`
`Anandita Vyakarnam
`Louis H. Weinstein
`WINDELS MARX LANE &
`MITTENDORF, LLP
`One Giralda Farms
`Madison, NJ 07940
`(973) 966-3200
`Attorneys for Defendants
`Slayback Pharma LLC and
`Slayback Pharma India LLP
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`BAUSCH & LOMB, INC.;
`BAUSCH & LOMB IRELAND LIMITED;
`and EYE THERAPIES, LLC,
`
`
`
`
`
`
`C.A. No. 3:21-16766-MAS-DEA
`
`Plaintiffs,
`
`
`
`
`
`
`
`
`SLAYBACK PHARMA LLC and
`SLAYBACK PHARMA INDIA LLP,
`
`
`v.
`
`Defendants.
`
`
`DEFENDANTS’
`FIRST SET OF REQUESTS FOR PRODUCTION TO PLAINTIFFS NOS. 1-2
`
`Pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure, Defendants Slayback
`
`Pharma LLC and Slayback Pharma India LLP (collectively, “Slayback” or “Defendants”) request
`
`that Plaintiffs Bausch & Lomb, Inc. (“Bausch”), Bausch & Lomb Ireland Limited (“Bausch
`
`Ireland”), and Eye Therapies, LLC (“Eye Therapies”) (collectively, “Plaintiffs”) respond to each
`
`Request set forth below and produce for inspection and copying the documents and things
`
`described below, within thirty (30) days of service of these Requests for Production. The
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`{80279745:1}
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`1
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`production shall be made at the offices of Defendants’ counsel, or at some other place or in some
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`other manner agreed upon by the Parties.
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`To the extent any Response or production pursuant to any of these Requests may at any
`
`time become incomplete or incorrect, Defendants request that Plaintiffs promptly supplement
`
`their Response and production pursuant to Rule 26 of the Federal Rules of Civil Procedure.
`
`DEFINITIONS
`
`1.
`
`“Plaintiffs” and “you” mean individually and collectively, Plaintiff Bausch &
`
`Lomb, Inc., Plaintiff Bausch & Lomb Ireland Limited, and Plaintiff Eye Therapies, LLC (“Eye
`
`Therapies”) and includes Plaintiffs’ current and former officers, directors, employees,
`
`consultants, attorneys, experts, agents, partners, corporate parents, subsidiaries, subdivisions,
`
`predecessors, or affiliates.
`
`2.
`
`“Defendants” means, Defendant Slayback Pharma LLC and Defendant Slayback
`
`Pharma India LLP.
`
`3.
`
`“Patents-in-Suit” means U.S. Patent Nos. 8,293,742 (“the ‘742 patent”) and
`
`9,259,425 (“the ‘425 patent”);
`
`4.
`
`5.
`
`Office.
`
`5.
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`6
`
`“U.S. FDA” means the United States Food & Drug Administration.
`
`“U.S. PTO” or “Patent Office” means the United States Patent & Trademark
`
`“PTAB” means the Patent Trial and Appeal Board of the U.S. PTO.
`
`“U.S. FDA Review” means any review by the U.S. FDA, of an IND Application
`
`or NDA, including without limitation any review that falls under the heading “Summary
`
`Review”, “Medical Review”, “Chemistry Review”, “Pharmacology Review”, “Statistical
`
`Review”, “Clinical Pharmacology Biopharmaceutics Review”, “Proprietary Name Review”,
`
`“Other Review”, or “Administrative Document(s) & Correspondence”.
`
`
`{80279745:1}
`
`2
`
`
`
`
`
`7.
`
`8.
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`9.
`
`“NDA” means New Drug Application.
`
`“IND Application” means Investigational New Drug Application.
`
`“Communication” means any transmission of information between two or more
`
`persons, including information transmitted by way of telephone conversations, letters, faxes,
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`email, computer links, written memorandums or other documents, bulletin board posting, and
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`face-to-face conversations.
`
`10.
`
`“Concerning” means relating to, referring to, describing, evidencing, embodying,
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`comprising, or constituting and is construed in the broadest sense to require the production of all
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`documents which contain or comprise any communication (including representations, requests,
`
`demands and the like) referred to and documents that discuss, mention, or pertain to the subject
`
`matter of the request.
`
`11.
`
`“Document” is defined to be synonymous in meaning and equal in scope to the
`
`usage of the term “documents or electronically stored information” in Federal Rule of Civil
`
`Procedure 34(a)(1)(A). A draft or non-identical copy is a separate document within the meaning
`
`of this term.
`
`INSTRUCTIONS
`
`
`
`1.
`
`IND Application and NDA materials submitted to U.S. FDA as electronic
`
`modules should be produced to Defendants as electronic modules in addition to being produced
`
`as individually Bates numbered pages.
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`
`
`
`
`
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`{80279745:1}
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`3
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`
`
`
`
`REQUESTS FOR PRODUCTION
`
`REQUEST NO. 1: A complete and unredacted copy of: IND Application No.
`
`108524; any supplements or amendments to IND Application No. 108524; and all other
`
`Documents filed with or received from the U.S. FDA concerning IND Application No. 108524,
`
`including without limitation all Briefing Packages, Meeting Comments or Summaries,
`
`Investigator Brochures and U.S. FDA Reviews.
`
`REQUEST NO. 2: A complete and unredacted copy of: NDA No. 208144; any
`
`supplements or amendments to NDA No. 208144; and all other Documents filed with or received
`
`from the U.S. FDA concerning NDA No. 208144, including without limitation all Briefing
`
`Packages, Meeting Comments or Summaries, Investigator Brochures and U.S. FDA Reviews.
`
`
`Dated: December 29, 2021
`
`
`
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`{80279745:1}
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`
`
`
`
`
`
`
`/s/ Louis H. Weinstein
`Anandita Vyakarnam
`Louis H. Weinstein
`WINDELS MARX LANE &
`MITTENDORF, LLP
`One Giralda Farms
`Madison, NJ 07940
`(973) 966-3200
`avyakarnam@windelsmarx.com
`lweinstein@windelsmarx.com
`
`Attorneys for Defendants Slayback Pharma
`LLC and Slayback Pharma India LLP
`
`
`
`
`4
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned attorney certifies that a true and accurate copy of the foregoing
`
`DEFENDANTS’ FIRST SET OF REQUESTS FOR PRODUCTION TO PLAINTIFFS NOS.
`
`1-2 was served on counsel for Plaintiffs by electronic mail on December 29, 2021.
`
`
`
`Dated: December 29, 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`s/ Louis H. Weinstein
`Louis H. Weinstein
`
`WINDELS MARX LANE &
`MITTENDORF, LLP
`One Giralda Farms
`Madison, NJ 07940
`(973) 966-3200
`avyakarnam@windelsmarx.com
`
`Attorneys for Defendants
`Slayback Pharma LLC and
`Slayback Pharma India LLP
`
`
`
`{80279745:1}
`
`5
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`
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