Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 1 of 94 PageID #: 6163
`
`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.
`
`)
`) REDACTED
`)
`)
`)
`) C.A. No. 22-252-MSG
`)
`)
`)
`)
`
`
`
`
`
`LETTER TO THE HONORABLE MITCHELL S. GOLDBERG
`FROM NATHAN R. HOESCHEN
`
`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
`
`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
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 2 of 94 PageID #: 6164
`
`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: December 15, 2023
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 3 of 94 PageID #: 6165
`
`BY CM/ECF
`The Honorable Mitchell S. Goldberg
`U.S. District Court for the Eastern District of Pennsylvania
`James A. Byrne U.S. Courthouse, Room 17614
`601 Market Street, Philadelphia, PA 19106-1797
`
`HIGHLY CONFIDENTIAL
`OUTSIDE COUNSEL’S EYES ONLY
`
`Nathan R. Hoeschen
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0709 – Direct
`nhoeschen@shawkeller.com
`
`FILED UNDER SEAL
`
`Re:
`
` Arbutus Biopharma Corporation, et. al. v. Moderna, Inc., et. al. C.A. No. 22-252-MSG
`
`Dear Judge Goldberg:
`
`Plaintiffs move to compel Defendant Moderna to produce the most basic discovery one can
`request in a patent case: samples of the accused product. Moderna has agreed to produce samples
`from only a minority of the accused product batches—about 480 expired batches plus a handful of
`other batches out of approximately 2000 (if not more) at issue.1 But Moderna refuses to produce
`samples of other batches,
`, all while maintaining the right to contest infringement of those unproduced batches.
`This position is untenable. Moderna’s accused product varies batch-by-batch. Plaintiffs thus seek
`samples from the remaining batches (or a sufficient sampling, if the prejudice of Moderna’s
`withholding of relevant discovery is mitigated by precluding it from disputing infringement of
`withheld batches). Plaintiffs also move to compel
`
`, along with associated data.
`
`Drug Product Samples (RFP No. 97). A central issue in this case is whether LNPs in
`batches of Moderna’s vaccine embody the lipid ratios covered by Plaintiffs’ patents.2 Each batch
`contains trillions of LNPs, each of which can have a different lipid ratio. Unlike cases involving
`products like an iPhone, where each product of the same model is essentially identical, discovery
`to date has revealed batch-to-batch variation in the lipid ratios of Moderna’s vaccine. Moderna’s
`own documents show that
`
`, which affects the infringement inquiry. See, e.g., Ex. 1 (showing
`
`); Ex. 2 at *146, *184 (showing
`
`
`
`). And that
`
`
`
`Moderna has no reasonable basis to dispute the salience of samples from each batch of its
`vaccine, and any contrary argument contravenes the case law.3 The only case Moderna has cited
`
`1 The parties also dispute discovery concerning batches manufactured overseas, which Plaintiffs
`allege were sold or offered for sale (and thereby infringed) in the U.S. Plaintiffs are filing a
`separate motion on this dispute, but for clarity, seek samples from all Moderna’s batches, including
`those manufactured overseas. Moderna to date has only identified U.S.-manufactured batches.
`2 While Moderna contends that the “particle[s]” in Plaintiffs’ claims must be “finished” in the
`narrow sense of not being subject to further processing, this and other claim construction disputes,
`D.I. 129, do not affect this dispute on the particles in undisputedly finished drug product samples.
`3 Everlight Elecs. Co. v. Nichia Corp., 2013 WL 6713789 at *2 (E.D. Mich. Dec. 20, 2013)
`(compelling production of “more than 1,000 Accused LED Products”); Invensas Corp. v. Renesas
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 4 of 94 PageID #: 6166
`
`SHAW KELLER LLP
`
`
`
`Page 2
`
`on this issue involves a simple product (“test cups” for urine screening) without batch-to-batch
`variation. Rembrandt Diagnostics, LP v. Innovocon, Inc., 2017 WL 4391707 (S.D. Cal. Oct. 3,
`2017). Given Moderna’s own data reflecting variation between batches, it is beyond cavil that
`samples of each batch matter in this case. Indeed, despite repeatedly refusing and delaying even
`to identify infringing batches and then offering only a handful, Ex. 3 at 1, Moderna abruptly
`reversed course and made an exploding offer of approximately 480 expired batches, which
`Plaintiffs accepted. Ex. 4 at 4, 7–9. As to the remaining batches, however, Moderna has agreed
`only to produce a single batch from each version or “part number” of its vaccine—roughly a dozen
`batches. Moderna’s proposal is prejudicial, and the justifications it has offered, related to its own
`testing and burden, are dubious and do not justify depriving Plaintiffs of this critical discovery.
`
`Moderna’s proposal to produce a sample from a single batch per part number—when part
`numbers can comprise hundreds of batches—prejudices Plaintiffs substantially, and ignores the
`undisputed variability in lipid ratios across batches. This prejudice is acute because Moderna
`intends to select unilaterally the single batch. See Ex. 5 at 1. Nor does Moderna’s proposal permit
`Plaintiffs to test both expired and unexpired batches, which is critical because Moderna (despite
`producing only expired batches) intends to dispute test results on the basis of expiry.
`
`The fundamental problem with Moderna’s proposal is that Moderna maintains its right to
`argue that unproduced batches do not infringe. Moderna cannot decline to produce batches only
`later to dispute infringement of what it withheld, thereby “den[ying Plaintiffs] the opportunity to
`conduct discovery.” Prism Techs., LLC v. T-Mobile USA Inc., 2015 WL 5883764, at *3 (D. Neb.
`Oct. 8, 2015). While Plaintiffs are amenable to Moderna limiting its sample production (albeit to
`more than one sample per part number, not unilaterally selected by Moderna), any such agreement
`“would have to include a stipulation [by Moderna] to not raise future objections” with respect to
`batches that have been withheld. Wonderland Nurserygoods Co. v. Baby Trend, Inc., 2021 WL
`2315191, at *4 (C.D. Cal. June 7, 2021); Apple Inc. v. Samsung Elecs. Co., 2012 WL 1511901, at
`*6 (N.D. Cal. Jan. 27, 2012) (“[T]o reduce Samsung’s burden . . . Samsung can negotiate a
`stipulation that its production adequately represents . . . the entire set of accused products.”). While
`Plaintiffs bear the burden of proving infringement, the choice for Moderna is simple: produce
`samples from each batch or agree not to dispute infringement of unproduced batches.
`
`Moderna has argued that Plaintiffs do not need samples of every batch because Moderna
`has conducted its own testing. But it is a basic principle of discovery that Plaintiffs need not accept
`Moderna’s testing as a substitute for their own. Vitamins Online, Inc. v. Heartwise, Inc., 2016 WL
`1305144, at *1–2 (D. Utah Mar. 31, 2016) (compelling production of lots despite defendant’s
`claim that it “already . . . tested” “a majority of those lots”); Seer Sys., Inc. v. Beatnik, Inc., 2006
`WL 1180058 at *1–2 (N.D. Cal. May 3, 2006) (ordering samples in addition to technical
`documents). Moderna may tout its production of “400,000 pages” of regulatory submissions, but
`those documents largely comprise information irrelevant to infringement and are no substitute for
`the highly relevant samples of the accused product itself. Indeed, in all of the cases cited above,
`
`Elecs. Corp., 2013 WL 1776112, at *1 (D. Del. Apr. 24, 2013); P&G Co. v. Be Well Mktg., Inc.,
`2013 WL 152801, at *5–6 (M.D. Pa. Jan. 15, 2013); Integra LifeSciences Corp. v. HyperBranch
`Med. Tech., Inc., 2016 WL 675553, at *1 (D. Del. Feb. 12, 2016); 3Com Corp. v. D-Link Sys.,
`Inc., 2007 WL 949596, at *1–2 (N.D. Cal. Mar. 27, 2007) (ordering production of code for “all”
`accused products and “all missing versions”); Alloc, Inc. v. Unilin Beheer B.V., 2006 WL 757871,
`at *4 (E.D. Wis. Mar. 24, 2006) (rejecting production only of products made after a certain date).
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 5 of 94 PageID #: 6167
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`SHAW KELLER LLP
`
`Page 3
`
`substantial document discovery did not obviate the need for sufficient samples. In any event,
`Moderna’s own testing need not be accepted uncritically—particularly given that Moderna
`conducted it while attacking the asserted patents unsuccessfully before the PTAB and Federal
`Circuit—and where the testing
`
`.
`
`E.g., D.I. 1-1, 91. While the former might be relevant to the latter, they are not the same.
`
`Moderna also has argued that the production of samples is burdensome. Any burden is
`proportional to the hundreds of millions of infringing doses it has sold (each batch contains tens
`of thousands of doses). There is no dispute that samples from each batch are readily available and
`accessible as part of Moderna’s FDA “regulatory retain.” Ex. 6 at 3; Vitamins Online, 2016 WL
`1305144, at *2 (compelling samples from retain). This “regulatory retain” necessarily permits
`Moderna to furnish, expeditiously, any batch(es) FDA requests. It is not burdensome for Moderna
`to produce samples of its batches; it simply does not want to produce them to Plaintiffs. Indeed,
`contrary to any notion of burden here, Moderna shifted, on a dime, from arguing for months that
`producing more than 13 batches was “extremely burdensome” to demanding that Plaintiffs accept
`480 batches within 3 business days. Ex. 4 at 1. Moderna is able to produce samples when it so
`chooses. Regardless, Moderna’s purported burden cannot outweigh the prejudice from its single-
`batch-per-part-number proposal. While Plaintiffs have sought, for months, a compromise that
`limits Moderna’s burden without prejudicing Plaintiffs, any compromise in which Moderna
`produces samples from fewer than all batches is undermined by Moderna’s unqualified reservation
`to dispute infringement as to unproduced batches. Moderna cannot simultaneously deny Plaintiffs
`discovery while reserving its ability to dispute infringement of what it has withheld.
`
` and Raw Data (RFP Nos. 108, 174). In its process for making
`the accused vaccine, Moderna
` Ex. 7 at *837.
`Moderna objects that
` and therefore does not infringe.
`Plaintiffs therefore requested samples of the particles in Moderna’s process
`
`, but Moderna responded that these
`particles are impossible to collect. The ratio in this unavailable intermediate particle differs from
`the final drug product and can separately infringe the asserted claims to “particle[s].” Ex. 8 at
`*169–70. As such, Plaintiffs requested samples of
`, from which infringement of the
`unavailable intermediate can be determined. Ex. 5 at 3. Moderna refused to produce samples, as
`well as raw data from its lipid testing of
`.
`
`The requested samples and data are relevant to infringement.
`. The lipid ratios of
`, but Moderna uses
`—which Plaintiffs seek to ascertain by testing samples and obtaining Moderna’s data—
`are relevant to the lipid composition of potentially infringing particles
`. Moreover, Moderna’s documents reflect that
`
`
`
`
` in
` Ex. 8 at *167. Moderna’s use of
`its “manufacturing processes [thus] bear[s] upon the properties of its finished products,” entitling
`Plaintiffs to discovery. Medtronic Ave, Inc. v. Adv. Cardio. Sys., 2004 WL 115594, at *3 (D. Del.
`Jan. 13, 2004). Sample production can be conducted according to the principles above; and the
`raw data underlying Moderna’s testing in light of its stated intent to rely on its own test results is
`plainly relevant.
`
`
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 6 of 94 PageID #: 6168
`
`SHAW KELLER LLP
`
`Page 4
`
`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)
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 7 of 94 PageID #: 6169
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`
`
`Plaintiffs,
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`
`
`)
`)
`)
`)
`) C.A. No. 22-252-MSG
`
`)
`)
`)
`)
`)
`
`
`
`
`RULE 7.1.1 STATEMENT
`
`Pursuant D. Del. LR 7.1.1, the undersigned counsel hereby certifies that a reasonable effort
`
`v.
`
`
`
`
`MODERNA, INC. and MODERNATX, INC.,
`
`
`
`
`
`Defendants.
`
`
`
`was made to reach agreement on the subject of this motion.
`
`
`
`/s/ Nathan R. Hoeschen
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`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
`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
`
`
`
`
`
`
`
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 8 of 94 PageID #: 6170
`
`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: December 15, 2023
`
`
`
`
`
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 9 of 94 PageID #: 6171
`
`Exhibit 1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 10 of 94 PageID #: 6172
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`
`C.A. No. 22-252-MSG
`
`CONTAINS INFORMATION
`MODERNA DESIGNATED HIGHLY
`CONFIDENTIAL – OUTSIDE
`COUNSEL EYES ONLY
`
`
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GMBH
`
`
`
`Plaintiffs,
`
`
`
`MODERNA, INC. and MODERNATX,
`INC.,
`
`
`
`
`v.
`
`
`
`
`
`Defendants.
`
`PLAINTIFFS’ INITIAL INFRINGEMENT CONTENTIONS
`
`Pursuant to the Court’s Scheduling Order (D.I. 72) and Paragraph 4(c) of the Court’s
`
`Default Standard for Discovery, Including Discovery of Electronically Stored Information,
`
`Plaintiffs Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH
`
`(“Genevant”) disclose their initial infringement contentions regarding U.S. Patent Nos. 8,058,069
`
`(“the ’069 patent”); 8,492,359 (“the ’359 patent”); 8,822,668 (“the ’668 patent”); 9,364,435 (“the
`
`’435 patent”); 9,504,651 (“the ’651 patent”); and 11,141,378 (“the ’378 patent”) to Defendants
`
`Moderna, Inc. and ModernaTX, Inc. (collectively, “Moderna”).
`
`Plaintiffs’ initial infringement contentions are based on the information currently available
`
`to, and known by, Plaintiffs. Fact discovery is ongoing, and Plaintiffs have not yet obtained any
`
`deposition testimony from Moderna. The Court has not yet construed any of the asserted claims
`
`of the patents-in-suit. The Court has set a schedule pursuant to which the parties will identify
`
`terms for construction, provide proposed constructions, cite evidence supportive of those
`
`constructions, confer to narrow the disputes before the Court, and then submit, through briefing
`
`and oral presentations, their arguments to the Court. The Court will then construe the disputed
`
`1
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 11 of 94 PageID #: 6173
`
`Arbutus Biopharma Corp. and Genevant Sciences GmbH v. Moderna, Inc., et al., C.A. No. 22-252-MSG (D. Del.)
`Paragraph 4(c) Charts – Appendix A
`
`Moderna Lot2
`
`Bates Begin
`
`Mfg. Stage
`
`Mfg. Date
`
`% RNA
`Encapsulation
`
`Total RNA
`(mg/mL)
`
`Particle
` Size (nm)
`
`PDI
`
`
`
`
`DSPC
`(mg/mL)
`
`Cholesterol
`(mg/mL)
`
`PEG2000-DMG
`(mg/mL)
`
`
`
`
`2 The batches and/or lots listed in Appendix A are based on information currently available and known to Plaintiffs. The data listed in Appendix A report the data
`as measured and reported by Moderna and/or Moderna’s contracted third-party, which Plaintiffs are investigating and reserve the right to amend and/or supplement.
`Plaintiffs further reserve the right to supplement or amend this listing as additional information is produced by Moderna and/or becomes known to Plaintiffs.
`CONTAINS INFORMATION MODERNA DESIGNATED
`Appendix A
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`Page 1 of 6
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 12 of 94 PageID #: 6174
`
`Arbutus Biopharma Corp. and Genevant Sciences GmbH v. Moderna, Inc., et al., C.A. No. 22-252-MSG (D. Del.)
`Paragraph 4(c) Charts – Appendix A
`
`Moderna Lot2
`
`Bates Begin
`
`Mfg. Stage
`
`Mfg. Date
`
`% RNA
`Encapsulation
`
`Total RNA
`(mg/mL)
`
`Particle
` Size (nm)
`
`PDI
`
`
`
`
`DSPC
`(mg/mL)
`
`Cholesterol
`(mg/mL)
`
`PEG2000-DMG
`(mg/mL)
`
`
`
`CONTAINS INFORMATION MODERNA DESIGNATED
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`Appendix A
`Page 2 of 6
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 13 of 94 PageID #: 6175
`
`Arbutus Biopharma Corp. and Genevant Sciences GmbH v. Moderna, Inc., et al., C.A. No. 22-252-MSG (D. Del.)
`Paragraph 4(c) Charts – Appendix A
`
`Moderna Lot2
`
`Bates Begin
`
`Mfg. Stage
`
`Mfg. Date
`
`% RNA
`Encapsulation
`
`Total RNA
`(mg/mL)
`
`Particle
` Size (nm)
`
`PDI
`
`
`
`
`DSPC
`(mg/mL)
`
`Cholesterol
`(mg/mL)
`
`PEG2000-DMG
`(mg/mL)
`
`
`
`CONTAINS INFORMATION MODERNA DESIGNATED
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`Appendix A
`Page 3 of 6
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 14 of 94 PageID #: 6176
`
`Arbutus Biopharma Corp. and Genevant Sciences GmbH v. Moderna, Inc., et al., C.A. No. 22-252-MSG (D. Del.)
`Paragraph 4(c) Charts – Appendix A
`
`Moderna Lot2
`
`Bates Begin
`
`Mfg. Stage
`
`Mfg. Date
`
`% RNA
`Encapsulation
`
`Total RNA
`(mg/mL)
`
`Particle
` Size (nm)
`
`PDI
`
`
`
`
`DSPC
`(mg/mL)
`
`Cholesterol
`(mg/mL)
`
`PEG2000-DMG
`(mg/mL)
`
`
`
`CONTAINS INFORMATION MODERNA DESIGNATED
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`Appendix A
`Page 4 of 6
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 15 of 94 PageID #: 6177
`
`Arbutus Biopharma Corp. and Genevant Sciences GmbH v. Moderna, Inc., et al., C.A. No. 22-252-MSG (D. Del.)
`Paragraph 4(c) Charts – Appendix A
`
`Moderna Lot2
`
`Bates Begin
`
`Mfg. Stage
`
`Mfg. Date
`
`% RNA
`Encapsulation
`
`Total RNA
`(mg/mL)
`
`Particle
` Size (nm)
`
`PDI
`
`
`
`
`DSPC
`(mg/mL)
`
`Cholesterol
`(mg/mL)
`
`PEG2000-DMG
`(mg/mL)
`
`
`
`CONTAINS INFORMATION MODERNA DESIGNATED
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`Appendix A
`Page 5 of 6
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 16 of 94 PageID #: 6178
`
`Arbutus Biopharma Corp. and Genevant Sciences GmbH v. Moderna, Inc., et al., C.A. No. 22-252-MSG (D. Del.)
`Paragraph 4(c) Charts – Appendix A
`
`Moderna Lot2
`
`Bates Begin
`
`Mfg. Stage
`
`Mfg. Date
`
`% RNA
`Encapsulation
`
`Total RNA
`(mg/mL)
`
`Particle
` Size (nm)
`
`PDI
`
`
`
`
`DSPC
`(mg/mL)
`
`Cholesterol
`(mg/mL)
`
`PEG2000-DMG
`(mg/mL)
`
`
`
`CONTAINS INFORMATION MODERNA DESIGNATED
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL EYES ONLY
`
`Appendix A
`Page 6 of 6
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 17 of 94 PageID #: 6179
`
`
`
`CERTIFICATE OF SERVICE
`
`I, Karen E. Keller, hereby certify that on April 24, 2023, this document was served on the
`
`persons listed below in the manner indicated:
`
`
`
`BY EMAIL:
`Jack B. Blumenfeld
`Brian P. Egan
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`
`James F. Hurst
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, IL 60654
`(312) 862-2000
`james.hurst@kirkland.com
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
`alina.afinogenova@kirkland.com
`
`
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker
`Mark C. McLennan
`Nancy Kaye Horstman
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
`patricia.carson@kirkland.com
`jeanna.wacker@kirkland.com
`mark.mclennan@kirkland.com
`kaye.horstman@kirkland.com
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street, 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`yanxin.li@kirkland.com
`
`
`
`
`
`/s/ Karen E. Keller
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`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
`Attorneys for Plaintiffs
`
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`

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`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 18 of 94 PageID #: 6180
`
`Exhibit 2
`Filed Under Seal
`
`

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`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 19 of 94 PageID #: 6181
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`Exhibit 3
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`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 20 of 94 PageID #: 6182
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`
`
`ANTHONY H. SHEH
`(202) 434-5436
`
`asheh@wc.com
`
`
`
`
`
`June 29, 2023
`
`CONTAINS INFORMATION MODERNA DESIGNATED
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`Via E-Mail
`
`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 to follow-up regarding the parties’ latest meet-and-confer on June 23, 2023,
`regarding Moderna’s failure to identify batches of the Accused Product. As we have raised
`repeatedly on our multiple meet-and-confers in March and April, as well as our correspondence
`dated April 18, April 28, May 11, and June 14, 2023, Moderna’s failure to identify these batches
`has prejudiced (and continues to prejudice) Plaintiffs’ ability to litigate this case, including by
`preventing the parties from productively negotiating the scope of sample production. Moderna
`originally contended that Plaintiffs’ request (in RFP 97) for 50 vials per batch would lead to
`millions of samples being produced. Since then, Moderna has suggested that the number is not so
`high, but has provided no information to either substantiate its claims or to provide a starting point
`for the parties’ negotiations. 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. Relatedly, Moderna still has not provided the
`availability of samples from those batches or even confirmed their existence.
`
`To be clear: Plaintiffs seek basic accounting information on Moderna’s batches of Accused
`Product so that the parties can productively negotiate the scope of sample production. As stated
`in Plaintiffs’ April 28, 2023 letter, Moderna clearly can—indeed, is required to—provide
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 21 of 94 PageID #: 6183
`
`
`
`
`June 29, 2023
`Page 2
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`information regarding its batches and their disposition to the FDA; and so it clearly can also do so
`in this litigation. See, e.g., MRNA-GEN-00044097 at *44103. And any information about
`samples from these batches would, given the storage conditions attendant to them, necessarily be
`in inventory records that Moderna presumably keeps in the ordinary course of business. To date,
`Moderna has not articulated the burden of providing this information, and its continued delay is
`prejudicial to Plaintiffs’ ability to conduct discovery in a timely fashion. See e.g. June 26, 2019
`Transcript from Merck Sharp & Dohme Corp. v. Alvogen Pine Brook LLC et al., C.A. No. 19-
`310-RGA (Judge Andrews: “[I]t’s incumbent on the defendants to make a reasonable effort to get
`[plaintiffs] unexpired samples, if such things exist, in a timely fashion.”) (emphasis added)
`(attached as Exhibit A).
`
`On our June 23, 2023 meet-and-confer, the only burden Moderna alluded to was that of
`completely responding to the other relevant information sought by Plaintiffs’ Interrogatories Nos.
`6 and 11, such as dispositional and financial/sales information regarding batches of the Accused
`Product. We understand that Moderna intends to supplement its interrogatory responses to provide
`this information sometime in July. But Moderna has not articulated any basis for not promptly
`providing the basic accounting information sufficient to identify batches of Accused Product
`Moderna months ago agreed was a necessary predicate for further discussions regarding sample
`production, and Moderna months ago agreed to provide.
`
`Please therefore identify by Friday, July 7, 2023, the batches of the Accused Product that
`Moderna has manufactured and/or sold, and provide the availability of samples from those batches.
`If Moderna is not able to do so, please provide a date certain by which Moderna will provide this
`information. Given the prejudice of Moderna’s delay in providing this information to date,
`Plaintiffs reserve all rights to further relief.
`
`Sincerely,
`
`Anthony H. Sheh
`
`
`
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`
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 22 of 94 PageID #: 6184
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`Exhibit 4
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`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 23 of 94 PageID #: 6185
`
`From:
`To:
`Cc:
`
`Subject:
`Date:
`
`Elenberg, Falicia
`"Afinogenova, Alina"; Sheh, Anthony; Haunschild, Philip; McLennan, Mark C.
`#KEModernaSpikevaxService; Li, Yan-Xin; Horstman, N. Kaye; "Arbutus_MoFo"; Parrado, Alvaro; Komis, Jihad;
`Genevant Team; Berl, David; Mahaffy, Shaun; Harber, Adam; Fletcher, Thomas; Ryen, Jessica;
`"NTan@mofo.com"; Bolte, Erik; *jshaw@shawkeller.com; "kkeller@shawkeller.com";
`"nhoeschen@shawkeller.com"; "EWiener@mofo.com"; "began@mnat.com"; "tmurray@morrisnichols.com";
`"jblumenfeld@morrisnichols.com"; Hurst, James F.; Carson, Patricia A.; Wacker, Jeanna
`RE: Arbutus v. Moderna, 1-22-cv-00252 - Letter to Counsel (Batch Information) - HIGHLY CONFIDENTIAL OCEO
`Monday, December 11, 2023 4:22:00 PM
`
`Alina,
` 
`Thank you for your response.
` 
`We are surprised by Moderna’s recent and abrupt change in position regarding samples.  Up until
`your November 10th email, Moderna maintained its position that it would produce samples from
`less than ~1% of batches of the Accused Products manufactured / imported into the U.S. (13 out of
`over 1000 batches).  Moderna refused to engage with Plaintiffs’ good faith efforts to negotiate
`regarding the scope of sample production, an effort that we undertook in based on Moderna’s
`representation about the immense burden associated with sample production.  Then, out of the
`blue, Moderna offered samples from approximately 480 batches.  Plaintiffs do not understand how
`the burden of production could have shifted so suddenly and significantly as to allow Moderna to
`produce samples from hundreds of batches after claiming for months on end that producing
`samples from anything more than 13 would be “extremely burdensome” (without producing any
`evidence of this burden).  See September 19, 2023 Letter from M. McLennan at 2.  Plaintiffs
`continue to maintain that Moderna should produce samples from each batch of the Accused
`Product, especially in light of Plaintiffs’ new understanding regarding the true burden of sample
`production.  Plaintiffs request that whatever preparatory efforts Moderna is currently undertaking to
`produce the offered samples, Moderna also apply to samples from the remaining batches of the
`Accused Product to prevent further prejudice to Plaintiffs.
` 
`We also have questions regarding the timing of sample production.  In its November 10th email,
`Moderna requested that Plaintiffs accept its offer within 3 business days and stated its
`understanding that production could be made within two weeks.  On the November 17th meet-and-
`confer, Moderna again conveyed time-pressure to Plaintiffs indicating that the timeline is dictated by
`the movement of the ~480 samples out of their current facility, which Moderna anticipated would
`take place within two weeks of the initial offer.  Not only did Moderna fail to deliver the samples
`within the timeframe provided, Moderna failed to respond to Plaintiffs’ correspondences for over
`two weeks.  Moderna now claims that it should be in a position to make the production sometime in
`the month of January (i.e., 1-2 months later than originally indicated), without any explanation for
`the delay or specificity regarding dates.  Plaintiffs are extremely prejudiced by Moderna’s continued
`delay in producing samples more than one year after Plaintiffs’ requested them.  Moderna is putting
`Plaintiffs in a position to be unable to meet the case schedule, perhaps strategically so, and this is
`plainly improper.  By  December 18, 2023, please provide Plaintiffs with a specific explanation of the
`reasons for the continued delay of sample production. 
` 
`Thank you,
`Falicia
`
`

`

`Case 1:22-cv-00252-MSG Document 174-2 Filed 12/21/23 Page 24 of 94 PageID #: 6186
`
` 
`Falicia Elenberg
`Associate | Williams & Connolly LLP
`680 Maine Avenue, S.W., Washington, DC 20024
`202-434-5989 | felenberg@wc.com | www.wc.com
` 
`From: Afinogenova, Alina <alina.afinogenova@kirkland.com> 
`Sent: Tuesday, December 5, 2023 9:48 PM
`To: Sheh, Anthony <ASheh@wc.com>; Haunschild, Philip <phaunschild@wc.com>; McLennan, Mark
`C. <mark.mclennan@kirkland.com>
`Cc: #KEModernaSpikevaxService <KEModernaSpikevaxService@kirkland.com>; Li, Yan-Xin
`<yanxin.li@kirkland.com>; Horstman, N. Kaye <kaye.horstman@kirkland.com>; 'Arbutus_MoFo'
`<Arbutus_MoFo@mofo.com>; Parrado, Alvaro <alvaro.parrado@kirkland.com>; Elenberg, Falicia
`<felenberg@wc.com>; Komis, Jihad <JKomis@wc.com>; Genevant Team
`<GenevantTeam@wc.com>; Berl, David <DBerl@wc.com>; Mahaffy, Shaun <SMahaffy@wc.com>;
`Harber, Adam <AHarber@wc.com>; Fletcher, Thomas <TFletcher@wc.com>; Ryen, Jessica
`<JRyen@wc.com>; 'NTan@mofo.com' <NTan@mofo.com>; Bolte, Erik <ebolte@wc.com>;
`*jshaw@shawkeller.com <jshaw@shawkeller.com>; 'kkeller@shawkeller.com'
`<kkeller@shawkeller.com>; 'nhoeschen@shawkeller.com' <nhoeschen@shawkeller.com>;
`'EWiener@mofo.com' <EWiener@mofo.com>; 'began@mnat.com' <began@mnat.com>;
`'tmurray@morrisnichols.com' <tmurray@morrisnichols.com>; 'jblumenfeld@morrisnichols.com'
`<jblumenfeld@morrisnichols.com>; Hurst, James F. <james.hurst@kirkland.com>; Carson, Patricia A.
`<patricia.carson@kirkland.com>; Wacker, Jeanna <jeanna.wacker@kirkland.com>
`Subject: RE: Arbutus v. Moderna, 1-22-cv-00252 - Letter to Counsel (Batch Information) - HIGHLY
`CONFIDENTIAL OCEO
` 
`Tony,
` 
`In follow-up to our November 10 email relating to the production of samples from 400+ lots of
`expired drug product, we are continuing to work through the burdensome exercise of setting up the
`logistics to make said production, which we now expect to be in a position to do in January. We will
`provide an update with additional information as soon as we are able.
` 
`Regards,
`Alina
` 
`Alina Afinogenova
`------------------------------------------------------