Industries

Following the declaration of a global pandemic due to the widespread transmission of the coronavirus (COVID-19), the issuance of shutdown and/or stay-at-home directives cascaded from commercial enterprises and state and local governments across the United States. During this period of extreme disruption to daily routine, the continuity and integrity of energy operations were necessary to ensure that the massive shift to home-based life could exist with minimal business disruption.

Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.

The Federal Energy Regulatory Commission (FERC) issued a notice on May 20 that it will convene a Commissioner-led technical conference to consider the ongoing, serious impacts that the emergency conditions caused by the coronavirus (COVID-19) pandemic are having on the energy industry. The conference will be free, open to the public, and held remotely on Wednesday and Thursday, July 8-9, 2020.

The NRC Staff released specific guidance to all licensees on how to request exemptions from emergency preparedness (EP) biennial exercise requirements on May 14. The guidance supplements the NRC’s April 30 teleconference, during which it acknowledged that there may be instances in which licensees are unable to comply with certain EP requirements, including required training and drills, during the coronavirus (COVID-19) public health emergency (PHE).

The US Department of the Treasury issued a letter on May 7 stating that it plans to modify the continuity safe harbor for both the production tax credit (PTC) and the energy investment tax credit (ITC). Under the current law, taxpayers seeking to claim a PTC for electricity produced from qualifying facilities or an ITC for qualifying energy property must generally begin construction on the qualifying facility or property by specified dates.

In response to President Donald Trump’s declaration of a national emergency due to the coronavirus (COVID-19) pandemic, the Pipeline Hazardous Materials Safety Administration (PHMSA) issued a notice that it does not intend to take enforcement action related to certain new gas pipeline safety regulations with which gas pipeline operators must comply by July 1, 2020.

Companies with substantial business interruption losses related to the coronavirus (COVID-19) pandemic must take immediate, concrete steps now to preserve their ability to pursue recoveries from insurance and/or financial relief from future governmental programs.

The NRC Staff hosted a public meeting via teleconference on April 30 to discuss regulatory relief from emergency preparedness (EP) requirements during the coronavirus (COVID-19) public health emergency (PHE).

The US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 29 to discuss available regulatory relief pathways from fire protection requirements during the coronavirus (COVID-19) public health emergency (PHE).

The US Department of the Treasury recently began accepting loan applications from qualifying Defense Industrial Base contractors, with a short deadline of May 1, 2020, to submit the application for expedited review.

The US Nuclear Regulatory Commission (NRC) issued a letter on April 27 to the Nuclear Energy Institute and the National Organization of Test, Research, and Training Reactors, and others, clarifying and expanding the guidance on respiratory protection requirements that it previously provided to stakeholders during an April 15 teleconference.

The US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 22 to discuss available regulatory relief pathways for medical licensees during the coronavirus (COVID-19) public health emergency (PHE).

Prepackaged bankruptcies, prearranged bankruptcies, and expedited sales are available options for businesses in need of accelerated restructurings during the coronavirus (COVID-19) pandemic.

The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.

New guidance from the UK Competition and Markets Authority warns that it will not relax its substantive or evidentiary standards for merger investigations during the coronavirus (COVID-19) pandemic. Statutory deadlines will not be altered, although aspects of investigations may be subject to delay, and the authority will continue to impose interim measures. The authority also set out its position on mergers involving “failing firms,” indicating some flexibility in its interpretation of the counterfactual test.

Compensation Committees are addressing whether compensation should be adjusted to reflect the effect of the coronavirus (COVID-19) pandemic on companies’ businesses and how to correlate executive compensation with changing company priorities. Here is how compensation committees can approach this challenge in the coming months.

In an order issued on April 17, the Federal Energy Regulatory Commission (FERC) agreed to defer implementation of certain cybersecurity and operational reliability standards administered by the North American Electric Reliability Corporation (NERC) that had important compliance milestones later this year, including the suite of supply chain risk management standards that have been under development for several years and were set to take effect on July 1. The move by FERC is intended to provide some measure of relief from impending compliance burdens and to allow electric utilities to focus their resources on responding to the coronavirus (COVID-19) pandemic.

The NRC’s Office of Nuclear Reactor Regulation (NRR) now has a web portal for nuclear reactor licensees to submit coronavirus (COVID-19) related regulatory exemption requests. The web portal currently allows online submissions for Part 26 Work Hour exemption requests. Online submissions for Part 55 Operator Licenses, Part 50.55a Owner’s Activity Reports, and Part 73 Physical Protection exemptions are coming soon.

The US Department of Homeland Security’s Cybersecurity & Infrastructure Security Agency (CISA) issued Version 3.0 of its guidance on April 17 on identifying essential critical infrastructure workers amid the coronavirus (COVID-19) pandemic.

The Occupational Safety and Health Administration has issued a new guidance allowing field offices flexibility in handling COVID-19-related matters, including complaints. The guidance focuses on highly affected industries, such as healthcare and first responders and prioritizes inspections in areas of imminent danger of exposures and fatalities. Enforcement for other industries is likely to shift from primarily on-site inspections to informal complaints and whistleblower actions.

The NRC’s Office of Enforcement (OE) recently issued Enforcement Guidance Memorandum (EGM) 20-002, providing guidance to NRC inspection staff for exercising enforcement discretion for licensees impacted by the coronavirus (COVID-19) pandemic.

In light of the ongoing coronavirus (COVID-19) pandemic, the ICC on April 9 released a guidance highlighting a number of measures that parties, counsel, and tribunal members can take in order to avoid extensive disruption to arbitral proceedings.

Morgan Lewis partners Julia Frost-Davies and Andrew Budreika, of counsel Jason Alderson, and associate Benjamin Stango authored a INSOL International article about access to bankruptcy courts in light of the coronavirus (COVID-19) pandemic.

The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.

Read the practical guidance provided by our labor and employment lawyers, highlighting key considerations employers should begin analyzing regarding how to reopen or expand operations. The focus is on what can be done now with the understanding that guidance on when and how workplaces can reopen or expand will rely in large part on jurisdiction-specific local orders and guidance.

In connection with the current state of emergency in Kazakhstan related to the coronavirus (COVID-19) pandemic, President Kassym-Zhomart Tokaev has signed a decree on a special military call-up in the Republic of Kazakhstan.

Shortly after the announcement that the 2020 Summer Olympics would be delayed until Summer 2021, the Japanese government on April 7 announced a state of emergency for Tokyo and six prefectures (Kanagawa, Saitama, Chiba, Osaka, Hyogo, and Fukuoka) in light of the coronavirus (COVID-19) pandemic. This LawFlash answers key questions about employers’ obligations to their employees during the state of emergency and provides an overview of the government subsidies currently available.

As New Jersey continues to battle the spread of coronavirus (COVID-19), Governor Phil Murphy ordered essential businesses in the state to adopt several measures including mandatory face coverings at worksites, occupancy limits for stores, and frequent handwashing breaks for employees. Employers should pay close attention to these comprehensive and far-reaching—and sometimes confusing—orders that impose affirmative duties and could raise a host of reasonable-accommodations issues.

The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.

US antitrust laws already on the books facilitate rapid investment without government delay: important practical tools and rules for dealmakers and their counsel in the wake of the coronavirus (COVID-19) pandemic and the current economic challenges.

The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a cooperation project in the generic pharmaceuticals sector aimed at ensuring the supply of critical hospital medicines. Other ad hoc “comfort letters” may follow at the EU Commission’s discretion.

The French government has been adopting a series of legal measures in response to the coronavirus (COVID-19) pandemic. The French Parliament voted on a law responding to the epidemic on 23 March (the Bill). In addition to measures relating to the holding of municipal elections and sanctions for breaches of the confinement regime which has been in force since 17 March, the government also took measures that affect French business and legal proceedings before the French courts in a variety of ways.

Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.

The Japanese government declared a state of emergency with respect to seven prefectures on April 7. The government also has issued emergency policies in response to the new coronavirus (COVID-19) pandemic, including the Emergency Economic Measures for New Coronavirus Infectious Disease Control, issued that same day.

The NRC issued its final Temporary Staff Guidance (Final Guidance) on April 6 on its review procedures for coronavirus (COVID-19)-related Part 26 exemption requests. The NRC previously issued a draft of this guidance on April 1 and also discussed the draft during a teleconference with the industry on April 2, which we reported on.

The US Nuclear Regulatory Commission (NRC) issued a letter on April 7 to all NRC licensees authorized to possess byproduct, source, and special nuclear material – excluding operating power reactor and research test reactor licensees – outlining how those licensees might seek relief from certain regulatory requirements as a result of the coronavirus (COVID-19) pandemic.

Texas Governor Greg Abbott issued Executive Order GA-14 on March 31, directing every person in Texas to minimize social gatherings and in-person contact with people who do not live in the same household except where necessary to provide or obtain essential services.

As the coronavirus (COVID-19) pandemic continues, state government agencies are increasingly responding with closures and cancellations. In Pennsylvania, the Department of Environmental Protection recently cancelled seven highly anticipated public hearings.

In response to the coronavirus (COVID-19) public health emergency, the US Nuclear Regulatory Commission (NRC) announced that it is prepared to grant upon request from individual Part 50 licensees, exemptions to the work-hour controls specified in 10 CFR 26.205(d)(1)-(7).

A week after first issuing guidance identifying the workers considered essential for critical industries in the United States during the coronavirus (COVID-19) pandemic, the US Department of Homeland Security’s Cybersecurity & Infrastructure Security Agency (CISA) on March 28, 2020, revised that guidance to capture a broader array of workers, particularly in the energy sector.

The ultimate impact of the coronavirus (COVID-19) pandemic on shareholder activism remains largely uncertain and comparisons with the surge in activism that followed the 2008 global financial crisis are tempting, but suspect as it remains questionable whether activists can still rely on the same forces that have been driving activism.

Overwhelmingly passed by both houses of the US Congress this week and signed into law by President Donald Trump on March 27, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) provides a $2 trillion economic stimulus and contains many major tax changes to help businesses and individuals.

Here are some frequently asked questions to help employers understand the legal ramifications of furloughs and terminations of H-1B workers in light of the coronavirus (COVID-19) outbreak.

Over the past few days, several civic and environmental organizations have requested that federal departments and agencies pause rulemaking activities in response to the worsening coronavirus (COVID-19) pandemic.

Widely expected to pass both houses of the US Congress by March 27, and to be signed into law by the president, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) lays out a $2 trillion economic stimulus, including over $300 million in emergency supplemental appropriations. This is a high-level summary of key portions of the bill.

Over the past days and weeks, various US state and local governments have issued orders that restrict travel and certain gatherings in an effort to slow the spread of the coronavirus (COVID-19). Although those orders have largely excepted, among others, individuals who are employed by industries that provide critical infrastructure, a lack of uniformity among those ordersand their piecemeal, jurisdictional naturehas caused some confusion. Recent guidance issued from the US Department of Homeland Security aims to reduce this confusion.

The US Federal Trade Commission and the Antitrust Division of the US Department of Justice have announced that they aim to respond within one week to coronavirus (COVID-19) collaborative proposals submitted pursuant to the agencies’ respective processes.

The NRC recently hosted a public meeting—exclusively via teleconference—to discuss regulatory implications of the coronavirus (COVID-19) pandemic for power reactor licensees. Of particular note, the NRC Staff is developing pandemic-related enforcement guidance. The first installment of this guidance is expected to be released early this week.

Functioning critical infrastructure is crucial during the response to the coronavirus (COVID-19) emergency for public health and safety reasons. And as noted in the Coronavirus Guidelines for America issued on March 16, US President Donald Trump has recommended that workers in critical infrastructure industries have a “special responsibility” to maintain normal work schedules. The Cybersecurity and Infrastructure Security Agency (CISA) on March 19 issued guidance on defining the Essential Critical Infrastructure Workforce. That guidance explicitly discusses workers in the nuclear and electric industries.

The rapidly evolving coronavirus (COVID-19) crisis has given rise to several immediate impacts to ongoing cleanups of contaminated sites under state and federal environmental laws.

FERC and NERC issued a joint notice on Wednesday providing compliance flexibility on certain key reliability standard requirements during the ongoing coronavirus (COVID-19) pandemic. Although this guidance can allow utilities to avoid findings of noncompliance for certain requirements where timely compliance activities could be difficult due to personnel shortages and other limitations, this is not a blanket waiver. Instead, utilities must provide written notices of their intent to use this guidance. The content of those notices must be drafted carefully as they will be necessary to demonstrate compliance in future reviews.

In responding to the coronavirus (COVID-19) pandemic, the mantra of “working together” is heard often. But as businesses confront sudden and extensive demand and supply disruptions—and a range of sometimes conflicting information and guidance from the public sector about the health crisis—questions inevitably arise about the extent to which the private sector can coordinate its responses consistent with the antitrust laws.

In responding to the coronavirus (COVID-19) pandemic, the mantra of “working together” is heard often. But as businesses confront sudden and extensive demand and supply disruptions—and a range of sometimes conflicting information and guidance from the public sector about the health crisis—questions inevitably arise about the extent to which the private sector can coordinate its responses consistent with the antitrust laws.

Morgan Lewis partner Jennifer Breen spoke with Law360 about the US Internal Revenue Service’s response to Coronavirus COVID-19.

A blog post authored by Morgan Lewis partner Michelle McCarthy and of counsel Saghi Fattahian was cited in an HR Daily Advisor article about the 2019 Novel Coronavirus (COVID-19) and HIPAA compliance.

Nonprofit organizations are on the front lines in the battle against the coronavirus (COVID-19), but they also number among the many victims of COVID-19’s devastating financial impact. In response, the Federal Reserve recently announced that loans would be available to nonprofit borrowers under the Main Street Lending Program, and issued a FAQ on two new facilities—the Nonprofit Organization New Loan Facility and the Nonprofit Organization Expanded Loan Facility.

The US Internal Revenue Service (IRS) issued news release IR-2020-194 on August 28, approving the temporary use of digital signatures for certain IRS forms that must be filed with the IRS manually.

The Financial Conduct Authority (FCA) has challenged eight insurers in a business interruption insurance test case in order to seek coverage for insureds. The UK’s financial services industry regulator is taking an adversarial stance in order to determine whether 17 different policy wordings can provide cover for businesses across the country, in the hope this will provide a level of certainty at this difficult time for businesses.

Morgan Lewis partner Roger Joseph spoke with Fund Directions for an article about virtual board meetings amid the coronavirus (COVID-19) pandemic.

The US Securities and Exchange Commission’s Office of Compliance Inspections and Examinations (OCIE) published a Risk Alert on August 12 highlighting compliance considerations created by the coronavirus (COVID-19) pandemic for SEC-registered investment advisers and broker-dealers (Firms). This LawFlash highlights the areas of focus in the Risk Alert and provides a checklist of considerations and actions to assist Firms in addressing COVID-19-related compliance issues.

As negotiations for a further comprehensive stimulus package drag on in Congress, US President Donald Trump on August 8 signed two executive actions—a combination of a memorandum and an executive order—that purportedly extend various aid measures previously provided through the Coronavirus Aid, Relief, and Economic Security (CARES) Act, or impose additional economic relief measures for homeowners, renters, and student loan borrowers impacted by the coronavirus (COVID-19) pandemic.

The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.

The Consumer Financial Protection Bureau (CFPB or Bureau) issued an interim final rule (IFR) on June 23, 2020 that temporarily permits mortgage servicers to offer to borrowers impacted by the coronavirus (COVID-19) pandemic certain loss mitigation options based on the evaluation of an incomplete loss mitigation application.

As governments around the world work to stem the coronavirus (COVID-19) pandemic, merger control authorities in jurisdictions around the globe are adapting their operations and procedures.

The Coronavirus Aid, Relief and Economic Security (CARES) Act provides two measures of relief to taxpayers, but taxpayers amending federal income tax returns should be aware these benefits may not reach their state income tax returns.

Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.

New guidance from the Internal Revenue Service will allows RICs and REITs to retain more capital by distributing less cash to shareholders in certain stock distributions—welcome relief during the current economic volatility resulting from the coronavirus (COVID-19) pandemic.

Federal and state regulators and Congress continue to release new guidance and requirements to assist mortgage borrowers facing economic hardships resulting from the coronavirus (COVID-19) pandemic. Due to the high volume of borrower requests, the associated burden on servicers, and the unknown duration of the COVID-19 pandemic, it is critical for servicers to be in compliance with all forbearance-related requirements and to be responsive to borrower communications and inquiries.

US companies trying to close international deals or set up new branches in foreign countries are struggling to secure apostilles to certify documents due to quarantine mandates and office closures resulting from the coronavirus (COVID-19) pandemic.

For-profit medical care providers that receive CARES Act grants to provide funds for healthcare-related expenses or lost revenues attributable to the coronavirus (COVID-19) may be taxed for those receipts. Because Congress did not otherwise exclude or address the tax treatment of these grant payments, taxability would be determined based upon applicable tax law and guidance, which require that such funds be reported as taxable income. For-profit healthcare providers that received these grants should consider this issue and its resulting tax implications.

Employers should be aware that remote working arrangements during the coronavirus (COVID-19) pandemic may inadvertently trigger state payroll tax registration and filing requirements for their businesses, and possibly trigger corporate income/franchise tax “nexus” with another state, subjecting the business to that state’s tax regime.

Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.

The Malaysia Securities Commission (SC) announced on April 28 that flexibility will be granted for businesses issuing convertible notes to venture capital (VC) and private equity (PE) firms registered with the SC.

New York’s Department of Financial Services (DFS) issued guidance on April 13 alerting regulated entities of the significant increase in cybercrime during the coronavirus (COVID-19) pandemic.

The coronavirus (COVID-19) pandemic has forced companies to reassess their financial projections amid the rapidly shifting landscape of the global economy. In response, there has been a rapid uptick in the number of corporations that have suspended dividend payments to preserve assets and capital. The last few weeks have seen corporations in the auto, aerospace, cruise line, entertainment, hospitality, mining, and restaurant industries, to mention a few, suspend dividends.

The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.

New guidance from the UK Competition and Markets Authority warns that it will not relax its substantive or evidentiary standards for merger investigations during the coronavirus (COVID-19) pandemic. Statutory deadlines will not be altered, although aspects of investigations may be subject to delay, and the authority will continue to impose interim measures. The authority also set out its position on mergers involving “failing firms,” indicating some flexibility in its interpretation of the counterfactual test.

In light of the UK government’s lockdown measures and the COVID-19 pandemic, there are key issues English public companies should consider for their annual general meetings (AGMs) while awaiting further legislation and flexibility.

Following the declaration of a state of emergency due to COVID-19, Japan’s Financial Services Agency (FSA) made recent announcements extending the filing deadline for annual securities reports and other disclosure reports, and providing guidance on annual shareholder meetings. In addition, the government announced additional areas subject to the declaration and an amended assistance plan.

For retailers, it is key to be prepared before, during, and after times of crisis. As retailers across the globe navigate the current coronavirus (COVID-19) crisis, they are dealing with having to close their doors if deemed nonessential, monitoring the safety and well-being of their employees, evaluating their liquidity, and preserving their cash position.

The UK government today launched a new loan guarantee programme for UK businesses—the Coronavirus Large Business Interruption Loan Scheme (CLBILS)—intended to plug the gap by providing loan guarantees for medium and large businesses which were not covered by the two earlier UK loan guarantee programmes related to the coronavirus (COVID-19) pandemic.

Insurance regulators across the country have enacted emergency regulations, issued administrative guidance, and requested carriers to take certain actions to try to address the financial impact of the coronavirus (COVID-19) pandemic on individuals and businesses. Requirements imposed on or requested of health insurers to expand access to telehealth and eliminate or limit prior authorization or concurrent review have been widely reported, but there have been numerous other industry-wide actions. And, some state legislators have introduced bills to expand the scope of coverage to ameliorate the impact of the pandemic on insureds.

As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”

A recent US Securities and Exchange Commission statement stressed the importance of disclosure and highlighted its role in the national effort to foster a meaningful, responsible increase in economic activity. In light of the coronavirus (COVID-19) pandemic and its effect on national and global economies, public companies should take a careful look at the impact of these circumstances on their disclosure obligations under federal securities laws.

The Internal Revenue Service has released guidance allowing partnerships subject to amended return filing restrictions enacted under the Bipartisan Budget Act of 2015 to amend 2018 and 2019 partnership returns, including in order to take advantage of retroactive relief provided under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

For companies forced to postpone or cancel live events during the coronavirus (COVID-19) pandemic, event cancellation insurance may serve as a way to protect assets and mitigate losses.

Businesses that avail themselves of financial assistance under Section 4003 or 4116 of the CARES Act must limit compensation and severance paid to certain officers and employees.

In continued efforts to help taxpayers address the challenges brought on by the coronavirus (COVID-19) pandemic, the Internal Revenue Service announced further relief on April 9, including automatically extending deadlines for various filing and payment obligations and allowing tentative carryback refunds for net operating losses.

The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a cooperation project in the generic pharmaceuticals sector aimed at ensuring the supply of critical hospital medicines. Other ad hoc “comfort letters” may follow at the EU Commission’s discretion.

Morgan Lewis partner Jennifer Breen spoke with Tax Notes about the US Internal Revenue Service’s decision to extend hundreds of tax deadlines to July 15.

As the outbreak of the coronavirus (COVID-19) continues, the Monetary Authority of Singapore has introduced a number of initiatives to assist Singapore financial institutions in supporting their customers. This LawFlash provides an overview of the MAS relief initiatives.

The US Securities and Exchange Commission, Financial Industry Regulatory Authority, Commodity Futures Trading Commission, and National Futures Association have each announced temporary regulatory relief for market participants whose operations may be affected by the coronavirus (COVID-19) pandemic.

Morgan Lewis partner Andrew Budreika was quoted in an Advertising Specialty Institute article about the latest developments in the CARES Act’s Paycheck Protection Program (PPP).

In three new Unemployment Insurance Program Letters, the US Department of Labor (DOL) issued guidance to state workforce agencies to implement the unemployment provisions in the CARES Act. The guidance has several important aspects for employers.

The Commodity Futures Trading Commission and the National Futures Association in recent weeks have issued relief in response to the challenges that many market participants face in light of the coronavirus (COVID-19) pandemic. This LawFlash covers the latest relief provided.

As the outbreak of the coronavirus (COVID-19) continues, the Hong Kong Monetary Authority has introduced a number of initiatives to further support small-medium enterprises. These initiatives include enhancements to standby liquidity facilities, including that banks may temporarily operate with a lower liquidity ratio and defer the implementation of certain aspects of Basel III.

Texas Governor Greg Abbott issued Executive Order GA-14 on March 31, directing every person in Texas to minimize social gatherings and in-person contact with people who do not live in the same household except where necessary to provide or obtain essential services.

The Ministry of Law of Singapore announced the introduction of a new bill on 1 April aimed at protecting individuals and businesses that are unable to fulfil their contractual obligations because of the coronavirus (COVID-19) pandemic.

The Massachusetts Office of the Attorney General issued an emergency rule on April 1 to prevent unfair and deceptive collection practices during the coronavirus (COVID-19) crisis. The rule temporarily prohibits some debt collectors from initiating or threatening collection lawsuits, acting on vehicle repossession, and taking steps toward wage garnishment – among other restrictions.

The Singapore Ministry of Health (MOH) imposed tighter safe-distancing measures on 24 March to minimize further spread of the coronavirus (COVID-19). Because of the fluid and unpredictable nature of COVID-19, companies and shareholders must maintain flexibility throughout this emergency and implement alternative means to ensure compliance with MOH directives.

The Hong Kong Securities and Futures Commission has released a number of circulars relating to COVID-19, including March 31 guidance on licensing and ongoing compliance matters. This LawFlash provides an overview of the guidance and its implications for licensed corporations.

Two orders from the US Securities and Exchange Commission amend previous regulatory relief for certain investment advisers and investment funds affected by the coronavirus (COVID-19), provide such investment advisers and investment funds with more time to satisfy certain filing and delivery requirements, and extend the relief from requirements to hold in-person board meetings.

In response to the coronavirus (COVID-19) pandemic, New Jersey Governor Phil Murphy has announced an initiative whereby participating financial institutions will provide mortgage forbearance and financial protections for New Jersey residents facing economic hardship as a result of COVID-19.

This is the first in a series of alerts from Morgan Lewis’s investment management team in Tokyo that summarize how the coronavirus (COVID-19) global pandemic impacts investment fund-related businesses in Japan. This first alert summarizes how the pandemic impacts annual business report filing requirements, particularly for financial instruments business operators and business operators conducting permitted businesses for qualified institutional investors under Article 63 of the Financial Instruments and Exchange Act.

The ultimate impact of the coronavirus (COVID-19) pandemic on shareholder activism remains largely uncertain and comparisons with the surge in activism that followed the 2008 global financial crisis are tempting, but suspect as it remains questionable whether activists can still rely on the same forces that have been driving activism.

All IRA owners have until July 15, 2020 to make IRA contributions for 2019 and pay early distribution penalties for 2019, but a few questions remain on deadlines and reporting for IRA providers.

The US Securities and Exchange Commission is providing increased flexibility to certain open-end funds and insurance company separate accounts, plus no-action relief to money market funds and their affiliates amid the coronavirus (COVID-19) pandemic.

This LawFlash addresses the potential impact of anti-price-gouging efforts by government enforcement officials on anticipated civil litigation, particularly class actions premised on state unfair and deceptive practices acts. Many parties in the supply chain for food, emergency, and medical supplies, as well as consumer goods, are potentially subject to price-gouging investigations by government officials and each therefore face risk from consumer actions based on the same alleged underlying conduct.

California Governor Gavin Newsom has issued multiple orders affecting how and under what conditions state and local agencies may meet and discuss and/or approve of contracts for services and products during the coronavirus (COVID-19) pandemic.

Morgan Lewis partners Jennifer Breen and Steven Johnson’s letter to the US Internal Revenue Service (IRS) regarding the coronavirus (COVID-19) outbreak was cited in a Tax Notes article about close-of-tax year issues.

The coronavirus (COVID-19) pandemic is historic, fast-moving, and constantly evolving. While the most immediate concerns involve the public health and restoring business operations to normalcy, certain steps may be necessary in the near term to protect your insurance assets, which may help mitigate financial losses.

The day after US Secretary of the Treasury Steven Mnuchin’s announcement on March 17, the Internal Revenue Service issued helpful guidance (Notice 2020-17) on the coronavirus (COVID-19) crisis. Importantly, the IRS is deferring all federal income tax payments due April 15, 2020 for 90 days.

The UK Financial Conduct Authority (FCA) issued a further statement on 17 March elaborating usefully on its initial statement of 4 March (see our prior blog). Strikingly, it has abandoned the rather terse tone of the initial statement in favour of a more reassuring and understanding one, recognising the pressures exerted by the pandemic on regulated firms and consumers. Here are the key points.

The US Securities and Exchange Commission on March 13 announced temporary regulatory relief for registered investment advisers and exempt reporting advisers as well as for registered funds, registered unit investment trusts, and business development companies whose operations may be affected by the coronavirus (COVID-19). Most notably, the relief provides up to an additional 45 days for eligible advisers and funds to satisfy relevant filing and delivery requirements, and exempts eligible funds from in-person voting requirements.

With significant business disruptions occurring as a result of coronavirus (COVID-19), companies should consider how insurance coverage, including business interruption, supply chain, and event cancellation coverage, can help mitigate losses.

The staff of the Securities and Exchange Commission’s Division of Corporation Finance on March 13 issued guidance designed to assist companies in complying with federal proxy rules in light of the coronavirus (COVID-19) outbreak. The guidance clarifies flexibility under the federal proxy rules for companies wishing to effect changes to annual meetings, including moving from physical locations to virtual or hybrid meetings.

The Asset Management Association of China encourages new private equity funds to invest in medical enterprises related to epidemic prevention and control, and has extended certain reporting deadlines.

Our healthcare team recently launched a publication series highlighting the global impact of COVID-19 on healthcare transactions. Around the globe, the healthcare industry has faced similar issues from the unprecedented pandemic, prioritizing their operational response to COVID-19. Now, as countries begin to reopen, healthcare entities may refocus on planning for long-term transformation of their business models. In this series, we will explore how the pandemic impacted healthcare transactions in specific regions and what we can expect in a post-pandemic world.

The recent rollout of various COVID-19 vaccines has raised many questions around their availability, distribution, and requirements for employers and other groups, including essential insurance, liability, and enforcement considerations. Here we provide key legal and regulatory perspectives for those organizations providing access to the vaccines and/or mandating vaccination. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease and what employers contemplating the administration of a closed point-of-delivery (POD) vaccination program need to know.

Associate Alana Genderson spoke to K-12 Dive about the potential of US schools to require students to receive the COVID-19 vaccine before returning to campus.

Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department of Health and Human Services (HHS) has again amended its declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to accommodate some workforce barriers that had not been previously contemplated.

It’s now been over a year since the COVID-19 pandemic was declared a public health emergency, ushering in monumental changes for telehealth regulation. If you’ve been following Health Law Scan, we hope our updates have provided some clarity to the everchanging regulatory healthcare framework and the legal issues that can vary across payers, across states, and even across countries.

In a Law360 feature, Morgan Lewis partner Dennis Gucciardo and associate Jacob Harper highlighted some of the defining moments for the healthcare and life sciences industries in the year since the US government declared the COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration.

With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Service has released guidance that provides a set of good practice principles for third-party partners to follow.

The US Department of Health and Human Services (HHS) announced on Friday, January 15, 2021, one month before the former reporting deadline, that it will push back the CARES Act Provider Relief Fund (PRF) reporting timeline due to the enactment of the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 (the Act).

With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act.

A LawFlash authored by Morgan Lewis partners Sharon Perley Masling and Kathy Sanzo, and associates Alana Genderson, Christopher Jaynes, and Maria Kalousi-Tatum was quoted in an EHS Today article about the potential for employers to establish policies related to a COVID-19 vaccine.

The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking.

During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services.

Imagine you are the primary caretaker for your 94-year-old terminally ill mother who lives in your home while under hospice care during the coronavirus (COVID-19) pandemic.

The coronavirus (COVID-19) pandemic has created unforeseen and unavoidable circumstances within the healthcare industry that may provoke further crisis for hospitals, nursing homes, physicians, and other frontline healthcare providers in the form of potential liability claims for noncompliance with COVID-19 protocols or other standards.

Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date.

As summarized in a July 17 LawFlash, FDA has resumed inspections of regulated domestic facilities using a new risk assessment rating system that takes into account the reopening phase of the applicable state, and county level COVID-19 statistics.

Singapore’s telehealth sector is driven by the growing telemedicine industry, which has seen an increase in digital self-help options to consult medical doctors through online web-based applications. Telehealth providers in Singapore are mainly focused on providing remote telemedicine and/or on-demand house call services.

Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation.

The UK Competition and Markets Authority on June 19 announced that it had opened investigations against four pharmacies and convenience stores in relation to suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the coronavirus (COVID-19) pandemic, and on June 29 published an open letter warning pharmacists against price gouging, raising the possibility of additional investigations.

Congressional stimulus packages appropriated $175 billion in relief funds under the CARES Act and the Paycheck Protection Program and Health Care Enhancement Acts for the benefit of hospitals and other healthcare providers in response to losses incurred due to the coronavirus (COVID-19) pandemic.

Morgan Lewis associate Jacob Harper spoke with Bloomberg Law about the increased use of telehealth services.

Morgan Lewis partner Albert Shay was quoted in a Bloomberg Law article about the whistleblower suits expected to arise as a result of the COVID-19 pandemic.

Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.

With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) has recently been updating its FAQs, providing some additional clarity, and potentially confusion, surrounding the acceptance of Relief Funds from its initial tranche $30 billion of General Distribution payments. Attestations for the first tranche of payments on April 10 are due May 25, and HHS continues to furnish guidance regarding the details of the General Distribution Relief Fund.

The Centers for Medicare & Medicaid Services and the US Department of Health and Human Services Office of Inspector General have provided additional guidance and clarification on the application of Stark Law blanket waivers and enforcement of the Anti-Kickback Statute amid the coronavirus (COVID-19) pandemic, helping providers establish new arrangements or modify existing arrangements to accommodate unprecedented demands.

The Centers for Medicare & Medicaid Services released a second, sweeping interim final rule in response to the coronavirus (COVID-19) pandemic on April 30, 2020. Building on the agency’s unprecedented March 31, 2020 regulation, which prioritized distancing patients from their care teams in response to the public health emergency, this second round of policy changes emphasized easing COVID-19 testing restrictions and expanding health system capacity for a phased reopening of the country.

For-profit medical care providers that receive CARES Act grants to provide funds for healthcare-related expenses or lost revenues attributable to the coronavirus (COVID-19) may be taxed for those receipts. Because Congress did not otherwise exclude or address the tax treatment of these grant payments, taxability would be determined based upon applicable tax law and guidance, which require that such funds be reported as taxable income. For-profit healthcare providers that received these grants should consider this issue and its resulting tax implications.

CMS recently issued Frequently Asked Questions (FAQs) clarifying requirements and considerations for hospitals and other providers related to the Emergency Medical Treatment and Labor Act (EMTALA) during the coronavirus (COVID-19) pandemic.

The US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 22 to discuss available regulatory relief pathways for medical licensees during the coronavirus (COVID-19) public health emergency (PHE).

Provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act signaled that the government intends to closely monitor the more than $2 trillion in relief funds, including loans through the Paycheck Protection Program. New developments confirm that businesses seeking these loans must understand the risks before accepting and retaining the funds.

The Centers for Medicare & Medicaid Services (CMS) announced on April 26 that it will no longer be accepting new applications for the Medicare Accelerated/Advanced Payment Program (AAPP).

The US Nuclear Regulatory Commission’s (NRC’s) Office of Nuclear Materials Safety and Safeguards (NMSS) issued an internal memorandum on April 10 to its regional directors describing a process that could be used to review medical licensees’ requests for temporary exemptions from certain NRC regulations due to the coronavirus (COVID-19) pandemic. Enclosed with the memorandum is a template letter that regions can use to streamline granting temporary exemptions.

The Occupational Safety and Health Administration has issued a new guidance allowing field offices flexibility in handling COVID-19-related matters, including complaints. The guidance focuses on highly affected industries, such as healthcare and first responders and prioritizes inspections in areas of imminent danger of exposures and fatalities. Enforcement for other industries is likely to shift from primarily on-site inspections to informal complaints and whistleblower actions.

The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.

Morgan Lewis is staying informed on all of the developments surrounding the coronavirus (COVID-19) pandemic. Our healthcare team continues to follow developments, producing a number of publications and webinars to help keep our healthcare industry readers informed.

The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.

The US Department of Health and Human Services recently announced the use of blanket waivers for healthcare providers under the Stark Law, and its Office of Inspector General noted it will exercise enforcement discretion in imposing administrative sanctions related to such blanket waivers under the Anti-Kickback Statute.

On March 30, 2020, the Centers for Medicare & Medicaid Services released a stunning and far-reaching interim final rule to address the coronavirus (COVID-19) crisis. The rule is a comprehensive set of policy changes designed to—almost overnight—shift the provision of healthcare services to Medicare beneficiaries from face-to-face care to remote care through telehealth. Healthcare providers must quickly understand what the rule entails to ensure that they can continue to treat their needy patient populations while maintaining compliance with Medicare billing and benefit rules.

Helping to address a critical COVID-19 need, Morgan Lewis guided Airon Corp, a privately held company specializing in high-tech pneumatic life support products, in a collaboration with GE Healthcare, one of the world’s largest healthcare companies.

The Morgan Lewis healthcare team continues to monitor the developments surrounding the coronavirus (COVID-19) pandemic. We are acutely aware of what the healthcare service provider community is currently facing and are here to help.

As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or incomplete submission of Program Year 2019 data in some cases.

Through FDA’s Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, FDA provides temporary relief from laboratory testing and imaging requirements for certain drugs and biologics subject to REMS with those specific prerequisites.

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources.

The US Federal Trade Commission and the Antitrust Division of the US Department of Justice have announced that they aim to respond within one week to coronavirus (COVID-19) collaborative proposals submitted pursuant to the agencies’ respective processes.

This LawFlash covers the regulatory relief that has been granted thus far, and where government enforcement and program integrity fits against that backdrop.

Aided by ingenuity and growing regulatory flexibility, retail pharmacies across the country are finding ways to serve their customers while reducing face-to-face contact. Protocols may vary by state.

As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the coronavirus (COVID-19) crisis.

CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the coronavirus (COVID-19) crisis.

The Morgan Lewis healthcare team is keeping up to date on all of the developments surrounding coronavirus (COVID-19). We have compiled a list of our recent publications for ease of access.

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade Commission to crack down on unapproved products.

The IRS issued guidance on March 11 that clears the way for employers to offer employees covered by a high-deductible health plan (HDHP) testing and treatment for the 2019 Novel Coronavirus (COVID-19) with no deductible or at a lower deductible.

The Centers for Medicare & Medicaid Services (CMS) issued a statement on March 9 related to actions the agency is taking to protect the health and safety of patients and providers. CMS urges providers to stay abreast of CDC guidance on the 2019 Novel Coronavirus (COVID-19).

Recent guidance from the Office for Civil Rights and the Centers for Medicare and Medicaid Services reiterates that existing privacy laws and emergency preparedness standards provide an effective framework for providers during the 2019 Novel Coronavirus outbreak.

The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits.

MedTech Dive featured comments from Morgan Lewis partner Dennis Gucciardo in an article about the US Department of Health and Human Services directive to the US Food and Drug Administration to review requests for emergency use authorization for COVID-19 laboratory developed tests "in a timely manner.”

The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking.

Morgan Lewis partner Robert Hibbert and associate Maria Kalousi-Tatum authored a Food Safety Magazine article about the US Food and Drug Administration (FDA) and the US Department of Agriculture’s memorandum of understanding (MOU) intended to prevent potential disruptions to the food supply chain resulting from the COVID-19 pandemic.

The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.

With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19 screening and risk assessments, digital therapeutics, and remote patient monitoring systems.

The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and life-supporting/life-sustaining devices.

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system.

Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation.

Two key amendments to the German competition law entered into effect on May 29, 2020, temporarily extending merger control review periods and temporarily suspending interest payments for antitrust fines, further to a bill adopted by the German Parliament to mitigate the consequences of the coronavirus (COVID-19) pandemic on trade.

Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections.

As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic.

Underscoring the significance of utilizing intellectual property (IP) in the ongoing fight against the coronavirus (COVID-19), the US Patent and Trademark Office (USPTO) on Monday publicly unveiled a new online database that acts as a patent “marketplace” aimed at facilitating the voluntary licensing and commercialization of key technologies related to the prevention, diagnosis, and treatment of COVID-19.

Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.

The Kazakhstan government has adopted a resolution that establishes the so-called “adjustment coefficient” zero to salary-related taxes and payments in an effort to stabilize the economy during the coronavirus (COVID-19) pandemic.

New guidance from the UK Competition and Markets Authority warns that it will not relax its substantive or evidentiary standards for merger investigations during the coronavirus (COVID-19) pandemic. Statutory deadlines will not be altered, although aspects of investigations may be subject to delay, and the authority will continue to impose interim measures. The authority also set out its position on mergers involving “failing firms,” indicating some flexibility in its interpretation of the counterfactual test.

As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”

The joint statement recognizes that while the COVID-19 pandemic offers businesses an opportunity for procompetitive collaboration and benefits, it also increases significant risk of anticompetitive conduct in the labor market. Here are some issues and factors that businesses should consider to mitigate antitrust risk as the Antitrust Division and Federal Trade Commission continue to consider enforcement actions for antitrust violations.

US antitrust laws already on the books facilitate rapid investment without government delay: important practical tools and rules for dealmakers and their counsel in the wake of the coronavirus (COVID-19) pandemic and the current economic challenges.

The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a cooperation project in the generic pharmaceuticals sector aimed at ensuring the supply of critical hospital medicines. Other ad hoc “comfort letters” may follow at the EU Commission’s discretion.

In three new Unemployment Insurance Program Letters, the US Department of Labor (DOL) issued guidance to state workforce agencies to implement the unemployment provisions in the CARES Act. The guidance has several important aspects for employers.

Morgan Lewis partners Dennis Gucciardo, Michele Buenafe, and Jacqueline Berman authored a Bloomberg Law Insight regarding the US Food and Drug Administration’s announcement to suspend onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19).

In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products during pandemics, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (the Guidance).

In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products.

The US Federal Trade Commission and the Antitrust Division of the US Department of Justice have announced that they aim to respond within one week to coronavirus (COVID-19) collaborative proposals submitted pursuant to the agencies’ respective processes.

FDA Announces Path Forward to Protect Food Supply During COVID-19 Period

The White House is reportedly in discussions with US auto companies to aid in the COVID-19 relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make hand sanitizer.

For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt to conduct domestic inspections through other means.

In responding to the coronavirus (COVID-19) pandemic, the mantra of “working together” is heard often. But as businesses confront sudden and extensive demand and supply disruptions—and a range of sometimes conflicting information and guidance from the public sector about the health crisis—questions inevitably arise about the extent to which the private sector can coordinate its responses consistent with the antitrust laws.

The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had confirmed diagnoses. Given the global impact of this virus, the global nature of the pharmaceutical and biotech industry, and the rapidly changing infection landscape, key operational areas will be impacted, and understanding the regulatory and legal implications of these effects and steps to mitigate them are critical.

Key questions and issues facing the UK retail sector, an industry that has been acutely impacted by the coronavirus (COVID-19) pandemic, include mitigation strategies, reopening in line with government guidance, and future expected challenges.

The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.

On July 1, California Governor Gavin Newsom announced closures of indoor dining and entertainment venues, as well as all bars, in 19 counties. California immediately issued Guidance describing these closures. Gov. Newsom also announced coordinated enforcement efforts, including the creation of Enforcement Strike Teams between state agencies and local counties and cities. Businesses are advised to regularly review the rules that remain in constant flux.

The UK Competition and Markets Authority on June 19 announced that it had opened investigations against four pharmacies and convenience stores in relation to suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the coronavirus (COVID-19) pandemic, and on June 29 published an open letter warning pharmacists against price gouging, raising the possibility of additional investigations.

New York State has continued to issue the state’s phased, regional plan for reopening businesses following the statewide closure of all nonessential businesses due to the coronavirus (COVID-19) public health emergency, a process known as “New York Forward.”

Additional reopening steps come several weeks after Illinois released a five-phase, regional plan for reopening businesses following the statewide closure of all nonessential businesses due to the coronavirus (COVID-19) public health emergency, a process known as Restore Illinois.

The offeror for Moss Bros sought to rely on standard material adverse change conditions to lapse the offer, on the basis of the impact of the coronavirus (COVID-19) pandemic and related UK governmental measures on Moss Bros. The Panel Executive ruled that the impact on Moss Bros’ business was not sufficiently material to permit the lapsing of the offer.

As local and national governments begin easing pandemic-related restrictions on in-person activities, businesses must weigh how best to proceed with reopening, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders, and protecting the safety of employees and customers. Here are a few key considerations. For more information, please see our Retail Reopens Guide.

As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic.

Key issues that UK employers should begin considering now to minimize difficulties as they reopen or expand their operations include reintegrating staff, assessing internal policies in light of the pandemic, testing for the coronavirus (COVID-19), and more.

The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.

Governor Charlie Baker signed emergency legislation on April 20 limiting evictions for residential and small business properties, and limiting foreclosures and requiring forbearance for residential properties. This legislation follows a number of actions by Governor Baker and the City of Boston to protect renters, homeowners, and small businesses during the coronavirus (COVID-19) pandemic.

For retailers, it is key to be prepared before, during, and after times of crisis. As retailers across the globe navigate the current coronavirus (COVID-19) crisis, they are dealing with having to close their doors if deemed nonessential, monitoring the safety and well-being of their employees, evaluating their liquidity, and preserving their cash position.

As jurisdictions contemplate lifting pandemic-related workplace restrictions, employers must start considering how best to cope with a vast array of issues, including restarting or expanding operations, reintegrating remote-working or furloughed employees, implementing new state and local orders/requirements, and protecting the safety of employees and customers. Employers who proactively plan for these challenges will be best positioned to adapt to the “new normal.”

The Internal Revenue Service on Monday, April 13 issued welcome relief to the securitization industry, providing that certain forbearances and related modifications to mortgages will generally not cause real estate mortgage investment conduits (REMICs) and other securitization vehicles to lose their special tax status if such modifications arise from new programs/procedures created by the CARES Act or by similar programs/procedures to address the coronavirus (COVID-19) emergency.

As New Jersey continues to battle the spread of coronavirus (COVID-19), Governor Phil Murphy ordered essential businesses in the state to adopt several measures including mandatory face coverings at worksites, occupancy limits for stores, and frequent handwashing breaks for employees. Employers should pay close attention to these comprehensive and far-reaching—and sometimes confusing—orders that impose affirmative duties and could raise a host of reasonable-accommodations issues.

US antitrust laws already on the books facilitate rapid investment without government delay: important practical tools and rules for dealmakers and their counsel in the wake of the coronavirus (COVID-19) pandemic and the current economic challenges.

Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.

This edition of Morgan Lewis Retail Did You Know? examines how the Coronavirus Aid, Relief, and Economic Security (CARES) Act impacts companies in the retail and hospitality sector, which has been severely impacted by the coronavirus (COVID-19) pandemic due to the government-mandated shutdown of “non-essential businesses” in some states, as well as the decrease in customer traffic given the uncertain economic climate. Companies in the retail and hospitality sectors should carefully consider the eligibility requirements for CARES Act relief measures.

The Los Angeles City Council held an emergency meeting on March 27 in response to the coronavirus (COVID-19) crisis and approved several ordinances, including one pertaining to sick leave and another relating to retail and delivery workers. The council tabled two controversial proposals that would subject employers to various obligations to retain and recall employees during and after the COVID-19 threat period.

Aided by ingenuity and growing regulatory flexibility, retail pharmacies across the country are finding ways to serve their customers while reducing face-to-face contact. Protocols may vary by state.

A financial crisis-era program is being resurrected to fight the liquidity crisis caused by the global coronavirus (COVID-19) pandemic through lending collateralized by new issuances of asset-backed securities.

New Jersey Governor Phil Murphy on March 21 signed Executive Orders 107 and 108, which took effect at 9:00 pm the same day. Executive Order 107 mandates that all residents remain home unless performing certain delineated activities; orders the closure of brick-and-mortar retail locations of all non-essential businesses; and instructs all businesses and nonprofits—even those deemed essential—to implement telework or work-from-home options for employees, to the extent practicable.

The UK government announced on March 19 that as part of a package of measures to allow supermarkets to work together to feed the nation during the coronavirus (COVID-19) outbreak, elements of competition law will be temporarily relaxed for the food sector. Authorities, however, stressed that they will remain vigilant against competition law infringements.

Investors pursing global investment opportunities across the sports industry should be aware of the key considerations likely to apply to the M&A process amid the coronavirus (COVID-19) pandemic.

The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. Here is what companies should know about the specific practices permitted under the comfort letter, as well as the specific conditions and safeguards for cooperation.

The Internal Revenue Service (IRS) and the US Department of the Treasury released two Revenue Procedures and a new FAQ on April 21 to provide relief to US residents and alien individuals affected by travel disruptions due to the coronavirus (COVID-19) emergency.

By the second week of March, the National Basketball Association, National Hockey League, Major League Soccer, and Major League Baseball had suspended games due to the coronavirus (COVID-19) pandemic. The good news for those missing the rush from watching a competitive game is that not all sports are suffering from the same challenges. Esports, the now mainstream billion-dollar industry, is on its way to being the most resilient sport during these devastating times.

The US Department of Labor’s Occupational Health and Safety Administration (OSHA) released a statement on April 8 reminding employers that they cannot retaliate against workers who report unsafe or unhealthy working conditions during the coronavirus (COVID-19) pandemic.

Businesses that avail themselves of financial assistance under Section 4003 or 4116 of the CARES Act must limit compensation and severance paid to certain officers and employees.

Employers considering layoffs in the face of the coronavirus (COVID-19) crisis have additional opportunities to support furloughed workers, aside from options offered by the CARES Act.

The European Commission has approved a £50 billion (EUR 57 billion) “umbrella” UK state aid scheme to support small and medium-sized enterprises and large corporates in the United Kingdom affected by the coronavirus (COVID-19) outbreak. The umbrella scheme was approved on April 6, 2020, under the State Aid Temporary Framework, as amended.

Given the number of employees and independent contractors working remotely, it is a good time for companies to reassess their trade secret policies and remind all personnel of their obligations to maintain and protect the confidentiality of company information.

As the effects of the coronavirus (COVID-19) pandemic hit the United States, downsizings and shutdowns are spreading indiscriminately throughout the economy.