Luven v. Soon-Shiong

CourtDistrict Court, S.D. California
DecidedJuly 29, 2025
Docket3:24-cv-02014
StatusUnknown

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

Bluebook
Luven v. Soon-Shiong, (S.D. Cal. 2025).

Opinion

1 2 3 4 5 6 7 8 9 UNITED STATES DISTRICT COURT 10 SOUTHERN DISTRICT OF CALIFORNIA 11 12 IN RE IMMUNITYBIO, INC. Case No.: 3:24-cv-02014-GPC-VET SHAREHOLDER DERIVATIVE 13 LITIGATION ORDER: 14

(1) GRANTING PROVISIONAL 15 THIS DOCUMENT RELATES TO: ALL APPROVAL OF DERIVATIVE 16 ACTION SETTLEMENT; ACTIONS 17 (2) CONDITIONALLY APPROVING 18 THE PROPOSED FORM AND MANNER OF NOTICE; AND 19

20 (3) SETTING DATE FOR FINAL SETTLEMENT HEARING 21

22 [ECF No. 34] 23

24 Before the Court is Plaintiffs’ Motion for Preliminary Approval of Derivative 25 Settlement. ECF No. 34. The Motion is unopposed. Id. at 3. For the reasons detailed 26 below, the Court GRANTS preliminary approval of the Parties’ settlement of this 27 derivative action and conditionally approves the proposed form and manner of settlement 28 1 notice. 2 I. BACKGROUND 3 A. Factual Allegations 4 This is a shareholder derivative action on behalf of nominal defendant 5 ImmunityBio, Inc. (“ImmunityBio” or “the Company”) against current and former 6 ImmunityBio directors and officers (collectively “Individual Defendants,” 1 and together 7 with ImmunityBio, the “Defendants”). ImmunityBio is a biotechnology company that 8 develops therapies and vaccines that bolster the body’s immune system to treat cancers 9 and infectious diseases. ECF No. 34-1 (“Motion” or “Mot.”) at 4. In May 2023, 10 ImmunityBio announced that the FDA had rejected its Biologics License Application 11 (“BLA”) for Anktiva (its lead biologic product) because of current good manufacturing 12 practice (“cGMP”) deficiencies identified during a pre-license inspection of its contract 13 manufacturing organizations (“CMOs”). Id. 14 Plaintiffs allege that between March 10, 2021 and May 10, 2023, the Individual 15 Defendants breached their fiduciary duties to ImmunityBio and its shareholders and 16 committed other misconduct by failing to conduct adequate oversight and making or 17 causing others to make a series of materially false and misleading statements that failed 18 to disclose the following: “(1) cGMP deficiencies at the Company’s third-party CMOs 19 for Anktiva; (2) that one or more of the Company’s CMOs for Anktiva did in fact suffer 20 from cGMP deficiencies; (3) that the foregoing deficiencies were likely to cause the FDA 21 to reject the Company’s BLA for Anktiva; and (4) that the Company overstated the 22 regulatory approval prospects for the Anktiva BLA.” Id. 23 B. Procedural Background 24 On February 9, 2024, ImmunityBio shareholder Roland Davies (“Davies”) 25 exercised his stockholder right to inspect, pursuant to 8 Del. C. § 220, and issued a 26 27 1 The Individual Defendants are Patrick Soon-Shiong, Richard Adcock, Cheryl L. Cohen, Michael D. Blaszyk, John Owen Brennan, Linda Maxwell, Wesley Clark, Christobel Selecky, Barry J. Simon, and 28 1 “Section 220” demand to ImmunityBio to see its books and records in connection with 2 the alleged misconduct. Id. at 5. In response, ImmunityBio responded produced over 3 600 pages of non-public, Board-level, internal corporate documents (“220 Documents”). 4 Id. Davies reviewed these documents, and on September 17, 2024, he served 5 ImmunityBio’s Board of Directors with a pre-suit demand under Delaware law asking the 6 Board to begin investigating the alleged misconduct described above in Section I.A. 7 and/or file a lawsuit against the Individual Defendants regarding said misconduct. Id. 8 On September 24, 2024, ImmunityBio shareholder Chris Pallas (“Pallas”) made a 9 substantially similar Section 220 demand on ImmunityBio. Id. ImmunityBio produced 10 the responsive documents to Pallas. Id. Davies’s demand and Pallas’s demand are 11 collectively known as the “Demands.” Id. at 8 12 On October 29, 2024, Plaintiff Gary Van Luven (“Van Luven”) filed a shareholder 13 derivative complaint on behalf of ImmunityBio against the Individual Defendants, 14 asserting claims for violation of the Securities Exchange Act of 1934 (the “Exchange 15 Act”) and for breach of fiduciary duty, unjust enrichment, and waste of corporate assets 16 under Delaware law. Id. at 12. On February 25, 2025, Plaintiff Angelo Barbieri 17 (“Barbieri”) filed a substantially similar shareholder derivative complaint on behalf of 18 ImmunityBio against certain of the Individual Defendants, asserting substantially similar 19 claims. Id. at 12–13. On February 26, 2025, Plaintiff Bong Shin (“Shin”) filed a third 20 substantially similar shareholder derivative complaint on behalf of ImmunityBio against 21 the Individual Defendants, asserting substantially similar claims. Id. at 13. 22 On May 2, 2025, the parties to these three derivative actions (the “Derivative 23 Actions”) jointly moved to consolidate their cases and to appoint Kuehn Law, PLLC as 24 Lead Counsel for plaintiffs Van Luven, Barbieri, and Shin (the “Plaintiffs”); the Court 25 granted their motion the same day. ECF No. 32. 26 Plaintiffs, Davies, and Pallas are collectively known as the “Shareholders,” Mot. at 27 1, and together with ImmunityBio and the Defendants, as the “Parties.” ECF No. 33-1 at 28 1 2. The Derivative Actions and Demands together are the “Derivative Matters.” Id. 2 C. Settlement Agreement 3 The key terms of the Stipulation of Settlement, ECF. No. 33-1 (“Settlement 4 Agreement” or “SA”), are as follows: 5 1. Settlement Benefits 6 ImmunityBio will keep the corporate governance reforms set forth in Exhibit A of 7 the Settlement Agreement in place for at least four years. Id. at 25. These reforms 8 include: 9 i. The appointment of an independent director to the Board of Directors on or 10 before December 31, 2025; 11 ii. Enhancements to the Disclosure Committee Charter; 12 iii. Enhancements to the Audit Committee Charter; 13 iv. Public posting of Corporate Governance Guidelines and Board Committee 14 Charters on the Company’s public website and if any such documents are 15 amended, the Company will post the updates within a reasonable time; 16 v. Quarterly Board discussion concerning topics relevant to allegations in the 17 Plaintiffs’ claims such as the Company’s and its CMOs’ compliance with 18 FDA regulations and cGMP, in order to identify material risks; 19 vi. Annual legal department review and report on effectiveness of Company 20 policies, procedures, and practices related to compliance with FDA 21 regulations; and 22 vii. Mandatory risk assessment and compliance training on annual basis for 23 Company employees involved with preparing financial statements, 24 manufacturing Company products, communicating with the FDA and 25 independent external auditor, and preparing public statements. 26 See Mot. at 8-12; ECF No. 33-1, Ex. A. 27

28 2 1 2. Releases 2 Under the Settlement Agreement, the Derivative Matters will be fully and finally 3 compromised and settled, the Released Claims will be released as against the Released 4 Persons, and the Derivative Actions will be dismissed with prejudice as against the 5 Released Persons. ECF No. 33-1 at 8. 6 The Released Claims include all claims, demands, rights, and causes of action 7 based on any jurisdiction’s laws that have been, could have been, or might be asserted in 8 the Derivative Matters or in any other court, tribunal, or proceeding by the Shareholders 9 or any other Current ImmunityBio Stockholder directly or derivatively on behalf of 10 ImmunityBio, or by ImmunityBio directly, against any of the Released Persons, or by the 11 Released Persons against ImmunityBio or any other Released Person, which arise out of 12 any matters related to the Derivative Action complaints, the allegations described in the 13 Demands, or the Derivative Actions and the institution, prosecution and settlement 14 thereof. Id. at 10.

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