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    • Apr 08, 2021

COVID-19: Legal and Business Toolkit

Alert September 2021

COVID-19: Legal and Business Toolkit

September 2021

As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are facing and develop plans and strategies in response.

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Reach out to our COVID-19 task force at COVID19@cov.com.

Below is a compendium of resources and updates about COVID-19 and its potential impact on different industries published by our lawyers and advisors in these areas.

Companies are also encouraged to visit coronavirus.gov and World Health Organization: WHO for updates and information from public health authorities and agencies on protecting individuals and businesses.

Jump to a practice area for practical guidance and resources:

 

Antitrust and Competition

Key Considerations

  • Competition Guardrails for Business Collaborations
    • How to collaborate, share information, and benchmark with competitors during the Covid-19 crisis
    • Watch-outs for pricing and price-gouging
  • Mergers and Filings
    • Impact of the Covid-19 crisis on the timing of merger reviews: what does it mean for your deal?
  • Government Investigations (conduct and cartels)
    • How does the Covid-19 crisis impact the timing and scope of ongoing investigations around the world?
    • Areas of heightened scrutiny amid the global pandemic
  • Antitrust Litigation, Private Enforcement Actions and Updates on the Courts
    • Updates on timing, filings, and other proceedings 
    • Best practices for ongoing litigations
  • EU State Aid
    • The return of EU State Aid review - with a vengeance 

    • What to look out for when you receive financial aid from EU governments

Resources

Media Mentions

Our Team

 

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Arbitration

Key Considerations

  • Notice requirements, termination and potential renegotiation of agreements
  • Force majeure, acts of god and other contract clauses and legal provisions justifying non-performance

  • Suspension of ongoing arbitration proceedings and new technologies for conducting hearings and considerations that apply

Our Team

Resources

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Contractual and Commercial Disputes

Key Considerations

  • Assess position with respect to contractual non-performance, including force majeure, frustration of purpose, material adverse event and impossibility/impracticality
  • Consider how to manage impediments to compliance with contractual notice requirements and service of proceedings
  • Review the impact of court closures on pending lawsuits, including hearings and deadlines, and on decisions regarding whether and on what terms to settle rather than litigate
  • Communicate proactively with counter-parties and establish a process for mutually agreed amended performance

  • Plan for the need for alternative and second sources of products and services

Resources

Media Mentions

Our Team

 

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Corporate: M&A, Securities and Capital Markets, Corporate Governance, Finance, Restructuring and Bankruptcy, and Technology Transactions

Key Considerations

  • Mergers & Acquisitions
    • Implications for existing acquisition agreements. Considerations regarding termination, MAE and covenant compliance, and financing
    • Implications for new deal agreements. Considerations for performance, deal certainty, and specific performance
    • Corporate governance. Advice to the Board on mitigating COVID-19 risk and implications for strategic transactions
  • Securities and Capital Markets / Corporate Governance
    • Conditional reporting relief for affected persons
    • Disclosure guidance for companies
    • Compliance policy considerations
    • Annual meeting and proxy disclosure considerations
    • Advice to boards of directors on managing COVID-19
  • Restructuring and Bankruptcy
    • Material contracts
    • Intellectual property licenses
    • Financing arrangements
    • Transactions
  • Technology and IP Transactions
    • Evaluation of commercial agreements

    • Analysis for force majeure, frustration and impossibility terminations or suspensions

Resources

Media Mentions

Our Team

M&A

Securities and Capital Markets / Corporate Governance

Restructuring and Bankruptcy

Technology and IP Transactions

Private Equity

Venture Capital and Emerging Companies

 

 

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Data Privacy and Cybersecurity

Key Considerations

  • Reviewing business strategies that involve the collection of health, travel, and other data from employees, customers, and other parties. 
    • This includes assisting with the drafting and review of health questionnaires or surveys that track employee health status to prevent COVID-19 contamination and advising on the use of thermal scanners and other technologies used to prevent such contamination.
  • Advising digital health and other clients on managing privacy risks in connection with technologies and solutions that are used to support individuals during the COVID-19 pandemic.
  • Advising clients responding to cyber-attacks and other external threats leveraging vulnerabilities caused by the COVID-19 pandemic and how to proactively manage those cyber risks
  • Helping clients manage the privacy and cyber risks that arise in connection with remote work.
  • Advising on the privacy issues relating to disclosures of health and other data from employees, customers, and others to public health authorities, other government regulators, and commercial partners.

  • Ensuring that COVID-19 policies and procedures take account of relevant guidance and directives from data privacy regulators.

  • Advising companies on lawful grounds for processing of health data generated by COVID-19 employee testing and screening programs.

Resources

Media Mentions

Our Team

 

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Election and Political Law

Key Considerations

  • Lobbying and FARA
    • Consider whether outreach to Congress or the executive branch regarding relief legislation or regulatory action trigger lobbying registration or reporting requirements.
    • Weigh whether contacts with state or local governments on issues related to the pandemic, such as relief legislation, emergency declaration, or "essential" business designation trigger state or local lobbying registration requirements.
    • Assess whether activities, such as foreign manufacturers seeking to import their products or foreign countries seeking assistance in procuring medical equipment, raise a requirement to register under the Foreign Agents Registration Act.
  • Bribery, Gratuities, Waste, Fraud, and Abuse
    • Watch out for communications that tie political contributions or charitable support to government actions such as contracts, bailouts, or loans
    • Bailout recipients should keep in mind that government investigations -- including Congressional investigations -- frequently focus on the recipients of government relief.
  • STOCK Act
    • Given recent market volatility, companies might revisit their insider trading policies to ensure they address trading on inside government information. 
  • Gifts to Government

    • Consider whether well-intentioned donations and in-kind gifts to government agencies comply with applicable "anti-deficiency," government ethics, and "behested" gift rules.

Resources

Our Team

 

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Employment and Employee Benefits

Key Considerations

  • Continuity of employment as the solution to the COVID-19-induced economic crisis 
  • Understanding new COVID-19 workplace and benefits legislation
  • Compliance issues raised by employment, privacy, and benefits obligations
  • Responsibilities to employees across jurisdictions 

  • Employee communications

  • Reporting obligations associated with COVID-19 employee testing and screening programs

Resources

Media Mentions

Our Team       

 

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Energy and Environmental

Key Considerations

  • Disinfectants: Compliance with FIFRA (and state law) for pesticides, including household disinfectants and other products used to kill or mitigate viruses on surfaces.
  • OSHA: Safe working environment for employees in light of COVID-19, including compliance with mandatory standards and the General Duty clause.
  • Emergency Exemptions: The COVID-19 crisis and associated shutdown orders can result in an inability to fully comply with standard environmental obligations. Most environmental statutes have certain exemptions for emergencies, and EPA has announced it will exercise some enforcement discretion in light of the pandemic.

Resources

Media Mentions

Our Team

 

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Financial Services Regulatory

Key Considerations

  • The CARES Act provides a number of opportunities for regulated financial institutions to participate in federal lending programs in support of businesses, states, and municipalities affected by the COVID-19 pandemic (e.g., expanded SBA loan program, Treasury-funded Federal Reserve loan facilities under section 13(3) of the Federal Reserve Act). 
    • Institutions should evaluate these opportunities and determine whether any are a good fit for their business.  
  • The act also contains provisions affecting regulated banks directly, such as limited capital relief for community banks, temporary relief from the accounting requirements for troubled debt restructurings, and optional and temporary relief from the current expected credit loss methodology (CECL), and banks should understand these provisions as they may help them navigate the uncertain economic climate during the pandemic.   

  • Federal and state banking agencies have been active in issuing guidance to banks to encourage them to lend and provide other banking services to customers affected by COVID-19.

Resources

Media Mentions

 

Our Team

 

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Food and Beverage

Key Considerations

  • The food and agriculture sector has been designated by the U.S. federal government (and several other governments around the world) as a critical infrastructure sector (“COVID-19 Update for Food Companies Navigating Quarantine Disruption”; "DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19"). While this designation does not automatically preempt state and local quarantines, curfews, and related restrictions, companies facing regional difficulties in sustaining their operations and getting their goods to market can point to federal guidance to underscore the essential nature of their operations. Companies should also consider providing their employees with certifications documenting their role in sustaining this critical infrastructure, as directed by the President in his Coronavirus Guidance. Food companies experiencing supply chain, business continuity, or delivery disruptions resulting from state and local quarantines or similar restrictions may also contact the FEMA National Business Emergency Operations Center at NBEOC@fema.dhs.gov in the U.S., or liaise with their local government and trade associations in other parts of the world.
  • FDA, CDC, and other public health authorities have confirmed that food and food packaging are not sources of transmission of COVID-19. Recalls would not be required if an employee handling food products tested positive for the virus.
  • The primary health and safety consideration in food facilities during this crisis is the safety of the work force. Facilities should conduct enhanced sanitation of common and high-touch areas, and may wish to consider whether to adjust shifts or other aspects of their operations to enhance social distancing where feasible. Food companies should develop protocols for anticipating and managing the risk that employees will test positive for COVID-19.
  • Food produced for foodservice, which market has shrunk drastically, might be able to be shifted to retail sale, even if not in fully-compliant retail packaging. The USDA's Food Safety and Inspection Service has already allowed such shifts for products it regulates, and the industry has asked FDA to consider allowing such flexibility as well. In other jurisdictions businesses should check local practice and consider asking regulators to be flexible.

  • Food companies should check their insurance policies carefully for coverage opportunities. The following policies potentially cover COVID-19-related losses: Property/Business Interruption, Event Cancellation, Pollution Legal Liability, General Liability, Directors and Officers Liability, Employment Practices Liability, and Professional Services.

Media Mentions

Our Team

Foods, Beverage, and Dietary Supplements

 

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Government Contracts

Resources

Media Mentions

Our Team

 

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Insurance

Key Considerations

  • Coverage for business interruption losses including lost revenue and supply chain disruptions (mostly via property insurance)
  • Coverage for clean-up, abatement, and removal cost recovery
  • Event cancellation insurance claims 
  • Liability insurance for defense/resolution of COVID-19 lawsuits and supply chain losses

  • D&O, Employment Practices, Trade Credit and other financial lines insurance claims

Resources

Media Mentions

Our Team

If you have any questions regarding coverage for the coronavirus, please contact one of the many experienced members of our Insurance Recovery Practice or one of the following practice group chairs:

 

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International Trade

Key Considerations

  • CFIUS
    • Reviews of foreign investment in technologies and other critical supplies for COVID-19 and distressed assets.
    • Impact of COVID-19 on Committee on Foreign Investment in the United States (CFIUS) operations.
  • Trade Controls
    • Export controls related to cross-border projects to combat COVID-19, including export controls relevant to virus samples and related equipment and technology.
    • New restrictions on the export from the European Union and United Kingdom of certain medical equipment and medicines.
    • Licenses related to exports of COVID-19 therapies to Iran, Cuba, and other sanctioned markets.
  • Trade Law, Policy, Disputes
    • Section 301 tariff exclusions for COVID-19-related imports.
    • Import of goods essential for combating COVID-19.

    • Duty, tax, and fee payment extensions and other duty deferral and mitigation options.

Resources

Media Mentions

Our Team

CFIUS

Trade Controls

Trade Law, Policy, Disputes

 

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Life Sciences

Key Considerations

  • Working with Food and Drug Administration (FDA), the European Medicines Agency (EMA), the China National Medical Products Administration (NMPA), and other health authorities on behalf of industry trade associations, pharmaceutical companies, and medical device companies to help expedite authorization of medical products to respond to the COVID-19 public health emergency.
  • Helping clients obtain FDA emergency use authorizations (EUA) and associated PREP Act protections for medical products to diagnose, prevent, and treat COVID-19.  This often involves navigating parallel and joint negotiations with HHS, FDA, BARDA, NIAID, and CDC on the research.
  • Handling unique regulatory issues presented by the pandemic, including challenges around ongoing clinical trials, supply chain disruptions, drug shortages, and GMP matters, among others.

  • Assisting companies outside of the life sciences industry to bring forward novel solutions and repurpose operations to aid with the response to the pandemic, including manufacture of hand sanitizers, personal protective equipment, and ventilators.

  • Given that many jurisdictions have issued “stay” or “shelter” in place orders, introduced restrictions on workers travel, and other measures, helping businesses assess exemptions for “essential” activities, which can include pharmaceutical, medical device, manufacturing, and other select activities based on the relevant country, state, and local orders.  For example, Ireland, a key jurisdiction for pharmaceutical manufacturing and the global supply chain of medicines has exempted such activities (see here).

  • Advising companies on COVID-19 employee testing and screening programs, including health authority approval requirements and regulation of testing materials (assays etc.).

Digital Health

  • Governments and private organizations are looking for digital solutions to help identify, monitor, track, prevent, mitigate and otherwise aid with the global response to COVID-19.
  • Life sciences companies, tech companies, and healthcare systems are entering into new collaborations (including with industrial manufacturers) -- in an expedited manner -- to bring expertise together around therapeutics, devices, diagnostics, manufacturing, and AI and machine learning, to advance solutions that will help combat the pandemic.
  • Telemedicine solutions are taking a new level of importance given the need for social distancing and for keeping our healthcare facilities open for patients who need it most.
  • 3-D printing as means of rapidly deploying manufacturing capabilities in response to a crisis.

  • Greater health surveillance may be a lasting trend for society and public health policy.

Healthcare

  • Drug and biotech companies are increasingly looking to donate drugs to hospitals on the front lines of the COVID-19 crisis--including drugs for unrelated conditions.
  • Drug and biotech companies are expanding their patient assistance programs to accommodate patients who can no longer afford their drugs as a result of the economic shut down.
  • Drug and biotech companies are shifting to a model of virtual detailing and virtual speaker programs with health care professionals and are considering other ways to engage with customers digitally.
  • Life Sciences companies are accelerating telemedicine partnerships and initiatives as both public and private payers broaden access and reimbursement to these services to help meet the challenges of social distancing related to COVID-19.
  • Life Science companies are considering changes to their patient support programs to address COVID-19 related limitations on capturing patient consents, prescription reauthorizations from providers, and related enrollment information.

  • Life sciences companies are actively exploring how their data and data analytics capabilities can be used to identify and intervene with  vulnerable populations, predict developing concentrations of infection, and effectively deploy limited resources.

Medical Devices

  • United States
    • FDA's Emergency Use Authorizations (EUA), GMP waivers, and enforcement policies for devices needed for COVID-19 response efforts (e.g., diagnostic tests and supplies, ventilators, mask/respirators, personal protective equipment, patient monitoring devices, digital tools) and how to engage with FDA
    • Regulatory requirements for efforts to increase production of critical medical devices, including modifying devices to address supply chain issues, increasing production at existing manufacturing lines, 3D printing, and manufacturing by non-traditional device companies
    • Impact of COVID-19 response on FDA and other regulator operations (e.g., inspections, review of submissions) and on medical device manufacturer compliance activities (e.g., postmarket reporting)
    • Lability considerations for companies manufacturing or distributing medical devices, including availability of PREP Act immunity
  • United Kingdom and European Union
    • EU Special Authorizations - Exceptional use rules of EU member state authorities to permit marketing of non-CE marked devices, including flexibility to market ventilators in the UK under the MHRA's “Rapidly Manufactured Ventilator System” Specification
    • European Commission's decisions on harmonized standards for conformity assessment procedures for certain devices critical to the pandemic response, including medical face masks, surgical drapes, gowns and suits, washer-disinfectors and sterilization
    • EU MDR - Implications of the European Commission's plans to postpone the application date of the new Medical Device Regulation 2017/745 in the EU
  • China
    • China's Special Approvals pathway for in vitro diagnostics for COVID-19
    • Evolution of e-diagnosis and internet hospital solutions and technology in response to the healthcare shortages in China
    • Considerations surrounding exportation from China of ventilators and masks, including issues surrounding medical-use versus industrial/hygiene-use masks
    • Restrictions on medical device manufacturing operations in China pursuant to the Emergency Response Law and other related legislation and policy

    • China's National Medical Product Administration's delay of medical device license amendments and renewal applications and continued marketing of existing products

Drugs/Pharmaceuticals and Biotechnology

  • Product liability aspects of off-label use of drugs and devices
  • Allocation of limited supplies of drugs and devices
  • Delay in regulatory action (e.g.  postponing pre-approval inspections)
  • Impact of the public health crisis on FDA and other regulators -- changed review priorities, inability to hold in-person meetings, postponement of required preapproval inspections, etc.
  • Effects on clinical trials -- informed consent procedures, enhanced remote monitoring, etc.
  • Procedures for expedited development and approval of medical products -- diagnostics, personal protective equipment, ventilators and other medical devices for treatment of patients, antivirals and other drug treatments, vaccines
  • Potential for public/private partnerships, government contracts or grants for development of needed medical products or construction of new manufacturing facilities
  • Expanded access and compassionate use programs for investigational products
  • Liability issues associated with expedited approvals
  • Commercial disputes and potential insurance claims related to voluntary or mandatory interruptions in manufacturing and supply operations

  • Scope of federal authority under the U.S. Defense Production Act and comparable laws in other jurisdictions

China

  • China's Special Approval pathway for drugs for COVID-19, including approvals for clinical development and testing issues
  • Restrictions on drug manufacturing operations in and supply from China pursuant to the Emergency Response Law and other related legislation and policy
  • Adjustments to development plans and clinical trial operations in China related to continued quarantine restrictions

  • Regulatory issues related to evolution of e-diagnosis and internet hospital solutions and technology in response to the healthcare shortages in China, including related to drug distribution and promotion

Resources

Food and Drug

Medical Devices and Diagnostics

Media Mentions

Our Team

Digital Health

Healthcare

Medical Devices

Drugs/Pharmaceuticals and Biotechnology

Drugs and Biologics, including Vaccines

 

 

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Policy

Key Considerations

Global

  • Business closure rules
  • Travel restrictions – both in-country and border closures
  • Designation of “critical workers” / “critical industries” that may continue operations
  • Engaging regional and national governments on support measures, continuity of operations (including ensuring that “critical industries” may operate)

  • Impact of responses to COVID-19 on EU FDI screening policy

Public Policy/State and Local

  • Essential business exemptions
  • "Stay at home" orders
  • State recovery legislation 
  • State implementation of federal recovery legislation

  • State and local lobbyist vetting

Resources

Media Mentions

Our Team

Legislative

Federal

Global

 

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Tax

Key Considerations

  • Tax provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act 
  • Impacts of the TCJA on companies with U.S. losses
  • Changes to certain rules and regimes, including net operating loss (NOL), global intangible low-taxed income (GILTI), foreign-derived intangible income (FDII), base erosion and anti-abuse tax (BEAT), and Section 965 Transition Tax
  • Payroll tax
  • Mitigation through planning

  • Mitigation through policy changes

Resources

Media Mentions

Our Team

 

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Technology

Key Considerations

  • Complying with applicable regulatory framework for technology being developed to address COVID-19, including a government “call to action” 
  • Technology collaborations and transactions – handling licensing, IP, and other key issues
  • Managing privacy, data security, and cybersecurity risks 
  • Mitigating product liability risks and insurance coverage issues 
  • Managing remote employees, contract workers, and handling possible reductions in workforce

  • Developing, securing and deploying AI and IoT technologies in COVID-19 response

Artificial Intelligence (“AI”)

  • AI continues to play an important role in combatting COVID-19, including by helping to identify high risk patients, promising treatments, and vaccine candidates.
  • As re-openings progress, AI increasingly will be leveraged in many contexts, including contact tracing, healthcare, logistics, supply chain management, robotics and other automation, autonomous vehicles, drones, and workforce management.
  • The global AI legal landscape is evolving rapidly, including with respect to “AI ethics and governance,” intellectual property, liability, privacy and cybersecurity, trade controls, and sector specific requirements.  Policymakers also are focusing on how AI can help respond to COVID-19.

  • These and other AI legal considerations can arise in many contexts, including when developing or using AI, when making AI available to others, and when entering into commercial transactions or other agreements involving AI.

Internet of Things   ("IoT")

  • With the loosening of COVID-19-related restrictions and re-opening initiatives around the world, there will be increased use of robotics, drones, wearable health devices, and IoT-connected medical, scanning, and other technologies for public health monitoring, including the use of surveillance and consumer devices for contact tracing.
  • Workplace environments will rely more heavily on IoT technologies, with more employees working remotely and the increased use of robotics in factories, warehouses, and other places of business. Businesses will use IoT technologies to reduce the need for human workers, increase efficiencies, and facilitate "contactless" transport and deliveries.
  • Legal and regulatory constructs for IoT will continue to evolve across the globe.  The importance of the collection, transmittal, handling, and security of data by IoT devices is constantly increasing, and concepts of ownership continue to evolve.  Differing laws from region to region complicate the launch of IoT devices globally.

  • Machine-to-machine-communication and IoT connectivity in connection with supply-chain issues becomes even more important in the future.

Resources

Media Mentions

Our Team 

Artificial Intelligence ("AI")

Internet of Things ("IoT")

 

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White Collar

Key Considerations

  • Preparing for and responding to congressional, governmental, and civil investigations related to CARES Act relief
  • Assessing and guarding against risk of unfair competition and price gouging investigations
  • Detecting bribery, fraud, and other misconduct in a remote-work environment
  • Managing shareholder demands and insider trading risks
  • Efficiently conducting necessary internal investigations
  • Coordinating with key enforcement agencies and navigating disclosure obligations 
  • Maintaining a strong compliance culture

  • Vetting third party suppliers in your supply chain

Resources

Media Mentions

 

Our Team

 

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