`
`1, Deanna J. Field, declare as follows:
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`1.
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`I submit this declaration at the request of Finnegan, Henderson,
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`Farabow, Garrett & Dunner, LLP who is representing Senju Pharmaceutical, Co.
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`Ltd. (“Senju”) in IPR 2015-01097, IPR2015-01099, IPR2015-1100, and IPR2015-
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`1105 (“lPRs”) before the United States Patent and Trademark Office (“PTO”)
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`Patent Trial and Appeal Board (“Board”).
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`2.
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`I am currently Vice President of Finance and Administration of
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`BioScience Laboratories, Inc., 1755 South 19"‘ Avenue, Bozeman, Montana 59718
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`(“BioScience”).
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`3.
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`I have been advised that in connection with the above-mentioned IPRS,
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`Senju filed certain confidential BioScience documents (Exhibits 2267-2278 and
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`2294) with the Board on February 25, 2016.
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`4.
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`I have also been advised that on July 6, 2016, Senju sent an email to the
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`Board requesting clarification on how third-party BioScience could offer evidence
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`to establish that certain exhibits contain BioScience proprietary information.
`
`I
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`have also been advised that on July 8, the Board authorized BioScience to submit a
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`declaration authorizing Senju to seek protection on BioScience’s behalf and
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`Page 1 of 12
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`SENJU EXHIBIT 2347
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`LUPIN v. SENJU
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`IPR20l5—01097
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`
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`explaining what information contained in Exhibits 2267-2278 and 2294 is
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`proprietary and why.
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`5. As requested by the Board, BioScience hereby authorizes Senju to seek
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`protection on BioScience’s behalf for the confidential information contained in
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`Exhibits 2267-2278 and 2294, because BioScience enters into confidential non-
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`disclosure agreements (NDAs) with their clients, employees, subcontractors,
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`consultants and any other non—related parties, and, for other reasons explained
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`herein. Furthermore, BioScience considers its Standard Operating Procedures
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`(SOPS) proprietary intellectual property and it do not allow their clients or other
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`parties to reproduce them at any time for any reason. Each page of the SOPS
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`contains a CONFIDENTIAL watermark and the following statement appears at the
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`bottom of each page:
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`Notice: Proprietary Information - Not for Publication.
`Confidential/proprietary information of BioScience
`Laboratories, Inc. is contained herein and may not be
`discussed, used, made available, duplicated, or
`distributed without its prior written consent. Failure to
`observe this may result in Liability for any damages and
`losses resulting therefrom.
`© Copyright 2016 by BioScience Laboratories, Inc.
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`Page 2 of 12
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`
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`6. As specifically noted below, Exhibits 2267-2278 and 2294 contain
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`confidential BioScience information, including trade secrets and intellectual
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`writings, protocol development, and/or commercial confidential information:
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`21.
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`Exhibit 2267 - Confidential BioScience Laboratories, Inc., Testing for
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`Study #151142-203, “A Non-GLP Antimicrobial Preservatives
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`Effectiveness Evaluation of Six Products When Challenged with Four
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`Microorganisms Species Based on European Pharmacopoeia Method
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`5.1.3,” January 7, 2016 - This document contains confidential
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`information, specifically on pages 5-18 and 36-65, which describes
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`the details of BioScience’s proprietary testing protocol and standard
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`operating procedures (“SOPs”), including but not limited to detailed,
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`step-by-step instructions of how to perform the testing, deviations
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`from the stated protocol, including the impact of such deviations when
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`applicable, and forms and calculations based on and reflecting the
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`study results. This information is confidential because BioScience’s
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`detailed testing methods and laboratory processes and procedures are
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`not disclosed to the public by BioScience and constitute sensitive and
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`proprietary business information. BioScience’s employees,
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`consultants, and subcontractors also must enter into a NDA as a
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`Page 3 of 12
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`3
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`
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`IPR20l5-01097 (Patent 8,754,131 B2)
`IPR20l5-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`condition of their employment or engagement. A public version of
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`Exhibit 2267 redacting out the above—mentioned confidential
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`materials will be filed.
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`Exhibit 2268 - Confidential BioScience Laboratories, Inc., Incubator
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`Log Forms, Refrigerator Log Form, Product Receipt Log Form,
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`Sample Submission Form, Product-Tracking Form for Study
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`# 151142-203 - This document contains confidential information,
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`specifically on pages 2-16, which includes forms with calculations
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`and record-keeping based on and reflecting the details of BioScience’s
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`proprietary SOPs. This information is confidential because
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`BioScience’s detailed testing methods and laboratory processes and
`
`procedures are not disclosed to the public by BioScience and
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`constitute sensitive and proprietary business information. Exhibit
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`2268 contains only one page without confidential information (a title
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`page) and as a result, filing a redacted exhibit would not be practical.
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`. Exhibit 2269 - Confidential BioScience Laboratories, Inc., Standard
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`Operating Procedure No. E-0003, January 14, 2016 - This document
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`contains confidential information, specifically on pages 1-2, which
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`describes the details of and step—by-step instructions for a proprietary
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`Page 4 of 12
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`4
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`
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 131)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`BioScience SOP for refrigerator operation. This information is
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`confidential because BioScience’s SOPS are not disclosed to the
`
`public by BioScience and constitute sensitive and proprietary business
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`information. Exhibit 2269 contains only one page without
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`confidential information (a signature page) and as result, filing a
`
`redacted exhibit would not be practical.
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`Exhibit 2270 - Confidential BioScience Laboratories, Inc., Standard
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`Operating Procedure No. E-0017, August 24, 2015 - This document
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`contains confidential information, specifically on pages 1-2, which
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`describes the details of and step-by-step instructions for a proprietary
`
`BioScience SOP for aerobic incubator operation. This information is
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`confidential because BioScience’s SOPs are not disclosed to the
`
`public by BioScience and constitute sensitive and proprietary business
`
`information. Exhibit 2270 contains only one page without
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`confidential information (a signature page) and as result, filing a
`
`redacted exhibit would not be practical.
`
`6.
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`Exhibit 2271 - Confidential BioScience Laboratories, Inc., Standard
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`Operating Procedure No. E—O005, October 20, 2015 - This document
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`contains confidential information, specifically on pages 1-9, which
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`Page 5 of 12
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`5
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`
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`19112015-01097 (Patent 8,754,131 B2)
`IPR20]5-01 100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`describes the details of and step-by-step instructions for a proprietary
`
`BioScience SOP for in-coming product handling. This information is
`
`confidential because BioScience’s SOPs are not disclosed to the
`
`public by BioScience and constitute sensitive and proprietary business
`
`information. Exhibit 2271 contains only one page without
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`confidential information (a signature page) and as result, filing a
`
`redacted exhibit would not be practical.
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`Exhibit 2272 - Confidential BioScience Laboratories, Inc., “Protocol
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`and/or SOP Deviation Recording Form”, Protocol Number: #151142-
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`203, January 19, 2016 - This document contains confidential
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`information, specifically on page 1, which describes details of
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`proprietary BioScience SOPs for refrigerator operation and aerobic
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`incubator operation and reflects record-keeping of deviations
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`therefrom. This information is confidential because BioScience’s
`
`SOPs are not disclosed to the public by BioScience and constitute
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`sensitive and proprietary business information. Exhibit 2272 contains
`
`only one page without confidential information (a signature page) and
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`as result, filing a redacted exhibit would not be practical.
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`Page 6 of 12
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`
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Exhibit 2273 - Confidential BioScience Laboratories, Inc., Equipment
`
`g.
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`Tracking Form for Study No. 151 142-203, test date November 23,
`
`2015 - This document contains confidential information, specifically
`
`on page 1, which includes a form with record-keeping based on and
`
`reflecting the details of a BioScience proprietary SOP. This
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`information is confidential because BioScience’s detailed testing
`
`methods, laboratory processes and procedures, and SOPs are not
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`disclosed to the public by BioScience and constitute sensitive and
`
`proprietary business information. Exhibit 2273 contains confidential
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`information on the only page of the exhibit, therefore filing a redacted
`
`exhibit would not be practical.
`
`. Exhibit 2274 - Confidential BioScience Laboratories, Inc., Inoculum
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`Preparation Tracking Form for Study No. 151142-203, test dates
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`November 2015 — January 2016 - This document contains confidential
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`information, specifically on pages 1-3, which includes forms with
`
`calculations and record-keeping based on and reflecting the details of
`
`BioScience’s proprietary testing protocol. This information is
`
`confidential because BioScience’s detailed testing methods and
`
`laboratory processes and procedures are not disclosed to the public by
`
`Page 7 of 12
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`7
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`
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`BioScience and constitute sensitive and proprietary business
`
`information. Exhibit 2274 contains confidential information on each
`
`page of the exhibit, therefore filing a redacted exhibit would not be
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`practical.
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`i. Exhibit 2275 - Confidential BioScience Laboratories, Inc.,
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`Media/Diluent Tracking Form for Study No. 151 142-203, test dates
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`November 2015 — December 2015 - This document contains
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`confidential information, specifically on pages 1-3, which includes
`
`forms with calculations and record-keeping based on and reflecting
`
`the details of BioScience’s proprietary testing protocol. This
`
`information is confidential because BioScience’s detailed testing
`
`methods and laboratory processes and procedures are not disclosed to
`
`the public by BioScience and constitute sensitive and proprietary
`
`business information. Exhibit 2275 contains confidential information
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`on each page of the exhibit, therefore filing a redacted exhibit would
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`not be practical.
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`j. Exhibit 2276 - Confidential BioScience Laboratories, Inc., Media
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`Production and Growth Testing Data Sheet for Study No. 151142-203,
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`dated October 2015 - January 2016 - This document contains pages of
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`Page 8 of 12
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`8
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`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01 100 (Patent 8,927,606 B1)
`IPR2015-01 105 (Patent 8,871,813 B2)
`
`the same testing data sheet completed over multiple days. This
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`document contains confidential information, including forms with
`
`calculations and record-keeping based on and reflecting the details of
`
`BioScience’s proprietary testing protocol. This information is
`
`confidential because BioScience’s detailed testing methods and
`
`laboratory processes and procedures are not disclosed to the public by
`
`BioScience and constitute sensitive and proprietary business
`
`information. Exhibit 2276 contains confidential information on each
`
`page of the exhibit, therefore filing a redacted exhibit would not be
`
`practical.
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`Exhibit 2277 - Confidential BioScience Laboratories, Inc.,
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`Neutralization Verification for Preservative Effectiveness Testing for
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`Study No. 151142-203, dated November 2015 — January 2016 - This
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`document contains confidential information, specifically on pages 1-3,
`
`which includes forms with calculations and record-keeping based on
`
`and reflecting the details of BioScience’s proprietary testing protocol.
`
`This information is confidential because BioScience’s detailed testing
`
`methods and laboratory processes and procedures are not disclosed to
`
`the public by BioScience and constitute sensitive and proprietary
`
`Page 9 of 12
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`9
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`
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`IPR20l5-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`business information. Exhibit 2277 contains confidential information
`
`on each page of the exhibit, therefore filing a redacted exhibit would
`
`not be practical.
`
`1. Exhibit 2278 - Confidential BioScience Laboratories, Inc., TSA/SDA
`
`Equivalency Evaluation for Study No. 151142-203, dated February 14,
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`2016 - This single page document contains confidential information,
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`which includes a form with calculations and record-keeping based on
`
`and reflecting the details of BioScience’s proprietary testing protocol.
`
`This information is confidential because BioScience’s detailed testing
`
`methods and laboratory processes and procedures are not disclosed to
`
`the public by BioScience and constitute sensitive and proprietary
`
`business information. The sole page of Exhibit 2278 contains
`
`confidential information, therefore filing a redacted exhibit would not
`
`be practical.
`
`in. Exhibit 2294 - Confidential BioScience Laboratories, Inc., Standard
`
`Operating Procedure No. L-2059 - This document contains
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`confidential information, specifically on pages 1-9, which describes
`
`which describes the details of and step-by-step instructions for a
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`proprietary BioScience SOP for plate counting and calculation
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`Page 10 of 12
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`10
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`
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`IPR20l5-01097 (Patent 8,754,131 B2)
`IPR20l5-01100 (Patent 8,927,606 B1)
`IPR20l5-01105 (Patent 8,871,813 B2)
`
`procedures for in-vitro studies. This information is confidential
`
`because BioScience’s SOPs are not disclosed to the public by
`
`BioScience and constitute sensitive and proprietary business
`
`information. Exhibit 2271 contains only one page without
`
`confidential information (a signature page) and as result, filing a
`
`redacted exhibit would not be practical.
`
`7. Disclosure of the confidential information contained in Exhibits 2267-
`
`2278 and 2294 to the public, including BioScience’s competitors, would harm
`
`BioScience’s ability to compete in the marketplace and would cause irreparable
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`financial damage to BioScience. The public’s interest in the instant proceeding
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`does not outweigh BioScience’s interest in protecting its confidential and
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`proprietary business information.
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`8. The information identified in this declaration as confidential has not
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`been previously published or otherwise made public.
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`9. BioScience authorizes Senju at the close of this proceeding to request
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`that the confidential information identified above be expunged, but BioScience
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`acknowledges that such a motion will not necessarily prevail if the Board has
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`relied on information sealed subject to the Protective Order in the Board’s Final
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`Written Decision.
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`Page 11 of 12
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`11
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`
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`IPR2015-01097 (Patent 8,754,131 132)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`10. I declare that these statements made herein of my knowledge are true,
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`and that all statements made on information and belief are believed to be true and
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`that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both under Section
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`1001 of Title 18 of the United States Code.
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`Dated:
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`<97;2/g20/4» By
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`Page 12 of 12
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`12