Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 1 of 10 PageID #: 14461
`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 1 of 10 PagelD #: 14461
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`EXHIBIT G
`EXHIBIT G
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 2 of 10 PageID #: 14462
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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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`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES ONLY1
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Plaintiffs,
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`v.
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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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`DEFENDANTS’ FIRST SUPPLEMENTAL OBJECTIONS AND RESPONSES TO
`PLAINTIFFS’ SECOND SET OF INTERROGATORIES (NO. 11)
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`Pursuant to Fed. R. Civ. P. 33, Defendants Moderna, Inc. and ModernaTX Inc.
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`(collectively, “Moderna” or “Defendants”) provide their First Supplemental Objections and
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`Responses to Plaintiffs Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences
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`GmbH’s (“Genevant,” collectively “Plaintiffs”) Second Set of Interrogatories (No. 11).
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`1 This document contains information designated HIGHLY CONFIDENTIAL – OUTSIDE
`COUNSEL’S EYES ONLY. Pursuant to the parties’ agreement, pending entry of the
`Protective Order, this information is subject to D. Del. L.R. 26.2 and the parties’ agreed-upon
`interim prosecution bar. See February 10, 2023 Production Correspondence.
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 3 of 10 PageID #: 14463
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`GENERAL OBJECTIONS & DEFINITIONS
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`Moderna incorporates by reference the General Objections provided in Defendants’
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`Objections and Responses to Plaintiffs’ First Set of Interrogatories, served March 20, 2023. These
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`general responses and objections apply to the response to Plaintiffs’ Interrogatory, as if fully set
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`forth therein. The failure to repeat any of the General Objections in the specific responses below
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`shall not be deemed a waiver of such objection or limitation.
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`Moderna incorporates by reference the Definitions provided in Defendants’ Objections and
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`Responses to Plaintiffs’ First Set of Requests for Production, served February 2, 2023, and in
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`Defendants’ Objections and Responses to Plaintiffs’ First Set of Interrogatories, served March 20,
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`2023. These definitions form a part of, and are hereby incorporated into, the response to the
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`Interrogatory set forth below.
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 4 of 10 PageID #: 14464
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`SPECIFIC OBJECTIONS AND RESPONSES
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`INTERROGATORY NO. 11:
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`Identify all final and intermediate batches and/or lots of the Accused Product by all batch
`numbers and/or lot numbers, including any batch and/or lot numbers used or assigned by Moderna
`or any third party, including:
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`(1) all batches and/or lots of mRNA-1273 Drug Product and any supplemental or booster
`COVID-19 mRNA vaccine product thereof, including any batches and/or lots of mRNA-
`1273.214 and mRNA-1273.222;
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`(2) all batches and/or lots of mRNA-1273 Lipid Nanoparticle (“LNP”), including all batches
`and/or lots of mRNA-1273 LNP-B, mRNA-1273.529 LNP, and mRNA-1273.045 LNP;
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`(3) all batches and/or lots of
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`;
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`(4) all batches and/or lots of SM-102, DSPC, Cholesterol, and PEG2000-DMG; and
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`(5) all batches and/or lots of mRNA, including all batches and/or lots of CX-024414, CX-
`034476, and CX-031302,
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`and for each batch and/or lot:
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`describe in detail the genealogy of the batch and/or lot, including the source and disposition
`of the batch and/or lot, including: the batches of SM-102, DSPC, Cholesterol, and PEG2000-DMG
`used to manufacture each batch of
` and/or mRNA-1273
`LNP; the batches of mRNA and batches of
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`to manufacture each batch of mRNA-1273 LNP; the batches of mRNA-1273 LNP used to
`manufacture each batch of mRNA-1273 Drug Product and/or other final drug product; the parties
`to whom or by whom the batch and/or lot was manufactured, sold, offered for sale, distributed,
`transferred, shipped, administered and/or used; where that manufacturing, sale, offer for sale,
`distribution, transfer, shipment, administration and/or use occurred; and the dates on which that
`manufacturing, sale, offer for sale, distribution, transfer, shipment, administration and/or use
`occurred; and
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`identify the unit sales, revenues, gross profit, net profit, average unit sales price to end
`users, average unit sales price to distributors (if any), list price to end users, list price to distributors
`(if any), cost of goods sold (including identification of the items included in cost of goods sold),
`and operating costs (i.e., other costs not included in cost of goods sold, such as selling, general,
`and administrative expenses) associated with the batch and/or lot.
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`RESPONSE TO INTERROGATORY NO. 11:
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`Moderna objects to this Interrogatory 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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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 5 of 10 PageID #: 14465
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`to the needs of this Action, at least with respect to the “source” of any material,
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`“all batches and/or lots of SM-102, DSPC, Cholesterol, and
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`PEG2000-DMG,” and “all batches and/or lots of mRNA, including all batches and/or lots of CX-
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`024414, CX-034476, and CX-031302.” Plaintiffs have not established why the identity of starting
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`materials and/or intermediates (other than four-component LNPs with nucleic acids) used by
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`Moderna in the manufacturing of its COVID-19 vaccine is relevant to any claim or defense
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`asserted in this Action, or to the Asserted Claims. Moderna will not identify all batches and/or lots
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`of these starting materials and/or intermediates. Moderna objects to this Interrogatory 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 Action, at least with respect to “the parties to whom . . . the batch and/or lot was
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`manufactured” and any “transfer” of batches. Plaintiffs have not established the relevance of at
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`least these activities to any claims or defenses in this Action. Moderna objects to this Interrogatory
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`as being overbroad, unduly burdensome, and calling for information not proportional to the needs
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`of this case at least with respect to “the parties to whom or by whom the batch and/or lot was . . .
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`distributed, transferred, shipped, administered and/or used; where that . . . distribution, shipment,
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`administration and/or use occurred; and the dates on which that . . . distribution, shipment,
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`administration and/or use occurred.” Hundreds of millions of doses of Moderna’s COVID-19
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`vaccine have been administered. Plaintiffs have provided no justification for requiring Moderna to
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`undergo the enormous task of tracing when, where, and by whom each of those doses was
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`distributed, shipped, administered and/or used. Moderna objects to this Interrogatory as vague and
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`ambiguous at least as to the terms “intermediate batches,” “transfer,” “transferred,” “source,”
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`“other final drug product,” and “disposition,” which are not defined. Moderna objects to this
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`Interrogatory to the extent it seeks a specific location “where [the] manufacturing, sale, offer for
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 6 of 10 PageID #: 14466
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`sale, distribution, transfer, shipment, administration and/or use occurred.” Subject to Moderna’s
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`General and Specific objections, Moderna will identify whether any of the relevant activity
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`occurred within the US or outside the US. Plaintiffs have not established why any greater level of
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`detail is relevant to any of the claims or defenses in this Action or proportional to the needs of this
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`Action. Moderna objects to this Interrogatory to the extent it seeks information related to the
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`identity of manufactured lots and/or batches that were not made, used, offered for sale, or sold
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`within the United States or imported into the United States. Moderna objects to this Interrogatory
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`as consisting of multiple discrete subparts that separately count towards Plaintiffs’ total
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`permissible number of interrogatories under Fed. R. Civ. P. 33. At least Plaintiffs’ requests for
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`“the genealogy of the batch and/or lot,” “the parties to whom or by whom the batch and/or lot was
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`manufactured, sold, offered for sale, distributed, transferred, shipped, administered and/or used,”
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`“the dates on which that manufacturing, sale, offer for sale, distribution, transfer, shipment,
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`administration and/or use occurred” and the extensive financial information2 “associated with the
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`batch and/or lot” each count as separate subparts.
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`Subject to the General and Specific Objections, Moderna responds to the non-objectionable
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`scope of this Interrogatory as follows:
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`Pursuant to Fed. R. Civ. P. 33(d), the following portions of Moderna’s regulatory
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`submissions identify batch information about Moderna’s mRNA-1273 Drug Product and mRNA-
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`1273 Lipid Nanoparticle: MRNA-GEN-00018712; MRNA-GEN-00034493; MRNA-GEN-
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`00038148; MRNA-GEN-00038969; MRNA-GEN-00044097. Pursuant to Fed. R. Civ. P. 33(d),
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`2
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`“[I]dentify the unit sales, revenues, gross profit, net profit, average unit sales price to end users, average unit
`sales price to distributors (if any), list price to end users, list price to distributors (if any), cost of goods sold
`(including identification of the items included in cost of goods sold), and operating costs (i.e., other costs not
`included in cost of goods sold, such as selling, general, and administrative expenses) associated with the batch
`and/or lot.”
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 7 of 10 PageID #: 14467
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`Moderna will produce non-privileged documents sufficient to show all batches and/or lots of
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`mRNA-1273 Drug Product and all batches and/or lots of mRNA-1273 Lipid Nanoparticle.
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`Moderna’s investigation is ongoing and Moderna reserves the right to supplement, revise,
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`or amend Moderna’s Response to this Interrogatory as discovery and Moderna’s investigation in
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`this Action proceed. Moderna is willing to meet and confer with Plaintiffs regarding any remaining
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`scope.
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`First Supplemental Response to Interrogatory No. 11 (December 15, 2023):
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`Moderna incorporates its objections to this Interrogatory as if fully set forth in response to
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`this Interrogatory. Moderna responds as follows:
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`Pursuant to Fed. R. Civ. P. 33(d), Moderna identifies the following documents from which
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`additional information responsive to the non-objectionable scope of this Interrogatory can be
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`derived or ascertained: MRNA-GEN-00456085; MRNA-GEN-00456086; MRNA-GEN-
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`00456360–6630.
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`Pursuant to Fed. R. Civ. P. 33(d), Moderna further identifies MRNA-GEN-00939821, which
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`includes information concerning the disposition of drug product batches of the Accused Product
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`that were made in the U.S. or imported into the U.S. The following abbreviations are used in the
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`Moderna’s investigation is ongoing and Moderna reserves the right to supplement, revise,
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`or amend Moderna’s Response to this Interrogatory as discovery and Moderna’s investigation in
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`this Action proceed.
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 8 of 10 PageID #: 14468
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Brian P. Egan
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`
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`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`Travis J. Murray (#6882)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
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`Attorneys for Defendants
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`OF COUNSEL:
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`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker, P.C.
`Mark C. McLennan
`Yan-Xin Li
`Caitlin Dean
`Nancy Kaye Horstman
`Shaoyao Yu
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
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`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
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`December 15, 2023
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 9 of 10 PageID #: 14469
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`CERTIFICATE OF SERVICE
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`I hereby certify that on December 15, 2023, copies of the foregoing were caused to be
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`served upon the following in the manner indicated:
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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
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`John W. Shaw, Esquire
`Karen E. Keller, Esquire
`Nathan R. Hoeschen, Esquire
`Emily S. DiBenedetto, 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
`Adam R. Brausa, Esquire
`Eric C. Wiener, Esquire
`Annie A. Lee, Esquire
`Shaelyn K. Dawson, 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 N. Tan, Esquire
`MORRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
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`Case 1:22-cv-00252-MSG Document 211-11 Filed 02/02/24 Page 10 of 10 PageID #: 14470
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`VIA ELECTRONIC MAIL
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`David I. Berl, Esquire
`Adam D. Harber, Esquire
`Thomas S. Fletcher, Esquire
`Jessica Palmer Ryen, Esquire
`Shaun P. Mahaffy, Esquire
`Anthony H. Sheh, Esquire
`Philip N. Haunschild, Esquire
`Jihad J. Komis, Esquire
`Matthew W. Lachman, Esquire
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`Attorneys for Plaintiff Genevant Sciences GmbH
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`/s/ Brian P. Egan
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`Brian P. Egan (#6227)
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`2
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