`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`TEVA PHARMACEUTICALS
`
`INTERNATIONAL GMBH and
`
`TEVA PHARMACEUTICALS
`
`USA, INC.,
`
`Plaintiffs,
`
`v.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`STIPULATED PROTECTIVE ORDER
`
`WHEREAS Plaintiffs Teva Pharmaceuticals International GmbH (“Teva GmbH”) and
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`Teva Pharmaceuticals USA, Inc. (“Teva USA” and together with Teva GmbH, “Plaintiffs” or
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`“Teva”) and Defendant Eli Lilly and Company (“Lilly” or “Defendant”) (Teva and Lilly
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`collectively, the “Parties”) expect that discovery in the above-captioned action (the “Litigation”)
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`will entail the disclosure and production of documents, things, testimony, and information
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`containing confidential, proprietary, personal, trade secret, and/or commercially sensitive
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`information within the meaning of Rule 26(c) of the Federal Rules of Civil Procedure;
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`WHEREAS the Parties believe that such information must be protected by certain terms
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`and conditions (the “Protective Order”) to preserve the Parties’ legitimate business interests;
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`WHEREAS the Parties have, through their undersigned counsel, stipulated to the entry of
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`this Protective Order in order to expedite the flow of discovery material, facilitate the prompt
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`resolution of any disputes over confidentiality, balance the Parties’ need for information to
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 2 of 33
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`conduct this Litigation against their need to maintain the confidentiality of information entitled
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`to be kept confidential; and
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`WHEREAS the Parties have established good cause for entry of this Protective Order;
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`IT IS HEREBY ORDERED that this Protective Order shall govern discovery in the
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`Litigation.
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`1.
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`Definitions. Words shall have their normally accepted meanings as employed in
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`this Protective Order. The word “shall” is mandatory. The words “includes” and “including” are
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`not limiting. The singular shall include the plural and vice versa. Additionally, the Parties
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`hereby incorporate by reference the definitions set forth in Rule 26.5 of the Local Rules of the
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`United States District Court for the District of Massachusetts (“Local Rules” or “L.R.”) as if
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`fully set forth herein. Certain definitions from the Local Rules have been reproduced below for
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`clarity. In addition, as used herein, the following words shall have the following meanings:
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`(a)
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`As used herein, the term “Document” is defined to be synonymous in
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`meaning and equal in scope to the usage of the term “documents or electronically stored
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`information” in Fed. R. Civ. P. 34(a)(1)(A) and Local Rule 26.5(c)(2). A draft or non-identical
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`copy is a separate document within the meaning of this term.
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`(b)
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`As used herein, the term “Information” includes information of any type,
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`kind or character whether it be a document, information contained in a document, information
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`revealed during a deposition, information revealed in an interrogatory or other discovery
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`response, or otherwise.
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`(c)
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`As used herein, the term “Litigation Material” shall mean Documents and
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`Information produced, disclosed (as outlined in Paragraph 7, below), or filed in the Litigation by
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`a Party or non-party, whether produced pursuant to formal or informal discovery requests or
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 3 of 33
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`motion practice, by agreement or otherwise, and whether revealed in a document, deposition
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`(including testimony and deposition exhibits), an interrogatory answer, a response to a request
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`for production or for admission(s), a submission to the court or otherwise, and including all
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`Documents and Information produced or disclosed by non-parties in this Litigation pursuant to
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`subpoena and/or deposition notice.
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`(d)
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`As used herein, the term “Producing Party” shall mean any Party to the
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`Litigation or any non-party or third party, including its counsel, retained experts, directors,
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`officers, employees, business partners, or agents, who produces, discloses, or files any Litigation
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`Material.
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`(e)
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`As used herein, the term “Receiving Party” shall mean any Party to the
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`Litigation, including its counsel, retained experts, directors, officers, employees, business
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`partners, or agents, who receives any Litigation Material.
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`(f)
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`As used herein, the term “Confidential Health Information” (“CHI”) shall
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`mean any patient health information protected by any state or federal law. CHI includes, without
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`limitation, information relating to: the past, present, or future physical health, mental health,
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`condition, or medical treatment of an individual which identifies or reasonably could be expected
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`to identify the individual. It also includes, but is not limited to, medical bills, claims forms,
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`charges sheets, medical records, medical charts, test results, notes, dictation, invoices, itemized
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`billing statements, remittance advice forms, explanation of benefits, checks, notices, and
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`requests, and includes all notes, summaries, compilations, extracts, abstracts or oral
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`communications that are based on or derived from CHI, regardless of form or format. CHI does
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`not include any document or information in which the Producing Party has redacted the
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`identifiers listed and does not have actual knowledge that information could be used alone or in
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 4 of 33
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`combination with other information to identify an individual who is subject of the information.
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`A Producing Party may, but is not required to, perform such redactions before producing
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`documents that originally contained CHI so long as the redactions do not result in prejudice to
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`another party.
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`(g)
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`As used herein, the term “Final Resolution of the Litigation” shall mean
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`the date thirty (30) calendar days following:
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`(i)
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`the Court’s entry of a stipulated dismissal disposing of all claims
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`and counterclaims in the Litigation,
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`(ii)
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`the Court’s entry of a voluntary dismissal disposing of all claims and
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`counterclaims in the Litigation, or
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`(iii)
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`the entry of a final, non-appealable order disposing of the case.
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`(h)
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`As used herein, the term “In-House Counsel” shall mean attorneys who
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`are employees of a Party, licensed patent attorneys admitted to practice before a national or
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`European patent office who are employees of a Party, or scientific litigation advisors who are
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`employees of a Party working in the Party’s legal department who are responsible for overseeing
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`this Litigation for a Party and who do not and shall not have direct responsibility for prosecuting
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`or filing any patent applications involving fremanezumab, galcanezumab, or any other anti-
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`CGRP antagonist antibody, and do not and shall not have direct responsibility for submitting
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`regulatory documents to FDA or for communications with FDA involving fremanezumab,
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`galcanezumab, or any other anti-CGRP antagonist antibody, including without limitation any
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`Citizen Petition, with the exception of the preparation of a notification under 42 U.S.C.
`
`§ 262(l)(6)(C)(i).
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 5 of 33
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`2.
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`Scope of Protective Order. This Protective Order includes within its scope any
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`and all Litigation Material.
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`3.
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`Scope and Designation of Confidentiality. “Protected Information” shall include
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`Litigation Material designated either “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL—
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`OUTSIDE COUNSEL ONLY,” as defined below. No information shall be regarded as
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`Protected Information:
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`(a)
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`if it is in the public domain at the time of disclosure, as evidenced by a
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`document, electronically stored information, or tangible thing;
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`(b)
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`if it becomes part of the public domain through no fault of the Receiving
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`Party, as evidenced by a document, electronically stored information, or tangible thing;
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`(c)
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`if it was in the rightful and lawful possession of the Receiving Party prior
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`to the time of the disclosure, without any applicable obligation of confidentiality, as evidenced
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`by a document, electronically stored information, or tangible thing; or
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`(d)
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`if it is received lawfully by the Receiving Party at a later date from a third
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`party without restriction as to disclosure, provided that such third party has the right to make
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`such unrestricted disclosure to the Receiving Party.
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`4.
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`Designation as “CONFIDENTIAL”. The designation “CONFIDENTIAL” shall
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`mean information that the Producing Party in good faith believes is of a proprietary or
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`commercially sensitive nature and/or information that is required to be treated as confidential
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`pursuant to statute or common law, including applicable foreign data privacy laws, including, but
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`not limited to, information that the Producing Party in good faith believes constitutes a trade
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`secret in the possession of the Producing Party, including the trade secrets of the Producing
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`Party’s customers, vendors, accountants, underwriters, or other party, that the Producing Party in
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`5
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 6 of 33
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`good faith believes constitutes other highly sensitive proprietary information that is entitled to
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`additional protections, or that is not generally available in the public domain and for which
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`Paragraphs 3(a)-(d) do not apply. Information designated “CONFIDENTIAL” may include, but
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`is not limited to, materials relating to research, development, commercial, personnel, or
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`marketing information that is non-public and confidential or proprietary, the value of which
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`arises from its secrecy.
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`5.
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`Designation as “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY”.
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`The designation “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY” is limited to
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`information that the Producing Party in good faith believes constitutes technical or business
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`information of a most sensitive nature that might be of significant value to an actual or potential
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`competitor of the Producing Party and which must be protected from disclosure as set forth
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`herein. Information designated “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY”
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`may include CHI, documents detailing highly sensitive research and development for any
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`indications or products that were not approved as of the filing of the Complaint in this Litigation,
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`projections related to FDA regulatory approval for indications or products that were not
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`approved as of the filing of the Complaint in this Litigation, future business plans or strategy,
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`financial analyses and projections, P&L statements, pricing, revenue, cost, contractual
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`relationships with third parties, and the identification of customers and suppliers.
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`6.
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`Limited Use of Discovery.
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`(a)
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`All Protected Information shall be used solely for this Litigation and the
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`preparation and trial in this Litigation (including any retrials and any appellate proceeding
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`resulting from this Litigation), and not for any other purpose whatsoever, including without
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`limitation, any other litigation; patent prosecution; post grant proceedings before the United
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`6
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 7 of 33
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`States Patent and Trademark Office, including without limitation, patent reexamination and
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`reissue proceedings; acquisition; or any communication with any U.S. or foreign regulatory
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`agency including, but not limited to, the FDA, or any business, research, development or
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`competitive purpose or function. Protected Information must not be distributed, disclosed, or
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`made available to anyone except as expressly provided in this Protective Order. This Protective
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`Order places no limitation on a Producing Party’s use or disclosure of its own Protected
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`Information.
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`(b)
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`Any person who receives or reviews HIGHLY CONFIDENTIAL—
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`OUTSIDE COUNSEL ONLY information produced by any party other than his or her client
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`shall not thereafter, during the pendency of the instant litigation and for one year after the final
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`conclusion of this litigation, including appeals:
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`(i)
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`Amend, draft, or otherwise substantively assist in the drafting or
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`amending of patent claims in any patent prosecution, reexamination, post-grant review (“PGR”),
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`or inter partes review (“IPR”) proceeding pertaining to fremanezumab, galcanezumab, or any other
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`anti-CGRP antagonist antibody.
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`(ii)
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`Participate in or aid in the filing of any FDA Citizen Petition related
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`to the technology that is the subject matter of the instant litigation.
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`(iii)
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`The foregoing restrictions of this Paragraph 6(b) shall apply only to
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`individuals, and not to the firms or organizations by which they are employed, nor to individuals
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`who received access to Protected Information solely in their capacity as clerical staff.
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`(c)
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`Protected Information and the information derived from such Protected
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`Information shall be kept confidential and shall not be given, shown, made available, discussed,
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 8 of 33
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`or otherwise directly communicated in any manner to any person not authorized to receive the
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`information under the terms of this Protective Order.
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`(d)
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`All Protected Information, including, but not limited to electronically
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`stored data, shall be maintained by the Receiving Party at a location and under circumstances to
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`ensure that access is limited to those persons entitled to have access under this Protective Order.
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`7.
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`Access to Protected Information
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`Unless otherwise ordered by the Court or permitted in writing by a Producing Party,
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`Protected Information may be disclosed only as follows:
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`(a)
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`Materials designated as “HIGHLY CONFIDENTIAL—OUTSIDE
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`COUNSEL ONLY” pursuant to this Protective Order, including copies thereof, extracts
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`therefrom, compilations and/or summaries thereof and information therein, may be disclosed
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`only to the following persons:
`
`(i)
`
`Any attorney who serves as outside counsel of record to any Party
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`to this Litigation and all attorneys, legal assistants, stenographic and clerical employees working
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`under the supervision of such attorney in this Litigation;
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`(ii)
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`The Parties’ independent expert(s) or consultant(s) in accordance
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`with Paragraphs 10 and 13 herein;
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`(iii)
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`Any person with prior knowledge of the Protected Information
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`designated “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY” in accordance with
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`Paragraph 13 herein;
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`(iv)
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`Any person from whom testimony is taken, where such person was
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`the author or specified recipient of the Protected Information or is the present employee or expert
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`witness for the Producing Party, or where counsel for the Producing Party has, either before or
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 9 of 33
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`during the deposition, approved the disclosure of such materials to that person, except that such
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`person may not retain any such Protected Information;
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`(v)
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`The Court and court personnel in this Litigation, including any
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`Court-appointed Special or Discovery Master, any Court-appointed mediator, any mediator agreed
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`to by the Parties, and any Court reporter or videographer transcribing or recording testimony,
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`whether at a deposition, hearing, or trial in accordance with Paragraph 21 herein;
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`(vi) Any person designated by the Court, in the interest of justice, upon
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`such terms as the Court may deem proper;
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`(vii) Any interpreters, or court or other shorthand reporters or typists
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`translating, recording or transcribing testimony;
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`(viii) Any employee of outside counsel of record or service contractors
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`(such as document copy services) involved in organizing, filing, coding, converting, storing or
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`retrieving data or in designing programs for handling documents or data connected with these
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`actions, including the performance of such duties in relation to a computerized litigation support
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`system in accordance with Paragraph 13 herein; and
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`(ix) Any employee of outside counsel of record or third-party contractor
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`involved in trial preparation in accordance with Paragraph 13 herein;
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`(x)
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`Any translators; persons providing graphics or design or document
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`services for purposes of preparing demonstrative or other exhibits in this Litigation; and non-
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`technical jury or trial consulting services in accordance with Paragraph 13 herein.
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`(b) Materials designated as “CONFIDENTIAL” pursuant to this Protective
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`Order, including copies thereof, extracts there from, compilations and/or summaries thereof and
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`information therein, may be disclosed to the persons designated and under the conditions
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`9
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 10 of 33
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`described in subparagraph 7(a), above, as well as three (3) designated In-House Counsel, in
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`accordance with Paragraphs 11 and 12 herein, for each of the Parties.
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`8.
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`Manner of Disclosure. The provisions of this Protective Order extend to all
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`Protected Information regardless of the manner in which it is disclosed, including but not limited
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`to any interrogatory answers; responses to requests for production or admission(s); deposition
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`testimony, transcripts, and exhibits; pleadings, motions, affidavits, briefs or other papers filed
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`with the Court that include quotes of, summaries of or copies of documents that may be accorded
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`status as Protected Information but, to the extent feasible, shall be prepared in such a manner that
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`the Protected Information is bound separately from the portions of the document not entitled to
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`protection; and any other discovery materials produced in response to or in connection with any
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`discovery conducted in the Litigation, in each case that has been designated consistent with the
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`manner set forth in Paragraph 9, and any copies, notes, abstracts or summaries of the foregoing
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`materials.
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`9.
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`Manner of Designating Confidentiality. Documents or information may be
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`designated as Protected Information within the meaning of this Protective Order in the following
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`ways:
`
`(a)
`
`In the case of documents and the information contained therein,
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`designation shall be made by means of placing a stamp, label, or other clear designation stating
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`“CONFIDENTIAL” or “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY” on the
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`documents to be so designated. In cases where it is impractical to stamp each page of a
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`document, the Producing Party shall indicate on the face of the document that the entire
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`document is either “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL—OUTSIDE
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`COUNSEL ONLY”
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`10
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 11 of 33
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`(b)
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`In the case of interrogatory answers, responses to requests for admissions
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`and the information contained therein, designation shall be made by placing on the front of any
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`set of interrogatory answers or responses to requests for admission containing Protected
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`Information: “Contains information designated [select one or more as appropriate]
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`CONFIDENTIAL/ HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY.” Designated
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`parts are not to be used, copied, or disclosed except as authorized by this Protective Order.
`
`(c)
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`Subject to Paragraph 25, designation of documents as “CONFIDENTIAL”
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`or “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY” will be made before or at the
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`time of production.
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`(d)
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`In the case of depositions and the information contained in depositions
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`(including exhibits), designation of the whole transcript or portions of the transcript (including
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`exhibits) that contain Confidential Information shall be made either on the record at the
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`deposition or by written notice from counsel within thirty (30) calendar days of receipt of the
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`deposition transcript. If the testimony involves material that a non-party designated as Protected
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`Information, the person taking the deposition must consult that non-party to determine whether
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`the affected portions of the testimony should be designated as Protected Information. The entire
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`deposition transcript (including exhibits) shall be treated as HIGHLY CONFIDENTIAL—
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`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
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`transcript of his or her own deposition during this thirty-day period. The Parties may also agree
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`to extend the time period for providing such designations. If no party or deponent timely
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`designates deposition testimony as “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL—
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`OUTSIDE COUNSEL ONLY”, none of the transcript or its exhibits will be treated as Protected
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`11
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 12 of 33
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`Information. If a timely designation is made, the confidential portions and exhibits shall be filed
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`under seal, separate from the portions and exhibits not so designated and all copies of the
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`confidential portions and exhibits shall be treated as Protected Information pursuant to the terms
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`of this Protective Order. If any party in good faith disagrees with a confidentiality designation of
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`any portion of a deposition transcript or of any deposition exhibit, the procedures of
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`Paragraph 14, below, will govern. Further, the notation, “Contains information designated
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`[select one or more as appropriate] CONFIDENTIAL/ HIGHLY CONFIDENTIAL—OUTSIDE
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`COUNSEL ONLY” shall be placed on the front of the deposition transcript, and, if the
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`deposition is videotaped, on the videocassette, CD-ROM, DVD, or other video container.
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`Designated parts are not to be used, copied, or disclosed except as authorized by this Protective
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`Order. Counsel retaining court reporters shall have the responsibility for ensuring their
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`compliance with this paragraph. No person shall attend the designated portions of such
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`depositions unless such person is an authorized recipient of Protected Information under the
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`terms of this Protective Order or the Parties agree to such person’s attendance.
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`(e)
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`To the extent that matter stored or recorded in the form of electronic or
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`magnetic media (including information, databases or programs stored on computers, discs,
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`networks or tapes) (“Computerized Material”) is produced by any Producing Party in such form,
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`the Producing Party may designate such matter as “CONFIDENTIAL” or “HIGHLY
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`CONFIDENTIAL—OUTSIDE COUNSEL ONLY” by placing a stamp, label or other clear
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`designation stating “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL—OUTSIDE
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`COUNSEL ONLY” on the disc or tape containing the Computerized Material.
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`10.
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`Disclosure To And Identification Of Experts and Consultants. If any Party
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`desires to disclose “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL—OUTSIDE
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`12
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 13 of 33
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`COUNSEL ONLY” information of another Party to any Expert or Consultant, it must first
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`identify each Expert or Consultant to the Producing Party’s attorneys in writing. Such
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`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 publications
`
`authored; (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; (4) a list of the Expert or Consultant’s past five years of
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`consulting history; and (5) an executed copy of the Acknowledgement and Agreement to be
`
`Bound (see Exhibit A).
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`The attorneys for the Producing Party shall have five (5) business days from receipt of
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`such notice to object to such disclosure, during which time no such disclosure shall be made.
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`If the Producing Party does object to the proposed disclosure, the Parties shall meet and
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`confer within five (5) business days of receipt of such objection to resolve the disagreement.
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`If the Parties are not able to come to an agreement, the Producing Party shall have the
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`burden of moving the Court for an order prohibiting the disclosure within ten (10) business days
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`of the meet and confer. If no motion is filed within ten (10) business days, the Producing Party’s
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`objection will be deemed withdrawn and the Receiving Party may share Confidential
`
`Information with the Expert or Consultant. 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
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`shall not be made until the Court has ruled on the motion and response. If the Court orders
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`disclosure, such disclosure shall not in any way affect the designation of the material or
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`information disclosed, nor shall it allow any Party to deviate from the requirements of this
`
`Protective Order regarding disclosure to any other person.
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`13
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 14 of 33
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`11.
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`Disclosure To And Identification Of In-House Counsel. If any Party desires to
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`disclose “CONFIDENTIAL” information of another Party to up to three (3) In-House Counsel, it
`
`must first identify such In-House Counsel to the Producing Party’s attorneys in writing. In-
`
`House Counsel identified under this paragraph shall review and sign an Acknowledgement and
`
`Agreement to be Bound attached as Exhibit A.
`
`The initial designations for Teva are as follows:
`
`FULL NAME OF IN-HOUSE
`COUNSEL (TEVA)
`Staci L. Julie, Esq.
`
`Senior Vice President and Chief
`IP Counsel
`
`JOB TITLE
`
`PROFESSIONAL ADDRESS
`
`Teva Pharmaceuticals
`145 Brandywine Parkway
`West Chester PA 19380
`Teva Pharmaceuticals
`Morris Corporate Center III
`400 Interpace Parkway
`Parsippany, NJ 07054
`Teva Pharmaceuticals
`Morris Corporate Center III
`400 Interpace Parkway
`Parsippany, NJ 07054
`
`Eli Lilly and Company
`Lilly Corporate Center,
`Indianapolis, IN 46285
`Eli Lilly and Company
`Lilly Corporate Center,
`Indianapolis, IN 46285
`Eli Lilly and Company
`Lilly Corporate Center,
`Indianapolis, IN 46285
`
`Colman Ragan, Esq.
`
`VP & General Counsel North
`America IP Litigation
`
`Lori Wolfe, Esq.
`
`Associate General Counsel,
`North America IP Litigation
`
`The initial designations for Lilly are as follows:
`
`FULL NAME OF IN-HOUSE
`COUNSEL (LILLY)
`Mark J. Stewart, Ph.D., J.D.
`
`Sr. Director – Asst. General
`Patent Counsel, IP Litigation
`
`Sanjay M. Jivraj, Ph.D., J.D. Asst. General Patent Counsel,
`IP Litigation
`
`Gerald P. Keleher, Ph.D., J.D. Advisor – Patent Research
`
`JOB TITLE
`
`PROFESSIONAL ADDRESS
`
`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
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`writing the proposed substitute In-House Counsel being added and the In-House Counsel being
`
`14
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 15 of 33
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`removed. Such identification shall include the proposed In-House Counsel’s: (1) full name; (2)
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`job title; and (3) professional address. Substitute In-House Counsel identified under this
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`paragraph shall review and sign an Acknowledgement and Agreement to be Bound attached as
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`Exhibit A.
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`The Producing Party shall have five (5) business days from receipt of such notice to
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`object to such substitution, during which time no such disclosure shall be made.
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`If the Producing Party objects to the proposed substitution, the Parties shall meet and
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`confer within five (5) business days of receipt of such objection to resolve the disagreement.
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`If the Parties are not able to come to an agreement, the Receiving Party shall have the
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`burden of moving the Court for an order allowing the disclosure. The Producing Party shall have
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`ten (10) business days after the receiving party has filed a motion seeking disclosure to respond.
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`If no motion is filed, the Producing Party’s objection is deemed withdrawn. If the Court issues
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`an order permitting disclosure, such disclosure shall not in any way affect the designation of the
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`material or information disclosed, nor shall it allow any Party to deviate from the requirements of
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`this Protective Order regarding disclosure to any other person.
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`13.
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`Preservation of Executed Acknowledgements. Before disclosing Protected
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`Information to any persons, such as Experts and Consultants, who are not parties to this
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`Litigation but will have access to Protected Information, the Receiving Party shall ensure each
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`such person to whom disclosure of Protected Information is to be made has been provided with a
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`copy of the Protective Order and has reviewed and signed an Acknowledgement and Agreement
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`to be Bound attached as Exhibit A, thereby agreeing to be bound by the terms of this Order
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`concerning receipt and disclosure of Protected Information.
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 16 of 33
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`(a) Where a company or firm is retained by outside counsel or a Party
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`pursuant to Paragraph 7(a)(viii), it shall be sufficient for the purposes of this Protective Order
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`that a representative of the company or firm sign a copy of the Acknowledgement and
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`Agreement to be Bound on behalf of that company or firm. That signatory shall be responsible
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`for ensuring that any employee, consultant, or representative of that company or firm abides by
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`the provisions of this Protective Order.
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`(b)
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`The originals of any executed Acknowledgment and Agreement to be
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`Bound (or electronic copies thereof) shall be deemed work product, and the Party who obtains
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`them shall maintain then until one (1) year after the Final Resolution of the Litigation.
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`14.
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`Challenges to Designations. The Producing Party bears the burden of establishing
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`confidentiality. The following procedures shall govern any challenges to confidentiality
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`designations:
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`(a)
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`If a Party in good faith believes that information should not be designated
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`as Protected Information or should have a different confidentiality designation, it must specify to
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`the Producing Party in writing (i) the information challenged and (ii) the grounds for questioning
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`the confidentiality designation. Upon the Producing Party’s receipt of written notification, the
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`parties will confer in an effort to resolve the dispute without Court intervention.
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`(b)
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`If, after conferring, the Receiving Party and the Producing Party do not
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`reach agreement despite good faith efforts to do so, then any party may move for a determination
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`by the Court as to the appropriateness of the confidential designation within ten (10) business
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`days after conferring. The proponent of confidentiality must show by a preponderance of the
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`evidence that the confidentiality designation is appropriate under this Order. . Until the Court
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`renders a decision that the information is not subject to the Protective Order and any and all
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`Case 1:18-cv-12029-ADB Document 58 Filed 07/15/20 Page 17 of 33
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`proceedings or interlocutory appeals challenging such decision have been concluded, the
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`confidentiality designation shall remain in effect.
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`Nothing in this Protective Order shall be deemed to allocate or reallocate any substantive
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`burdens with respect to confidentiality, which shall be determined in accordance with governing
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`law.
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`15.
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`Option to Redact Information. The Producing Party may choose to produce
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`documents, electronically stored information, or tangible things in redacted form. Such
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`redactions may be made to (1) information that is protected by the attorney-client privilege, the
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`work-product doctrine or other legal privilege protecting information from discovery in the
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`Litigation, which shall be identified in a privilege log, but no privilege log entry is required
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`where the face of the document containing the redacted information provides what would
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`otherwise appear on a privilege log, (2) CHI; (3) personal information not the specific focus of a
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`Request for Production and (4) trade secret and confidential commercial information not relevant
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`to this Litigation, including but not limited to (i) any information related to products not relevant
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`to this Litigation; (ii) any irrelevant information protected by confidentiality agreements with any
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`third party. The Producing Party shall make it clear that a redaction has been made on each
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`redacted portion of the document, electronically stored information, or tangible thing and such
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`redaction shall be labeled with the basis for the redaction. A Receiving Party may, in good faith
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`and within reason, request in writing that the Producing Party provide the basis for any
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`redactions made to one or more identifi