Industries

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.

This LawFlash provides a summary on navigating the regulatory landscape in various jurisdictions throughout the Latin America region during the global coronavirus (COVID-19) crisis.

The NRC’s Office of Enforcement (OE) recently issued Attachment 3 to Enforcement Guidance Memorandum (EGM) 20-002, providing guidance to NRC Staff to disposition violations of emergency preparedness (EP) regulations during the coronavirus (COVID-19) public health emergency (PHE). The guidance applies to entities licensed under 10 CFR Parts 30, 40, 50, 52, 70, and 72.

The NRC’s Office of Enforcement (OE) recently issued Attachment 2 to Enforcement Guidance Memorandum (EGM) 20-002, providing guidance to NRC inspection staff for exercising enforcement discretion for certain byproduct material licensees that suspended their use of licensed material and are maintaining the licensed material in safe storage because of the coronavirus (COVID-19) public health emergency (PHE).

The NRC Staff released specific guidance to operating and decommissioning reactor licensees on requesting exemptions from fire protection requirements during the coronavirus (COVID-19) public health emergency (PHE) on May 14. The guidance supplements the NRC’s April 29 teleconference, during which it contemplated such regulatory relief pathways. Morgan Lewis reported on the teleconference earlier this month.

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.

The NRC issued a draft letter to holders of licensees (other than operating power reactor licensees) to possess Category 1 or 2 quantities of radioactive material (RAM) as defined in Appendix A to 10 CFR Part 37.

The NRC issued a letter to the National Organization of Test, Research, and Training Reactors on April 30 regarding the NRC’s expedited review of requests for regulatory relief from certain material control and accounting (MC&A) requirements during the coronavirus (COVID-19) public health emergency (PHE).

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.

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 NRC issued temporary Staff guidance intended to help Staff review and process requests for regulatory relief from fuel facilities on April 21. Although intended for NRC Staff, the guidance provides insights into the process licensees should follow when submitting requests for relief and the information they should anticipate including.

The Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 23 to discuss available regulatory relief pathways for materials licensees subject to 10 CFR Parts 30 and 34 during the coronavirus (COVID-19) public health emergency (PHE).

This is our first edition of Morgan Lewis Spark, a quarterly update highlighting new and amended Russian legislation of importance to companies operating in the Russian energy and mining sectors.

As the coronavirus (COVID-19) pandemic disrupts everyday life throughout the world, boards of directors of corporations working around the clock to understand, address, and mitigate its effects on business operations must direct attention to their fiduciary duties. Boards must act affirmatively, and with an eye on the future, to assure that duties to corporations and stockholders continue to be met.

The US Nuclear Regulatory Commission (NRC) Staff issued SECY-20-0034 on April 22, informing the NRC Commissioners of the Staff’s plan to exercise enforcement discretion for licensee noncompliance with regulatory requirements resulting from illnesses or other factors caused by the coronavirus (COVID-19) public health emergency (PHE).

In response to coronavirus (COVID-19) pandemic, the US Securities and Exchange Commission’s Corporation Finance Division and Investment Management Division have issued guidance to assist companies in making changes to the format of its shareholder meetings, the way in which companies accept shareholder proposals, and the timing of Form 10-K corporate governance and compensation disclosures that are all adaptive to the changing times. Additionally, various states have loosened the restrictions around annual shareholder meetings. This LawFlash gives an overview of this guidance and relief.

In connection with the current national state of emergency, Republic of Kazakhstan Prime Minister Askar Mamin signed Resolution of the Government No. 220 on Certain Issues of Entry into (Exit from) the Republic of Kazakhstan and the Stay of Immigrants in the Republic of Kazakhstan on April 17, suspending the effect of certain norms of the law providing visa-free travel regime for citizens of specific countries.

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 US Department of Labor’s chief administrative law judge (ALJ) issued a supplemental administrative order on April 10, extending the suspension of in-person hearings before the Office of Administrative Law Judges (OALJ).

US Nuclear Regulatory Commission (NRC) regulations at 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6) require licensees to maintain a respiratory protection program that requires (1) a periodic—often annual—determination by a physician that the user is medically fit to use respiratory protection, and (2) annual “fit testing” to ensure that the licensee’s respiratory protection seals tightly to the licensee’s face.

Morgan Lewis partner Philip Miscimarra spoke with Bloomberg Law about how businesses are responding 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.

This Insight authored by Morgan Lewis lawyers and published by Bloomberg Law poses 100 questions related to the COVID-19 payroll tax and fringe benefits provisions, which we have been explained in our LawFlashes.

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.”

Our labor and employment colleagues have prepared a LawFlash providing our current thinking regarding key issues that employers should begin considering now to minimize difficulties as they reopen or expand current operations.

Following a recent trend, New York Governor Andrew Cuomo has issued two executive orders requiring individuals to wear face coverings when near other people. One order requires all customer/public-facing employees to wear face coverings and requires employers to provide these face coverings at no cost to employees. The other order requires all individuals in a public place to use a mask or face covering.

The US Environmental Protection Agency (EPA) has released additional interim guidance for field work decisions at cleanup sites under EPA authority, emphasizing its commitment to ensuring the health and safety of the public, its staff, and others performing work at the sites. In its guidance, the EPA provides principles to consider when evaluating whether to proceed with or pause field work related to Superfund (CERCLA) cleanups, Resource Conservation and Recovery Act (RCRA) corrective actions, Toxic Substance and Control Act PCB cleanups, Oil Pollution Act spill responses, and Underground Storage Tank Program actions.

In response to the coronavirus (COVID-19) pandemic, Russia has introduced non-work days through 30 April 2020 to keep people at home. The non-work days are mandatory for all employers with limited exemptions. On 2 April, President Vladimir Putin authorized the heads of subjects of the Russian Federation (Russia’s constituencies) to provide further exemptions or stricter rules depending on the epidemiological situation in a particular territory. In this alert we address the most recent restrictions introduced by the Mayor of Moscow, including the introduction of digital passes.

The US Department of the Treasury on April 10 released updated criteria outlining which businesses are eligible to apply for CARES Act loans out of the $17 billion allocated for businesses “critical to maintaining national security.”

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.

The US Department of Energy’s National Nuclear Security Administration (NNSA) recently posted guidelines on its continued operations during the coronavirus (COVID-19) pandemic. While NNSA personnel are mostly working remotely, the agency is otherwise operating business-as-usual.

As the coronavirus (COVID-19) pandemic continues to impact most countries around the world, governments have introduced travel restrictions, temporarily suspended flights, imposed mandatory home isolation measures, and suspended services for some immigration procedures, as well as closed some government agencies. For employers looking to move essential employees globally, and/or repatriate them to their home countries, we’ve compiled a list of current immigration updates to consider.

In response to the coronavirus (COVID-19) pandemic and the resulting economic fallout, the government of Kazakhstan has introduced several emergency measures to stabilize the country’s economy and help businesses. This LawFlash discusses some of those measures, including tax incentives and extended grace periods for loans, among others.

The US Nuclear Regulatory Commission (NRC) issued a letter on April 9 to provide guidance on reporting requirements under 10 CFR 50.55a, “Codes and Standards,” in light of the coronavirus (COVID-19) pandemic. The guidance is applicable to nuclear reactors licensed under 10 CFR Part 50.

The US Nuclear Regulatory Commission (NRC) issued a letter including frequently asked questions (FAQs) on April 7 to all agreement and non-agreement states to address the NRC’s regulation of nuclear materials—and its policies and recent activities related thereto—in light of the coronavirus (COVID-19) pandemic. The NRC posted a copy of the FAQs to its password-protected Materials Security Toolbox and intends to update that site “as additional information becomes available.”

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 coronavirus (COVID-19) pandemic in France has led to travel bans and restrictions, including the quarantine of individuals. These measures have disrupted many businesses’ supply chains and operations, including factory and store closures.

Federal Energy Regulatory Commission Chairman Neil Chatterjee on April 2, 2020, announced the commission’s plan to assist regulated entities in managing enforcement- and compliance- related burdens during the ongoing coronavirus (COVID-19) pandemic.

As we recently reported, the US Nuclear Regulatory Commission (NRC) is prepared to grant exemptions to the work-hour controls in 10 CFR 26.205(d)(1)-(7) if the coronavirus (COVID-19) public health emergency affects a licensee’s staffing for workers who fall within the scope of Part 26.

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).

The US Department of Homeland Security’s Cybersecurity & Infrastructure Security Agency (CISA), revised on March 28, 2020, guidance it had previously provided to capture a broader array of workers, particularly in the energy sector. For workers who are considered essential, energy companies should consider issuing supporting paperwork for these claims.

As the coronavirus (COVID-19) continues to spread around the world, this remains an unprecedented time for global industry. The same is true for outsourcing and managed services arrangements: both service providers and customers find themselves under unique pressures and in unchartered circumstances testing the parameters and strengths of their solutions and business continuity plans.

The US Department of Labor (DOL) issued additional frequently asked questions on March 27 to explain how the recently enacted Emergency Paid Sick Leave Act and the Emergency Family Medical Leave Expansion Act (Emergency FMLA) will work in various situations during the coronavirus (COVID-19) crisis.

The US Environmental Protection Agency announced a temporary policy regarding its enforcement of certain environmental legal obligations in an effort to protect workers and the public from exposure to the coronavirus (COVID-19).

In response to the US president’s declaration of a national emergency due to the coronavirus (COVID-19) pandemic, on March 20 the Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a notice to operators stating that, effective immediately and until further notice or modification, PHMSA does not intend to take any enforcement action with respect to operator qualification (OQ) and control room management (CRM) requirements, and will consider exercising enforcement discretion regarding certain drug testing requirements.

The Families First Coronavirus Response Act imposes a mandate on all employers with fewer than 500 employees, and on all federal and state employers, to provide paid time off to employees who need leave for reasons connected to the public health emergency.

The US Securities and Exchange Commission announced on the morning of March 25 the extension of filing periods covered by previously enacted conditional reporting relief for certain public company filing obligations, and provided current views regarding disclosure considerations and other securities law matters related to the coronavirus (COVID-19) crisis.

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.

In light of the coronavirus (COVID-19) pandemic, here are some questions for employers to consider with regard to Form I-9 compliance.

In response to the coronavirus (COVID-19), the US Department of Labor’s (DOL’s) chief administrative law judge (ALJ) issued an administrative order on March 19 clarifying the status of matters pending before the DOL’s Office of Administrative Law Judges (OALJ).

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.

Commission Chairman Neil Chatterjee held a press conference on March 19 to discuss FERC’s work during the current pandemic, provide updates regarding the coronavirus (COVID-19), and respond to questions from the media.

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.

As countries grapple with the spread of the coronavirus (COVID-19) pandemic, recent international travel restrictions have been put in place around the world, including in Europe, Canada, India, and Australia. This LawFlash covers the latest travel impacts in those areas and discusses visa and other considerations for international travelers, employers, and employees.

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.

Following the increased spread of COVID-19 within the United States, the North American Electric Reliability Corporation (NERC) issued a Level 2 Alert on March 10 to all users, owners, and operators of the bulk-power system, outlining a series of recommendations and requiring certain responses from each entity about their plans for continued reliable operation under pandemic circumstances.

The 2019 Novel Coronavirus (COVID-19) outbreak has led to travel bans and restrictions, the lockdown of cities, and the quarantine of individuals. These government measures have disrupted businesses and supply chains, and many companies listed on the Singapore stock exchange have announced disruptions to their operations in China, including factory and store closures.

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.

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.

The Federal Financial Institutions Examination Council (FFIEC) on behalf of its members issued a statement on August 3 setting forth prudent risk management and consumer protection principles for financial institutions as initial coronavirus (COVID-19) related loan accommodation periods end and they consider additional accommodations.

Although many companies are already revisiting contractual provisions relating to nonperformance, like force majeure clauses, as the coronavirus (COVID-19) pandemic continues to wreak havoc on public health and the economy.

With the issuance of Notice 2020-39 (the Notice), the Internal Revenue Service (IRS) has provided relief for Qualified Opportunity Zone Funds (QOFs) and for investors in QOFs. While the relief provided in the Notice does not solve every challenge for QOFs and investors during the pandemic, investors and sponsors alike should warmly receive the specific relief.

This LawFlash provides a summary on navigating the regulatory landscape in various jurisdictions throughout the Latin America region during the global coronavirus (COVID-19) crisis.

Measures under the Targeted Economic Support Scheme include allowing UAE banks to temporarily defer loan repayments and extend existing facilities for corporate and retail clients.

Temporary relief provided by the US Securities and Exchange Commission focuses on financial statements and timing and cancellation requirements with regard to Regulation Crowdfunding, and is expected to make it easier and faster for small businesses to complete offerings.

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.

Members of our emerging business and technology team recently hosted a webinar on seed financing structures for digital health companies. The program, led by partner Benjamin David Novak and associate Jessica Lee, discussed the market trends in digital health company financings as well as the various deal structures frequently used in seed financings.

Associate Alana Genderson was quoted in a Law360 article regarding the Occupational Safety and Health Administration’s (OSHA’s) most recent COVID-19 workplace safety emergency temporary standards (ETS).

Partner Sharon Masling spoke to CNBC after the US Food and Drug Administration (FDA) approved Pfizer’s COVID-19 vaccine for children ages 12–15 years.

Morgan Lewis associate Alanda Genderson spoke to Axios about the possibility of schools in the US requiring students to receive COVID-19 vaccines as they are approved for younger people.

States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.

Our immigration team has been actively publishing resources as the Biden administration continues to make changes to existing immigration framework. These topics may be of importance to Health Law Scan readers, and we encourage you to access these publications below.

The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by perpetrators of various fraud schemes. While this is in part due to the meteoric rise in use of telehealth services during the past year and the need to quickly formalize permanent policy around the technology, the federal government’s concern extends well before the COVID-19 public health emergency (PHE).

In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force from 30 January 2021. The Commission intends for the Export Authorization Regulation to apply until at least 31 March 2021.

Our finance, corporate and business transactions, litigation, and tax teams recently published a LawFlash discussing the new coronavirus (COVID-19) relief stimulus package that is part of the Consolidated Appropriations Act, 2021 (CAA), highlighting key provisions and guidance for small businesses seeking to participate in the revived Paycheck Protection Program (PPP).

Associate Jacob Harper spoke with Modern Healthcare about the need for congressional action as the coronavirus (COVID-19) pandemic continues to increase the use of telehealth services.

Healthcare systems have been on the front lines of the coronavirus (COVID-19) pandemic and may have several questions about how to manage workforce challenges as we look toward the upcoming months.

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.

Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the 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.

US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.

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.

Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations.

The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical Review Contractors, and Recovery Audit Contractors, including those under the Targeted Probe and Educate program, on August 3, 2020.

If a proposed bill by the California Senate is passed, parties to certain post-pandemic healthcare transactions involving private equity groups, hedge funds, healthcare systems, facilities, and provider groups would need to plan for and obtain regulatory approval from the California attorney general.

Much to the relief of the healthcare provider community, US Department of Health and Human Services (HHS) spokesperson Michael Caputo tweeted on Monday that HHS intended to extend the public health emergency that was declared earlier this year.

To keep you abreast of these changes, our tax lawyers have produced a chart, updated regularly, detailing state and local responses to COVID-19.

Morgan Lewis associate Jacob Harper was quoted in a Becker’s Hospital Review article about the impact of the COVID-19 pandemic on the telehealth industry. “With the COVID-19 pandemic, we’ve seen an overnight switch from in-person to telehealth services, and I think this is a dress rehearsal for telehealth as a mainstream modality of providing healthcare,” said Jake.

The Centers for Medicare & Medicaid Services released guidance on April 19 updating its previous recommendation to delay all elective surgeries and procedures during the coronavirus (COVID-19) pandemic. In response, state and local officials are issuing updated orders easing or removing restrictions previously placed on elective, nonurgent surgeries and procedures.

CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance from March 29.

As we all settle into our new sense of normalcy, Health Law Scan continues to monitor developments surrounding the coronavirus (COVID-19) pandemic. We have lawyers across the firm providing updates on a wide variety of topics to keep our clients apprised of all the developments.

US President Donald Trump signed the Paycheck Protection Program and Healthcare Enhancement Act (HR 266) into law on April 24. HR 266 appropriates $483 billion in new spending, including $321 billion for the Payment Protection Program, an additional $75 billion for the Public Health and Social Services Emergency Fund, and $25 billion to support expanded testing across the United States.

Medicare providers that receive grant money under the CARES Act Relief Fund must pay close attention to the terms and conditions of the assistance and rigorously document how the funds are used to avoid potential future False Claims Act allegations.

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.”

Not to be confused with the $100 billion in Provider Relief Funds established as grants to healthcare providers through the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Congress also broadened the access to the Medicare Accelerated/Advanced Payment Program (AAPP) as a tool to address financial concerns associated with reduced cash flow during the pandemic.

FEMA exercised the authority recently granted to it by Executive Orders and pursuant to the Defense Production Act to regulate and redirect respirators, surgical masks, gloves, and other personal protective equipment (PPE) designated as scarce or threatened materials that are prepared for export. FEMA and CBP will work together to identify “commercial quantities” of these items to be redirected for domestic use.

In response to the coronavirus (COVID-19) pandemic, Russia has introduced non-work days through 30 April 2020 to keep people at home. The non-work days are mandatory for all employers with limited exemptions. On 2 April, President Vladimir Putin authorized the heads of subjects of the Russian Federation (Russia’s constituencies) to provide further exemptions or stricter rules depending on the epidemiological situation in a particular territory. In this alert we address the most recent restrictions introduced by the Mayor of Moscow, including the introduction of digital passes.

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.

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 Center for Medicare and Medicaid Services (CMS) released a far-reaching interim final rule (IFR) to address the coronavirus (COVID-19) pandemic on March 30. The IFR represents a comprehensive set of policy changes designed to shift the provision of Medicare services from face-to-face care to remote care through telehealth, in order to mitigate the risks of exposure to COVID-19 for patients and healthcare providers. Above all else, the IFR prioritizes physically distancing patients from their care teams and other patients.

With each passing day, more US companies are voluntarily rising to answer the president’s call to manufacture face masks, ventilators, and other critical coronavirus (COVID-19) protective equipment, but without a government contract, they may not be exempt from patent infringement liability.

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).

The Centers for Medicare & Medicaid Services has expanded its payment program to provide emergency funding and increased cash flow to providers and suppliers that participate in Medicare based on historical Medicare payments in response to the coronavirus (COVID-19) pandemic.

The Coronavirus Aid, Relief, and Economic Security Act establishes mechanisms for relief that healthcare providers are anxious to access. This alert outlines those mechanisms.

During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies. Providers should communicate their medical judgments and the risks to their patients, and manufacturers should document and summarize steps taken to accommodate patient access to such drugs in their next REMS assessment report to FDA.

The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs.

The Families First Coronavirus Response Act (Act), signed into law Wednesday, requires group health plans to provide coverage for coronavirus (COVID-19) diagnostic testing, including the cost of healthcare provider visits (as well as telehealth visits), urgent care center visits, and emergency room visits in order to receive testing. Coverage must be provided at no cost-sharing to participants.

In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to ensure that healthcare providers have flexibility in responding quickly to the growing need in the United States.

Following President Donald Trump’s national emergency declaration on March 13, the US Department of Health and Human Services has finalized licensure waivers that would permit physicians participating in Federal health care programs to receive payment for telemedicine services in states where they do not hold a license during the coronavirus (COVID-19) emergency. The waivers were published on March 15, with a retroactive effect back to March 1.

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.

In this LawFlash, Morgan Lewis healthcare industry partner Susan Feigin Harris analyzes recent CMS guidance on Emergency Medical Treatment and Labor Act (EMTALA) requirements and implications related to the coronavirus (COVID-19).

The Centers for Medicare & Medicaid Services (CMS) continues to issue frequent guidance to the healthcare industry, including guidance after receiving questions on fulfilling Emergency Medical Treatment and Labor Act screening obligations by hospitals and critical access hospitals while minimizing the risk of exposure from COVID-19 patients.

As part of emergency funding to combat the threat of the 2019 Novel Coronavirus (COVID-19), last week Congress waived many of the telehealth restrictions for Medicare services in certain situations. This monumental change could—depending on how it is implemented—radically alter how telehealth is performed in connection with the government’s most ubiquitous healthcare program.

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.

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.

Morgan Lewis partner Dennis Gucciardo spoke with MedTech Dive for an article about the COVID-19 pandemic’s impact on the US Food and Drug Administration’s enforcement efforts. In the piece, he discussed the potential for virtual inspections.

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.

As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products.

Kathy Sanzo spoke with MedCity News regarding the Department of Health and Human Services’ Covid-19 vaccine development program, Operation Warp Speed, which aims to develop vaccines against the SARS-CoV-2 in the space of a year rather than the multiple years normally required

A LawFlash authored by Morgan Lewis partners Kathy Sanzo and Jacqueline Berman was cited in a BioProcess International article about guidance recently issued by the US Food and Drug Administration (FDA) for firms developing vaccines against SARS-CoV-2. As noted by the publication, the LawFlash advised developers to track FDA’s COVID-19-related actions, “as additional guidance and modifications to existing guidances are likely to be issued as reopening plans are implemented.”

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders. Now, as states begin to reopen, FDA appears to be looking toward the future, specifically providing guidance on prospectively addressing the impact of COVID-19 on clinical trials and compliance with current Good Manufacturing Practices (cGMPs). Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date.

Morgan Lewis partner Kathy Sanzo spoke with Bloomberg Law about the efforts by drugmakers to produce a vaccine and navigate a web of US Food and Drug Administration (FDA) regulations.

The US Patent and Trademark Office (USPTO) on May 8 announced a new COVID-19 Prioritized Examination Pilot Program (Pilot Program), under which eligible small and micro entities will receive prioritized examination without payment of the additional fees for prioritized examination. As such, eligible small and micro entities will save $2,000 and $1,000, respectively, when making a request for prioritized examination under the new Pilot Program.

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.

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 UK government has announced two new schemes for funding to innovative companies and startups, launching in May 2020.

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.

The US Department of Agriculture Food Safety Inspection Service (FSIS) and US Food and Drug Administration (FDA) have released policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency 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.

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.

As the federal government seeks innovative solutions from a broader group of suppliers to respond to the coronavirus (COVID-19) pandemic, new or nontraditional contractors will want to familiarize themselves with the intellectual property rights associated with different contracting vehicles and circumstances.

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.

With each passing day, more US companies are voluntarily rising to answer the president’s call to manufacture face masks, ventilators, and other critical coronavirus (COVID-19) protective equipment, but without a government contract, they may not be exempt from patent infringement liability.

The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9 billion supporting agriculture, rural development, the US Food and Drug Administration, and related industries. This LawFlash addresses the act’s drug, device, and food product provisions, and outlines the impact of those provisions on manufacturers and other affected parties.

During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies. Providers should communicate their medical judgments and the risks to their patients, and manufacturers should document and summarize steps taken to accommodate patient access to such drugs in their next REMS assessment report to FDA.

Can the government compel your company to sell its products to the government, even if committed to commercial customers? In the last few days, many companies have received their first “rated order” under the Defense Product Act of 1950 (DPA), or their employees are seeing rated orders for the first time. Here is what you need to know about the DPA and rated orders.

In light of the hand sanitizer shortage during the coronavirus (COVID-19) emergency, many companies have been trying to find alternative sources of product, especially employers in healthcare and essential service sectors where employees are still present or interacting with consumers. In response, the US Food and Drug Administration (FDA) issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make over-the-counter (OTC) drugs.

FDA representatives on March 18 initiated a conference call with representatives of the food industry to discuss public health and food safety issues related to the coronavirus (COVID-19) outbreak. The FDA was represented by Frank Yiannas (FDA Deputy Commissioner for Food Policy and Response), Michael Rogers (Assistant Commissioner for Human and Animal Foods), and Dr. Susan Mayne (Director of the Center for Food Safety and Applied Nutrition).

As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. The guidance provides general considerations to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity . . . .”

With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.

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.

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 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.

The United Kingdom is starting to see a return of the workforce for nonessential retail, which reopened on June 15. Shortly thereafter, the prime minister announced further easing of lockdown restrictions as the United Kingdom begins the third stage of its plan. From July 4, pubs, restaurants, hairdressers, hotels, and other outdoor activities are able to reopen if they comply with new guidance. From July 13, beauticians, spas, and salons are able to reopen. The UK government has also launched a new scheme, “Eat Out to Help Out,” to help the restaurant industry, giving diners 50% (up to £10) off their bill if they eat in a registered cafe or restaurant on a Monday, Tuesday, or Wednesday during August. To facilitate the reopening of these retail stores, the well-established two-meter social distancing rule will change to “one meter plus.” This Retail Did You Know? explores the issues UK nonessential retailers face from an employment perspective.

Morgan Lewis partners Leni Battaglia, Gregory Parks, and Melissa Rodriguez authored a Chain Store Age article about the impact of COVID-19 on luxury retail brands and best practices for reopening and continuing business. In the piece, they discuss how convincing retailers it’s safe to start shopping will be key to recovery.

As Latin America continues to manage the adverse economic effects resulting from the coronavirus (COVID-19) pandemic and prepares for what lies ahead, there are certain post-shutdown processes and regulatory requirements to keep in mind before the restart of operations in the region.

The US Department of Labor (DOL) published a Final Rule on June 8 confirming that paying bonuses, commissions, and other incentive-based pay to salaried, nonexempt employees does not disqualify employers from using the fluctuating workweek (FWW) method of calculating overtime pursuant to the Fair Labor Standards Act (FLSA).

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 Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) have announced a memorandum of understanding (MOU) to help prevent potential disruptions to the food supply chain, particularly fruit and vegetable processing plants, resulting from the coronavirus (COVID-19) pandemic.

New York State began on May 15 to implement 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.” Pursuant to New York Forward, certain industries in qualifying regions of New York can begin in-person operations, provided they affirm compliance with industry-specific health and safety guidance promulgated by the state and develop and post a compliant safety plan. This LawFlash discusses the nature and scope of the New York Forward reopening process, and key provisions from health and safety guidance issued to date.

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.

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

In response to the coronavirus (COVID-19) pandemic, US bankruptcy courts have granted extraordinary equitable relief in some cases. As government orders enforcing stay-at-home measures have forced many businesses to shutter indefinitely, bankruptcy courts have implemented procedures to allow the ongoing—albeit virtual—administration of bankruptcy cases.

As the coronavirus (COVID-19) pandemic evolves, governmental executive and legislative authorities are taking actions in the form of emergency declarations and proposed legislation that could improve a company’s ability to mitigate business income losses by maximizing its insurance recovery. Keeping an eye on these developments and documenting your losses accordingly could make all the difference.

Following a recent trend, New York Governor Andrew Cuomo has issued two executive orders requiring individuals to wear face coverings when near other people. One order requires all customer/public-facing employees to wear face coverings and requires employers to provide these face coverings at no cost to employees. The other order requires all individuals in a public place to use a mask or face covering.

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.

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.

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 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.

As local jurisdictions attempt to slow the spread of the coronavirus (COVID-19) and “flatten the curve,” several Northern and Central California counties have updated their existing shelter-in-place orders to impose more restrictions on employers and company operations. Employers should immediately prepare for compliance with the new protocols, some of which take effect on April 2.

In the midst of coronavirus (COVID-19) and quarantine mandates, companies are struggling to close current transactions, increase lines of credit with lenders, and finalize various matters. One hurdle is how to effectively notarize documents when offices are closed and in-person meetings are not permitted. Many states are enacting legislation to allow either temporary or permanent remote online notarization so that documents can be effectively notarized.

In response to the coronavirus (COVID-19) pandemic, California Governor Gavin Newsom has issued two executive orders that place temporary restraints on the ability of landlords to evict residential tenants, authorize local governments to halt residential and commercial evictions, and call on banks and other financial institutions to suspend residential and commercial foreclosures and related evictions.

This edition of Morgan Lewis Retail Did You Know? examines the impact of anti–price-gouging efforts by government enforcement officials in the time of the coronavirus (COVID-19) pandemic.

FDA representatives on March 18 initiated a conference call with representatives of the food industry to discuss public health and food safety issues related to the coronavirus (COVID-19) outbreak. The FDA was represented by Frank Yiannas (FDA Deputy Commissioner for Food Policy and Response), Michael Rogers (Assistant Commissioner for Human and Animal Foods), and Dr. Susan Mayne (Director of the Center for Food Safety and Applied Nutrition).

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.

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.

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.

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 impact of the coronavirus (COVID-19) pandemic on the global sports industry and its affiliated sectors is substantial and unprecedented. Constructive stakeholder engagement at all levels is crucial to ensuring business continuity. Organizations should be cognizant that decisions made now will attract post-crisis scrutiny, and start planning for post-pandemic recovery and growth.

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.”

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.

Loans for US small businesses to keep employees on payroll during business slowdowns resulting from the coronavirus (COVID-19) pandemic became available April 3 under the Paycheck Protection Program. Loan forgiveness may be available if businesses meet certain requirements.

The threat of coronavirus (COVID-19) has caused a sudden, unprecedented disruption to many areas of our lives. The decision to suspend the English Premier League (PL) is far from the most important or immediate concern, but it does factor as one of the many social, cultural, and financial fallouts of the crisis. We explore some of the legal issues arising out of the current suspension of the 2019/20 season and the legal challenges the PL and its key stakeholders will be considering in relation to the prospect of a total cancellation.

HM Revenue & Customs has made available further details to the UK government’s 20 March announcement on a series of initiatives, including a valued added tax deferral, to support British businesses in the face of the coronavirus (COVID-19) pandemic.

As the coronavirus (COVID-19) pandemic continues to evolve, regulatory and legislative authorities are taking actions, in the form of directives and orders, that could directly impact companies’ business interruption coverage. Careful review of insurance policies and insurers’ responses in light of these actions, as well as monitoring of regulatory and legislative developments, will be critical in preserving companies’ rights to coverage for COVID-19 losses.

Tenants and landlords should consider whether certain provisions such as force majeure, frustration of purpose, and/or impracticability of performance can protect them under current leases—and whether to include such provisions in future leases—as a result of the current coronavirus (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.

US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.

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.

Morgan Lewis managing partners Bill Nash and Ayman Klaleq were interviewed by LexisNexis for a special edition of the Lexis Middle East Law Alert magazine, which gives a round-up of legal, finance, and tax developments across the Middle East.

Elearning company Skillsoft provided two expedited alternatives to bankruptcy in its first-day filings in the Bankruptcy Court for the District of Delaware.

The US Citizenship and Immigration Services (USCIS) announced Friday that it will resume premium processing for certain petitions in phases over the next month. Petitions using Form I-129, Petition for a Nonimmigrant Worker, such as H-1B, L-1, O-1, TN, and Form I-140, Immigrant Petition for Alien Workers for permanent residency applications, will be eligible for premium processing based on the schedule below, which is subject to change.

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.

While artificial intelligence promises to be useful in responding to the coronavirus (COVID-19) pandemic, companies should be aware of potential copyright considerations.

The unprecedented conditions created by the coronavirus (COVID-19) pandemic and resulting government shutdown orders have placed significant roadblocks for the last step of documenting a contract or other legal document: authentication. The steps to overcome these roadblocks are highlighted two recent Morgan Lewis LawFlashes.

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.

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.

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 UK government has announced two new schemes for funding to innovative companies and startups, launching in May 2020.

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.

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.

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.”

Germany debates whether apps related to the coronavirus (COVID-19) pandemic would be useful, what they should cover, and what the ramifications would be under applicable data protection laws.

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.

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.

President Donald Trump signed the $2.2 trillion Coronavirus Aid, Relief, and Economic Security Act (CARES Act or the Act) into law on March 27. The CARES Act aims to offer economic relief to companies and their employees due to the coronavirus (COVID-19) pandemic in the United States. Many of the CARES Act provisions impact the technology industry although the Act does not expressly provide industry-specific relief.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, the historic $2.2 trillion fiscal stimulus bill signed into law on March 27, authorizes the US Patent and Trademark Office and US Copyright Office to extend statutory deadlines in response to the coronavirus pandemic.

The Federal Communications Commission is easing gift rules for participants in the RHC and E-Rate programs so that broadband providers can help support these critical institutions responding to the coronavirus.

The EU General Data Protection Regulation allows the temporary suspension of some data-protection rights in times of crisis, such as the outbreak of the 2019 Novel Coronavirus. This installment of The eData Guide to GDPR discusses the nature of those suspensions, and how the need to address the ongoing health crisis is being balanced with data-protection rights in Italy, France, and Germany.

Since the 2019 Novel Coronavirus (COVID-19) was first detected in December, the death toll has continued to rise as the virus quickly spreads. Centers for Disease Control (CDC) officials have stated that while the immediate risk of the virus to the American public is believed to be low at this time, US employers should more closely consider employee safety and ways to address disease prevention in the workplace.