Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 1 of 192 PageID #: 19512
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`v.
`
`
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`
`)
`)
`)
`)
`)
`) C.A. No. 22-252-MSG
`)
`) HIGHLY CONFIDENTIAL –
`) OUTSIDE COUNSEL’S EYES ONLY -
`) FILED UNDER SEAL
`
`LETTER BRIEF TO THE HONORABLE MITCHELL S. GOLDBERG REGARDING
`PLAINTIFFS’ MOTION FOR LEAVE TO AMEND COMPLAINT
`
`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
`Jessica Palmer Ryen
`Shaun P. Mahaffy
`Jihad J. Komis
`Anthony H. Sheh
`Matthew W. Lachman
`Philip N. Haunschild
`Falicia Elenberg
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`(202) 434-5000
`Attorneys for Plaintiff Genevant
`Sciences GmbH
`
`1
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 2 of 192 PageID #: 19513
`
`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: April 17, 2024
`
`2
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`

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`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 3 of 192 PageID #: 19514
`
`Dear Judge Goldberg:
`
`Following the Court’s February 27, 2024 Discovery Order, D.I. 229, Moderna finally—after a year
`of repeated requests by Plaintiffs—supplemented its response to Interrogatory No. 11 on March
`12 to provide crucial details needed to identify infringing batches of the Accused Product. That
`supplement revealed new evidence that Moderna is infringing Plaintiffs’ asserted patents not just
`under the statutory provisions asserted in the Complaint, but also under an additional provision in
`U.S. patent law. In particular, Moderna’s supplemental response incorporates a newly-produced
`“export of the part number genealogy” for the Accused Product showing that Moderna supplied
`its foreign manufacturing sites with U.S.-manufactured components of the Accused Product (the
`mRNA and
`). See Exs. A; B at 2–3. This constitutes infringement under 35 U.S.C.
`§ 271(f). While the witnesses and major factual issues in the case are unchanged by this new
`theory, it could significantly increase the number of batches at issue, and thus the amount of
`damages, including by providing another basis for those batches where the parties’ dispute whether
`they qualify as U.S. sales. Plaintiffs thus respectfully move for leave to amend their Complaint.
`
`“The Third Circuit has adopted a liberal policy favoring the amendment of pleadings to ensure that
`claims are decided on the merits rather than on technicalities.” WebXchange Inc. v. Dell Inc., 2010
`WL 256547, at *2 (D. Del. Jan. 20, 2010). Under Federal Rule 15(a)(2), leave should be granted
`absent undue delay, bad faith, dilatory motives, or futility. Id. When leave is sought after the
`deadline in a scheduling order, good cause is required under Federal Rule 16(b)(4), meaning that
`the movant must show that “despite diligence, the proposed claims could not have been reasonably
`sought in a timely manner.” Roquette Freres v. SPI Pharma, Inc., 2009 WL 1444835, at *4 (D.
`Del. May 21, 2009). That standard is easily met here—the Court should not reward Moderna’s
`failure to meet its discovery obligations.
`
`Plaintiffs have repeatedly sought discovery regarding the locations of manufacture for
`components of the Accused Product. After Moderna disclosed the use of multiple intermediate
`components in the Accused Product in early in 2023, Plaintiffs sought discovery into those
`components, including their manufacturing location. On March 16, 2023, Plaintiffs served an
`Interrogatory seeking detailed information about Moderna’s manufacturing process, including
`asking Moderna to identify each of the intermediates (such as the mRNA and
`) in its
`product and “where that manufacturing occurred.” Ex. C. In short, Plaintiffs sought a “genealogy”
`for each batch of the finished vaccine—information regarding the
`
`—so Plaintiffs could identify the infringing batches.
`
`Moderna refused to provide this information. Specifically, Moderna objected to providing
`information about “batches and/or lots of these starting materials and/or intermediates.” Ex. D,
`Response to Interrogatory No. 11 at 4. Plaintiffs immediately asked Moderna to supplement its
`response. On April 18, 2023, Plaintiffs informed Moderna that it had not provided Plaintiffs with
`“even a basic accounting of the infringing units that Moderna has manufactured, distributed, and
`sold to date.” Ex. E. Plaintiffs specifically called out the relevance of “intermediate products and
`their components,” explaining that “Moderna’s restriction of its agreed-upon scope to the final
`drug product and mRNA-1273 Lipid Nanoparticle is improper.” Ex. F, April 28, 2023 Genevant
`Letter; Ex. G, June 29, 2023 Genevant Letter.
`
`1
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 4 of 192 PageID #: 19515
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`Over the span of 9 months—from April to December 2023—Moderna strung Plaintiffs along with
`piecemeal information, without disclosing the location of manufacture for the components that
`went into the batches that Moderna contended were manufactured abroad. In July, Moderna said
`it hoped to produce the requested genealogy information—the key evidence supporting this
`amendment—that same month. Ex. H, July 12, 2023 Moderna Letter (hoping “to collect” and
`provide “batch disposition and genealogy” in July, but would provide an update “in due course”).
`But Moderna did not produce this genealogy information in July or even in the following 4 months,
`despite Plaintiffs’ continued entreaties. E.g., Ex. I, Nov. 7, 2023 Genevant Email.
`
`Not until December 15, 2023, did Moderna serve the promised supplement. In doing so, Moderna
`again omitted disclosure of the use of U.S.-manufactured components for batches finished
`overseas. Instead, it only provided genealogies for batches of the finished vaccine manufactured
`at the locations in the U.S. See Ex. J, First Supp. Resp. to Interrogatory No. 11 at 6. Plaintiffs filed
`a motion to compel that same day, December 15, 2023, seeking samples of Moderna’s Accused
`Product, together with the information necessary to select the samples. See D.I. 161.
`
`On February 27, the Court ordered Moderna to “produce to Plaintiffs all remaining information
`about batch/lot numbers.” D.I. 229. Only on March 8, 2024, did Moderna finally produce the
`genealogy information cited in its Interrogatory supplement a few days later, which showed that
`supposedly foreign-made batches in fact were made with components manufactured in the United
`States. Ex. A. Plaintiffs wrote to Moderna shortly thereafter, on March 22, 2024, Ex. B, Genevant
`Letter, and met and conferred on seeking leave to amend on April 10. Moderna refused to consent,
`necessitating a contested motion.
`
`The newly-produced evidence is good cause to amend under Rule 16. There is good cause to
`amend after the deadline in the scheduling order where a plaintiff “only discovered the evidence
`motivating its motion for leave to amend after the . . . deadline for moving to amend had passed.”
`Int’l Constr. Prod. LLC v. Caterpillar Inc., 2018 WL 4611216 at *2 (D. Del. Sept. 26, 2018). Here,
`Plaintiffs only discovered that evidence when Moderna finally supplemented its interrogatory
`response on March 12, 2024—per a Court order—pointing Plaintiffs to part number genealogy
`information produced a few days earlier. Until Moderna answered Plaintiffs’ question about where
`vaccine components were manufactured, Plaintiffs were left with Moderna’s public statements
`suggesting that it used “a dedicated supply chain to support Europe and countries other than the
`United States” in Switzerland and Spain. Ex. K, Press Release (Nov. 25, 2020).
`
`Because of Moderna’s intransigence, Plaintiffs did not learn the truth about Moderna’s supply
`chain until well after the deadline for amendment, and this motion promptly followed. During the
`parties’ meet and confer regarding this motion, Moderna has never asserted that Plaintiffs could
`have learned of the relevant facts earlier. And even if it had, a Plaintiff is not judged by when it
`hypothetically knew enough to amend, but instead is entitled to first obtain key documents or other
`corroborating discovery. Targus Int’l LLC v. Victorinox Swiss Army, Inc., 2021 WL 2291978 at
`*3 (D. Del. June 4, 2021); Caterpillar Inc., 2018 WL 4611216 at *2–3.
`
`Plaintiffs acted diligently to obtain the information needed for this amendment and to seek
`leave once it was obtained. Repeatedly, for more than a year, Plaintiffs sought information about
`the manufacturing location for the components of Moderna’s vaccine. Moderna only provided that
`
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 5 of 192 PageID #: 19516
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`information in the last several weeks, and only in response to a Court order for it to do so. Ex. L,
`Moderna Email (Mar 12, 2024) (indicating that the discovery at issue was provided to “comply
`with Paragraph 1(a) of the Court’s Order dated February 27, 2024”).
`
`If Plaintiffs cannot amend their complaint, Moderna would unfairly benefit from its earlier refusal
`to disclose that key components of supposedly foreign batches were made in the U.S—the
`significance of which Moderna undoubtedly understood. Moderna should not be permitted to
`permanently avoid the consequences of supplying components from the U.S. on the basis of its
`own discovery conduct. Plaintiffs’ diligence is clear: they sought discovery on this issue from the
`start, repeatedly asked Moderna for more complete responses, and ultimately needed the Court’s
`assistance. As in similar cases, Moderna “really cannot win an argument that Plaintiff should have
`been more aggressive in getting Defendant[] to meet their obligations.” Caterpillar, 2018 WL
`4611216 at *3 (holding that Defendants’ delay did not show Plaintiff’s lack of diligence).
`
`Plaintiffs also acted diligently “once [they] became aware of the issues underlying [their] proposed
`amendments,” Compagnie des Grands Hotels d’Afrique SA v. Starwood Cap. Grp. Glob. I LLC,
`2021 WL 6883231 at *5 (D. Del. Feb. 10, 2021), writing Moderna nine days after receiving the
`supplement, conferring a week after receiving Moderna’s response, and filing this motion five
`days later. Just over a month passed between Moderna’s delinquent disclosure and this motion.
`See Home Semiconductor Corp. v. Samsung Elecs. Co., 2019 WL 2135858 at *5 (D. Del. May 16,
`2019) (filing three months after receiving information was diligent).
`
`Granting leave would not prejudice Moderna.1 While prejudice to the non-moving party is the
`“touchstone” of the Rule 15 inquiry, Arthur v. Maersk, Inc., 434 F.3d 196, 204 (3d Cir. 2006),
`additional expense or discovery does not establish prejudice. Rather, Moderna must show “that its
`ability to present its case would be seriously impaired were amendment allowed.” Dole v. Arco
`Chemical Co., 921 F.2d 484, 488 (3d Cir. 1990). There is no possible prejudice here because the
`amendment asserts a new legal theory based on virtually the same facts. Cf. Home Semiconductor,
`2019 WL 2135858 at *5 (no prejudice from adding allegations under § 271(g) because
`infringement allegations remained the same). Plaintiffs’ amendment would not change the asserted
`patents, the underlying infringement analysis, the damages theories, the relevant fact witnesses, or
`the case schedule. It would simply expand the number of doses for which Plaintiffs can obtain
`damages. The extent of the additional discovery needed is essentially lines on a spreadsheet
`reflecting the batches for which components were manufactured in the U.S. and targeted financial
`and technical information relating to those batches.
`
`Prejudice is particularly absent here because all of the new information is already in Moderna’s
`possession. See Dasso Int’l, Inc. v. MOSO N. Am., Inc., 2020 WL 6287673 at *4 (D. Del. Oct. 27,
`2020) (minimal prejudice where information already in party’s control). The parties also still have
`more than a month left of fact discovery—indeed, neither party has yet begun taking depositions.
`Targus Int’l, 2021 WL 2291978 at *3 (no prejudice where a month of discovery remained).
`Moderna should not be rewarded for its stonewalling, and Plaintiffs respectfully request leave to
`file the attached Amended Complaint, Exs. M (redline); N (clean).
`
`1 There is no undue delay under Rule 15 where diligence is found under Rule 16. See Home
`Semiconductor, 2019 WL 2135858 at *5.
`
`
`
`3
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 6 of 192 PageID #: 19517
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`Respectfully submitted,
`/s/ Nathan R. Hoeschen
`Nathan R. Hoeschen (No. 6232)
`
`cc:
`
`Clerk of the Court (by CM/ECF)
`All counsel of record (by CM/ECF & Email)
`
`4
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 7 of 192 PageID #: 19518
`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 7 of 192 PagelD #: 19518
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`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`
`
`
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 8 of 192 PageID #: 19519
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 22-252-MSG
`
`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES ONLY
`
`
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`v.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Counterclaim-Plaintiffs,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`
`
`DEFENDANTS’ SECOND SUPPLEMENTAL OBJECTIONS AND RESPONSES TO
`PLAINTIFFS’ SECOND SET OF INTERROGATORIES (NO. 11)
`
`Pursuant to Fed. R. Civ. P. 33, Defendants Moderna, Inc. and ModernaTX Inc.
`
`(collectively, “Moderna” or “Defendants”) provide their Second Supplemental Objections and
`
`Responses to Plaintiffs Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences
`
`GmbH’s (“Genevant,” collectively “Plaintiffs”) Second Set of Interrogatories (No. 11).
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 9 of 192 PageID #: 19520
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`GENERAL OBJECTIONS & DEFINITIONS
`
`Moderna incorporates by reference the General Objections provided in Defendants’
`
`Objections and Responses to Plaintiffs’ First Set of Interrogatories, served March 20, 2023. These
`
`general responses and objections apply to the response to Plaintiffs’ Interrogatory, as if fully set
`
`forth therein. The failure to repeat any of the General Objections in the specific responses below
`
`shall not be deemed a waiver of such objection or limitation.
`
`Moderna incorporates by reference the Definitions provided in Defendants’ Objections and
`
`Responses to Plaintiffs’ First Set of Requests for Production, served February 2, 2023, and in
`
`Defendants’ Objections and Responses to Plaintiffs’ First Set of Interrogatories, served March 20,
`
`2023. These definitions form a part of, and are hereby incorporated into, the response to the
`
`Interrogatory set forth below.
`
`
`
`2
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 10 of 192 PageID #: 19521
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`SPECIFIC OBJECTIONS AND RESPONSES
`
`INTERROGATORY NO. 11:
`
`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:
`
`(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;
`
`(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;
`
`(3) all batches and/or lots of
`
`;
`
`(4) all batches and/or lots of SM-102, DSPC, Cholesterol, and PEG2000-DMG; and
`
`(5) all batches and/or lots of mRNA, including all batches and/or lots of CX-024414, CX-
`034476, and CX-031302,
`
`and for each batch and/or lot:
`
`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
` used
`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
`
`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.
`
`RESPONSE TO INTERROGATORY NO. 11:
`
`Moderna objects to this Interrogatory as overbroad, unduly burdensome, and calling for
`
`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`3
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 11 of 192 PageID #: 19522
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`to the needs of this Action, at least with respect to the “source” of any material,
`
`
`
` “all batches and/or lots of SM-102, DSPC, Cholesterol, and
`
`PEG2000-DMG,” and “all batches and/or lots of mRNA, including all batches and/or lots of CX-
`
`024414, CX-034476, and CX-031302.” Plaintiffs have not established why the identity of starting
`
`materials and/or intermediates (other than four-component LNPs with nucleic acids) used by
`
`Moderna in the manufacturing of its COVID-19 vaccine is relevant to any claim or defense
`
`asserted in this Action, or to the Asserted Claims. Moderna will not identify all batches and/or lots
`
`of these starting materials and/or intermediates. Moderna objects to this Interrogatory as
`
`overbroad, unduly burdensome, and calling for information not relevant to any of the claims or
`
`defenses in this Action, at least with respect to “the parties to whom . . . the batch and/or lot was
`
`manufactured” and any “transfer” of batches. Plaintiffs have not established the relevance of at
`
`least these activities to any claims or defenses in this Action. Moderna objects to this Interrogatory
`
`as being overbroad, unduly burdensome, and calling for information not proportional to the needs
`
`of this case at least with respect to “the parties to whom or by whom the batch and/or lot was . . .
`
`distributed, transferred, shipped, administered and/or used; where that . . . distribution, shipment,
`
`administration and/or use occurred; and the dates on which that . . . distribution, shipment,
`
`administration and/or use occurred.” Hundreds of millions of doses of Moderna’s COVID-19
`
`vaccine have been administered. Plaintiffs have provided no justification for requiring Moderna to
`
`undergo the enormous task of tracing when, where, and by whom each of those doses was
`
`distributed, shipped, administered and/or used. Moderna objects to this Interrogatory as vague and
`
`ambiguous at least as to the terms “intermediate batches,” “transfer,” “transferred,” “source,”
`
`“other final drug product,” and “disposition,” which are not defined. Moderna objects to this
`
`Interrogatory to the extent it seeks a specific location “where [the] manufacturing, sale, offer for
`
`4
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 12 of 192 PageID #: 19523
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`sale, distribution, transfer, shipment, administration and/or use occurred.” Subject to Moderna’s
`
`General and Specific objections, Moderna will identify whether any of the relevant activity
`
`occurred within the US or outside the US. Plaintiffs have not established why any greater level of
`
`detail is relevant to any of the claims or defenses in this Action or proportional to the needs of this
`
`Action. Moderna objects to this Interrogatory to the extent it seeks information related to the
`
`identity of manufactured lots and/or batches that were not made, used, offered for sale, or sold
`
`within the United States or imported into the United States. Moderna objects to this Interrogatory
`
`as consisting of multiple discrete subparts that separately count towards Plaintiffs’ total
`
`permissible number of interrogatories under Fed. R. Civ. P. 33. At least Plaintiffs’ requests for
`
`“the genealogy of the batch and/or lot,” “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,”
`
`“the dates on which that manufacturing, sale, offer for sale, distribution, transfer, shipment,
`
`administration and/or use occurred” and the extensive financial information1 “associated with the
`
`batch and/or lot” each count as separate subparts.
`
`Subject to the General and Specific Objections, Moderna responds to the non-objectionable
`
`scope of this Interrogatory as follows:
`
`Pursuant to Fed. R. Civ. P. 33(d), the following portions of Moderna’s regulatory
`
`submissions identify batch information about Moderna’s mRNA-1273 Drug Product and mRNA-
`
`1273 Lipid Nanoparticle: MRNA-GEN-00018712; MRNA-GEN-00034493; MRNA-GEN-
`
`00038148; MRNA-GEN-00038969; MRNA-GEN-00044097. Pursuant to Fed. R. Civ. P. 33(d),
`
`1
`
`
`“[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.”
`
`5
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`

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`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 13 of 192 PageID #: 19524
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`Moderna will produce non-privileged documents sufficient to show all batches and/or lots of
`
`mRNA-1273 Drug Product and all batches and/or lots of mRNA-1273 Lipid Nanoparticle.
`
`Moderna’s investigation is ongoing and Moderna reserves the right to supplement, revise,
`
`or amend Moderna’s Response to this Interrogatory as discovery and Moderna’s investigation in
`
`this Action proceed. Moderna is willing to meet and confer with Plaintiffs regarding any remaining
`
`scope.
`
`First Supplemental Response to Interrogatory No. 11 (December 15, 2023):
`
`Moderna incorporates its objections to this Interrogatory as if fully set forth in response to
`
`this Interrogatory. Moderna responds as follows:
`
`Pursuant to Fed. R. Civ. P. 33(d), Moderna identifies the following documents from which
`
`additional information responsive to the non-objectionable scope of this Interrogatory can be
`
`derived or ascertained: MRNA-GEN-00456085; MRNA-GEN-00456086; MRNA-GEN-
`
`00456360–6630.
`
`Pursuant to Fed. R. Civ. P. 33(d), Moderna further identifies MRNA-GEN-00939821, which
`
`includes information concerning the disposition of drug product batches of the Accused Product
`
`that were made in the U.S. or imported into the U.S. The following abbreviations are used in the
`
`“Delivery Type” column:
`
`•
`
`•
`
`•
`
` – Inter/Intra Company Transfer
`
` – Standard Customer Delivery
`
` – Standard Customer Return
`
`Moderna’s investigation is ongoing and Moderna reserves the right to supplement, revise,
`
`or amend Moderna’s Response to this Interrogatory as discovery and Moderna’s investigation in
`
`this Action proceed.
`
`6
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`

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`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 14 of 192 PageID #: 19525
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`Second Supplemental Response to Interrogatory No. 11 (March 12, 2024):
`
`Moderna incorporates its objections to this Interrogatory as if fully set forth in response to
`
`this Interrogatory.
`
`Based on our reasonable investigation to date, Moderna responds as follows: MRNA-GEN-
`
`01424228 is
`
`
`
`. Moderna does
`
`not represent that each batch listed in MRNA-GEN-01424228 was commercial/sold. Additionally,
`
`MRNA-GEN-01424942 provides information concerning part numbers used in the commercial
`
`manufacture of mRNA-1273; this document is updated in the ordinary course of business.
`
`Furthermore, as explained in Moderna’s Response to Interrogatory No. 15, MRNA-GEN-
`
`01424942 refers to numerous part numbers that do not correspond to accused batches and therefore
`
`are not relevant to any claim or defense in this case. Moderna incorporates by reference its response
`
`to Interrogatory No. 15.
`
`The subset of commercial part numbers for drug product and
`
` used in drug
`
`product batches that were either made in the U.S. or imported into the U.S. are listed in MRNA-
`
`GEN-01382331. Moderna is currently aware of
`
`
`
` Moderna
`
`does not represent that every batch made with part numbers listed in MRNA-GEN-01382331 was
`
`commercial/sold.
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`Where information regarding the country a batch was shipped to and the expiration date
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`were available in the genealogy dashboard, that information is provided in MRNA-GEN-
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`01424227.
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`7
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 15 of 192 PageID #: 19526
`
`In instances where a drug product batch was made with more than one mRNA-LNP part
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`number, the different mRNA-LNP part numbers appear in separate rows in MRNA-GEN-
`
`01424228 for the same drug product batch number. In instances where more than one lot of
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`mRNA-LNP was used (whether from the same or different part numbers) to make a drug product
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`batch, those also appear in separate rows in MRNA-GEN-01424228.
`
`Moderna’s investigation is ongoing and Moderna reserves the right to supplement, revise,
`
`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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`
`
`
`
`
`
`8
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 16 of 192 PageID #: 19527
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Alina Afinogenova
`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
`mdellinger@morrisnichols.com
`
`Attorneys for Defendants
`Moderna, Inc. and ModernaTX, Inc.
`
`
`
`OF COUNSEL:
`
`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
`Caitlin Dean
`Nancy Kaye Horstman
`Shaoyao Yu
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4679
`
`Yan-Xin Li
`Laura Ashley Harris
`KIRKLAND & ELLIS LLP
`555 California Street, 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
`
`March 12, 2024
`
`
`
`
`
`
`
`9
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`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 17 of 192 PageID #: 19528
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on March 12, 2024, copies of the foregoing document were caused to
`
`be served upon the following in the manner indicated:
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`
`
`
`John W. Shaw, Esquire
`Karen E. Keller, Esquire
`Nathan 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
`
`Daralyn J. Durie, Esquire
`Eric C. Wiener, Esquire
`Shaelyn K. Dawson, Esquire
`Adam R. Brausa, Esquire
`Annie A. Lee, Esquire
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
`
`Kira A. Davis, Esquire
`MORRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
`
`David N. Tan, Esquire
`MORRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`10
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 18 of 192 PageID #: 19529
`
`David I. Berl, Esquire
`Adam D. Harber, Esquire
`Thomas S. Fletcher, Esquire
`Shaun P. Mahaffy, Esquire
`Jessica Palmer Ryen, Esquire
`Anthony H. Sheh, Esquire
`Matthew W. Lachman, Esquire
`Jihad J. Komis, Esquire
`Philip N. Haunschild, Esquire
`Falicia Elenberg, Esquire
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`
`Attorneys for Plaintiff Genevant Sciences
`GmbH
`
`
`
`
`
`
`
`
`
`VIA ELECTRONIC MAIL
`
`
`
`
`
`
`
`/s/ Alina Afinogenova
`Alina Afinogenova
`
`
`
`11
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 19 of 192 PageID #: 19530
`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 19 of 192 PagelD #: 19530
`
`
`
`
`
`EXHIBIT B
`EXHIBIT B
`
`
`
`
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 20 of 192 PageID #: 19531
`
`
`
`MATTHEW W. LACHMAN
`(202) 434-5249
`MLachman@wc.com
`
`
`
`
`
`
`
`
`
`
`Via Email
`
`March 22, 2024
`
`CONTAINS INFORMATION MODERNA DESIGNTED
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSELS EYES ONLY
`
`
`
`Mark C. McLennan
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 909-3451
`mark.mclennan@kirkland.com
`
`
`Re:
`
`Arbutus Biopharma Corporation and Genevant Sciences GmbH v. Moderna, Inc.
`and ModernaTX, Inc., Case 1:22-cv-00252-MSG (D. Del.)
`
`Dear Mark:
`
`I write concerning the locations at which Moderna manufactured components of the Accused
`Product, as identified in Moderna’s supplemental response last week to Interrogatory No. 11, and
`the documents Moderna has produced in response to the Court’s February 27, 2024 Order (D.I.
`229).
`
`Plaintiffs have been seeking information about the locations at which Moderna manufactures the
`Accused Product and its components for over a year. For example, on March 16, 2023, Plaintiffs
`served Interrogatory No. 11, which requested, inter alia, the location where batches of mRNA
`and
` where manufactured. Moderna refused to provide this information, including
`by objecting to providing information about “batches and/or lots of these starting materials
`and/or intermediates.” Moderna’s Response to Plaintiffs’ Interrogatory No. 11 at 4 (Apr. 17,
`2024). Plaintiffs diligently pursued this information over the next year, with Moderna
`attempting to stifle Plaintiffs’ efforts at every turn. See, e.g., A. Sheh Letter to M. McLennan
`(June 29, 2023) (“Despite the passage of more than four months since the parties first discussed
`this issue, Moderna still has not provided the requested information, and its June 12, 2023,
`supplemental response to Plaintiffs’ Interrogatories Nos. 6 and 11 did not even identify a date
`certain by which Moderna would do so.”); A. Sheh Email to A. Afinogenova (Nov. 7, 2023)
`(Moderna has not supplemented its response to Interrogatory No. 11 . . . . Plaintiffs are entitled to
`discovery into these issues and to test Moderna’s as-of-yet unsupported contentions.”).
`
`
`

`

`Case 1:22-cv-00252-MSG Document 325-3 Filed 05/20/24 Page 21 of 192 PageID #: 19532
`
`
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`
`March 22, 2024
`Page 2 of 4
`
`
`Finally, following the Court’s February 27, 2024 Order, Moderna produced some information
`about where these components are manufactured in its March 12, 2024 supplementa