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`Exhibit D
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`Case: 1:16-cv-00651 Document #: 93 Filed: 01/29/18 Page 1 of 4 PageID #:2563Case: 1:16-cv-00651 Document #: 99-4 Filed: 05/03/18 Page 2 of 5 PageID #:2600
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`HOSPIRA, INC.
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`FRESENIUS KABI USA, LLC
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`v.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`JOINT STIPULATION
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`C.A. No. 16-cv-651
`C.A. No. 17-cv-7903
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`Hon. Judge Rebecca R. Pallmeyer
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`Plaintiff,
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`Defendant.
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`This stipulation is made by and between Plaintiff Hospira, Inc. (“Hospira”) and
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`Defendant Fresenius Kabi USA, LLC (“Fresenius Kabi”).
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`WHEREAS, on January 15, 2016, Hospira filed a Complaint against Fresenius Kabi for
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`infringement of U.S. Patent Nos. 8,242,158; 8,338,470; 8,455,527; and 8,648,106, captioned
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`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. No. 16-cv-651 (“the First Action”), related to
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`Fresenius Kabi’s submission of Amended New Drug Application No. 208129 (“ANDA
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`208129”) to the Food and Drug Administration seeking approval to market dexmedetomidine
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`hydrochloride for injection, 80 mcg/20 mL, 200 mcg/50 mL, and 400 mcg/100 mL (“Fresenius
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`Kabi’s Proposed ANDA Products”);
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`WHEREAS, on November 1, 2017, Hospira filed a Complaint against Fresenius Kabi for
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`infringement of later-issued U.S. Patent No. 9,616,049, captioned Hospira, Inc. v. Fresenius
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`Kabi USA, LLC, C.A. No. 17-cv-7903 (“the Second Action”), related to Fresenius Kabi’s
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`submission of ANDA 208129 to the Food and Drug Administration seeking approval to market
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`Fresenius Kabi’s Proposed ANDA Products;
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`Case: 1:16-cv-00651 Document #: 93 Filed: 01/29/18 Page 2 of 4 PageID #:2564Case: 1:16-cv-00651 Document #: 99-4 Filed: 05/03/18 Page 3 of 5 PageID #:2601
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`WHEREAS, on December 1, 2017, Fresenius Kabi filed a Counterclaim in the Second
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`Action asking for declaratory judgment of non-infringement and invalidity of U.S. Patent No.
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`9,320,712 and Hospira answered the Counterclaim on December 22, 2017;
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`WHEREAS, on November 27, 2017, the Court issued its Claim Construction Opinion
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`and Order (D.I. 69) in the First Action, which the parties agree applies to the same claim terms in
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`the Second Action;
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`WHEREAS, the parties jointly agreed to limit the number of claims asserted from each
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`patent in the First and Second Action to simplify issues for expert discovery and trial;
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`It is hereby STIPULATED AND AGREED, subject to the approval of the Court, that:
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`1.
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`Hospira asserts only these claims from all asserted patents and waives the
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`assertion of all other claims: claims 6, 8, and 13 of U.S. Patent No. 8,455,527; claims 6 and 9 of
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`U.S. Patent No. 8,648,106; claim 5 of U.S. Patent No. 9,320,712 and claims 4, 8, 13, and 14 of
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`U.S. Patent No. 9,616,049. Fresenius Kabi will not assert counterclaims of non-infringement or
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`invalidity of any other claims.
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`2.
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`Fresenius Kabi hereby stipulates, in the First Action, that Fresenius Kabi’s
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`Proposed ANDA Products described in ANDA 208129, and/or the use of Fresenius Kabi’s
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`Proposed ANDA Products, would meet the limitations of claim 6 of U.S. Patent No. 8,455,527;
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`and claims 6 and 9 of U.S. Patent No. 8,648,106 under 35 U.S.C. § 271(e) under the claim
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`constructions entered in this action, to the extent these claims are valid and enforceable. This
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`Stipulation does not limit or otherwise affect Fresenius Kabi’s ability to defend against Hospira’s
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`asserted claims on any other ground, including, but not limited to, asserted defenses of invalidity
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`and/or unenforceability.
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`2
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`Case: 1:16-cv-00651 Document #: 93 Filed: 01/29/18 Page 3 of 4 PageID #:2565Case: 1:16-cv-00651 Document #: 99-4 Filed: 05/03/18 Page 4 of 5 PageID #:2602
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`3.
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`Fresenius Kabi hereby stipulates, in the Second Action, that Fresenius Kabi’s
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`Proposed ANDA Products described in ANDA 208129, and/or the use of Fresenius Kabi’s
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`Proposed ANDA Products, would meet the limitations claim 5 of U.S. Patent No. 9,320,712 and
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`claims 4, 8, 13, and 14 of U.S. Patent No. 9,616,049 under 35 U.S.C. § 271(e) under the claim
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`constructions entered in this action, to the extent these claims are valid and enforceable. This
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`Stipulation does not limit or otherwise affect Fresenius Kabi’s ability to defend against Hospira’s
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`asserted claims on any other ground, including, but not limited to, asserted defenses of invalidity
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`and/or unenforceability.
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`Fresenius Kabi withdraws the following invalidity theories that are the subject of
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`4.
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`Hospira’s Motion to Strike Untimely Invalidity Contentions (see D.I. 81 at 5-6):
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`• Alleged invalidating prior use under 35 U.S.C. § 102(b) based on
`Investigational New Drug Application (“IND”) No. 32,934 (Pages 35-37
`of Fresenius Kabi’s Amended Final Invalidity Contentions); and
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`• Alleged prior invention under Section 102(g) based on work relating to the
`IND (Pages 120-125 of Fresenius Kabi’s Amended Final Invalidity
`Contentions).
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`The Revised Scheduling Order (Case No. 17-7903, D.I. 23) is amended as
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`5.
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`follows:
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`Event
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`Fresenius Kabi’s Non-Infringement Contentions (of ‘527 Claims
`8 and 13)
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`Hospira’s Response to Fresenius Kabi’s Amended Final
`Invalidity Contentions
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`Close of Fact Discovery
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`Opening expert reports [Pl. Infringement, Secondary
`Considerations; Def. Invalidity]
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`Date
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`March 26, 2018
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`March 26, 2018
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`April 2, 2018
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`April 16, 2018
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`3
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`Case: 1:16-cv-00651 Document #: 93 Filed: 01/29/18 Page 4 of 4 PageID #:2566Case: 1:16-cv-00651 Document #: 99-4 Filed: 05/03/18 Page 5 of 5 PageID #:2603
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`Responsive expert reports [Pl. Validity; Def. Non-
`infringement, Secondary Considerations]
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`Close expert discovery
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`Hospira’s draft Pre-trial Order
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`Final Pre-trial Order
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`Bench Trial
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`Fresenius Kabi Will Not Launch (Without Opinion) Before
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`Date: January 29, 2018
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`May 21, 2018
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`June 13, 2018
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`June 20, 2018
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`July 2, 2018
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`July 16-20, 2018
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`ENTER:
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`_______________________________________
`REBECCA R. PALLMEYER
`United States District Judge
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`4
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