`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07 102-5426
`(973) 286-6700
`clizza@saul.com
`
`Sean R. Kelly (srk@saiber.com)
`Katherine A. Escanlar (kescanlar@saiber.com)
`SAIBER LLC
`18 Columbia Turnpike
`Suite 200
`Florham Park, NJ 07932
`(973) 645-4801
`
`Attorneysfor Plainqffs
`Jazz Pharmaceuticals, Inc. and
`Jazz Pharmaceuticals Ireland Limited
`
`Attorneysfor Defendant
`Par Pharmaceutical, Inc.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Civil Action No. 13-391 (ES)(JAD)
`(consolidated)
`
`(Filed Electronically)
`
`JAZZ PHARMACEUTICALS, INC. and
`JAZZ PHARMACEUTICALS IRELAND
`LIMITED,
`
`Plaintiffs,
`
`V.
`
`ANNEAL PHARMACEUTICALS LLC, et
`aL
`
`Defendants.
`
`STIPULATION AN]) ORDER OF DISMISSAL
`
`Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively,
`
`“Jazz”) and Defendant Par Pharmaceutical Inc. (“Par”), 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 Par for infringement of certain
`
`patents, including, inter alia, U.S. Patent Nos. 6,472,431 (“the ‘431 patent”), 6,780,889 (“the ‘889
`
`patent”), 7,262,219 (“the ‘219 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
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 313 Filed 08/15/16 Page 2 of 5 PageID: 6097
`
`patent”), and 8,952,062 (“the ‘062 patent”) (collectively, the “Formulation Patents”) in connection
`
`with Par’s submission of Abbreviated New Drug Application (“ANDA”) No. 205403;
`
`WHEREAS, pursuant to Section 505 ofthe Federal Food Drug and Cosmetic Act
`
`(“FFDCA”), Par filed ANDA No. 205403 (“Par’s ANDA”) seeking approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of 500 mg/mi sodium oxybate oral
`
`solution (“Par’s Proposed Product”), before the Formulation Patents expire;
`
`WHEREAS, Par has amended its ANDA No. 205403 to remove the certification under
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ‘889, ‘219, ‘506, ‘650, ‘275, ‘619, and ‘062
`
`patents, submitted certifications for those patents under Section 505 ofthe FFDCA, 21 U.S.C. §
`
`355(j)(2)(A)(vii)(III) (“Par’s Paragraph III Certifications”), and is no longer seeking FDA approval
`
`of ANDA No. 205403 prior to the expiration of the Formulation Patents;
`
`WHEREAS, Jazz has agreed to dismiss the Formulation Patents from this action against Par
`
`without prejudice based on Par’s agreement to the injunction described below if Par changes its
`
`Paragraph ifi Certifications for any ofthe Formulation Patents back to certifications under 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV);
`
`WHEREAS, the parties agree that, if (i) Par amends ANDA No. 205403 to contain a
`
`certification under 21 U.S.C.(j)(2)(A)(vii)(IV) for any of the foregoing patents and (ii) Jazz
`
`brings an action for infringement of at least one patent that is the subject of the first such
`
`amendment of the certification (“Jazz’s First New Formulation Patent Action”) within 45 days of
`
`receiving a complete notice from Par under 21 U.S.C. § 355(b)(3) regarding each such patent
`
`identified in the first amended certification (“Par’s First New Paragraph IV Notice”), then Par
`
`agrees to be enjoined from launching its Proposed Product for the shorter of 30 months from Jazz’s
`
`1
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 313 Filed 08/15/16 Page 3 of 5 PageID: 6098
`
`receipt of Par’s First New Paragraph 1V Notice or the duration of Jazz’s First New Formulation
`
`Patent Action;
`
`NOW, THEREFORE, it is hereby stipulated and agreed by and between the parties that:
`
`1.
`
`Pursuant to Federal Rules of Civil Procedure 41 (a)( 1 )(A)(ii) and 41(c) that the
`
`following counts, affirmative defenses, and counterclaims are dismissed without prejudice, each
`
`party to bear its own costs, disbursements, and attorney fees:
`
`• Counts I-Vu of the Complaint in C.A. No. 13-7884-ES-JAD (D.I. 1), Par’s first
`
`through fourteenth Affirmative Defenses in C.A. No. 13-7884-ES-JAD (D.I. 7), and
`
`Par’s Counterclaim Counts I-X1V (id.);
`
`• Count I of the Complaint in C.A. No. 15-00173-ES-JAD (D.I. 1), Par’s first, second,
`
`and thirdAffirmative Defenses in C.A. No. 15-00173-ES-JAD (D.I. 9), and Par’s
`
`Counterclaim Counts I-TI (id.); and
`
`• Count II of the Complaint in C.A. No. 15-03217-ES-JAD (D.I. 1), as well as Par’s
`
`first, second, third,, and fourth Affirmative Defenses in 15-03217-ES-lAD (D.I. 12),
`
`and Par’s Counterclaim Counts I-HI (id.).’
`
`2.
`
`If Par changes its Paragraph III Certifications for any ofthe Formulation Patents
`
`back to certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), and Jazz brings a First New
`
`Formulation Patent Action within 45 days of receiving Par’s First New Paragraph IV Notice, Par
`
`will request that the FDA institute a new 30-month stay of approval with regard to Par’s ANDA.
`
`If the FDA does not enter a new 30-month stay of approval pursuant to Par’s Request, then Par shall
`
`The dismissal of the parties’ claims, defenses, and counterclaims with respect to the
`Formulation Patents asserted against Par in this Action shall not result in the dismissal of claims,
`defenses, and counterclaims with respect to the other patents Jazz has asserted against Par in this
`Action. Nor shall it result in the dismissal of claims, defenses, and counterclaims in this Action
`with respect to Amneal Pharmaceuticals LLC, Watson Laboratories, Inc., Lupin Ltd., Lupin
`Pharmaceuticals, Inc., and Lupin Inc.
`
`2
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 313 Filed 08/15/16 Page 4 of 5 PageID: 6099
`
`be enjoined from launching its Proposed Product for the shorter of 30 months from Jazz’s receipt of
`
`Par’s First New Paragraph 1V Notice, the duration of Jazz’s First New Formulation Patent Action,
`
`or the expiration of all of the Formulation Patents. The duration of any stay or injunction relating to
`
`the Formulation Patents shall not affect the duration of any other applicable stay relating to Par’s
`
`ANDA No. 205403.
`
`3.
`
`This Court retains jurisdiction over Jazz and Par for purposes of enforcing this
`
`Stipulation and Order of Dismissal.
`
`4.
`
`The Clerk ofthe Court is directed to enter this judgment forthwith.
`
`3
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 313 Filed 08/15/16 Page 5 of 5 PageID: 6100
`
`Dated: August 12, 2016
`
`By:
`
`5/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07 102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneysfor Plaintiffs
`Jazz Pharmaceuticals, Inc. and
`Jazz Pharmaceuticals Ireland
`Limited
`
`By:
`
`s/ Sean R. Kelly
`Sean R. Kelly (srk@saiber.com)
`Katherine A. Escanlar
`(kescanlar@saiber.com)
`SAIBER LLC
`18 Columbia Turnpike
`Suite 200
`Florham Park, NJ 07932
`(973) 645-4801
`
`Attorneysfor Defendant
`Par Pharmaceutical Inc.
`
`OfCounsel:
`
`OfCounsel:
`
`Richard J. Berman
`Janine A. Carlan
`Bradford C. Frese
`Ahmed Abdel-Rahman
`ARENT Fox LLP
`1717 K Street NW
`Washington, D.C. 20006-5344
`(202) 857-6000
`richard.berman@arentfox.com
`janine.carlan@arentfox.com
`bradford.frese@arentfox.com
`ahmed.abdel-rahman@arentfox.com
`
`F. Dominic Cerrito
`Eric C. Stops
`Evangeline Shih
`Gabriel P. Brier
`QuINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22’ Floor
`New York, New York 10010
`(212) 849-7000
`
`Richard G. Greco
`RICHARD G. GRECO PC
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
`IT IS on this/
`
`TI-V1 HO’TO,RABLE\ESTHER SALAS
`7JITED S
`)STRICT JUDGE
`
`4
`
`