Operational Resilience & Supply Chain
Pivoting Business Operations to Navigate and Survive the Outbreak
COVID-19 has emphasized the importance of business agility for companies handling sudden and extremely adverse operational events. Many companies have been forced to alter their business model as a result of the virus, which presents new risks and opportunities, while the exposed vulnerability of the global supply chain has triggered a host of contractual and vendor disputes. The intense pressure on supply chains has also led to recent legislation and enforcement actions aimed at preventing fraud and unfair or unlawful practices. The ability for companies to weather the current storm and emerge as more resilient organizations depends on their ability to quickly adapt while also effectively managing risks.
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In Case You Missed It: The Influence of Bioethics in Research and Development
October 27, 2020| Blog|
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Our Approach
Our interdisciplinary team understands the pressure on companies and health care providers to quickly adapt to this unprecedented environment. We work collaboratively with our clients to develop innovative solutions to their business challenges and if needed, resolve disputes with commercial partners as efficiently as possible.
- Providing guidance regarding the FDA’s Emergency Use Authorizations (EUAs) and enforcement discretion policies for manufacturers of medical products
- Counseling developers of potential COVID-19 therapeutics on regulatory standards for expedited pathways
- Counseling existing product sponsors in the life sciences industries on FDA actions to alleviate regulatory burdens
- Providing FDA guidance to distributors who are able to facilitate importation of personal protective equipment (PPE) and devices
- Advising clients on new product development marketing and labeling claims
- Advising health care and mental health providers on the use of telehealth platforms to deliver care, including state and federal licensure, HIPAA compliance, reimbursement changes, and funding opportunities through the CARES Act
- Counseling clinical laboratories on regulatory / approval guidance related to COVID-19 testing
- Advising retail health clinics on all issues relating to becoming a COVID-19 test site, including engaging with state departments of health, the Department of Health and Human Services, and other regulatory bodies and state agencies
- Analyzing proposed competitor collaborations for potential antitrust issues
- Advising clients on considerations for purchasing, outsourcing, and commercial contracts in response to supply chain disruptions
- Advising clients on disputes with vendors
- Advising on re-bidding of contracts for COVID-19 impacts
- Counseling clients on contractual obligations in existing commercial contracts
- Advising clients on potential contractual termination rights based on force majeure
- Drafting new contracts to include language on provisional rates based on current market standards
- Counseling clients post M&A on contractual matters such as breach of contract and representations and warranties claims
Our Team
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Member / Chair, Technology Transactions & Licensing Practice
Other COVID-19 Business Issues
Liquidity & Capital Management
The severe business and societal disruption caused by COVID-19 has resulted in decreased demand for most products and services across the gamut of industries. Many companies are facing liquidity issues as they look to maintain operations. The ability for businesses to meet financial obligations is still evolving and will create opportunities and challenges for businesses and their investors.
Managing Risk, Compliance & Litigation
The current period of uncertainty and unprecedented disruption reinforces the critical importance of taking a proactive approach towards continuously assessing and managing key risks to the organization. Whether our attorneys are helping a company safeguard its data against external threats, providing guidance to ensure compliance with relevant regulatory bodies, or working with a client to implement an effective strategy to minimize litigation risk, we leverage deep experience to advise clients on a broad range of risk management and compliance matters.
Navigating Federal, State & Local Government Responses
The current COVID-19 pandemic has generated a host of government responses to mitigate the impact of the virus, including Presidential Orders, state and local orders, enforcement actions and the sweeping stimulus packages. Keeping a finger to the pulse of government responses and their potential impacts before they happen can offer critical time for planning or the ability to more quickly access much needed relief for your business.
Workforce & Human Capital Management
The COVID-19 pandemic has dramatically altered the way that we live, work, and interact in a very short time. Understanding the diverse and multi-jurisdictional challenges created by containment efforts, while ensuring the safety and well-being of your employees and attempting to minimize risk and business disruption, can be a daunting task. Our experienced attorneys assist clients with navigating the legal considerations of these complex workforce issues, while keeping your organization and its most important resource – its people – front of mind.
Navigating Capital Markets & Public Company Reporting
The current COVID-19 pandemic has generated a host of issues for public companies. The SEC, NYSE, Nasdaq, and others are taking actions that impact access to capital markets, financial reporting, and disclosure obligations. Navigating the legal and practical implications of the pandemic is crucial to ensuring compliance with the securities laws and keeping investors fully informed.
Related Practices
- Bankruptcy & Restructuring
- Debt Financing
- Mergers & Acquisitions
- Private Equity
- Public Finance
- Securities & Capital Markets
- Tax
- Venture Capital & Emerging Companies
- Employment Counseling and Training
- Complex Commercial Litigation
- M&A Litigation
- Insolvency & Creditor Rights Litigation
- Employment Litigation & Arbitration
- Bondholder, Bond Trustee & Bondholder Committee Representation
- Distressed Asset Sales & Acquisitions
- Official, Ad Hoc & Other Creditor Representation
- Insolvency & Creditor Rights Litigation
- Education & Health Care Financings
- Government / Quasi Government Financings
- Bondholder / Trustee Representation