In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Deon Govender discuss Regulatory and policy developments from South Africa: SAHPRA’s proposed Black Economic Empowerment (BEE) policy and its potential impact on license holders for medicines and medical devices
Ninth Circuit Holds Courts Cannot Decide Factual Disputes in Standing Challenges Where Standing and Merits Analyses Are Intertwined
Under Ninth Circuit precedent, when a defendant brings a factual challenge to jurisdiction, the district court may resolve factual disputes so long as the jurisdictional and merits inquiries are not intertwined. But where the jurisdictional and merits inquiries are intertwined, the court must treat the motion like a motion for summary judgment and “leave the
Five key takeaways from recent EU developments on the GDPR’s “legitimate interests” legal basis
In the past few weeks, there have been significant developments relating to the “legitimate interests” legal basis under Article 6(1)(f) of the GDPR:
- On 4 October 2024, the Court of Justice of the EU (“CJEU”) handed down its judgment in a case relating to the Royal Dutch Lawn Tennis Association (Case C-621/22, KNLTB),
NIS2 Deadline Today
Today, October 18, is the deadline for EU Member States to start to apply the EU cybersecurity law “NIS2” under national laws. NIS2 builds on requirements under the prior NIS Directive. See our post on the Inside Privacy blog to find out more.
Is Your Workplace Election Ready? Voting Leave Laws Across the States
With Election Day just weeks away, employers should quickly brush up on laws that permit employees to take time off to vote. There is no federal law permitting time off to vote, but a majority of states and the District of Columbia have some form of voting leave law, with variations regarding the amount of
The Nagoya Protocol at Its 10th Anniversary: Lessons Learned and New Challenges from ‘Access and Benefit-Sharing’
October 12, 2024, marks the 10-year anniversary of entry into force of the Nagoya Protocol on Access to Genetic Resources and Fair Benefit-Sharing from their Utilization (“ABS”). This additional treaty to the Convention on Biological Diversity (“CBD”) has now been ratified by 142 countries. Over the past decade, Nagoya Protocol has resulted in the mushrooming
September 2024 Developments Under President Biden’s Cybersecurity Executive Order and National Cybersecurity Strategy
This is part of a series of Covington blogs on implementation of Executive Order 14028, “Improving the Nation’s Cybersecurity,” issued by President Biden on May 12, 2021 (the “Cyber EO”). The first blog summarized the Cyber EO’s key provisions and timelines, and the subsequent blogs described the actions taken by various government agencies to implement
EU Talking Life Sciences Audiocast: Developments in the African Medicines Agency and Regulatory Convergence
In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Grant Castle discuss developments in the African Medicines Agency and regulatory convergence.
DOE Announces up to $1.8 Billion in Funding in Next Phase of Regional Direct Air Capture Program
On October 10, the U.S. Department of Energy’s Office of Clean Energy Demonstrations (OCED) hosted a webinar providing an overview of the recently issued Notice of Intent (NOI) to award up to $1.8 billion in funding for new mid- and large-scale commercial direct air capture (DAC) facilities. The NOI represents the start of the next
Public Comments to Proposed Rule Underscore the Need for Additional Clarity on SBA Recertification Requirements
The Small Business Administration (“SBA”) recently issued a proposed rule that would significantly change the rules concerning small business recertification in M&A transactions and other events (the “Proposed Rule”). SBA has framed the Proposed Rule as a consolidation of what is currently a scattered set of regulations, but the rule goes further than consolidating and