UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON,D.C.
`
`In the Matter of
`
`CERTAIN BOTULINUM TOXIN
`
`PRODUCTS AND PROCESSES FOR
`
`MANUFACTURING OR RELATING TO
`
`SAME
`
`
`
`Inv. No. 337-TA-1313
`
`COMPLAINANT MEDYTOX’S MOTION TO COMPEL PRODUCTION OF CELL
`
`BANKS FROM HUGEL’S SINBUK FACILITY AND THE USE OF CCTV DURING
`
`LABORATORY TESTING
`
`Public Version
`
`Document ID: 797552
`
`Document ID: 798160
`
`Motion Number: 1313-010
`
`

`

`Ground Rule 5.1 Certification
`
`Pursuant to Ground Rule 5.1, Complaimant Medytox (“Medytox” or “Complainants’’)
`
`certifies that on May 25, 2023, counsel for Medytox met with counsel for Respondents Hugel,
`
`Inc. and Hugel America, Inc. (collectively “Respondents” or “Hugel”) and the Commission
`
`Investigative Staff in order to make reasonable goodfaith efforts to resolve the issues raised in
`
`this Motion.
`
`The parties’ dispute could not be resolved. Complainants understand that
`
`Respondents will oppose this motion.
`
`Dated: May 31, 2023
`
`Respectfully submitted,
`
`/S/ Alex Lasher
`
`S. Alex Lasher
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`1300 I Street, NW, Suite 900
`Washington, D.C. 20005
`Telephone.: (202) 538-8000
`
`James Baker
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`Telephone: (212) 849-7000
`
`Sean Pak
`David Bilsker
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`50 California Street, 22nd Floor
`
`

`

`San Francisco, California 94111
`Telephone: (415) 875-6600
`
`Steve Cherny
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`111 Huntington Avenue, Suite 520
`Boston, Massachusetts 02199
`Telephone: (617) 712-7100
`
`Attorneysfor Medytox Inc.
`
`i
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION 0000... ..ccccccccecescescesceesesseeseeseseeseeneacacesscsecsaesacaeeaeeseesecsecseeseeaeeseeateaseaeeaes 1
`
`A
`
`LEGAL STANDARD W000. occ cece cesses cesses sesseeseeseseeseeseeecsecsecssceaeeceeseeseeseesecseeeeesseseeseeseeeeeaes 2
`
`ARGUMENT..oo.ec ccc ceccescesceseesceseeseseesessesseesesseeseesesecsecseesecsaesaeeneeseesecseeseeseeeeeseeseeseeaeeaeeaes 3
`
`A.
`
`B.
`
`The ALJ Should Compel Hugel to Allow Sample Collection and Testing
`From the Remaining Sinbuk Cell Banks ..0.......000..00ccceeccccecceescceeceeeseeeeceeeeeesseeeeees 3
`
`The ALJ Should Compel Hugel to Use CCTV Rather Than Individual
`Monitors in the Laboratory Space................c.ccccccesceeeceeeseeeeeeeseeeseeeeseeeseeeeeeesseeesees 8
`
`CONCLUSION(000... ocecceeeeccecceccescesceseeseeseeeeeseessessceaeeeeeecsecsecsecsessaeseeeeeaeeaeeseseeeeseesesseeseateats 8
`
`ill
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`
`Page
`
`Beloit Corp. v. U.S. Int’l Trade Comm’n,
`845 F.2d 1033 (Fed. Cir. 1988)........ceccecceccecccesceeseeseeeseesseeseesseeseeeseeesecsaeeseeeaesaeeeseaeesseeneeeeeees 7
`
`Certain Audiovisual Components & Prod. Containing the Same,
`Inv. No. 337-TA-837, Order No. 59, 2013 WL 459044 (Feb. 4, 2013) .0.....eeeeeeeeeeeteeeeeeeees 7
`
`Certain Biometric Scanning Devices, Components Thereof, Associated Software,
`& Products Containing The Same,
`Inv. No. 337-TA-720, Order No. 10, 2010 WL 4786591 (Sept. 7, 2010)...........ceeeeeeeeeee2,3
`
`Certain Cold Cathode Fluorescent Lamp (“CCFL”) Inverter Circuits & Products
`Containing the Same,
`Inv. No. 337-TA-666, Order No. 16, 2009 WL 2573608 (Aug. 4, 2009) .00........cceeeeeeeeeeeeeeeee2
`
`Certain Encapsulated Integrated Circuit Devices and Products Containing Same,
`Inv. No. 337-TA-501, Order No. 50 (May 18, 2004) ..........cceccceceeeceeceescceceeeceeeeeeseeseeeseeeeeeseenes 3
`
`Certain Integrated Circuits, Chipsets, & Prods. Containing Same Including
`Televisions, Media Players,& Cameras,
`Inv. No. 337-TA-709, Order No. 8, 2010 WL 4783037 (Jun. 18, 2010)... ceeeeeeeeeeeeeee2
`
`Certain Rechargeable Lithium-Ion Batteries,
`Inv. No. 337-TA-600, Order No. 8, 2007 WL 2570861 (July 25, 2007).......0....0.ccceccceeeeeeeeeeeees 3
`
`Certain Semiconductor Devices & Prod. Containing Same,
`Inv. No. 337-TA-525, Order No. 7, 2004 WL 3091206 (Dec. 20, 2004)............eceeeeeteeeeeeteees 7
`
`Suprema, Inc. v. Int'l Trade Comm’n,
`796 F.3d 1338 (Fed. Cir. 2015).....eccccceccccecceccceceeseesceeseesseessesseesceeseeaecsaeeseeeseeeeeeeeeseeseeeneeeseeeses 7
`
`Statutes
`
`19 CFR. § 210.27(D) ooeccecceccecccccecccescesceeseesecseeeseesseesaeeseceaeesaceaecesecaceaeseaeesesseseaeseseeeseeeeaeeseees2,3
`
`Tariff Act of 1930 Section 337 .........cecccccesccescessseseesseeseceseeescesecsaecsscesecaecseceseceaeeseeeaeeeaeeseeeeeeseessees 5
`
`iv
`
`

`

`L
`
`INTRODUCTION
`
`On June 7, 2023, experts for Complainant Medytox Inc. (“Medytox”) and Respondents
`
`Hugel, Inc. and Hugel America, Inc.’s (collectively, “Hugel”) will begin sample collection and
`
`testing of cell banks stored at Hugel’s Geodu and Sinbuk facilities in Seoul, South Korea. As the
`
`Administrative Law Judge is aware, the parties previously agreed that Medytox’s experts would
`
`be allowed to take samples from a cell banks stored at Hugel’s Geodufacility. Hugel
`
`refused, however, to allow Medytox’s experts to sample and test any cell banks from Hugel’s
`
`Sinbuk facility. During the May 18, 2023, oral hearing on this issue, the ALJ ordered Hugel to
`
`supplement its interrogatory responses by providing full information concerningall cell banks
`
`stored at its Geodu and Sinbuk facilities by May 24, 2023. The ALJ further ordered Medytox
`
`then to identify no more than two cell banks from the Sinbuk facility for collection and testing by
`
`May26, 2023, if deemed necessary by Medytox’s experts. The ALJ further orderedthat, if after
`
`receiving Hugel’s supplemental interrogatory responses, Medytox andits expertsstill believed it
`
`wasnecessary to sample and test more than two cell banks from Sinbuk the parties should meet
`
`and confer, and Medytox should file a motion with accompanying evidence (including expert
`
`declarations) by May 31, 2023.
`
`Having followed the procedure the Court outlined, Medytox and its experts determined
`
`intI ctl bank ot Sini
`
`four so-called “reference” strains—also needed to be tested. Consequently,
`
`the parties met and
`
`conferred on May 25, 2023. During the meet and confer, Medytox explained the basis for its
`
`request to sample andtestP| Sinbuk cell bank and four reference strains, but Hugel
`still refused. Thus, Medy.
`respectfully submits this motion to compel production ofa
`Po cell bank and four reference strains from Hugel’s Sinbuk facility. As
`
`explained further below, Hugel’s statements to the United States Food and Drug Administration
`
`

`

`(“FDA”) and in its interrogatory responses, call into question the identity of these strains.
`
`Therefore, Medytox should be allowedto test a// the C. botulinumstrain cell banks at the Sinbuk
`
`and Geodufacilities, including all four reference strains. Medytox’s motion is accompanied by
`
`the supporting declarations of its experts Dr. Paul Keim and Dr. Andrew Pickett, as well as
`
`relevant discovery.!
`
`Medytox also respectfully requests the ALJ to compel Hugel to use CCTV to monitor
`
`Medytox’s experiments, rather than individuals present
`
`in the same laboratory space as
`
`Medytox’s experts. After meeting and conferring, the parties have determined that the use of
`
`CCTV is possible, but Hugelis still insisting that individuals should be allowed in the room.
`
`II.
`
`LEGAL STANDARD
`
`“{A] party may obtain discovery regarding any matter, not privileged, that is relevant to
`
`... [t]he claim or defense of the party seeking discovery or to the claim or defense of any other
`
`party.” 19 C.F.R. § 210.27(b). Discovery in a Section 337 investigation is not limited to the
`
`allegations of the complaint. Certain Biometric Scanning Devices, Components Thereof,
`
`Associated Software, & Prods. Containing the Same, Inv. No. 337-TA-720, Order No. 10, 2010
`
`WL 4786591, at *1 (Sept. 7, 2010) (“Biometric Scanning Devices”).
`
`Instead, the scope of
`
`discovery is “governed by the Notice of Investigation.” Jd.
`
`(citing multiple orders); Certain
`
`Cold Cathode Fluorescent Lamp (“CCFL”) Inverter Circuits & Prods. Containing the Same,
`
`Inv. No. 337-TA-666, Order No. 16, 2009 WL 2573608, at *4 (Aug. 4, 2009) (“The Notice of
`
`Investigation (‘NOI’) defines the scope of an investigation.”). And in practice, the scope of
`
`discovery is “generally somewhat broader than the scope of the investigation itself.” Certain
`
`issue are Medytox’s First Request for Entry Upon Land for
`1 The discovery requests at
`Inspection to Respondents,
`including Numbers 1-5, Medytox’s First Set of Interrogatories,
`including Numbers 1—6, 9, 12-13, 18, 21, and 24~—25, and Medytox’s First Set of Requests for
`Production, including Numbers 1-8. (Exs. 1-3).
`
`

`

`Integrated Circuits, Chipsets, & Prods. Containing Same Including Televisions, Media
`
`Players,& Cameras, Inv. No. 337-TA-709, Order No. 8, 2010 WL 4783037, at *6 (Jun. 18,
`
`2010); see also Certain Rechargeable Lithium-Ion Batteries, Inv. No. 337-TA-600, Order No.8,
`
`2007 WL 2570861, at *2 (July 25, 2007) (“Batteries”) (The scope of discovery is, at the very
`
`least, “commensurate with the scope of the investigation.”). Where “the scope of the present
`
`investigation is broadly defined, so too is the scope of discovery.” Batteries, 2007 WL 2570861,
`
`at *2.
`
`It is “[b]ecause of this broad discovery rule,” that “‘the burden of proving that an issue is
`
`beyond discovery rests squarely with the party resisting the discovery.’” Biometric Scanning
`
`Devices, 2010 WL 4786591 at *2 (quoting Certain Encapsulated Integrated Circuit Devices and
`
`Prods. Containing Same, Inv. No. 337-TA-501, Order No. 50 (May 18, 2004)). Commission
`
`tules specify that “[iJt
`
`is not grounds for objection that
`
`the information sought will be
`
`inadmissible at the hearing if the information sought appears reasonably calculated to lead to the
`
`discovery of admissible evidence.” 19 C.F.R. § 210.27(b).
`
`Tl.
`
`ARGUMENT
`
`A.
`
`The ALJ Should Compel Hugel to Allow Sample Collection and Testin
`
`From the Remaining Sinbuk Cell Banks
`
`On May24, 2023, Hugel supplemented its interrogatory responses to Medytox’s First Set
`
`of Interrogatories to provide additional information aboutthe cell banks stored at its Geodu and
`
`Sinbuk facilities.
`
`(See Ex. 4, Hugel’s Sixth Supplemental Responses and Objections to
`
`Medytox’s First Set of Interrogatories (“Hugel’s Suppl. ROG Resp.”) at 19-21). According to
`
`
`
`Hugel’s supplemental responses, there are|| cell banks at Hugel’s Sinbuk facilities
`
`containing Hugel’s bacterial strain at issue (designated “CBFC26”) that are not also at Hugel’s
`
`Geodu facility. FL a. There are also four so-called “reference
`
`

`

`strains” located at Hugel’s Sinbuk facility that are not at Hugel’s Geodu facility
`ee
`P| (“the Sinbuk Reference Strains”).
`(Ex. 4, Hugel’s Suppl. ROG Resp. at 18).
`
`According to its supplemental interrogatory responses, Hugel purchased these four reference
`
`strains through a third party from the National Collection of Type Culture (“NCTC”) at the
`
`United Kingdom Health Security Agency. (See id. at 11).
`
`On May26, 2023, after consulting with its experts, Medytox identified cell banksa
`andi as the two cell banks from Hugel’s Sinbuk facility that its experts will sample and
`
`test pursuant to the ALJ’s May 18 oral order. As explained below, Medytox’s experts should
`
`also be allowed to sample andtestfP| and the Sinbuk Reference Strains for
`
`several reasons.
`
`First,
`
`the accuracy of the imformation provided by Hugel
`
`in its
`
`supplemental
`
`interrogatory responses is called into question by Hugel’s previous statement
`
`to the FDA
`
`ee. (Ex. 5, Declaration of Paul Keim (“Keim Decl.”) at
`
`9 14-16; Ex. 6, Declaration of Andy Pickett (“Pickett Decl.”) at § 6). Specifically, in its
`
`Biologics License Application (“BLA”) seeking approval
`
`to market and sell
`
`the Accused
`
`Products in the United States, Hugel represented to the FDA thatPo
`
`Gs (Ex. 7, HUGELITC-01032712 at 722). This statement was madeto the
`
`FDA underpenalty of perjury.
`
`(See Ex. 8, HUGELITC-00277185 at 187). As explained by
`
`Medytox’s experts, however, this statement is very likely false. (Ex. 5, Keim Decl. at § 14-16;
`
`Ex. 6, Pickett Decl. at § 6).
`
`

`

`In this investigation, Hugel produced three genomic sequences that Hugel alleges
`
`represent its CBFC26 bacterial strain.
`
`(Ex. 5, Keim Decl. at § 13; Ex. 4, Hugel’s Suppl. ROG
`
`Resp. at 26).
`
`a (Ex. 5, Keim Decl. at §§ 13-15). Although the Hall A hyperstrain wasoriginally found
`
`in nature (like all other C. botulinumstrains), it has been in laboratory cultivation for at least 80
`
`years.
`
`(/d. at § 13). During the laboratory cultivation process, the DNA sequenceof the Hall A
`
`hyper strain mutated at various locations in the genome from the original starting sequence.
`
`(d.). These mutations provide a unique DNA orgenetic fingerprint that distinguish these
`
`laboratory progeny from any other strains observed in nature.
`
`(/d.).
`
`a T
`
`he importance of this finding cannot be overstated because it draws into question
`
`Hugel’s statement to the FDAPe as well as the
`
`information provided to Medytox in its supplemental interrogatory responses.
`
`(Ex. 5, Keim
`
`Decl. at §§ 14-16; Ex. 6, Pickett Decl. at § 6). Put simply, it is statistically impossible that i
`
`| (Ex. 5, Keim Decl. at §§ 13, 15). As such, “any statements to this court or to the FDA
`mmm 21516). For tis
`
`? As explained in Medytox’s Complaint, although Medytox’s
`
`proprietary
`
`strain is related to the
`
`Hall A hyperstrain andeee| it also contains
`
`unique genetic mutations that are not found in the Hall A hyperstrain or any otherstrain of C.
`botulinum.
`(Inv. No. 337-TA-1313, Certain Botulinum Toxin Products and Processes for
`Manufacturing or Relating to Same, Verified Complaint of Medytox UnderSection 337 of the
`Tariff Act of 1930, as Amended, March 30, 2022 (“Complaint”) at § 14).
`
`nN
`
`

`

`reason alone, Medytox should be allowed to sample and test P| and the Sinbuk
`
`Reference Strains.
`
`Second, the veracity of the information provided in Hugel’s supplemental interrogatory
`
`responsesis also called into question by the informationitself.
`
`(Ex. 6, Pickett Decl. at §§ 3-4).
`
`Specifically, in its supplemental interrogatory responses, Hugel alleges thatPo
`PO (See Ex. 4, Hugel’s Suppl. ROG Resp.at 20; Ex. 6,
`Pickett Decl. at § 4).ae
`PG (See Ex. 4, Hugel’s Suppl. ROG Resp. at 19-—
`
`20; Ex. 6, Pickett Decl. at § 4).
`
`It is highly unusual that a professional biopharmaceutical
`
`company would have allowedee
`eS
`
`6, Pickett Decl. at § 7). Nevertheless, Hugel has provided no explanation regarding the
`
`circumstances surrounding why or whenPo (Ex. 6, Pickett Decl. at § 8).
`Thus, Hugel’s claim thatPo and its refusal to provide any additional
`information surrounding the circumstances ofpo also calls into question the veracity
`
`of the information provided in Hugel’s supplemental interrogatory responses.
`
`(See Ex. 4,
`
`Hugel’s Suppl. ROG Resp.at 19-20; Ex. 6, Pickett Decl. at 4] 7-8).
`
`Third, Hugel’s disclosures concerning the Sinbuk Reference Strains are also highly
`
`unusual. (Ex. 6, Pickett Decl. at §§ 9-11). As explained above,in addition to its CBFC26strain,
`
`Hugel possesses four strains of C. botulinumthatit refers to as “reference” strains. Hugel claims
`
`that Medytox does not need access to these strains because they are simply reference strains that
`
`3 During the May 18 hearing with the ALJ, Hugelstated that the oldest CBFC26strain cell bank
`would be available for testing. See Tr. at 17:23-24 (“So the oldest parent cell bank_will be
`
`available to — at the Geodusite... 7 As it turns - this is incorrect.
`
`

`

`Hugel purchased for research purposes only and are not used for the production of any of
`
`Hugel’s BTX products. Hugel, however, has providedlittle information about why it purchased
`
`these so-called “reference” strains.
`
`For example, Hugel has not explained what is being
`
`referenced against the so called “reference” strains or how that relates to Hugel’s CBFC26strain
`
`or its BTX products.
`
`(/d.) Moreover, counsel for Medytox has been unable to find
`
`documentation in Hugel’s production that would be expected to be required as part of Hugel’s
`
`acquisition of “reference” strains from NCTC, for example things like purchase orders, export
`
`licenses, shipment information, etc. Thus, Medytox should be allowed to sequence the so called
`
`“reference”strains to confirm their identity.
`
`Finally,
`
`the ALJ should compel production ofP| and the Sinbuk Reference
`
`Strains because Congress granted the Commission (and its predecessor) “with broad enforcement
`
`authority to remedy unfair trade acts.” Suprema, Inc. v. Int’] Trade Comm’n, 796 F.3d 1338,
`
`1350 (Fed. Cir. 2015). As a natural complement to its broad enforcement authority, Congress
`
`also “granted the Commission broad powers to conduct its investigation.” Beloit Corp. v. U.S.
`
`Int’l Trade Comm’n, 845 F.2d 1033 (Fed. Cir. 1988). Complainants that allege misappropriation
`
`of trade secrets, as with any Section 337 complainant, are entitled to broad discovery, and must
`
`be allowed to “fully investigate” and “conclusively determine” whether their trade secrets have
`
`been misappropriated. See Certain Audiovisual Components & Prod. Containing the Same, Inv.
`
`No. 337-TA-837, Order No. 59, 2013 WL 459044, at *5 (Feb. 4, 2013) (recommending
`
`enforcement of third-party subpoenas). Such is the case here. The discovery that Medytox is
`
`seeking is critical to the allegations in this investigation. Whether or not Hugel is using
`
`Medytox’s strain, orI 200s t0 the core of this
`
`investigation. See Certain Semiconductor Devices & Prods. Containing Same, Inv. No. 337-TA-
`
`

`

`525, Order No. 7, 2004 WL 3091206, at *5 (Dec. 20, 2004) (holding that “[w]ithout requiring
`
`discovery concerning [respondents’] products and their manufacture,” “it would be difficult, if
`
`not impossible” to determine “with particularity the allegedly misappropriated trade secrets”).
`
`B.
`
`The ALJ Should Compel Hugel to Use CCTV Rather Than Individual
`Monitors in the Laboratory Space
`
`Oneof the issues discussed at the May 18 oral hearing was how Hugel would monitor
`
`Medytox’s experts while in Hugel’s laboratory space. During the hearing, the ALJ stated that
`
`the parties should meet and confer to determine whether the use of CCTV,as opposed to human
`
`monitors, was feasible. On May 25, counsel for the parties conducted this meet and confer, and
`
`Hugel confirmed that its laboratory space included CCTV that could be used to monitor
`
`Medytox’s experts. Hugel also stated, however, that it would still insist on individual human
`
`monitors in the room because Hugel did not understand the ALJ’s order to preclude this option.
`
`Medytox disagrees. During the May 18 hearing, Medytox argued that the best way to maintain
`
`the integrity of the sample collection and testing process was through CCTV monitoring, not
`
`individuals in the room. See Tr. at 64:6-11. As discussed, the use of CCTV monitoring allows
`
`for minimaldistractions and/or “meddling” while Medytox’s experts carry out their experiments.
`
`Medytox understood this was the ALJ’s preference as well but will of course defer to whatever
`
`method of monitoring the ALJ deems appropriate. See Tr. at 67:3-4. (“[The ALJ] would prefer
`
`there only to be cameras.”’).
`
`IV.
`
`CONCLUSION
`
`Basedon the foregoing, Medytox respectfully requests that the ALJ compel production of
`
`P| and the Sinbuk Reference Strain Banks and compel Hugel to use CCTV rather than
`
`personal monitors.
`
`

`

`Dated: May 31, 2023
`
`Respectfully submitted,
`
`/s/ Alex Lasher
`
`S. Alex Lasher
`NinaS. Tallon
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`1300 I Street, NW, Suite 900
`Washington, D.C. 20005
`Telephone: (202) 538-8000
`
`James Baker
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`Telephone: (212) 849-7000
`
`Sean Pak
`David Bilsker
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`50 California Street, 22nd Floor
`San Francisco, California 94111
`Telephone: (415) 875-6600
`
`Steve Cherny
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`111 Huntington Avenue, Suite 520
`Boston, Massachusetts 02199
`Telephone: (617) 712-7100
`
`Attorneysfor Medytox Inc.
`
`

`

`Certain Botulinum Toxin Products and Processes for Manufacturing or Relating to Same
`ITC Inv No. 337-TA-1313
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that true and correct copies of the foregoing document have been served on this 31st day
`of May 2023, on the following:
`
`
`The Honorable Lisa R. Barton
`Secretary
`U.S. International Trade Commission
`500 E Street, SW
`Washington, D.C. 20436
`The Honorable Bryan F. Moore
`Administrative Law Judge
`U.S. International Trade Commission
`500 E Street, SW
`Washington, DC 20436
`Email: Moore1313@usitc.gov
`Irina Kushner
`U.S. International Trade Commission
`500 E Street, SW
`Washington, DC 20436
`Email: Irina.Kushner@usitc.gov
`Brian Gold
`U.S. International Trade Commission
`500 E Street, SW
`Washington, DC 20436
`Email: Brian.Gold@usitc.gov
`Megan Wantland
`The Office of Unfair Import Investigations (OUII)
`U.S. International Trade Commission
`500 E Street, S.W.
`Washington, D.C. 20436
`megan.wantland@usitc.gov
`
` Via First Class Mail
` Via Hand Delivery (2 copies)
` Via Electronic Mail
` Via EDIS
` Not Served
` Via First Class Mail
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` Via Electronic Mail
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` Via First Class Mail
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` Not Served
`
`
`
`
`
`

`

`Certain Botulinum Toxin Products and Processes for Manufacturing or Relating to Same
`ITC Inv No. 337-TA-1313
`
` Via First Class Mail
` Via Hand Delivery (2 copies)
` Via Electronic Mail
` Via EDIS
` Not Served
`
` Via First Class Mail
` Via Hand Delivery (2 copies)
` Via Electronic Mail
` Via EDIS
` Not Served
`
`
`
`Eric S. Namrow
`Stephanie L. Roberts
`Kandis C. Gibson
`Min Woo Park
`Emily K. Burge
`Morgan, Lewis & Bockius LLP
`1111 Pennsylvania Ave, N.W.
`Washington, D.C. 20004-2541
`
`Krista Vink Venegas, Ph.D.
`Zachary D. Miller
`Morgan, Lewis & Bockius LLP
`110 North Wacker Drive, Suite 2800
`Chicago, IL 60606-1511
`
`Tae-Woong Koo, Ph.D.
`Morgan, Lewis & Bockius LLP
`1400 Page Mill Road
`Palo Alto, CA 94304
`MLB-Hugel-ITC@morganlewis.com
`
`Counsel for Respondents Hugel, Inc. and Hugel
`America, Inc.
`Daniel Zaheer
`Kobre & Kim LLP
`150 California St.
`San Francisco, CA 94111
`
`Benjamin Sirota
`Benjamin J. A. Sauter
`Kobre & Kim LLP
`800 3rd Avenue
`New York, NY 10022
`
`Daniel Lee
`Kobre & Kim LLP
`9F, Tower B, The-K Twin Towers
`50, Jong-ro 1-gil, Jongno-gu
`Seoul, 03142
`South Korea
`KK-Hugel-1313@kobrekim.com
`
`Counsel for Respondents
`Hugel, Inc. and Hugel America, Inc.
`
`
`
`
`
`
`
`

`

`Certain Botulinum Toxin Products and Processes for Manufacturing or Relating to Same
`ITC Inv No. 337-TA-1313
`
`
`
`Goutam Patnaik
`David J. Shaw
`Tuhin Ganguly
`Elizabeth Connors
`Desmarais LLP
`1899 Pennsylvania Avenue, NW
`Suite 200
`Washington, DC 20006
`cromamedytoxservice@desmaraisllp.com
`
`Counsel for Respondent
`Croma Pharma GmbH
`
` Via Federal Express
` Via Hand Delivery (2 copies)
` Via Electronic Mail
` Via EDIS
` Not Served
`
`
`
`
`/s/ Ian Ibarra
`Ian Ibarra
`
`
`
`
`
`
`
`
`
`
`
`

`

`INDEX OF EXHIBITS
`
`Exhibit No.
`
`Medytox’s First Request for Entry Upon Land ForInspection to Respondents
`
`Medytox’sFirst Set of Interrogatories
`
`Medytox’s First Set of Requests for Production
`
`Hugel’s Sixth Supplemental Responses and Objections to Medytox’s First Set
`of Interrogatories
`
` 1
`
`Application to Market a New or Abbreviated new Drug or Biologic for Human
`Use (“HUGELITC-00277185”)
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`Declaration of Paul Keim
`
`Declaration of Andy Pickett
`
`BLA 761,225 Control of Materials Section 3.2.S.2.3 (“HUGELITC-
`01032712”)
`
`
`
`

`

`EXHIBIT 1
`EXHIBIT |
`
`

`

`
`
`
`
` UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Clark S. Cheney
`Chief Administrative Law Judge
`
`
`In the Matter of
`
`CERTAIN BOTULINUM TOXIN
`PRODUCTS AND PROCESSES FOR
`MANUFACTURING OR RELATING TO
`SAME
`
`
`Inv. No. 337-TA-1313
`
`COMPLAINANT MEDYTOX INC.’S FIRST SET OF REQUESTS FOR ENTRY UPON
`LAND OR OTHER PROPERTY (NOS. 1-5) TO RESPONDENTS HUGEL, INC. AND
`HUGEL AMERICA, INC.
`
`Pursuant to Rules 210.27 and 210.30 of the United States International Trade Commission
`
`Rules of Practice and Procedure, Complainant Medytox, Inc. (“Medytox”) request that
`
`Respondents Hugel, Inc. and Hugel America, Inc. (collectively, “Hugel”) respond fully and in
`
`writing to this First Set of Requests for Entry Upon Land or Other Property (“Requests”) within
`
`ten (10) days of service of these Requests, and permit entry upon the designated land or other
`
`property as requested herein on a date to be agreed upon by the parties.
`
`The inspection will be conducted by Medytox’s outside counsel and its expert witnesses
`
`and/or consultants. All or portions of the inspection may be recorded by photographic or
`
`videographic means, in accordance with the Commission’s Rules of Practice and Procedure and
`
`Ground Rules, and will continue from day to day until completed.
`
`DEFINITIONS
`
`1.
`
`The term “Hugel” means and includes Hugel, Inc. and Hugel America, Inc. and all
`
`predecessors, successors, subsidiaries, divisions, parents and/or affiliates thereof, past or present,
`
`and all past or present officers, directors, agents, employees, consultants, accountants, attorneys,
`
`
`
`1
`
`

`

`
`
`representatives, and any other person or entity acting on behalf of any of the foregoing.
`
`2.
`
`The term “Croma” means and includes Croma Pharma GmbH and all predecessors,
`
`successors, subsidiaries, divisions, parents and/or affiliates thereof, past or present, and all past or
`
`present officers, directors, agents, employees, consultants, accountants, attorneys, representatives,
`
`and any other person or entity acting on behalf of any of the foregoing.
`
`3.
`
`The term “Respondents” means and includes each of the named Respondents in
`
`this Investigation, individually and/or collectively, and all predecessors, successors, subsidiaries,
`
`divisions, parents and/or affiliates thereof, past or present, and all past or present officers, directors,
`
`agents, employees, consultants, accountants, attorneys, representatives, and any other person or
`
`entity acting on behalf of any of the foregoing.
`
`4.
`
`The term “Investigation” means the above-captioned investigation, In the Matter of
`
`Certain Botulinum Toxin Products And Processes For Manufacturing Or Relating To Same,
`
`Investigation No. 337-TA-1313.
`
`5.
`
`The term “Complaint” means the Complaint under Section 337 of the Tariff Act of
`
`1930, as amended, filed by Medytox with the Secretary’s Office of the United States International
`
`Trade Commission on March 30, 2022, as well as all exhibits, appendices, and any supplement
`
`thereto or amended version thereof.
`
`6.
`
`The term “Letybo” means Letybo® or its other trade names or other designations,
`
`including, but not limited to, Botulax®, Regenox®, Zentox®, Reage®, Magnion®, Hugel Toxin®,
`
`Juvenlife®, Botulim®, Botoshot®, Letibotulinumtoxina, BoNT/A-DP, Botulinum toxin type A –
`
`Hugel, or HG-102.
`
`7.
`
`8.
`
`
`
`The term “C. botulinum” means Clostridium botulinum.
`
`The term “BTX” means botulinum toxin, including, but not limited to, BTX used
`
`2
`
`

`

`
`
`as an active drug substance.
`
`9.
`
`The term “BTX Drug Product” means a drug product containing BTX as an
`
`ingredient.
`
`10.
`
`The term “exporter” shall mean any person or entity engaged, directly or indirectly,
`
`in sending goods, either directly or indirectly, to the United States from another country for the
`
`purpose of sale in the United States.
`
`11.
`
`The term “importer” shall mean any person engaged in bringing or receiving,
`
`directly or indirectly, goods from another country into the United States for the purpose of sale or
`
`display.
`
`12.
`
`“Document(s)” is synonymous in meaning and equal in scope to the usage of the
`
`terms as defined by Commission Rule 210.30 and Federal Rule of Civil Procedure 34, and includes
`
`all things within the meaning and scope of that term as used in the Commission’s Rules of Practice
`
`and Procedure, the Federal Rules of Civil Procedure, and the Federal Rules of Evidence, and
`
`includes without limitation the following items, whether printed, recorded, microfilmed,
`
`reproduced by any process, written or produced by hand, or recorded in any other way, and whether
`
`or not claimed to be privileged, confidential, or personal: letters; correspondence; memoranda;
`
`notes; reports; records; agreements; working papers; communications (including intradepartmental
`
`and interdepartmental communications); summaries or records of personal conversations;
`
`calendars; diaries; forecasts; statistical statements; graphs; laboratory or research reports and
`
`notebooks; charts; minutes or records of conferences; expressions or statements of policy; lists of
`
`persons attending meetings or conferences; reports of or summaries of interviews; reports of or
`
`summaries of investigations; opinions or reports of consultants; patents and patent application
`
`materials; patent appraisals; printed publications; trademark applications, certificates of
`
`
`
`3
`
`

`

`
`
`registration, opinions of counsel; memoranda of agreements, assignments, licenses; reports of or
`
`summaries of either negotiations within or without the corporation or preparations for such;
`
`bulletins; material and manufacturing specifications; material packaging; manufacturing logs;
`
`equipment specifications and operating information; product packaging; designs; instructions;
`
`advertisements; literature; work assignments; memoranda of conversations; notes; notebooks;
`
`drafts; data sheets; worksheets; contracts; memoranda of agreements; assignments; licenses;
`
`minute books of account; orders; invoices; statements; bills; checks; vouchers; photographs;
`
`drawings; charts; catalogs; brochures; computer files; computer discs; articles; manuals;
`
`pamphlets; advertisements; circulars; press releases; drafts of any documents; books; instruments;
`
`accounts; bills of sale; tapes; electronic communications including but not limited to e-mails;
`
`telegraphic communications and all other material of any tangible medium of expression; and
`
`original or preliminary notes. Any comment or notation appearing on any document, and not a
`
`part of the original text, is to be considered a separate “document.”
`
`13.
`
`“Thing(s)” has the broadest meaning allowable under Commission Rule 210.30 and
`
`Federal Rule of Civil Procedure 34. This meaning encompasses any tangible object of any kind
`
`and nature other than a document, including without limitation prototypes, models, and physical
`
`specimens thereof.
`
`14.
`
`“Communication(s)” means any oral, written, or other contact between two or more
`
`persons or entities by which any information or knowledge of any nature is transmitted or
`
`conveyed or attempted to be transmitted or conveyed, including letters, memoranda, telegrams,
`
`telefaxes,
`
`telecopies,
`
`telexes, emails,
`
`text messages, face-to-face meetings,
`
`telephone
`
`conversations, voicemails, answering machine messages, and telephonic notes.
`
`15.
`
`“Entity” or “entities” means any natural person, corporation, company, partnership,
`
`
`
`4
`
`

`

`
`
`sole proprietorship, firm, board, joint venture, association, organization, trust, governmental body,
`
`agency, authority, commission, or any other juristic person, business unit, or collective
`
`organization, and any legal, governmental, organizational, or political subdivision thereof.
`
`16.
`
`“Person(s)” means any individual, group, or entity. The acts of a person shall
`
`include the acts of the person’s directors, officers, owners, members, employees, agents, attorneys,
`
`and all other representatives acting on the person’s behalf.
`
`17.
`
`“Relating to,” “related to,” “relates to,” or “relate to,” when referring to any given
`
`subject matter, means without limitation any information, document, or thing that in whole or in
`
`part and directly or indirectly relates to, concerns, regards, discusses, describes, depicts,
`
`demonstrates, shows, evidences, supports, refutes, contradicts, summarizes, analyzes, bears upon,
`
`comments upon, pertains to, constitutes, comprises, involves, contains, embodies, reflects, alludes
`
`to, identifies, states, mentions, refers to, deals with, or is in any way relevant to the particular
`
`subject matter identified.
`
`18.
`
`“Including” shall mean “including without limitation” and “including but not
`
`limited to.”
`
`19.
`
`“And,” “or,” and “and/or” shall be construed conjunctively or disjunctively,
`
`whichever maximizes the scope of each request in which they are used.
`
`20.
`
`21.
`
`22.
`
`23.
`
`“Any” and “all” shall be construed to mean “any and all.”
`
`“Each” and “ev