UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable David P. Shaw
`Administrative Law Judge
`
`
`In the Matter of
`
`CERTAIN BOTULINUM TOXIN
`PRODUCTS, PROCESSES FOR
`MANUFACTURING OR RELATING TO
`SAME AND CERTAIN PRODUCTS
`CONTAINING SAME
`
`Inv. No. 337-TA-1145
`
`
`
`
`
`
`
`FINAL EXHIBIT LIST OF JOINT, COMPLAINANTS, AND STAFF EXHIBITS
`
`Pursuant to Ground Rule 9 and the Procedural Schedule, Complainants Medytox, Inc.
`
`(“Medytox”) and Allergan plc and Allergan, Inc. (together, “Allergan,” and with Medytox,
`
`“Complainants”) hereby respectfully submit their Final Exhibit List including CX, CDX, CPX,
`
`JX, and SX exhibits1 (attached hereto as Exhibit A).
`
`
`
`Dated: February 21, 2020
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`GIBSON, DUNN & CRUTCHER LLP CLEARY GOTTLIEB STEEN & HAMILTON LLP
`
` By: /s/ Joshua A. Jessen
`
`
`Jeffrey T. Thomas
`Joshua A. Jessen
`Gibson, Dunn & Crutcher LLP
`3161 Michelson Drive
`Irvine, CA 92612-4412
`Telephone: (949) 551-3967
`
`By: /s/ Nowell D. Bamberger
`
`
`Nowell D. Bamberger
`Elsbeth Bennett
`Cleary Gottlieb Steen & Hamilton LLP
`2112 Pennsylvania Avenue, N.W.
`Washington, D.C. 20037
`Telephone: (202) 974-1500
`
`
`1 The Staff has requested that Complainants include the SX exhibits in Complainants’ submission.
`
`FINAL EXHIBIT LIST OF JOINT, COMPLAINANTS, AND STAFF EXHIBITS
`
`

`

`Fax: (949) 451-4220
`AllerganITC3359@gibsondunn.com
`
`Brian M. Buroker
`Haley S. Morrisson
`Gibson, Dunn & Crutcher LLP
`1050 Connecticut Avenue, N.W.
`Washington, D.C. 20036-5306
`Telephone: (202) 955-8541
`Fax: (202) 467-0539
`AllerganITC3359@gibsondunn.com
`
`Michael Sitzman
`DLA PIPER LLP
`555 Mission Street, Suite 2400
`San Francisco, California 94105-2933
`Telephone: (415) 615-6175
`michael.sitzman@us.dlapiper.com
`
`Attorneys for Allergan plc and Allergan,
`Inc.
`
`Facsimile: (202) 974-1999
`Team-ITC-Medytox-1145@cgsh.com
`
`David H. Herrington
`Joon H. Kim
`Arminda B. Bepko
`Charity E. Lee
`Cleary Gottlieb Steen & Hamilton LLP
`One Liberty Plaza
`New York, NY 10006
`Telephone: (212) 225-2000
`Team-ITC-Medytox-1145@cgsh.com
`
`T. Spence Chubb
`Law Office of T. Spence Chubb
`1025 Connecticut Avenue, N.W.,
`Suite 1000
`Washington, D.C. 20036
`Telephone: (703) 623-7739
`Facsimile: (703) 563-6055
`Team-ITC-Medytox-1145@cgsh.com
`
`Attorneys for Medytox Inc.
`
`FINAL EXHIBIT LIST OF JOINT, COMPLAINANTS, AND STAFF EXHIBITS
`
`
`2
`
`

`

`Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and
`Certain Products Containing Same, Inv. No. 337-TA-1145
`
`CERTIFICATE OF SERVICE
`
`I, Charity E. Lee, certify that on February 21, 2020, copies of the foregoing document
`
`were served on the following in the manner so indicated:
`
`
`The Honorable Lisa Barton
`Secretary to the Commission
`U.S. INTERNATIONAL TRADE COMMISSION
`500 E Street, S.W.,
`Washington, DC 20436
`
`
`The Honorable David P. Shaw
`Administrative Law Judge
`U.S. INTERNATIONAL TRADE COMMISSION
`500 E Street, S.W., Room 317
`Washington, DC 20436
`
`Brian Koo
`Office of Unfair Import Investigations
`U.S. INTERNATIONAL TRADE COMMISSION
`500 E Street, S.W., Suite 401
`Washington, D.C. 20436
`Telephone: (202) 205-2580
`
`Counsel for Respondent Daewoong
`Pharmaceuticals Co., Ltd.
`
`David F. Nickel (Lead Attorney)
`FOSTER, MURPHY, ALTMAN & NICKEL, PC
`1150 18th St., NW
`Washington, D.C. 20036
`Telephone: (202) 822-4104
`
`
`Via EDIS
`
`Via Courier (1 copy)
`Via E-Mail:
`Shaw337@usitc.gov
`Joseph.Speyer@usitc.gov
`
`Via E-mail:
`Brian.Koo@usitc.gov
`
`Via E-mail:
`FM-Daewoong-
`1145@fostermurphy.com
`
`
`
`

`

`Via E-mail:
`KK-Daewoong-1145@kobreKim.com
`
`Counsel for Respondent Daewoong
`Pharmaceuticals Co., Ltd.
`
`Michael Kim
`Benjamin J. A. Sauter
`Benjamin Sirota
`Jeffrey Newton
`800 3rd Avenue
`New York, NY 10022
`Telephone: (212) 488-1200
`Fax: (212) 488-1220
`
`Daniel Zaheer
`150 California St.
`San Francisco, CA 94111
`Telephone: (415) 582-4800
`Fax: (415) 582-4811
`
`Won Joon Lee
`Daniel Lee
`9F, Tower B, The-K Twin Towers
`50, Jong-ro l-gil, Jongno-gu
`Seoul, 03142 South Korea
`Telephone: +82 2-369-1212
`Fax: +82 2-369-1220
`
`Matthew Boucher
`1919 M. Street, NW
`Washington, D.C. 20036
`Telephone: (202) 664-1950
`Fax: (202) 664-1920
`
`Matthew I. Menchel
`201 South Biscayne Boulevard, Suite 1900
`Miami, Florida 33131
`Telephone: (305) 967-6100
`Fax: (305) 967-6120
`
`
`
`

`

`
`
`Via E-mail:
`grp-evolus-itc@paulweiss.com
`
`
`Via Email:
`AllerganITC3359@gibsondunn.com
`michael.sitzman@us.dlapiper.com
`
`Counsel for Respondent Evolus, Inc.
`
`Nicholas Groombridge
`Joseph J. Bial
`Josephine Young
`Ariane Rockoff-Kirk
`PAUL, WEISS, RIFKIND, WHARTON &
`GARRISON LLP
`1285 Avenue of the Americas
`New York, NY
`Telephone: (212) 373-3000
`Counsel for Complainants Allergan plc and
`Allergan, Inc.
`
`Brian M. Buroker (Lead Attorney)
`Haley Morrisson
`GIBSON, DUNN & CRUTCHER LLP
`1050 Connecticut Avenue, N.W.
`Washington, D.C. 20036-5306
`Telephone: (202) 955-8500
`
`Jeffrey T. Thomas
`Joshua A. Jessen
`GIBSON, DUNN & CRUTCHER LLP
`3161 Michelson Drive
`Irvine, CA 92612-4412
`Telephone: (949) 451-3800
`
`Soolean Choy
`GIBSON, DUNN & CRUTCHER LLP
`555 Mission Street, Suite 3000
`San Francisco, CA 94105-0921
`Telephone: (415) 393-8200
`
`Nathan R. Curtis
`GIBSON, DUNN & CRUTCHER LLP
`2100 McKinney Avenue
`Dallas, TX 75201-6912
`Telephone: (214) 698-3100
`
`Lori C. Arakaki
`GIBSON, DUNN & CRUTCHER LLP
`333 South Grand Avenue
`Los Angeles, CA 90071-3197
`Telephone: (213) 229-7000
`
`
`
`
`

`

`Michael Sitzman
`DLA PIPER LLP
`555 Mission Street, Suite 2400
`San Francisco, California 94105-2933
`Telephone: (415) 615-6175
`
`
`
`
`
`
`
`
`/s/ Charity E. Lee
`Charity E. Lee
`Cleary Gottlieb Steen & Hamilton LLP
`One Liberty Plaza
`New York, NY 10006
`Telephone: (212) 225-2000
`
`
`Date: February 21, 2020
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`

`EXH. NO.
`CDX-0001
`
`Confidential
`C
`
`Beginning Bates
`N/A
`
`Ending Bates
`N/A
`
`CDX-0002
`
`CDX-0003
`CDX-0004
`
`CDX-0006
`
`CDX-0007
`
`CDX-0008
`
`CDX-0009
`
`CDX-0010
`
`C
`
`C
`C
`
`C
`
`C
`
`C
`
`C
`
`C
`C
`C
`
`N/A
`
`N/A
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`EXHIBIT A - Final Exhibit List of Joint, Complainants, and Staff Exhibits
`
`Description
`Demonstrative Exhibit Referenced in the Witness Statement of Dr. Seong Hun Chang - BK Lee Strain
`Access
`Demonstrative Exhibit Referenced in the Witness Statement of Dr. Seong Hun Chang - Cell Bank
`Security
`Demonstrative Exhibit Referenced in the Witness Statement of Dr. Hack Woo Kim
`Demonstrative Exhibit Referenced in the Witness Statement of Dr. Paul Keim
`
`Sponsoring Witness
`Seong Hun Chang
`
`Seong Hun Chang
`
`Hack Woo Kim
`Paul Keim;
`David Sherman
`James Malackowski
`
`Demonstrative Exhibit Referenced in the Witness Statement of Sesha Neervannan – BOTOX®
`Indications Approved by the FDA
`
`Irvine Campus identifying locations where BOTOX®-related activities occur
`
`States identifying relevant facilities where BOTOX®-related activities occur
`Demonstrative Exhibit Referenced in the Witness Statement of James Malackowski – Allergan’s
`Investments in Domestic Research and Development from 1992 to 2018
`Demonstrative Exhibit Reference in the Witness Statement of Dr. Andrew Pickett
`
`Demonstrative Exhibit Referenced in the Witness Statement of Sesha Neervannan – Map of the Allergan James Malackowski
`
`Demonstrative Exhibit Referenced in the Witness Statement of James Malackowski – Map of the United James Malackowski
`
`James Malackowski
`
`Andrew Pickett;
`Brenda Wilson
`
`David Moatazedi
`Brenda Wilson
`
`Paul Keim
`
`Admitted
`Admitted
`
`Admitted
`
`Admitted
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`CDX-0011
`CDX-0012
`CDX-0013
`CDX-0014
`CPX-0001
`CPX-0002
`CPX-0003
`CPX-0004
`CPX-0005
`CPX-0006
`CX-0001
`CX-0002
`
`CX-0003
`CX-0004
`CX-0005
`CX-0006
`CX-0007
`CX-0008
`
`CX-0009
`
`CX-0010
`
`CX-0011
`
`CX-0012
`
`CX-0013
`
`CX-0014
`CX-0015
`
`C
`
`C
`
`C
`C
`
`C
`
`C
`
`C
`
`C
`
`C
`
`C
`C
`
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`N/A
`
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`N/A
`
`Literature Citations in Daewoong Documents
`Pickett Demonstrative
`Guidepoint Market Share
`Bacterial Toxins: Methods and Protocols (Otto Holst ed., 2000)
`Vials of BOTOX®
`Vials of Jeuveau®
`BOTOX® Packaging
`Jeuveau® Packaging
`Expert Report of Dr. Paul Keim - Exhibit 12
`Empty Sample 1.8 ml Vial
`Complaint Exhibit A - Evolus, Inc. 10K dated March 29, 2018
`Complaint Exhibit C - Letter from Allergan Asia Ltd. to Daewoong, "Re: Termination of Distributorship
`Agreement," February 1, 2006
`Complaint Exhibit U - Evolus, Inc. S-1, July 16, 2018
`Complaint Exhibit V - Evolus, Inc. 10-Q, Nov. 5, 2018
`Complaint Exhibit X - Declaration of Theresa Smith
`Complaint Exhibit EE - Evolus, Inc., 8-K dated January 4., 2019
`Response of Evolus, Inc. to the Complaint and Notice of Institution of Investigation
`Witness Statement of Ben Marzouk
`
`Witness Statement of Colleen McKenna
`
`Witness Statement of Dr. Andrew Pickett
`
`Witness Statement of Dr. Chang Hoon Rhee
`
`Witness Statement of Dr. Hack Woo Kim
`
`Witness Statement of Dr. Hyun Ho Jung
`
`Contingent Rebuttal Witness Statement of Dr. Kyu Hwan Yang
`Witness Statement of Dr. Paul Keim
`
`Page 1 of 53
`
`Withdrawn
`Withdrawn
`Admitted
`Admitted
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Admitted
`Withdrawn
`Admitted
`Admitted
`
`Admitted
`Admitted
`Admitted
`Admitted
`Withdrawn
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`Admitted
`
`Joint Stipulation (Dkt. No. 701591)
`Joint Stipulation (Dkt. No. 701591)
`
`Joint Stipulation (Dkt. No. 701591)
`Joint Stipulation (Dkt. No. 701591)
`Brenda Wilson
`Joint Stipulation (Dkt. No. 701591)
`
`Ben Marzouk;
`James Malackowski;
`Carla Mulhern
`Colleen McKenna;
`James Malackowski;
`Carla Mulhern
`Andrew Pickett;
`David Sherman;
`Brenda Wilson;
`Bal Ram Singh;
`Ryan Sullivan;
`Carla Mulhern
`Chang Hoon Rhee;
`David Sherman;
`Ryan Sullivan;
`Carla Mulhern
`Hack Woo Kim;
`David Sherman;
`Carla Mulhern
`Hyun Ho Jung;
`David Sherman;
`Ryan Sullivan;
`Carla Mulhern
`Kyu Hwan Yang
`Paul Keim;
`David Sherman;
`Ryan Sullivan;
`Carla Mulhern
`
`

`

`EXH. NO.
`CX-0016
`
`Confidential
`C
`
`Beginning Bates
`N/A
`
`Ending Bates
`N/A
`
`Witness Statement of Dr. Sesha Neervannan
`
`Description
`
`EXHIBIT A - Final Exhibit List of Joint, Complainants, and Staff Exhibits
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`Witness Statement of Dr. Sung Hun Chang [Seong Hun Chang]
`
`Witness Statement of James Malackowski
`
`Medytox-ITC-00000398
`Medytox-ITC-00004196
`Medytox-ITC-00004213
`Medytox-ITC-00004310
`
`Daewoong Answer in Korean Civil Litigation dated January 26, 2018
`Presentationtitled "P2 - sBTA06XX Plant Media Applications" dated November 9, 2006
`Batch record dated from August 23, 2006 to September 4, 2006.
`PowerPoint Presentation for PO.5-sBTA0600 dated September 20, 2006
`
`Medytox-ITC-00004461
`Medytox-ITC-00004484
`
`Medytox-ITC-00004474
`Medytox-ITC-00004486
`
`CX-0017
`
`CX-0018
`
`CX-0019
`CX-0025
`CX-0026
`CX-0027
`
`CX-0028
`CX-0030
`CX-0031
`CX-0035
`CX-0036
`CX-0038
`
`CX-0041
`CX-0042
`
`CX-0046
`CX-0047
`CX-0049
`CX-0050
`CX-0056
`CX-0057
`CX-0058
`CX-0059
`
`CX-0061
`CX-0062
`CX-0066
`CX-0067
`CX-0068
`CX-0070
`CX-0087
`CX-0092
`CX-0097
`CX-0098
`CX-0099
`CX-0100
`CX-0101
`CX-0102
`CX-0103
`
`CX-0104
`CX-0105
`CX-0106
`CX-0107
`CX-0108
`CX-0109
`CX-0110
`CX-0112
`CX-0113
`
`CX-0114
`CX-0115
`CX-0116
`CX-0117
`CX-0118
`CX-0119
`CX-0120
`
`C
`
`C
`
`C
`C
`C
`
`C
`C
`C
`C
`C
`C
`
`C
`C
`
`C
`C
`C
`C
`C
`C
`C
`C
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`C
`C
`C
`C
`C
`C
`C
`
`Medytox-ITC-00000350
`Medytox-ITC-00004190
`Medytox-ITC-00004197
`Medytox-ITC-00004214
`
`Medytox-ITC-00004311
`Medytox-ITC-00004380
`Medytox-ITC-00004385
`Medytox-ITC-00004408
`Medytox-ITC-00004425
`Medytox-ITC-00004430
`
`Medytox-ITC-00004525
`Medytox-ITC-00004716
`Medytox-ITC-00005289
`Medytox-ITC-00005312
`Medytox-ITC-00005401
`Medytox-ITC-00005407
`Medytox-ITC-00005420
`Medytox-ITC-00005422
`
`Medytox-ITC-00005428
`Medytox-ITC-00005434
`Medytox-ITC-00005470
`Medytox-ITC-00005558
`Medytox-ITC-00005564
`Medytox-ITC-00005572
`Medytox-ITC-00006019
`Medytox-ITC-00006205
`Medytox-ITC-00006367
`Medytox-ITC-00006481
`Medytox-ITC-00006547
`Medytox-ITC-00006555
`Medytox-ITC-00006561
`Medytox-ITC-00006624
`Medytox-ITC-00006636
`
`Medytox-ITC-00006639
`Medytox-ITC-00006642
`Medytox-ITC-00006648
`Medytox-ITC-00006650
`Medytox-ITC-00006652
`Medytox-ITC-00006657
`Medytox-ITC-00006659
`Medytox-ITC-00006700
`Medytox-ITC-00006707
`
`Medytox-ITC-00006728
`Medytox-ITC-00006730
`Medytox-ITC-00006733
`Medytox-ITC-00006738
`Medytox-ITC-00006754
`Medytox-ITC-00006773
`Medytox-ITC-00006776
`
`Sponsoring Witness
`Sesha Neervannan;
`James Malackowski;
`Carla Mulhern
`Seong Hun Chang;
`Carla Mulhern
`James Malackowski;
`Ryan Sullivan;
`Carla Mulhern
`
`Hack Woo Kim;
`Seong Hun Chang
`
`Andrew Pickett
`Andrew Pickett
`
`Admitted
`Admitted
`
`Admitted
`
`Admitted
`
`Withdrawn
`Withdrawn
`Withdrawn
`Admitted
`
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`
`Withdrawn
`Admitted
`
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Admitted
`Admitted
`Withdrawn
`Withdrawn
`
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`
`Medytox-ITC-00004310
`Medytox-ITC-00004384
`Medytox-ITC-00004394
`Medytox-ITC-00004424
`Medytox-ITC-00004426
`Medytox-ITC-00004434
`
`Medytox-ITC-00004531
`Medytox-ITC-00004723
`Medytox-ITC-00005297
`Medytox-ITC-00005317
`Medytox-ITC-00005406
`Medytox-ITC-00005419
`Medytox-ITC-00005421
`Medytox-ITC-00005425
`
`Medytox-ITC-00005433
`Medytox-ITC-00005437
`Medytox-ITC-00005486
`Medytox-ITC-00005563
`Medytox-ITC-00005568
`Medytox-ITC-00005572
`Medytox-ITC-00006052
`Medytox-ITC-00006222
`Medytox-ITC-00006371
`Medytox-ITC-00006487
`Medytox-ITC-00006554
`Medytox-ITC-00006560
`Medytox-ITC-00006569
`Medytox-ITC-00006635
`Medytox-ITC-00006638
`
`Experimental Batch Record dated October 10, 2006 to October 24, 2006
`Potency tests conducted dated Sept 29, 2006
`Potency tests conducted dated October 17 and October 30, 2006
`Fermentation and purification time schedule dated September 5, 2006
`Gel electrophoresis conducted on December 15, 2006
`Process Development Team (Weekly) Work Report dated from November 2, 2006 to November 22,
`2006.
`Collection of academic papers relating to the purification of botulinum toxin
`Process Development Team (Weekly) Work Report dated from September 1, 2006 to October 18, 2006 Hack Woo Kim;
`Seong Hun Chang
`
`Gel electrophoresis dated February 12, 2007
`PowerPoint Presentation forMedy-Tox substrate production process shc[ch]eme dated June 7
`PowerPoint Presentation for Progress Report 20070726 dated July 26, 2007
`PowerPoint Presentation for Progress Report 20070626 dated June 26, 2007
`Progress Report 20070921
`Progress Report 20070831
`Experiment report dated October 24, 2005
`PowerPoint Presentation for Process Improvement Action Plan: Animal-free media Set-updated
`December 2, 2005.
`Stability test schedule dated December 2, 2005
`Animal-free media Set-updated December 1, 2005
`Research on stability and manufacturing process dated January 24, 2006
`Test report on the potency of plant-derived culture medium
`Test report on the product stability
`Test report dated February 27, 2006
`Gel electrophoresis conducted dated July 17-September 17, 2007
`HPLC analysis of KKS sample dated June 20, 2007
`Product excipient stability test report dated December 30, 2005
`HPLC peak analysis dated April 24, 2007
`KHW 7S Toxin Presentation dated April 20, 2007
`215 nm analysis & 278 nm analysis presentation
`HPLC peak analysis presentation dated April 5, 2007
`PowerPoint Presentation for Purification condition design dated September 28, 2007
`Process Development Team (Weekly) Work Report dated from October 29, 2007 to November 9, 2007
`
`Batch ID: P2sBTA0707-F02 dated May 6, 2007
`Medytox-ITC-00006641
`Batch test result reports: P2sBTA0704 - F01 and P2sBTA0705 - F02
`Medytox-ITC-00006647
`Process Development Team (Weekly) Work Report dated from March 26, 2007 to April 6, 2007
`Medytox-ITC-00006649
`Process Development Team (Weekly) Work Report dated from June 11, 2007 to June 22, 2007
`Medytox-ITC-00006651
`Medytox-ITC-00006656 Work Report dated July 30, 2007
`Medytox-ITC-00006658
`Test reports on vegetable culture medium efficacy test dated April 23, 2007
`Medytox-ITC-00006661 Work Report dated July 12, 2007
`Medytox-ITC-00006705
`PowerPoint Presentation for Progress Report 20070824 dated August 24, 2007
`Medytox-ITC-00006727
`Process Development Team Monthly Plan regarding fermentation, isolation, and purification by the use
`of a disposable bag dated August 17, 2007
`Process Development Team (Weekly) Work Report dated from July 23, 2007 to August 3, 2007
`Process Development Team (Weekly) Work Report dated from July 30, 2007 to August 24, 2007
`Process Development Team (Weekly) Work Report dated from June 18, 2007 to July 27, 2007
`PowerPoint Presentation for Medy-Tox substrate production process shc[ch]eme
`PowerPoint Presentation for Progress Report 20070626 dated June 26, 2007
`Process Development Team (Weekly) Work Report dated from May 1, 2007 to May 18, 2007
`Process Development Team (Weekly) Work Report dated from March 26, 2007 to April 6, 2007
`
`Medytox-ITC-00006729
`Medytox-ITC-00006732
`Medytox-ITC-00006737
`Medytox-ITC-00006743
`Medytox-ITC-00006772
`Medytox-ITC-00006775
`Medytox-ITC-00006776
`
`Page 2 of 53
`
`

`

`EXH. NO.
`CX-0121
`
`Confidential
`C
`
`Beginning Bates
`Medytox-ITC-00006777
`
`Ending Bates
`Medytox-ITC-00006778
`
`Description
`Process Development Team (Weekly) Work Report dated from February 26, 2007 to March 9, 2007
`
`Sponsoring Witness
`
`Admitted
`Withdrawn
`
`EXHIBIT A - Final Exhibit List of Joint, Complainants, and Staff Exhibits
`
`CX-0122
`CX-0123
`
`CX-0124
`
`CX-0125
`
`CX-0126
`
`CX-0127
`CX-0129
`
`CX-0130
`
`CX-0131
`
`CX-0132
`
`CX-0133
`
`CX-0134
`CX-0136
`
`CX-0141
`
`CX-0143
`CX-0144
`CX-0145
`CX-0147
`CX-0148
`CX-0151
`
`CX-0152
`CX-0153
`CX-0154
`CX-0155
`CX-0156
`CX-0157
`CX-0160
`CX-0161
`CX-0164
`
`CX-0166
`CX-0170
`CX-0171
`CX-0172
`CX-0173
`CX-0174
`CX-0175
`CX-0176
`CX-0177
`CX-0178
`CX-0179
`CX-0180
`
`C
`C
`
`C
`
`C
`
`C
`
`C
`C
`
`C
`
`C
`
`C
`
`C
`
`C
`C
`
`C
`
`C
`C
`C
`C
`C
`C
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`Medytox-ITC-00006779
`Medytox-ITC-00006785
`
`Medytox-ITC-00006782
`Medytox-ITC-00006788
`
`Process Development Team (Weekly) Work Report dated from February 5, 2007 to March 2, 2007
`Process Development Team (Weekly) Work Report dated from February 12, 2007 to March 5, 2007
`
`Medytox-ITC-00006789
`
`Medytox-ITC-00006789
`
`Process Development Team (Weekly) Work Report dated from January 29, 2007 to February 9, 2007
`
`Medytox-ITC-00006790
`
`Medytox-ITC-00006800
`
`Medytox-ITC-00006801
`
`Medytox-ITC-00006802
`
`Process Development Team (Weekly) Work Report dated from January 22, 2007 to February 2, 2007 Hack Woo Kim;
`Seong Hun Chang
`
`Process Development Team (Weekly) Work Report dated from September 1, 2006 to October 18, 2006
`
`Medytox-ITC-00006803
`Medytox-ITC-00007217
`
`Medytox-ITC-00006807
`Medytox-ITC-00007227
`
`Process Development Team (Weekly) Work Report dated from March 5, 2007 to March 23, 2007
`Hand-written notes dated July 3, 2000 to July 27, 2000
`
`Medytox-ITC-00007228
`
`Medytox-ITC-00007274
`
`Hand-written notes dated August 3, 2000 to August 30, 2000
`
`Medytox-ITC-00007275
`
`Medytox-ITC-00007311
`
`8L Culture type A #8 SDS Page
`
`Medytox-ITC-00007312
`
`Medytox-ITC-00007325
`
`Hand-written notes dated November 2, 2000 to December 1, 2000
`
`Medytox-ITC-00007326
`
`Medytox-ITC-00007345
`
`Hand-written notes dated December 1, 2000 to December 27, 2000
`
`Medytox-ITC-00007346
`Medytox-ITC-00007383
`
`Medytox-ITC-00007348
`Medytox-ITC-00007523
`
`Handwritten Notes dated January 1, 2001
`Purification of BoNT/A
`
`Medytox-ITC-00007654
`
`Medytox-ITC-00007668
`Medytox-ITC-00007730
`Medytox-ITC-00007751
`Medytox-ITC-00007771
`Medytox-ITC-00007802
`Medytox-ITC-00008677
`
`Medytox-ITC-00008698
`Medytox-ITC-00008984
`Medytox-ITC-00009046
`Medytox-ITC-00009060
`Medytox-ITC-00009077
`Medytox-ITC-00009083
`Medytox-ITC-00009450
`Medytox-ITC-00009455
`Medytox-ITC-00012566
`
`Medytox-ITC-00012715
`Medytox-ITC-00013807
`Medytox-ITC-00014506
`Medytox-ITC-00014516
`Medytox-ITC-00014527
`Medytox-ITC-00014539
`Medytox-ITC-00014551
`Medytox-ITC-00014563
`Medytox-ITC-00014576
`Medytox-ITC-00014591
`Medytox-ITC-00014597
`Medytox-ITC-00015110
`
`Medytox-ITC-00008715
`Medytox-ITC-00009012
`Medytox-ITC-00009059
`Medytox-ITC-00009066
`Medytox-ITC-00009082
`Medytox-ITC-00009135
`Medytox-ITC-00009454
`Medytox-ITC-00009459
`Medytox-ITC-00012601
`
`Medytox-ITC-00007664
`
`Medytox-ITC-00007729
`Medytox-ITC-00007750
`Medytox-ITC-00007757
`Medytox-ITC-00007773
`Medytox-ITC-00007813
`Medytox-ITC-00008697
`
`PowerPoint Presentation for Process Improvement Action Plan: Animal-free media Set-updated
`December 2, 2005
`Product stability test schedule dated December 2, 2005
`Research on product stability and manufacturing process development dated January 24, 2006
`Meeting minutes dated May 11, 2006
`Sample Table Report dated October 13, 2006
`Test Plan regarding Effectiveness validation test related to plant-derived medium dated July 28, 2005
`Stability Test of MCB (CBAM0301) Clostridium botulinum Type A, Hall strain for 3 years dated
`November 3, 2006
`Report titled "Stability Test of WCB for 3 years" dated November 3, 2006
`Validation Protocol for Method Validation of Potency Assay (Retrospective) dated Sept. 2, 2005
`SDS Page assay Method Validation dated May 18, 2005
`Protein assay (Bradford Method) Method Validation dated October 29, 2005
`Prepared media validation by Sun Hee In dated Sept 22, 2005
`SDS Page assay Method Validation dated June 21, 2005
`Cell Banking with Plant-derived Media Protocol dated September 7, 2006
`Toxin Production Study Using Plant Media dated September 8, 2006
`Document titled "5. Method of Production, Separation and Purification of Target Molecule in
`Manufacturing Process".Draft of manufacturing process flow chart and batch record version no. 00,
`initially dated October 1, 2003
`Document titled "10. General Test Method Material Relating to All Steps of Manufacturing Process"
`Medytox-ITC-00012773
`Medytox-ITC-00013807 Working Cell Bank Management Log for CBAW0301 - Clostridium botulinum type A, Hall
`Medytox-ITC-00014515
`Statement of Tax Adjustments, 1st Term: from May2, 2000 to December 31, 2000
`Medytox-ITC-00014526
`Statement of Tax Adjustments, 2ndTerm: from January 1, 2001 to December 31, 2001
`Medytox-ITC-00014538
`Statement of Tax Adjustments, 3rd Term: from January 1, 2002 to December 31, 2002
`Medytox-ITC-00014550
`Statement of Tax Adjustments, 4th Term: from January 1, 2003 to December 31, 2003
`Medytox-ITC-00014562
`Statement of Tax Adjustments, 5th Term: from January 1, 2004 to December 31, 2004
`Medytox-ITC-00014575
`Statement of Tax Adjustments, 6thTerm: from January 1, 2005 to December 31, 2005
`Medytox-ITC-00014590
`Statement of Tax Adjustments, 7th Term: from January 1, 2006 to December 31, 2006
`Medytox-ITC-00014596
`Statement of Tax Adjustments, 8th Term: from January 1, 2007 to December 31, 2007
`Medytox-ITC-00014604
`Statement of Tax Adjustments, 9th Term: from January 1, 2008 to December 31, 2008
`Medytox-ITC-00015113
`The effect of Yeast Extract for Clostridium Botulinum Type A Growth Protocol dated April 16, 2008
`
`Page 3 of 53
`
`Withdrawn
`Withdrawn
`
`Withdrawn
`
`Admitted
`
`Withdrawn
`
`Withdrawn
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`
`Admitted
`Admitted
`
`Admitted
`
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Admitted
`
`Admitted
`Admitted
`Admitted
`Admitted
`Admitted
`Withdrawn
`Admitted
`Admitted
`Admitted
`
`Admitted
`Admitted
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Admitted
`
`Hack Woo Kim;
`Andrew Pickett
`Hyun Ho Jung;
`Seong Hun Chang
`Hyun Ho Jung;
`Hack Woo Kim;
`Seong Hun Chang
`Hyun Ho Jung;
`Hack Woo Kim;
`Seong Hun Chang
`Hyun Ho Jung;
`Hack Woo Kim;
`Seong Hun Chang
`Hyun Ho Jung;
`Hack Woo Kim;
`Seong Hun Chang
`Hyun Ho Jung
`Hyun Ho Jung;
`Hack Woo Kim;
`Seong Hun Chang
`Hack Woo Kim;
`Seong Hun Chang
`
`Seong Hun Chang
`
`Seong Hun Chang
`Seong Hun Chang
`Seong Hun Chang
`Seong Hun Chang
`Seong Hun Chang
`
`Seong Hun Chang
`Seong Hun Chang
`Hack Woo Kim;
`Seong Hun Chang
`
`Chang Hoon Rhee
`Seong Hun Chang
`
`Seong Hun Chang
`
`

`

`EXH. NO.
`CX-0181
`
`Confidential
`C
`
`Beginning Bates
`Medytox-ITC-00015114
`
`Ending Bates
`Medytox-ITC-00015118
`
`EXHIBIT A - Final Exhibit List of Joint, Complainants, and Staff Exhibits
`
`Description
`The effect of Yeast Extract, Carbohydrate, and amino acids on Growth, and Clostridium Botulinum
`Toxin Type A production without animal and plant derived media Protocol dated May 20, 2008
`The effect of Yeast Extract for Clostridium botulinum Type A Growth dated May 20, 2008.
`
`Medytox-ITC-00015119
`
`Medytox-ITC-00015124
`
`CX-0182
`
`CX-0213
`
`CX-0215
`CX-0217
`
`CX-0261
`CX-0262
`
`CX-0263
`CX-0269
`CX-0273
`CX-0274
`CX-0276
`
`CX-0287
`
`CX-0330
`CX-0331
`
`CX-0332
`
`CX-0334
`
`CX-0335
`CX-0336
`CX-0337
`CX-0338
`CX-0339
`CX-0349
`CX-0350
`CX-0351
`CX-0370
`CX-0375
`CX-0377
`CX-0379
`CX-0384
`CX-0390
`CX-0391
`CX-0392
`CX-0393
`CX-0394
`CX-0395
`CX-0396
`CX-0397
`CX-0398
`CX-0399
`CX-0415
`CX-0416
`CX-0421
`
`CX-0422
`
`CX-0423
`
`CX-0424
`
`CX-0425
`CX-0426
`CX-0427
`CX-0428
`CX-0429
`
`C
`
`C
`
`C
`C
`
`C
`C
`
`C
`C
`C
`C
`C
`
`C
`
`C
`C
`
`C
`
`C
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`C
`
`C
`
`C
`
`C
`C
`C
`C
`C
`
`Medytox-ITC-00017521
`
`Medytox-ITC-00021280
`Medytox-ITC-00021319
`
`Medytox-ITC-00039390
`Medytox-ITC-00039394
`
`Medytox-ITC-00039399
`Medytox-ITC-00039545
`Medytox-ITC-00039577
`Medytox-ITC-00039583
`Medytox-ITC-00039630
`
`Medytox-ITC-00039393
`Medytox-ITC-00039398
`
`Medytox-ITC-00017525
`
`Medytox-ITC-00021306
`Medytox-ITC-00021352
`
`Bacterial Endotoxin Limit Test: Kinetic Turbidimetric Method Standard Operating Procedure dated
`August 7, 2006
`Batch record for Clostridium botulinum Type A, Hall strain MCB, version no. 01 dated April 4, 2008
`Batch record for Clostridium botulinum Type A, Hall strain MCB, version no. 01 dated February 2,
`2008
`The effect of Yeast Extract for Clostridium Botulinum Type A Growth Protocol dated April 16, 2008
`The effect of Yeast Extract, Carbohydrate, and amino acids on Growth, and Clostridium Botulinum
`Toxin Type A production without animal and plant derived media Protocol dated May 20, 2008
`The effect of Yeast Extract for Clostridium Botulinum Type A Growth Protocol dated May 20, 2008
`Medytox-ITC-00039404
`Medytox-ITC-00039548 WCB manufacturing protocol dated July 8, 2008
`Medytox-ITC-00039582
`MCB manufacturing protocol dated April 3, 2008
`Medytox-ITC-00039589
`MCB manufacturing protocol dated February 11, 2008
`Medytox-ITC-00039636
`Report for history of Clostridium botulinum strain in Medy-tox Inc. dated November 5, 2008
`
`Medytox-ITC-00041783
`
`Medytox-ITC-00041820
`
`Test request, order and results for various drug substance batches
`
`Medytox-ITC-00044212
`Medytox-ITC-00044282
`
`Medytox-ITC-00044245
`Medytox-ITC-00044315
`
`Master Batch Record: Botulinum toxin type A dated October 27, 2004
`Master Batch Record: Botulinum toxin type A dated August 10, 2004
`
`Medytox-ITC-00044422
`
`Medytox-ITC-00044496
`
`Master Batch Record: Botulinum toxin type A dated December 27, 2004
`
`Medytox-ITC-00067150
`
`Medytox-ITC-00067246
`
`BTA0301 Batch Record version no. 00 dated October 1, 2003
`
`Medytox-ITC-00071215
`Medytox-ITC-00071272
`Medytox-ITC-00071377
`Medytox-ITC-00071401
`Medytox-ITC-00072307
`Medytox-ITC-00080197
`Medytox-ITC-00080198
`Medytox-ITC-00080199
`Medytox-ITC-00080638
`Medytox-ITC-00080671
`Medytox-ITC-00080677
`Medytox-ITC-00080689
`Medytox-ITC-00080716
`Medytox-ITC-00080753
`Medytox-ITC-00080756
`Medytox-ITC-00080770
`Medytox-ITC-00080784
`Medytox-ITC-00080798
`Medytox-ITC-00080812
`Medytox-ITC-00080826
`Medytox-ITC-00080840
`Medytox-ITC-00080854
`Medytox-ITC-00080868
`Medytox-ITC-00083176
`Medytox-ITC-00083382
`Medytox-ITC-00086244
`
`Medytox-ITC-00086253
`
`Medytox-ITC-00086256
`
`Medytox-ITC-00086260
`
`Medytox-ITC-00086341
`Medytox-ITC-00086344
`Medytox-ITC-00086347
`Medytox-ITC-00086350
`Medytox-ITC-00086361
`
`BTA0302 Batch Record dated December 2003
`Medytox-ITC-00071271
`BTA0601 Batch Record dated January 11, 2006
`Medytox-ITC-00071376
`Medytox-ITC-00071400 Written Test Request dated February 1, 2006
`Medytox-ITC-00071430
`BTA0302 Batch Record dated October 1, 2003
`Medytox-ITC-00072403
`BTX0804 Batch Record dated October 30, 2008
`Medytox-ITC-00080197
`Stability test reports on botulinum toxin type A dated November 12, 2003
`Medytox-ITC-00080198
`Stability test reports on botulinum toxin type A dated December 3, 2003
`Medytox-ITC-00080199
`Stability test reports on botulinum toxin type A dated December 24, 2003
`Medytox-ITC-00080641
`Test report on solution (BTA 0301-24"month"-1.2.3) dated February 10, 2006
`Medytox-ITC-00080673
`Test report on solution (BTA 0301-1) dated January 10, 2006 (test conducted by Byung Kook Lee)
`Medytox-ITC-00080680
`Test report on solution (BTA 0302-24"month"-1.2.3) dated February 10, 2006
`Test report on solution (BTA 0302-1) dated January 17, 2006
`Medytox-ITC-00080691
`Medytox-ITC-00080719
`Test report on solution (BTA 0303-24"month"-1.2.3) dated February 10, 2006
`Medytox-ITC-00080755
`Test report on solution (BTA 0303-1) dated January 24, 2006
`Medytox-ITC-00080769
`Long term stability test (phase 1) on C. botulinum toxin type A (BTA0301) dated December 7, 2006
`Medytox-ITC-00080783
`Long term stability test (phase 1) on C. botulinum toxin type A (BTA0302) dated December 7, 2006
`Medytox-ITC-00080797
`Long term stability test (phase 1) on C. botulinum toxin type A (BTA0303) dated December 7, 2006
`Medytox-ITC-00080811
`Long term stability test (phase 2) on C. botulinum toxin type A (BTA0301) dated December 7, 2006
`Medytox-ITC-00080825
`Long term stability test (phase 2) on C. botulinum toxin type A (BTA0302) dated December 7, 2006
`Medytox-ITC-00080839
`Long term stability test (phase 2) on C. botulinum toxin type A (BTA0303) dated December 7, 2006
`Medytox-ITC-00080853
`Long term stability test (phase 3) on C. botulinum toxin type A (BTA0301) dated December 7, 2006
`Medytox-ITC-00080867
`Long term stability test (phase 3) on C. botulinum toxin type A (BTA0302) dated December 7, 2006
`Medytox-ITC-00080881
`Long term stability test (phase 3) on C. botulinum toxin type A (BTA0303) dated December 7, 2006
`Medytox-ITC-00083255
`Botulinum toxin type A Batch Record dated January 11, 2006
`Medytox-ITC-00083415
`Master Batch Record Botulinum toxin type A version no. 00, dated October 1, 2003
`Medytox-ITC-00086249
`Identification of Type A Botulinum Toxin Producing Bacterium Strain Using 16s DNA sequencing
`analysis dated September 4, 2006
`Morphological analysis of Type A Botulinum Toxin Producing Bacterium Strain dated September 4,
`2006
`Identification of Type A Botulinum Toxin Producing Bacterium Strain Using API 20 A kit dated
`September 4, 2006
`Identification of Type A Botulinum Toxin Producing Bacterium Strain Using Mutiplex PCR dated
`September 4, 2006
`HPLC analysis of BTA Substance dated September 5, 2006
`IEF analysis of BTA Substance dated September 5, 2006
`2DE analysis of BTA Substance dated September 6, 2006
`SDS-PAGE analysis of BTA Substance dated September 6, 2006
`Peptide mapping analysis of BTA Substance dated September 6, 2006
`
`Medytox-ITC-00086255
`
`Medytox-ITC-00086259
`
`Medytox-ITC-00086262
`
`Medytox-ITC-00086343
`Medytox-ITC-00086346
`Medytox-ITC-00086349
`Medytox-ITC-00086354
`Medytox-ITC-00086371
`
`Page 4 of 53
`
`Sponsoring Witness
`
`Admitted
`Withdrawn
`
`Hack Woo Kim;
`Seong Hun Chang
`
`Hack Woo Kim
`
`Seong Hun Chang
`
`Seong Hun Chang
`
`Chang Hoon Rhee;
`Hyun Ho Jung
`Chang Hoon Rhee;
`Paul Keim
`Hack Woo Kim
`Hack Woo Kim;
`Seong Hun Chang
`Hack Woo Kim
`Seong Hun Chang
`Hack Woo Kim;
`Seong Hun Chang
`
`Seong Hun Chang
`
`Admitted
`
`Withdrawn
`
`Withdrawn
`Admitted
`
`Admitted
`Withdrawn
`
`Admitted
`Withdrawn
`Withdrawn
`Withdrawn
`Admitted
`
`Admitted
`
`Admitted
`Admitted
`
`Admitted
`
`Admitted
`
`Withdrawn
`Withdrawn
`Admitted
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`
`Withdrawn
`
`Withdrawn
`
`Withdrawn
`
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`Withdrawn
`
`

`

`EXH. NO.
`CX-0430
`
`Confidential
`C
`
`Beginning Bates
`Medytox-ITC-00086829
`
`Ending Bates
`Medytox-ITC-00086845
`
`Description
`Experimental Batch Record, Version No. 03 dated August 4, 2008
`
`EXHIBIT A - Final Exhibit List of Joint, Complainants, and Staff Exhibits
`
`CX-0431
`
`CX-0432
`CX-0433
`CX-0434
`
`CX-0435
`CX-0436
`CX-0437
`CX-0438
`CX-0439
`CX-0440
`CX-0441
`CX-0442
`CX-0443
`CX-0444
`CX-0445
`
`CX-0446
`
`CX-0447
`
`CX-0448
`
`CX-0449
`
`C
`
`C
`C
`C
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`C
`
`C
`
`C
`
`C
`
`C
`
`Medytox-ITC-00086846
`
`Medytox-ITC-00086863
`
`Experimental Batch Record Version, Version No. 04 dated January 11, 2006
`
`Medytox-ITC-00086864
`Medytox-ITC-00086895
`Medytox-ITC-00086896
`
`Medytox-ITC-00086899
`Medytox-ITC-00086900
`Medytox-ITC-00086901
`Medytox-ITC-00086902
`Medytox-ITC-00086903
`Medytox-ITC-00086904
`Medytox-ITC-00086907
`Medytox-IT