Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 1 of 5 PageID #: 13687
`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 1 of 5 PagelD #: 13687
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`EXHIBIT 22
`EXHIBIT 22
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`

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`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 2 of 5 PageID #: 13688
`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 2 of 5 PagelD #: 13688
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`KIRKLAND & ELLIS LLP
`AND AFFILIATED PARTNERSHIPS
`
`601 Lexington Avenue
`New York, NY 10022
`United States
`
`+1 212 446 4800
`
`wwwkirkland.com
`
`September 19, 2023
`
`Facsimile:
`+1 212 446 4900
`
`HIGHLY CONFIDENTIAL - OUTSIDE
`COUNSEL EYES ONLY
`
`Mark McLennan
`To Call Writer Directly:
`+1 212 909 3451
`Mark.mclennan@kirkland.com
`
`By E-mail
`
`Anthony H. Sheh
`Williams & Connolly LLP
`680 Maine Avenue SW
`Washington, DC 20024
`asheh@we.com
`
`Re:=Arbutus Biopharma Corporation and Genevant Sciences GmbH v. Moderna, Inc. and
`ModernaTX, Inc., Case 1:22-cv-00252-MSG (D.Del.) — Sample Requests
`
`DearTony,
`
`Your September6 letter is unresponsive to the questions raised in our August 24 letter,
`and any delay in moving this discussion forward in a meaningful manneris of Plaintiffs’ own
`making. For example, we have repeatedly requested justification for your request for 50 samples
`per batch, but you have provided none. Instead, Plaintiffs take weeks to respond to Moderna’s
`letters, which only repeat the same recycled position and demand for an immediate response.
`Moderna’s investigations have also been hampered by Plaintiffs’ continually shifting inquires,
`including most recently asking Moderna to investigate the possibility of imterrupting its
`continuous manufacturing processto collect mid-process samples.
`
`As an initial matter, Plaintiffs’ letter is unclear on what it is they
`
`are seeking and your
`
`understanding of what Moderna has offered to produce.
`
`. August 24, 2023
`McLennan Letter. Specifically, Moderna offered
`to produce samples o
`1g product that were
`
`made with each part number of mRNA-LNP that was made, sold, or imported into the U.S.
`
`1 Wenote that Plaintiffs’ complaint accuses the drug productof infringement.
`
`Austin Beijing Boston Brussels Chicago Dallas HongKong Houston London Los Angeles Miami Munich NewYork Paris SaltLake City Shanghai Washington, D.C.
`
`

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`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 3 of 5 PageID #: 13689
`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 3 of 5 PagelD #: 13689
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`KIRKLAND & ELLIS LLP
`
`Anthony H. Sheh
`September 19, 2023
`Page 2
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`HIGHLY CONFIDENTIAL - OUTSIDE
`COUNSEL EYES ONLY
`
`With regard to availability of batches, Moderna has been working to ascertain this
`information but is continually frustrated by Plaintiffs’ refusal to explain why it needs 50 samples
`of each batch from more than one thousand batches, or propose any more reasonable quantity.
`Plaintiffs have admitted to having their own analytical methods for determining lipid content and
`are well aware of the quantities necessary to run those methods. If Plaintiffs were aware of any
`method requiring 50 samples for a single batch, they would have identified it by now.
`
`Based on the unprecedented amount that Plaintiffs have continued to seek and the
`absence of any justification, we can only interpret these RFPs as designed to burden and harass
`Moderna, and delay the litigation. Simply put, Plaintiffs’ repeated requests for 50 drug product
`samples from more than one thousand batches, totaling more than 50,000 samples, is absurd,
`and far more than Plaintiffs could ever hope to test with the current case schedule,
`let alone store
`in extreme temperatures.
`
`laintiffs’ most recent demands for mRNA-LNP samples (100
`mg of lipid for 10% of all batches) is still extreme—amounting to samples from at least 80
`
`batches, totaling more than 8,000 doses. If Plaintiffs were aware of
`
`
`that
`a method
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`required such extreme amounts, Plaintiffs have had months to inform Moderna. Based on
`Plaintiffs silence, we can only assumethat Plaintiffs have no good basis to request such extreme
`amounts.
`
`With regard to the number of samples that Plaintiffs seek, Plaintiffs’ reliance on Everlight
`Electronics Co., Ltd. v. Nichia Corp. is misplaced, as Modernais already agreeing to provide a
`comparable amount of discovery compared to what wasordered in Everlight. The 1,000 samples
`produced were the total number of samples across all accused products, not 1,000 samples of
`each accused product. 2013 WL 6713789, at *1-2 (D. Del. Dec. 20, 2013). There, the defendant
`had produced over 600 “part numbers” of the accused product, and was agreeing to produce a
`
`

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`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 4 of 5 PageID #: 13690
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`Anthony H. Sheh
`September 19, 2023
`Page 3
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`
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`HIGHLY CONFIDENTIAL - OUTSIDE
`COUNSEL EYES ONLY
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`limited number of samples of each part number, not samples from every batch of every part
`number as you demand here. See Civ. No. 4:12-cv-11758-GAD-MKM, ECF No. 173-3. For
`comparison, Plaintiffs’ demand for 50 samples of every batch equates to more than 50,000
`samples—50 times the number of samples in Everlight. By contrast, Moderna has already
`identified a far smaller number of part numbers of accused product and components thereof and
`intends to make a reasonable production of samples of each. Finally, production of LED lights is
`clearly far less burdensome than production of an FDA-approved prescription drug product
`subject to compliance and regulatory holds, which requires complex storage at extreme
`temperatures. Tellingly, Plaintiffs have not come forward with any case suggesting that a
`defendant needs to produce 50 samples of more than 1,000 batches. Instead, Courts have denied
`motions to compel the production of “duplicative and irrelevant product samples” as
`“disproportionate to the needs of the case and unduly burdensome.” Rembrandt Diagnostics, LP
`v. Innovacon, Inc., No. 3:16-cv-0698, ECF Nos. 127, 130, at 5-6 (S.D. Cal. Oct. 3, 2017). In
`Rembrandt, the requested product samples would have resulted in the production of 1,150
`sample test cups, and despite Plaintiffs’ objections regarding defendants’ “unilaterally select[ing]
`representative samples,” the Court agreed that defendants’ production of representative samples
`was sufficient. Id., at 5. The same is true here. Just like in Rembrandt, “due to the nature of the
`products, the requests at issue [a]re duplicative and burdensome.” Id.
`
`In any event, based on its investigation to date, Moderna expects to have some amount of
`each commercial drug product batch manufactured in the U.S. in its possession, but notes that it
`must retain a certain amount for compliance with regulatory and/or statutory requirements.
`Asking Moderna to determine (for more than a thousand batches) from the quantity of retained
`samples available, how much has already been used for regulatory and/or statutory compliance
`purposes, and how much can be spared and/or is needed for future compliance purposes is an
`incredibly burdensome exercise. This is particularly true given Plaintiffs have refused to narrow
`the requests to a reasonable quantity or number of samples, let alone to a reasonable number of
`batches. Moreover, Moderna personnel in the various departments involved in these
`investigations are currently under immense pressure to rapidly distribute Moderna’s upcoming
`updated booster product in time for the fall season, which has limited the time available to assist
`with these requests. Moderna is willing to further investigate a reasonable and proportionate
`number of samples from a reasonable and proportionate number of batches if Plaintiffs are
`willing to narrow the request.
`
`Please explain (1) your basis for the proposition that Plaintiffs are entitled to “select”
`batches, (2) what selection criteria Plaintiffs will use to “select” batches and how that would be
`consistent with the samples being treated as “representative,” (3) why Moderna’s proposal to
`produce samples from a recent batch is insufficient, and (4) why a sample of 10% of batches is
`required. Assuming Plaintiffs can answer these questions, we are willing to consider a proposed
`stipulation on representativeness and can be available to meet and confer.
`
`

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`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 5 of 5 PageID #: 13691
`Case 1:22-cv-00252-MSG Document 195-29 Filed 01/16/24 Page 5 of 5 PagelD #: 13691
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`KIRKLAND & ELLIS LLP
`
`Anthony H. Sheh
`September19, 2023
`Page 4
`
`HIGHLY CONFIDENTIAL - OUTSIDE
`COUNSEL EYES ONLY
`
`Regarding the specific questions in Plaintiffs’ email, such information is more properly
`sought through an interrogatory. But in the interests of cooperation, we will provide updates
`here:
`e Modernais working to collect a listing of all batches of mRNA-LNPs of Moderna’s COVID-
`19 Vaccine that were madein the U.S. or imported into the U.S. Weexpect that the vast
`majority are already listed in the drug product spreadsheets that have already been produced.
`
`e Moderna has producedspecifications for relevant part numbers of mRNA-LNP and drug
`product. Modernawill update this information as needed throughout fact discovery as new
`part numbersare created and/or as we locate additional documents. We will look into your
`specific query regarding part number
`
`
`
`e Moderna has produced aninitial summary listing of lipid content testing. As discussed in
`separate correspondence,at Plaintiffs’ request, Moderna continuesto investigate collection of
`additional testing information in summary form, COAs, or through underlying raw data. We
`do not appreciate your demand that Moderna produce thousands of COAs within a matter of
`days after the parties have had productive discussions on the burden in manually collecting
`them one by one, with an understanding that Moderna would investigate alternative means of
`obtaining this information. We continue to expeditiously investigate these RFPs.
`
`With regard to Plaintiffs’ endless demands for other pieces of information—this time
`expiration dates—weare workingto diligently collect this information and produceit in usable
`form. Although Moderna was working diligently to compile a comprehensive summary of batch
`information including expiry, disposition, etc., Plaintiffs insisted that we immediately produce a
`listing of batch numbers and then continues to demand immediate production of additional
`information piecemeal, which only increases the burden on Moderna and delays production.
`
`Sincerely,
`
`/s/ Mark McLennan
`
`Mark McLennan
`
`