRVVLEOH WKH ,QYHVWLJDWRU PXVW LQIRUP WKH
6SRQVRU DERXW HDFK SDUWLFLSDQW ZKR LV EHLQJ FRQVLGHUHG IRU ZLWKGUDZDO GXH WR $(V
$GGLWLRQDO UHSRUWV PXVW EH SURYLGHG ZKHQ UHTXHVWHG
,I D SDUWLFLSDQW LV ZLWKGUDZQ IURP WKH WULDO IRU PXOWLSOH UHDVRQV WKDW LQFOXGH $(V WKH UHOHYDQW
SDJH RI WKH &5) VKRXOG LQGLFDWH WKH ZLWKGUDZDO ZDV UHODWHG WR DQ $(
,Q WKH FDVH RI SDUWLFLSDQWV ORVW WR IROORZXS DWWHPSWV WR FRQWDFW WKH SDUWLFLSDQW PXVW EH PDGH
DQG GRFXPHQWHG LQ WKH SDUWLFLSDQW¶V PHGLFDO UHFRUGV
$Q HDUO\ WHUPLQDWLRQ YLVLW VKRXOG EH FRQGXFWHG IRU DOO SDUWLFLSDQWV ZKR ZHUH UDQGRPL]HG EXW
GR QRW FRPSOHWH WKH WULDO DFFRUGLQJ WR WKH WULDO SURWRFRO

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

3DUWLFLSDQW 5HSODFHPHQW
7KHUH LV QR SURYLVLRQ IRU UHSODFLQJ SDUWLFLSDQWV

3DUWLFLSDQW )ROORZ8S
)ROORZXS ZLWKLQ  ZHHNV IURP WKH GDWH RI ZLWKGUDZDO ZLOO EH FRQGXFWHG IRU DOO SDUWLFLSDQWV
ZKR UHFHLYH WKH ,3 EXW GR QRW FRPSOHWH WKH WULDO DFFRUGLQJ WR WKH WULDO SURWRFRO

7ULDO 0DWHULDO $FFRXQWDELOLW\
7KH ,QYHVWLJDWRU ZLOO HQVXUH WKDW DGHTXDWH UHFRUGV VKRZLQJ WKH UHFHLSW GLVSHQVLQJ UHWXUQ RU
RWKHU GLVSRVLWLRQ RI WKH ,3 LQFOXGLQJ WKH GDWH TXDQWLW\ EDWFK RU FRGH QXPEHU DQG
LGHQWLILFDWLRQ RI WULDO SDUWLFLSDQWV ZKR UHFHLYH WKH ,3 DUH PDLQWDLQHG 7KH ,QYHVWLJDWRU ZLOO QRW
VXSSO\ WKH ,3 WR DQ\ SHUVRQ H[FHSW 6XE,QYHVWLJDWRUV DV VXEPLWWHG WR WKH ORFDO UHJXODWRU\
DXWKRULW\ GHVLJQDWHG VWDII DQG SDUWLFLSDQWV LQ WKLV WULDO 7KH ,QYHVWLJDWRU ZLOO QRW GLVSHQVH
WKH ,3 IURP DQ\ VLWHV RWKHU WKDQ WKRVH VXEPLWWHG WR WKH ORFDO UHJXODWRU\ DXWKRULW\ 7KH ,3 ZLOO
QRW EH UHODEHOHG RU UHDVVLJQHG IRU XVH E\ RWKHU SDUWLFLSDQWV
(DFK ,3 VKLSPHQW ZLOO LQFOXGH D SDFNLQJ VOLS OLVWLQJ WKH FRQWHQWV RI WKH VKLSPHQW UHWXUQ
LQVWUXFWLRQV DQG DQ\ DSSOLFDEOH IRUPV
7KH ,QYHVWLJDWRU LV UHVSRQVLEOH IRU HQVXULQJ GHOLYHULHV RI WKH ,3 DQG RWKHU WULDO PDWHULDOV IURP
WKH 6SRQVRU DUH FRUUHFWO\ UHFHLYHG UHFRUGHG KDQGOHG DQG VWRUHG VDIHO\ DQG SURSHUO\ LQ
DFFRUGDQFH ZLWK DSSOLFDEOH UHJXODWRU\ UHTXLUHPHQW DQG XVHG LQ DFFRUGDQFH ZLWK WKLV
SURWRFRO
2QO\ SDUWLFLSDQWV HQUROOHG LQ WKH WULDO PD\ UHFHLYH WKH ,3 DQG RQO\ DXWKRUL]HG VWDII DW WKH
LQYHVWLJDWLRQDO FHQWHU PD\ VXSSO\ RU DGPLQLVWHU WKH ,3 ZKLFK PXVW EH VWRUHG LQ D VHFXUH
HQYLURQPHQWDOO\ FRQWUROOHG DQG PRQLWRUHG PDQXDO RU DXWRPDWHG DUHD LQ DFFRUGDQFH ZLWK
WKH ODEHOHG VWRUDJH FRQGLWLRQV RU DSSURSULDWH LQVWUXFWLRQV ZLWK DFFHVV OLPLWHG WR WKH
,QYHVWLJDWRU DQG DXWKRUL]HG VWDII DW WKH LQYHVWLJDWLRQDO FHQWHU
$ UHFRUG RI ,3 DFFRXQWDELOLW\ LH ,3 DQG RWKHU WULDO PDWHULDOV UHFHLYHG XVHG UHWDLQHG
UHWXUQHG RU GHVWUR\HG PXVW EH SUHSDUHG DQG VLJQHG E\ WKH SULQFLSDO ,QYHVWLJDWRU RU GHVLJQHH
ZLWK DQ DFFRXQW JLYHQ IRU DQ\ GLVFUHSDQFLHV 8SRQ FRPSOHWLRQ RI WKH WULDO XQXVHG ,3 ZLOO EH
UHWXUQHG WR WKH 6SRQVRU¶V GHVLJQHH RU GHVWUR\HG ORFDOO\ SHU WKH 3KDUPDF\ 0DQXDO

6(/(&7,21 $1' :,7+'5$:$/ 2) 3$57,&,3$176
7KH WULDO ZLOO LQFOXGH DSSUR[LPDWHO\  SDUWLFLSDQWV IURP DSSUR[LPDWHO\  FHQWHUV
,QFOXVLRQ &ULWHULD 3DUW $ 6FUHHQLQJ
 3DUWLFLSDQW RU OHJDO UHSUHVHQWDWLYH YROXQWDULO\ DJUHHG WR SDUWLFLSDWH E\ VLJQLQJ DQG
GDWLQJ WKH ZULWWHQ LQIRUPHG FRQVHQW IRUP DIWHU WULDO KDV EHHQ IXOO\ H[SODLQHG
 3DUWLFLSDQW  \HDUV RI DJH RU ROGHU
 +LVWRU\ RI UHFXUUHQW &', GHILQHG DV

  HSLVRGHV RI &', ZLWK  HSLVRGHV RFFXUULQJ ZLWKLQ WKH SUHYLRXV
 PRQWKV LQFOXVLYH RI WKH FXUUHQW HSLVRGH 25

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

3DUWLFLSDQWV ZLWK D KLVWRU\ RI  HSLVRGHV RI &', RFFXUULQJ ZLWKLQ WKH
SUHYLRXV  PRQWKV LQFOXVLYH RI WKH FXUUHQW HSLVRGH PD\ EH HOLJLEOH LI
 \HDUV RI DJH RU ROGHU
 )RU WKH TXDOLI\LQJ &', HSLVRGH WKH IROORZLQJ FULWHULD  PXVW EH VDWLVILHG

+LVWRU\ RI GLDUUKHD !  XQIRUPHG VWRROV SHU GD\ IRU  RU PRUH
FRQVHFXWLYH GD\V WKDW LV FOLQLFDOO\ FRQVLVWHQW ZLWK &',
$1'

'RFXPHQWHG SRVLWLYH VWRRO WHVW E\ ORFDO ODERUDWRU\ IRU WR[LJHQLF
& GLIILFLOH WR[LQ (,$ RU SRO\PHUDVH FKDLQ UHDFWLRQ >3&5@EDVHG
WHVWLQJ IRU WKH FXUUHQW &', HSLVRGH DQG ZLWKLQ  GD\V SULRU WR
5DQGRPL]DWLRQ
$1'

5HFHLYHG D FRXUVH RI 62& &', DQWLELRWLFV IRU WKH PRVW UHFHQW &',
HSLVRGH IRU  WR  GD\V ZLWK H[DFW GXUDWLRQ DQWLELRWLF W\SH DQG
GRVH DW WKH GLVFUHWLRQ RI WKH ,QYHVWLJDWRU
$1'

'HPRQVWUDWHG DQ DGHTXDWH FOLQLFDO UHVSRQVH GHILQHG DV   XQIRUPHG
VWRROV LQ  KRXUV IRU  RU PRUH FRQVHFXWLYH GD\V GXULQJ 62& &',
DQWLELRWLFV SULRU WR 5DQGRPL]DWLRQ
127( $// 4XDOLI\LQJ &', HSLVRGH UHTXLUHV &/,1,&$/ DQG /$%25$725<
&21),50$7,21 RI HOLJLELOLW\ E\ 0HGLFDO 0RQLWRU
 )HPDOHV DVVLJQHG DW ELUWK PXVW IXOILOO DW OHDVW  RI WKH IROORZLQJ FULWHULD

3RVWPHQRSDXVDO GHILQHG DV DPHQRUUKHD   \HDU RU

6XUJLFDOO\ VWHULOH K\VWHUHFWRP\ ELODWHUDO RRSKRUHFWRP\ RU WXEDO
OLJDWLRQ RU

$EVWLQHQW RU ZLOOLQJ WR XVH DGHTXDWH FRQWUDFHSWLRQ IURP 6FUHHQLQJ
WKURXJK WKH :HHN  YLVLW SHU 6HFWLRQ 
 0DOHV DV DVVLJQHG DW ELUWK PXVW IXOILOO WKH IROORZLQJ FULWHULD $EVWLQHQW RU ZLOOLQJ WR
XVH DGHTXDWH FRQWUDFHSWLRQ IURP 6FUHHQLQJ WKURXJK WKH :HHN  YLVLW SHU
6HFWLRQ 
([FOXVLRQ &ULWHULD 3DUW $ 6FUHHQLQJ
 .QRZQ VWRRO VDPSOHV WHVWLQJ SRVLWLYH IRU HQWHULF SDWKRJHQV HJ 6DOPRQHOOD
6KLJHOOD GLDUUKRHDJHQLF ( FROL &DPS\OREDFWHU *LDUGLD ZLWKLQ  GD\V SULRU WR
6FUHHQLQJ
 ,QDELOLW\ WR LQJHVW FDSVXOHV HJ VHYHUH QDXVHD YRPLWLQJ JDVWURSDUHVLV JDVWULF RXWOHW
REVWUXFWLRQ G\VSKDJLD DQGRU KLVWRU\ RI FKURQLF DVSLUDWLRQ
 $FWLYH RU VXVSHFWHG LOHXV WR[LF PHJDFRORQ RU ERZHO REVWUXFWLRQ
 +LVWRULFDO RU FXUUHQW GLDJQRVLV RI LQIODPPDWRU\ ERZHO GLVHDVH HJ &URKQ¶V GLVHDVH
XOFHUDWLYH FROLWLV LQGHWHUPLQDWH FROLWLV RU PLFURVFRSLF FROLWLV
 5HFHQW GLDJQRVLV   PRQWKV SULRU WR 6FUHHQLQJ RI GLDUUKHDSUHGRPLQDQW LUULWDEOH
ERZHO V\QGURPH SRVWLQIHFWLRQ RU QRW UHODWHG WR DQ HQWHULF LQIHFWLRQ 3DUWLFLSDQWV
ZLWK GLDUUKHDSUHGRPLQDQW LUULWDEOH ERZHO V\QGURPH   PRQWKV SULRU WR 6FUHHQLQJ
PD\ EH UDQGRPL]HG IROORZLQJ FRQILUPDWLRQ RI HOLJLELOLW\

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
 &XUUHQW GLDJQRVLV RI FKURQLF GLDUUKHDO LOOQHVV ZLWK SUH&', EDVHOLQH GLDUUKHD 7KLV
LQFOXGHV EXW LV QRW OLPLWHG WR FHOLDF GLVHDVH ELOH VDOW GLDUUKHD FKURQLF SDQFUHDWLWLV
DQG VKRUW JXW V\QGURPH
 3DVW DGPLQLVWUDWLRQ RI EH]ORWR[XPDE =LQSODYD RU SDVW HQUROOPHQW LQ D & GLIILFLOH
YDFFLQH WULDO ZKHUH SDUWLFLSDQW UHFHLYHG DFWLYH LQYHVWLJDWLRQDO SURGXFW ,3 ZLWKLQ
 PRQWKV SULRU WR 5DQGRPL]DWLRQ 3DUWLFLSDQWV EOLQGHG WR WUHDWPHQW DVVLJQPHQW RU
ZLWK XQNQRZQ VWDWXV DUH H[FOXGHG 3DUWLFLSDQWV ZKR RQO\ UHFHLYHG SODFHER ZRXOG QRW
EH H[FOXGHG
 3DUWLFLSDWLRQ LQ 35,60 &', RU 35,60(;7 &3&',( ZKHUH
SDUWLFLSDQW UHFHLYHG DFWLYH ,3 RU UHFHLYHG &3 DW DQ\ WLPH LQ WKH SDVW 3DUWLFLSDQWV
ZKR RQO\ UHFHLYHG SODFHER ZRXOG QRW EH H[FOXGHG
 )HFDO WUDQVSODQW RU RWKHU OLYH PLFURELRPH WKHUDSHXWLFV IRU DQ\ FRQGLWLRQ UHJDUGOHVV RI
URXWH RI DGPLQLVWUDWLRQ ZLWKLQ  PRQWKV SULRU WR 5DQGRPL]DWLRQ
 ,QLWLDWLRQ RI DQ\ V\VWHPLF FDQFHU WUHDWPHQW HJ FKHPRWKHUDS\ UDGLRWKHUDS\
ELRORJLF LPPXQRWKHUDS\ RWKHUV IRU DFWLYH PDOLJQDQF\ WKDW LV SODQQHG  ZHHNV SULRU
WR 5DQGRPL]DWLRQ RU GXULQJ WKH  ZHHNV IROORZLQJ 5DQGRPL]DWLRQ 3DUWLFLSDQWV RQ
PDLQWHQDQFH WUHDWPHQW IRU PDOLJQDQF\ PD\ EH UDQGRPL]HG IROORZLQJ FRQILUPDWLRQ RI
HOLJLELOLW\ 127( 3DUWLFLSDQWV RQ KRUPRQH WKHUDS\ DORQH DUH HOLJLEOH
 .QRZQ SULPDU\ RU VHFRQGDU\ LPPXQRGHILFLHQF\ LQFOXGLQJ EXW QRW OLPLWHG WR ,J$
GHILFLHQF\ FRPPRQ YDULDEOH LPPXQRGHILFLHQF\ VHYHUH FRPELQHG
LPPXQRGHILFLHQF\ RU KXPDQ LPPXQRGHILFLHQF\ YLUXVDFTXLUHG LPPXQH GHILFLHQF\
V\QGURPH
 +LVWRU\ RI VROLG RUJDQ WUDQVSODQWDWLRQ RU VWHP FHOO WUDQVSODQW
 ,QLWLDWLRQ RU GRVH HVFDODWLRQ RI V\VWHPLF LPPXQRVXSSUHVVLYH DJHQWV DW WKH GLVFUHWLRQ
RI WKH ,QYHVWLJDWRU IRU DQ\ FRQGLWLRQ GXULQJ WKH  ZHHNV SULRU WR 5DQGRPL]DWLRQ RU
SODQQHG GXULQJ WKH  ZHHNV IROORZLQJ 5DQGRPL]DWLRQ ([DPSOHV PD\ LQFOXGH EXW DUH
QRW OLPLWHG WR FRUWLFRVWHURLG DJHQWV JLYHQ RUDOO\ RU LQWUDYHQRXVO\ F\FORVSRULQH
WDFUROLPXV RU WXPRU QHFURVLV IDFWRU LQKLELWRUV 3DUWLFLSDQWV RQ VWDEOH ORZ GRVH RI
V\VWHPLF LPPXQRVXSSUHVVLYH DJHQWV RU VKRUW FRXUVHV   ZHHNV PD\ EH UDQGRPL]HG
IROORZLQJ FRQILUPDWLRQ RI HOLJLELOLW\
 0DMRU LQWUDDEGRPLQDO VXUJHU\ HJ ERZHO UHVHFWLRQ ZLWKLQ WKH SDVW  GD\V SULRU WR
6FUHHQLQJ H[FOXGLQJ DSSHQGHFWRP\ RU FKROHF\VWHFWRP\ DQGRU SODQQHG LQYDVLYH
VXUJHU\KRVSLWDOL]DWLRQ GXULQJ WKH WULDO
 +LVWRU\ RI WRWDO FROHFWRP\ RU LOHRVWRP\
 8VH RI D V\VWHPLF DQWLELRWLF IRU DQ\ FRQGLWLRQ RWKHU WKDQ &', GXULQJ WKH 6FUHHQLQJ
SHULRG RU DQ\ DQWLFLSDWHG XVH RI D V\VWHPLF DQWLELRWLF IRU DQ\ FRQGLWLRQ RWKHU WKDQ
&', GXULQJ WKH WULDO IRU  ZHHNV DIWHU 5DQGRPL]DWLRQ 7KLV LQFOXGHV SDUWLFLSDQWV ZKR
KDYH D NQRZQ PHGLFDO SURFHGXUH WKDW UHTXLUHV DQWLELRWLF SURSK\OD[LV HJ HOHFWLYH
VXUJLFDO SURFHGXUH RU GHQWDO SURFHGXUH UHTXLULQJ SURSK\ODFWLF DQWLELRWLFV VFKHGXOHG
GXULQJ WKH WULDO
 $FWLYH GUXJ FKHPLFDO RU DOFRKRO GHSHQGHQF\ DV GHWHUPLQHG E\ WKH ,QYHVWLJDWRU
WKURXJK KLVWRU\ RU RSWLRQDO WR[LFRORJ\ VFUHHQ

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
)LJXUH 
$VVHVVPHQW RI ,QFOXVLRQ &ULWHULD
$EEUHYLDWLRQV &',  &ORVWULGLRLGHV GLIILFLOH LQIHFWLRQ (,$ HQ]\PH LPPXQRDVVD\ 3&5 SRO\PHUDVH FKDLQ
UHDFWLRQ

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
7KH ,QYHVWLJDWRU ZLOO FKHFN WKDW DOO LQFOXVLRQH[FOXVLRQ FULWHULD KDYH EHHQ GRFXPHQWHG
FRPSOHWHO\ DQG WKH WULDO 0HGLFDO 0RQLWRU ZLOO EH UHTXLUHG WR FRQILUP ILQDO HOLJLELOLW\ IRU
3DUW % 6FUHHQLQJ IRU 3DUW % 6HFWLRQ  PD\ EH FRPELQHG ZLWK WKH UHOHYDQW VFKHGXOHG RU
XQVFKHGXOHG YLVLW GXULQJ 3DUW $ LI IHDVLEOH

3DUW % ,QFOXVLRQ &ULWHULD 6FUHHQLQJ
7KH IROORZLQJ FULWHULD PXVW EH VDWLVILHG IRU HQWU\ LQWR 3DUW % RI WKH WULDO
,QFOXVLRQ &ULWHULD 3DUW % RI WKH WULDO

3UHYLRXVO\ HQUROOHG LQ 3DUW $ 3DUWLFLSDQWV ZKR KDYH DQ RQWULDO FHQWUDO
ODERUDWRU\SRVLWLYH & GLIILFLOHUHODWHG GLDUUKHD ZLWKLQ  ZHHNV DIWHU UHFHLYLQJ &3
RU SODFHER LQ 3DUW $ GHILQHG DV
D 'LDUUKHD !  XQIRUPHG VWRROV LQ  KRXUV IRU  RU PRUH FRQVHFXWLYH GD\V RU
GLDUUKHD WKDW GRHV QRW PHHW WKH GHILQLWLRQ EXW WKH ,QYHVWLJDWRU KDV D VWURQJ FOLQLFDO
VXVSLFLRQ RI & GLIILFLOHUHODWHG GLDUUKHD DQG 0HGLFDO 0RQLWRU KDV FRQILUPHG SHU
VWXG\ )LJXUH 
$1'
E $ VWRRO VSHFLPHQ WHVWLQJ SRVLWLYH IRU & GLIILFLOH E\ FHQWUDO ODERUDWRU\ WHVWLQJ
DOJRULWKP RU ORFDO ODERUDWRU\SRVLWLYH XQGHU H[WHQXDWLQJ FLUFXPVWDQFHV VXFK DV
FHQWUDO ODE FORVXUH
$1'
F 3DUWLFLSDQW KDV UHFHLYHG D FRXUVH RI 62& &', DQWLELRWLFV IRU WKH PRVW UHFHQW &',
HYHQW IRU  WR  GD\V ZLWK H[DFW GXUDWLRQ DQWLELRWLF W\SH DQG GRVH DW WKH
GLVFUHWLRQ RI WKH ,QYHVWLJDWRU
$1'
G 3DUWLFLSDQW KDV KDG DQ DGHTXDWH FOLQLFDO UHVSRQVH GHILQHG DV   XQIRUPHG VWRROV
LQ  KRXUV IRU  RU PRUH FRQVHFXWLYH GD\V GXULQJ 62& &', DQWLELRWLFV SULRU WR ,3
DGPLQLVWUDWLRQ
127( &RQILUPDWLRQ RI HOLJLELOLW\ E\ 0HGLFDO 0RQLWRU LV UHTXLUHG EHIRUH HQWU\ LQWR 3DUW %
([FOXVLRQ &ULWHULD 3DUW % 6FUHHQLQJ

1HZ RQVHW RI DQ\ DFXWH FKURQLF RU XQVWDEOH PHGLFDO FRPRUELGLW\ SV\FKLDWULF VRFLDO
RU RWKHU FLUFXPVWDQFHV WKDW LQ WKH RSLQLRQ RI WKH ,QYHVWLJDWRU PD\ LQWHUIHUH ZLWK WULDO
FRPSOLDQFH FRPSOHWLRQ RU DFFXUDWH DVVHVVPHQW RI WULDO RXWFRPHVVDIHW\ ([DPSOHV
LQFOXGH EXW QRW OLPLWHG WR DFXWH P\RFDUGLDO LQIDUFWLRQ DFXWH VWURNH XQFRPSHQVDWHG
FRQJHVWLYH KHDUW IDLOXUH DQG GHFRPSHQVDWHG OLYHU GLVHDVH

3UHJQDQW EUHDVWIHHGLQJ RU SODQQLQJ WR EHFRPH SUHJQDQW GXULQJ WKH WULDO

6FUHHQLQJ QDVDO 3&5 WHVW LV SRVLWLYH IRU VHYHUH DFXWH UHVSLUDWRU\ V\QGURPH
FRURQDYLUXV  6$56&R9 DQG SDUWLFLSDQW H[KLELWV V\PSWRPV WKDW LQ WKH RSLQLRQ

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
)RU HDFK QHZ HSLVRGH RI GLDUUKHD !  XQIRUPHG VWRROV LQ  KRXUV IRU  FRQVHFXWLYH
GD\V GXULQJ WKH WULDO SHULRG D VWRRO VDPSOH IRU FHQWUDO ODERUDWRU\ WHVWLQJ PXVW EH
FROOHFWHG
$Q 8QVFKHGXOHG 9LVLW VKRXOG EH FRQGXFWHG ZLWK WKH SDUWLFLSDQW LI WKHUH LV D SRVLWLYH
ODERUDWRU\ VWRRO WHVW )LJXUH  $ FHQWUDO ODERUDWRU\ WHVW LV D UHTXLUHPHQW IRU WKLV WULDO DQG
VKRXOG QRW EH UHSODFHG ZLWK D ORFDO ODERUDWRU\ WHVW XQOHVV XQGHU H[WHQXDWLQJ
FLUFXPVWDQFHV HJ FHQWUDO ODERUDWRU\ LV FORVHG GXH WR SDQGHPLF 7KLV VDPSOH VKRXOG EH
FROOHFWHG EHIRUH 62& &', DQWLELRWLFV DUH FRPPHQFHG
 ,QYHVWLJDWRU HYDOXDWLRQ 7KH RQVHW RI D QHZ HSLVRGH RI GLDUUKHD ZLOO WULJJHU DQ
,QYHVWLJDWRU HYDOXDWLRQ IRU &', ,QYHVWLJDWRU HYDOXDWLRQ ZLOO LQFOXGH D UHYLHZ RI GLDUUKHD
GDWD !  XQIRUPHG VWRROV LQ  KRXUV IRU  RU PRUH FRQVHFXWLYH GD\V E DVVHVVPHQW RI
VWRRO & GLIILFLOH WHVWLQJ E\ FHQWUDO ODERUDWRU\ WHVWLQJ DOJRULWKP )LJXUH  DQG F WKH
FOLQLFDO GHFLVLRQ WR VWDUW D FRXUVH RI 62& &', DQWLELRWLFV )LJXUH  RXWOLQHV WKH SRVVLEOH
RXWFRPHV RI WKH ,QYHVWLJDWRU HYDOXDWLRQ SURFHVV LQFOXGLQJ WKH VWHSV WR EH WDNHQ IRU FDVHV
ZKHUH GLDUUKHD GRHV QRW PHHW WKH GHILQLWLRQ EXW WKH ,QYHVWLJDWRU KDV D VWURQJ FOLQLFDO
VXVSLFLRQ RI & GLIILFLOHUHODWHG GLDUUKHD
 $GMXGLFDWLRQ ERDUG 7KH GHWHUPLQDWLRQ RI WKH ,QYHVWLJDWRU HYDOXDWLRQ SURPSWV UHYLHZ RI
WKH HYHQW E\ DQ LQGHSHQGHQW $% 7KH SXUSRVH RI WKH LQGHSHQGHQW $% LV WR LV WR FRQILUP LI
WKH HYHQW LV D &', UHFXUUHQFH 7KH $% GHFLVLRQ ZLOO EH LQFOXGHG LQ WKH GDWDVHW IRU WKH
VWDWLVWLFDO DQDO\VLV RI WKH SULPDU\ HIILFDF\ HQGSRLQW RI WKH WULDO
)LJXUH 
&HQWUDO /DERUDWRU\ 7HVWLQJ $OJRULWKP

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
)LJXUH 
,QYHVWLJDWRU $VVHVVPHQW RI D 1HZ 'LDUUKHD (SLVRGH
$EEUHYLDWLRQV &',  &ORVWULGLRLGHV GLIILFLOH LQIHFWLRQ (,$  HQ]\PH LPPXQRDVVD\ 3&5  SRO\PHUDVH FKDLQ
UHDFWLRQ
On-Study New Episode of 
Diarrhea (>3 unformed stool in 
24 hours for 2 consecutive 
days)
 Central Laboratory
C. difficile testing 
x
Meets diarrhea definition  
(>3 unformed stool in 24 
hours for 2 consecutive 
days) AND
x
Multistep central laboratory 
positive C. difficile-related 
diarrhea
Patient provided the 
option to enter Part B 
(Open-Label Treatment 
Arm) of Protocol
Yes
Probable C. difficile-
related diarrhea
C. difficile-related 
diarrhea unlikely and 
patient to continue in 
Part A
No
x
Meets diarrhea definition 
OR symptoms are clinically 
consistent with CDI 
recurrence AND
x
No multistep laboratory 
positive C. difficile-related 
diarrhea**
 Patient continues 
follow-up on Part A of 
Protocol 
Unlikely C. difficile-
related diarrhea
x
Symptoms are clinically 
consistent with CDI 
recurrence AND 
x
Multistep† central or local 
laboratory positive C. 
difficile-related diarrhea* 
Investigator Evaluation of the new 
episode of diarrhea
a) Review of diarrhea data
b) Assessment of stool C. difficile testing 
by central laboratory testing algorithm
c) Clinical decision to start a course of 
standard-of-care CDI antibiotics
Does not meet diarrhea 
definition BUT strong 
clinical suspicion of C. 
difficile-related diarrhea 
by Investigator 
Probable C. difficile-
related diarrhea
Inconclusive
†Multistep laboratory testing may include highly sensitive and highly specific testing
*Under extenuating circumstances
 
C. difficile-related 
diarrhea unlikely and 
patient to continue in 
Part A
No
Discuss case with 
Medical Monitor 
and obtain approval 
for Central 
Laboratory testing
Yes
Yes
No

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
LQFOXGHG LQ WKH GHWHUPLQDWLRQ RI HIILFDF\ ,I WKH RQWULDO & GLIILFLOHUHODWHG GLDUUKHD UHVXOWV LQ
KRVSLWDOL]DWLRQ RI WKH SDUWLFLSDQW UHTXLULQJ DQ RYHUQLJKW VWD\ WKLV ZLOO EH UHFRUGHG DV DQ 6$(
DQG UHSRUWHG SHU WKH FULWHULD IRU VDIHW\ UHSRUWLQJ

'HILQLWLRQ RI $GYHUVH (YHQWV
$Q $( LV DQ XQWRZDUG PHGLFDO RFFXUUHQFH LQ D FOLQLFDO LQYHVWLJDWLRQ SDUWLFLSDQW DGPLQLVWHUHG
D SKDUPDFHXWLFDO SURGXFW DQG ZKLFK GRHV QRW QHFHVVDULO\ KDYH WR KDYH D FDXVDO UHODWLRQVKLS
ZLWK WKLV PHGLFLQDO SURGXFW $Q $( FDQ WKHUHIRUH EH DQ\ XQIDYRUDEOH DQG XQLQWHQGHG VLJQ
LQFOXGLQJ DQ DEQRUPDO ODERUDWRU\ ILQGLQJ IRU H[DPSOH V\PSWRP RU GLVHDVH WHPSRUDOO\
DVVRFLDWHG ZLWK WKH XVH RI WKH PHGLFLQDO SURGXFW ZKHWKHU RU QRW FRQVLGHUHG UHODWHG WR WKH
PHGLFLQDO SURGXFW
$(V PD\ LQFOXGH EXW DUH QRW OLPLWHG WR
x
6XEMHFWLYH RU REMHFWLYH V\PSWRPV VSRQWDQHRXVO\ RIIHUHG E\ WKH SDUWLFLSDQW DQGRU
REVHUYHG E\ WKH ,QYHVWLJDWRU RU PHGLFDO VWDII
x
)LQGLQJV DW SK\VLFDO H[DPLQDWLRQV
x
/DERUDWRU\ DEQRUPDOLWLHV RI FOLQLFDO VLJQLILFDQFH
'LVHDVH VLJQV V\PSWRPV DQGRU ODERUDWRU\ DEQRUPDOLWLHV DOUHDG\ H[LVWLQJ SULRU WR WKH XVH RI
WKH ,3 DUH QRW FRQVLGHUHG $(V DIWHU WUHDWPHQW XQOHVV WKH\ UHRFFXU DIWHU WKH SDUWLFLSDQW KDV
UHFRYHUHG IURP WKH SUHH[LVWLQJ FRQGLWLRQ RU LQ WKH RSLQLRQ RI WKH ,QYHVWLJDWRU WKH\
UHSUHVHQW D FOLQLFDOO\ VLJQLILFDQW H[DFHUEDWLRQ LQ LQWHQVLW\ RU IUHTXHQF\
,I FOLQLFDOO\ VLJQLILFDQW ZRUVHQLQJ IURP EDVHOLQH LV QRWHG WKH FKDQJHV ZLOO EH GRFXPHQWHG DV
$(V RQ WKH $( SDJH RI WKH &5) &OLQLFDO VLJQLILFDQFH LV GHILQHG DV DQ\ YDULDWLRQ LQ VLJQV
V\PSWRPV RU WHVWLQJ WKDW KDV PHGLFDO UHOHYDQFH DQG PD\ UHVXOW LQ DQ DOWHUDWLRQ LQ PHGLFDO
FDUH 7KH ,QYHVWLJDWRU ZLOO FRQWLQXH WR PRQLWRU WKH SDUWLFLSDQW XQWLO WKH DVVHVVPHQW UHWXUQV WR
EDVHOLQH RU XQWLO WKH ,QYHVWLJDWRU GHWHUPLQHV WKDW IROORZXS LV QR ORQJHU PHGLFDOO\ QHFHVVDU\
,QYHVWLJDWRUV VKRXOG LQIRUP WKH 6SRQVRU UHJDUGLQJ DQ\ HYHQW WKDW VHHPV XQXVXDO HYHQ LI
WKLV HYHQW PD\ EH FRQVLGHUHG DQ XQDQWLFLSDWHG EHQHILW WR WKH SDUWLFLSDQW

$GYHUVH (YHQW 5HSRUWLQJ

5HFRUGLQJ $GYHUVH DQG 6HULRXV $GYHUVH (YHQWV
7KH FROOHFWLRQ RI $(V ZLOO EHJLQ IURP WKH WLPH RI LQIRUPHG FRQVHQW RI WKURXJK WKH ILQDO WULDO
YLVLW $OO $(V VHULRXV DQG QRQVHULRXV VKRXOG EH UHFRUGHG RQ WKH &5)
5HIHU WR 6HFWLRQ  IRU GHILQLWLRQ DQG UHSRUWLQJ UHTXLUHPHQW RI 6$(V 6$(V UHODWHG WR WULDO
SURFHGXUHV DIWHU VLJQLQJ LQIRUPHG FRQVHQW DQG EHIRUH WKH ILUVW GRVH RI &3 VKDOO DOVR EH
UHSRUWHG
 $GYHUVH (YHQWV 2FFXUULQJ 6HFRQGDU\ WR 2WKHU (YHQWV
,Q JHQHUDO $(V RFFXUULQJ VHFRQGDU\ WR RWKHU HYHQWV HJ FDVFDGH HYHQWV RU FOLQLFDO
VHTXHODH VKRXOG EH LGHQWLILHG E\ WKHLU SULPDU\ FDXVH )RU H[DPSOH LI VHYHUH GLDUUKHD LV

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
NQRZQ WR KDYH UHVXOWHG LQ GHK\GUDWLRQ LW LV VXIILFLHQW WR UHFRUG RQO\ ZKDW LV FRQVLGHUHG WKH
SULPDU\ GLDJQRVLV GLDUUKHD DV WKH $( RQ WKH &5) DQG LI DOVR VHULRXV RQ WKH 6$( IRUP
+RZHYHU PHGLFDOO\ VLJQLILFDQW $(V RFFXUULQJ VHFRQGDU\ WR DQ LQLWLDWLQJ HYHQW WKDW DUH
VHSDUDWHG LQ WLPH VKRXOG EH UHFRUGHG DV LQGHSHQGHQW HYHQWV RQ WKH &5) )RU H[DPSOH LI D
VHYHUH JDVWURLQWHVWLQDO KHPRUUKDJH VXEVHTXHQWO\ OHDGV WR UHQDO IDLOXUH ERWK HYHQWV VKRXOG EH
UHFRUGHG VHSDUDWHO\ RQ WKH &5)
 3HUVLVWHQW RU 5HFXUUHQW $GYHUVH (YHQWV
$ SHUVLVWHQW $( LV RQH WKDW H[WHQGV FRQWLQXRXVO\ ZLWKRXW UHVROXWLRQ EHWZHHQ SDUWLFLSDQW
HYDOXDWLRQ WLPH SRLQWV 6XFK HYHQWV VKRXOG RQO\ EH UHFRUGHG RQFH LQ WKH &5) XQOHVV WKHLU
VHYHULW\ LQFUHDVHV ,I D SHUVLVWHQW $( EHFRPHV PRUH VHYHUH LW VKRXOG EH UHFRUGHG DJDLQ RQ
WKH $( &5)
$ UHFXUUHQW $( LV RQH WKDW RFFXUV DQG UHVROYHV EHWZHHQ SDUWLFLSDQW HYDOXDWLRQ WLPH SRLQWV
DQG VXEVHTXHQWO\ UHFXUV $OO UHFXUUHQW $(V VKRXOG EH UHFRUGHG LQGLYLGXDOO\ RQ WKH $( &5)
 $EQRUPDO /DERUDWRU\ 9DOXHV
&OLQLFDOO\ VLJQLILFDQW ODERUDWRU\ DEQRUPDOLWLHV ZLOO EH UHFRUGHG DV $(V RQ WKH &5) DQG 6$(
IRUP LI DSSOLFDEOH
,I WKH FOLQLFDOO\ VLJQLILFDQW ODERUDWRU\ DEQRUPDOLW\ LV D VLJQ RI D GLVHDVH RU V\QGURPH HJ
DONDOLQH SKRVSKDWDVH DQG ELOLUXELQ  î XSSHU OLPLW RI QRUPDO DVVRFLDWHG ZLWK FKROHF\VWLWLV
RQO\ WKH GLDJQRVLV HJ FKROHF\VWLWLV QHHGV WR EH UHFRUGHG RQ WKH $( &5) DQG WKH 6$(
IRUP LI DSSOLFDEOH
,I WKH ODERUDWRU\ DEQRUPDOLW\ FDQ EH FKDUDFWHUL]HG E\ D SUHFLVH FOLQLFDO WHUP WKH FOLQLFDO WHUP
VKRXOG EH UHFRUGHG DV WKH $( RU 6$( )RU H[DPSOH DQ HOHYDWHG VHUXP SRWDVVLXP OHYHO RI
 P(T/ VKRXOG EH UHFRUGHG DV ³K\SHUNDOHPLD´
2EVHUYDWLRQV RI WKH VDPH FOLQLFDOO\ VLJQLILFDQW ODERUDWRU\ DEQRUPDOLW\ IURP YLVLW WR YLVLW
VKRXOG QRW EH UHSHDWHGO\ UHFRUGHG DV $(V RQ WKH &5) DQG 6$( IRUP LI DSSOLFDEOH XQOHVV
WKHLU VHYHULW\ VHULRXVQHVV RU HWLRORJ\ FKDQJHV

6ROLFLWDWLRQ RI 6SHFLILF $GYHUVH (YHQWV
,Q DGGLWLRQ WR WKH FROOHFWLRQ RI DOO $(V WKH IROORZLQJ $(V ZLOO EH VSHFLILFDOO\ VROLFLWHG XVLQJ
D GDLO\ SDUWLFLSDQW GLDU\ IRU  GD\V IROORZLQJ ,3 DGPLQLVWUDWLRQ 'D\  WR 'D\  DEGRPLQDO
GLVWHQWLRQ RU EORDWLQJ FKLOOVVHYHUH VKLYHULQJ DEGRPLQDO SDLQ RU FUDPSLQJ LQFUHDVHG
GLDUUKHD FRQVWLSDWLRQ QDXVHD YRPLWLQJ DQG IHYHU 7KH GLDU\ ZLOO EH UHYLHZHG DW WKH :HHN 
YLVLW DQG DQ\ $(V FDSWXUHG LQ WKH GLDU\ DQG FRQILUPHG E\ WKH ,QYHVWLJDWRU ZLOO DOVR EH
GRFXPHQWHG RQ WKH $( &5) SDJH

$VVHVVPHQW RI 6HYHULW\
7KH VHYHULW\ RU LQWHQVLW\ RI DQ $( UHIHUV WR WKH H[WHQW WR ZKLFK DQ $( DIIHFWV WKH
SDUWLFLSDQW¶V GDLO\ DFWLYLWLHV 7KH VHYHULW\ RI DQ $( ZLOO EH HYDOXDWHG DFFRUGLQJ WR WKH

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
1DWLRQDO &DQFHU ,QVWLWXWH &RPPRQ 7HUPLQRORJ\ &ULWHULD IRU $GYHUVH (YHQWV 1&,&7&$(
YHUVLRQ  7KH FOLQLFDO VLJQLILFDQFH RI DQ $( LV GHWHUPLQHG E\ WKH ,QYHVWLJDWRU
&KDQJHV LQ WKH VHYHULW\ RI DQ $( VKRXOG EH GRFXPHQWHG LQ WKH &5)

$VVHVVPHQW RI &DXVDOLW\
7KH UHODWLRQVKLS RI HDFK $( WR ,3 RU WULDO LQWHUYHQWLRQ ZLOO EH GHILQHG XVLQJ WKH WHUPV EHORZ
1RW 5HODWHG XQUHODWHG QRW UHODWHG QR UHODWLRQ ± 7KH ELRORJ\ WLPH FRXUVH EHWZHHQ WKH
DGPLQLVWUDWLRQ RI ,3 DQG WKH RFFXUUHQFH RU ZRUVHQLQJ RI WKH $( RU RWKHU IDFWRUV UXOHV RXW D
FDXVDO UHODWLRQVKLS DQGRU DQRWKHU FDXVH FRQFRPLWDQW GUXJV WKHUDSLHV FRPSOLFDWLRQV HWF LV
VXVSHFWHG
5HODWHG ± 7KH WLPH FRXUVH EHWZHHQ WKH DGPLQLVWUDWLRQ RI ,3 DQG WKH RFFXUUHQFH RU ZRUVHQLQJ
RI WKH $( LV FRQVLVWHQW ZLWK D FDXVDO UHODWLRQVKLS DQG QR RWKHU FDXVH FRQFRPLWDQW GUXJV
WKHUDSLHV FRPSOLFDWLRQV HWF FDQ EH LGHQWLILHG 7KH GHILQLWLRQ LPSOLHV D UHDVRQDEOH
SRVVLELOLW\ RI D FDXVDO UHODWLRQVKLS EHWZHHQ WKH HYHQW DQG WKH ,3 7KLV PHDQV WKDW WKHUH DUH
IDFWV HYLGHQFH RU DUJXPHQWV WR VXJJHVW D FDXVDO UHODWLRQVKLS
7KH IROORZLQJ IDFWRUV VKRXOG DOVR EH FRQVLGHUHG
x
7KH WHPSRUDO VHTXHQFH IURP ,3 DGPLQLVWUDWLRQ

7KH HYHQW VKRXOG RFFXU DIWHU WKH ,3 LV JLYHQ 7KH OHQJWK RI WLPH IURP ,3
H[SRVXUH WR HYHQW VKRXOG EH HYDOXDWHG LQ WKH FOLQLFDO FRQWH[W RI WKH HYHQW
x
8QGHUO\LQJ FRQFRPLWDQW LQWHUFXUUHQW GLVHDVHV

(DFK UHSRUW VKRXOG EH HYDOXDWHG LQ WKH FRQWH[W RI WKH QDWXUDO KLVWRU\ DQG
FRXUVH RI WKH GLVHDVH EHLQJ WUHDWHG DQG DQ\ RWKHU GLVHDVH WKH SDUWLFLSDQW PD\
KDYH
x
&RQFRPLWDQW GUXJ

7KH RWKHU GUXJV WKH SDUWLFLSDQW LV WDNLQJ RU WKH WUHDWPHQW WKH SDUWLFLSDQW
UHFHLYHV VKRXOG EH H[DPLQHG WR GHWHUPLQH ZKHWKHU DQ\ RI WKHP PLJKW EH
UHFRJQL]HG WR FDXVH WKH HYHQW LQ TXHVWLRQ
x
.QRZQ UHVSRQVH SDWWHUQ IRU WKLV FODVV RI ,3

&OLQLFDO DQGRU SUHFOLQLFDO GDWD PD\ LQGLFDWH ZKHWKHU D SDUWLFXODU UHVSRQVH LV
OLNHO\ WR EH D FODVV HIIHFW
x
([SRVXUH WR SK\VLFDO DQGRU PHQWDO VWUHVVHV

7KH H[SRVXUH WR VWUHVV PLJKW LQGXFH DGYHUVH FKDQJHV LQ WKH UHFLSLHQW DQG
SURYLGH D ORJLFDO DQG EHWWHU H[SODQDWLRQ IRU WKH HYHQW
x
7KH SKDUPDFRORJ\ RI WKH ,3

7KH NQRZQ SKDUPDFRORJLF SURSHUWLHV DEVRUSWLRQ GLVWULEXWLRQ PHWDEROLVP
DQG H[FUHWLRQ RI WKH ,3 VKRXOG EH FRQVLGHUHG
1RWH 7KH ,QYHVWLJDWRU¶V DVVHVVPHQW RI FDXVDOLW\ IRU LQGLYLGXDO $( UHSRUWV LV SDUW RI WKH WULDO
GRFXPHQWDWLRQ SURFHVV DQG ZLOO EH UHFRUGHG LQ WKH SDUWLFLSDQW
V PHGLFDO UHFRUG $( &5) DQG
RQ WKH 6$( IRUP LI DSSOLFDEOH $(V UHFRUGHG ZLWKRXW WKH ,QYHVWLJDWRU¶V DVVHVVPHQW RI WKH
UHODWLRQVKLS WR ,3 ZLOO EH IROORZHG XS XQWLO FDXVDOLW\ LV DVVLJQHG

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

6HULRXV $GYHUVH (YHQWV
$Q 6$( LV DQ\ HYHQW WKDW PHHWV DQ\ RI WKH IROORZLQJ FULWHULD
x
'HDWK
x
/LIHWKUHDWHQLQJ
x
,QSDWLHQW KRVSLWDOL]DWLRQ RU SURORQJDWLRQ RI H[LVWLQJ KRVSLWDOL]DWLRQ
x
3HUVLVWHQW RU VLJQLILFDQW GLVDELOLW\LQFDSDFLW\
x
&RQJHQLWDO DQRPDO\ELUWK GHIHFW QRW SUHVHQW DW 6FUHHQLQJ
x
2WKHU ,PSRUWDQW PHGLFDO HYHQWV WKDW PD\ QRW UHVXOW LQ GHDWK EH OLIHWKUHDWHQLQJ RU
UHTXLUH KRVSLWDOL]DWLRQ PD\ EH FRQVLGHUHG DQ 6$( ZKHQ EDVHG XSRQ DSSURSULDWH
PHGLFDO MXGJPHQW WKH\ PD\ MHRSDUGL]H WKH SDUWLFLSDQW DQG PD\ UHTXLUH PHGLFDO RU
VXUJLFDO LQWHUYHQWLRQ WR SUHYHQW RQH RI WKH RXWFRPHV OLVWHG LQ WKLV GHILQLWLRQ HJ
LQWHQVLYH WUHDWPHQW LQ DQ HPHUJHQF\ URRP RU DW KRPH IRU DOOHUJLF EURQFKRVSDVP

'HILQLWLRQ RI 7HUPV
/LIHWKUHDWHQLQJ $Q $( LV OLIHWKUHDWHQLQJ LI WKH SDUWLFLSDQW ZDV DW LPPHGLDWH ULVN RI GHDWK
IURP WKH HYHQW DV LW RFFXUUHG LH LW GRHV QRW LQFOXGH D UHDFWLRQ WKDW LI LW KDG RFFXUUHG LQ D
PRUH VHULRXV IRUP PLJKW KDYH FDXVHG GHDWK )RU H[DPSOH GUXJ LQGXFHG KHSDWLWLV WKDW
UHVROYHG ZLWKRXW HYLGHQFH RI KHSDWLF IDLOXUH ZRXOG QRW EH FRQVLGHUHG OLIHWKUHDWHQLQJ HYHQ
WKRXJK GUXJ LQGXFHG KHSDWLWLV FDQ EH IDWDO
+RVSLWDOL]DWLRQ LV GHILQHG E\ WKH 6SRQVRU DV DQ DGPLVVLRQ WR KRVSLWDO IRU GLDJQRVLV DQG
WUHDWPHQW UHTXLULQJ DQ RYHUQLJKW VWD\ 3URORQJDWLRQ RI DQ H[LVWLQJ LQSDWLHQW KRVSLWDOL]DWLRQ
GXH WR DQ HYHQW DOVR PHHWV WKH UHJXODWRU\ FULWHULD RI DQ 6$(
([DPSOHV RI YLVLWV WR D KRVSLWDO IDFLOLW\ WKDW GR QRW PHHW WKH VHULRXV FULWHULD IRU
KRVSLWDOL]DWLRQ LQFOXGH
x
(PHUJHQF\ URRP YLVLWV WKDW GR QRW UHVXOW LQ D IXOO KRVSLWDO DGPLVVLRQ
x
3UHSODQQHG RU HOHFWLYH SURFHGXUHV SULRU WR WULDO HQUROOPHQW HJ RXWSDWLHQW VXUJHU\
x
3URWRFRO SURFHGXUHV
+RVSLWDOL]DWLRQ VLJQLILHV WKDW WKH SDUWLFLSDQW KDV EHHQ GHWDLQHG XVXDOO\ LQYROYLQJ DW OHDVW DQ
RYHUQLJKW VWD\ DW WKH KRVSLWDO RU HPHUJHQF\ ZDUG IRU REVHUYDWLRQ DQGRU WUHDWPHQW WKDW
ZRXOG QRW KDYH EHHQ DSSURSULDWH LQ WKH SK\VLFLDQ
V RIILFH RU RXWSDWLHQW VHWWLQJ :KHQ LQ
GRXEW DV WR ZKHWKHU KRVSLWDOL]DWLRQ RFFXUUHG RU ZDV QHFHVVDU\ WKH $( VKRXOG EH FRQVLGHUHG
VHULRXV
+RVSLWDOL]DWLRQ SODQQHG SULRU WR WULDO HQUROOPHQW HJ IRU HOHFWLYH VXUJHU\ RU URXWLQH FOLQLFDO
SURFHGXUHV WKDW DUH QRW WKH UHVXOW RI $( HJ HOHFWLYH VXUJHU\ IRU D SUHH[LVWLQJ FRQGLWLRQ
WKDW KDV QRW ZRUVHQHG QHHG QRW EH FRQVLGHUHG $(V RU 6$(V ,I DQ\WKLQJ XQWRZDUG LV UHSRUWHG

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
GXULQJ WKH SURFHGXUH WKDW RFFXUUHQFH PXVW EH UHSRUWHG DV DQ $( HLWKHU VHULRXV RU
QRQVHULRXV DFFRUGLQJ WR VHULRXVQHVV FULWHULD GHVFULEHG LQ 6HFWLRQ 
'LVDELOLW\LQFDSDFLWDWLQJ $Q $( LV LQFDSDFLWDWLQJ RU GLVDEOLQJ LI WKH H[SHULHQFH UHVXOWV LQ D
VXEVWDQWLDO DQGRU SHUPDQHQW GLVUXSWLRQ RI WKH SDUWLFLSDQW
V DELOLW\ WR FDUU\ RXW QRUPDO OLIH
IXQFWLRQV
6HYHULW\ LV QRW WKH VDPH DV VHULRXVQHVV 6HYHULW\ RU LQWHQVLW\ UHIHUV WR WKH H[WHQW WR ZKLFK DQ
$( RU 6$( DIIHFWV D SDUWLFLSDQW
V GDLO\ DFWLYLWLHV 6HULRXVQHVV PXVW EH HTXDO WR DW OHDVW RQH RI
WKH FULWHULD OLVWHG LQ 6HFWLRQ  DERYH

5HSRUWLQJ 6HULRXV $GYHUVH (YHQWV
$Q\ $( WKDW PHHWV 6$( FULWHULD 6HFWLRQ  PXVW EH UHSRUWHG YLD ('& LPPHGLDWHO\
ZLWKLQ  KRXUV RI NQRZOHGJH E\ WKH ,QYHVWLJDWRU 5HJDUGOHVV RI FDXVDOLW\ VHYHULW\ DQG
ZKHWKHU WKH SDUWLFLSDQW KDV XQGHUJRQH DQ\ WULDOUHODWHG SURFHGXUHV DOO 6$(V PXVW EH
UHSRUWHG DQG ZLOO EH FROOHFWHG DQG UHFRUGHG IURP WKH WLPH WKH SDUWLFLSDQW VLJQV WKH FRQVHQW
IRUP XQWLO  GD\V IROORZLQJ WKH ILQDO IROORZXS YLVLW
7KH LQLWLDO UHSRUW LQ WKH ('& VKRXOG LQFOXGH DW OHDVW WKH IROORZLQJ LQIRUPDWLRQ
x
7ULDO QXPEHU
x
3DUWLFLSDQW¶V LGHQWLILFDWLRQ QXPEHU
x
'HVFULSWLRQ RI WKH HYHQW
x
'DWH DQG WLPH RI RQVHW RI WKH HYHQW
x
6HULRXVQHVV FULWHULD
x
6HYHULW\
x
,QYHVWLJDWRU¶V DVVHVVPHQW RI &DXVDOLW\ WR WKH ,3
x
3DUWLFLSDQW¶V HYHQW RXWFRPH DV FXUUHQWO\ NQRZQ
:KHQ DGGLWLRQDO LQIRUPDWLRQ UHJDUGLQJ DQ 6$( LV EURXJKW WR WKH DWWHQWLRQ RI WKH ,QYHVWLJDWRU
WKLV LQIRUPDWLRQ VKRXOG EH HQWHUHG LQWR ('& ([DPSOHV ZRXOG LQFOXGH EXW DUH QRW OLPLWHG WR
WKH IROORZLQJ
x
6LJQV DQG V\PSWRPV LQLWLDOO\ UHSRUWHG IRU ZKLFK WKHUH LV QRZ D GLDJQRVLV OHDGLQJ WR D
FKDQJH LQ WKH UHSRUWHG WHUP
x
/DERUDWRU\ WHVW UHVXOWV
x
2XWFRPH RI WKH 6$(
x
&KDQJH LQ ,QYHVWLJDWRU FDXVDOLW\ DVVHVVPHQW GXH WR UHVXOWV RI IXUWKHU LQYHVWLJDWLRQV

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

&RQWUDFHSWLRQ 5HTXLUHPHQWV DQG 3UHJQDQF\

&RQWUDFHSWLRQ 5HTXLUHPHQWV
)HPDOHV DVVLJQHG DW ELUWK PXVW DJUHH WR XVH DQ DFFHSWDEOH IRUP RI FRQWUDFHSWLRQ IURP WKH
WLPH RI VLJQLQJ LQIRUPHG FRQVHQW DQG WKURXJK  ZHHNV DIWHU WKH ODVW GRVH RI ,3 0DOHV
DVVLJQHG DW ELUWK PXVW DJUHH WR XVH RU KDYH WKHLU SDUWQHU XVH DQ DFFHSWDEOH IRUP RI
FRQWUDFHSWLRQ IURP WKH WLPH RI VLJQLQJ LQIRUPHG FRQVHQW DQG WKURXJK  ZHHNV
$FFHSWDEOH PHWKRGV RI FRQWUDFHSWLRQ DV DSSOLFDEOH SHU ORFDO SUDFWLFHV DQG UHJXODWLRQV DUH
LQWUDXWHULQH GHYLFH GLDSKUDJP ZLWK VSHUPLFLGH FRQWUDFHSWLYH VSRQJH FRQGRP YDVHFWRP\
WKDW WDNHV SODFH DW OHDVW  ZHHNV SULRU WR 6FUHHQLQJ ZLWK GRFXPHQWDWLRQ RI D]RRVSHUPLD
DQG DQ\ UHJLVWHUHG DQG PDUNHWHG KRUPRQDO FRQWUDFHSWLYHV WKDW FRQWDLQ DQ HVWURJHQ DQGRU D
SURJHVWDWLRQDO DJHQW LQFOXGLQJ RUDO VXEFXWDQHRXV LQWUDXWHULQH RU LQWUDPXVFXODU DJHQWV
3DUWLFLSDQWV GR QRW UHTXLUH FRQWUDFHSWLRQ LI WKH\ DUH KLJKO\ XQOLNHO\ WR EHFRPH SUHJQDQW RU WR
LPSUHJQDWH D SDUWQHU VLQFH WKH\ PHHW DW OHDVW  RI WKH IROORZLQJ FULWHULD
x
$ IHPDOH DV DVVLJQHG DW ELUWK SDUWLFLSDQW ZKR LV QRW RI UHSURGXFWLYH SRWHQWLDO LV
HOLJLEOH ZLWKRXW UHTXLULQJ WKH XVH RI FRQWUDFHSWLRQ $ IHPDOH SDUWLFLSDQW ZKR LV QRW
RI UHSURGXFWLYH SRWHQWLDO LV GHILQHG DV RQH ZKR KDV HLWKHU  UHDFKHG QDWXUDO
PHQRSDXVH GHILQHG DV  PRQWKV RI VSRQWDQHRXV DPHQRUUKHD   ZHHNV
SRVWVXUJLFDO ELODWHUDO RRSKRUHFWRP\ ZLWK RU ZLWKRXW K\VWHUHFWRP\ RU  ELODWHUDO
WXEDO OLJDWLRQ 6SRQWDQHRXV DPHQRUUKHD GRHV QRW LQFOXGH FDVHV IRU ZKLFK WKHUH LV DQ
XQGHUO\LQJ GLVHDVH WKDW FDXVHV DPHQRUUKHD HJ DQRUH[LD QHUYRVD
x
$ PDOH DV DVVLJQHG DW ELUWK RU IHPDOH DV DVVLJQHG DW ELUWK SDUWLFLSDQW ZKR LV RI
UHSURGXFWLYH SRWHQWLDO DJUHHV WR UHPDLQ DEVWLQHQW RU XVH RU KDYH WKHLU SDUWQHU XVH
 DFFHSWDEOH PHWKRGV RI ELUWK FRQWURO VWDUWLQJ DW HQUROOPHQW DQG WKURXJK WKH ZHHN
WULDO SHULRG

3UHJQDQF\
$OWKRXJK SUHJQDQF\ LV QRW DOZD\V FRQVLGHUHG DQ $( RU 6$( E\ UHJXODWRU\ GHILQLWLRQ IRU WKLV
WULDO SUHJQDQFLHV LQ DQ\ SDUWLFLSDQW RU LQ WKH SDUWQHU RI D PDOH SDUWLFLSDQW UHFHLYLQJ DW OHDVW 
FDSVXOH RI ,3 PXVW EH UHSRUWHG LQ WKH VDPH PDQQHU DV 6$(V XVLQJ WKH 3UHJQDQF\ 5HSRUWLQJ
)RUP
$Q\ SUHJQDQF\ FRPSOLFDWLRQ RU HOHFWLYH WHUPLQDWLRQ RI D SUHJQDQF\ IRU PHGLFDO UHDVRQV ZLOO
EH UHFRUGHG DV DQ $( RU LI DSSURSULDWH DQ 6$(
7KH ,QYHVWLJDWRU PXVW VXEPLW WKH 3UHJQDQF\ 5HSRUWLQJ )RUP LPPHGLDWHO\ ZLWKLQ  KRXUV
DIWHU WKH SUHJQDQF\ LV FRQILUPHG ,I WKH SDUWLFLSDQW KDV UHFHLYHG WKH ,3 SULRU WR EHFRPLQJ
SUHJQDQW WKH SDUWLFLSDQW ZLOO FRQWLQXH WKH HIILFDF\ DQG VDIHW\ DVVHVVPHQW XQWLO  PRQWKV DIWHU
OLYH ELUWK RU  ZHHNV DIWHU WKH ODVW GRVH RI ,3 ZKLFKHYHU LV ORQJHU
7KH SDUWLFLSDQW VKRXOG EH IROORZHG XQWLO WKH RXWFRPH RI WKH SUHJQDQF\ LV GHWHUPLQHG ,W LV WKH
UHVSRQVLELOLW\ RI WKH ,QYHVWLJDWRU WR REWDLQ DQG GRFXPHQW SUHJQDQF\ LQIRUPDWLRQ RQ WKH PRVW
UHFHQW 3UHJQDQF\ 5HSRUW )RUP )XUWKHUPRUH DQ\ 6$( RFFXUULQJ DV RXWFRPH RI WKH
SUHJQDQF\ PXVW EH UHSRUWHG SHU WKH 6$( 5HSRUWLQJ SURFHGXUHV 6HFWLRQ 
6KRXOG SUHJQDQF\ RFFXU LQ D SDUWQHU WKH VDPH 6$( SUHJQDQF\ UHSRUWLQJ SURFHGXUHV VKRXOG
EH IROORZHG 7KH SDUWLFLSDQW PD\ FRQWLQXH LQ WKH WULDO

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

9LWDO 6LJQV +HLJKW DQG :HLJKW
9LWDO VLJQV WHPSHUDWXUH KHDUW UDWH UHVSLUDWRU\ UDWH EORRG SUHVVXUH DQG SXOVH R[LPHWU\ ZLOO
EH DVVHVVHG SHU 62& DV OLVWHG LQ WKH 6FKHGXOH RI $VVHVVPHQWV 7DEOH  DQG 7DEOH  9LWDO
VLJQV ZLOO EH PHDVXUHG EHIRUH ,3 DGPLQLVWUDWLRQ ZKHQ DSSOLFDEOH 9LWDO VLJQ PHDVXUHPHQW DW
:HHN  LV DW WKH GLVFUHWLRQ RI WKH ,QYHVWLJDWRU
%RG\ ZHLJKW DQG KHLJKW ZLOO EH PHDVXUHG SHU 62& +HLJKW DQG ZHLJKW ZLOO EH XVHG WR
FDOFXODWH ERG\ PDVV LQGH[ %0, +HLJKW DQG ZHLJKW IRU ZKHHOFKDLUERXQG SDUWLFLSDQWV LV
RSWLRQDO +HLJKW LV RQO\ UHTXLUHG DW 'D\ 
3UH&', %0, ZLOO EH FROOHFWHG DV SDUW RI WKH SDUWLFLSDQW¶V PHGLFDO KLVWRU\
$Q\ YLWDO VLJQ DEQRUPDOLW\ WKDW LV MXGJHG E\ WKH ,QYHVWLJDWRU DV FOLQLFDOO\ VLJQLILFDQW H[FHSW
DW WKH 6FUHHQLQJ YLVLW ZLOO EH FRQVLGHUHG DQ $( UHFRUGHG RQ WKH &5) DQG PRQLWRUHG DV
GHVFULEHG LQ 6HFWLRQ 

3K\VLFDO ([DPLQDWLRQV
$ SK\VLFDO H[DPLQDWLRQ LQFOXGLQJ HYDOXDWLRQ RI JHQHUDO DSSHDUDQFHPHQWDO VWDWXV KHDG
H\HV HDUV QRVH WKURDW DQG WKH IROORZLQJ ERG\ V\VWHPV VNLQ KHDUW OXQJV DEGRPHQ DQG
H[WUHPLWLHV ZLOO EH SHUIRUPHG DW WKH WLPH SRLQWV OLVWHG LQ WKH 6FKHGXOH RI $VVHVVPHQWV 7DEOH 
DQG 7DEOH 
$Q\ SK\VLFDO H[DPLQDWLRQ ILQGLQJ WKDW LV MXGJHG E\ WKH ,QYHVWLJDWRU DV FOLQLFDOO\ VLJQLILFDQW
H[FHSW DW WKH 6FUHHQLQJ YLVLW ZLOO EH FRQVLGHUHG DQ $( UHFRUGHG RQ WKH &5) DQG PRQLWRUHG
DV GHVFULEHG LQ 6HFWLRQ  ,QYHVWLJDWRUV VKRXOG SD\ VSHFLDO DWWHQWLRQ WR FOLQLFDO VLJQV
UHODWHG WR SUHYLRXV VHULRXV GLVHDVHV

(OHFWURFDUGLRJUDPV
6LQJOH OHDG HOHFWURFDUGLRJUDPV (&*V ZLOO EH SHUIRUPHG SHU 62& DW WKH WLPH SRLQWV
OLVWHG LQ WKH 6FKHGXOH RI $VVHVVPHQWV 7DEOH  DQG 7DEOH  (YLGHQFH RI FOLQLFDOO\
VLJQLILFDQW DEQRUPDOLWLHV GXULQJ WKH 6FUHHQLQJ YLVLW PD\ UHVXOW LQ H[FOXVLRQ IURP WKH WULDO $
OHDG (&* ZLOO RQO\ EH SHUIRUPHG DW :HHN  DQG :HHN  LI PHGLFDOO\ LQGLFDWHG DQG LV DW
WKH GLVFUHWLRQ RI WKH ,QYHVWLJDWRU
$Q\ (&* DEQRUPDOLW\ WKDW LV MXGJHG E\ WKH ,QYHVWLJDWRU DV FOLQLFDOO\ VLJQLILFDQW H[FHSW DW
WKH 6FUHHQLQJ YLVLW ZLOO EH FRQVLGHUHG DQ $( UHFRUGHG RQ WKH &5) DQG PRQLWRUHG DV
GHVFULEHG LQ 6HFWLRQ 

&OLQLFDO 6DIHW\ /DERUDWRU\ (YDOXDWLRQV
6DPSOHV RI EORRG DQG XULQH 7DEOH  DUH VFKHGXOHG IRU FROOHFWLRQ DV VKRZQ LQ 7DEOH  DQG
7DEOH  5HSHDW FOLQLFDO VDIHW\ ODERUDWRU\ HYDOXDWLRQV PD\ EH FRQGXFWHG DW WKH GLVFUHWLRQ RI
WKH ,QYHVWLJDWRU
$GGLWLRQDO IROORZXS VDPSOHV IRU FOLQLFDO ODERUDWRU\ WHVWLQJ VKRXOG EH REWDLQHG DV FOLQLFDOO\
LQGLFDWHG $ P/ VHUXP DOLTXRW ZLOO EH FROOHFWHG DW HDFK WLPH SRLQW DQG DUFKLYHG IRU VDIHW\
WHVWLQJ DV PD\ EH UHTXLUHG E\ HPHUJHQFH RI DGYHUVH FRQGLWLRQV
3DUWLFLSDQWV ZLWK D ZKLWH EORRG FHOO FRXQW !  î / ODERUDWRU\ HYLGHQFH RI DFXWH NLGQH\
LQMXU\ RU DQ DEVROXWH QHXWURSKLO FRXQW RI   î / QHXWURSKLOV DW 6FUHHQLQJ DUH WR EH

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
ZULWWHQ WR GHVFULEH LQ GHWDLO DOO VWDWLVWLFDO DQDO\VHV SODQQHG IRU WKH WULDO ,W ZLOO EH
DFFRPSDQLHG E\ PRFN WDEOHV ILJXUHV DQG OLVWLQJV 7KH 6$3 ZLOO EH ILQDOL]HG DQG DSSURYHG
E\ VLJQDWXUHV DQG GDWHV SULRU WR GDWDEDVH ORFN IRU :HHN  7KH 6$3 ZLOO WDNH SUHFHGHQFH
RYHU WKH SURWRFRO IRU GHWDLOV DERXW WKH VWDWLVWLFDO DQDO\VHV IRU WKH WULDO H[FHSW DV QRWHG DERYH
,Q DGGLWLRQ WR WKH 6$3 RWKHU JUDSKLFDO UHSUHVHQWDWLRQV RI WKH UHVXOWV PD\ EH SURGXFHG DIWHU
UHYLHZ RI WKH GDWD SRVWKRF
9HUEDWLP WHUPV UHFRUGHG IRU PHGLFDO KLVWRU\ FRQGLWLRQV VXUJLFDO KLVWRU\ SURFHGXUHV DQG
$(V ZLOO EH PDSSHG WR D V\VWHP RUJDQ FODVV DQG SUHIHUUHG WHUP XVLQJ WKH 0HG'5$ DQG DOO
SULRU DQG FRQFRPLWDQW PHGLFDWLRQV ZLOO EH FRGHG XVLQJ WKH :RUOG +HDOWK 2UJDQL]DWLRQ 'UXJ
'LFWLRQDU\
7KH ,3 EOLQG ZLOO EH PDLQWDLQHG WKURXJK :HHN  3DUWLFLSDQWV WKH 6SRQVRU ,QYHVWLJDWRUV DQG
DOO WULDO VLWH SHUVRQQHO LQYROYHG ZLWK WKH WULDO FDUU\LQJ RXW WULDO SURFHGXUHV HYDOXDWLQJ
SDUWLFLSDQWV HQWHULQJ WULDO GDWD DQGRU HYDOXDWLQJ WULDO GDWD ZLOO UHPDLQ EOLQGHG WR WUHDWPHQW
DOORFDWLRQV XQWLO DOO SDUWLFLSDQWV KDYH FRPSOHWHG WKH :HHN  DVVHVVPHQWV DQG WKH GDWDEDVH KDV
EHHQ ORFNHG IRU WKH DQDO\VLV DW :HHN  7KH ,QYHVWLJDWRUV WULDO VLWH SHUVRQQHO DQG
SDUWLFLSDQWV ZLOO UHPDLQ EOLQGHG XQWLO :HHN 
3ODQQHG LQWHULP DQDO\VHV DUH GHVFULEHG LQ 6HFWLRQ  3DUWLFLSDQWOHYHO XQEOLQGLQJ ZLOO EH
UHVWULFWHG WR WKH LQGHSHQGHQW VWDWLVWLFLDQ ZKR ZLOO EH SUHSDULQJ WKH ,$ DQG ZKR ZLOO KDYH QR
RWKHU UHVSRQVLELOLWLHV DVVRFLDWHG ZLWK WKH WULDO

$QDO\VLV 3RSXODWLRQV
)RXU DQDO\VLV SRSXODWLRQV DUH SODQQHG IRU WKH WULDO
,QWHQWWRWUHDW SRSXODWLRQ
,77 RU $OO 5DQGRPL]HG
$OO SDUWLFLSDQWV UDQGRPL]HG LQWR WKH WULDO LQFOXGLQJ
WKRVH ZKR ZHUH QRW H[SRVHG WR DQ\ ,3 ZLOO EH
LQFOXGHG LQ WKH ,77 SRSXODWLRQ 3DUWLFLSDQWV LQ WKH
,77 SRSXODWLRQ ZLOO EH DQDO\]HG DFFRUGLQJ WR WKH
WUHDWPHQW JURXS WR ZKLFK WKH\ ZHUH UDQGRPL]HG 7KH
,77 SRSXODWLRQ ZLOO EH WKH SULPDU\ DQDO\VLV
SRSXODWLRQ IRU DOO HIILFDF\ DQDO\VHV
7KH P,77 SRSXODWLRQ
$OO SDUWLFLSDQWV LQ WKH ,77 SRSXODWLRQ ZKR UHFHLYH DW
OHDVW  FDSVXOH RI ,3 DW 5DQGRPL]DWLRQ 'D\ 
3HUSURWRFRO SRSXODWLRQ
33 SRSXODWLRQ
$OO SDUWLFLSDQWV LQ WKH P,77 SRSXODWLRQ ZKR KDYH
UHFHLYHG DW OHDVW  RI WULDO PHGLFDWLRQ FRPSOHWHG
 ZHHNV RI IROORZXS RU KDG DGMXGLFDWHG &',
UHFXUUHQFH SULRU WR WKH ZHHN IROORZXS DQG GLG QRW
KDYH DQ\ PDMRU SURWRFRO GHYLDWLRQ WKDW DIIHFW WKH
HIILFDF\ RU VDIHW\ RI WKH ,3
6DIHW\ SRSXODWLRQ
$OO HQUROOHG SDUWLFLSDQWV ZKR UHFHLYHG DW OHDVW 
FDSVXOH RI ,3 8QOHVV RWKHUZLVH VWDWHG WKH 6DIHW\
SRSXODWLRQ ZLOO EH WKH GHIDXOW DQDO\VLV SRSXODWLRQ IRU

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

&OLQLFDO /DERUDWRU\ (YDOXDWLRQV
'HVFULSWLYH VWDWLVWLFV IRU FOLQLFDO ODERUDWRU\ WHVWV IRU KHPDWRORJ\ FKHPLVWU\ DQG FRDJXODWLRQ
OLVWHG LQ 7DEOH  ZLOO EH SUHVHQWHG E\ WULDO YLVLW DV ZHOO DV WKH FKDQJH IURP EDVHOLQH
/DERUDWRU\ DEQRUPDOLWLHV ZLOO EH JUDGHG DFFRUGLQJ WR 1&,&7&$( 9HUVLRQ  IRU DQDO\WHV
ZKHUH &RPPRQ 7HUPLQRORJ\ &ULWHULD IRU $GYHUVH (YHQWV &7&$( JUDGLQJ DSSOLHV 7KH
QXPEHU DQG SHUFHQWDJH RI SDUWLFLSDQWV H[SHULHQFLQJ WUHDWPHQWHPHUJHQW JUDGHG WR[LFLWLHV
ZLOO EH VXPPDUL]HG E\ WUHDWPHQW JURXS DQG VHYHULW\ JUDGH $ VKLIW WDEOH SUHVHQWLQJ WKH 
ZD\ IUHTXHQF\ WDEXODWLRQ IRU EDVHOLQH DQG WKH ZRUVW SRVWWUHDWPHQW YDOXH DFFRUGLQJ WR WKH
1&,&7&$( JUDGH ZLOO EH SURYLGHG E\ WUHDWPHQW JURXS )RU ODERUDWRU\ SDUDPHWHUV ZLWK QR
&7&$( JUDGLQJ VKLIW WDEOHV ZLWK FDWHJRULHV RI ORZ QRUPDO KLJK IURP EDVHOLQH WR ZRUVW
SRVWWUHDWPHQW YDOXH ZLOO EH SURYLGHG E\ WUHDWPHQW JURXS %RWK VFKHGXOHG DQG XQVFKHGXOHG
SRVWWUHDWPHQW YDOXHV GXULQJ WKH WUHDWPHQW SHULRG ZLOO EH FRQVLGHUHG
$OO FOLQLFDO ODERUDWRU\ GDWD ZLOO EH OLVWHG 9DOXHV RXWVLGH WKH QRUPDO UDQJHV ZLOO EH LGHQWLILHG
LQ WKH GDWD OLVWLQJV ZLWK IODJV IRU ORZ DQG KLJK

$GYHUVH (YHQWV
$Q\ $( UHSRUWHG RQ WKH &5) WKDW RFFXUV GXULQJ RU SRVW WKH DGPLQLVWUDWLRQ RI ,3 LV GHILQHG DV
7($( $GGLWLRQDOO\ LW ZLOO EH DVVXPHG WKDW DQ $( WKDW ZDV UHSRUWHG WR KDYH VWDUWHG DW
5DQGRPL]DWLRQ 'D\  ZLWKRXW DQ DVVRFLDWHG RQVHW WLPH PD\ KDYH RFFXUUHG DIWHU WKH
DGPLQLVWUDWLRQ RI ,3 +HQFH $(V RFFXUULQJ DW 5DQGRPL]DWLRQ 'D\  ZLWK QR DVVRFLDWHG
RQVHW WLPH DUH DVVXPHG WR EH WUHDWPHQWHPHUJHQW
)RU WKH SULPDU\ VDIHW\ HQGSRLQW WKH LQFLGHQFH UDWH RI 7($(V ZLOO EH SUHVHQWHG E\ WUHDWPHQW
JURXS WKURXJK :HHN 
)RU WKH RWKHU VDIHW\ HQGSRLQWV WKH LQFLGHQFH UDWH RI 7($(V DQG 7(6$(V ZLOO EH SUHVHQWHG
E\ WUHDWPHQW JURXS WKURXJK :HHN 
,Q DGGLWLRQ DQ RYHUYLHZ RI 7($(V ZLOO EH SURYLGHG ZKLFK VXPPDUL]HV WKH LQFLGHQFH RI WKH
IROORZLQJ LQIRUPDWLRQ
x
$OO 7($(V
x
'UXJUHODWHG 7($(V
x
0D[LPXP VHYHULW\ RI 7($(V
x
'HDWKV
x
6$(V
7KH QXPEHU DQG SHUFHQWDJH RI SDUWLFLSDQWV ZKR H[SHULHQFHG DW OHDVW  7($( ZLOO EH
SUHVHQWHG E\ 0HG'5$ V\VWHP RUJDQ FODVV DQG SUHIHUUHG WHUP 'UXJUHODWHG 7($(V
ZLWKGUDZDOV GXH WR 7($(V DQG DOO 6$(V ZLOO EH VXPPDUL]HG LQ WKH VDPH PDQQHU

6XPPDULHV RI %DVHOLQH &KDUDFWHULVWLFV 'HPRJUDSKLFV DQG 2WKHU $QDO\VHV
'HVFULSWLYH VWDWLVWLFDO PHWKRGV ZLOO EH XVHG WR VXPPDUL]H DOO WULDO GDWD 8QOHVV VWDWHG
RWKHUZLVH WKH WHUP ³GHVFULSWLYH VWDWLVWLFV´ UHIHUV WR QXPEHU RI SDUWLFLSDQWV Q PHDQ
PHGLDQ VWDQGDUG GHYLDWLRQ PLQLPXP DQG PD[LPXP IRU FRQWLQXRXV GDWD DQG UHIHUV WR
IUHTXHQFLHV DQG SHUFHQWDJHV IRU FDWHJRULFDO GDWD )RU VRPH GDWD WKDW PD\ EH SUHVHQWHG DV
FRQWLQXRXV YDULDEOHV WKHUH PD\ EH VFLHQWLILF UHDVRQV WR SUHVHQW WKRVH GDWD LQ FRQVWUXFWHG

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

75,$/ 021,725,1* $8',7,1* $1' ,163(&7,1*

5LVN%DVHG 4XDOLW\ 0DQDJHPHQW
7KH 6SRQVRU ZLOO LPSOHPHQW D ULVNEDVHG TXDOLW\ PDQDJHPHQW V\VWHP DV GHVFULEHG LQ ,&+ (
5 ZLWK PHWKRGV WR DVVXUH DQG FRQWURO WKH TXDOLW\ RI WKH WULDO WKURXJKRXW DOO VWDJHV RI WKH
WULDO SURFHVV WKDW ZLOO EH SURSRUWLRQDWH WR WKH ULVNV LQKHUHQW LQ WKH WULDO DQG WKH LPSRUWDQFH RI
WKH LQIRUPDWLRQ FROOHFWHG 7KH 6SRQVRU ZLOO LGHQWLI\ &ULWLFDO 'DWD DQG &ULWLFDO 3URFHVVHV DQG
WKH UHVSHFWLYH ULVNV DVVRFLDWHG ZKLFK ZLOO EH WKH IRFXV RI 6SRQVRU RYHUVLJKW PRQLWRULQJ DQG
UHSRUWLQJ DFWLYLWLHV GXULQJ WKH FRQGXFW RI WKLV WULDO

7ULDO 6LWH 7UDLQLQJ
%HIRUH WULDO LQLWLDWLRQ DW VLWH LQLWLDWLRQ YLVLW FRQGXFWHG RQ VLWH RU YLUWXDOO\ RU DW DQ
,QYHVWLJDWRU¶V PHHWLQJ D 6SRQVRU UHSUHVHQWDWLYH &5$ ZLOO UHYLHZ WKH SURWRFRO &5)V DQG
RWKHU WULDO GRFXPHQWV ZLWK WKH ,QYHVWLJDWRUV DQG WKHLU VWDII 7UDLQLQJ WRSLFV PD\ LQFOXGH EXW
DUH QRW OLPLWHG WR WULDO EDFNJURXQG DQG UDWLRQDOH FOLQLFDO GDWD VXPPDU\ SURWRFRO UHYLHZ
,&+ *&3 WULDOVSHFLILF SURFHGXUHV ,3 UHYLHZ $( UHSRUWLQJ &5)V WULDO GRFXPHQWDWLRQ
LQIRUPHG FRQVHQW SURFHVV WULDO PRQLWRULQJ HWF DV DSSOLFDEOH
&5$ ZLOO FRQILUP WKDW DOO VWXG\ SURFHGXUHV DUH LQ FRPSOLDQFH ZLWK WKH 6WXG\ 6WDUW8S 3ODQ
SULRU WR VLWH DFWLYDWLRQ

0RQLWRULQJ 3URFHGXUHV
7KH 6SRQVRU &5$ RU GHVLJQHH ZLOO EH LQ UHJXODU FRQWDFW ZLWK WKH LQYHVWLJDWLRQDO WHDP
WKURXJK WHOHSKRQH FDOOV DQG UHJXODU IROORZXS YLVLWV
,QYHVWLJDWRUV PXVW DOORZ WKH &5$ WR FRQGXFW PRQLWRULQJ YLVLWV DW DOO WKH WULDO VLWH ORFDWLRQV
LQ SHUVRQ DQGRU YLUWXDOO\ DW PXWXDOO\ DJUHHG WLPHV GXULQJ WKH WULDO DQG DIWHU WKH WULDO KDV
EHHQ FRPSOHWHG 7KH ,QYHVWLJDWRU RU GHOHJDWH PXVW EH DYDLODEOH IRU WKHVH YLVLWV DQG PXVW
DOORZ WKH &5$ GLUHFW DFFHVV WR VRXUFH GRFXPHQWV UHJXODWRU\ ILOHV DQG &5)V
0RQLWRULQJ YLVLWV ZLOO EH FRQGXFWHG LQ DFFRUGDQFH ZLWK WKH DSSURYHG FOLQLFDO PRQLWRULQJ
SODQ 7KH SXUSRVH RI WULDO PRQLWRULQJ LV WR YHULI\ WKH IROORZLQJ
x
7KH ULJKWV DQG ZHOOEHLQJ RI SDUWLFLSDQWV DUH SURWHFWHG LQFOXGLQJ REWDLQLQJ LQIRUPHG
FRQVHQW
x
7KH FRQGXFW RI WKH WULDO LV LQ FRPSOLDQFH ZLWK WKH FXUUHQWO\ DSSURYHG SURWRFRO ZLWK
,&+ *&3 ( 5 DQG DSSOLFDEOH ODZV DQGRU UHJXODWLRQV
x
7KH ,QYHVWLJDWRU¶V REOLJDWLRQV DUH EHLQJ IXOILOOHG
x
(QVXUH WKH DFFXUDF\ DQG LQWHJULW\ RI WULDO GDWD
x
5HVROYH DQ\ LQFRQVLVWHQFLHV LQ WKH WULDO UHFRUGV
7KH &5$ ZLOO HYDOXDWH WKH SURJUHVV RI WKH WULDO LQFOXGLQJ SURJUHVV RI HQUROOPHQW DQG HQVXUH
WKDW ,3 LV EHLQJ VWRUHG GLVSHQVHG DQG DFFRXQWHG IRU DFFRUGLQJ WR WKLV SURWRFRO DQG DVVRFLDWHG
3KDUPDF\ 0DQXDO 7KH &5$ ZLOO GLVFXVV WKH FRQGXFW RI WKH WULDO ZLWK WKH ,QYHVWLJDWRU DQG
YHULI\ WKDW WKH IDFLOLWLHV UHPDLQ DFFHSWDEOH 7KH &5$ ZLOO QRWLI\ WKH 6SRQVRU RI DQ\ LVVXHV
LGHQWLILHG LQ D WLPHO\ PDQQHU DQG ZLOO ZRUN ZLWK WKH VLWH RQ UHVROXWLRQ RI LVVXHV

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 

$33(1',&(6

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
$SSHQGL[ 
'HFODUDWLRQ RI +HOVLQNL
3OHDVH UHIHU KWWSVZZZZPDQHWSROLFLHVSRVWZPDGHFODUDWLRQRIKHOVLQNLHWKLFDO
SULQFLSOHVIRUPHGLFDOUHVHDUFKLQYROYLQJKXPDQVXEMHFWV

)LQFK 5HVHDUFK DQG 'HYHORSPHQW
3URWRFRO ),1&', 35,60 $PHQGPHQW  $SSURYDO  0D\ 
&RQILGHQWLDO
3DJH  RI 
$SSHQGL[ 
7ULDO 3URFHGXUHV )ORZFKDUW7DEOH