Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 1 of 6 PageID #: 13665
`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 1 of 6 PagelD #: 13665
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`EXHIBIT 20
`EXHIBIT 20
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`

`

`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 2 of 6 PageID #: 13666
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`
`
`601 Lexington Avenue
`New York, NY 10022
`United States
`
`+1 212 446 4800
`
`www.kirkland.com
`
`October 20, 2023
`
`Facsimile:
`+1 212 446 4900
`
`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL EYES ONLY
`
`Shaelyn K. Dawson
`Morrison & Foerster LLP
`425 Market Street
`San Francisco, CA, 94105
`shaelyndawson@mofo.com
`
`
`
`
`
`Mark C. McLennan
`To Call Writer Directly:
`+1 212 909 3451
`mark.mclennan@kirkland.com
`
`
`
`
`
`By Email
`
`Anthony Sheh
`Williams & Connolly LLP
`680 Maine Ave SW
`Washington, DC 20024
`asheh@wc.com
`
`
`
`
`Re: Arbutus Biopharma Corporation et al. v. Moderna, Inc. et al., C.A. No. 22-
`252-MSG (D. Del.) – Samples
`
`Counsel:
`
`We write regarding the parties’ September 28, 2023 meet-and-confer and Plaintiffs’ October
`6, 2023 letter.
`
`We understand that Plaintiffs’ current proposal is as follows: Plaintiffs seek samples of drug
`product vials containing the equivalent of 100 mg lipid content from each of 50 finished drug batches
`that Plaintiffs’ will select across the mRNA-1273 LNP part numbers identified by Moderna.
`
`Thank you for agreeing to meet and confer again on Monday, October 23.
`1.
`
`Drug Product Samples
`
`Plaintiffs’ persist in ignoring important, undisputed facts in their continued request for an
`extreme and unreasonable volume of samples.
`
`First, this is not a situation where testing and related documentation does not already exist.
`Plaintiffs continue to ignore that Moderna has already produced data concerning the lipid content of
`its product generally and each batch individually, and has committed to further producing additional
`testing data kept in the ordinary course regarding the lipid content of each batch. The fact that
`Plaintiffs appear to just not like the results of such testing does not automatically make the production
`of large amounts of samples necessary or proportionate with respect to resolution of the issues in this
`case.
`
`Austin Bay Area Beijing Boston Brussels Chicago Dallas Hong Kong Houston London Los Angeles Munich Paris Salt Lake City Shanghai Washington, D.C.
`
`
`

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`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 3 of 6 PageID #: 13667
`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 3 of 6 PagelD #: 13667
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`KIRKLAND & ELLIS LLP
`Anthony Sheh; Shaelyn K. Dawson
`October 20, 2023
`Page 2
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`Second, even considering the very large volume of documents and data that has already been
`or will be produced with respect to lipid content, Moderna has nevertheless offered to take a step-
`wise approach to production of samples, beginning with production of 3 drug product samples from
`one batch of each part number, so that Plaintiffs may receive additional samples sooner,! wherein
`Plaintiffs could come back to Moderna in the event that, when they complete tests on those batches,
`they determine that further batches are necessary. Plaintiffs rejected Moderna’s offer. As we have
`previously stated, Moderna is actively working on producing up to 3 drug product vials from each
`part number(if available). Moderna wouldalso retain 3 corresponding samples for purposes ofthis
`litigation. Moderna has been attempting to work with Plaintiffs in trying to reach a reasonable
`compromise, yet Plaintiffs have persisted with their extremely high-volumerequests.
`
`(a)
`
`Plaintiffs Seek an Unreasonable Number of Samples from 50 batches
`
`With regard to the number of samples, as we pointed out on the meet-and-confer, Plaintiffs’
`comparison of the number of samples they request to Moderna’s manufacturing capacity is entirely
`urelevant. See, e.g., Sheh Oct. 6, 2023 letter at 1 (“Plaintiffs disagree that it is reasonable for Moderna
`to limit its sample production to 39 vials from 13 batches where millions of vials have been
`manufactured and sold across approximately a thousand batches”); id. at 2 (“a tiny fraction of the
`total number of batches and material that Moderna has manufactured to date’). Proportionality is not
`based on how much product Moderna makes and how manybatches, but what quantity of samples
`Plaintiffs need to prove their case. WhatPlaintiffs refer to as a “tiny fraction” amounts to production
`of thousands of doses, an amount Plaintiffs are highly unlikely to test during the course of this
`litigation.
`
`Plaintiffs Seek Unreasonable Amounts of Samples (vials equivalent to
`(b)
`100 mglipid content) Per Batch
`
`With regard to the amount of each sample, for months we have asked Plaintiffs why they need
`vials equivalent to 100 mgoflipid per batch and not once have Plaintiffs provided an answer. Your
`October6 letter once again evades the question. In fact, your only acknowledgment of this query is
`followed by: “we have madeclearthat the requested quantities are needed for testing and in light of
`Moderna’s position that it may dispute infringement on a batch-by-batch basis.” Sheh Oct. 6, 2023
`letter at 3. This provides no clarity to Moderna as to why Plaintiffs demand such large amounts of
`Moderna’s product. As we have stated, Modernais not aware of any testing that would require such
`large amounts of material. Plaintiffs likewise confirmed during the meet-and-confer that they would
`not provide anyjustification for the amount of sample they seek, claiming these discussions are not
`
`“‘a vehicle for Modernato get insi
`
`1
`
`Wenote that Plaintiffs previously agreed to Moderna’s production of 3 vials from a single batch
`of drug product and Moderna made such production back in April 2023.
`
`

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`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 4 of 6 PageID #: 13668
`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 4 of 6 PagelD #: 13668
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`KIRKLAND & ELLIS LLP
`Anthony Sheh; Shaelyn K. Dawson
`October 20, 2023
`Page 3
`
`It also appears that Plaintiffs are taking the position that they cannot determinelipid content
`of the drug productas it exists in the ordinary course (i.e., as sold) by Moderna,” and instead are
`seeking these samples with the intent to somehow combine samples to amass 100 mg oflipid.
`Plaintiffs have been entirely unwilling to compromise—maintaining their request for vials equivalent
`100 mg of lipid per batch since serving the RFP in December 2022. Further, despite months of
`meeting and conferring, Plaintiffs informed Modernaforthefirst time during the September 28, 2023
`meet-and-confer that they refused to reduce the amount of samples they were seeking.
`
`With respect to your questions regarding Moderna’s regulatory retained samples of drug
`product, Moderna’s standard operating procedure is compliant with FDA’s regulation under 21 CFR
`211-170, which requires a reserved sample that is representative of each lot in each shipment be
`retained, and that the quantity of the reserved sample be two times the quantity
`sufficient to perform
`all the required tests (except for sterility
`and
`
`pyrogens).
`
`Forthe purposesofthis litigation, Moderna expects to be able to produce upto three vials of
`drug product across drug product lots that have expired. As described above and in our September
`19, 2023 letter, Moderna would producethose 3 vials from one batch of each of the different part
`numbers. Consistent with Moderna’s earlier sample production, Moderna would retain 3
`corresponding samples for purposesofthis litigation. With respect to expired drug product, Moderna
`would produce samples with the understanding that the expired materials may not exhibit the same
`lot characteristics demonstrated at the time ofinitial release. In the absence of any justification from
`Plaintiffs as to why 100 mg oflipid content per batch is needed, Moderna’s proposal is reasonable
`and proportional to the needs of the case.
`
`Finally, with regard to recently manufactured batches, as we previously explained, Moderna
`is currently working to rapidly distribute Moderna’s updated booster product for this fall season.
`Plaintiffs’ requests for large amounts of samples (equivalent to 100 mg of lipid per batch) are
`unnecessary for the reasons mentioned above, as well as burdensometo the extent Plaintiffs seek a
`significant diversion of product from the market and dosesforpatient use.
`
`nN
`
`

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`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 5 of 6 PageID #: 13669
`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 5 of 6 PagelD #: 13669
`
`KIRKLAND & ELLIS LLP
`Anthony Sheh; Shaelyn K. Dawson
`October 20, 2023
`Page 4
`
`(c)
`
`Plaintiffs’ Request is Overly Burdensome and Not Proportional
`
`Re_ardin_ burden as we havealready ex, lained to Plaintiffs, identification of the numberof
`sam, les remainin_ in a __iven batch across more than one thousandbatches will be a manualexercise
`of not onl, checkin_ electronic s_ stems forsaid availability, but confirming inventory in Moderna’s
`freezers, which will be a laborious and time-consumin__, rocess that will not onl. ex_ end the time of
`Moderna’s em, lo_ ees who will be doin_ this on to, of their re_ular roles and responsibilities at the
`com, an__ but will also , ut other sam_ les at risk of bein_ ex, osed to hi_hertem, eratures. Given the
`burden Moderna cannot _ erform this inventor exercise until the parties have settled on what will
`need to be produced.In addition to identif, in_ what is available extensive _ aperwork will be needed
`to justify the deviation of productionof regulatory retains. This too is not a quick procedure.
`
`Forall the reasons discussed above at least the re uest for 100 m_ of li, id_ erbatchis entirel_
`unreasonable | articularl, where Plaintiffs have never . rovided a reason wh_ such an enormous
`uantit_ is needed. Additionall. Moderna hasdescribed at least a _ ortion of the costs associated
`with the _ roduction of the re uested sam, les above. Moderna cannot uantif the costs and ex, enses
`_iven that the , arties have reached no a_reement on the uantit. of sam_les to be _roduced. Moderna
`understandsthat Plaintiffs are refusing to confirm they will coverthe costs at this time.
`
`(d)
`
`Plaintiffs’ Proposal on “Representativeness”
`
`With re_ard to re, resentativeness Plaintiffs’ ro_osed “selection” _ rocess likewisefails to
`_ ass muster. First Plaintiffs’ ro. osal continues to i_nore the testin_ results and data Moderna has
`alread. _ roduced orhas a_reed to _ roduce. Second Plaintiffs intend to cherr_ -, ick the batches to be
`_toduced but then ar_ue that those hand-selected batches should be representative of all material
`within the same part number. As we noted on the meet-and-confer, hand-selecting the ones Plaintiffs
`wish Modernato _ roduceis entirel,
`inconsistent with the batches bein_ considered re_ resentative.
`Plaintiffs refused to state during the meet-and-confer what criteria they would use to make such a
`selection further ham, erm_ Moderna’s ability to tr,
`to reach a common_round onthis issue.
`Plaintiffs’ letter is also unclear as to how representativeness would apply in practice. For example, if
`Plaintiffs demand samples from10 batches for one , art number_it would be unreasonable to suggest
`that Plaintiffs could offer evidence of a single test or a sin_le sam_le while withholding others and
`have that one test result supersede all others. Re_ardless . lease . rovide a draft stipulation that lays
`out Plaintiffs’ proposal in more detail so that we may consideryourposition.
`
`2.
`
`RFPs 110 and 111
`
`
`
`

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`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 6 of 6 PageID #: 13670
`Case 1:22-cv-00252-MSG Document 195-26 Filed 01/16/24 Page 6 of 6 PagelD #: 13670
`
`KIRKLAND & ELLIS LLP
`Anthony Sheh; Shaelyn K. Dawson
`October 20, 2023
`Page 5
`
`
`
`Furthermore, Plaintiffs’ attempt to shoehorn their unfounded theory—about“samples,” of a
`mid-manufacturing process, which do not exist in the ordinary course—into the allegations in their
`Complaint, mischaracterizes the Complaint. Specifically, Plaintiffs argue that “[s]uch samples plainly
`relate to Plaintiffs’ claims that Moderna has infringed through manufacturing the Accused Product
`incorporating Arbutus’s patent LNP technology, and by selling, importing, and inducing others to
`make and use a product that embodies a component of a patented manufacture, combination or
`composition.” Sheh Oct. 6, 2023 letter at 3. But that is not what the Complaint says; the Complaint
`only alleges infringement “under 35 U.S.C. § 271(a) by manufacturing, offering to sell, selling, or
`using within the United States, or importing into the United States, the Accused Product.” See, e.g.,
`D.I. 1, §§70, 89, 108, 130, 154, 173. Regardless, as explained in our September 19, 2023 letter and
`again on our most recent meet-and-confer, Moderna doesnot have anything to produce in response
`to Plaintiffs’ request for samples of this mid-process material whichis not available in the ordinary
`course. We understand these RFPsto be resolved.
`
`3. || Product Samples
`
`Regarding samples of
`
`, Plaintiffs have not articulated any claim or defense to
`
`which such samples would be relevant. Moderna will respond to the newly
`
`served RFP in duecourse.
`
`Sincerely,
`
`/s/Mark C. McLennan
`Mark C. McLennan
`
`cc: Counsel of Record
`
`