Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 1 of 95 PageID #: 19896
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`v.
`
`
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`
`)
`)
`)
`)
`)
`) C.A. No. 22-252-MSG
`)
`) HIGHLY CONFIDENTIAL –
`) OUTSIDE COUNSEL’S EYES ONLY -
`) FILED UNDER SEAL
`
`LETTER BRIEF TO THE HONORABLE MITCHELL S. GOLDBERG REGARDING
`PLAINTIFFS’ MOTION TO COMPEL
`
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`Emily S. DiBenedetto (No. 6779)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`edibenedetto@shawkeller.com
`Attorneys for Plaintiffs
`
`OF COUNSEL:
`David I. Berl
`Adam D. Harber
`Thomas S. Fletcher
`Jessica Palmer Ryen
`Shaun P. Mahaffy
`Jihad J. Komis
`Anthony H. Sheh
`Matthew W. Lachman
`Philip N. Haunschild
`Falicia Elenberg
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`(202) 434-5000
`Attorneys for Plaintiff Genevant
`Sciences GmbH
`
`

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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 2 of 95 PageID #: 19897
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`Daralyn J. Durie
`Adam R. Brausa
`Eric C. Wiener
`Annie A. Lee
`Shaelyn K. Dawson
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`(415) 268-6080
`
`Kira A. Davis
`MORRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`(213) 892-5200
`
`David N. Tan
`MORRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`(202) 887-1500
`Attorneys for Plaintiff Arbutus
`Biopharma Corporation
`
`Dated: April 23, 2024
`
`

`

`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 3 of 95 PageID #: 19898
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`Dear Judge Goldberg:
`
`Plaintiffs return to the Court to renew their motion for a targeted search of Moderna CEO
`Stéphane Bancel’s documents. D.I. 133. The Court previously denied Plaintiffs’ motion without
`prejudice to re-raise the request if Moderna’s subsequent document production indicated there
`was a need for information from Bancel that was not “redundant.” D.I. 142 at 6:23-8:5.
`Moderna’s production has confirmed that Bancel is a key source of significant relevant
`information that is not redundant of other discovery. Bancel was directly—and uniquely—
`involved in some of the most important areas of this case. Nevertheless, Moderna has refused to
`negotiate over any search of Bancel’s documents, despite Plaintiffs’ good-faith proposal of a
`narrow, targeted set of search terms for Bancel. Ex. A, April 8, 2024 Genevant Proposal.
`
`Plaintiffs are entitled to a reasonable search of Bancel’s documents. Courts routinely
`approve requests seeking documents from senior executives where those executives were
`directly involved in the disputed issues and are thus “likely to possess unique, relevant
`information.” E.g., In re Facebook, Inc. Consumer Priv. User Profile Litig., 2021 WL 10282213,
`at *2 (N.D. Cal. Nov. 14, 2021). Here, the evidence obtained in discovery shows that Bancel had
`unique involvement in a series of relevant issues, demonstrating that far from being redundant,
`Bancel is the only source for critical information. That distinguishes this case from the authority
`Moderna previously cited, D.I. 134, which provided only cases where the CEO was either
`uninvolved or had no unique involvement.
`
`Bancel was directly and uniquely involved in Government negotiations relevant to
`damages. Moderna’s document production has confirmed, consistent with public reports, that
`Bancel has unique, first-hand knowledge of Moderna’s negotiations with the U.S. Government.
`Bancel was in direct communication with several senior Government officials about the
`Government’s partnership with Moderna, including with respect to contractual and funding
`issues, throughout 2020.
`
`These direct communications began at the outset of the pandemic, when Bancel testified that he
`personally “immediately reached out to the U.S. Government” in December 2019 about the
`Wuhan outbreak. Ex. B, U.S. Senate Hr’g Tr. 21:22–22:4 (Mar. 22, 2023). From the limited
`discovery available to Plaintiffs, there are repeated references Bancel’s regular, one-on-one
`communication with Government officials throughout 2020. For example, in February 2020,
`Bancel forwarded an email from
`
`
` Ex. C. In May, Bancel asked
`
`
`
`
`
`
`colleagues for
` Ex. D. A June email produced by the Government includes an from an NIH official
`referencing
`
` Ex. E. In July, a Moderna email shows
`
`
`Ex. F. These documents provide insight into Bancel’s role in Government negotiations,
`but they do not disclose the content of his communications with the Government—that would
`require a search of Bancel’s documents.
`
`1
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`

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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 4 of 95 PageID #: 19899
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`Bancel testified under oath to his involvement in Government pricing negotiations, telling
`Congress “in the letter I wrote to the Government, when we started discussing about procuring
`the vaccine in September of 2020, we proposed a discount.” Ex. B, Tr. 54:5-8. Bancel also
`testified to discussing vaccine pricing with Moderna’s Board. Ex. B, Tr. 82:12–83:12 ([“W]e
`started to discuss with the Government toward the end of the summer 2020 about purchasing
`vaccine . . . . [and] we started to discuss with our Board. And it became very clear, like, a five-
`minute discussion at a Board meeting, that we had to find a way to give the money back to the
`U.S. Government.”).
`
`Moderna’s negotiations with the Government are important evidence concerning e.g., damages.1
`The Government’s willingness to pay Moderna enormous sums, along with pressure from the
`Government to produce the vaccine quickly, would have been significant considerations in the
`hypothetical negotiation. And Bancel was directly involved in at least these issues: the price the
`Government would pay, Ex. B, Tr. 54:5-8, and “timelines” for manufacturing the vaccine, Ex. C.
`
`Although Moderna has produced thousands of documents about its interactions with the U.S.
`Government in 2020 through lower-level custodians, there are strikingly few documents
`addressing these key aspects of the negotiations. Indeed, Moderna has not even produced the
`letter Bancel told Congress about. Given his direct communications with the Government,
`Bancel’s documents are essential to understanding the full picture of Moderna’s negotiations.
`
`Bancel was directly and uniquely involved in Moderna’s effort to license the patented
`technology. Genevant’s own documents show that Bancel led Moderna’s repeated efforts to
`license Plaintiffs’ technology. As early as October 2013, Bancel discussed the possibility of a
`collaboration with Ian MacLachlan, Arbutus-predecessor Tekmira’s Chief Scientific Officer. Ex.
`G at 7. Bancel then engaged in a series of one-on-one communications with Mark Murray (CEO
`of Tekmira) as early as 2014, in which he shared proposals and discussed the structure of a
`potential deal. E.g., Exs. H–J.
`
`The direct involvement of Moderna’s CEO in its attempt to procure the very intellectual property
`at issue in this suit goes directly to Moderna’s willfulness. It shows that at the highest level,
`Moderna was familiar with Plaintiffs’ intellectual property, ultimately chose not to license it, and
`instead simply took it. Moderna’s failure to produce many of its communications with Plaintiffs
`about a license to the patented technology is remarkable. While Plaintiffs obviously have copies
`of their actual communications with Bancel, his corresponding internal communications—which
`would reveal Moderna’s thinking about Plaintiffs, their technology, and its value—are missing.
`
`Bancel was directly and uniquely involved in Moderna’s negotiations with other licensing
`counter-parties. Moderna’s communications with counter-parties to its executed license
`agreements are relevant to damages, including the comparability of Moderna’s other patent
`licenses to the license that would result from a hypothetical negotiation. Some of these
`negotiations also go to Moderna’s willfulness, such as its negotiations with Acuitas, which tried
`to sublicense Plaintiffs’ technology to Moderna. Despite the importance of these
`communications, Plaintiffs have failed to produce many of the communications that led up to
`
`1 Moderna also directly put its relationship with the Government at issue with its § 1498 defense.
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 5 of 95 PageID #: 19900
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`these licenses. Bancel’s direct involvement in these licensing negotiations makes it clear that a
`search of his emails is necessary.
`
`For example, one of the few documents Moderna has produced from the Acuitas negotiations
`shows that Bancel was personally involved—a February 2014 meeting agenda disclosing a one-
`on-one meeting with Acuitas CEO (and former Tekmira employee) Tom Madden and Bancel’s
`participation in a lengthy meeting about Acuitas’s capabilities. Whether or not Bancel was
`involved in every meeting with Acuitas, the agenda shows unique engagement without any other
`Moderna employees.
`
`Without a search of Bancel’s emails, it is impossible to identify all of the license negotiations in
`which he personally participated. But Plaintiffs have reason to believe Bancel personally
`engaged in discussions with licensing partners. E.g., Ex. K (reflecting Bancel’s one-on-one
`meeting with potential licensor’s CEO and a subsequent follow up meeting).2 And Bancel
`personally signed many of the license agreements Moderna contends are relevant. See, e.g., Exs.
`L–Q (agreements with Acuitas, Alexion, AstraZeneca, Chiesi, Merck, and Vertex).
`
`The Court should order a targeted search of Bancel’s documents. The evidence of Bancel’s
`involvement in these key areas means a targeted search of his documents is more than
`proportional. Indeed, Moderna has never provided any specificity around its generalized burden
`claims, or any search term hit report. The volume of other discovery Moderna produced in the
`case does not excuse address the need for the requested documents. Even after that Moderna’s
`production, critical gaps remain in areas of Bancel’s unique purview. Moderna also has relied on
`the Delaware Standard’s presumptive default of 10 custodians, but that limit is not absolute. Ex.
`R, Oral Order D.I. 247, United States v. Gilead Sciences, Inc., No. 19-CV-2103 (D. Del.
`December 21, 2021) (granting limited search of 11th custodian); Frontier Commc’ns Corp. v.
`Google Inc., 2014 WL 12606321, at *3-4 (D. Del. Feb. 3, 2014). Based on principles of
`proportionality, there is no reason that default should apply in a multi-billion-dollar patent
`litigation involving Moderna’s sole product the same way it applies in a $75,000 contract
`dispute. Plaintiffs have proposed targeted search terms that would impose little burden
`(particularly if Moderna’s contentions about Bancel’s involvement are true). See Ex. A.
`
`Nor can Moderna rely on Bancel’s position as CEO to avoid document discovery. The apex
`doctrine affecting depositions “is not a protective shield that prohibits document discovery from
`high-ranking officials.” L.A. All. v. City of Los Angeles, 2023 WL 5505037, at *5–6 (C.D. Cal.
`Aug. 2, 2023) (collecting cases). An additional document production does not impose a
`significant burden, nor is that burden heightened because the custodian is a CEO. Dyson, Inc. v.
`Sharkninja Operating LLC, 2016 WL 1613489, at *2 (N.D. Ill. Apr. 22, 2016). Indeed, Plaintiffs
`have produced documents from three of current or former CEOs of Plaintiffs or their related
`entities, and Moderna will be deposing all three. Plaintiffs respectfully ask the Court to order
`Moderna to conduct these targeted searches and produce Bancel’s documents within three weeks
`of the order.
`
`2 This communication involves a potential license, but evidences Bancel’s involvement in
`executed licenses as well. Plaintiffs proposed search terms only for executed licenses.
`
`3
`
`

`

`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 6 of 95 PageID #: 19901
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`Respectfully submitted,
`/s/ Nathan R. Hoeschen
`Nathan R. Hoeschen (No. 6232)
`
`cc:
`
`Clerk of the Court (by CM/ECF)
`All counsel of record (by CM/ECF & Email)
`
`4
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`

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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 7 of 95 PageID #: 19902
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`Exhibit A
`
`

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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 8 of 95 PageID #: 19903
`
`Lachman, Matthew
`From:
`Lachman, Matthew
`Sent:
`Monday, April 08, 2024 8:33 PM
`To:
`Horstman, N. Kaye; Li, Yan-Xin; 'Arbutus_MoFo'; Genevant Team; Nate R. Hoeschen
`(nhoeschen@shawkeller.com); Karen E. Keller (kkeller@shawkeller.com)
`#KEModernaSpikevaxService; Travis J. Murray (tmurray@morrisnichols.com); Jack Blumenfeld
`(jblumenfeld@morrisnichols.com); Egan, Brian P.
`RE: Genevant v. Moderna - Bancel Documents
`
`Subject:
`
`Cc:
`
`Mark, 
` 
` 
`Moderna’s response failed to address many of the issues Plaintiffs have raised, including with respect to Mr. Bancel’s 
`sworn testimony concerning his involvement in government negotiations and the decision to offer a discount, as well as 
`the lack of documents relating to key licensing discussions he was involved in, including with Acuitas and some of the 
`negotiations with Plaintiffs or their predecessors.  Where Moderna did respond, it could only point to some degree of 
`involvement by other Moderna employees, without addressing the unique role Mr. Bancel had in these areas. 
` 
` 
`Since my prior letter, 
`
` 
`
` 
`
` 
`
` 
`
` 
`
` 
`
`  
`
` 
` 
`While we disagree with your portrayal of the facts concerning Mr. Bancel’s involvement, we do appreciate your offer to 
`consider search terms for Mr. Bancel’s documents.  Plaintiffs are willing to negotiate in good faith over search terms in 
`order to avoid burdening the Court with this dispute, provided that Moderna will provide us with its positions promptly 
`given the upcoming case deadlines.  Our proposed search terms are below.  Plaintiffs would also agree that Moderna 
`can exclude correspondence on which one of Moderna’s other ESI custodians is in the to/from/cc fields.  If Moderna is 
`correct about the limits of Mr. Bancel’s unique involvement, there should be very little burden to these searches. 
` 
` 
`Please let us know by Wednesday, April 10, 2024, if these search terms are acceptable to Moderna: 
`  
`
`
`
`((Government OR USG OR DOD OR HHS OR BARDA OR 0100 OR 0017 OR appropriation OR congress OR Perna 
`OR Disbrow OR “Robert Johnson” OR “moncef.slaoui@hhs.gov” OR “gustave.f.perna@hhs.gov” OR 
`“gary.disbrow@hhs.gov” OR “robert.johnson@hhs.gov”) W/30 (discount OR contract OR negotiate* OR 
`proposal)) AND (mRNA‐1273 OR COV* OR NCOV* OR Corona*) 
`(Pric* OR Cost* OR Negotiat* OR Sale*) W/30 (mRNA‐1273 OR COV* OR NCOV* OR Corona*) 
`(mRNA‐1273 OR COV* OR NCOV* OR Corona*) AND ((collaborat* OR partner) W/30 (scale OR manufact* OR 
`distrib*)) [Date limited from February 15, 2020, to May 31, 2020] 
`(Acuitas OR AstraZeneca OR Axolabs OR Merck OR Alexion OR Vertex OR Chiesi OR CytomX OR Cellscript OR 
`NIAID OR “Allergy and Infectious Diseases” OR LifeEdit) W/30 (LNP OR license OR agreement OR patent* OR IP 
`OR “intellectual property” OR encapsulat* OR ratio OR ratios) 
`(Inex OR Protiva OR Tekmira OR Arbutus OR Genevant OR Roivant OR “Mark Murray” OR “Bruce Cousins” OR 
`“Paul Brennan” OR Zorn OR “MMurray@tekmirapharm.com” OR “BCousins@tekmirapharm.com” OR 
`“PBrennan@tekmirapharm.com”) W/30 (LNP OR license OR agreement OR patent* OR IP OR “intellectual 
`property” OR encapsulat* OR ratio OR ratios) 
` Agreed‐upon patent terms (I‐28 to I‐32) that are identified in D.I. 206 Ex. CC 
`
`
`
`
`
`
`
`
`1
`
`

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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 9 of 95 PageID #: 19904
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`Exhibit B
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`

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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 10 of 95 PageID #: 19905
`Transcript of Hearing
`Conducted on March 22, 2023
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` SENATE COMMITTEE ON HEALTH, EDUCATION, LABOR,
`
` AND PENSIONS
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`SPEAKERS:
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`STEPHANE BANCEL, CEO, Moderna
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`CHRISTOPHER MORTEN, JD, PhD
`
`AMEET SARPATWARI, PhD, JD
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`CRAIG GARTHWAITE, PhD
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` THE CHAIR: The Senate Committee on
`Health, Education, Labor, and Pensions will come
`to order.
` Let me begin by thanking Mr. Bancel,
`the CEO of Moderna, for being with us today and
`all other panelists who will be joining us.
` Mr. Bancel very early on agreed to be
`here voluntarily, and I appreciate that very
`much.
` I also want to take this opportunity,
`0
`so there is no confusion, to congratulate
`11
`Moderna, Pfizer, other companies, and the great
`12
`scientists at the National Institute of Health
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`and other Federal agencies for their
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`extraordinary work in rapidly producing COVID
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`vaccines that have saved millions of lives. We
`16
`should be grateful to all those in Government
`17
`and in the private sector who worked so hard to
`18
`save lives.
`19
` This hearing, to my mind, is about
`20
`several enormously important and interrelated
`21
`issues that are on the minds of the American
`22
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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` HEARING O THE
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` SENATE COMMITTEE ON HEALTH, EDUCATION,
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` LABOR, AND PENSIONS
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` UNITED STATES SENATE
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` STEPHANE BANCEL, MODERNA CEO
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` Testifies on COVID
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`9 Vaccine Price Increase
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`Job No.: 5
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`Pages: 8
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`Transcribed by: Esther M. Taylor
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` SENATE COMMITTEE ON HEALTH, EDUCATION, LABOR,
`
` AND PENSIONS
`
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`BERNIE SANDERS, Vermont, Chair
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`BILL CASSIDY, M.D., Louisiana, Ranking
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`RAND PAUL, M.D., Kentucky
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`ROBERT P. CASEY, JR., Pennsylvania
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`MITT ROMNEY, Utah
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`PATTY MURRAY, President Pro Tempore, Washington
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`TOMMY TUBERVILLE, Alabama
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`TINA SMITH, Minnesota
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`MIKE BRAUN, Indiana
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`JOHN HICKENLOOPER, Colorado
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`ROGER MARSHALL, M.D., Kansas
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`TAMMY BALDWIN, Wisconsin
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`MARKWAYNE MULLIN, Oklahoma
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`MAGGIE HASSAN, New Hampshire
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`EDWARD MARKEY, Massachusetts
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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 11 of 95 PageID #: 19906
`Transcript of Hearing
`Conducted on March 22, 2023
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`coming back at you.
` That would mean a future company
`would not work closely with the Government.
`They would run away from that quick response.
` Now, there are legitimate policy
`questions to ask how Moderna will price their
`vaccine post commercialization. We re
`interested in that. We ve never been in this
`situation before where a company has taken the
`reins back from the Federal Government after the
`Federal Government controlled distribution of
`the product.
` But this is not the time to discuss
`eliminating intellectual property rights by
`destroying business models of those whom our
`country will need to respond to the next
`pandemic and to develop the next life-changing
`cure.
` And we can t live in a fantasy world
`and pretend that what we do in this Committee
`will not affect those future decisions. I want
`people to know that this Committee is doing
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`condition.
` Now, it s easy to put the COVID
`vaccine as one of these success stories. But it
`happened over 10 months. At first, we had no
`way to prevent. Ten months later, there it was.
` It seems like we, in this Committee,
`need to keep the bigger picture in mind. We ve
`got an ecosystem of innovation that is leading
`to lives being saved. There are people in this
`room who would not be alive today were it not
`for capitalism interfacing with the
`pharmaceutical and medical device industry that
`allows you to be alive today. In a crowd this
`size, that is absolutely the case.
` Now, we can disturb that ecosystem
`and assume there is no harm. But there are
`literally lives, future lives, at stake. And so
`for decades this Committee has passed
`legislation knowing that at one point, we would
`have to ask companies to step up and do
`something quickly and put everything aside.
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`whatever it can to encourage cures for cancer,
` Moderna was one of those companies.
`Alzheimer s, ALS, and other devastating disease.
`We authorized grant funding. We set the
`And if they do, and if a private company does
`groundwork for public-private partnerships. We
`it, they shall be rewarded. Lives depend upon
`set up new institutions all with the purpose
`it.
`that if something like a pandemic happened,
` Senator Sanders, we have pledged to
`something will be quickly developed.
`work together. But I will say that if the
` Well, when we did it in 2020, Moderna
`purpose of the hearing is to demonize
`responded -- to their credit. I m not defending
`capitalism, we should not hate the thought of a
`any salaries. I m not defending any profit.
`person or a company making a profit, that we
`What I am defending and pointing out is the
`0
`lose sight of the ideas and accomplishments if
`great benefit our country and the world received
`11
`their profit is rewarding.
`from this technology that was translated out of
`12
` We can t be a country that encourages
`a lab into clinical practice.
`13
`citizens and companies to succeed and step up
` Now, others did not make the same
`14
`and make a difference and then shames them when
`choice as Moderna. And I will say it is
`15
`they do. If we want to consider real policies
`important that through this hearing and
`16
`that work to lower the cost Americans pay for
`otherwise, that we do not send a hostile signal
`17
`medicines, let s work together.
`to future prospective partners that if you do
`18
` Thanks, and I look forward to hearing
`something and you do it well and you profit,
`19
`from our witness.
`after it happens, we may come right back at you.
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` THE CHAIR: Thank you, very much,
`You saved a million lives but, hey, buddy, we
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`Senator Cassidy.
`don t like your management decisions. We re
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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 12 of 95 PageID #: 19907
`Transcript of Hearing
`Conducted on March 22, 2023
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`Government for their supports.
` We built or mRNA platform before the
`pandemic with $3.8 billion of private
`investment. In mid-2020, we raised an
`additional $1.3 billion from shareholders for
`manufacturing scale-up for the pandemic.
` In November, I received long-awaited
`news. The result of our Phase 3 study showed
`that our vaccine was 94 percent effective at
`preventing COVID. I literally cried tears of
`joy and relief.
` We had accomplished in 10 months what
`would normally take 10 years. After a decade of
`building or mRNA platform, we have changed the
`future of medicine.
` The vaccine brought relief in the
`hospital system, put children and teachers back
`in classrooms, reopened our economy, and made it
`safe to reconnect in person.
` We were under no obligation to do so,
`but recognizing the U.S. Government s
`investment, our company decided to provide the
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` We will now turn to our witness.
`Mr. Stephan Bancel is the Chief Executive
`Officer of Moderna.
` Mr. Bancel, thank you very much for
`being with us. You may proceed with your
`testimony.
` MR. BANCEL: Chairman Sanders,
`Ranking Member Cassidy, distinguished Members of
`the Committee, good morning.
` My name is Stephane Bancel, and I am
`the CEO of Moderna. While I speak with an
`accent, I lead a company that is an American
`success story.
` After losing money for 10 years,
`Moderna created a vaccine that helped end the
`pandemic. We were able to move quickly because
`of a decade of private investment in our mRNA
`platform and because of a decision in 2016 to
`build a manufacturing plant in Massachusetts.
`We made these investments before most people had
`heard of mRNA.
` Over Christmas break 2019, I read
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`about an outbreak of pneumonia-like illness in
`Wuhan, China. I immediately reached out to the
`U.S. Government because I believed our mRNA
`technology could make a difference.
` Two days after Chinese scientists put
`the genetic sequence online, our team created
`mRNA 1273 of COVID vaccine.
` As the world shut down in March, we
`moved faster. Every day brought new pressure as
`case counts and deaths rose in the country and
`around the world.
` I am so grateful for our teams who
`worked relentlessly including Saturdays and
`Sundays, locked down from home and from our lab
`in our factory.
` In the spring of 2020, we worked
`through Operation Warp Speed to develop a
`vaccine faster than we could have done alone.
`The U.S. Government gave us, and four other
`vaccine companies, funding to accelerate
`clinical trials.
` We thank our partners in the Federal
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`Government a discount versus the other mRNA
`vaccine.
` While the Government provided
`$1.7 billion in grant funding, Moderna returned
`$2.9 billion.
` The U.S. vaccination program is
`responsible for an estimated $5 trillion of
`economic value, prevention of 18 million
`hospitalization in this country, and 3 million
`American lives saved.
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` Innovations like our vaccine can only
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`happen in America.
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` The public-private partnership of
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`Operation Warp Speed enabled a world-leading
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`response to a crippling pandemic.
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` We, at Moderna, along with the people
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`of this country and the people of the world, owe
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`the U.S. Government a debt of gratitude.
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` Let me now address the transition
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`from pandemic to endemic.
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` First, we are committed to ensuring
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`anyone who wants a vaccine can get one without
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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 13 of 95 PageID #: 19908
`Transcript of Hearing
`Conducted on March 22, 2023
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`the National Institute of Health, the NIH, once,
`nor the research that they did.
` As I mentioned earlier, according to
`a letter I recently received from the NIH,
`distributed to our members, what the NIH says is
`the three scientists at the NIH, quote, are
`coinventors and were integral members of a
`collaborative team of scientists working to
`design and produce it.
` That s the scientists at the NIH, not
`to mention the many billions of dollars the
`Federal Government that came to Moderna in order
`to produce the vaccine and do the clinical
`trials.
` How come in -- in your judgment, what
`role did the NIH play in coauthoring and
`developing this vaccine?
` MR. BANCEL: Thank you, Mr. Chairman.
`Let me start by saying that we have a lot of
`respect -- great respect for the NIH team, and
`we believe what the NIH does for this country
`and for the world is really important to advance
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`price being a barrier.
` Until now, the U.S. Government has
`purchased and distributed the vaccine. Now,
`Moderna, a small company, must ensure that
`anyone who wants a vaccine can get one at a
`location convenient to them.
` With this role comes increased
`complexity and increased risk. In the pandemic
`market, we had one customer: The U.S.
`Government. In the endemic market, we re going
`to have 10,000 customers.
` In the pandemic market, the U.S.
`Government took the risk for wasted doses. In
`the endemic market, Moderna will take that risk
`and that cost.
` In the pandemic market, we only had
`to deliver to three CDC warehouses. In the
`endemic market, we re going to have to manage
`logistics to deliver to 60,000 pharmacies,
`doctors office, and hospital.
` In the pandemic market, we had one
`vial with 10 dose in there. In the endemic
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`market, where the market requires a single-dose
`vial or even better, pre-filled syringe.
` On top of all this, we are expecting
`a 90 percent, nine-zero, reduction in demand.
`As you can see, we are losing economies of
`scale, we must deal with supply-chain
`complexity, and we must assume the wasted risk
`and costs that the U.S. Government used to
`assume.
` So what s next for Moderna? This
`year, we are investing $4.5 billion in R&D. We
`are working hard on developing medicines to
`treat cancer, cystic fibrosis, multiple
`sclerosis, and very other important diseases.
` Thank you for the opportunity to
`share our story and our perspective.
` THE CHAIR: Mr. Bancel, thank you
`very much for your testimony.
` You sent us a -- I think it s a nine-
`page, single-spaced document, longer than your
`testimony. We appreciate that. But in these
`nine pages, as I read it, you did not mention
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`science that industry might not fund.
` What happened when the sequence came
`online is our team at Moderna were working on
`the technology. The way one needs to think
`about Moderna is like an operating system. What
`we spent 10 years doing is developing all the
`tools to make products.
` THE CHAIR: I don t mean to be rude,
`but isn t it absolutely true that the NIH was
`also doing that and had done research for many
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` MR. BANCEL: So what is correct,
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`Mr. Chairman, is that the NIH has worked on the
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`virus and on the protein. So what our team did
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`is develop the mRNA molecule. What the NIH did,
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`which was a great confirmation, is they designed
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`the same protein that our team did in -- in
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`parallel. But the design of the mRNA vaccine
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`was done by our team. This is our technology.
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` THE CHAIR: The NIH considers
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`themselves to be coauthors of the vaccine. Do
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`you disagree?
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`Case 1:22-cv-00252-MSG Document 325-5 Filed 05/20/24 Page 14 of 95 PageID #: 19909
`Transcript of Hearing
`Conducted on March 22, 2023
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`salary of billions of dollars?
` MR. BANCEL: No, Senator.
` SEN. ROMNEY: You re a billionaire
`because the stock that you got when you started
`the company, you kept some of it, I presume.
` MR. BANCEL: Mm-hmm.
` SEN. ROMNEY: That stock is now worth
`a lot of money because your technology has been
`proven to actually work.
` Is it going to work beyond vaccines?
`And what kinds of things are you working on?
` MR. BANCEL: So thank you, Senator.
` So we are very excited because this
`is a platform that we worked on for 10 years.
`We shared, just before Christmas, exciting data
`in cancer, which we are very excited because, of
`course, all of us have been touched or are being
`touched right now by cancer. And we show
`44 percent reduction in recurrence of disease
`for melanoma cancer or deaths.
` We are working very quickly to get
`this to the FDA, in a Phase 3 study this year.
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`doesn t, I lose it all.
` There are, right now, in our country,
`hundreds of startup businesses trying to develop
`drugs that will cure diseases.
` I happen to know that because I
`invested in some in my prior life. I lost my
`money in every single one. Studied them as well
`as we could. We lost our money. That s the
`nature. But we thought, if it works, we re
`going to really get a huge return for ourselves
`and for our investors.
` So, you know, I don t know how much
`money is the right amount of money, but the idea
`that somehow corporate greed has just been
`invented in America is absurd. It s been there
`from the beginning of free enterprise.
`Individuals investing, hoping that if it
`succeeds, they ll do very well financially,
`extraordinarily well. So I want to applaud the
`example we have.
` By the way, the socialist countries,
`China and Russia and Northern Europe, did they
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`We are also working with our partners at Merck
`come up with a vaccine that saved lives?