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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
Commissions electronic docket EDIS
at https edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. General information concerning the Commission may also be obtained by accessing its internet server at https www.usitc.gov.
The public record for this investigation may be viewed on the Commissions electronic docket EDIS at https
edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commissions TDD
terminal on 202 2051810.
SUPPLEMENTARY INFORMATION: On March 6, 2019, the Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19
U.S.C. 1337 section 337, based on a complaint filed by Medytox Inc. of Seoul, South Korea Medytox;
Allergan plc of Dublin, Ireland; and Allergan, Inc. of Irvine, California collectively, Allergan all collectively, Complainants. See 84
FR 811213 March 6, 2019. The complaint, as supplemented, alleges a violation of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain botulinum toxin products, processes for manufacturing or relating to same and certain products containing same by reason of misappropriation of trade secrets, the threat or effect of which is to destroy or substantially injure a domestic industry in the United States. See id. The notice of investigation names as respondents Daewoong Pharmaceuticals Co., Ltd.
Daewoong of Seoul, South Korea and Evolus, Inc. Evolus of Irvine, California collectively, Respondents.
See id. The Office of Unfair Import Investigations OUII was also a party to the investigation. See id.
On July 6, 2020, the Administrative Law Judge issued a final initial determination FID finding a violation of section 337 based on the misappropriation of Complainants asserted trade secrets including the Medytox bacterial strain and Medytox manufacturing processes, the threat or effect of which is to destroy or substantially injure an industry in the United States. On September 21, 2020, the Commission issued a notice determining to review the FID in part.
See 85 FR 6048990 September 25, 2020.
On December 16, 2020, the Commission found a violation of section 337 based on the misappropriation of Complainants trade secrets including the Medytox manufacturing processes
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but not the Medytox bacterial strain.
See 85 FR 8361011 Dec. 22, 2020.
The Commission issued a limited exclusion order LEO against certain botulinum neurotoxin products that are imported and/or sold by Respondents Daewoong and Evolus and a cease and desist order CDO against Evolus. Id.
The Commission also set a bond during the period of Presidential review in an amount of $441 per 100U vial of Respondents accused products. Id On February 12, 2021, Complainants filed an appeal from the Commissions final determination with the Federal Circuit. On the same day, Respondents also filed an appeal from the Commissions final determination of a violation of section 337. On February 18, 2021, Complainants and Evolus collectively, the Settling Parties announced that they had reached a settlement agreement to resolve all pending issues between them.
On March 3, 2021, the Settling Parties filed a joint petition to rescind the LEO
and CDO collectively, the remedial orders based on the settlement agreement. On the same day, the Settling Parties also filed a joint motion to limit service of the settlement agreement. On March 16, 2021, Daewoong filed a notice of nonopposition to the joint motion to limit service. On April 1, 2021, the Settling Parties further filed a joint motion to terminate the investigation without prejudice pursuant to 19 CFR 210.21b.
On April 5, 2021, Daewoong filed a response to the Settling Parties petition to rescind the remedial orders stating that it does not oppose the Settling Parties petition for recission.
Daewoongs response also included a motion for vacatur of the Commissions final determination. On April 8, 2021, OUII filed a response in support of the Settling Parties petition to rescind and their joint motion to limit service. On April 12, 2021, Daewoong filed a response to the Settling Parties motion to terminate the investigation, arguing that the motion to terminate should be denied as moot and opposing termination without prejudice. On April 15, 2021, Medytox filed a response in opposition to Daewoongs motion to vacate the final determination. On April 23, 2021, Daewoong filed a motion for leave to file a reply in support of its motion to vacate and on April 29, 2021, Medytox filed a response in opposition to the motion for leave to file a reply;
the Commission accepts both of these filings and Daewoongs motion for leave to file a reply is granted.
Having reviewed the parties submissions relating to and in response to the Settling Parties petition to
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rescind, their joint motion to limit service, their joint motion to terminate, and Daewoongs motion to vacate, and for the reasons discussed in the Commission Opinion issued concurrently herewith, the Commission has determined to grant the joint petition to rescind the remedial orders and the joint motion to limit service, and to deny as moot the joint motion to terminate the investigation. The Commission has further determined that, if the Federal Circuit dismisses the pending appeals as moot, the Commission will vacate its final determination. Commissioner Karpel concurs in the determination to grant the Settling Parties motion to rescind the remedial orders and their motion to limit service; and to deny as moot their motion to terminate the investigation.
However, Commissioner Karpel would deny Daewoongs motion to vacate the Commissions final determination as procedurally improper. She would also deny Daewoongs motion for leave to file a reply. Further, Commissioner Karpel would decline to issue an indicative ruling as to whether Daewoong has established equitable entitlement to the extraordinary remedy of vacatur on the basis of the record before the Commission.
The rescission proceeding is terminated.
The Commissions vote on this determination took place on May 3, 2021.
The authority for the Commissions determination is contained in section 337 of the Tariff Act of 1930, as amended 19 U.S.C. 1337, and in part 210 of the Commissions Rules of Practice and Procedure 19 CFR part 210.
By order of the Commission.
Issued: May 3, 2021.
Lisa Barton, Secretary to the Commission.
FR Doc. 202109652 Filed 5621; 8:45 am BILLING CODE 702002P

DEPARTMENT OF JUSTICE
Drug Enforcement Administration Docket No. DEA814

Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Indian Flower LLC
Drug Enforcement Administration, Justice.
ACTION: Notice of application.
AGENCY:

E:FRFM07MYN1.SGM

07MYN1