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`__________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`__________
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
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`v.
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`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`__________
`
`Case IPR2020-01318
`Patent 9,220,631
`
`__________
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`MODIFIED DEFAULT PROTECTIVE ORDER
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`Novartis Exhibit 2048.001
`Regeneron v. Novartis, IPR2020-01318
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`MODIFIED DEFAULT PROTECTIVE ORDER
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`This protective order governs the treatment and filing of confidential
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`information, including documents and testimony.
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`1.
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`Confidential information shall be clearly marked “CONTAINS
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`CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO
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`PROTECTIVE ORDER MATERIAL.”
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`2.
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`Access to confidential information is limited to the following
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`individuals who 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
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`and other persons who are named parties to the proceeding.
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`(A)
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`(B) Party Representatives. Representatives of record for a party in
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`the proceeding.
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`(B)
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`(C) Experts. Retained experts of a party in the proceeding who
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`further certify in the Acknowledgement that they are not a
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`competitor to any party, or a consultant for, or employed by, such a
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`competitor with respect to the subject matter of the proceeding.
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`(C)
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`(D) In-house counsel. In houseOne in-house counsel representative
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`Novartis Exhibit 2048.002
`Regeneron v. Novartis, IPR2020-01318
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`of a party.
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`(D)
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`(E) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other support personnel of the foregoing persons who
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`are reasonably necessary to assist those persons in the proceeding
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`shall not be required to sign an Acknowledgement, but shall be
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`informed of the terms and requirements of the Protective Order by
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`the person they are supporting who receives confidential
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`information.
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`(E)
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`(F) The Office. Employees and representatives of the United States
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`Patent and Trademark Office who have a need for access to the
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`confidential information shall have such access without the
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`requirement to sign an Acknowledgement. Such employees and
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`representatives shall include the Director, members of the Board and
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`their clerical staff, other support personnel, court reporters, and
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`other persons acting on behalf of the Office.
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`3.
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`Employees (e.g., corporate officers), consultants, or other persons
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`performing work for a party, other than those persons identified above in
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`(d)(2)(A)–(ED), shall be extended access to confidential information only upon
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`agreement of the parties or by order of the Board upon a motion brought by the
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`2
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`Novartis Exhibit 2048.003
`Regeneron v. Novartis, IPR2020-01318
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`
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`party seeking to disclose confidential information to that person and after signing
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`the Acknowledgment. The party opposing disclosure to that person shall have the
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`burden of proving that such person should be restricted from access to
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`confidential information.
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`4.
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`Persons receiving confidential information shall use reasonable
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`efforts to maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which persons
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`not authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of
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`the information, which efforts shall be no less rigorous than those
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`the recipient uses to maintain the confidentiality of information not
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`received from the disclosing party;
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`(C)
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`Ensuring that support personnel of the recipient who have access to
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`the confidential information understand and abide by the obligation
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`to maintain the confidentiality of information received that is
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`designated as confidential; and
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`(D)
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`Limiting the copying of confidential information to a reasonable
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`number of copies needed for conduct of the proceeding and
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`maintaining a record of the locations of such copies.
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`3
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`Novartis Exhibit 2048.004
`Regeneron v. Novartis, IPR2020-01318
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`5.
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`Persons receiving confidential information shall use the following
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`procedures to maintain the confidentiality of the information:
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`(A)
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`Documents and Information Filed With the Board.
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`(i)
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`A party may file documents or information with the Board
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`along with a Motion to Seal. The Motion to Seal should provide a
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`non-confidential description of the nature of the confidential
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`information that is under seal, and set forth the reasons why the
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`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
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`by opposing the Motion to Seal. The documents or information shall
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`remain under seal unless the Board determines that some or all of it
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`does not qualify for confidential treatment.
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`(ii) Where confidentiality is alleged as to some but not all of the
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`information submitted to the Board, the submitting party shall file
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`confidential and non-confidential versions of its submission,
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`together with a Motion to Seal the confidential version setting forth
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`the reasons why the information redacted from the non-confidential
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`version is confidential and should not be made available to the
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`4
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`Novartis Exhibit 2048.005
`Regeneron v. Novartis, IPR2020-01318
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`
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`public. A party may challenge the confidentiality of the information
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`by opposing the Motion to Seal. The non-confidential version of the
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`submission shall clearly indicate the locations of information that
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`has been redacted. The confidential version of the submission shall
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`be filed under seal. The redacted information shall remain under seal
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`unless the Board determines that some or all of the redacted
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`information does not qualify for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties.
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`Documents (including deposition transcripts) and other information
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`designated as confidential that are disclosed to another party during
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`discovery or other proceedings before the Board shall be clearly
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`marked as “CONTAINS CONFIDENTIAL BUSINESS
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`INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`MATERIAL” and shall be produced in a manner that maintains its
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`confidentiality.
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`6.
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`Within 60 days after the final disposition of this action, including
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`the exhaustion of all appeals and motions, each party receiving confidential
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`information must return, or certify the destruction of, all copies of the
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`confidential information to the producing party.
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`5
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`Novartis Exhibit 2048.006
`Regeneron v. Novartis, IPR2020-01318
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`6
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`Novartis Exhibit 2048.007
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`Regeneron V. Novartis, IPR2020-013 18
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`Novartis Exhibit 2048.007
`Regeneron v. Novartis, IPR2020-01318
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`
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`Standard Acknowledgment for Access to Protective Order Material
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`I
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`, affirm that I have
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`read the Protective Order; that I will abide by its terms; that I will use the
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`confidential information only in connection with this proceeding and for no other
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`purpose; that I will only allow access to support staff who are reasonably
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`necessary to assist me in this proceeding; that prior to any disclosure to such
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`support staff I informed or will inform them of the requirements of the Protective
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`Order; that I am personally responsible for the requirements of the terms of the
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`Protective Order and I agree to submit to the jurisdiction of the Office and the
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`United States District Court for the Eastern District of Virginia for purposes of
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`enforcing the terms of the Protective Order and providing remedies for its breach.
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`_____________________________
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`Date:
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`7
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`Novartis Exhibit 2048.008
`Regeneron v. Novartis, IPR2020-01318
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`