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Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic

Apr
7
2020

Date: April 7, 2020

Time: 1:00PM - 2:00PM

Location: View the Webinar Recording

This was the first in a series of Life Sciences-specific webinars by Mintz and ML Strategies on a spectrum of legal issues companies are facing during this complicated period. The program covered issues of:

Employment Law

  • Families First Coronavirus Response Act 
  • Defining “Essential Business”
  • Responding to refusals to work
  • Communications regarding a positive test

FDA

  • Emergency use authorizations (EUAs) and enforcement discretion policies
  • Program setup for developers of potential COVID-19 therapeutics
  • Actions to help alleviate regulatory burdens on existing product sponsors in the life sciences industries

Clinical Trials

  • Regulatory authority accommodations for ongoing clinical trials that may be affected by COVID-19 and regional restrictions
  • Key considerations for sponsors and sites regarding ongoing and planned clinical trials

M&A

  • State of the M&A deal market
  • Impacts on deal processes and associated timeline
  • Allocating pandemic risk (MAC clauses come into focus)

Capital Markets

  • State of the public capital markets
  • Recent SEC developments related to COVID-19
  • Impacts on financing options for life sciences companies

Federal Legislation

  • Accessing funds for businesses creating COVID-19 diagnostics, therapeutics or vaccines
  • Financial assistance for businesses provided by CARES Act and other legislation

Speakers

Professional_Cropped_Fox_Joshua_Mintz

Joshua D. Fox

Moderator

Joshua D. Fox is a corporate attorney at Mintz who represents clients in milestone transactions and general corporate matters throughout the business lifecycle. He focuses on the life sciences (biotechnology, diagnostics, devices) and tech industry, including digital health, software, technology-enabled services, and consumer products.
Dianne J. Bourque advises health care clients on licensure, regulatory, contractual, risk management, and patient care matters for Mintz. Dianne counsels researchers and research sponsors on FDA and OHRP regulations. She also counsels clients on data privacy issues, including HIPAA standards.
Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.
Aaron L. Josephson is a Senior Director of ML Strategies who advises clients on health care policy issues related to medical devices and pharmaceuticals. Earlier, he was with the US Food and Drug Administration, including as a senior policy advisor in the Center for Devices and Radiological Health.
Professional Cropped Mantell Marc Mintz

Marc D. Mantell

Speaker

Marc D. Mantell handles corporate and securities law matters at Mintz, primarily for technology clients. He represents companies, investors, underwriters, and other parties in mergers and acquisitions, securities offerings, debt financings, and other transactions.
H. Andrew Matzkin is an employment litigator at Mintz, and he provides counsel on labor and employment issues. Drew represents clients in life sciences, technology, industrial, and professional services before federal and state courts, arbitrators, and administrative agencies.
Professional Cropped Rudy John Mintz

John T. Rudy

Speaker

John T. Rudy is a Mintz Member who represents clients in capital markets transactions, securities, equity debt financings, and mergers and acquisitions. John's clients include public and private companies and investment banks. Before joining Mintz, he was an associate in a New York law firm.
Benjamin M. Zegarelli is a Mintz Associate who counsels clients on compliance and regulatory issues, with a focus on FDA regulations. Benjamin advises clients in the pharmaceutical, medical device, and biotech industries. He provides counsel on research approval, sales, and contract negotiations.

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Apr
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2020

FDA in the Time of COVID-19

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21
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Clinical Trials in the Time of COVID-19

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May
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