Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 1 of 7 PageID #: 12518
`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 1 of 7 PagelD #: 12518
`
`EXHIBIT 1
`EXHIBIT 1
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`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 1 of 7 PagelD #: 12518
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`EXHIBIT 1
`EXHIBIT 1
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`
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`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 2 of 7 PageID #: 12519
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`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`
`)
`)
`)
`
`))
`
` C.A. No. 22-252-MSG
`)
`) CONTAINS INFORMATION
`) MODERNA DESIGNATED HIGHLY
`) CONFIDENTIAL – OUTSIDE
`) COUNSEL EYES ONLY
`
`Plaintiffs,
`
`v.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`
`PLAINTIFFS’ THIRD SET OF REQUESTS
`FOR PRODUCTION TO DEFENDANTS (NOS. 128–173)
`
`Pursuant to Federal Rules of Civil Procedure 26 and 34, Plaintiffs Arbutus Biopharma
`
`Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) direct the following
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`requests for production to Defendants Moderna, Inc. and ModernaTX Inc. (collectively,
`
`“Moderna” or “Defendants”). Responses to these requests shall be served upon Plaintiffs’
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`undersigned counsel within 30 days of service of these requests, or at such time and location as
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`may be mutually agreed upon by the parties. Copies shall be produced as they are kept in the
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`ordinary course of business, including their labeling as to the source of the documents. Pursuant
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`to Fed. R. Civ. P. 26(e), these requests are continuing and require supplemental answers.
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`DEFINITIONS & INSTRUCTIONS
`
`Plaintiffs incorporate herein by reference as though fully set forth herein the Definitions
`
`and Instructions of Plaintiffs’ First Set of Requests for Production to Defendants (Nos. 1–98)
`
`served December 20, 2022.
`
`1
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`
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`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 3 of 7 PageID #: 12520
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`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
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`1.
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`The “2013 Moderna-AstraZeneca Agreement” refers to the 2013 agreement
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`between Moderna and AstraZeneca related to the development of “mRNA therapeutics.” See,
`
`e.g., https://news.modernatx.com/news/news-details/2013/AstraZeneca-and-Moderna-
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`Therapeutics-Announce-Exclusive-Agreement-to-Develop-Pioneering-Messenger-RNA-
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`Therapeutics-in-Cardiometabolic-Diseases-and-Cancer/default.aspx; https://www.
`
`astrazeneca.com/media-centre/press-releases/2013/astrazeneca-moderna-therapeutics-
`
`cardiometabolic-diseases-cancer-treatment-21032013.html#!; https://www.sec.gov/Archives/
`
`edgar/data/1682852/000095012318009738/filename5.htm.
`
`REQUESTS FOR PRODUCTION
`
`REQUEST FOR PRODUCTION NO. 128
`
`All documents that estimate, define, describe, assess, study, or summarize the market for
`
`the Accused Product, including but not limited to company reports or studies, third-party
`
`research, or other information related to the market for the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 129
`
`All documents and other information relating to the pricing strategies for the Accused
`
`Product, including, but not limited to, the factors, information, and/or data that Moderna
`
`considered in developing pricing strategies for the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 130
`
`All documents and communications created, prepared, and/or reviewed for or by
`
`Moderna’s Board of Directors, or any committee of such Board, related to the Accused Product,
`
`including, but not limited to, meeting minutes of Moderna’s Board of Directors, presentations
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`prepared for or provided to Moderna’s Board of Directors, or financial analyses or projections
`
`about sales of the Accused Product provided to Moderna’s Board of Directors.
`
`2
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`
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`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 4 of 7 PageID #: 12521
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`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`REQUEST FOR PRODUCTION NO. 160
`
`All documents and communications relating to the conception, reduction to practice,
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`research, or development of the subject matter disclosed and/or claimed in WO 2023/019181 and
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`any priority application thereto (including U.S. Provisional Application No. 63/232,128 listed on
`
`the cover of WO 2023/019181), including but not limited to laboratory notebooks, notes,
`
`records, logs, files, invention disclosures, or other documents generated by or at the direction of
`
`any named inventors, and all laboratory notebooks, notes, records, logs, files, invention
`
`disclosures, or other documents in which any named inventors made any entries.
`
`REQUEST FOR PRODUCTION NO. 161
`
`All documents and communications regarding the disclosure in WO 2023/019181
`
`concerning the effect of adding steric stabilizers, such as polyethylene glycol (PEG)
`
`REQUEST FOR PRODUCTION NO. 162
`
`All documents and communications regarding the disclosure in WO 2023/019181 of
`
`“turbulent mixing (‘T-mix’),” “vortex mixing (“V-mix”),” or “microfluidic mixing.”
`
`REQUEST FOR PRODUCTION NO. 163
`
`Documents sufficient to show the lipid composition and/or lipid molar ratio for all
`
`Investigational New Drug Applications submitted by Moderna to the U.S. Food & Drug
`
`Administration and Moderna’s reasons for selecting the lipid composition and lipid molar ratio.
`
`9
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`
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`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 5 of 7 PageID #: 12522
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`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`REQUEST FOR PRODUCTION NO. 164
`
`Documents sufficient to show the lipid composition and/or lipid molar ratio for all
`
`Investigational New Drug Applications submitted by Moderna to the U.S. Food & Drug
`
`Administration using (1) 50 mol % to 65 mol % cationic lipid; (2) 4 mol % to 10 mol % of
`
`phospholipid; (3) 30 mol % to 40 mol % cholesterol or derivative thereof; and (4) 0.5 mol % to
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`2 mol % PEG-lipid or conjugated lipid that inhibits aggregation of particles, and Moderna’s
`
`reasons for selecting the lipid composition and lipid molar ratio.
`
`REQUEST FOR PRODUCTION NO. 165
`
`Documents sufficient to show the lipid composition and/or lipid molar ratio for all
`
`Investigational New Drug Applications submitted by Moderna to the U.S. Food & Drug
`
`Administration using (1) 50 mol % to 65 mol % cationic lipid; (2) 3 mol % to 15 mol % of
`
`phospholipid; (3) 30 mol % to 40 mol % cholesterol or derivative thereof; and (4) 0.5 mol % to
`
`2 mol % PEG-lipid or conjugated lipid that inhibits aggregation of particles, and Moderna’s
`
`reasons for selecting the lipid composition and lipid molar ratio.
`
`REQUEST FOR PRODUCTION NO. 166
`
`Documents sufficient to show the LNP manufacturing process for all Investigational New
`
`Drug Applications submitted by Moderna to the U.S. Food & Drug Administration wherein the
`
`proposed product comprised LNPs.
`
`REQUEST FOR PRODUCTION NO. 167
`
`Documents sufficient to show the lipid composition and lipid molar ratio for all
`
`Investigational New Drug Applications submitted by Moderna to the U.S. Food & Drug
`
`Administration wherein the proposed product comprised LNPs.
`
`10
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`
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`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 6 of 7 PageID #: 12523
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`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`Respectfully submitted,
`
`/s/ Emily S. DiBenedetto
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`Emily S. DiBenedetto (No. 6779)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`edibenedetto@shawkeller.com
`Attorneys for Plaintiffs
`
`OF COUNSEL:
`David I. Berl
`Adam D. Harber
`Thomas S. Fletcher
`Shaun P. Mahaffy
`Jessica Palmer Ryen
`Anthony H. Sheh
`Jihad J. Komis
`Philip N. Haunschild
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`(202) 434-5000
`Attorneys for Plaintiff Genevant
`Sciences GmbH
`
`Daralyn J. Durie
`Adam R. Brausa
`Eric C. Wiener
`Annie A. Lee
`Shaelyn K. Dawson
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`(415) 268-6080
`
`Kira A. Davis
`MORRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`(213) 892-5200
`
`David N. Tan
`MORRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`(202) 887-1500
`Attorneys for Plaintiff Arbutus
`Biopharma Corporation
`
`Dated: August 3, 2023
`
`13
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`
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`Case 1:22-cv-00252-MSG Document 193-1 Filed 01/16/24 Page 7 of 7 PageID #: 12524
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`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`CERTIFICATE OF SERVICE
`
`I, Emily S. DiBenedetto, hereby certify that on August 3, 2023, this document was served
`
`on the persons listed below in the manner indicated:
`
`BY EMAIL:
`Jack B. Blumenfeld
`Brian P. Egan
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`
`James F. Hurst
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, IL 60654
`(312) 862-2000
`james.hurst@kirkland.com
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
`alina.afinogenova@kirkland.com
`
`
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker
`Mark C. McLennan
`Nancy Kaye Horstman
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
`patricia.carson@kirkland.com
`jeanna.wacker@kirkland.com
`mark.mclennan@kirkland.com
`kaye.horstman@kirkland.com
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street, 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`yanxin.li@kirkland.com
`
`
`
`
`
`/s/ Karen E. Keller
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`Emily S. DiBenedetto (No.
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`edibenedetto@shawkeller.com
`Attorneys for Plaintiffs
`
`14
`
`
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