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Contract analysis / environmental-dd-memo.docx
environmental-dd-memo.docx
1018-00008 · 31 clauses
High · 1 Medium · 4 Standard · 2
I. EXECUTIVE SUMMARY Standard
⚑ Commercial term
I. EXECUTIVE SUMMARY Calderwood & Harkness LLP ("C&H" or the "Firm") has conducted an environmental due diligence review of Veridian Biosciences, Inc. ("Veridian" or the "Company"), a privately held, clinical-stage biotechnology company focused on the development of immuno-oncology therapeutics, in connection with Penterra Pharmaceuticals Corp.'s ("Penterra" or "PPC") proposed acquisition of 100% of the outstanding c
II. SCOPE OF REVIEW
II. SCOPE OF REVIEW A. Documents and Information Reviewed Our environmental due diligence review was based on documents and information uploaded by Veridian's counsel, Zalcourt Archer & Cole LLP (Rebecca Whitmore, Partner; Jonathan Pratt, Associate), to the virtual data room maintained by Thackeray Solutions in connection with the Transaction (the "Data Room"), in response to C&H's Preliminary Due Diligence Request L
1. The lease agreement for 550 Gateway Drive, Cambridge, MA 02142, between Veridian (as t
1. The lease agreement for 550 Gateway Drive, Cambridge, MA 02142, between Veridian (as tenant) and Gateway Life Sciences Properties LLC (as landlord), including all amendments, addenda, and side letters, with particular attention to the environmental provisions, tenant obligations with respect to hazardous materials management, laboratory decommissioning requirements, and allocation of environmental liabilities betw
2. Environmental permits, licenses, and registrations held by Veridian, including the Com
2. Environmental permits, licenses, and registrations held by Veridian, including the Company's RCRA Small Quantity Generator registration, Massachusetts Radioactive Materials License, Cambridge Biosafety Committee registration, and Institutional Biosafety Committee registration with the NIH Office of Science Policy.
3. Hazardous waste generator registrations and manifests for the period from 2021 through
3. Hazardous waste generator registrations and manifests for the period from 2021 through the first quarter of 2024, documenting the types, quantities, and disposition of hazardous waste generated by Veridian at the Facility.
4. Chemical hygiene plans and biological safety plans maintained by Veridian in connectio
4. Chemical hygiene plans and biological safety plans maintained by Veridian in connection with its laboratory operations, including the Company's written Chemical Hygiene Plan, Biological Safety Plan/Exposure Control Plan, and Radiation Safety Manual.
5. The Company's complete inventory of Material Safety Data Sheets (SDS/MSDS) for chemica
5. The Company's complete inventory of Material Safety Data Sheets (SDS/MSDS) for chemicals and hazardous materials maintained or used at the Facility, as compiled in Veridian's electronic chemical management system.
6. Environmental, health, and safety policies and procedures manuals, including standard
6. Environmental, health, and safety policies and procedures manuals, including standard operating procedures for hazardous waste management, spill response, emergency procedures, and laboratory safety protocols.
7. Environmental compliance audit reports, both internal self-assessments and third-party
7. Environmental compliance audit reports, both internal self-assessments and third-party audits, for the period from 2020 through 2024.
8. Correspondence with federal, state, and local environmental and regulatory agencies, i
8. Correspondence with federal, state, and local environmental and regulatory agencies, including the U.S. Environmental Protection Agency ("EPA"), the Massachusetts Department of Environmental Protection ("MassDEP"), the Cambridge Public Health Department, and the Cambridge Biosafety Committee ("CBC").
9. Records of any environmental incidents, spills, releases, or remediation activities at
9. Records of any environmental incidents, spills, releases, or remediation activities at or associated with the Facility during Veridian's tenancy.
10. Phase I and Phase II Environmental Site Assessments (ESAs) for the building at 550 Ga
10. Phase I and Phase II Environmental Site Assessments (ESAs) for the building at 550 Gateway Drive, to the extent available in the Data Room. As described further herein, a Phase I ESA was conducted by the landlord in 2017; no Phase II ESA has been performed.
11. Insurance policies covering environmental liabilities, reviewed in coordination with
11. Insurance policies covering environmental liabilities, reviewed in coordination with the Insurance Due Diligence Memorandum.
12. Employee training records related to EH&S matters, including records of initial onboa
12. Employee training records related to EH&S matters, including records of initial onboarding training and annual refresher training for laboratory personnel.
13. Veridian's Institutional Biosafety Committee (IBC) records and registrations, includi
13. Veridian's Institutional Biosafety Committee (IBC) records and registrations, including IBC meeting minutes, protocol approvals, and annual reports for the period from 2021 through 2024. B. Interviews Conducted In addition to our review of Data Room materials, we conducted the following management interviews and discussions in connection with this memorandum:
1. Dr. Priya Chandrasekaran, Chief Scientific Officer & Co-Founder. We conducted a manage
1. Dr. Priya Chandrasekaran, Chief Scientific Officer & Co-Founder. We conducted a management interview with Dr. Chandrasekaran on April 2, 2024, regarding the nature and scope of Veridian's laboratory operations, the types of biological and chemical materials used in the Company's research programs, biosafety protocols, and the Company's general approach to environmental and laboratory safety compliance. Dr. Chandra
2. Veridian's Director of Facilities. We conducted a discussion on April 8, 2024, with th
2. Veridian's Director of Facilities. We conducted a discussion on April 8, 2024, with the Company's Director of Facilities (as identified in the Data Room records) regarding day-to-day waste management practices, environmental permit compliance, facility infrastructure (including chemical fume hoods, biological safety cabinets, autoclave systems, and wastewater neutralization systems), and coordination with the buil
3. Broadleaf Scientific Consulting LLC. We coordinated with Dr. Raymond Kapoor, Managing
3. Broadleaf Scientific Consulting LLC. We coordinated with Dr. Raymond Kapoor, Managing Director of Broadleaf Scientific Consulting LLC, which was engaged by Penterra to conduct the clinical and scientific due diligence for the Transaction, regarding matters of overlapping interest, including laboratory safety practices, biological materials handling, and the classification of the Company's research activities under
1. No Independent Environmental Site Assessment. No independent Phase I or Phase II Envir
1. No Independent Environmental Site Assessment. No independent Phase I or Phase II Environmental Site Assessment was commissioned by Penterra or C&H for purposes of this Transaction. Our review of environmental site conditions is based on the existing Phase I ESA conducted by the landlord in 2017, as described in Section VIII below, together with the other Data Room materials and management discussions described abo
2. Leased Facility; Landlord Responsibility. Veridian does not own real property. Its sol
2. Leased Facility; Landlord Responsibility. Veridian does not own real property. Its sole Facility is leased, and the environmental conditions of the underlying real property are primarily the responsibility of the landlord under the terms of the Lease, subject to Veridian's obligations with respect to tenant-caused contamination. Our review was accordingly focused on Veridian's operations within the leased premises
3. Scope Limited to Environmental Matters. This memorandum addresses environmental compli Medium
⚑ Liability cap to check against exposure
3. Scope Limited to Environmental Matters. This memorandum addresses environmental compliance and liability matters. Occupational health and safety matters governed by the Occupational Safety and Health Administration ("OSHA") are addressed herein only to the extent they overlap with environmental compliance (e.g., the Chemical Hygiene Plan required by the OSHA Laboratory Standard, and the Biological Safety Plan requ
4. Reliance on Information Provided. Our analysis is based on the documents and informati
4. Reliance on Information Provided. Our analysis is based on the documents and information provided to us in the Data Room and through management discussions. We have not independently verified the accuracy or completeness of such information, and our conclusions are necessarily limited by the scope and quality of the materials made available to us.
III. FACILITY OVERVIEW Medium
⚑ Liability cap to check against exposure
III. FACILITY OVERVIEW A. Principal (and Sole) Facility — 550 Gateway Drive, Cambridge, MA 02142 Veridian's sole physical location is its leased laboratory and office space at 550 Gateway Drive, Cambridge, Massachusetts 02142. The key characteristics of the Facility are summarized below. Nature of Occupancy. Veridian occupies leased laboratory and office space within a multi-tenant life sciences and biotechnology bui
IV. ENVIRONMENTAL REGULATORY FRAMEWORK Medium
⚑ Liability cap to check against exposure
IV. ENVIRONMENTAL REGULATORY FRAMEWORK A. Applicable Federal Laws and Regulations The following federal environmental laws and regulations are applicable, or potentially applicable, to Veridian's operations at the Facility: Resource Conservation and Recovery Act (RCRA). RCRA, as amended, and the regulations promulgated thereunder by the EPA at 40 CFR Parts 260–272, govern the generation, transportation, treatment, st
V. HAZARDOUS MATERIALS AND WASTE MANAGEMENT Medium
⚑ Liability cap to check against exposure
V. HAZARDOUS MATERIALS AND WASTE MANAGEMENT A. Hazardous Waste Generator Status Veridian is registered as a Small Quantity Generator ("SQG") of hazardous waste under RCRA and the Massachusetts Hazardous Waste Regulations (310 CMR 30.000). The Company's EPA Identification Number is on file with the EPA and MassDEP, and its generator registration is current as of the date of this memorandum. As an SQG, Veridian generat
VI. AIR EMISSIONS AND WATER DISCHARGES
VI. AIR EMISSIONS AND WATER DISCHARGES A. Air Emissions Veridian operates chemical fume hoods and biological safety cabinets in its laboratory space as part of the standard engineering controls required for safe handling of chemical and biological materials. Chemical fume hoods provide ventilation to protect laboratory personnel from exposure to hazardous chemical vapors, and their exhaust air is ducted through the b
VII. ENVIRONMENTAL PERMITS, LICENSES, AND REGISTRATIONS — SUMMARY
VII. ENVIRONMENTAL PERMITS, LICENSES, AND REGISTRATIONS — SUMMARY The following table summarizes the environmental-related permits, licenses, and registrations currently held by Veridian in connection with its operations at the Facility: Based on our review, all permits, licenses, and registrations identified above appear to be in good standing. No pending enforcement actions, notices of violation, consent orders, ad
VIII. ENVIRONMENTAL SITE CONDITIONS AND CONTAMINATION Standard
⚑ Commercial term
VIII. ENVIRONMENTAL SITE CONDITIONS AND CONTAMINATION A. Phase I Environmental Site Assessment A Phase I Environmental Site Assessment ("Phase I ESA") for the building at 550 Gateway Drive, Cambridge, MA 02142, was conducted by TerraVerde Environmental Partners, Inc. in November 2017 at the direction of Gateway Life Sciences Properties LLC (the landlord), in connection with the acquisition and financing of the buildi
IX. ENVIRONMENTAL, HEALTH, AND SAFETY (EH&S) PROGRAMS
IX. ENVIRONMENTAL, HEALTH, AND SAFETY (EH&S) PROGRAMS A. EH&S Management System Veridian maintains an internal EH&S program managed by a designated Environmental, Health, and Safety Manager who reports to the Company's Director of Facilities. The EH&S program is responsible for overseeing the Company's compliance with applicable environmental, health, and safety laws and regulations, maintaining the Company's environ
X. ENVIRONMENTAL INSURANCE COVERAGE High
⚑ Non-compete / exclusivity restraint
X. ENVIRONMENTAL INSURANCE COVERAGE This section summarizes Veridian's environmental insurance coverage at a high level. A detailed analysis of the Company's insurance program, including policy limits, deductibles, exclusions, and adequacy, is set forth in the Insurance Due Diligence Memorandum (dated May 16, 2024), which should be consulted for a comprehensive assessment. Veridian maintains a commercial general liab
XI. ENVIRONMENTAL REPRESENTATIONS AND WARRANTIES IN THE SPA
XI. ENVIRONMENTAL REPRESENTATIONS AND WARRANTIES IN THE SPA The Stock Purchase Agreement (execution version dated June 10, 2024) includes environmental representations and warranties made by the Sellers (as defined in the SPA) in Section 3 of the SPA. The environmental representations cover the following principal topics: (a) Compliance with Environmental Laws. The Sellers represent that the Company is, and during th