`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioner
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
`
`IPR Trial No. IPR2022-00855
`U.S. Patent No. 9,540,445
`
`DECLARATION OF THOMAS S. FLETCHER
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`Miltenyi v. UPenn
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`I, Thomas S. Fletcher, make the following Declaration pursuant to 28 U.S.C.
`§ 1746:
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`1. I am a partner at the law firm of Williams & Connolly LLP, Backup Counsel
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`for Real Party in Interest and Licensee Novartis Pharma AG. I am a member
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`of the bars of the State of California and the District of Columbia and
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`registered to practice in front of the United States Patent and Trademark
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`Office.
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`2. I submit this Declaration in connection with the above-identified Inter
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`Partes Review proceeding of U.S. Patent No. 9,540,445 that has been
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`instituted at the U.S. Patent and Trademark Office under 35 U.S.C §§ 311-
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`319, 37 C.F.R. § 42.
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`3. Exhibit 2001 is a true and correct copy of Jason Fagone, Has Carl June
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`Found a Key to Fighting Cancer?, PHILA. MAG. (Aug. 1, 2013), which
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`was downloaded from NewsBank and can be accessed behind a paywall at
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`the URL https://www.newsbank.com/. An exhibit label and page number
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`have been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`4. Exhibit 2002 is a true and correct copy of Denise Grady, An Immune System
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`Trained to Kill Cancer, N.Y. TIMES (Sept. 12, 2011), which was accessed
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`via the URL https://www.nytimes.com/2011/09/13/health/13gene.html and
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`printed to PDF. The article is now permanently accessible at the URL
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`IPR2022-00855
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`https://perma.cc/58EM-KPT5. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`5. Exhibit 2003 is a true and correct copy of Jasone Fagone, Walt Keller,
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`Leukemia Survivor, Has Passed, PHILA. MAG. (Feb. 20, 2014), which was
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`accessed via the URL https://www.phillymag.com/news/2014/02/20/walt-
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`keller-leukemia-survivor-obituary-1953-2014/ and printed to PDF. The
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`article is now permanently accessible at the URL https://perma.cc/5CL7-
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`ZPHV. An exhibit label and page number have been added to the bottom
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`right corner of this document, but no other alterations have been made.
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`6. Exhibit 2004 is a true and correct copy of Gina Kolata, A Cancer Treatment
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`Makes Leukemia Vanish, but Creates More Mysteries, N.Y. TIMES (Feb. 2,
`
`2022), which was accessed via the URL
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`https://www.nytimes.com/2022/02/02/health/leukemia-car-t-
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`immunotherapy.html and printed to PDF. The article is now permanently
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`accessible at the URL https://perma.cc/UV2W-PGCN. An exhibit label and
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`page number have been added to the bottom right corner of this document,
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`but no other alterations have been made.
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`7. Exhibit 2005 is a true and correct copy of Denise Grady, In Girl’s Last Hope,
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`Altered Immune Cells Beat Leukemia, N.Y. TIMES (Dec. 9, 2012), which
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`was accessed via the URL https://www.nytimes.com/2012/12/10/health/a-
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`breakthrough-against-leukemia-using-altered-t-cells.html and printed to
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`PDF. The article is now permanently accessible at the URL
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`https://perma.cc/NUD3-B43D. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`8. Exhibit 2006 is a true and correct copy of Denise Grady, F.D.A. Approves
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`First Gene-Altering Leukemia Treatment, Costing $475,000, N.Y. TIMES
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`(Aug. 30, 2017), which was accessed via the URL
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`https://www.nytimes.com/2017/08/30/health/gene-therapy-cancer.html and
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`printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/6T4Q-9W8D. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`9. Exhibit 2007 is a true and correct copy of FOOD AND DRUG ADMIN.,
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`FDA APPROVAL BRINGS FIRST GENE THERAPY TO THE UNITED
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`STATES (Aug. 30, 2017), which was accessed via the URL
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`https://www.fda.gov/news-events/press-announcements/fda-approval-
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`brings-first-gene-therapy-united-states and printed to PDF. The article is
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`now permanently accessible at the URL https://perma.cc/26LT-ESRX. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`10. Exhibit 2008 is a true and correct copy of FOOD AND DRUG ADMIN.,
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`BREAKTHROUGH THERAPY (Jan. 4, 2018), which was accessed via the
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`URL https://www.fda.gov/patients/fast-track-breakthrough-therapy-
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`accelerated-approval-priority-review/breakthrough-therapy and printed to
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`PDF. The article is now permanently accessible at the URL
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`https://perma.cc/FE35-UMTZ. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`11. Exhibit 2009 is a true and correct copy of FOOD AND DRUG
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`ADMIN., PRIORITY REVIEW (Jan. 4, 2018), which was accessed via
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`the URL https://www.fda.gov/patients/fast-track-breakthrough-therapy-
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`accelerated-approval-priority-review/priority-review and printed to
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`PDF. The article is now permanently accessible at the URL
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`https://perma.cc/HCV8-DDH6. An exhibit label and page number have
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`been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`12. Exhibit 2010 is a true and correct certified copy of Barbara Savoldo et al.,
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`CD28 costimulation improves expansion and persistence of chimeric antigen
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`receptor-modified T cells in lymphoma patients, 121 J. CLINICAL
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`INVESTIGATION 1822 (2011), which was accessed via the URL
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`https://www.jci.org/articles/view/46110/pdf and printed to PDF. The article
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`IPR2022-00855
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`is now permanently accessible at the URL https://perma.cc/UP9X-5BQ3. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`13. Exhibit 2011 is a true and correct copy of Brian G. Till et al., Adoptive
`
`immunotherapy for indolent non-Hodgkin lymphoma and mantle cell
`
`lymphoma using genetically modified autologous CD20-specific T cells, 112
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`BLOOD 2261 (2008), which was accessed via the URL
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`https://ashpublications.org/blood/article-
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`pdf/112/6/2261/1482883/zh801808002261.pdf and printed to PDF. The
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`article is now permanently accessible at the URL https://perma.cc/C8VW-
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`8PRT. An exhibit label and page number have been added to the bottom
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`right corner of this document, but no other alterations have been made.
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`14. Exhibit 2012 is a true and correct copy of Renier J. Brentjens et al., Safety
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`and persistence of adoptively transferred autologous CD19-targeted T cells
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`in patients with relapsed or chemotherapy refractory B-cell leukemias, 118
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`BLOOD 4817 (2011), which was downloaded from the journal website, and
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`is accessible behind a paywall at https://ashpublications.org/blood. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`15. Exhibit 2013 is a true and correct copy of Renier Brentjens et al., Treatment
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`of chronic lymphocytic leukemia with genetically targeted autologous T
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`cells: case report of an unforeseen adverse event in a phase I clinical trial,
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`18 MOLECULAR THERAPY 666 (2010), which was accessed via the
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`URL https://www.cell.com/action/showPdf?pii=S1525-
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`0016%2816%2932320-6 and printed to PDF. The article is now
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`permanently accessible at the URL https://perma.cc/R4QK-MCPH. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`16. Exhibit 2014 is a true and correct copy of Renier J. Brentjens et al., A Phase
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`I Trial for the Treatment of Chemo refractory Chronic Lymphocytic
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`Leukemia with CD19-Targeted Autologous T Cells, 16 MOLECULAR
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`THERAPY S15 (2008), which was accessed via the URL
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`https://www.cell.com/action/showPdf?pii=S1525-0016%2816%2939441-2
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`and printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/Z96K-WXU2. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`17. Exhibit 2015 is a true and correct copy of Jennifer Couzin-Frankel, The
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`dizzying journey to a new cancer arsenal, 340 SCI. 1514 (2013), which was
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`downloaded from the journal website, and is accessible behind a paywall at
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`https://www.science.org/. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`Miltenyi v. UPenn
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`have been made.
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`18. Exhibit 2016 is a true and correct copy of Jennifer Couzin-Frankel,
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`Breakthrough of the Year 2013: Cancer Immunotherapy, 342 SCI. 1432
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`(2013), which was accessed via the URL
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`https://www.science.org/doi/reader/10.1126/science.342.6165.1432 and
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`printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/5HSG-2PXX. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`19. Exhibit 2017 is a true and correct copy of David L. Porter et al., Chimeric
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`Antigen Receptor Modified T Cells Directed Against CD 19 (CTL0l 9 cells)
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`Have Long-Term Persistence And Induce Durable Responses In Relapsed,
`
`Refractory CLL, 122 BLOOD 4162 (2013), which was accessed via the
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`URL https://doi.org/10.1182/blood.V122.21.4162.4162 and printed to PDF.
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`The article is now permanently accessible at the URL
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`https://perma.cc/Q37K-TBLJ. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`20. Exhibit 2018 is a true and correct copy of David L. Porter et al.,
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`Randomized, Phase II Dose Optimization Study Of Chimeric Antigen
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`Receptor Modified T Cells Directed Against CD 19 (CTL019) In Patients
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`With Relapsed Refractory CLL, 122 BLOOD 873 (2013), which was
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`accessed via the URL https://doi.org/10.1182/blood.V124.21.1982.1982 and
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`printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/VH3U-PHED. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`21. Exhibit 2019 is a true and correct copy of Stephan A. Grupp et al., T Cells
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`Engineered With A Chimeric Antigen Receptor (CAR) Targeting CD 19
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`(CTL0l 9) Produce Significant In Vivo Proliferation, Complete Responses
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`And Long-Term Persistence Without GVHD In Children And Adults With
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`Relapsed, Refractory ALL, 122 BLOOD 67 (2013), which was accessed via
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`the URL https://doi.org/10.1182/blood.V122.21.67.67 and printed to PDF.
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`The article is now permanently accessible at the URL
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`https://perma.cc/A2UW-HG6Z. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`22. Exhibit 2020 is a true and correct copy of James N. Kochenderfer et al., B-
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`cell depletion and remissions of malignancy along with cytokine-associated
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`toxicity in a clinical trial of anti-CD 19 chimeric-antigen-receptor
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`transduced T cells, 119 BLOOD 2709 (2012), which was accessed via the
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`URL http://ashpublications.org/blood/article-
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`pdf/119/12/2709/1350836/zh801212002709.pdf and printed to PDF. The
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`article is now permanently accessible at the URL https://perma.cc/XV8C-
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`2MB6. An exhibit label and page number have been added to the bottom
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`right corner of this document, but no other alterations have been made.
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`23. Exhibit 2021 is a true and correct copy of Carl June Named One of Time’s
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`100 Most Influential People in the World, PENN MEDICINE (Apr. 26,
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`2018), which was accessed via the URL
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`https://pathology.med.upenn.edu/news/carl-june-named-one-times-100-
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`most-influential-people-world and printed to PDF. The article is now
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`permanently accessible at the URL https://perma.cc/53EQ-PAA6. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`24. Exhibit 2022 is a true and correct copy of Holly Auer, Penn Medicine
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`Immunotherapy Pioneer Carl June, MD, Awarded 2015 Paul Ehrlich and
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`Ludwig Darmstaedter Prize, PENN TODAY (Mar. 11, 2015), which was
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`accessed via the URL https://penntoday.upenn.edu/news/penn-medicine-
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`immunotherapy-pioneer-carl-june-md-awarded-2015-paul-ehrlich-and-
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`ludwig-darmstaed and printed to PDF. The article is now permanently
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`accessible at the URL https://perma.cc/J3ZX-6U5P. An exhibit label and
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`page number have been added to the bottom right corner of this document,
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`but no other alterations have been made.
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`25. Exhibit 2023 is a true and correct copy of Andrew Pollock, Setting the
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`Body’s ‘Serial Killers’ Loose on Cancer, N.Y. TIMES (Aug. 1, 2016),
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`which was accessed via the URL
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`https://www.nytimes.com/2016/08/02/health/cancer-cell-therapy-immune-
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`system.html and printed to PDF. The article is now permanently accessible
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`at the URL https://perma.cc/8627-LFXZ. An exhibit label and page number
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`have been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`26. Exhibit 2024 is a true and correct copy of 2015 Watanabe Award Winner
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`Carl H. June, IND. CLINICAL AND TRANSLATIONAL SCIS. INST.,
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`which was accessed via the URL https://indianactsi.org/awards/watanabe-
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`award-winners/2015-watanabe-award-winner-carl-h-june/ and printed to
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`PDF. The article is now permanently accessible at the URL
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`https://perma.cc/8C7V-82UD. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`27. Exhibit 2025 is a true and correct copy of Agilent Presents Thought Leader
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`Award to Drs. Carl H. June and Michael Milone, AGILENT TECHS. INC.
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`(Nov. 17, 2020), which was accessed via the URL
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`https://www.agilent.com/about/newsroom/presrel/2020/17nov-ca20030.html
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`and printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/Y5XK-P9XV. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`28. Exhibit 2028 is a true and correct copy of World Intell. Prop. Org. Patent
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`Application No. WO 02/077029 A2, which was downloaded as a PDF via
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`the URL
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`https://patentimages.storage.googleapis.com/ef/37/cd/ac3bb81b2861a9/WO
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`2002077029A2.pdf. An exhibit label and page number have been added to
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`the bottom right corner of this document, but no other alterations have been
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`made.
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`29. Exhibit 2029 is a true and correct certified copy of Pilot Study for Patients
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`with Chemotherapy Resistant or Refractory CD19 Leukemia and Lymphoma
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`(CART-19), CLINICALTRIALS.GOV (April 29, 2009), which was
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`accessed via the URL
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`http://web.archive.org/web/20090903002304/http://clinicaltrials.gov/ct2/sho
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`w/NCT00891215 and printed to PDF. The article is now permanently
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`accessible at the URL https://perma.cc/9XCR-AK6R. An exhibit label and
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`page number have been added to the bottom right corner of this document,
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`but no other alterations have been made.
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`30. Exhibit 2031 is a true and correct copy of Steven A. Rosenberg et al., Use of
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`Tumor-Infiltrating Lymphocytes and Interleukin-2 in the Immunotherapy of
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`Patients with Metastatic Melanoma, 319 NEW ENG. J. MED. 1676 (1988),
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`which was downloaded from the journal website, and is accessible behind a
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`paywall at https://www.nejm.org/. An exhibit label and page number have
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`been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`31. Exhibit 2032 is a true and correct copy of Michael C. Jensen et al.,
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`Antitransgene Rejection Responses Contribute to Attenuated Persistence of
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`Adoptively Transferred CD20/CD19-Specific Chimeric Antigen Receptor
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`Redirected T Cells in Humans, 16 BIOLOGY BLOOD AND MARROW
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`TRANSPLANTATION 1245 (2010), which was accessed via the URL
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`https://www.astctjournal.org/action/showPdf?pii=S1083-
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`8791%2810%2900119-9 and printed to PDF. The article is now
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`permanently accessible at the URL https://perma.cc/L4C7-6FVD. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`32. Exhibit 2033 is a true and correct copy of Richard A. Morgan et al., Case
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`Report of a Serious Adverse Event Following the Administration of T Cells
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`Transduced With a Chimeric Antigen Receptor Recognizing ERBB2, 18
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`MOLECULAR THERAPY 843 (2010), which was accessed via the URL
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`https://www.cell.com/action/showPdf?pii=S1525-0016%2816%2932342-5
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`and printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/TFX5-D5W3. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`33. Exhibit 2034 is a true and correct copy of David L. Porter et al., A phase 1
`
`trial of donor lymphocyte infusions expanded and activated ex vivo via
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`CD3/CD28 costimulation, 107 BLOOD 1325 (2006), which was accessed
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`via the URL
`
`https://www.sciencedirect.com/science/article/pii/S0006497120663819/pdfft
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`?md5=71c1c9655096c9d57eef2490a3cc20a2&pid=1-s2.0-
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`S0006497120663819-main.pdf and printed to PDF. The article is now
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`permanently accessible at the URL https://perma.cc/9TRY-KHUZ. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`34. Exhibit 2035 is a true and correct copy of Grazyna Lipowska-Bhalla,
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`Targeted immunotherapy of cancer with CAR T cells: achievements and
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`challenges, 61 CANCER IMMUNOLOGY, IMMUNOTHERAPY 953
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`(2012), which was accessed via the URL
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`https://link.springer.com/article/10.1007/s00262-012-1254-0 and printed to
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`PDF. An exhibit label and page number have been added to the bottom right
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`corner of this document, but no other alterations have been made.
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`35. Exhibit 2036 is a true and correct copy of Latest paper from the father of
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`CAR-T: CAR-T really completely cured cancer, MEDICALTREND.ORG,
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`which was accessed via the URL https://medicaltrend.org/2022/02/03/latest-
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`paper-from-the-father-of-car-t-car-t-really-completely-cured-cancer/ and
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`printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/Q63N-5MZZ. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`36. Exhibit 2037 is a true and correct copy of Bipulendu Jena et al., Redirecting
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`T-cell specificity by introducing a tumor-specific chimeric antigen receptor,
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`116 BLOOD 1035 (2010), which was accessed via the URL
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`https://ashpublications.org/blood/article-
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`pdf/116/7/1035/1333755/zh803310001035.pdf and printed to PDF. The
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`article is now permanently accessible at the URL https://perma.cc/A9UN-
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`FALF. An exhibit label and page number have been added to the bottom
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`right corner of this document, but no other alterations have been made.
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`37. Exhibit 2038 is a true and correct copy of Michael H. Kershaw et al., A
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`Phase I Study on Adoptive Immunotherapy Using Gene-Modified T Cells for
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`Ovarian Cancer, 12 CLINICAL CANCER RSCH. 6106 (2006), which was
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`accessed via the URL https://aacrjournals.org/clincancerres/article-
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`pdf/12/20/6106/1965492/6106.pdf and printed to PDF. The article is now
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`permanently accessible at the URL https://perma.cc/Y8G3-44H9. An exhibit
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`label and page number have been added to the bottom right corner of this
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`document, but no other alterations have been made.
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`38. Exhibit 2039 is a true and correct copy of Cor H.J. Lamers et al., Treatment
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`of Metastatic Renal Cell Carcinoma With Autologous T-Lymphocytes
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`Genetically Retargeted Against Carbonic Anhydrase IX: First Clinical
`
`Experience, 24 J. CLINICAL ONCOLOGY e20 (2006), which was accessed
`
`via the URL
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`https://ascopubs.org/doi/pdf/10.1200/JCO.2006.05.9964?role=tab and
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`printed to PDF. The article is now permanently accessible at the URL
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`https://perma.cc/J3R6-4FWD. An exhibit label and page number have been
`
`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`39. Exhibit 2040 is a true and correct copy of ASH honors Bruce R. Blazar,
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`M.D., and Carl H. June, M.D., with 2012 Ernest Beutler Lecture and Prize,
`
`SCIENCEX (Aug. 27, 2012), which was accessed via the URL
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`https://sciencex.com/wire-news/107531358/ash-honors-bruce-r-blazar-md-
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`and-carl-h-june-md-with-2012-ernest.html and printed to PDF. The article is
`
`now permanently accessible at the URL https://perma.cc/NR7V-86KJ. An
`
`exhibit label and page number have been added to the bottom right corner of
`
`this document, but no other alterations have been made.
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`40. Exhibit 2041 is a true and correct copy of Renier J. Brentjens et al.,
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`Miltenyi v. UPenn
`IPR2022-00855
`Page 16
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`Genetically Targeted T Cells Eradicate Systemic Acute Lymphoblastic
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`Leukemia Xenografts, 13 CLINICAL CANCER RSCH. 5426 (2007), which
`
`was accessed via the URL https://aacrjournals.org/clincancerres/article-
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`pdf/13/18/5426/1972030/5426.pdf and printed to PDF. The article is now
`
`permanently accessible at the URL https://perma.cc/LX5K-Z86V. An
`
`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`41. Exhibit 2042 is a true and correct copy of U.S. Patent No. 7,402,431, which
`
`was downloaded as a PDF via the URL https://patentcenter.uspto.gov/. An
`
`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`42. Exhibit 2043 is a true and correct copy of Cancer treatment myths: Any
`
`truth to these common beliefs?, MAYO CLINIC (March 22, 2022), which
`
`was accessed via the URL https://www.mayoclinic.org/diseases-
`
`conditions/cancer/in-depth/cancer/art-20046762 and printed to PDF. The
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`article is now permanently accessible at the URL https://perma.cc/6VDG-
`
`YS55. An exhibit label and page number have been added to the bottom
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`right corner of this document, but no other alterations have been made.
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`43. Exhibit 2045 is a true and correct copy of SITC Smalley Award 2013
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`Recipient, SOC’Y FOR IMMUNOTHERAPY OF CANCER, which was
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`accessed via the URL https://www.sitcancer.org/funding/named-funds-and-
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`Miltenyi v. UPenn
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`awards2/smalley/2013 and printed to PDF. The article is now permanently
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`accessible at the URL https://perma.cc/3WZF-CH3F. An exhibit label and
`
`page number have been added to the bottom right corner of this document,
`
`but no other alterations have been made.
`
`44. Exhibit 2046 is a true and correct copy of AAI-Steinman Award for Human
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`Immunology Research Past Recipients, AM. ASS’N OF
`
`IMMUNOLOGISTS, which was accessed via the URL
`
`https://www.aai.org/Awards/Career-Awards/AAI-Steinman-Award-for-
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`Human-Immunology-Research/Past-Recipients.aspx and printed to PDF.
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`The article is now permanently accessible at the URL
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`https://perma.cc/3PCP-UG43. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`45. Exhibit 2047 is a true and correct copy of File History of the ’445 Patent,
`
`which was downloaded as a PDF via the URL
`
`https://patentcenter.uspto.gov/. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`Miltenyi v. UPenn
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`I declare under penalty of perjury under the law of the United States of
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`America that the foregoing is true and correct.
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`Dated: November 8, 2022
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` /s/ Thomas S. Fletcher
`Thomas S. Fletcher
`Reg. No. 72,383
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