`U.S. Patent No. 7,049,328
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
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`v.
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`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
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`Case No. IPR2017-01446
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`U.S. Patent No. 7,049,328 B2
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`Title: USE FOR DEFERIPRONE
`________________
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`[REDLINE] MODIFIED DEFAULT STANDING PROTECTIVE ORDER
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`1 of 11
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`Taro Pharmaceuticals, Ltd
`Exhibit 1050
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`This standing protective order governs the treatment and filing of
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`confidential information, including documents and testimony.
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`1.
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`Confidential information shall be clearly marked “PROTECTIVE
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`ORDER MATERIAL.”
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`2.
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`Confidential information shall include any material that contains or
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`pertains to information that is not publicly available and is maintained as
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`confidential in the normal course of business, including but not limited to: (a) the
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`names, or other information tending to reveal the identities of a party’s suppliers,
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`present or prospective customers, or distributors, or other personal information of a
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`party’s employees; (b) information related to pending patent applications; (c)
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`financial information of a party; (d) information constituting product specification,
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`formulations, and/or regarding the manufacture of the party’s product(s) or the
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`party’s proposed or potential product(s); (e) technical notebooks and technical
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`reports of a party; (f) confidential marketing plans, market research and business
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`strategy, including research regarding competitors; (g) information the producing
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`party believes is a proprietary trade secret; (h) personal information and/or
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`identities of physicians and patients; (i) all information relating to a party’s
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`research and development efforts; (j) New Drug Applications (“NDAs”) and
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`Abbreviated New Drug Applications (“ANDAs”) submitted to FDA, and
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`corresponding material related thereto; (k) licensing agreements and documents
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`discussing the terms of licensing agreements; and (l) such additional categories as
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`may become necessary and is agreed between the parties in this Proceeding in
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`writing.
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`2.3. Any person receiving access to confidential information in this
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`proceeding shall, prior to receipt of any such confidential information, first sign an
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`Acknowledgment, appended to this order.
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`4.
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`Each party
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`to
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`the proceeding
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`shall maintain
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`a
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`signed
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`Acknowledgment from each person acting on its behalf who obtains access to
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`confidential information after signing an Acknowledgment, as set forth herein, and
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`shall produce such Acknowledgments to the opposing party upon request.
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`3.5. 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
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`proceeding and other persons who are named parties to the proceeding.
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`(B)(A)
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`Party Representatives. Representatives of record for a
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`party in the proceeding.
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`(C)(B)
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`Experts. Retained experts of a party in the
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`proceeding who 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 competitor
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`with respect to the subject matter of the proceeding.
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`(D)
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`In-house counsel. In-house counsel of a party.
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`(E) Other Employees of a Party. Employees, consultants or other
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`persons performing work for a party, other than in-house counsel and in-house
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`counsel’s support staff, who sign the Acknowledgement shall be extended access
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`to confidential information only upon agreement of the parties or by order of the
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`Board upon a motion brought by the party seeking to disclose confidential
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`information to that person. The party opposing disclosure to that person shall have
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`the burden of proving that such person should be restricted from access to
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`confidential information.
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`(F)(C) The Office. Employees and representatives of the Office who
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`have a need for access to the confidential information shall have such access
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`without the requirement to sign an Acknowledgement. Such employees and
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`representatives shall include the Director, members of the Board and their clerical
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`staff, other support personnel, court reporters, and other persons acting on behalf of
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`the Office.
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`(D) Support Personnel. Administrative assistants, clerical staff,
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`court reporters and other support personnel of the foregoing persons who are
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`reasonably necessary to assist those persons in the proceeding shall not be required
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`to sign an Acknowledgement, but shall be informed of the terms and requirements
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`of the Protective Order by the person they are supporting who receives confidential
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`information.
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`(E)
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`Independent stenographic reporters and videographers retained
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`to record and transcribe testimony in connection with this proceeding and graphics
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`or design services retained by outside counsel for purposes of preparing
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`demonstratives or other exhibits for deposition or oral hearing in this proceeding
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`shall not be required to sign an Acknowledgement, but shall be informed of the
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`terms and requirements of the Protective Order by the person they are supporting
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`who receives confidential information.
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`(F) Persons who are “Designated Litigation In-House Counsel”
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`pursuant to the protective order entered in ApoPharma Inc. v. Taro Pharmaceutical
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`Industries, Ltd., Case No. 2:16-cv-00528 (E.D.Tex.).
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`4.6. Persons receiving confidential information shall use reasonable efforts
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`to maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which
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`persons not authorized to receive the information shall not have access;
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`(B) Otherwise using
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`reasonable
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`efforts
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`to maintain
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`the
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`confidentiality of 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 received from
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`the disclosing party;
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`(C) Ensuring that support personnel of the recipient who have
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`access to the confidential information understand and abide by the obligation to
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`maintain the confidentiality of information received that is designated as
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`confidential; and
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`(D) Limiting
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`the copying of confidential
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`information
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`to a
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`reasonable number of copies needed for conduct of the proceeding and maintaining
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`a record of the locations of such copies.
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`5.7. 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) Documents and Information Filed With the Board.
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`(i) A party may file documents or information with the
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`Board under seal, together with a non-confidential description of the nature of the
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`confidential information that is under seal and the reasons why the information is
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`confidential and should not be made available to the public. The submission shall
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`be treated as confidential and remain under seal, unless, upon motion of a party
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`and after a hearing on the issue, or sua sponte, the Board determines that the
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`documents or information do not to qualify for confidential treatment.
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`(ii) Where confidentiality is alleged as to some but not all of
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`the information submitted to the Board, the submitting party shall file confidential
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`and 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 the
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`public. The non-confidential version of the submission shall clearly indicate the
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`locations of information that has been redacted. The confidential version of the
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`submission shall be filed under seal. The redacted information shall remain under
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`seal unless, upon motion of a party and after a hearing on the issue, or sua sponte,
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`the Board determines that some or all of the redacted information does not qualify
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`for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties.
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`Information designated as confidential that is disclosed to another party during
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`discovery or other proceedings before the Board shall be clearly marked as
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`“PROTECTIVE ORDER MATERIAL” and shall be produced in a manner that
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`maintains its confidentiality.
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`8.
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`Confidential Testimony. A Party may, during the testimony of any
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`person in the proceeding, preliminary designate the entirety of such testimony and
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`all transcriptions thereof as Confidential, pending further review. Within ten days
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`of the receipt of the transcript of the testimony, the Party seeking to maintain the
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`confidentiality of the testimony shall advise the opposing party of those portions of
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`the testimony to which a claim of confidentiality is to be maintained, and the
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`reasons in support of that claim. Such portions of the testimony shall be treated as
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`7 of 11
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`Exhibit 1050
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`confidential and maintained under seal in any filings to the Board unless, upon
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`motion of a party and after hearing on the issue, or sua sponte, the Board
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`determines that some or all of the redacted information does not qualify for
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`confidential treatment. Similarly, any testimony from another proceeding that was
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`designated on the record as Confidential Information or Highly Confidential
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`Information – Outside Counsel Only shall be preliminarily designated
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`Confidential, pending further review.
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`9.
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`Confidential information received in the proceeding may not be used
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`in any other matter or proceeding in which the providing party is not also a party.
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`6.10. Disposal of Confidential Information. Representatives of each party
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`shall assemble all copies of all confidential information they have received,
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`including confidential information provided to their experts, and shall destroy the
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`confidential information and provide a certification of destruction to the party who
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`produced the confidential information by the later of Within one month after final
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`termination of the proceeding, including any appeals, or within one month after the
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`time for appeal from this proceeding has expired, or within 60 days of final
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`termination of ApoPharma Inc. v. Taro Pharmaceutical Industries, Ltd., Case No.
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`2:16-cv-00528, (E.D.Tex.) and any appeals. representatives of each party shall
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`assemble all copies of all confidential information they have received, including
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`confidential information provided to their experts, and shall destroy the
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`8 of 11
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`Exhibit 1050
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`confidential information and provide a certification of destruction to the party who
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`produced the confidential information.
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`2.
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`Standard Acknowledgement of Protective Order. The following form
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`may be used to acknowledge a protective order and gain access to information
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`covered by the protective order:
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`9 of 11
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`Taro Pharmaceuticals, Ltd
`Exhibit 1050
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case No. IPR2017-01446
`
`U.S. Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`________________
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`
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`ACKNOWLEDGMENT FOR ACCESS TO PROTECTIVE
`ORDER MATERIAL
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`I, __________________________, affirm that I have read the Protective
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`Order; that I will abide by its terms; that I will use the confidential information
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`only in connection with this proceeding and for no other purpose; that I will only
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`allow access to support staff who are reasonably necessary to assist me in this
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`proceeding; that prior to any disclosure to such support staff I informed or will
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`inform them of the requirements of the Protective Order; that I am personally
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`responsible for the requirements of the terms of the Protective Order and I agree to
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`10 of 11
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`Taro Pharmaceuticals, Ltd
`Exhibit 1050
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`submit 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 Protective
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`Order and providing remedies for its breach.
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`______________________________
`Signature and Date
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`11 of 11
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`Taro Pharmaceuticals, Ltd
`Exhibit 1050
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