COVID-19 Report for Life Sciences and Health Care Companies (June 2021)

Wednesday, 30 June 2021

• The U.S. Food and Drug Administration (FDA) has approved a novel COVID-19 diagnostic called “CovAb” from Diabetomics Inc. The test is the first saliva-based test for COVID-19 antibodies to be granted an emergency use authorization (EUA) by FDA. Diabetomics said CovAB can be administered at the point of care using an oral fluid sample obtained with a swab of the gumline, and that the test yields results in approximately 15 minutes. The diagnostic detects IgA, IgG and IgM antibodies, and had already received a CE mark in Europe. In the U.S., CovAb is marketed by Diabetomics' COVYDx subsidiary. Previously, all FDA-authorized COVID-19 antibody tests required drawing blood. Diabetomics reported a 97.6% sensitivity rate and 98.8% specificity rate for the test. (Authored by Randy Prebula)

• In light of the impact of the global COVID-19 pandemic, employers have made adjustments to facilitate remote working, with some considering maintaining expanded remote work policies even after government restrictions are lifted. However, employers should be aware of several legal issues that may apply when employees work from home and that “home” is located in another state or country.  Online here we have analyzed concerns for employees in the United States, the United Kingdom, and France, including tax implications, pay and labor laws, "force majeure" clauses and "exceptional circumstances," collective agreements, and other implications. (Authored by David W. D. Mitchell)

• The unprecedented challenges of the COVID 19 pandemic are still with us, not only in terms of the grim toll the virus has taken on individuals and families, but also in terms of wider implications for how people and societies live and interact. Data protection regulation emerged as a key regulatory pressure point during the pandemic in respect of a host of issues, from the collection of medical, biometric and contact tracing data, through to data protection and cybersecurity aspects of remote working as workers increasingly stayed home. Our Asia Pacific Data Protection and Cyber Security Guide 2021 will take you through the developments and key initiatives of APAC countries and discuss the implications of an ever-shifting landscape. (Authored by Sherry Gong)

Wednesday, 23 June 2021

• It was announced last week that there will be a three month extension on the blanket prohibition on statutory demands and the restriction on winding up petitions based on a company’s inability to pay its debts in the UK (unless the creditor has reasonable grounds for believing that either COVID-19 has not had a financial effect on the company or that the circumstances forming the basis of the winding up petition would have occurred even if COVID-19 had not had a financial effect on the company). This extension follows previous extensions of the prohibitions on filing statutory demands and winding up petitions. Both extensions are longer than expected. Perhaps more interestingly, the announcement includes reference to the imposition of an arbitration mechanic for arrears – a step from the government that will provide another route to impose a compromise on arrears. Read more online here. (Authored by Tom Astle)

Tuesday, 15 June 2021

• Pursuant to Executive Order 14017, issued by U.S. President Biden on 24 February 2021, a federal government task force examined the vulnerabilities in America’s supply chains for semiconductor manufacturing and advanced packaging, large capacity batteries, critical minerals and materials, and pharmaceuticals and active pharmaceutical ingredients. On 8 June, 2021, the Administration released its report detailing the task force’s findings and announcing several immediate actions it plans to take to address the weaknesses identified, focusing on increased domestic production and decreased dependence on foreign supply. Supply chain challenges, along with economic security, are front and center in the global economic agenda, as countries around the world continue to struggle with the human and economic costs of the COVID-19 pandemic. Although federal investment in the private sector’s innovation allowed the US to develop a strong COVID-19-related products supply chain, the report found that the nation remains critically dependent on imports of pharmaceutical products and active pharmaceutical ingredients, which represent 90 percent of all prescriptions filled. Online here we've summarized the report's key findings. (Authored by Kelly Ann Shaw)

• The U.S. Department of Agriculture (USDA) recently announced plans to invest more than US$4 billion to strengthen critical supply chains under President Biden’s “Build Back Better” initiative. The plan is designed to support the economy in the wake of the COVID-19 pandemic, including direct relief to Americans, providing resources for economic recovery, rebuilding the country’s infrastructure, and rebuilding the middle class. In addition to the USDA Press Release, Secretary of Agriculture Tom Vilsack hosted a USDA webinar on 9 June to discuss the Build Back Better initiative and department priorities, as well as answer questions from industry. He repeated the messages from the USDA announcement that the department believes the new effort will strengthen the food system, create new market opportunities, tackle the climate crisis, help communities that have been left behind, and support jobs throughout the supply chain. Read more online here. (Authored by Elizabeth Fawell)

Thursday, 10 June 2021

• It is over a year since the first UK-wide lockdown and, as time has passed, our understanding of the virus and familiarity with the safety measures it necessitates has increased.  But neither individuals or organizations can afford to become complacent. The global pandemic is constantly evolving and businesses in all sectors continue to have a number of legal duties to minimize risks posed by the virus. As the country eagerly awaits the end of the current lockdown roadmap, we take a moment to consider what reopening means to UK companies and their health & safety obligations to their employees and to the general public. Read more online here. (Authored by Helen Boniface)

• The COVID-19 pandemic presents new and unique legal issues and challenges in many areas, including M&A litigation, and likely will continue to do so for years to come. For M&A litigation, difficult issues arose when transactions were signed in the pre-COVID-19 world but were not scheduled to close until after the pandemic took hold. Buyers were confronted with the prospect of having to close deals on target companies that faced new and uncertain economic prospects. Sellers often found themselves in desperate need of financial lifelines while constrained by merger agreements signed prior to the onset of the pandemic. Online here is a Q&A-style cross-practice publication covering M&A issues in 18 different countries. This quick reference guide contains side-by-side comparison of local insights into M&A Litigation, including types of shareholder claim; class or collective actions; derivative litigation; interim relief and early dismissal; claims against third-party advisers or counterparties; limitations on claims; standards of liability; legal restrictions on indemnities; challenges to particular clauses or terms; pre-litigation tools and procedure; the role of directors’ and officers’ insurance; forum and discovery considerations; damages and settlements; directors’ duties regarding unsolicited or unwanted M&A proposals; types of counterparty claim; and recent trends. (Authored by Andrea Atteritano)

Thursday, 3 June 2021

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. President Joe Biden released his $6 trillion FY-2022 Budget request Friday, which includes significant new investments in federal health programs and pandemic preparedness. The Centers for Disease Control and Prevention (CDC) released a study showing thousands more kidney failure patients died during the first seven months of the coronavirus pandemic than usual. President Biden on Wednesday urged Americans to get vaccinated against COVID-19 if they haven't yet, declaring a “national month of action” to reach his goal of having 70 percent of adults with at least one shot by 4 July. Twelve U.S. states now have 70 percent of adult residents who have had at least one COVID-19 vaccine shot, CDC data published Tuesday shows. Moderna announced that it has a new drug substance production agreement in the Netherlands and will be doubling its expected EU production with an additional 300 million doses per year. Read more about these developments online here. (Authored by Ivan Zapien)

• On 12 May 2021, the French Government issued a Statutory Instrument implementing Articles 17 to 23 of the European Union Directive on Copyright in the Digital Single Market 2019/790 of 17 April 2019. France had been a key actor in the negotiations leading to the adoption of the Directive, especially with regard to the protection of authors and rights holders. The French Government pushed, among others, for increased accountability and transparency on the part of online content service providers. France was already the first Member State to implement Article 15 of the Directive in July 2019 by Act of Parliament. Article 17 of the Directive was scheduled to be implemented in the same way. Therefore, a draft bill was issued in December 2019 to that effect. However, the parliamentary debates were delayed by a series of national strikes, and were eventually called off due to the COVID-19 pandemic. To meet the implementation deadline, the Government decided to legislate by Statutory Instrument and this process was approved by Parliament in December 2020. Read more online here. (Authored by David Taylor)

• We analyze online here the legal impact on Italian loan transactions of the current health emergency caused by COVID-19 in light of the recent case law and the latest legislative measures, including a suspension of interest and principal payments on loans to SMEs, the rescheduling of repayment plans, and a State guarantee for loans to larger corporates. SMEs also benefit from a mandatory hold of credit facilities, and there is a general suspension of insolvency proceedings, mandatory recapitalizations and subordination of shareholder loans. In accordance with the EU Commission's Temporary Framework on State aid, financial support is not available for non-performing or otherwise impaired loans, and our observations relate to loans which were fully performing until COVID-19. (Authored by Carlo Massini)

• Hogan Lovells has developed a Trade Secrets Toolkit to help businesses protect their trade secrets and confidential know-how. The Toolkit consists of four modules: Identify, Protect, Respond, and Commercialize. Each module has been designed to support innovators throughout the lifecycle of a trade secret. By drawing on the market leading expertise of our intellectual property, employment, privacy and cybersecurity professionals, the Toolkit will enable businesses to take into account a broad range of legal and commercial risks when developing their trade secrets strategies. Joe Raffetto, Washington, D.C.-based partner and Trade Secrets co-lead noted: "the ongoing COVID-19 pandemic has forced businesses to rapidly implement large scale remote working arrangements creating new risks for trade secrets holders. The importance of taking proactive steps to protect proprietary information is more crucial than ever." (Authored by Anna Katharina-Friese)

Compiled by Aaron Armstrong