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Cooley Shortlisted Across Multiple Categories in LMG Life Sciences Americas Awards

Tue, 21 Jul 2026 19:26:36 Z

New York – July 21, 2026 – Cooley was shortlisted across 11 categories for the 2026 LMG Life Sciences Americas Awards, which recognize the most distinguished lawyers and firms across the US, Canada and Brazil for exemplary work in life sciences.

The firm was shortlisted in the following practice area award categories: Corporate Firm of the Year, Licensing and Collaboration Firm of the Year, M&A Firm of the Year, and Venture Capital Firm of the Year.

Seven Cooley lawyers were also shortlisted for individual awards:

Jamie Leigh – M&A Attorney of the Year
Christian Plaza – Corporate Attorney of the Year
Ryan Sansom – VC Attorney of the Year
Sonia Nath – Regulatory Attorney of the Year – FDA Pharmaceutical
Eric Greig – Regulatory Attorney of the Year – Pricing and Reimbursement
Chad Shear – General Patent Litigator of the Year – California
Betsy Flanagan – General Patent Litigator of the Year – Midwest

View the full list

An awards ceremony will be held in New York City on September 10.

Life sciences breakthroughs happen with Cooley. The firm’s collaborative approach draws upon unparalleled life sciences sector experience to drive strategic solutions and resolve challenges.

The firm’s practitioners are versed in all aspects of life sciences technologies, delivering an unmatched combination of innovative legal guidance, deep industry knowledge and practical understanding of clients’ needs. Many Cooley lawyers worked as pharmaceutical marketing professionals, business consultants, financial leaders, biotech researchers and in-house counsel at life sciences companies before joining the firm. Cooley serves as trusted counsel to 2,500+ public and private life sciences company clients worldwide, including nearly 50% of the Nasdaq Biotechnology Index. The firm’s clients include innovative biotech and specialty pharmaceutical companies at the forefront of new technologies, including cell and gene therapies, artificial intelligence-led drug discovery, and new vaccine technologies.

European Commission Adopts Revised EU CSRD Reporting Standards

Tue, 21 Jul 2026 07:00:00 Z

On 3 July 2026, the European Commission adopted a delegated act setting out revised European Sustainability Reporting Standards (ESRS) and a delegated act setting out voluntary reporting standards for smaller companies. The revised ESRS will replace the previous version of the ESRS (Previous ESRS).

The ESRS are the mandatory reporting standards for European Union (EU) companies subject to the EU Corporate Sustainability Reporting Directive (CSRD). These updates will affect many US companies that fall within the CSRD’s scope through their EU subsidiaries and are required to file CSRD reports starting from fiscal year 2027. The standards are now effectively final – they still require formal adoption by the EU but they can no longer be amended. We anticipate formal adoption to happen in the coming months.

The overarching goal of the revision was to simplify and streamline the Previous ESRS, complementing the changes to the scope of the CSRD introduced by the Omnibus I package (read our alert here). The European Commission states that the mandatory data points have been reduced by over 60%, and as a result, estimates reporting costs will decrease by approximately 30% per company.

Our key takeaways

1. Topics have not changed

The revised ESRS continue to cover the same topics as the Previous ESRS: ESRS 1 and 2 (general requirements and disclosures), five environmental standards (climate change, pollution, water, biodiversity and ecosystems, and resource use and circular economy), four social standards (own workforce, workers in the value chain, affected communities and consumers and end users), and one governance standard (business conduct).

2. Mandatory data points reduced by 60%, but a new ‘fair presentation’ requirement is introduced

According to the European Commission, mandatory data points have been reduced by over 60% and total data points by over 70% compared to the Previous ESRS. However, a new ‘fair presentation’ requirement introduced in ESRS 1 requires that the information disclosed is comparable, verifiable and understandable. It also requires the disclosure of entity-specific information where the topical disclosures do not cover them in sufficient granularity to allow users to understand the material impacts, risks and opportunities. In practice, this gives companies more flexibility but also places a heavier burden on them to justify their conclusions, including to their CSRD assurance provider.

3. Prohibition on reporting nonmaterial information

The revised ESRS generally prohibit reporting disclosure requirements, data points and entity-specific information where they are not material. Nonmaterial information may still be included in the CSRD report where it:

Must be disclosed under other legislation.
Stems from generally accepted reporting standards or frameworks, including nonmandatory or sector-specific guidance published by other standard-setting bodies (such as the Global Reporting Initiative).
Is needed to meet the data demands of a specific user.

Any nonmaterial information must be clearly identified as such, comply with the faithful representation principle, and not obscure material information. Companies that have been using CSRD reporting for broader sustainability disclosures should take particular note of this restriction, which will limit the amount of additional ‘marketing-speak’ that can be included in a CSRD report.

4. Double materiality perspective retained

Companies will still need to consider both financial and impact materiality and when working out what is material, it is still necessary to consider both financial users of the report and nonfinancial users of the report. Financial materiality continues to require consideration of material risks and opportunities attributable to business relationships across the upstream and downstream value chain, unchanged from the Previous ESRS.

5. ‘Top-down’ approach permitted for the double materiality assessment

Revised ESRS 1 introduces the option to use a ‘top-down’ approach. According to the top-down approach, the double materiality assessment (DMA) begins with an analysis of the business model, including sectors, geographies, and the features of the upstream and downstream value chain to identify the most evident material topics. However, companies can continue using the ‘bottom-up’ approach or even combine a ‘top-down’ approach for some topics and a ‘bottom-up’ analysis for others. This provision will apply from FY 2026.

As for refreshing the DMA, revised ESRS 1 requires companies to consider annually whether significant changes – such as changes to activities, structure, business relationships, understanding of impacts, risks or opportunities, assessment methodologies, or the external environment – would affect their materiality assessment conclusions. If so, the DMA must be reviewed and updated. Companies should be aware that any decision not to refresh the DMA is likely to be questioned by their assurance provider.

6. Taking account of mitigating measures in the double materiality assessment

A significant area of uncertainty under the Previous ESRS was to what extent mitigating measures can be taken into account when defining material topics for CSRD reporting. The revised ESRS 1 take the following approach to considering mitigating measures:

For the severity of actual negative impacts, the assessment must not consider remediation activities to address impacts if those activities were undertaken during the reporting period.
For the severity and likelihood of potential negative impacts, the assessment should take into account implemented prevention and mitigation policies and actions only if those policies and actions can reasonably be assumed to effectively reduce the severity or likelihood. Actions or policies that have not yet been implemented must not be considered.
The materiality assessment needs to consider information on policies and actions used to manage negative impacts if they are decision-useful to users, irrespective of how effectively the company manages the impacts or of how effectively the corresponding topics are regulated.
Companies must assess positive impacts “without netting against negative impacts”. Actions to prevent, mitigate, end, minimise or remediate negative impacts or mere compliance with legal requirements do not qualify as positive impacts. Companies should therefore ensure they do not conflate positive impacts with mitigation or prevention measures.

7. Reduced scope for reporting on opportunities

Under the Previous ESRS, it was left open to companies to report on sustainability-related opportunities, including at the sector level. Revised ESRS 1 now prohibits reporting on general sector-level opportunities. Companies must limit their disclosures to opportunities that are currently being pursued or incorporated into their strategy.

8. Greater flexibility to rely on proxies and estimates in value chain reporting

Revised ESRS 1 gives companies greater flexibility to rely on proxies and estimates for value chain information, and removes the previous obligation to “make reasonable efforts” to obtain information from value chain partners. This is a significant practical relief, particularly for companies with complex or fragmented supply chains.

However, important limitations remain:

Data and assumptions used in sustainability reporting must, to the extent possible, be consistent with those used to prepare the financial statements, and any differences must be explained.
For the first three financial years (FY) of CSRD reporting, where not all necessary value chain information is available, the company must explain the efforts made to obtain the information, why it was not available and its plans to obtain it in the future.

9. New ‘undue cost or effort’ relief

Under the revised ESRS, when carrying out the materiality assessment and preparing the CSRD report, the company must “use all reasonable and supportable information that is available to the undertaking at the reporting date without undue cost or effort”. This proportionality mechanism, inspired by the International Sustainability Standards Board’s S1 and S2 standards, means companies need not gather information for materiality assessments or metrics disclosures if doing so would entail an undue cost or effort. “Undue cost or effort” is not directly defined and will depend on a company’s specific circumstances, requiring a balanced assessment of the costs and efforts involved against the benefits of the resulting information for users. What is reasonable and supportable information that is available to the undertaking without undue cost or effort must be reassessed for each reporting period.

10. Disclosures on anticipated financial effects

Disclosure of qualitative and quantitative information on anticipated financial effects remains mandatory for material risks and opportunities. However, this is subject to exceptions and phase-in periods, e.g., allowing companies starting to report from FY 2027 to omit information on anticipated financial effects for the first two reporting years, and to omit quantitative information about anticipated financial effects for their first four reporting years. Qualitative and quantitative information about current financial effects for which there is a significant risk of a material adjustment within the next annual reporting period to the carrying amounts of assets and liabilities reported in the related financial statements is also mandatory.

In addition, under ESRS 2, companies are also required to disclose the amounts of significant financial resources allocated to key actions taken to manage material impacts, risks and opportunities and achieve the objectives or related policies in the reporting period (if any) and provide an indicative range of significant future financial resources expected to be allocated. Anticipated financial effects from material climate-related physical and transition risks and opportunities must also be disclosed under ESRS E1. However, some of this information on transition risks and opportunities is subject to a two-year grace period (four years for certain quantitative information) for companies starting to report from FY 2027.

11. Changes to environmental and social standards

A number of changes have been made to the environmental and social disclosure standards. For example, if a company does not have a transition plan for climate change mitigation that includes certain key features such as greenhouse gas (GHG) emission reduction targets, key actions, and compatibility with the 1.5°C target, it must disclose this fact and indicate whether and, if so, when it expects to adopt one. For S1-16 (Incidents of discrimination and other human rights incidents), only substantiated and verified instances of human rights incidents need to be reported. This is narrower than under the Previous ESRS, which required reporting of mere complaints.

12. Value chain cap and other reliefs

The revised ESRS reflect the Omnibus I amendments, which introduced a value chain cap to CSRD: companies subject to the CSRD cannot require companies in their value chain that have 1,000 employees or fewer to provide more sustainability information than is required by the voluntary reporting standard adopted alongside the revised ESRS. However, this exemption does not cover ESRS E1-8 metrics (gross Scope 1, 2 and 3 GHG emissions). The exemption will apply from FY 2026.

Additional specific reliefs include the option to exclude activities from metric calculations if they are not a significant driver of the relevant impacts, risks, or opportunities and their exclusion is not expected to impair the relevance and faithful representation of the reported information. If this relief is relied on, that fact should be disclosed in the CSRD report. Another new relief provides that companies which acquire a subsidiary during the reporting period may defer its inclusion in the materiality assessment and sustainability statement to the following reporting period. Conversely, if a subsidiary leaves the group during the reporting period, the company may adjust the scope of its materiality assessment and reporting boundary from the beginning of the current reporting period.

13. Presentation and structuring for machine readability

Companies should also consider how their sustainability statements will be reviewed in practice. Benchmarking bodies, proxy advisors and institutional investors are increasingly using large language models and automated text-analysis tools to review and compare sustainability reports at scale. Clear structure, consistent headings, well-defined key terms and a logical information architecture will play an increasingly important part in determining how a company’s disclosures are interpreted and ranked.

The revised ESRS introduce an optional executive summary and the ability to present EU Taxonomy disclosures in a separate appendix, which may improve accessibility and navigability.

Next steps

The revised ESRS and the voluntary reporting standards have been presented to the Council and the European Parliament, which have two months to scrutinise the texts. They cannot propose amendments. They may only reject the delegated act in full, which is widely considered unlikely. Upon publication in the Official Journal of the EU, the revised ESRS will enter into force on 20 November 2026 and apply to financial years beginning on or after 1 January 2027. We recommend that in-scope companies begin assessing the impact of these changes on their reporting processes and materiality assessments now.

Please reach out to any member of the Cooley ESG team if you have any questions.

Keyrock Acquires BlockFills’ Trading and Brokerage Assets

Mon, 20 Jul 2026 19:13:00 Z

London – July 20, 2026 – Cooley advised Keyrock, a global crypto investment group, on the completion of its acquisition of assets of BlockFills’ institutional digital asset trading and brokerage business. This marks a major milestone in Keyrock’s global expansion, integrating its technology and market talent into its global business.

Lawyers Jonathan Cohen, Rita Sobral, Charlotte Witherington, Michael Klein, Caroline Hobson, John Paul Oleksiuk, Sydney Sawyier, Struan Clark, Amanda Lindner, Anna Caro and Elizabeth Reinhardt led the Cooley team advising Keyrock.

VivaTech 2026: Cooley and the French Innovation Ecosystem

Mon, 20 Jul 2026 15:50:00 Z

VivaTech 2026 brought more than 200,000 technology leaders, entrepreneurs, investors and policymakers to Paris for four days of discussion on the forces shaping the global innovation economy. Across the conference, conversations reflected a maturing European ecosystem, where AI, life sciences, enterprise technology and capital formation are increasingly interconnected.

Event summary

For Cooley, the week offered a timely view into the priorities and ambitions of the French and European innovation ecosystems. Our presence at VivaTech focused on engaging directly with founder-led companies, investors and industry leaders across technology, life sciences and AI, as well as better understanding how companies in France and across Europe are navigating growth, funding, regulation and international expansion.

The week also marked the Paris launch of Cooley Off the Record, a discussion series designed to create space for candid exchange among the people building and backing high-growth companies.

Cooley Off the Record, hosted at Hotel Molitor on 17 June, created a new forum in Paris for intimate, practical conversations among founders, investors and industry professionals about the opportunities and challenges of building and scaling companies.

Key takeaways

A global platform with local relevance. VivaTech’s scale underscored Paris’ role as a convening point for the international technology community, while highlighting the strength and ambition of the French market.
AI as both opportunity and operating reality. Discussions moved beyond broad enthusiasm to practical questions about adoption, governance, sector-specific applications and long-term business models.
Cross-sector innovation is accelerating. The overlap among technology, life sciences and data-driven business models was a recurring theme, particularly for companies operating in healthcare, enterprise technology and other regulated or complex sectors.
France’s innovation ecosystem is gaining depth. The market is supported by a growing base of ambitious founders, experienced investors and sector expertise across technology and life sciences.
Responsible adoption is a central theme. The most relevant conversations at VivaTech focused not only on what new technologies can do, but also on how companies can responsibly adopt, commercialize and scale them.
Cross-border growth brings added complexity. As companies scale internationally, legal, regulatory and strategic considerations are becoming increasingly central to growth conversations, particularly for businesses operating at the intersection of innovation and regulated markets.
Sustained engagement matters. Cooley’s engagement in Paris reflects a continued commitment to participating in the French ecosystem, not only around major industry events but through ongoing dialogue with the startups, investors and innovators shaping the market. Visit our France webpage to find out more about our commitment to the French ecosystem.

VivaTech reinforced that innovation ecosystems are built through sustained engagement, shared perspective and practical collaboration. Cooley’s time in Paris, including the launch of Cooley Off the Record, reflected that approach and underscored the importance of continued connection with the people and companies shaping the future of France as a leading global player in the technology and life sciences ecosystems.

Personalis to be Acquired by Tempus AI for $1.9 Billion

Mon, 20 Jul 2026 14:02:00 Z

Cooley advised Personalis, a company transforming the active management of cancer through breakthrough personalized testing, on its agreement to be acquired by Tempus AI, a technology company leading the adoption of AI to advance precision medicine and patient care, based on an equity value for Personalis of $1.9 billion. Under the terms of the agreement, Tempus will acquire all outstanding shares of Personalis not already owned by Tempus at a price of $16.25 per common share. Consideration will be structured as a 100% stock transaction with Tempus having the option to elect payment in cash at Tempus’ discretion, capped at 50% of the consideration paid. Personalis shareholders will receive a floating exchange ratio of Tempus AI common stock for each share of Personalis common stock they own at closing, subject to a maximum exchange ratio of 0.3356, which shall be finalized closer to the closing of the transaction.

The transaction was announced publicly in the following press release, which can be viewed here.

Bill Roegge, Laura Berezin, Sangitha Palaniappa, Kyle Hess, Asa Henin, and Allison Peth led the Cooley team advising Personalis.

Norm Armstrong, Megan Browdie, Barbara Mirza, Stephanie Gentile, Charity Williams, David Burns, Simon Trisk, Hanna Ali, Joe Perry, Harrison Platt, Jenna Ventorino, Sofia Chadwick, Matt Choy, Natalie Vernon, Justin Kisner, Jared Abes, Alexander Ellebracht, Alexandra Leavy, and Dillon Jones provided invaluable support.

Cooley has served as Personalis’ primary corporate and transactional counsel for approximately 15 years. During that time, the firm has advised the company on a variety of matters, including its commercial collaboration with Tempus AI, including an equity investment by Tempus into Personalis (2023), and the company’s initial public offering (2019).

Capital Markets Update – July 2026 One-Minute Reads

Mon, 20 Jul 2026 07:00:00 Z

SEC proposes rescission of climate-related disclosure rules

The Securities and Exchange Commission (SEC) announced it has proposed to rescind the climate-related disclosure rules and has requested comments by August 3, 2026. See the proposed rules and the fact sheet. Comments can be submitted or viewed here, and you can also read statements from Chair Paul Atkins, Commissioner Mark Uyeda and Commissioner Hester Peirce. For information and insights on the proposal, see this Cooley alert and this TheGovernanceBeat.com post. For other thoughts on the proposed rescission, see this ESG Dive article, this Responsible Investor article, this Bloomberg Law article, this TheCorporateCounsel.net blog post and this TheCorporateCounsel.net blog post.

SEC settles charges for violating whistleblower protection rule

The SEC announced settled charges against Foot Locker for using separation agreements with a provision that purported to waive employees’ rights to receive SEC whistleblower awards. According to the SEC’s order, approximately 148 departing Foot Locker employees signed separation agreements in order to receive severance payments. The order finds that the agreements contained a provision that purported to waive employees’ rights to receive whistleblower awards from the SEC, and that Foot Locker phased out the award waiver provision in its separation agreements and no longer requires departing employees to waive such rights. The SEC’s order finds that Foot Locker violated Rule 21F-17(a) of the Securities Exchange Act of 1934, which prohibits any person from taking any action to impede an individual from communicating directly with SEC staff about a possible securities law violation. Without admitting the findings in the order, Foot Locker consented to the entry of a cease-and-desist order and agreed to pay a $148,000 civil penalty. For more information, see this CompensationStandards.com blog post.

SEC approves new Nasdaq delisting rule

Per this SEC order, Nasdaq’s proposed rule change (SR-NASDAQ-2026-009), as modified by Amendment No. 1, is approved on an accelerated basis. Nasdaq Rule IM-5101-4 provides that where a security exhibits trading activity that is indicative of potential manipulation, and the SEC has implemented a temporary trading suspension of that security pursuant to Section 12(k) of the Act (Section 12(k) suspension), Nasdaq may exercise its authority under Nasdaq Rule 5101 to delist the security when it determines that doing so is necessary to protect investors. Nasdaq would be permitted to exercise the discretionary authority even when the security and the listed company otherwise satisfy all applicable Nasdaq listing standards at the time of determination. For more information, see this TheCorporateCounsel.net blog post.

Corp Fin posts new CFI – Rights listings in business combinations

The SEC’s Division of Corporation Finance has posted new Securities Act sections corporation finance interpretation (CFI) 142.01, which addresses the contents of a registration statement of securities underlying rights that are to be listed on an exchange. For more information, see this TheCorporateCounsel.net blog post.

Question: A company seeks to list rights on a national securities exchange in connection with a business combination transaction without the underlying securities also being listed. As required by the exchange, the company must have an effective registration statement, prior to the rights being listed, that registers the issuance of the underlying securities upon exercise of the rights. Must the registration statement contain information regarding the specific transaction and the business to be acquired?

Answer: Yes. The registration statement must contain information about the contemplated business combination transaction and the business to be acquired.

Supreme Court validates SEC’s use of disgorgement without investor loss

Per this TheCorporateCounsel.net blog post, the US Supreme Court issued its decision in Sripetch v. SEC, in which it unanimously held that the SEC may obtain a disgorgement award from a defendant in an enforcement proceeding without a showing of pecuniary loss to investors. In his opinion for the Supreme Court, Justice Neil Gorsuch reviewed the history of the SEC’s use of the disgorgement remedy, the Supreme Court’s 2020 decision in Liu v. SEC limiting the agency’s use of disgorgement and federal legislative responses to that decision. Citing a variety of judicial precedent, Justice Gorsuch concluded that neither the Supreme Court’s decision in Liu nor traditional equitable principles required the SEC to establish pecuniary harm in order to use disgorgement as a remedy. For more information, see this SCOTUSblog post.

CapitalXchange offers current SEC rulemaking overview

In this CapitalXchange blog, Cooley’s Liz Dunshee explores the five recent SEC rulemakings (touching capital markets access, scaled disclosure accommodations, reporting cadence, climate disclosure and enforcement practice) and how they fit together and reflect growing momentum for the overarching goal of SEC Chair Paul Atkins to “make IPOs great again.”

SBTi releases finalized new corporate net-zero standard

Per this ESGtoday article, the Science Based Targets initiative (SBTi) announced the release of Corporate Net-Zero Standard Version 2.0, its update to its flagship standard to assess, certify and track companies’ decarbonization commitments and support science-based climate target setting. Among the key changes introduced with the new standard is the use of a “best-efforts” framework, enabling companies to remain in compliance with the standard even if targets are not achieved, with an expectation for companies to utilize “all available levers to drive emissions reductions,” and to be transparent about implementation barriers and mitigating actions, with the SBTi “acknowledging that factors outside a company’s control may affect progress.” See also this article from The Wall Street Journal.

CARB proposes revisions to SB 253 and deferral of reporting deadline

The California Air Resources Board (CARB) announced it is updating its regulatory proposal to defer the reporting deadline for entities to report Scope 1 and Scope 2 greenhouse gas emissions from August 10, 2026, to November 10, 2026. In addition, CARB will be proposing limited changes to the regulation to clarify certain requirements and will make these available for comment as part of a 15-day public comment period. A new proposed reporting deadline of November 10 will help ensure reporting entities have additional clarity following approval of the final regulation before reporting is due. For more information, see this ESG Dive article.

Nasdaq amends proposed $5 million market cap for continued listings

In January, Nasdaq filed a proposal with the SEC to adopt a continued listing requirement of at least $5 million market value of listed securities (MVLS). Since January, the SEC has extended the time to act on the proposal and posted an order instituting proceedings to determine whether to approve the proposed rule change. Now, the SEC has posted a new notice to solicit comments on a revised proposal from Nasdaq. Comments on the amended proposal were due July 10, 2026. To address comments previously received, Nasdaq amended its proposal by giving the Hearings Panel more discretion. Nasdaq proposes to modify the initial proposal, which would have prevented a Hearings Panel from reinstating a company that failed to maintain a minimum of $5 million MVLS. Instead, Nasdaq now proposes to adopt Listing Rule 5815(c)(1)(I) to provide that in the case of a company that received a Staff Delisting Determination due to a failure to maintain MVLS of at least $5 million under Rule 5450(a)(3) or 5550(a)(6), the Hearings Panel, where it deems appropriate, may grant an exception for a period not to exceed 180 days from the Staff Delisting Determination for the company to demonstrate that it meets all requirements for initial listing. For more information, see this TheCorporateCounsel.net blog post.

Enablement Risks for Method of Treatment Claims After Wyeth v. AstraZeneca

Fri, 17 Jul 2026 20:54:00 Z

On July 9, 2026, the US Court of Appeals for the Federal Circuit issued a precedential decision in Wyeth LLC v. AstraZeneca Pharmaceuticals LP, No. 2024-2325. The Federal Circuit affirmed the district court’s holding that the asserted claims were invalid for lack of enablement and granting AstraZeneca judgment as a matter of law to set aside Wyeth’s $107.5 million jury verdict. (Slip op. at 2, 19.)

Following the US Supreme Court’s 2023 decision in Amgen v. Sanofi, the trend toward increased scrutiny for enablement for life sciences patents has continued. The Wyeth decision has implications for patents claiming methods of treatment, which are frequently sought prior to the availability of clinical data.

The patents at issue

The Wyeth patents claimed methods of treating non-small cell lung cancer (NSCLC) that has become resistant to standard drug therapies, using a class of drugs called irreversible epidermal growth factor receptor (EGFR) inhibitors. (Slip op. at 2-3.)

The specification described three candidate drugs and provided experimental cell assay data (not in patients) showing that these compounds could kill cancer cells (the “in vitro” testing). (Slip op. at 3-4). The specification also listed broad daily dose ranges of approximately 1 to 1,000 mg. However, the patents taught that “[p]recise amounts of active ingredient … depend on the judgment of the practitioner and are peculiar to each individual” but contained no examples of any of these drugs administered to human patients. (Id. at 4.)

Claim construction: ‘Unit dosage’ requires more than in vitro activity

An exemplary claim recited a method “comprising administering daily to the patient ... a pharmaceutical composition comprising a unit dosage” of the claimed drug. (Slip op. at 3 (quoting ’314 patent 35:52-60).)

Before trial, the district court construed the term “unit dosage” according to the specification’s own express definition as “physically discrete units suitable as unitary dosage for the subject, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect in association with the required diluents; i.e., carrier, or vehicle.” (Slip op. at 5, citing Claim Construction Decision, 2023 WL 2683559, at *9 (emphasis added).) At the judgment as a matter of law (JMOL) stage, the district court explained the practical consequence of that construction in the context of the full claim was the requirement for an actual repeatable dosing regimen capable of producing a therapeutic effect in a human patient, not merely a compound shown to kill cancer cells in a laboratory setting. In other words, based on the claim language as construed by the court, the claimed dosage must work in a person, not just in the laboratory. (Id. at 6.)

Wyeth argued on appeal that the district court improperly imported clinical safety and efficacy requirements into the claims, contending the claims required nothing more than inhibiting EGFR activity and killing cancer cells in vitro. (Slip op. at 9.) The Federal Circuit disagreed because the claims, as construed, required the daily administration of a dosage “calculated to produce the desired therapeutic effect.” (Id. at 10-11.) This construction drew in patient-level efficacy as a required part of the claim. (Id.) According to the Federal Circuit, however, this does not mean Wyeth’s specification needed to demonstrate US Food and Drug Administration-approved safety or clinical optimality. Instead, the claim as construed required only that the claimed dosage be capable of producing a therapeutic effect when administered to a patient. (Id.)

The Federal Circuit also rejected Wyeth’s argument that the district court had amended its claim construction post-verdict, finding that the district court’s statements in its JMOL order were permissible clarifications of its original pre-trial construction. (Slip op. at 12.)

Enablement: The specification’s in vitro data could not bridge the gap to patient dosing

The Federal Circuit identified several interconnected failures in the disclosure of Wyeth’s specification:

No working patient examples. The specification provided no examples of any irreversible EGFR inhibitor being given to a human patient at a dose that worked. (Slip op. at 14.) The three candidate drugs described in the patents were tested only in in vitro experiments on cancer cells, and the specification gave no guidance on how to convert those lab results into a dose that could safely and effectively be given to a real patient. (Id.)
Broad, unvalidated dose ranges. The dose ranges disclosed in the specification – a per-body-weight range of approximately 0.5 to 1,000 mg/kg, and a total daily dosage range of 1 to 1,000 mg (preferably 2 to 500 mg), which the specification described as “general” and “projected” – came with no explanation of how those numbers were arrived at, how a skilled artisan would select among them for a given compound, or how they related to the claimed unit dosage calculated to produce a therapeutic effect in a (Slip op. at 15.)
Lab doses were toxic in humans. Testimony from Wyeth’s own experts and the inventors confirmed AstraZeneca’s unrebutted evidence that the doses at which at least two of the three described drugs (HKI-272 and EKB-569) appeared to work in the lab exceeded the maximum dose a human patient could safely tolerate. (Slip op. at 15-16.) In other words, the “effective” in vitro dose indicated by the disclosure would translate to a dose that would be dangerous in a person. For example, one of the inventors confirmed that “[t]he concentrations in the test tube are higher than those you can give to patients.” (Id. at 16.) The court acknowledged that the mere presence of nonworking examples in the specification will not always defeat a patent, citing Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576–77 (Fed. Cir. 1984). (Id. at 16.) Here, however, the nonfunctionality of several of the drug dosages described in the specification played a direct evidentiary role, especially in the absence of any affirmative examples of doses that did work in human patients. The Federal Circuit concluded that the disclosed doses could not serve as a starting point for patient treatment across the claimed category. (Id.)
Specification acknowledges its own gaps. Rather than providing a methodology for calculating a unit dosage, the specification stated that “[t]he skilled artisan is aware of the effective dose for each patient” and precise amounts “depend on the judgment of the practitioner and are peculiar to each individual.” (Slip op. at 17.) The Federal Circuit held that relying on skilled artisan knowledge cannot substitute for the obligation to supply the novel aspects of the claimed invention in the specification. (Id.)

The Federal Circuit emphasized that, in a complex and unpredictable field, the specification must provide greater guidance. (Slip op. at 17.) Because the specification identified only a starting point for further research, leaving the skilled artisan to conduct an iterative, trial-and-error process to identify operative dosing regimens, practicing the claims would require undue experimentation, and therefore the claims were not enabled. (Id. at 17-18.)

Importantly for life sciences innovators, the Federal Circuit acknowledged the generally accepted practice of claiming a method of treatment with a range of doses without providing clinical data from large human trials. (Slip op. at 19.) But it distinguished this general trend from Wyeth’s patents based on the specific facts relevant to those patents. For the court, the problem was not the absence of clinical data per se, but instead the specification’s failure to disclose any actual dosages suitable for patient administration, combined with unrebutted evidence that at least two of the three disclosed compounds could not be administered to patients because all therapeutically effective dosage levels across the disclosed ranges would exceed the maximum tolerated dose in humans. (Id. at 15-16, 19.)

The outcome in Wyeth provides a noteworthy contrast to the Federal Circuit’s recent opinion in Teva Pharmaceuticals International GmbH v. Eli Lilly & Co., No. 24-1094 (Fed. Cir. Apr. 16, 2026), which also concerned method claims in which a class of compounds were defined by their function – a class of humanized antibodies (humanized anti-CGRP antagonist antibodies) to treat headache. Unlike the Wyeth case, in Teva the Federal Circuit held that the claimed antibody class was well known in the prior art, the specification disclosed that all antibodies would work for the claimed purpose (which was unrebutted at trial), and the point of novelty was not the compounds themselves but the application of those compounds to treating headache. (Teva Pharms., No. 24-1094, at 13, 22–23.)

The different outcome in Wyeth seems to have turned on the inventive concept captured by the claims and the state of the specification: The claims at issue in Teva were directed to a novel therapeutic use (treating headache) with a known class of compounds, and the specification directly addressed the novel aspect of the invention (the therapeutic use). In contrast, the claims at issue in Wyeth were directed to a dosing regimen, and the specification left the novel and critical element (a dosing regimen capable of producing a therapeutic effect in a patient) insufficiently addressed, with most of the disclosed compounds proving inoperative at some of the very doses the patents claimed.

Practical implications

For a variety of reasons, life sciences companies need to file patent applications covering methods of treatment before clinical data is available, including publications on clinical trial registries, scientific presentations and fundraising. Companies in this situation should consider two practical points following Wyeth:

Be aware of how claim language and the specification can introduce unintended functional limitations. In Wyeth, claim scope created an unexpected enablement problem through the construction of a single term. The term “unit dosage” appeared in every asserted claim, and the district court’s construction –uncontested on appeal – required “a therapeutic effect.” (Slip op. at 5, 10.)
Avoid unnecessary language about uncertainty in the specification. In Wyeth, the specification’s own statements (“[p]recise amounts of active ingredient … depend on the judgment of the practitioner and are peculiar to each individual” and “[t]he skilled artisan is aware of the effective dose for each patient”) were used by the court as evidence that determining the claimed unit dosage was a complex and individualized task that the specification failed to address. (Slip op. at 17.) Patent drafters should consider avoiding unnecessary language overemphasizing dosing unpredictability or patient-by-patient variability because it can become evidence against enablement when broad method claims are later asserted.

However, life sciences companies should also exercise caution in attempting to enable method-of-treatment applications with speculative and excessive disclosure around doses and dosing regimens. The safe and effective dosing regimen for a particular drug and indication will be discovered in clinical trials, which may occur several years after initial in vitro data. Filing applications for dosing claims contemporaneously with such clinical results can lead to additional – and often more defensible – patents with later expiration dates, potentially adding valuable exclusivity to the commercial product.

Conclusion

Wyeth v. AstraZeneca reinforces the principle the Supreme Court established in Amgen v. Sanofi: Where a claim limitation requires dosage form and/or patient-level efficacy, the specification must provide the guidance necessary to achieve that outcome across the full scope of the claimed compounds. In vitro data, broad projected dose ranges and reliance on skilled artisan knowledge may not suffice.

So You Want to Buy a Sports Franchise? Why Entering Sports Ownership Gives the Rich a ‘Very Elite and Exclusive Club’ With Great Tax Benefits

Fri, 17 Jul 2026 18:47:00 Z

Cooley partner David Silverman was quoted in Fortune about the growing involvement of private equity in the sports industry and highlighted his work in the Boston Celtics deal.

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How Cooley Became a Leading Litigation Firm

Fri, 17 Jul 2026 18:26:07 Z

Cooley's litigation practice was featured in an Original Jurisdiction article exploring the firm's rise as a litigation leader. Ian Shapiro, partner and chair of the firm’s litigation department, discussed Cooley's investment in prominent litigation talent to meet the evolving needs of its client base, while Elizabeth Prelogar emphasized Cooley's momentum in the litigation space as one of the reasons she decision to rejoin the firm after her tenure as US Solicitor General. The article also highlighted Simona Agnolucci and Benedict Hur’s move to Cooley, along with five other litigation partners, noting the firm’s willingness and reputation for handling high-profile, high-stakes matters.

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Why Cooley’s Startup Practice Made It a Natural Fit for LA28

Fri, 17 Jul 2026 18:05:55 Z

Dave Young, partner and co-chair of Cooley’s sports+ practice, was featured in a Daily Journal article about Cooley’s selection as an Official Legal Services Provider the LA28 Olympic and Paralympic Games and Team USA. Young highlights how Cooley’s work in startups and technology companies will translate into its work for LA28, drawing a parallel between LA28’s rapid expansion leading up to the Games and companies that Cooley advised through similar growth. Cooley was also highlighted for advising the Boston Celtics, the Professional Fighters League, League One Volleyball and Street League Skateboarding.

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Lilly to Acquire AtaiBeckley

Thu, 16 Jul 2026 18:48:00 Z

Washington, DC – July 16, 2026 Cooley advised AtaiBeckley, a clinical-stage biopharmaceutical company developing innovative therapeutics for mental health conditions, on its definitive agreement to be acquired by Eli Lilly and Company (Lilly).

The Cooley intellectual property team advising AtaiBeckley on its product exclusivity strategy, IP and the company’s due diligence efforts was led by partner Michael Tuscan with support from Jason Valentine, Audrey Gallagher, Jasmine Su, Dou Youn, Kassity Mai and Will Cutchins.

Cooley Advises Uber on Approximately €14 Billion Bridge Financing Commitment in Connection With Delivery Hero Acquisition

Thu, 16 Jul 2026 14:54:14 Z

San Francisco – July 16, 2026
Cooley advised Uber Technologies (Uber) on an approximately €14 billion bridge financing agreement in connection with its offer to acquire Delivery Hero.

The Cooley team advising Uber on the financing was led by partners Mischi a Marca and Addison Pierce and included partner Carlos Ramirez, of counsel Siana Lowrey, special counsel Katherine Denby and associates Matt Kong, Xueqing Li, Yoni Horn and Peter Haddad.

Walden Robotics Launches With a $1.1 Billion Valuation

Wed, 15 Jul 2026 19:42:29 Z

Boston – July 15, 2026 – Cooley advised Walden Robotics, a humanoid robotics company, on its launch with approximately $300 million in funding. The round values the company at $1.1 billion and was co-led by Toyota Motor Corp. and Deviation Capital, with participation from other leading investors.

Lawyers Laura Stoffel, Eric Popp and Elizabeth Morrison led the Cooley team advising Walden Robotics, with support from Adam Ruttenberg and Sharon Connaughton.

Erasca Announces Upsized $632.5 Million Public Offering of Common Stock

Wed, 15 Jul 2026 18:34:00 Z

San Francisco – July 15, 2026 – Cooley advised the underwriters of Erasca (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, in connection with Erasca’s upsized $632.5 million public offering. Erasca issued and sold 36,142,857 shares of its common stock priced at a public offering price of $17.50 per share, which includes the full exercise of the underwriters’ option to purchase 4,714,285 additional shares of its common stock. J.P. Morgan, Morgan Stanley, Jefferies, and Evercore ISI acted as joint book-running managers for the offering.

Lawyers Denny Won, Kristin VanderPas, Charlie Kim, JJ Meng, Peter Haddad and Amna Naseem Shafi led the Cooley team advising the underwriters. The team also included Madhuri Roy, Shannon Eagan, Xander Lee, Natasha Leskovsek, Phil Mitchell, Jen Shanley, Sarah Miller, Randy Sabett, Karen Tsai, Claire Keast-Butler and Fran Wheeler.

COOLEY NAMED AN OFFICIAL LEGAL SERVICES PROVIDER OF LA28 OLYMPIC AND PARALYMPIC GAMES

Wed, 15 Jul 2026 16:00:00 Z

Los Angeles – July 15, 2026 –Cooley today announced it has been selected as an Official Legal Services Provider of the LA28 Olympic and Paralympic Games and Team USA. As part of the partnership, Cooley will provide a full suite of legal services to LA28 over the next three years, supporting both corporate and litigation matters as the organization prepares to host the world in Los Angeles in 2028.

Cooley’s work will span the breadth of LA28’s legal needs, helping the organization navigate the commercial, operational and regulatory complexities associated with delivering a global event of this magnitude. The firm will bring to bear its integrated approach and experience advising clients at the intersection of sports and technology. The partnership will also create opportunities for Cooley to engage in pro bono legal support to LA28, which will help to facilitate LA28’s goal of creating an inclusive Olympic and Paralympic Games and a monumental moment for the city of Los Angeles.

“We are honored to partner with LA28 in bringing the Olympic and Paralympic Games to Los Angeles,” said Rachel Proffitt, CEO of Cooley. “There is an extraordinary energy and purpose behind building an event of this scale – one that unites athletes, fans and communities around the world. At Cooley, we are proud to contribute to that effort, drawing on our experience supporting some of the most dynamic companies, leagues and emerging platforms in sports. Just as importantly, this partnership allows us to create meaningful impact beyond the Games – giving back to the Los Angeles community in ways that reflect our values as a firm.”

Cooley has long advised leading organizations across the sports landscape, including teams, leagues, investors, media platforms and companies operating in adjacent sectors such as fitness, gaming, collectibles and data. Through its sports+ offering, the firm supports clients on matters ranging from transactions and financings to intellectual property, regulatory compliance and dispute resolution.

“The LA28 Games will set a new standard for what a home Games can be – and having the right partners in place is how we get there,” said Elisabeth Freinberg, chief legal officer of LA28. “We’re excited to work with Cooley as an Official Legal Services Provider, leveraging their experience and strategic insight to help deliver a Games that reflects the spirit, creativity and innovation of Los Angeles.”

Cooley will advise LA28’s legal operations across multiple areas in the lead-up to the Games and will act as a key advisor as preparations accelerate, and the global spotlight turns to Los Angeles.

ABOUT THE LA28 OLYMPIC AND PARALYMPIC GAMES

LA28 will bring the Olympic and Paralympic Games to Los Angeles in 2028, uniting more than 15,000 of the world’s greatest athletes in a celebration of sport, culture and human potential. Set against a diverse collection of venues only Southern California can deliver, from the Pacific Ocean to Hollywood stages to world-class arenas, Los Angeles will become the third city ever to host three Olympic Games, following 1932 and 1984, and will also host its first ever Paralympic Games. The LA28 Games will celebrate historic milestones, including becoming the first Olympic Games in history to feature more women athletes than men, the debut of new Olympic and Paralympic sports, and becoming the first Games since 1948 to not build any new permanent infrastructure. Operating as an independently funded, nonprofit organization, LA28 has built a strong foundation of successful commercial partnerships alongside licensing, hospitality, ticketing and with the support of the International Olympic Committee.

ABOUT TEAM USA

Team USA is the world’s largest, and most diverse, team of athletes from across the United States who compete at the Olympic, Paralympic, Youth Olympic, Pan American and Parapan American Games. The United States Olympic & Paralympic Committee, founded in 1894, serves as the National Olympic Committee and National Paralympic Committee for the United States and is responsible for protecting, supporting and empowering Team USA athletes.

For more information, please visit TeamUSA.com.

Five Largest VC Rounds of H1 2026

Tue, 14 Jul 2026 20:25:44 Z

Mike Nelson, partner and corporate head of Cooley’s Denver office, was quoted in BioSpace about the investment trends for the biopharma sector in H1 2026, noting investments remain concentrated in later-stage as opposed to early-stage companies.

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Law Firms Are Building Their Own AI Tools. Should They Share Them?

Tue, 14 Jul 2026 19:41:33 Z

Matthew Bartus, partner and global co-chair of Cooley’s emerging companies and venture capital practice group, was quoted in Law.com about the launch of Cooley GO Lab, an artificial intelligence-powered workspace designed to help startups in real time as they build in collaboration with Legora and Y Combinator. He notes that Cooley GO Lab is built on the underlying principle of Cooley GO, which launched in 2014.

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Cover Genius Raises $100 Million

Tue, 14 Jul 2026 18:33:00 Z

New York – July 14, 2026 – Cooley advised Cover Genius, the global infrastructure for embedded protection, on its $100 million capital raise, valuing the business at $1.9 billion. The raise was backed by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on enterprise software.

Lawyers Danielle Gershowitz, Alexandra Leavy, Dennis Craig and Harriet Fraser led the Cooley team advising Cover Genius, with support from Amanda Fant, Madeline Mavro, Aaron Pomeroy, Jonathan Rivinus, Rick Jantz, Rebecca Ross, Morgan Perna, Andrew Epstein, Nyron Persaud, David Walsh and Carly Mitchell.

Avere Therapeutics Announces Merger Agreement With NextCure, Concurrent $320 Million Private Placement

Tue, 14 Jul 2026 18:21:00 Z

San Francisco – July 14, 2026 – Cooley advised Jefferies and Wedbush as the placement agents to Avere Therapeutics, a privately held biotechnology company advancing oral therapies for IL-23 driven inflammatory diseases, in connection with a $320 million private investment concurrent with its merger with NextCure. The private placement was led by Fairmount and Hansoh Pharmaceutical Group, with participation from Venrock Healthcare Capital Partners, General Atlantic, Janus Henderson Investors, Wellington Management, Boyu Capital, Sirona Capital, funds and accounts advised by T. Rowe Price Investment Management, RTW Investments, Sirenia Capital Management, Logos Capital, Redmile, Affinity Asset Advisors, Balyasny Asset Management, Wedbush Healthcare Partners and other institutional investors. Upon completion of the transaction, which is expected to occur in the second half of 2026, the combined company is expected to operate as Avere Therapeutics, Inc., and trade on Nasdaq under the ticker symbol AVRX.

Lawyers Denny Won, Charlie Kim, Div Gupta and Peter Haddad led the Cooley team advising the placement agents. The team also included Carol Laherty, Marcelo Pomeranz, Natasha Leskovsek, Phil Mitchell and Karen Tsai.

AI Is Coming for Lawyers. Are They Ready?

Tue, 14 Jul 2026 17:46:26 Z

Rachel Proffitt, Cooley partner and CEO, was featured in an episode of Semafor’s “Compound Interest” podcast about how artificial intelligence (AI) is changing the current Big Law business model, what rainmakers of the future look like, the rise of AI-native law firms and how Cooley is using AI. The launch of Cooley GO Lab in collaboration with Legora and Y Combinator was also highlighted.

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UK OFSI Fines Tech Company £1M for Sanctions Breach

Tue, 14 Jul 2026 13:58:42 Z

On 26 May 2026, the UK’s Office of Financial Sanctions Implementation (OFSI) imposed a civil monetary penalty of £1,000,920.59 on Sabre Global Technologies Limited (SGTL), a UK-registered technology company, for breaches of UK financial sanctions.

This is the UK’s largest sanctions breach penalty since Standard Chartered was fined £20 million in 2020, and the first penalty that deals with sanctions circumvention under OFSI’s new settlement framework.

One week later, HMRC publicly named Petrofac Facilities Management Limited (PFML), following a £569,157 compound settlement, for breaches of the Russia sanctions regime, although no further details were released. Together, these cases indicate an increasingly assertive UK sanctions enforcement landscape, with penalties appearing to be on an upward trajectory.

The OFSI decision regarding SGTL confirms that software, data services and digital tools constitute “economic resources” under UK sanctions law which must not be made available to designated persons.

The decision also sets out detailed expectations on screening, escalation, self-reporting and senior accountability – and should be read as required reading for sanctions professionals across the technology sector.

Background

SGTL operates a global distribution system (GDS), providing entities within the travel industry with access to travel content from a broad range of travel suppliers. SGTL receives a booking fee from travel suppliers in exchange for distribution of their content via the GDS.

On 14 September 2007, SGTL entered into a contract with Ural Airlines, granting the airline access to its GDS and other related services. The agreement was extended multiple times, with the most recent contract update on 1 December 2021 and an amendment agreement on 1 September 2022. The contract was due to expire on 30 November 2022, though access to the GDS in fact continued until 6 December 2022. This contractual framework is a significant element of the case, as OFSI found that SGTL’s invoicing of Ural Airlines and instruction that funds be paid into its account constituted making funds available for the benefit of a designated person.

On 19 May 2022, Ural Airlines was designated under the Russia (Sanctions) (EU Exit) Regulations 2019 (Russia Regulations). SGTL’s legal representatives notified SGTL of the designation on the same day.

Notwithstanding the designation, SGTL continued to provide services to and receive funds from Ural Airlines for a period thereafter. SGTL was repeatedly notified by its UK bank of sanctions concerns in relation to payments received from Ural Airlines. The bank flagged and held payments on 6 June, 27 June, and 5 July 2022, and SGTL’s US bank subsequently flagged a further payment in September 2022. Despite these repeated red flags, SGTL continued to explore alternative payment routes, including testing whether payments from Ural Airlines could be received via its US bank account. SGTL ultimately decided not to renew the contract when it expired on 30 November 2022.

OFSI identified three breaches of the Russia Regulations:

Making funds available for the benefit of a designated person.
Making economic resources available to a designated person.
Circumventing the prohibitions.

The total value of the breaches was assessed as £2,634,001.54 ($3,222,379.89), covering funds and economic resources in breach of regulations 13, 14 and 19 of the Russia Regulations.

Why this decision matters

1. Invoicing, instructing and receiving payment from a sanctioned party can constitute ‘making funds available’

SGTL’s contract with Ural Airlines created a debt obligation. OFSI found that by invoicing Ural Airlines and instructing that funds be paid into its bank account, SGTL made funds available to its bank for the benefit of a designated person.

OFSI found that Ural Airlines received a significant financial benefit because the payments served to discharge its financial obligations to SGTL.

This is an interesting, and perhaps surprising, interpretation of the asset freeze restrictions, since OFSI’s position is that making available funds to a third party for the benefit of the designated person can occur even though the payment is made by the designated person and relates to a debt addressed to the designated person. Unfortunately, no further detail is provided in the penalty notice of why OFSI has taken this approach or how it will seek to interpret this in other situations.

2. Digital services and software as a service (SaaS) products are within scope of ‘economic resources’

OFSI considered that, by enabling Ural Airlines to access and use the GDS platform, SGTL made an economic resource available. Platform operators should take note that providing access to a digital platform or service may itself give rise to sanctions risk.

OFSI explicitly confirms that intangible services – including software platforms, data services and digital tools – can constitute an “economic resource” for the purposes of UK sanctions regulations.

Under the UK sanctions framework, economic resources are defined broadly as assets of every kind, whether tangible or intangible, movable or immovable, which are not funds but which can be used to obtain funds, goods or services. OFSI confirmed that a service which enables a designated person or entity to generate revenue, maintain operations or otherwise obtain an economic advantage may amount to making an economic resource available – regardless of whether that service is intangible or provided entirely digitally.

The decision is a useful reminder for technology companies, including SaaS providers, that deliver software platforms, data feeds, API access or other digital services to customers that the provision of their services can fall squarely within sanctions restrictions.

3. Circumvention will be treated as aggravating

During July and August 2022, SGTL explored alternative routes to receive funds. It engaged with its US bank to scope receiving payments from Ural Airlines into its US account in light of sanctions issues with its UK account. Internal emails show that, if a test payment succeeded, SGTL expected full outstanding GDS fees to be paid via this route.

On 21 September 2022, Ural Airlines sent a £176.48 ($200) test payment to SGTL’s US account.

OFSI’s decision confirms that attempts to restructure or reroute payment pathways to avoid the effect of UK sanctions – including by staging payments through third countries – will be treated as circumvention and may constitute a breach in their own right. Such conduct will be treated as an aggravating factor and will significantly increase the seriousness of any enforcement outcome.

4. UK-specific policies and procedures are required

SGTL’s sanctions documentation at the time focused on general procedures and US requirements, with limited coverage of UK-specific regimes. In addition, its third-party screening tool did not automatically flag the relevant designation to the compliance team, contributing to a delay in identifying and addressing the issue.

OFSI has emphasised that sanctions compliance frameworks must be specifically tailored to the UK sanctions regime. Thus, reliance on groupwide policies designed primarily for other jurisdictions (such as the US Office of Foreign Assets Control regime or EU sanctions) is not sufficient. For a comparison of US and UK economic sanctions authorities, see the joint OFAC-OFSI comparative overview published on 23 June 2026, produced under the OFAC-OFSI Enhanced Partnership established in October 2022, which outlines key similarities and differences between the regimes.

The SGTL penalty notice specifies that firms must ensure that:

Policies and procedures are current and address UK-specific requirements.
Sanctions screening systems are tested and verified to be working as intended.
There are robust escalation protocols for red flags, including blocked payments or notifications of concerns from banking partners.
Clear senior accountability exists at board and executive level for sanctions compliance.

5. Early and comprehensive self-reporting is essential

SGTL voluntarily self-reported the breach without prompting but provided only limited detail and continued servicing a designated person. It later cooperated fully with OFSI when prompted, and overall, this factor was treated as neutral (neither mitigating nor aggravating) by the OFSI when determining how seriously to view this case.

OFSI has reiterated the importance of prompt, comprehensive and detailed self-reporting of suspected breaches, as soon as reasonably practicable. Delays and incomplete submissions are likely to undermine any mitigation argument. In practice:

Firms should contact OFSI early, even where the full picture is not yet clear.
Where full disclosure is not immediately possible, firms should make an early partial disclosure, clearly stating that a further and fuller disclosure will follow.
Firms should provide a timeline for full disclosure and keep OFSI updated if that timeline is likely to slip.
Firms should not allow the process of taking legal advice – while important – to cause unnecessary delay in making initial contact with OFSI.

Key compliance actions

In light of this decision, we recommend that technology and digital services companies take the following steps:

Audit your customer base and product suite. Regularly review whether any existing or prospective customers are designated persons or entities under UK financial sanctions.

Review and update your UK sanctions compliance framework. Ensure your policies, procedures and training materials are specifically tailored to the UK sanctions regime.

Establish clear escalation protocols. Ensure that there are well-understood, documented escalation routes for any potential sanctions, and that these protocols survive personnel changes.

Assess your self-reporting readiness. Ensure your compliance and legal teams have a clear plan for engaging with OFSI promptly in the event of a suspected breach.

Take legal advice where uncertainty exists.

Cooley Further Reinforces Leading Privacy and Cybersecurity Practice

Tue, 14 Jul 2026 07:00:00 Z

New York – July 14, 2026 – Cooley today announced that Michael La Marca has joined the firm as a partner in its global cyber/data/privacy group, where he will be based in New York, less than two months after adding Meredith Halama and Katie Cramer to the practice, in Washington, DC, and Denver, respectively. Like the rest of the lawyers in Cooley’s cyber/data/ privacy practice, La Marca has extensive experience with companies engaged in cutting-edge technology and information practices, including AI, biometrics, geolocation tracking and connected devices. In addition, he has a special focus on advising financial institutions, fintechs and investment management firms.

Together, La Marca, Halama and Cramer enhance the litigation department’s cyber/data/privacy team, which is already recognized among the industry’s best, and reinforce its capabilities to serve both major technology companies and the thousands of up-and-coming innovative companies that Cooley uniquely represents.

“Cooley has long had one of the best privacy and cybersecurity practices for counseling, defense of government investigations and privacy class actions. And, as a result of our reputation in this practice, the demand for counseling is unyielding,” said Ian Shapiro, partner and chair of Cooley’s global litigation department. “Through an extensive process, we identified Michael as among the best of the next generation of privacy and cybersecurity lawyers. Like Meredith and Katie, Michael significantly expands our counseling practice by contributing his exceptional experience in privacy and cybersecurity. We look forward to supporting his emergence as a preeminent practitioner.”

La Marca joins Cooley from Hunton Andrews Kurth where he was a partner in its data, cyber and privacy group. La Marca advises a range of clients, from startups to multinational companies, on privacy, cybersecurity and AI laws, with a focus on companies in the financial services sector. He also negotiates the privacy, cybersecurity and AI-related aspects of commercial agreements and M&A transactions.

“As counsel to the global digital economy, Cooley sits at the center of the most consequential data, AI and cybersecurity questions facing companies today,” said Travis LeBlanc, partner and co-chair of Cooley’s global cyber/data/privacy practice. “Michael brings exactly the depth our clients need. He has built governance programs that keep financial services and AI-driven businesses ahead of regulators, guided clients through the most sensitive data breaches and defended them from enforcement. He makes us a stronger partner to clients navigating the full life cycle of data risk.”

“Cooley’s market-leading platform, exceptional client base and collaborative culture make it the ideal place to help companies navigate their most critical privacy, cybersecurity and AI challenges,” said La Marca. “I’m excited to join a team that’s at the forefront of shaping how these challenges are addressed.”

Cooley’s global litigation department includes more than 500 lawyers in the US and Europe and is the top litigation department for the representation of technology, life sciences and other innovative companies. Since 2025, Cooley has added numerous elite, next-generation lawyers to its litigation department throughout the US, including Elizabeth Prelogar, Raymond Tolentino, Ephraim McDowell, Brian Nelson and Janet Kim in DC; Simona Agnolucci, Ben Hur, Jonathan Patchen, Eduardo Santacana, Joshua Anderson and Tiffany Lin in San Francisco; Michael Rome and Brian Klein in Los Angeles; Lyndsey Kruzer in Boston; and James Kim, Tejal Shah and Sean Quinn in New York.

State Of 2026 Energy Dealmaking: Midyear Report

Mon, 13 Jul 2026 16:00:00 Z

Mona Dajani, partner and co-chair of Cooley’s infrastructure, energy and real estate practice, was quoted in a Law360 article about the trends shaping energy deal work, noting that clean energy is increasingly being underwritten as an enabler of digital infrastructure and no longer viewed solely as clean energy.

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HHS and Congress Push to Streamline and Onshore Clinical Trials

Mon, 13 Jul 2026 14:40:48 Z

Conducting first-in-human clinical trials in the United States is often associated with significant cost, complexity and delay. There is a growing consensus among policymakers that the current US requirements are unnecessarily rigid and burdensome for early-stage clinical development. Companies often view foreign jurisdictions, such as Australia and China, as offering faster, more flexible pathways for initiating clinical trials. On June 22, 2026, the US Department of Health and Human Services (HHS) announced a coordinated, departmentwide effort – Operation TrialBlazer – to reverse that trend and restore American leadership in clinical research. As part of this initiative, the Food and Drug Administration (FDA) and other HHS agencies, including the HHS Office of Inspector General (OIG), are advancing reforms aimed at streamlining the clinical trial process, eliminating inefficiencies, increasing participation and improving transparency for biopharmaceutical companies and other stakeholders. Momentum for streamlining and improving the clinical trial process extends beyond the executive branch, with Congress also actively considering proposals to accelerate early-phase development, reduce administrative burdens and encourage sponsors to keep early-stage clinical research in the US. Companies, particularly small and mid-size biopharma companies, should closely monitor these initiatives and leverage this momentum to engage with FDA, OIG and other HHS agencies to help shape reform efforts.

Efforts to address a long-standing shift of early clinical research overseas

The migration of clinical research from the US to foreign countries is not a recent phenomenon. For example, in 2010, HHS reported that more than half of all clinical trial sites were located outside the US, and that 80% of marketing applications submitted to FDA contained data from foreign studies. In April 2026, then-FDA Commissioner Martin Makary noted that China had four times more Phase 1 trial initiations than the US since at least 2024, and that the average time between a pre-investigational new drug (IND) request and IND go-ahead is approximately 380 days in the US versus 220 days in China, with China having announced plans to reduce that timeline even further.

China is not the only country that has attracted early-stage research; Australia has also become a popular jurisdiction for initiating clinical trials. Australia’s appeal stems in part from its regulatory framework, which allows certain clinical trials to proceed using a streamlined notification process. These competitive pressures have not gone unnoticed. HHS agencies, including FDA and OIG, and Congress have begun taking concrete steps to reclaim the US’s position as the preeminent destination for early-phase clinical research.

FDA’s request for an expedited IND pathway

Before creation of Operation TrialBlazer, in an effort to reshore clinical trials, FDA had already asked Congress to create a risk-based expedited IND pathway for certain Phase 1 clinical trials. This pathway would serve as an alternative to the traditional IND process intended to reduce duplicative and time-consuming requirements that are not necessary to maintain safety and ethical standards. FDA recognizes that such a pathway is particularly important for smaller companies, which face proportionally greater barriers under the current framework. Those barriers that have contributed to the migration of preclinical and early Phase 1 research to jurisdictions like China and Australia. According to FDA’s request, the proposed pathway would be optional and risk-based and rely more heavily on existing preclinical evidence and validated alternative testing methods to accelerate initiation of US-based Phase 1 programs.

FDA RFI on expedited IND pilot program

Without waiting for Congress to act, FDA has also moved administratively to pilot a version of this approach. As part of Operation TrialBlazer, on June 24, FDA published a request for information (RFI) soliciting public comments on a proposed Expedited Investigational New Drug Pilot Program designed to shorten the time from drug identification to first-in-human Phase 1 clinical trials. The pilot would enlist a network of Qualified Research Institutions (QRIs), such as academic medical centers and contract research organizations (CROs), to partner with sponsors in developing and reviewing Phase 1 IND protocols. QRIs would provide advisory recommendations on the pharmacology/toxicology, clinical, and chemistry, manufacturing and controls (CMC) components of an IND submission, with the aim of improving submission quality and reducing the incidence of clinical holds. QRIs would also support parallel activities, such as Institutional Review Board (IRB) review and clinical trial site activation, while FDA retains full oversight and regulatory authority, including the ability to issue clinical holds, disqualify investigators and conduct inspections. The pilot also proposes a rolling IND submission process, which would allow sponsors to receive earlier and more frequent feedback from FDA. According to FDA, the pilot’s core objectives are to improve IND submission quality, reduce FDA review time, and accelerate the interval from nonclinical research to first-in-human study initiation. FDA is seeking input from sponsors, CROs, academic institutions, health networks/systems, IRBs, patient advocacy organizations, investors and other stakeholders on the pilot’s structure, scope and implementation.

Comments are due by July 22, 2026.

FDA AI initiatives

FDA has also been pursuing a related initiative that predated the June 22 HHS announcement. Nearly two months earlier, in late April 2026, FDA published an RFI on a proposed pilot program focusing on improving efficiency and decision-making quality within the existing Phase 1 trial framework. FDA sought input on how AI could support dose selection, safety monitoring, patient recruitment and go/no-go decisions while maintaining FDA’s existing scientific and regulatory standards. The fact that FDA subsequently launched a separate, more sweeping set of initiatives as part of the June 22 HHS announcement suggests the agency concluded that AI-enabled optimization of the current process, while valuable, is not sufficient on its own to close the competitiveness gap with countries like Australia and China. This gap is rooted in the regulatory process itself, which no amount of AI-driven efficiency within FDA’s existing framework can eliminate. The June 22 initiatives, by contrast, take aim at that structural gap directly. FDA received nearly 200 comments in response to the AI RFI, and the comment period closed on June 29, 2026.

OIG RFI on potential fraud and abuse barriers to clinical trial participation

As part of Operation TrialBlazer, OIG issued an RFI seeking public input “on whether any additions or modifications are needed to the safe harbor regulations under the Federal Anti-Kickback Statute [(AKS)] or the exceptions to the civil monetary penalty [(CMP)] provision prohibiting inducements to beneficiaries … for remuneration provided to individuals in connection with their participation in clinical trials.”¹

The inclusion of this RFI within HHS’s broader clinical trial reform framework reflects a recognition that fraud and abuse compliance uncertainty may itself be a barrier to advancing clinical research. To the extent such uncertainty exists and remains, it may undermine the administration’s broader goals of accelerating drug development, increasing participation in clinical research and expanding patient access to innovative therapies.

Clinical trial participation imposes real costs on patients, including transportation to and from trial sites, childcare, time away from work and other out-of-pocket burdens. Financial constraints may result in enrollment failure and participant dropout. These challenges are particularly acute in rare disease research, where enrollment difficulty is compounded by small patient populations. Further, as participants and/or trial sites may be, and often are, geographically dispersed, participants may need to travel substantial distances to reach a qualifying trial site. In such contexts, the ability to offer meaningful logistical and financial support to participants could be determinative of whether certain individuals are able to participate.

However, sponsors seeking to offer such support have faced uncertainty and persistent compliance questions. In the RFI, OIG notes that it has published 10 favorable advisory opinions over the past two decades permitting certain cost-sharing waivers or subsidization of certain federal healthcare program cost-sharing obligations for clinical trial participants in specific situations and circumstances, but that it has “not issued any advisory opinions or guidance relating to other remuneration provided to clinical trial participants, such as transportation costs, childcare costs, or stipends.”² In the absence of clear guidance, sponsors considering whether to offer such support face questions and uncertainty in seeking to assess whether a given arrangement may or may not be viewed as compliant. That uncertainty can have a chilling effect. As a result, sponsors potentially may either forego compensation programs entirely or limit them in ways that could contribute to or perpetuate enrollment challenges.

OIG’s new RFI is a step toward addressing these questions and the uncertainty that sponsors and other organizations currently face. OIG is seeking public input on a number of areas, including, among others:

Whether, and if so, how, clinical trial participation is meaningfully enhanced by providing appropriate remuneration to federal healthcare program enrollees.
Whether clinical trial sponsors, clinical trial sites or other organizations view the AKS and Beneficiary Inducements CMP as barriers to providing appropriate remuneration to clinical trial participants, and, if so, why.
The types and amounts, if applicable, of remuneration stakeholders may seek to provide to clinical trial participants to facilitate participation.
The fraud and abuse risks that may be associated with the offer and provision of such remuneration.
The types of arrangements necessary to provide such remuneration.
Safeguards that may be necessary or prudent to prevent fraud and abuse when clinical trial participants receive remuneration.

OIG states that it is seeking to identify ways in which it might modify or add new AKS regulatory safe harbors or new exceptions to the Beneficiary Inducements CMP’s regulatory definition of “remuneration” to address these considerations. Additionally, OIG seeks to identify other guidance it could publish or amend “to foster arrangements that facilitate clinical trial participation, while also protecting against harms caused by fraud and abuse.”³ The RFI also lists several specific questions for stakeholder input.⁴

Comments are due no later than 5:00 pm ET on August 24, 2026.

FDA draft guidance on substantial evidence of effectiveness

The June 22 HHS announcement also referenced a new FDA draft guidance titled, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. While this draft guidance addresses the evidentiary standard for drug approval broadly and not the IND process specifically, it is directly relevant to sponsors conducting early-phase trials in the US, as it signals FDA’s latest interpretation of the statutory standard for the data that will ultimately be required to support approval. This 2026 draft guidance revises a 2019 draft guidance and contains significant substantive updates reflecting FDA’s evolving views on topics such as externally controlled trials and Bayesian statistical analysis. More broadly, the 2026 draft guidance moves away from the rigid examples provided in the 2019 draft guidance toward a more comprehensive view of the overall development program, the broader context of the disease state, and the role of external and real-world evidence when assessing whether a sponsor has met the substantial evidence standard.

Perhaps the most notable example of this shift is the reorganization and reframing of the discussion around the number of clinical trials required to demonstrate effectiveness. While the 2019 draft guidance positioned two adequate and well-controlled clinical trials as the standard approach for demonstrating substantial evidence of effectiveness, the 2026 draft guidance reframes multiple clinical trials as one possible way that sponsors may meet this requirement depending on the needs of the drug development program. Likewise, the 2026 draft guidance expands the potential scenarios in which one adequate and well-controlled trial may be sufficient to meet the substantial evidence standard. Whereas the 2019 draft guidance organized regulatory flexibilities around three scenarios – life-threatening or severely debilitating diseases, rare diseases and situations where human efficacy trials are infeasible – the 2026 draft guidance does away with these distinct categories and instead states that the clinical context is critical to informing the approach to establishing substantial evidence of effectiveness. While regulatory flexibilities may still be warranted for a rare disease, those flexibilities may differ for a life-threatening rare disease with no current treatment options versus one that is less debilitating and/or has available treatment options.

Trial design is another area that received a significant update in the revised draft guidance. The 2026 draft guidance devotes considerable discussion to study designs, such as noninferiority studies and external controls, but expands upon the situations in which these designs can offer meaningful evidence of efficacy, consistent with FDA’s more flexible approach across the updated guidance. The guidance also notes that trial design elements, such as eligibility criteria, a control arm and supportive therapies that reflect standard of care, and a meaningful primary endpoint, should be selected to provide results that are relevant to patients and prescribers. FDA states that trial design is an area where the agency may exercise regulatory flexibility, including by relying on trial designs that generate less certainty regarding efficacy if warranted based upon a holistic view of clinical considerations.

One area where the 2019 and 2026 draft guidance overlap is in the categories of confirmatory evidence that may be considered to demonstrate substantial evidence of effectiveness. Specifically, FDA confirms that mechanistic evidence, natural history data and data from trials in a related disease or condition are examples of types of confirmatory evidence. With the 2026 draft guidance, FDA provides some additional confirmatory evidence considerations. For example, FDA cautions that natural history data used as confirmatory evidence should be separate from any data used as a control for a single and adequately controlled clinical trial. FDA also specifically addresses real-world data as a subset of natural history data that may be appropriate as confirmatory evidence in rare diseases or conditions, depending on considerations such as reliability and relevance of the data source and appropriateness of the study design and statistical methods for studies that leverage this data.

FDA is also accepting comments on the newly released Substantial Evidence of Effectiveness draft guidance. This comment period is an important opportunity for any company seeking drug or biologic approval and is especially relevant for sponsors developing treatments for rare, serious or life-threatening conditions, or those who may be planning to rely on single trial or novel trial designs to support approval.

Comments are due by September 22, 2026.

Bipartisan proposals on Capitol Hill

Along with these FDA and other HHS initiatives, Congress is developing its own proposals seeking to align with and compliment FDA’s recent actions. In May 2026, Rep. Jake Auchincloss (D-MA), a member of the House Energy and Commerce Committee, released a legislative discussion draft of the Cures in Care Initiative, which outlines a broad plan to modernize the US clinical trial system. The draft proposes to revamp FDA oversight of first-in-human and Phase 1 studies, including modernizing IRBs and streamlining Phase 1 processes. It also points to Australia’s notification process as a model and calls on FDA to pilot a third-party oversight framework, termed an “IND alternative pathway,” and issue guidance for pre-certifying third-party organizations.

Similarly, in a February 2026 roadmap of various FDA reforms, Sen. Bill Cassidy (R-LA), chair of the Senate Committee on Health, Education, Labor, and Pensions, proposed that the agency launch a pilot program testing expedited clearance of low-risk Phase 1 studies, similar to the regulatory framework used in Australia.

The House Appropriations Committee made a similar recommendation in a report accompanying its markup of the FDA Fiscal Year 2027 appropriations bill. The committee directed FDA to revise its IND processes and data requirements for initial human trials to streamline administrative requirements, reduce filing burdens and tailor the process and requirements to make them risk and trial phase appropriate. The committee also encouraged FDA to develop and implement a pilot program to test an Australian-style clinical trial notification system in the US.

While committee report directives and draft legislative language do not carry the force of law, they are powerful policy signals from Congress to FDA. These bipartisan, bicameral signals bear watching for future congressional action as the appropriations bills and Prescription Drug User Fee Act (PDUFA) reauthorization work their way through the legislative process.

Opportunities to shape reform efforts

These developments signal a rapidly growing momentum within the government to modernize and accelerate the clinical trial framework in the US. The FDA and OIG RFIs and FDA draft guidance, in particular, represent concrete and time-sensitive opportunities for sponsors and other stakeholders to provide input that can help shape the contours of future US clinical trial reform. For sponsors, especially small and mid-size biopharma companies, these comment periods present important vehicles for communicating ideas and perspectives that could meaningfully accelerate development timelines.

Cooley’s life sciences and healthcare regulatory team will continue to closely monitor these developments and their implications for companies across the clinical and commercial landscape. For any questions on how these proposals might affect your development timelines, how to engage with FDA, or how to submit comments in response to the RFIs or FDA’s guidance documents, please contact one of the lawyers listed below.

Cooley senior regulatory analyst Kelly Marco also contributed to this alert.

Notes

Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, 91 Fed. Reg. 37902 (June 24, 2026).
Id. at 37903.
Id.
Id. at 37904 – 37905.

Cooley’s Vanilla Platform Surpasses $100 Billion in Fund Subscriptions, Introduces Vanilla Transfers to Streamline Investor Transactions

Mon, 13 Jul 2026 12:30:00 Z

New York – July 13, 2026

Cooley today announced that Vanilla, its cloud-based fund subscription platform, has surpassed $100 billion in closed subscriptions, helping more than 1,200 fund clients manage subscriptions with over 50,000 limited partners (LPs).[1] The milestone underscores Vanilla’s role as the leading automated solution for fund formation and investor onboarding – and highlights Cooley’s continued investment in technology-driven innovation for fund managers and investors.

Alongside this milestone, Cooley is introducing Vanilla Transfers, a new feature within Vanilla designed to simplify one of the fund life cycle’s most complex and administratively burdensome processes – introducing a clearer and more predictable pricing model with a $495 flat fee.

Since its launch in 2019, Vanilla has transformed how venture capital, private equity and other private fund managers raise capital by replacing fragmented workflows with a vertically integrated platform. Envisioned by Cooley lawyers – who have formed more than 1,200 funds over the past five years – Vanilla embeds legal, operational, LP and administrative processes into a single system, enabling managers and investors to move efficiently from subscription to subsequent closes and beyond.

“Crossing $100 billion in subscriptions is a powerful validation of how much the market needed a better approach to fund formation and investor onboarding,” said Jordan Silber, partner at Cooley and founder of Vanilla. “Vanilla reflects years of insight from helping clients raise capital at scale. But the reality is, some of the biggest pain points in private funds come after the close. We’re seeing even the most sophisticated investors in our fund clients struggle with transfers that drag on for months, require excessive documentation and cost thousands of dollars for what should be simple changes. Vanilla Transfers is about fixing that for our fund clients. By embedding Cooley’s experience directly into a guided workflow, we’re transforming a historically fragmented, high-friction process into one that is streamlined, transparent and built to scale with our fund clients.”

Addressing a critical pain point: Vanilla Transfers

LP transfers – such as moving an interest from an individual to a family trust – have long been a source of inefficiency in private funds. Traditionally, even simple transfers required extensive paperwork, multiple rounds of review among fund counsel, managers and investors, and costs often running into the thousands of dollars.

Vanilla’s new transfer functionality reimagines this process through a guided, self-service workflow:

Investors can initiate and complete transfers online
Executed documents are delivered digitally for immediate download
Transfer times in as little as one business day

Unlike third-party tools that require bespoke coding of transfer agreements and still rely on back-and-forth coordination, Vanilla brings LPs, general partners and fund counsel together in a unified system.

“This milestone is not just about scale – it’s about how we are rethinking the way legal and operational workflows come together,” said David Wang, chief innovation officer at Cooley. “Vanilla and Vanilla Transfers reflect a broader approach to innovation at Cooley: designing systems that perform under pressure and scale expertise in ways that help clients move faster with confidence. By integrating decades of Cooley experience directly into technology, we’re enabling smarter, more seamless experiences across the fund life cycle.”

A platform built for what’s next

The introduction of Vanilla Transfers marks the next step in Vanilla’s evolution, building on a foundation of lawyer-led innovation that continues to expand across Cooley’s technology ecosystem. Future enhancements, including new AI-powered capabilities, will further extend the platform’s ability to streamline workflows, surface insights and accelerate decision-making.

[1] Use of Vanilla does not create an attorney-client relationship with Cooley and any use of the platform is subject to the terms of use agreement.

Cooley Advises LionLight Capital on Oversubscribed $215 Million Private Equity Fund I Close

Thu, 09 Jul 2026 18:43:00 Z

New York – July 9, 2026 – Cooley advised LionLight Capital on the successful close of LionLight Capital Fund I, with $215 million in capital commitments. The inaugural fund was oversubscribed, reached its hard cap, and closed in just ten weeks. LionLight is a private equity firm that partners with exceptional leadership teams to build market-leading financial and professional services platforms through long-term minority and majority investments.

Lawyers Jaclyn Rabin, Kevin Beckoff and Heather Walsh led the Cooley team advising LionLight Capital, with support from Corey Zarse and Aalok Virmani.

As Democrats Prep for Surge in Post-Midterm Investigations, so do Law Firms

Wed, 08 Jul 2026 19:55:14 Z

Cooley partner Susanne Grooms was quoted in a GIR article about how law firms are advising clients in anticipation of a potential rise in congressional oversight and investigations following the November midterm elections. Grooms noted that companies may receive congressional inquiries as investigators seek information that the White House may be reluctant to provide and may face scrutiny even when complying with the law.

Read the article (subscription required)

Pearl Health Raises $110 Million

Wed, 08 Jul 2026 19:44:11 Z

New York – July 8, 2026 – Cooley advised Pearl Health, a healthcare technology company helping manage risk and deliver better care to Medicare patients, on its $110 million capital raise, comprised of a $50 million equity investment led by Andreessen Horowitz with participation from Viking Global Investors, AlleyCorp and Ulysses Capital, and a $60 million debt facility led by Trinity Capital.

The new capital will expand Pearl's AI platform, turning clinical intelligence into measurable outcomes, and accelerate its growth across enterprise health system and payer partnerships, its expansion into Medicare Advantage, and new risk offerings.

Lawyers Roy Moran, Greg Reith, Alexis Finkelberg Bortniker, Xiaoyu Huang, Michael Bruno and Mariam Kamal led the Cooley team advising Pearl Health.

Cooley previously advised Pearl Health on its $75 million oversubscribed Series B in January 2023.

Prime Intellect Raises $130 Million Series A

Wed, 08 Jul 2026 16:49:00 Z

Miami – July 8, 2026 – Cooley advised Prime Intellect, a full-stack platform and an open research lab, making frontier AI training accessible to every company, on its $130 million Series A. The round brings its total funding to more than $150 million to build the open superintelligence stack and values the company at $1 billion.

Radical Ventures led the round, with participation from Intel Capital, Dell Technologies Capital and other existing investors.

Lawyers Derek Colla, David Safren and Sara Siddiqi led the Cooley team advising Prime Intellect.

Cooley Bets Big on Litigation – and So Far, It’s Paying Off

Wed, 08 Jul 2026 14:35:44 Z

Ian Shapiro, Cooley partner and chair of the firm’s litigation department, spoke with Bloomberg Law about the firm’s investment in building a premier litigation practice for technology, life sciences, and other innovative companies. Elizabeth Prelogar discussed her decision to return to Cooley after serving as US Solicitor General, while Simona Agnolucci shared that the firm’s commitment to principled advocacy and fearless litigation was a key factor in her and Benedict Hur’s decision to bring their practice to Cooley.

Read the article (subscription required)

Cooley Partner Shortlisted as Attorney of the Year for the New York Legal Awards 2026

Wed, 08 Jul 2026 14:28:12 Z

Cooley partner Kathleen Hartnett was named one of three Attorney of the Year finalists for the New York Legal Awards 2026.

Among her most significant accomplishments this year, Kathleen served as lead counsel in a First Amendment challenge to an executive order targeting Jenner & Block, securing a permanent injunction and a ruling that the order was unconstitutional retaliation.

She also appeared before the Supreme Court of the United States as it heard oral arguments in Little v. Hecox and West Virginia v. B.P.J., which addressed the rights of transgender girls under the Equal Protection Clause and Title IX.

The award ceremony will take place in New York in September.

Read the full shortlist (subscription required)

Big Law Preps Clients for Democrat-Led Probes if House Flips

Wed, 08 Jul 2026 14:20:48 Z

Cooley partner Susanne Grooms was quoted in a Bloomberg Law article examining how major law firms are helping clients prepare for a potential increase in congressional investigations if Democrats gain control of the US House in midterm elections. Grooms emphasized the importance of mapping out the congressional landscape and understanding what it may look like under new leadership.

Read the article (subscription required)

Illinois Mandates Independent AI Audits: What Developers Should Know

Tue, 07 Jul 2026 19:40:28 Z

I. Illinois SB 315 signals next phase of AI regulation – from transparency to verification

Over the last several years, lawmakers in the United States and around the world have increasingly focused on regulating AI systems through transparency, documentation and internal risk management requirements.

Recent frameworks, such as California’s Transparency in Frontier Artificial Intelligence Act (TFAIA), New York’s amended Responsible AI Safety and Education (RAISE) Act and portions of the European Union’s AI Act, generally require developers to assess and disclose how they identify, evaluate and manage AI-related risks. Common obligations include transparency reports, system/model cards, risk assessments, governance frameworks and incident reporting.

Illinois’ recently enacted Artificial Intelligence Safety Measures Act (AISMA) builds on these existing frameworks by introducing a significant new requirement: independent verification. Rather than relying solely on developer-created documentation and self-reported compliance measures, AISMA requires covered large frontier model developers to undergo audits by independent third parties. This move reflects a broader shift in regulatory efforts from requiring companies to document how they manage AI risk to requiring them to demonstrate that those processes are actually operating as intended. This is a significant change from self-reported compliance, mirroring a trend in third-party audit requirements in content regimes like the EU’s Digital Services Act and South Carolina’s Age-Appropriate Code Design.

AISMA may represent the next phase of AI regulation – one focused not only on disclosure, but also on third-party verification.

II. Key elements of the law

Who does Illinois’ law apply to?

Developers responsible for the most advanced foundation models.

The law regulates “frontier models” (models trained using more than 10²⁶ floating-point or integer operations) and imposes obligations on frontier developers broadly. However, its most significant requirements fall on “large frontier developers” – those with annual gross revenues exceeding $500 million.

When does it go into effect?

January 1, 2028

What does the law require?

Mandatory framework: Large frontier developers must establish, implement, comply with and publicly publish a Frontier AI Framework that:

Describes how the developer incorporates national and international standards and industry best practices.
Defines and assesses catastrophic risk thresholds.
Applies mitigation measures to address potential catastrophic risks.
Reviews risk assessments and mitigations before deployment and significant internal use.
Uses third-party evaluators.
Updates and maintains its framework over time.
Protects unreleased model weights through cybersecurity controls.
Identifies and responds to critical safety incidents.
Implements internal governance processes.
Assesses catastrophic risks arising from internal use of frontier models, including risks associated with models circumventing oversight mechanisms.

Transparency report: Before deploying a new frontier model, or a substantially modified version of an existing model, a frontier developer must publish, among other things, the model’s release date, supported languages, output modalities, intended uses, applicable use restrictions and contact information for the developer.

Large frontier developers must also disclose summaries of catastrophic risk assessments, assessment results, involvement of third-party evaluators and other measures taken to comply with their Frontier AI Framework.

Developers may satisfy many of these disclosure requirements through existing system cards or model cards.

Ongoing reporting to regulators: Large frontier developers must provide the Illinois Emergency Management Agency and Office of Homeland Security (Agency) every three months (or on another reasonable schedule) with summaries of assessments regarding catastrophic risks arising from internal use of frontier models.

In addition, frontier developers must report any “critical safety incident” to the Agency and the Illinois attorney general within 72 hours after learning facts sufficient to establish a reasonable belief that such an incident has occurred, or within 24 hours to an appropriate authority where the incident “poses an imminent risk of death or serious physical injury.”

Independent audits: Developers must annually retain an independent third party to audit compliance with AISMA, which:

Evaluates whether the developer has substantially complied with AISMA.
Assesses the developer’s internal controls and governance processes.
Identifies any material deviations from statutory requirements.
Provides recommendations for improvement where appropriate.

Auditors must possess appropriate expertise, operate free from specified conflicts of interest and conduct their reviews in accordance with generally accepted auditing standards and best practices.

Within 30 days of receiving the report, the developer must publish a high-level summary of the audit findings, publish a redacted version of the audit report and provide the audit report to the Agency and the Illinois attorney general.

III. Illinois compared with California and New York

What do all three state laws have in common?

Illinois joins a growing number of states seeking to regulate the development and deployment of frontier AI models. Before Illinois enacted AISMA, both California and New York had enacted regulatory frameworks for frontier model developers. Although the details differ, California’s TFAIA and New York’s RAISE Act impose a common set of obligations, including AI framework requirements, transparency and reporting obligations, catastrophic risk assessments, critical safety incident reporting and enforcement by the state attorney general. Together, these laws reflect a broader trend toward requiring frontier model developers to document and disclose how they identify, assess and manage catastrophic AI risks.

Like California’s law, AISMA includes whistleblower protections and internal reporting mechanisms intended to surface AI safety concerns before they develop into critical incidents.

Like New York’s law, AISMA requires large frontier developers to make registration-style disclosures, identify responsible contacts and pay assessments supporting administration of the regulatory regime.

What ultimately sets Illinois’ law apart?

Against this shared backdrop, what distinguishes Illinois from both states is its audit requirement. Neither California’s TFAIA nor New York’s RAISE Act require covered developers to undergo independent audits of their compliance programs. Illinois moves beyond transparency toward independent auditing. The statute reflects the view that AI governance programs should not only be self-reported, but also undergo external verification.

IV. AI audits in the global context

Although Illinois is the first US state to require annual independent audits of frontier model developers, the concept of independent review and ongoing audits is not unique to AISMA. Similar themes are increasingly appearing in AI regulatory frameworks around the world. For example:

EU AI Act: Providers of certain high-risk AI systems must satisfy conformity assessment requirements and maintain technical documentation, risk management procedures and post-market monitoring processes – reflecting a similar push for documented and verifiable compliance measures.
EU Digital Services Act (DSA): Very large online platforms and search engines must conduct systemic risk assessments and undergo independent audits. Though not AI-specific, the DSA reflects the same regulatory shift toward requiring organizations to demonstrate governance effectiveness through independent, external review.
Vietnam’s AI law: Vietnam’s AI law takes a risk-based framework tied to particular AI systems based on their risk classification. High-risk AI systems must undergo conformity assessments, audits and independent testing before deployment and following significant changes. Medium- and low-risk systems are subject to key obligations, such as transparency and incident reporting. Both the Illinois and Vietnam frameworks reflect a similar underlying interest in independent review of AI systems.

Taken together, AISMA’s audit requirement may be less of an outlier than it initially appears. Instead, it represents a growing trend toward companies not only maintaining governance programs, but also programmatically demonstrating that those programs are operating effectively.

V. How AI audits differ from audits clients already know – and why that matters

Most companies are already familiar with financial, cybersecurity and privacy audits. While there are some common elements, AI audits are different in several important ways.

Unlike traditional compliance exercises, AI audits require organizations to evaluate and substantiate complex judgments regarding:

Evaluating and substantiating judgments about model safety and catastrophic risks.
Assessing internal governance processes and deployment decisions.
Demonstrating and verifying the actual effectiveness of risk mitigation measures.

This expanded evaluation scope creates both strategic advantages and potential legal vulnerabilities for frontier developers.

Opportunities include:

Independent audits can help organizations concretely demonstrate compliance with evolving AI governance and regulatory obligations – mitigating the risk of regulatory inquiries.
External verification increases confidence in model safety and security among regulators, customers, investors and the public.
Rigorous audits can identify weaknesses in internal risk management programs before they escalate into enforcement or litigation issues.

Risks include:

Audit reports may inadvertently become roadmaps for regulators by exposing governance deficiencies, unresolved risks or gaps between documented policies and actual practices.
Although these audits can improve governance, the findings may also become relevant evidence in regulatory investigations, enforcement actions or litigation.

VI. Practical steps companies should consider now

Although AISMA’s audit requirement does not take effect until January 1, 2028, or 90 days after an organization first qualifies as a large frontier developer, companies should begin their preparations well before the first audit cycle arrives.

Frontier labs looking to prepare for the audit should consider:

Assessing whether current or anticipated AI development activities could trigger audit requirements.
Building and operationalizing audit-ready governance structures, which can take a long time to design and launch.
Reviewing documentation practices with a view to maintaining consistent model evaluations, safety testing, risk assessments and incident response records.
Reviewing the role of legal privilege in audit processes.

While independent third-party audits represent a new frontier for AI regulation, navigating first-of-their-kind statutory audit frameworks is not new territory for Cooley. Combining market-leading AI legal acumen with proven, practical experience guiding clients through novel external audit regimes around the globe, Cooley serves as a trusted strategic advisor to technology companies on their most complex digital regulation challenges.

Navigating the SFC’s Operational Rulebook on Listed Closed-Ended Alternative Asset Funds

Tue, 07 Jul 2026 14:27:14 Z

On June 30, 2026, the Securities and Futures Commission (SFC) published Frequently Asked Questions on Listed Closed-ended Alternative Asset Funds (FAQs), accompanied by the Takeovers Executive’s Practice Note 28 (PN 28). Together, these instruments signal a shift of regulatory focus from the gating criteria of the February 2025 Circular – which established the baseline eligibility framework for listed closed-ended alternative asset funds (LAFs) – to the day-to-day operational requirements that govern LAFs after listing. For alternative asset managers, accessing Hong Kong’s retail capital markets via an LAF entails public company governance obligations, robust investor protection safeguards and exit rights enforceable by investors.

This alert provides a practical operational roadmap for alternative asset managers, cross-referencing the Code on Unit Trusts and Mutual Funds (UT Code), the Main Board Listing Rules (MBLRs), the Codes on Takeovers and Mergers and Share Buy-backs (Codes) and the Overarching Principles (OAP).

1. Structural thresholds

1.1 Segregation of liquidity profiles

The SFC enforces a strict alignment of liquidity profiles within umbrella entities. To prevent systemic cross-contamination, the SFC prohibits comingling LAFs with open-ended unlisted funds or conventional exchange-traded funds (ETFs) under a single umbrella. Open-ended structures require liquid portfolios to meet periodic redemptions, whereas LAFs warehouse private, illiquid alternative assets.

However, multi-strategy managers can establish multiple LAFs under a single, dedicated LAF umbrella, provided all sub-funds are closed-ended (e.g., separate sub-funds for private equity buyouts, private credit and infrastructure debt). This provides commercial economies of scale by consolidating establishment costs and regulatory filings on the Stock Exchange of Hong Kong (SEHK), subject to a case-by-case demonstration of robust asset and liability ring-fencing.

1.2 Master-feeder integration

International asset managers can deploy master-feeder architectures to channel Asian retail and institutional capital into established offshore master funds (e.g., in the Cayman Islands, Delaware or Luxembourg), enabling fund managers to list a Hong Kong feeder into an existing flagship strategy.

The master fund must be acceptable to the SFC. Principles and rules under the UT Code and the Circular on streamlined requirements for eligible exchange-traded funds adopting a master-feeder structure will generally be applicable to the feeder fund structure.
The listed Hong Kong feeder fund must mathematically align its investment restrictions, borrowing limits and valuation methodologies with the SFC retail product standards.
Managers must ensure feeder investors receive proportionate voting and economic rights equivalent to direct master fund investors, mitigating structural subordination.

1.3 Capital deployment window

Unlike institutional “blind pools” with multi-year capital calls, LAFs raise capital upfront via an initial public offering (IPO). To mitigate early-stage uninvested capital drag, the SFC permits an operational ramp-up period:

The investment period to build out the portfolio must generally not exceed one year from the IPO.
Uninvested capital during this 12-month window may be held in cash, cash equivalents or highly liquid money market instruments.
Sponsors must explicitly disclose the deployment timeline and interim cash-management strategy in offering documents (pre-listing assets must be disclosed as well), balancing rapid deployment against their fiduciary duty of rigorous due diligence under OAP General Principle 6 (diligence).

2. The governance mandate

Because LAFs are listed and available to retail investors, the SFC mandates a governance architecture that mirrors Chapter 3 of the MBLRs. These provisions must be hardwired into the LAF’s constitutive documents (trust deed, articles of incorporation or limited partnership agreement).

2.1 Board composition and independent oversight

The SFC requires independent oversight to police subjective valuations of illiquid assets and connected transactions. Constitutive documents must stipulate that at least one-third of the board (with an absolute minimum of three) are independent nonexecutive directors (INEDs). The structural application depends on the legal form:

Corporate LAFs: The requirement applies directly at the fund board level.
Noncorporate LAFs (e.g., unit trusts): The requirement is pushed upward to the board of the management company. This requires global managers to reconstitute the boards of their private Hong Kong management subsidiaries to include at least three INEDs.
Audit committee: An audit committee matching MBLRs standards must be established at the fund level (corporate) or management company level (unit trust) to scrutinize financial reporting, risk management and Level 3 asset valuations.

2.2 Enhanced unitholder rights

Departing from manager-friendly offshore private equity terms, the FAQs empower retail unitholders by enhancing minority control:

Requisition of meetings: Minority holders with a maximum threshold of 10% of voting rights can convene an extraordinary general meeting (EGM) and add resolutions.
Removal of management company: Can be achieved via an ordinary resolution. Crucially, the manager and its associates can vote their own units and count toward the quorum, allowing sponsors with significant co-investment stakes to defend against hostile removals.
Replacement manager and auditor: Appointing a replacement manager requires SFC’s prior approval and an ordinary unitholder resolution. Removing an auditor also requires an ordinary resolution, preventing managers from unilaterally dismissing auditors over valuation disputes.
Proxy mechanics: Constitutive documents must expressly entitle the Hong Kong Securities Clearing Company to appoint proxies, ensuring beneficial owners holding units through the Central Clearing and Settlement System can vote.

2.3 Contractual replication of SFO Part XV disclosures

To maintain market transparency regarding concentrated ownership, LAFs must replicate the substantial shareholder disclosure regime. For corporate LAFs, Part XV of the Securities and Futures Ordinance (SFO) applies statutorily. For noncorporate unit trusts, the trust deed must contractually replicate Part XV, forcing unitholders crossing the 5% ownership threshold to notify the manager and the SEHK. This identifies potential concert parties and alerts the market to hostile takeover threats.

3. Takeovers, mergers and application of Practice Note 28

To prevent regulatory arbitrage stemming from the fact that unit trusts and partnerships fall outside the strict statutory definition of a “company” under the Codes, the SFC mandates that constitutive documents for all LAFs must explicitly bind the fund, its managers and its investors to the Codes.

3.1 The REIT analogy under PN 28

PN 28 establishes that because LAFs share governance and yield-focused profiles with real estate investment trusts (REITs), the Takeovers Executive will treat them equivalently:

The 30% mandatory general offer (MGO) trigger: If an investor or concert party accumulates 30% or more of an LAF’s voting rights, they must launch a mandatory general offer to all unitholders at the highest price paid in the preceding six months.
Concert party aggregation: The Takeovers Executive will scrutinize relationships between parallel funds managed by the same sponsor to determine if their holdings must be aggregated against the 30% threshold.
Frustrating actions: Under Rule 4 of the Codes, once a bona fide offer is communicated, the management company is strictly prohibited from taking frustrating actions (e.g., issuing units or selling material assets) without unitholder approval.

This framework protects retail investors from creeping takeovers while restricting activist hedge funds from aggressively buying out discounts to net asset value (NAV) without triggering a public offer.

4. Share buyback mechanics

Closed-ended alternative funds routinely trade at a discount to NAV due to the illiquidity premium of their underlying assets. Share buybacks are indispensable tools to support secondary market prices, and the FAQs integrate the UT Code requirements with MBLRs Rule 10.06.

4.1 On-market versus off-market execution

On-market execution: Independent unitholders may grant the management company a specific approval or general mandate by ordinary resolution, permitting on-market buybacks up to a cap of 10% of total issued units/shares (excluding treasury shares) per financial year, enabling tactical interventions when the NAV discount widens.
Off-market execution: These require specific unitholder approval by independent holders. Where the buyback targets specific holder(s), approval must be by extraordinary resolution; where the buyback is structured as a general offer to all holders, approval may be by ordinary resolution. Both mechanisms mitigate the risk of related-party bailouts.

4.2 The dual-cap pricing mechanism

To safeguard fund assets and protect nonselling investors, repurchases under MBLRs 10.06 are bound by a strict dual-cap pricing mechanism. The purchase price cannot exceed the lower of:

A 5% premium over the average closing price of the units for the five preceding trading days on the SEHK.
The most recently published NAV per unit.

4.3 Pricing limits and manager duties

If an LAF trades at a 30% discount to NAV, the 5% premium cap means the manager executes the buyback at a deep discount to actual asset value. Buybacks at such prices are generally expected to be accretive to the NAV of remaining long-term holders.

Managers must execute a rigorous fiduciary assessment prior to any buyback, ensuring that the intervention will not impair working capital, breach the 30% borrowing limit or force a fire sale of illiquid assets.

5. Pre-listing asset injections, valuations and connected transactions

Valuing private equity, private credit or unlisted infrastructure relies heavily on subjective, Level 3 discounted cash flow models. The FAQs impose precautions against valuation conflicts.

5.1 Pre-listing asset injections and due diligence

When a sponsor seeds an LAF with assets transferred from its proprietary balance sheet, the valuation must be transparently disclosed in the offering documents and included in the audited financial statements.

If the listing agent assumes the dual role of sponsor, it is legally accountable for conducting independent due diligence on these underlying valuations.
The management company must establish and document valuation policies and processes, which should be subject to the oversight of the audit committee of the LAF.

5.2 Connected transactions (MBLRs Chapter 14A)

Asset transactions between an LAF and its management company, investment delegates or connected persons trigger compliance with the UT Code and the Fund Manager Code of Conduct, including the arm’s length and best interests requirements under 10.11 of the UT Code. Beyond OAP General Principle 4, which mandates that providers avoid conflicts of interest, the SFC may also, on a case-by-case basis with reference to MBLRs Chapter 14A, impose additional requirements tailored to the specific transaction. By way of illustration, such additional requirements may include:

Formal review and approval by the INEDs.
A detailed shareholder circular and/or an independent financial adviser’s fairness opinion.
Affirmative approval from independent unitholders at a general meeting; where applicable, the connected sponsor may be required to abstain from voting.

5.3 Co-investment and allocation policies

Where managers concurrently run parallel commingled funds or separately managed accounts, they must implement documented allocation measures. The LAF’s offering documents must outline the precise methodology used to distribute limited capacity private market opportunities (e.g., pro rata based on uncalled capital). Strict adherence to this policy must be disclosed annually in the fund’s audited report to ensure retail vehicles are not systematically disadvantaged in favor of institutional offshore flagship funds.

6. Investor exit rights and winding-up mechanics

A structural vulnerability of listed closed-ended funds is the NAV discount trap: When secondary market prices trade at a sustained and severe discount to underlying asset value, investors lacking a direct redemption mechanism are effectively locked in. The experience of an earlier-generation-listed, closed-ended vehicle in Hong Kong demonstrated this vulnerability. Where a fund held cross-border assets subject to foreign exchange controls or regulatory approval requirements, investor exit was further constrained because the orderly repatriation of underlying assets could not be guaranteed. The absence of a functioning market maker compounded the discount, and investors had no contractual mechanism to demand liquidation. The FAQs’ exit provisions are a direct regulatory response to these observed pathologies.

6.1 Unitholder-initiated voluntary winding up

Q&A 5(k) of the FAQs introduces a mandatory exit mechanism that fundamentally recalibrates the balance of power between retail investors and fund managers. The constitutive documents of every LAF must empower unitholders to initiate a voluntary winding up, delisting and withdrawal of SFC authorization by extraordinary resolution at any time after one year from the listing date. This right to mandatory withdrawal cannot be contractually disapplied or deferred beyond the initial one-year lock-up period.

Practically, this provision represents a significant departure from the traditional general partner/limited partner dynamic. Unlike institutional private equity where capital is commonly locked for 10 to 12 years without unilateral right of exit, the LAF regime now empowers the investors: If a fund trades at an insurmountable NAV discount, underperforms post-listing or fails to deploy capital efficiently within the mandated window, retail investors hold the right to initiate a voluntary winding up after 12 months, compelling a distribution of the underlying net assets.

6.2 Contested wind-downs and change of control

The legal right to wind up is distinct from the ability to execute a wind-down smoothly. Fund managers and investors should anticipate several friction points:

(a) Phased liquidation timelines. Where the underlying portfolio includes assets subject to regulatory approval prior to repatriation, for instance, assets held under QFII quotas that require tax clearance from PRC authorities, interim distributions may be made from offshore liquid assets while onshore positions remain suspended. This bifurcated realization process can span several months, during which investors receive only partial value and the fund remains in a protracted limited-operation phase.

(b) Regulatory waivers during wind-down. During liquidation, the SFC has demonstrated willingness to grant case-by-case operational relief from ongoing disclosure obligations that have become commercially impractical, including relief from continuous suspension announcements under UT Code 10.7, relief from updating offering circulars and publishing closing NAVs under UT Code 8.11, and permission to consolidate annual reporting with a final termination audit under UT Code 11.6. Managers should engage the SFC proactively at the earliest stage of a wind-down to identify and secure the appropriate waivers.

(c) Cost provisioning. Constitutive documents should require the manager to set aside an appropriate liquidation reserve from fund assets once a termination notice is issued. Failure to adequately discharge liquidation costs (including trustee fees, regulatory filings, tax advisers and asset disposal expenses) can erode the final distribution to unitholders. Where a voluntary winding-up resolution is requisitioned by a minority bloc or coincides with a change-of-control situation, the interaction with the Codes demands careful navigation. Once a bona fide offer for an LAF has been communicated, Rule 4 of the Codes prohibits frustrating actions by the management company without unitholder approval. In a contested wind-down scenario, managers must therefore assess whether any portfolio disposal, asset transfer or restructuring proposed during the liquidation period constitutes a frustrating action, and if so, whether independent unitholder consent is required before proceeding. The overlap between the UT Code wind-up mechanics and the Codes’ offer period restrictions creates a compliance window that must be managed with precision and care.

7. Integration with MPF pension capital

The commercial scalability of the LAF regime is significantly bolstered by the Mandatory Provident Fund Schemes Authority’s (MPFA) recent policy alignment. The MPFA issued guidance indicating a case-by-case willingness to approve “listed PE funds” for Mandatory Provident Fund (MPF) portfolios under Section 8(2)(c) of Schedule 1 to the Mandatory Provident Fund Schemes (General) Regulation.

The MPFA will evaluate whether an LAF maintains acceptable volatility, charges reasonable fees and adheres to core MPF investment restrictions. Inclusion on the MPFA-approved list could provide LAFs with access to long-term retirement capital, subject to case-by-case approval, potentially broadening the investor base beyond the retail segment.

Strategic implications for alternative asset managers

The updated regime is another major step toward the maturation of Hong Kong’s capital liquidity profile. The regulatory intent is unmistakable: to democratize access to private markets while imposing uncompromising, public market governance standards and robust exit mechanisms. For asset managers, the structural implications are profound.

The ability to launch multiple LAFs under a single, segregated umbrella presents an efficient capital-raising mechanism. However, the price of admission to the SEHK is full compliance with public company governance norms. Managers must prepare for board structures dominated by INEDs (even within private management subsidiaries running unit trusts), rigorous scrutiny of pre-listing asset valuations by listing agents, and the right of minority unitholders to requisition EGMs and, after one year from listing, to initiate a voluntary winding up.

Furthermore, navigating the Codes under PN 28 requires meticulous ownership monitoring. Sponsors must track concert party aggregations relentlessly to avoid inadvertently triggering a 30% MGO, while simultaneously utilizing MBLRs 10.06 buyback mechanics to surgically manage NAV discounts.

Ultimately, the success of the LAF regime will depend on how effectively managers can deploy capital within the mandated one-year window, how transparently they navigate connected transactions and whether they can actively manage secondary market liquidity to avoid structural traps. The regulatory architecture provides a rigorous pathway for alternative fund formation in Asia. The onus now shifts to the market to execute within these boundaries.

Abivax Announces Closing of Upsized $920 Million Public Offering

Mon, 06 Jul 2026 20:30:11 Z

New York – July 6, 2026

Cooley advised Abivax SA (Euronext Paris: FR0012333284 – ABVX, Nasdaq: ABVX), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, on its underwritten public offering of 7,360,000 American Depositary Shares (ADSs), each representing one ordinary share, €0.01 nominal value per share, of the company, at a public offering price of $125.00 per ADS. The aggregate gross proceeds from the offering were $920 million (€807.4 million), before deducting underwriting commissions and other offering expenses payable by the company, and includes the full exercise of the underwriters’ option to purchase additional 960,000 ADSs.

Lawyers Div Gupta, Minkyu Park, Ryan Sansom, David Brinton, Melanie Simon-Giblin, Camille Awono and Chelsea Braun led the Cooley team advising Abivax. The team also included debt finance lawyers Mischi a Marca, Jason Savich, Timothy Nguyen, Yoni Horn and Stevie Yu; tax lawyers Timothy Shapiro, Xander Lee, Calvin Lee and Rick Jantz; life sciences and healthcare regulatory lawyer Natasha Leskovsek; and cybersecurity lawyer Randy Sabett. Francis Wheeler provided opinion committee review.

Cooley previously advised Abivax on its $700+ million follow-on offering in July 2025 and on its $235.8 million initial public offering in October 2023.

'Forensics First' Approach Gains Ground in US Trade Secret Litigation

Mon, 06 Jul 2026 20:17:59 Z

Cooley attorney Michael Berkovits was quoted in a MLex article about a draft report issued by a Sedona Conference working group on forensic issues in trade secret disputes. Berkovits noted that early digital forensic investigations can help both plaintiffs and defendants assess the key facts of a case, support early resolution efforts and develop litigation strategy, adding that some judges are skeptical of trade secret misappropriation allegations that are not supported by digital forensic evidence.

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US Clean Power Prices Set To Soar as AI Demand Coincides With Subsidy Cuts

Mon, 06 Jul 2026 17:33:10 Z

Mona Dajani, partner and co-chair of Cooley’s infrastructure, energy and real estate practice, was quoted in Financial Times about the increase in green energy costs due to the underlying fundamental changes in interconnection, transformers, permitting and capital costs.

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Blockbuster IPOs Bolster Capital Markets in First Half

Mon, 06 Jul 2026 17:26:05 Z

David Peinsipp, partner and co-chair of Cooley’s global capital markets practice, was quoted in Law360 on the momentum and excitement by the top five initial public offerings (IPOs) in the first half of 2026 and whether it will continue through the end of the year.

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FCC Proposes Expansive E-Rate Program Review

Mon, 06 Jul 2026 13:55:00 Z

The Federal Communications Commission (FCC) adopted a Notice of Proposed Rulemaking and Further Notice of Proposed Rulemaking on June 25 on how it can ensure E-Rate-funded services are advancing educational outcomes. The FCC proposes to narrow the scope of services and equipment eligible for E-Rate support and to adopt new rules aimed at protecting children online and providing oversight of third-party consultants.

Evaluating E-Rate Program success

The FCC seeks input from interested parties on whether and to what extent the E-Rate Program has fulfilled its mission to ensure that schools and libraries in the United States “have access to advanced telecommunications services.” Citing the increase in broadband connectivity across schools nationwide, the FCC seeks comment on whether continued support for special construction of networks and managed internal broadband services is necessary. The FCC is also considering reducing support for internet access.

The FCC uses the National School Lunch Program eligibility and urban/rural status to determine an applicant’s discount rate. The FCC seeks comment on whether this is still an appropriate method for calculating support and whether it should limit E-Rate support to areas where applicants face the highest costs for E-Rate-supported services. In practical terms, such a change likely would reduce funding to suburban and urban areas and could direct more funding to rural areas. It also seeks comment on whether continued support for self-provisioned network construction and dark fiber is necessary, given private investment and other federal infrastructure funding programs, such as the Broadband Equity, Access, and Deployment (BEAD) program.

Children’s safe use of E-Rate-funded services

Under E-Rate Program rules, applicants must certify that the services requested through the program will be used primarily for educational purposes. The FCC seeks comment on how it can ensure that E-Rate-funded networks and services are being utilized for these purposes, and also requests input on the measures schools and libraries are taking to limit screen time.

Reexamining CIPA

The FCC currently interprets the Children’s Internet Protection Act (CIPA) restrictions to apply only to the use of devices owned by schools or libraries receiving E-Rate support for internet access, internet service or internal connections. The FCC seeks comment on this interpretation. The FCC also seeks comment on whether social networking sites are “harmful to minors” under CIPA and whether the FCC can impose additional protections to limit screen time.

Strengthening oversight of consultants and consulting firms

Consultants and consulting firms support E-Rate Program applicants across all phases of the program, including assisting with the submission of FCC Form 471 applications, responses to program integrity assurance review and audit inquiries. The FCC seeks to prevent the potential for fraud due to consultants’ influence on the competitive bidding process and lack of direct oversight by the Universal Service Administrative Company or the FCC.

Defining ‘consultant’

The FCC proposes defining a “consultant” as “any non-employee working on behalf of a school, library, consortium that includes an eligible school or library, or service provider that participates in or is seeking to participate in the E-Rate program and who assists the school, library, consortium that includes an eligible school or library, or service provider, whether or not for a fee, with any aspect of participating in the E-Rate program, including, but not limited to, the application, competitive bidding, or disbursement processes.”

The FCC seeks comment on whether the proposed definition should exclude certain individuals, such as certain nonemployees working on behalf of service providers in the ordinary course of their commercial relationship (e.g., channel partners, resellers, agents, authorized dealers). It also asks for comment on whether there is anything unique about the service provider-channel partner relationship and how channel partners are compensated that warrants excluding them from the definition.

Consultant certification and registration

The FCC proposes requiring service providers to submit an annual consultant certification and disclosure form and establishing a consultant registration database for individual consultants. The certification would require consultants to certify compliance with E-Rate Program rules.

Prohibiting percentage-based fee arrangements

The FCC is concerned that fees based on a percentage of money received under E-Rate may be contrary to the efficient use of limited funding and create incentives for consultants to encourage applicants to request more E-Rate funding than needed. The FCC proposes, and seeks comment on, strict prohibition on applicants and service providers from entering into any fee arrangement based on a percentage of the E-Rate contracts with and/or disbursements to the applicant or service provider the consultant represents.

Lowest corresponding price (LCP)

The LCP rule requires service providers to offer equipment and services to E-Rate eligible schools and libraries at prices less than or no higher than the lowest price the service provider charges similarly situated nonresidential customers for the same or similar equipment or services. The FCC seeks to clarify the scope and meaning of the rule and invites comment on whether it should modify the E-Rate rules to deter violations of the LCP rule.

For more information on the proposed rules and the potential impact, please reach out to one of the Cooley lawyers listed below.

Show Me the Money (or the Wage Range): New State Pay Transparency Laws

Mon, 06 Jul 2026 07:00:00 Z

Several states recently enacted new pay transparency laws imposing salary history bans, wage range disclosures, recordkeeping and other obligations on employers. Below is a summary of key provisions in Virginia, Maine, Connecticut and Delaware, along with recommended compliance steps.

Virginia: Salary history ban, wage range disclosure and private right of action

Effective July 1, 2026, Virginia employers must disclose the wage or salary range in all public and internal job postings (including promotions and transfers). Notably, the law has no minimum employee threshold and broadly applies to “employers,” defined in the state Labor Code as any entity “doing business in or operating within this Commonwealth who employs another to work for wages, salaries, or on commission.”

The range (minimum and maximum wage or salary for the position) must be set in good faith by reference to applicable pay scales, prior ranges, equivalent-position salaries or the budgeted amount. The range’s breadth is relevant to whether it has been set in good faith. In addition, employers are also prohibited from seeking or relying on an applicant’s wage or salary history, except where voluntarily disclosed, in which case the employer may use it only to support a higher offer consistent with federal and state equal pay laws. Unlike some other pay transparency laws, the law does not require a description of benefits in postings. It is unclear whether the law’s pay disclosure requirements cover remote positions that could be performed in Virginia or only positions physically performed in Virginia.

The law provides for attorney general enforcement and a private right of action. For attorney general enforcement, employers may face civil penalties of up to $1,000 for a first violation and up to $5,000 for subsequent violations, plus legal and equitable relief. For the private right of action, an aggrieved individual must sue within one year. In this case, for posting or good-faith range violations, the individual must first give the employer a 15-business-day written cure period; if the employer corrects the posting, no action may be brought. A written notice received from any person relating to a particular posting constitutes adequate notice for the duration of such posting. Employees may recover actual damages, plus legal and equitable relief.

Maine: Wage range disclosure and recordkeeping

Effective July 29, 2026, Maine employers with 10 or more employees must include the prospective pay range in all job postings, whether made directly or through a third party. Commission-only positions, however, need not include the range, but must indicate that the position is commission-only. The “range of pay” means the range the employer anticipates relying on when setting wages, determined by reference to:

Any applicable pay scale.
Previously determined range of wages for the position.
Actual range of wages for those currently holding equivalent positions.
The budgeted amount for the position.

Upon request, employers must also disclose to current employees the pay range for their position. Employers must maintain records of each position and the employee’s pay history for the duration of employment and three years after termination. The Maine Department of Labor will enforce the law.

Connecticut: Existing obligations expanded to include upfront wage ranges and benefits

Effective October 1, 2026, Connecticut’s HB 5003 expands existing pay transparency requirements, which currently only require disclosure of wage ranges in certain circumstances. Under HB 5003, which broadly applies to all employers regardless of size, employers must now include the wage or wage range and a general description of benefits in all internal and public job advertisements. The “wage range” must be set in good faith and may include references to any applicable pay scale or previously determined range for the position. “Benefits” include health insurance, retirement benefits, fringe benefits, paid leave and any other compensation other than wages offered with the position. HB 5003 also clarifies that the law covers positions performed in Connecticut and positions where the employee works outside the state but reports “directly to a supervisor, office or other worksite located within the state.”

Existing disclosure requirements for applicants and employees have also been expanded. For applicants, if the position has not been advertised, employers must provide the wage range and general description of benefits upon the earlier of the applicant’s request, or before any discussion of compensation or offer is made. For employees, employers must provide the wage range and benefits information upon hire, upon a change in position or upon the employee’s first request.

The law also expands anti-retaliation protections to cover refusal to interview, hire, promote or retain employees who exercise their rights under the law. Private actions must be brought within two years, and punitive damages are no longer recoverable in such actions.

Delaware: Wage range disclosure and recordkeeping

Effective September 26, 2027, Delaware employers with more than 25 employees must disclose the hourly or salary compensation or hourly or salary compensation range and a general description of benefits and other compensation applicable to the position in all internal and external job postings. The range must reflect the minimum to maximum pay for the position, set in good faith by reference to any applicable pay scale, previously determined range, equivalent-position salaries or the budgeted amount. The breadth of the disclosed range is a factor in assessing good-faith compliance. The law covers jobs located in Delaware and noninternational remote positions offered by Delaware-based employers. Notably, the law does not clarify whether the 25-employee threshold includes only Delaware-based employees or also those located outside the state.

Commission-based roles must disclose that fact but are not required to include a wage range, while tipped roles must disclose that fact and the base wage or range. If a posting was not made available to an applicant, the employer must provide the range and benefits description before any offer or compensation discussion and at any time at the applicant’s request. Temporary or immediate-hire positions are exempt from wage range disclosure obligations, with the Department of Labor tasked with promulgating regulations for these job opportunities necessitating immediate hire. Employers must retain job descriptions and salary history for each employee for at least three years. Employers are not liable for job postings that are digitally replicated or reposted by third parties without their consent. The Department of Labor will enforce the law. For a first offense, employers will receive a written warning; subsequent offenses carry civil penalties of $500 to $10,000 per violation.

Next steps

Employers operating in Virginia, Maine, Connecticut and Delaware should take the following steps to ensure compliance:

Audit job postings. Confirm that all postings for covered jurisdictions include good-faith compensation ranges and, where required, benefits descriptions.
Update salary history practices. If not done already, eliminate wage history inquiries from applications, interview protocols and recruiter instructions, and train hiring managers accordingly.
Establish recordkeeping protocols. Maintain job descriptions, compensation ranges and employee pay histories for the required retention periods.
Map jurisdictional coverage. Identify which positions are covered under each state’s law, with careful attention to remote work positions.
Strengthen anti-retaliation compliance. Where applicable, train managers and supervisors on the anti-retaliation protections under each law, including prohibited conduct, such as refusing to interview, hire, promote or retain employees who exercise their rights.
Monitor guidance and implementing regulations. Several of the new laws leave important implementation questions unanswered, and agency rulemaking or regulatory guidance may provide further clarity. Employers should track developments as new guidance emerges.
Monitor pay data reporting developments. The Equal Employment Opportunity Commission (EEOC) recently proposed eliminating EEO-1 Component 1 pay data reporting, which may prompt states and localities to enact their own workforce data collection requirements, and some already have. For example, Massachusetts’ pay transparency law requires employers required to file EEO-1 reports with the EEOC to also submit those reports to the state annually, and New York City recently enacted a multistage pay data reporting and pay equity study law, which will require large employers to report pay data to a designated city agency. Other jurisdictions, including Colorado, have enacted or proposed similar measures. Employers with multistate operations should monitor this evolving landscape closely and build state-level reporting compliance into their broader pay equity programs.

If you have questions about pay transparency laws or are interested in conducting a privileged pay equity audit, please contact the Cooley employment team.

The Sedona Conference Commentary on Forensic Issues in Trade Secret Disputes (Public Comment Version)

Thu, 02 Jul 2026 20:33:42 Z

Cooley special counsel Michael Berkovits co-wrote an article for The Sedona Conference on the applications of digital forensics in trade secret disputes, featuring a sample forensic inspection protocol agreement designed to serve as a point of first reference in any pre-litigation or litigated dispute involving computer forensics.

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Cooley Maintains Top Rankings in Global M&A and Private Equity

Wed, 01 Jul 2026 14:01:53 Z

Cooley’s global mergers and acquisitions and private equity practices were again recognized for top ranking positions in Q2 2026 league tables from Bloomberg.* Despite the unpredictable market, Cooley continues to dominate in public and private deals around the world.

Top rankings by deal count include:

#1 for US and global life sciences M&A
#1 for US and global tech M&A
#3 for US and global M&A
#1 for US mid-market M&A
#2 for global mid-market M&A
#1 for US and global private equity deals

In 2026, Cooley handled transactions across a range of industries while also maintaining its top position in technology and life sciences. The firm’s market-leading transactions include:

Since 2021, Cooley’s world-class transactional team has worked on 1,600+ M&A deals for an aggregate value of more than $750 billion – guiding top public and private companies, financial advisors and private equity sponsors in some of the market’s largest and most complex transactions. The firm’s M&A and PE groups include 180+ practitioners in major business and technology centers worldwide, representing all categories of participants in transactions.

* The Bloomberg platform data has not been published by Bloomberg.

Small State, Big Bite: What Sets Vermont’s New Privacy Law Apart

Tue, 30 Jun 2026 20:32:00 Z

Vermont became the 23rd state to enact a comprehensive consumer privacy law with the Vermont Data Privacy and Online Surveillance Act (VDPOSA), which was signed into law on June 16, 2026. At a high level, the VDPOSA takes the now-familiar US state law approach of a controller/processor framework with consumer rights. But it also includes a number of more expansive and distinctive provisions – such as low applicability thresholds for sensitive data and stand-alone provisions for consumer health data – that put it alongside Connecticut at the more aggressive end of the state consumer privacy law spectrum. As a result, despite Vermont’s small size, companies may need to reevaluate and update their multistate privacy compliance programs to account for these new requirements from the Green Mountain State.

Below, we describe key features of the VDPOSA and what companies should do to evaluate and update their compliance status before the law takes effect on January 1, 2028.

Low applicability thresholds

The VDPOSA’s general applicability thresholds encompass companies that:

Control or process personal data for at least 35,000 Vermont residents.
Control or process sensitive data for at least 3,000 Vermont residents.
Offer for sale in trade or commerce personal data of at least 3,000 Vermont residents.

The regular personal data threshold of 35,000 residents is not particularly low relative to Vermont’s population. However, the VDPOSA’s thresholds for sensitive data and sales of personal data are more aggressive than similar laws in most other states. Vermont does not go as far as Connecticut, whose similar thresholds are triggered by processing any amount of sensitive data or selling any amount of personal data, but its thresholds of 3,000 are still quite low. As a result, they could easily ensnare companies that are handling sensitive data or selling personal data at any sort of scale, particularly given the law’s broad definitions of “sensitive data” and “sale.”

Consumer health data

The VDPOSA also includes consumer health data protections that only a few other states – such as Connecticut via its consumer privacy law, Washington via its stand-alone My Health My Data Act and Nevada’s similar law – have enacted laws to protect. Companies that handle any amount of consumer health data must meet the law’s provisions related to such data, regardless of whether they meet the general VDPOSA thresholds discussed above.

The law’s requirements for consumer health data include requiring an affirmative opt-in consent before selling, or offering to sell, consumer health data and prohibiting geo-fencing within 1,850 feet of any healthcare facility (for the purpose of identifying, tracking, collecting data from or sending any notification to consumers regarding their health data). The VDPOSA also requires a company’s employees and contractors to be subject to a contractual or statutory duty of confidentiality before accessing consumer health data. Companies processing consumer health data must ensure that they comply with these requirements, which may also require updating existing applicable contracts to include a contractual duty of confidentiality.

Due to the VDPOSA’s broad definition of consumer health data, and the relevant obligations being triggered if a company handles any amount of consumer health data, companies could easily become subject to these requirements, even if they do not think of themselves as a healthcare-related business.

Expansion of sensitive data and additional obligations

As referenced above, the VDPOSA’s definition of sensitive data is, like Connecticut’s, one of the broadest among the 23 state consumer privacy laws. For example, Vermont includes financial account numbers with login credentials and certain government-issued identification numbers as sensitive data. Vermont also – similar to California, Colorado and Connecticut – treats neural data as a type of sensitive data, albeit limiting it only to data generated by the central nervous system, instead of both the central and peripheral nervous systems. Vermont also follows recent privacy laws’ trend of explicitly including nonbinary or transgender status as sensitive data.

In addition to the VDPOSA being triggered by a company’s control or processing of sensitive data of only 3,000 Vermont residents, handling such sensitive data triggers heightened obligations, including a requirement to obtain affirmative opt-in consent from consumers before processing their sensitive data. Additionally, Vermont requires companies to only process data that is necessary in relation to the purpose they disclose to consumers when they collect their data, and to obtain opt-in consent from consumers before selling any sensitive data.

Companies should assess their sensitive data collection and disclosure practices to ensure that their handling of data elements treated as sensitive data in Vermont complies with the VDPOSA.

Transparency about AI training

Reflecting recent regulatory and legislative concerns about AI, Vermont, like Connecticut, imposes a transparency obligation on companies regarding large language models (LLMs). Companies must include, in their privacy notice, a statement disclosing whether they collect, use or sell personal data for the purpose of training LLMs. For the many companies that leverage personal data in training their AI models, or sell personal data to train LLMs, this obligation will likely require updates to their current privacy disclosures and could generate additional consumer friction.

Broadening the right to access

Vermont has followed the lead of Connecticut and Minnesota in expanding a consumer’s right to access information about a company’s handling of their personal data. Under the VDPOSA, a consumer can obtain a list of third parties to which the company has sold the particular consumer’s personal data – or, if the company does not maintain this list, it must instead provide the consumer with a list of all third parties to which the company sells personal data of consumers generally. Even if companies take the latter, less granular approach that is not specific to the particular consumer making the access request, for many companies preparing to honor such requests is likely to require nontrivial back-end data mapping and other compliance work.

Derived data

Data derived from other information about a consumer is commonly understood to be personal data. However, the VDPOSA goes a step further by including derived data as a stand-alone defined term and explicitly including it as a type of personal data.

Enforcement and cure period

The VDPOSA does not contain a private right of action, so like most other state consumer privacy laws, it will be enforced exclusively by the state attorney general. Similar to some other state laws, Vermont also includes a 60-day cure period for a limited time following the law’s initial rollout – between January 1, 2028, and June 30, 2029 – to help businesses ease into compliance with the VDPOSA.

Interestingly, Vermont’s legislators also included a statement that if additional resources are not provided to the Office of the Attorney General to enforce the VDPOSA, then the General Assembly may consider adding a private right of action. This statement is unique among state consumer privacy laws, and the addition of a private right of action would represent a seismic shift in enforcement and potential exposure for companies. However, it appears unlikely that such a private right of action will make it into law in Vermont, as it would undoubtedly face vociferous opposition from industry.

What should companies do?

Due to Vermont’s relatively aggressive and distinctive provisions for certain types of personal data and activities, companies should work closely with privacy counsel to assess potential exposure under the VDPOSA, as well as similar provisions under Connecticut’s amended consumer privacy law. Relevant steps should include:

Assess whether you are in scope of the VDPOSA. Vermont’s relatively low and distinctive thresholds for certain activities – such as selling personal data or handling sensitive data or consumer health data – will bring many companies within scope of the law. Companies should carefully assess whether they are engaging in such activities, particularly given the broad ways that terms like “sensitive data,” “consumer health data” and “sale” are defined under the VDPOSA.
Revisit your sensitive data and consumer health data practices and obligations. Vermont includes many additional data elements as sensitive data and expands companies’ obligations for handling of sensitive data. It also has separate obligations that trigger if a company handles any amount of consumer health data (which is also defined as a type of sensitive data). These obligations related to specific data types may require additional compliance efforts.
Update privacy notices. Vermont requires companies to disclose in their privacy notice whether any personal data is collected, used or sold for training LLMs. Companies should also review their privacy notice for other updates needed to address the VDPOSA, such as whether their disclosures about their handling of sensitive data are accurate under the VDPOSA’s broad definition of that term.
Track data flows for sales of personal data. Under the VDPOSA, consumers have the right to obtain a list of all third parties to which their personal data is sold, so companies should conduct internal data mapping and similar exercises to ensure that they can fulfill this obligation. Companies also need to understand their personal data sales to assess whether they meet the VDPOSA’s applicability thresholds, one of which triggers if a company sells personal data of at least 3,000 Vermont residents.

LeapXpert Raises $180 Million

Tue, 30 Jun 2026 15:05:00 Z

Colorado – June 30, 2026 – Cooley advised LeapXpert, the leader in governed communication intelligence, on its $180 million growth investment led by Riverwood Capital. LeapXpert will use the proceeds to deepen the platform's ability to understand and act on governed conversations, accelerate growth across financial services, the public sector, and the broader enterprise market, and expand its senior leadership team.

Lawyers Laura Medina, Kester Spindler, Jeffrey Tolin, Ryan Montgomery, Joanna Leung and Hannah Barcus led the Cooley team advising LeapXpert.

Summer Doldrums – or Time to Think About 2027 Executive Compensation Programs?

Tue, 30 Jun 2026 13:23:31 Z

‘Let’s go surfin’ now
Everybody’s learnin’ how
Come on and “comp safari” with me!’

School is out, and vacations are in full force. At the risk of throwing cold water on hot summer fun, one question you nonetheless should be asking yourself now as a professional responsible for executive compensation is, in the fall, what will you wish you had done last summer? Some more surfing? Of course. But that still leaves enough time to get ahead of the compensation curve so that, when November rolls around, you’re well clear of where you need to be (and perhaps even feeling a bit smug) instead of wishing there were just a couple more weeks to prepare.

And so, what does that type of summer reading list look like? The most logical first step probably is to look at your compensation committee meeting checklist and identify those items that would benefit from a head start, even (and perhaps especially) those items that are not fully ripe for some time, which could include things like the following:

Evaluate how in-flight 2026 compensation programs are faring, and, as a result, whether there may be reason to give early thought to changes for the 2027 programs.
Evaluate whether the existing programs are resulting in any unanticipated risks due to changes in economic and geopolitical circumstances since grant.
Evaluate whether new-hire practices remain generally appropriate to avoid undue scrambling at the time of hire.
Evaluate the adequacy of share reserves given dilution projections so that you can start marshaling support for an increase.
Consider whether any additional clawback protections may be appropriate considering your circumstances.
Evaluate the adequacy of compensation governance procedures generally and whether changes should be put in place for the coming compensation season.
Give thought to whether the annual proxy disclosure could benefit from a fundamental refresh, which is a notoriously time-consuming exercise and ill-fitted to a pivot late in the year.
Make sure any annual stockholder outreach is on track and preferably ahead of pace, whether driven by reason of say-on-pay results or otherwise.

Of course, if you don’t already have a compensation committee meeting checklist, one thing that should be near the very top of your summer list is to develop one. And, for companies that do have a checklist, another item for consideration is whether any changes in content or timing are appropriate.

One of the best ways to do that is to find time for an informal meeting with the compensation committee chair to get their views on what is and is not working and what might be best handled differently. Having that meeting when there actually is time for quiet reflection will be most effective and likely also greatly appreciated by the chair.

That also might give rise to discussion about the need for collateral actions that could be scheduled for the fall, such as committee member education sessions about, for example, the status of the proposed executive compensation disclosure rule changes, shifts in market practices and any other noteworthy trends.

In a similar and complementary vein, a reach-out to your compensation consultant (if you have one) to get their views on the foregoing and any other items they see as important to the coming compensation season will better position you to address those matters when the time comes.

Finally, similar considerations to all of the foregoing apply where a compensation committee has been delegated responsibilities that often are lodged with other board committees, such as succession planning and human capital issues generally.

* * *

Sorry to bum you out when all you want to do is surf and then surf some more, but it’s just a word to the wise: A little time found and spent now likely will save you a lot of time later and result in a much smoother process when time is short and you are wishing it were still the dog days of summer.

Cooley’s compensation and benefits group is ready to help you craft an efficient review of the type contemplated here so that you still have plenty of time to rejoice in those summer doldrums. For our friends attending the 2026 Society for Corporate Governance National Conference in Nashville from July 7 to 10, please reach out – we’d love to connect with you!

Cooley Co-Chair Featured in The Economist on Chinese Clean Energy Asset Divestments

Tue, 30 Jun 2026 12:47:48 Z

Mona Dajani, partner and co-chair of Cooley’s infrastructure, energy and real estate practice, was quoted in The Economist discussing how Chinese clean energy companies are forming joint ventures with US partners as part of efforts to comply with the One Big Beautiful Bill Act.

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Cooley Co-Chair Featured in The Economist on Chinese Clean Energy Asset Divestments

Mon, 29 Jun 2026 15:57:52 Z

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What Employers Should Know About Washington’s New Ban on Noncompete Agreements

Mon, 29 Jun 2026 07:00:00 Z

On March 23, 2026, the Evergreen State became the latest state to enact a near wholesale ban on all employment noncompete agreements, effective June 30, 2027. The new law has significant implications for employers – voiding existing agreements retroactively, broadening the definition of what constitutes a now banned noncompete (including certain repayment agreements, such as sign-on or retention bonus agreements) and narrowing permissible nonsolicitation agreements. Below is a summary of the key changes, what remains permissible and steps employers should take to prepare.

The recent history and current landscape of Washington’s noncompete law

Washington’s crackdown on noncompetes began in 2020, when the state imposed restrictions – including a minimum compensation threshold for entering into a noncompete (equal to $126,858.83 as of January 1, 2026); an 18-month noncompete duration limit; a “garden leave” provision requiring employers to pay base salary during enforceable post-layoff periods; a prohibition on adjudication outside Washington or application of choice-of-law principles or substantive law of any jurisdiction other than the state of Washington; and moonlighting and anti-poaching provisions.

Initially, the restrictions applied only to traditional noncompetes and not to:

Confidentiality agreements.
Agreements not to solicit an employee to leave an employer.
Agreements not to solicit a current or former customer of an employer to cease or reduce the extent to which it is doing business with the employer.
Certain restrictions in connection with the sale of a business.

In 2024, the state again expanded its restrictions on noncompete agreements, broadening the definition of noncompetes to include agreements that directly or indirectly prohibit accepting or transacting business with a potential customer, clarifying that the customer nonsolicitation exception applies only to current customers. Further, the amended noncompete law narrowed the sale-of-business exception and required employers to provide notice of a noncompete “no later than the time of the initial oral or written acceptance of the offer.”

Washington’s new near-total ban

In enacting HB 1155, the legislature found that earlier reforms “did not go far enough,” citing that noncompetition covenants “restrict workers’ mobility, impede efforts to correct inequities, and significantly suppress workers’ wages across all sectors.” Washington joins several other states that have banned noncompetes, including California, Minnesota, North Dakota and Oklahoma.

Scope of the prohibition

The new ban voids nearly all noncompetes regardless of an employee’s salary or when an employee entered into the noncompete agreement. Similar to California’s law on noncompetes, Washington’s amended noncompete law defines a noncompete broadly as “every written or oral covenant, agreement, or contract that prohibits or restrains an employee or independent contractor from engaging in a lawful profession, trade, or business of any kind.” As of June 30, 2027, employers are prohibited from entering into, attempting to enter into, enforcing, attempting to enforce or threatening to enforce a noncompete. Employers will also be prohibited from representing that an employee or contractor is subject to a prohibited noncompete covenant (to such employee, contractor or any third party).

Repayment agreements included in prohibition

Following the recent trend on restricting certain repayment agreements (e.g., New York, California), Washington also joins the bandwagon by expanding the definition of a noncompete to also include any agreement that “threatens, demands, requires, or otherwise effectuates that an individual return, repay, or forfeit any right, benefit, or compensation as a consequence of the individual engaging in a lawful profession, trade, or business of any kind.” As a result of this expanded definition, agreements requiring repayment of retention bonuses, advanced payments or similar benefits upon departure may constitute prohibited noncompetes. Employers should review any such repayment agreement or provision to determine whether they fall within this expanded definition.

The law applies retroactively: All existing noncompete agreements, including repayment agreements, are void and unenforceable as of the effective date, regardless of when they were signed. However, legal proceedings filed before the effective date remain governed by the prior version of the law.

Notice requirement

Similar to California’s AB 1076 playbook, which required employers to notify current and former employees that noncompete clauses in their agreements were void, HB 1155 imposes its own notice requirement. By October 1, 2027, employers must make “reasonable efforts” to provide written notice to all current and former employees and contractors with active noncompetes that their agreements are void and unenforceable. The legislative history of HB 1155 does not clarify what constitutes a “reasonable effort” to provide written notice. However, to err on the conservative side, employers may consider providing both physical mail and email notice to current and former employees that any active noncompete clauses in their agreements are void and unenforceable.

Permissible covenants

The following provisions are excluded from the noncompete ban:

Nonsolicitation agreements: Nonsolicitation agreements remain enforceable in limited circumstances. Nonsolicitation of current employees is permissible and includes agreements prohibiting solicitation “of any employee of the employer to leave the employer.” Further, current or prospective customer nonsolicitation provisions are permissible only if they:

Are limited to preventing an employee from shifting business away from the employer where the employee established or substantially developed a direct relationship with the customer or prospective customer “through the employee’s work for the employer.”
Do not exceed 18 months following employment.

Notably, unlike the current law, which prohibits all prospective customer nonsolicitation agreements, HB 1155 appears to now permit them, provided that they meet the foregoing requirements. Importantly, any agreement that directly or indirectly prohibits a worker from accepting or transacting business with a customer is treated as a noncompete – not a nonsolicitation agreement – and is therefore banned.

Confidentiality and trade secret agreements: Agreements that protect confidential information, trade secrets or inventions are not affected by the ban.
Sale of business: Noncompetes entered into in connection with the purchase or sale of the goodwill of a business remain enforceable, but only if the person signing the agreement holds an ownership interest of 1% or more in the business.
Franchise agreements: A noncompete entered into by a franchisee in connection with a franchise sale that complies with applicable franchise law is still permitted.
Educational expense repayment: Employers may still require repayment of out-of-pocket educational expenses, provided the agreement:

Expires within 18 months of the employee’s start date.
Limits repayment to a pro rata portion of the remaining time in that 18-month period.
Releases the employee from the repayment obligation if the employee separates for “good cause,” as defined in the state’s unemployment benefit statute.

Further, the noncompete ban does not affect Washington’s existing moonlighting limitations under RCW 49.62.070, which remain unchanged. Under that provision, employers cannot restrict, restrain or prohibit employees earning less than twice the applicable state minimum wage (or, less than $34.26 an hour as of 2026) from working for another employer, working as an independent contractor or being self-employed. In addition, employers may continue to impose moonlighting restrictions on employees earning at or above that threshold.

Penalties for noncompliance

As before, persons “aggrieved” by a violation of the law have a private right of action. Further, the Washington attorney general may bring enforcement actions on behalf of affected workers. If a court or arbitrator finds a violation, the employer must pay the greater of the worker’s actual damages or a statutory penalty of $5,000, plus reasonable attorneys’ fees, expenses and costs. Notably, liability is triggered even when an employer merely attempts to enforce a noncompete or suggests that one still applies.

Next steps for employers

Because employers must provide written notice to all employees and contractors subject to an active noncompete by October 1, 2027 (regardless of when it was signed), employers should consider updating their practices before the June 30, 2027, effective date.

Employers can take the following steps to prepare for compliance:

Audit all existing agreements. Review all employment and contractor agreements, offer letters and related documents to identify provisions that may qualify as a noncompete under the law’s expanded definition. Beyond just noncompete and certain customer nonsolicitation agreements, this includes stay-or-pay agreements, training repayment agreement provisions (TRAPs) and other repayment obligations that could be construed as prohibited noncompetes.
Plan for mandatory worker notices. By October 1, 2027, employers must make reasonable efforts to notify current and former workers still within the term of a noncompete that those provisions are void. Employers should begin compiling a list of affected individuals, verifying contact information and identifying what “reasonable efforts” they will take to ensure compliance with this notice requirement. Note that this requirement also covers employees or contractors with repayment agreements that qualify as noncompetes under the law.
Evaluate and strengthen alternative protections. As noted, confidentiality and trade secrets agreements are not affected by the ban. Employers should assess whether such agreements, along with narrowly tailored nonsolicitation agreements, provide sufficient protection for the company’s legitimate business interests under the new law. Where insufficient, consult with counsel to strengthen these provisions and/or identify additional lawful strategies to safeguard the company’s interests.
Update templates and policies. Revise all standard employment agreement templates, confidential information and invention assignment agreement templates, restrictive covenant agreement templates, offer letter templates, contractor agreements and repayment agreements to remove or restructure any provisions that will be void under the new law.
Train HR and management. The law prohibits employers from representing to a worker that they are subject to a noncompete or attempting to enter into one. Employers should therefore ensure that HR personnel, managers and recruiters understand these broad prohibitions, as even an informal suggestion of enforceability could expose the company to liability.
Consider enforcement of existing noncompetes/repayment agreements. As noted above, the amended noncompete statute will not apply to legal proceedings commenced before June 30, 2027. Therefore, as such date approaches, employers may consider whether it may be prudent to commence litigation to enforce noncompete agreements (which, as emphasized above, also include repayment agreements) and to otherwise address breaches of any such agreements that have occurred before June 30, 2027.

If you have any questions about these laws or how to comply, please contact your Cooley employment lawyer or one of the lawyers listed below.

Litigator of the Week Runners-Up and Shout-Outs

Fri, 26 Jun 2026 20:20:58 Z

A Cooley team earned a shout out on The American Lawyer’s Litigator of the Week Runners-Up and Shout-Outs list for securing an appellate victory that eliminated a fraud lawsuit against identity verification and fraud prevention client Socure Inc. The New York Appellate Division, First Department overturned a trial court’s decision that allowed a former Socure employee to pursue claims seeking hundreds of millions of dollars after alleging that his shares were fraudulently diluted and that the company misrepresented its value before buying out his remaining equity in 2018. The Court also awarded attorneys' fees and costs to Socure.

The Cooley team was led by partners Tim Cook and Ephraim McDowell, and associates Anna Mohan, Connie Wang, Katelyn Kang and Mikhaila Fogel.

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AI Chatbot’s Medical Claims Draw Regulatory Scrutiny

Fri, 26 Jun 2026 17:46:00 Z

On May 1, 2026, the Pennsylvania State Board of Medicine filed a complaint in the Commonwealth Court of Pennsylvania against Character Technologies, the corporate entity operating the Character.AI generative artificial intelligence platform.¹ The complaint raises immediate questions about state licensing board enforcement, but the regulatory picture it reveals extends further – to US Food and Drug Administration (FDA) oversight and an accelerating wave of state legislation targeting AI in healthcare. Character Technologies also faces a separate lawsuit brought by the Kentucky attorney general, which alleges that the company preys on children and leads them to self-harm.²

Background

The platform and the investigation

Character.AI is a generative AI platform with 20 million+ monthly users that allows users to create chatbot characters with specific personalities. A Pennsylvania Professional Conduct Investigator created an account, searched “psychiatry” and interacted with a character named “Emilie” described as a “Doctor of psychiatry.” Note that the character had approximately 45,500 user interactions as of mid-April, during which “Emilie” claimed to have medical credentials, offered to conduct a psychiatric assessment and represented that it held a valid Pennsylvania medical license, providing a fabricated license number.

Character Technologies does not hold a license to practice medicine in Pennsylvania.

The commonwealth’s case

Pennsylvania asserts that Character Technologies engaged in the unauthorized practice of medicine and surgery.³ The crux of the state’s allegations is that Character Technologies permitted its chatbot to hold itself out as a licensed psychiatrist by claiming a Pennsylvania license, using the title “psychiatrist” and providing a fabricated license number.

Character.AI contests the suit, reasoning that its user-created characters are fictional and intended for entertainment and roleplaying. The company points out that the platform includes in-chat disclaimers stating that characters are not real people and all statements should be treated as fiction, along with additional disclaimers warning users not to rely on characters for professional advice.⁴

Legal issues

State licensing

In Pennsylvania, medicine and surgery is defined as “[t]he art and science of which the objectives are the cure of diseases and the preservation of the health of man, including the practice of the healing art with or without drugs, except healing by spiritual means or prayer.”⁵ Medical doctors, including psychiatrists, as with most distinct healthcare professions (e.g., nurses, physician assistants, etc.), are licensed at the state level.

Further, Pennsylvania, like other states, prohibits the unauthorized practice of medicine, which includes:

Practicing medicine.
Purporting to practice medicine.
Holding forth as authorized to practice medicine through use of a title.
Otherwise holding forth as authorized to practice medicine.⁶

Given the breadth of these statutory prohibitions, the bar for demonstrating the unauthorized practice of medicine appears low. For example, a platform need not deliver clinical care in the traditional sense to run afoul of the statute; merely holding itself forth as authorized to practice medicine, whether through the use of a title, the assertion of credentials or other representations of licensure, may be sufficient. In this case, the complaint expressly alleges that the “Emilie” character represented that it was a medical doctor, claimed to have attended medical school at Imperial College London and to have been practicing psychiatry for seven years, asserted that it was licensed to practice medicine in Pennsylvania, and provided a fabricated Pennsylvania license number. Each of these allegations, standing alone or in combination, may be used as evidence that the chatbot held itself out as authorized to practice medicine.

‘Intended use’ and FDA’s medical device regulatory framework

The Character.AI matter also raises significant questions under federal law – specifically, whether a chatbot that performs diagnostic or treatment-related functions could be classified as a medical device⁷ subject to FDA oversight. Platform operators and their counsel should not assume that the absence of FDA enforcement to date reflects a settled regulatory position; to the contrary, the agency’s existing statutory and regulatory framework is more than sufficient to reach AI chatbot platforms with these types of functions, and the Pennsylvania complaint may accelerate federal attention to this space.

Under the Federal Food, Drug, and Cosmetic Act (FDCA), a product qualifies as a “device” if it is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” or is “intended to affect the structure or any function of the body” – provided that, unlike a drug, it does not achieve its primary intended purposes through chemical action within or on the body and does not depend on being metabolized to achieve such purposes.⁸ Critically, FDA does not simply accept a company’s characterization of what its product is intended to do. Under 21 CFR § 801.4, a product’s “intended use” can be established by, among other things, its design, the circumstances surrounding its distribution, website claims, advertising, and oral and written statements. FDA evaluates the totality of the circumstances – how a product is actually used, what it actually communicates and what the objective evidence shows about the manufacturer’s intent.

Importantly, FDA regulates Software as a Medical Device (SaMD) in the same manner as other products, unless the software is subject to one of the statutory carve-outs from the 21st Century Cures Act, such as software intended for general wellness purposes.⁹ Thus, software that is intended for use in the diagnosis or treatment of a disease or condition is subject to regulation as a medical device under the FDCA.

While the FDCA may already provide a basis for reaching chatbot operators, enforcement to date has largely been driven by state attorneys general rather than FDA. That gap likely reflects issues of timing and resource constraints rather than any meaningful limitation in federal authority. In the current environment, states like Pennsylvania also appear more willing to devote their limited resources to enforcement in this space. For platform operators, that combination of latent federal authority and active state-level activity means the question is not whether regulatory scrutiny is coming, but how to be ready as it continues to evolve.

The best defense is a good offense

So, what can platform operators do now to get ahead of the regulatory curve? First, they can start with a regulatory risk assessment to map the landscape of applicable state laws across all jurisdictions in which the platform operates before deploying health AI features.

Based on that assessment, platforms can strengthen their regulatory position by calibrating their compliance practices either to the highest applicable state standards or to emerging national frameworks. The Federation of State Medical Boards, for example, announced in May 2026 the formation of a new workgroup charged with developing recommendations and model guidelines for state medical boards on the regulation of AI tools used in the practice of medicine. At the federal level, and as discussed further below, the Trump administration has also signaled its desire to establish a uniform federal framework for AI.¹⁰

Platform operators should also define and implement clear boundaries around what their AI systems can do in all healthcare contexts. This does not mean shutting down all health-related conversations, but it does mean drawing a line between providing educational information or a general wellness function and conduct or messaging that may appear to be providing clinical advice requiring a professional license, which is a distinction that matters equally under state unauthorized practice statutes and the FDA’s device classification framework. A chatbot offering generic stress-management tips will be analyzed differently than one that asks about symptoms, offers a diagnosis or recommends a treatment course. Those boundaries should be enforced through content moderation systems and model-level constraints, not through user-facing disclaimers alone, given that a company’s disclaimers may actually be used to demonstrate knowledge of the law and do not change a product’s status as a device under the FDCA.¹¹> Platforms that build these guardrails in before a regulator comes knocking will be in a far stronger position than those that wait and react.

Will the Character.AI case open the floodgates?

It is too early to say whether the Character.AI lawsuit will open the floodgates for state enforcement actions, but the conditions are there. State licensing boards now have a live case that hands them a roadmap for going after AI platforms whose responses stray into regulated territory. And they are not the only ones: A growing number of state legislatures have moved to regulate AI systems directly (e.g., California, Texas and Illinois), and more will follow.

These developments suggest a regulatory landscape that may become both broader and more varied over time – though federal pressure on state AI regulation is mounting. On December 11, 2025, President Donald Trump signed an executive order directing federal agencies to establish “a minimally burdensome national policy framework for AI.” While the order does not preempt existing state AI laws, it identifies several mechanisms for challenging state AI laws inconsistent with that policy, including Department of Justice litigation, Commerce Department review of “onerous” state laws, and a White House mandate to prepare a legislative recommendation establishing a uniform federal framework that would preempt state laws conflicting with the administration’s policy of sustaining and enhancing US global AI dominance through a minimally burdensome national framework.¹²

For now, state AI compliance obligations remain in effect. The scope of these regulations varies considerably from state to state, ranging from disclosure requirements mandating that users be informed they are interacting with an AI agent to data privacy obligations, advertising restrictions and other consumer protection measures. Of particular relevance to the issues raised by the Character.AI matter, Delaware recently enacted legislation that expressly prohibits a “nonhuman entity,” including an “agent powered by artificial intelligence,” from using professional titles or abbreviations associated with licensed healthcare professions, including, but not limited to, “advanced practice registered nurse,” “registered nurse,” “doctor” and similar designations.¹³ The Delaware law further prohibits the licensure of a nonhuman entity to practice medicine, nursing or related healthcare professions, and bars any such entity from engaging in the practice of medicine within the state. Legislation of this nature may reflect a growing desire among state legislatures to expressly address this practice in an attempt to rein in AI platforms that offer medical advice without state oversight – though their durability will depend on whether federal legal challenges to these laws materialize and succeed, or whether Congress moves to preempt them through a federal AI framework.

What makes the Pennsylvania case especially notable is how it started – not with a purpose-built health app, but with a single chatbot on a general-purpose platform that a state investigator found by searching “psychiatry.” The takeaway: Regulators are looking at what the AI actually says, and if those responses look like the practice of a licensed profession or the function of a regulated device, disclaimers may not be enough. That said, enforcement is not the only model. Some states have signaled a preference for regulatory partnership over litigation. Utah, for example, has entered into a regulatory mitigation agreement with mental health chat app ElizaChat, under a framework created by Utah law¹⁴ that allows companies to operate under agreed terms in exchange for regulatory flexibility. Whether other states follow Utah’s lead remains to be seen, but the gap between a regulatory partnership and an enforcement action may come down to whether the platform drew the lines itself before a regulator had to – or, where a regulator has already drawn them, whether the platform engaged constructively with those boundaries rather than ignoring them.

Notes

The Pennsylvania State Board of Medicine operates under the Pennsylvania Department of State, Bureau of Professional and Occupational Affairs.
Commonwealth of Kentucky ex rel. Coleman v. Character Technologies, Inc., No. 26-CI-00029 (Ky. Franklin Cir. Ct. filed Jan. 8, 2026).
In violation of Sections 422.10 and 422.38 of the Medical Practice Act.
Cailey Gleeson, “Pennsylvania Sues Character.ai Over AI Chatbot Allegedly Presenting Itself as Licensed Medical Professional,” Fierce Healthcare, May 7, 2026.
63 Pa. Stat. Ann. § 422.2.
63 Pa. Stat. Ann. § 422.10.
21 USC § 321(h)(1).
Id.
21 USC § 360j(o). See also, Cooley, “FDA Opens Aperture for Wearables in Latest General Wellness Guidance,” January 20, 2026.
“Ensuring a National Policy Framework for Artificial Intelligence,” Exec. Order No. 14365, 90 FR 58499, December 11, 2025).
See, e.g., United States v. 789 Cases of Latex Surgeons’ Gloves, 799 F. Supp. 1275, 1285 (D.P.R. 1992) (“Whether a product’s intended use makes it a device depends, in part, on the manufacturer’s objective intent in promoting and selling the product. All of the circumstances surrounding the promotion and sale of the product constitute the ‘intent.’ It is not enough for the manufacturer to merely say that he or she did not ‘intend’ to sell a particular product as a device.”).
“Ensuring a National Policy Framework for Artificial Intelligence,” Exec. Order No. 14365, 90 FR 58499, December 11, 2025. See also, Cooley, “Showdown: New Executive Order Puts Federal Government and States on a Collision Course Over AI Regulation,” December 12, 2025.
Del. H.B. 191, 153d Gen. Assemb. (2026).
UT Code § 13-72-302.