Regulatory Playbook

Trending Issues

Trump 2.0
11.07.2024

Former President Donald J. Trump won the U.S. presidential election on November 5, prevailing in the key “battleground states” necessary to win the Electoral College.

China Issues New Export Control Regulations on Civil-Military Dual-Use Items
11.07.2024

On October 19, 2024, the State Council of the People’s Republic of China (China or PRC) promulgated the Regulations on the Export Control of Dual-Use Items of China (Export Control Regulations), which will become effective on December 1, 2024.

The Treasury Department Finalizes U.S. Outbound Investment Rules
11.07.2024

On October 28, 2024, the U.S. Department of Treasury issued the long-awaited Final Rule implementing its outbound investment review framework. This follows prior stages of rulemaking, including an Advance Notice of Proposed Rulemaking (ANPRM) in August 2023 and a Notice of Proposed Rulemaking (NPRM) in June 2024, and formalizes a new governmental system to monitor and, when necessary, restrict investments in China that may be viewed as a national security risk.

Navigating the EU’s “NIS 2” Directive: Key Cybersecurity Compliance Points for Businesses Operating in the EU to Consider
11.04.2024

As cybersecurity threats continue to evolve, the European Union has advanced its regulatory framework with the introduction of a new cyber law, Directive 2022/2555, commonly referred to as “NIS 2”. It replaces Directive 2016/1148 (NIS 1), aiming to address the fragmented cybersecurity landscape across the EU by creating a unified approach to risk management and response. While NIS 1 focused on essential sectors, such as energy and transport, NIS 2 expands its reach to a broader range of industries, reflecting the digitalization of the European economy and the increasing risks associated with cyber threats across sectors.

Biden Administration Announces Research and Development Program to Accelerate Semiconductor Advanced Packaging
11.04.2024

On October 18, the Biden Administration released a $1.6 billion Notice of Funding Opportunity (NOFO) funded by the CHIPS and Science Act to accelerate U.S. Semiconductor Advanced Research and Development (R&D) across five key R&D areas. Aligning with the Administration’s goal of investing in domestic manufacturing industries, the program is projected to provide $1.6 billion in funding across the five R&D areas.

Small Business Administration Expands the “Rule of Two"
11.01.2024

On October 25, 2024, the Small Business Administration (SBA) issued a proposed rule that would expand the applicability of the “Rule of Two.” Under the proposed rule, the Rule of Two would apply to orders issued under multiple award contracts, with certain exceptions.

New York Department of Financial Services’ New Enhanced Cybersecurity Requirements Effective November 1, 2024
10.30.2024

On November 1, 2024, the next phase of several significant amendments to the New York Department of Financial Services’ (NYDFS) cybersecurity regulation take effect. These specific amendments, enacted in 2023, impact the scope of entities covered by the regulation and require covered entities to implement enhanced governance, business continuity and encryption standards.

U.S. Department of Energy Announces $900 Million Funding Opportunity for Generation III+ Small Modular Reactors
10.28.2024

On October 16, 2024, the U.S. Department of Energy (DOE) issued a $900 million funding initiative to support the deployment of Generation III+ Small Modular Reactors (Gen III+ SMRs). The application deadline is January 17, 2025, and entities well-positioned to collaborate with utilities and nuclear technology providers to demonstrate a clear path to deployment should consider this opportunity.

Hurricanes Helene and Milton: Evaluating Business Interruption Claims Following a Large-Scale Disaster
10.28.2024

Hurricanes Helene and Milton physically damaged large areas of the South, particularly in Florida, North and South Carolina, Georgia and Virginia. Businesses in the region are also certainly suffering long-lasting economic damage as they remain closed—and they will rightly want to secure business interruption coverage for those losses.

U.S. Bankruptcy Court Holds that State-Court Receivership Order Does Not Bar Managing Member from Seeking LLC Bankruptcy Relief
10.25.2024

When disputes involving financially distressed real estate or other property cannot readily be resolved through foreclosure, deed-in-lieu, consensual out-of-court restructuring, or a cooperative bankruptcy filing, a lender/mortgagee (or other creditors or interest holders) can ask a court to appoint a receiver to take control of the property, its rents, and sometimes the borrower entity. Typical receivership orders often grant receivers broad authority to take actions with respect to property and receivership assets. The orders also typically grant broad injunctive relief barring creditors, managers, equity holders and others, from taking actions against the property.

From Anatomy to Action: Navigating Data Center Contracts
10.24.2024

Our colleagues recently provided a comprehensive overview of the anatomy of a data center, which explored the structural, energy and real estate implications of these essential facilities.

The Department of Defense Issues Final Rule Establishing CMMC 2.0
10.24.2024

On October 15, 2024, the Department of Defense (DoD) published a long-awaited final rule implementing the Cybersecurity Maturity Model Certification (CMMC) program 2.0. The final rule will take effect on December 16, 2024. Spanning 146 pages in the Federal Register, this rule finalizes DoD’s regulations concerning CMMC 2.0. This rule does not, however, revise the DoD Federal Acquisition Regulation Supplement (DFARS). As we previously reported, in August DoD issued a proposed rule revising the DFARS to implement CMMC 2.0 in solicitations and contracts (the DFARS rule). The comment period for that proposed rule closed on October 15, 2024. Once the DFARS rule is also finalized, the phased roll out of the CMMC program will begin.

Pentagon Unveils $984 Million Loan Program to Promote Critical Technologies
10.18.2024

On September 27, the Department of Defense (DoD) published a Notice of Funding Availability to accelerate the commercialization of technologies critical to U.S. national security and defense. DoD’s Office of Strategic Capital (OSC) will carry out this program in line with its mission to “attract and scale private capital” to critical technologies. The program will provide direct loans ranging from $10 million to $150 million for eligible entities investing in technologies that benefit DoD but are not limited to DoD operations.

Lenders Beware: The Ponzi Scheme Presumption Can Trap an Unwitting Lender
10.15.2024

The Ponzi scheme presumption applies when a bankruptcy trustee (or similarly situated plaintiff) establishes that a Ponzi scheme exists. As a matter of law, it allows the court to infer the Ponzi scheme perpetrator’s actual intent to hinder, delay or defraud creditors with respect to seemingly all payments made during the existence of the scheme. See, e.g., Johnson v. Neilson (In re Slatkin), 525 F.23 805, 814 (9th Cir. 2008). Even payments received from the perpetrator in good faith can be clawed back, though recipients should be entitled to retain payments applied to their principal or actual investment in the scheme.

The Challenge Organizations Face to Become DORA Compliant Is Not to Be Underestimated
10.15.2024

Financial entities within the EU are required to submit registers of information detailing their contractual arrangements with providers of information and communication technology (ICT) services (ICT Providers) to the European Supervisory Authorities (ESAs) prior to DORA’s compliance deadline. Financial entities should now be engaging with their existing ICT Providers to prepare such registers of information to enable the ESAs to designate “critical” ICT Providers (CTPPs).

The Beginning of the End for the USPTO’s After Final Consideration Pilot Program 2.0
10.14.2024

On October 1, 2024, the U.S. Patent and Trademark Office (USPTO) announced the termination of the After Final Consideration Pilot Program 2.0 (AFCP 2.0), a program widely used by patent applicants since 2013. As the program enters its final extension period, patent applicants should be aware of key deadlines and explore alternative strategies for responding to final office actions. Initially set to expire on September 30, 2024, the AFCP 2.0 has been extended to December 14, 2024, after which no further participation requests will be accepted. The decision to end the program follows public resistance to a proposed fee structure aimed at offsetting its high administrative costs.
 

District Court Finds Qui Tam Provisions of the False Claims Act Unconstitutional
10.14.2024

In a groundbreaking decision issued on September 30, 2024, Judge Kathryn Mizelle of the U.S. District Court for the Middle District of Florida broke with decades of precedent and held that the qui tam provisions of the False Claims Act (FCA) are unconstitutional. See U.S. ex rel. Zafirov v. Florida Medical Assocs., LLC, No. 8:19-CV-01236-KKM-SPF, (M.D. Fla. Sept. 30, 2024).

New UK Trade Sanctions Enforcement Body Goes Live October 10, 2024
10.10.2024

The Trade, Aircraft and Shipping Sanctions (Civil Enforcement) Regulations 2024 (the Regulations) were published on September 12, 2024, and are effective from October 10, 2024. They grant the Office of Trade Sanctions Implementation (OTSI) new civil enforcement powers in respect of most UK trade sanctions, and the Department for Transport (DfT) corresponding powers in relation to aircraft and shipping sanctions. Businesses operating in the UK should expect substantially heightened trade sanctions enforcement risk, particularly as penalties for breaches of trade sanctions will be imposed on a strict liability basis. Certain parties in the financial, legal, shipping and aviation sectors will also be impacted by new mandatory reporting obligations.

Corporate Transparency Act: Is Your Company Prepared to Meet the Deadline for Filing on January 1, 2025?
10.10.2024

The federal Corporate Transparency Act (CTA) became effective on January 1, 2024, and set a deadline of January 1, 2025, for entities existing on the effective date to file an initial report. As we enter the fourth quarter of 2024, that deadline is fast approaching. Many entities have waited to see if the statute would be invalidated, the rules further clarified, or the deadline postponed, or have decided to wait until the deadline is at hand. It now may be time for entities formed or qualified to do business in the United States to determine if they are required to file and, if so, to determine who are the “beneficial owners” whose name and personal information needs to be collected, and to begin to collect this information.

Is the Federal Circuit Breathing Life Back Into False Patent Marking Claims?
10.09.2024

On October 3, 2024, the Federal Circuit issued a decision in Crocs, Inc. v. Effervescent, Inc. holding that a cause of action arises under Section 43(a)(1)(B) of the Lanham Act “where a party falsely claims that it possesses a patent on a product feature and advertises that product feature in a manner that causes consumers to be misled about the nature, characteristics, or qualities of its product.”

Federal Court Issues Injunction to Prevent Presumptive Gender and Race Preferences for DOT Contracts Within Kentucky and Indiana
10.08.2024

On September 23, 2024, the U.S. District Court Eastern District of Kentucky granted a preliminary injunction, enjoining the U.S. Department of Transportation (DOT) from using the rebuttable presumption that businesses owned by women and persons of certain races and ethnicities are socially disadvantaged and therefore should be given preference when awarding federal contracts

DOJ Debuts Updates to Its Evaluation of Corporate Compliance Programs Aimed at the Responsible Use of Artificial Intelligence
10.08.2024

On September 23, 2024, the U.S. Department of Justice (DOJ) Criminal Division released an updated version of its Evaluation of Corporate Compliance Programs (ECCP) guidance. DOJ first published the ECCP in 2017 to provide clear guidance on which factors federal prosecutors will consider when evaluating the strength of a corporation’s compliance programs in the context of an investigation or enforcement action. The ECCP instructs prosecutors on how to evaluate a company’s risk assessment mechanisms, to ensure that the company’s policies and procedures are responsive to the risks that it has identified and communicate those risks, and the established risk mitigations, to the corporation’s stakeholders, such as employees and vendors. The ECCP is a critical resource that companies should consider when developing compliance programs to avoid penalties associated with DOJ enforcement action.

Bipartisan Legislation Presents Opportunity for Passing PFAS Laws
10.04.2024

With appropriations settled until December 20, Congress now has one other piece of “must-pass” legislation to address: the National Defense Authorization Act (NDAA). The NDAA authorizes the activities of the Department of Defense (DoD) for the following fiscal year and the legislation has passed on a bipartisan basis for over 60 consecutive years. Because of the nature of the bill and its legacy as a successful, bipartisan movement, the NDAA has become critical for Congress to pass each year. However, the NDAA, as with other must-pass pieces of legislation, has also become a vehicle for attaching policy items that would not otherwise pass on their own, either because they are too controversial or not popular enough. As a result, the passage of the NDAA has become more controversial in the past few years as social programs and partisan priorities have been added to the negotiation process. One area of attention in recent years addresses DoD handling of PFAS chemicals. As the House and Senate versions of the NDAA have differing provisions concerning PFAS, this will prove to be another topic that the NDAA conferees will need to negotiate in the coming weeks. Below is an overview of the PFAS provisions that may or may not be included in the final bill.

California Climate Disclosures Remain on Schedule
10.02.2024

California is set to launch its first-in-the-nation mandatory climate disclosure framework next year as provided in the 2023 Climate Accountability Package, Senate Bills SB 253 and SB 261. (For more information on the Climate Accountability Package, see Pillsbury’s prior reporting here and here.) But the bills have not come without some lingering controversy over the ability of businesses to meet the aggressive January 1, 2026, deadline to report their carbon footprints and submit climate risk assessments to the California Air Resources Board (CARB), as well as CARB’s ability to adopt implementing regulations by this coming January 1. A proposal by California Governor Gavin Newsom to provide relief through two-year extensions for compliance arrived back in the form of a bill from the Legislature—SB 219—for his signature, but it was stripped of those extensions and only granted an additional six months for CARB to adopt regulations. On September 27, Newsom acquiesced and signed SB 219 into law. The development confirms the need for businesses to continue preparing for mandated climate disclosures by January 1, 2026, and to consider participating in the CARB rulemaking to emphasize the implementation concerns recognized by Newsom.

No Comity Tonight
10.02.2024

Upon recognition of a foreign insolvency proceeding under chapter 15 of the U.S. Bankruptcy Code, the foreign debtor may request additional assistance from the U.S. Bankruptcy Court under section 1507 or additional relief under section 1521. Such additional relief often includes requests to recognize and enforce in the United States specific orders entered by the foreign court. While such requests are freely granted, there are limits to the relief a foreign debtor may receive. For example, in In re Nexgenesis Holdings Ltda., No. 22-14043-BKC-LMI, 2024 WL 3616732 (Bankr. S.D. Fla. July 31, 2024) (In re Nexgenesis), the bankruptcy court denied the foreign representatives’ request for recognition of an asset freeze order because, among other reasons, it would be manifestly contrary to U.S. public policy to recognize the order, even though the Brazilian insolvency proceeding had been recognized as a foreign main proceeding under Chapter 15.

From AI Doomers to E/Accs: How SB 1047 and the 38 AI Laws in California Are Shaping Future AI Law
09.26.2024

The California legislature sent 38 AI bills to the Governor’s office as the 2024 legislation session came to a close, eight of which have already been signed, regulating everything from deepfake nudes and AI-generated celebrity clones to election tampering. Governor Newsom has until September 30 to sign the rest, including California Senate Bill 1047, known as the Safe and Secure Innovation for Frontier Artificial Intelligence Models Act. SB 1047 is one of the first significant regulations of artificial intelligence in the United States that, if signed, would place liability on the developers of AI models.

California Employers Required to Have a Workplace Violence Prevention Plan
09.25.2024

According to the Occupational Safety and Health Administration (OSHA), workplace violence affects nearly two million American workers annually. In 2021, 57 people died from acts of workplace violence in California.