Meyer v. Erck

CourtDistrict Court, D. Maryland
DecidedAugust 21, 2023
Docket8:21-cv-02996
StatusUnknown

This text of Meyer v. Erck (Meyer v. Erck) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Meyer v. Erck, (D. Md. 2023).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MARYLAND

IN RE NOVAVAX INC. STOCKHOLDER DERIVATIVE LITIGATION, Civil Action No. TDC-21-2996 Tis Doce Relat Ts ee ALL ACTIONS

MEMORANDUM OPINION In this shareholder derivative action filed on behalf of Novavax, Inc. (“Novavax”), Plaintiffs allege that Novavax Chief Executive Officer Stanley C. Erck, three other Novavax officers, and members of Novavax’s Board of Directors engaged in violations of the Securities Exchange Act of 1934, 15 U.S.C. § 78n(a)(1) (2018) (“the Exchange Act”) and Securities and Exchange Commission (“SEC”) Rule 14a-9, 17 C.F.R. § 240.14a-9 (2022); breaches of fiduciary duty; and unjust enrichment. Defendants have filed a Motion to Dismiss, which is fully briefed. Having reviewed the submitted materials, the Court finds that no hearing is necessary. See D. Md. Local R. 105.6. For the reasons set forth below, Defendants’ Motion will be GRANTED IN PART and DENIED IN PART. BACKGROUND Prior relevant factual background is set forth in the Court’s December 12, 2022 Memorandum Opinion in the related class action, Sinnathurai v. Novavax, Inc., No. TDC-21-2910, which is incorporated by reference. Sinnathurai v. Novavax, Inc.,___ F. Supp. 3d ___, No. TDC- 21-2910, 2022 WL 17585715 (D. Md. Dec. 12, 2022). The specific factual allegations and procedural history relevant to the Motion are set forth below.

I. Novavax Corporate Structure Novavax, a Delaware corporation, is a biotechnology company headquartered in Gaithersburg, Maryland that engages in the development and commercialization of vaccines to prevent serious infectious diseases. Novavax has common stock that trades on the NASDAQ stock exchange. Defendant Stanley C. Erck has served as the Chief Executive Officer (“CEO”) and President of Novavax since 2011 and as a member of its Board of Directors (“the Board”) since 2009. At the time of the events at issue in this case, between March and October 2021, Defendant John J. Trizzino was Novavax’s Chief Business Officer, Chief Commercial Officer, and an Executive Vice President. Defendant Gregory M. Glenn was Novavax’s President of Research and Development. Defendant John A. Herrmann III was the Corporate Secretary, the Chief Legal Officer, and an Executive Vice President. Defendants Erck, Trizzino, Glenn, and Herrmann will be collectively referred to as “the Officer Defendants.” During the same time period, Novavax’s Board of Directors included Defendants Erck, Gregg H. Alton, Richard H. Douglas, Margaret G. McGlynn, David M. Mott, Rachel K. King, Michael A. McManus, Jr., James F. Young, and Gary C. Evans. Evans concluded his service on the Board in June 2021. Defendants Erck, Alton, Douglas, McGlynn, Mott, King, McManus, Young, and Evans will be referred to collectively as “the Director Defendants.” The Board has four standing committees, including the Audit Committee, the Research and Development Committee (“the R&D Committee”), the Compensation Committee, and the Nominating and Corporate Governance Committee. The Audit Committee’s responsibilities include overseeing Novavax’s accounting and financial reporting processes; the preparation, presentation, and integrity of the financial reports and information provided to governmental and regulatory bodies and the public; the adequacy and efficacy of Novavax’s systems of internal

accounting, auditing, and financial controls; and Novavax’s compliance with applicable federal and state laws and regulations. The R&D Committee has responsibilities which include reviewing and assessing Novavax’s R&D programs; evaluating Novavax’s progress in achieving R&D goals and objectives; advising the Board on the scientific and R&D aspects of licensing, strategic partnerships, and acquisition or divestiture transactions; overseeing management’s exercise of its responsibility to assess and manage risks associated with Novavax’s R&D programs and regulatory matters; identifying and reporting to the Board on significant emerging scientific and technological developments; serving as a resource for management to consult on scientific and regulatory matters; and selecting, retaining, and supervising any advisors retained to further Novavax’s R&D efforts. Young is the Chair of the R&D Committee and Douglass and Mott are _members. Il. COVID-19 Vaccine Development Prior to the onset of the COVID-19 pandemic in late 2019, Novavax was facing significant financial hardship. Novavax’s attempts to develop vaccines for HIV, SARS, swine flu, and the Ebola virus were all unsuccessful. In mid-2019, Novavax sold all of its manufacturing facilities to stem financial losses. By March 2020, Novavax had only 127 employees. Novavax’s shares traded at under $4.00 per share and, as a result, Novavax was at risk of being delisted from the NASDAQ stock exchange. At that point, Novavax had only enough cash to survive for another six months. The onset of the COVID-19 pandemic in early 2020 provided Novavax with an opportunity to revive itself by finally developing a vaccine and bringing it to market. On February 26, 2020, Novavax announced that it was developing a COVID-19 vaccine, known as NVX-CoV2373 (“the Vaccine”) using a proprietary technology. The development of the Vaccine was critical for the

company. According to a market analyst, the Center for Financial Research and Analysis (“CFRA”), “the future financial success of [Novavax] and its ability to record a positive bottom- line [was] highly dependent on successful approvals and rapid commercialization of its COVID- 19 vaccine.” Third Amended Complaint (“TAC”) § 66, ECF No. 52. On June 4, 2020, Novavax announced that it had received an award of up to $60 million from the United States Department of Defense (“DOD”) to manufacture the antigen component of the Vaccine and deliver 10 million doses of the Vaccine to DOD for use in clinical trials in 2020. On July 7, 2020, Novavax announced that it had been selected to participate in Operation Warp Speed, the federal government’s program to develop and deliver a COVID-19 vaccine. Specifically, Novavax was awarded a $1.6 billion federal government grant to complete late-stage clinical development, establish large scale manufacturing, and deliver 100 million doses of the Vaccine as early as late 2020. As a condition of the grant, Novavax was required to demonstrate that it could scale up manufacturing of the Vaccine. Because Novavax did not have its own manufacturing facilities, on July 23, 2020, Novavax entered into an agreement with FUJIFILM Disoynth Biotechnologies (“FUJIFILM”) to manufacture bulk drug substance for the Vaccine at facilities in College Station, Texas (“the Texas Facility”) and Morrisville, North Carolina (“the North Carolina Facility”). As Trizzino stated in his February 2021 testimony before the U.S. House of Representatives, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, the antigen produced at the Texas and North Carolina Facilities was a “critical component” of Novavax’s U.S. supply chain. Jd. § 69. Throughout the development and manufacturing process, Novavax was required to adhere strictly to United States Food and Drug Administration (“FDA”) standards, including the FDA Current Good Manufacturing Practices (“cGMP”) Regulations, which establish requirements to

ensure the proper design, monitoring, and control of manufacturing processes and facilities and the strength, quality, and purity of drug products. 21 C.F.R. §§ 210.1-211.208 (2022). In its 2020 SEC Form 10-K, Novavax acknowledged that, “[t]o supply products for use either in the U.S. or outside the U.S., including clinical trials, U.S.

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