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Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 1 of 15
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`))))))))))
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`C.A. No. _________
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`COMPLAINT
`
`PURDUE PHARMA L.P.,
`PURDUE PHARMACEUTICALS L.P.,
`and RHODES TECHNOLOGIES,
`
`
`Plaintiffs,
`
`v.
`
`
`COLLEGIUM PHARMACEUTICAL, INC.,
`
`
`Defendant.
`
`Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P., and Rhodes Technologies
`
`(collectively, “Purdue” or “Plaintiffs”), for their Complaint against Collegium Pharmaceutical,
`
`Inc. (“Collegium” or “Defendant”), aver as follows:
`
`NATURE OF THE ACTION
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`1.
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`This is an action for relief from patent infringement, arising under the
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`patent laws of the United States, Title 35, United States Code for infringement of U.S. Patent No.
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`10,407,434 (“the ’434 patent”). This action relates to Collegium’s submission of New Drug
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`Application (“NDA”) No. 208090 (including any amendments and/or supplements thereto,
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`“Collegium’s NDA”) to the U.S. Food & Drug Administration (“FDA”), under § 505(b)(2) of the
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`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(b)(2)), seeking approval to engage in the
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`commercial manufacture, use, sale, offer for sale or importation of Xtampza® ER oxycodone
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`extended release capsules, 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg (“the Collegium NDA
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`Products”) before the expiration of the ’434 patent.
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`2.
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`Plaintiffs seek judgment that Defendant has infringed the ’434 patent.
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`The ’434 patent is listed in the FDA Approved Drug Products With Therapeutic Equivalence
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`

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`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 2 of 15
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`Evaluations (“Orange Book”) as covering Purdue’s OxyContin® (oxycodone hydrochloride)
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`(“OxyContin”), an extended-release pain medication. Collegium has infringed the ’434 patent
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`under 35 U.S.C. § 271(e)(2)(A) by filing the Collegium NDA on the Collegium NDA Products
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`and under 35 U.S.C. §§ 271(a), (b), (c), and (g) by actual marketing of the Collegium NDA
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`Products.
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`3.
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`The present action is related to currently-pending patent infringement
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`actions Purdue previously filed against Collegium that also relate to the filing of Collegium’s NDA
`
`and Collegium’s marketing of the Collegium NDA Products. These previously-filed actions
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`include Case No. 15-cv-13099-FDS (“the Lead Action”), in which Purdue has asserted
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`infringement of U.S. Patent Nos. 9,073,933 (“the ’933 patent”) and 9,522,919 (“the ’919 patent”),
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`patents that are related to the ’434 patent. The ’434, ’933, and ’919 patents share, e.g., the same
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`claim of priority, same inventors and same specification.
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`4.
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`These previously-filed actions also include Case No. 17-cv-11814-FDS
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`(the “’961 Patent Action”), in which Purdue has asserted infringement of U.S. Patent No.
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`9,693,961 (“the ’961 patent”). The ’961 Patent Action, which has been consolidated with the Lead
`
`Action for pretrial purposes, is related to the present action in that, inter alia, they both involve the
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`same infringing product, the Collegium NDA Products.
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`5.
`
`Purdue and Collegium have agreed to consolidate the present action with
`
`the Lead Action for pretrial purposes, subject to the Court’s approval.
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`THE PARTIES
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`6.
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`Purdue Pharma L.P. (“Purdue Pharma”) is a limited partnership
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`organized and existing under the laws of the State of Delaware, having a place of business at One
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`Stamford Forum, 201 Tresser Boulevard, Stamford, CT 06901-3431. Purdue Pharma is an owner
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`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 3 of 15
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`
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`of the ’434 patent. Purdue Pharma is also the holder of NDA No. 022272 for the extended-release
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`oxycodone pain-relief medication OxyContin and is involved in the sale of OxyContin in the
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`United States.
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`7.
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`Purdue Pharmaceuticals L.P. (“Purdue Pharmaceuticals”) is a limited
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`partnership organized and existing under the laws of the State of Delaware, having a place of
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`business at 4701 Purdue Drive, Wilson, NC 27893. Purdue Pharmaceuticals is an owner of the
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`’434 patent, and is involved in the manufacture of OxyContin.
`
`8.
`
`Rhodes Technologies (“Rhodes”) is a general partnership organized and
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`existing under the laws of the State of Delaware, having a place of business at 498 Washington
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`Street, Coventry, RI 02816. Rhodes is an owner of the ’434 patent, and is involved in the
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`manufacture of the active pharmaceutical ingredient (“API”) used in OxyContin.
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`9.
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`Upon information and belief, Collegium is a corporation organized and
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`existing under the laws of the Commonwealth of Virginia, having its principal place of business
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`at 780 Dedham Street, Suite 800, Canton, MA 02021.
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`JURISDICTION AND VENUE
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`10.
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`This action arises under the patent laws of the United States, including
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`35 U.S.C. § 271.
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`11.
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`This Court has jurisdiction over the subject matter of this action pursuant
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`to 28 U.S.C. §§ 1331 and 1338(a).
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`12.
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`This Court has personal jurisdiction over Collegium, and venue is proper
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`in this Judicial District under 28 U.S.C. §§ 1391(b) and (c) and § 1400(b), because Collegium has
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`its principal place of business in this Judicial District.
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`13.
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`Collegium is in the business of preparing pharmaceuticals that it
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`distributes in the Commonwealth of Massachusetts and throughout the United States.
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`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 4 of 15
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`14.
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`Upon information and belief, once Collegium’s NDA was approved, the
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`Collegium NDA Products were, among other things, marketed and distributed in Massachusetts,
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`and/or prescribed by physicians practicing and dispensed by pharmacies located within
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`Massachusetts, all of which have a substantial effect on Massachusetts.
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`THE ’434 PATENT
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`15.
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`The Orange Book identifies drug products that have been approved by
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`the FDA under the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.). The Orange
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`Book also provides a listing of certain patents that cover a given drug product or the use thereof.
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`16.
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`Purdue is the lawful owner of all right, title, and interest in the ’434
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`patent, entitled “PROCESS FOR PREPARING OXYCODONE COMPOSITIONS,” including all
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`right to sue and to recover for past infringement thereof, which patent is listed in the FDA’s
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`Orange Book as covering the drug OxyContin, which is the subject of approved NDA No.
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`022272. The ’434 patent was duly and legally issued on September 10, 2019, naming Robert
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`Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, and Robert Kupper as the inventors. A copy of
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`the ’434 patent is attached as Exhibit A .
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`COLLEGIUM’S NDA
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`17.
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`Upon information and belief, Collegium submitted Collegium’s NDA to
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`the FDA under § 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(2)),
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`seeking approval to engage in the commercial manufacture, use, sale, offer for sale, or importation
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`of the Collegium NDA Products.
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`18.
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`On or about April 26, 2016, the FDA issued its final approval of
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`Collegium’s NDA based on Collegium’s filings as of that date.
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`19.
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`On June 20, 2016, Collegium issued a press release announcing the
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`commercial launch of the Collegium NDA Products.
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`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 5 of 15
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`20.
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`Collegium has begun commercial manufacture of the Collegium NDA
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`Products, has begun offering for sale and selling the Collegium NDA Products, and continues to
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`manufacture (or have manufactured), offer for sale, sell, and distribute the Collegium NDA
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`Products, including in this district.
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`21.
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`After having already begun marketing the Collegium NDA Products, on
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`or about October 4, 2016, Collegium filed a supplemental application relating to Collegium’s NDA
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`(“Collegium’s sNDA”).
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`22.
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`On or about November 6, 2017, the FDA issued its final approval of
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`Collegium’s sNDA.
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`23.
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`On information and belief, Collegium has marketed the Collegium NDA
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`Products according to Collegium’s sNDA.
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`CLAIMS FOR RELIEF:
`
`COUNT I
`(Collegium’s Filing of Its NDA Constitutes Infringement of the ’434 Patent)
`
`24.
`
`Purdue incorporates by reference and realleges paragraphs 1-23 above as
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`
`
`though fully restated herein.
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`25.
`
`Collegium’s submission of its NDA for a drug claimed in the ’434 patent
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`was an act of infringement under the United States Patent Law, 35 U.S.C. § 271(e)(2)(A).
`
`26.
`
`Upon information and belief, the Collegium NDA Products use or,
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`according to Collegium, contain oxycodone base. The oxycodone base and the process by which
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`the oxycodone base is made is covered by one or more claims of the ’434 patent, including but not
`
`limited to at least claims 1-7, 9, 13-15, 17, and 19, which recite, inter alia, a process of purifying
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`oxycodone free base or oxycodone HCl that contains 8α,14-dihydroxy-7,8-dihydrocodeinone; a
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`process of purifying oxycodone free base or oxycodone HCl that contains 8α,14-dihydroxy-7,8-
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`dihydrocodeinone, wherein the ratio of 8α, 14-dihydroxy-7,8-dihydrocodeinone or HCl salt
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`thereof to oxycodone free base or oxycodone HCl following step (i) is 0.04% or less as measured
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`by HPLC; and purified oxycodone free base prepared according to such processes, wherein the
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`ratio of 8α, 14-dihydroxy-7,8-dihydrocodeinone to oxycodone free base is 0.04% or less as
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`measured by HPLC.
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`27.
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`For example, upon information and belief, the oxycodone base used in
`
`the Collegium NDA Products is made according to the process of independent claim 1 of the ’434
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`patent. More specifically, the oxycodone base, which Collegium uses in its manufacture of the
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`Collegium NDA Products, is made in a process that includes purifying oxycodone free base that
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`contains 8α,14-dihydroxy-7,8-dihydrocodeinone. That process comprises:
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`(i)
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`reducing the amount of 8α,14-dihydroxy-7,8-dihydrocodeinone in the
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`oxycodone free base;
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`(ii)
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`dissolving the resultant oxycodone free base from step (i) in a suitable
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`recrystallization solvent;
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`(iii)
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`cooling the recrystallization solvent to precipitate purified oxycodone free
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`base; and
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`(iv)
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`recovering the purified oxycodone free base.
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`28.
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`Based upon knowledge of Noramco Inc.’s (“Noramco”) oxycodone
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`process and documents produced in the Lead Action, Noramco performs all the steps of at least
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`claims 1-7, 9, 13-15 and 17 of the ’434 patent.
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`29.
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`Upon information and belief, the oxycodone base used in the Collegium
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`NDA Products, and the process intermediates of the oxycodone base of Noramco’s process, meets
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`the claim element whereby the ratio of 8α, 14-dihydroxy-7,8-dihydrocodeinone or HCl salt thereof
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`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 7 of 15
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`to oxycodone free base or oxycodone HCl is 0.04% or less as measured by HPLC (“8α ratio claim
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`element”) contained in certain dependent claims.
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`30.
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`Further, Collegium has represented to this Court that the Collegium NDA
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`Products contain oxycodone base. Specifically, Collegium has stated that “[t]he API, or drug
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`substance, in XTAMPZA® ER is oxycodone base, not oxycodone myristate.” Defendant
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`Collegium Pharmaceutical, Inc.’s Local Rule 56.1 Statement Of Material Facts As To Which
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`There Is No Genuine Issue To Be Tried, No. 15-cv-13099, D.I. 108-2 ¶ 66. In addition, Collegium
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`has represented to this Court that “[t]he XTAMPZA® ER microspheres contain oxycodone base,
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`myristic acid, yellow beeswax, carnauba wax, and stearoyl polyoxyl-32 glycerides.” Id. ¶ 18.
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`31.
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`Upon information and belief, Collegium’s commercial manufacture, use,
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`sale, offer for sale, and/or importation of the oxycodone base and/or the Collegium NDA Products
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`using the claimed oxycodone base has infringed, contributed to the infringement of, and/or induced
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`the infringement of one or more claims of the ’434 patent under 35 U.S.C. §§ 271(a), (b), (c), and
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`(g).
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`32.
`
`Collegium without authority uses, offers to sell or sells in the United
`
`States the Collegium NDA products that use or, according to Collegium, contain the purified
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`oxycodone base covered by claim 19 of the ’434 patent. Thus, Collegium is liable for infringement
`
`under 35 U.S.C. § 271(a).
`
`33.
`
`The marketing materials, and/or the labeling associated with the
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`Collegium NDA Products, including, but not limited to, any package inserts, medication guides,
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`full prescribing information, or other materials related to such labeling, instructs healthcare
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`providers and patients to use the oxycodone base from the Collegium NDA Products made
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`according to the process of one or more claims of the ’434 patent, thereby infringing the asserted
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`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 8 of 15
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`claims. Collegium intends to cause infringement of the ’434 patent and has knowledge that the
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`use of the Collegium NDA Products according to Collegium’s instructions causes direct
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`infringement of the ’434 patent under 35 U.S.C. § 271(g) by healthcare providers, physicians, other
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`medical care workers, patients, and any other persons using the Collegium NDA Products. Thus,
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`Collegium is liable for inducing infringement under 35 U.S.C. § 271(b) of those using the
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`Collegium NDA Products.
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`34.
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`Collegium without authority uses, offers to sell or sells in the United
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`States the Collegium NDA Products that use or, according to Collegium, contain the purified
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`oxycodone base covered by claim 19 of the ’434 patent. Claim 19 recites “[p]urified oxycodone
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`free base prepared according to the process of claim 2, wherein the ratio of 8α, 14-dihydroxy-7,8-
`
`dihydrocodeinone to oxycodone free base is 0.04% or less as measured by HPLC.” Based upon
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`knowledge of Noramco’s oxycodone process and documents produced in the Lead Action,
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`Noramco performs all the steps of claim 2 of the ’434 patent. Further, upon information and belief,
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`the oxycodone base used in the Collegium NDA Products, and process intermediates of the
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`oxycodone base of Noramco’s process, meets the 8α ratio claim element of claim 2 and the 8α
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`ratio claim element of claim 19. Thus, Collegium is liable for infringement under 35 U.S.C. §
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`271(a).
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`35.
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`Further, Collegium uses Patheon Pharmaceuticals Inc. (“Patheon”) as a
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`contract manufacturer to make the Collegium NDA Products.
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`36.
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`Patheon makes the Collegium NDA Products using specifications and
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`instructions from Collegium, including specification and manufacturing parameters set forth in
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`Collegium’s NDA.
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`37.
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`Patheon uses oxycodone base to make the Collegium NDA Products and
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`makes the Collegium NDA Products in the United States.
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`38.
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`In making the Collegium NDA Products that will be used, offered for
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`sale or sold under Collegium’s NDA, Patheon must follow the manufacturing parameters set forth
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`in Collegium’s NDA. Thus, Patheon makes the Collegium NDA Products under Collegium’s
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`direction and control.
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`39.
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`Accordingly, Collegium’s contract manufacturer, Patheon, under
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`Collegium’s direction and control and pursuant to Collegium’s specifications and instructions,
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`including specification and processes set forth in Collegium’s NDA, uses the purified oxycodone
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`base covered by claim 19 of the ’434 patent to make the Collegium NDA Products. Thus,
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`Collegium is directly liable for Patheon’s infringement of claim 19 of the ’434 patent under 35
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`U.S.C. § 271(a).
`
`40.
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`In addition, those manufacturing and/or using the oxycodone base used
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`in the manufacture of the Collegium NDA Products pursuant to Collegium’s specifications,
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`including Collegium’s NDA specifications and instructions, including but not limited to, for
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`example, Noramco and/or Patheon, directly infringe one or more of at least claims 1-7, 9, 13-15,
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`17 and 19 of the ’434 patent. Collegium intends to cause infringement of the ’434 patent and has
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`knowledge that manufacturing of the oxycodone base used in the Collegium NDA Products and/or
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`the Collegium NDA Products according to Collegium’s instructions and NDA specifications
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`causes direct infringement of the ’434 patent by manufacturers. Thus, upon information and belief,
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`Collegium is liable for inducing infringement under 35 U.S.C. § 271(b) of those manufacturing
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`the oxycodone base used in the Collegium NDA Products and/or the Collegium NDA Products.
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`41.
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`The oxycodone base used in the Collegium NDA Products constitutes a
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`material part of the inventions covered by the claims of the ’434 patent, is especially made or
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`adapted to infringe the asserted claims, and there are no substantial non-infringing uses for the
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`oxycodone base used in Collegium NDA Products. Thus, Collegium is liable for contributory
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`infringement under 35 U.S.C. § 271(c).
`
`42.
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`Collegium without authority offers to sell, sells or uses within the United
`
`States the Collegium NDA Products that use, or according to Collegium, contain oxycodone base
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`made by a process covered by at least claims 1-7, 9, 13-15 and 17 of the ’434 patent.
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`43.
`
`Based upon knowledge of Noramco’s oxycodone process and documents
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`produced in the Lead Action, Noramco performs all the steps of at least claims 1-7, 9, 13-15 and
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`17 of the ’434 patent.
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`44.
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`Upon information and belief, the oxycodone base used in the Collegium
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`NDA Products, and the process intermediates of the oxycodone base of Noramco’s process, meets
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`the 8α ratio claim element contained in certain dependent claims.
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`45.
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`Further, the oxycodone base covered by the claims of the ’434 patent is
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`not materially changed by subsequent processes, including formulation into the Collegium NDA
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`Products and is not a trivial and nonessential component of the Collegium NDA Products. Thus,
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`Collegium is directly liable for infringement under 35 U.S.C. § 271(g).
`
`46.
`
`Collegium without authority uses within the United States the oxycodone
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`base made by a process covered by at least claims 1-7, 9, 13-15 and 17 of the ’434 patent.
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`Specifically, Collegium’s contract manufacturer, Patheon, under Collegium’s direction and control
`
`and pursuant to Collegium’s specifications and instructions, including specification and processes
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`set forth in Collegium’s NDA, uses the oxycodone base covered by at least claims 1-7, 9, 13-15
`
`and 17 of the ’434 patent to make the Collegium NDA Products.
`
`47.
`
`Further, the oxycodone base covered by the claims of the ’434 patent is
`
`not materially changed by subsequent processes, including formulation into the Collegium NDA
`
`Products and is not a trivial and nonessential component of the Collegium NDA Products. Thus,
`
`Collegium is directly liable for Patheon’s direct infringement of at least claims 1-7, 9, 13-15 and
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`17 of the ’434 patent under 35 U.S.C. § 271(g).
`
`COUNT II
`(Collegium’s Marketing of the Collegium NDA Products Infringes and Has Infringed the
`’434 Patent)
`
`48.
`
`Purdue incorporates by reference and realleges paragraphs 1-47 above as
`
`though fully restated herein.
`
`49.
`
`Upon information and belief, Collegium has begun commercial
`
`manufacture of the Collegium NDA Products, began offering for sale and selling the Collegium
`
`NDA Products, and continues to manufacture (or have manufactured), offer for sale, sell, and
`
`distribute the Collegium NDA Products.
`
`50.
`
`Since at least the issue date of the ’434 patent, Collegium has been
`
`infringing the ’434 patent by making, using, offering for sale, selling, and distributing products
`
`embodying the patented inventions in violation of 35 U.S.C. § 271(a) and (g), inducing others to
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`make, use, sell, or offer for sale products and methods embodying the patented inventions in
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`violation of 35 U.S.C. § 271(b), and/or by contributing to the manufacture, use, sale, or offer for
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`sale of products embodying the patented inventions in violation of 35 U.S.C. § 271(c).
`
`51.
`
`Collegium’s infringement of the ’434 patent has been willful, egregious,
`
`and in disregard of the ’434 patent.
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`52.
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`Collegium has had knowledge of the ’434 patent at or around the date of
`
`issuance of the ’434 patent, and no later than October 30, 2020.
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`53.
`
`By the issue date of the ’434 patent or by at least October 30, 2020,
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`Collegium has had knowledge that it had no good-faith non-infringement and invalidity positions
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`regarding the ’434 patent.
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`54.
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`Purdue has been and will continue to be substantially and irreparably
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`damaged and harmed by Collegium’s manufacture, use, sale, or offer for sale of the Collegium
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`NDA Products if such infringement is not enjoined. Purdue does not have an adequate remedy at
`
`law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Purdue prays for judgment:
`
`A.
`
`Adjudging that Collegium has infringed, and that Collegium’s commercial sale,
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`offer for sale, use, manufacture, and/or importation of the Collegium NDA Products has infringed,
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`induced infringement of, and/or contributed to the infringement of the ’434 patent;
`
`B.
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`Adjudging, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval
`
`of Collegium’s NDA, under § 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
`
`§ 355(b)(2)), to be a date not earlier than the date of expiration of the ’434 patent, plus any
`
`additional periods of exclusivity;
`
`C.
`
`Preliminarily and permanently enjoining, pursuant to 35 U.S.C. §§ 271(e)(4)(B)
`
`and 283 and Rule 65, Fed. R. Civ. P., Collegium, its officers, partners, agents, servants, employees,
`
`parents, subsidiaries, divisions, affiliate corporations, other related business entities, and all other
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`persons acting in concert, participation, or in privity with them, and their successors and assigns,
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`from any commercial manufacture, use, offer to sell, or sale within the United States, or
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`importation into the United States, of any drug product that infringes the ’434 patent;
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`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 13 of 15
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`D.
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`Awarding, pursuant to 35 U.S.C. §§ 271(e)(4)(C) and 284, damages to Purdue
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`resulting from Collegium’s commercial manufacture, use, importation into the United States, offer
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`for sale, or sale of the Collegium NDA Products prior to the expiration of the ’434 patent, increased
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`to treble the amount found or assessed, together with interest;
`
`E.
`
`Declaring this an exceptional case and awarding Purdue its attorneys’ fees, as
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`provided by 35 U.S.C. §§ 271(e)(4) and 285; and
`
`F.
`
`Awarding Purdue such other and further relief as this Court may deem just and
`
`proper.
`
`
`
`- 13 -
`
`

`

`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 14 of 15
`
`
`
`Dated: April 9, 2021
`
`/s/ Christopher M. Morrison
`Christopher M. Morrison (BBO# 651335)
`JONES DAY
`100 High Street
`21st Floor
`Boston, MA 02110
`Telephone: (617) 960-3939
`Facsimile: (617) 449-6999
`cmorrison@jonesday.com
`
`John J. Normile (pro hac vice)
`JONES DAY
`250 Vesey Street
`New York, NY 10281-1047
`Telephone: (212) 326-3939
`Facsimile: (212) 755-7306
`jjnormile@jonesday.com
`
`Gregory Castanias (pro hac vice)
`Jennifer L. Swize (pro hac vice)
`JONES DAY
`51 Louisiana Avenue, N.W.
`Washington, D.C. 20001
`Telephone: (202) 879-3939
`Facsimile: (202) 626-1700
`gcastanias@jonesday.com
`jswize@jonesday.com
`
`Pablo D. Hendler (pro hac vice)
`POTOMAC LAW GROUP, PLLC
`1177 Avenue of the Americas, 5th Floor
`New York, NY 10036
`Telephone: (914( 893-6883
`Facsimile: (202) 318-7707
`phendler@potomaclaw.com
`
`Counsel for Plaintiffs
`
`
`
`
`
`
`- 14 -
`
`

`

`Case 1:21-cv-10598-FDS Document 1 Filed 04/09/21 Page 15 of 15
`
`
`
`CERTIFICATE OF SERVICE
`
`I, Christopher M. Morrison, hereby certify that I have on this 9 day of April 2021 filed a copy of
`the foregoing through the Court’s CM/ECF system, which will serve an electronic copy on
`counsel of record identified in the Notice of Electronic Filing.
`
`
`
`
`
`
`/s/ Christopher M. Morrison
`
`
`
`
`
`
`

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