Appendix of Trial Evidence

1. IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
RECRO GAINESVILLE LLC,
Plaintiff,
v.
ACTAVIS LABORATORIES FL, INC.,
Defendant.
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C.A. No. 14-1118 (GMS)
CONSOLIDATED
JOINT APPENDIX OF TRIAL EVIDENCE
MORRIS, NICHOLS, ARSHT & TUNNELL LLP
Jack B. Blumenfeld (#1014)
Maryellen Noreika (#3208)
Jeremy A. Tigan (#5239)
Megan E. Dellinger (#5739)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899-1347
(302) 658-9200
jblumenfeld@mnat.com
mnoreika@mnat.com
jtigan@mnat.com
mdellinger@mnat.com
Attorneys for Recro Gainesville LLC
RICHARDS, LAYTON & FINGER, P.A.
Kelly E. Farnan (#4395)
920 N. King Street
Wilmington, DE 19801
(302) 651-7700
farnan@rlf.com
OF COUNSEL:
B. Jefferson Boggs
MERCHANT & GOULD, P.C.
1701 Duke Street, Suite 310
Alexandria, VA 22314
Christopher J. Sorenson
Rachel C. Hughey
Aaron M. Johnson
Andrew O. Larsen
MERCHANT & GOULD, P.C.
3200 IDS Center
80 S. Eighth Street
Minneapolis, MN 55402
Thomas J. Meloro
Heather M. Schneider
WILLKIE FARR & GALLAGHER LLP
787 Seventh Avenue
New York, NY 10019
Attorneys for Actavis Laboratories FL, Inc.
November 7, 2016
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 1 of 9 PageID #: 1834

2. - 1 -
JOINT APPENDIX OF TRIAL EVIDENCE
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 002 06/07/05 U.S. Patent No. 6,902,742 (Devane et al.) Siepmann Direct; Siepmann Cross;
Fleckenstein Direct; Fleckenstein
Cross; Felton Direct; Felton Cross;
Dowling Direct; Dowling Cross
JTX 003 09/15/15 U.S. Patent No. 9,132,096 (Rekhi et al.) Siepmann Direct; Siepmann Cross;
Felton Direct
JTX 010 05/01/02 ACT-HYD-0100899–
ACT-HYD-0101008;
FLECK_ALV 0000001–
FLECK_ALV 0000110
Center for Drug Evaluation and
Research, Appl. No. 202880Orig1s000,
Clinical Pharmacology and
Biopharmaceutics Review(s)
Fleckenstein Direct
JTX 021 00/00/11 FLECK_ALV 0000194–
FLECK_AVL 0000259;
FLECK_ACT 0000090–
FLECK_ACT 0000155
Tozer et al., Clinical Pharmacokinetics &
Pharmacodynamics: Concepts &
Applications, Chapters 2 and 7
(Lippincott Williams & Wilkins (4th ed.,
2011))
Fleckenstein Direct
JTX 022 01/00/16 FLECK_ALV 0000260–
FLECK_ALV 0000285
Zohydro® ER Package Insert Fleckenstein Direct
JTX 030
[SEALED]
02/26/14 ACT-HYD-0001362–
ACT-HYD-0001455
Hydrocodone Bitartrate Extended
Release Capsules 10, 15, 20, 30, 40 &
50 mg (ANDA# 206952) Product
Development Report
Siepmann Direct; Fleckenstein
Cross; Fleckenstein Direct;
Felton Cross
JTX 031 02/26/14 ACT-HYD-0004344–
ACT-HYD-0004892
Hydrocodone Bitartrate ER Capsules
10 mg (Fasted Study) - Bioequivalence
Study Report for ACT-12719
Fleckenstein Direct;
Dowling Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 2 of 9 PageID #: 1835

3. - 2 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 032 02/26/14 ACT-HYD-0007314–
ACT-HYD-0007866
Hydrocodone Bitartrate ER Capsules
10 mg (Fed Study) - Bioequivalence
Study Report for ACT-12720
Fleckenstein Direct;
Dowling Direct
JTX 033 03/07/15 ACT-HYD-0018551–
ACT-HYD-0018852
Analytical Report - An Open Labeled,
Randomized, Single Dose, Two Way
Crossover Bioequivalence Study of
Hydrocodone Bitartrate Extended
Release Capsules, 10 mg, CII in Healthy,
Adult, Human, Subjects Under Fasting
Conditions (Protocol # ACT-15030)
ANDA Sequence 0006
Fleckenstein Re-Direct
JTX 034 03/26/15 ACT-HYD-0015667–
ACT-HYD-0015728
An Open-Label, Randomized, Single
Dose, Two Way Crossover
Bioequivalence Study of Hydrocodone
Bitartrate Extended Release Capsules,
10 mg, CII in Healthy, Adult, Human
Subjects Under Fasting Conditions
(Study # ACT-15030) ANDA Sequence
0006
Dowling Direct
JTX 035
[SEALED]
04/06/15 ACT-HYD-0012415–
ACT-HYD-0012479
Hydrocodone Bitartrate Extended
Release Capsules 10, 15, 20, 30, 40 &
50 mg (ANDA# 206952) Addendum to
Product Development Report ANDA
Sequence 0006
Siepmann Direct; Fleckenstein
Cross; Felton Cross
JTX 041 ACT-HYD-0015617–
ACT-HYD-0015630
Hydrocodone Bitartrate ER Capsules,
10 mg CII (Fasting Study), pages from
Study ACT-15030, plasma
concentrations
Fleckenstein Direct;
Dowling Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 3 of 9 PageID #: 1836

4. - 3 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 042 ACT-HYD-0035905–
ACT-HYD-0035907
Actavis testing documents, ER Capsules
USP Method
Fleckenstein Direct
JTX 043 ACT-HYD-0036111–
ACT-HYD-0036117
Actavis testing documents, ER Capsules
USP Method
Fleckenstein Direct
JTX 044
[SEALED]
ACT-HYD-0085245–
ACT-HYD-0085339
Actavis Laboratories FL, Inc. ANDA #
206952 Sequence # 0012
2.3 Quality Overall Summary
Siepmann Direct;
Fleckenstein Direct
Felton Direct
JTX 045
[SEALED]
ACT-HYD-0085660–
ACT-HYD-0085870
Actavis Laboratories FL, Inc. ANDA #
206952 Sequence # 0012
2.7 Clinical Summary (Hydrocodone
Extended-Release Capsules)
Fleckenstein Direct
JTX 098 04/11/12 DARA_Z0132703–
DARA_Z0132810
Formulation Report for Hydrocodone
Bitartrate Extended-Release (ER)
Capsules Comprehensive Pharmaceutical
Development Report [10, 15, 20, 30, 40
and 50 mg] (RD-2012-FOR-003)
Sidwell Designations
JTX 105 DARA_Z0093624–
DARA_Z0093676
Zogenix Hydrocodone Bitartrate ER
NDA Module 2.5 Clinical Overview
Rekhi Designations
JTX 107 Curriculum Vitae of Dr. Thomas
Dowling
Dowling Direct
JTX 108 Curriculum Vitae of Linda Felton, Ph.D. Felton Direct
JTX 109 Curriculum Vitae of Lawrence L.
Fleckenstein, Pharm.D.
Fleckenstein Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 4 of 9 PageID #: 1837

5. - 4 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
JTX 112 Curriculum Vitae of Prof. Dr. Jürgen
Siepmann
Siepmann Direct
PTX 030 00/00/01 SIE_ACT 0000213–
SIE_ACT 0000296
Edgar et al., Advances in Cellulose Ester
Performance and Application, Progress
Polymer Sci., 26:1605–88 (2001)
Siepmann Direct
PTX 038 00/00/01 SIE_ACT 0000504–
SIE_ACT 0000504
Heinze et al., Unconventional Methods in
Cellulose Functionalization, Progress
Polymer Sci., 26:1689–1762 (2001)
Siepmann Direct
PTX 048 00/00/10 SIE_ACT 0000073–
SIE_ACT 0000085
Mandal et al., Drug Delivery System
Based on Chronobiology – A Review, J.
Controlled Release, 147:314–25 (2010)
Siepmann Direct
PTX 051 00/00/06 SIE_ACT 0000111–
SIE_ACT 0000117
Mohamad et al., pH-independent
Pulsatile Drug Delivery System Based on
Hard Gelatin Capsules and Coated with
Aqueous Dispersion Aquacoat ECD,
European Journal of Pharmaceutics and
Biopharmaceutics, 64:173–79 (2006)
Siepmann Direct
PTX 056 12/00/11 SIE_ACT 0000126–
SIE_ACT 0000141
Patil et al., Development and
Characterization of Chronomodulated
Drug Delivery System of Captopril, Int. J.
Pharma. Investig., 1(4):227–33 (Oct.–
Dec. 2011)
Felton Cross
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 5 of 9 PageID #: 1838

6. - 5 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
PTX 060 00/00/00 SIE_ACT 0000202–
SIE_ACT 0000212
Porter, Coating of Pharmaceutical
Dosage Forms in Remington: The
Science and Practice of Pharmacy,
Chapter 46 (Alfonso R. Gennaro ed.,
20th ed. 2000)
Siepmann Direct
PTX 064 00/00/01 SIE_ACT 0000616–
SIE_ACT 0000634
Siepmann et al., Modeling of Drug
Release from Delivery Systems Based on
Hydroxypropyl Methylcellulose (HPMC),
Advanced Drug Delivery Revs. 48:139–
157 (2001)
Siepmann Direct
PTX 065 00/00/08 SIE_ACT 0000635–
SIE_ACT 0000649
Siepmann et al., Polymer Blends for
Controlled Release Coatings, J.
Controlled Release 125:1–15 (2008)
Siepmann Direct
PTX 068 00/00/04 SIE_ACT 0000170–
SIE_ACT 0000182
Sungthongjeen et al., Development of
Pulsatile Release Tablets with Swelling
and Rupturable Layers, Journal of
Controlled Release, 95:147–59 (2004)
Siepmann Direct;
Felton Cross
PTX 072 00/00/11 SIE_ACT 0000183–
SIE_ACT 0000192
Yadav et al., Dual Coating of Swellable
and Rupturable Polymers on Glipizide
Loaded MCC Pellets for Pulsatile
Delivery: Formulation Design and in
vitro Evaluation, Int’l. J. of Pharma.
419:121–30 (2011)
Siepmann Direct
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 6 of 9 PageID #: 1839

7. - 6 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
PTX 074 00/00/98 FLECK_ACT 0000156–
FLECK_ACT 0000164
Yuan et al., The Safety and Efficacy of
Oral Methylnaltrexone in Preventing
Morphine-Induced Delay in Oral-Cecal
Transit Time, Clin. Pharmacology &
Therapeutics, 61(4):467–75 (Apr. 1997)
Fleckenstein Direct
PTX 126 12/02/14 ACT-HYD-0028659–
ACT-HYD-0028660
Email from M. Udan to S. Mukherjee re:
Pilot Bio Shipping for Hydrocodone
Bitartrate ER Capsules (Zohydro Abuse
Deterrent)
Fleckenstein Direct
PTX 131 02/18/15 ACT-HYD-0020966–
ACT-HYD-0021039
Clinical Study Protocol - An Open
Labeled, Randomized, Single Dose, Two
Way Crossover Bioequivalence Study of
Hydrocodone Bitartrate Extended
Release Capsules, 10 mg, CII in Healthy,
Adult, Human, Subjects Under Fasting
Conditions (Protocol # ACT-15030)
Fleckenstein Direct
PTX 175 ACT-HYD-0085235–
ACT-HYD-0085238
Actavis Laboratories FL, Inc.
ANDA # 206952 Sequence # 0012
1.12.15 Request for In Vivo
Bioequivalence Waiver
Fleckenstein Direct
DTX 512 5/8/2000 ACT-HYD-0100535–
ACT-HYD-0100542
Serial 09/566,636 - Response Felton Direct
DTX 513 12/05/00 ACT-HYD-0100543–
ACT-HYD-0100546
Serial 09/566,636 - Notice of
Allowability
Felton Direct
DTX 519 Serial 10/827,689 Reply Felton Direct; Felton Cross
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 7 of 9 PageID #: 1840

8. - 7 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
DTX 550 12/29/15 Order Construing Terms of ‘398 and ‘742
Patents, D.I. 69
Felton Direct;
Dowling Direct
DTX 559 08/29/99 ACT-HYD-0107820–
ACT-HYD-0107832
US Patent 5,445,829 to Paradissis Felton Direct
DTX 568 12/25/12 ACT-HYD-0105521–
ACT-HYD-0105544
US Patent 8,337,888 Wright Felton Cross
DTX 572 10/26/06 ACT-HYD-0105163–
ACT-HYD-0105189
US Application Publication No.
2006/0240105 Devane
Fleckenstein Cross;
Rekhi Designation
DTX 579 06/19/91 ACT-HYD-0107868–
ACT-HYD-0107891
EP Patent Specification 0 274 734 B1 La
Manna
Felton Cross
DTX 592 11/00/87 DARA_Z0205565 Baumann, “Analgesic Safety and Efficacy
of Controlled Release Hydrocodone”,
Journal of Pharmaceutical Sciences S107,
76(11) Poster E 03-X-02 (November
1987)
Rekhi Designations
DTX 602 00/00/91 DARA_Z0068181–
DARA_Z0068186
Giunchedi et al., “Ketoprofen pulsatile
absorption from ‘multiple unit’
hydrophilic matrices,” Int’l J. of
Pharmaceutics, 77:17–181 (1991)
Dowling Direct
DTX 616 00/00/08 McGinity, Felton, “Aqueous Polymeric
Coatings for Pharmaceutical Dosage
Forms”, 3rd Ed., Chapter 8, pp. 203–235;
(2008)
Siepmann Cross
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 8 of 9 PageID #: 1841

9. - 8 -
EXHIBIT
NO.
DATE BATES NOS. DESCRIPTION ADMITTED
DTX 650 DARA_Z0067790–
DARA_Z0067813
Elan Technology Focus, Helping You
Bring Products to Market, presentation
Sidwell Designations
DTX 651 05/05/15 DARA_Z0223416–
DARA_Z0223449
Recro Gainesville, Recro Pharma-Pernix
Therapeutics Face to Face Meeting
PowerPoint presentation
Sidwell Designations
DTX 653 10/23/12 DARA_Z0240054–
DARA_Z0240114
Zogenix Pre-IND 115,964 Meeting
Briefing Document, ER capsules/abuse
deterrent
Sidwell Designations
DTX 661 Gurvinder Singh Rekhi CV Rekhi Designations
DTX 662 10/00/00 DARA_Z0198082–
DARA_Z0198091
Elan Pharmaceutical Technologies’
Proposal to Elan Pharmaceuticals to
develop a once daily controlled release
formulation of hydrocodone
Rekhi Designations
DTX 666 03/26/01 DARA_Z0210719–
DARA_Z0210743
Elan Ireland Memo from Tembe to Butler
re hydrocodone simulations
Rekhi Designations
DTX 668 06/25/02 DARA_Z0203216–
DARA_Z0203356
Elan letter to FDA submitting IND
application for hydrocodone ER capsules
(ELN 154088) (attached)
Rekhi Designations
DTX 672 10/25/13 NDA 202880rig1s000 Summary Review,
Zohydro ER
Rekhi Designations
DTX 812 4/9/1998 DARA_Z0046769–
DARA_Z0046810
WO 98/14168 - Alza Corp. Application
for International Patent
Fleckenstein Cross
10528465
Case 1:14-cv-01118-GMS Document 124 Filed 11/07/16 Page 9 of 9 PageID #: 1842