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`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________
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`APOTEX INC.,
`Petitioner
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`v.
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`NOVO NORDISK A/S,
`PATENT OWNER
`_____________________
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`CASE IPR2024-00631
`U.S. PATENT NO. 10,335,462
`ISSUED: JULY 2, 2019
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`TITLE:
`USE OF LONG-ACTING GLP-1 PEPTIDES
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`APOTEX’S MOTION TO SEAL AND FOR ENTRY OF A PROTECTIVE
`ORDER PURSUANT TO 37 C.F.R. § 42.54
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`I.
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`INTROUDCTION
`Pursuant to 37 C.F.R. §§ 42.14, 42.54, and 42.55, Petitioner Apotex Inc.
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`(“Apotex”) hereby moves for entry of the protective order (Appendix A below)
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`and further moves to seal (1) its Motion for Joinder Under 35 U.S.C. § 315(c) and
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`37 C.F.R. §§ 42.22 and 42.122(b) to inter partes review of IPR2023-00724 (the
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`“joinder motion”) and (2) the Declaration of Robert Shapiro, Ex. 1507 (the
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`“Shapiro declaration”). That order is the Board’s default protective order. Patent
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`Owner Novo Nordisk A/S (“Novo”) has likewise moved for entry of the Board’s
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`default protective order in Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-
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`00724 (the “Mylan IPR proceeding”). Good cause exists for sealing those
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`documents. That is because they contain Apotex’s confidential business
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`information, which, if disclosed, would likely cause competitive harm to Apotex.
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`II. ENTRY OF A PROTECTIVE ORDER
`Apotex moves for entry of the Board’s default protective order, submitted
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`here as Appendix A below. See Patent Trial and Appeal Board Consolidated Trial
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`Practice Guide 117–22 (Nov. 2019). Novo has moved for entry of the same
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`protective order in the Mylan IPR proceeding. Mylan, IPR2023-00724, Paper No.
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`28 (PTAB Jan. 17, 2024). The challenged patent in that proceeding is the same as
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`in this proceeding: U.S. Patent No. 10,335,462. Apotex seeks joinder to that
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`proceeding.
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`-1-
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`III. GOOD CAUSE EXISTS TO SEAL APOTEX’S JOINDER MOTION
`AND THE DECLARATION OF ROBERT SHAPIRO
`Pursuant to the protective order and 37 C.F.R. §§ 42.54 and 42.55, Apotex
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`moves to seal its joinder motion and the Shapiro declaration (Ex. 1507). As the
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`Board has found in similar cases, “good cause” exists to seal these documents
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`because they contain Apotex’s non-public business information. Celltrion, Inc., v.
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`Genentech, Inc., IPR2016-01667, Paper No. 20 at 4 (PTAB Aug. 18, 2017)
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`(granting motion to seal non-public business information, including information
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`about drug development and regulatory strategies), Paper No. 31 at 4 (PTAB July
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`23, 2018) (granting motion to expunge that information from the record); Unified
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`Patents Inc. v. Dragon Intellectual Prop., LLC, IPR2014-00216, Paper No. 40, 6-7
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`(PTAB Feb. 27, 2015) (granting motion to seal non-public business information,
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`including information relating to business strategies); see also 37 C.F.R. § 42.54.
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`Specifically, the entirety of the Shapiro declaration describes Apotex’s confidential
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`drug development and regulatory approval strategies. Ex. 1507. Certain portions
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`of Apotex’s joinder motion rely on the declaration and contain the same
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`confidential information. If that confidential information were publicly disclosed,
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`it would likely cause competitive business harm to Apotex.
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`Apotex has filed unredacted, nonpublic versions of its joinder motion and
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`the Shapiro declaration concurrently with this motion and its petition for inter
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`-2-
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`partes review. Apotex has also concurrently filed a redacted version of its joinder
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`motion redacting the limited portions of the motion that rely on the confidential
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`Shapiro declaration. Because the entirety of the Shapiro declaration contains
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`confidential information, Apotex has not filed a redacted version.
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`IV. CONCLUSION
`For the foregoing reasons, Apotex respectfully requests that the Board grant
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`this motion to seal and for entry of a protective order.
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`-3-
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`Dated: March 1, 2024
`STEPTOE LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Telephone: 212-506-3900
`Fax: 212-506-3950
`Email: Semaglutide@Steptoe.com
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`Respectfully submitted,
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`
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`/John J. Molenda/
`John J. Molenda
`Reg. No. 47,804
`Lead Counsel for Apotex
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`-4-
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that, in accordance with 37 C.F.R. § 42.6(e) and 37
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`C.F.R. § 42.105, and with Patent Owner’s consent, electronic service of APOTEX’S
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`MOTION TO SEAL AND FOR ENTRY OF A PROTECTIVE ORDER
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`PURSUANT TO 37 C.F.R. § 42.54 was made on Patent Owner to the following
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`email addresses:
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`Dated: March 1, 2024
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`
`J. Steven Baughman
`Megan Raymond
`Michael F. Milea
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
`megan.raymond@groombridgewu.com
`mike.milea@groombridgewu.com
`Novo-Semaglutide-IPR@groombridgewu.com
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`
`
`/s/ John J. Molenda
`John J. Molenda (Reg. No. 47,804)
`Lawrence Kass (Reg. No. 40,671)
`Tyler Doh (Reg. No. 80,274)
`Michael I. Green (Reg. No. 80,436)
`STEPTOE LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Tel: (212) 506-3900
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`Counsel for Apotex
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`
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`Appendix A
`Appendix A
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`DEFAULT PROTECTIVE ORDER
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`The following Default Protective Order will govern the filing and treatment of
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`confidential information in the proceeding:
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`Default Protective Order
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`This protective order governs the treatment and filing of confidential information,
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`including documents and testimony.
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`1. Confidential information shall be clearly marked "PROTECTIVE ORDER
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`MATERIAL."
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`2. Access to confidential information is limited to the following individuals who
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`have executed the acknowledgment appended to this order:
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`(A) Parties. Persons who are owners of a patent involved in the proceeding and
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`other persons who are named parties to the proceeding.
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`(B) Party Representatives. Representatives of record for a party in the
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`proceeding.
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`(C) Experts. Retained experts of a party in the proceeding who further certify in
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`the Acknowledgement that they are not a competitor to any party, or a consultant
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`for, or employed by, such a competitor with respect to the subject matter of the
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`proceeding.
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`(D) In-house counsel. In-house counsel of a party.
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`(E) Support Personnel. Administrative assistants, clerical staff, court reporters and
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`other support personnel of the foregoing persons who are reasonably necessary to
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`assist those persons in the proceeding shall not be required to sign an
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`Acknowledgement, but shall be informed of the terms and requirements of the
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`Protective Order by the person they are supporting who receives confidential
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`information.
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`(F) The Office. Employees and representatives of the United States Patent and
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`Trademark Office who have a need for access to the confidential information shall
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`have such access without the requirement to sign an Acknowledgement. Such
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`employees and representatives shall include the Director, members of the Board
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`and their clerical staff, other support personnel, court reporters, and other persons
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`acting on behalf of the Office.
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`3. Employees (e.g., corporate officers), consultants, or other persons performing
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`work for a party, other than those persons identified above in (d)(2)(A}-(E), shall be
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`extended access to confidential information only upon agreement of the parties or by
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`order of the Board upon a motion brought by the party seeking to disclose confidential
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`information to that person and after signing the Acknowledgment. The party opposing
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`disclosure to that person shall have the burden of proving that such person should be
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`restricted from access to confidential information.
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`4. Persons receiving confidential information shall use reasonable efforts to
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`maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which persons not
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`authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of the
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`information, which efforts shall be no less rigorous than those the recipient uses to
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`maintain the confidentiality of information not received from the disclosing party;
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`(C) Ensuring that support personnel of the recipient who have access to the
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`confidential information understand and abide by the obligation to maintain the
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`confidentiality of information received that is designated as confidential; and
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`(D) Limiting the copying of confidential information to a reasonable number of
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`copies needed for conduct of the proceeding and maintaining a record of the
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`locations of such copies.
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`5. Persons receiving confidential information shall use the following procedures
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`to maintain the confidentiality of the information:
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`(A) Documents and Information Filed With the Board
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`(i) A party may file documents or information with the Board along with a Motion
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`to Seal. The Motion to Seal should provide a non-confidential description of the
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`nature of the confidential information that is under seal, and set forth the reasons
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`why the information is confidential and should not be made available to the
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`public. A party may challenge the confidentiality of the information by opposing
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`the Motion to Seal. The documents or information shall remain under seal unless
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`the Board determines that some or all of it does not qualify for confidential
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`treatment.
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`(ii) Where confidentiality is alleged as to some but not all of the information
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`submitted to the Board, the submitting party shall file confidential and
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`non-confidential versions of its submission, together with a Motion to Seal the
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`confidential version setting forth the reasons why the information redacted from
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`the non-confidential version is confidential and should not be made available to
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`the public. A party may challenge the confidentiality of the information by
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`opposing the Motion to Seal. The non-confidential version of the submission
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`shall clearly indicate the locations of information that has been redacted. The
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`confidential version of the submission shall be filed under seal. The redacted
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`information shall remain under seal unless the Board determines that some or all
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`of the redacted information does not qualify for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties. Documents
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`(including deposition transcripts) and other information designated as confidential
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`that are disclosed to another party during discovery or other proceedings before
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`the Board shall be clearly marked as "PROTECTIVE ORDER MATERIAL" and
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`shall be produced in a manner that maintains its confidentiality.
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`6. Within 60 days after the final disposition of this action, including the
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`exhaustion of all appeals and motions, each party receiving confidential information must
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`return, or certify the destruction of, all copies of the confidential information to the
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`producing party.
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`(k) Standard Acknowledgement of Protective Order. The following form may be used to
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`acknowledge a protective order and gain access to information covered by the protective
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`order:
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`[CAPTION]
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`Standard Acknowledgment for Access to Protective Order Material
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`affirm that I
`I
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`have read the Protective Order; that I will abide by its terms; that I will use
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`the confidential information only in connection with this proceeding and
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`for no other purpose; that I will only allow access to support staff who are
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`reasonably necessary to assist me in this proceeding; that prior to any
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`disclosure to such support staff I informed or will inform them of the
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`requirements of the Protective Order; that I am personally responsible for
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`the requirements of the terms of the Protective Order and I agree to submit
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`to the jurisdiction of the Office and the United States District Court for the
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`Eastern District of Virginia for purposes of enforcing the terms of the
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`Protective Order and providing remedies for its breach.
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`[Signature]
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