Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 1of5 PagelD #: 3894
`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 1 of 5 PageID #: 3894
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`REGENERON PHARMACEUTICALS,INC.
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`Plaintiff,
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`v.
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`CELLTRION,INC.,
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`Defendant.
`
`
`
`CIVIL CASE NO. 1:23-CV-89
`Judge Kleeh
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`JURY TRIAL DEMANDED
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`
`
`DECLARATION OF DONGIKSHIN IN SUPPORT OF DEFENDANT’S MOTION TO
`DISMISS FOR LACK OF PERSONAL JURISDICTION, OR ALTERNATIVELY, TO
`TRANSFER VENUE
`
`

`

`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 2 of5 PagelD #: 3895
`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 2 of 5 PageID #: 3895
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`I, Dongik Shin, declare as follows:
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`1.
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`I am the head of Global Legal Departmentat Celltrion, Inc.
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`I have been a
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`Celltrion, Inc. employee since 2016.
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`I live and work in Incheon, Korea.
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`I submitthis
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`Declaration in support of Defendant’s Motion to Dismiss for Lack of Personal Jurisdiction or
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`Alternatively, to Transfer Venuein the above-referenced case.
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`I have personal knowledgeofthe
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`matters stated in this Declaration.
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`2.
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`Celltrion, Inc. is a corporation organized and existing underthe lawsof the
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`Republic of Korea with its principal place of business located at 23, Academy-ro, Yeonsu-gu,
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`Incheon, 22014, Republic of Korea.
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`3.
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`Celltrion, Inc. was founded in 2002. It is a leading global biopharmaceutical
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`company that focuses on the research, development, and manufacture of high-quality biosimilars
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`and novel biopharmaceuticals. Its biosimilar medicines are marketed by local partner companies
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`in approximately 110 countries around the world.
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`4.
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`Celltrion, Inc. filed abbreviated Biologics Drug Application No. 761377 with the
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`FDAfor “CT-P42”on June 29, 2023. CT-P42’s active ingredientis aflibercept andit is a
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`proposedbiosimilar to Regeneron’s EYLEA® product.
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`5.
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`All research, development, and manufacturing activities for CT-P42 have
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`occurred and will continue to occur outside the United States.
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`6.
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`Celltrion, Inc. is not registered to conduct businessin anystates, including West
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`Virginia and does not have an agent to accept service in West Virginia. Celltrion, Inc. does not
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`have any employees in West Virginia. Furthermore, it does not own, lease, or operate any
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`offices, real property, or otherfacilities in the United States, including West Virginia.
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`

`

`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 3 of 5 PagelD #: 3896
`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 3 of 5 PageID #: 3896
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`7.
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`Celltrion, Inc. does not design, manufacture,sell, or offer to sell any products in
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`West Virginia. Celltrion, Inc. does not ship products to West Virginia, and it does not conduct
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`any marketing or advertising in, or directed toward, West Virginia.
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`8.
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`9.
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`Celltrion, Inc. has never been a party to litigation in West Virginia.
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`Celltrion, Inc. is not and will not be responsible for the sale and distribution of
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`CT-P42 in the United States, including in West Virginia. Upon receiving FDA approval,
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`Celltrion USA,Inc., a separate corporate entity from Celltrion, Inc., will be solely responsible for
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`marketing, advertising, offeringto sell, selling, and distributing CT-P42 in the United States.
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`10.‘
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`Celltrion USA,Inc. was founded in 2018. It is a corporation organized and
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`existing underthe laws of the State of Delaware with its principal place of business located at
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`OneEvertrust Plaza, Suite 1207, Jersey City, New Jersey.
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`11.—Celltrion USA,Inc. through agreement with Celltrion, Inc., has been solely
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`responsible for marketing, advertising, offering to sell, selling, and distributing Celltrion, Inc.’s
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`other FDA approved productsin the United States, including Vegzelma® (bevacizumab-adcd),
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`Yuflyma® (adalimumab-aaty), and Zymfentra™ (infliximab-dyyb).
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`12.
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`Celltrion, Inc. has also contracted with unaffiliated third-parties who are solely
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`responsible for the marketing, sales, and distribution of Celltrion, Inc.’s other FDA approved
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`products in the United States. Celltrion, Inc. contracted with unaffiliated third-party Pfizer Inc.
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`to market,sell, and distribute Inflectra® (infliximab-dyyb). Celltrion, Inc. contracted with
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`unaffiliated third-party Teva Pharmaceutical Industries Ltd. to market,sell, and distribute
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`Truxima® (rituximab-abbs) and Herzuma® (trastuzumab-pkrb).
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`13.
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`Atthe time the Complaint wasfiled on November8, 2023, Celltrion USA,Inc.
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`was a wholly-owned subsidiary of Celltrion Healthcare Co. Ltd—also a separate corporate
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`

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`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 4 of5 PagelD #: 3897
`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 4 of 5 PageID #: 3897
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`entity from Celltrion, Inc. and a non-party to this case. Celltrion Healthcare Co. Ltd. is a
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`corporation organized and existing under the laws of the Republic of Korea with its principal
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`place of business located at 19 Academy-ro 51 beon-gil, Yeonsu-gu, Incheon, 22014, Republic
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`of Korea.
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`14,
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`Like Celltrion, Inc., Celltrion Healthcare Co. Ltd. is not registered to conduct
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`business in West Virginia. Celltrion Healthcare Co. Ltd. does not own, lease, or operate any
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`offices, real property, or other facilities in West Virginia.
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`15.
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`On December28, 2023, Celltrion, Inc. merged with Celltrion Healthcare Co. Ltd.
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`Thereafter, Celltrion USA, Inc. became a wholly-ownedsubsidiary of Celltrion, Inc. but retains
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`its status as a separate corporate entity incorporated in Delaware and with its principal place of
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`business in NewJersey.
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`16.
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`No witnesses, documents, samples, information or other potential evidence
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`concerning the development, marketing or distribution of CT-P42 is located in West Virginia.
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`All such witnesses and evidence either reside in the Republic of Korea or at Celltrion USA,
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`Inc.’s corporate headquarters in New Jersey.
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`17.
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`Celltrion, Inc. has approximately 2,000 employees, most of whom live in the
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`Republic of Korea. Celltrion, Inc. does not have any employeesoragents that live in West
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`Virginia.
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`18.
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`Celltrion USA,Inc. has approximately 60 employees wholive in the United
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`States. None of the Celltrion USA, Inc. employees reside nor work in West Virginia.
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`19.
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`Celltrion USA,Inc. does not have any agents in West Virginia. Nor doesit own,
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`lease, or operate any offices, real property, or other facilities in West Virginia.
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`

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`se 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 5of5 PagelD #: 3898
`Ca
`:23-CV-
`Case 1:23-cv-00089-TSK Document 68-1 Filed 01/17/24 Page 5 of 5 PageID #: 3898
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`I declare under penalty ofperjury underthe laws ofthe United States ofAmerica that the
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`foregoing is true and correct.
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`Dated: January 17, 2024
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`=
`
`Dongik Shin
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`