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`Case 1:15-cv-OO697-RGA Document 31 Filed 12/18/15 Page 1 of 19 PagelD #: 172
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`
`
`v.
`
`Civil Action No. 15-697-RGA
`
`AMNEAL PHARMACEUTICALS LLC
`
`Defendant.
`
`|PROPOSED| STIPULATED PROTECTIVE ORDER
`
`Plaintiff Hospira, Inc. (“Hospira”) and Defendant Amneal Pharmaceuticals LLC
`
`(“Amneal”; collectively with Hospira, the “Parties”), having stipulated to the entry of this
`
`Protective Order (“Order”) pursuant to Federal Rule of Civil Procedure 26(c) to facilitate the
`
`orderly completion of discovery, request entry of the following Protective Order.
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`1.
`
`Scope of Order. This Protective Order shall apply to all information, documents,
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`and things produced by any Producing Party or third-party to a Receiving Party in the
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`above-captioned litigation (the “Action”) including, without limitation, all testimony adduced at
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`depositions, documents or things produced in response to requests for the production of documents
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`and things, answers to interrogatories, responses to requests for admission, and all other discovery
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`taken pursuant to the Federal Rules of Civil Procedure, as well as hearing or trial transcripts,
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`matters in evidence, and any other information furnished, directly or indirectly, by or on behalf of
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`any Party to this Action.
`
`2.
`
`Definitions.
`
`a.
`
`The term “Producing Party” shall mean the Party or person designating
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`documents or information as Confidential Information under this Order.
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`

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`b.
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`The term “Receiving Party” shall mean the Party to whom the Confidential
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`Information is disclosed.
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`c.
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`The term “In-House Counsel” shall mean attorneys who are employees of a
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`Party or employed by an affiliate of a Party (e. g., a parent company) who are responsible
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`for overseeing this Action for a Party and who are not involved in competitive decision-
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`making and do not and shall not have responsibility for, or involvement in, prosecuting or
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`filing any patent applications involving dexmedetomidine or dexmedetomidine products,
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`and do not and shall not have responsibility for submitting regulatory documents to or
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`communications with regulatory agencies involving dexmedetomidine or
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`dexmedetomidine products, including without limitation any Citizen Petition, or the like.
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`d.
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`The term “Confidential Information” shall mean and include any
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`information, document, or thing, or portion of any document or thing:
`
`i.
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`that contains: trade secrets, competitively sensitive technical, marketing,
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`financial, sales, or other confidential business information (including but
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`not limited to non—public business plans and strategies; non-public business
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`relationship information pertaining to potential and/or existing customers,
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`competitors, suppliers, distributors, affiliates, subsidiaries, and parents;
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`information related to budgeting, accounting, sales figures, and advertising
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`expenditures; non-public information concerning research, development,
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`testing, or evaluation of pharmaceuticals; non—public patent applications
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`and files; non-public manufacturing information; non—public license
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`agreements or negotiations; non-public information concerning drug
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`applications; and non-public communications with the Food and Drug
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`

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`Administration). Information designated as “Confidential Information”
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`may include, but shall not be limited to, materials relating to the research,
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`development, manufacturing, marketing, sales and regulatory approval of
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`dexmedetomidine or dexmedetomidine products;
`
`ii.
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`that contains private or confidential personal information (including but not
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`limited to information concerning compensation, evaluations, and other
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`employment information);
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`iii.
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`that contains information received in confidence from third parties; or
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`iv. which the Producing Party otherwise believes in good faith to be entitled to
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`protection under Rule 26(c)(1) of the Federal Rules of Civil Procedure.
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`v. All copies, recordings, abstracts, excerpts, analyses, or other writings,
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`documents or things that contain, reveal, or otherwise disclose such
`
`Confidential Information shall be deemed Confidential Information.
`
`3.
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`Manner of Designating Confidential Information. Any Party to this Action and
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`any third party shall have the right to designate information, documents, or things, in accordance
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`with the procedures set forth herein, as “Confidential Information” subject to this Order. The
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`Producing Party may designate material as Confidential Information in the following manner:
`
`a.
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`Documents and Things. The Producing Party shall label or mark
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`documents and things that constitute or contain Confidential Information as
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`“CONFIDENTIAL.” At least the first page of a document and every page of the document
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`on which Confidential Information appears shall be so labeled or marked.
`
`b.
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`Non-Written Material. With respect to non—written material and other
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`material that cannot be marked on its face, such as recordings, magnetic media,
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`

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`photographs, and things, the Producing Party shall label or mark the material, the
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`container, or the package as “CONFIDENTIAL.”
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`0.
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`Inspections of Documents and Things. Inspections of documents and
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`things by any Party shall be conducted by persons authorized to access Confidential
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`Information under Paragraph 6 below. Such persons shall initially treat all information
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`obtained from any inspection as Confidential Information until such time as copies of the
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`documents or things from the inspection are produced, and, thereafter, such produced
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`documents and things shall be treated in accordance with the confidentiality designation
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`appearing on the document or thing at the time of its production.
`
`d.
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`Court Filings and Written Discovery. Any affidavit, brief,
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`memorandum, or other paper filed with the court in this Action, or any discovery request or
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`response served on a Party, containing Confidential Information, shall be designated on its
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`face near the caption and on every page containing such information with an appropriate
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`legend in the form set forth in Paragraph 3(a). In addition, every response to written
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`discovery that contains or constitutes Confidential Information shall indicate that it
`
`constitutes or contains such information.
`
`e.
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`Deposition Testimony. When deposition testimony is or
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`contains Confidential Information, any attorney of record present may so designate that
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`testimony by notifying others present on the record of the deposition. The deposition
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`reporter shall then so mark the transcript that reports that portion of the testimony. The
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`Parties also may designate the entire deposition testimony of a witness as containing
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`Confidential Information. With respect to any depositions that involve a disclosure of
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`Confidential Information, including exhibits, the Producing Party shall have until fourteen
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`

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`(14) calendar days after receipt of the deposition transcript within which to inform all other
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`Parties in writing of the specific pages and lines of the transcript and exhibits that are to be
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`designated, which period may be extended by agreement of the Parties. No such
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`deposition transcript or exhibits or information contained therein shall be disclosed to any
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`individual other than the individuals described in Paragraphs 6(a)-(e) and (g)-(h) and the
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`deponent during these fourteen (14) calendar days, and no individual attending such a
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`deposition shall disclose the contents of the deposition to any individual other than those
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`described in Paragraphs 6(a)-(e) and (g)-(h) during said fourteen (14) calendar days. Upon
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`being informed that certain portions of a deposition are to be designated as Confidential, all
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`Parties shall immediately limit disclosure of that transcript in accordance with Paragraphs
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`4 and 6. If no such designations are made either on the record at the time the deposition is
`
`taken or within the time period specified above, the transcript and exhibits shall not be
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`deemed to contain Confidential Information. At the expiration of the fourteen (14)
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`calendar day period, unless designations in writing or at deposition are provided prior to
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`the expiration of said period, the entire transcript and exhibits, or any part thereof that is not
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`designated, shall be deemed non-confidential.
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`4.
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`Limited Use of Confidential Information. All Confidential Information received
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`from a Producing Party shall be disclosed, disseminated, and used by the Receiving Party solely
`
`for purposes of the prosecution or defense of this Action, or any related appellate proceeding, and
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`shall not be used by the Receiving Party for any other business, commercial, competitive,
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`personal, or other purpose, including without limitation use or citation in any submissions to the
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`FDA, USPTO, or other regulatory bodies, and shall not be disclosed by the Receiving Party to
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`

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`anyone other than those set forth in Paragraph 6, unless and until the restrictions herein are
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`removed either by written agreement of the Producing Party or by Order of the Court.
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`5.
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`Maintenance of Confidential Information. Designations of Confidential
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`Information shall constitute a representation that there is a valid basis for such designation. The
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`attorneys of record for the Parties shall exercise reasonable efforts to ensure that the information
`
`and documents governed by this Order are (i) used only for the purposes set forth herein, and (ii)
`
`disclosed only to authorized persons. Moreover, any person in possession of Confidential
`
`Information shall exercise reasonably appropriate care with regard to the storage, custody, or use
`
`of such information to ensure that the confidential nature of the same is maintained.
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`6.
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`Access to Confidential Information. Except with the prior written
`
`consent of the Producing Party, and subject to Paragraph 19 below, material designated as
`
`“Confidential Information” pursuant to this Protective Order, including copies thereof, extracts
`
`there from, compilations and/or summaries thereof and information therein, any writing or thing
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`containing or revealing such material, may be disclosed only to the following persons:
`
`a.
`
`Any attorney who serves as outside counsel of record to any Party to this
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`Action and supporting personnel employed in the law firm(s) of outside litigation counsel
`
`of record, such as attorneys, paralegals, clerks, secretaries, contract attorneys, IT
`
`personnel, and clerical personnel for the respective Parties to this litigation;
`
`b.
`
`The following In-House Counsel employed by each of the Parties who are
`
`actively working on or are responsible for this case:
`
`0
`
`Hospira: Leah Taylor, Vice President, Intellectual Property;
`
`Michael P. Bauer, Senior Counsel, Intellectual Property;
`
`

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`
`Amneal: Lars Taavola, Senior Patent Counsel; Bryan
`
`o
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`Sommese, Director, Global Intellectual Property; and Kenneth
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`Zeidner, Senior Patent Counsel, Senior Director, Global
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`Intellectual Property;
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`provided that before the disclosure of any Confidential Information, such In-House
`
`Counsel has signed the undertaking attached hereto as Exhibit A, and the undertaking
`
`has been provided to outside counsel for the other Party. Should the Parties seek to
`
`modify this Order pursuant to Paragraph 25 to permit access to Confidential
`
`Information by In-House Counsel not specifically identfied above, the Parties will
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`confer with each other in good faith to reach agreement prior to seeking modification. In
`
`the event the Parties are unable to reach agreement, they will seek the assistance of the
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`Court.
`
`c.
`
`The Parties’ independent expert(s) or consultant(s) retained by outside
`
`counsel for purposes of this action, not including officers, directors, or employees of any
`
`Party, provided they have signed the undertaking attached hereto as Exhibit A and have
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`been approved by the Producing Party according to Paragraph 8(b) and who are employed,
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`retained, or otherwise consulted by outside counsel of record to assist in any way in the
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`preparation for or trial of this litigation;
`
`d.
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`Secretarial, paralegal, clerical, duplicating, and data processing personnel
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`of the foregoing;
`
`e.
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`The Court and court personnel, in the conduct of their official duties, and
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`the trier of fact;
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`

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`f.
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`Any person from whom testimony is taken, if it appears that such person
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`was the author, recipient or intended recipient of the information, prepared or reviewed the
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`information prior to its production in the Action, or is employed by the Party who produced
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`the information, document, or thing, or if the Producing Party consents to such disclosure;
`
`g.
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`Vendors retained by or for the Parties to assist in preparing for pretrial
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`discovery, trial, and/or hearings including, but not limited to, court reporters, litigation
`
`support services (e. g., photocopying, videotaping, scanning, translating, or organizing,
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`storing or retrieving data in any form or medium), jury consultants, individuals to prepare
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`demonstrative and audiovisual aids for use in the courtroom or in depositions or mock jury
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`sessions, including staff, stenographic, and clerical employees of any of the foregoing
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`whose duties and responsibilities require access to such materials; provided, however, that
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`the vendor has an obligation of confidentiality to the Receiving Party, and the Receiving
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`Party has made such vendor aware of the provisions of this Order; and
`
`h.
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`Any other person, either with the prior written consent of the Producing
`
`Party or pursuant to an Order of the Court.
`
`7.
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`Limitations on Disclosure of Confidential Information. Confidential
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`Information shall be used only by individuals permitted access to it under Paragraph 6.
`
`Confidential Information and copies thereof shall not be disclosed in any manner to any other
`
`individual, until and unless (i) outside counsel for the Party asserting confidentiality waives the
`
`claim of confidentiality, or (ii) the Court orders such disclosure. If any such information is
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`disclosed to any person not entitled to receive disclosure of such information under this Order,
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`counsel for the Receiving Party will promptly inform counsel for the Producing Party and, without
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`

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`prejudice to other rights and remedies of any party, make a reasonable good faith effort to retrieve
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`such material and to prevent further disclosure of it by the person who received such information.
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`8.
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`Disclosure to and Identification of Experts and Consultants. If any Party
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`desires to disclose “CONFIDENTIAL” information of another Party to any expert or consultant, it
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`must first 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
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`address, and employer(s); and (2) an up—to—date curriculum vitae; (3) a list of the cases in which the
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`expert or consultant has testified at a deposition or at trial within the last four years; and (4) an
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`executed copy of the Acknowledgement of Protective Order attached hereto as Exhibit A. In
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`addition, the following procedures shall be followed:
`
`a.
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`No Confidential Information shall be revealed or disclosed, in whole or in
`
`part, directly or indirectly, to any individuals described in Paragraphs 6(b) or 6(c) until
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`such individual executes an undertaking in the form attached hereto as Exhibit A. The
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`original of each undertaking shall be retained, until the conclusion of this Action including
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`all appeals, by counsel for each Party who intends to or does disclose to such individual
`
`any Confidential Information.
`
`b.
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`If a Producing Party reasonably believes it would be harmed by the
`
`proposed disclosure, it may object in writing to such disclosure within five (5) business
`
`days after receipt of the notice. In the event of an objection, the Parties shall promptly
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`confer to attempt to resolve the concerns giving rise to the objection. If the Parties are
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`unable to reach agreement regarding such disclosure, the Party seeking disclosure may
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`request that the Court issue an order permitting the disclosure. No disclosure shall be made
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`until the expiration of the five (5) business day period for the Producing Party to make an
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`

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`objection, or if such objection is made, until the resolution of the objection, whether
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`formally or informally.
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`c.
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`It is understood and agreed that if pursuant to this Order, a Party identifies a
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`person as an expert, no other Party shall contact the expert nor subject the expert to
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`discovery to inquire into matters arising within the expert’s consultation with the
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`designating Party, except as provided by Federal Rule of Civil Procedure 26(b)(4) or by
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`Order of the Court. Notwithstanding Fed. R. Civ. P. 26(b)(4)(C)(i), (ii) and (iii), the Parties
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`agree that the following materials will be excluded from discovery in this case: expert
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`witnesses’ notes, drafts, and communications with counsel.
`
`(1.
`
`The disclosure of the identity of a non-testifying expert will not be a waiver
`
`of any privilege that applies to communications with the expert or the expert’s work
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`product. The Parties agree that by stipulating to the entry of this Order, the Parties do not
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`otherwise intend to modify in any way the discovery rules applicable to experts.
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`9.
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`Use During Examination or Cross Examination. Nothing herein shall limit a
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`Party’s ability to use Confidential Information to examine or cross—examine at deposition or trial
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`(or other hearing) persons who are (a) a currently employed officer or employee of a Producing
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`Party, and such Confidential Information is within the scope of the ordinary performance of the
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`duties of such officer or employee; (b) an expert of a Producing Party; or (c) designated by the
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`Producing Party as a Rule 30(b)(6) witness and such Confidential Information is within the scope
`
`of the witness’s 30(b)(6) designation.
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`10.
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`Limitations on Attendance at Deposition. A Party or non-party may exclude
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`from portions of a deposition that inquire about or disclosefionfidential Information any person
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`who is not entitled to have access to Confidential Information under this Order. If individuals not
`
`10
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`

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`authorized to access Confidential Information fail to leave the deposition room during any portion
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`of the deposition that inquires about or discloses what counsel for the Producing Party identifies as
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`Confidential Information, counsel for the Producing Party may seek relief from the Court and,
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`pending resolution of its request for relief, instruct the witness not to answer questions relating to,
`
`or limit disclosure of, the Confidential Information at issue.
`
`11.
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`Publicly Available Information. The following categories of information shall be
`
`deemed not to be Confidential Information:
`
`a.
`
`Any information that at the time of its disclosure in this action is part of the
`
`public domain by reason of prior publication or otherwise;
`
`b.
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`Any information that after its disclosure in this action has become part of
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`the public domain by reason of prior publication or otherwise through no improper act,
`
`omission, or fault of any Receiving Party;
`
`0.
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`Any information that at the time of its disclosure in this action is rightfully
`
`in the possession of the Receiving Party, its trial counsel, or any expert retained by or for
`
`the Receiving Party under no obligation of confidentiality;
`
`d.
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`Any information that after its disclosure in this action is rightfully received
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`without any obligation of confidentiality by the Receiving Party, its trial counsel, or any
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`expert retained by or for the Receiving Party from a third party having the right to disclose
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`such information; or
`
`e.
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`Any information that was independently developed by the Receiving Party
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`without the use of or reliance upon any designated material disclosed by the Producing
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`Party.
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`11
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`

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`12.
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`Filing Under Seal. If any Party files Confidential Information with the Court,
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`including documents that reveal, disclose, or summarize information contained in documents
`
`designated as “CONFIDENTIAL” such shall be filed under seal and subsequently redacted
`
`according to the Local Rules and the District of Delaware’s Administrative Procedures Governing
`
`Filing and Service by Electronic Means (the “CM/ECF Procedures”), as applied and interpreted in
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`connection with the District of Delaware CM/ECF User’s Manual Preservation of Rights and
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`Privileges.
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`13.
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`Redaction of Documents and Things. Documents and things produced or made
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`available for inspection may be subject to redaction, in good faith, by the Producing Party, of
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`information subject to the attorney-client privilege, work product immunity, or any other
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`applicable privilege or immunity. Each such redaction, regardless of size, shall be clearly labeled.
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`This Paragraph shall not be construed as a waiver of any Party’s right to seek disclosure of
`
`redacted information. All documents based on attorney client privilege, work product immunity,
`
`or any other applicable privilege or immunity shall be listed on a privilege log in accordance with
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`Federal Rule of Civil Procedure 26(b)(5).
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`14.
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`Challenging Designations. There shall be no obligation on a Receiving Party to
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`challenge a designation by a Producing Party as “Confidential Information” when such
`
`designation is made, and failure to do so shall not preclude a subsequent challenge. If a Receiving
`
`Party believes in good faith that information should not be designated as “Confidential
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`Information” that Receiving Party must specify to the Producing Party in writing (i) Confidential
`
`Information challenged and (ii) the grounds for questioning the designation. Within seven (7)
`
`business days, or within such additional time as is reasonable (taking into account the number of
`
`documents or other information challenged) and as agreed to by counsel or as ordered by the
`
`12
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`

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`Court, the Producing Party must respond in writing stating whether it will maintain, change, or
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`remove the designation. If the objecting Party and the Producing Party do not reach agreement
`
`within five (5) business days after the Producing Party has responded to the objecting Party, then
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`the objecting Party may move the Court for an order that the information or material shall not be so
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`designated. The challenged designation shall remain in effect until the Court enters an Order
`
`removing the designation or the Producing Party withdraws its objection.
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`15.
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`Use of Confidential Information in Court. If the need arises
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`during trial or at any hearing before the Court for any Party to disclose Confidential Information, it
`
`may do so only after giving notice to the Producing Party and as directed by the Court.
`
`16.
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`Inadvertent Disclosure of Confidential Information. To the
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`extent consistent with applicable law, the inadvertent or unintentional disclosure of Confidential
`
`Information that should have been designated as such, regardless of whether the information,
`
`document, or thing was so designated at the time of disclosure, shall not be deemed a waiver in
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`whole or in part of a Party’s claim of confidentiality, either as to the specific information,
`
`document, or thing disclosed or as to any other material or information concerning the same or
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`related subject matter. Such inadvertent or unintentional disclosure may be rectified by the
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`Producing Party promptly notifying in writing, upon discovery of the unintentional disclosure,
`
`counsel for all Parties to whom the material was disclosed that the material should have been
`
`designated as Confidential Information. Such notice shall constitute a designation of the
`
`information, document, or thing as Confidential Information under this Order. The Producing
`
`Party shall provide copies of the properly marked information along with the written notice, or as
`
`soon thereafter as practicable. Upon receipt of the notice and properly marked information, the
`
`Receiving Party shall, within 10 business days, return to Counsel for the Producing Party or
`
`13
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`

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`destroy all unmarked copies of said Confidential Information to the extent practicable and shall not
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`retain copies thereof, and shall undertake a best effort to correct the disclosure of such information
`
`contrary to the re-designation, including informing any unauthorized recipients of the existence
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`and terms of this Order and demanding the return of the information. However, disclosure of such
`
`Confidential Information prior to the receipt of notice under this Paragraph 16 shall not be deemed
`
`a violation of this Order.
`
`17.
`
`Inadvertent Disclosure of Privileged or Work Product Information. When the
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`inadvertent or mistaken disclosure of any information, document, or thing protected by privilege,
`
`work—product immunity, or any other applicable privilege or immunity is discovered by the
`
`Producing Party and brought to the attention of the Receiving Party, the treatment of such material
`
`shall be in accordance with Federal Rule of Civil Procedure 26(b)(5)(B). Such inadvertent or
`
`mistaken disclosure of such information, document, or thing shall not constitute a waiver by the
`
`Producing Party of any claims of privilege, work-product immunity, or any other applicable
`
`privilege or immunity. Within ten (10) business days of notice of such inadvertent disclosure, the
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`documents or materials described in that notice shall be returned to counsel for the Producing
`
`Party, sequestered pursuant to Rule 26(b)(5)(B), and/or all copies of such documents or materials
`
`in the recipient’s possession shall be destroyed, and any future reference to such documents or
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`materials in any other documents or materials shall be in accordance with Federal Rule of Civil
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`Procedure 26(b)(5)(B).
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`18.
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`Third Party Production. Third parties who produce information in this action
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`may avail themselves ofthe provisions of this Order by signing a copy of this Protective Order and
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`serving the same on all counsel of record, and in such event discovery materials produced by third
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`parties shall be treated by the Parties in conformance with this Order.
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`19.
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`Efforts by Non-Parties to Obtain Confidential Information. In the event that
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`any of the Parties (i) is subpoenaed in another action, (ii) is served with a demand in another action
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`to which it is a party, or (iii) is served with any other legal process by a person not a party to this
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`litigation, and is requested to produce or otherwise disclose discovery material that is designated as
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`Confidential Information by another Party, the Party subpoenaed or served in accordance with this
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`Paragraph shall object to production of the Confidential Information and shall give written notice
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`to the Producing Party within ten (10) calendar days from the receipt of such a request. The
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`Receiving Party shall cooperate to the extent necessary to permit the Producing Party to seek to
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`quash or otherwise address such subpoena, process or discovery request and shall not produce or
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`disclose the documents, things, or information unless the Producing Party consents in writing to
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`production or the Receiving Party is ordered by a court of competent jurisdiction to produce or
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`disclose the documents, things, or information. Nothing in this Order shall be construed as
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`precluding production of Confidential Information covered by this Order in response to a lawful
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`court order or by consent of the Producing Party.
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`20.
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`Disclosure to Unauthorized Persons. If Confidential Information is disclosed to
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`any person not entitled to receive disclosure of such information under this Order, counsel for the
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`Receiving Party responsible for the unauthorized disclosure shall immediately inform counsel for
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`the Producing Party of all pertinent facts relating to the unauthorized disclosure including, without
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`limitation, an identification of the Confidential Information disclosed and the person(s) to whom
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`the unauthorized disclosure was made. Without prejudice to other rights and remedies of any
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`Party, counsel for the Receiving Party also shall use its best efforts to recover immediately the
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`material disclosed without authorization and to ensure that no further or greater unauthorized
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`disclosure or use of such information is made. In such event, the Receiving Party shall also (a)
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`promptly inform such person of all the provisions of this Order; (b) identify such person
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`immediately to the Producing Party; and (c) request such person to execute the Acknowledgment
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`of Protective Order in the form shown in Exhibit A.
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`21.
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`Termination of Access. In the event that any person or Party ceases to be engaged
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`in the conduct of this litigation, such person’s or Party’s access to any and all Confidential
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`Information shall be terminated, and all copies thereof shall be returned or destroyed as soon as
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`practicable after such person or Party ceases to be engaged in the conduct of this litigation. The
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`provisions of this Order shall remain in full force and effect as to any person or Party who
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`previously had access to any Confidential Information, except as may be specifically ordered by
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`the Court or consented to by the Producing Party.
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`22.
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`Termination of Action.
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`a.
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`Upon final conclusion of this Action (including appeals), each Party or
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`other individual subject to the terms hereof shall return to the originating source, or certify
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`destruction of, all originals and unmarked copies of documents and things containing
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`Confidential Information; provided, however, that outside counsel of record (as identified
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`in Paragraph 6(a)) shall be entitled to retain its correspondence file for the case; a copy of
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`all court papers, discovery responses and requests (excluding produced documents and
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`things); deposition and trial transcripts; exhibits used in affidavits, at depositions and at
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`trial; and attorney work product (except for certain litigation databases, as set forth below).
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`Confidential Information kept by outside counsel pursuant to this paragraph shall continue
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`to be maintained in accordance with the terms of this Order.
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`b.
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`Litigation databases (or portions of databases) containing the full text of
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`Confidential Information or abstracts thereof shall be destroyed in accordance with this
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