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1029-00002 · Client 1029 · Findings & Reports
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[slide 1]

Privileged and Confidential — Attorney-Client Communication

PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION

Presentation to the Board Governance & Compliance Committee of Thornwick Medical Research Institute

Investigation Summary: Grievance Investigation into Research-Laboratory Supervision Practices — Dr. Marcus Ellender, Director of Biomedical Engineering Laboratories

Presented by: Renata Vasquez, Partner, and Nadia Petrov, Associate — Calderwood & Harkness LLP

November 26, 2024

C&H Matter No. 1029-00002

[slide 2]

Agenda

1. Engagement Background and Investigation Scope

2. Methodology and Timeline of Key Events

3. Summary of Evidence Collected

4. Findings by Category: Retaliation, Hostile Work Environment, Safety-Protocol Violations, Falsification of Records

5. Parallel EHS Audit Results (Haverford Safety Consulting Group)

6. Institutional Exposure Analysis — Legal, Regulatory, and Financial

7. Recommended Corrective Actions

8. Next Steps and Implementation Priorities

9. Questions

[slide 3]

Engagement Background

Between August 12 and September 4, 2024, five TMRI employees filed formal written grievances under Employee Handbook § 7.3 alleging misconduct by Dr. Marcus Ellender, Director of Biomedical Engineering Laboratories

VP-HR Grace Okenwa escalated the matter to General Counsel Elena Graff on September 3, 2024, recommending outside counsel given the severity and volume of allegations

Calderwood & Harkness LLP was formally engaged on September 10, 2024, under engagement letter signed by Elena Graff

C&H represents TMRI as the employer — not any individual employee or Dr. Ellender

Dr. Ellender was placed on paid administrative leave effective September 18, 2024

Litigation-hold memorandum issued by Elena Graff on September 13, 2024

[slide 4]

Investigation Scope — Four Categories of Alleged Misconduct

1. Retaliation against employees who reported safety concerns — M.G.L. c. 149, § 185 (Massachusetts Whistleblower Protection Act); TMRI Policy HR-2021-009

2. Hostile work environment — verbal intimidation, discriminatory scheduling, punitive assignments — M.G.L. c. 151B, § 4; Title VII of the Civil Rights Act of 1964; TMRI Respectful Workplace Policy HR-2021-005

3. Safety-protocol violations — directed circumvention of OSHA-mandated PPE requirements (29 C.F.R. § 1910.132 et seq.); biohazard-containment protocols (NIH Guidelines for Recombinant or Synthetic Nucleic Acid Molecules)

4. Falsification or alteration of records — safety-incident reports (IR-2024-031, IR-2024-038) and lab-notebook entries

[slide 5]

The Complainants

Dr. Yuna Sakata — Senior Research Scientist, Lab B-2 (since March 2019): Retaliation following chemical-spill report; reassignment from NIH-funded project without justification — Filed August 12, 2024

Trevor Hollins — Lab Technician III, Lab B-3 (since June 2020): Hostile work environment; verbal intimidation; falsified safety-incident reports attributing equipment failures to his error — Filed August 19, 2024

Dr. Priya Chandrasekaran — Postdoctoral Fellow, Lab B-1 (since September 2022): Discriminatory scheduling; denial of conference opportunities; retaliatory negative performance review — Filed August 26, 2024

Miguel Ferreira — Lab Technician II, Lab B-4 (since January 2021): Directed to bypass OSHA-mandated PPE protocols; threatened with termination for raising safety concerns — Filed August 30, 2024

Sandra Nix — Research Associate, Lab B-2 (since November 2020): Hostile work environment; witnessed instruction to alter lab-notebook entries to conceal September 2023 biohazard-containment breach — Filed September 4, 2024

[slide 6]

Investigation Methodology

14 unique witnesses interviewed across 19 interview sessions (5 complainants, 8 corroborating witnesses, 1 respondent; plus 3 follow-up sessions)

All witnesses received Upjohn / corporate-Miranda advisement

1,247 documents collected pursuant to litigation hold and reviewed

Document categories: 312 email threads, 47 safety-incident reports, 15 lab-notebook pages flagged for alteration, 28 performance evaluations, 6 EHS audit reports, plus scheduling records, meeting minutes, grant-progress reports, and HR files

Respondent interview conducted October 23–24, 2024, with Dr. Ellender's personal counsel Rachel Whitmore of Hadley, Brennan & Morrow LLP present

Parallel EHS audit conducted by Haverford Safety Consulting Group, LLC (Liam Garrett, CIH, CSP) — preliminary findings received October 28, 2024

Investigation conducted by Renata Vasquez (Partner), Nadia Petrov (Lead Associate), and James Underwood (Working Associate)

[slide 7]

Timeline of Key Events

Aug 2, 2024 — Dr. Sakata oral report of chemical spill to EHS Director Alan Murdoch

Aug 9, 2024 — Dr. Ellender email to Joanna Pratt directing Sakata's reassignment

Aug 12 – Sep 4, 2024 — Five formal grievances filed

Sep 3, 2024 — Okenwa escalation memo to Graff

Sep 10, 2024 — Calderwood & Harkness engaged; investigation opened

Sep 13, 2024 — Litigation hold issued

Sep 18, 2024 — Dr. Ellender placed on paid administrative leave

Sep 23 – Oct 11, 2024 — Complainant interviews (5 sessions)

Oct 14 – Oct 18, 2024 — Corroborating-witness interviews (8 witnesses)

Oct 21, 2024 — Document-production review completed (1,247 documents)

Oct 23–24, 2024 — Respondent interview (Ellender with counsel Whitmore)

Oct 28, 2024 — Haverford preliminary EHS findings received

Nov 4, 2024 — Interim findings memo to Graff and Okenwa

Nov 11–13, 2024 — Follow-up interviews (3 sessions)

Nov 22, 2024 — Final investigative report delivered to TMRI

[slide 8]

Finding 1: Retaliation — Substantiated

Dr. Yuna Sakata was reassigned from NIH Grant No. 5R01-EB029174 to a lower-profile internal project within 11 business days of her August 2, 2024 oral safety report to EHS Director Alan Murdoch

No documented performance basis for the reassignment was identified in Dr. Sakata's personnel file or in any contemporaneous records

Direct documentary evidence: August 9, 2024 email from Dr. Ellender to Lab B-2 Supervisor Joanna Pratt — 'Sakata is becoming a problem — move her off the grant and onto the sterilization-protocol review'

Temporal proximity between protected activity (safety report) and adverse action (reassignment) establishes strong inference of retaliatory motive

Violates M.G.L. c. 149, § 185 (Massachusetts Whistleblower Protection Act) and TMRI Anti-Retaliation Policy HR-2021-009

[slide 9]

Finding 2: Hostile Work Environment — Substantiated in Part

Corroborating witnesses confirmed a pattern of Dr. Ellender raising his voice, using demeaning language (e.g., calling technicians 'replaceable'), and singling out Dr. Chandrasekaran for unfavorable scheduling

Trevor Hollins's account of verbal intimidation during lab meetings was corroborated by multiple witnesses

Substantiated as a violation of TMRI Respectful Workplace Policy HR-2021-005

Evidence was insufficient to establish that conduct was motivated by Dr. Chandrasekaran's national origin or gender

Therefore, NOT substantiated as a violation of M.G.L. c. 151B, § 4 or Title VII — but policy violation alone warrants disciplinary action

28 performance-evaluation forms reviewed; pattern of disproportionately negative reviews for complainants identified

[slide 10]

Finding 3: Safety-Protocol Violations — Substantiated

Miguel Ferreira's account corroborated by two independent witnesses — Lab Technician IV Karen Ashby and Research Associate Derek Loomis

On at least three occasions between March and July 2024, Dr. Ellender directed technicians to proceed without required respiratory protection during aerosol-generating procedures in Lab B-4

Violates 29 C.F.R. § 1910.132 et seq. (OSHA PPE standards)

Ferreira reported being threatened with termination for raising safety concerns to the EHS office — further corroborating the retaliation pattern

Haverford Safety Consulting Group parallel audit independently identified 9 PPE-compliance deficiencies and 3 biohazard-containment protocol violations in Labs B-1 and B-4

Violations also implicate NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

[slide 11]

Finding 4: Falsification of Records — Substantiated

Sandra Nix's allegation of lab-notebook alteration corroborated by forensic comparison of original and scanned notebook entries

Altered entries related to a September 14, 2023 biohazard-containment breach in Lab B-2 involving BSL-2 materials

Original entries (by Sandra Nix) documented the breach; subsequently altered entries, in Dr. Ellender's handwriting, minimized the scope of the incident

15 lab-notebook pages from Lab B-2 (September–October 2023) flagged for potential alteration

Safety-incident reports IR-2024-031 and IR-2024-038 contained narrative descriptions inconsistent with contemporaneous email accounts — falsely attributed equipment malfunctions to operator error by Trevor Hollins

Record falsification implicates research-integrity obligations and federal grant-compliance requirements

[slide 12]

Haverford Safety Consulting Group — EHS Audit Summary

Haverford Safety Consulting Group, LLC (Liam Garrett, CIH, CSP) engaged by TMRI for independent EHS audit of Labs B-1 through B-4

Flat-fee engagement: $34,500

Preliminary findings received October 28, 2024

9 PPE-compliance deficiencies identified across Labs B-1 and B-4

3 biohazard-containment protocol violations identified

Findings independently corroborate complainant testimony and documentary evidence regarding safety-protocol violations

Haverford's full audit report available separately

[slide 13]

Institutional Exposure Analysis — Legal Risks

Whistleblower retaliation claims under M.G.L. c. 149, § 185 — potential treble damages, attorneys' fees, and reinstatement remedies for Dr. Sakata and Miguel Ferreira

OSHA enforcement action for PPE-protocol violations (29 C.F.R. § 1910.132 et seq.) — potential citations and penalties; possible willful-violation classification given the directed nature of the bypass

Potential individual complainant lawsuits for hostile work environment, wrongful retaliation, and related claims

If Dr. Ellender is terminated and contests the action, anticipate claims through Hadley, Brennan & Morrow LLP (Rachel Whitmore) — wrongful termination, defamation, or breach of contract

Research-integrity and federal-grant-compliance implications discussed on next slide

[slide 14]

Institutional Exposure Analysis — NIH Grant Compliance

Dr. Ellender is named Principal Investigator on two active NIH R01 grants:

— Grant No. 5R01-EB029174: $2.9 million (2022–2027)

— Grant No. 1R01-EB034851: $1.9 million (2023–2028)

Combined remaining funds: approximately $3.1 million

If Dr. Ellender is terminated, TMRI must notify NIH Grants Management and request approval for a PI change — failure to maintain a qualified PI could jeopardize continued funding

Lab-notebook falsification related to BSL-2 biohazard breach could trigger NIH Office of Research Integrity (ORI) inquiry

Safety-protocol violations may also implicate TMRI's Institutional Biosafety Committee (IBC) reporting obligations under NIH Guidelines

[slide 15]

Institutional Exposure Analysis — Financial and Insurance

EPLI coverage through Meridian Indemnity Group — Policy No. MIG-EPLI-2024-00417

— $5,000,000 per-occurrence limit / $10,000,000 aggregate limit

— $250,000 self-insured retention (SIR)

— Policy period: January 1, 2024 – December 31, 2024 / Annual premium: $87,200

TMRI must provide timely notice to Meridian of potential claims to preserve coverage — notice should be made promptly through broker Crestline Brokerage Partners, Inc.

Investigation and consulting costs to date: C&H fees $198,740 + Haverford fees $34,500 = $233,240 total

Potential additional exposure: complainant settlements or judgments, OSHA penalties, NIH grant disruption (~$3.1 million at risk), and defense costs for any Ellender counterclaims

[slide 16]

Recommended Corrective Actions

1. Terminate Dr. Ellender's employment for cause under TMRI Employee Handbook § 9.2 — supported by substantiated findings across all four categories of misconduct

2. Refer safety violations to TMRI's Institutional Biosafety Committee (IBC) and to OSHA if required under mandatory-reporting thresholds

3. Notify NIH Grants Management regarding PI change for active grants 5R01-EB029174 and 1R01-EB034851 (combined remaining funds ~$3.1M) — identify successor PI candidates immediately

4. Implement mandatory anti-retaliation and supervisory-conduct training for all lab directors and supervisors (~18 individuals) within 90 days

5. Revise TMRI's safety-incident reporting process to include an anonymous-reporting option and independent EHS review of all incident reports

6. Provide individual remediation for affected complainants — restore Dr. Sakata to NIH grant role; correct performance records for Dr. Chandrasekaran and Trevor Hollins

[slide 17]

Implementation Priorities and Next Steps

Immediate (within 5 business days):

— Board authorization of termination for cause (Committee recommendation to full Board if required)

— Elena Graff and Grace Okenwa to execute termination process with C&H guidance

— Provide EPLI notice to Meridian Indemnity Group via Crestline Brokerage Partners

Short-term (within 30 days):

— Notify NIH Grants Management of PI change; submit successor PI nomination

— IBC referral and OSHA reporting assessment

— Begin individual complainant remediation (Dr. Sakata restoration, record corrections)

Medium-term (within 90 days):

— Complete mandatory anti-retaliation and supervisory-conduct training for ~18 supervisory personnel

— Implement revised safety-incident reporting procedures including anonymous-reporting option

Ongoing: Monitor for any counterclaims by Dr. Ellender or external regulatory inquiries

[slide 18]

Questions and Discussion

Full Final Investigative Report (November 22, 2024) available for Board review — PRIVILEGED AND CONFIDENTIAL

Corrective-Action Implementation Memorandum (November 26, 2024) available for Board review

Calderwood & Harkness LLP remains engaged and available to support implementation

Contact: Renata Vasquez, Partner — Calderwood & Harkness LLP, One Federal Place, Suite 3200, Boston, MA 02110

Contact: Nadia Petrov, Associate — Calderwood & Harkness LLP