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`Case 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 1 of 34 PageID #: 1103
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)Case No.: 22-ev-00252-MSG
`ARBUTUS BIOPHARMA
`1]
`CORPORATION AND GENEVANT_)
`SCIENCES GMBH,
`)
`Plaintiffs,)
`)
`)
`)
`)
`)
`Defendants.)
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`V.
`
`PROPOSED CLASS ACTION
`COMPLAINT FOR
`DECLARATORYRELIEF
`
`MODERNA,INC. and MODERNATX,
`INC.
`
`18
`
`19
`| 20
`
`21
`
`22
`
`23
`
`)
`EMANUEL MCCRAY,On Behalfof
`Himselfand All Others Similarly Situated, )
`)
`Intervenors-Plaintiffs.)
`)
`a)
`
`I.
`
`INTRODUCTION
`
`24
`1.=‘The Plaintiffs’ Complaint was filed on February 28, 2022 (Doc. 1). On
`25
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`November2, 2022, (Doc. 32), Judge Goldberg denied Moderna’s motion to dismiss
`
`26
`
`27
`
`28
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`

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`and directed that: “Within fourteen (14) days from the date of this Order,
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`Defendants shall file an answer to the Complaint.”
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`2.
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`On November 30, 2022, Modernafiled an Answerto Plaintiffs’ Complaint,
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`which was accompaniedby a counterclaim against the Plaintiffs (Doc. 35).
`
`3.
`
`On December21, 2022, Plaintiffs filed an Answer to Defendants’
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`counterclaim (DOC. 38). On February 14, 2023, the United States filed a Statement
`
`of Interest (Doc. 49). On February 16, 2023, Judge Goldberg filed an Order
`
`directing that: “Within fourteen (14) days from the date of this Order, the parties
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`and the U.S. Governmentshall submit a letter of no more than ten pages regarding
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`the impact of the Governments Statementof Interest on the scheduling ofthis
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`matter.” (Doc. 51).
`
`4.
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`The course ofthe existing litigation has been abruptly changed with
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`Moderna’s counterclaim and the statementof interest by the United States.
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`5.|Emanuel McCray (“McCray”), Proposed Intervenor, respectfully pursues this
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`proposedclass action on behalf of himself andall other citizens of the United States
`
`similarly situated, as a class, pursuant to Rule 23 of the Federal Rules of Civil
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`Procedure (Fed. R. Civ. P.), our sovereign powers reserved to the People in the
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`Tenth Amendment, and our poweras a group acting as a class pursuant to Bondv.
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`

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`—CofonNDBDweSPWDWH
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`United States, 572 U.S. 844, 853 (2014),!' and Califano v. Yamasaki, 442 U.S. 682,
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`700,(1979).
`
`6.
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`Proposed Intervenors-Plaintiffs seek a narrow declaration that Contract No.
`
`W911QY-20-C-0100 (the ‘-0100 Contract) and 28 U.S.C. § 1498 are unavailable
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`for use by the United States and Modernato shift Moderna’s liability to the People
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`of the United States forits infringements of Plaintiffs’ patents and Moderna’s
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`liability for the safety and efficacy of the vaccine products made from these
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`infringements.
`
`II.
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`JURISDICTION AND VENUE
`
`7.
`
`This Court has original subject matter jurisdiction pursuant to 28 U.S.C. §§
`
`1331, 2201 and 2202.
`
`8.
`
`This Court has jurisdiction pursuant to the Class Action Fairness Act
`
`(“CAFA”), 28 U.S.C. § 1332(d), because: (i) the proposed class consists of well
`
`over 300,000,000 Members; (ii) the Members of the proposedClassare citizens of
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`states different from Defendants’ homestates; and(iii) the aggregate amountin the
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`controversy exceeds $5,000,000, exclusive of interest and costs, in a future suit
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`related to this current action which only seeks declaratory relief.
`
`' Holding that: “‘An individual may ‘assert injury from governmentalaction taken in excess of the authority
`that federalism defines.’”
`? Holding that “class relief is appropriate in civil actions brought in federal court, including those seeking to
`overturn determinations of the departments of the Executive Branch of the Government in cases where judicial review
`of such determinationsis authorized... Indeed, a wide variety of federal jurisdictional provisions speak in terms of
`individualplaintiffs, but class relief has never been thought to be unavailable under them.”
`
`3
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`

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`9.
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`Pursuant to 28 U.S.C. § 1391(b)(1), venue is proper because the Defendants’
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`principal places of business are located in the State of Delaware.
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`Ill.
`
`PARTIES
`
`10.
`
`Plaintiff Arbutus Biopharma Corporation is a corporation organized and
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`existing under the laws of Canada, with its principal place of business at 701
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`Veterans Circle, Warminster, Pennsylvania, 18974.
`
`11.
`
`Plaintiff Genevant Sciences GmbH is a company organized and existing
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`underthe laws of Switzerland, with its principal place of business at Viaduktstrasse
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`8, 4051 Basel, Switzerland.
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`12. Defendant Moderna, Inc. is a corporation organized and existing under the
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`laws of the State of Delaware, with its principal place of business at 200
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`Technology Square, Cambridge, MA 02139.
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`13. Defendant ModernaTX,Inc., a wholly owned subsidiary of Moderna, Inc.
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`(collectively, “Moderna”), is a corporation organized and existing under the laws of
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`the State of Delaware, with its principal place of business at 200 Technology
`
`Square, Cambridge, MA 02139.
`
`14.
`
`Intervenor-Plaintiff Emanuel McCray (“McCray”) is a citizen of the United
`
`States and resides in the State of Washington. McCray served in the United States
`
`military as an Intelligence Officer, a Staff Counterintelligence Officer, a Human
`
`—O
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`oOoNYHDASFWYNWN
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`

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`Intelligence Officer, and as Commanderof a Technical Surveillance
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`Countermeasures Unit.
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`IV.
`
`FACTUAL ALLEGATIONS
`
`15. Defendants conspired with agents of Biomedical Advanced Research and
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`Development Authority (“BARDA”) and agents of National Institute of Allergy and
`
`Infectious Diseases (“NIAID”)to infringe Plaintiffs’ patents, many months or even
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`manyyears before executing a contract on or about August 11, 2020 when the
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`United States granted Moderna, Inc. and ModernaTX,Inc. (“Moderna”),
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`“authorization and consent” to manufacture and use inventions covered by United
`
`States patents under Contract No. W911QY-20-C-0100 (the ’-0100 Contract).
`
`16.
`
`On February 28, 2022,Plaintiffs filed suit seeking compensation for the use
`
`of the patented technology they claim to have developed. [Doc.1]
`
`17.
`
`On November 2, 2022, Judge Goldberg a Memorandum followed by an Oder
`
`denying Moderna’s motion to dismiss and directing that: “Within fourteen (14) days
`
`from the date of this Order, Defendants shall file an answer to the Complaint.”
`
`(Docs. 31 and 32, respectively).
`
`18.
`
`On November30, 2022, Modernafiled an Answerto Plaintiffs’ Complaint,
`
`which was accompanied by a counterclaim against the Plaintiffs, which included an
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`intent to shift liability infringement of Plaintiffs’ patents to the United States. (Doc.
`
`35),
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`

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`19. On December 21, 2022, Plaintiffs filed an Answer to Defendants’
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`counterclaim (Doc. 38).
`
`20. On February 14, 2023, the United States filed its Statement of Interest in the
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`litigation and is seeking an interpretation from this Court of 28 U.S.C. § 1498 which
`
`will allow the United States to shift liability for some of Defendants’ unlawful
`
`infringing acts to the United States but not “all of Moderna’s allegedly infringing
`
`activity as described in the Complaint.” Statementof Interest at 1. (Doc. 49).
`
`21.
`
`The argument of the United States contained its StatementofInterest is
`
`inconsistent with Larson v. United States, 26 Cl. Ct. 365, 369-370 (1992) (The
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`infringing activity must have “occurred with the government’s authorization or
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`consent” and “[s]tatutory waivers of governmental immunity, such as are embodied
`
`in § 1498(a), must be narrowly construed.” (Citations omitted).
`
`22.
`
`Prior to execution ofthe “-0100 Contract” in August 2020, Defendants were
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`already in the advancedstages ofat least two clinical trials involving Plaintiffs’
`
`patents:
`
`(1) A Study to Evaluate Efficacy, Safety, and Immunogenicity of mMRNA-
`1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-
`19. (Phase 3. July 14, 2020)
`Sponsor: ModernaTX,Inc. Collaborators: Biomedical Advanced
`Research and Development Authority and NationalInstitute of Allergy
`and Infectious Diseases (NIAID)
`
`(2)
`
`Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and
`Immunogenicity of mMRNA-1273 COVID-19 Vaccine in Adults Aged
`18 Years and Older. (Phase 2. May 28, 2020)
`
`6
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`

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`Sponsor: ModernaTX,Inc. Collaborator: Biomedical Advanced
`Research and DevelopmentAuthority
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`23. Onor about April 21, 2020, Anthony Fauci, Director of the NIAID,in an
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`inter-agency communication, informed Francis Collins, Patricia Conrad, Renate
`
`Myles, Courtney Billet and John Burklow he was aware Bright had been removed
`
`from his work on vaccines with Moderna and Johnson and Johnson.
`
`24.
`
`Inits coverage of Rick Bright’s reassignment published on April 21, 2020,
`
`CNBC newsreportedthat:
`
`“BARDAwas expected to play an even larger role in the coming
`months; Congress more than tripled BARDA’s budget in the most
`recent coronavirus stimulus package. Already,the office has a role in
`someofthe splashiest Covid-19 projects, including partnerships with
`Johnson & Johnson and Moderna Therapeutics, both of which are
`developing potential Covid-19 treatments.’
`
`25.
`
`The CNBCnewsarticle exposed a conspiracy to usurp President Trump’s
`
`authority and the authority of his HHS Secretary to procure products for the
`
`pandemic.
`
`26.
`
`In or about 2015, Moderna applied for a European patent, “EP3134131B1”,
`
`related to human coronavirus vaccines, specifically “nucleic acid vaccines” (NAVs)
`
`related to “ribonucleic acid (RNA)vaccines, i.e, mRNA vaccines”:4
`
`“In the invention, the virus is a strain of Influenza A or Influenza B or
`combinations thereof. In some embodiments, the strain of Influenza A
`or Influenza B is associated with birds, pigs, horses, dogs, humans or
`
`3 Available from https:/Awww.cnbce.com/2020/04/21 /coronavirus-director-of-us-agenc
`development-leaves-role-suddenly.html.
`* Available from https://patents.google.com/patent/EP3 134131B1/en.
`
`
`
`7
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`non-human primates. In the invention, the antigenic polypeptide
`encodes a hemagglutinin protein or fragment thereof. In some
`embodiments, the hemagglutinin protein is H1, H2, H3, H4, H5, H6,
`H7, H8, H9, H10, H11, H12, H13, H14, H15, H16, H17, H18, ora
`fragmentthereof.
`
`2 T
`
`he vaccine of claim 1, wherein the infectious agentis a virus selected
`from the group consisting of HIN], H3N2, H7N9, and H10N8.”
`
`27.
`
`The existence of four different “data” versions of the same China virus led to
`
`this confirmation in newsreports. On or about December11, 2020, Yasemin
`
`Saplakoglu (“Saplakoglu”), a writer for Live Science,” reported that the “COVID-19
`
`vaccines developed by Pfizer and Moderna” were based on “data” supplied by
`
`Communist-controlled China:
`
`“On Jan. 10, Chinese researchersfirst published the genetic sequence
`[““data”] of the novel coronavirus on a preprint online; within a week,
`Weissman andhis team at the University of Pennsylvania were already
`developing synthetic mRNA against the virus and both Moderna and
`Pfizer licensed this team’s formulation from The University of
`Pennsylvania, according to a perspective posted on Sep. 3 in the
`journal JAMA.Within 66 days of the sequence [“data”] being
`published, Moderna,in collaboration with [Anthony Fauci’s] National
`Institute of Allergy and Infectious Diseases, developed a vaccine and
`kickstarted the first U.S. clinicaltrial to test it against COVID-19.”
`
`28.
`
`On or about March 25, 2021, Jon Gertner of the New York Times also
`
`reported the vaccines were based on “data” from Communist China® andthat the
`
`lack of specimens was correctable as a “software problem”:
`
`> Yasemin Saplakoglu. COVID-19 vaccines: The new technology that made them possible. Live Science.
`December 11, 2020. Available from https://www.livescience.com/mrna-vaccines-future-vaccine-development.html.
`6 Jon Gertner. Unlocking the Covid Code. The New York Times. March 25, 2021. Available from
`https://www.nytimes.com/interactive/202 1/03/25/magazine/genome-sequencing-covid-variants.html.
`
`8
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`—Oo©SNDHOHFFWYBY
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`OoSeINDBDNHF&FWHY—
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`NywoBPNHNNHPPOKNVNROommemepeepumpmmmmeeoSNDNCAFSFWYNYS|§SFOOCSINHNHOSFYSNHS|FS
`
`“Tt’s typically the case, for instance, that a pharmaceutical company
`needs samplesof a virus to create a vaccine. But once the sequence
`[“data’”’] was in the public realm, Moderna, an obscure biotech
`company in Cambridge, Mass., immediately began working with the
`National Institutes of Health on a plan. ‘They never had the virus on
`site at all; they really just used the sequence [“data”’], and they viewed
`it as a software problem,’ Francis deSouza, the chief executive of
`Illumina, which makes the sequencer that [Yong-Zhen’] Zhang used,
`told me with some amazement last summer, six months before the
`Moderna vaccine received an emergency-use authorization by the Food
`and Drug Administration. The virus’s code [“data”] also set the testing
`industry into motion. Only by analyzing characteristic aspects of the
`virus’s genetic sequence [“data”] could scientists create kits for the
`devices known as P.C.R. machines, which for decades have used
`genetic information [“‘data”’] to formulate fast diagnostic tests.”
`
`29.
`
`Stated differently, Moderna was in the process of receiving an emergency-use
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`authorization from the Food and Drug Administration months before executing “the
`
`-0100 Contract”.
`
`30.
`
`Researchers have been studying and working with mRNAvaccines for more
`
`than 60 years after the mRNA molecule was first described by S. Brenner and his
`
`colleagues in 1961.°
`
`7 Severe acute respiratory syndrome coronavirus 2 isolate Wuhan-Hu-1, complete genome. GenBank No.
`MN908947,3. Available from https://www.ncbi.nlm.nih.gov/nuccore/MN908947.3; Wu F, Zhao S, Yu B, et al. A
`new coronavirus associated with human respiratory disease in China [published correction appears in Nature. 2020
`Apr;580(7803):E7]. Nature, 2020;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Available from
`hitps://Awww.ncbi.nlm.nih.gov/pme/articles/PMC7094943/.
`® BRENNER §S, JACOB F, MESELSONM.An unstable intermediate carrying informationfrom genesto
`ribosomesfor protein synthesis. Nature. 1961 May 13;190:576-581. doi: 10.1038/190576a0. PMID: 20446365.
`Available from https://pubmed.ncbi.nlm.nih.gov/20446365/; https://www.nature.com/articles/190576a0. See, Fang E,
`Liu X, Li M, Zhang Z, Song L, Zhu B, Wu X,Liu J, Zhao D, Li Y. Advances in COVID-19 mRNA vaccine
`development. Signal Transduct Target Ther. 2022 Mar 23;7(1}:94. doi: 10.1038/s41392-022-00950-y. PMID:
`35322018; PMCID: PMC8940982. Available from https://www.ncbi.nim.nih.gov/pme/articles/PMC8940982/.
`
`9
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`31.
`
`In 1987, Dr. Robert Wallace Malone and colleagues successfully employed
`
`cationic lipids to encapsulate mRNAforinjection into eukaryotic cells, resulting in
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`a highly efficient system for the expression of mRNAinvitro.”
`
`32.
`
`In or about 2015, Modernaprovedits ability to deliver vaccines when
`
`Modernadelivered the “first-in-human dose of an mRNA vaccine (mRNA-1440),
`
`an H10N8flu vaccine candidate”,'® without infringing Plaintiffs’ patents.
`
`33.
`
`Plaintiffs alleged in their Complaint:
`
`“Moderna broughtits vaccine from lab bench to arms in record speed.
`That unprecedented accomplishment was made possible by Moderna’s
`use of breakthrough technology Arbutus had already created and
`patented—a revolutionary lipid nanoparticle (“LNP”’) delivery platform
`that took the scientists of Arbutus years of painstaking work to develop
`and refine. Moderna was well aware of Arbutus’s LNP patents and
`licensed them for other product programs, but it chose notto do so for
`its COVID-19 vaccine.” Jd. J 1.
`
`“Without adequate protection, mRNA quickly degrades in the body.
`For mRNAvaccineslike Moderna’s to work, they must incorporate a
`mechanism for protecting the fragile mRNA,delivering it throughcell
`membranes,and then releasingit inside the cell. In the words of one
`Nobel Prize winning scientist, the secret for making RNA-based
`products work has always been “delivery, delivery, delivery. Jd. J 3.
`
`34.
`
`In furtherance of the conspiracy to intentionally unleash a pandemic
`
`biological hoax against the People of the United States in violation of 18 U.S. Code
`
`§1038, Moderna chose notto seek licensing authority from Plaintiffs’, as it had
`
`> Malone RW,Felgner PL, Verma IM. Cationic liposome-mediated RNA transfection. Proc Natl Acad Sci U
`S A. 1989 Aug;86(16):6077-81. doi: 10.1073/pnas.86.16.6077, PMID: 2762315; PMCID: PMC297778. Available
`from https://www.ncbi.n!m.nih.gov/pme/articles/PMC297778/. See also: Nature. The tangled history ofmRNA
`vaccines (September 14, 2021). Available from https://www.nature.com/articles/d4 1586-02 1-02483-w.
`10 Available from bitps://www.modernatx.com/about-us/our-story.
`
`10
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`So
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`1]
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`donein the past for other vaccines, as part of an effort to keep secret the planning
`
`for this alleged biological hoax, which coincides with Moderna’s founding.
`
`35.
`
`In furtherance of the 18 U.S. Code §1038 biological hoax conspiracy,
`
`Modernahas brought to market a very fragile vaccine that relies upon delivery
`
`vehicles secretly obtained through the infringementofPlaintiffs’ patents. This in
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`turn complicates the chain of product and Governmenttort liability associated with
`
`the Federal class tort claims filed by putative class member Jerzy Gruca (“Gruca”),
`
`HHS Administrative Tort Claim No. 2021-0064, Emanuel McCray, HHS
`
`Administrative Tort Claim No. 2020-1415,"! andothers, for Marta Reyes, etal. v.
`
`Republic of China, et al., Class Action No. 20-cv-21108-AMCin the U.S. District
`
`Court for the Southern District of Florida (Miami), filed on March 12, 2020.
`
`36.
`
`The Miamiclass action is currently on administrative hold to allow the
`
`Plaintiffs time to “Continue Service of Process Pursuant To The FSIA”against the
`
`Peoples Republic of China, et a/. and to amend the Complaint by “expand[ing] the
`
`factual allegations of how the pandemic unfolded and how agents and actors of
`
`Defendants committed wrongful acts within the United States...since the research
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`for the April 15" [2021] brief does appear to lead to additional U.S. based
`
`defendants who acted on behalf ofor in aid of China to further the pandemic. ...” Jd.
`
`q4 6-9.
`
`'' See Exhibit 3 to Intervenors’ Complaint.
`
`11
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`10
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`37.
`
`In its counterclaim, Moderna, citing a non-peer reviewed Preprint, alleged
`
`that: “On January 10, 2020, the genetic sequence of the SARS-CoV-2 virus became
`
`public.” Jd. 710.
`
`38.
`
`The Preprint!? cited by Moderna makesnoreferenceto the full genome
`
`sequence of the SARS-CoV-2 virus which wasfirst submitted by the Shanghai
`
`Public Health Clinical Center & School of Public Health, Fudan University,
`
`Shanghai, China to the U.S. National Institutes of Health (NIH) on January 5, 2020
`
`as “Primary Locus Genome Sequence GenBank No. MN908947”(Severe acute
`
`respiratory syndromecoronavirus 2 isolate Wuhan-Hu-1, complete genome).
`
`39.
`
`On January 10, 2020, after the genome sequence was made public in
`
`GenBank, Eddie C. Holmes, an acquaintance of Anthony Fauci, posted a link to
`
`GenBankonthe Virological.org website."
`
`40. On January 11, 2020, news of the genome sequence posted by Eddie C.
`
`Holmes was reported by Science Magazine."
`
`41. Moderna’s Preprint named Barney S. Graham and Kizzmekia S. Corbett,
`
`Vaccine Research Center, NIAID and “Ralph S. Baric”, University ofNorth
`
`12 SARS-CoV-2 mRNA Vaccine Development Enabled by Prototype Pathogen Preparedness, bioRvix.org, at
`5-6 (June 11, 2020) (“Moderna/NITH Preprint”). Available from
`https://www.biorxiv.org/content/10.1101/2020.06.11.145920v1.full.
`3 Available from https://www.ncbi.nlm.nih.gov/nuccore/MN908947.
`4 Novel 2019 coronavirus genome. January 10, 2020. Available from https://virological.org/t/novel-2019-
`coronavirus-genome/319
`'5 Jon Cohen. Chinese researchers reveal draft genomeofvirus implicated in Wuhan pneumonia outbreak.
`January 11, 2020. Available from https://www.sciencemag.org/news/2020/01/chinese-researchers-reveal-draft-
`genome-virus-implicated-wuhan-pneumonia-outbreak.
`
`12
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`15
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`Carolina at Chapel Hill, among the authors, and Moderna and the following U.S.-
`
`based entities associated with the other authors:
`
`A.
`
`Vaccine Research Center; NationalInstitute of Allergy and
`Infectious Diseases; National Institutes of Health; Bethesda,
`Maryland, 20892
`B. Moderna Inc., Cambridge, MA, 02139; United States of America
`C.
`Department of Epidemiology; University of North Carolina at
`Chapel Hill; Chapel Hill, North Carolina, 27599
`Department of Microbiology and Immunology, School of
`Medicine, University of North Carolina at Chapel Hill; Chapel
`Hill, North Carolina, 27599
`National Institute of Allergy and Infectious Diseases; National
`Institutes of Health; Bethesda, Maryland, 20892
`Department of Pediatrics, Vanderbilt University Medical Center,
`Nashville, Tennessee, 37212
`Institute for Biomedical Sciences, George Washington
`University, Washington, DC 20052
`Department of Molecular Biosciences; University of Texasat
`Austin; Austin, Texas, 78712
`Biostatistics Research Branch, Division of Clinical Research,
`NationalInstitute of Allergy and Infectious Diseases, National
`Institutes of Health; Bethesda, Maryland, 20892
`
`D.
`
`E.
`
`m7
`
`mo
`
`— .
`
`42.
`
`Moderna’s Preprint further acknowledged support and funding as follows:
`
`“We thank Gabriela Alvarado, Karin Bok, Kevin Carlton, Masaru
`Kanekiyo, Robert Seder, and additional membersofall included
`laboratories for critical discussions, advice, and review of the
`manuscript. We thank Judy Stein and Monique Youngfor technology
`transfer and administrative support, respectively. We thank membersof
`the NIH NIAID VRCTranslational Research Program for technical
`assistance with mouse experiments. This work was supported by the
`Intramural Research Program of the VRCand the Division of
`Intramural Research, NIAID, NIH (B.S.G) and NIH NIAID grant RO1-
`AI127521 (J.S.M.). mRNA-1273 has been funded in part with Federal
`funds from the Department of Health and HumanServices, Office of
`the Assistant Secretary for Preparedness and Response, Biomedical
`Advanced Research and Development Authority, under Contract
`
`13
`
`

`

`Case|[1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 14 of 34 PagelD #: 1116
`Case 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 14 of 34 PageID #: 1116
`
`—oOfoNNDBDWDFSFWYWN
`
`75A50120C00034. PRNT assays were funded under NIH Contract
`HHSN261200800001E Agreement 17198 (to J.D.C.), furnished
`through Leidos Biomedical Research, Inc. MERS mRNA mouse
`challenge studies were funded under NIH Contract
`HHSN272201700036I Task Rrder No. 75N93019F00132 Requisition
`No. 5494549 (to R.B.). K.S.C.’s research fellowship was partially
`funded by the Undergraduate Scholarship Program, Office of
`Intramural Training and Education, Office of the Director, NIH.
`D.R.M.was funded by NIH NIAID grant T32-A1I007151 and a
`Burroughs Wellcome Fund Postdoctoral Enrichment Program Award.”
`
`43. NIH NIAID Grant No. T32-AI007151, referenced in Moderna’s Preprint, is
`
`commonly associated with research conducted at the University of North Carolina
`
`at Chapel Hill and funded by the NIAIDsince at least 1985 under the “Project
`
`Narrative”titled “Infectious Disease Pathogenesis Research Training Program”.'®
`
`44.
`
`This program, which “seeksto train postdoctoral trainees to conduct
`
`outstanding researchin the fields of bacterial pathogenesis, immunology, virology
`
`and epidemiology of infectious disease pathogenesis”, has cost taxpayers millions
`
`of dollars, and is the same funding mechanism used by Modernato prepare a
`
`“prototype pathogen”for its COVID-19 vaccines.!”
`
`45.
`
`Inits Preprint, Moderna provided the prototype pathogen timelineforits
`
`mRNA-1273’s progression to clinical trial in 2020 whichstarted back in 2013:"8
`
`'6 Available from https://reporter.nih.gov/search/! DhNG2eJl0a_pl96ntZZrO/proiects.
`17 Id.
`'8 Extended Data Figure 2 to “Moderna/NIH Preprint”. Available from
`https://www.biorxiv.org/content/10.1101/2020.06.11.145920v1.full.pdf.
`
`14
`
`

`

`Cage 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 15 of 34 PagelD #: 1117
`Case 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 15 of 34 PageID #: 1117
`
`2013-2019
`
`2020
`
`SARS-CoV-2 Pandemic
`2013-2019
`
`Extensive work on ArsAd Feb 2, 2020|Feb 4, 2020Rees
`
`MERS-CoV & other CoVs
`
`VRC & Moderna
`decide on
`mRNA-1273
`
`1" report of
`respiratory virus
`outbreakin
`
`Wuhan,China
`
`2019-nCoV
`sequences
`published
`
`sequence
`
`Moderna
`initiates
`cGMP
`production
`
`
`
`VRC
`Moderna
`validates in- vaccinates
`vitro
`mice
`of mRNA-
`ELE«1273
`
`expression
`
`|
`
`Moderna
`ships
`
`Immunogenicity
`confirmed in
`mice
`
`Moderna ships
`clinical drug
`product
`
`Phase 1
`clinical
`trial starts
`
`Ee
`
`Spike structure
`publishedin
`Science
`
`IND
`submitted
`
`FDAsafe-
`to-proceed
`
`May 29, 2020
`
`Phase 2
`clinical
`trial starts
`
`
`
`8||46. To state differently, Moderna claimed its COVID-19 vaccines are based on a
`
`“Prototype Pathogen”: “This is fundamentalto the prototype pathogen approach for
`
`10
`11||Pandemic preparedness”.'
`
`12147. Moderna’s “Prototype Pathogen”is a “critical component of the NIAID plan
`.
`for pandemic preparedness” which was funded by Anthony Fauci while Director of
`
`5||the NIAID.2°
`
`16||48.|Moderna’s “Prototype Pathogen”, which wasrevealed by the Biden
`.
`Administration in September 2022,7' directly supports the allegation that COVID-
`
`19||19 wasaplanned “infodemic”that violates 18 U.S. Code §1038.
`
`20
`
`zl
`
`22
`
`23
`
`'9 Id. at 5, lines 73-74.
`*° Anthony Fauci, et al., Prototype Pathogen Approachfor Vaccine and Monoclonal Antibody Development:
`A Critical Componentofthe NIAID Planfor Pandemic Preparedness. J \nfect Dis. 2022 Jul 25:jiac296. doi:
`24
`10.1093/infdis/jiac296. Epub ahead of print. PMID: 35876700; PMCID: PMC9384504. Available from
`25||https://www.ncbi.nlm.nih.gov/pme/articles/PMC9384504/;
`*! See First Annual Report on Progress Towards Implementation of the American Pandemic Preparedness
`Plan (“The U.S. Government continues to expandits capabilities for development of next-generation COVID
`vaccines and vaccines against other high-priority viruses. ..utilizing the prototype pathogen approach...” Available
`from https://www.whitehouse.gov/wp-content/uploads/2022/09/09-2022-A P3-FIRST-ANNUAL-REPORT-ON-
`
`PROGRESS. pdf
`
`26
`
`27
`
`28
`
`
`
`15
`
`
`
`

`

`Casel|L:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 16 of 34 PagelD #: 1118
`Case 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 16 of 34 PageID #: 1118
`
`—OoCOJTHAUOfFWWN
`
`49.
`
`Subsequent to Shanghai’s January 5, 2020 report to the United States of the
`
`genomesequence for “SARS-CoV-2”, the data underwent three uniquerevisions,
`
`manipulations, and or edits:2”
`
`GenBank: MN908947.3.
`
`Version 1.1: MIN908947.1 (30473 bp ss-RNA).”> Wuhan seafood market
`pneumoniavirus isolate Wuhan-Hu-1, complete genome, GenBank:
`MN908947.1;
`
`Version 1.2: MN908947.2 (29875 bp ss-RNA).”4 Wuhan seafood market
`pneumonia virus isolate Wuhan-Hu-1, complete genome GenBank:
`MN908947.2; and
`
`Version 1.3: GenBank No. MN908947.3 (29903 bp ss-RNA).”° Severe acute
`respiratory syndrome coronavirus 2 isolate Wuhan-Hu-1, complete genome,
`
`50. On February 24 and 25, 2023, McCray underwent urgent medical care from
`
`hospitals operated by the U.S. Department of Veteran Affairs (“DVA”). These
`
`hospitals had a policy in place mandating the wearing of masks that are known to
`
`the United States and the DVA to be incapable of preventing SARS-COV-2
`
`infection and transmission.
`
`51.
`
`The medical policies of President Biden’s Administration directed the
`
`hospitals to disregard the vaccination status of patients and visitors and instead
`
`mandate masks.
`
`22 See Exhibit 1 to Intervenors’ Complaint, 4] 168-197.
`33 Available from https://www.ncbi.nlm.nih.gov/nuccore/MN908947.1.
`% Available from https://www.ncbi.nlm.nih,gov/nuccore/MN908947.2.
`25 Available from https://www.ncbi.nlm.nih.gov/nuecore/MN908947.
`
`16
`
`

`

`Case|[L:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 17 of 34 PagelD #: 1119
`Case 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 17 of 34 PageID #: 1119
`
`Oof©&NNBAOo&WwWWB=
`
`
`
`vemmetemtBSNHN—=&&
`
`14
`
`52.
`
`The intentional disregard of the vaccination status by the Biden
`
`Administration and State health officials demonstrates zero confidence in the safety
`
`and efficacy of all vaccines, including those manufactured by Moderna. Thisanti-
`
`vaccine policy unwittingly promotes “natural immunity”, which in turn defeats the
`
`need to mandate vaccines, renders fatal Moderna’s efforts to shift liability forits
`
`wrongdoings to the United States.
`
`53.
`
`The current conflicting public health policies of the Biden Administration, the
`
`DVAandthe States of Washington and Oregon,in centuries past, were shown to be
`
`responsible for General George Washington suffering defeat during his military
`
`campaign to capture the cities of Montréal and Quebec,”® in the Province of Quebec,
`
`Canada”’ during the period 1775-1776.Fritz Hirschfeld contributed Washington’s
`
`defeat directly to the health policies of General Washington and the “United
`
`Colonies”:78
`
`“For approximately the first eighteen months of his command,
`however, Washington seemed committed to pursuing an anti-
`inoculation policy. He did so for several valid reasons. Many ofthe
`colonies had statutes on the books prohibiting inoculation and
`Washington,as a public figure, prided himself on obeying the law. As
`has been emphasized in previous chapters, public opinion itself was
`sharply divided, often very passionately, on the issue. Enlistments were
`
`6 Hirschfeld, Fritz, “Smallpox, the Continental Army, and General Washington”(1991). Dissertations,
`Theses, and Masters Projects. William & Mary. Paper 1539625695. https://dx.doi.org/doi:10.21220/s2-ecgj-sq04.
`Available from https://scholarworks.wm.edu/cgi/viewcontent.cgi?article=4733&context=etd.
`27 The Province of Quebec was a colony in North America (1763-1791) created by Great Britain in 1763
`after the Seven Years’ War for world supremacy between Great Britain and France, two ofthe powers ofthe Earth at
`the timeof the signing of the Declaration of Independence in 1776. Wikipedia. Province ofQuebec (1763-1791).
`Available from https://en.wikipedia.org/wiki/Province of Quebec_(1763%E2%80%93 1791).
`8 Hirschfeld at 55.
`
`17
`
`

`

`Case 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 18 of 34 PagelD #: 1120
`Case 1:22-cv-00252-MSG Document 60-1 Filed 03/02/23 Page 18 of 34 PageID #: 1120
`
`mn&WwWWw
`
`aD
`
`dropping off; perhaps in part due to the smallpox scare. In New York
`in the spring and summerof 1776, sickness and disease had begun to
`take a serioustoll of the men ofthe Continental Army.... The total
`numberof sick was 8,528, more than a third of the army. A program of
`mandatory inoculation might well serve to worsen the medicalcrisis.”
`
`54.
`
`The fear that a “program of mandatory inoculation might well serve to
`
`worsen