`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 1 of 6 PagelD #: 10504
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 22-252-MSG
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`REDACTED - PUBLIC VERSION
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`) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Plaintiffs,
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`Vv.
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`MODERNA,INC. and MODERNATX,INC.,
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`Defendants.
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`MODERNA,INC. and MODERNATX,INC.,
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`Counterclaim-Plaintiffs,
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`V.
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Counterclaim-Defendants.
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`DECLARATION OF PETER WOJCIECHOWSKI
`IN SUPPORT OF MODERNA’S MOTION TO SEAL
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`
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`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 2 of 6 PageID #: 10505
`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 2 of 6 PagelD #: 10505
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`I, Peter Wojciechowski, hereby declare as follows:
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`1.
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`I am CMC Knowledge Management Lead at ModernaTX,
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`Inc.
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`(hereinafter,
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`“Moderna”). In this role, I am familiar with Moderna’s technical research and development
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`information. I am familiar with the fact that Moderna maintains this information as confidential’,
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`and I am familiar with the extensive efforts Modernatakesto protect its confidential information.
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`I have personal knowledge of the facts stated in this declaration of have become aware of such
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`facts through myrole at Moderna.If called uponto testify, I could and would competently testify
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`thereto.
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`2.
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`I write this declaration in support of Moderna’s request to avoid disclosure of
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`sensitive and confidential information on the public record. I discuss below how and why Moderna
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`keepscertain technical information confidential, and the serious harm that would result to Moderna
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`from disclosure of this information to Moderna’s competitors.
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`3.
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`I understandthis case relates to Moderna’s COVID-19 Vaccine, known as mRNA-
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`1273 or “SpikeVax.” SpikeVax is comprised of messenger RNA (mRNA) whichis encased in
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`lipid nanoparticles (LNPs). Moderna’s proprietary LNP is comprised of four lipid components
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`including SM-102, cholesterol, phospholipid, and PEGDMG-2000.
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`4,
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`I have been provided and have reviewedthe information that Modernaproposesto
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`redact from the Joint Claim Construction Brief, as well as from the Joint Appendix to the Claim
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`Construction Brief. Specifically, the Joint Claim Construction Brief and Exhibits 77 and 81 of the
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`'T understand that the Protective Order in this case (D.I. 91) includes two categories of Protected
`Material: “Confidential” and “Highly Confidential — Outside Counsel’s Eyes Only.” I
`understand that
`the Joint Claim Construction Brief and Exhibits of the Joint Claim
`Construction Appendix include both categories of Protected Material. For the purposesofthis
`declaration, I have used the term “confidential” to cover both categories, neither of which
`should be disclosed to the public for the reasons explained herein.
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`
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`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 3 of 6 PageID #: 10506
`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 3 of 6 PagelD #: 10506
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`Joint Claim Construction Appendix contain Moderna confidential information. These documents
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`reflect Moderna confidential technical and business information regarding Moderna’s COVID-19
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`vaccine.
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`5.
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`It is critical to Moderna that the Court maintain under seal Moderna’s confidential
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`information. Moderna has always taken extensive measures to maintain the confidentiality of its
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`technical information, including by implementing procedures that restrict access to sensitive
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`information even within Moderna. Employees have confidentiality obligations as part of their
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`employmentand are provided guidance regarding how to treat sensitive information. Specifically,
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`confidential Moderna information is not to be disclosed outside of Moderna except under
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`confidentiality agreement and when necessary. Documents containing such information may be
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`marked as confidential or otherwise indicate they contain restricted or sensitive information.
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`Internal to Moderna, employee access to commercially sensitive and trade secret information is
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`often restricted on a need-to know basis, as determined by a person’s grouporrole on a project.
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`Modernahasbeen extremely concerned aboutthe protection of its confidential information during
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`this litigation and has been very careful to alwaysprotect this information.
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`6.
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`Moderna’s proposed redactions
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`seek to seal portions of the Joint Claim
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`Construction Brief and Exhibits 77 and 81 of the Joint Claim Construction Appendix, which refer
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`to, quote, summarize, or otherwise disclose Moderna’s sensitive and confidential technical
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`information. Specifically, (1) the information on page 25, lines 15-18 and page 29,lines 1-3 of the
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`Joint Claim Construction Brief refers to the composition of Moderna’s COVID-19 Vaccine which
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`indirectly references the quantities of the components, which Moderna maintainsas confidential,
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`and (2) the information on page 3, lines 6-7; page 25, lines 15-18; page 28, lines 3-15; page 29,
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`lines 1-3 (including the figure); page 34, lines 17-21 of the Joint Claim Construction Brief and
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`
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`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 4 of 6 PageID #: 10507
`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 4 of 6 PagelD #: 10507
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`Exhibits 77 and 81 of the Joint Claim Construction Appendix (which are confidential regulatory
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`submissions to the FDA)disclose specific information concerning Moderna’s proprietary and trade
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`secret manufacturing methods for its COVID-19 Vaccine including steps in the manufacturing
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`process and parametersfor those steps.
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`7.
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`The information within the Joint Claim Construction Brief and Exhibits 77 and 81
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`of the Joint Claim Construction Appendix that Moderna proposes redacting is confidential and
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`sensitive information that Moderna does not disclose publicly, which it wishes to remain
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`confidential. There is significant competition between established vaccine suppliers, including
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`suppliers with mRNA-based vaccines. Additionally, there are companies considering entering the
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`vaccine market and companies developing mRNA-based vaccines and therapeutics for other
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`diseases or developing lipid nanoparticles for mRNA-based products. Because there are so few
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`competitors in these markets, the markets are highly competitive, and any information about one
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`of the competitors, even seemingly minor information, may prove competitively advantageous.
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`Modernahasspent significant resources to develop its formulation and manufacturing methods,
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`and the release of such information to the public,
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`including Moderna’s competitors, would
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`significantly harm Moderna.
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`8.
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`With respect to Moderna’s formulation, Moderna considersits precise formulation,
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`including the quantities of ingredients, a trade secret, which is not public knowledge.
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`9.
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`With respect
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`to Moderna’s proprietary manufacturing process for SpikeVax,
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`Moderna considers its process-as-a-whole a trade secret, including the steps in the process, the
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`records of each step, the parameters or specification for each step (such as timing, sequence,
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`amount and kind of raw materials, temperatures, measurements, equipmentused etc.). Moderna
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`has not publicly disclosed its proprietary manufacturing process. Exhibits 77 and 81 of the Joint
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`
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`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 5 of 6 PagelD #: 10508
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`Claim Construction Appendix disclose many ofthese details, which are referenced in the portions
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`of the Joint Claim Construction Brief that Moderna proposesto redact.
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`10.|Based on mypersonal knowledge and experience in the pharmaceutical business,I
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`believe that disclosure of this information would significantly harm Moderna by revealing
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`confidential data to its direct competitors and the public generally. If the confidential information
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`were made public, Moderna’s competitors would be able to potentially replicate Moderna’s
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`products, features within Moderna’s products, and methods of making Moderna’s products, or
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`make decisions about where, when, and how to offer directly competitive goods with full
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`knowledge of Moderna’s technology. Moderna’s competitors would gain a significant advantage
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`in creating their own businessstrategies, which would put Modernaat a significant competitive
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`disadvantage, causing it real and serious harm. Moderna’s competitors may also seek patent claims
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`to cover Moderna’s technology.
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`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 6 of 6 PageID #: 10509
`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 6 of 6 PagelD #: 10509
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`I declare under penalty of perjury under the laws of the United States of America that the
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`foregoing is true and correct to the best of my knowledge.
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`Executed on this December 20, 2023
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`Respectfully submitted,
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`/s/ Peter Wojciechowski
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`Peter Wojciechowski
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`