Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 1 of 10 PageID #: 1852
`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 1 of 10 PagelD #: 1852
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`EXHIBIT L
`EXHIBIT L
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 2 of 10 PageID #: 1853
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Plaintiffs,
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`
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`v.
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`MODERNA, INC. and MODERNATX, INC.,
`
`
`Defendants.
`
`C.A. No. 22-252 (MSG)
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`)))))))))))
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`MODERNA, INC. and MODERNATX, INC.,
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`Counterclaim-Plaintiffs,
`
`v.
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`Counterclaim-Defendants.
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`
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`
`
`DEFENDANTS’ OBJECTIONS AND RESPONSES TO PLAINTIFFS’
`FIRST SET OF REQUESTS FOR PRODUCTION (NOS. 1–98)
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`Pursuant to Fed. R. Civ. P. 34, Defendants Moderna, Inc. and ModernaTX Inc.
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`(collectively, “Moderna” or “Defendants”) respond to Plaintiffs Arbutus Biopharma Corporation
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`(“Arbutus”) and Genevant Sciences GmbH’s (“Genevant,” and collectively, “Plaintiffs”) First Set
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`of Requests for Production (“Requests” and each individually, a “Request”).
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`GENERAL OBJECTIONS
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`The following general responses and objections apply to each individual response to
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`Plaintiffs’ Requests, as if fully set forth therein. The failure to repeat any of the following General
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`Objections in the specific responses below shall not be deemed a waiver of such objection or
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`limitation.
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`

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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 3 of 10 PageID #: 1854
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 3:
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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 “any other U.S. or foreign regulatory
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`submission relating to approval or emergency authorization of the Accused Product,” which
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`presumes that all such documents are relevant. Moderna will not search for or produce irrelevant
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`documents, including documents relating to aspects of the Accused Products that are not relevant
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`to the Asserted Claims. Moderna will not search for or produce regulatory submissions relating to
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`doses that were not made, used, offered for sale, or sold within the United States or imported into
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`the United States, which are not accused of infringement. Moderna objects to this Request to the
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`extent it seeks proprietary, confidential, or trade secret information of Moderna or of others to
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`whom Moderna is under an obligation of confidentiality (by agreement or by law).
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce a copy of BLA No. 125752, IND 19745, and EUA No. 27073, as well as supplements and
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`amendments thereto, excluding subsections containing patient Personal Identifiable Information.
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`REQUEST FOR PRODUCTION NO. 4:
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`All documents related to the research and development of the Accused Product.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 4:
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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 “[a]ll documents related to the research and
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`development of the Accused Product,” which presumes that all such documents are relevant.
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`Moderna will not search for or produce irrelevant documents, including documents relating to
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 4 of 10 PageID #: 1855
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`aspects of the Accused Products that are not relevant to the Asserted Claims. Moderna objects to
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`this Request as overbroad, unduly burdensome, and calling for information not relevant to any of
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`the claims or defenses in this litigation and/or not proportional to the needs of this case, specifically
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`because it lacks reasonable temporal restrictions. 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-
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`client privilege, the work-product doctrine, or any other applicable privilege or immunity.
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`Moderna will not produce such documents.
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce non-privileged documents relating to the LNP formulation research and development
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`efforts for Moderna’s COVID-19 Vaccine identified after a reasonable and proportionate search.
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`REQUEST FOR PRODUCTION NO. 5:
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`All documents related to the manufacture of the Accused Product.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 5:
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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 “[a]ll documents related to manufacture of the
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`Accused Product,” which presumes that all such documents are relevant. Moderna will not search
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`for or produce irrelevant documents, including documents relating to aspects of the Accused
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`Products that are not relevant to the Asserted Claims, which do not recite methods of
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`manufacturing. Moderna will not search for documents relating to doses that were not made, used,
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`offered for sale, or sold within the United States or imported into the United States, which are not
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 5 of 10 PageID #: 1856
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce non-privileged documents sufficient to show the lipids and lipid molar ratio of the LNPs
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`in Moderna’s COVID-19 Vaccine identified after a reasonable and proportionate search.
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`REQUEST FOR PRODUCTION NO. 15:
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`All documents related to the selection of the lipid composition or lipid molar ratio of, or to
`the determination of any variability of the lipid molar ratio in, the LNPs in the Accused Product,
`including but not limited to documents related to the consideration, research and development,
`and/or testing of the lipid composition or lipid molar ratio of the LNPs in the Accused Product or
`any alternative lipid compositions or lipid molar ratios.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 15:
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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 “[a]ll documents related to” the subject matter
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`of the Request, which presumes that all such documents are relevant. Moderna will not produce
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`irrelevant and/or non-responsive documents, including documents relating to aspects of the
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`Accused Products that are not relevant to the Asserted Claims, and documents relating to
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`“alternative[s]” which are not accused of infringement. Moderna objects to this Request as
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`overbroad, unduly burdensome, and calling for information not relevant to any of the claims or
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`defenses in this litigation and/or not proportional to the needs of this case, specifically because it
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`lacks reasonable temporal restrictions. Moderna objects to this Request to the extent it seeks
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`proprietary, confidential, or trade secret information of Moderna or of others to whom Moderna is
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`under an obligation of confidentiality (by agreement or by law). Moderna objects to this Request
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`as vague and ambiguous, at least with respect to the phrase “lipid composition,” which is not
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`defined in this context. Moderna also objects to this Request as seeking the production of
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`documents protected from discovery by the attorney-client privilege, the work-product doctrine,
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 6 of 10 PageID #: 1857
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`or any other applicable privilege or immunity. Moderna will not produce such documents.
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`Moderna objects to this Request as duplicative of other Requests, including RFP No. 14.
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce non-privileged documents relating to the lipids and lipid molar ratio (including the
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`variability thereof) of the LNPs in Moderna’s COVID-19 Vaccine identified after a reasonable and
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`proportionate search.
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`REQUEST FOR PRODUCTION NO. 16:
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`All documents related to the manufacturing process for the Accused Product, including but
`not limited to the manufacturing process for the LNPs in the Accused Product.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 16:
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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 “documents related to the manufacturing
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`process for the Accused Product,” which are not relevant to the Asserted Claims, which do not
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`recite methods of manufacturing. Moderna will not produce irrelevant and/or non-responsive
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`documents, including documents relating to aspects of the Accused Products that are not relevant
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`to the Asserted Claims. Moderna objects to this Request as overbroad, unduly burdensome, and
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`calling for information not relevant to any of the claims or defenses in this litigation and/or not
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`proportional to the needs of this case, specifically because it lacks reasonable temporal restrictions.
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`Moderna objects to this Request to the extent it seeks proprietary, confidential, or trade secret
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`information of Moderna or of others to whom Moderna is under an obligation of confidentiality
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`(by agreement or by law). Moderna also objects to this Request as seeking the production of
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`documents protected from discovery by the attorney-client privilege, the work-product doctrine,
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`or any other applicable privilege or immunity. Moderna will not produce such documents.
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 7 of 10 PageID #: 1858
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce non-privileged documents sufficient to show the stability studies of the LNPs in
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`Moderna’s COVID-19 Vaccine identified after a reasonable and proportionate search.
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`REQUEST FOR PRODUCTION NO. 31:
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`All documents related to any testing conducted during the manufacture of any batch of the
`Accused Product.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 31:
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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 “[a]ll documents related to any testing … of
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`any batch,” which presumes that all such documents and testing are relevant. Moderna will not
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`produce irrelevant and/or non-responsive documents, including documents relating to testing of
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`aspects of the Accused Products that are not relevant to the Asserted Claims, and documents not
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`relating to testing of the accused batches of the Accused Products. Moderna will not search for
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`documents relating to doses that were not made, used, offered for sale, or sold within the United
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`States or imported into the United States, which are not accused of infringement. Moderna objects
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`to this Request as overbroad, unduly burdensome, and calling for information not relevant to any
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`of the claims or defenses in this litigation and/or not proportional to the needs of this case,
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`specifically because it lacks reasonable temporal restrictions. Moderna objects to this Request to
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`the extent it seeks proprietary, confidential, or trade secret information of Moderna or of others to
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`whom Moderna is under an obligation of confidentiality (by agreement or by law). Moderna
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`objects to this Request as seeking the production of documents protected from discovery by the
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`attorney-client privilege, the work-product doctrine, or any other applicable privilege or immunity.
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`40
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 8 of 10 PageID #: 1859
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`Moderna will not produce such documents. Moderna objects to this Request as duplicative of at
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`least RFP Nos. 1–3.
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce non-privileged documents relating to the characterization of Moderna’s COVID-19
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`Vaccine as to the appearance, particle size, lipid identity, lipid content, RNA content, and % RNA
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`encapsulation identified after a reasonable and proportionate search.
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`REQUEST FOR PRODUCTION NO. 32:
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`All documents, including but not limited to testing protocols, regarding variation in lipid
`ratios, including molar ratios, within each batch and between batches of the Accused Product.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 32:
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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 “[a]ll documents . . . regarding variation in
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`lipid ratios . . . within each batch and between batches of the Accused Product,” which presumes
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`that all such documents are relevant. Moderna objects to this Request as overbroad, unduly
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`burdensome, and calling for information not relevant to any of the claims or defenses in this
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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 will not search for documents relating to doses that were not made,
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`used, offered for sale, or sold within the United States or imported into the United States, which
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`are not accused of infringement. Moderna also objects to this Request as seeking the production
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`of documents protected from discovery by the attorney-client privilege, the work-product doctrine,
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`or any other applicable privilege or immunity. Moderna will not produce such documents.
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`Moderna objects to this Request to the extent it seeks proprietary, confidential, or trade secret
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 9 of 10 PageID #: 1860
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`to the needs of this case, including because it seeks “a 10 g sample . . . of each ingredient in the
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`Accused Product,” which presumes all such ingredients are relevant to the Asserted Claims.
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`Moderna will not produce samples and information that are irrelevant and/or not proportional to
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`the needs of this case. Moderna objects to the Request for 10 g samples as overly broad and unduly
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`burdensome and not proportionate to the needs of the case. Moderna objects to this Request to the
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`extent it seeks material equally available to Plaintiffs.
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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 this Request.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Brian P. Egan
`
`
`
`
`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
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`Attorneys for Defendants
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`OF COUNSEL:
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`James F. Hurst
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, IL 60654
`(312) 862-2000
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker, P.C.
`Mark C. McLennan
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
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`February 2, 2023
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`Case 1:22-cv-00252-MSG Document 134-5 Filed 10/03/23 Page 10 of 10 PageID #: 1861
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`CERTIFICATE OF SERVICE
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`I hereby certify that on February 2, 2023, copies of the foregoing were caused to be served
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`upon the following in the manner indicated:
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`John W. Shaw, Esquire
`Karen E. Keller, Esquire
`Nathan R. Hoeschen, Esquire
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`Attorneys for Plaintiffs Arbutus Biopharma
`Corporation and Genevant Sciences GmbH
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`Daralyn J. Durie, Esquire
`Eric C. Wiener, Esquire
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
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`Kira A. Davis, Esquire
`MORRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
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`David I. Berl, Esquire
`Adam D. Harber, Esquire
`Thomas S. Fletcher, Esquire
`Jessica Palmer Ryen, Esquire
`Lydia B. Cash, Esquire
`Shaun P. Mahaffy, Esquire
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`Attorneys for Plaintiff Genevant Sciences
`GmbH
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
`
`/s/ Brian P. Egan
`
`
`
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`Brian P. Egan (#6227)
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`
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