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

Wednesday, 1 September 2021

• On 27 August, the U.S. Food and Drug Administration (FDA) authorized the use of the monoclonal antibodies bamlanivimab and etesevimab, administered together. The Emergency Use Authorization applies only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab  and etesevimab administered together is less than or equal to 5%. Separately, on 30 August, FDA  issued a letter to veterinarians and retailers asking for assistance in sharing important safety information with consumers about the dangerous misuse of animal ivermectin to prevent or treat COVID-19 in people. Poison control centers across the U.S. are seeing a sharp spike in reports of people suffering adverse health effects after taking animal ivermectin. FDA warned that treating human medical conditions with veterinary drugs can be very dangerous. FDA also announced September virtual Town Hall dates for test developers for SARS-CoV-2, which will take place on 8 and 22 September. (Authored by Randy Prebula)

• On 9 August, Washington state announced that it will be requiring state employees and in-state health care workers to be fully vaccinated against COVID-19 by 18 October 2021, which was followed by a similar announcement from Oregon on 19 August. Other U.S. states announced earlier in July that state employees, including patient-facing employees in state-run health care facilities, will be required to get vaccinated for COVID-19 or else will be required to be tested for COVID-19 on a weekly basis after 6 September. This announcement came shortly after the U.S. federal government’s announcement that all federal employees would similarly be required to get vaccinated or be subjected to weekly tests and other safety measures. Read more online here. (Authored by Tao Leung)

• In Snow Phipps Group, LLC v. KCAKE Acquisition, Inc. (C.A. No. 2020-0282-KSJM), the Delaware Court of Chancery ordered specific performance of a US$550 million acquisition, rejecting the buyer’s argument that the impact of COVID-19 was reasonably expected to constitute a materially adverse event (MAE). The court found specific performance appropriate because the plaintiff failed to use reasonable best efforts to obtain appropriate financing, including making unreasonable demands of the potential lenders. Ultimately, the court characterized its decision as a “victory for deal certainty,” reaffirming that Delaware courts set a high bar for purchasers seeking to terminate an acquisition agreement on the basis of an MAE. The holding demonstrates that while other deal parties recently were able to demonstrate MAEs, including AB Stable VIII LLC and Akorn, the burden to do so remains high and requires a “persistent and sustained” failure in an acquisition target’s business. We analyzed this case in depth online here. (Authored by Ryan Philp)