DECLARATION OF Deanna J. Field
`
`1, Deanna J. Field, declare as follows:
`
`1.
`
`I submit this declaration at the request of Finnegan, Henderson,
`
`Farabow, Garrett & Dunner, LLP who is representing Senju Pharmaceutical, Co.
`
`Ltd. (“Senju”) in IPR 2015-01097, IPR2015-01099, IPR2015-1100, and IPR2015-
`
`1105 (“lPRs”) before the United States Patent and Trademark Office (“PTO”)
`
`Patent Trial and Appeal Board (“Board”).
`
`2.
`
`I am currently Vice President of Finance and Administration of
`
`BioScience Laboratories, Inc., 1755 South 19"‘ Avenue, Bozeman, Montana 59718
`
`(“BioScience”).
`
`3.
`
`I have been advised that in connection with the above-mentioned IPRS,
`
`Senju filed certain confidential BioScience documents (Exhibits 2267-2278 and
`
`2294) with the Board on February 25, 2016.
`
`4.
`
`I have also been advised that on July 6, 2016, Senju sent an email to the
`
`Board requesting clarification on how third-party BioScience could offer evidence
`
`to establish that certain exhibits contain BioScience proprietary information.
`
`I
`
`have also been advised that on July 8, the Board authorized BioScience to submit a
`
`declaration authorizing Senju to seek protection on BioScience’s behalf and
`
`Page 1 of 12
`
`SENJU EXHIBIT 2347
`
`LUPIN v. SENJU
`
`IPR2015—0l099
`
`
`
`1, Deanna J. Field, declare as follows:
`
`1.
`
`I submit this declaration at the request of Finnegan, Henderson,
`
`Farabow, Garrett & Dunner, LLP who is representing Senju Pharmaceutical, Co.
`
`Ltd. (“Senju”) in IPR 2015-01097, IPR2015-01099, IPR2015-1100, and IPR2015-
`
`1105 (“lPRs”) before the United States Patent and Trademark Office (“PTO”)
`
`Patent Trial and Appeal Board (“Board”).
`
`2.
`
`I am currently Vice President of Finance and Administration of
`
`BioScience Laboratories, Inc., 1755 South 19"‘ Avenue, Bozeman, Montana 59718
`
`(“BioScience”).
`
`3.
`
`I have been advised that in connection with the above-mentioned IPRS,
`
`Senju filed certain confidential BioScience documents (Exhibits 2267-2278 and
`
`2294) with the Board on February 25, 2016.
`
`4.
`
`I have also been advised that on July 6, 2016, Senju sent an email to the
`
`Board requesting clarification on how third-party BioScience could offer evidence
`
`to establish that certain exhibits contain BioScience proprietary information.
`
`I
`
`have also been advised that on July 8, the Board authorized BioScience to submit a
`
`declaration authorizing Senju to seek protection on BioScience’s behalf and
`
`Page 1 of 12
`
`SENJU EXHIBIT 2347
`
`LUPIN v. SENJU
`
`IPR2015—0l099
`
`
`
`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
`
`proprietary and why.
`
`5. As requested by the Board, BioScience hereby authorizes Senju to seek
`
`protection on BioScience’s behalf for the confidential information contained in
`
`Exhibits 2267-2278 and 2294, because BioScience enters into confidential non-
`
`disclosure agreements (NDAs) with their clients, employees, subcontractors,
`
`consultants and any other non—related parties, and, for other reasons explained
`
`herein. Furthermore, BioScience considers its Standard Operating Procedures
`
`(SOPS) proprietary intellectual property and it do not allow their clients or other
`
`parties to reproduce them at any time for any reason. Each page of the SOPS
`
`contains a CONFIDENTIAL watermark and the following statement appears at the
`
`bottom of each page:
`
`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.
`
`Page 2 of 12
`
`
`
`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
`
`confidential BioScience information, including trade secrets and intellectual
`
`writings, protocol development, and/or commercial confidential information:
`
`21.
`
`Exhibit 2267 - Confidential BioScience Laboratories, Inc., Testing for
`
`Study #151142-203, “A Non-GLP Antimicrobial Preservatives
`
`Effectiveness Evaluation of Six Products When Challenged with Four
`
`Microorganisms Species Based on European Pharmacopoeia Method
`
`5.1.3,” January 7, 2016 - This document contains confidential
`
`information, specifically on pages 5-18 and 36-65, which describes
`
`the details of BioScience’s proprietary testing protocol and standard
`
`operating procedures (“SOPs”), including but not limited to detailed,
`
`step-by-step instructions of how to perform the testing, deviations
`
`from the stated protocol, including the impact of such deviations when
`
`applicable, and forms and calculations based on and reflecting the
`
`study results. 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. BioScience’s employees,
`
`consultants, and subcontractors also must enter into a NDA as a
`
`Page 3 of 12
`
`3
`
`
`
`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
`
`Exhibit 2267 redacting out the above—mentioned confidential
`
`materials will be filed.
`
`Exhibit 2268 - Confidential BioScience Laboratories, Inc., Incubator
`
`Log Forms, Refrigerator Log Form, Product Receipt Log Form,
`
`Sample Submission Form, Product-Tracking Form for Study
`
`# 151142-203 - This document contains confidential information,
`
`specifically on pages 2-16, which includes forms with calculations
`
`and record-keeping based on and reflecting the details of BioScience’s
`
`proprietary SOPs. 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
`
`2268 contains only one page without confidential information (a title
`
`page) and as a result, filing a redacted exhibit would not be practical.
`
`. Exhibit 2269 - Confidential BioScience Laboratories, Inc., Standard
`
`Operating Procedure No. E-0003, January 14, 2016 - This document
`
`contains confidential information, specifically on pages 1-2, which
`
`describes the details of and step—by-step instructions for a proprietary
`
`Page 4 of 12
`
`4
`
`
`
`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
`
`confidential because BioScience’s SOPS are not disclosed to the
`
`public by BioScience and constitute sensitive and proprietary business
`
`information. Exhibit 2269 contains only one page without
`
`confidential information (a signature page) and as result, filing a
`
`redacted exhibit would not be practical.
`
`Exhibit 2270 - Confidential BioScience Laboratories, Inc., Standard
`
`Operating Procedure No. E-0017, August 24, 2015 - This document
`
`contains confidential information, specifically on pages 1-2, which
`
`describes the details of and step-by-step instructions for a proprietary
`
`BioScience SOP for aerobic incubator operation. This information is
`
`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
`
`confidential information (a signature page) and as result, filing a
`
`redacted exhibit would not be practical.
`
`6.
`
`Exhibit 2271 - Confidential BioScience Laboratories, Inc., Standard
`
`Operating Procedure No. E—O005, October 20, 2015 - This document
`
`contains confidential information, specifically on pages 1-9, which
`
`Page 5 of 12
`
`5
`
`
`
`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
`
`confidential information (a signature page) and as result, filing a
`
`redacted exhibit would not be practical.
`
`Exhibit 2272 - Confidential BioScience Laboratories, Inc., “Protocol
`
`and/or SOP Deviation Recording Form”, Protocol Number: #151142-
`
`203, January 19, 2016 - This document contains confidential
`
`information, specifically on page 1, which describes details of
`
`proprietary BioScience SOPs for refrigerator operation and aerobic
`
`incubator operation and reflects record-keeping of deviations
`
`therefrom. This information is confidential because BioScience’s
`
`SOPs are not disclosed to the public by BioScience and constitute
`
`sensitive and proprietary business information. Exhibit 2272 contains
`
`only one page without confidential information (a signature page) and
`
`as result, filing a redacted exhibit would not be practical.
`
`Page 6 of 12
`
`
`
`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.
`
`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
`
`information is confidential because BioScience’s detailed testing
`
`methods, laboratory processes and procedures, and SOPs are not
`
`disclosed to the public by BioScience and constitute sensitive and
`
`proprietary business information. Exhibit 2273 contains confidential
`
`information on the only page of the exhibit, therefore filing a redacted
`
`exhibit would not be practical.
`
`. Exhibit 2274 - Confidential BioScience Laboratories, Inc., Inoculum
`
`Preparation Tracking Form for Study No. 151142-203, test dates
`
`November 2015 — January 2016 - This 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
`
`Page 7 of 12
`
`7
`
`
`
`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
`
`practical.
`
`i. Exhibit 2275 - Confidential BioScience Laboratories, Inc.,
`
`Media/Diluent Tracking Form for Study No. 151 142-203, test dates
`
`November 2015 — December 2015 - This 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
`
`business information. Exhibit 2275 contains confidential information
`
`on each page of the exhibit, therefore filing a redacted exhibit would
`
`not be practical.
`
`j. Exhibit 2276 - Confidential BioScience Laboratories, Inc., Media
`
`Production and Growth Testing Data Sheet for Study No. 151142-203,
`
`dated October 2015 - January 2016 - This document contains pages of
`
`Page 8 of 12
`
`8
`
`
`
`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
`
`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.
`
`Exhibit 2277 - Confidential BioScience Laboratories, Inc.,
`
`Neutralization Verification for Preservative Effectiveness Testing for
`
`Study No. 151142-203, dated November 2015 — January 2016 - This
`
`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
`
`9
`
`
`
`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,
`
`2016 - This single page document contains confidential information,
`
`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
`
`confidential information, specifically on pages 1-9, which describes
`
`which describes the details of and step-by-step instructions for a
`
`proprietary BioScience SOP for plate counting and calculation
`
`Page 10 of 12
`
`10
`
`
`
`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
`
`financial damage to BioScience. The public’s interest in the instant proceeding
`
`does not outweigh BioScience’s interest in protecting its confidential and
`
`proprietary business information.
`
`8. The information identified in this declaration as confidential has not
`
`been previously published or otherwise made public.
`
`9. BioScience authorizes Senju at the close of this proceeding to request
`
`that the confidential information identified above be expunged, but BioScience
`
`acknowledges that such a motion will not necessarily prevail if the Board has
`
`relied on information sealed subject to the Protective Order in the Board’s Final
`
`Written Decision.
`
`Page 11 of 12
`
`11
`
`
`
`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,
`
`and that all statements made on information and belief are believed to be true and
`
`that these statements were made with the knowledge that willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both under Section
`
`1001 of Title 18 of the United States Code.
`
`Dated:
`
`<97;2/g20/4» By
`
`Page 12 of 12
`
`12
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