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2004 Exhibit: Centers for Disease Control and Prevention, Putting Collective Wisdom to Work for People with Epilepsy Nov 2016

Document IPR2019-00449, No. 2004-70 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)
Some of these epilepsy self-management programs are available by phone, online, and on other electronic devices, eliminating barriers to care, such as lack of access to transportation, functional limitations, and stigma.
As with any chronic condition, many people with epilepsy can benefit f om learning skills and techniques that help them better manage their disorder and its effects on daily life.
/11 HOBSCOTCH (Home-Based Self-Management and Cognitive Training Changes Lives) is a program led by Dartmouth College that is designed to address memory and attention problems among people with epilepsy through a combination of in-person visits and phone calls that provide coaching.
It is also testing a web-based group format approach designed to reach people at high risk of negative health events, such as seizures, hospitalizations, accidents or traumatic injuries, or self-harm attempts.
Blixen C, A Perzynski, Kanuch S, et al. Training peer educators to promote self-management skills in people with serious mental illness (SMI) and diabetes (DM) in a primary health care setting.
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2002 Exhibit: Food Drug Administration, Grant Fast Track IND 112621 NRL 1 diazepam intranasal solution 27 Dec 2016

Document IPR2019-00449, No. 2002-68 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. - IPR2019-00449
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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 IPR2019-00449, No. 2005-71 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...
Estimates of the prevalence and incidence of epi- lepsy worldwide vary considerably, likely reflecting differences in measurement and reporting, along with clinical characteristics such as etiology and seizure type.
Articles were included if they met the following criteria: (1) original research, (2) population-based (selecting the entire population or using probability-based sampling methods), (3) reported a prevalence or incidence of epilepsy (or raw numbers that allowed the calculation of an estimate).
Epilepsy prevalence or incidence estimates, raw numbers, and confidence in- tervals (CIs) (when provided) were recorded along with any strati- fied results by age, sex, or year of data collection.
Congruent with pre- the vious descriptive reports,35 we found that incidence of epilepsy was generally higher in the youngest and oldest age groups; however, there were insufficient studies to perform a meta-analysis.
Ideally, a multivariable meta- regression would have been employed to deal with the possible confounding effects of variables such as age and location, though this would have required a very large number of studies, and as such only strat- ified estimates are provided.
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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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1007 Exhibit: Part 5 Pages 1601 2000 File History for Non Provisional Patent Applic...

Document IPR2019-00450, No. 1007-19 Exhibit - Part 5 Pages 1601 2000 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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1004 Exhibit: Part 8 Pages 2451 2681 File History for 546 Patent, Ser No 13495,94...

Document IPR2019-00450, No. 1004-12 Exhibit - Part 8 Pages 2451 2681 File History for 546 Patent, Ser No 13495,942 546 FH (P.T.A.B. Jan. 29, 2019)

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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 Cartt865 (P.T.A.B. Jan. 29, ...

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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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