throbber
"""!
` 
`
`
`
` 
    #
`
` !
`   ! 
`   

`
`
`AFFIDAVIT OF DUNCAN HALL
`
` 
`
` (4 ( ,*69+: ,8<,:; 96*,::69 (; ;/, 5;,95,; 9*/0=, 36*(;,+ 05 (5 9(5*0:*6
`(30-6950(  4(2, ;/0: +,*3(9(;065 6- 4@ 6>5 7,9:65(3 256>3,+.,
`
`
` /, 5;,95,; 9*/0=, 0: ( >,):0;, ;/(; 796=0+,: (**,:: ;6 ( +0.0;(3 30)9(9@ 6- 5;,95,;
`:0;,: (5+ 6;/,9 *<3;<9(3 (9;0-(*;: 05 +0.0;(3 -694 02, ( 7(7,9 30)9(9@ >, 796=0+,
`-9,, (**,:: ;6 9,:,(9*/,9: /0:;690(5: :*/63(9: (5+ ;/, .,5,9(3 7<)30* /, 5;,95,;
`9*/0=, /(: 7(9;5,9,+ >0;/ (5+ 9,*,0=,: :<7769; -964 =(906<: 05:;0;<;065:
`05*3<+05. ;/, 0)9(9@ 6- 65.9,::
`
`  /, 5;,95,; 9*/0=, /(: *9,(;,+ ( :,9=0*, 256>5 (: ;/, #(@)(*2 (*/05, /,
`#(@)(*2 (*/05, 4(2,: 0; 76::0)3, ;6 )96>:, 469, ;/(5
 )033065 7(.,: :;69,+
`05 ;/, 5;,95,; 9*/0=,: >,) (9*/0=, "0:0;69: ;6 ;/, #(@)(*2 (*/05, *(5 :,(9*/
`(9*/0=,: )@ ! 0, ( >,):0;, (++9,:: - (9*/0=,+ 9,*69+: -69 ( ! (9,
`(=(03()3, ;/, =0:0;69 >033 ), 79,:,5;,+ >0;/ ( +0:73(@ 6- (=(03()3, +(;,: /, =0:0;69
`4(@ :,3,*; 65, 6- ;/6:, +(;,: (5+ ),.05 )96>:05. (5 (9*/0=,+ =,9:065 6- ;/, #,)
`052: 65 (9*/0=,+ -03,: 05 ;/, #(@)(*2 (*/05, 7605; ;6 6;/,9 (9*/0=,+ -03,:
` >/,;/,9   7(.,: 69 6;/,9 -03, ;@7,: 0- (5@ (9, -6<5+ -69 ;/, ! 05+0*(;,+
`)@ ( .0=,5 3052 69 05:;(5*, ;/, #(@)(*2 (*/05, 0: +,:0.5,+ :<*/ ;/(; >/,5 (
`=0:0;69 *30*2: 65 ( /@7,93052 65 (5 (9*/0=,+ 7(., ;/(; 7605;: ;6 (56;/,9 ! ;/,
`=0:0;69 >033 ), :,9=,+ ;/, (9*/0=,+ -03, -6<5+ -69 ;/, /@7,93052C: ! >0;/ ;/,
`*36:,:; (=(03()3, +(;, ;6 ;/, 050;0(3 -03, *65;(0505. ;/, /@7,93052
`
`
 /, (9*/0=,+ +(;( 4(+, =0,>()3, (5+ )96>:,()3, )@ ;/, #(@)(*2 (*/05, 0:
`6);(05,+ )@ <:, 6- >,) (9*/0=05. :6-;>(9, ;/(; (<;64(;0*(33@ :;69,: *670,: 6- -03,:
`(=(03()3, =0( ;/, 5;,95,; ,(*/ -03, 79,:,9=,+ (: 0; ,?0:;,+ (; ( 7(9;0*<3(9 7605; 05
`;04,
`
`  /, 5;,95,; 9*/0=, (::0.5: ( ! 65 0;: :0;, ;6 ;/, (9*/0=,+ -03,: 05 ;/, -694(;
`/;;7>,)(9*/0=,69.>,)%$,(9 05 @@@@&%65;/ 05 44&%(@ 05 ++&% 04, *6+, 05
`//44::&%9*/0=,+ !& (2( (5 A,?;,5+,+ !B /<: ;/, ,?;,5+,+ !
`/;;7>,)(9*/0=,69.>,) 
`

`/;;7>>>(9*/0=,69. >6<3+ ), ;/,
`! -69 ;/, 9,*69+ 6- ;/, 5;,95,; 9*/0=, /64, 7(.,   -03,
` /;;7>>>(9*/0=,69. (9*/0=,+ 65 (5<(9@
`  (;
  (4 (5+
`
`:,*65+:  
` (; 
 
`  >,) )96>:,9 4(@ ), :,; :<*/ ;/(; ( 7905;6<;
`-964 0; >033 +0:73(@ ;/, ! 6- ( >,) 7(., 05 ;/, 7905;6<;C: -66;,9 /, +(;,
`05+0*(;,+ )@ (5 ,?;,5+,+ ! (7730,: ;6 ( 79,:,9=,+ 05:;(5*, 6- ( -03, -69 ( .0=,5
`! )<; 56; 5,*,::(903@ ;6 (5@ 6;/,9 -03,: 3052,+ ;/,9,05 /<: 05 ;/, *(:, 6- (
`7(., *65:;0;<;,+ )@ ( 7904(9@   -03, (5+ 6;/,9 :,7(9(;, -03,: ,. -03,: >0;/
`04(.,: (<+06 4<3;04,+0( +,:0.5 ,3,4,5;: 69 6;/,9 ,4),++,+ *65;,5; 3052,+
`>0;/05 ;/(; 7904(9@   -03, ;/, 7904(9@   -03, (5+ ;/, 6;/,9 -03,: >033 ,(*/
`/(=, ;/,09 6>5 9,:7,*;0=, ,?;,5+,+ !: (5+ 4(@ 56; /(=, ),,5 (9*/0=,+ 65 ;/,
`:(4, +(;,:
`
`Apotex Exhibit 1022
`Page 1 of 11
`
`

`

`ARCHIVE
`
`a[
`
`a4
`se
`
`me
`ea}
`
` ;;(*/,+ /,9,;6 (: ?/0)0;  (9, ;9<, (5+ (**<9(;, *670,: 6- 7905;6<;: 6-
`Attached hereto as Exhibit A are true and accurate copies of printouts of
`:*9,,5:/6;: 6- ;/, 5;,95,; 9*/0=,: 9,*69+: 6- ;/, (9*/0=,+ -03,: -69 ;/, !: (5+
`screenshots of the Internet Archive's records of the archived files for the URLs and
`;/, +(;,: :7,*0-0,+ 05 ;/, (;;(*/,+ *6=,9:/,,; 6- ,(*/ 7905;6<;
`the dates specified in the attached coversheet of each printout.
`
`
`
` +,*3(9, <5+,9 7,5(3;@ 6- 7,91<9@ ;/(; ;/, -69,.605. 0: ;9<, (5+ *699,*;
`I declare under penalty of perjury that the foregoing is true and correct.
`
`01/27/2021 eee? YUeaALL
`
`01/27/2021
`  ''''''''''''''''''''''''
`''''''''''''''''''''''''
`DATE:
`<5*(5 (33
`Duncan Hall
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 2 of 11
`Page 2 of 11
`
`=c
`
`e=
`
`

`

`EXHIBIT A
`EXHIBIT A
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 3 of 11
`Page 3 of 11
`
`

`

`
`
`  #" # 
`

 
 
`  !
`https://web.archive.org/web/20090813064936/https://clinicaltrials.gov/ct2/show/NCT006373
`!!
`77
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 4 of 11
`Page 4 of 11
`
`

`

`
`
`Home StudyTopics Glossary Search
`
`
`
`
`
`| Search
`
`
`
`https: //clinicaltrials.gov/ct2 /show/NCT00637377
`INTERNET ARCHIVE
`
`
`
`
`Wayogebmactine21captures
`18 Jan 2009 - 23 Jan 2017
`tat
`ron odes
`0&
`2010 QaNrnauremetadics
`Skip to Main Content
`ClinicalTrials.gov
`Aservice of the U.S. National Institutes of Health
`
`
`( Tabular View | ( No Study Results Posted
`
`Full Text View
`
`Related Studies
`
`|
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)
`
`This study is currently recruiting participants.
`Verified by Bayer, July 2009
`
`
`First Received: March 12,2008 Last Updated: July 3, 2009 History of Changes
`
`ClinicalTrials.gov Identifier:|NCT00637377
`
`Information provided by:
`
`> Purpose
`
`This study is a phase III, double-masked, randomized,study ofthe efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration.
`Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
`
` Macular Degeneration
`
`Drug: VEGF Trap-Eye
`Drug: Ranibizumab
`
`PhaseIII
`
`Interventional
`Study Type:
`Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
`
`Official Title:|A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Dosesof Intravitreal VEGF Trap in Subjects
`With Neovascular Age-Related Macular Degencration (AMD).
`
`Resource links provided by NLM:
`
`Genetics Home Referencerelated topics: X-linked juvenile retinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`Drug Information available for: Ranibizumab Aflibercept
`US. FDA Resources
`
`Further study details as provided by Bayer:
`
`Primary Outcome Measures:
`e The proportion of subjects who maintain vision at Week 52, where a subjectis classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRSchart
`comparedto baseline (ie, prevention of moderate vision loss) [ Time Frame: week 52 ] [ Designated as safety issue: Yes]
`
`Secondary Outcome Measures:
`¢ Mean change from baseline in BCVA as measured by ETDRSletter score at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
`e The proportion of subjects who gain at least 15 letters of vision at Week 52 [ Time Frame: week 52 ] [| Designated as safety issue: No ]
`¢ Mean change from baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
`¢ Mean change from baseline in CNV area at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
`
`Estimated Enrollment:
`Study Start Date:
`Estimated Study Completion Date:
`Estimated Primary Completion Date:
`
`1200
`April 2008
`September 2011
`July 2011 (Final data collection date for primary outcome measure)
`
`Experimental
`
`Drug: VEGFTrap-Eye
`2.0 mg VEGFTrap-Eye administered every 8 weeks(including one additional 2,0 mg dose at Week 4) during the first year. Thereafter a dose may be
`administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
`
`Assigned Interventions Arm 3:
`
`Arm 1:
`Experimental
`
`Arm 2:
`Experimental
`
`Drug: VEGFTrap-Eye
`0.5 mg VEGF Trap-Eye administered every 4 weeksduring the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no
`less frequently than every 12 weeks.
`
`Drug: VEGF Trap-Eye
`Vann Lan wee ne,41e- shen 22 enee AD ween nT
`2.0 mg VEGFTrap-Eye administered every 4 weeksduring thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but no
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 5 of 11
`Page 5 of 11
`
`

`

`Jess LICYUCLILLY Widll CVELY 12 WCCKS.
`
`Arm 4: Active
`Comparator
`
`every 12 weeks.
`
`Drug: Ranibizumab
`0.5 mg administered every 4 weeksduring the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than
`
`P Eligibility
`
`AgesEligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`Inclusion Criteria:
`
`50 Years and older
`Both
`No
`
`e Signed informed consent.
`¢ Men and women >/=S0yearsof age.
`e Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveallesions that affect the fovea as evidenced by FAin the study eye.
`¢ ETDRSbest-corrected visual acuity of: 20/40 to 20/320(letter score of 73 to 25) in the study eye at 4 meters.
`e Willing, committed, and able to return for ALLclinic visits and complete all study-related procedures.
`Able to read,(or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and
`willing to sign the informed consent form.
`Exclusion Criteria:
`
`e Anyprior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
`e Any prior or concomitant therapy with another investigational agent to treat neovascular AMDinthe study eye.
`e Anyprior treatment with anti-VEGF agentsin the study eye.
`¢ Total lesion size >12 disc areas (30.5 mm&#xfffd;, including blood, scars and neovascularization) as assessed by FA in the study eye.
`¢ Subretinal hemorrhagesthat is either 50% or more of the total lesion area,or if the blood is under the fovea andis 1 or more disc areas in size in the study eye (if the blood is
`underthe fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
`¢ Scar orfibrosis making up >50% ofthe total lesion in the study eye.
`¢ Scar,fibrosis, or atrophy involving the center of the fovea in the study eye.
`e Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
`e History of any vitreous hemorrhage within 4 weeksprior to Visit 1 in the study eye.
`e Presence of other causes of CNV inthe study eye.
`¢ Prior vitrectomy in the study eye.
`e History of retinal detachmentor treatment or surgery for retinal detachmentin the study eye.
`e Any history of macular hole of stage 2 and abovein the study eye.
`e Anyintraocular or periocular surgery within 3 months of Day | on the study eye, except lid surgery, which may not have taken place within 1 month of Day1, as longasit is
`unlikely to interfere with the injection.
`¢ History or clinical evidence of diabetic retinopathy, diabetic macular edemaoranyretinal vascular disease other than AMDineithereye.
`
`P Contacts and Locations
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00637377
`
`Contacts
`
`Contact: Bayer Clinical Trials Contact
`
`clinical-trials-contact@bayerhealthcare.com
`
`“F| Show 212 Study Locations
`
`Sponsors and Collaborators
`Bayer
`
`Investigators
`Study Director: Bayer Study Director Bayer
`
`P More Information
`
`Additional Information:
`
`Click here and search for drug information provided by the FDA Ei
`
`
`
`Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product =a)
`
`Click here to find results for studies related to marketed products =m
`
`No publications provided
`
`Bayer Schering Pharma AG ( Therapeutic Area Head )
`Responsible Party:
`91689, EurdaCT No.: 2007-000583-25
`Study ID Numbers:
`March 12, 2008
`Study First Received:
`July 3, 2009
`Last Updated:
`
`ClinicalTrials.gov Identifier: NCT00637377 History of Changes
`Health Authority:
`Switzerland: Ethikkommission
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 6 of 11
`Page 6 of 11
`
`

`

`Keywords provided by Bayer:
`Eye diseases
`Vision Impairment and Blindness
`Eyesand Vision
`
`Study placedin the following topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Macular Degeneration
`
`Additional relevant MeSH terms:
`Growth Substances
`Eye Diseases
`Physiological Effects of Drugs
`Retinal Degeneration
`
`ClinicalTrials.gov processed this record on August 12, 2009
`
`Backto top of Main Content
`
`Seniors
`Neovascular Age-Related Macular Degeneration (AMD)
`Retinal Disease
`
`Blindness
`Endothelial Growth Factors
`Retinal Diseases
`Vision, Low
`
`Macular Degeneration
`Endothelial Growth Factors
`Pharmacologic Actions
`Retinal Diseases
`
`Contact Help Desk
`Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicine,
`US. NationalInstitutes of Health, U.S. Department of Health & Human Services,
`USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act
`os
`oteg
`
`oM¢
`
`Linksto all studies - primarily for crawlers
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 7 of 11
`Page 7 of 11
`
`

`

`
`
`  ##   
`

 
 
` #!
`https://web.archive.org/web/20090911163626/https://clinicaltrials.gov/ct2/show/NCT005097
`#
`95
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 8 of 11
`Page 8 of 11
`
`

`

`INTERNET ARCHIVE
`Wayogedmaenine
`
`
`
`https: //clinicaltrials.gov/ct2 /show/NCT00509795
`
`
`
`
`21 captures
`1 Dec 2008 - 23 Sep 2020
`
`
`Clinica[TriaIs. gov
`Home
`Search
`Study Topics Glossary
`
`arch
`
`A service of the U.S. National Institutes of Health
`I Searc'
`
`
`Full Text View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration(AMD)(VIEW 1)
`
`This studyis currently recruiting participants.
`Verified by Regeneron Pharmaceuticals, April 2009
`
`First Received: July 31, 2007 Last Updated: April 28, 2009 History of Changes
`
`ClinicalTrials.gov Identifier:|NCT00509795
`
`SponsorsandCollaborators: ao Pharmaceuticals
`
`
`
`Purpose
`This study is a phaseIII, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eyein patients with neovascular age-related macular degeneration. Approximately
`1200 patients will be randomized in the US and Canada.
`
`
`
`Drug: VEGF Trap-Eye
`Drug: Ranibizumab
`
`PhaseIll
`
`Macular Degeneration
`
`Interventional
`Study Type:
`Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
`Official Title:|A Randomized, Double Masked, Active Controlled PhaseII| Study of the Efficacy, Safety, and Tolerability of Repeated DosesofIntravitreal VEGF Trap in Subjects With
`Neovascular Age-Related Macular Degeneration
`
`Resourcelinks provided by NLM:
`
`Genetics Home Referencerelated topics: X-linked juvenile retinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`Drug Information available for: Ranibizumab Aflibercept
`U.S. FDA Resources
`
`Further study details as provided by Regeneron Pharmaceuticals:
`
`Primary Outcome Measures:
`« The proportion of subjects who maintain vision at Week 52, where a subjectis classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS
`chart comparedto baseline (i.e. prevention of moderate vision loss) [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
`
`Secondary Outcome Measures:
`« Mean changefrom baseline in BCVA as measured by ETDRSletter score at Week 52 [ Time Frame: Week 52 ] [ Designated assafety issue: Yes]
`« The proportion of subjects who gain at least 15 letters of vision at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
`« Mean changefrom baselinein total NEI VFQ-25 score at Week 52 [ Time Frame: Week52 ] [ Designated as safety issue: No ]
`« Mean changefrom baseline in CNV area at Week 52 [ Time Frame: Week 52] [ Designated as safety issue: Yes ]
`
`1200
`Estimated Enrollment:
`August 2007
`Study Start Date:
`December2011
`Estimated Study Completion Date:
`Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
`
`jarms|AssignedInterventions
`1:
`Drug: VEGF Trap-Eye
`Experimental
`0.5 mg VEGF Trap-Eye administered every 4 weeks duringthefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`than every 12 weeks.
`
`2:
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks,but
`no less frequently than every 12 weeks.
`
`3:
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 8 weeks(including one additional 2.0 mg doseat week4) during thefirst year. Thereafter a dose may be
`administered as frequently as every 4 weeks,but no less frequently than every 12 weeks.
`
`4: Active
`Comparator
`
`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 9 of 11
`Page 9 of 11
`
`

`

`Eligibility
`
`AgesEligible for Study:
`GendersEligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`50 Years and older
`Both
`No
`
`KeyInclusion Criteria:
`1.
`Signed Informed Consent.
`2.
`Men and women= 50 yearsof age.
`3.
`Active primary or recurrent subfoveal CNV lesions secondary to AMD,including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
`4.
`ETDRSbest-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
`5.
`Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
`6.
`Able to read,(or, if unable to read dueto visual impairment, be read to verbatim by the person administering the informed consentor a family member. See Appendix J.4)
`understand andwilling to sign the informed consent form.
`
`arwon
`oOONOD
`
`Key Exclusion Criteria:
`1.
`Anyprior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplementsor vitamins.
`. Any prior or concomitant therapy with anotherinvestigational agent to treat neovascular AMD in the study eye, except dietary supplementsorvitamins.
`. Any prior treatment with anti-VEGF agentsin the study eye.
`. Total lesion size > 12 disc areas (30.5 mm2,including blood, scars and neovascularization) as assessed by FA in the study eye.
`. Subretinal hemorrhagethatis either 50% or moreof the total lesion area,orif the blood is under the fovea and is 1 or more disc areasin sizein the study eye. (If the blood
`is underthe fovea, then the fovea must be surrounded 270 degreesbyvisible CNV.)
`. Scar or fibrosis, making up > 50% of totallesion in the study eye.
`. Scar, fibrosis, or atrophy involving the center of the fovea.
`. Presenceofretinal pigment epithelial tears or rips involving the macula in the study eye.
`. History of any vitreous hemorrhage within 4 weeksprior to Visit 1 in the study eye.
`. Presence of other causes of CNVin the study eye.
`. History or clinical evidence of diabetic retinopathy, diabetic macular edemaor any other vascular disease affecting the retina,other than AMD, in either eye.
`12.
`Prior vitrectomyin the study eye.
`13.
`History of retinal detachmentor treatment or surgery forretinal detachmentin the study eye.
`14.
`Anyhistory of macular hole of stage 2 and abovein the study eye.
`15.
`Anyintraocular or periocular surgery within 3 months of Day 1 on the study eye, exceptlid surgery, which may not have taken place within 1 month of day1, as long asits
`unlikely to interfere with the injection.
`
`Contacts and Locations
`
`Pleasereferto this study by its ClinicalTrials.gov identifier: NCT00509795
`
`Contacts
`Contact: Regeneron
`
`866-549-8439 VIEWistudy@rtp.ppdi.com
`
`=| Show 191 Study Locations
`Sponsorsand Collaborators
`Regeneron Pharmaceuticals
`Bayer
`
`Investigators
`Study Director: Avner Ingerman, MD Regeneron Pharmaceuticals
`
`MoreInformation
`
`No publications provided
`
`Regeneron Pharmaceuticals ( Dr. Avner Ingerman )
`Responsible Party:
`VGFT-OD-0605
`Study ID Numbers:
`July 31, 2007
`Study First Received:
`April 28, 2009
`Last Updated:
`History of Changes
`ClinicalTrials.gov Identifier: NCT00509795
`Health Authority:
`United States: Food and Drug Administration; Canada: Health Canada
`
`Study placedin the following topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Additional relevant MeSH terms:
`Growth Substances
`Eye Diseases
`Physiological Effects of Drugs
`Retinal Degeneration
`
`Macular Degeneration
`Endothelial Growth Factors
`Retinal Diseases
`
`Macular Degeneration
`Endothelial Growth Factors
`Pharmacologic Actions
`Retinal Diseases
`
`ClinicalTrials.gov processed this record on September 11, 2009
`
`
`Contact Help Desk
`Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicine,
`U.S. NationalInstitutes of Health, U.S. Department of Health & Human Services,
`USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act
`
`\p_US. NationalInstitutes of Health |pUS: National Library of Medicine |pUS: Departmentof Health & Human Services
`
`Apotex Exhibit 1022
`Apotex Exhibit 1022
`Page 10 of 11
`Page 10 of 11
`
`

`

`(cid:45)(cid:56)(cid:53)(cid:36)(cid:55)
`
`(cid:54)(cid:87)(cid:68)(cid:87)(cid:72)(cid:18) )'')(0 &-#)!(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`FLORIDA
`
` $-2(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3) ).(-2 (cid:3)(cid:3)(cid:3))!(cid:3)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`Broward
`
`(cid:12)(cid:3)
`(cid:12)(cid:3)(cid:3)(cid:3)
`(cid:12)(cid:3)
`
`(cid:50)(cid:81)(cid:3)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:15)(cid:3)(cid:69)(cid:72)(cid:73)(cid:82)(cid:85)(cid:72)(cid:3)(cid:80)(cid:72)(cid:15)(cid:3)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:3)(cid:15)(cid:3)
`Mikhail Clarke
`01/27/2021
`(cid:39)(cid:68)(cid:87)(cid:72)
`(cid:49)(cid:82)(cid:87)(cid:68)(cid:85)(cid:92)(cid:3)(cid:49)(cid:68)(cid:80)(cid:72)
`(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:72)(cid:74)(cid:82)(cid:76)(cid:81)(cid:74)(cid:3)(cid:76)(cid:81)(cid:86)(cid:87)(cid:85)(cid:88)(cid:80)(cid:72)(cid:81)(cid:87) (cid:90)(cid:68)(cid:86) (cid:86)(cid:88)(cid:69)(cid:86)(cid:70)(cid:85)(cid:76)(cid:69)(cid:72)(cid:71)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:86)(cid:90)(cid:82)(cid:85)(cid:81)(cid:3)(cid:11)(cid:82)(cid:85)(cid:3)(cid:68)(cid:73)(cid:73)(cid:76)(cid:85)(cid:80)(cid:72)(cid:71)(cid:12) (cid:69)(cid:72)(cid:73)(cid:82)(cid:85)(cid:72) (cid:80)(cid:72)(cid:3)(cid:69)(cid:92)(cid:29)
`
`(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:17)
`Duncan Hall
`(cid:49)(cid:68)(cid:80)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:36)(cid:73)(cid:73)(cid:76)(cid:68)(cid:81)(cid:87)(cid:11)(cid:86)(cid:12)
`(cid:137) (cid:51) +,)(&&2 %()0( -) ' (cid:16)(cid:16)(cid:3)(cid:50)(cid:53)(cid:3)(cid:16)(cid:16)
`(cid:137) (cid:51)+)/  -) ' )( -# ,$, )! (cid:87)(cid:75)(cid:72)(cid:3)(cid:82)(cid:68)(cid:87)(cid:75)(cid:3)(cid:82)(cid:73)(cid:3)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:3)(cid:16)(cid:16)(cid:3)(cid:50)(cid:53)(cid:3)(cid:16)(cid:16)
` (cid:3)(cid:82)(cid:73)(cid:3)(cid:38)(cid:85)(cid:72)(cid:71)(cid:76)(cid:69)(cid:79)(cid:72)(cid:3)(cid:58)(cid:76)(cid:87)(cid:81)(cid:72)(cid:86)(cid:86)
`(cid:137) (cid:51)(cid:85)(cid:82)(cid:89)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:80)(cid:72)(cid:3)(cid:82)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:69)(cid:68)(cid:86)(cid:76)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:86)(cid:68)(cid:87)(cid:76)(cid:86)(cid:73)(cid:68)(cid:70)(cid:87)(cid:82)(cid:85)(cid:92)(cid:3)(cid:72)(cid:89)(cid:76)(cid:71)(cid:72)(cid:81)(cid:70)(cid:72)(cid:29)(cid:3)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`driver_license
`(cid:137)
`(cid:55)(cid:92)(cid:83)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:44)(cid:39)(cid:3)(cid:51)(cid:85)(cid:72)(cid:86)(cid:72)(cid:81)(cid:87)(cid:72)(cid:71)
`
`Notarized online using audio-video communication
`
`  '2 #( ( )!!$$& , &
`
`(cid:49)(cid:82)(cid:87)(cid:68)(cid:85)(cid:92)(cid:3)(cid:51)(cid:88)(cid:69)(cid:79)(cid:76)(cid:70)(cid:3)$"(-.+  (cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`
`(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66) (cid:66)(cid:66)
`
`
`(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66) (cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`
`(cid:49)(cid:82)(cid:87)(cid:68)(cid:85)(cid:92)(cid:3)(cid:49)(cid:68)(cid:80)(cid:72)(cid:29)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`Mikhail Clarke
`)-+(cid:92) (cid:38)(cid:82)(cid:80)(cid:80)(cid:76)(cid:86)(cid:86)(cid:76)(cid:82)(cid:81) .' +(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:3)
`HH7610
`(cid:49)(cid:82)(cid:87)(cid:68)(cid:85)(cid:92)(cid:3) )''$,,$)( 1*$+ ,(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`06/08/2024
`(cid:49)(cid:82)(cid:87)(cid:68)(cid:85)(cid:76)(cid:93)(cid:72)(cid:71)(cid:3)(cid:82)(cid:81)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:88)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:68)(cid:88)(cid:71)(cid:76)(cid:82)(cid:16)(cid:89)(cid:76)(cid:71)(cid:72)(cid:82)(cid:3)(cid:70)(cid:82)(cid:80)(cid:80)(cid:88)(cid:81)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)
`
`(cid:39)(cid:40)(cid:54)(cid:38)(cid:53)(cid:44)(cid:51)(cid:55)(cid:44)(cid:50)(cid:49)(cid:3)(cid:50)(cid:41)(cid:3)(cid:36)(cid:55)(cid:55)(cid:36)(cid:38)(cid:43)(cid:40)(cid:39)(cid:3)(cid:39)(cid:50)(cid:38)(cid:56)(cid:48)(cid:40)(cid:49)(cid:55)
`
`(cid:55)(cid:76)(cid:87)(cid:79)(cid:72)(cid:3)(cid:82)(cid:85)(cid:3)(cid:55)(cid:92)(cid:83)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:39)(cid:82)(cid:70)(cid:88)(cid:80)(cid:72)(cid:81)(cid:87)(cid:29) (cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`Affidavit of Authenticity
`
`(cid:39)(cid:82)(cid:70)(cid:88)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:39)(cid:68)(cid:87)(cid:72)(cid:29) (cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`01/27/2021
`
`(cid:49)(cid:88)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:82)(cid:73)(cid:3)(cid:51)(cid:68)(cid:74)(cid:72)(cid:86)(cid:3)(cid:11)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)(cid:81)(cid:82)(cid:87)(cid:68)(cid:85)(cid:76)(cid:68)(cid:79)(cid:3)(cid:70)(cid:72)(cid:85)(cid:87)(cid:76)(cid:73)(cid:76)(cid:70)(cid:68)(cid:87)(cid:72)(cid:12)(cid:29) (cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)(cid:66)
`11
`
`Apotex Exhibit 1022
`Page 11 of 11
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket