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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
` JAZZ PHARMACEUTICALS, INC,
`(Consolidated)
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`
`
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`Defendants.
`
`WHEREAS,
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`Jazz Pharmaceuticals,
`
`Inc.
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`(“Jazz”), Amneal Pharmaceuticals LLC
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`(“Amneal”), Par Pharmaceutical, Inc. (“Par”), Sun Pharmaceutical Industries, Ltd. and Ranbaxy,
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`Inc. (together, “Sun”), Watson Laboratories, Inc. (“Watson”), Wockhardt Bio AG, Wockhardt
`
`Limited, and Wockhardt USA LLC (collectively, “Wockhardt”), and Lupin Ltd., Lupin
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`Pharmaceuticals, Inc., and Lupin Inc. (collectively, Lupin”) are the parties to Civil Action No.
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`13-391 (ES)(JAD) (consolidated) (the “action” or “litigation”);
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`WHEREAS, the parties to this action believe that one or more of them will or may be
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`required to disclose to another party certain documents, things, and information that constitute or
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`contain trade secrets,
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`technical know-how, or other confidential or proprietary research,
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`development, business, commercial, or financial information relating to the subject matter of this
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`action;
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`WHEREAS, the parties consider such information to be confidential and proprietary
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`within the meaning of Fed. R. Civ. P. 26(c)(1)(G), Pansy v. Borough of Stroudsburg, 23 F.3d
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`772 (3d Cir. 1994) and Glenmede Trust Co. v. Thompson, 56 F.3d 476 (3d Cir. 1995) and,
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`therefore, mutually desire that a Discovery Confidentiality Order limiting use, access to, and
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`Plaintiff,
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`Civil Action No. 13-391 (ES)(JAD)
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`DISCOVERY CONFIDENTIALITY
`ORDER
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`(Filed Electronically)
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`
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`disclosure of such information be entered;
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`WHEREAS, the parties desire to preserve the legitimate business interests of the parties
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`or non-parties in their confidential information without unduly encroaching upon the public’s
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`right to be informed ofjudicial proceedings in accordance with Local Civil Rule 5.3;
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`WHEREAS, a party seeking to protect information filed under seal with the Court must
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`show good cause for sealing that part of the record, in accordance with Local Civil Rule 5.3;
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`WHEREAS,
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`the parties contemplate that confidential
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`information produced in this
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`action may be produced by a non-party, and the parties also seek to facilitate the production and
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`protection of such confidential information;
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`WHEREAS, the parties have and/or expect to exchange discovery in connection with
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`this matter and recognize that confidential information may be disclosed in the course of this
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`discovery, and in other proceedings in this matter;
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`WHEREAS,
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`the parties desire to limit
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`the extent of disclosure and use of such
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`confidential information, and to protect such confidential information from unauthorized use
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`and/or further disclosure, and wish to ensure that no advantage is gained by any party by the use
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`of such confidential information which could not have been gained had discovery in this action
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`not occurred;
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`WHEREAS, this action involves highly technical subject matter requiring discovery of
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`trade secrets and proprietary information pertaining to, among other things, drug formulations,
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`manufacturing processes and techniques, scientific research and development, and other sensitive
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`competitive information; and
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`WHEREAS, the parties have consented to the entry of this Discovery Confidentiality
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`Order pursuant to Fed. R. Civ. P. 26(c)(1)(G) and Local Civil Rule 5.3 and the Court having
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`considered the foregoing and for good cause shown,
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`IT IS on this _ day of
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`, 2016,
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`ORDERED, that the following provisions shall govern the conduct of further
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`proceedings in this action:
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`Definitions
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`1.
`
`(a)
`
`The term “Confidential Information” shall mean any tangible thing or oral
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`testimony that contains or reveals what a party or non-party considers to be its trade secret,
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`business
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`confidential, or proprietary research, development,
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`commercial, or
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`financial
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`information.
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`It may include, without limitation, documents produced in this action, during
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`formal discovery or otherwise; information of non-parties which the producing or designating
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`party is under an obligation to maintain in confidence;
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`initial disclosures; answers to
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`interrogatories and responses to requests for admission or other discovery requests; deposition or
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`hearing transcripts; affidavits; exhibits; experts’ reports; memoranda of law; and tangible things
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`or objects that are designated confidential pursuant to this Order. The information contained
`
`therein and all copies, abstracts, excerpts, analyses, notes or other writings that contain, reflect,
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`reveal or otherwise disclose such confidential information shall also be deemed “Confidential
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`Information.” Information originally designated as “Confidential Information” shall not retain
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`that status after any ruling by the Court denying such status to it. Each party shall act in good
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`faith in designating information as “Confidential Information.”
`
`(b)
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`The term “Highly Confidential Information” shall mean all information
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`regarding (i) confidential, highly sensitive, and/or proprietary information pertaining to
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`marketing, sales, revenues, profits, forecasts, or business plans or strategies for any existing
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`products or products in development; (ii) past, current or future products other than sodium
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`
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`oxybate-containing drug products,
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`(iii) past, current or
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`future plans regarding treatment
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`indications for sodium oxybate-containing drug products other than the treatment indications for
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`which FDA approval is or has been sought; and (iv) scientific or technical information relating
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`to, referring to, or concerning Xyrem®, Amneal’s ANDA No. 203631, Par’s ANDA No. 205403,
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`Sun’s ANDA No. 203351, Watson’s ANDA No. 204952, Wockhardt’s ANDA No. 207526,
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`Lupin’s ANDA No. 207415, and/or the associated products (including compositions, methods,
`
`uses, or processes) that constitute or reflect trade secrets or other proprietary information,
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`including, but not limited to, draft patent applications, invention disclosures, non-public patent
`
`filings; confidential research, development,
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`testing and studies relating to drug products,
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`methods, uses or processes; any correspondence or draft correspondence with the FDA regarding
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`ANDA No. 203631, ANDA No. 205403, ANDA No. 203351, ANDA No. 204952, ANDA No.
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`207526; or ANDA No. 207415; any research, development, testing, analysis and/or studies,
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`including analytical data and/or any chemical materials used to produce a sodium oxybate-
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`containing composition that the producing party reasonably believes the disclosure of which is
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`likely to cause harm to the competitive position of the party producing the information or could
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`be used in patent prosecution by the party receiving the information to the competitive
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`disadvantage of the party producing the information.
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`It may include, without
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`limitation,
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`documents produced in the actions, during formal discovery or otherwise; information of non-
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`parties which the producing or designating party is under an obligation to maintain in
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`confidence; initial disclosures; answers to interrogatories and responses to requests for admission
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`or other discovery requests; deposition or hearing transcripts; affidavits; exhibits; experts’
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`reports; memoranda of law; and tangible things or objects that are designated confidential
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`pursuant to this Order. The information contained therein and all drafts, copies, abstracts,
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`
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`excerpts, analyses, notes or other writings that contain, reflect, reveal or otherwise disclose such
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`highly confidential
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`information shall also be deemed “Highly Confidential
`
`Information.”
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`Information originally designated as “Highly Confidential Information” shall not retain that
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`status after any ruling by the Court denying such status to it. Each party shall act in good faith in
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`designating information as “Highly Confidential Information.”
`
`(c)
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`The term “party” means Jazz, Amneal, Par, Sun, Watson, Wockhardt,
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`Lupin, and/or any other party who is joined in the action.
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`(d)
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`The term “Defendant” means Amneal, Par, Sun, Watson, Wockhardt,
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`Lupin, andr'or any other defendant who is joined in the action.
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`(e)
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`The term “producing party” means any party or nonparty producing
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`documents or information as Confidential Information or Highly Confidential Information under
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`this Order.
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`(f)
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`The term “receiving party” shall mean any party to whom Confidential
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`Information or Highly Confidential Information is produced.
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`Designation of Confidential and Highly Confidential Information
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`2.
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`Each producing party who produces or discloses any material that it believes
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`comprises Confidential Information may so designate it by marking the document containing the
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`information “CONFIDENTIAL—SUBJECT TO DISCOVERY CONFIDENTIALITY ORDER.”
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`Each producing party who produces or discloses any material that it believes comprises Highly
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`Confidential
`
`Information may so designate it by marking the document containing the
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`information “HIGHLY CONFIDENTIAL—SUBJECT TO DISCOVERY CONFIDENTIALITY
`
`ORDER.” When documents are produced for inspection, the documents shall be treated by the
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`receiving party as “Highly Confidential” until copies are provided and otherwise designated.
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`Deposition testimony will be treated as Highly Confidential Information unless otherwise
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`
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`designated or confidentiality is waived either on the record during the deposition or within thirty
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`(30) days after receipt of the transcript. Each transcript and/or recording of the deposition shall
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`be prominently marked on the front with a statement
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`that provides “THIS DEPOSITION
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`CONTAINS [HIGHLY] CONFIDENTLAL INFORMATION SUBJECT TO DISCOVERY
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`CONFIDENTLALITY ORDER.”
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`3.
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`If any Confidential Information or Highly Confidential Information is produced
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`by a nonparty to these litigations, such a nonparty shall be considered a producing party within
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`the meaning of that term as it is used in the context of this Order and each of the parties shall be
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`treated as a receiving party. Confidential Information or Highly Confidential Information that
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`originated with a nonparty may be designated as such and shall be subject to the restrictions on
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`disclosure specified herein.
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`4.
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`In the event any producing party produces Confidential Information or Highly
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`Confidential Information that has not been designated as such or not correctly designated, the
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`producing party may designate or re-designate the information to the same extent as it may have
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`designated the information before production, by a subsequent notice in writing specifically
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`identifying the re-designated information, in which event the parties shall henceforth treat such
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`information in accord with this Order, and shall undertake their best efforts to correct any
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`disclosure of such information contrary to the re-designation, including retrieving any documents
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`from persons not qualified to receive them under the re-designation and informing such persons
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`that they should not further use or disseminate the information thereon. No demonstration or
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`proof of error, inadvertence, or excusable neglect by the designating party shall be required for
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`such re-designation.
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`5.
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`A party shall not be obligated to challenge the propriety of any designation of
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`Confidential Information or Highly Confidential Information at the time the designation is made,
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`and failure to do so shall not preclude a subsequent challenge to the designation.
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`In the event
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`that any party to this action disagrees at any stage of this action with any designation, such party
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`shall provide written notice of its disagreement with the designation to the producing party. The
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`parties shall first try to dispose of such dispute in good faith on an informal basis without judicial
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`involvement.
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`If the dispute cannot be resolved, the party challenging the designation may
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`request appropriate relief from the Court within ten (10) business days after written notice of an
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`impasse between the parties is provided. The burden of proving that information has been
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`properly designated is on the producing party. However, the parties agree that designating
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`information as Confidential or Highly Confidential is improper if such information (i) can be
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`shown to be generally available to the public at the time of such designation; (ii) becomes part of
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`the public domain or publicly known or available by publication or otherwise not as the result of
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`any unauthorized act or omission on the part of the non-designating party; or (iii) is thereafter
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`disclosed to the non-designating party by a third party as a matter of right.
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`Disclosure and Use of Confidential Information and Highly Confidential
`Information
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`6.
`
`(a)
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`Subject to Paragraphs 10-14, Confidential Information of the producing
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`party may be disclosed, summarized, described, revealed or otherwise made available in whole
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`or in part only in accordance with the terms of this Order, and only to the following persons
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`identified in Paragraphs 6(a)(i)-(viii), with the exception that Jazz may not disclose, summarize,
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`describe, reveal, or otherwise make available in whole or in part any Confidential Information
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`produced by one Defendant to any representative,
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`including in-house attorneys, employees,
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`independent consultants or experts, and witnesses of another Defendant, excluding any outside
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`counsel attorneys of record:
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`(i)
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`the outside counsel attorneys of record for Jazz, Amneal, Par, Sun,
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`Watson, Wockhardt, and Lupin, all of whom represent and agree that they do not undertake
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`patent preparation or prosecution activities as set forth below in Paragraph 6(b) of this Order;
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`and their attendant staff and support personnel;
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`(ii)
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`a total of up to two (2) designated in-house attorneys employed by
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`Jazz, a total of up to two (2) designated in-house attorneys employed by Amneal, a total of up to
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`two (2) designated in—house attorneys employed by Par, a total of up to two (2) designated in-
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`house IP personnel employed by Sun, a total of up to two (2) designated in-house attorneys
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`employed by Watson, a total of up to two (2) designated in—house IP personnel employed by
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`Wockhardt, and a total of up to two (2) designated in-house IP personnel employed by Lupin,
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`who have a need to know Confidential Information or Highly Confidential Information to fiilfill
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`their duties and responsibilities in connection with this litigation, provided such attorneys and
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`staff have complied with Paragraph 12 hereof,
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`the designated in-house attorneys (and IP
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`personnel for Sun, Wockhardt and Lupin) for the parties being as follows:
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`For Jazz: Jana Gold and Daniel Epstein;
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`who, after receipt of Confidential Information or Highly Confidential Information, and in
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`addition to the other terms of this Discovery Confidentiality Order, shall not disclose to the FDA,
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`the PTO, or any nonparty, any Confidential Information or Highly Confidential Information.
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`For Amneal: Ken Zeidner and Lars Taavola;
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`who, after receipt of Confidential Information or Highly Confidential Information, and in
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`addition to the other terms of this Discovery Confidentiality Order, shall not disclose to the FDA,
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`the PTO, or any nonparty, any Confidential Information or Highly Confidential Information.
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`Further, the designated in-house attorneys for Amneal may not receive Confidential Information
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`or Highly Confidential Information of Par, Sun, Watson, Wockhardt, or Lupin.
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`For Par: Gina Gencarelli and Larry Brown
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`who, after receipt of Confidential Information or Highly Confidential Information, and in
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`addition to the other terms of this Discovery Confidentiality Order, shall not disclose to the FDA,
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`the PTO, or any nonparty, any Confidential Information or Highly Confidential Information.
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`Further, the designated in-house attorneys for Par may not receive Confidential Information or
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`Highly Confidential Information of Amneal, Sun, Watson, Wockhardt, or Lupin.
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`For Sun: Kathryn Jones and B Vij ayaraghavan
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`who, after receipt of Confidential Information or Highly Confidential Information, and in
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`addition to the other terms of this Discovery Confidentiality Order, shall not disclose to the FDA,
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`the PTO, or any nonparty, any Confidential Information or Highly Confidential Information.
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`Further, the designated in-house IP personnel for Sun may not receive Confidential Information
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`or Highly Confidential Information of Amneal, Par, Watson, Wockhardt, or Lupin.
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`For Watson: Brian Anderson;
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`who, after receipt of Confidential Information or Highly Confidential Information, and in
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`addition to the other terms of this Discovery Confidentiality Order, shall not disclose to the FDA,
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`the PTO, or any nonparty, any Confidential Information or Highly Confidential Information.
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`Further, the designated in-houSe attorneys for Watson may not receive Confidential Information
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`or Highly Confidential Information of Amneal, Par, Sun, Wockhardt, or Lupin.
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`For Wockhardt:
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`;
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`who, after receipt of Confidential Information or Highly Confidential Information, and in
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`addition to the other terms of this Discovery Confidentiality Order, shall not disclose to the FDA,
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`the PTO, or any nonparty, any Confidential Information or Highly Confidential Information.
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`Further, the designated in-house personnel for Wockhardt may not receive Confidential
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`Information or Highly Confidential Information of Amneal, Par, Sun, Watson, or Lupin.
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`For Lupin: Minaksi Bhatt and Pavan Kumar Vitta;
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`who, after receipt of Confidential Information or Highly Confidential Information, and in
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`addition to the other terms of this Discovery Confidentiality Order, shall not disclose to the FDA,
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`the PTO, or any nonparty, any Confidential Information or Highly Confidential Information.
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`Further, the designated in-house personnel for Lupin may not receive Confidential Information
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`or Highly Confidential Information of Amneal, Par, Sun, Watson, or Wockhardt.
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`(iii)
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`independent consultants or experts retained by a party to this
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`action, who are not employees, officers or directors of any party, and not anticipated to become
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`employees, officers or directors of that party and who are retained or employed as bona fide
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`consultants or experts for purposes of this litigation, whether full or part time, by or at the
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`direction of counsel for that party, and any employees and/or assistants working under the direct
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`supervision and control of such consultants or experts, provided such persons have complied
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`with Paragraph 12 hereof;
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`(iv)
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`potential witnesses in this action who are directors, officers,
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`employees, or corporate designees of the producing party under Fed. R. Civ. P. 30(b)(6), but
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`only at deposition or trial;
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`(v)
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`potential witnesses in this action (including, but not limited to,
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`those who were formerly directors, officers, employees or experts of the producing party), but
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`only for those witnesses if the Confidential or Highly Confidential Information was in existence
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`during the period of his or her service or employment and foundation is established that the
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`witness was involved in the project to which the Confidential or Highly Confidential Information
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`relates so that
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`it
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`is reasonable that
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`the witness had access to the Confidential or Highly
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`Confidential Information during the course of his or her service or employment) and their
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`counsel, provided that the information was authored by, created by, addressed to, received by,
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`signed by, or is otherwise established to have been known to the witness; but only at deposition
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`or trial;
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`(vi)
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`the Court, including clerks, court personnel, and court reporters
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`and videographers employed in connection with this action;
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`(vii)
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`outside photocopying,
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`imaging, data base, graphics or design
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`services or other support services retained by outside counsel for purposes of this action; and
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`(viii)
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`other persons only upon Order of the Court for good cause shown
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`or upon written stipulation of the Producing Party.
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`(b)
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`Subject
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`to Paragraphs 10-14, Highly Confidential Information of the
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`producing party shall be subject to the same restrictions as Confidential Information. Jazz may
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`not disclose, summarize, describe, reveal, or otherwise make available in whole or in part any
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`Highly Confidential Information produced by one Defendant to any representative, including in-
`
`house attorneys, employees,
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`independent consultants or experts, and witnesses of another
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`Defendant, excluding any outside counsel attorneys of record. Notwithstanding the foregoing,
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`the specified persons designated by the parties in Paragraphs 6(a)(i)-(ii) shall not have access to
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`Highly Confidential Information if they are involved, either formally or informally, for the
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`length of this litigation plus one year after a final, non-appealable judgment in this litigation, in
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`the preparation or prosecution of any patent application that covers sodium oxybate (including
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`compositions, methods, distribution methods, uses, or processes). Such involvement in the
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`preparation or prosecution of any patent application includes, but is not limited to: (1) obtaining
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`disclosure materials for new inventions and inventions under development; (2) investigating
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`prior art relating to those inventions; (3) making or consulting or advising in any way on
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`strategic decisions on the type and scope of patent prosecution that might be available or worth
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`pursuing for such inventions; (4) writing, reviewing, editing or approving new applications or
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`continuations-in—part of applications to cover those inventions; or (5) strategically amending or
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`surrendering claim scope during prosecution. For the avoidance of doubt, any attorney identified
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`in Paragraphs 6(a)(i)—(ii) who accesses Highly Confidential Information shall not be involved,
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`formally or informally, for the length of this litigation plus one year after a final, non-appealable
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`judgment in this litigation, in patent preparation and prosecution activities as set forth above.
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`Further, the specified persons designated by the parties in Paragraphs 6(a)(i)-(ii) that have
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`access to Highly Confidential or Confidential Information shall not rely, in any way, in the post-
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`grant proceedings (including inter partes review, post-grant review, covered business method
`
`review, or ex parte reexamination), on Highly Confidential or Confidential Information produced
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`under this order.
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`In addition, persons designated by the parties in Paragraphs 6(a)(i)-(ii) that
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`have access to Highly Confidential or Confidential Information shall not participate, either
`
`formally or informally,
`
`in any of the following activities relating to post-grant proceedings
`
`concerning any patent that covers sodium oxybate: ( 1) the decision to prepare or file any motion
`
`to amend the claims; (2) any decision regarding the scope of any amendments to the claims; or
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`(3) making or consulting or advising in any way on strategic decisions on the type and scope of
`
`any such amendments.
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`7.
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`Nothing in this Discovery Confidentiality Order shall prevent disclosure of
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`Confidential Information or Highly Confidential Information if the producing party consents to
`
`such disclosure or if the Court, after notice to all parties, orders such disclosure.
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`8.
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`All Confidential Information and Highly Confidential Information disclosed
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`pursuant to this Order shall be used by a recipient thereof solely for the purposes of this litigation
`
`and not for any business or competitive purposes.
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`It shall be the duty of each party and each
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`individual having notice of this Discovery Confidentiality Order to comply with this Order from
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`the time of such notice.
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`A recipient of Confidential or Highly Confidential Information disclosed pursuant to this
`
`order shall not use that information to draft discovery requests in any post-grant proceeding
`
`before the United States Patent and Trademark Office.
`
`If the receiving party wishes to pursue
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`discovery in the post—grant proceeding, it must first document to the producing party how every
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`aspect of its discovery request
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`is based exclusively on information that
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`is either publicly
`
`available or that the producing party has previously produced in the post-grant proceeding. The
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`producing party then has five (5) business days to object to the receiving party’s discovery
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`request as violating this order. If any objection is made, and the receiving party wishes to further
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`pursue its discovery request, the receiving party must first make an application before this Court
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`showing that the discovery request is not based on the producing party’s Confidential or Highly
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`Confidential Information. The receiving party cannot make any motion before the United States
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`Patent and Trademark Office until this Court decides whether there has been a violation of this
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`order.
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`A receiving party’s compliance with the above paragraph in this section 8 does not
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`release such a party from the requirement that it not use a producing party’s Confidential or
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`Highly Confidential Information outside of this litigation. A receiving party may m request, in
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`writing in this action, to use a producing party’s Highly Confidential or Confidential information
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`for the limited purpose of rebutting a representation by the producing party that it does not
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`possess documents responsive to a legitimate discovery demand in a post-grant proceeding
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`before the United States Patent and Trademark Office. The producing party must respond to
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`such a request in writing within five (5) business days of receiving such a request.
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`If the
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`producing party refuses to agree to the recipient’s request, the producing party must set forth the
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`reasons for denying the request in its written correspondence to the recipient, and be available to
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`meet and confer with the recipient within five (5) business days.
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`If the parties are unable to
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`resolve the dispute, the recipient may make an application to this Court to allow use of the
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`Highly Confidential or Confidential information in the proceeding before the United States
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`Patent and Trademark Office for the limited purpose of rebutting the producing party’s
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`representation that it does not possess documents responsive to a legitimate discovery demand.
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`The recipient must, in that application, identify the documents or things it seeks to use in the
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`proceeding before the United States Patent and Trademark Office, specifically identify where the
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`producing party has represented that it does not possess the identified documents, and show that
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`the proposed limited use of such information is not for an improper business or competitive
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`purpose.
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`9.
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`By written agreement of the parties, or upon motion and order of the Court, the
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`list of individuals designated under Paragraph 6 to whom Confidential Information or Highly
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`Confidential Information may be disclosed may be modified or expanded.
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`10.
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`If a producing party seeks to protect Confidential
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`Information or Highly
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`Confidential Information from public disclosure or use during a trial, court appearance or hearing
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`which is open to the public (a “Court Disclosure”), the producing party shall make an application
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`to the Court
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`to restrict such disclosure or use, unless consent from the receiving party is
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`previously obtained. Such application may be made at any time before the Court Disclosure or
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`within ten (10) business days after the Court Disclosure.
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`11.
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`Any party filing any document, material or information designated by another
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`party as “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL” shall move pursuant to Local
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`Civil Rule 5.3 , to seal such document, material or information to prevent public disclosure.
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`The party making such a motion also shall designate any document, material or information
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`which is the subject of the motion as “confidential materials” pursuant to Local Civil Rule
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`5.3(c)
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`, and take appropriate action necessary to assure that such document, material or
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`information shall remain sealed.
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`Should a party fail to properly file documents or materials containing Confidential
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`Information in accordance with this Order, the Local Civil Rules or the ECF Polices, any party
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`who in good faith believes that filing under seal is required may, within ten (10) days of learning
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`of the allegedly defective filing, file a motion with the Court to request an order sealing such
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`documents or materials. Nothing in this provision relieves a party of liability for damages
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`caused by the electronic filing of Confidential Information or for damages caused by failure to
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`properly file under seal documents or materials containing Confidential Information.
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`12.
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`No person identified in Paragraph 6(a)(ii)-(viii)
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`shall be given access to
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`Confidential and/or Highly Confidential Information (if they are entitled to receive Highly
`
`Confidential Information) unless such person shall first sign a Declaration of Compliance with
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`this Order in the form attached as Exhibit A hereto, acknowledging receipt and understanding of
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`this Discovery Confidentiality Order; agree to be bound thereby; agree to use the Confidential or
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`Highly Confidential Information solely for this litigation, and not to disclose any Confidential or
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`Highly Confidential Information to any other person, firm, or concern in violation of this
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`Discovery Confidentiality Order; and agree never to use any Confidential or Highly Confidential
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`Information, directly or indirectly,
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`in competition with the party that disclosed it, nor to
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`encourage or induce any other person to do so.
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`13.
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`Before any person identified in Paragraphs 6(a)(ii)-(iii) may be given access to
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`Confidential and/or Highly Confidential Information (if they are entitled to receive Highly
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`Confidential Information), the party seeking to provide such access shall deliver a copy of the
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`Declaration referred to in Paragraph 12, fully executed by such person, and written notice (by
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`facsimile or e-mail) to the attorneys for the producing party of the intention to make such
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`disclosure.
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`In the case of a disclosure to persons identified in Paragraph 6(a)(iii) hereof, the
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`notice shall state the name and address of the p