`
`www.archive.org
`415.561.6767
`415.840-0391 e-fax
`
`Internet Archive
`300 Funston Avenue
`San Francisco, CA 94118
`_____________________
`
`
`
`
`AFFIDAVIT OF NATHANIEL E FRANK-WHITE
`
`
`1. I am a Records Request Processor at the Internet Archive. 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`may select one of those dates, and begin browsing an archived version of the Web.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`visitor clicks on a hyperlink on an archived page that points to another URL, the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). 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.
`
`6. Attached hereto as Exhibit A are true and accurate copies 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.
`
`Regeneron Exhibit 1232.001
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`
`
`7. I declare under penalty of perjury under the laws of the United States of America
`that the foregoing is true and correct.
`
`
`
`
`
`
`
`
`
`DATE: ________________________
`
`
`________________________
`Nathaniel E Frank-White
`
`Regeneron Exhibit 1232.002
`Regeneron v. Novartis
`IPR2021-00816
`
`03/04/2022
`
`

`

`
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`Regeneron Exhibit 1232.003
`Regeneron Exhibit 1232.003
`Regeneron v. Novartis
`Regeneronv. Novartis
`IPR2021-00816
`IPR2021-00816
`
`

`

`https://web.archive.org/web/20110202085222/http:/eyetech.com/
`
`Regeneron Exhibit 1232.004
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`InteERNET ARCHIVE
`wayogenmachine
`
`
`
`|http://eyetech.com/
`
`
`
`
`136 captures
`
`OMX)
`
`2013 Gartner feet
`
`23 May 1998 - 22 May 2016 Ho
`
`xp techInc.
`
`science, vision, hope.
`
`
`
`EEF Home Patient/Caregiver|Health Care Provider|News &Media a
`
`Recent Accomplishments
`A A A|Adjust Text Size
`
`Eyetech developed and
`introduced the Luer Lok®
`syringe delivery for Macugen,
`representing a significant
`advancein delivery technology:
`
`* Only FDA-approvedpre-filled
`syringe designedforintravitreal
`injection
`
`* Entire syringe packageis
`terminally sterilized for delivery
`safety
`
`Improved detached 30-gauge
`e
`needle for comfort and
`consistency
`
`* Eyetech continuesto offer an
`enhanced Macugen Access
`Program™ (MAP)to assist
`patients with reimbursement.
`(Learn more.]
`
`* Eyetech more than doubled
`the size of its workforce since
`launching the company in August
`2008. Eyetech is committed to
`being the most knowledgeable
`sales force in the ophthalmic
`industry.
`
`Helpful Links
`
`Macugen.com
`
`Our Vision
`
`Weaspire to be a leading ophthalmic biotechnology companythat
`applies innovative science to help improvethe vision health of
`patients with sight-threatening diseasesofthe retina.
`
`Our Product
`
`Macugen®(pegaptanib sodium injection)is a novel selective anti-
`VEGF inhibitor indicated for the treatment of neovascular (wet) age-
`related macular degeneration (AMD). Macugen was approved by the
`Food and Drug Administration (FDA) in December 2004 and has
`been shownto be effective for long-term use. Eyetech Inc. markets
`and sells Macugenin the United States and Pfizer Inc. markets and
`sells Macugenoutside of the United States. Pleasevisit
`www.macugen.com to learn more about Macugen.
`
`Important Safety Information
`
`MACUGENis contraindicated in patients with ocular or periocular
`infections or with known hypersensitivity to pegaptanib sodium or any
`other excipient in this product.
`
`Safety or efficacy of MACUGEN beyond 2 years has not been
`demonstrated.
`
`Intravitreal injections including those with MACUGENhave been
`associated with endophthalmitis. Proper aseptic injection technique—
`whichincludes useofsterile gloves,a sterile drape, and a sterile eyelid
`speculum (or equivalent)—should alwaysbe utilized when
`administering MACUGEN. In addition, patients should be monitored
`during the weekfollowingthe injection to permit early treatment, should
`aninfection occur.
`
`Increasesin intraocular pressure (IOP) have been seen within 30
`minutesof injection with MACUGEN. Therefore, IOP as well as the
`perfusion of the optic nerve head should be monitored and managed
`appropriately.
`
`Rare cases of anaphylaxis/anaphylactoid reactions, including
`angioedema, have been reported in postmarketing experience
`following the intravitreal administration procedure.
`
`Serious adverse eventsrelated to the injection procedure occurring in
`<1% of intravitreal injections included endophthalmitis, retinal
`detachment, and iatrogenic traumatic cataract.
`
`Mostfrequently reported adverse events in patients treated for up to 2
`years were anterior chamberinflammation,blurred vision, cataract,
`
`Regeneron Exhibit 1232.005
`Regeneron Exhibit 1232.005
`Regeneron v. Novartis
`Regeneronv. Novartis
`IPR2021-00816
`IPR2021-00816
`
`

`

`conjunctival hemorrhage, corneal edema, eye discharge, eyeirritation,
`eye pain, hypertension, increased IOP, ocular discomfort, punctate
`keratitis, reduced visual acuity, visual disturbance, vitreous floaters,
`and vitreous opacities. These events occurred in approximately 10% to
`40% of patients.
`
`© Eyetech Inc. 2009 | Terms and Conditions | Privacy Policy | Prescribing Information
`This information is intended only for residents of the United States
`
`Regeneron Exhibit 1232.006
`Regeneron Exhibit 1232.006
`Regeneron v. Novartis
`Regeneronv. Novartis
`IPR2021-00816
`IPR2021-00816
`
`

`

` 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): _____________
`
`Regeneron Exhibit 1232.007
`Regeneron v. Novartis
`IPR2021-00816
`
`TEXAS
`
`Harris
`
`03/04/2022
`
`Abby Spotsville
`
`Nathaniel E Frank-White
`
`driver_license
`
`Notary Public, State of Texas
`
`Abby Spotsville
`133226427
`07/22/2025
`
`Affidavit of Nathaniel E Frank-White
`
`03/04/2022
`
`7
`
`