`Case 1:15-cv-00116-LPS Document 162 Filed 07/25/16 Page 1 of 7 PagelD #: 4038
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`PTRABEMARK.
`
`Mall Sten 8
`Director of the U.S. Patent sad Trademark Office
`P.O. Box 1480
`Alexandria, VA 223E-1450
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`REPORT ON THE
`FILING QR DETERMINATION OF AN
`ACTION REGARDINGA PATENT OR
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`ia Compliance wih:SUS. § B80 andlor ELS. § PLN you arehereby advised (hat. w court action has boon
`filed ig the US. CNeadet
`for the District of Delaware
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`EY Trademarks os
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`15.476 (LPS)
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`DEFENDANT
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`PAR PHARMACEUTICAL INC.
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`ROLDEROF PATENT OR TRADEMARK
`Cosma Tachnologigs Linkted
`Dismissed fram Action by First Amended Complaint ta6/204 §
`Cosmo Technologies Limited
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`iv the abowe-—cniitied cane, te folowing pateniis¥ fadamariys) have been inched:
`PINCLUDED BY
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`af Agwendetit
`DATE OP PATENT
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`inthe abass-sentitiad cass, the folowing decision has been rendered oF hicigemant dssasd:
`DECMONGUDBEMERT
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`Carent Judgment Bkgh Vrtom isgad
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`CopyUpon initiation of ection, mailthis capy to Director Copy d—~Upan termination af action, mail this copy iy Director
`Copy 2Upon Gling document adding patent(s} mall this copy io Dirextor Cony 4--Clase fle copy
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`Eee 2018 |
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`Case 1:15-cv-00116-LPS Document 162 Filed 07/25/16 Page 2 of 7 PagelD #: 4039
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`COSMO TECHNOLOGIES LIMITED, af al.
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`PAR PHARMACEUTICAL, ING.
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`snnenntnnenmnnnnimnrnnnnnnannapacnnsnannacnannnnnennnnnt
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`PATENTOR
`DATE OF PATENT
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`HOLDER OF PATENT OR TRADEMARK
`TRADEMARK NO.
`OR TRADEMARK
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`Cosmo Technologies Limited
`TUS2042
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`DATE FILED
`US. DISTRICT COURT
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`ROCKET NO.
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`2f2i2015
`for the District of Delaware
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`15-716 (LPS)
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`DEFENDANT
`PLAINTIFF
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`Case 1:15-cv-00116-LPS Document 162 Filed 07/25/16 Page 3 of 7 PagelD #: 4040
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`COSMO TECHNOLOGIES LIMITED,
`VALEANT PHARMACEUTICALS
`LUXEMBOURG 8.A. RBLL., and
`SANTARUS,INC.,
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`Plaintiffs,
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`vv,
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`PAR PHARMACEUTICAL, INC.,
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`Defendant.
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`Civil Action No. 1:15-cv-00116-LPS
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`SmeeSane!Nae!“ane!Sane!“ane!“ann!“ann!“mee!“Sage“Sage“neenee’
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`Plaintiffs Cosmo Technologies Limited (“Cosmo”}, Valeant Pharmaceuticals
`Luxembourg Sard. CValeant’}, Santarus, Inc. (‘Santarus”) (collectively, “Plaintiffs”)} and
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`Detendant Par Pharmaceutical, Inc. (hereinafter “Par” and, together with Plaintiffs, ““Parties’”)
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`have agreed to terms and conditions representing a negotiated settlement of this action and have
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`set forth those terms and conditions in a Settlement and License Agreement by and between the
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`Parties.
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`Accordingly, the Parties, by their respective undersigned attorneys, herebystipulate and
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`consent to the entry of a judgment and an mypunction in and dismissal of this action pursuant to
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`Rule 41(a}(2) of the Federal Rules of Civil Procedure, as follows:
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`The CourtHEREBY ORDERS, ADJUDGES AND DECREES:
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`1,
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`This Court has jurisdiction over the subject matter of this action and personal
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`yurisdiction over the Parties.
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`Case 1:15-cv-00116-LPS Document 162 Filed 07/25/16 Page 4 of 7 PagelD #: 4041
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`2.
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`The term “Affiliate” means: any Person that controls, is controlled by or is under
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`common control with such first Person. For purposes of this definition only, “control” means (1)
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`to possess, directly or indirectly, the power to direct managementorpolicies of a Person,
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`whether through ownership of votimg securities, by contract relating to voting rights or corporate
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`governance, or otherwise or (2) to own, directly or indirectly, more than fifty percent (50%) of
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`the outstanding voting securities, or other voting ownership interest, of a Person.
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`3.
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`The term “NDA Approved Product” means the product that is approved for
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`distribution in the United States under New Drug Application No. 203634.
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`4.
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`The term “Par’s ANDA” means AbbreviatedNow Drag Application No, 266131,
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`including all amendments and supplements thereto.
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`5.
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`The term “Par’s ANDA Product” means budesonide tablets that are the subject of
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`Par’s ANDA.
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`6.
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`The term “Person” means an individual, sole proprietorship, partnership, limited
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`partnership, limited liability partnership, corporation, limited hability company, business trast,
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`joint stock company, trust, incorporated association, joint venture or sumilar entityor
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`organization, including a government or political subdivision, department or agency of a
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`government,
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`7.
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`The term “Proceeding” means anyaction, litigation or other proceeding
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`(including any interference, re-examination, infer partes review, post-grant, ex parte, or
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`opposition proceeding) at or before the USPTOor any court or other governmental body.
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`&,
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`The term “USPTO” means the United States Patent and Trademark Office and
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`shall include the Patent Trial and Appeal Board, the Board of Patent Appeals and Interferences,
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`and any other admmistrative board or court related thereto.
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`Case 1:15-cv-00116-LPS Document 162 Filed 07/25/16 Page 5 of 7 PagelD #: 4042 |
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`9.
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`Par, its Affiliates and each of their respective predecessors, successors, assigns,
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`agents, officers, directors, employees, and representatives (collectively “Par’s Releasors”) have
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`acknowledged, admitted, and agreed that each of US. Patent No. 7,416,651; U.S. Patent No.
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`7,431,943; US. Patent No. 8,293,273: US. Patent No. 8,784,888: US. Patent No. 8,895,064;
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`ULS. Patent No. RE 43,799; US. Patent No. 9,192,581; and U.S. Patent No. 9,320,716 (each
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`hereinafter “Asserted Patent}, is valid and enforceable in the above-captioned litigation or any
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`other or fature Proceeding the subject matter of which is Par’s ANDA Product.
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`10.
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`Each of Par’s Releasors has acknowledged, admitted, and agreed that each
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`Asserted and Related Patent would be infrmeed by the making, having made, use, sale, offer to
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`sell, or importation of Par’s ANDA Product in or for the United States.
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`Li.
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`Each of Par’s Releasors has agreed not to challenge or otherwise dispute or
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`contest, and not to assist any other Person, whether directly or indirectly, m challenging or
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`otherwise disputing or contesting, the validity, enforceability or patentability of anyof the
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`Asserted Patents in any Proceeding, as such assertions relate to Par’s ANDA or Par’sANDA
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`Product; or the infringement of any of the Asserted Patents by the making, having made, use,
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`sale, offer to sell, or importation of Par’s ANDA Product in or for the United States.
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`12.
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`Par, inchiding its successors and assigns, are enjoined, directly and indirectly, on
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`their own part or through their respective Affiliates, licensees, sublicensees or other Persons,
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`from (a) marketing, distributing, having distributed, offering for sale, selling or taking orders for
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`Pars ANDA Product in or for the United States or (b) icensing, sublicensing, enabling,
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`permitting or causing (or continuing to license, sublicense, knowingly enable, permit or cause}
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`any Person to do any of the foregoing, except in each case (a} and (b) solelyas andto the extent
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`specifically authorized by the Settlement and License Agreement.
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`» Case 1:15-cv-00116-LPS Document 162 Filed 07/25/16 Page 6 of 7 PagelD #: 4043
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`~
`13.
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`In the event of breach or violation of the terms of this Consent Judgment and
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`Dismissal, jurisdiction and venue for an action for preliminary and permanent mjunctions against
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`the breaching conduct exists in this Court, and the Parties hereby waive anyand all defenses
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`based on subject matter yuarisdiction, personal jurisdiction and mconvenient or improper forum or
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`venue.
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`i4.
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`is.
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`All claims and counterclaims im this action are dismissed with prejudice.
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`‘This Consent Judgment and Dismissal affects a settlement between the Parties of
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`thei claims and counterclaims in the present action.
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`It does not constitute a judgment on the
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`mierits in respect of any such claim or counterclaim.
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`16.
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`Except as otherwise provided by the Settlement and License Agreement, cach
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`Party shall bear its own costs and attorneys’ fees in respect of this action.
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`i7.
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` Complance with this Consent Judgment and Eismissal may be enforced by the
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`Parties and their respective successors and permitted assigns.
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`18.
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`This Court retains jurisdiction to enforce or supervise performance underthis
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`Consent Judgment and Dismussal of the aforesaid Settlement and License Agreement.
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`[Signatures appear on next page.|
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`» Case 1:15-cv-00116-LPS Document 162 Filed 07/25/16 Page 7 of 7 PagelD #: 4044.
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`eo.
`SO ORDERED this “3 day of “4
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` The Honorable Leonard P. Stari
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`United States District Court Judge
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`Morris, NICHOLS, ARSHT & TUNNELL LLP
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`YOUNG CONAWAYSTARGAT? & TAYtor LLP
`
`/3f Maryellen Noreika
`
`Jack B. Bhimenfeld Gi014)
`Maryellen Noreika 3203}
`i201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`{302} 658-9266
`fohumenfeld@mnat.com
`mnoreika@mmai.com
`
`/i/ Karen £, Pascale
`Karen L. Pascale (#2903)
`James L. Higeims (#5021}
`Rodney Square
`1000 North King Street
`Wilmington, DE 19899-0391
`Telephone: 302-571-6600
`kpascale@ycst.com
`jhiggins@yest.com
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`Attornevs for Plaintiffs
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`Attorneys for Par Pharmaceuticals, Inc.
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`OF COUNSEL:
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`OF COUNSEL:
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`Melanie R. Rupert
`Dravid M. Conca
`Nicholas Tymoczko
`Jennifer Nguyen
`Scott Peachman
`PAUL HasTineas LEP
`200 Park Avenue
`NewYork, NY 10166
`(212) 318-6000
`
`Richard J. Berman
`Janine A. Carlan
`TanielBE. Anderson
`Abmed Abdel-Rahman
`ARENT FOX LLP
`i717 & Street, NW
`Washington, DC 20036-3342
`(202) 857-6000
`
`'
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`Cay
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`