Industries

The Department for Business, Energy & Industrial Strategy published a statement on 30 July announcing that furloughed employees will receive statutory redundancy pay based on their normal wages, rather than a reduced furlough rate.

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.

Hosted by the Morgan Lewis energy industry team, our next Evening in Energy will discuss common issues concerning executory contracts and 363 Sales that arise in oil and gas bankruptcy cases and an overall market outlook, specifically the impact of the coronavirus (COVID-19) pandemic and recent commodity price environment on the oil and gas industry and bankruptcy filings in the industry.

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 coronavirus (COVID-19) pandemic provides unique challenges to supply chain issues and the changing landscape of national security.

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.

Brad Nes will share the latest legal developments, regulations, compliance, and requirements for prosecuting and defending insurance claims related to the coronavirus (COVID-19) pandemic on a webinar panel presented by Rossdale CLE.

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.

Please join us for part two of our five part webinar series focusing on labor management relations in the time of a pandemic.

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 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.

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.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) provided a $2 trillion economic stimulus and contained many major tax changes to help businesses and individuals. This recorded webinar discusses major modifications to net operating losses, technical corrections of the Tax Cuts and Jobs Act, and changes on business interest deductions.

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.

During this webinar, our lawyers will discuss tax changes brought by the Families First Coronavirus Response Act; the Coronavirus Aid, Relief and Economic Security (CARES) Act; and recent federal and state guidance intended to improve or preserve liquidity for taxpayers and their businesses during the COVID-19 pandemic.

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.

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.

Morgan Lewis partner Harry I. Johnson, III will be speaking at the upcoming webinar, “Labor-Management Relations in the Midst of a Pandemic: Conflict or Accommodation?”, hosted by Cornell University and The Center on Innovative Hospitality Labor and Employment Relations (CIHLER).

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.

Please join Morgan Lewis corporate partner and shareholder activism defense practice leader Keith E. Gottfried and corporate partner Sean M. Donahue for the webinar, "Shareholder Activism Defense: Impact of COVID-19 on Shareholder Activism.”

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.

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.

Join us for a webinar addressing frequently asked benefits questions, top-of-mind workplace concerns, and guidance for companies navigating the rapidly changing situation across the globe.

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.

The shock, turmoil, uncertainty, and lack of visibility that followed the immediate onset of the coronavirus (COVID-19) pandemic in March 2020 were significant factors accounting for why shareholder activism was relatively subdued during the 2020 proxy season. However, given that activist investors have now had more than eight months to acquire their “sea legs” and recalibrate their playbook for the evolving “new normal,” it is likely that, even as the COVID-19 pandemic shows no signs of abating, activist investors will be less reluctant to wage an activism campaign in whatever “new normal” we find ourselves in during the 2021 proxy season.

Morgan Lewis partners Matthew Schernecke and Kristen Campana authored a Bloomberg Law article about the concessions lenders have made in exchange for additional credit support, capital contributed, and/or additional covenants amid the coronavirus (COVID-19) pandemic.

The Centers for Disease Control and Prevention (CDC) on September 1 issued an order under Section 361 of the Public Health Service Act to temporarily—at least through the end of 2020—halt residential rental evictions for Americans struggling to pay rent due to the coronavirus (COVID-19) pandemic.

As state revenue agencies train their auditors in traditional IRC §482 transfer-pricing methodologies or outsource transfer-pricing audits to third-party specialists, a recent initiative by the Indiana Department of Revenue follows another, alternative federal transfer-pricing compliance tool: advance pricing agreements (APAs).

The coronavirus (COVID-19) pandemic has caused upheaval in the global economy. This massive disruption has led to a wave of class action lawsuits relating, directly or indirectly, to COVID-19. This White Paper reviews the various categories of such class actions, the most commonly asserted theories of liability, and possible defenses to such actions, both as to the merits and against class certification.

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.

Please join us to discuss the new Main Street Lending Program Forms and updated FAQs released on Wednesday, May 27 by the Federal Reserve Bank of Boston in anticipation of program launch.

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.

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.

In a recent keynote speech, Co-Director of the US Securities and Exchange Commission’s Division of Enforcement Steven Peikin made it clear that the Division has made coronavirus (COVID-19) related enforcement matters a top priority and is dedicating significant time and resources to respond to such issues.

Please join us for a 60-minute webinar as we address key issues for institutional investors.

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.

Please join us to discuss the newly issued term sheets and guidance on the Main Street Lending Program, including changes relevant to borrowers and lenders across all industries and sizes.

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

On April 23, Congress passed the Paycheck Protection Program and Health Care Enhancement Act (the Enhancement Act), which expanded funding for the existing Paycheck Protection Program (PPP). This follow-up webinar will discuss key features of the Enhancement Act, in addition to recent Small Business Administration (SBA) guidance.

This article summarizes a recent webinar presented by Morgan Lewis partners Andrew Budreika and Raechel Kummer and associate Ben Stango in conjunction with the American Bakers Association.

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.

The US Senate approved an additional $310 billion in funds for the Paycheck Protection Program (PPP) on April 20, and the House of Representatives is expected to approve these additional funds within days.

Recent announcements from the US Securities and Exchange Commission make it clear that, although it will not be business as usual, the agency will ably navigate the coronavirus (COVID-19) crisis and its work will move forward. However, over the next several months, the SEC and its staff will be confronted with choices about where and how to deploy the Commission’s limited enforcement and examination resources, and those decisions will have a profound effect on regulated entities.

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.

The Nasdaq Stock Market has temporarily suspended the continued listing bid price and market value of publicly held shares listing requirements for its issuers through June 30, 2020. This relief, effective immediately, provides issuers with additional time to regain compliance with the bid price and/or market value of publicly held share requirements.

The US Securities and Exchange Commission, the Financial Industry Regulatory Authority, and state securities regulators recognize the significant impact of the coronavirus (COVID-19) pandemic on broker-dealers, investors, and other stakeholders, and have provided important guidance and relief to broker-dealers on how to meet some of these challenges.

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.

Our panelists will compare and contrast UK and US practices as they relate to the negotiation of a sales and purchase agreement. Key issues highlighted in this webinar will include pricing mechanisms, execution risk, and seller warranties.

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.

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.

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.

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.

Morgan Lewis partner William Yonge was quoted in an ACA Insight article about two new sets of “expectations” issued recently by the United Kingdom’s Financial Conduct Authority and Prudential Regulation Authority that investment advisory firms and brother-dealers are required to follow.

Morgan Lewis partner Jennifer Breen was quoted in a Tax Notes article about the CARES Act implications on restrictions in the Tax Cuts and Jobs Act.

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.

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.

This alert reviews the impact of the Government of Japan’s recent state of emergency declaration due to the coronavirus (COVID-19) global pandemic on the practices of the Kanto Local Finance Bureau, which has switched to rotating shift work resulting in the anticipation of longer filing times.

To help address market participants in the face of the coronavirus (COVID-19) crisis, the Basel Committee on Banking Supervision and the International Organization of Securities Commissions have provided a one-year extension to the fifth and sixth phases of the implementation schedule of the rules requiring margin for uncleared swaps.

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).

The UK Financial Conduct Authority and Prudential Regulation Authority have published statements setting out their expectations of dual-regulated and solo-regulated firms on their senior managers and certification regime requirements in the context of the coronavirus (COVID-19). They intend to provide flexibility to firms where they can and have made specific provisions in light of COVID-19.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act offers broad-based economic support for companies contending with the disruptions caused by the coronavirus (COVID-19) pandemic. This LawFlash provides a comprehensive overview of the aid that is available to or directly affects banks and related companies.

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.

Both borrowers and lenders need to be aware of issues arising from a new US government loan program for small businesses relative to existing capital structures, although some guidance also is not yet available. Both borrowers and lenders may also request negotiations of various terms.

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.

Please join Morgan Lewis corporate partner and shareholder activism defense practice leader Keith E. Gottfried and corporate partner Sean M. Donahue for the webinar, "Shareholder Activism Defense: Impact of COVID-19 on Shareholder Activism.”

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

While offering guidance on which financial services workers could be considered essential, the UK Financial Conduct Authority says that firms themselves are best placed to make those decisions.

Join us for a webinar as we share practical perspectives to help guide legal departments, business leaders, and boards through the broad scope of corporate, M&A, and capital markets issues brought on by this public health challenge.

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.

Morgan Lewis partners Steve Stone and Christine Lombardo spoke at MMI’s member-only NetMeeting webinar titled “Update on SEC Conditional Relief for Investment Advisers from Filling and Disclosure Obligations.”

The Federal Housing Finance Agency (FHFA) and the US Department of Housing and Urban Development (HUD) announced on March 18 that they have directed Fannie Mae and Freddie Mac, the government sponsored enterprises (GSEs), to suspend foreclosures and evictions for at least 60 days due to the coronavirus (COVID-19) national emergency.

Many Commodity Futures Trading Commission registrants and other market participants are responding to the coronavirus (COVID-19) pandemic by implementing business continuity plans that move personnel from their “normal business sites,” which implicates CFTC regulatory requirements.

Global financial markets have experienced unprecedented volatility as heightened concerns about the ongoing coronavirus (COVID-19) pandemic take hold and its impact on the global macroeconomic landscape remains unknown. From its record high, the S&P 500 has plunged as much as 30%, and companies in sectors disproportionately impacted by COVID-19–particularly those that have had to reduce or suspend operations to comply with the current social distancing guidance from the US Centers for Disease Control and Prevention–have experienced stock price declines of more than 70% from their 52-week highs.

The spread of the coronavirus (COVID-19) continues to impact global financial markets and private funds. Institutional investors, funds-of-funds, family offices, and other investors in private funds should consider the economic exposure to their private fund investments from operational disruptions that may occur as a result of the pandemic.

The Russian parliament urgently passed a new law on 14 March that amends the Federal Law on Joint Stock Companies (the JSC Law) to allow shareholder meetings in 2020 to be conducted by absentee voting if the agenda includes certain items.

The EU watchdog, The European Securities and Markets Authority (ESMA), which coordinates securities market supervision across the 27 countries of the European Union, announced on March 11 that it was prepared to use its powers to ensure the orderly functioning of markets, financial stability, and investor protection, and issued the following recommendations to financial market participants (FMPs) in the European Union.

With the situation surrounding the 2019 Novel Coronavirus rapidly changing, key practical considerations for financial institutions regulated by the Hong Kong Securities and Futures Commission and Hong Kong Monetary Authority include business continuity planning, contract issues, and notification and filing requirements.

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.

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.

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) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients to “include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions.”

Join us for our next Fast Break webinar, where we will discuss current enforcement trends as well as strategies for managing fraud and abuse risks related to the pandemic.

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 partner Reece Hirsch was quoted in a Report on Patient Privacy article about HIPAA compliance challenges in the midst of the coronavirus (COVID-19) pandemic.

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.

Morgan Lewis partner Reece Hirsch was quoted in a Healthcare Risk Management article about waivers issued by the US Department of Health and Human Services Office for Civil Rights (OCR) concerning HIPPA compliance.

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).

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.

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.

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.

Our COVID-19 Healthcare Provider Update Webinar Series will address the evolving, unprecedented legal issues that arise from 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.

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.

Our COVID-19 Healthcare Provider Update Webinar Series will address the evolving, unprecedented legal issues that arise from the coronavirus (COVID-19) pandemic. We will host updates on Tuesdays and Thursdays at 12:00 pm ET. Visit our Healthcare Provider Update page for additional information and a full list of upcoming sessions.

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).

Our COVID-19 Healthcare Provider Update Webinar Series will address the evolving, unprecedented legal issues that arise from the coronavirus (COVID-19) pandemic. We will host updates on Tuesdays and Thursdays at 12:00 pm ET. Visit our Healthcare Provider Update page for additional information and a full list of upcoming sessions.

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.

Join us for an upcoming webinar on medical waivers. Our COVID-19 Healthcare Provider Update Webinar Series will address the evolving, unprecedented legal issues that arise from the coronavirus (COVID-19) pandemic. We will host half hour updates on Tuesdays and Thursdays, from 12:00 to 12:30 pm ET. Visit our Healthcare Provider Update page for additional information and a full list of upcoming sessions.

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 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.”

Please join us for a two-part webinar series on key legal, employment, and regulatory trends and issues impacting the European life sciences market.

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.

Please join us for a webinar on emerging trends in commercial business tactics and strategies that will necessitate injunctive relief or require a plan to oppose injunctive relief in the wake of the coronavirus (COVID-19) pandemic.

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.

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.

While retailers in China have been permitted to reopen, required steps to do so include health and sanitation measures. Some local governments are also considering extending the weekend in order to stimulate consumption and promote economic recovery.

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).

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.

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.

Please join us to discuss the newly issued term sheets and guidance on the Main Street Lending Program, including changes relevant to borrowers and lenders across all industries and sizes.

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.

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.

Our panelists will discuss relief provided by the CARES Act to retail companies and additional areas of risk that should be carefully reviewed for any retail company resulting from the impact that COVID-19.

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.

This discussion provides an overview of the Federal Reserve programs, including Main Street and other federal COVID-19 relief programs, and the loan programs under the CARES Act. The presentation highlights key aspects of the Main Street Lending Program broadly, with a focus on primary and secondary corporate credit facilities, the Paycheck Protection Program term financing, and the municipal liquidity facility.

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.

Join us for a discussion of the Small Business Administration’s Paycheck Protection Program and related small business funding opportunities.

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.

Join our labor-management relations lawyers, including two former National Labor Relations Board Members, for a webinar focusing on the workforce and legal compliance challenges facing union and nonunion employers during these unprecedented times.

Join us for a webinar addressing frequently asked benefits questions, top-of-mind workplace concerns, and guidance for companies navigating the rapidly changing situation across the globe.

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.

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.

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 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.