Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 1 of 5 PageID #: 913
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 1 of 5 PagelD #: 913
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`
`
`v.
`
`Civil Action No. 15-697-RGA
`
`AMNEAL PHARMACEUTICALS LLC,
`
`Defendant.
`
`HOSPIRA’S NOTICE OF DEPOSITION OF DEFENDANT
`
`AMNEAL PHARMACEUTICALS LLC PURSUANT TO FED. R. CIV. P. 30(b)(6)
`
`PLEASE TAKE NOTICE that Plaintiff Hospira, Inc. (“Hospira”) will take the deposition
`
`of Defendant Amneal Pharmaceuticals LLC (“Amneal”) under Federal Rule of Civil Procedure
`
`30(b)(6) on the Topics set forth in Schedule A. The deposition will be taken on September 19,
`
`2016, beginning at 9am, or at a mutually agreeable date and time at Jenner & Block LLP, 353
`
`North Clark St., Chicago, IL 60654. The deposition will be recorded by videotape and by
`
`stenographic means before a Notary Public or other officer authorized by law to administer
`
`oaths. If the deposition is not completed on the agreed upon day, it will continue until completed
`
`with such adjournment as to time and place as may be necessary.
`
`Under Rule 30(b)(6), Amneal has a duty to designate one or more officers, directors, or
`
`managing agents or other persons who are able to and consent to testify on its behalf, to testify
`
`regarding the Topics for which examination is requested. The designee(s) should be a person or
`
`persons knowledgeable about the Topics set forth in Schedule A. Hospira requests that Amneal
`
`identify, in writing at least ten business days in advance of the deposition, the name and title of
`
`
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 1 of 5 PagelD #: 913
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`
`
`v.
`
`Civil Action No. 15-697-RGA
`
`AMNEAL PHARMACEUTICALS LLC,
`
`Defendant.
`
`HOSPIRA’S NOTICE OF DEPOSITION OF DEFENDANT
`
`AMNEAL PHARMACEUTICALS LLC PURSUANT TO FED. R. CIV. P. 30(b)(6)
`
`PLEASE TAKE NOTICE that Plaintiff Hospira, Inc. (“Hospira”) will take the deposition
`
`of Defendant Amneal Pharmaceuticals LLC (“Amneal”) under Federal Rule of Civil Procedure
`
`30(b)(6) on the Topics set forth in Schedule A. The deposition will be taken on September 19,
`
`2016, beginning at 9am, or at a mutually agreeable date and time at Jenner & Block LLP, 353
`
`North Clark St., Chicago, IL 60654. The deposition will be recorded by videotape and by
`
`stenographic means before a Notary Public or other officer authorized by law to administer
`
`oaths. If the deposition is not completed on the agreed upon day, it will continue until completed
`
`with such adjournment as to time and place as may be necessary.
`
`Under Rule 30(b)(6), Amneal has a duty to designate one or more officers, directors, or
`
`managing agents or other persons who are able to and consent to testify on its behalf, to testify
`
`regarding the Topics for which examination is requested. The designee(s) should be a person or
`
`persons knowledgeable about the Topics set forth in Schedule A. Hospira requests that Amneal
`
`identify, in writing at least ten business days in advance of the deposition, the name and title of
`
`
`
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 2 of 5 PageID #: 914
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 2 of 5 PagelD #: 914
`
`each person who will testify on its behalf, along with the Topics as to which that person will
`
`testify.
`
`This deposition is being taken for the purpose of discovery, for use at trial, and for any
`
`other purpose permitted under the Federal Rules of Civil Procedure.
`
`Dated: September 2, 2016
`
`Respectfully Submitted,
`
`HOSPIRA, INC.
`
`By:
`
`/s/ Arthur G. Connolly III
`
`CONNOLLY GALLAGHER LLP
`
`Arthur G. Connolly III (# 2667)
`Ryan P. Newell (# 4744)
`The Brandywine Building
`1000 West Street, Suite 1400
`Wilmington, Delaware 19801
`Telephone:
`(3 02) 757-73 00
`
`Bradford P. Lyerla
`Sara T. Horton
`
`Yusuf Esat
`
`JENNER & BLOCK LLP
`
`353 N. Clark Street
`
`Chicago, IL 60654-3456
`Telephone: 312 222-9350
`Facsimile: 312 527-0484
`
`blyerla@j enner.com
`shorton@j enner.com
`yesat@jenner.com
`
`Attorneys for Plaintifl'Hospira, Inc.
`
`
`
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 3 of 5 PageID #: 915
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 3 of 5 PagelD #: 915
`
`SCHEDULE A — TOPICS FOR DEPOSITION
`
`DEFINITIONS
`
`Hospira incorporates the definitions set forth in its May 6, 2016, First Set of Requests for
`
`the Production of Documents and Things and its September 1, 2016, First Set of Requests for
`
`Admission.
`
`DEPOSITION TOPICS
`
`1.
`
`The preparation,
`
`filing, prosecution, and status of the ANDA,
`
`including all
`
`communications,
`
`research, development,
`
`testing,
`
`studies,
`
`evaluations,
`
`submissions,
`
`and
`
`amendments, along with the identification of the individuals knowledgeable of or involved with
`
`any of the foregoing.
`
`2.
`
`Communications with the FDA concerning the ANDA, including the preparation
`
`and filing of any amendments, responses to FDA requests, deficiency letters, and Complete
`
`Response Letters, and identification of the individuals knowledgeable of or involved with any of
`
`the foregoing.
`
`3.
`
`Communications between personnel employed by, retained by, or related to
`
`Defendant concerning the ANDA, Defendant’s generic dexmedetomidine product, the NDA, the
`
`patents-in-suit, or PrecedexTM, and identification of the individuals knowledgeable of or involved
`
`with any of the foregoing.
`
`4.
`
`The decision to pursue Defendant’s generic dexmedetomidine product, including
`
`the decision to file the ANDA and the Certification(s), Defendant’s method(s) of evaluating
`
`potential generic drug products, any analysis of market potential, and any creation, review, or
`
`M
`analysis of sales information for PrecedexT , including sales information for each indication of
`
`
`
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 4 of 5 PageID #: 916
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 4 of 5 PagelD #: 916
`
`PrecedexTM, and identification of individuals knowledgeable of or involved with any of the
`
`foregoing.
`
`5.
`
`The research,
`
`formulation,
`
`testing, development, and properties,
`
`including
`
`stability, of Defendant’s generic dexmedetomidine product.
`
`6.
`
`The manufacture and importation of Defendant’s generic dexmedetomidine
`
`product, including all agreements, processes, standard operating procedures, GMP practices or
`
`violations, quality assurance and/or quality control reports, and qualification of suppliers, and
`
`identification of the individuals knowledgeable of or involved with any of the foregoing.
`
`7.
`
`The marketing, distribution, offer for sale, and sale of Defendant’s generic
`
`dexmedetomidine product, including projected sales prices and volumes, planned marketing or
`
`promotional materials, conversations with customers about planned sales, and any agreements or
`
`contract terms among any of the Defendant, Defendant’s customers, and any other third parties
`
`relating to any of the foregoing, and identification of the individuals knowledgeable of or
`
`involved with any of the foregoing.
`
`8.
`
`The use of Defendant’s generic dexmedetomidine product or PrecedexTM,
`
`including any knowledge, information, communications, or investigation relating to how doctors
`
`or clinicians will prescribe and use Defendant’s generic dexmedetomidine product or PrecedexTM
`
`and in what setting and to which patients the products will be administered, and identification of
`
`the individuals knowledgeable of or involved with any of the foregoing.
`
`9.
`
`Preparation of the Certification and Notice Letter, including Defendant’s first
`
`knowledge of the patents-in-suit, all prior art cited in the Notice Letter, and the bases for the
`
`Certification and Notice Letter, and identification of the individuals knowledgeable of or
`
`involved with any of the foregoing.
`
`
`
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 5 of 5 PageID #: 917
`Case 1:15-cv-00697-RGA Document 65 Filed 09/02/16 Page 5 of 5 PagelD #: 917
`
`10.
`
`Defendant’s knowledge of PrecedexTM,
`
`including any testing,
`
`analysis,
`
`evaluation, or other investigation or consideration of PrecedexTM and its uses, by or on behalf of
`
`Defendant, and identification of the individuals knowledgeable of or involved with any of the
`
`foregoing.
`
`11.
`
`Any purported differences between PrecedexTM Premix and Defendant’s generic
`
`dexmedetomidine product.
`
`12.
`
`All meetings and other forms of communication in which the patents-in—suit were
`
`discussed, including the dates of such meetings, the attendees of such meetings, the location(s) of
`
`such meetings, and identification of the individuals knowledgeable of or involved with any of the
`
`foregoing.
`
`13.
`
`Facts or evidence relating to secondary considerations of non-obviousness,
`
`including the commercial success of PrecedexTM Premix, the unexpected stability of the ready-
`
`to-use dexmedetomidine formulation claimed in the patents—in-suit, the long-felt need for a
`
`ready-to-use dexmedetomidine formulation, industry praise for PrecedexTM Premix, and failure
`
`of entities other than Hospira to develop a ready-to-use dexmedetomidine formulation.
`
`14.
`
`The advantages and/or disadvantages of a
`
`ready-to-use dexmedetomidine
`
`formulation relative to a dexmedetomidine concentrate formulation.
`
`15.
`
`Any facts relating to the validity of the patents-in-suit, including facts relating to
`
`secondary considerations relevant to whether the patents—in-suit were obvious to one of ordinary
`
`skill in the art as of January 2012.
`
`
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