Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 1 of 10 PageID #: 14254
`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 1 of 10 PagelD #: 14254
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`EXHIBIT A
`EXHIBIT A
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 2 of 10 PageID #: 14255
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
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`C.A. No. 22-252-MSG
`
`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES
`ONLY
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`JURY TRIAL DEMANDED
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`
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
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`Plaintiffs,
`
`
`
`v.
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`MODERNA, INC. and MODERNATX, INC.,
`
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`Defendants.
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`
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`MODERNA, INC. and MODERNATX, INC.,
`
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`Counterclaim-Plaintiffs,
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`v.
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`
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
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`Counterclaim-Defendants.
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`DEFENDANTS’ RESPONSES AND OBJECTIONS TO PLAINTIFFS’ THIRD SET OF
`REQUESTS FOR PRODUCTION TO DEFENDANTS (NOS. 128-173)
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`Pursuant to Federal Rules of Civil Procedure 26 and 34, Defendants Moderna, Inc. and
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`ModernaTX, Inc. (collectively, “Moderna” or “Defendants”) provide their responses and
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`objections to Plaintiffs Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences
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`GmbH (“Genevant”)’s requests for production (Nos. 128-173).
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`GENERAL OBJECTIONS
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`Moderna incorporates by reference its General Objections provided in Moderna’s
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`Responses and Objections to Plaintiffs’ First Set of Requests for Production to Defendants (Nos.
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`1–98) served February 2, 2023.
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`

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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 3 of 10 PageID #: 14256
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`litigation and/or not proportional to the needs of this case, specifically because it lacks reasonable
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`temporal restrictions. Moderna objects to this Request as vague and ambiguous, at least with
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`respect to the phrase “regarding the disclosure,” which is not defined. Moderna also objects to this
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`Request as seeking the production of documents protected from discovery by the attorney-client
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`privilege, the work-product doctrine, or any other applicable privilege or immunity. Moderna will
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`not produce such documents. Moderna also objects to this Request as duplicative of at least RFP
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`Nos. 113 and 114. Moderna objects to this Request to the extent it calls for the production of
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`documents that are publicly available. Moderna will not search for documents that are publicly
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`available.
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`Subject to and without waiving any of its general or specific objections, Moderna will not
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`produce documents responsive to this Request.
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`REQUEST FOR PRODUCTION NO. 163
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`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.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 163:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`to the needs of this case, including because it seeks “[d]ocuments sufficient to show the lipid
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`composition and/or lipid molar ratio for all Investigational New Drug Applications submitted by
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`Moderna,” which presumes that all such documents are relevant. Moderna will not produce
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`irrelevant and/or non-responsive documents, including documents not relevant to the Accused
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`Products or the Asserted Claims. Moderna will not search for or produce regulatory submissions
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`relating to products that are not accused of infringement, particularly where Moderna has already
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`produced hundreds of thousands of pages of regulatory documents for Moderna’s COVID-19
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`40
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 4 of 10 PageID #: 14257
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`Vaccine—the only product accused of infringement. Moderna objects to this Request as overbroad,
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`unduly burdensome, and calling for information not relevant to any of the claims or defenses in
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`this litigation and/or not proportional to the needs of this case, specifically because it lacks
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`reasonable temporal restrictions. Moderna objects to this Request as vague and ambiguous, at least
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`with respect to the phrase “lipid composition,” which is not defined in this context. Moderna
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`objects to this Request to the extent it seeks proprietary, confidential, or trade secret information
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`of Moderna or of others to whom Moderna is under an obligation of confidentiality (by agreement
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`or by law). Moderna also objects to this Request as seeking the production of documents protected
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`from discovery by the attorney-client privilege, the work-product doctrine, or any other applicable
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`privilege or immunity. Moderna will not produce such documents. Moderna objects to this Request
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`as duplicative of at least RFP Nos. 1–3, 70, 72, in response to which Moderna has already agreed
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`to produce a copy of BLA No. 125752, IND 19745, and EUA No. 27073, as well as supplements
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`and amendments thereto, excluding subsections containing patient Personal Identifiable
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`Information.
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`Subject to and without waiving any of its general or specific objections, Moderna will not
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`produce documents responsive to this Request.
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`REQUEST FOR PRODUCTION NO. 164
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`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 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.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 164:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`41
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 5 of 10 PageID #: 14258
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`to the needs of this case, including because it seeks “[d]ocuments sufficient to show the lipid
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`composition and/or lipid molar ratio for all Investigational New Drug Applications submitted by
`
`Moderna to the U.S. Food & Drug Administration” as described, which presumes that all such
`
`documents are relevant. Moderna will not produce irrelevant and/or non-responsive documents,
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`including documents not relevant to the Accused Products or the Asserted Claims. Moderna will
`
`not search for or produce regulatory submissions relating to products that are not accused of
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`infringement. Moderna objects to this Request as overbroad, unduly burdensome, and calling for
`
`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`to the needs of this case, specifically because it lacks reasonable temporal restrictions. Moderna
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`objects to this Request as vague and ambiguous, at least with respect to the phrase “lipid
`
`composition,” which is not defined in this context. Moderna objects to this Request to the extent it
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`seeks proprietary, confidential, or trade secret information of Moderna or of others to whom
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`Moderna is under an obligation of confidentiality (by agreement or by law). Moderna also objects
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`to this Request as seeking the production of documents protected from discovery by the attorney-
`
`client privilege, the work-product doctrine, or any other applicable privilege or immunity. Moderna
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`will not produce such documents. Moderna objects to this Request to the extent it seeks a legal
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`conclusion and/or expert discovery. Moderna also objects to this Request as duplicative of at least
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`RFP Nos. 9, 13, 15, 115, and 116.
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`Subject to and without waiving any of its general or specific objections, Moderna will not
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`produce documents responsive to this Request.
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`REQUEST FOR PRODUCTION NO. 165
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`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
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`42
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 6 of 10 PageID #: 14259
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`mol % PEG-lipid or conjugated lipid that inhibits aggregation of particles, and Moderna’s reasons
`for selecting the lipid composition and lipid molar ratio.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 165:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
`
`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`to the needs of this case, including because it seeks “[d]ocuments 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” as described, which presumes that all such
`
`documents are relevant. Moderna will not produce irrelevant and/or non-responsive documents,
`
`including documents not relevant to the Accused Products or the Asserted Claims. Moderna will
`
`not search for or produce regulatory submissions relating to products that are not accused of
`
`infringement. Moderna objects to this Request as overbroad, unduly burdensome, and calling for
`
`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`to the needs of this case, specifically because it lacks reasonable temporal restrictions. Moderna
`
`objects to this Request as vague and ambiguous, at least with respect to the phrase “lipid
`
`composition,” which is not defined in this context. Moderna objects to this Request to the extent it
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`seeks proprietary, confidential, or trade secret information of Moderna or of others to whom
`
`Moderna is under an obligation of confidentiality (by agreement or by law). Moderna also objects
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`to this Request as seeking the production of documents protected from discovery by the attorney-
`
`client privilege, the work-product doctrine, or any other applicable privilege or immunity. Moderna
`
`will not produce such documents. Moderna objects to this Request to the extent it seeks a legal
`
`conclusion and/or expert discovery.
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`Subject to and without waiving any of its general or specific objections, Moderna is willing
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`to meet and confer regarding the scope and relevance of this Request.
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 7 of 10 PageID #: 14260
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`REQUEST FOR PRODUCTION NO. 166
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`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.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 166:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`to the needs of this case, including because it seeks “[d]ocuments sufficient to show the LNP
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`manufacturing process for all Investigational New Drug Applications submitted by Moderna to the
`
`U.S. Food & Drug Administration wherein the proposed product comprised LNPs,” which
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`presumes that all such documents are relevant. Moderna will not produce irrelevant and/or non-
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`responsive documents, including documents not relevant to the Accused Products or the Asserted
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`Claims. Moderna will not produce documents relating to the LNP manufacturing process, of which
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`Plaintiffs have not shown the relevancy. Plaintiffs have conceded that the Asserted Claims do not
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`recite manufacturing methods. Moderna will not search for or produce regulatory submissions
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`relating to products that are not accused of infringement. Moderna objects to this Request as
`
`overbroad, unduly burdensome, and calling for information not relevant to any of the claims or
`
`defenses in this litigation and/or not proportional to the needs of this case, specifically because it
`
`lacks reasonable temporal restrictions. Moderna objects to this Request as vague and ambiguous,
`
`at least with respect to the phrase “lipid composition,” which is not defined in this context. Moderna
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`objects to this Request to the extent it seeks proprietary, confidential, or trade secret information
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`of Moderna or of others to whom Moderna is under an obligation of confidentiality (by agreement
`
`or by law). Moderna also objects to this Request as seeking the production of documents protected
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`from discovery by the attorney-client privilege, the work-product doctrine, or any other applicable
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 8 of 10 PageID #: 14261
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`privilege or immunity. Moderna will not produce such documents. Moderna objects to this Request
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`as duplicative of at least RFP Nos. 1–3, 5, 16, 17, 21, 70, 72.
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`Subject to and without waiving any of its general or specific objections, Moderna will not
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`produce documents responsive to this Request.
`
`REQUEST FOR PRODUCTION NO. 167
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`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.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 167:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
`
`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`to the needs of this case, including because it seeks “[d]ocuments 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,”
`
`which presumes that all such documents are relevant. Moderna will not produce irrelevant and/or
`
`non-responsive documents, including documents not relevant to the Accused Products or the
`
`Asserted Claims. Moderna will not search for or produce regulatory submissions relating to
`
`products that are not accused of infringement. Moderna objects to this Request as overbroad,
`
`unduly burdensome, and calling for information not relevant to any of the claims or defenses in
`
`this litigation and/or not proportional to the needs of this case, specifically because it lacks
`
`reasonable temporal restrictions. Moderna objects to this Request as vague and ambiguous, at least
`
`with respect to the phrase “lipid composition,” which is not defined in this context. Moderna
`
`objects to this Request to the extent it seeks proprietary, confidential, or trade secret information
`
`of Moderna or of others to whom Moderna is under an obligation of confidentiality (by agreement
`
`or by law). Moderna also objects to this Request as seeking the production of documents protected
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`45
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 9 of 10 PageID #: 14262
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`from discovery by the attorney-client privilege, the work-product doctrine, or any other applicable
`
`privilege or immunity. Moderna will not produce such documents. Moderna objects to this Request
`
`as duplicative of at least RFP Nos. 1–3, 70, 72, in response to which Moderna has already agreed
`
`to produce a copy of BLA No. 125752, IND 19745, and EUA No. 27073, as well as supplements
`
`and amendments thereto, excluding subsections containing patient Personal Identifiable
`
`Information.
`
`Subject to and without waiving any of its general or specific objections, Moderna will not
`
`produce documents responsive to this Request.
`
`
`
`
`
`
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`Case 1:22-cv-00252-MSG Document 210-1 Filed 02/02/24 Page 10 of 10 PageID #: 14263
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Mark McLennan
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`
`Attorneys for Defendants
`
`Dated: September 5, 2023
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`
`
`OF COUNSEL:
`
`Patricia A. Carson
`Jeanna M. Wacker
`Mark C. McLennan
`Nancy Kaye Horstman
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4679
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street 47th Floor
`Boston, MA 0211
`(617) 385 -7500
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`May 25, 2023
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