E- ARCHIVE
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`l,l.J ; : :~
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`~ 1111
`
`archive.org
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`DECLARATION OF NATHANIEL E FRANK-WHITE
`
`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`may select one of those dates, and begin browsing an archived version of the Web.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`visitor clicks on a hyperlink on an archived page that points to another URL, the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). 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.
`
`Miltenyi Ex. 1039 Page 1
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`

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`E- ARCHIVE
`l,l.J iC~
`
`~ 1111
`
`archive.org
`
`7.
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`April 1, 2022
`DATE: ________________________
`
`________________________
`Nathaniel E Frank-White
`
`Miltenyi Ex. 1039 Page 2
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`

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`
`
`EXHIBIT A
`EXHIBIT A
`
`Miltenyi Ex. 1039 Page 3
`
`Miltenyi Ex. 1039 Page 3
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`

`

`https://web.archive.org/web/20110924175244/http://www.nejm.org/doi/full/10.1056/NEJMoa110384
`9
`
`Miltenyi Ex. 1039 Page 4
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`

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`, . , ""' , • • , • , v ,
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`lhttp://Www.nejm.org/doi/full/10. 1056/NEJMoa 1103849
`
`ms~1ae~m~u~m~ 315 caP.tures
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`J3 Sep 2011 ;,,1 Mar?On
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`O RIGLNAL ARTJQ.E
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`l9 E. MA.IL
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`DOWNL OAD CITATION
`
`Chimeric Antigen Receptor- Modified T Cells in Chronic
`Lymphoid Leukemia
`David L. Porter. M.D .. Bruce L. Levine, Ph.D .. Michael Kalos Ph.D., Adam Bagg, M.D., and Carl H. June, M.D
`N Engl J Med 2011; 365:725-733 August 25, 2011
`
`;\lf.l)IA 1N1"1-11$ AR'l'I CU:
`
`FIGURE 1
`
`Clinical Response In lhe
`Patient.
`
`FIGURE 2
`
`L
`Serum and Bone Marrow
`Cytokines belo,e and after
`Chimeric Antigen Reoeptor T(cid:173)
`Cell Infusion.
`
`A RTICU~ .,\ CTJ\ TI\'
`2 artlctes Mve ctted IN!. attictc
`
`We designed a lentiviral vector expressing a chimeric antigen
`receptor with specificity for the B-cell antigen CD19, coupled with
`CD137 (a costimulatory receptor in T cells (4-16B1) and CD3-zeta (a
`signal-transduction component or the T-cell antigen receptor)
`signaling domains. A low dose (approximately 1.5• 105 cells per
`kilogram of body weight) of autologous chimeric antigen receptor(cid:173)
`modified T cells reinfused into a patient with refractory chronic
`lymphocytic leukemia (CLL) expanded to a level that was more than
`1000 times as high as the initial engraftment level in vivo. with
`delayed development or the tumor lysis syndrome and wilh complete
`remission. Apart from the tumor lysis syndrome. the only other grade
`314 toxic effect related to chimeric antigen receptor T cells was
`lymphopenia. Engineered cells persisted at high levels for 6 months in
`the blood and bone marrow and continued to express the chimeric
`antigen receptor. A specific immune response was detected in the
`bone marrow, accompanied by loss of normal B cells and leukemia
`cells that express CD19. Remission was ongoing 10 months after
`treatment. Hypogammaglobulinemia was an expected chronic toxic
`effect.
`
`Supported in part by granls from the National lnsUlules of Health {K24
`CA11787901, 1PN2-EY016586, and R01CA120409), theAlliancefor
`cancer Gene Therapy. and the Leukemia and LymphOma society
`(7000-02).
`
`Disclosure fomis provided by the authors are available with the full
`text of this article at NEJM.org.
`
`This article (10.1056/NEJMoa1103849) was published on August 10,
`201 1. at NEJM.org.
`
`We thank Irina Kulikovskaya for the quanlitative polymerase-chain(cid:173)
`reaction (Q-PCR) assay: Erica Suppa and Casey Krebs for the
`Luminex assay: Jennifer Wright for Q-PCR assay development: John
`Scholler for assay development; Tatiana Mikheeva for sample
`processing; Qun-Bin Xiong for now-cytometric analysis; Zhaohui
`Zheng, Julio Cotte, Andrea Brennan. and members of the Clinical Cell
`and Vaccine Production facility for developing methods for clinical(cid:173)
`scale ex vivo lentiviral transduction and for cell manufacturing; the
`Human Immunology Core for reagents; Baro Dropulic (Lentigen) for
`clinical-grade vector production; Elizabeth Veloso. Lester Lledo, Joan
`Gilmore, Gwendolyn Binder, and Anne Chew for assistance in clinical
`research support: Sharyn Katz for assistance with imaging: and
`Stephan Schuster. Elizabetll Hexner, Stephan Grupp, Carmine
`Carpenito, Michael Milone, and Donald Siegel for advice.
`
`Miltenyi Ex. 1039 Page 5
`
`

`

`SOURCE I:\'FOR.\IATIO;\
`
`From the Abramson Canc0< Genier (D.l.P., B.L.L., M.K., A.8., C.H.J.), the
`Oepanment of Medicine (O.L.P.). the Department of Palhology and Laboratory
`Medicine (B.L.L., M.K., A.B .. C.H.J.), and the Abramson Family Cancer Research
`lnstilute (8.L.l., M.K., C.H.J.), Perelman School of Medicine, Umversityof
`Pennsyrvania, Philadelphia.
`
`Address reprint requests to Or. Porter at tho Division of Hematology and
`Oncology, University of Penn$ylvllnia Modica.I Center, 3400 Civic Center 0tvd.,
`PCAM 2 West Pavilion, Philadelphia, PA 19104. or al
`david.poner@uphs.upenn.edu.
`
`Acce,"i thi, :irricle: Subscribe to NEJM I Purchase this article
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`Miltenyi Ex. 1039 Page 6
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