throbber
Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 1 of 28 PageID #: 706
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`C.A. No. 1:14-cv-001171-GMS
`
`(CONSOLIDATED)
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 1
`
`

`
`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 2 of 28 PageID #: 707
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`[PROPOSED] STIPULATED PROTECTIVE ORDER
`
`IT IS HEREBY STIPULATED AND AGREED by and between Plaintiffs Teva
`
`Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., Teva Neuroscience, Inc., and
`
`Yeda Research and Development Co., Ltd. (collectively, “Plaintiffs”) and Defendants Sandoz Inc.
`
`and Momenta Pharmaceuticals Inc. (collectively, “Sandoz”); Doctor Reddy’s Laboratories, Ltd.
`
`and Doctor Reddy’s Laboratories, Inc. (collectively, “DRL”); Mylan Pharmaceuticals Inc. and
`
`Mylan Inc. (collectively, “Mylan”); Synthon Pharmaceuticals Inc., Synthon B.V., and Synthon
`
`S.R.O. (collectively, “Synthon”); Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals
`
`Company GmbH (“Amneal”) (collectively, “Defendants”) (Plaintiffs and Defendants collectively,
`
`“the Parties” or “a Party”), through their undersigned counsel, that in order to expedite the flow of
`
`discovery material, facilitate the prompt resolution of disputes over confidentiality, adequately
`
`protect material entitled to be kept confidential, and ensure that confidentiality is afforded only to
`
`material so entitled, the following terms and conditions (the “Protective Order”) shall govern
`
`discovery in the above referenced action (the “Litigation”):
`
`1.
`
`Definitions. Words shall have their normally accepted meanings as employed in
`
`this Protective Order. The word “shall” is mandatory. The words “includes” and “including” are
`
`not limiting. The singular shall include the plural and vice versa. Additionally, the following
`
`terms shall have the listed definitions.
`
`(a)
`
`As used herein, the term “Document” is defined to be synonymous in
`
`meaning and equal in scope to the usage of the term “documents or electronically stored
`
`information” in Fed. R. Civ. P. 34(a)(1)(A). A draft or non-identical copy is a separate document
`
`within the meaning of this term.
`
`(b)
`
`As used herein, the term “Information” includes information of any type,
`
`kind or character whether it be a document, information contained in a document, information
`
`2
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`PETITIONERS' EXHIBIT NO. 1076 PAGE 2
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 3 of 28 PageID #: 708
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`revealed during a deposition, information revealed in an interrogatory or other discovery response,
`
`or otherwise.
`
`(c)
`
`As used herein, the term “In-House Counsel” shall mean attorneys, licensed
`
`patent attorneys admitted to practice before a national or European patent office who are
`
`employees of a Party, or scientific litigation advisors who are employees of a Party working in the
`
`Party’s legal department who are responsible for overseeing this Litigation for a Party and who do
`
`not and shall not have direct responsibility for prosecuting or filing any patent applications
`
`involving glatiramer acetate, and do not and shall not have direct responsibility for submitting
`
`regulatory documents to FDA or for communications with FDA involving glatiramer acetate (with
`
`the exception of involvement in the preparation and filing of certifications pursuant to 21 U.S.C.
`
`§ 355(b)(2)(A)(i)-(iv) and 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV) and (viii) and notices pursuant to
`
`21 U.S.C. § 355(j)(2)(B)), including without limitation any Citizen Petition.
`
`2.
`
`Scope. This Stipulated Protective Order (the “Order”) includes within its scope any
`
`Documents and Information produced, disclosed or filed in the Litigation, whether by a party or
`
`non-party (each individually, a “Source”), whether pursuant to formal or informal discovery
`
`requests or motion practice, and whether revealed in a document, deposition, an interrogatory
`
`answer, a response to a request for documents, a submission to the court or otherwise and
`
`including all Documents and all such Information produced or disclosed by non-parties in this
`
`Litigation pursuant to subpoena and/or deposition notice (collectively, “Litigation Material”).
`
`3.
`
`Scope and Designation of Confidentiality. “Confidential Information” shall
`
`include Litigation Material designated either “HIGHLY CONFIDENTIAL” or “OUTSIDE
`
`COUNSEL ONLY”, as defined below. Any information not designated as one of the above
`
`3
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`PETITIONERS' EXHIBIT NO. 1076 PAGE 3
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 4 of 28 PageID #: 709
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`categories by a Source shall be considered to be non-confidential. No information shall be
`
`regarded as Confidential Information:
`
`(a)
`
`if it is in the public domain at the time of disclosure, as evidenced by a
`
`document, electronically stored information, or tangible thing;
`
`(b)
`
`if it becomes part of the public domain through no fault of the receiving
`
`party, as evidenced by a document, electronically stored information, or tangible thing;
`
`(c)
`
`if it was in the rightful and lawful possession of the receiving party prior to
`
`the time of the disclosure, without any applicable obligation of confidentiality, as evidenced by a
`
`document, electronically stored information, or tangible thing; or
`
`(d)
`
`if it is received lawfully by the receiving party at a later date from a third
`
`party without restriction as to disclosure, provided that such third party has the right to make such
`
`unrestricted disclosure to the receiving party.
`
`4.
`
`Designation as “HIGHLY CONFIDENTIAL”. The designation “HIGHLY
`
`CONFIDENTIAL” shall mean information that the Source in good faith believes is of a
`
`proprietary or commercially sensitive nature and/or information that is required to be treated as
`
`confidential pursuant to statute or common law, including applicable foreign data privacy laws,
`
`including, but not limited to, information that the Source in good faith believes constitutes a trade
`
`secret in the possession of the Source, including the trade secrets of the Source’s customers,
`
`vendors, accountants, underwriters, or other party, or that the Source in good faith believes
`
`constitutes other highly sensitive proprietary information that is entitled to additional protections.
`
`Information designated “HIGHLY CONFIDENTIAL” may include, but is not limited to, materials
`
`relating to ongoing research and development.
`
`4
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 4
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 5 of 28 PageID #: 710
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`5.
`
`Designation as “OUTSIDE COUNSEL ONLY”. The designation “OUTSIDE
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`COUNSEL ONLY” is limited to information that the Source in good faith believes constitutes
`
`technical or business information of a most sensitive nature that might be of significant value to an
`
`actual or potential competitor of the Source and which must be protected from disclosure as set
`
`forth herein. Information designated “OUTSIDE COUNSEL ONLY” may include, but is not
`
`limited to, certain materials relating to highly sensitive research and development, regulatory
`
`approval, and/or future business plans, financial analyses and projections, contractual
`
`relationships with third parties, and the identification of customers and suppliers.
`
`6.
`
`Limited Use of Discovery.
`
`(a)
`
`All Confidential Information shall be used solely for this Litigation and the
`
`preparation and trial in this Litigation, or any appellate proceeding resulting from this Litigation,
`
`and not for any other purpose whatsoever, including without limitation, any other litigation, patent
`
`prosecution, patent reexamination and reissue proceedings, acquisition, or any communication
`
`with any U.S. or foreign regulatory agency including, but not limited to, the FDA, or any business,
`
`research, development or competitive purpose or function. Confidential Information must not be
`
`distributed, disclosed, or made available to anyone except as expressly provided in this Order.
`
`This Order places no limitation on a Source’s use or disclosure of its own Confidential Information.
`
`In addition, any person who receives or reviews OUTSIDE COUNSEL ONLY information
`
`produced by any party other than his or her client shall not thereafter, during the pendency of the
`
`instant litigation and for one year after the final conclusion of this litigation, including appeals:
`
`(i)
`
`amend, draft, or otherwise substantively assist in the drafting or
`
`amending of patent claims in any patent prosecution, reexamination, post-grant review (“PGR”) or
`
`inter partes review (“IPR”) proceeding pertaining to glatiramer acetate.
`
`5
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 5
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 6 of 28 PageID #: 711
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`(ii)
`
`participate in or aid in the filing of any FDA Citizen Petition related
`
`to the technology that is the subject matter of the instant litigation.
`
`(iii)
`
`The foregoing restrictions of this Paragraph 6(a) shall apply only to
`
`individuals, and not to the firms or organizations by which they are employed, nor to individuals
`
`who received access to Confidential Information or Highly Confidential Information solely in
`
`their capacity as clerical staff.
`
`(b)
`
`Confidential Information and the information derived from such
`
`Confidential Information shall be kept confidential and shall not be given, shown, made available,
`
`discussed, or otherwise communicated in any manner, either directly or indirectly, to any person
`
`not authorized to receive the information under the terms of this Order.
`
`(c)
`
`All Confidential Information, including, but not limited to electronically
`
`stored data, shall be maintained by the receiving party at a location and under circumstances to
`
`ensure that access is limited to those persons entitled to have access under this Order.
`
`7.
`
`Access to Confidential Information
`
`Unless otherwise ordered by the Court or permitted in writing by a Source, Confidential
`
`Information may be disclosed only as follows:
`
`(a)
`
`Materials designated as “OUTSIDE COUNSEL ONLY” pursuant to this
`
`Protective Order, including copies thereof, extracts there from, compilations and/or summaries
`
`thereof and information therein, may be disclosed only to the following persons:
`
`(i)
`
`Any attorney who serves as outside counsel of record to any party to
`
`this Litigation and all attorneys, legal assistants, stenographic and clerical employees working
`
`under the supervision of such attorney in this Litigation;
`
`6
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 6
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 7 of 28 PageID #: 712
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`(ii)
`
`For each party to this Litigation, the attorneys at one additional law
`
`firm that is not of record in this Litigation but serves as outside counsel to such party and all
`
`attorneys, legal assistants, stenographic and clerical employees working under the supervision of
`
`such attorneys. If any party desires to disclose materials designated as “OUTSIDE COUNSEL
`
`ONLY” to such additional law firm, the additional law firm must first be identified to the Source’s
`
`attorneys in writing, and must agree to be bound by this Protective Order by signing a copy of the
`
`Acknowledgement and Agreement to be Bound attached as Exhibit A;
`
`(iii)
`
`The Parties’ independent expert(s) or consultant(s) in accordance
`
`with Paragraphs 10 and 13 herein;
`
`(iv)
`
`Any person from whom testimony is taken, where such person was
`
`the author or specified recipient of the Confidential Material or is the present employee or expert
`
`witness for the Source, or where counsel for the Source has, either before or during the deposition,
`
`approved the disclosure of such materials to that person, except that such person may not retain
`
`any such Confidential Material;
`
`(v)
`
`The Court and court personnel in this Proceeding, including Court
`
`reporters in accordance with Paragraph 18 herein;
`
`(vi)
`
`Any interpreters, or court or other shorthand reporters or typists
`
`translating, recording or transcribing testimony;
`
`(vii) Any service contractors (such as document copy services); and
`
`(viii) Any translators, persons providing graphics or design or document
`
`services for purposes of preparing demonstrative or other exhibits in this Litigation and
`
`non-technical jury or trial consulting services, provided that any such person(s) agrees to be bound
`
`7
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 7
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 8 of 28 PageID #: 713
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`by this Protective Order by signing a copy of the Acknowledgement and Agreement to be Bound
`
`attached as Exhibit A.
`
`(b)
`
`Materials designated as “HIGHLY CONFIDENTIAL” pursuant to this
`
`Protective Order, including copies thereof, extracts there from, compilations and/or summaries
`
`thereof and information therein, may be disclosed to the persons designated in subparagraph 7(a),
`
`above, as well as to the following persons:
`
`(i)
`
`Plaintiffs shall collectively be entitled five (5) designated In-House
`
`Counsel, in accordance with Paragraphs 11 and 12 herein;
`
`(ii)
`
`Sandoz shall be entitled five (5) designated In-House Counsel, in
`
`accordance with Paragraphs 11 and 12 herein;
`
`(iii)
`
`DRL shall be entitled five (5) designated In-House Counsel, in
`
`accordance with Paragraphs 11 and 12 herein;
`
`(iv)
`
`Mylan shall be entitled five (5) designated In-House Counsel, in
`
`accordance with Paragraphs 11 and 12 herein;
`
`(v)
`
`Synthon shall be entitled five (5) designated In-House Counsel, in
`
`accordance with Paragraphs 11 and 12 herein; and
`
`(vi)
`
`Amneal shall be entitled five (5) designated In-House Counsel, in
`
`accordance with Paragraphs 11 and 12 herein.
`
`(c)
`
`Limited Exception:
`
`(i)
`
`Witnesses: If a document designated as “HIGHLY
`
`CONFIDENTIAL” or “OUTSIDE COUNSEL ONLY” refers to the conduct or affairs of a
`
`potential witness, the Parties’ attorneys may discuss such conduct or affairs with the witness
`
`without revealing that such a document exists, its contents, its author or its source.
`
`8
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`PETITIONERS' EXHIBIT NO. 1076 PAGE 8
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 9 of 28 PageID #: 714
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`8.
`
`Manner of Disclosure. The provisions of this Protective Order extend to all
`
`Confidential Information regardless of the manner in which it is disclosed, including but not
`
`limited to any interrogatory answers; responses to requests for admission; deposition testimony,
`
`transcripts, and exhibits; and any other discovery materials produced in response to or in
`
`connection with any discovery conducted in the Litigation, in each case that has been designated
`
`consistent with the manner set forth in Paragraph 9, and any copies, notes, abstracts or summaries
`
`of the foregoing materials.
`
`9.
`
`Manner of Designating Confidentiality. Documents or information may be
`
`designated as Confidential Information within the meaning of this Protective Order in the
`
`following ways:
`
`(a)
`
`In the case of documents and the information contained therein, designation
`
`shall be made by means of placing a stamp, label, or other clear designation stating “HIGHLY
`
`CONFIDENTIAL” or “OUTSIDE COUNSEL ONLY” on the documents to be so designated. In
`
`cases where it is impractical to stamp each page of a document, the Source shall indicate on the
`
`face of the document that the entire document is either Highly Confidential or Outside Counsel
`
`Only.
`
`(b)
`
`In the case of interrogatory answers, responses to requests for admissions
`
`and the information contained therein, designation shall be made by placing on the front of any set
`
`of interrogatory answers or responses to requests for admission containing Confidential
`
`Information: “Contains information designated [select one or more as appropriate] HIGHLY
`
`CONFIDENTIAL/ OUTSIDE COUNSEL ONLY.” Designated parts are not to be used, copied,
`
`or disclosed except as authorized by this Protective Order.
`
`9
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 9
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 10 of 28 PageID #: 715
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`(c)
`
`In the case of depositions and the information contained in depositions
`
`(including exhibits), designation of the whole transcript or portions of the transcript (including
`
`exhibits) that contain Confidential Information shall be made either on the record at the deposition
`
`or by letter from counsel within seven (7) days of receipt of the deposition transcript. If the
`
`testimony involves material that a non-party designated as confidential, the person taking the
`
`deposition must consult that non-party to determine whether the affected portions of the testimony
`
`should be designated as Confidential Information. The entire deposition transcript (including
`
`exhibits) shall be treated as OUTSIDE COUNSEL ONLY under this Protective Order until the
`
`expiration of the above-referenced thirty-day period for designation by letter, except that the
`
`deponent may review the transcript of his or her own deposition during this seven-day period. The
`
`parties may also agree to extend the time period for providing such designations. Further, the
`
`notation, “Contains information designated [select one or more as appropriate] HIGHLY
`
`CONFIDENTIAL/OUTSIDE COUNSEL ONLY” shall be placed on the front of the deposition
`
`transcript, and, if the deposition is videotaped, on the videocassette, CD-ROM or other video
`
`container. Designated parts are not to be used, copied, or disclosed except as authorized by this
`
`Protective Order. Counsel retaining court reporters shall have the responsibility for ensuring their
`
`compliance with this paragraph.
`
`(d)
`
`To the extent that matter stored or recorded in the form of electronic or
`
`magnetic media (including information, databases or programs stored on computers, discs,
`
`networks or tapes) (“Computerized Material”) is produced by any Source in such form, the Source
`
`may designate such matter as “HIGHLY CONFIDENTIAL” or “OUTSIDE COUNSEL ONLY”
`
`by placing a stamp, label or other clear designation stating “HIGHLY CONFIDENTIAL” or
`
`“OUTSIDE COUNSEL ONLY” on the disc or tape containing the Computerized Material.
`
`10
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`PETITIONERS' EXHIBIT NO. 1076 PAGE 10
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 11 of 28 PageID #: 716
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`10.
`
`Disclosure To And Identification Of Experts and Consultants. If any party desires
`
`to disclose “HIGHLY CONFIDENTIAL” or “OUTSIDE COUNSEL ONLY” information of
`
`another party to any Expert or Consultant, it must first identify each Expert or Consultant to the
`
`Source’s attorneys in writing. Such identification shall include: (1) the proposed Expert or
`
`Consultant’s full name, professional address, and professional affiliations; (2) an up-to-date
`
`curriculum vitae identifying the past five years of consulting history; and (3) a list of the cases in
`
`which the Expert or Consultant has testified at a deposition or at trial within the last four years; and
`
`(4) an executed copy of the Acknowledgement and Agreement to be Bound (see Exhibit A).
`
`The attorney for the Source shall have seven (7) calendar days from receipt of such notice
`
`to object to such disclosure, during which time no such disclosure shall be made.
`
`If the Source does object to the proposed disclosure, the parties shall meet and confer
`
`within seven (7) calendar days of receipt of such objection to resolve the disagreement.
`
`If the parties are not able to come to an agreement, the producing party shall have the
`
`burden of moving the Court for an order prohibiting the disclosure. The receiving party shall have
`
`ten (10) business days after the producing party has filed a motion to respond. If such a motion is
`
`filed, disclosure shall not be made until the Court has ruled on the motion and response. If the
`
`Court orders disclosure, such disclosure shall not in any way affect the designation of the material
`
`or information disclosed, nor shall it allow any party to deviate from the requirements of this
`
`Protective Order regarding disclosure to any other person.
`
`11.
`
`Disclosure To And Identification Of In-House Counsel. If any party desires to
`
`disclose “HIGHLY CONFIDENTIAL” information of another party to an In-House Counsel, it
`
`must first identify such in-house counsel to the Source’s attorneys in writing. The initial
`
`designations for Plaintiffs are as follows:
`
`11
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`PETITIONERS' EXHIBIT NO. 1076 PAGE 11
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 12 of 28 PageID #: 717
`
`JOB TITLE
`
`PROFESSIONAL ADDRESS
`
`Teva Pharmaceuticals
`425 Privet Road
`Horsham PA 19044-8005
`Teva Pharmaceuticals
`425 Privet Road
`Horsham PA 19044-8005
`Teva Pharmaceuticals 425
`Privet Road
`Horsham PA 19044-8005
`Teva Pharmaceuticals 425
`Privet Road
`Horsham PA 19044-8005
`Yeda Research &
`Development Co. Ltd.
`P.O. Box 95
`Rehovot 76100, Israel
`
`FULL NAME OF IN-HOUSE
`COUNSEL (TEVA)
`David Stark, Esq.
`
`Staci L. Julie, Esq.
`
`General Counsel
`for Global Markets
`
`Vice President, Global
`Intellectual Property
`
`Matthew Blischak, Esq.
`
`Associate General Counsel,
`Global Branded IP Litigation
`
`Lori Wolfe, Esq.
`
`Gil Granot-Mayer
`
`Senior Counsel, Global
`Branded IP Litigation
`
`Deputy CEO & General
`Counsel
`
`The initial designations for Sandoz are as follows:
`
`PARTY
`
`Sandoz Inc.
`
`FULL NAME OF
`IN-HOUSE
`COUNSEL
`Josephine Liu
`
`JOB TITLE
`
`Senior IP Litigation
`Counsel
`
`Sandoz Inc.
`
`Ram Ramamoorthy
`
`Scientific Advisor
`
`Sandoz Inc.
`
`Markus Hartmann
`
`Momenta
`Pharmaceuticals, Inc.
`
`Leda Trivinos
`
`Vice President &
`North American
`General Counsel
`Chief Patent Counsel
`
`To be determined
`
`The initial designations for DRL are as follows:
`
`PROFESSIONAL
`ADDRESS
`
`Sandoz Inc.
`100 College Rd. West
`Princeton, NJ 08540
`Sandoz Inc.
`100 College Rd. West
`Princeton, NJ 08540
`Sandoz Inc.
`100 College Rd. West
`Princeton, NJ 08540
`Momenta
`Pharmaceuticals, Inc.
`675 West Kendall Street
`Cambridge, MA 02142
`
`FULL NAME OF
`IN-HOUSE COUNSEL
`(DRL)
`Lee Banks
`
`JOB TITLE
`
`PROFESSIONAL ADDRESS
`
`Vice President, Intellectual
`Property
`
`Dr. Reddy’s Laboratories, Inc.
`107 College Rd E, Princeton, NJ
`
`12
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`PETITIONERS' EXHIBIT NO. 1076 PAGE 12
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`

`
`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 13 of 28 PageID #: 718
`
`08540
`
`Anjum Swaroop
`
`A. Mallikarjun Prasad Rao
`
`Srinivas Reddy Madduri
`
`Deputy Head, Intellectual
`Property
`
`Senior Analyst, Intellectual
`Property
`
`Associate Director,
`Intellectual Property
`
`Dr. Reddy’s Laboratories, Inc.
`107 College Rd E, Princeton, NJ
`08540
`Dr. Reddy’s Laboratories, Inc.
`107 College Rd E, Princeton, NJ
`08540
`Dr. Reddy’s Laboratories, Inc.
`107 College Rd E, Princeton, NJ
`08540
`
`The initial designations for Mylan are as follows:
`
`FULL NAME OF
`IN-HOUSE COUNSEL
`(MYLAN)
`Jill Ondos
`
`Tom Jenkins
`
`JOB TITLE
`
`PROFESSIONAL ADDRESS
`
`Senior Vice President and
`Global General Counsel,
`Litigation
`
`Vice President and
`Assistant Global General
`Counsel, Patent Litigation
`
`Mylan
`1000 Mylan Boulevard
`Canonsburg, PA 15317
`
`Mylan
`1000 Mylan Boulevard
`Canonsburg, PA 15317
`
`To be determined
`
`The initial designations for Synthon are as follows:
`
`JOB TITLE
`
`PROFESSIONAL ADDRESS
`
`Synthon B.V.
`Microweg 22
`PO Box 7071
`6503 CM Nijmegen
`The Netherlands
`Synthon B.V.
`Microweg 22
`PO Box 7071
`6503 CM Nijmegen
`
`FULL NAME OF
`IN-HOUSE COUNSEL
`(SYNTHON)
`Dominique van de Kamp
`
`Head of IPR Development
`Products
`
`Theo Peters
`
`Director, I.P. Litigation
`
`13
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`PETITIONERS' EXHIBIT NO. 1076 PAGE 13
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`

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`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 14 of 28 PageID #: 719
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`The Netherlands
`
`To be determined
`
`The initial designations for Amneal are as follows:
`
`JOB TITLE
`
`PROFESSIONAL ADDRESS
`
`Amneal Pharmaceuticals
`400 Crossing Boulevard, Third
`Floor, Bridgewater, New Jersey
`08807-2863
`Amneal Pharmaceuticals
`400 Crossing Boulevard, Third
`Floor, Bridgewater, New Jersey
`08807-2863
`Amneal Pharmaceuticals
`400 Crossing Boulevard, Third
`Floor, Bridgewater, New Jersey
`08807-2863
`Amneal Pharmaceuticals
`400 Crossing Boulevard, Third
`Floor, Bridgewater, New Jersey
`08807-2863
`
`FULL NAME OF
`IN-HOUSE COUNSEL
`(AMNEAL)
`Lars Taavola
`
`Senior Patent Counsel -
`Global Intellectual Property
`
`Bryan J. Sommese
`
`Director, Global
`Intellectual Property
`
`Ken M. Zeidner
`
`Kenneth Cappel
`
`To be determined
`
`Senior Patent
`Counsel/Senior Director -
`Global Intellectual Property
`
`Vice President Global
`Intellectual Property
`
`12.
`
`Substitution of in-house counsel. If any party subsequently proposes a substitution
`
`of designated in-house counsel identified in paragraph 11, it must identify in writing the proposed
`
`substitute in-house counsel being added and the in-house counsel being removed. Such
`
`identification shall include the proposed in-house counsel’s: (1) full name; (2) job title; and (3)
`
`professional address.
`
`The Source shall have seven (7) calendar days from receipt of such notice to object to such
`
`substitution, during which time no such disclosure shall be made.
`
`If the Source objects to the proposed substitution, the parties shall meet and confer within
`
`seven (7) calendar days of receipt of such objection to resolve the disagreement.
`
`14
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 14
`
`

`
`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 15 of 28 PageID #: 720
`
`If the parties are not able to come to an agreement, the receiving party shall have the burden
`
`of moving the Court for an order allowing the disclosure. The Source shall have ten (10) business
`
`days after the receiving party has filed a motion seeking disclosure to respond. If the Court issues
`
`an order permitting disclosure, such disclosure shall not in any way affect the designation of the
`
`material or information disclosed, nor shall it allow any party to deviate from the requirements of
`
`this Protective Order regarding disclosure to any other person.
`
`13.
`
`Preservation of Executed Acknowledgements. Persons, such as experts and
`
`consultants, who are not parties to this Litigation but will have access to Confidential Information
`
`shall review and sign an Acknowledgement and Agreement to be Bound (see Exhibit A). The
`
`originals of any executed Acknowledgments of Stipulated Protective Order shall be deemed work
`
`product, and the party who obtains them shall maintain them until (30) days after the filing of the
`
`decision from the last reviewing court that disposes of the Litigation in its entirety (“the Final
`
`Resolution of the Litigation”). In any action or proceeding to enforce the terms of this Order, upon
`
`a showing of good cause to the Court, copies of all executed Acknowledgments of Stipulated
`
`Protective Order shall be provided to the court for in cam e ra review.
`
`14.
`
`Objections to Designations. The following procedures shall govern any challenges
`
`to confidentiality designations:
`
`(a)
`
`If a party in good faith believes that information should not be designated as
`
`Confidential Information, it must specify to the Source in writing (i) the information challenged
`
`and (ii) the grounds for questioning the confidentiality designation. The Source must respond in
`
`writing within ten (10) business days, or within such additional time as is reasonable (taking into
`
`account the number of documents or other information challenged) and is agreed to by counsel or
`
`as ordered by the Court.
`
`15
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 15
`
`

`
`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 16 of 28 PageID #: 721
`
`(b)
`
`If the objecting party and the Source do not reach agreement within ten (10)
`
`business days after the Source has responded to the challenging party, then the party opposing the
`
`confidentiality designation has ten (10) business days to move the Court to compel. Until the Court
`
`rules, the confidentiality designation shall remain in effect.
`
`(c)
`
`Nothing in this Protective Order shall be deemed to allocate or reallocate
`
`any substantive burdens with respect to confidentiality, which shall be determined in accordance
`
`with governing law.
`
`15.
`
`Option to Redact Information. The Source may choose to produce documents,
`
`electronically stored information, or tangible things in redacted form, redacting information that is
`
`nonresponsive (including confidential material unrelated to the litigation), or information that is
`
`protected by the attorney-client privilege or the work-product doctrine. The Source will make it
`
`clear that a redaction has been made on each redacted portion of the document, electronically
`
`stored information, or tangible thing. If requested by a receiving party, the Source will, within ten
`
`(10) business days of such request, provide the basis for any redactions made to identified
`
`documents.
`
`16.
`
`Objection to Redactions. The following procedures shall govern any challenges to
`
`a redaction:
`
`(a)
`
`If a party in good faith believes that a redaction is improper, it must specify
`
`to the Source in writing (i) the redaction challenged and (ii) the grounds for questioning the
`
`redaction. The Source must respond in writing within ten (10) business days, or within such
`
`additional time as is reasonable (taking into account the number of documents or other information
`
`challenged) and is agreed to by counsel or as ordered by the Court.
`
`16
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 16
`
`

`
`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 17 of 28 PageID #: 722
`
`(b)
`
`The Source and the party challenging a redaction may choose, but are not
`
`required, to designate a mutually acceptable party to inspect the redacted information and to
`
`provide a recommendation as to whether the redaction was proper. The Source is not required to
`
`make such a disclosure of redacted information, but if such a disclosure is made, it shall be
`
`considered to have been made only to expedite resolution of the dispute over the redaction and
`
`shall not constitute a waiver by the Source of any privilege, immunity, or other protection from
`
`disclosure. The mutually acceptable party inspecting the redacted information shall sign an
`
`Acknowledgement and Agreement to be Bound and shall not disclose the redacted information to
`
`any other person or use such information for any other purpose other than to inspect the redacted
`
`information and to provide a recommendation as to whether the redaction was proper.
`
`(c)
`
`If the objecting party and the Source do not reach agreement within ten (10)
`
`business days after the Source has responded to the challenging party, then the party opposing the
`
`redaction has ten (10) business days to move the Court to compel. Until the Court rules, the
`
`redaction shall remain in place.
`
`(d)
`
`Nothing in this Protective Order shall be deemed to allocate or reallocate
`
`any substantive burdens with respect to assertions of attorney-client privilege, work-product
`
`doctrine, or trade secret, which shall be determined in accordance with governing law.
`
`17.
`
`Filing Confidential Information with the Court. The Clerk of the Court is directed
`
`to maintain under seal any pleading, motion, brief, memorandum, exhibit, affidavit, declaration,
`
`transcript, response to a discovery request, or other paper filed with the Court in compliance with
`
`Local Rule 5.1.3, which has been designated, in whole or in part, as containing or revealing
`
`Confidential Information under this Stipulated Protective Order. Such documents shall be filed
`
`under seal and subsequently redacted according to the Local Rules and the District of Delaware’s
`
`17
`
`PETITIONERS' EXHIBIT NO. 1076 PAGE 17
`
`

`
`Case 1:14-cv-01171-GMS Document 66 Filed 05/22/15 Page 18 of 28 PageID #: 723
`
`Administrative Procedures Governing Filing and Service by Electronic Means (the “CM/ECF
`
`Procedures”), as applied and interpreted in connection with the District of Delaware CM/ECF
`
`User’s Manual Preservation of Rights and Privileges.
`
`18.
`
`Confidential Designations and Objections Thereto. Parties shall limit their
`
`“HIGHLY CONFIDENTIAL” or “OUTSIDE COUNSEL ONLY” designations solely to
`
`information which they in good faith believe to fall within this Protective Order. No receiving
`
`party shall be under any obligation to object to the designation of any document or information as
`
`“HIGHLY CONFIDENTIAL” or “OUTSIDE COUNSEL ONLY” at the time such designation is
`
`made, or at any time thereafter, and no party shall, by failure to object, be found to have acquiesced
`
`or agreed to such designation or be barred from objecting to such designation at any time.
`
`19.
`
`Preservation of Rights and Privileges. Nothing contained in this Protective Order
`
`shall: (a) affect the right, if any, of any party or non-party to make any type of objection, claim, or
`
`other response to any discovery request, including, without limitation, any interrogatories,
`
`requests for admissions, requests for production of documents or questions at a deposition; (b) be
`
`construed as a waiver of any legally cognizable privilege to withhold any Confidential Information,
`
`or of any right to assert such privilege at any stage of the Litigation; or (c) prevent any party fro

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