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Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 1 of 6 PageID #: 10504
`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 1 of 6 PagelD #: 10504
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 22-252-MSG
`
`REDACTED - PUBLIC VERSION
`
`) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`Vv.
`
`MODERNA,INC. and MODERNATX,INC.,
`
`Defendants.
`
`MODERNA,INC. and MODERNATX,INC.,
`
`Counterclaim-Plaintiffs,
`
`V.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
`DECLARATION OF PETER WOJCIECHOWSKI
`IN SUPPORT OF MODERNA’S MOTION TO SEAL
`
`

`

`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
`
`I, Peter Wojciechowski, hereby declare as follows:
`
`1.
`
`I am CMC Knowledge Management Lead at ModernaTX,
`
`Inc.
`
`(hereinafter,
`
`“Moderna”). In this role, I am familiar with Moderna’s technical research and development
`
`information. I am familiar with the fact that Moderna maintains this information as confidential’,
`
`and I am familiar with the extensive efforts Modernatakesto protect its confidential information.
`
`I have personal knowledge of the facts stated in this declaration of have become aware of such
`
`facts through myrole at Moderna.If called uponto testify, I could and would competently testify
`
`thereto.
`
`2.
`
`I write this declaration in support of Moderna’s request to avoid disclosure of
`
`sensitive and confidential information on the public record. I discuss below how and why Moderna
`
`keepscertain technical information confidential, and the serious harm that would result to Moderna
`
`from disclosure of this information to Moderna’s competitors.
`
`3.
`
`I understandthis case relates to Moderna’s COVID-19 Vaccine, known as mRNA-
`
`1273 or “SpikeVax.” SpikeVax is comprised of messenger RNA (mRNA) whichis encased in
`
`lipid nanoparticles (LNPs). Moderna’s proprietary LNP is comprised of four lipid components
`
`including SM-102, cholesterol, phospholipid, and PEGDMG-2000.
`
`4,
`
`I have been provided and have reviewedthe information that Modernaproposesto
`
`redact from the Joint Claim Construction Brief, as well as from the Joint Appendix to the Claim
`
`Construction Brief. Specifically, the Joint Claim Construction Brief and Exhibits 77 and 81 of the
`
`'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.
`
`

`

`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
`
`Joint Claim Construction Appendix contain Moderna confidential information. These documents
`
`reflect Moderna confidential technical and business information regarding Moderna’s COVID-19
`
`vaccine.
`
`5.
`
`It is critical to Moderna that the Court maintain under seal Moderna’s confidential
`
`information. Moderna has always taken extensive measures to maintain the confidentiality of its
`
`technical information, including by implementing procedures that restrict access to sensitive
`
`information even within Moderna. Employees have confidentiality obligations as part of their
`
`employmentand are provided guidance regarding how to treat sensitive information. Specifically,
`
`confidential Moderna information is not to be disclosed outside of Moderna except under
`
`confidentiality agreement and when necessary. Documents containing such information may be
`
`marked as confidential or otherwise indicate they contain restricted or sensitive information.
`
`Internal to Moderna, employee access to commercially sensitive and trade secret information is
`
`often restricted on a need-to know basis, as determined by a person’s grouporrole on a project.
`
`Modernahasbeen extremely concerned aboutthe protection of its confidential information during
`
`this litigation and has been very careful to alwaysprotect this information.
`
`6.
`
`Moderna’s proposed redactions
`
`seek to seal portions of the Joint Claim
`
`Construction Brief and Exhibits 77 and 81 of the Joint Claim Construction Appendix, which refer
`
`to, quote, summarize, or otherwise disclose Moderna’s sensitive and confidential technical
`
`information. Specifically, (1) the information on page 25, lines 15-18 and page 29,lines 1-3 of the
`
`Joint Claim Construction Brief refers to the composition of Moderna’s COVID-19 Vaccine which
`
`indirectly references the quantities of the components, which Moderna maintainsas confidential,
`
`and (2) the information on page 3, lines 6-7; page 25, lines 15-18; page 28, lines 3-15; page 29,
`
`lines 1-3 (including the figure); page 34, lines 17-21 of the Joint Claim Construction Brief and
`
`

`

`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
`
`Exhibits 77 and 81 of the Joint Claim Construction Appendix (which are confidential regulatory
`
`submissions to the FDA)disclose specific information concerning Moderna’s proprietary and trade
`
`secret manufacturing methods for its COVID-19 Vaccine including steps in the manufacturing
`
`process and parametersfor those steps.
`
`7.
`
`The information within the Joint Claim Construction Brief and Exhibits 77 and 81
`
`of the Joint Claim Construction Appendix that Moderna proposes redacting is confidential and
`
`sensitive information that Moderna does not disclose publicly, which it wishes to remain
`
`confidential. There is significant competition between established vaccine suppliers, including
`
`suppliers with mRNA-based vaccines. Additionally, there are companies considering entering the
`
`vaccine market and companies developing mRNA-based vaccines and therapeutics for other
`
`diseases or developing lipid nanoparticles for mRNA-based products. Because there are so few
`
`competitors in these markets, the markets are highly competitive, and any information about one
`
`of the competitors, even seemingly minor information, may prove competitively advantageous.
`
`Modernahasspent significant resources to develop its formulation and manufacturing methods,
`
`and the release of such information to the public,
`
`including Moderna’s competitors, would
`
`significantly harm Moderna.
`
`8.
`
`With respect to Moderna’s formulation, Moderna considersits precise formulation,
`
`including the quantities of ingredients, a trade secret, which is not public knowledge.
`
`9.
`
`With respect
`
`to Moderna’s proprietary manufacturing process for SpikeVax,
`
`Moderna considers its process-as-a-whole a trade secret, including the steps in the process, the
`
`records of each step, the parameters or specification for each step (such as timing, sequence,
`
`amount and kind of raw materials, temperatures, measurements, equipmentused etc.). Moderna
`
`has not publicly disclosed its proprietary manufacturing process. Exhibits 77 and 81 of the Joint
`
`

`

`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 5 of 6 PageID #: 10508
`Case 1:22-cv-00252-MSG Document 182-1 Filed 01/03/24 Page 5 of 6 PagelD #: 10508
`
`Claim Construction Appendix disclose many ofthese details, which are referenced in the portions
`
`of the Joint Claim Construction Brief that Moderna proposesto redact.
`
`10.|Based on mypersonal knowledge and experience in the pharmaceutical business,I
`
`believe that disclosure of this information would significantly harm Moderna by revealing
`
`confidential data to its direct competitors and the public generally. If the confidential information
`
`were made public, Moderna’s competitors would be able to potentially replicate Moderna’s
`
`products, features within Moderna’s products, and methods of making Moderna’s products, or
`
`make decisions about where, when, and how to offer directly competitive goods with full
`
`knowledge of Moderna’s technology. Moderna’s competitors would gain a significant advantage
`
`in creating their own businessstrategies, which would put Modernaat a significant competitive
`
`disadvantage, causing it real and serious harm. Moderna’s competitors may also seek patent claims
`
`to cover Moderna’s technology.
`
`

`

`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
`
`I declare under penalty of perjury under the laws of the United States of America that the
`
`foregoing is true and correct to the best of my knowledge.
`
`Executed on this December 20, 2023
`
`Respectfully submitted,
`
`/s/ Peter Wojciechowski
`
`Peter Wojciechowski
`
`

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