`
`www.archive.org
`
`415.561.6767
`
`415.840-0391 e-fax
`
`
`
`Internet Archive
`
`300 Funston Avenue
`
`San Francisco, CA 94118
`
`_____________________
`
`AFFIDAVIT OF DUNCAN HALL
`
`
`
`1. I am a Records Request Processor at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink’s URL with the
`closest available date to the initial file containing the hyperlink.
`
`
`4. The archived data made viewable and browseable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL] aka an “extended URL”. Thus, the extended URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28
`seconds (1997/01/26 at 04:58:28). A web browser may be set such that a printout
`from it will display the URL of a web page in the printout’s footer. The date
`indicated by an extended URL applies to a preserved instance of a file for a given
`URL, but not necessarily to any other files linked therein. Thus, in the case of a
`page constituted by a primary HTML file and other separate files (e.g., files with
`images, audio, multimedia, design elements, or other embedded content) linked
`within that primary HTML file, the primary HTML file and the other files will each
`have their own respective extended URLs and may not have been archived on the
`same dates.
`
`
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 1
`
`

`

`
`
`6. Attached hereto as Exhibit A are true and accurate copies of printouts of
`screenshots of the Internet Archive's records of the archived files for the URLs and
`the dates specified in the attached coversheet of each printout.
`
`
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`
`
`
`
`
`
`
`DATE: ________________________
`
`
`________________________
`Duncan Hall
`
`01/27/2021
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`

`

`
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, |PR2021-00881
`Page 3
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 3
`
`

`

`https://web.archive.org/web/20090813064936/https://clinicaltrials.gov/ct2/show/NCT006373
`77
`
`
`
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 4
`
`

`

`mrmn ,\ R r u x \ r
`
`
`
`https://clinicaltria|s.gov/ct2/show/NCT00637377
`
`
`
`
`
`llllllllllltlllflllflfllflll 214m
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`18lan 20097 23Jan 2017
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`&p to Maln Content
`'
`'
`°
`ClmlcalTrials.gov
`Asmice 01th! u.s. National Institutes of Health
`
`
`{ Tabular View | { No Study Results Posted
`
`Full T6)“ View
`
`2010 VAbuutthis cam
`
`
`Home
`Search
`Stud To ics Gloss
`y
`P
`“y-
`
`I Search I
`
`
`
`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 Change_s
`
`Information provided by: ClinicalTrials.g0v Identifier: NCT00637377
`
`> Purpose
`
`This study is a phase III, double-masked, randomized, study of the 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
`
`Phase III
`
`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 Doses of Intravitreal VEGF Trap in Subjects
`With Neovascular Age-Related Macular Degeneration (AMD).
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: X-linked juvenile retinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`D_rug Information available for: Ranibizumab Aflibercep_t
`US. FDA Resources
`
`Further study details as provided by Bayer:
`
`Primary Outcome Measures:
`- The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart
`compared to 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 ETDRS letter score at Week 52 [ Time Frame: week 52 ] [ Designated as safety 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 ]
`I 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)
`
`Assigned Interventions
`
`Arm 3:
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-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.
`
`Arm 1:
`Experimental
`
`Drug: VEGF Trap-Eye
`0.5 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no
`
`less frequently than every 12 weeks.
`
`Arm 2:
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, |PR2021-00881
`Page 5
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 5
`
`

`

`ICED ricqucuuy Lll'dJl CVCIy 1A WCCIKS.
`
`Arm 4: Active
`Comparator
`
`every 12 weeks.
`
`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 than
`
`b Eligibility
`
`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`Inclusion Criteria:
`
`50 Years and older
`Both
`N0
`
`- Signed informed consent.
`- Men and women >/=50 years of age.
`- 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.
`- ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
`- Willing, committed, and able to return for ALL clinic 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:
`
`- Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
`- Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
`- Any prior treatment with anti-VEGF agents in the study eye.
`- Total lesion size >12 disc areas (30.5 mm�, including blood, scars and neovascularization) as assessed by FA in the study eye.
`- Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is
`under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
`- Scar or fibrosis making up >50% of the total lesion in the study eye.
`- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
`- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
`- History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
`- Presence of other causes of CNV in the study eye.
`- Prior vitrectomy in the study eye.
`- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
`- Any history of macular hole of stage 2 and above in the study eye.
`- Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is
`unlikely to interfere with the injection.
`- History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
`
`> 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
`
`fl Show 212 Study Locations
`
`Sponsors and Collaborators
`Bayer
`
`Investigators
`Study Director: Bayer Study Director Bayer
`
`> More Information
`
`Additional Information:
`
`Click here and search for drug information provided by the FDA fl
`
`Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product w
`
`
`
`Click here to find results for studies related to marketed products E
`
`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 Changg
`Health Authority:
`Switzerland: Ethikkommission
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, |PR2021-00881
`Page 6
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 6
`
`

`

`Keywords provided by Bayer:
`Eye diseases
`Vision Impairment and Blindness
`Eyes and Vision
`
`Study placed in 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
`
`Back to 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,
`U.S. National Institutes of Health, U.S. Department of Health & Human Services,
`USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act
`
`fat I! <¢
`
`an,“ NLM x.
`
`Links to all studies - primarily for crawlers
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, |PR2021-00881
`Page 7
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 7
`
`

`

`https://web.archive.org/web/20090911163626/https://clinicaltrials.gov/ct2/show/NCT005097
`95
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 8
`
`

`

`
`
`mrnmn A R r u l V r
`https://clinicaltria|s.gov/ct2/show/NCT00509795
`
`
`
`
`mflunflflllmflfllllllll Mm1 Dec 2008 7 23 Sep 2020
`
`
`
`
`ClinicalTrialS gov
`Home
`Search
`Study Topics Glossary
`
`
`Aslrvicn mm u.s. National Inflitmls of Health
`I Search |
`
`
`Fun TEXt View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`Vascular Endothelial Growth Factor(VEGF)Trap-Eye:lnvestigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration(AMD) (VIEW 1)
`
`This study is currently recruiting participants.
`Verified by Regeneron Pharmaceuticals, April 2009
`
`First Received: July 31, 2007 Last Updated: April 28, 2009 History of Changfi
`
`Sponsors and Collaborators: gzgeerneron Pharmaceuticals
`
`ClinicalTrials.govIdentifier: NCT00509795
`
`Purpose
`This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately
`1200 patients will be randomized in the US and Canada.
`
`M—— Macular Degeneration
`
`Drug: VEGF Trap-Eye
`Drug: Ranibizumab
`
`Phase III
`
`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 ”I Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With
`Neovascular Age-Related Macular Degeneration
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: X-linked juvenile retinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`flg Information available for: Ranibizumab Aflibercem
`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 subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS
`chart compared to baseline (i.e. prevention of moderate vision loss) [Time Frame: Week 52 ] [ Designated as safety issue: Yes]
`
`Secondaw Outcome Measures:
`. Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 [Time Frame: Week 52 ] [ Designated as safety 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 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 ]
`
`1200
`Estimated Enrollment:
`August 2007
`Study Start Date:
`December 2011
`Estimated Study Completion Date:
`Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
`
`m Assigned Interventions
`1'
`Drug: VEGF Trap-Eye
`Experimental
`0.5 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`2'
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during the first 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.
`
`3'
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-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.
`
`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
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, |PR2021-00881
`Page 9
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 9
`
`

`

`tllnglllIy
`
`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`50 Years and older
`Both
`No
`
`Key Inclusion Criteria:
`1. Signed Informed Consent.
`2. Men and women 2 50 years of 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. ETDRS best-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 due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4)
`understand and willing to sign the informed consent form.
`
`Key Exclusion Criteria:
`1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
`2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
`3. Any prior treatment with anti-VEGF agents in the study eye.
`4. Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
`5 . Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood
`is under the fovea, then the fovea must be surrounded 270 degrees by Visible CNV.)
`. Scar or fibrosis, making up > 50% of total lesion in the study eye.
`. Scar, fibrosis, or atrophy involving the center of the fovea.
`. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
`9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
`0 . Presence of other causes of CNV in the study eye.
`11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
`12. Prior vitrectomy in the study eye.
`13. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
`14. Any history of macular hole of stage 2 and above in the study eye.
`15. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its
`unlikely to interfere with the injection.
`
`67 8
`
`Contacts and Locations
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00509795
`
`Contacts
`Contact: Regeneron
`
`866-549-8439 VIEW1study@rtp.ppdi.com
`
`i] Show 191 Study Locations
`Sponsors and Collaborators
`Regeneron Pharmaceuticals
`Bayer
`
`Investigators
`Study Director: Avner lngerman, MD Regeneron Pharmaceuticals
`
`More Information
`
`No publications provided
`
`Regeneron Pharmaceuticals ( Dr. Avner lngerman )
`Responsible Party:
`VGFT—OD-0605
`Study ID Numbers:
`July 31, 2007
`Study First Received:
`April 28, 2009
`Last Updated:
`History of Changfi
`ClinicalTrials.gov Identifier: NCT00509795
`Health Authority:
`United States: Food and Drug Administration; Canada: Health Canada
`
`Study placed in 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. National Institutes of Health, U.S. Department of Health & Human Services,
`USA.gov, Copyflght, Privacy, Accessibility, Freedom of Information Act
`
`,AUS. National Institutes of Health ,MUS. National Library of Medicine [MUS Department of Health a Human SeNices
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 10
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 10
`
`

`

` JURAT
`
`State/Commonwealth of _____________________
`
` City County of ______________________
`
`)
`)
`)
`
`On __________________, before me, _________________________________________ ,
`Date
`Notary Name
` the foregoing instrument was subscribed and sworn (or affirmed) before me by:
`
`________________________________________________________________________.
`Name of Affiant(s)
`
` Personally known to me -- OR --
`
` Proved to me on the basis of the oath of _____________________________ -- OR --
`Name of Credible Witness
` Proved to me on the basis of satisfactory evidence: ________________________________
`Type of ID Presented
`
`WITNESS my hand and official seal.
`
`Notary Public Signature: _________________________
`
`Notary Name:__________________________________
`Notary Commission Number:______________________
`Notary Commission Expires:______________________
`Notarized online using audio-video communication
`
`DESCRIPTION OF ATTACHED DOCUMENT
`
`Title or Type of Document: ____________________________________________________
`
`Document Date: ________________________________
`
`Number of Pages (including notarial certificate): _____________
`
`FLORIDA
`
`Broward
`
`01/27/2021
`
`Mikhail Clarke
`
`Duncan Hall
`
`driver_license
`
`Notarized online using audio-video communication
`
`Mikhail Clarke
`HH7610
`06/08/2024
`
`Affidavit of Authenticity
`
`01/27/2021
`
`11
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00881
`Page 11
`
`