Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 1 of 4 PageID: 7474
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 1 of 4 PageID: 7474
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`JAZZ PHARMACEUTICALS, INC. and
`JAZZ PHARMACEUTICALS IRELAND
`
`
`
`LIMITED,
`
`Plaintiffs,
`
`V.
`
`AMNEAL PHARMACEUTICALS, LLC, et (11.,
`
`Defendants.
`
`LIMITED,
`
`v.
`
`Plaintiffs,
`
`PAR PHARMACEUTICAL, INC.
`
`
`
`
`
`
`
`JAZZ PHARMACEUTICALS, TNC. and
`JAZZ PHARMACEUTICALS IRELAND
`
`
`
`
` Defendants.
`
`
`
`Consolidated Civil Action No.
`2:13-cv-00391-ES-JAD
`
`(Filed Electronically)
`
`Civil Action No.
`2: 1 5-cv-75 80-ES-JAD
`
`(Filed Electronically)
`
`
`
`
`
`STIPULATION, CONSOLIDATION, BIFURCATION AND STAY ORDER
`
`WHEREAS Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland
`
`Limited (collectively, “Jazz”) initiated Civil Action No. 15-7580-ES-JAD alleging infringement
`
`of United States Patent No. 9,050,302 by Defendant Par Pharmaceutical, Inc.’s ("Par”)
`
`submission of Abbreviated New Drug Application (“ANDA”) No. 205402 to the United States
`
`Food and Drug Administration (“FDA”) for regulatory approval of a 500 mg/ml sodium oxybate
`
`oral solution;
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 1 of 4 PageID: 7474
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`JAZZ PHARMACEUTICALS, INC. and
`JAZZ PHARMACEUTICALS IRELAND
`
`
`
`LIMITED,
`
`Plaintiffs,
`
`V.
`
`AMNEAL PHARMACEUTICALS, LLC, et (11.,
`
`Defendants.
`
`LIMITED,
`
`v.
`
`Plaintiffs,
`
`PAR PHARMACEUTICAL, INC.
`
`
`
`
`
`
`
`JAZZ PHARMACEUTICALS, TNC. and
`JAZZ PHARMACEUTICALS IRELAND
`
`
`
`
` Defendants.
`
`
`
`Consolidated Civil Action No.
`2:13-cv-00391-ES-JAD
`
`(Filed Electronically)
`
`Civil Action No.
`2: 1 5-cv-75 80-ES-JAD
`
`(Filed Electronically)
`
`
`
`
`
`STIPULATION, CONSOLIDATION, BIFURCATION AND STAY ORDER
`
`WHEREAS Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland
`
`Limited (collectively, “Jazz”) initiated Civil Action No. 15-7580-ES-JAD alleging infringement
`
`of United States Patent No. 9,050,302 by Defendant Par Pharmaceutical, Inc.’s ("Par”)
`
`submission of Abbreviated New Drug Application (“ANDA”) No. 205402 to the United States
`
`Food and Drug Administration (“FDA”) for regulatory approval of a 500 mg/ml sodium oxybate
`
`oral solution;
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 2 of 4 PageID: 7475
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 2 of 4 PageID: 7475
`
`WHEREAS this cause of action is substantially related to the consolidated litigation
`
`initiated by Jazz captioned, Jazz Pharmaceuticals, Inc, et al. v. Amneal Pharmaceuticals LLC, et
`
`al., Civil Action No. l3-0039l-ES-JAD (consolidated), which is before this Court;
`
`WHEREAS the parties have agreed to the consolidation of Civil Action No. 15-7580-ES-
`
`JAD with Civil Action No. 13-391-ES-JAD (consolidated) for all purposes;
`
`WHEREAS Jazz has served its disclosure of Asserted Claims of the ’302 patent on Par,
`
`Par has provided its invalidity contentions for the ’302 patent, Jazz will provide its responses to
`
`Par’s invalidity contentions on August 7, 2017, and the Scheduling Order entered in Civil Action
`
`No. l3-391-ES—JAD (consolidated) under Docket Entry 215, as amended by Docket Entries 293,
`
`301, 340, and 370 shall apply to the remainder of the case now proceeding under Civil Action
`
`No. 15-7580-ES-JAD;
`
`WHEREAS the parties have agreed to be bound by the Discovery Confidentiality Order
`
`entered in Civil Action No. 13-391-ES-JAD (consolidated) under Docket Entry 144 or any
`
`subsequent amendments thereto;
`
`WHEREAS good cause exists to consolidate this action with Civil Action No. 13-391-
`
`ES-JAD;
`
`WHEREAS Jazz and Par have agreed that Jazz’s allegations that Par will infringe the
`
`’302 and ’306 patent should be bifurcated and stayed until the FDA indicates in writing that Par
`
`has submitted proposed labeling in ANDA No. 205403 that is acceptable;
`
`WHEREAS Jazz and Par have agreed that they will negotiate in good faith an amended
`
`schedule with respect to Jazz’s allegations that Par will infringe the ’302 and ’306 patents,
`
`including a schedule in which the parties will exchange their respective Infringement and Non-
`
`Infringement Contentions, when the stay is lifted;
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 3 of 4 PageID: 7476
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 3 of 4 PagelD: 7476
`
`WHEREAS Par has agreed to continue producing its correspondence with the FDA
`
`regarding ANDA No. 205403 pursuant to L. Pat. R. 3.60) while Jazz’s infringement allegations
`
`regarding the ’302 and ’306 patent are stayed;
`
`WHEREAS Par agrees to notify the Court within 7 days that the FDA has indicated in
`
`writing that Par has submitted proposed labeling in ANDA No. 205403 that is acceptable;
`
`WHEREAS Par and Jazz agree that Par’s counterclaims seeking a declaration of
`
`invalidity of the ’302 and ’306 patents will proceed pursuant to the Court’s July 24, 2017
`
`Scheduling Order (D.I. 370), provided, however, that if all of the remaining defendants in Civil
`
`Action No. 13-391 other than Par settle their respective litigations with Jazz, or are otherwise
`
`dismissed from this litigation prior to a finaljudgment on the merits, then Par’s counterclaims
`
`seeking a declaration of invalidity of the ’302 and ’306 patents will also be stayed along with the
`
`infringement portion of the case;
`
`WHEREFORE Jazz and Par, by and through their attorneys, respectfully request that this
`
`Court:
`
`1) consolidate Civil Action No. 15-7580-ES-JAD with Civil Action No. 13-39l-ES-JAD
`
`for all purposes and that all of the papers in these consolidated actions should be filed and
`
`maintained in Civil Action No. l3-39l-ES-JAD;
`
`2) bifurcate and stay Jazz’s allegations that Par will infringe the ’302 and ’306 patents
`
`until Far and Jazz notify the Court that the FDA has indicated in writing that Par’s proposed
`
`labeling in ANDA No. 205403 is acceptable.
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 4 of 4 PageID: 7477
`
`Case 2:13-cv-00391-ES-JAD Document 380 Filed 08/15/17 Page 4 of 4 PagelD: 7477
`
`Dated: August 3, 2017
`
`/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
`wbaton@saul.com
`
`OF COUNSEL:
`
`F. Dominic Cerrito
`
`Eric C. Stops
`Evangeline Shih
`Gabriel P. Brier
`
`Frank C. Calvosa
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd 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
`
`Respectfully submitted,
`
`“s/ Sean R. Kelly
`Sean R. Kelly
`Katherine A. Escanlar
`SAIBER LLC
`
`18 Columbia Turnpike
`Suite 200
`Florham Park, NJ 07932
`(973) 622-3333
`skelly@saiber.com
`kescanlar@saiber.com
`
`OF COUNSEL:
`
`Richard J. Berman
`Janine A. Carlan
`Bradford C. Frese
`
`Gary A. Coad
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006-5344
`(202) 857-6000
`richard.berman@arentfox.com
`janine.carlan@arentfox.com
`bradford.frese@arentfox.com
`gary.coad@arentfox.com
`
`Counselfor Plaintifls Jazz Pharmaceuticals,
`Inc. and Jazz Pharmaceuticals Ireland Limited
`
`Counselfor Defendant Par Pharmaceutical,
`Inc.
`
`AK
`333
`
`IT IS so ORDERED this \5 1 day of webs
`
`
`Hon. Jo p11 A. Dickson, U.S.M. J
`
`2017.
`
`cc: Hon. Esther Salas, U.S.D.J.
`
`
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