Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 1 of 12 PageiD #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GALDERMA LABORATORIES, L.P.;
`NESTLE SKIN HEALTH S.A.; and
`TCD ROYALTY SUB, LLC,
`
`Plaintiffs,
`
`v.
`
`DR. REDDY'S LABORATORIES, LTD.;
`DR. REDDY'S LABORATORIES, INC.; and
`PROMIUS PHARMA, LLC,
`
`Defendants.
`
`)
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`) C.A. No. ________ _
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`COMPLAINT
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`Plaintiffs Galderma Laboratories, L.P. ("Galderma"), Nestle Skin Health S.A.
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`(''NSH") and TCD Royalty Sub, LLC ("TCD") (collectively, "Plaintiffs"), for their Complaint
`
`against Defendants Dr. Reddy's Laboratories, Ltd. ("DRL Ltd."), Dr. Reddy's Laboratories,
`
`Inc.
`
`("DRL Inc."), and Promius Pharma, LLC ("Promius") (collectively, "DRL" or
`
`"Defendants"), hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Galderma is a privately held partnership registered in the State of Texas,
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`having a principal place of business at 14501 North Freeway, Fort Worth, Texas 76177.
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`2.
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`Plaintiff NSH is a "societe anonyme" organized and existing under the laws of
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`Switzerland, having a principal place of business at Avenue Gratta Paille 2, 1018 Lausanne,
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`Switzer land.
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`3.
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`PlaintiffTCD is a limited liability company organized and existing under the laws
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`of the State of Delaware, having a principal place of business at 222 Delaware Avenue, Suite
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`1200, Wilmington, DE 19801.
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1045
`
`

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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 1 of 12 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`GALDERMA LABORATORIES, L.P.;
`NESTLÉ SKIN HEALTH S.A.; and
`TCD ROYALTY SUB, LLC,
`
`COMPLAINT
`
`Plaintiffs Galderma Laboratories, L.P. (“Galderma”), Nestlé Skin Health S.A.
`
`(“NSH”) and TCD Royalty Sub, LLC (“TCD”) (collectively, “Plaintiffs”), for their Complaint
`
`against Defendants Dr. Reddy’s Laboratories, Ltd. (“DRL Ltd.”), Dr. Reddy’s Laboratories,
`
`Inc. (“DRL Inc.”), and Promius Pharma, LLC (“Promius”) (collectively, “DRL” or
`
`“Defendants”), hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Galderma is a privately held partnership registered in the State of Texas,
`
`having a principal place of business at 14501 North Freeway, Fort Worth, Texas 76177.
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`2.
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`Plaintiff NSH is a “societe anonyme” organized and existing under the laws of
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`Switzerland, having a principal place of business at Avenue Gratta Paille 2, 1018 Lausanne,
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`Switzerland.
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`3.
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`Plaintiff TCD is a limited liability company organized and existing under the laws
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`of the State of Delaware, having a principal place of business at 222 Delaware Avenue, Suite
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`1200, Wilmington, DE 19801.
`
`
`
`
`
`C.A. No.
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`)))))))))
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`Plaintiffs,
`
`v.
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`
`
`
`
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`DR. REDDY’S LABORATORIES, LTD.;
`DR. REDDY’S LABORATORIES, INC.; and
`PROMIUS PHARMA, LLC,
`
`
`
` Defendants.
`
`
`
`
`
`Exh. 1045
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`

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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 2 of 12 PageID #: 2
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`
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`4.
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`Upon information and belief, Defendant Promius is a limited liability company
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 200 Somerset Corporate Blvd, Bridgewater, New Jersey 08540, and is a wholly-
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`owned subsidiary and agent of Defendants DRL Inc. and DRL Ltd.
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`5.
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`Upon information and belief, Defendant DRL Inc. is a corporation organized and
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`existing under the laws of the State of New Jersey, having a principal place of business at 107
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`College Road East, Princeton, New Jersey 08540, and is a wholly-owned subsidiary and agent of
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`Defendant DRL Ltd.
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`6.
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`Upon information and belief, Defendant DRL Ltd. is a corporation organized and
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`existing under the laws of India, having a principal place of business at 8-2-337, Road No. 3,
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`Banjara Hills, Hyderabad 500 034, Telangana, India.
`
`NATURE OF THE ACTION
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`7.
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`This is a civil action for infringement of United States Patent Nos. 7,211,267 (“the
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`’267 patent”); 7,232,572 (“the ’572 patent”); 8,603,506 (“the ’506 patent”); 7,749,532 (“the ’532
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`patent”); 8,206,740 (“the ’740 patent”); 8,394,405 (“the ’405 patent”); 8,394,406 (“the ’406
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`patent”); 8,470,364 (“the ’364 patent”); and 8,709,478 (“the ’478 patent”) (collectively, “the
`
`patents-in-suit”). (Exhibits A-I.) This action arises under the Patent Laws of the United States,
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`35 U.S.C. §§ 100 et seq., as well as the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02.
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`JURISDICTION AND VENUE
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`8.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a).
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`9.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391(b)-(d) and 1400(b).
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`2
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 3 of 12 PageID #: 3
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`
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`10.
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`This Court has personal jurisdiction over Defendants Promius, DRL Inc. and DRL
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`Ltd. by virtue of the fact that, inter alia, Defendants have committed, aided, abetted, contributed
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`to, and/or participated in the commission of a tortious act of patent infringement under 35 U.S.C.
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`§ 271(e)(2) that has led and/or will lead to foreseeable harm and injury to Plaintiffs, including in
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`the State of Delaware. Defendants state that they intend to engage in the commercial
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`manufacture, use, and/or sale under DRL’s New Drug Application (“NDA”) No. 208286 of a 40
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`mg doxycycline capsules product proposed for the indication of “treatment of only inflammatory
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`lesions (papules and pustules) of rosacea in adult patients” (“DRL’s NDA Product”), before the
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`expiration of the patents-in-suit, throughout the United States, including in the State of Delaware.
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`11.
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`Upon information and belief, Promius, as a subsidiary and agent of DRL Inc. and
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`DRL Ltd., “focus[es] on [DRL’s] U.S. Specialty Business, which is engaged in the development
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`and sales of branded specialty products in the therapeutic areas of dermatology and neurology.”
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`Upon information and belief, Promius is the “commercial arm” of DRL Ltd.’s Proprietary
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`Products Group. Upon information and belief, Promius “leverages [DRL Ltd.’s] research,
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`development and manufacturing facilities in Hyderabad, India,” including with respect to DRL’s
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`NDA No. 208286 and DRL’s NDA Product.
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`12.
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`Upon information and belief, DRL Inc. is the agent for DRL Ltd. for purposes of
`
`making regulatory submissions to the United States Food and Drug Administration (“FDA”),
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`including DRL’s NDA No. 208286 at issue in this litigation.
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`13.
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`Upon information and belief, Promius, DRL Inc. and DRL Ltd. have acted in
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`concert with respect to the preparation and filing of NDA No. 208286 for DRL’s NDA Product
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`and in preparation to sell the NDA Product in the United States, including in the State of
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`Delaware.
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`3
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`Exh. 1045
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`

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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 4 of 12 PageID #: 4
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`
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`14.
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`Upon information and belief, following approval of NDA No. 208286 by the
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`FDA, Promius will act in concert with DRL Ltd. and DRL Inc. to commercialize DRL’s NDA
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`Product throughout the United States, including in the State of Delaware. Upon information and
`
`belief, DRL has estimated potential U.S. sales of DRL’s NDA Product of $50-75 million in the
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`near term.
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`15.
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`DRL’s infringing activities with respect to its filing of NDA No. 208286 and
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`intent to commercialize DRL’s NDA Product have led and/or will lead to foreseeable harm and
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`injury to Plaintiffs, including to TCD, a Delaware company located in Wilmington, Delaware.
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`16.
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`This Court also has personal jurisdiction over Promius by virtue of the fact that,
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`upon information and belief, inter alia, it is organized and existing under the laws of the State of
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`Delaware, has availed itself of the rights and benefits of Delaware law, and has engaged in
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`systematic and continuous contacts with the State of Delaware.
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`17.
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`This Court also has personal jurisdiction over DRL Inc. and DRL Ltd. by virtue of
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`the fact that, upon information and belief, inter alia, DRL Inc. and DRL Ltd. have availed
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`themselves of the rights and benefits of Delaware law, and have engaged in systematic and
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`continuous contacts with the State of Delaware.
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`18.
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`Upon information and belief, DRL Inc. and DRL Ltd., directly or through their
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`subsidiaries, affiliates or agents, develop, formulate, manufacture, market, import and sell
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`pharmaceutical products, including branded drug products and generic drug products, throughout
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`the United States, including in the State of Delaware.
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`19.
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`Upon information and belief, Promius, on behalf of DRL Inc. and DRL Ltd. as
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`their subsidiary and agent, sells branded dermatologic pharmaceutical products in the United
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`States, including in the State of Delaware, through its sales force including 54 sales
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`4
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`Exh. 1045
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`

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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 5 of 12 PageID #: 5
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`
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`representatives, six regional sales managers and one sales director. Upon information and belief,
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`Promius’s sales force targets approximately 8000 physicians in the field of dermatology and is
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`supported by a direct marketing team and a public relations program.
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`20.
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`Upon information and belief, DRL Ltd. directs the operations, management and
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`activities of Promius and DRL Inc. in the United States. Upon information and belief, DRL Ltd.
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`and Promius share executive officers in common, including Dr. Raghav Chari, who upon
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`information and belief is the Executive Vice President of Proprietary Products of DRL Ltd. and a
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`member of the Management Council of DRL Ltd., and is also the President and Head of
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`Promius.
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`21.
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`This Court also has personal jurisdiction over Defendants DRL Inc. and DRL Ltd.
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`because they have previously submitted to the jurisdiction of this Court and have affirmatively
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`availed themselves of the legal protections of the State of Delaware, having asserted
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`counterclaims in this jurisdiction. See Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy’s
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`Laboratories, Ltd. et al., C.A. No. 14-157-LPS (D. Del.); Cephalon, Inc. v. Dr. Reddy's
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`Laboratories, Ltd. et al, C.A. No. 15-179-GMS (D. Del.); Allos Therapeutics, Inc. et al. v. Teva
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`Pharmaceuticals USA, Inc. et al., C.A. No. 14-778-RGA (D. Del.); Genzyme Corporation et al.
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`v. Dr. Reddy’s Laboratories Ltd. et al., C.A. No. 13-1506-GMS (D. Del); Teva Pharmaceuticals
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`USA, Inc. et al. v. Dr. Reddy’s Laboratories, Ltd., et al., C.A. No. 15-306-GMS (D. Del.); Teijin
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`Ltd. et al. v. Dr. Reddy’s Laboratories, Ltd. et al., C.A. No. 13-1780-SLR (D. Del.); and Pfizer
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`Inc. et al. v. Dr. Reddy’s Laboratories, Ltd. et al., C.A. No. 13-989-SLR (D. Del.).
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`5
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 6 of 12 PageID #: 6
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`
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`THE PATENTS-IN-SUIT
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`22.
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`Plaintiff Galderma holds New Drug Application (“NDA”) No. 50-805 on
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`ORACEA® (doxycycline, USP) 40 mg Capsules, and is the exclusive distributor of ORACEA®
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`Capsules in the United States.
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`23.
`
`On May 1, 2007, the ’267 patent, entitled “Methods of Treating Acne” was duly
`
`and legally issued to CollaGenex Pharmaceuticals, Inc. A copy of the ’267 patent is attached as
`
`Exhibit A.
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`24.
`
`25.
`
`NSH is the current owner of the ’267 patent.
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`On June 19, 2007, the ’572 patent, entitled “Methods of Treating Rosacea” was
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`duly and legally issued to CollaGenex Pharmaceuticals, Inc. A copy of the ’572 patent is
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`attached as Exhibit B.
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`26.
`
`27.
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`NSH is the current owner of the ’572 patent.
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`On December 10, 2013, the ’506 patent, entitled “Methods of Treating Acne” was
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`duly and legally issued to Galderma Laboratories, Inc. A copy of the ’506 patent is attached as
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`Exhibit C.
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`28.
`
`29.
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`NSH is the current owner of the ’506 patent.
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`On July 6, 2010, the ’532 patent, entitled “Once Daily Formulations of
`
`Tetracyclines” was duly and legally issued to Supernus Pharmaceuticals, Inc. A copy of the ’532
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`patent is attached as Exhibit D.
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`30.
`
`31.
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`TCD is the current owner of the ’532 patent.
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`On June 26, 2012, the ’740 patent, entitled “Once Daily Formulations of
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`Tetracyclines” was duly and legally issued to Supernus Pharmaceuticals, Inc. A copy of the ’740
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`patent is attached as Exhibit E.
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`6
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 7 of 12 PageID #: 7
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`
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`32.
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`33.
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`TCD is the current owner of the ’740 patent.
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`On March 12, 2013, the ’405 patent, entitled “Once Daily Formulations of
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`Tetracyclines” was duly and legally issued to Supernus Pharmaceuticals, Inc. A copy of the ’405
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`patent is attached as Exhibit F.
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`34.
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`35.
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`TCD is the current owner of the ’405 patent.
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`On March 12, 2013, the ’406 patent, entitled “Once Daily Formulations of
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`Tetracyclines” was duly and legally issued to Supernus Pharmaceuticals, Inc. A copy of the ’406
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`patent is attached as Exhibit G.
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`36.
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`37.
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`TCD is the current owner of the ’406 patent.
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`On June 25, 2013, the ’364 patent, entitled “Once Daily Formulations of
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`Tetracyclines” was duly and legally issued to Supernus Pharmaceuticals, Inc. A copy of the ’364
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`patent is attached as Exhibit H.
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`38.
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`39.
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`TCD is the current owner of the ’364 patent.
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`On April 29, 2014, the ’478 patent, entitled “Once Daily Formulations of
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`Tetracyclines” was duly and legally issued to Supernus Pharmaceuticals, Inc. A copy of the ’478
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`patent is attached as Exhibit I.
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`40.
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`41.
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`TCD is the current owner of the ’478 patent.
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`The patents-in-suit are listed in the FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations (“Orange Book”) for ORACEA® Capsules.
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`DRL’S NDA AND NOTICE LETTERS
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`42.
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`Upon information and belief, DRL Inc., with the collaboration or assistance of
`
`Promius and DRL Ltd., submitted NDA No. 208286 to the FDA under § 505(b)(2) of the Federal
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`Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(2)), including a certification with respect to
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`7
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 8 of 12 PageID #: 8
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`
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`the patents-in-suit under § 505(b)(2)(A)(iv) of the Federal Food, Drug and Cosmetic Act
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`(“Paragraph IV Certification”), seeking approval to engage in the commercial manufacture, use,
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`sale, or offer for sale within the United States, or importation into the United States, of DRL’s
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`NDA Product prior to the expiration of the patents-in-suit.
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`43.
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`Upon information and belief, DRL has used the name “DFD-09” in public
`
`statements to refer to DRL’s NDA Product.
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`44.
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`Upon information and belief, DRL has stated that the proposed labeling for
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`DRL’s NDA Product is “similar” to the FDA approved labeling for ORACEA® Capsules.
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`45.
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`Upon information and belief, DRL has stated that it has successfully completed
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`bioequivalence studies comparing DRL’s NDA Product to ORACEA® Capsules.
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`46.
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`DRL Inc., on behalf of DRL Ltd. sent a letter to Galderma dated June 22, 2015,
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`signed by Lee Banks Esq., Vice President, Intellectual Property, DRL Inc., representing that
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`DRL Ltd. had filed a Paragraph IV Certification in NDA No. 208286 with respect to the ’267,
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`’572 and ’506 patents (collectively, the “Ashley patents”), and that DRL is seeking approval of
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`its NDA Product under NDA No. 208286 prior to the expiration of those patents (“the Ashley
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`Notice Letter”).
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`47.
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`DRL Inc., on behalf of DRL Ltd. sent a letter to Galderma and TCD dated June
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`22, 2015, signed by Lee Banks Esq., Vice President, Intellectual Property, DRL Inc.,
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`representing that DRL Ltd. had filed a Paragraph IV Certification in NDA No. 208286 with
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`respect to the ’532, ’740, ’405, ’406, ’364, and ’478 patents (collectively, the “Chang patents”),
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`and that DRL is seeking approval of its NDA Product under NDA No. 208286 prior to the
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`expiration of those patents (“the Chang Notice Letter”).
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`8
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 9 of 12 PageID #: 9
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`48.
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`Galderma received the Ashley Notice Letter on June 25, 2015 via U.S. Certified
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`Mail. Galderma and TCD received the Chang Notice Letter on June 25, 2015 via U.S. Certified
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`mail.
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`49.
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`This action is being commenced by Plaintiffs within 45 days of the date of the
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`receipt of DRL’s Ashley Notice Letter and Chang Notice Letter.
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`50.
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`Both DRL’s Ashley Notice Letter and Chang Notice Letter included an
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`accompanying Offer of Confidential Access (“OCA”) to certain DRL confidential information
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`regarding the DRL NDA Product. Galderma subsequently, over the course of several weeks,
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`negotiated with DRL in an effort to agree on reasonable terms for DRL’s OCA. The parties were
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`not able to reach an agreement with respect to the reasonable revisions to the terms of DRL’s
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`OCA that Galderma proposed.
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`51.
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`To date, DRL has not provided Plaintiffs with a copy of any portions of DRL’s
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`NDA or any information regarding the DRL NDA Product, beyond the information that was set
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`forth in DRL’s Notice Letter.
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`DRL’S INFRINGEMENT OF THE PATENTS-IN-SUIT
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`Plaintiffs re-allege paragraphs 1-51 as if fully set forth herein.
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`By seeking approval of their NDA No. 208286 to engage in the commercial
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`52.
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`53.
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`manufacture, use, sale, or offer for sale within the United States, or importation into the United
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`States, of DRL’s NDA Product prior to the expiration of the ’267, ’572, ’506, ’532, ’740, ’405,
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`’406, ’364, and ’478 patents, Defendants have infringed those patents-in-suit under 35 U.S.C.
`
`§ 271(e)(2)(A).
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`54.
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`Defendants Promius, DRL Inc. and DRL Ltd. are jointly and severally liable for
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`infringement of the ’267, ’572, ’506, ’532, ’740, ’405, ’406, ’364, and ’478 patents under 35
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`9
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 10 of 12 PageID #: 10
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`
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`U.S.C. § 271(e)(2)(A). Upon information and belief, Promius, DRL Inc. and DRL Ltd. actively
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`and knowingly caused to be submitted, assisted with, participated in, contributed to, or directed
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`the submission of NDA No. 208286 seeking to engage in the commercial manufacture, use, sale,
`
`or offer for sale within the United States, or importation into the United States, of DRL’s NDA
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`Product prior to the expiration of the patents-in-suit.
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`55. Moreover, if Defendants manufacture, use, offer for sale, or import into the
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`United States any of the DRL NDA Product, or induce or contribute to any such conduct, prior to
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`the expiration of the ’267, ’572, ’506, ’532, ’740, ’405, ’406, ’364, and ’478 patents, including
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`any applicable exclusivities or extensions, Defendants would infringe the one or more claims of
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`those patents-in-suit under 35 U.S.C. § 271(a), (b) and/or (c).
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`56.
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`Plaintiffs are entitled to relief provided by 35 U.S.C. § 271(e)(4), including an
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`order of this Court that the effective date of the approval of the NDA No. 208286 be a date that
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`is not earlier than the expiration date of the patents-in-suit, or any later expiration of any patent
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`term extension or exclusivity for the patents-in-suit to which Plaintiffs become entitled.
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`57.
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`Plaintiffs will be irreparably harmed by Defendants’ infringing activities unless
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`those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law.
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`PRAYER FOR RELIEF
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`Plaintiffs request that the Court grant the following relief:
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`A.
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`An Order adjudging and decreeing that Defendants Promius, DRL Inc. and
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`DRL Ltd. have infringed the ’267, ’572, ’506, ’532, ’740, ’405, ’406, ’364, and ’478 patents by
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`submitting NDA No. 208286 to the FDA;
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`B.
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
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`date of any FDA approval of DRL’s NDA No. 208286 will not be earlier than the expiration date
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`10
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 11 of 12 PageID #: 11
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`
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`of the ’267, ’572, ’506, ’532, ’740, ’405, ’406, ’364, and ’478 patents, or any later expiration of
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`any patent term extension or exclusivity for the aforementioned patents-in-suit to which
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`Plaintiffs are or become entitled;
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`C.
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`An Order permanently enjoining Defendants Promius, DRL Inc. and DRL
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`Ltd., their directors, officers, agents, attorneys, affiliates, divisions, successors and employees,
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`and those acting in privity or concert with them, from manufacturing, using, offering to sell,
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`selling, marketing, distributing, or importing DRL’s NDA Product identified in this Complaint,
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`or any product that infringes the ’267, ’572, ’506, ’532, ’740, ’405, ’406, ’364, or ’478 patents,
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`prior to the expiration of the patents-in-suit, including any extensions to which Plaintiffs are or
`
`become entitled;
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`D.
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`That Plaintiffs be awarded monetary relief to the extent Defendants
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`commercially manufacture, use, offers for sale, or sell within the United States, or import into
`
`the United States any product that infringes or induces or contributes to the infringement of the
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`’267, ’572, ’506, ’532, ’740, ’405, ’406, ’364, or ’478 patents, within the United States prior to
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`the expiration of the aforementioned patents, including any later expiration of any patent term
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`extension or exclusivity for the patents to which Plaintiffs are or will become entitled, and that
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`any such monetary relief be awarded to Plaintiffs with prejudgment interest; and
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`E.
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`Such other and further relief as the Court may deem just and proper.
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`11
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`Exh. 1045
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`Case 1:15-cv-00670-UNA Document 1 Filed 07/31/15 Page 12 of 12 PageID #: 12
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Maryellen Noreika
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiffs
`
`
`
`
`OF COUNSEL:
`
`Gerald J. Flattmann, Jr.
`Evan D. Diamond
`Vanessa Y. Yen
`PAUL HASTINGS LLP
`75 East 55th Street
`New York, NY 10022
`(212) 318-6000
`
`July 31, 2015
`
`12
`
`Exh. 1045