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`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`JAZZ PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`ROXANE LABORATORIES, INC.,
`
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`
`(Filed Electronically)
`
`
`
`
`
`
`
`Defendant.
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`Plaintiff Jazz Pharmaceuticals, Inc. (“Jazz Pharmaceuticals”), by its undersigned
`
`attorneys, for its Complaint against defendant Roxane Laboratories, Inc. (“Roxane”), alleges as
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`follows:
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`Nature of the Action
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, 35 U.S.C. §100, et seq., arising from Roxane’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking
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`approval to commercially market a generic version of Jazz Pharmaceuticals’ XYREM® drug
`
`product prior to the expiration of United States Patent No. 7,895,059 (the “’059 patent”) owned
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`by Jazz Pharmaceuticals.
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`The Parties
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`2.
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`Plaintiff Jazz Pharmaceuticals is a corporation organized and existing under the
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`laws of the State of Delaware, having a principal place of business at 3180 Porter Drive, Palo
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`Alto, California 94304.
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`3.
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`On information and belief, defendant Roxane is a corporation organized under
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`the laws of Nevada, having a principal place of business at 1809 Wilson Road, Columbus,
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`Ohio 43228.
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`4.
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`On information and belief, Roxane is registered to do business in the State of
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`New Jersey, and maintains a registered agent for service of process in New Jersey. On
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`information and belief, Roxane regularly transacts business within this judicial district.
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`Further, on information and belief, Roxane develops numerous generic drugs for sale and use
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`throughout the United States, including in this judicial district. On information and belief,
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`Roxane has litigated patent cases in this district in the past without contesting personal
`
`jurisdiction, and, in at least some of those actions, Roxane has asserted counterclaims.
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`Jurisdiction and Venue
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`5.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`6.
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`This Court has personal jurisdiction over Roxane by virtue of, inter alia, its
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`systematic and continuous contacts with the State of New Jersey. On information and belief,
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`Roxane has purposefully availed itself of this forum by, among other things, making, shipping,
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`using, offering to sell or selling, or causing others to use, offer to sell, or sell, pharmaceutical
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`products in the State of New Jersey and deriving revenue from such activities. Further, on
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`information and belief, Roxane has customers in the State of New Jersey.
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`7.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`The Patent-in-Suit
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`8.
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`On February 22, 2011, the United States Patent and Trademark Office
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`(“USPTO”) duly and lawfully issued the ’059 patent, entitled “Sensitive Drug Distribution
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`System and Method” to inventors Dayton Reardan, Patti Engle and Bob Gagne. A copy of the
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`’059 patent is attached hereto as Exhibit A.
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`The XYREM® Drug Product
`
`9.
`
`Jazz Pharmaceuticals holds an approved New Drug Application (“NDA”) under
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`Section 505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a),
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`for sodium oxybate oral solution (NDA No. 21-196), which it sells under the trade name
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`XYREM®. The claims of the ’059 patent cover, inter alia, methods of use and administration of
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`sodium oxybate or pharmaceutical compositions containing sodium oxybate. Jazz
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`Pharmaceuticals owns the ’059 patent.
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`10.
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`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, ’059 patent is
`
`listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence
`
`Evaluations” (the “Orange Book”), with respect to XYREM®.
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`Acts Giving Rise to this Suit
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`11.
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`Pursuant to Section 505 of the FFDCA, Roxane filed ANDA No. 202-090
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`(“Roxane’s ANDA”) seeking approval to engage in the commercial use, manufacture, sale,
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`offer for sale or importation of 500 mg/ml sodium oxybate oral solution (“Roxane’s Proposed
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`Product”), before the ’059 patent expires.
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`12.
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`In connection with the filing of its ANDA as described in the preceding
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`paragraph, Roxane has provided a written certification to the FDA, as called for by Section 505
`
`of the FFDCA, alleging that the claims of the ’059 patent are invalid, unenforceable, and/or
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`will not be infringed by the activities described in Roxane’s ANDA.
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`13.
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`No earlier than March 22, 2011, Roxane sent written notice of its ANDA
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`certification to Jazz Pharmaceuticals (“Roxane’s Notice Letter”). Roxane’s Notice Letter
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`alleged that the claims of the ’059 patent are invalid, unenforceable, and/or will not be
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`infringed by the activities described in Roxane’s ANDA. Roxane’s Notice Letter also
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`informed Jazz Pharmaceuticals that Roxane seeks approval to market Roxane’s Proposed
`
`Product before the ’059 patent expires.
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`Count for Infringement of the ’059 Patent
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`14.
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`Plaintiff repeats and realleges the allegations of paragraphs 1-13 as though fully
`
`set forth herein.
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`15.
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`Roxane’s submission of its ANDA to obtain approval to engage in the
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`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral
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`solution, prior to the expiration of the ’059 patent, constitutes infringement of one or more of
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`the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
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`16.
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`There is a justiciable controversy between the parties hereto as to the
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`infringement of the ’059 patent.
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`17.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
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`will infringe the ’059 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
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`importing, and/or selling Roxane’s Proposed Product in the United States.
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`18.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
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`will induce infringement of the ’059 patent under 35 U.S.C. § 271(b) by making, using,
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`offering to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
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`information and belief, upon FDA approval of Roxane’s ANDA, Roxane will intentionally
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`encourage acts of direct infringement with knowledge of the ’059 patent and knowledge that its
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`acts are encouraging infringement.
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`19.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
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`will contributorily infringe the ’059 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
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`information and belief, Roxane has had and continues to have knowledge that Roxane’s
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`Proposed Product is especially adapted for a use that infringes the ’059 patent and that there is
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`no substantial non-infringing use for Roxane’s Proposed Product.
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`20.
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`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed
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`if Roxane’s infringement of the ’059 patent is not enjoined.
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`21.
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`22.
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`Jazz Pharmaceuticals does not have an adequate remedy at law.
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`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
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`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff Jazz Pharmaceuticals respectfully requests the following relief:
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`(A) A Judgment be entered that Roxane has infringed the ’059 patent by submitting
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`ANDA No. 202-090;
`
`(B) A Judgment be entered that Roxane has infringed, and that Roxane’s making,
`
`using, selling, offering to sell, or importing Roxane’s Proposed Product will infringe one or more
`
`claims of the ’059 patent;
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`(C) An Order that the effective date of FDA approval of ANDA No. 202-090 be a
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`date which is not earlier than the later of the expiration of the ’059 patent, or any later expiration
`
`of exclusivity to which Plaintiff is or becomes entitled;
`
`(D)
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`Preliminary and permanent injunctions enjoining Roxane and its officers, agents,
`
`attorneys and employees, and those acting in privity or concert with them, from making, using,
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`selling, offering to sell, or importing Roxane’s Proposed Product until after the expiration of the
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`’059 patent, or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
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`(E)
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`A permanent injunction be issued, pursuant to 35 U.S.C. § 271(e)(4)(B),
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`restraining and enjoining Roxane, its officers, agents, attorneys and employees, and those acting
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`in privity or concert with them, from practicing any methods as claimed in the ’059 patent, or
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`from actively inducing or contributing to the infringement of any claim of the ’059 patent, until
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`after the expiration of the ’059 patent, or any later expiration of exclusivity to which Plaintiff is
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`or becomes entitled;
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`(F)
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`A Declaration that the commercial manufacture, use, importation into the United
`
`States, sale, or offer for sale of Roxane’s Proposed Product will directly infringe, induce and/or
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`contribute to infringement of the ’059 patent;
`
`(G)
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`To the extent that Roxane has committed any acts with respect to the methods
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`claimed in the ’059 patent, other than those acts expressly exempted by 35 U.S.C. § 271(e)(1),
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`that Plaintiff Jazz Pharmaceuticals be awarded damages for such acts;
`
`(H)
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`If Roxane engages in the commercial manufacture, use, importation into the
`
`United States, sale, or offer for sale of Roxane’s Proposed Product prior to the expiration of the
`
`’059 patent, a Judgment awarding damages to Plaintiff Jazz Pharmaceuticals resulting from such
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`infringement, together with interest;
`
`(I)
`
`(J)
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`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
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`Costs and expenses in this action; and
`
`(K)
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`Such further and other relief as this Court may deem just and proper.
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`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`Dated: May 2, 2011
`
`
`
`
`
`
`
`Of Counsel:
`
`F. Dominic Cerrito
`Daniel L. Malone
`JONES DAY
`222 East 41st Street
`New York, New York 10017-6702
`(212) 326-3939
`
`Richard G. Greco
`RICHARD G. GRECO PC
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
`
`
`
`
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`
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
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`I hereby certify that the matters captioned, Jazz Pharmaceuticals, Inc. v. Roxane
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`Laboratories, Inc., Civil Action No. 10-6108 (SDW)(MCA) and Jazz Pharmaceuticals, Inc. v.
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`Roxane Laboratories, Inc., Civil Action No. 11-660 (SDW)(MCA), are related to the matter in
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`controversy because the matter in controversy involves the same plaintiff, the same defendant,
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`and in both cases, the defendant is seeking FDA approval to market a generic version of the same
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`sodium oxybate drug product.
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`I further certify that, to the best of my knowledge, the matter in controversy is not the
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`subject of any other action pending in any court, or of any pending arbitration or administrative
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`
`
`
`
`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`proceeding.
`
`Dated: May 2, 2011
`
`
`
`
`
`Of Counsel:
`
`F. Dominic Cerrito
`Daniel L. Malone
`JONES DAY
`222 East 41st Street
`New York, New York 10017-6702
`(212) 326-3939
`
`Richard G. Greco
`RICHARD G. GRECO PC
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
`
`
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`EXHIBIT A
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