Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 1 of 6 PageID #: 13437
`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 1 of 6 PagelD #: 13437
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`EXHIBIT 5
`EXHIBIT 5
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`

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`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 2 of 6 PageID #: 13438
`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 2 of 6 PagelD #: 13438
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`LAW OFFICES
`
`WILLIAMS & CONNOLLYte:
`
`SHAUN P. MAHAFFY
`(202) 434-5554
`smahaffy@wc.com
`
`680 MAINE AVENUE SW
`
`WASHINGTON, DC 20024
`
`EDWARD BENNETT WILLIAMS (1920-1988)
`PAUL R. CONNOLLY(1922-1978)
`
`(202) 434-5000
`
`WWW.WC.COM
`
`August 29, 2023
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL’S EYES ONLY
`
`Via Email
`
`Mark C. McLennan
`
`KIRKLAND & ELLIs LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 909-3451
`mark.mclennan@kikland.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 memorialize the parties’ meet and confer on August 23, 2023. As explained in
`more detail below,the parties are at an impasse with respect to several disputes, including related
`to productions from otherlitigations, RFP Nos. 99-100, and RFP Nos. 113-114.
`
`With respect to most of Plaintiffs’ other RFPs, Moderna does not dispute their relevance,
`but rather is investigating how to collect and produce the documents (or, in a few cases, whether
`responsive documents exist). Plaintiffs served these RFPs approximately three months ago, and
`we are concemed that Modernastill apparently does not have a plan as to howit intends to collect
`
`and_roduce res_onsive documents manyofwhich—such asCOAsanddatarelatedtolipidmolar
`
`Please provide a response to this letter no later than
`September5 that sets forth Moderna’s plan for producing responsive documents anda timeline for
`that production.
`
`I.
`
`Productions from Other Litigations
`
`The parties discussed the production of documents from other litigations. We appreciate
`that Modermahas agreed to produce the documents Moderna producedor will produce in A/nylam
`Pharmaceuticals, Inc. v. Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc., No. 22-ev-335-
`CFC (D. Del.). We will likewise produce the documents Plaintiffs produced or will produce in
`Acuitas Therapeutics Inc. v. Genevant Sciences GmbHet al., No. 1-22-cv-02229 (S.D.N.Y.): Acuitas
`
`

`

`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 3 of 6 PageID #: 13439
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`
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`August 29, 2023
`Page 2 of 7
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`Therapeutics Inc. v. Genevant Sciences GmbH et al., No. 3-23-cv-04200 (D.N.J.); and Arbutus Pharma
`Corp. et al. v. Pfizer Inc. et al., No. 3-23-cv-01876 (D.N.J.).
`
`
`
`On the call, we repeated our request that Moderna produce documents that it has produced
`or will produce in ModernaTX, Inc. and Moderna US, Inc. v. Pfizer Inc., BioNTech SE, BioNTech
`Manufacturing GmbH, and BioNTech US Inc., No. 1:22-cv-11378-RGS (D. Mass.), which are
`relevant to, for example, damages to the extent that Moderna intends to assert in this case that the
`value of the Accused Products derives from the patented subject matter at issue in the Pfizer case.
`You did not deny that Moderna intends to make such arguments, and you did not dispute the
`relevance of these documents. You instead argued that producing these already-produced
`documents would be unduly burdensome, including due to the cost of FTPing the documents to
`counsel in this case. We disagree that any such burden justifies Moderna’s refusal to produce these
`plainly relevant documents. The parties are at an impasse on this issue.
`
`You also confirmed that you were still investigating whether or not you represented
`Moncef Slaoui and would notify us when that is resolved.
`II.
`
`Plaintiffs’ Second Requests for Productions
`
`The parties discussed Moderna’s responses to Plaintiffs’ Second Requests for Production,
`including Moderna’s correspondence on this issue from August 1, 2023.
`A.
`
`RFP Nos. 99-100
`
`We repeated our request that Moderna produce documents from Stéphane Bancel, which
`are plainly relevant in view of his role in Moderna’s product-development and patent-licensing
`decisions (including of the Patents-in-Suit), as well as his public statements about Arbutus’s
`technology. You did not dispute that Mr. Bancel possesses relevant documents that would be non-
`cumulative of the documents from the other custodians that Moderna has identified. However,
`you were unable to explain why Moderna selected those other individuals as custodians, rather
`than Mr. Bancel, and you were unable to represent that those other individuals were more involved
`in licensing decisions than Mr. Bancel. You refused to comment on whether or not Mr. Bancel
`was the ultimate decisionmaker with respect to Moderna’s licensing decisions, including of the
`Patents-in-Suit. Given that Moderna has refused to produce plainly relevant documents in Mr.
`Bancel’s possession, the parties are at an impasse.
`
`In order to arrive at a potential compromise on this issue, Plaintiffs would be willing to
`consider substituting Mr. Bancel for Al Thomas, whom Moderna has included as one of its
`document custodians but not in its Rule 26(a) initial disclosures. Please confirm that Moderna is
`amenable to this change. In the event that Moderna does not accept this compromise, Plaintiffs
`intend to seek relief from the Court.
`
`

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`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 4 of 6 PageID #: 13440
`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 4 of 6 PagelD #: 13440
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`WILLIAMS & CONNOLLYwe:
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`August 29, 2023
`Page 3 of 7
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`B.
`
`RFP Nos. 101, 102
`
`With respect to RFP No. 101, we are amenable to narrowingthis request to certificates of
`analysis for the PEG used to manufacture the Accused Products. We explained that the molecular
`weight of the PEG used in the Accused Products could potentially impact the lipid molarratio, and
`youdid not dispute the relevance of this information. You asked whetherPlaintiffs would be
`amenable to accepting summary information concerning the PEG certificates of analysis (for
`example, a chart containing certain of the information from the CoAs). We are
`potentiall
`
`amenable to such a compromise.
`
`With respect to RFP No. 102,
`
`
`
`. Youdid not dispute these relevance grounds, instead stating that you
`
`needed to take this issue back and considerit further. We have, however, repeatedly explained
`this
`infringement
`theory to Moderna,
`including in our
`infringement contentions and
`correspondence, see Ltr. from A. Sheh at 8 (July 5, 2012). Moderna’s delay in producing these
`concededly relevant documents is unjustified and prejudicial. Please promptly confirm that
`Modernawill produce the requested documents.
`
`Cc.
`
`RFP Nos. 103, 105, 107
`
`With respect to RFP No. 103 and 105, you asked if we werestill seeking batch records for
`the Accused Product ora. Wearestill evaluating this request and will revert as
`
`necessary.
`
`D.
`
`RFP Nos. 104, 106
`
`With res, ect to RFP Nos. 104 and 106were_eated our re uest for all certificates of
`anal_ sis for an_ batch or lot ofmRNA-1273 LNP used to manufacture the Accused Product, or for
`the Accused Productitself. As we have repeatedly explained, these documents are plainly relevant
`at least to infringement, and we remain surprised that Modernahasstill not produced them in this
`litigation. Youasserted that it was burdensome to produce these documents, but you could not
`articulate the nature of that burden, other than to state that it would be a manualprocessto collect
`these documents. You suggested that it might be possible to export the underlying data from the
`certificates of analysis, and youaskedusto identify the data in the CoAs that we wereinterested
`in receiving. Weare potentially amenable to such a compromise, but—as we explained on the
`call—weneedto see that exported data before we can agree to forgo production of the CoAs
`themselves. Moreover, we need to receive more details from Moderna about the how the data
`
`export would be conducted to ensure its reliabili
`
`

`

`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 5 of 6 PageID #: 13441
`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 5 of 6 PagelD #: 13441
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`WILLIAMS & CONNOLLYwe:
`
`August 29, 2023
`Page 4 of 7
`
`
`
`To be clear, our investigation is continuing, and we mayneed additional information as the
`case progress. If Modernaintendsto refuse to provide further information from its CoAsafter the
`parties reach an initial agreement on parameters—onrelevance, burden, or any other grounds—
`then Plaintiffs must insist on Moderna simply producing the CoAsin full.
`
`E.
`
`RFP No. 108
`
`WediscussedtwoaspectsofthisRFP. First,werepeatedourrequestthatModernaa
`
`and
`all testing of the lipid molar ratios for its Accused Product (including on both
`testing on the
`mRNA-1273 LNP).
`In other words, to the extent Moderna conducted additional
`lipid ratio/content of its LNPs—separate and apart from the CoA-related testing described in the
`previous section—Moderna must produce documents related to that testing. Youdid not dispute
`the relevance of such information, and our understanding is that Moderna will produce these
`documents.
`
`
`Second, we explained that we needed the raw data underlying Moderna’s testing of lipid
`molarratios. These data are important because
`
` Youdid not dispute the relevance of these raw data, and youstated that you were
`still investigating how to collect and produce them. We confirmed that we were potentially
`amenable to an export of these data (if, for example, the underlying files do not readily convert to
`comprehensible text). However, since Moderna has not produced any such data to-date, we are
`unable to specify the exact contours of the information that we need. To facilitate this discussion,
`please provide us with an example of the exported data that you would proposeto produce,as well
`as the corresponding underlying data file itself. To the extent these data are recorded in a lab
`notebook or similar, we maintain our request for these documents as well.
`
`F.
`
`RFP No. 109
`
`Wereiterated our request forall versions of the analytical methods that Moderna has used
`to test lipid molar ratios of the Accused Product. You did not dispute the relevance of these
`documents, and youstated that you were investigating howbest to collect these documents. You
`confirmed that you were not simply relying on search terms, but were instead reviewing centralized
`repositories to identify these protocols. Our understanding is that Moderna will be producing the
`full scope of documents responsive to this RFP.
`
`Our RFPidentifies several specific SOPs that we believe Moderna mayhaveusedto test
`lipid molar ratios. We made clear that these SOPs were exemplary and that—if Moderna has
`tested lipid molar ratio in some other manner—Moderna should produce documents related to
`those methods as well. You asked us to let Moderna know if we are aware of any other SOPs.
`
`

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`Case 1:22-cv-00252-MSG Document 195-7 Filed 01/16/24 Page 6 of 6 PageID #: 13442
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`August 29, 2023
`Page 7 of 7
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`taking discovery relevant to estoppel. We cannot—as you suggested on the call—hold this issue
`in abeyance until Moderna actually identifies such art, as fact discovery may be over by that point.
`We could only consider forgoing this discovery if Moderna will agree that it will not rely on art
`that it contends is exempt from estoppel and that it will stipulate that all art and grounds it raises
`in this case could have been found by a skilled searcher. Please let us know if Moderna is willing
`to so agree. Otherwise, please confirm that Moderna will produce the full scope of documents
`responsive to these RFPs.
`
`Please provide Moderna’s responses to the above issues no later than September 5.
`
`*
`
`*
`
`*
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`
`
`
`
`
`
`cc: Counsel of Record
`
`Sincerely,
`
`Shaun P. Mahaffy
`
`
`
`