DROPLETS
US companies and their counsel must immediately verify whether any ongoing beneficial ownership reporting obligations survive FinCEN's final rule, as the compliance landscape shifts permanently.
On August 11, 2026, FinCEN issued a final rule permanently eliminating beneficial ownership information (BOI) reporting requirements for most U.S. companies and entities formed under U.S. law. The rule implements a statutory directive and removes the burden of filing and updating BOI reports for domestic reporting companies. However, certain entities—such as banks, broker-dealers, and other financial institutions—remain subject to separate customer due diligence rules that require collecting similar information. Counsel should review client entity structures to confirm exemption status, update compliance policies, and monitor for any state-level reporting initiatives that may still impose obligations.
Parties designated by OFAC must understand the new reconsideration portal’s procedures and evidentiary standards to effectively petition for removal from the Specially Designated Nationals List.
OFAC has launched a formal reconsideration portal for parties seeking removal from the Specially Designated Nationals (SDN) List. The portal establishes a structured process for submitting petitions, including specific requirements for evidence demonstrating a change in circumstances, mistaken identity, or that the basis for designation no longer applies. This shift from informal channels to a centralized digital system introduces new procedural rules and timelines. Designated parties and their counsel must now navigate this formal process, ensuring submissions meet OFAC’s criteria to avoid rejection. The portal’s existence signals OFAC’s move toward greater transparency and efficiency in delisting decisions, while raising the bar for the quality and organization of petition materials.
Vetted private companies may now participate in government-directed offensive cyber operations against foreign criminal groups under a new White House framework, creating both significant contracting opportunities and substantial legal and operational risks for participants.
The August 12 National Security Presidential Memorandum establishes a narrow program permitting vetted U.S. companies to conduct cyber surveillance and effects operations against foreign cyber-enabled transnational criminal organizations under DOJ or DHS contracts and oversight. The program does not authorize independent hack-back activity; all operations require written government approval and direction. Participating firms face strict requirements including annual vetting, $1 million minimum bonding, detailed reporting, and operational safeguards to protect U.S. persons and systems. Companies must assess retaliation risks, cross-border legal exposure, insurance coverage, False Claims Act liability, and potential derivative sovereign immunity protections before participating. The framework remains executive-branch policy without congressional authorization, making it vulnerable to reversal by future administrations.
Pharmaceutical sponsors and legal counsel must track and comment on proposed PDUFA VIII changes by October 16, 2026, as the draft introduces new review timelines, meeting structures, and user fee provisions that will govern FDA interactions through 2032.
On August 14, 2026, the FDA published a proposed eighth commitment letter under the Prescription Drug User Fee Act, covering fiscal years 2028 through 2032. The draft, which replaces the expiring PDUFA VII framework, introduces new mechanisms to reduce complete response letters and missed goal dates, including a discretionary one-time goal date extension tied to pre-approval inspection responses and a formal process for prioritizing pivotal protocols. It expands multi-divisional meeting opportunities, creates new Chemistry, Manufacturing, and Controls (CMC) facility lifecycle engagement pathways, and transitions several regulatory science pilots—such as Model-Informed Drug Development and rare-disease endpoint advancement—into routine review practices. The proposal also teases structural user fee changes, including incentives for U.S.-based clinical trials and a new supplement fee for non-orphan indications, which will require subsequent legislation. A hybrid public meeting is scheduled for September 16, 2026, with written comments due October 16, 2026. In-house counsel for pharmaceu
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California healthcare providers must adapt to a new state-level enforcement landscape as federal antitrust and fraud oversight recedes, with the state Attorney General actively targeting private equity and management services organization arrangements.
Federal antitrust and fraud enforcement is weakening through withdrawn safe harbors, reduced merger-reporting tools, and slower investigations due to HHS staffing cuts. In contrast, California has enacted SB 351 and AB 1415 (effective January 1, 2026), which impose corporate practice of medicine restrictions on private equity and hedge funds and bring these entities under the Office of Health Care Affordability’s pre-transaction notice requirements. The California Attorney General is already enforcing these rules through recent settlements with Aspen Dental and Carbon Health, plus an amicus brief advocating a broad interpretation of the corporate practice ban. Healthcare providers must reassess deal structures, diligence processes, OHCA notice timing, MSO-PC arrangements, and governance to comply with this rapidly evolving state-level scrutiny.
Foreign LLCs operating in New York must now comply with the narrowed LLC Transparency Act disclosure requirements, while domestic entities are exempt from the new reporting obligations.
New York's LLC Transparency Act has been significantly amended to apply exclusively to foreign limited liability companies conducting business in the state, removing the prior broad applicability to all LLCs. The revised law mandates that qualifying foreign LLCs file beneficial ownership information with the New York Department of State, aligning with but not duplicating the federal Corporate Transparency Act requirements. Entities must disclose details about their beneficial owners, including names, addresses, and identification information. Compliance deadlines are tied to the entity's registration or renewal timeline. Domestic New York LLCs are no longer subject to these state-level disclosure requirements, creating a distinct compliance divide between foreign and domestic entities.
Ontario employers using RSU and equity compensation plans must review termination provisions, as a new appellate ruling undermines the enforceability of clauses that limit or forfeit equity upon dismissal.
The Ontario Court of Appeal recently issued a decision in a wrongful dismissal case that directly impacts equity compensation plans. Although the dispute arose from a termination, the court’s reasoning casts doubt on the validity of termination provisions embedded in restricted stock unit (RSU) and other equity plans that restrict or eliminate equity awards when employment ends. The ruling suggests such clauses may be unenforceable if they conflict with employment standards or are not clearly communicated. Employers with operations or employees in Ontario should audit their equity plan documents, particularly termination and forfeiture clauses, and consider revisions to ensure compliance with the decision’s framework.
Trademark owners must now prove likely reputational harm—not just an offensive association—to win dilution-by-tarnishment claims involving parodic products.
The Ninth Circuit vacated a permanent injunction against VIP Products’ Bad Spaniels dog toy and ruled for VIP on Jack Daniel’s dilution-by-tarnishment claim. The court held that an offensive or scatological association with a famous mark is insufficient; plaintiffs must show the association is likely to harm the mark’s reputation. The decision also requires fame to be proven mark by mark, rejecting the assumption that a house mark’s fame extends to taglines or packaging elements. While parody is no longer an automatic defense when the accused use functions as a trademark, the court found that an obvious joke can reduce the likelihood of reputational injury. The ruling raises the evidentiary bar for tarnishment claims and gives accused parody users a stronger defense if consumers understand the use as humor rather than a source identifier.
Pharmaceutical sponsors and legal counsel must track and comment on proposed PDUFA VIII changes by October 16, 2026, as the draft introduces new review timelines, meeting structures, and user fee provisions that will govern FDA interactions through 2032.
On August 14, 2026, the FDA published a proposed eighth commitment letter under the Prescription Drug User Fee Act, covering fiscal years 2028 through 2032. The draft, which replaces the expiring PDUFA VII framework, introduces new mechanisms to reduce complete response letters and missed goal dates, including a discretionary one-time goal date extension tied to pre-approval inspection responses and a formal process for prioritizing pivotal protocols. It expands multi-divisional meeting opportunities, creates new Chemistry, Manufacturing, and Controls (CMC) facility lifecycle engagement pathways, and transitions several regulatory science pilots—such as Model-Informed Drug Development and rare-disease endpoint advancement—into routine review practices. The proposal also teases structural user fee changes, including incentives for U.S.-based clinical trials and a new supplement fee for non-orphan indications, which will require subsequent legislation. A hybrid public meeting is scheduled for September 16, 2026, with written comments due October 16, 2026. In-house counsel for pharmaceu
…
Foreign LLCs operating in New York must now comply with the narrowed LLC Transparency Act disclosure requirements, while domestic entities are exempt from the new reporting obligations.
New York's LLC Transparency Act has been significantly amended to apply exclusively to foreign limited liability companies conducting business in the state, removing the prior broad applicability to all LLCs. The revised law mandates that qualifying foreign LLCs file beneficial ownership information with the New York Department of State, aligning with but not duplicating the federal Corporate Transparency Act requirements. Entities must disclose details about their beneficial owners, including names, addresses, and identification information. Compliance deadlines are tied to the entity's registration or renewal timeline. Domestic New York LLCs are no longer subject to these state-level disclosure requirements, creating a distinct compliance divide between foreign and domestic entities.
Vetted private companies may now participate in government-directed offensive cyber operations against foreign criminal groups under a new White House framework, creating both significant contracting opportunities and substantial legal and operational risks for participants.
The August 12 National Security Presidential Memorandum establishes a narrow program permitting vetted U.S. companies to conduct cyber surveillance and effects operations against foreign cyber-enabled transnational criminal organizations under DOJ or DHS contracts and oversight. The program does not authorize independent hack-back activity; all operations require written government approval and direction. Participating firms face strict requirements including annual vetting, $1 million minimum bonding, detailed reporting, and operational safeguards to protect U.S. persons and systems. Companies must assess retaliation risks, cross-border legal exposure, insurance coverage, False Claims Act liability, and potential derivative sovereign immunity protections before participating. The framework remains executive-branch policy without congressional authorization, making it vulnerable to reversal by future administrations.
Ontario employers using RSU and equity compensation plans must review termination provisions, as a new appellate ruling undermines the enforceability of clauses that limit or forfeit equity upon dismissal.
The Ontario Court of Appeal recently issued a decision in a wrongful dismissal case that directly impacts equity compensation plans. Although the dispute arose from a termination, the court’s reasoning casts doubt on the validity of termination provisions embedded in restricted stock unit (RSU) and other equity plans that restrict or eliminate equity awards when employment ends. The ruling suggests such clauses may be unenforceable if they conflict with employment standards or are not clearly communicated. Employers with operations or employees in Ontario should audit their equity plan documents, particularly termination and forfeiture clauses, and consider revisions to ensure compliance with the decision’s framework.
Pharmaceutical sponsors and legal counsel must track and comment on proposed PDUFA VIII changes by October 16, 2026, as the draft introduces new review timelines, meeting structures, and user fee provisions that will govern FDA interactions through 2032.
On August 14, 2026, the FDA published a proposed eighth commitment letter under the Prescription Drug User Fee Act, covering fiscal years 2028 through 2032. The draft, which replaces the expiring PDUFA VII framework, introduces new mechanisms to reduce complete response letters and missed goal dates, including a discretionary one-time goal date extension tied to pre-approval inspection responses and a formal process for prioritizing pivotal protocols. It expands multi-divisional meeting opportunities, creates new Chemistry, Manufacturing, and Controls (CMC) facility lifecycle engagement pathways, and transitions several regulatory science pilots—such as Model-Informed Drug Development and rare-disease endpoint advancement—into routine review practices. The proposal also teases structural user fee changes, including incentives for U.S.-based clinical trials and a new supplement fee for non-orphan indications, which will require subsequent legislation. A hybrid public meeting is scheduled for September 16, 2026, with written comments due October 16, 2026. In-house counsel for pharmaceu
…
US companies and their counsel must immediately verify whether any ongoing beneficial ownership reporting obligations survive FinCEN's final rule, as the compliance landscape shifts permanently.
On August 11, 2026, FinCEN issued a final rule permanently eliminating beneficial ownership information (BOI) reporting requirements for most U.S. companies and entities formed under U.S. law. The rule implements a statutory directive and removes the burden of filing and updating BOI reports for domestic reporting companies. However, certain entities—such as banks, broker-dealers, and other financial institutions—remain subject to separate customer due diligence rules that require collecting similar information. Counsel should review client entity structures to confirm exemption status, update compliance policies, and monitor for any state-level reporting initiatives that may still impose obligations.
California healthcare providers must adapt to a new state-level enforcement landscape as federal antitrust and fraud oversight recedes, with the state Attorney General actively targeting private equity and management services organization arrangements.
Federal antitrust and fraud enforcement is weakening through withdrawn safe harbors, reduced merger-reporting tools, and slower investigations due to HHS staffing cuts. In contrast, California has enacted SB 351 and AB 1415 (effective January 1, 2026), which impose corporate practice of medicine restrictions on private equity and hedge funds and bring these entities under the Office of Health Care Affordability’s pre-transaction notice requirements. The California Attorney General is already enforcing these rules through recent settlements with Aspen Dental and Carbon Health, plus an amicus brief advocating a broad interpretation of the corporate practice ban. Healthcare providers must reassess deal structures, diligence processes, OHCA notice timing, MSO-PC arrangements, and governance to comply with this rapidly evolving state-level scrutiny.
Trademark owners must now prove likely reputational harm—not just an offensive association—to win dilution-by-tarnishment claims involving parodic products.
The Ninth Circuit vacated a permanent injunction against VIP Products’ Bad Spaniels dog toy and ruled for VIP on Jack Daniel’s dilution-by-tarnishment claim. The court held that an offensive or scatological association with a famous mark is insufficient; plaintiffs must show the association is likely to harm the mark’s reputation. The decision also requires fame to be proven mark by mark, rejecting the assumption that a house mark’s fame extends to taglines or packaging elements. While parody is no longer an automatic defense when the accused use functions as a trademark, the court found that an obvious joke can reduce the likelihood of reputational injury. The ruling raises the evidentiary bar for tarnishment claims and gives accused parody users a stronger defense if consumers understand the use as humor rather than a source identifier.
Parties designated by OFAC must understand the new reconsideration portal’s procedures and evidentiary standards to effectively petition for removal from the Specially Designated Nationals List.
OFAC has launched a formal reconsideration portal for parties seeking removal from the Specially Designated Nationals (SDN) List. The portal establishes a structured process for submitting petitions, including specific requirements for evidence demonstrating a change in circumstances, mistaken identity, or that the basis for designation no longer applies. This shift from informal channels to a centralized digital system introduces new procedural rules and timelines. Designated parties and their counsel must now navigate this formal process, ensuring submissions meet OFAC’s criteria to avoid rejection. The portal’s existence signals OFAC’s move toward greater transparency and efficiency in delisting decisions, while raising the bar for the quality and organization of petition materials.
Grade 3 — worth a glance, not the full analysis.
- Itaú Unibanco Secures Preliminary OCC Approval for U.S. De Novo Bank
Itaú Unibanco must complete remaining FDIC and Federal Reserve approvals before launching U.S. banking operations, marking a significant expansion of Latin American banking presence into the U.S. market.