`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
` AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`HALE BIOPHARMA VENTURES, LLC,
`Patent Owner.
`____________________
`
`Case IPR2019-00451
`Patent 9,763,876
`____________________
`
`PATENT OWNER UPDATED EXHIBIT LIST
`
`
`
`Exhibit
`No.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`Description
`
`Epilepsy Fast Facts, CDC (Center for Disease Control and
`Prevetions), CDC 24/7: Saving Lives, Protection People™, Apr. 9,
`2019, pp. 1-2.
`
`Grant Fast Track – Dept. of Health and Human Services re: IND
`112621; NRL-1 (diazepam intranasal solution), Dec. 27, 2016, pp
`1-2.
`
`Howard LeWine, M.D., “Quick Injection Helps Stop Epileptic
`Seizures,” Harvard Health Blog, Feb. 23, 2012; p. 1
`
`“Managing Epilepsy Well Network and Selected Self-Management
`Programs; Putting Collective Wisdom to Work for People with
`Epilepsy,” Prevention Research Centers (PRC), CDC , Nov. 2016,
`pp.1-17
`
`K.M. Fiest, et al., “Prevalence and Incidence of Epilepsy, A
`Systematic Review and Meta-Analysis of International Studies,”
`NEUROLOGY 88, Jan. 17, 2017, pp.296-303
`
`SIGMA Chemical Company Catalog (1988)
`
`E. Bechgaard et al., “Solubilization of Various Benzodiazepines for
`Intranasal Administration, A Pilot Study,” Pharmaceutical
`Development and Technology 2:293-296 (1997)
`
`A. Hussain et al. “Nasal Absorption of Propranolol in Humans,”
`Journal of Pharmaceutical Sciences 69:1240 (1980)
`
`S. Lau and J. Slattery, “Absorption of Diazepam and Lorazepam
`Following Intranasal Administration,” International Journal of
`Pharmaceutics, 54:171-174 (1989)
`
`M. Schols-Hendriks et al., “Absorption of Clonazepam After
`Intranasal and Buccal Administration,” British Journal of Clinical
`Pharmacology 39:449-451 (1995)
`
`2011
`
`Dr. Nicholas Peppas Deposition Transcript, October 24, 2019.
`
`-2-
`
`
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`Declaration of Dr. Sveinbjorn Gizurarson, Ph.D.
`
`J. Riss et al., “Benzodiazepines in Epilepsy: Pharmacology and
`Pharmacokinetics,” Acta Neurologica Scandinavica 118:69-86
`(2008)
`
`D. Wermeling, U.S. Patent No. 6,610,271, issued August 26, 2003
`
`C. Cole et al., “Community Survey of Carer’s: Individual Epilepsy
`Guidelines (IEG) for Rescue Medication,” Seizure 18:220-224
`(2009)
`
`D. Terry et al., “Acceptance of the Use of Diazepam Rectal Gel in
`School and Day Care Settings,” Journal of Child Neurology
`22:1135-1138 (2007)
`
`Diastat® Label (2005)
`
`“UCB announces NAYZILAM® (midazolam) nasal spray now
`approved by FDA to treat intermittent, stereotypic episodes of
`frequent seizure activity in people living with epilepsy in the U.S.,”
`UCB Press Release,
`https://www.biospace.com/article/releases/ucb-announces-
`nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-
`intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-
`people-living-with-epilepsy-in-the-u-s-/ (2019) (Accessed October
`31, 2019)
`
`J. French and T. Pedley, “Initial Management of Epilepsy,” New
`England Journal of Medicine 359:166-176 (2008)
`
`G. Corbo et al. “Measurement of Nasal Mucociliary Clearance,”
`Archives of Disease in Childhood 64:546-550 (1989)
`
`“How does the nose work? The nasal mucosa,”
`https://www.fitonasal2act.com/how-does-the-nose-work/the-nasal-
`mucosa/ (Accessed November 5, 2019)
`
`N. Mygind, “Nasal Allergy,” 9 (Blackwell Scientific Publications,
`1979)
`
`-3-
`
`
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`“Neurelis Files New Drug Application With The FDA For
`VALTOCO™ (Diazepam Nasal Spray), An Investigational
`Treatment For Pediatric, Adolescent And Adult Epilepsy Patients,”
`https://www.neurelis.com/neurelis-news/neurelis-files-new-drug-
`application-fda-valtocotm-nasal-spray-investigational-treatment-
`pediatric (2018) (Accessed November 1, 2019)
`
`“Neurelis Receives FDA Orphan Drug Designation for NRL-1 in
`the Treatment of Acute Repetitive Seizures,”
`https://www.neurelis.com/neurelis-news/fda-orphan-drug-
`designation (2015) (Accessed November 1, 2019)
`
`Affidavit of Robert Cleary (Dated November 21, 2019) [SERVED
`BUT NOT FILED]
`
`Affidavit of Ronald Figueroa (Dated November 21, 2019)
`[SERVED BUT NOT FILED]
`
`Transcript of Telephone Conference on Feb. 11, 2020
`
`Date: 13 February 2020
`
`/Lorelei Westin/
`Lorelei Westin, Reg. No. 52,353
`Counsel for Neurelis, Inc.
`
`-4-
`
`
`
`CERTIFICATE OF SERVICE
`I certify that this paper was served electronically on February 13, 2020, to
`
`the following addresses:
`
`Daniel A. Scola, Jr.
`
`dscola@hbiplaw.com
`
`Michael I. Chakansky
`
`mchakansky@hbiplaw.com
`
`James F. Harrington
`
`jharrington@hbiplaw.com
`
`Matthew J. Solow
`
`John T. Gallagher
`
`msolow@hbiplaw.com
`
`jgallagher@hbiplaw.com
`
`Hoffmann & Baron, LLP
`
`876IPR@hbiplaw.com
`
`Date: February 13, 2020
`
`/Robyn Moriarty/
`Robyn Moriarty
`
`-5-
`
`
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