a
`MRR-EJS-EBIB 12: a? FROM: CUNNELLFULEY
`
`973535921?
`
`TD: 1 856 75? 5876
`
`P. 2/6
`
`[N THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Civil Action No. 1:09-cv-37-RB'K-JS
`
`(Consolidated)
`
`Civil Action No. 1:]. 0-CV»OO I 35—RBK-JS
`
`SClElLE PHARMA, INC, ANDRX
`CORPORATION, ANDRX
`PHARMACEUTICMS, INC. (N/K/A WATSON
`LABORATORIES, INC-FLORIDA), ANDRX
`PHARMACEUTICALS, L.L.C., ANDRX
`LABORATORIES (NJ), INC, ANDRX EU
`LTD, and ANDRX LABS, L.L.C.,
`
`Plaintifi's,
`
`v.
`
`LUPIN LTD. and LUPIN
`
`PHARMACEUTICALS, INC,
`
`Defendants.
`
`SHIONOGI PHARMA, INC, ANDRX
`CORPORATION, ANDRX
`PHARMACEUTICALS, INC. (N/K/A WATSON
`LABORATORIES, INC-FLORIDA), ANDRX
`PHARMACEUTICALS, L.L.C., ANDRX
`LABORATORIES (NI), INC, ANDRX EU
`LTD., and ANDRX LABS, I...L.C.,
`
`Plaintiffs,
`
`v.
`
`MYLAN INC, and MYIJAN
`PHARMACEUTICALS INC .,
`
`
`
`Defendants-
`
`STIPULATION AND QRDER OF DISMISSAL
`
`Whereas this action for patent infringement (the “Patent LitigatiOn”) has been brought by
`Shionogi Inc. (formerly Shionogi Pharma, Inc), Aner Corporation, Andrx Pharmaceuticals,
`Inc.
`(n/k/a Watson Laboratories,
`Inc-Florida), Andrx Pharmaceuticals, L.L.C., Andrx
`Labmaiories (NJ), Inc, Andrx EU Ltd., Andrx Labs, L.L.C. (collectively ‘Tlaintiffs’? against
`Defendants Mylan Phannaceuticals Inc. and Mylan Inc. (collectively ‘Mylan’j (collectively,
`Plaintiffs and Mylan may be referred to as “the Parties”) for alleged infringement of United
`States Patent Nos. 6,099,859 (“the ”859 patent") and 6,866,866 (“the ‘866 patent);
`
`AUROBINDO EX1009, 1
`
`AUROBINDO EX1009, 1
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`

`

`MQR-ES-E'Bl3 18:27 FRUM:CDNNELLFULEY
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`973535921?
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`TD:1 856 75? 5876
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`P.3/ 6
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`Whereas this Court has subject matter jurisdiction over the above-captioned patent
`infringement action and has personal jurisdiction over the Parties;
`
`Whereas Mylan does not contest personal jurisdiction for the purposes of the Patent
`Litigation;
`
`Whereas venue is preper in this Court as to the Parties;
`
`Whereas Mylan does not contest venue for the purposes of the Patent Litigation;
`
`Whereas in this Patent Litigation, Plaintiffs have charged Mylan with infringement of the
`’859 and ‘866 patents;
`
`Whereas the ’859 and ‘866 patents are owned by Andrx Corporation, Andrx
`Pharmaceuticals, Inc. (n/lc/a Watson Laboratories, Inc-Florida), Andrx Pharmaceuticals, L.L.C.,
`Andrx Laboratories (NJ), lnc., Andrx EU Ltd, Andrx Labs, L.L.C. (collectively “Andi-x”), and
`Andrx has granted Shionogi Inc. an exclusive license to the “859 and ‘866 patents in the United.
`States with regard to extended release tablets containing metformin HCl;
`
`Whereas Andrx holds New Drug Application (“NDA”) No, 21-574 for 500 mg and 1000
`mg mctformin HCl extended release tablets and Shionogi Inc. markets these tablets in the United
`States under the trade name “Fortamet®;”
`
`Whereas the ’859 and ‘866 patents are listed for Fortamet® in the Approved Drug
`Products with Therapeutic Equivalence Evaluations (“Orange Book”) published by the United
`States Food 85 Drug Administration (“FDA”);
`
`Whereas the commencement of the Patent Litigation by Plaintiffs was based on
`Plaintiffs’ receipt of notice from Mylan that Mylan had filed Abbreviated New Drug Application
`20-0690 (the “Mylan ANDA”) with the FDA containing a certification pursuant to 21 U.S.C. §
`3550)(2)(A)(vii)(IV) directed to the ’859 and ‘866 patents as well as US. Patent Nos. 6,495,162
`(“the ‘162 patent”), 6,790,459 (“the ‘459 patent”) and 7,919,1l6 (“the ‘116 patent) seeking
`approval for the commercial manufacture, use, and sale of 500 mg and 1000 mg metfonnin HCl
`extended release tables (“Mylan’s ANDA Products”);
`
`infringement, Mylan has
`Whereas in response to the charges by Plaintiffs of patent
`alleged certain defenses and eounterclaims, including that the ’859, ‘866, "I62, ‘459 and ‘116
`patents are invalid, unenforceable, and not infringed by Mylan’s generic products defined by the
`Mylan ANDA;
`
`Whereas Plaintifi's have not asserted any charges of infringement against Mylan with
`to the ‘162,
`‘459 and ‘116 patents, but Mfylan has asserted certain defenses and
`respect
`eonnterelaims for these patents,
`
`Whereas, to date, this COurt has not ruled on Plaintit‘fs’ charges of patent infringement
`against Mylan, nor Mylan’s defenses and ecunterclaims;
`
`Whereas, no Party concedes that its claims, defenses, or counterclaims lack merit;
`
`2
`
`AUROBINDO EX1009, 2
`
`AUROBINDO EX1009, 2
`
`

`

`MRR-ES-2813 18: 2? FROM: CDNNELLFDLEY
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`973535921?
`
`TE]: 1 856 75? 5876
`
`P. 4/6
`
`Whereas the Patent Litigation has been hard fought and expensive to Plaintiffs and to
`
`Mylan;
`
`Whereas the Parties have entered into a good-faith final Settlement and License
`Agreement regarding this Patent LitigatiOn, on the expectation and belief that this settlement
`would eliminate the substantial litigation costs, risks, and uncertainty that w0uld otherwise be
`incurred and experienced by the parties during the Patent Litigation, while also serving the
`public interest by saving judicial rescurecs and avoiding the risks to each of the Parties
`associated with continued litigation;
`
`Whereas the reasonable final settlement will afford the Parties the pro-competitive
`opportunity to more productively use resources that would have been spent in the continued
`prosecution and defense of this Patent Litigation, to the benefit of the Parties and consumers
`alike, such as by investing more resources into pharmaceutical research and development;
`
`Whereas under the Settlement and License Agreement entered into by the Parties, Mylan
`was granted the right to market generic versions of products covered by the ’859, ‘866, ‘162,
`‘459 and ‘116 patents no later than August 1, 2013, allowing entry of generic versions of
`Fortamet® over seven years in advance of the March 17, 2021 expiration of the ‘866 patent;
`
`Whereas the Patties acknowledge there is significant risk and uncertainty to each of them
`associated with continued prosecution and defense of this Patent Litigation, and each has
`consented to entry of this Order of Dismissal through a final settlement as reflected herein;
`
`Whereas this settlement resolves all litigation involving the Mylan ANDA among the
`
`Parties;
`
`In consideration of the above factual representations, the request and consent of the
`Parties and upon due cunsideration of the Settlement and License Agreement, IT IS HEREBY
`ORDERED, ADJUDGED, AND DECREED THAT:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`All claims, counterclaims, and affinnative defenses presented by the Parties in
`this Patent Litigation are hereby dismissed with prejudice;
`
`The Parties agree to be bound by the terms of the Settlement and License
`Agreement;
`
`Shionogi Inc, Andl‘x, and Mylan, each expressly waives any right to appeal or
`otherwise move for relief from this Order of Dismissal;
`
`This Court retains jurisdiction over the Parties for purposes of enforcing and
`interpreting this Order of Dismissal;
`
`The Clerk of the Court is directed to enter this Order of Dismissal forthwith.
`
`Dated: March 13, 2013
`
`LR
`
`AUROBINDO EX1009, 3
`
`AUROBINDO EX1009, 3
`
`

`

`01912—252913 18: 2? FROM: CCINNELLFDLEY
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`973535981?
`
`TD: 1 856 75? 5876
`
`F’. 5/ 6
`
`MORRIS NICHOLS ARSHT & TUNNELL LLP
`
`MORRIS JAMES LLP
`
`(51 {Mag (3. SMattmer
`Mary B. Matterer (m. #2696)
`Richard K. Hemnann (LD. #405)
`500 Delaware Avenue, Suite 1500
`Wilmington, Delaware 19801-1494
`(302) 888-6800
`mmattcrer@rnorrisjmnes.com
`rhennann@morrisjames.com
`
`.
`
`(2f(.‘ozmsel:
`Timothy H. Kratz
`Robert L. Florence
`George J. Barry 11.1
`.Ani] H. Patel
`
`Micheal L. Binns
`Karen L. Carroll
`
`MCGUJREWOODS LLP
`
`1230 Peachtree Street, Suite 2100
`Atlanta, Georgia 30309
`(404) 443-5500
`
`A uomeysfor Mylan Inc. and Mylar:
`Pharmaceuticals Inc.
`
`[51 15.’gm: 2M068 film
`Jack B. Blumcnfeld (1.13. #1014)
`Karen Jacobs London (ID. #2881)
`1201 North Market Street
`Wilmington, Delaware 19801-1494
`(302) 658-9200
`jblumenfeld@mnat.com
`k10uden@mnat.eom
`
`OfCounsel:
`David B. Bassett
`David A. Manspeizcr
`Christopher R. NOyeS
`WILM ERHALE LLP
`
`7 World Trade Center
`250 Greenwich Street
`
`New York, NY 10007
`
`(212) 230-8800
`
`Anormzysfor Shionogi Pharma, Inc.
`
`RICHARDS, LAYTON & FINGER PA
`
`[shfite‘ven 2. Human
`Frederick L. Cottrell , 111 (ID. #2555)
`Steven J. Fineman (ID. #4025)
`920 N. King Street
`Wilmington, DE 19801
`(302) 651-7700
`cotrrell@rlf.com
`fineman@r1f.com
`
`OfCounsel:
`
`Gary E. Hood
`POLSINELU SHUGHART PC
`
`161 N. Clark Street, Suite 4200
`Chicago, 1.1.. 60606
`(312) 819-1900
`
`AttomeyrforAndI-x Cmpomtirm, Andra: Pharms., Inc.
`Andra: Pharmaceuticals, L.L.C., Andrx Labs. (NJ), 1m:
`Andra: EU, Ltd. and Andrx Labs, l..L.C_
`
`AUROBINDO EX1009, 4
`
`AUROBINDO EX1009, 4
`
`

`

`MRR-ES-E’Bl3 18:28 FRUM:CUNNELLFDLEY
`
`973535921?
`
`TD:1 856 75? 5876
`
`P.6/6
`
`A
`
`IT IS HEREBY SO ORDERED.
`
`Dakar—f; ' M“ ‘ ‘2’ %%—
`"_
`THE HONORABLE ROBERT B. KUGLER
`United States District Judge
`District Ochw Jersey
`
`1050489
`
`AUROBINDO EX1009, 5
`
`AUROBINDO EX1009, 5
`
`