Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 1 of 9 PageID #: 13641
`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 1 of 9 PagelD #: 13641
`
`EXHIBIT 19
`EXHIBIT 19
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`

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`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 2 of 9 PageID #: 13642
`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 2 of 9 PagelD #: 13642
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`
`
`From:
`Sent:
`To:
`Ce:
`
`Subject:
`
`Sheh, Anthony <ASheh@wc.com>
`Monday, November20, 2023 6:06 PM
`Afinogenova, Alina; Haunschild, Philip; McLennan, Mark C.
`#KEModernaSpikevaxService; Li, Yan-Xin; 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, JamesF.; Carson, Patricia A.;
`Wacker, Jeanna
`RE: Arbutus v. Moderna, 1-22-cv-00252 - Letter to Counsel (Batch Information) - HIGHLY
`CONFIDENTIAL OCEO
`
`
`
`This messageis from an EXTERNAL SENDER
`
`Be cautious,particularly with links and attachments.
`
`Mark and Alina,
`
`Further to Moderna’s November10 email and the meet-and-confer on November17,Plaintiffs understand that
`Moderna’s production of the “480 batches/lots referenced below doesnotresolve the parties’ dispute as to the
`remaining batches, but we appreciate Moderna’s efforts to narrow the scope ofthe parties’ dispute.
`
`=
`
`also understand that Moderna is not withholding samples as to post-complaint batches. We understand that Moderna
`is looking into whetherthere 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 anestimateof 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 (e.g., minus 80
`degreeCelsius), 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 ofinfringement.” As outlined in previous correspondence, Plaintiffs disagree that such batches
`are not accused. See, e.g., E.g., D.l. 1 9] 50-54, 70, 89, 108, 130, 154. Plaintiffs understand that Moderna is
`investigating the scope of documentsit 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 whetherlocated in the United States
`or abroad, and whetherto a public or private entity), its communications with such third-parties concerning sales or
`
`1
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`

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`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 3 of 9 PageID #: 13643
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`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 <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
`2
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`

`

`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 4 of 9 PageID #: 13644
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`<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 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.”
`
`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
`
`
`3
`
`

`

`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 5 of 9 PageID #: 13645
`
`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 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
`
`4
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`

`

`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 6 of 9 PageID #: 13646
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`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 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>
`
`5
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`

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`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 7 of 9 PageID #: 13647
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`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)
`
` 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,
`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>;
`6
`
`

`

`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 8 of 9 PageID #: 13648
`
`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.
`
`Have a nice weekend,
`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: Tuesday, October 31, 2023 2:53 PM
`To: Parrado, Alvaro <alvaro.parrado@kirkland.com>; Afinogenova, Alina <alina.afinogenova@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>
`
`7
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`

`

`Case 1:22-cv-00252-MSG Document 195-23 Filed 01/16/24 Page 9 of 9 PageID #: 13649
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`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
`
`Mark,
`
`Plaintiffs understood from our meet-and-confer on October 23, 2023, that Moderna would be getting back to us last
`week regarding whether it would be willing to produce more than three vials from a batch. Could you please let us
`know by COB tomorrow the results of Moderna’s investigation?
`
`Likewise, Plaintiffs have been working to narrow the parties’ dispute regarding samples with respect to the number of
`vials. For Moderna’s convenience, we have been able to identify the following drug product part numbers based on
`information Moderna has produced to date:
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`
`
` Could you please confirm whether there are any other drug
`product part numbers that are at issue, including for ex-US batches? We have excluded “unlabeled” drug product part
`numbers from this set, but if those are relevant, please let us know. For the part numbers that are not in bold, we have
`been unable to identify a specification sheet in MRNA-GEN-VOL013 to ascertain the lipid content per vial. Could you
`please confirm that Moderna will produce these specification sheets this week?
`
`We’d also like to make sure that the parties share an understanding of the mRNA LNP part numbers that are at issue
`with respect to Moderna’s proposal. As set forth in Plaintiffs’ September 6, 2023 letter, we are aware of the following
`part numbers:
`
` Please confirm whether there are any other mRNA LNP part numbers at issue. We understand from Moderna’s
`August 24, 2023 letter that it has been working to collect and produce specifications for each part number relevant to
`batches of the Accused Product.
`
`We are happy to discuss any of the foregoing by phone if helpful. Thanks.
`
`Best,
`Tony
`
`Anthony Sheh | Associate | Williams & Connolly LLP | (202) 434-5436 | vcard
`
`From: Parrado, Alvaro <alvaro.parrado@kirkland.com>
`Sent: Friday, October 20, 2023 6:28 PM
`To: Sheh, Anthony <ASheh@wc.com>; Afinogenova, Alina <alina.afinogenova@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.
`8
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