`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 22-252 (MSG)
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`v.
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`MODERNA, INC. and MODERNATX, INC.
`
`Defendants.
`MODERNA, INC. and MODERNATX, INC.,
`
`Counterclaim-Plaintiffs,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
`
`
`STIPULATED PROTECTIVE ORDER
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`Disclosure and discovery activity in the above-captioned action may call for the production
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`or disclosure of trade secret or other proprietary or confidential research, development, or
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`commercial information within the meaning of Fed. R. Civ. P. 26(c), other private or competitively
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`sensitive information, and/or personally identifiable information for which protection from public
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`disclosure and from use for any purpose other than prosecuting and defending the above-captioned
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`action is warranted. Accordingly, Plaintiffs Arbutus Biopharma Corporation (“Arbutus”) and
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`Genevant Sciences GmbH (“Genevant”) and Defendants Moderna, Inc. and ModernaTX, Inc.
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`(collectively, “Moderna”) (Plaintiffs and Defendants may be referred to herein as individually as
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`a “Party,” or collectively as the “Parties”), hereby stipulate to and ask the Court to enter this
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`Stipulated Protective Order (“Order”) pursuant to Fed. R. Civ. P. 26(c) and Fed. R. Evid. 502(d).
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`
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`Case 1:22-cv-00252-MSG Document 91 Filed 04/28/23 Page 2 of 32 PageID #: 1500
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`The Court retains the right to allow disclosure of any subject covered by this Order or to modify
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`this Order at any time in the interest of justice.
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`Case 1:22-cv-00252-MSG Document 91 Filed 04/28/23 Page 3 of 32 PageID #: 1501
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`I.
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`DEFINITIONS
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`1.1
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`Challenging Party means a Party or Non-Party that challenges the designation of
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`information or items under this Order.
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`1.2
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`“CONFIDENTIAL” Material means any Discovery Material a Producing Party
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`has, subject to the provisions of this Order, designated as “CONFIDENTIAL,” based on the
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`Producing Party’s reasonable and good faith belief that the Discovery Material constitutes or
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`reveals information or material not generally known and which the Producing Party would
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`normally not reveal to third parties, including but not limited to:
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`(a)
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`(b)
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`“CONFIDENTIAL”;
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`Confidential business information;
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`Sales
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`figures
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`and
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`projections, which will
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`be
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`designated
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`(c)
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`the lipid molar ratio of the Accused Products and the lipid molar ratio of
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`products developed or licensed by Plaintiffs (for clarity, the lipid molar ratio itself will be treated
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`CONFIDENTIAL, but not necessarily documents that disclose such lipid molar ratios, which are
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`to be designated according to the criteria in this paragraph 1.2 and paragraph 1.8);
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`(d)
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`Non-public communications with regulators or other governmental bodies
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`that are protected from disclosure by statute or regulation;
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`(e)
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`Information, materials, and/or other documents reflecting non-public
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`business or financial strategies, and/or confidential competitive information which, if disclosed,
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`could result in competitive harm to the disclosing party;
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`(f)
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`Sensitive, non-public personal, client, or customer information concerning
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`individuals or other entities.
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`(g)
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`Information as to which applicable law ‒ foreign or domestic, including but
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`not limited to the EU General Data Protection Regulation ‒ requires the equivalent of
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`“CONFIDENTIAL” treatment or other protection from unauthorized disclosure as set forth in this
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`Order.
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`1.3
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`1.4
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`Counsel (without qualifier) means Outside Counsel and In-House Counsel.
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`Designating Party means any Party or Non-Party that designates Discovery
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`Material produced by itself or any other Producing Party as “CONFIDENTIAL” or “HIGHLY
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`CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY.”
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`1.5
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`Designated In-House Counsel means In-House Counsel who seek access to
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`“CONFIDENTIAL” information in this action. Unless otherwise agreed to by the Parties,
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`Designated In-House Counsel means up to two (2) in-house attorneys for Arbutus, (2) in-house
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`attorneys for Genevant, and two (2) in-house attorneys for Defendants. Designated In-House
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`Counsel for Genevant may be employed by Genevant Sciences Ltd., Genevant Sciences, Inc.,
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`Genevant Sciences Corporation, or Genevant Sciences GmbH. If Designated In-House Counsel
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`ceases to be employed by the respective party, that party may substitute Designated In-House
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`Counsel with written notice to all other Parties, which shall include the name, job title, and
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`affiliation of the Designated In-House Counsel to be substituted. In the event of such a
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`substitution, the new Designated In-House Counsel may not receive “CONFIDENTIAL”
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`information for seven (7) days after the notice is provided. In the event of an objection to the
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`substitution of Designated In-House Counsel during this period, the Parties will meet-and-confer
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`and the objecting party will have seven (7) days after the objection to initiate the applicable dispute
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`resolution mechanism. Initial Designated In-House counsel, and their present job titles and
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`affiliations, are set forth below:
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`For Arbutus:
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`(1)
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`[To be named at a later date].
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`(2)
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`[To be named at a later date].
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`For Genevant:
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`(1)
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`(2)
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`Peter Zorn, President and Chief Legal Officer, Genevant Sciences, Inc.
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`[To be named at a later date].
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`For Defendants:
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`(1)
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`(2)
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`1.6
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`[To be named at a later date].
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`[To be named at a later date].
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`Discovery Material means all items or information, regardless of the medium or
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`manner in which it is generated, stored or maintained (including, among other things, testimony,
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`transcripts, and tangible things), that are produced in this action.
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`1.7
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`Expert and/or Consultant means a person with specialized knowledge or experience
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`in a matter pertinent to this action, along with his or her employees and support personnel, who
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`has been retained by a Party or its Counsel to serve as an expert witness or a consultant in this
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`action, and who is not currently an employee of a Party and who, at the time of retention, is not
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`anticipated to become an employee of a Party.
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`1.8
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`“HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” Material
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`means any Discovery Material a Producing Party has, subject to the provisions of this Order,
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`designated as “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” based on
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`the Producing Party’s reasonable and good faith belief that the Discovery Material constitutes or
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`reveals:
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`(a)
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`Confidential trade secret, know-how, personnel, financial, or other
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`proprietary information the disclosure of which would result in competitive, commercial, of
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`financial harm to the Producing Party or its personnel, clients, or customers;
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`(b)
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`Information that is likely to cause harm to the interests of individuals (e.g.,
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`research subjects or patients) who are not parties to this litigation.
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`1.9
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`In-House Counsel means the individuals listed in Paragraph 1.5.
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`1.10 Non-Party means any natural person or entity that is not a named Party to this
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`action.
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`1.11 Outside Counsel means attorneys, along with their paralegals and other support
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`personnel assisting them with this action (including temporary or contract staff, assistants, and
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`other employees of the respective law firms of Outside Counsel), who are not employees of a Party
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`and who have entered an appearance in this action and did not file a notice of withdrawal before
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`February 10, 2023.
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`1.12
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`Party means any party to this action, including all of its officers, directors,
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`employees, consultants, retained Experts, and Outside Counsel (and their support personnel).
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`1.13
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`Privileged Material means Discovery Material protected from disclosure under the
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`attorney-client privilege, attorney work product doctrine, United States or foreign bank disclosure
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`laws or regulations, and/or any other applicable United States or foreign statute, law, regulation,
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`privilege, or immunity from disclosure.
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`1.14
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`Producing Party means any Party or Non-Party that produces Discovery Material
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`in this action.
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`1.15
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`Professional Vendors means persons or entities that provide litigation support
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`services (e.g., photocopying; videotaping; translating; preparing exhibits or demonstrations;
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`organizing, storing, or processing data in any form or medium) and their employees and
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`subcontractors.
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`1.16
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`Protected Material means
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`any Discovery Material
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`designated
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`as
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`“CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY.”
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`1.17 Receiving Party means any Party or Non-Party that receives Discovery Material
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`from a Producing Party.
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`II.
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`SCOPE
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`2.1
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`The protections conferred by this Order cover not only Protected Material, but also:
`
`(a)
`
`(b)
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`(c)
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`Any information copied or extracted from Protected Material;
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`All copies, excerpts, summaries, or compilations of Protected Material; and
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`Any testimony, conversations, or presentations by Parties or their Counsel
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`that might reveal Protected Material.
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`2.2
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`The protections conferred by this Order do not cover the following information:
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`(a)
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`Any information that is in the public domain at the time of disclosure to a
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`Receiving Party or becomes part of the public domain after its disclosure to a Receiving Party as
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`a result of publication not involving a violation of this Order, including becoming part of the public
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`record through litigation or otherwise; and
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`(b)
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`Any information known to the Receiving Party prior to the disclosure or
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`obtained by the Receiving Party after the disclosure from a source who obtained the information
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`lawfully and under no obligation of confidentiality to the Designating Party.
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`(c)
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`Any use of Protected Material at trial shall be governed by a separate
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`agreement or order.
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`III.
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`DURATION
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`3.1
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`The confidentiality obligations imposed by this Order shall remain in effect
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`(including after an order, mandate, or dismissal terminating this action with prejudice) until the
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`Designating Party agrees otherwise in writing, this Court orders otherwise, or the information is
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`made public by the Designating Party.
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`IV.
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`DESIGNATING PROTECTED MATERIAL
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`4.1 Manner and Timing of Designations: Except as otherwise provided in this Order,
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`or as otherwise stipulated or ordered, material that qualifies for protection under this Order must
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`be clearly so designated before the material is disclosed or produced. Designation in conformity
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`with this Order requires:
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`(a)
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`For documents in hardcopy form or any other tangible items, that the
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`Producing Party affix the legend “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL –
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`OUTSIDE COUNSEL’S EYES ONLY” to each page that contains Protected Material in such a
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`way so as not to obscure any part of the text or content or in a prominent place on the item itself
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`or exterior of the container or containers in which the information or item is stored.
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`(b)
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`In the case of electronically stored documents, that the Producing Party note
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`on the image for each document or in the file name when noting on the image is not practicable,
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`in any suitable and readily viewable manner, “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL
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`– OUTSIDE COUNSEL’S EYES ONLY”. Whenever a Receiving Party to whom electronically
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`stored Discovery Material so designated is produced reduces such information to hard copy form,
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`to the extent such pages have not previously been marked by the Producing Party, such Receiving
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`Party shall mark the hard copy by affixing the designation to such document.
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`(c)
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`For deposition transcripts, that the Designating Party or Non-Party identify
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`on the record, before the close of the deposition, all protected testimony and specify the level of
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`protection being asserted. Alternatively, a Designating Party or Non-Party may specify, at the
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`deposition, or up to 30 days after receipt of the final transcript or recording that (1) the entire
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`transcript shall be treated as “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – OUTSIDE
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`COUNSEL’S EYES ONLY”; or (2) the designating Party or Non-Party may designate the specific
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`portions of the testimony as to which protection is sought and specify the level of protection being
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`asserted. Only those portions of the testimony that are appropriately designated for protection
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`within the 30 days, subject to any other time periods agreed upon by the Parties and Non-Parties,
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`shall be covered by the provisions of this Protective Order.
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`The use of a document as an exhibit at a deposition shall not in any way affect its
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`designation as “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S
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`EYES ONLY.”
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`Transcripts containing Protected Material shall have an obvious legend on the title page
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`that the transcript contains Protected Material, and when the entire transcript has not been so
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`designated the title page shall be followed by a list of all pages (including line numbers as
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`appropriate) that have been designated as Protected Material and the level of protection being
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`asserted by the Designating Party. The Designating Party shall inform the court reporter of these
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`requirements. Any transcript prepared before the expiration of the 30-day period for designation
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`shall be treated during that period as if it had been designated “HIGHLY CONFIDENTIAL –
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`OUTSIDE COUNSEL’S EYES ONLY” in its entirety unless otherwise agreed. After the
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`expiration of that period, and any extensions agreed upon by the Parties (and Non-Parties where
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`applicable), the transcript shall be treated only as actually designated.
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`(d)
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`For reports created by an Expert or Consultant relying on or incorporating
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`Protected Material in whole or in part, that the Party responsible for its creation include the
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`confidentiality designation “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – OUTSIDE
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`COUNSEL’S EYES ONLY” on the report.
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`4.2
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`Inadvertent Failures to Designate: If corrected, an inadvertent failure to designate
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`qualified information or items does not waive the Designating Party’s right to secure protection
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`under this Order for such material of the Producing Party learning of the inadvertent failure to
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`designate. The Party discovering such inadvertent failure to designate must promptly notify
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`counsel for the Receiving Party in writing. Upon such notification of an inadvertent failure to
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`designate, the Receiving Party must make reasonable efforts to assure the material is treated in
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`accordance with the provisions of this Order and notify the Producing Party of any disclosure of
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`the Protected Material, including identifying the persons or entities to whom the Protected Material
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`was disclosed, within ten (10) days of the notification by the Producing Party. The Producing
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`Party shall reproduce the Protected Material with the correct confidentiality designation upon its
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`notification to the Receiving Party. Upon receiving the Protected Material with the correct
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`confidentiality designation, the Receiving Party shall return or securely destroy all Discovery
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`Material that was not designated properly.
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`A Receiving Party shall not be in breach of this Order for any use of such Discovery
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`Material before the Receiving Party receives notice that such Discovery Material is protected under
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`one of the categories of this Order.
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`4.3
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`Upward Designation of Information or Items Produced by Other Parties or Non-
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`Parties: A Party may upward designate (i.e., change any Discovery Material produced without a
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`designation of “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S
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`EYES ONLY” to one of those designations, or change any Discovery Material produced as
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`“CONFIDENTIAL” to a designation of “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S
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`EYES ONLY”) any Discovery Material produced by another Party or Non-Party, provided that
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`said Discovery Material contains the upward Designating Party’s “CONFIDENTIAL” or
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`“HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” Material, or otherwise is
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`entitled to protective treatment under Federal Rule of Civil Procedure 26(c) or other law, foreign
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`or domestic, such that the upward designation is appropriate under the terms of this Order. Upward
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`designation shall be accomplished by providing written notice to all Parties identifying (by Bates
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`number or other individually identifiable information) the Discovery Material to be re-designated.
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`Any Party may object to the upward designation of Discovery Material pursuant to the procedures
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`set forth in Section V regarding challenging designations.
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`V.
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`CHALLENGING CONFIDENTIALITY DESIGNATIONS
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`5.1
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`Timing of Challenges: Any Party or Non-Party may challenge a designation of
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`confidentiality at any time consistent with the Court’s Scheduling Order. A Party does not waive
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`its right to challenge a confidentiality designation by electing not to mount a challenge promptly
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`after the original designation is disclosed.
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`5.2 Meet and Confer: If a Party elects to challenge a Designating Party’s
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`confidentiality designation, it must do so in good faith and must begin the process by notifying the
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`Designating Party in writing of its challenge and identifying the challenged material with as much
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`specificity as reasonably practical, including for example, by production number, and by providing
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`a basis for the challenge. The objecting Party and the Designating Party shall, within seven (7)
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`days after service of the written objections, meet and confer concerning the objections, unless
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`otherwise agreed. The Parties shall meet and confer regarding any challenge to confidentiality
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`designations before raising those disputes with the Court.
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`5.3
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`Judicial Intervention: If the Parties are not able to resolve a dispute about a
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`confidentiality designation during the meet and confer process set forth in Section 5.2, the Party
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`challenging the designation may seek relief promptly from the Court in accordance with its rules
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`and procedures. At all times, the Designating Party carries the burden of establishing the propriety
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`of the designation and protection level. Until the Court rules on the dispute, all Parties shall
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`continue to afford the material in question the level of protection to which it is entitled under the
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`Designating Party’s designation. In the event the Court rules that the challenged material’s
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`designation should be changed, the Designating Party shall reproduce copies of all materials with
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`their designations removed or changed in accordance with the ruling.
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`VI.
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`ACCESS TO AND USE OF DISCOVERY MATERIAL
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`6.1
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`Basic Principles. A Receiving Party may access or use Protected Material that is
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`disclosed or produced by a Producing Party only in connection with the prosecution of, defense
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`of, appeal of, attempted settlement of, or the enforcement of insurance rights with respect to this
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`action or any related appellate proceeding. Except as required by law, Discovery Material may
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`not be used for any other purpose, including, without limitation, any business or commercial
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`purpose, contractual demands, or any purpose related to any other investigation or proceeding.
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`With respect to disclosure of Discovery Material as required by law, the party intending to reveal
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`such Discovery Material shall provide reasonable notice and opportunity to object to the party that
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`produced the Discovery Material, unless consent from the party that produced the Discovery
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`Material was previously obtained. Protected Material may be disclosed only to the categories of
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`persons and under the conditions described in this Order. Following the termination of this action,
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`each Receiving Party must comply with the provisions of Section 12.1, below.
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`6.2
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`This Order does not preclude any Party or Non-Party from using Protected Material
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`with the consent of the Designating Party or by order of the Court.
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`6.3
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`The recipient of any Protected Material shall maintain such material in a secure and
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`safe area and shall exercise a standard of due and proper care with respect to the storage, custody,
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`use, and/or dissemination sufficient under all applicable laws to safeguard against unauthorized or
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`inadvertent disclosure of such material to persons or entities not authorized under this Order.
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`6.4
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`Disclosure of Confidential Material: Unless otherwise ordered by the Court or
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`permitted in writing by the Designating Party, material designated “CONFIDENTIAL” may be
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`disclosed by a Receiving Party only to the following persons:
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`(a)
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`(b)
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`The Receiving Party’s Outside Counsel;
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`Designated In-House Counsel of the Receiving Party who have signed the
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`“Agreement To Be Bound By Protective Order” (Exhibit A), following the required disclosure
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`procedure set forth in Paragraph 1.5;
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`(c)
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`Experts and/or Consultants retained by a Party or its Counsel to serve as an
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`expert witness or as a consultant in this action, following the disclosure procedure set forth in
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`Paragraph 6.6, provided that Counsel, in good faith, requires their assistance in connection with
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`this action; and provided further that any part of a report created by such expert or consultant
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`incorporating Protected Material in whole or in part shall be designated appropriately by the Party
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`responsible for its creation; and provided further that experts or consultants may not use Protected
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`Material for any purpose that does not relate to this action (including but not limited to other
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`litigations and other work in their respective fields);
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`(d)
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`(e)
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`The Court and its personnel;
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`Special masters, mediators, or other third parties who are appointed by the
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`Court or retained by the Parties for settlement purposes or resolution of discovery or other disputes
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`and their necessary personnel and, in the case of persons retained by the Parties, who have signed
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`the “Agreement To Be Bound By Protective Order” (Exhibit A);
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`(f)
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`Court reporters and/or videographers, their staffs, and Professional Vendors
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`to the extent that such disclosure is reasonably necessary for this action and with respect to
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`Professional Vendors only, those Professional Vendors must first sign the “Agreement To Be
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`Bound By Protective Order” (Exhibit A);
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`(g)
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`The author, addressees, or recipients of the document, or any other natural
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`person who reviewed or had access to such document during his or her employment as a result of
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`the substantive nature of his or her employment position, or who is specifically identified as an
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`author, addressee, or recipient in the document or its accompanying metadata;
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`(h)
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`(i)
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`Current employees of the Designating Party;
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`During their depositions or other evidentiary action, former employees of
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`the Designating Party to whom disclosure is reasonably necessary, unless otherwise ordered by
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`the Court;
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`(j)
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`Professional jury or trial consultants or mock jurors who have signed the
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`“Agreement To Be Bound By Protective Order” (Exhibit A);
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`(k)
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`(l)
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`Any other person agreed to by the Designating Party in writing; and
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`Any other person to whom the Court compels disclosure of the Confidential
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`Material or to whom disclosure is required by law.
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`6.5
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`Disclosure of “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES
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`ONLY” Material: Material produced and marked as “HIGHLY CONFIDENTIAL – OUTSIDE
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`COUNSEL’S EYES ONLY” may be disclosed by the Receiving Party only to individuals
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`identified in Paragraphs 6.4(a), (c)-(l), unless otherwise ordered by the Court or permitted in
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`writing by the Designating Party.
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`6.6
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`Any “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY”
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`material produced in discovery shall be made available in an electronic format allowing it to be
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`reasonably reviewed and searched. The Receiving Party’s Outside Counsel shall host any
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`electronically stored “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY”
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`material at their offices and/or the offices of any data hosting Professional Vendor employed by
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`said Outside Counsel, provided that the following restrictions shall apply:
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`(a)
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`Only Outside Counsel of record (and their support staff) and the hosting
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`Professional Vendor employed by said Outside Counsel shall have direct access to the database(s)
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`that store the entirety of the production of “HIGHLY CONFIDENTIAL – OUTSIDE
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`COUNSEL’S EYES ONLY” material;
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`(b)
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`The Receiving Party shall store “HIGHLY CONFIDENTIAL – OUTSIDE
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`COUNSEL’S EYES ONLY” material in a secure electronic review database in such a manner as
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`to allow the Receiving Party, if needed and with respect to a good-faith allegation of improper
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`disclosure and upon order of the Court, to generate a list of the specific documents by Bates number
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`from a Producing Party that a given individual has accessed or downloaded in the electronic review
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`database. Outside Counsel shall be required only to track the identity of Outside Counsel who
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`accessed specific documents in a secure electronic review database, but shall not otherwise be
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`required to track Outside Counsel who had access to documents by other means such as a print
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`copy, email, or the like. For clarity, the Receiving Party shall not be required to log any attorney
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`work product or material subject to Fed. R. Civ. P. 26(b)(4) that cites, excerpts, or otherwise
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`references “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” material. The
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`Receiving Party shall, within a reasonable period of time, provide a copy of this log to the
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`Producing Party upon request after order of the Court;
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`(c)
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`The Receiving Party may provide access to “HIGHLY CONFIDENTIAL –
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`OUTSIDE COUNSEL’S EYES ONLY” material to the individuals identified in Section 6.5.
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`Except as otherwise provided herein, the Receiving Party may only provide such access to
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`“HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” material to the
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`individuals identified in Paragraphs 6.4 (c), (f), (j), and (k) through a secured web-based interface,
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`a secure electronic review database, or a secure electronic file transfer portal (collectively, “Secure
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`File Platforms”) in such a manner as to allow the Receiving Party, if needed and with respect to
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`a good-faith allegation of improper disclosure and upon order of the Court, to generate a list of the
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`specific documents by Bates number from a Producing Party that a given individual has been
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`provided access to and/or downloaded. For clarity, the Receiving Party shall not be required to
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`log any attorney work product or material subject to Fed. R. Civ. P. 26(b)(4) that cites, excerpts,
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`or otherwise references “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY”
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`material. The Receiving Party shall, within a reasonable period of time, provide a copy of this log
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`to the Producing Party upon request after order of the Court; and
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`(d)
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`The Receiving Party shall maintain all paper copies of any printed portions
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`of the “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” material in a
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`secured, locked area when not in use or in transport. When in use or transport, access to such
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`materials shall be limited to those persons identified in 6.5. The Receiving Party shall not create
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`any electronic or other images of the paper copies and shall not convert any of the information
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`contained in the paper copies into any electronic format, except as provided in this section. The
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`Receiving Party shall only make additional paper or electronic copies if such additional copies are
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`(1) necessary to prepare court filings, pleadings, or other papers (including a testifying Expert’s
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`expert report), (2) necessary for deposition, or (3) otherwise necessary for the preparation of its
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`case. Subject to Section XI and the foregoing provisions of Section 6.6, all copies of any portion
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`of the “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” material in
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`whatever form shall be securely destroyed if they are no longer in use.
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`6.7
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`Procedures for Approving or Objecting to Disclosure of “CONFIDENTIAL” or
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`“HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY” Information or Items to
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`Experts.
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`(a)
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`Unless otherwise ordered by the Court or agreed to in writing by the
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`Designating Party, a Party that seeks to disclose to an Expert any information or item that has been
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`designated “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S
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`EYES ONLY” information first must make a written request to the Designating Party that (1) sets
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`forth the full name of the Expert and the city and state of his or her primary residence and (2)
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`attaches a copy of the Expert’s most recent curriculum vitae or resume, (3) provides a list of all
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`publications the Expert authored in the previous 10 years and a list of all other cases in which the
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`Expert testified as an expert at trial or by deposition in the previous 4 years, (4) discloses any work
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`the Expert has previously undertaken for any of the Parties, and (5) attaches a copy of the
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`“Agreement To Be Bound By Protective Order” (Exhibit A) signed by the Expert. If the most
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`recent curriculum vitae or resume of the Expert provides the information required under this
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`paragraph, then the information need not be separately provided.
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`(b)
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`A Party that makes a request and provides the information specified in the
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`preceding paragraph may disclose the subject Protected Material to the identified Expert unless
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`the Party receives a written objection from the Designating Party within seven (7) days of
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`delivering the request, or as otherwise agreed by the parties. Any such objection must set forth in
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`detail the grounds on which it is based.
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`(c)
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`A Party that receives a timely written objection must meet and confer with
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`the Designating Party to try to resolve the matter by agreement within seven (7) days of the written
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`objection, or as otherwise agreed by the parties. If no agreement is reached, the Party seeking to
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`prevent the disclosure to the Expert must initiate the applicable dispute resolution mechanism
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`within fourteen (14) days of the written objection, or as otherwise agreed by the parties.
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`In any such proceeding, the Party opposing disclosure to the Expert shall bear the burden
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`of proving that the risk of harm the disclosure would entail (under the safeguards proposed)
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`outweighs the Receiving Party’s need to disclose the Protected Material to the Expert.
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`6.8
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`Retention of Exhibit A: Counsel for the Party that obtains the signed “Agreement
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`To Be Bound By Protective Order” (Exhibit A), as required above, shall retain the hardcopy or
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`electronic copy for six (6) months following the final termination of this action, including any
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`appeals, and shall make them available to other Parties or the Court upon good cause shown.
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`VII.
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`PROSECUTION, FDA, AND COMPETITION BAR
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`7.1
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`Absent written consent from the Producing Party, any individual who receives
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`access to “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES
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`ONLY” information shall not be involved in the prosecution of patents or patent applications
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`pertaining to (1) lipid nanopartic