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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`AQUESTIVE THERAPEUTICS, INC.
`
`
`Petitioner
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`v.
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`NEURELIS, INC.
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`Patent Owner
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`_______________________
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`Case: IPR2019-00451
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`U.S. Patent No. 9,763,876
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`______________________
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`
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`DECLARATION OF MICHAEL I. CHAKANSKY
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`AQUESTIVE EXHIBIT 1152 Page 0000
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`IPR2019-00451
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`I, Michael I. Chakansky, declare as follows:
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`
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`U.S. Patent No. 9,763,876
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`1. I am an attorney with Hoffmann & Baron, LLP, and Back Up Counsel
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`for Petitioner Aquestive Therapeutics, Inc. in IPR2019-00451.
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`2.
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`I submit this declaration pursuant to 37 C.F.R. § 42.64(b)(2) in
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`response to Patent Owner’s Objections dated February 4, 2020 (Paper 23).
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`3.
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`Exhibit 1069 is a true and correct copy of the Florida Regional
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`Common EMS Protocols Field Guide, Jones and Barlett Publishers, MA (2005). If
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`Patent Owner desires, Aquestive will make the original pamphlet available for
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`inspection and copying at our offices.
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`4.
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`Exhibit 1072 is a true and correct copy of the Nayzilam Product Label
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`and Instructions for Use obtained from the U.S. Food and Drug Administration’s
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`website and publically accessible at the following url:
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`https://www.accessdata.fda.gov/drugsatfda docs/label/2019/211321s000lbl.pdf
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`5.
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`Exhibit 1074 is a true and correct copy of the cover, the copyright
`
`page, and pages 1948, 1944, 1983 and 1976 of Hardman, et al, Editors, Goodman
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`& Gilman’s, The Pharmacological Basis of Therapeutics, 10th Edition (2001).
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`Substitute Exhibit 1074, submitted contemporaneously with this declaration, is a
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`clearer true and correct copy of the cover, the copyright page, and pages 1948,
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`1944, 1983 and 1976 of Hardman, et al, Editors, Goodman & Gilman’s, The
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`Pharmacological Basis of Therapeutics, 10th Edition (2001).
`1
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`AQUESTIVE EXHIBIT 1152 Page 0001
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`6.
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`Exhibit 1076 is a true and correct copy of the cover, the inside cover
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`page, the copyright page, and pages xiii-xviii, 508, 189, 641, 642 and 1712 of
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`Budavari, et al, Editors, The Merck Index, 12th Edition (1996).
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`7.
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`Exhibit 1077 is a true and correct copy of the cover, the inside cover
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`page, the copyright page, and pages 367-368, 376-377, 386-389 of Ritchel, W.A.,
`
`et al., Handbook of Basic Pharmocokinetics …. Including Clinical Applications, 6th
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`Edition, 2004.
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`8.
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`Exhibit 1078 is a true and correct copy of the cover, the inside cover
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`page, the copyright page, and pages 59-60 of USP/NF 2003, The Official
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`Compendia of Standards, Ethanol, Copyright 2002.
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`9.
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`Exhibit 1080 is a true and correct copy of the Valium® Tablet Label,
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`Roche, January 2008, obtained from the U.S. Food and Drug Administration’s
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`website and publically accessible at the following url:
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`https://www.accessdata.fda.gov/drugsatfda docs/label/2008/013263s083lbl.pdf.
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`10. Exhibit 1081 is a true and correct copy of the pages showing Drug
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`Prices from Internet for: Diazepam), publically accessible at
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`https://www.webmd.com/rx/drug-prices/diazepam (choose: form - syringe, dosage
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`- 2ml of 5mg/ml); Diastat Acudial publically accessible at
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`https://www.webmd.com/rx/drug-prices/diazepam (choose: form- gel, dosage
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`10mg); and “How much should I expect to pay for Nayzilam® (midazolam) nasal
`2
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`
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`AQUESTIVE EXHIBIT 1152 Page 0002
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`IPR2019-00451
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`spray, CIV?” publically accessible at https://ucb-
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`
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`U.S. Patent No. 9,763,876
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`usa.com/Responsibility/Affordability/Nayzilam-Pricing-Info.
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`11. Exhibit 1082 is a true and correct copy of the cover, the inside cover
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`page, the copyright page, and pages 1-26 (Chapter 1, “Anatomy and Physiology of
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`the Nose”) of Chien, Y.W., et al., “Nasal Systemic Drug Delivery”, Chapter 1,
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`Anatomy and Physiology of the Nose, Drugs and the Pharmaceutical Sciences, Vol.
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`39, Marcel Decker, 1989.
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`12. Exhibit 1118 is a true and correct copy of Constantino HR, Illum L,
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`Brandt G, et al., Intranasal delivery: Physicochemical and therapeutic aspects,
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`Intl J Pharmaceutics 2007; 337: 1-24 publically accessible at
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`https://www.sciencedirect.com/science/article/pii/S0378517307002748 (available
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`online March 25, 2007); also publically accessible at
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`https://www.ncbi.nlm.nih.gov/pubmed/17475423 (e published March 25, 2007).
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`13. Exhibit 1146 is a true and correct copy of the U.S. Food and Drug
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`Administration’s publication FDA GUI FINAL, Determining Whether to Submit
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`an ANDA or a 505(b)(2) Application, Published May 2019, obtained from the U.S.
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`Food and Drug Administration’s website and publically accessible at
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`https://www.fda.gov/media/123567/download. According to this publication,
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`additional copies are available from the Office of Communications, Division of
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`Drug Information Center for Drug Evaluation and Research, Food and Drug
`3
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`AQUESTIVE EXHIBIT 1152 Page 0003
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`IPR2019-00451
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`Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver
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`U.S. Patent No. 9,763,876
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`
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`Spring, MD 20993-0002.
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`14. Exhibit 1147 is a true and correct copy of the U.S. Food and Drug
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`Administration’s publication of CDER (Center for Drug Evaluation and Research)
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`2019-09-19- “Abbreviated Approval Products: 505(b)(2) or ANDA?, obtained
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`from the U.S. Food and Drug Administration’s website and publically accessible at
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`https://www.fda.gov/drugs/cder-small-business-industry-assistance-
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`sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda-september-19-
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`2019-issue (click “Download (PDF - 283KB)”).
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`15. Exhibit 1148 is a true and correct copy of the U.S. Food and Drug
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`Administration’s publication FDA GUIDANCE FOR INDUSTRY (1999),
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`Applications Covered by Section 505(b)(2), obtained from the U.S. Food and Drug
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`Administration’s website and publically accessible
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`athttps://www.fda.gov/media/72419/download, According to this document,
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`additional copies are available by contacting Drug Information Branch Division of
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`Communications Management, HFD-210, Center for Drug Evaluation and
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`Research (CDER), 5600 Fishers Lane, Rockville, MD 20857.
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`4
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`AQUESTIVE EXHIBIT 1152 Page 0004
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`
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`I declare underpenalty ofperjury that the foregoingis true and correct.
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`Executed on this the 19th day of February 2020.
`
`
`
`
`
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel:
`973.331.1700
`
`‘
`
`First Back Up Counsel for
`Petitioner Aquestive Therapeutics, Inc.
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`AQUESTIVE EXHIBIT 1152 Page 0005
`AQUESTIVE EXHIBIT 1152 Page 0005
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that on this the 19th day of February 2020, the foregoing
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`DECLARATION OF MICHAEL I. CHAKANSKY was served in its entirety on
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`the following counsel of record by electronic service by email at the email
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`addresses as set forth below.
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` Jeffrey Guise
`Richard Torczon
`Lorelei Westin
`Lee Johnson
`Nathaniel Leachman
`Alina L. Litoshyk
`Wendy Devine
`WILSON SONSINI GOODRICH & ROSATI
`jguise@wsgr.com
`rtorczon@wsgr.com
`lwestin@wsgr.com
`ljohnson@wsgr.com
`nleachman@wsgr.com
`alitoshyk@wsgr.com
`wdevine@wsgr.com
`35401.652.palib1@matters.wsgr.com
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`By:
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`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
`
`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
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`
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`6
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`AQUESTIVE EXHIBIT 1152 Page 0006
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