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5 Mandatory Notice: Patent Owners Mandatory Notices

Document IPR2019-00450, No. 5 Mandatory Notice - Patent Owners Mandatory Notices (P.T.A.B. Feb. 19, 2019)
The patent owner provides the following notice pursuant to 37 CFR §42.8(a)(2).
Real parties-in-interest Neurelis, Inc. (“Neurelis”) owns the involved patent.
Related matters The petitioner has filed two additional inter partes review petitions
Neurelis has an application (15/470,498) that claims benefit under 35 U.S.C. 120 to the application that issued as the involved patent.
above counsel, is of record for the involved patent.
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1 Power of Attorney: Power of Attorney

Document IPR2019-00450, No. 1 Power of Attorney - Power of Attorney (P.T.A.B. Jan. 29, 2019)
In accordance with 37 CPR.
I have authority to sign this document on behalf of Petitioner Aquestive
Mark Sc e1 Aquestive Therapeutics, Inc.
Title: Chief Innovation & Technology Officer Date
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2002 Exhibit: Food Drug Administration, Grant Fast Track IND 112621 NRL 1 diazepam intranasal solution 27 Dec 2016

Document IPR2019-00450, No. 2002-70 Exhibit - Food Drug Administration, Grant Fast Track IND 112621 NRL 1 diazepam intranasal solution 27 Dec 2016 (P.T.A.B. May. 6, 2019)
Neurelis, Inc. c/o Pacific Link Consulting, LLC Attention: Richard Lowenthal, MS, MSEL President, Pacific-Link Consulting 8195 Run of the Knolls Court San Diego, CA 92127 Dear Mr. Lowenthal: Food and Drug Administration Silver Spring MD 20993
We have reviewed your request and concluded that it meets the criteria for Fast Track designation.
Therefore, we are designating as a Fast Track development program the investigation of NRL-1 for the management of selected, refractory patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizures.
Please note that if the clinical development program you pursue does not continue to meet the criteria for Fast Track designation, the application will not be reviewed under the Fast Track program.
Sincerely, {See appended electronic signature page} Billy Dunn, MD Director Division of Neurology Products Office of Drug Evaluation I Center for Drug Evaluation and Research Reference ID: 4034029 Neurelis - EX. 2002 Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00450
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2005 Exhibit: KM Fiest et al, Prevalence and Incidence of Epilepsy, A Systematic Review and Meta Analysis of International Studies, 88 Neurology 296 17 Jan 2017

Document IPR2019-00450, No. 2005-73 Exhibit - KM Fiest et al, Prevalence and Incidence of Epilepsy, A Systematic Review and Meta Analysis of International Studies, 88 Neurology 296 17 Jan 2017 (P.T...
... • Not original (61) • Pre-1985 data (41) • No estimate provided (36) • Foreign language (33) • Not population-based (29) • Status epilepticus only (13) • Neonatal seizures only (13) • Abstract only (7) • Febrile seizures only (5) • Nonepileptic ...
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2001 Exhibit: Centers for Disease Control and Prevention, Epilepsy Fast Facts 9 Ap...

Document IPR2019-00450, No. 2001-69 Exhibit - Centers for Disease Control and Prevention, Epilepsy Fast Facts 9 Apr 2019, available at httpswwwcdcgovepilepsyaboutfast factshtmCDC AA refValhttps%...

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2004 Exhibit: Centers for Disease Control and Prevention, Putting Collective Wisdo...

Document IPR2019-00450, No. 2004-72 Exhibit - Centers for Disease Control and Prevention, Putting Collective Wisdom to Work for People with Epilepsy Nov 2016 (P.T.A.B. May. 6, 2019)

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2003 Exhibit: Howard LeWine, MD, Quick Injection Helps Stop Epileptic Seizures, H...

Document IPR2019-00450, No. 2003-71 Exhibit - Howard LeWine, MD, Quick Injection Helps Stop Epileptic Seizures, Harvard Health Blog 23 Feb 2012, available at httpswwwhealthharvard edublogquick in...

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1045 Exhibit: Maitani, et al, Design of ocularlacrimal and nasal systems through an...

Document IPR2019-00450, No. 1045-63 Exhibit - Maitani, et al, Design of ocularlacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 4...

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1007 Exhibit: Part 2 ¿¿¿ Pages 401 800 File History for Non Provisional Patent Applic...

Document IPR2019-00450, No. 1007-16 Exhibit - Part 2 ¿¿¿ Pages 401 800 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019)

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1013 Exhibit: Sonne, US Patent No 6,193,985, Tocopherol Compositions For Delive...

Document IPR2019-00450, No. 1013-29 Exhibit - Sonne, US Patent No 6,193,985, Tocopherol Compositions For Delivery Of Biologically Active Agents, issued February 27, 2001 Sonne (P.T.A.B. Jan. 29, 2...

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1007 Exhibit: Part 9 ¿¿¿ Pages 3201 3488 File History for Non Provisional Patent App...

Document IPR2019-00450, No. 1007-23 Exhibit - Part 9 ¿¿¿ Pages 3201 3488 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019...

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1031 Exhibit: Rowe et al, Handbook of Pharmaceutical Excipients, Fourth Edition 2...

Document IPR2019-00450, No. 1031-47 Exhibit - Rowe et al, Handbook of Pharmaceutical Excipients, Fourth Edition 2003, Monographs, American Pharmaceutical Association, Washington DC Rowe (P.T.A...

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1045 Exhibit: Maitani, et al, Design of ocularlacrimal and nasal systems through an...

Document IPR2019-00450, No. 1045-63 Exhibit - Maitani, et al, Design of ocularlacrimal and nasal systems through analysis of drug administration and absorption, Journal of Controlled Release, Volume 4...

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1010 Exhibit: US Patent Application Publication No US 20090258865, Administratio...

Document IPR2019-00450, No. 1010-26 Exhibit - US Patent Application Publication No US 20090258865, Administration of Benzodiazepine Compositions, Serial No 12413,439 Cartt¿¿¿865 (P.T.A.B. Jan. 2...

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1016 Exhibit: Kee et al, US Patent No 5,369,095, Compositions And Method Compr...

Document IPR2019-00450, No. 1016-32 Exhibit - Kee et al, US Patent No 5,369,095, Compositions And Method Comprising Substituted Glycosides As Mucus Membrane Permeation Enhancers, issued No...

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