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

Notice of Refund

PETITIONER'S REQUEST FOR REFUND OF POST INSTITUTION FEES

Decision Denying Institution of Inter Partes Review

Patent Owner's Mandatory Notices

Centers for Disease Control and Prevention, Epilepsy Fast Facts (9 Apr. 2019), available at https://www.cdc.gov/epilepsy/about/fast-facts.htm?CDC_ AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fepilepsy%2Fbasics%2Ffast-facts.htm

Food & Drug Administration, Grant Fast Track (IND 112621; NRL-1 (diazepam intranasal solution)) (27 Dec. 2016)

Howard LeWine, M.D., Quick Injection Helps Stop Epileptic Seizures, Harvard Health Blog (23 Feb. 2012), available at https://www.health.harvard. edu/blog/quick-injection-helps-stop-epileptic-seizures-201202234319/print/

Patent Owner's Preliminary Response

Centers for Disease Control and Prevention, Putting Collective Wisdom to Work for People with Epilepsy (Nov. 2016)

K.M. Fiest et al., Prevalence and Incidence of Epilepsy, A Systematic Review and Meta-Analysis of International Studies, 88 Neurology 296 (17 Jan. 2017)

Patent Owner's Mandatory Notices

EXPUNGED

Notice of Accord Filing Date

Part 1 - Pages 1-270 - 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 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 4 ¿¿¿ Pages 1051-1400 -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)

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

Part 2 ¿¿¿ Pages 401-800 - 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)

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

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

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

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)

Provisional Patent Application No. 61/570,110, filed December 13, 2011 (¿¿¿110 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 4 ¿¿¿ Pages 1201-1600 - 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 9 ¿¿¿ Pages 3201-3488 - File History for Non-Provisional Patent Application Serial No. 12/413,439, filed March 27, 2009 (¿¿¿439 FH)

Kee et al., U.S. Patent No. 5,369,095, Compositions And Method Comprising Substituted Glycosides As Mucus Membrane Permeation Enhancers, issued November 29, 1994 (Kee)

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)

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)

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)

Meezan et al., U.S. Patent Application Publication No. US 2006/0046962, Absorption Enhancers for Drug Administration, Serial No. 11/127,786, published March 2, 2006 (Meezan¿¿¿962)

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)

Sonne, U.S. Patent No. 6,193,985, Tocopherol Compositions For Delivery Of Biologically Active Agents, issued February 27, 2001 (Sonne)

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

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

Merkus, U.S. Patent Application Publication No. US 2005/0153956, Serial No. 11/034,474, published July 14, 2005 (Merkus)

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)

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)

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

Ueda et al., U.S. Patent No. 4,657,901, Pharmaceutical Composition, issued April 14, 1987 (Ueda)

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

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

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)

Kibbe, editor, Handbook of Pharmaceutical Excipients, Third Edition (2000), American Pharmaceutical Association, Washington DC (Kibbe)

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

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)

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)

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

French et al., Pharmacopeial Standards and Specifications for Bulk Drugs and Solid Oral Dosage Forms, Journal of Pharmaceutical Sciences, December 1967, Vol. 56(12):1622-1641 (French)

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)

Bara, U.S. Patent Application Publication No. US/2006/0178290, Serial No. 10/563,967, published August 10, 2006 (Bara)

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

Declaration of Dr. Nicholas A. Peppas

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)

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

Colombo, Mucosal Drug Delivery, Nasal, pp. 592-605, Vol 2, Encyclopedia of Controlled Drug Delivery (Mathiowitz, editor), John Wiley & Sons, 1999 (Colombo)

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

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

Kagatani, et al., U.S. Patent No. 4,690,952, Pharmaceutical Compositions for Nasal administration Comprising Calcitonin and an Absorption-Promoting Substance, issued September 1, 1987 (Kagatani).

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

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.

USP NF 2003, The United States Pharmacopeia, The National Formulary, United States Pharmacopeial Convention, Inc. (¿¿¿USP/NF¿¿¿)

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.

Provisional Patent Application No. 61/040,281, Pharmaceutical Solutions and Method for Solubilizing Therapeutics Agents, filed March 28, 2008, Gwozdz, (Gwozdz ¿¿¿281 Provisional)

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)

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

Power of Attorney

Petition