`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`BAUSCH & LOMB INCORPORATED,
`BAUSCH & LOMB PHARMA HOLDINGS
`CORP. and SENJU PHARMACEUTICAL CO.,
`LTD.,
`
`Plaintiffs,
`
`V.
`
`PADDOCK LABORATORIES, LLC, L.
`PERRIGO COMPANY, and PERRIGO
`COMPANY,
`
`Defendants.
`
`Civil Action No. 1:1 5-cv-00337-JBS-KMW
`
`STIPULATED CONSENT JUDGMENT AND INJUNCTION
`
`Whereas the parties in the above-captioned action have agreed to terms and conditions
`
`representing a negotiated settlement of this action and have set forth those terms and conditions
`
`in a Confidential Settlement and License Agreement (the “Settlement Agreement”),
`
`IT IS HEREBY STIPULATED AND AGREED, by and between the parties, through
`
`their undersigned counsel of record, that:
`
`1.
`
`In the event that the claims of Plaintiffs’ U.S. Patent No. 8,129,431 (“the ‘431
`
`patent”), U.S. Patent No. 8,669,290 (“the ‘290 patent”), U.S. Patent No. 8,754,131 (“the ‘131
`
`patent”), U.S. Patent No. 8,871,813 (“the ‘813 patent”), and U.S. Patent No. 8,927,606 (“the
`
`‘606 patent”) asserted against Defendants are not held invalid or unenforceable and in the
`
`absence of a license or other authorization from Plaintiffs, the ‘431, ‘290, ‘131, ‘813, and the
`
`Page 1 of 5
`
`SENJU EXHIBIT 2028
`LUPIN v. SENJU
`IPR2015-01099
`
`
`
`Case 1:15-cv-00337-JBS-KMW Document 33 Filed 06/05/15 Page 2 of 5 PageID: 166
`
`‘606 patents are valid, enforceable, and would be infringed by any unlicensed manufacture, sale,
`
`offer for sale, use, or importation in the United States of the generic product that is the subject of
`
`Defendants’ Abbreviated New Drug Application Number 207584 (the “Paddock Product”, as
`
`defined in the Settlement Agreement).
`
`2.
`
`Defendants and anyone acting on the behalf of any of Defendants, except as
`
`expressly licensed by Plaintiffs in the Settlement Agreement, will be enjoined until expiration of
`
`the ‘431,
`
`‘290,
`
`‘131,
`
`‘813, and ‘606 patents (or as otherwise provided in the Settlement
`
`Agreement) from (i) making, using, offering to sell, selling, or importing into the United States
`
`of America the Paddock Product, and (ii) participating in the profits from making, using, offering
`
`to sell, selling, or importing the Paddock Product in the United States, and (iii) indemni’ing
`
`others with respect to any making, using, offering to sell, selling, or importing the Paddock
`
`Product in the United States.
`
`3.
`
`Notwithstanding any provision of the foregoing, Defendants shall be entitled to
`
`contest the infringement, validity and/or enforceability of the ‘431, ‘290, ‘131, ‘813 and ‘606
`
`patents in any future litigation, patent office proceeding, or otherwise over the ‘431, ‘290, ‘131,
`
`‘813 or ‘606 patents pertaining to any product that is not the Paddock Product and is not the
`
`subject of the Paddock ANDA (as defined in the Settlement Agreement).
`
`4.
`
`5.
`
`Each party will bear its own attorneys’ fees and costs.
`
`This Court will retain jurisdiction to enforce this Stipulated Consent Judgment
`
`and Injunction and the parties’ related agreements resolving this matter.
`
`6.
`
`Plaintiffs acknowledge that Defendants are entitled to maintain their Paragraph 1V
`
`certification to the ‘431,
`
`‘290,
`
`‘131,
`
`‘813, and ‘606 patents pursuant
`
`to 21 C.F.R.
`
`§
`
`2
`
`Page 2 of 5
`
`
`
`Case 1:15-cv-00337-JBS-KMW Document 33 Filed 06/05/15 Page 3 of 5 PageID: 167
`
`314.94(a)(12)(v). Each Party acknowledges and agrees that the 30-month stay with respect to
`
`the approval of the Paddock ANDA under 21 U.S.C. § 355(j)(5)(B)(iii) is hereby terminated.
`
`7.
`
`The Clerk of Court
`
`is directed to enter this Stipulated Consent Judgment and
`
`Inj unction.
`
`3
`
`Page 3 of 5
`
`
`
`Case 1:15-cv-00337-JBS-KMW Document 33 Filed 06/05/15 Page 4 of 5 PageID: 168
`
`Dated: June 4, 2015
`
`PEPIER HAMILTON LLP
`
`/sI Melissa A. Chuderewicz
`Melissa A. Chuderewicz
`PEPPER HAMILTON LLP
`Suite 400
`301 Carnegie Center
`Princeton. New Jersey. 08543-5276
`(609) 951-4193
`chuderewiczrnpepperlaw .com
`
`Attorneys for Plain t(/fs
`
`BAUSCH & LOMB INCORPORA TED, BA USCH &
`LOMB PJ-L4RAL4 HOLDINGS CORP., and SENJU
`PHARMACEUTICAL CO., LTD.
`
`Of Counsel:
`Bryan C. Diner
`Justin J. Hasford
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`CARELLA BYRNE
`
`/s/ Melissa E. Flax
`Melissa E. Flax
`Michael Cross
`CARELLA BYRNE CECCHI OLSTEIN BRODY
`& AGNELLO, PC
`5 Becker Farm Road
`Roseland, NJ 07068
`(973) 994-1700
`
`Attorney’s for Defendants
`
`4
`
`Page 4 of 5
`
`
`
`Case 1:15-cv-00337-JBS-KMW Document 33 Filed 06/05/15 Page 5 of 5 PageID: 169
`
`PADDOCK LABORATORiES, LLC, L. PERRJGO
`COMPANY, and PERRIGO COMPANY
`
`Of CounseL
`
`Jeffrey S. Ward
`Wendy M. Ward
`MERCHANT & GOULD PC
`10 East Doty Street, Suite 600
`Madison, WI 53703
`608-280-6750
`
`So Ordered this 5day of
`
`,20 / S
`
`7erome B. Simandle, Chief U.S. District Judge
`
`Page 5 of 5