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` SUPREME COURT OF THE STATE OF NEW YORK
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`NEW YORK COUNTY
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`PEOPLE OF THE STATE OF NEW YORK,
`by LETITIA JAMES, Attorney General
`of the State of New York
`Plaintiff,
`- against –
`Robert G. Kramer,
`Defendant
`
`COMPLAINT
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`Index number:
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`Plaintiff, People of the State of New York, by its attorney, Letitia James, Attorney
`General of the State of New York (“OAG” or “Plaintiff”), alleges as follows against Defendant
`Robert G. Kramer (“Kramer” or “Defendant Kramer”):
`NATURE OF THE ACTION
`
`1. In the midst of the COVID-19 crisis, Defendant Kramer, the then-CEO of
`Emergent BioSolutions Inc. (“Emergent”), engaged in illegal insider trading of Emergent stock.
`Kramer entered into the illegal trades while in possession of material nonpublic information
`regarding serious and unresolved contamination issues Emergent faced in manufacturing
`COVID-19 vaccine drug substance for AstraZeneca PLC (“AstraZeneca”).
`2. Kramer sold over $10 million worth of Emergent stock while the contamination
`and production problems remained undisclosed to the public and just days before the stock’s
`price began a steady decline following analyst concerns about production.
`3. Operation Warp Speed was an effort by the U.S. government to support the rapid
`development of COVID-19 vaccine candidates. On June 1, 2020, Emergent joined the federal
`government’s effort by committing space in Emergent’s plant located in Bayview, Maryland, to
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`support the rapid development and distribution of COVID-19 vaccines. Emergent also entered
`into lucrative partnerships with both AstraZeneca and Johnson & Johnson to produce drug
`substance for the companies’ COVID-19 vaccine candidates.
`4. On June 11, 2020, Emergent publicly announced an agreement, valued at $87
`million, to provide development and manufacturing services for AstraZeneca’s COVID-19
`vaccine candidate, ChAdOxl nCOV-19 (AZD1222) (the “Product” or “AZD1222”), at
`Emergent’s Bayview facility.
`5. On July 27, 2020, Emergent announced a second contract with AstraZeneca,
`publicly valued at $174 million, which provided for contract development and manufacturing
`(“CDMO”) services for vaccine drug substance production by Emergent between July 2020 and
`June 2021 at large scale for commercial supply. Emergent’s two contracts with AstraZeneca
`were worth a combined value of $261 million.1
`6. In the week following Emergent’s announcement of its CDMO contract with
`AstraZeneca, Emergent’s stock price climbed 29.5%, going from $94.78 on July 27, 2020, to
`close at $134.46 on August 5, 2020.
`7. As development of the manufacturing process progressed over the fall of 2020,
`Emergent experienced serious manufacturing difficulties, particularly with contamination of
`AZD1222. Specifically, Emergent discovered excess bioburden (bacteria) and elevated
`endotoxin (a type of toxin released by bacteria) in multiple drug substance batches, as early as
`
`1 The manufacturing and production contracts Emergent secured with AstraZeneca were its
`second foray into manufacturing a COVID-19 vaccine substance. On April 23, 2020, prior to the
`U.S. government’s announcement of Operation Warp Speed, Emergent secured a contract to
`manufacture vaccine substance for Johnson & Johnson also at Emergent’s Bayview facility. On
`July 2, 2020, the parties entered into a second large scale drug substance manufacturing
`agreement which expanded the term of the agreement and was valued at more than $480 million.
`The two vaccines would later become cross-contaminated.
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`September 26, 2020. Kramer, as CEO, knew of the contamination at least as early as October 6,
`2020.
`8. In early October, these contamination issues led to the rejection and destruction of
`multiple batches of vaccine drug substance, each containing potentially millions of dose-
`equivalents of vaccine.
`9. Because of the serious, continuing and unresolved contamination, Emergent and
`AstraZeneca agreed to pause production of AZD1222 to investigate the root cause, and
`ultimately aborted, rejected or destroyed multiple batches. These manufacturing issues led to
`Emergent’s inability to meet the rapid production schedule anticipated in its contracts with
`AstraZeneca.
`10. In mid-October 2020, shortly after learning of the contamination problems at
`Emergent, Defendant Kramer asked his investment adviser to complete a Rule 10b5-1 stock
`trading plan (the “Trading Plan”) which would allow Kramer to exercise stock options and
`simultaneously sell the acquired shares. Kramer had not implemented such a Trading Plan since
`2016.
`11. On November 13, 2020, while Emergent was in an all-hands-on-deck
`manufacturing crisis and still in the midst of an internal investigation of the unresolved
`contamination and manufacturing problems that had not been disclosed to the public, Defendant
`Kramer finalized and entered into the Trading Plan. The terms of the Trading Plan required the
`immediate sale of shares upon Emergent’s stock reaching a preset price.
`12. The Martin Act, New York General Business Law § 352 et seq., forbids
`fraudulent practices, including the trading of stock by company insiders in possession of material
`nonpublic information. No statute, rule or law permits Rule 10b5-1 trading plans to be used as a
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`way of evading insider trading laws when an insider is aware of material nonpublic information
`at the time the trading plan is adopted.
`13. Defendant Kramer realized proceeds of $10,121,079.50 on the sale of Emergent
`stock under his Trading Plan. On January 15, January 20, January 21 and February 8, 2021,
`Defendant Kramer exercised various Emergent stock options to purchase Emergent stock at
`prices ranging from $25.62 to $30.86 per share. Pursuant to the Trading Plan, Defendant Kramer
`then immediately sold multiple lots of the shares he had acquired. Kramer sold 19,026 shares on
`January 15, then sold 2,232 shares on January 20, another 21,900 shares on January 21, followed
`by the sale of an additional 45,397 shares on February 8, 2021. These Emergent stock sales were
`consummated at weighted average sales prices ranging between approximately $106 and $120
`per share, significantly higher than Kramer’s purchase price.
`14. Shortly after Kramer completed these sales of stock on February 8, 2021,
`information about some of Emergent’s struggles was revealed to the public. After reaching a
`high of $125.19 per share on February 12, 2021, Emergent’s stock price began a steady decline
`from which it has not recovered. As of the date of this filing, Emergent stock currently trades at
`approximately $12 per share.
`15. Defendant Kramer’s actions violated the Martin Act.
`PARTIES
`16. Plaintiff is the People of the State of New York, represented by Letitia James,
`Attorney General of the State of New York, and is authorized to bring this action in the name
`and on behalf of the People of the State of New York pursuant to the Martin Act.
`17. Defendant Kramer was employed by Emergent for more than two decades in
`multiple roles. He joined Emergent as its Chief Financial Officer in 1999. In that role, he was
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`responsible for financial accounting and reporting, budgeting and analysis, and investor relations.
`From March 2018 to April 2019, Defendant Kramer was Emergent’s Chief Operating Officer,
`responsible for supervising manufacturing operations, among other duties. Defendant Kramer
`became the CEO of Emergent on April 1, 2019. As CEO, Defendant Kramer was responsible for
`management of the entire company. Kramer retired from Emergent on August 1, 2023.
`JURISDICTION AND VENUE
`18. This Court has jurisdiction over the subject matter of this action, jurisdiction over
`Defendant Kramer, and authority to grant the relief requested pursuant to the Martin Act.
`19. The Martin Act authorizes the Attorney General to commence a civil action for
`restitution, disgorgement and other relief against any person or corporation engaging or
`participating in fraudulent practices in the issuance, exchange, purchase, sale, promotion,
`negotiation, advertisement, investment advice, or distribution of securities or commodities within
`or from New York State.
`20. The transactions complained of were arranged and executed for Kramer by
`Defendant Kramer’s investment adviser, Merrill Lynch, on the New York Stock Exchange
`through its block trading desk in New York. The stock sales at issue were made pursuant to a
`Trading Plan which provided that it be governed by New York law. On November 13, 2020,
`Defendant Kramer signed the Trading Plan and agreed that his transactions were governed by
`New York law.
`21. New York investors, including New York State employee retirement funds,
`bought, sold, and held hundreds of thousands of shares in Emergent stock during the relevant
`period.
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`22. Pursuant to C.P.L.R. 503, venue is proper in New York County because
`Plaintiff’s office is located in this county.
`FACTUAL ALLEGATIONS
`A. Emergent Secures and Publicizes Multimillion Dollar Contracts from AstraZeneca
`
`23. In light of the COVID-19 emergency, the federal government announced
`Operation Warp Speed on May 15, 2020, with the goal of coordinating efforts in the public and
`private sectors to get vaccines for the coronavirus produced and approved as quickly as possible.
`24. One week later, on May 21, 2020, AstraZeneca, a multinational pharmaceutical
`company headquartered in Cambridge, United Kingdom, announced its vaccine candidate,
`AZD1222.
`25. On June 10, 2020, AstraZeneca and Emergent entered into a Master Services
`Agreement pursuant to which Emergent would produce bulk drug substance for AZD1222.
`26. On June 11, 2020, Emergent issued a press release announcing the agreement to
`support the manufacturing of AZD1222.2
`27. Emergent’s Form 8-K filed with the SEC on June 11, 2020, stated that “[o]n June
`10, 2020, Emergent entered into an agreement with AstraZeneca to provide CDMO services,
`technology transfer, analytical testing, drug substance process and performance qualification and
`will reserve certain large-scale manufacturing capacity through 2020.” In the press release,
`Emergent valued the agreement at approximately $87 million.
`28. On July 24, 2020, Emergent and AstraZeneca entered into a Master Services
`Agreement to produce drug substance at large scale for commercial supply. On that same date,
`
`2 https://www.emergentbiosolutions.com/press/news-release-details-emergent-biosolutions-signs-
`agreement-be-us-manufacturing-0/
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`the parties also agreed on a Manufacturing Product Schedule and Work Order for the large-scale
`manufacturing of AZD1222.
`29. On July 27, 2020, Emergent issued a press release announcing that it had signed a
`COVID-19 vaccine manufacturing agreement with AstraZeneca pursuant to which “Emergent
`will provide contract development and manufacturing services beginning in 2020 to produce
`drug substance at large scale for commercial supply.” In the press release, Emergent also
`announced that the “Agreement is valued at approximately $174 million through 2021 and brings
`the total AstraZeneca commitment to $261 million.”
`30. In response to the announcements, Emergent’s stock price almost doubled in
`price, increasing from a low of $68.11 on June 11, 2020, to a high of $134.46 on August 5, 2020.
`31. Pursuant to the Manufacturing Product Schedule and Work Order dated July 24,
`2020, Emergent agreed to manufacture up to 95 vaccine drug substance batches by April 30,
`2021, and 120 batches by June 30, 2021. Each batch contained several million dose-equivalents
`of COVID-19 vaccine drug substance. The expected production schedule called for up to 15
`batches (12 initial, 3 additional) of AZD1222 at Emergent’s Bayview, Maryland, manufacturing
`facility, Area 13, from July 1 through November 30, 2020. The expected production schedule
`included the manufacture of up to 80 batches of AZD1222 (32 initial, 48 additional) at Bayview
`Area 3 from September 1, 2020, through April 30, 2021, and 25 additional batches in Area 3
`from May 1 through June 30, 2021.
`32. Emergent’s November 19, 2020, CDMO Executive Management Team Budget
`Review projected 79 batches of AZD1222 in 2021 for revenue of $158 million.
`
`3 Emergent’s manufacture of AstraZeneca and Johnson & Johnson’s COVID-19 vaccine candidates was
`scheduled to take place in separate areas within Emergent’s Bayview facility.
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`B. Emergent’s Manufacture of AZD1222 Suffers from Early Microbial Contamination
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`33. Emergent’s production, manufacture and quality control of AZD1222 was led by
`Sean Kirk (“Kirk”), Executive Vice President, Manufacturing and Technical Operations, and
`Adam Havey (“Havey”), Executive Vice President and Chief Operating Officer. Both Kirk and
`Havey reported directly to Defendant Kramer and kept him apprised of Emergent’s progress.
`34. During this time, Defendant Kramer, who resided in Michigan, spent five weeks
`at a time onsite at Bayview. Kramer received regular updates from his direct reports, including
`Kirk and Havey. Kramer spoke to Kirk on a near daily basis and spoke to Havey multiple times
`per week during Operation Warp Speed. Kramer additionally held separate one-on-one meetings
`with Kirk and Havey on at least a weekly basis.
`35. As a matter of safety, pharmaceutical products generally undergo bacterial
`contamination tests including for endotoxin (toxic components of bacteria which can cause
`dangerous reactions) and bioburden (bacterial colonies). These tests ensure the safety and
`usability of pharmaceuticals, including vaccines. Tests that exceed certain levels can trigger
`“alerts” or “alarms,” and result in the destruction of pharmaceutical or vaccine drug substance
`batches.
`36. On or about September 26, 2020, Emergent began noticing indices of
`contamination in its production of AZD1222, including elevated levels of endotoxin and excess
`bioburden.
`37. On or about October 1, 2020, Emergent began an investigation into “initial
`indications of microbial contamination” in the early batches of AZD1222.
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`38. On October 2, 2020, following procedures defined by the U.S. Food & Drug
`Administration (“FDA”) for quality management, Emergent discovered a deviation4 in its
`vaccine manufacturing process that it classified as “Critical.” The deviation related to an
`“endotoxin event” on the same date. In the context of FDA manufacturing rules, critical
`deviations mean that a batch of drug substance is likely unusable. 21 U.S.C.S. § 331(a) and 21
`C.F.R. § 210.1.
`39. Kirk and Havey met with AstraZeneca at least once a week to discuss Emergent’s
`progress in successfully manufacturing AZD1222. They also frequently had larger meetings
`with AstraZeneca which included Emergent’s partners in the federal government.
`40. On October 5, 2020, during a regularly scheduled weekly meeting to review the
`progress of the COVID-19 project, Emergent notified the U.S. government’s Biomedical
`Advance Research and Development Authority (“BARDA”), a Department of Health and
`Human Services (“HHS”) working group that was involved in the management of Operation
`Warp Speed, that Emergent had aborted two batches of AZD1222. Each aborted batch meant the
`destruction of millions of dose-equivalents of vaccine drug substance.
`41. On October 6, 2020, Kirk provided Defendant Kramer with a copy of a
`PowerPoint presentation, including slides about the aborted, contaminated batches discussed at
`the previous day’s meeting.
`42. On October 13, 2020, key managers and employees working for both Emergent
`and AstraZeneca concluded that five out of the first seven batches of AZD1222 produced by
`Emergent were likely to be lost to contamination due to alarm level tests for endotoxin and
`
`4 A deviation is a term in FDA-regulated industries defined as follows: “Discrepancy – Datum or result
`outside of the expected range; an unfulfilled requirement; may be called non-conformity, defect,
`deviation, out-of-specification, out-of-limit, out-of-trend” https://www.fda.gov/media/71023/download
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`bioburden (tests that indicated the presence of unacceptably high levels of toxic bacteria), and
`discussed the possible need to stop manufacturing in order to investigate the cause of the
`contamination.
`43. That same day, Emergent’s Quality Assurance Chief sent an email to Havey
`stating “. . . [W]e’re likely to lose 5 of 7 batches to date due to contamination issues . . . . My
`question is if we need to stop production to investigate [the ongoing contamination issue].”
`44. On October 13, 2020, Kirk emailed senior leadership at AstraZeneca saying that
`Emergent had “all hands on deck to evaluate the current challenges …”. An AstraZeneca EVP
`replied: “The situation is indeed worrisome and we are very concerned.”
`45. On October 13, 2020, Kirk also told Defendant Kramer that he worried that the
`concerning bioburden test results would likely be discussed in a meeting later that day with
`AstraZeneca and BARDA. Later in the day, Kirk sent Defendant Kramer an email stating “Bob,
`Drawing your attention to Slide 10. Couple of issues last week. I can cover in today…with
`[BARDA] meeting if they come up. The bioburden issue may create some tension between us
`and [AstraZeneca] and could require a process change….”
`46. Slide 10, labeled “Update since 10/5”, notes some of the contamination identified
`as of October 13, 2020:
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`Update since 10/5 emergent
`AZAreas 1 &3
`" First DSShipment ever! 21001940+
`" Endotoxin/Bioburden issue emerging possibly starting at AEXstep
`" 21001941, 21002064affected
`" CompletedDSbatch 21002064
`" Small leak at DSbag - re-filtered
`" 21001904- contaminated 2,000L bioreactor
`" Investigation in-progress
`- All relevant samples collected &submitted
`- Bag, connections, penetrations examined
`. BARDAUpdate- 13Oct2020
`11
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`47. The following day, on October 14, 2020, in response to an email from an
`AstraZeneca employee regarding agenda items for an October 16, 2020, weekly BARDA
`meeting, an expert at HHS sent an email to AstraZeneca requesting the addition of the following
`new agenda item: “the QC [quality control] testing model provided by Emergent and proposed
`strategy related to downstream endotoxin failures.”
`48. On October 15, 2020, a member of the AstraZeneca team replied to HHS’s expert
`and requested Emergent’s participation in the discussion regarding its quality control and
`proposed strategy for handling its endotoxin failures.
`49. Because of the serious, unresolved contamination problems, Emergent and
`AstraZeneca agreed to pause production of multiple batches of AZD1222, each containing up to
`millions of dose-equivalents of vaccine drug substance, and multiple batches were ultimately
`aborted or rejected and destroyed.
`C. In the Midst of Serious, Undisclosed Contamination Issues, Defendant Kramer
`Pursued a Rule 10b5-1 Trading Plan
`
`50. In mid-October, with knowledge of the destruction of multiple batches of
`AZD1222 due to contamination issues and after an internal investigation was underway,
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`Defendant Kramer sought to exercise his Emergent stock options to purchase stock and then
`immediately sell it off.
`51. As part of Kramer’s compensation and incentive package, he regularly received
`options to purchase shares of Emergent stock. In October 2020, Kramer held 231,764 options to
`purchase Emergent stock at exercise prices ranging from $25.62 to $61.44.
`52. On Sunday October 11, 2020, Defendant Kramer called and spoke to his
`investment adviser at Merrill Lynch. He asked him about entering into the Trading Plan to sell
`Emergent stock.
`53. On October 12, 2020, Defendant Kramer sent an email to his investment adviser
`with a summary of his stock options saying: “Please review and lets [sic] discuss the best way to
`incorporate this into my portfolio investment planning.”
`54. On October 14, 2020, in a scheduled call, Defendant Kramer again spoke with his
`investment adviser to discuss drafting a Rule 10b5-1 plan.
`55. On October 16, 2020, Defendant Kramer and his investment adviser again had a
`phone conversation where they discussed the Trading Plan, including the type of equity awards
`that could be covered under the plan and the limit price.
`56. On October 20, 2020, Merrill Lynch sent Defendant Kramer a draft of the Trading
`Plan. Under the draft Trading Plan, once a 60 day ‘cooling-off’ period after signing the Trading
`Plan had passed, Defendant Kramer would exercise his options and sell the stock when the price
`was greater than $100. At the time of drafting the Trading Plan, the price of Emergent stock was
`approximately $100, and had traded at over $111 a few days prior.
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`D. Emergent’s Contamination Problem Intensifies at the End of October
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`57. Defendant Kramer was fully aware of the escalating manufacturing problems.
`Kirk and Havey, reporting directly to Defendant Kramer, met and spoke regularly with Kramer
`throughout the investigation into the contamination problems and kept Kramer fully apprised of
`the continuing and unresolved problems at Emergent’s Bayview facility where AZD1222 was
`being manufactured.
`58. Defendant Kramer’s handwritten diary from October 21, 2020, notes “at scale
`contamination,” “bioburden/endotoxin,” “pushing for downstream filtration step,” and that “AZ
`has resisted.”
`59. On October 23, 2020, an AstraZeneca SVP emailed Kirk and stated: “The
`situation is clearly deeply concerning as [also] the most recent batch has endotoxin/Bio hits and
`my understanding is that we now have found it in the buffer solution. This really makes me
`concerned that we may have a bigger and more systematic issue at the Site . . . .”
`60. The same day, an AstraZeneca EVP emailed Kirk stating: “We remain very
`concerned and sincerely hope that EBS [Emergent] can turn this around rapidly . . . . While I
`understand your point on the speed of what we are doing, I must share that others in our partner
`network have performed more reliably to date. We are simply nervous that the US supply chain
`is falling behind.”
`61. The increasing concerns about contamination led to a “Senior Leader Call” that
`included Kirk and Havey, the AstraZeneca SVP, and representatives of BARDA, where
`AstraZeneca executives expressed “concerns at a number of levels” about “Emergent’s ability to
`meet our expectations (and commitments.)”
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`62. On October 25, 2020, Kirk texted Havey complaining that “Issues keep piling up.
`This was last night. The AZ meeting is 8:30am on Tuesday at bayview. They asked to do a
`gemba5 walk and I said ‘no’.”
`63. During a meeting that took place the following day on October 26, 2020, a slide
`from a COVID-19 Projects Update PowerPoint presentation highlighted multiple vaccine batches
`as “late, can’t recover,” and contained a revised manufacturing schedule identifying the number
`of batches that were reduced in 2020 and early 2021.
`64. On the morning of October 26, 2020, Kirk texted Havey and told Havey that he
`had given Defendant Kramer the “full landscape.”
`65. As Emergent’s CEO, Defendant Kramer was aware of Emergent’s continuing
`contamination problems and understood that the U.S. government was expressing concern about
`the ability of Emergent to implement AstraZeneca’s process in accordance with Operation Warp
`Speed.
`E. Emergent Promoted the AstraZeneca Contracts in SEC Filings and Analyst Calls
`but Failed to Disclose the Serious, Unresolved Contamination Issues
`
`66. On November 6, 2020, Emergent filed its 3Q2020 10-Q quarterly report with the
`SEC which touted its contracts for the production of AZD1222 but omitted any mention of
`Emergent’s serious and unresolved manufacturing and contamination problems with AZD1222.
`67. Defendant Kramer concealed Emergent’s problems during Emergent’s 3Q2020
`analyst earnings call on November 5, 2020. Specifically, Defendant Kramer told analysts that
`Emergent had met the goal of establishing the manufacturing process for its COVID-19 vaccine
`contracts with both AstraZeneca and Johnson & Johnson, stating “…we were to have established
`
`5 A Gemba Walk is a business term derived from Japanese crime fiction; “genba” meaning “the actual
`place”, where management walks the “crime scene” looking for the source of the problems.
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`a large-scale manufacturing infrastructure and tech-transfer their candidates to this infrastructure
`to our Bayview facility outside of Baltimore during 2020 and early into 2021, and that is
`essentially complete. The second commitment of obligation, if you will, is to manufacture and
`supply drug substance to their vaccine candidates in support of their global supply chain goals...”
`68. Defendant Kramer also responded to questions regarding Emergent’s overall
`procurement and contracting outlook without acknowledging the existence of any problems,
`including the ongoing unresolved bioburden and endotoxin contamination problems, the rejected
`and destroyed vaccine drug substance batches, manufacturing delays, or their impact on the
`vaccine drug substance production schedule.
`69. At the time of Defendant Kramer’s statements on November 5, 2020, Emergent
`had not yet successfully completed what is known as a Process Performance Qualification
`(“PPQ”) batch—a successful batch of drug substan ce according to a replicable set of procedures
`that will produce successful batches without further changes—of AZD1222. Without a PPQ
`batch, the tech transfer process was not complete, the FDA could not issue an authorization, and
`Emergent was not prepared to begin manufacturing commercial batches of AZD1222.
`F. In Early November, the Contamination Issue Remained Unresolved
`
`70. At the beginning of November 2020, at AstraZeneca’s urging, Emergent initiated
`a “war room” approach to its bioburden investigation.
`71. On Friday, November 6, 2020, Kirk complained in a group text that Emergent’s
`failures to take promised actions and deliver results was hurting Emergent’s relationship with
`AstraZeneca, stating “If we don’t get more active on the floor leadership dealing with this stuff
`then we are doomed from a credibility perspective. We are currently at a significant relational
`deficit with AZ and need to get aggressive to get out of this hole.”
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`72. On Saturday November 7, 2020, as Emergent staff were still working through the
`weekend and overwhelmed by the number of problematic test results, Kirk exchanged the
`following texts with Havey expressing his concern over the situation:
`Sean Kirk <[redacted phone number]>
`2020-11-07T09:51:26.0000000Z
`Endotoxin hits throughout ppq 1 in area 1. This is in addition to the endotoxin hit we got
`on the first run in area 3. Call with AZ is at noon. Word is they are going to tell us they
`want to come in Monday and assess our overall operational readiness.
`
`Havey, Adam <[redacted phone number]>
`2020-11-07T10:01:21.0000000Z
`What's your position?
`
`Havey, Adam <[redacted phone number]>
`2020-11-07T10:01:31.0000000Z
`What are mike and Sue saying?
`
`Sean Kirk <[redacted phone number]>
`2020-11-07T10:13:20.0000000Z
`We have a prep call at 11. I'm not sure I have a position. it's not like I can’t tell them
`they can’t come with all the concerns they have
`
`Havey, Adam <[redacted phone number]>
`2020-11-07T10:13:42.0000000Z
`Understood
`
`Havey, Adam <[redacted phone number]>
`2020-11-07T10:14:12.0000000Z
`The area 1 hits are concerning...
`
`Sean Kirk <[redacted phone number]>
`2020-11-07T10:25:12.0000000Z
`At this point everything is concerning. Like fighting the Chinese army
`
`Havey, Adam <[redacted phone number]>
`2020-11-07T10:38:50.0000000Z
`Sorry, I wasn’t trying to pile on or be glib. I was just thinking out loud
`
`73. On Saturday November 7, 2020, senior AstraZeneca executives spoke with
`members of the Emergent Executive Management Team and expressed their concerns about the
`lack of progress in resolving the bioburden contamination problem. Emergent understood that
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`the situation at that time was urgent and severe. In an internal AstraZeneca email summarizing
`the meeting, one AstraZeneca manager said: “We where [sic] very clear with them that we need
`to see a totally different level of senior leadership from their side from now on and that we are
`bringing in the cavalry in form of our most experienced SME-s/Leaders…”
`74. Over the course of the weekend, AstraZeneca management suggested to Kirk and
`others at Emergent that production be halted and the schedule slowed down while Emergent
`continued to investigate the source of the contamination, so as not to lose additional batches of
`vaccine.
`75. Defendant Kramer was aware of the escalating situation. On Sunday November 8,
`2020, Kirk texted Defendant Kramer to update him on conversations Kirk had with
`AstraZeneca’s leadership and with BARDA over the weekend and notifying Kramer that he may
`be receiving a call regarding same:
`Sean Kirk <[redacted phone number] (IMessage)>
`
`Bob sorry to bother you but could you please give me a call when you have a
`couple minutes. Would like to update you on some conversations with
`AstraZeneca leadership and Ba[r]da this weekend. You make it a call from
`[G]eneral Perna [head of BARDA] so I wanted to give you an update in the event
`that happens
`
`76. On Monday, November 9, 2020, Defendant Kramer texted Kirk about the
`pressure they were under:
`Kramer, Robert <[redacted phone number]>
`2020-11-09T14:59:42.0000000Z
`Let's talk before our call with Perna. I’m open until 4:30 PM.
`
`Sean Kirk <[redacted phone number]>
`2020-11-09T15:05:53.0000000Z
`I will call at 4 or just before. Having a challenging day. Ows/ barda asking for me to
`run bayview full time
`
`Kramer, Robert <[redacted phone number]>
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`2020-11-09T15:11:55.0000000Z
`I know, I spoke to Adam.
`
`Sean Kirk <[redacted phone number]>
`2020-11-09T16:40:55.0000000Z
`Az presented it as their gift to us to slow down. Such bullshit.
`
`Kramer, Robert <[redacted phone number]>
`2020-11-09T16:41:30.0000000Z
`For sure.
`
`77. By November 10, 2020, Emergent and AstraZeneca had agreed to slow down
`production and come up with a plan to implement the slowdown, which ultimately included
`removing three batches from the schedule to further investigate and implement corrective
`actions.
`78. On November 13, 2020, the federal government, AstraZeneca, and Emergent held
`yet another meeting. A slide from a PowerPoint presentation show