Case 1:22-cv-00252-MSG Document 299 Filed 05/01/24 Page 1 of 4 PageID #: 16847
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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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`MODERNA, INC. and MODERNATX, INC.,
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`Defendants.
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`Plaintiffs,
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`v.
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`C.A. No. 22-252 (MSG)
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`STIPULATION CONCERNING
`PLAINTIFFS’ MOTION FOR LEAVE TO AMEND COMPLAINT
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`WHEREAS, on April 17, 2024, Plaintiffs filed a motion for leave to amend the Complaint
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`(D.I. 277);
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`WHEREAS, pursuant to the stipulation between the parties, Defendants Moderna, Inc. and
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`ModernaTX, Inc. (“Moderna”) have not yet responded to the motion to amend (D.I. 289 & 292);
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`WHEREAS, the parties have continued to meet and confer on the motion in an effort to
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`avoid burdening the Court with further briefing on the issue and have subsequently reached an
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`agreement;
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`NOW THEREFORE, the parties hereby stipulate and agree, subject to the approval of the
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`court that:
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`1.
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`Although Moderna disagrees with the characterizations of the discovery record in
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`Plaintiffs’ motion for leave to amend the complaint (D.I. 278), Moderna will not oppose the motion
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`for leave based on the terms in this stipulation, but reserves all rights to answer, move to dismiss,
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`or otherwise respond to Plaintiffs’ amended complaint if entered by the Court.
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`Case 1:22-cv-00252-MSG Document 299 Filed 05/01/24 Page 2 of 4 PageID #: 16848
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`2.
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`Based on presently known information, Plaintiffs will not seek to extend any
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`current deadline in the scheduling order based on its amended complaint, including its new 271(f)
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`claim.
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`3.
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`Plaintiffs will supplement their infringement contentions to address their new
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`271(f) claim by May 6, 2024.
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`4.
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`The depositions of Moderna’s 30(b)(1) and 30(b)(6) witnesses will not be
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`rescheduled or deferred as a result of Plaintiffs’ amended complaint asserting a new 271(f) claim.
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`5.
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`Based on Moderna’s current understanding, any follow-up discovery for additional
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`batches potentially implicated by Plaintiffs’ new 271(f) claim will be of a similar nature to
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`discovery Plaintiffs already have (additional rows in a spreadsheet, additional COAs,
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`specifications, financial information, etc.). In addition, Moderna is investigating its ability to
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`produce other discovery requested by Plaintiffs, including information sufficient to show for each
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`batch of the specific components identified in Plaintiffs’ Amended Complaint (Exhibit N to D.I.
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`278) at ¶¶ 56–58, 77-78, 98-99, 119-120, 143-144, 169-170, 190-191 used in batches of the
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`Accused Product, the exportation dates and shipping destination, as well as information enabling
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`Plaintiffs to identify the number of doses sold that included such exported components, the price
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`per dose, and revenue and profit associated with such dose(s).1 Moderna will aim to produce such
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`follow-up discovery, including discovery specifically referenced in this paragraph, and any
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`supplemental interrogatory responses (as supplementation of responses may be required under
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`1 Moderna is still investigating the availability of this requested discovery. The parties agree to
`work in good faith to resolve any disputes concerning the information Moderna subsequently
`produces, and reserve the right to raise any disputes with respect to this requested discovery or the
`implication (including the preclusive effect, if any) of not producing this information (including
`because this information is not maintained in the ordinary course of business).
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`2
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`Case 1:22-cv-00252-MSG Document 299 Filed 05/01/24 Page 3 of 4 PageID #: 16849
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`Rule 26(e)) or other document production relating to Plaintiffs’ 271(f) claim, by May 10, 2024 and
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`will complete such productions by close of fact discovery.
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`6.
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`For any new mRNA-LNP part numbers placed at issue based on Plaintiffs’ 271(f)
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`claim, the parties will treat the selection and production of samples for such part numbers in
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`accordance with paragraphs 1–2 of Exhibit A of the parties’ February 26, 2024 stipulation (D.I.
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`225). Based on Moderna’s representation that the genealogy (MRNA-GEN-01424942, MRNA-
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`GEN-01711164) it has produced contains all of the part numbers that use components
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`manufactured in the United States, Plaintiffs will inform Moderna what additional part numbers
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`Plaintiffs seek samples of based on the genealogy information Moderna has produced to date.
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`Because Plaintiffs’ new 271(f) claim implicates overseas drug product, if there are logistical issues
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`with collecting and producing such samples within the time periods in the stipulation, the parties
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`will work together in good faith on an appropriate schedule for production and any other schedule.
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`7.
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`Based on the discovery Plaintiffs have received to date and Moderna’s
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`representations, Plaintiffs do not presently intend to take any additional depositions of Moderna’s
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`witnesses or serve new written discovery requests related to Plaintiffs’ new 271(f) claim (although
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`supplementation of existing responses may be required under Rule 26(e)). Because Plaintiffs have
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`not yet seen the information Moderna intends to produce and do not know the precise timing,
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`however, this stipulation does not preclude the taking of additional discovery or deposition
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`testimony where there is a good-faith basis for doing so in light of the information Moderna
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`produces and/or the timing of that production. The parties agree to work together in good faith to
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`address any such additional discovery based on the information Moderna produces and will present
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`any disputes to the Court about the scope of discovery at that time.
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`3
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`Case 1:22-cv-00252-MSG Document 299 Filed 05/01/24 Page 4 of 4 PageID #: 16850
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`8.
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`Upon approval of this Stipulation by the Court, and as set forth in the Stipulation
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`and Order to Extend Time (D.I. 291), Plaintiffs have leave to file the Amended Complaint
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`(attached as Exhibit N to their Motion for Leave to Amend, D.I. 278) under seal, and Moderna
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`shall file any motion to seal within three (3) business days from the date it is docketed. If no motion
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`to seal is required, Moderna shall notify the Court that the Amended Complaint can be unsealed.
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`SHAW KELLER LLP
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`/s/ Karen E. Keller
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`John W. Shaw (#3362)
`Karen E. Keller (#4489)
`Nathan R. Hoeschen (#6232)
`Emily S. DiBenedetto (#6779)
`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
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`Attorney for Plaintiffs
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`April 29, 2024
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Travis J. Murray
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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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`1st
`May
`SO ORDERED this ______ day of ___________________, 2024.
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`/s/ Mitchell S. Goldberg
`UNITED STATES DISTRICT JUDGE
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`4
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