UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, D.C.
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`Before the Honorable David P. Shaw
`Administrative Law Judge
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`
`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
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`COMPLAINANTS’ PRE-HEARING STATEMENT
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`COMPLAINANTS’ PRE-HEARING STATEMENT
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`Pursuant to Order No. 26 and Ground Rule 7, Complainants Medytox Inc.
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`(“Medytox”) and Allergan plc and Allergan, Inc. (together with their subsidiaries, “Allergan”)
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`(collectively, “Complainants”) submit this Pre-hearing Statement. Complainants are filing
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`concurrently a Pre-hearing Brief that sets forth in detail the legal, factual, and equitable bases for the
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`arguments they will present at the hearing.
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`I.
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`OPENING STATEMENT
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`Complainants intend to present a brief opening statement prior to presenting our case
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`in chief. The purpose of the opening statement will be to orient the Administrative Law Judge to the
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`technology and concepts in dispute, as well as the issues that are anticipated to consume the majority
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`of the evidentiary hearing time in light of the Parties’ respective Pre-hearing Briefs. Complainants
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`have estimated 36 minutes for their opening statement.
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`II.
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`COMPLAINANTS’ ANTICIPATED HEARING WITNESSES
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`Pursuant to Order No. 26 and Ground Rule 7(a), Complainants identify the following
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`known fact and expert witnesses they expect to appear at the hearing. A brief summary of each
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`witness’s proposed testimony is included below. Copies of the curriculum vitae for Complainants’
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`expert witnesses are attached as Attachments A - C.
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`A.
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`Complainants’ Case In Chief
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`Complainants will call the following witnesses as part of their case in chief:
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`i. Dr. Paul Keim
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`Dr. Keim is the leading expert in the United States on genetic tracing of the
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`evolutionary origin of pathogens. He is a Regents Professor of Biology at Northern Arizona
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`University (“NAU”), where he also holds the E. Raymond and Ruth Reed Endowed Chair in Food
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`Microbiology and serves as the Executive Director of the Pathogen and Microbiome Institute. He is
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`Complainants’ Pre-Hearing Statement
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`also jointly employed at The Translational Genome Research Institute (“TGen”), where he holds the
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`rank of Distinguished Professor. He founded the Pathogen Genome Division at TGen in 2003 and
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`has directed or co-directed the division since. He is also affiliated with the BioSciences Division at
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`Los Alamos National Laboratory in New Mexico and is an elected fellow of the American Academy
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`of Microbiology and the American Academy for the Advancement of Science. Dr. Keim has devoted
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`his career to tracing evolutionary relationships in bacteria and other pathogens. He has pioneered
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`the field of using DNA fingerprinting to identify the source of toxic organisms and infectious agents
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`and has worked with the Department of Justice, FBI, FDA, Centers for Disease Control (CDC), and
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`Department of Homeland Security (DHS). He has published over 450 scientific research articles that
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`have been cited over 30,000 times. This includes articles on botulism neurotoxin producing bacteria.
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`Dr. Keim will testify regarding his DNA analysis of the Clostridium botulinum (“C.
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`botulinum”) strains used by Daewoong and Medytox, and in particular that (a) the Medytox strain is
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`derived from the Hall A-hyper strain, and (b) the Daewoong strain is derived from the Medytox
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`strain, and not – as Daewoong has long maintained in false submissions to Korean and U.S.
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`authorities (including in this case) – from a strain that it independently isolated from soil in South
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`Korea. Dr. Keim will also respond to the analysis put forth by Respondents’ expert, Dr. David
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`Sherman, a professional witness with a history of providing outcome-oriented opinions that at least
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`two federal district courts have excluded on credibility grounds, and whose analysis in this case has
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`repeatedly been discredited.
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`Dr. Keim’s curriculum vitae is attached to this Statement as Attachment A.
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`ii. Dr. Hyun Ho Jung
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`Dr. Jung is a former university professor and one of the leading experts in South Korea
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`on C. botulinum. In 2000, as part of a government effort to encourage academics to pursue
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`entrepreneurship, Dr. Jung founded Medytox – initially a three-person company, which has now
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`Complainants’ Pre-Hearing Statement
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`grown to over 600 employees and become one of the most dynamic biotechnology firms in South
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`Korea. Dr. Jung has served as the CEO of Medytox since its founding.
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`Dr. Jung will testify regarding the founding of Medytox and Medytox’s development
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`of many of the trade secrets at issue in this Investigation, specifically, the process by which Medytox
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`developed its manufacturing for Meditoxin, Medytox’s first and leading botulinum neurotoxin
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`product, and its continued innovation regarding the manufacture of botulinum neurotoxin products
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`after obtaining regulatory approval for the sale of Meditoxin in Korea (and other countries outside
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`the United States). The manufacturing processes that Dr. Jung will address are reflected in the
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`documents that Medytox’s former employee, Byung Kook Lee, misappropriated from Medytox and
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`include the manufacturing know-how that Daewoong used to develop the botulinum neurotoxin
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`products currently known as DWP-450 and planned to be marketed under the name Jeuveau
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`(“Accused Products”). Dr. Jung will also testify to the facts and circumstances that caused Medytox
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`to become aware of Daewoong’s misappropriation of its bacterial strain and manufacturing process,
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`as well as the steps that Medytox undertook to protect its trade secrets against misappropriation.
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`iii. Hack Woo Kim
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`Hack Woo Kim is one of the earliest employees of Medytox, having joined the
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`company in March 2001 soon after receiving his master’s degree in biotechnology. Since 2018, Mr.
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`Kim has been a director of Medytox, and he is also the head of a production business department and
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`the team lead for one of Medytox’s manufacturing facilities. Early in his career at Medytox, Mr.
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`Kim was directly involved in Medytox’s development of its manufacturing process for the drug
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`substance of Meditoxin, and in Medytox’s subsequent research and development.
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`Like Dr. Jung, Mr. Kim will testify regarding the process by which Medytox
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`developed its manufacturing process for Meditoxin and its continued innovation regarding the
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`manufacture of botulinum neurotoxin products after obtaining regulatory approval for the sale of
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`Complainants’ Pre-Hearing Statement
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`Meditoxin. In that sense, Mr. Kim’s testimony will concern Medytox’s development of the trade
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`secrets at issue in this Investigation, as well as to their independent economic value to Medytox. Mr.
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`Kim will also testify regarding Medytox’s application for various patents, and specifically how the
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`trade secrets at issue in this Investigation differ from the information disclosed in Medytox’s patents,
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`as well as Medytox’s business and document retention practices.
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`iv. Dr. Seong Hun Chang
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`Dr. Chang is a longstanding employee of Medytox, having joined the company in
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`June 2002. Dr. Chang currently serves as the Head of Quality System Management at Medytox, a
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`position which he has held since 2016. His earlier roles at the company included research and
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`development regarding Medytox’s C. botulinum strain and the manufacturing process for Medytox’s
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`products, including Meditoxin. Dr. Chang will testify regarding Medytox’s development of the trade
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`secrets at issue in this Investigation and their independent economic value to Medytox. Since mid-
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`2002, Dr. Chang has also had responsibility for Medytox’s confidentiality policies and security, and
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`has been responsible for the implementation of Medytox’s IT security systems since approximately
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`2007. Accordingly, in addition to his testimony concerning Medytox’s research and development of
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`the trade secrets at issue, Dr. Chang will testify regarding Medytox’s security systems and its efforts
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`to safeguard those trade secrets, as well as concerning Medytox’s use of its information security
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`system to identify Byung Kook Lee’s printing and emailing of documents containing trade secrets.
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`v. Dr. Chang Hoon Rhee
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`Dr. Rhee is the head of the Biopharmaceutical Development Department at Medytox,
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`a position he has held since 2012. He joined Medytox in November 2007 and has been a Director at
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`Medytox since 2016. Dr. Rhee was the head of the Drug Form Development and Analysis Team
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`(also known as the Formulation and Analysis Team) at the Microbial Toxin R&D Center from 2007
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`to 2014. In 2012, Dr. Rhee also became the head of the Biopharmaceutical Development department.
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`Complainants’ Pre-Hearing Statement
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`Dr. Rhee will testify as to the attributes of Medytox’s Hall A-hyper strain, one of the
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`trade secrets asserted in this Investigation, including the independent economic value of the strain to
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`Medytox, how Medytox stores and safeguards its strain, and how Medytox propagated Medytox’s
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`cell banks, certain of which were the subject of testing and analysis by the experts in this
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`Investigation. Dr. Rhee will also testify concerning Medytox’s drug substance manufacturing
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`process, including the significance and independent economic value of various of the manufacturing
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`process trade secrets to Medytox. Finally, Dr. Rhee will testify concerning aspects of Byung Kook
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`Lee’s work at Medytox and the knowledge gained by Byung Kook Lee regarding Medytox’s
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`manufacturing process through his work at Medytox.
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`vi. Dr. Andrew Pickett
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`Dr. Pickett is one of the foremost experts in the area of commercial botulinum toxin
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`(“BTX”). He has worked on a wide range of biological products since joining the industry in 1979.
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`In the course of his career, Dr. Pickett has been associated with Dista Products Limited (the UK
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`production company for Eli Lilly & Co. Ltd.), Biogen SA (where he became Head of Process
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`Development), Porton Products (where he was Head of Fermentation Production and Development
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`(Large Scale) at the Centre for Applied Microbiology and Research, Director of Production, and later
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`Director of Technical Affairs), Ipsen Limited (where he was Director of Technical Affairs and later
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`Senior Director, Biologicals Science and Technology), and Galderma S.A., where he was Head of
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`Development. Dr. Pickett is a member of the British Pharmacopoeia Panel of Experts BIO
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`(Biological and Biotechnical products) and a Board Member of the Botulinum Research Center,
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`Institute for Advanced Studies. Over his career, he has worked with and managed many teams
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`involved with research, development, production, quality control, regulatory affairs, technical
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`support, and project management with respect to botulinum toxin products (as well as other
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`biological and chemical products). Dr. Pickett began working with botulinum toxin in the mid-1980s
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`while working at Porton Products, with responsibility for obtaining the first marketing authorization
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`for the product now called Dysport®. Dr. Pickett has some 90 publications in learned journals,
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`magazines, and books (as chapters), mainly dedicated to botulinum toxin, and holds a number of
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`patents and patent applications related to botulinum toxin. Dr. Pickett is regularly invited to
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`participate in national and international conferences and to give updates on the science and clinical
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`uses of botulinum toxins, and has given over 500 lectures to the worldwide clinical community,
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`including department heads, relating to the science of botulinum toxin and how to interpret these
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`matters for clinical applications.
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`Dr. Pickett will testify to his opinions on the implausibility of Daewoong’s assertion
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`regarding having isolated the strain of C. botulinum used in its manufacturing process from soil in
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`South Korea, the extent to which Medytox’s Hall A-hyper strain has commercial value and would
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`not be publicly available, the evidence showing Daewoong misappropriated information from
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`Medytox in developing its botulinum product DWP-450, and the advantages gained and time saved
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`by Daewoong for its development of DWP-450 as a result of its improper acquisition and use of
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`Medytox’s C. botulinum strain and manufacturing process.
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`Dr. Pickett’s curriculum vitae is attached to this Statement as Attachment B.
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`vii. Dr. Seshadri Neervannan
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`Dr. Neervannan is Senior Vice President of Pharmaceutical Development within the
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`Research and Development Division of Allergan. Dr. Neervannan has worked at Allergan since
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`2007, and he presently oversees Allergan’s development of its small molecule and biologics drug
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`products, including BOTOX®. Dr. Neervannan also plays a leadership role in Allergan’s partnership
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`with Medytox for the development, regulatory approval, and commercialization of MT10109L, a
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`neurotoxin product that Allergan is licensing from Medytox. Dr. Neervannan is expected to testify
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`about BOTOX®, including providing a general overview of BOTOX®, its manufacturing and
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`research and development, as well as the domestic Allergan facilities where such activities occur.
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`Dr. Neervannan also is expected to testify about Allergan’s partnership with Medytox and Allergan’s
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`role, activities, and investment in the development, regulatory approval, and commercialization of
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`MT10109L.
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`viii. Mr. Ben Marzouk
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`Ben Marzouk is an Executive Director of Finance at Allergan, where he is responsible
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`for directing the planning, forecasting, analysis, and reporting for Allergan’s U.S. Medical Aesthetics
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`Business, which includes BOTOX® Cosmetic. Mr. Marzouk joined Allergan in December 2004.
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`Mr. Marzouk is expected to testify about topics relating to BOTOX® (comprising BOTOX®
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`Cosmetic and BOTOX® therapeutic) and BOTOX® Cosmetic alone, including Allergan’s related
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`domestic investments, activities, and sales. He is also expected to testify regarding Allergan’s
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`foreign investments relating to BOTOX®. Mr. Marzouk further is expected to testify about
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`Allergan’s domestic and foreign investments and activities relating to MT10109L, the neurotoxin
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`product licensed by Allergan (and being jointly developed by Allergan and Medytox).
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`ix. Ms. Colleen McKenna
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`Colleen McKenna is the Vice President of Marketing for Facial Aesthetics at
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`Allergan. She has worked at Allergan for thirteen years and served in her current position for four
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`years. Ms. McKenna is responsible for marketing and promotional activities for Allergan’s facial
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`aesthetic products, including BOTOX® Cosmetic, and has knowledge and involvement in analyzing
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`the competitive landscape for such products and pricing decisions.
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`Ms. McKenna is expected to testify about topics relating to the neurotoxin market,
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`including market research and the competitive landscape, as well as the BOTOX® product (and
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`BOTOX® Cosmetic alone), including its pricing and marketing. Ms. McKenna further is expected
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`to testify about the impact of Respondents’ Jeuveau on BOTOX® and the BTX market in the United
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`Complainants’ Pre-Hearing Statement
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`States. Ms. McKenna also is expected to testify regarding the MT10109L neurotoxin product
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`licensed by Allergan from Medytox (and being jointly developed by Allergan and Medytox),
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`including current expectations regarding marketing of, potential pricing of, and impact of Jeuveau
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`on MT10109L.
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`x. Mr. James Malackowski
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`Mr. Malackowski is an expert in the areas of economic and market analysis, injury
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`analysis, and the valuation and analysis of intellectual property and licenses, among other topics.
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`Mr. Malackowski, who has provided valuation, transaction, and financial advisory assistance for
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`more than 30 years and frequently instructs on IP management and markets, as well as emerging
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`technology markets, has served as an expert witness on more than 50 occasions in cases in the U.S.
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`International Trade Commission and numerous federal and state courts on questions relating to the
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`economics and valuation of intellectual property, and specifically trade secrets and patents.
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`Mr. Malackowski is expected to testify regarding the domestic industry for BTX
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`products in the United States, Complainants’ products comprising such domestic industry, and the
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`injury that will be and already has been suffered due to the importation and sale of the Accused
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`Products and Respondents’ activities. Mr. Malackowski also is expected to testify regarding the
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`appropriateness, duration, and reach of the remedies that should be entered in this matter, as well as
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`the amount of bond that should be posted during the presidential review period.
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`Mr. Malackowski’s curriculum vitae is attached to this Statement as Attachment C.
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`*
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`*
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`*
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`In addition to these witnesses, Complainants anticipate that their adverse examination
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`of witnesses proffered by Respondents Daewoong Pharmaceuticals Co. Ltd. (“Daewoong”) and
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`Evolus, Inc. (“Evolus”) will exceed the scope of those witnesses’ written witness statements, certain
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`of which omit critical topics relevant to this Investigation – such as, for example, testimony
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`Complainants’ Pre-Hearing Statement
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`concerning the supposed discovery of Daewoong’s C. botulinum strain from the soil in South Korea,
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`a cover-story that has been disproven and which Daewoong has omitted from the presentation of its
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`case.
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`Complainants will further rely on deposition testimony, subject to designation before
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`the hearing and any agreements reached by the parties. Specifically, Complainants intend to rely on
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`the deposition testimony of witnesses deposed in this matter, including those identified in
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`Complainants’ Pre-hearing Brief, filed concurrently. Complainants may seek leave to call any
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`deposition witness live in the event that individual’s deposition testimony is not admitted into the
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`record.
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`B.
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`Complainants’ Rebuttal Case
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`Complainants intend to move in limine to preclude Respondents from introducing
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`arguments and evidence that are irrelevant to the issues on which the Commission has instituted this
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`Investigation. The Investigation concerns Respondents’ unfair acts in violation of Section 337 of the
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`Tariff Act of 1930. Respondents have sought to distract from that focus by attempting to litigate a
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`myriad of other allegations against Complainants unrelated to that subject matter. But Respondents
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`lack standing to, for example, mount a hypothetical challenge to Medytox’s legal ownership of its C.
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`botulinum strain on behalf of third parties who themselves have never asserted the rights that
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`Daewoong purports to advance. Nor is it a defense to a Section 337 case to rely on other unrelated,
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`alleged bad acts by Complainants under the guise of an “unclean hands” defense.
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`In the event that the Administrative Law Judge does not grant Complainants’ motions
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`in limine and intends to take evidence on these so-called defenses at the evidentiary hearing,
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`Complainants would rely on the testimony of the following witnesses, who submitted contingent
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`written rebuttal statements.1 In that eventuality, Complainants believe that witnesses whose
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`1
`Complainants’ submission of those rebuttal statements is contingent on the Administrative
`Complainants’ Pre-Hearing Statement
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`testimony is also part of Complainants’ affirmative case should be questioned as part of Respondent’s
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`cross examination of these witnesses, rather than being required to appear twice, and have provided
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`their time estimates on that basis.
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`i. Dr. Hyun Ho Jung
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`As described above, Dr. Jung is the founder and CEO of Medytox. On rebuttal, Dr.
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`Jung will address various of Respondents’ asserted affirmative defenses, including specifically their
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`unfounded allegations concerning Medytox’s “unclean hands,” Medytox’s alleged lack of legal title
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`to its C. botulinum strain, and Complainants’ alleged unjustifiable delay in filing this Investigation.
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`ii. Dr. Hack Woo Kim
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`As discussed above, Dr. Kim is a director of Medytox and head of its production
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`business department. On rebuttal, Dr. Kim will address various of Respondents’ asserted affirmative
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`defenses, including specifically their unfounded allegations concerning Medytox’s “unclean hands,”
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`as well as Respondents’ arguments that Medytox employees other than Byung Kook Lee printed or
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`emailed documents containing Medytox trade secrets.
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`iii. Dr. Seong Hun Chang
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`As discussed above, Dr. Chang is a Head of Quality Systems Management and head
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`of information technology security at Medytox. On rebuttal, Dr. Chang will address various of
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`Respondents’ asserted affirmative defenses, including specifically their unfounded allegations
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`concerning Medytox’s “unclean hands,” as well as Respondents’ arguments that Medytox employees
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`other than Byung Kook Lee printed or emailed documents containing Medytox trade secrets.
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`iv. Dr. Kyu Hwan Yang
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`Dr. Yang is among the founding generation of modern botulinum researchers, an
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`Law Judge’s denial of Complainants’ motion in limine, and Complainants would seek leave to
`withdraw them in the event that the motion is granted.
`Complainants’ Pre-Hearing Statement
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`academic mentor of Medytox’s founder, Dr. Hyun Ho Jung, and a former senior South Korean
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`government official. His work in C. botulinum toxins stretches back to his time as a graduate student
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`in the 1970s, in the early stages of academic research related to botulinum. His professional
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`achievements include serving as the commissioner of the Korean Ministry of Food and Drug Safety
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`and as the president of the Korea Research Institute of Bioscience and Biotechnology.
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`On rebuttal, Dr. Yang will respond to Respondents’ unfounded allegations that Dr.
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`Jung and Medytox lack legal title or ownership of Medytox’s Hall A-hyper strain, one of the trade
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`secrets that Daewoong misappropriated. Dr. Yang will testify to this matter from his personal
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`knowledge, having personally obtained the strain from Dr. Hiroshi Sugiyama at the University of
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`Wisconsin Food Research Institute, brought it to Korea, provided it to Dr. Jung, and given his
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`approval for Dr. Jung to use the strain to develop Medytox’s products.
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`III.
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`EXHIBIT LIST
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`Pursuant to Order No. 26 and Ground Rule 7(b), Respondents identify the exhibits
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`expected to be introduced at the hearing as set out in Attachment D.
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`IV.
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`STATEMENT REGARDING SETTLEMENT
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`Pursuant to Ground Rule 3, Complainants certify that good faith efforts were
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`undertaken to attempt to settle the remaining disputed issues to be presented at the evidentiary
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`hearing. The Parties have been unable to resolve those issues.
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`V.
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`STATEMENT OF THE ISSUES TO BE CONSIDERED AND CONTENTIONS
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`With respect to Complainants’ statement of the issues to be considered at the hearing
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`and their contentions with respect thereto, as required by Ground Rule 7(c), Complainants refer to
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`their Pre-hearing Brief filed contemporaneously herewith.
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`Complainants’ Pre-Hearing Statement
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`VI.
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`TABLE OF WITNESSES AND TIME ESTIMATES
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`The Parties have jointly prepared the following table describing the projected order
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`of anticipated witnesses and time estimates:
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`Openings
`Complainants
`Respondents
`Staff
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`
`
`Subtotal
`Complainants’ Case
`
`Paul Keim
`Hyun Ho Jung
`Hack Woo Kim
`Seong Hun Chang
`Chang Hoon Rhee
`Andrew Pickett
`Sesha Neervannan
`Ben Marzouk
`Colleen McKenna
`James Malackowski
`Subtotal
`Respondents’ Case
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`
`
`Byung Kook Lee
`Brenda Wilson
`Chung Se Kim
`Kyoung Yoon Kim
`Chris Marmo
`David Sherman
`BalRam Singh
`Chang Woo Suh
`Ryan Sullivan
`David Moatazedi
`Carla Mulhern
`Subtotal
`Complainants’
`Rebuttal Case
`Kyu Hwan Yang
`Subtotal
`TOTAL TIMES
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`
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`
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`
`
`
`
`
`
`
`
`
`
`
`36
`
`
`36
`Complainants’
`Direct/Redirect
`50
`15
`12
`12
`12
`35
`12
`12
`12
`20
`192
`Complainants’
`Cross
`30
`25
`35
`20
`20
`45
`20
`30
`20
`25
`30
`300
`Complainants’
`Direct/Redirect
`12
`12
`540
`
`
`
`
`30
`
`30
`Respondents’
`Cross
`60
`45
`20
`20
`20
`30
`10
`10
`10
`15
`240
`Respondents’
`Direct/Redirect
`70
`22
`25
`15
`10
`37
`12
`25
`12
`10
`12
`250
`Respondents’
`Cross
`20
`20
`540
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`30
`30
`Staff’s Cross
`
`30
`15
`6
`6
`6
`15
`10
`10
`5
`15
`118
`Staff’s Cross
`
`15
`15
`15
`10
`6
`30
`15
`15
`7
`6
`13
`147
`Staff Cross
`
`5
`5
`300
`
`
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`Complainants’ Pre-Hearing Statement
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`Dated: January 10, 2020
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`Respectfully submitted,
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`GIBSON, DUNN & CRUTCHER LLP CLEARY GOTTLIEB STEEN & HAMILTON LLP
`
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`By: /s/ Jeffrey T. Thomas .
`
`Jeffrey T. Thomas
`Joshua A. Jessen
`Gibson, Dunn & Crutcher LLP
`3161 Michelson Drive
`Irvine, CA 92612-4412
`Telephone: (949) 551-3967
`Facsimile: (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
`Facsimile: (202) 467-0539
`AllerganITC3359@gibsondunn.com
`
`Michael A. Sitzman
`DLA PIPER LLP
`555 Mission Street, Suite 2400
`San Francisco, CA 94105-0921
`Telephone: (415) 615-6175
`Facsimile: (415) 659-7411
`AllerganITC3359@gibsondunn.com
`
`Attorneys for Allergan plc and Allergan, Inc.
`
`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
`Facsimile: (202) 974-1999
`Team-ITC-Medytox-1145@cgsh.com
`
`David H. Herrington
`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.
`
`
`
`
`
`Complainants’ Pre-Hearing Statement
`
`
`
` 13
`
`

`

`
`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, Natalie Noble, certify that on January 10 and 13, 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
`
`Date:
`
`January 13, 2020
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Natalie Noble
`Natalie Noble
`Cleary Gottlieb Steen & Hamilton LLP
`One Liberty Plaza
`New York, NY 10006
`Telephone: (212) 225-2000
`
`
`
`
`
`

`

`Attachment A
`
`Attachment A
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`Paul S. Keim, Ph.D.
`Curriculum vitae
`
`Table of Contents
`
`
`
`
`Section Description
`
`Short Summary CV ..............................................................................................................2
`Education, Training and Professional Experience ...............................................................3
`Honors and Awards..............................................................................................................4
`Professional Societies (Past and Present) ............................................................................4
`Professional Service .............................................................................................................4
`Advisory and Policy Committees .......................................................................................5
`Scholarship and Award Selection Committees ....................................................................6
`Journal Editorial Boards ......................................................................................................6
`Chaired Sessions ..................................................................................................................6
`Competitive Grants Review Panel Member ........................................................................6
`Ad Hoc Grant Reviewer ......................................................................................................7
`Ad Hoc Paper Reviewer ......................................................................................................7
`Competitive Grants Review Panel Member: .......................................................................7
`Expert Witness Testimony ...................................................................................................7
`Patents Issued .......................................................................................................................7
`Patents Pending ....................................................................................................................8
`Publications ..........................................................................................................................9
`Published Reports .............................................................................................................49
`Invited Seminars/Lectures .................................................................................................50
`Extramural Research ..........................................................................................................64
`Students and faculty trained ..........................................................