Aquestive Therapeutics, Inc. formerly Monosol RX, LLC vs Neurelis, Inc.

Trial Certificate Checklist

Patent Owner Neurelis, Incs. Notice of Appeal

Termination Decision Document

Hearing Transcript

PETITIONER'S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE EVIDENCE

Patent Owner's Reply to Petitioner¿¿¿s Opposition to Patent Owner¿¿¿s Motion to Exclude Evidence

DECLARATION OF MICHAEL I. CHAKANSKY

PETITIONER'S SECOND UPDATED EXHIBIT LIST

PETITIONER'S OPPOSITION TO PATENT OWNER'S MOTION TO EXCLUDE EVIDENCE

Patent Owner's Updated Exhibit List

Affidavit of Robert Cleary

Patent Owner's Opposition to Petitioner's Motion to Exclude

Affidavit of Ronald Figueroa

Order Trial Hearing

PETITIONER'S MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. ¿¿ 42.64(c)

Patent Owner¿¿¿s Motion to Exclude Evidence 37 C.F.R. ¿¿42.64

PETITIONER'S REQUEST FOR ORAL ARGUMENT

Patent Owner's Updated Exhibit List

Patent Owner's Request for Oral Argument

PETITIONER'S OBJECTIONS PURSUANT TO 37 C.F.R. ¿¿ 42.64(b)(1) SECOND SET

Patent Owner's Updated Exhibit List

¿¿¿Intranasal Technology, Inc. Licenses Aegis Therapeutics' Intravail Drug Delivery Technology¿¿¿ (Business Wire) (April 13, 2005)

J. Wyse, U.S. Patent No. 9,192,570 issued November 24, 2015

Daniel P. Wermeling Deposition Transcript, February 26, 2020

Handbook of Pharmaceutical Excipients (Pharmaceutical Press and American Pharmacists Association, Publishers) (Fifth Edition, 2006)

Patent Owner's Surreply

Patent Owner's Mandatory Change-of-Information Notices

PARTIES' JOINT SUBMISSION OF PATENT OWNER'S IDENTIFICATION OF NEW ARGUMENTS AND PETITIONER'S RESPONSES THERETO

Patent Owner Updated Exhibit List

Transcript of Telephone Conference on Feb. 11, 2020

Notice of Deposition of Daniel P. Wermeling

Patent Owner Neurelis Inc. Objections

Florida Regional Common EMS Protocols Field Guide, Jones and Barlett Publishers, MA (2005).

Gizurarson, Patent Application Publication No. US 2008/0275030, Nov. 6, 2008.

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Illum L. Is nose to brain transport of drugs a reality?. JPP 2004; 56: 3-17.

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Nayzilam Product Label and Instructions for Use

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USP/NF 2003, The Official Compendia of Standards, Ethanol, Copyright 2002.

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Drug Prices from Internet

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CDER 2019-09-19-Abbreviated Approval Products:505(b)(2) or ANDA? https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda-september-19-2019-issue

FDA GUI FINAL, Determining Whether to Submit an ANDA or a 505(b)(2) Application, Published May 2019, https://www.fda.gov/media/123567/download

FDA GUIDANCE FOR INDUSTRY (1999), Applications Covered by Section 505(b)(2), https://www.fda.gov/media/72419/download

PETITIONER'S FIRST UPDATED EXHIBIT LIST

Transcript of the January 14, 2020 deposition of Dr. Gizararson,

Declaration of Daniel P. Wermeling, Pharm.D.

Wermeling, D.P., Intranasal delivery of antiepileptic medications for treatment of seizures, Neurotherapeutics, April 2009, Volume 6, Issue 2, pp 352¿¿¿358

PETITIONER'S REPLY TO PATENT OWNER'S RESPONSE TO THE PETITION

PETITIONER'S NOTICE OF DEPOSITION OF SVEINBJORN GIZURARSON, PH.D.

PETITIONER'S OBJECTIONS

Order Denying POP Request

Petitioner's First Updated Mandatory Notices Update

E. Bechgaard et al., ¿¿¿Solubilization of Various Benzodiazepines for Intranasal Administration, A Pilot Study,¿¿¿ Pharmaceutical Development and Technology 2:293-296 (1997)

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)

Diastat¿¿ Label (2005)

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)

¿¿¿Neurelis Files New Drug Application With The FDA For VALTOCO¿¿¿ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients,¿¿¿ (2018) (Accessed November 1, 2019)

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)

J. Riss et al., ¿¿¿Benzodiazepines in Epilepsy: Pharmacology and Pharmacokinetics,¿¿¿ Acta Neurologica Scandinavica 118:69-86 (2008)

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)

¿¿¿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 (2019) (Accessed October 31, 2019)

¿¿¿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)

¿¿¿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)

Dr. Nicholas Peppas Deposition Transcript, October 24, 2019.

IPR2019-00451 Patent Owner's Response

Declaration of Dr. Sveinbjorn Gizurarson, Ph.D.

Notification of Receipt of POP Request

Ex. 3001

Decision - Denying Patent Owner's Request on Rehearing of Decision on Institution - 37 CFR 42.71(d)

Notice of Deposition of Dr. Nicholas Peppas

Patent Owner Neurelis Inc.'s Mandatory Change-of-Information Notices

Neurelis, Inc. Request for Rehearing

Neurelis, Inc. Objections

Institution of Inter Partes Review 35 U.S.C. sec 314

SCHEDULING ORDER

Patent Owner's Mandatory Notices

Patent Owner Preliminary Response

¿¿¿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)

Epilepsy Fast Facts, CDC (Center for Disease Control and Preventions), 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

NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

Patent Owner's Mandatory Notices

Part 2 ¿¿¿ Pages 351-700 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

Part 3 ¿¿¿ Pages 701-1050 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

Part 5 ¿¿¿ Pages 1401-1750 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

U.S. Patent No. 9,763,876, Administration Of Benzodiazepine Compositions, filed October 29, 2014 (¿¿¿876 Patent)

Part 1 - Pages 1-270 - File History for ¿¿¿876 Patent, Ser. No. 14/527,613 (¿¿¿876 FH)

Part 2 - Pages 271-530 - File History for ¿¿¿876 Patent, Ser. No. 14/527,613 (¿¿¿876 FH)

U.S. Patent No. 8,895,546, Administration Of Benzodiazepine Compositions, filed June 13, 2012 (¿¿¿546 Patent)

Part 1 ¿¿¿ Pages 1-350 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

Part 4 ¿¿¿ Pages 1051-1400 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

Part 6 ¿¿¿ Pages 1751-2100 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

Power of Attorney

Provisional Patent Application No. 61/570,110, filed December 13, 2011 (¿¿¿110 Provisional)

Part 2 ¿¿¿ Pages 401-800 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Part 5 ¿¿¿ Pages 1601-2000 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Part 6 ¿¿¿ Pages 2001-2400 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Part 7 ¿¿¿ Pages 2401-2800 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Part 8 ¿¿¿ Pages 2801-3200 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

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Cartt et al., U.S. Patent Application Publication No. US 2008/0279784, Nasal Administration Of Benzodiazepines, Serial No. 12/116,842, published November 13, 2008 (Cartt ¿¿¿784)

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Part 7 ¿¿¿ Pages 2101-2450 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

Part 8 ¿¿¿ Pages 2451-2681 -File History for ¿¿¿546 Patent, Ser. No. 13/495,942 (¿¿¿546 FH)

Provisional Patent Application No. 61/497,017, filed June 14, 2011 (¿¿¿017 Provisional)

Part 1 ¿¿¿ Pages 1-400 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Part 3 ¿¿¿ Pages 801-1200 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Part 4 ¿¿¿ Pages 1201-1600 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Part 9 ¿¿¿ Pages 3201-3488 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Provisional Patent Application No. 61/040,558, filed March 28, 2008 (¿¿¿558 Provisional)

Cartt et al., WO 2009/121039, Administration Of Benzodiazepine Compositions, published October 1, 2009, International Filing Date March 27, 2009 (PCT/US2009/038696) (Cartt ¿¿¿039)

U.S. Patent Application Publication No. US 2009/0258865, Administration of Benzodiazepine Compositions, Serial No. 12/413,439 (Cartt¿¿¿865)

Jamieson et al., U.S. Patent Application Publication No. US 2008/0070904, Pharmaceutical Compositions of Benzodiazepines and Method of Use Thereof, Serial No. 11/897,028, published March 20, 2008 (Jamieson)

Gwozdz et al., WO 2009/120933, Pharmaceutical Solutions And Method For Solubilizing Therapeutic Agents, published October 1, 2009, International Filing Date March 27, 2009 (PCT/US2009/038518) (Gwozdz)

Cartt et al., WO 2008/137960, Nasal Administration Of Benzodiazepines, published November 13, 2008, International filing date May 7, 2008 (PCT/US2008/062961) (Cartt ¿¿¿960)

Tenta, U.S. Patent No. 3,949,072, Topical Composition for Treatment of Seborrheic Keratosis, issued April 6, 1976 (Tenta)

Meezan et al., U.S. Patent No. 5,661,130, Absorption Enhancers For Drug Administration, issued August 26, 1997 (Meezan¿¿¿130)

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Liversidge et al., U.S. Patent Application Publication No. US 2006/0198896, Serial No. 11/354,249, published September 7, 2006 (Liversidge)

Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36 (Bioavailability and Bioequivalence), Drug Intelligence Publications, Illinois, 1992 (Ritschel)

Lindhardt et al., Electroencephalographic effects and serum concentrations after intranasal and intravenous administration of diazepam to healthy volunteers, Blackwell Science Ltd Br J Clin Pharmacol, 52, 521-527, 2001 (Lindhardt)

Ivaturi et al., Pharmacokinetics and tolerability of intranasal diazepam and midazolam in healthy adult volunteers, Acta Neurol Scand. 2009 Nov;120(5):353-7. doi: 10.1111/j.1600-0404.2009.01170.x. Epub 2009 May 14 (Ivaturi)

Rowe et al., editors, Handbook of Pharmaceutical Excipients, Fourth Edition (2003), Monographs, American Pharmaceutical Association, Washington DC (Rowe)

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Edman [I] et al., (D) Routes of Delivery: Case Studies - (1) Nasal delivery of peptide drugs, Advanced Drug Delivery Reviews, 8 (1992) 165-177 (Edman I)

Davis, Delivery of peptide and non-peptide drugs through the respiratory tract, Pharmaceutical Science & Technology Today, Vol. 2, No. 11 November 1999, pages 450-456 (Davis)

Deshmukh et al., Lorazepam in the Treatment of Refractory Neonatal Seizures, Am J Dis Child. 1986;140(10):1042-1044 (Deshmukh)

Part 2 - Pages 251-500 - File History for EP 128 01372.9, based on WO 2012/174158 and PCT/US2012/042311

Part 3 ¿¿¿ Pages 501-662 - File History for EP 128 01372.9, based on WO 2012/174158 and PCT/US2012/042311

Declaration of Dr. Nicholas A. Peppas

PDR 54th Edition 2000, DIASTAT¿¿ (diazepam rectal gel); MIACALCIN¿¿ (Calcitonin Nasal Spray); VALIUM¿¿ (diazepam injection), Physicians¿¿¿ Desk Reference.

Osborne et al., Skin Penetration Enhancers Cited in the Technical Literature, Pharmaceutical Technology, November 1997 (Osborne)

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Illum, Nasal drug delivery-possibilities, problems and solutions, Journal of Controlled Release 87 (2003) 187-198 (Illum)

O¿¿¿Dell et al., School nurses¿¿¿ experience with administration of rectal diazepam gel for seizures, J Sch Nurs., June 2007, 23(3):166-9 (O¿¿¿Dell)

Gizurarson et al., Intranasal Administration of Diazepam Aiming at the Treatment of Acute Seizures: Clinical Trials in Healthy Volunteers, Biological and Pharmaceutical Bulletin, Volume 22 (1999) Issue 4 Pages 425-427 (Gizurarson)

Edman [II] et al., Microspheres as a nasal delivery system for peptide drugs, Journal of Controlled Release, Vol. 21 (1992) 165-l72 (Edman II)

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Behl et al., Effects of physicochemical properties and other factors on systemic nasal drug delivery, Advanced Drug Delivery Reviews 29 (1998) 89¿¿¿116 (Behl)

Part 1 - Pages 1-250 - File History for EP 128 01372.9, based on WO 2012/174158 and PCT/US2012/042311

Knoester, et al., Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers, Br J Clin Pharmacol. 2002 May;53(5):501-7.

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Gwozdz Assignment of Provisional in Non-Provisional Case, dated April 21, 2008, recorded September 23, 2010 (Gwozdz Assignment).

Cartt¿¿¿784 Assignment, dated March 6, 2012, recorded March 29, 2012 (Cartt¿¿¿784 Assignment)

Maitani, et al., Design of ocular/lacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 49, Issues 2¿¿¿3, 15 December 1997, Pages 185-192.

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Table of Various Diazepam Solutions Described in or Modified From Sonne¿¿¿s Example 11 (¿¿¿DS11¿¿¿)

EXPUNGED

Petition for Inter Partes Review