Case 2:13-cv-00391-ES-JAD Document 390 Filed 09/08/17 Page 1 of 5 PageID: 7705
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark. NJ 07102-5426
`Tel: 973.286.6700
`
`Attorneys for Plaintiffs’
`,Jazz Pharmaceuticals, Inc. and
`,Jazz Pharmaceuticals Ireland Limited
`
`Paul H. Kochanski
`LERNER. DAVID, LITTENBERG,
`KRUMI-IOLZ & MENTLIK. LLP
`600 South Avenue West
`Westfield, NJ 07090
`Tel: 908.654.5000
`Fax: 908.654.7866
`
`Attouiwy for Defendant
`Aunwal Pharmaceuticals LLC
`
`Document Filed Electronically
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`JAZZ PHARMACEUTICALS. INC.. and
`JAZZ PHARMACEUTICALS IRELAND
`LIMITED,
`
`Plaintiffs.
`
`v.
`
`AMNEAL PHARMACEUTICALS, LLC, et al.,
`
`Defendants.
`
`:
`
`:
`
`x
`
`Civil Action No. 13-391-ES-JAD
`(consolidated)
`
`Esther Salas, U.S.D.J.
`Joseph A. Dickson, U.S.M.J.
`
`STIPULATION AND ORDER OF DISMISSAL
`
`Plaintiffs Jazz Pharmaceuticals. Inc. and Jazz Pharmaceuticals Ireland Limited (collectively.
`
`“Jazz”) and Defendant Amneal Pharmaceuticals LLC (“Amneal”). by their undersigned counsel,
`
`hereby stipulate and agree, subject to the approval of the Court, that:
`
`WHEREAS, in this action, Jazz has brought claims against Amneal for infringement of certain
`
`patents,
`
`including,
`
`inter alia, U.S. Patent Nos. 6,472,431 (“the ‘431 Patent”), 7,851,506 (“the
`
`‘506 Patent”), 8,263,650 (“the
`
`‘650 Patent”),
`
`8,324.275
`
`(“the
`
`‘275 Patent”),
`
`8,461,203
`
`(“the
`
`‘203 Patent”), 8,859,619 (“the ‘619 Patent”), and 8,952,062 (“the ‘062 Patent”)
`
`(collectively,
`
`the
`
`‘Formulation Patents”) in connection with Amneal’s submission of Abbreviated New Drug Application
`
`(“ANDA”) No. 203631;
`
`5123813 I do
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`

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`Case 2:13-cv-00391-ES-JAD Document 390 Filed 09/08/17 Page 2 of 5 PageID: 7706
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`WHEREAS, pursuant to Section 505 of the Federal Food Drug and Cosmetic Act (“FFDCA”),
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`Amneal filed ANDA No. 203631 (“Amneal’s ANDA”) seeking approval to engage in the commercial
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`use, manufacture, sale, offer for sale, or importation of 500 mg/mI sodium oxybate oral
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`solution
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`C’Amneal’s Proposed Product”), before the Formulation Patents expire;
`
`WHEREAS, Amneal has amended its ANDA No. 203631 to remove the certification under
`
`21 U.S.C. § 355(j)(2)(A)(vii)V) with respect to the ‘506, ‘650, ‘275, ‘619, and ‘062 Patents,submitted
`
`certifications for those patents under Section 505 of the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)Oll)
`
`C’Amneal’s Paragraph III Certifications”), and is no longer seeking FDA approval of ANDA
`
`No. 203631 prior to the expiration of the Formulation Patents;
`
`WHEREAS, Amneal agrees
`
`that
`
`it will not amend, convert, or otherwise change its
`
`Paragraph Ill Certifications for the ‘506,
`
`‘650, ‘275, ‘619, and ‘062 Patents to certifications under
`
`21 U.S.C. § 355(j)(2)(A)(vii)(lV);
`
`WHEREAS, Amneal agrees that it will not seek to market its Proposed Product prior to the
`
`expiration of the last to expire of the Formulation Patents, including any extensions and/or regulatory
`
`exclusivities;
`
`WHEREAS, Jazz has agreed to dismiss the Formulation Patents from this action against Amneal
`
`without prejudice;
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`NOW, TI-IEREFORE, it is hereby stipulated and agreed by and between the parties that:
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`Pursuant to Federal Rules of Civil Procedure 41 (a)( I )(A)Oi) and 41(c) that the
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`following counts, affirmative defenses, and counterclaims are dismissed without prejudice, each
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`party to bear its own costs, disbursements, and attorney fees:
`
`•
`
`Counts I,
`
`IV, VI, and VII of the Complaint
`
`in C.A. No. 13-39l-ES-JAD
`
`(D.I. I), Amneal’s First Defense, Second Defense, Seventh Defense, Eighth
`
`Defense, Eleventh through Fourteenth Defenses,
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`in C.A. No. 13-391-ES-JAD
`
`(D.l. 9),
`
`and Amneal’s Counterclaim Counts with respect
`
`to only the
`
`5123843
`
`.docx
`
`

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`Case 2:13-cv-00391-ES-JAD Document 390 Filed 09/08/17 Page 3 of 5 PageID: 7707
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`•
`
`•
`
`•
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`Formulation Patents iii Counterclaim Counts
`
`and II (Id.).
`
`Count
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`ii of the Complaint
`
`in C.A, No. 13-5450-ES-MD (Di. I). Amneal’s
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`Third Defense and Fourth Defense in C.A. No. 13-5450-ES-JAD (DI. 5), and
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`Amneal’s Counterclaim Counts III and IV (k!).
`
`Count Ill of the Complaint in CA. No. 15-1043-ES-JAD (D.l.
`
`I), Amneal’s
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`Fifth through Eighth Defenses in C.A. No. I5-l043-ES-JAD (D.[.
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`II), and
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`Amneal’s Counterclaim Counts V through VII (Id).
`
`Count I of the Complaint in C.A. No. l5-32l7-ES-JAD (DI. 1), Amneal’s First
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`through Fifth Defenses in C.A. No. 15-3217-ES-JAD (Dl. 14), and Amneal’s
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`Counterclaim Counts I and II (itt).
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`2.
`
`Amneal
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`shall
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`not amend,
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`convert or otherwise
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`change
`
`its Paragraph Ill
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`Certifications lbr the ‘506, ‘650, ‘275, ‘619, and ‘062 Patents to certifications under 21 U.s.c.
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`355(j)(2)(A)(vii)(IV).
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`3.
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`Amneal shall not market its Proposed Product prior to the expiration of the last to
`
`expire of the Formulation Patents, including any extensions and/or regulatory exclusivities.
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`4.
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`This Court retains jurisdiction over Jazz and Amneal for purposes of enforcing
`
`this Stipulation and Order of Dismissal.
`
`5.
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`The Clerk of the Court is directed to enter this stipulation and order forthwith.
`
`5123K431.docx
`
`

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`Case 2:13-cv-00391-ES-JAD Document 390 Filed 09/08/17 Page 4 of 5 PageID: 7708
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`Dated: September 5, 2017
`
`By: s/Charles M. Lizza
`
`By:
`
`s/ Paul H. Kochanski
`
`Paul H. Kochanski
`LERNER. DAVID, LITTENBERG.
`KRUMHOLZ & MENTLIK, LLP
`600 South Avenue West
`Westfield. NJ 07090
`Tel: 908.654.5000
`Fax: 908.654.7866
`E-mail: pkochanski@lernerdavid.com
`litigationIernerdavid.com
`
`Attorney for Defendant
`Amneal Pharmaceuticals LLC
`
`Of Counsel:
`
`Steven A. Maddox (pro hac vice)
`Matthew C. Ruedy (pro hoc vice)
`MADDOX EDWARDS PLLC
`1900 K Street NW — Suite 725
`Washington, DC 20006
`Tel: 202.830.0707
`Fax: 202.830.0704
`E-mail: smaddox@rneiplaw.com
`mruedymeiplaw.com
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`Tel: 973.286.6700
`E-mail: clizza@saiil.com
`
`Attorneys for Plaintiffs
`,Jazz Pharmace ut/cats, Inc. and .Jazz
`Pharmaceuticals Ireland Limited
`
`Of Counsel:
`
`F. Dominic Cerrito Eric
`C. Stops Evangeline Shik
`Gabriel P. Brier
`QUINN EMANUEL URQuIIART&
`SULLIVAN. LLP
`5! Madison Avenue. 22”’ Floor
`New York. New York I 00 I 0
`Tel: 212.849.7000
`
`Richard G. Greco
`RICHARD G. GREco PC
`90 State Street, Suite 700
`Albany, New York 12207
`Tel: 212.203.7625
`
`5123S43_Idocx
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`Case 2:13-cv-00391-ES-JAD Document 390 Filed 09/08/17 Page 5 of 5 PageID: 7709
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`IT IS on this
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`day OfA7, so o
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`SA LA S
`STRICT JUDGE
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`51238431 .docx
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