Caitlin Milligan Nicole Scheff Juliana Quarterman D. Graduate Students Paul Kiptoo Stan Banks Caroline Strasinger Mikolaj Milewski Courtney Swadley—NIH NRSA Fellowship Nicole K Brogden—NIH NRSA Fellowship Priyanka Ghosh Charity Wallace Soo Shin Sagar Shukla Sherin Thomas Paige Lane Qingzhao Zhang Audra L. Stinchcomb Curriculum Vitae Page 3 01/04-05/05 05/07-05/08 09/15-08/16 02/03-05/07 03/04-04/08 08/05-01/09 03/07-03/11 06/07-02/11 02/09-07/12 03/09-04/13 09/12-12/13 08/13-01/18 08/14-now 08/14-now 08/16-now 08/16-now E. Member of Thesis Committee Maggie Abbassi Daniel Liput Miranda Crowe Jason H Tucker Stephanie Morris Carol Gee, Monash University, Australia Josh Eldridge Bhavesh Kothari Mukul Kelkar Sheniqua Brown, UMBC Brittany Avaritt Jukkarin Srivilai, Naresuan University, Thailand Sophie Peng Yewon Joanna Pak Heather Boyce Tanvi Deshpande

Audra L. Stinchcomb Curriculum Vitae Page 7 Defense Threat Reduction Agency's Basic Research: Combating Weapons of Mass Destruction 2016 American Foundation for Pharmaceutical Education Board of Grants Member 2015-16 AAPS PPB Section Fellows Selection Committee Member 2016 NSF Phase I and II: Drug Delivery Panels 2017-19 NIH: National Center for Advancing Translational Sciences (NCATS) March 2018 NIH: National Center for Complementary and Integrative Health (NCCIH), Behavioral Research to Improve Medication-Assisted Treatment (MAT) for Opioid Use Disorder (OUD) 2019 IX.

Audra L. Stinchcomb Curriculum Vitae Page 9 Transdermal Delivery Bench to Bedside” Institute of Marine and Environmental Technology, Baltimore, MD, June 19, 2013, “7-Day Microneedle Enhanced Transdermal Delivery Bench to Bedside” Albany College of Pharmacy, Albany, NY, June 2013, “7-Day Microneedle Enhanced Transdermal Delivery Bench to Bedside” Gordon Conference, Preclinical Form & Formulation for Drug Discovery, Waterville Valley, NH, June 2013, “Form and Formulation Optimization for Transdermal Delivery” U.S. Government’s Science and Technical Expert Partnership (STEP) Program, The Biosciences Working Group (BSWG) meeting on Drug Delivery, McLean, VA, June 2013, “7-day Drug Delivery For Small and Large Molecules Via the Transdermal Route” Skin Trailblazer Annual Meeting, Boston, MA, August 2011, “Writing for a Successful Grant in the United States” Controlled Release Society Meeting, National Harbor, MD, July 2011, Soapbox session, “AllTranz” University of New Mexico College of Pharmacy, May 2011, “Pore lifetime and formulation aspects in microneedle-assisted transdermal delivery” NIDA Training Grant Night, Lexington, KY, May 2011, “Transdermal Prodrugs for Drug and Alcohol Dependence Treatment” PharmaEd Resources, Transdermal Drug Delivery Systems, Philadelphia, PA, February 2011, “Pore lifetime and formulation aspects in microneedle-assisted delivery” Ohio Valley Affiliates for Life Sciences annual meeting, Louisville, KY, April 16, 2010, “OVALS Innovation and Economic Spotlight” Perspectives in Percutaneous Penetration, La Grand Motte, France, April 7, 2010, “Pore lifetime in microneedle-assisted delivery” Kentucky BioAlliance annual meeting, Louisville, KY, December 9, 2009, “Life Science Opportunities in Kentucky” UK Commercialization and Economic Development/Center for Clinical and Translational Science, University of Kentucky, Lexington, KY, July 30, 2009, “Faculty Business StartUp Share Session” New York Venture Summit, Young Startup Ventures, 50 Top Innovator Company Award Speaker, New York, NY, June 16, 2009, “AllTranz” College of Health Sciences Faculty Retreat, University of Kentucky, Lexington, KY, February 20, 2009, “Successes and Hurdles of Starting a Company” Leadership Lexington Program, Commerce Lexington, KY, December 11, 2008, “Start-Up Pharmaceutical Company Development at the University of Kentucky” UK Commercialization and Economic Development Bench2Business, Lexington, KY, October 22, 2008, “Emerging Technology Presentation” 2nd World Conference on Magic Bullets, EHRLICH II, Nurnberg, Germany, October 3, 2008, “Transdermal delivery of naltrexone, in vitro testing to human volunteers” MidAmerica Healthcare Venture Forum, Cincinnati, OH, October 1, 2008, “Biotechnology and Pharmaceutical Company Showcase” Kentucky Girls Science, Technology, Engineering & Mathematics Collaborative Mylan (IPR2019-01095) MYLAN1036, p. 009

Shin, Soo Hyeon; Ghosh, Priyanka; Newman, Bryan; Hammell, Dana C.; Raney, Sam G.; Hassan, Hazem E.; Stinchcomb, Audra L. On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl.

Shin, Soo Hyeon; Srivilai, Jukkarin; Ibrahim, Sarah A.; Strasinger, Caroline; Hammell, Dana C.; Hassan, Hazem E.; Stinchcomb, Audra L. The Sensitivity of In Vitro Permeation Tests to Chemical Penetration Enhancer Concentration Changes in Fentanyl Transdermal Delivery Systems.

Indeed, none of Garrett’s disclosures teach dapsone compositions that also include adapalene.

Indeed, none of Garrett’s disclosures teach dapsone compositions that also include adapalene.

Nonetheless, no reliable way exists to predict the risk for dapsone hypersensitivity.

www.Healthtap.com (August 2014 – current) Position: Founding doctor and dermatologist/allergist practicing telemedicine for dermatology and general medicine patients.

Membership and Honorary/Professional Societies: Golden Key International Academic Honor Society, American Medical Student Association (AMSA), American Medical Association (AMA), American Academy of Pediatrics (AAP), Fellow, ACAAI, Fellow AAAAI, Fellow FAAD Honors / Awards: Academic All American; Verizon Academic All-Midwest; Member of Golden Key International Academic Honor Society; Snake Award Winner given annually to the highest achieving medical student group at UMKC; Student Representative at Chancellor's Symposium On Future Planning For Statewide University of Missouri System; Elected fellow representative for Children’s Mercy Hospital residency council.

Clinical utility of pseudopod development on skin prick testing (under review) Textbook chapter: The Autoimmune diseases.

My responsibilities included interviewing and evaluating applicants to the School of Medicine and making recommendations for acceptance for incoming classes 04/ 2001 - 04/2006 Kansas City Parks and Recreation Department, Missouri Volunteer soccer coach for underprivileged youth This volunteer based organization was designed to promote health and wellness as well as a safe environment for underprivileged youth of Kansas City.

Background, Hobbies & Interests: I grew up in Long Island New York and attended the 6 year combined BA/MD program at the University of Missouri-Kansas City.

(Exhibit 1037) Nguyen, R. and Su, J., “Treatment of Acne Vulgaris” Pediatrics and Child Health 21: 119-125 (2010) Williams, H., et al., “Acne vulgaris” Lancet 379: 361–72 (2012) Barclay, L., “Use of Topical Corticosteroids for Dermatologic Conditions Reviewed” Medscape - Jan 21, 2009, accessed from https://www.medscape.com/viewarticle/587159_print Basis of my analysis with respect to obviousness

without a certification in dermatology (i.e., a primary care physician, or a pediatrician) may qualify as a clinical POSA, assuming that they have more than two years of knowledge and experience treating skin conditions.

(MYLAN1004, 1) A POSA in 2012 would understand that Garrett teaches methods of treating both rosacea and acne consisting of inflammatory and non-inflammatory lesions by applying topical compositions containing dapsone to a patient’s affected areas.

Consequently, a POSA would have understood that the 5% to 10% w/w dapsone range in Garrett would have exhibited similar exposure levels and would also not result in the significant adverse effects known with oral administration.

First, the reduction in number of daily applications is not unexpected, as dermatologists expected at the time of invention that the potency, or strength, of a given drug is related to both its duration of action and its side effects.