Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 1 of 37 PageID #: 12643
`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 1 of 37 PagelD #: 12643
`
`EXHIBIT 11
`EXHIBIT 11
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`

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`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 2 of 37 PageID #: 12644
`
`Li, Yan-Xin
`Afinogenova, Alina; Sheh, Anthony; Haunschild, Philip; McLennan, Mark C.
`#KEModernaSpikevaxService; Horstman, N. Kaye; "Arbutus MoFo"; Parrado, Alvaro; Elenberg, Falicia; 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
`Thursday, December 7, 2023 9:51:49 PM
`
`From:
`To:
`Cc:
`
`Subject:
`Date:
`
`Tony and Philip:
`
`Further to your email of November 15 and the parties’ meet and confer on November 17, we understand that
`Plaintiffs are seeking production of Moderna’s contracts associated with batches manufactured outside the United
`States (“OUS”) and sold to customers OUS. Plaintiffs proposed that Moderna produce these documents first for
`Plaintiffs to assess whether additional information about the OUS batches should be produced (e.g., COAs).
`
`Plaintiffs appear to suggest that Moderna’s OUS batches are a “sale” within the ambit of 35 U.S.C. § 271(a). We
`disagree. As the Cal. Inst. of Tech. v. Broadcom Ltd. court noted, there is no dispute that § 271(a) “appl[ies] only
`domestically,” and the issue is whether “the relevant transactions [] were domestic or extraterritorial in nature.”
`Cal. Inst. of Tech. v. Broadcom Ltd., 25 F.4th 976, 992 (Fed. Cir. 2022). Yet as your November 15 email concedes,
`OUS batches are manufactured OUS and sold to customers OUS—i.e., extraterritorial in nature. See 11/15/2023 P.
`Haunschild Email (“certain batches were simply manufactured abroad”). Plaintiffs have not identified any relevance
`or basis for seeking discovery of extraterritorial sales or activities. And indeed, the Broadcom court further noted
`that “the key question” is “whether there were such substantial activities in the United States,” which there are not
`for Moderna’s OUS batches. See Broadcom, 25 F.4th at 993 (discussing Halo Elecs., Inc. v. Pulse Elecs., Inc., 831 F.3d
`1369 (Fed. Cir. 2016), including how pricing and contracting negotiations in the United States alone do not
`constitute or transform those extraterritorial activities into a sale under § 271(a) (emphasis added)). In addition, the
`Federal Circuit noted that the place of signing a contract is only one of many factors to consider in determining the
`location of a “sale” under § 271(a). See Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd., 807 F.3d 1283, 1309 (Fed.
`Cir. 2015). To hold otherwise would effectively extend the scope of § 271(a) to “confer a worldwide exclusive right
`to a U.S. patent holder, which is contrary to the statute and case law.” Halo, 831 F.3d at 1379.
`
`Batches that were manufactured OUS and sold to customers OUS are therefore beyond the scope of Plaintiffs’
`accusations of infringement. This is not because of “Moderna’s own self-serving analysis,” but rather precedential
`case law on this issue, including cases Plaintiffs identified. Moderna will not permit an unduly burdensome fishing
`expedition by Plaintiffs into its extraterritorial business.
`
`Best regards,
`Yan-Xin
`
`Yan-Xin Li
`------------------------------------------------------------
`KIRKLAND & ELLIS LLP
`555 California Street, San Francisco, CA 94104
`T +1 415 439 1618
`F +1 415 439 1500
`------------------------------------------------------------
`yanxin.li@kirkland.com
`
`From: Afinogenova, Alina <alina.afinogenova@kirkland.com>
`Sent: Tuesday, December 5, 2023 6:48 PM
`To: Sheh, Anthony <ASheh@wc.com>; Haunschild, Philip <phaunschild@wc.com>; McLennan, Mark
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 3 of 37 PageID #: 12645
`
`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
`---------------------------------------------------------
`KIRKLAND & ELLIS LLP
`200 Clarendon Street, Boston, MA 02116
`T +1 617 385 7526 M +1 917 324 5094
`F +1 212 446 4900
`---------------------------------------------------------
`alina.afinogenova@kirkland.com
`
`From: Sheh, Anthony <ASheh@wc.com>
`Sent: Wednesday, November 29, 2023 6:16 PM
`To: Afinogenova, Alina <alina.afinogenova@kirkland.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>;
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 4 of 37 PageID #: 12646
`
`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
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`Mark,
`
`Could you please let us know if Moderna has an update regarding our questions on sample shipping
`and storage? If there additional arrangements that need to be made, we’d like to start putting them
`in place. Thanks.
`
`Best,
`Tony
`
`Anthony Sheh | Associate | Williams & Connolly LLP | (202) 434-5436 | vcard
`
`From: Sheh, Anthony <ASheh@wc.com>
`Sent: Monday, November 20, 2023 6:06 PM
`To: Afinogenova, Alina <alina.afinogenova@kirkland.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
`
`Mark and Alina,
`
`Further to Moderna’s November 10 email and the meet-and-confer on November 17, Plaintiffs
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 5 of 37 PageID #: 12647
`
`understand that Moderna’s production of the ~480 batches/lots referenced below does not resolve
`the parties’ dispute as to the remaining batches, but we appreciate Moderna’s efforts to narrow the
`scope of the parties’ dispute. We understand that the ~480 batches Moderna is agreeing to produce
`are being transferred by a third-party to another location. We also understand that Moderna is not
`withholding samples as to post-complaint batches. We understand that Moderna is looking into
`whether there are post-complaint batches that are due to imminently expire and that the parties’
`should have ample time before expiry to address samples from Moderna’s ongoing booster
`production.
`
`Plaintiffs are willing to consider covering the cost for Moderna to ship the samples and/or for a
`courier. As discussed, please let us know an estimate of the shipping costs. Additionally, we’d
`appreciate information regarding storage conditions and the capacity needed to store the samples.
`Assuming that the conditions are as before
` Plaintiffs currently have
`90% capacity left in a 19.4 cubic feet (549 L) freezer with interior dimensions of 51.2 in x 23.1 in x
`28.3 (H x W x D, 130.1 cm x 58.8 cm x 97.37 cm) and will acquire additional space if needed. The
`shipping address would be:
`
`Triclinic Labs, Inc.
`Attn: Sample Submission
`2660 Schuyler Ave. Ste. A.
`Lafayette, IN 47905
`
`Plaintiffs understand that Moderna considers batches that were not manufactured or imported into
`the U.S. to be batches “not accused of infringement.” As outlined in previous correspondence,
`Plaintiffs disagree that such batches are not accused. See, e.g., E.g., D.I. 1 ¶¶ 50–54, 70, 89, 108,
`130, 154. Plaintiffs understand that Moderna is investigating the scope of documents it is willing to
`produce concerning these batches, including its agreements with the relevant third-parties for sales
`of such batches (besides the U.S. Government, and whether located in the United States or abroad,
`and whether to a public or private entity), its communications with such third-parties concerning
`sales or offers to sell batches of the Accused Product, documents evidencing the location and timing
`of any negotiations or meetings regarding such sales, and Moderna’s marketing and strategic plans
`regarding such sales. Such documents are responsive to at least Plaintiffs’ RFPs 51, 53, 60, 64, 69,
`74, 75, 81, and 83. Please confirm the scope of documents that Moderna will agree to produce by
`December 1, 2023.
`
`Best,
`Tony
`
`Anthony Sheh | Associate | Williams & Connolly LLP | (202) 434-5436 | vcard
`
`From: Afinogenova, Alina <alina.afinogenova@kirkland.com>
`Sent: Thursday, November 16, 2023 11:07 AM
`To: Haunschild, Philip <phaunschild@wc.com>; McLennan, Mark C.
`<mark.mclennan@kirkland.com>; Sheh, Anthony <ASheh@wc.com>
`Cc: #KEModernaSpikevaxService <KEModernaSpikevaxService@kirkland.com>; Li, Yan-Xin
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 6 of 37 PageID #: 12648
`
`<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
`
`Hi Philip,
`
`We are not available before 3pm ET today, but can be available tomorrow before 12pm ET or
`between 1 and 3pm ET.
`
`Thank you,
`Alina
`
`Alina Afinogenova
`---------------------------------------------------------
`KIRKLAND & ELLIS LLP
`200 Clarendon Street, Boston, MA 02116
`T +1 617 385 7526 M +1 917 324 5094
`F +1 212 446 4900
`---------------------------------------------------------
`alina.afinogenova@kirkland.com
`
`From: Haunschild, Philip <phaunschild@wc.com>
`Sent: Wednesday, November 15, 2023 11:20 AM
`To: McLennan, Mark C. <mark.mclennan@kirkland.com>; Sheh, Anthony <ASheh@wc.com>
`Cc: #KEModernaSpikevaxService <KEModernaSpikevaxService@kirkland.com>; Li, Yan-Xin
`<yanxin.li@kirkland.com>; Horstman, N. Kaye <kaye.horstman@kirkland.com>; Afinogenova, Alina
`<alina.afinogenova@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'
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 7 of 37 PageID #: 12649
`
`<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
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`Hi Mark,
`
`Thank you for your email. Please let us know when Moderna is available to meet-and-confer
`tomorrow before 3:00 PM (ET) regarding Moderna’s proposal as to the samples that Moderna has
`agreed to produce. We have a number of questions that we would like to address on the meet-and-
`confer, including at least the following:
`
`Does your email mean to draw a distinction between the “lots” that Moderna is agreeing to
`produce and the “batches” that the parties have previously been discussing? We understand
`these to be interchangeable terms, but please let us know if that is wrong.
`
`How did Moderna select the approximately 480 lots that it has agreed to produce samples
`from?
`
`Is Moderna refusing to produce samples from any unexpired lots?
`
`Will Moderna be producing samples from lots manufactured after February 28, 2022, the
`date of the filing of the complaint?
`
`For part numbers with unexpired lots, will Moderna be producing both expired and unexpired
`lots from the same part number?
`
`What is Moderna’s position as to representativeness and the ability to argue non-
`infringement of lots that Moderna is not agreeing to produce samples from?
`
`Has Moderna determined whether there are additional part numbers for Drug Product or
`mRNA-LNP beyond those that we have identified in our October 31, 2023 email?
`
`
`Further, regarding the batches that Moderna will be providing samples from, we have made clear in
`multiple meet-and-confers in March, April, and November, and in separate correspondence, e.g.,
`March 3, 2023 Letter from A. Sheh; May 11, 2023 Letter from L. Cash, that Moderna’s refusal to
`provide discovery on the basis that certain batches were simply manufactured abroad is improper.
`Moderna cannot shield batches from discovery based on Moderna’s own self-serving analysis of
`whether such batches infringe. See, e.g., California Inst. of Tech. v. Broadcom Ltd., 25 F.4th 976, 992
`(Fed. Cir. 2022); Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd., 807 F.3d 1283, 1308 (Fed. Cir.
`2015). Plaintiffs are entitled to take relevant discovery regarding all batches that have been accused
`of infringement. Please be prepared to discuss this on our meet-and-confer. Please also be
`prepared to explain how Moderna is determining what batches “can be accused of infringement.”
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 8 of 37 PageID #: 12650
`
`Thank you,
`
`Philip N. Haunschild
`Associate | Williams and Connolly LLP
`680 Maine Avenue SW, Washington, DC 20024
`202-434-5979 phaunschild@wc.com | www.wc.com
`
`From: McLennan, Mark C. <mark.mclennan@kirkland.com>
`Sent: Friday, November 10, 2023 3:00 PM
`To: Sheh, Anthony <ASheh@wc.com>
`Cc: #KEModernaSpikevaxService <KEModernaSpikevaxService@kirkland.com>; Li, Yan-Xin
`<yanxin.li@kirkland.com>; Horstman, N. Kaye <kaye.horstman@kirkland.com>; Afinogenova, Alina
`<alina.afinogenova@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
`
`CONTAINS INFORMATION MODERNA HAS DESIGNATED HIGHLY CONFIDENTIAL – OUTSIDE
`COUNSEL’S EYES ONLY
`
`Counsel,
`
`Regarding Plaintiffs’ questions from the meet-and-confer on the number of vials per lot Moderna is
`able to produce from regulatory retains, we confirm that Moderna maintains its agreement to
`produce 3 vials per lot. This is proportional to the needs of the case in light of the extensive data
`Moderna is agreeing to produce about each lot, in the absence of any explanation from Plaintiffs as
`to why more than 3 vials is needed, and due to Moderna’s need to retain samples for regulatory and
`compliance purposes, as laid out in detail in our October 20, 2023 letter.
`
`With regard to the number of accused lots that Moderna will produce samples from, in the spirit of
`compromise and in an effort to narrow the dispute, Moderna is preparing to produce samples of 3
`vials of expired drug product from approximately 480 lots. We will provide the lot numbers shortly,
`but can confirm they correspond to the part numbers below. Moderna will produce (if not already
`produced) specifications for these part numbers and CoAs for each lot later today or Monday (we
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 9 of 37 PageID #: 12651
`
`are still waiting for the final production volume). Moderna will continue to making rolling
`productions of additional CoAs and specifications for accused batches as we review them, but we
`wanted to prioritize these 480 lots first.
`
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`Moderna will make this production in the spirit of compromise and does so without waiving any
`objections to Plaintiffs’ RFPs for samples from the remaining accused batches (both the number of
`samples and quantity of lots). Moderna also makes this production without any representations that
`the expired drug product is representative of its characteristics at release. Moderna will agree to this
`production if Plaintiffs agree to pay for the shipping costs or arrange a courier to collect the vials in a
`single shipment – please confirm Plaintiffs’ position by COB November 15, including confirmation of
`a shipping address if Plaintiffs request that Moderna ship the samples.
`
`We are confirming the exact timing of the production but we understand it can be made in the next
`two weeks.
`
`Regarding your questions on the batches at issue in this case, we’re surprised by Plaintiffs’ recent
`change in position, attempting to dramatically expand the scope of discovery at this late stage.
`Moderna has been consistent and clear in its position that it would not provide discovery on batches
`not accused of infringement:
`Moderna’s February 2, 2023 Objections to 1st RFPs (including general objection: “Moderna
`objects to Plaintiffs’ requests to the extent they seek information, documents, and/or things
`relating to batches and doses of the Accused Products not accused of infringement, including
`batches of doses of the Accused Products not made, used, offered for sale, or sold within the
`United States or imported into the United States, which are not accused of infringement.
`Moderna will not produce irrelevant information, documents, and/or things concerning such
`batches and doses.”)
`Moderna’s April 17, 2023 Objections to Rog. 11 (“Moderna objects to this Interrogatory to the
`extent it seeks information related to the identity of manufactured lots and/or batches that
`were not made, used, offered for sale, or sold within the United States or imported into the
`United States.”)
`McLennan Sept. 19, 2023 Letter (“ Moderna offered to produce samples of drug product that
`were made with each part number of mRNA-LNP that was made, sold, or imported into the
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 10 of 37 PageID #: 12652
`
`U.S.”)
`McLennan July 21, 2023 Email (“Moderna confirms it has produced information in MRNA-
`GEN-00456085 and MRNA-GEN-00456086 showing batches of Moderna’s COVID-19 Vaccine
`manufactured in the U.S.”)
`
`
`Our objections to Interrogatory No. 11, and all correspondence concerning it since then have been
`crystal clear that Moderna is properly limiting discovery concerning batches to those that can be
`accused of infringement. Although you take statements from our August 1, 2023 letter out of
`context, in reality we repeated the same objection in that letter. McLennan August 1, 2023 Letter
`(“Moderna did not agree that Moderna is broadly required to “produce information regarding that
`foreign activity.” . . . If you have support indicating that batches made outside the U.S. and never
`imported into the U.S. can constitute infringement of a U.S. patent, we remain willing to consider
`it.”). Despite Moderna consistently placing Plaintiffs on notice of its position, Plaintiffs delayed
`raising this purported issue for months. Unfortunately this appears to be yet another attempt to
`delay resolution of the sample dispute and exponentially increase the burden of Moderna’s
`discovery.
`
`Regards,
`Mark
`
`Mark C. McLennan
`-----------------------------------------------------
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue, New York, NY 10022
`T +1 212 909 3451
`-----------------------------------------------------
`mark.mclennan@kirkland.com
`
`From: Sheh, Anthony <ASheh@wc.com>
`Sent: Tuesday, November 7, 2023 11:42 AM
`To: Afinogenova, Alina <alina.afinogenova@kirkland.com>; Parrado, Alvaro
`<alvaro.parrado@kirkland.com>; McLennan, Mark C. <mark.mclennan@kirkland.com>; Elenberg,
`Falicia <felenberg@wc.com>; Komis, Jihad <JKomis@wc.com>; Genevant Team
`<GenevantTeam@wc.com>; 'Arbutus_MoFo' <Arbutus_MoFo@mofo.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>
`Cc: #KEModernaSpikevaxService <KEModernaSpikevaxService@kirkland.com>; Li, Yan-Xin
`<yanxin.li@kirkland.com>; Horstman, N. Kaye <kaye.horstman@kirkland.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>
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 11 of 37 PageID #: 12653
`
`Subject: RE: Arbutus v. Moderna, 1-22-cv-00252 - Letter to Counsel (Batch Information)
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`Alina,
`
`Thanks for your email and for confirming that Moderna will be producing CoAs and specifications, as
`well as responding to Plaintiffs’ inquiry regarding the number of vials Moderna is willing to produce
`per batch, this week. The part numbers below were intended to assist Moderna, necessitated by
`Moderna’s incomplete responses to Plaintiffs’ Interrogatories Nos. 6 and 11, and based on Plaintiffs’
`efforts to analyze information that has been readily available in the first instance to Moderna, not
`Plaintiffs. We appreciate that Moderna will be producing CoAs and specifications this week, but
`both of these have been the subject of months-long requests. Plaintiffs have been prejudiced and
`continue to be prejudiced by Moderna’s delays.
`
`With respect your points below regarding batches purportedly “not accused of infringement,”
`Plaintiffs’ Complaint alleges that Moderna infringes the patent-in-suit by inter alia “manufacturing,
`offering to sell, selling, or using within the United States, the Accused Product.” E.g., D.I. 1 ¶¶ 70,
`89, 108, 130, 154. The Complaint further addresses “doses made in the United” but “administered
`abroad,” contracts Moderna has entered worldwide, and “emergency authorizations” for Moderna’s
`COVID-19 vaccine “from more than 70 countries, including Canada, Israel, the United Kingdom,
`Switzerland, Singapore, Qatar, Taiwan, and the Philippines, as well as from the European Union.”
`D.I. 1 ¶¶ 50–54. With respect to “foreign” batches, Moderna’s August 1, 2023 letter (at 7)
`acknowledges that Moderna’s response to Plaintiffs’ Interrogatory No. 11 “may provide all of the
`information Plaintiffs want and/or need,” but Moderna has not supplemented its response to
`Interrogatory No. 11. In any event, Moderna cannot unilaterally shield from discovery batches it
`contends were assertedly “not made, sold, used, or imported into the U.S.” See, e.g., Carnegie
`Mellon Univ. v. Marvell Tech. Grp., Ltd., 807 F.3d 1283, 1308 (Fed. Cir. 2015) (“Places of seeming
`relevance [to a sale] include a place of inking the legal commitment to buy and sell and a place of
`delivery . . . and perhaps also a place where other ‘substantial activities of the sales transactions’
`occurred.”). Plaintiffs are entitled to discovery into these issues and to test Moderna’s as-of-yet
`unsupported contentions. Moderna’s email suggests, contrary to its August 1, 2023 letter, that
`Moderna’s response to Interrogatory No. 11 in fact will not include information on batches Moderna
`contends to be “not accused of infringement” on the basis of such batches being “ex-US” or “OUS,”
`which is improper.
`
`Please therefore confirm (1) that the batches Moderna has “identified to date” extends to all of the
`batches Moderna has manufactured and/or sold, regardless of whether that activity occurred in the
`United States or purportedly not, (2) that Moderna’s responses to Plaintiffs’ Interrogatory Nos. 6 and
`11 will not exclude batches simply because Moderna deems them to be batches “not accused of
`infringement,” and (3) that Moderna’s listing or identification of part numbers for the purpose of
`sample production will include all batches. To the extent that Moderna has been excluding “ex-US”
`or “OUS” batches from discovery, please inform us of Moderna’s basis for doing so. Please provide
`Moderna’s confirmation by this Friday, November 10, 2023, so that Plaintiffs can promptly seek
`relief from the Court if necessary.
`
`Best,
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 12 of 37 PageID #: 12654
`
`Tony
`
`Anthony Sheh | Associate | Williams & Connolly LLP | (202) 434-5436 | vcard
`
`From: Afinogenova, Alina <alina.afinogenova@kirkland.com>
`Sent: Friday, November 3, 2023 5:35 PM
`To: Sheh, Anthony <ASheh@wc.com>; Parrado, Alvaro <alvaro.parrado@kirkland.com>; McLennan,
`Mark C. <mark.mclennan@kirkland.com>; Elenberg, Falicia <felenberg@wc.com>; Komis, Jihad
`<JKomis@wc.com>; Genevant Team <GenevantTeam@wc.com>; 'Arbutus_MoFo'
`<Arbutus MoFo@mofo.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>
`Cc: #KEModernaSpikevaxService <KEModernaSpikevaxService@kirkland.com>; Li, Yan-Xin
`<yanxin.li@kirkland.com>; Horstman, N. Kaye <kaye.horstman@kirkland.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)
`
`CONTAINS INFORMATION MODERNA HAS DESIGNATED HIGHLY CONFIDENTIAL – OUTSIDE
`COUNSEL’S EYES ONLY
`
`Tony,
`
`As we will explain in more detail when we respond to your letter on Plaintiffs’ 2nd set of RFPs, in the
`spirit of compromise, next week we expect to produce Moderna’s CoAs for accused batches of DP,
`mRNA-1273 LNP, and
` identified to-date. We trust this (in addition to the drug product
`genealogy spreadsheet) will resolve many, if not all, of your questions below. We expect to produce
`additional specifications next week too, and are still investigating whether a complete listing of part
`numbers exists.
`
`We note that from your email below, which lists many part numbers not referenced in earlier
`correspondence, Plaintiffs appear to now be seeking information concerning batches that were not
`made, sold, used, or imported into the U.S. and thus not accused of infringement. Moderna has
`been clear in its objections to the RFPs, and in correspondence concerning samples since then, that
`Moderna is not producing samples from batches that are not accused of infringement. We maintain
`that such batches bear no relevance to this litigation, and thus collection of samples and information
`from those batches is unduly burdensome and not proportionate to the needs of the case.
`
`We hope to get back to you next week on whether Moderna agrees to produce more than 3 vials
`per batch.
`
`

`

`Case 1:22-cv-00252-MSG Document 193-11 Filed 01/16/24 Page 13 of 37 PageID #: 1265