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HKSTP Leads Five High-Potential Biotech Startups to Explore Global Collaboration and Financing at Premier Biopharma Summit in Seoul

Thu, 16 Apr 2026 14:09:16 Z

Yiming Liu, partner in charge of Cooley’s Shanghai’s office, was quoted in The Standard during his participation in Hong Kong Science and Technology Parks Corporation’s (HKSTP) 2026 BioCentury-BayHelix East-West Summit in Seoul, South Korea. He highlighted how Hong Kong’s legal system supports cross-border transactions and underpins market confidence.

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MAHA Push Accelerates Reformulation, But Leaves Food Industry in Limbo

Thu, 16 Apr 2026 14:01:07 Z

Laura Akowuah, Cooley special counsel and former FDA attorney, was quoted in a Food Navigator USA article about how the Trump Administration’s Make America Health Again (MAHA) movement is pushing the food industry to reformulate rapidly based on informal policy signals rather than durable regulations, creating significant uncertainty for the industry. Akowuah also highlighted potential risks to the Generally Recognized As Safe (GRAS) pathway and urged the food industry to prioritize science‑based innovation, including healthier products for children.

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Terremoto Biosciences Closes $108 Million Series C

Wed, 15 Apr 2026 18:27:15 Z

San Diego – April 15, 2026 – Cooley advised Terremoto Biosciences, a biotechnology company developing highly targeted, small molecule medicines, on its $108 million Series C financing round. The round includes new investors RA Capital Management, Deep Track Capital, Osage University Partners, and BeOne Medicines, and participation from existing investors OrbiMed, Third Rock Ventures, Novo Holdings, and Cormorant Asset Management.

Lawyers Ken Rollins, Edmond Lay and Rachel Lydon led the Cooley team advising Terremoto.

Cooley Shortlisted for Four Awards at ALB SE Asia Law Awards 2026

Wed, 15 Apr 2026 11:49:25 Z

Singapore – April 15, 2026 – Cooley was shortlisted by Asian Legal Business (ALB) in its annual SE Asia Law Awards series, which honours outstanding performance by private practitioners and in-house legal teams in Southeast (SE) Asia.

Cooley was shortlisted as International Deal Firm of the Year, Private Equity and Venture Capital Law Firm of the Year, and SE Asia Law Firm of the Year.

Additionally, the firm was noted for its work representing AvePoint on the company's SG$260 million underwritten public offering and SGX listing – a deal which is shortlisted as Equity Market Deal of the Year.

Read the full shortlist

The awards will be presented in May during the annual awards ceremony in Singapore.

Cooley Receives Three Managing IP Americas Awards

Tue, 14 Apr 2026 19:33:10 Z

New York – April 14, 2026 – Cooley received three Managing IP Americas Awards in the latest edition of the publication’s annual awards series.

The firm’s 2026 honors were:

Firm of the Year: Trademark Disputes (West)
Practitioner of the Year: Trademark Litigator (West) – Bobby Ghajar
Impact Case of the Year: Kadrey v. Meta (N.D. Cal.)

These recognitions of Cooley’s intellectual property practice follow the firm’s trademark, copyright and advertising (TCA) practice’s receipt in February of multiple honors from Managing IP’s sister publication, World Trademark Review.

With more than 25 TCA lawyers and paralegals across the US and UK, Cooley has one of the largest dedicated TCA practice groups among Am Law 50 firms. As a fully integrated, full-service practice, the group represents clients in complex infringement suits where core products and brands are at stake while also providing prosecution and strategic counseling services that allow clients to maximize their trademark value globally. Cooley’s TCA team also plays a critical role in thousands of high-value financings, M&A deals, capital markets offerings and other transactions.

European Commission Proposes EU Industrial Accelerator Act Including ‘Made in EU’ and Low-Carbon Requirements, Stricter Rules for FDI in Strategic Sectors

Tue, 14 Apr 2026 14:11:20 Z

On 4 March 2026, the European Commission published a proposal for an EU Industrial Accelerator Act (IAA). The proposal will now be negotiated in the European Parliament and by EU Member States in the Council. If adopted as proposed, the IAA would introduce several measures aimed at making the EU more competitive and resilient, increasing manufacturing in the EU and contributing to the EU’s climate goals.

The IAA could have broad implications for non-EU investors, businesses taking part in public tenders in the EU, and any companies operating manufacturing sites in strategic sectors in the EU, such as steel, cement, aluminium, automotive, batteries, solar, wind and heat pumps.

Background

The IAA aims to increase manufacturing activity in the EU generally, with the European Commission targeting the manufacturing sector reaching 20% of the EU’s gross domestic product (GDP) by 2035 by including this objective in the IAA. This follows a decline of manufacturing in the EU from 17.4% to 14.3% of GDP between 2000 and 2024.

The IAA is being proposed against the background of the EU striving for greater strategic autonomy and security. The recitals of the proposal expressly refer to the IAA being a response to factors such as hostile economic actions, cyberattacks, foreign interference, the weaponisation of EU economic dependencies, the arbitrary deployment of trade measures, the increasing effects of climate change and rising geopolitical tensions. While there is a general consensus among Member States that the EU’s vulnerabilities and dependencies need to be addressed, there is some disagreement on how to do this. Ahead of publication of this final proposal, a debate had already started. This will continue as the IAA makes its way through the legislative procedure.

The measures of the proposed IAA can be divided into four broad categories:

1.‘Made in EU’ and low-carbon requirements

‘Made in EU’ requirements

The proposed IAA introduces “Made in EU” requirements in public procurement and other forms of public intervention, such as government schemes supporting individuals or businesses purchasing electric vehicles or renovating buildings. These new EU-origin requirements would apply to sectors that are considered strategic, including steel, cement and aluminium, as well as technologies included in the EU’s Net-Zero Industry Act (NZIA), such as battery energy storage systems, solar photovoltaic (PV) technologies, heat pumps, onshore and offshore wind technologies, electrolysers and nuclear fission energy technologies. For example, for solar PV technologies, from three years after entry into force of the IAA, the PV inverter and the PV cells purchased by a public body would need to be of “EU origin”.

The concept of “EU origin” is broad and would include content originating in third countries with which the EU has an agreement establishing a free trade area or a customs union, or that are parties to the World Trade Organization Government Procurement Agreement, including the US.

However, the European Commission would have the power to adopt delegated acts to exclude countries from this broad approach where:
(a) The country failed to give EU products and entities access under the relevant agreement on terms no less favourable than to their domestic entities or products (national treatment).
(b) The exclusion is justified to avoid dependencies or a threat to the security of supply in the EU.
(c) The exclusion is justified under any other exception under the relevant agreement.

Low-carbon requirements

For public procurement and other forms of public intervention benefiting households or companies in the EU, the proposed IAA would also introduce low-carbon requirements in relation to steel, cement and aluminium used in buildings, infrastructure and motor vehicles. These sectors were selected as they are some of the most energy-intensive sectors, and the European Commission aims to create demand for low-carbon versions of these products.

The European Commission would also be empowered to adopt delegated acts laying down additional EU-level demand-side measures for products from the chemical industry.

2. Foreign direct investment in strategic sectors subject to prior authorisation requirement

With the IAA, the European Commission proposes a new mandatory foreign direct investment (FDI) regime for “emerging strategic sectors”. This supplements Member States’ existing, broader FDI approval systems and the updated EU FDI Screening Regulation.

The new review system would apply to investments that afford investors “control” (defined as 30% or more of share capital/voting rights/ownership) over an EU target where:

The value of the investment exceeds €100 million.
More than 40% of global manufacturing capacity in the target’s sector is held by a third country of which the foreign investor is a national or undertaking.

The relevant “emerging strategic sectors” are battery technologies, electric vehicles, and solar PV technologies, and extraction, processing and recycling of critical raw materials. The European Commission would have powers to extend this list of emerging strategic sectors by adopting delegated acts, but such acts could not cover digital technologies, artificial intelligence, quantum technologies or semiconductors.

Investors and investments covered by economic partnership agreements or free trade agreements concluded by the EU, and investments targeted at providing services and portfolio investments, are not subject to this pre-approval requirement.

Notifications under the new system should be made to the national investment authority designated by the Member State where the target is based (or to all relevant authorities and the European Commission, in parallel, where the target is located in more than one Member State). Although reviews are conducted nationally, the substantive standard for approval is set at the EU level and common to all Member States. Departing from the traditional approach to FDI in the EU, focused on security and public order criteria, approval under the IAA would only be granted to investments that meet at least four out of the following six conditions:

Ownership requirement: The ownership interest to be acquired, held or exercised is no more than 49%.

JV requirement: The investment is a joint venture (JV) with an EU entity meeting relevant conditions.

Technology transfer requirement: The investor licensed intellectual property and know-how to benefit the EU target to help carry out its economic activities in the context of the investment.

R&D requirement: The foreign investor annually directs at least 1% of gross annual revenue of the EU target, or generated by the EU asset, to research and development (R&D) spending in the EU as applied in proportion to the foreign investor’s share of control.

Workforce requirement: At least 50% of the workforce at implementation and throughout the operation of the investment is made up of EU workers across all levels of the workforce.

Input requirement: The foreign investor publishes a strategy for enhancing EU value chains and endeavours to source at least 30% of inputs for products placed on the EU market from the EU.

Although Member State authorities would be responsible for the review and retain the last word on approvals, the IAA envisages central oversight and coordinating roles for the European Commission.

Investments that qualify for review under the IAA would be subject to a mandatory standstill requirement and must not be implemented unless and until approval has been granted. This could result in potential delays, with review taking up to 75 days (which can be extended by 30 days) from receipt of the application. However, many of these investments, particularly in Member States which already have sophisticated FDI screening mechanisms in place, would likely already have been covered by national screening requirements and would therefore already have to undergo screening even without the IAA.

Even after approval, foreign investors would need to report regularly to the investment authority on the ongoing compliance with the conditions.

Penalties for failure to notify are high at no less than 5% of the average daily aggregate turnover of the foreign investor undertaking.

3. Boosting sustainable manufacturing through creation of industrial manufacturing acceleration areas

Within one year of the IAA’s entry into force, each Member State is required to designate at least one “industrial manufacturing acceleration area” within its territory for projects in one or more of the strategic sectors listed in an annex to the proposed IAA. This includes energy-intensive industries like paper manufacturing, the automotive industry and net-zero technologies listed in the NZIA, such as heat pumps, battery and energy storage technologies, and biotech climate and energy solutions. These areas are intended to make it easier for industrial activities to cluster in one geographical zone with the aim of promoting favourable conditions for the industries established there.

Once established, industrial manufacturing acceleration areas would benefit from a range of measures. For example, Member States would be required to facilitate financing of projects, promote research and innovation investments, analyse the energy needs and identify the required energy infrastructure, and support the development of a highly skilled workforce.

Member States also need to issue an aggregated baseline permit authorising industrial activities within the industrial manufacturing acceleration area. This would be a single permit that covers all necessary permits generally needed for industrial manufacturing projects in that area.

4. Easier permitting via digital one-stop shop at national level

To facilitate the development of industrial manufacturing projects, the proposed IAA requires processes to be streamlined and digitalised. It requires Member States to set up a single access point at the national level where project promoters can submit one single application to obtain all necessary permits for an industrial manufacturing project. An authority designated by the Member State then coordinates the permitting processes via a single permit-granting procedure. They should be able to pass on the applications to relevant authorities and provide information, all via the digital European Business Wallet.

Energy-intensive decarbonisation projects will moreover be subject to the streamlined administrative and permit-granting procedures under the NZIA and benefit from the measures in the proposed regulation to speed up environmental assessments once it is adopted.

Next steps

The IAA proposal is now being scrutinised by the European Parliament and the representatives of the 27 EU Member States in the Council. The Council and the European Parliament can each propose amendments and will enter into negotiations to reach a compromise on a final text. This process usually takes around one to one-and-a-half years. We do not expect the IAA to be adopted before 2027. Given the intensity of debate around this proposal even before it was published, the text as it now stands is likely to undergo considerable amendments before it is adopted.

CrossBridge Bio Acquired by Eli Lilly and Co. for up to $300 Million

Tue, 14 Apr 2026 12:12:00 Z

Cooley advised CrossBridge Bio, a pre-clinical biotechnology company pioneering the development of next-generation dual-payload antibody-drug conjugates (ADCs), on its agreement to be acquired by Eli Lilly and Company (“Lilly”) for up to $300 million in cash, inclusive of an upfront payment and a subsequent payment upon achieving a specified development milestone.

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

Lead Team: Rowook Park, Caitlin Cunningham, Nathan Baum, Allie Pilmer and John DelMastro led the Cooley team advising CrossBridge Bio.

Supporting Team: Ryan Sansom, Christophe Beauduin, John Forrest, Paul Holmer, Jeff Tolin, Patrick Sharma, Ali Murata, Tony Guan, Christian Lee and Ross Eberly provided invaluable support.

Cooley previously advised CrossBridge Bio on its $10 million seed financing in November 2024 as well as other general corporate matters.

Cooley Partner Named to India International A-List

Mon, 13 Apr 2026 16:40:26 Z

Cooley partner Rishab Kumar has been named to India Business Journal’s International A-List for the third consecutive year. Kumar was praised for his work on M&A technology transactions.

View the full list

The list recognizes lawyers outside of India who distinguished themselves as the top practice area experts for India-related legal matters.

Cooley Strengthens Fund Formation Practice With Private Equity Partner in New York

Mon, 13 Apr 2026 16:19:00 Z

New York – April 13, 2026 – Derek Pease has joined Cooley’s New York office as a partner in the firm’s fund formation practice. Pease joins Cooley from Silver Lake, one of the world’s largest private equity firms, and brings more than two decades of industry experience from several in-house and external advisory roles. With Pease’s addition, Cooley expands its private equity team, advancing its service to its sophisticated clients and its ongoing commitment to the sector.

“Derek brings the rare combination of elite in-house leadership and top-tier private practice experience at the highest level,” said John Clendenin, partner and chair of Cooley’s global fund formation practice. “Having led multibillion-dollar fundraises and coordinated global compliance and operational frameworks, he understands the full life cycle of modern investment platforms. His addition to our strong bench in New York reinforces Cooley’s position as a premier destination for sophisticated private equity sponsors.”

At Silver Lake, Pease most recently served as legal director of fund formation, working on a series of investment funds that raised billions of dollars from institutional investors and structured global technology investments. He has a substantial background in leading all aspects of fund formation through every step of the fundraising process and overseeing multifaceted fund operations.

Before joining Silver Lake, Pease was a partner at Kirkland & Ellis, where he represented leading domestic and international sponsors in fund development and operations and advised on fund-related transactions – including minority-stake sales, co-investments and joint ventures – and legal and regulatory issues.

“I’m energized to return to private practice at a collaborative and well-regarded global firm that serves many of the world’s leading and most innovative sponsors,” said Pease. “Cooley’s impressive momentum in the private equity space, along with its industry presence and strengths in fund formation, provides an exceptional platform for serving clients across multiple geographies and asset classes.”

Cooley’s fund formation practice provides primary counsel to more than 950 investment fund organizations. The practice’s deep bench of 60+ lawyers has helped collate $120 billion+ in committed capital in closings over the past five years. Its client investments span the US, China, Europe, India, Vietnam, Singapore, Israel, South America and elsewhere. The group formed the first venture capital limited partnership in the western US and has been active in China for four decades and in India for three decades. The team advises on every type of fund formation, including private equity, venture capital, fund of funds, evergreen, growth equity and other managers at all states and sizes, from individual angel funds to billion-dollar investment funds.

Cooley Shortlisted for Nine Life Sciences EMEA Awards

Mon, 13 Apr 2026 07:00:00 Z

London – April 13, 2026 – Cooley and its lawyers have been shortlisted for nine honors at the annual awards presented by LBG Life Sciences EMEA (Europe, the Middle East and Africa). Specifically, the firm has been nominated as:

International Firm of the Year
Cross-border M&A Firm of the Year
Equity Capital Markets Firm of the Year
Licensing & Collaboration Firm of the Year
Venture Capital Firm of the Year

Moreover, four Cooley lawyers are shortlisted individually, including Simon Amies as M&A Lawyer of the Year; Frances Stocks Allen as Licensing & Collaboration Lawyer of the Year; Alexandra Paterson as M&A Rising Star, and Philip Whitehead as Banking and Capital Markets Rising Star

View the full shortlists

An awards ceremony will be held in London on June 4. In 2025, the publication recognized Cooley as Licensing and Collaboration Firm of the Year for EMEA.

Connected Cars: Privacy Compliance Guidance

Fri, 10 Apr 2026 17:03:15 Z

Cooley special counsel Claire Gibbs was quoted in a Cybersecurity Law Report article outlining the privacy and compliance challenges that original equipment manufacturers (OEMs) face as connected vehicles collect and share sensitive data, emphasizing that OEMs must provide clear, timely notice and obtain meaningful consent so consumers understand how their information will be collected, used, and shared before any processing occurs.

Read the article (subscription required) >

GreenSpark and ReMatter Combine to Form ReSpark

Fri, 10 Apr 2026 16:23:00 Z

New York – April 10, 2026 – Cooley advised GreenSpark Software, a cloud-native, AI-first platform for the metal recycling industry, on its combination with ReMatter, creating a single company known as ReSpark. The combined entity brings together two of the most advanced purpose-built software platforms in the metal recycling and scrap yard industry, unifying their products, teams and customer bases to serve operators across the United States, Canada and internationally.

Lawyers Roy Moran, Izzy Lubarsky, Kathryn Benvenuti, Norris Kadet, Joy Chow, Melanie Simon-Giblin, Paula Fleckenstein, Chris Chynoweth, Ryan Montgomery and Patrick Sharma led the Cooley team advising GreenSpark.

AI Hype, Hard Lessons: Where SEA’s Startup Capital Is Really Going

Thu, 09 Apr 2026 19:26:05 Z

Cooley partner David He was quoted in an e27 article about Southeast Asia’s (SEA) startup ecosystem, analyzing how capital, expectations and behavior have fundamentally changed in the past few years. He also highlighted the trend of increased investments in artificial intelligence (AI) and the four areas in which investors are scrutinizing startups.

Read the full article on e27 here.

FCC Proposes Sweeping Rules on Foreign Call Centers: Onshoring Mandates, Consumer Protections and Robocall Deterrence

Thu, 09 Apr 2026 17:27:00 Z

FCC Proposes Sweeping Rules on Foreign Call Centers: Onshoring Mandates, Consumer Protections and Robocall Deterrence

On March 27, 2026, the Federal Communications Commission (FCC) released a Notice of Proposed Rulemaking (Call Center NPRM) seeking comment on a broad package of rules governing foreign call centers. The rulemaking addresses three distinct objectives: encouraging the onshoring of call center operations to the United States; establishing quality and security standards for foreign call center operations that remain; and deterring unlawful robocalls originating from foreign countries through financial mechanisms, such as bonds and fees.

The proposed rules would apply to providers of telecommunications services, commercial mobile radio services (CMRS), interconnected voice over internet protocol (VoIP), cable television, and direct broadcast satellite (DBS) services, as well as their affiliates that provide internet access service. The FCC also seeks comment on extending some or all of these rules more broadly, including all calls covered by the Telephone Consumer Protection Act (TCPA), which could subject a range of commercial entities to new FCC requirements. Companies that use or rely on foreign call centers for customer service, sales or telemarketing should evaluate these proposals and consider participating in the comment process.

Key proposals

Cap on foreign-handled calls

The FCC proposes to limit the percentage of customer service calls that providers may route to or answer at foreign call centers. The NPRM uses 30% as an illustrative threshold and seeks comment on whether this cap should apply separately to inbound and outbound calls or on a combined basis. The FCC asks about the appropriate measurement period (annual, quarterly, monthly or daily) and whether to phase in the cap over time to allow providers to build domestic capacity.

English proficiency requirements

The proposed rules would require providers using offshore call centers to ensure that all calling staff are proficient in both spoken and written American Standard English. The FCC emphasizes that proficiency must extend beyond vocabulary to include understanding of tone, idioms and cultural context. The NPRM seeks comment on which testing regime should apply (referencing the OET, TOEFL and TOEIC as potential models) and whether the FCC should assess compliance per employee or on an aggregate basis. The FCC also asks how these requirements would apply to call centers serving non-English-speaking US customers.

Consumer right to transfer to a US-based representative

Upon consumer request, the proposed rules would require providers to transfer any call that a foreign call center is handling to a representative located in the US. Providers would need to ensure that wait times for transferred calls are no longer than for calls they initially route domestically.

Mandatory disclosure of foreign call center use

The proposed rules would require providers to inform customers at the beginning of each call that a representative outside the US is handling the call. The FCC proposes specific disclosure language that would include the name of the country where the call center operates and notification of the consumer’s right to request transfer to a US-based representative. The disclosure requirement would apply to both inbound and outbound calls.

Sensitive transactions: Domestic-only requirement

The FCC proposes to require that US-based call centers exclusively handle customer interactions involving sensitive data like passwords, multifactor authentication information, Social Security numbers, and bank account or credit card numbers. This requirement would apply regardless of the communication channel used (voice, chat, email or text) and proposes to exclude calls handling sensitive data from any percentage-cap calculation.

Prohibition on call centers in foreign adversary nations

The NPRM proposes to prohibit covered providers from using call centers located in “foreign adversary” nations, as defined under existing Commerce Department regulations. Foreign adversary nations include China, Russia, Iran, North Korea, Cuba and Venezuela. The FCC further seeks comment on an even broader prohibition –barring the use of any call center, wherever located, that employs citizens or residents of a foreign adversary nation. This is a hard prohibition, not a cap.

Broadband label and transparency disclosures

The FCC proposes to amend its broadband consumer label rules to require display of the percentage of customer service calls handled by US-based representatives. For providers of non-broadband services covered by the proposed rules, the FCC asks whether providers should publish comparable information on their websites.

Compliance tracking and reporting

The proposed rules would require providers to track and report to the FCC their compliance with all adopted rules. Reports would cover English proficiency testing results, call volumes by location (domestic versus foreign), transfer rates, wait times and dropped call data. The FCC seeks comment on reporting frequency (monthly, quarterly or annually) and whether the FCC should make compliance reports public.

Extension to nonvoice channels

Beyond the sensitive-transaction requirement (which already extends to all channels), the FCC asks whether all of the proposed rules should apply to nonvoice customer communications, including online chat, text messages, email and video conferencing.

Bond and fee requirements for robocall deterrence

In a separate but related set of proposals, the FCC seeks comment on requiring providers that transmit calls from foreign countries to the US, particularly international gateway providers, to post bonds. The FCC asks detailed questions about bond amounts, drawdown triggers, due process safeguards, replenishment obligations and administration. As an alternative, the FCC also asks about government-imposed fees on unlawful traffic.

Comment dates will be set after publication in the Federal Register. If you have questions about this proceeding or are considering submitting comments, please contact one of the Cooley lawyers listed below.

Cooley Partner Again Named Among Hollywood’s Top Attorneys

Thu, 09 Apr 2026 13:41:18 Z

For the second consecutive year, Los Angeles-based Cooley partner Bobby Ghajar was named to Variety’s Legal Impact Report. The prestigious annual report profiles Hollywood’s leading entertainment lawyers, and includes the litigators, deal lawyers and in-house counsel behind some of the industry’s biggest stories.

Ghajar’s profile highlighted his representation of Meta, for which his team secured a partial summary judgment victory in the company’s artificial intelligence (AI) copyright case. In June 2025, the district court dismissed the plaintiffs’ copyright infringement claims when it ruled that Meta’s use of copyrighted books to train its Llama AI was “highly transformative” and that the books’ authors failed to prove it harmed the market for their works.

Ghajar was also noted for his ongoing defense of Midjourney in a suit brought by Disney, Universal, and Warner Bros. challenging his client’s ability to generate images of iconic Hollywood characters.

Read Ghajar’s profile ›

Washington State Expands Personality Rights Law to Cover AI-Generated Deepfakes

Thu, 09 Apr 2026 07:00:00 Z

Washington state expanded its existing property rights law to address use of a person’s “forged digital likeness” without the person’s consent. Substitute Senate Bill 5886 (SSB 5886), signed into law by Gov. Bob Ferguson on March 16, 2026, amends Washington’s Personality Rights Law to address the growing use of artificial intelligence to create realistic but deceptive audio and video, and impacts those that rely on such technology to create content. The law takes effect on June 11, 2026.

What changed?

The Personality Rights Law already prohibited the use of an individual’s name, voice, signature, photograph or likeness without their consent. The amended law expands that list to include a person’s “forged digital likeness,” defined as:

A visual representation which is either persistent or transmitted in real-time of an actual and identifiable individual, or an audio recording which is either persistent or transmitted in real-time of an actual and identifiable individual’s voice, which: (a) has been digitally created, adapted, altered, or modified to be indistinguishable from a genuine visual representation or audio recording of the individual; (b) misrepresents the appearance, speech, or conduct of the individual; and (c) is likely to deceive a reasonable person into believing that the visual representation or audio recording is genuine.

This property right applies to both living and certain deceased individuals.

Strengthened remedies

In addition to the potential for injunctive relief, actual damages and recovery of attributable profits and reasonable attorneys’ fees, the law significantly increases the potential consequences violators face:

Doubled civil penalty: Under the prior law, violators could be subject to financial penalties of $1,500 or actual damages, whichever was greater. The amended law raises the potential civil penalty to $3,000. There remains the potential recovery of actual damages and any attributable profits.
Noneconomic damages for deepfake violations: Where the violation involves a forged digital likeness, the violator is also responsible for noneconomic damages, such as mental or physical pain and suffering, or injury to reputation and humiliation.

Broader legal landscape

SSB 5886 is part of a broader national trend. Washington had already passed a law extending the state’s criminal impersonation statute to cover the distribution of someone’s forged digital likeness with the intent to defraud, harass or threaten them. Other states, such as California, New York and Tennessee, have passed legislation regulating digital likenesses.

Key takeaways and next steps

Businesses and content creators should act now to prepare for the June 11, 2026, effective date. In particular:

Review content workflows. Any use of AI tools to generate, alter or reproduce audio or visual representations of real individuals should be audited for compliance.
Update consent frameworks. Existing consent language in contracts, talent agreements and terms of service may not be sufficient to cover AI-generated digital likenesses under the new statutory definition.
Assess liability exposure. The expanded civil penalty and the addition of noneconomic damages for deepfake-specific infringements substantially raise the stakes of noncompliance.

Areas requiring further clarification include how courts will interpret the “likely to deceive a reasonable person” standard in practice, and how the law will interact with First Amendment protections for satire, parody and commentary.

FDA Guidance May Move Goalposts For Form 483 Responses

Thu, 09 Apr 2026 07:00:00 Z

Cooley lawyers Sonia Nath, Laura Akowuah and Auguste Humphries co-authored an article for Law360 analyzing the US Food and Drug Administration’s new draft guidance on Form 483 responses, which provides a clearer structure for drug manufacturers to document, assess and correct any underlying systemic issues, but may also create timing issues and disadvantage many small and midsize companies.

Read the article

State Laws About Pay Transparency in Job Ads are Gaining Popularity, Lawyers Say

Wed, 08 Apr 2026 17:24:35 Z

Cooley partner Lyndsey Kruzer was quoted in an ABA Journal article about how pay transparency laws are expanding quickly as part of a broader push to increase salary equity, noting that compliance could become complicated for remote roles that may need to meet multiple states’ disclosure requirements.

Read the article (subscription required)

Cooley Shortlisted for Three Financial Times Innovative Lawyers Asia-Pacific Awards

Wed, 08 Apr 2026 16:00:00 Z

April 8, 2026 –Cooley was shortlisted for three honors in the Financial Times’ annual Innovative Lawyers Asia-Pacific awards. The series recognizes outstanding firms and individuals delivering exceptional value to their clients while bringing innovation to the practice of law.

The firm was shortlisted as Most Innovative Law Firm in Asia-Pacific, in the category specific to global law firms headquartered outside the region.

Additionally, a global Cooley team was shortlisted for Innovative Lawyers in Deal Making, based on its representation of Hengrui Pharma in its licensing agreement with GSK, valued up to $12.5 billion, to develop medicines complementing GSK’s extensive respiratory, immunology, inflammation and oncology pipeline.

Hong Kong partner Pang Lee was also shortlisted as an Innovative Practitioner, based in part on his leading role in supporting initiatives positioning Hong Kong as a global hub for innovation and entrepreneurship – including his contributions to the launch of the Hong Kong Venture Capital and Private Equity Association’s set of model legal documents designed to empower the local startup and investment community.

The awards will be presented in May during a ceremony at the Asia Society in Hong Kong.

Cooley Secures Three #1 Vault Practice Rankings

Wed, 08 Apr 2026 15:44:49 Z

Palo Alto – April 8, 2026For the ninth consecutive year, Cooley earned at least one market-leading ranking based on Vault’s annual nationwide survey of thousands of law firm associates. Each Spring, Vault publishes an industrywide report ranking law firms based on overall prestige, practice area prestige, quality of life and other factors.

Cooley earned a #1 ranking in three practice areas on Vault’s 2026 – 2027 report:

Emerging Companies & Venture Capital
Life Sciences
Privacy & Data Security

The firm’s first overall ranking for life sciences is based on Vault’s inaugural survey regarding this industry sector.

For the sixth consecutive year, Cooley earned a top spot on Vault’s Privacy & Data Security rankings. Additionally, Cooley maintained its #1 ranking for Emerging Companies & Venture Capital, a position the firm has held for nine consecutive years. The firm also maintained its fourth-place ranking for Intellectual Property.

On the Vault Law 100 list, Cooley remained in the #22 position for overall prestige. In Vault’s regional rankings, Cooley maintained its #1 ranking in Northern California, maintained its top five rankings in the Mountain States and Pacific Northwest, and also ranked in Boston, Chicago, New York and Washington, DC, as well as Southern California.

Read Cooley’s Vault profile >

Cooley’s cyber/data/privacy practice is a cross-functional, integrated team of lawyers in the US, Europe and Asia spanning the spectrum of advisory, transactional, regulatory and litigation matters involving privacy, cybersecurity and data governance.

Cooley’s emerging companies group works closely with startups and venture capital firms as they launch dynamic new ventures – to take them forward and beyond. The firm advises 7,000+ innovative, high-growth companies, from preformation founder teams to many of the most sophisticated tech companies in the world. Cooley serves as primary fund counsel to more than 800 investment fund organizations and represents venture funds or corporate investors in 2,100+ private financings each year.

Cooley’s market-leading life sciences practice has represented leading global life sciences companies for 40+ years and advises entities across the industry landscape – currently serving as trusted counsel to 2,500+ public and private life sciences company clients worldwide. The practice spans the gamut of regulatory, corporate and litigation services provided by lawyers who have extensive US and global experience counseling on a range of complex regulatory matters, advising on intricate deals, conducting investigations, and representing clients in litigation involving these issues.

UK Competition and Consumer Regulator Sets Key Regulatory Priorities for 2026 – 2027

Wed, 08 Apr 2026 14:02:22 Z

The UK’s Competition and Markets Authority (CMA) published its Annual Plan for 2026 to 2027 on 23 March 2026 setting out its strategic priorities for the coming year. This is the first detailed plan for implementation under its 2026 – 2029 Strategy, which seeks to put into practice some of the regulator’s longer-term objectives of protecting consumers and promoting competition in the wake of its mandate to help drive economic growth and improve household prosperity.

The plan was published against the backdrop of a government consultation on refining the UK competition regime, which seeks to speed up and streamline market investigations, provide clarity on merger control thresholds and implement a new decision-making model for in-depth mergers (see our February alert). It further embeds the CMA’s framework for acting with pace, predictability, proportionality and process (the 4Ps) in order to make the UK economy a more business-friendly environment and to “put money back” in people’s pockets.

In terms of key initiatives, the plan is notable for a strong shift in the CMA prioritising its enforcement of UK consumer protection laws, potentially to a greater extent than its competition law enforcement, a focus on encouraging innovation by supporting small and medium-sized enterprises (SMEs) and startups, policing public procurement markets for signs of anticompetitive conduct, and aligning its interventions to support the UK government’s eight Industrial Strategy sectors.

Key objectives

The plan reiterates the CMA’s key objectives from its 2026 – 2029 Strategy, namely:

Remaining a strong advocate for, and independent enforcer of, effective competition across the UK economy.
Championing consumers.
Helping government deploy tailored pro-competition interventions to support growth, innovation and investment-related policies.
Contributing to a UK regulatory landscape which instils business confidence and acts as a magnet for investment.
Delivering tangible benefits for the UK economy, citizens and businesses.

These key objectives contrast with those set out in previous annual plans, which had a stronger focus on competition in digital and fast-growing markets, complex (often digital) merger review, and sustainability. This shift has arisen not only from the Strategic Steer received from the government in 2025, but also from the coming into force of the Digital Markets, Competition and Consumer Act (DMCCA), which bolstered the CMA’s consumer protection enforcement powers. Under this regime, the CMA can act more quickly and investigate and impose fines directly, without having to go through lengthy UK court procedures.

We set out the CMA’s key areas of focus for the year ahead and what this means for businesses below.

1. Consumer protection

Under the DMCCA, the CMA received new enforcement powers to protect consumers against unfair commercial practices (see our April 2025 alert). The plan states that implementing the enhanced consumer protection regime under the DMCCA is a core priority, combining support for business compliance with enforcement action. The CMA highlights that this approach is intended to “put money back in people’s pockets” and strengthen consumer confidence.

The plan explains that the CMA will continue to prioritise areas of essential spend to help people struggling with pressure on household budgets, focusing in particular on the following behaviours:

Providing objectively false information to consumers
Fake reviews
Hidden fees
Aggressive sales practices
Imbalanced and unfair contract terms

In addition, the plan also sets out that the CMA will drive at behavioural change in businesses and across sectors through the use of advisory letters, noting that this approach has already driven behavioural change without the CMA needing to deploy a full case team to an enforcement investigation.

Takeaways

The CMA is clearly prioritising its enforcement of UK consumer protection laws. This is a continuation of the CMA’s 2025 strategy, which saw the agency send more than 100 advisory letters to businesses that it considered to be out of compliance with their consumer law obligations. It also launched its first investigations under the regime. For the remainder of 2026, we expect to see further enforcement of consumer issues, with the CMA seeking decisive resolutions for consumers.

In addition to the enforcement priorities named above, the DMCCA also sets out new obligations on businesses in relation to subscriptions, which we expect to come into force during the course of 2026. Businesses are advised to review their existing subscription offers to check if these fall within the remit of the DMCCA, and if so, put in place a compliance plan.

2. Competition enforcement

The plan sets out the CMA’s targeted focus for competition enforcement as follows:

Tackling anticompetitive conduct in key growth sectors and areas that may help to improve household prosperity; as part of this, the CMA will actively target anticompetitive activity which prevents startups and scale-ups from growing
Facilitating pro-growth, legitimate business collaboration, particularly in the eight Industrial Strategy priority sectors – advanced manufacturing, clean energy industries, creative industries, defence, digital and technologies, financial services, life sciences, and professional and business services – and in relation to sustainability agreements
Prioritising action against bid-rigging in the public sector and using AI and data science tools to support evidence gathering
Ensuring that AI is not used to impede competition in the UK, including through algorithmic collusion; in this context, the CMA is also making further investments into its detection tools, including AI, to scan public data and identify suspicious activity in all areas of focus, and the CMA’s recent guidance on Complying with Consumer Law When Using AI Agents supports this as a key area of focus in the consumer space as well (see our March 2026 alert).

Takeaways

The CMA’s competition enforcement focus is clearly targeted to support the government’s growth agenda. Notable is the emphasis both in the plan and in public statements currently being made by the CMA with regards to identifying how the CMA can support startups to scale up in the UK. These reflect a wider programme of work commenced in Autumn 2025 in which the CMA looked at the role of competition policy to encourage startup growth and investment in the UK, including tackling sector-specific barriers, such as public-sector procurement and regulation, the role of data and interoperability in scaling in the UK and from a merger control perspective, and the role of consolidation to achieve scale. Now, more than ever, the CMA is likely to be receptive to complaints by SMEs regarding market structures or the behaviours of competitors.

Also notable are how AI developments are now shaping the CMA’s workplan – both with regards to new tools that it is using to monitor market behaviour, such as in public-sector markets and to detect cartels, but also with regards to the use of algorithms and AI where these tools enable market collusion. Whilst to date the CMA has confined itself to issuing guidance on the use of AI and algorithms, and decisions are awaited, companies that use pricing algorithms and other AI tools to gather information are strongly recommended to review the compliance position of these.

3. Markets

With regard to the CMA’s markets work, while the agency has the ability to investigate entire markets, even in the absence of consumer or competition law breaches, the plan confirms a continued focus on those markets that are consumer facing. The plan specifically calls out the progression of the CMA’s market study into the private dentistry sector, along with implementation of remedies that result from its veterinary services market investigation, which concluded on 24 March 2026 and resulted in, amongst others, a price cap on prescriptions.

The plan further provides that the CMA will use its market function to support the government’s Industrial Strategy to help reduce cross-economy barriers to growth, supporting interoperability and access to data. The UK government’s proposed reforms to the competition regime also include changes to the CMA’s markets regime, which seek to replace the existing market study and market investigation model with a new single-phase market review tool and ensure market remedies remain necessary and proportionate. In implementing these aims, the plan seeks to be mindful of not placing more burden on business than necessary – for example, by focusing on light-touch and fast interventions, being guided by proportionality, and ensuring an effective monitoring of remedies, including removing remedies that are no longer needed.

Takeaways

The CMA continues to focus its market function on key areas of consumer need and spend, and we expect to see extensive use of this tool in the coming year. For example, on 20 March 2026, the CMA launched a market study into the supply of heating oil as an area of essential spend following the sudden rise in oil prices caused by the current conflict in the Middle East. On 24 March 2026, the Chancellor set out a plan to help protect households from unfair price increases set for profiteering during the crisis. As part of this, the government may act to give time-limited, targeted powers to the CMA so it can clamp down on “price gouging”.

4. Digital markets

In the digital realm, the plan sets out the CMA’s priorities in implementing its digital market regulation powers, including its work on its first designations of strategic market status (SMS) under the DMCCA in relation to search and mobile platforms. The CMA has recently indicated that it will open its next SMS investigation in May 2026.

Takeaways

We expect the CMA to focus on delivering a pragmatic approach to the regulation of digital markets with a focus on ensuring a level playing field for startups and scale-ups across the UK tech sector, particularly in areas like fintech and digital wallets, browsers, and platforms, with a particular focus on choice architecture, data access and interoperability. Commitments in the current designation process came into force on 1 April, and we expect at least one further designation to land in 2026. We therefore do not expect the regulator to put its current focus on digital regulation on the backburner just yet, particularly in areas where technology intersects with essential consumer spend, such as banking and finance.

5. Merger control

The CMA plans to apply its merger control powers in a targeted way, emphasising that most mergers do not raise competition concerns, but that it wants to be a strong advocate for effective competition across the UK economy. As part of this, the CMA will continue implementing its wait-and-see approach to global mergers.

Takeaways

On 20 January 2026, the UK government opened a consultation on legislative changes to the UK merger control regime aimed at enhancing predictability for businesses in support of economic growth which we wrote about in February. This came on the heels of a number of reforms and significant shifts in the CMA’s enforcement and merger review priorities, emphasising its alignment with the UK government’s pro-growth, pro-business agenda. As part of this, we expect:

Mergers involving global markets, but with only peripheral UK-specific overlaps, to be less likely to attract scrutiny, with more concentration on those transactions with a clear UK nexus.
More deals to continue to be cleared through the briefing-paper route with less full Phase 1 reviews.
A more flexible approach to remedies following the removal of the presumption against behavioural remedies at Phase 1 review.

The government consultation proposes to refine this further, with more streamlined investigations, greater certainty on notification thresholds and more time for businesses to agree remedies following a Phase 1 merger investigation.

What’s next?

Overall, the draft Annual Plan highlights the CMA’s ambition to be a consumer champion and enabler of economic growth in the UK. It also reinforces the CMA’s role in shaping markets – not just policing them – offering both risks and opportunities for businesses with UK operations.

In particular, while much of the commentary focuses on increased enforcement, the plan also presents strategic opportunities. The CMA is explicitly seeking to facilitate investment, sustainability initiatives and pro‑growth collaboration, including in the government’s priority sectors. Firms that understand how to operate within this framework can gain an advantage, particularly where regulatory clarity or market opening measures create new avenues for innovation.

If you would like to discuss what this means for your business, please do not hesitate to get in touch with a member of the Cooley team listed below.

Cooley Shortlisted for Three Awards by Chambers USA 2026

Wed, 08 Apr 2026 13:55:09 Z

April 8, 2026Cooley has been named a Finalist for three awards at the annual Chambers USA awards, which honors excellence in client service, exceptional leadership, and innovative and strategic impact on the legal profession.

Cooley is shortlisted in the following categories:

Artificial Intelligence
Healthcare & Life Sciences
Intellectual Property

Read the shortlists ›

The winners will be announced at Chambers’ award event June in New York City.

CFTC Issues No-Action Relief to Self-Custodial Crypto-Wallet Application

Wed, 08 Apr 2026 07:00:00 Z

On March 17, 2026, the Market Participants Division (MPD) of the US Commodity Futures Trading Commission (CFTC) issued a no-action letter to Phantom Technologies, a self-custodial crypto-wallet software company, recommending that the CFTC should not take enforcement action against Phantom for failing to register as an introducing broker (IB) under Section 4d(g) of the Commodity Exchange Act (CEA), or for certain of its personnel failing to register as associated persons (APs) under Section 4k of the CEA (no-action relief).

Phantom’s proposed activities

Phantom has developed one of the most popular self-custodial crypto-wallets for use on Solana and several other major blockchains. Phantom’s software enables users to generate and manage cryptographic credentials for viewing, storing and conducting self-directed crypto transactions. In a request letter to the CFTC, Phantom proposed to offer a front-end interface that enables users to access trading in CFTC-regulated derivatives, including event contracts, perpetual contracts, on registered designated contract markets (DCMs) or through registered futures commission merchants (FCMs) or IBs (collectively, collaborators). Phantom does not hold, control or custody user assets, generate express “buy” or “sell” signals, or exercise discretion with respect to the routing or execution of user orders. It merely provides software on the user’s mobile device or via a browser extension to enable users to transmit their orders directly to the collaborators. Phantom may receive a portion of the revenue of the collaborators and may also charge a transaction-based fee to users.

Registration requirement for introducing brokers

Under Section 4d(g) of the CEA, any person that, for compensation or profit, is engaged in soliciting or accepting orders for the purchase or sale of, among other financial products, any commodity for future delivery, is required to be registered as an IB with the CFTC. The phrase “soliciting or accepting orders” has been interpreted broadly to encompass solicitation of customers or acceptance of their orders for referral to FCMs for the execution of those orders. In addition, any individual associated with an IB as a partner, officer, employee or agent (or similar status) involved in solicitation or acceptance of customers’ orders (other than in a clerical capacity) or the supervision of persons so engaged is required to be registered as an associated person of the IB.

Prior CFTC staff letters had established that certain independent software vendors (ISVs) need not register as IBs, subject to specified requirements. Phantom’s proposed activities satisfy most of the conditions set out in those prior letters but depart in two key respects. First, Phantom would recommend, propose or encourage its users to use particular collaborators; and second, Phantom might contract with those collaborators to share a specified portion of their relevant revenues in exchange for Phantom providing its software to the collaborators’ users. Phantom therefore sought no-action relief.

Conditions for no-action relief

The CFTC granted the no-action relief to Phantom subject to the following conditions:

Collaborator liability undertaking

Phantom and each collaborator execute a written undertaking to be jointly and severally liable for any violations of the CEA or CFTC regulations in connection with Phantom’s proposed activities and to consent to the jurisdiction of the CFTC for relevant enforcement actions. Such undertakings shall be filed with the MPD.

User onboarding and disclosures

Phantom provides and each user acknowledges receipt of:
- Disclosures regarding Phantom’s relationship with the collaborators, addressing potential conflicts of interest (including fees).
- A risk disclosure statement meeting specific requirements for the relevant trading activities, unless such risk disclosure statement has been provided by the collaborator.
Users are onboarded with the collaborator and retain the ability to access the collaborator independently of Phantom.

Business conduct and notifications to the CFTC

Phantom adopts and enforces policies and procedures reasonably designed to ensure compliance with applicable CFTC and National Futures Association (NFA) rules regarding communications with the public and marketing as if Phantom were registered as an IB.
Phantom does not engage in advertising or promotions that would require preapproval by NFA if Phantom were registered as an IB.
Phantom, its principals and any individual engaged in soliciting users as part of the proposed activities are not subject to certain statutory disqualifications under the CEA. Phantom shall promptly notify the MPD of the relevant facts should any such person become subject to statutory disqualification.
Phantom provides notice to the MPD if it becomes insolvent or enters a bankruptcy proceeding.
Phantom maintains records regarding its compliance with these conditions and its business involving CFTC-regulated activity.
Phantom files a notice with the MPD agreeing to satisfy these conditions and consenting to be subject to the CFTC’s jurisdiction for related enforcement actions.

Key takeaways

The no-action relief opens the door for the development of “super apps” that allow users to access multiple trading venues through a single software application. For noncustodial crypto-wallet providers considering entry into CFTC-regulated derivatives markets, the no-action relief provides a useful pathway of entry without being subject to IB registration and ongoing compliance obligations. The CFTC’s relief builds on the reasoning in SEC v. Coinbase, Inc., No. 23 Civ. 4738 (KPF) (SDNY Mar. 27, 2024), in which Judge Katherine Polk Failla of the US District Court for the Southern District of New York dismissed the Securities and Exchange Commission’s claim that Coinbase acted as an unregistered securities broker through its self-custodial Coinbase Wallet application. Judge Failla found that the factual allegations concerning Coinbase Wallet were insufficient to support the plausible inference that Coinbase “engaged in the business of effecting transactions in securities for the account of others” through its wallet application, noting in particular that Coinbase does not maintain custody over user assets and does not exercise discretion over the routing or execution of transactions, and that the provision of pricing comparisons and access to third-party decentralized exchanges does not rise to the level of brokerage activity. Taken together with the CFTC’s no-action relief, noncustodial wallet providers now have meaningful guidance under both the commodities and securities regulatory frameworks that the provision of self-custodial software infrastructure facilitating user-directed access to trading venues may not, without more, constitute broker activity requiring registration.
In granting the no-action relief, the CFTC emphasized Phantom’s passive involvement in order submission. Noncustodial software providers seeking similar relief should ensure that their platforms do not generate express “buy” or “sell” signals or exercise discretion with respect to the routing or execution of user orders, and that users will continue to have direct access to collaborating DCMs, FCMs or IBs.
In addition, noncustodial software providers seeking similar relief should proactively update user agreements and conflict-of-interest and risk disclosures, implement internal policies regarding marketing and public communications, and include appropriate liability undertakings when negotiating collaboration arrangements with DCMs, FCMs and IBs.
Lastly, it is worth noting that, in addition to a transaction-based fee to be paid by users, the no-action relief allows Phantom to receive a portion of the revenue from the collaborators, so long as Phantom’s relationship with the collaborators, potential conflicts of interest and fees are adequately disclosed.

Cooley Special Counsel Receives Two Community Service Honors

Tue, 07 Apr 2026 17:15:58 Z

San Diego – April 7, 2026 –Cooley special counsel Kate Lee Carey has been named a 2026 Community Service Award honoree by both the San Diego County Bar Association and Lawyers Club of San Diego.

Kate was selected by the San Diego County Bar Association awards committee and board of directors as the 2026 Community Service Award recipient and will be recognized at the organization’s Annual Awards Ceremony & Celebration of Community Service luncheon on May 14.

In addition, Kate was named the 2026 recipient of the Lawyers Club of San Diego’s Community Service Award. Established in 1985, the award honors a Lawyers Club member whose community service has contributed to improving the status of women and promoting equality.

These recognitions acknowledge Kate’s sustained service and leadership within the broader legal community as well as the education and edtech sectors.

Stricter Chinese Scrutiny of Offshore Vehicles a Blow for Tech and Biotech IPO Candidates

Tue, 07 Apr 2026 16:05:00 Z

Michael Yu, partner in charge of Cooley’s Hong Kong office, was quoted in a South China Morning Post article about tightened Chinese regulatory scrutiny of offshore listing structures, explaining how such vehicles have historically helped attract US dollar‑denominated funds to Chinese companies. He also highlighted the additional regulatory procedures some funds may face when investing directly into entities incorporated in China versus the Cayman Islands.

Read the full article on the South China Morning Post.

Litigator of the (Past) Week: Shout-Out

Tue, 07 Apr 2026 16:02:30 Z

A Cooley team earned a shout-out on The American Lawyer’s Litigator of the (Past) Week Runners-Up and Shout-Outs list for representing Textron Aviation in litigation brought by 400 individual owners of Textron’s flagship, pursuing claims related to cosmetic cracking around the planes’ windows. US District Judge Daniel Crabtree granted summary judgment to Textron Aviation, finding that the express warranties for the planes had expired and that the plaintiffs couldn’t prove their breach of express warranty, fraud and negligent misrepresentation claims.

The Cooley team was led by William O’Connor and included Joshua Siegel, Matthew Martinez, Rachael Heller, and Mike Tetreault.

Read the article (subscription required) >

EU AI Act: Second Draft of Code of Practice on Transparency and Watermarking Published

Tue, 07 Apr 2026 16:00:00 Z

On 18 December 2025, we shared an update about the first draft of Code of Practice, which set critical and broadly applicable transparency and watermarking rules under the European Union Artificial Intelligence Act.

On 5 March 2026, the group of experts responsible for the code published the second draft of the Code of Practice on Transparency of AI-Generated Content (second draft code).

Where the first draft provided a high-level directional framework, this second draft represents a significant step forward. The document is moving towards an operationally concrete instrument that businesses can realistically map against their existing transparency and content provenance frameworks. While the final code will be a voluntary instrument, it is expected to become a key benchmark against which regulators assess compliance with Article 50.

Updated requirements for providers

Digitally signed metadata is now mandatory

This is the most operationally demanding new requirement. The second draft code mandates digitally signed, timestamped metadata containing:

Whether content is AI-generated or manipulated.
Interoperable identifier cross-referenceable by other layers.
Information on how to access the provider’s detection tool, all secured with certificate management.

Operationalising this requirement will require dedicated PKI infrastructure, integration with content provenance standards (likely C2PA or equivalent) and ongoing certificate life cycle management.

Fingerprinting or logging mechanisms for AI-generated or manipulated content which allow for checking whether an output has been generated or manipulated by a generative AI system are now framed explicitly as an optional additional measure which can be implemented at the discretion of the signatory in addition to digitally signed metadata and imperceptible watermarking.

Reclassification of GPAI model provider obligations from mandatory to voluntary

General-purpose AI (GPAI) model providers are now “encouraged” rather than required to implement relevant marking techniques at the model level. This increases the burden on system providers integrating such models, who cannot assume upstream models will arrive with built-in watermarking capabilities. For providers making models directly available to system providers, it reduces direct regulatory exposure, but it is possible that industry practice will evolve, or commercial contracts may include provisions requiring watermarking regardless of what the second draft code requires.

Mandatory, free of charge, EU-localised detection mechanisms

The second draft code requires signatories to provide a publicly available detection tool for the content generated or manipulated by their AI systems, which is free of charge, EU localised (implementable locally or hosted within the EU) and General Data Protection Regulation-compliant in its processing. Providers will also be required to make their detection tools available to authorities if the provider exits the market.

Mandatory cooperation on provider-agnostic detection interface and interoperability infrastructure

The second draft code introduces a cooperative obligation to develop an interoperable, provider-agnostic detection interface. This is combined with the development of a shared repository of public watermarks, metadata repository addresses and detector addresses. The detection interface is required to be executable locally on a computer and must provide a common entry point to all detection mechanisms employed by providers of generative AI systems.

These cooperation obligations are framed as mandatory for signatories in the second draft code. For providers, particularly the largest AI system providers, it means current proprietary detection approaches will need to be designed (or redesigned) with interoperability in mind or stand-alone detection frameworks negotiated across industry from scratch.

Updated requirements for deployers

Update from common taxonomy to labelling requirements

The first draft required deployers to classify content as “fully AI-generated” or “AI-assisted” and apply different disclosure accordingly. This would have been a significant ongoing classification burden. Its removal simplifies compliance, and the second draft code replaces this with modality-specific placement rules for the “AI” acronym design standard. This provides more of a checklist approach to compliance with the marking requirement.

Deployers across media, advertising, platforms and publishing will need to redesign content workflows to ensure they are compliant with the requirements detailed in the second draft code. The detailed modality-specific rules (persistent display for short video, repeated disclaimers for long audio, etc.) offer greater compliance certainty in most cases, though deployers should note that implementation of labelling is contextual. Where the disclosure options mentioned in the second draft code are not available or would affect the display or enjoyment of the work, a deployer may conceive of alternative solutions.

Reduced compliance framework burden

Splits training, compliance and monitoring requirements from the first draft into proportionate compliance, awareness and review, with:

Internal compliance documentation.
Awareness and training (which softened from mandatory training to reasonable and proportionate efforts).
Review, feedback, and cooperation, introducing channels for flagging missing or incorrect disclosures.

Prohibition on label removal for onward content dissemination

When making reference to disclosures/markings of generated or manipulated content, the second draft code states that disclosure should always “travel with the content”. The second draft code, like the first, does not make any suggestion as to how deployers could prevent end-users from removing content markings before sending generated or manipulated content onward.

The logic of this requirement is also not clear. Given that the provisions of the EU AI Act only apply to deployers when generating deep fakes and/or AI-generated and -manipulated text using an AI model, an end-user could, and very likely will, remove the AI labelling. This could be done for a number of reasons, including the end-user’s own enjoyment of the content or the incorporation of the whole, or a piece, of that generated content into another piece of work. Content that should be marked as synthetic in one context does not obviously need to retain that marking in subsequent contexts.

Compliance documentation changes

Deployers are now no longer required to record date of review, approval reference and file identifiers – a departure from the previous draft, which required specific logs for reliance on the editorial exemption. These requirements are replaced with the need to publish:

Identification of the person with editorial responsibility.
An overview of organisational measures ensuring adequate review.
A new requirement to publish contact details, where not already publicly available.

What’s next?

Now that feedback from stakeholders has been incorporated into the draft, the European Commission will consider any further comments with a view to finalising the code by the beginning of June.

This final code will eventually serve as a key mechanism for demonstrating compliance with the EU AI Act’s transparency obligations (which will come into effect on 2 August 2026), though adherence to the code will not by itself constitute conclusive evidence of compliance. Companies operating in the EU should review the changes above, along with our December 2025 Cooley alert, to assess the readiness of their current watermarking and labelling infrastructure and consider making comments if they feel strongly about any aspect of the second draft code.

Bell Textron Secures Dismissal of State Claims in Osprey Product Liability Litigation

Tue, 07 Apr 2026 07:00:00 Z

San Diego – April 7, 2026 – Cooley secured a major litigation victory for Bell Textron, winning dismissal of all state law claims in a high-profile product liability case pending in the US District Court for the Eastern District of Pennsylvania.

District Judge John F. Murphy granted Bell’s motion to dismiss, ruling that federal law – specifically, the Death on the High Seas Act (DOHSA) – preempts the plaintiffs’ state law claims in their entirety.

The case arises from the 2023 crash of a US Air Force CV-22B Osprey off the coast of Japan, in which eight airmen tragically perished. The plaintiffs are the personal representatives of the decedents, who alleged various state law claims against several manufacturers of the Osprey and its components, including strict product liability, negligence and others. Judge Murphy’s ruling prevents those claims from going forward, instead requiring the plaintiffs to re-plead their claims under the federal DOHSA statute.

Bell Textron, manufacturer of the Huey, Cobra and a host of other iconic rotorcraft, is one of the most storied aircraft manufacturers in the world. It is a subsidiary of Textron, a New York Stock Exchange-listed American industrial conglomerate based in Providence, Rhode Island.

Read the order

The Cooley team advising Bell is led by partners William O’Connor and Koji Fukumura, and supported by associates Chip Harrison, Rachael Heller, Mike Tetreault and Harris McLeod.

The case is Boozer et al. v. Bell Textron, Inc. et al.

Neurocrine Acquisition of Soleno for $2.9 Billion

Mon, 06 Apr 2026 19:59:00 Z

Cooley advised Neurocrine, a leading biopharmaceutical company, on its agreement to acquire Soleno, a biopharmaceutical company developing and commercializing novel therapeutics for the treatment of rare diseases, for $2.9 billion.

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

Lead Team: Jamie Leigh and Kevin Cooper led the Cooley team advising Neurocrine.

Supporting Team: Ryan Genkin, Nicholaus Johnson, Katie Benvenuti, Nicholas Orr, Sunny Liu, Michelle Hunt, Vittoria Rainone, Joe Perry, Matthew Scarano and Sharon Davidov provided invaluable support.

Cooley has served as Neurocrine’s primary corporate and transactional counsel for approximately 20 years. During that time, the firm has advised the company on a variety of matters, including its acquisition of Diurnal (2023) and its $517.5 million private offering of convertible senior notes (2017). Cooley has also counseled Neurocrine on numerous license agreements with leading life sciences companies, including Mitsubishi Tanabe Pharma (2015), Xenon (2019), Takeda (2020), Sosei Heptares (2021), Voyager Therapeutics (2023), and TransThera (2025).

Is FDA Moving the Goalposts on 483 Responses? What the New Draft Guidance Means for Your Company

Mon, 06 Apr 2026 07:00:00 Z

The US Food and Drug Administration (FDA) has issued new draft guidance giving drug manufacturers – for the first time – formal guidance on how the agency expects firms to respond to a Form FDA 483 following a drug current Good Manufacturing Practice (cGMP) inspection. The guidance is broad in scope and applies to both foreign and domestic facilities that manufacture human or animal drugs regulated by the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) or Center for Veterinary Medicine (CVM), extending to combination-product manufacturers when CDER or CBER is the lead center. Until now, companies have largely relied on experience and institutional knowledge to determine what a “good” response looks like. This draft guidance puts structure around the process, signaling that FDA now expects 483 responses to follow a more consistent structure and be clearly tied to the strength and reliability of a facility’s broader quality system.

FDA also explicitly asks manufacturers to identify the response preparer and, if the preparer is not the company itself, to provide a letter of authorization from the consultant or outside counsel who prepared the response on the manufacturer’s behalf. Moreover, FDA is specific in its requests for large-scale compliance efforts, such as reports covering global pharmacovigilance investigations. In this way, the new guidance articulates what FDA insiders have often advised: FDA wants to see that a company has not only addressed, or is actively addressing, the observations in a 483, but is also fully assessing and correcting any underlying systemic issues.

Recommended practices

The draft guidance highlights several elements FDA views as important for a robust response. Several of these elements relate to format or other logistical requirements – a table of contents, a copy of the 483, identity of the response preparer and letters of authorization if the company retained a consultant or outside counsel. More substantively, FDA recommends an executive summary of all remediation activities followed by a more detailed description of each observation and associated remediation plans, including risk assessments of the observations, detailed investigation reports and signed attachments to support the company’s response.

Disagreements

FDA recommends that companies seek clarification and address disagreements related to scientific or technical issues during an inspection with FDA investigators. If a significant disagreement is not resolved before issuance of the 483, companies should communicate these concerns in their 483 response. Companies will want to describe the contested facts and provide scientific data and supporting information to allow FDA to better evaluate the concern. Moreover, companies should reference applicable laws, regulations and guidance that support their position.

Preliminary results and interim reporting

FDA recommends that, if there are remediation activities that are not complete at the time a company submits its response (which is often the case), the company should submit preliminary results with a timeline for completion. Companies should also highlight interim measures put in place until the corrective actions and preventive actions (CAPAs) are complete. FDA expects CAPA plans to be measurable and verifiable, and companies can expect such plans to be evaluated by FDA in a future inspection to ensure the planned actions were effectively implemented.

Importance of timing

The 15-business-day time frame for a 483 response is critical. Although a company is not required to provide a response within this time frame, timely submission improves a company’s likelihood of avoiding a compliance or enforcement action. That said, some corrective actions, particularly those of the holistic nature FDA expects, cannot be accomplished in a 15-day time frame. Moreover, FDA states in the draft guidance that it will not typically delay a regulatory action, such as issuing a warning letter, particularly if FDA observed significant deficiencies concerning product quality or patient safety during the inspection. This leaves companies in the hard position of promising comprehensive corrective actions on a broader scale and wanting to submit complete responses within the 15-day time frame that reflect the actions the company has taken in that time period. In this way, the guidance may not actually achieve FDA’s goals, leaving manufacturers to determine the best strategy for the 483 response in light of their specific timelines for corrective actions.

See the big picture

While the draft guidance clarifies what FDA expects to see in an individual response, it also makes clear that the agency is looking for companies to conduct systemic investigations and assess observations in the context of their overall quality system. Specifically, FDA encourages companies to explain “conditions or systemic issues that led to the observations,” and to include information about “the scope of the issue, effect on other drugs, and whether the observation is an isolated incident or is systemic in nature.” Put simply, FDA wants to understand whether a finding reflects a one off problem or evidence of a broader breakdown. The guidance also notes that firm management plays an important role in ensuring the quality system can support this kind of evaluation and in maintaining the overall effectiveness of the system.

Manufacturers should be prepared for FDA to continue to take a broad view of their operations as it evaluates the response. FDA will consider not only the observation itself, but also what the company’s assessment and supporting information reveal about the strength and effectiveness of its quality system.

Practical concerns

The guidance raises some practical concerns that may warrant submission of comments for the agency’s consideration. For example, as discussed above, the tension between the 15-business-day response window and the breadth of information FDA expects in the initial response, coupled with the agency’s position that it will not ordinarily delay regulatory action to review late-submitted responses, could disadvantage many small and mid-size companies. Although the guidance encourages interim reporting, it does not expressly commit FDA to consider such submissions in its enforcement decision-making. This dynamic could encourage companies to rush comprehensive investigations to avoid having their assessments and corrective actions disregarded.

Bottom line: Companies should continue to prioritize submitting as comprehensive a response as possible within the 15-business-day window. A timely, well-organized submission that acknowledges ongoing remediation efforts can demonstrate good faith and may position a company more favorably if FDA initiates further enforcement action. This is particularly important in the context of more serious enforcement tools, such as injunctions. To obtain injunctive relief, FDA must show, among other things, a likelihood of recurring violations, and that the company is unwilling or unable to comply with the law. A company’s documented efforts to investigate and remediate 483 observations –including interim reports and CAPA implementation timelines – may be directly relevant to that analysis and could undermine FDA’s ability to satisfy this standard. In addition, the guidance appears to take an expansive view of quality investigation requirements. It recommends that companies prepare an investigation plan that includes a detailed protocol and methodology, a scientifically justified and risk-based scope, and justification for excluding any part of an establishment’s operations from the investigation.

These recommendations – together with the guidance’s recommendation that a comprehensive investigation plan be prepared to address FDA’s 483 observations by including identification of any related trends, linking any connected FDA 483 observations, assessing risks and analyzing root cause – appear to go beyond what is currently required under existing regulations. Thus, this particular area seems to merit industry comments, as the guidance’s detailed recommendations concerning the form and substance of the 483 response may set a higher bar than current regulations warrant.

Looking ahead

In short, while the draft guidance provides a helpful framework,¹ it leaves important questions unanswered, including the role of interim submissions and how FDA will weigh ongoing remediation efforts in its enforcement decision-making.

The Cooley team, including former FDA enforcement attorneys, is available to help you assess how this draft guidance may affect your operations and prepare for evolving FDA expectations. FDA is accepting public comments on the draft guidance through May 8, 2026, and submitting by that date will ensure your feedback is considered as the agency works on the final guidance. Please reach out with any questions or if you would like assistance preparing comments.

Note

This draft guidance does not apply to medical devices and, thus, device companies should continue to follow 21 CFR Part 820 and related guidance concerning device inspections. However, some key points from the draft guidance, including the importance of submitting a 483 response within 15 business days and developing comprehensive, risk-based CAPA plans with root-cause analysis, provide useful guidance for device firms as well.

Drinks With The Deal: Cooley’s Proffitt on Leading Through Change

Thu, 02 Apr 2026 20:40:33 Z

Rachel Proffitt, Cooley partner and CEO, discusses her approach to leadership, talent management, structural shifts in the legal industry and the use of artificial intelligence on Drinks With The Deal, a podcast series hosted by David Marcus.

Listen to the podcast

‘Cracks show’ as CDRH Staff Contend With Heavy Workloads

Wed, 01 Apr 2026 20:23:48 Z

Cooley special counsel Son Nguyen was quoted in a Medtech Dive article examining how the US Department of Health and Human Services, specifically the Center for Devices and Radiological Health (CDHR), is impacted by staff cuts a year later. He noted the continued uncertainty among current staff members and mid-application decision changes.

Read the article

Daily Journal Names Cooley Partner Among Leading Litigators

Wed, 01 Apr 2026 18:17:00 Z

San Diego – April 1, 2026 – The Daily Journal has recognized Cooley partner Michael Attanasio among its Leading Commercial Litigators in an annual series honoring California’s best attorneys working on commercial litigation and bet-the-company cases nationwide.

In its coverage, the publication noted Attanasio’s advocacy on behalf of market-leading companies and in headline-grabbing cases.

Attanasio’s successes include his role as lead counsel to Jenner & Block LLP in its challenge to a retaliatory executive order issued by President Donald Trump, which threatened the firm by revoking security clearances and restricting work with federal contractors. Attanasio led a Cooley team that secured a temporary restraining order, followed by a permanent injunction and summary judgment. Attanasio argued both motions before packed courtrooms.

As Attanasio noted in the article, “Our successful defence of Jenner and the rule of law is one of the highlights of my career.” Addressing the role of mentorship in the profession, Attanasio stated, “The throughline is that zealous advocacy and integrity are not mutually exclusive, and a lawyer’s reputation for those qualities is priceless.” A former prosecutor in the U.S. Department of Justice’s Public Integrity Section, Attanasio also reflected in the article on recent developments in the Department and his former unit.

Read Attanasio’s profile (subscription required) >

Attanasio is a nationally recognized first-chair trial lawyer who focuses on commercial litigation and white-collar defense and investigations. A Fellow in the American College of Trial Lawyers, he chaired Cooley’s global litigation department from 2013 to 2024, overseeing not only the department’s courtroom successes, but also its unprecedented expansion and economic growth.

Korsana Biosciences Announces Merger With Cyclerion Therapeutics, Concurrent $380 Million Private Financing

Wed, 01 Apr 2026 16:10:00 Z

San Diego – April 1, 2026 – Cooley advised the placement agents to Korsana Biosciences, a privately held biotechnology company discovering and developing novel therapies to reduce the burden of neurodegenerative diseases, in connection with an approximately $380 million private placement concurrent with its merger with Cyclerion Therapeutics. The syndicate of investors is led by Fairmount and Venrock Healthcare Capital Partners, with participation from General Atlantic, TCGX, Forbion, Wellington Management, Commodore Capital, RA Capital Management, RTW Investments, Vivo Capital, Janus Henderson Investors, Foresite Capital, J.P. Morgan Life Sciences Private Capital, SR One, Sanofi Ventures, Kalehua Capital, Spruce Street Capital and other leading investment management firms.

Partners Charlie Kim, Div Gupta and Denny Won led the Cooley team advising the placement agents.

New York’s Frontier AI Law Gets a California Makeover – With Some Key Differences

Wed, 01 Apr 2026 15:31:00 Z

New York is joining California in regulating the most advanced forms of artificial intelligence – frontier models – and creating a state-led US AI regulatory approach in the absence of federal legislation. On March 27, 2026, Gov. Kathy Hochul signed an amended version of the Responsible AI Safety and Education (RAISE) Act, substantially overhauling the original law she signed in December 2025. The result closely tracks California’s Transparency in Frontier Artificial Intelligence Act (TFAIA) in many respects but diverges in a few important ways.

Hochul signed the original RAISE Act with an approval memo flagging concerns and conditioning her signature on an agreement with lawmakers to adopt chapter amendments in 2026. Those amendments are now law. Most changes align the RAISE Act with the TFAIA, which took effect January 1, 2026, as the first state law requiring standardized safety and transparency disclosures from frontier model developers. But the amended RAISE Act also makes important additions related to incident response, ownership disclosures, penalties and regulatory oversight.

These state laws are emerging as the federal government considers its own AI regulation. As we discussed on March 25, the White House is urging Congress to preempt state AI laws, which could have an impact on the RAISE Act and the TFAIA. However, until Congress or courts act, both laws remain in force, and frontier AI companies should ensure their compliance programs are prepared.

Below, we outline the most notable changes in the amended RAISE Act and where those changes align with or diverge from the TFAIA.

Notable RAISE Act changes aligning with the TFAIA

New framework and transparency requirements

The amended RAISE Act replaces the original law’s requirement to publish and maintain a “safety and security protocol,” with a new obligation to publish a “frontier AI framework” – the same term used in the TFAIA. Under the original RAISE Act, the safety and security protocol had to specify protections to reduce the risk of “critical harm,” describe cybersecurity measures, detail testing procedures, and designate senior compliance personnel. The amended law instead requires large frontier developers to publish a frontier AI framework describing how the developer handles “catastrophic risk” thresholds, mitigations, third-party evaluations, cybersecurity practices, critical safety incidents, and internal governance. These framework requirements, including the defined term “catastrophic risk,” are copied from the TFAIA.

The amended RAISE Act introduces a transparency report requirement that has no counterpart in the original law and mirrors the TFAIA. Before or concurrently with deploying a new frontier model or a substantially modified version of an existing one, frontier developers must publish a report disclosing the model’s release date, supported languages, output modalities, intended uses, and any restrictions on use. Large frontier developers must additionally include summaries of catastrophic risk assessments and the extent of third-party evaluator involvement. In the industry, these reports are often referred to as model cards.

Dropped audit requirement

The original RAISE Act required large developers to annually retain a third party to perform an independent compliance audit and publish a redacted version of the resulting report. The amended law dropped this audit requirement entirely, aligning with the TFAIA, which contains no audit mandate.

Deployment restriction removed

The original RAISE Act prohibited large developers from deploying a frontier model if doing so would “create an unreasonable risk of critical harm.” The amended law removes this prohibition. Like the TFAIA, the amended RAISE Act focuses on transparency and reporting rather than imposing prescriptive deployment restrictions.

Revised definitions for key terms

The amended RAISE Act overhauls several key definitions. The original law’s “critical harm” threshold meant death or serious injury of 100 or more people or at least $1 billion in damages arising from specific types of frontier model conduct related to chemical, biological, radiological or nuclear (CBRN) weapons or autonomous conduct. In the amended law, this term is replaced by “catastrophic risk,” which is defined as a foreseeable and material risk of death or serious injury to more than 50 people or more than $1 billion in damage. In addition, the “catastrophic risk” definition relies on the same general categories of model conduct but revises the language to specify harm from a single incident involving a frontier model providing expert-level CBRN weapon assistance, engaging in specified criminal conduct without meaningful human oversight, or evading developer or user control. This definition of “catastrophic risk” is also found in the TFAIA.

The amended RAISE Act also revises which companies are covered. The original law defined “large developers” by compute cost, meaning those spending more than $5 million on a single frontier model and more than $100 million in aggregate. The amended version instead covers “large frontier developers,” defined – as in the TFAIA – that, together with their affiliates, had annual gross revenues exceeding $500 million in the preceding calendar year.

The amended RAISE Act also changed the definition of “frontier model,” tracking California’s approach. The original RAISE Act captured any AI model trained using more than 10²⁶ computational operations and costing more than $100 million in compute, or any model derived through knowledge distillation from a frontier model. The amended law removed both the dollar-cost threshold and the knowledge distillation prong, leaving in its place the compute threshold for the most advanced, emerging models. Under the amended law, a “frontier model” is now a “foundation model” trained using computing power of more than 10²⁶ operations, which includes “any subsequent fine-tuning, reinforcement learning, or other material modifications.” That definition is lifted nearly verbatim from California’s TFAIA. For developers, the explicit inclusion of fine-tuning and reinforcement learning runs in the compute count means post-training modifications could push a model across the threshold even if the original pre-training run did not.

Catastrophic risk assessment submissions

The amended RAISE Act adds a requirement for large frontier developers to transmit summaries of catastrophic risk assessments from internal use of their frontier models to the regulator every three months or on another reasonable schedule agreed upon with the regulator. This matches the TFAIA’s requirements.

Federal reciprocity for incident reporting

The amended RAISE Act introduces a federal reciprocity provision permitting frontier developers to satisfy the law’s “critical safety incident” reporting requirements by complying with federal laws, regulations, or guidance documents that impose “substantially equivalent” or stricter standards, as designated by the New York regulator. Developers electing the reciprocity path must send copies of any federal incident reports to the New York regulator concurrently. This mechanism mirrors the TFAIA’s approach.

Notable RAISE Act changes diverging from the TFAIA

Reduction of monetary penalties

The amended RAISE Act reduces maximum civil penalties from the original law’s $10 million for a first violation and $30 million for subsequent violations to $1 million and $3 million, respectively. While this is a significant reduction, the RAISE Act still permits higher penalties than the TFAIA, which caps all violations at $1 million per violation, regardless of whether it is a first or subsequent offense.

Removal of frontier-specific whistleblower and employee protections

The original RAISE Act contained a dedicated section protecting employees, including contractors, subcontractors, and corporate officers, from retaliation for reporting safety concerns to the developer or the New York attorney general. The amended law removes this section entirely. This is a notable departure from the TFAIA, which includes frontier-specific whistleblower protections, prohibiting frontier developers from retaliating against covered employees who disclose information about catastrophic risks or TFAIA violations, and requiring large frontier developers to maintain an anonymous internal reporting process.

Shorter incident reporting timelines

The amended RAISE Act retains the original version’s 72-hour window for reporting critical safety incidents but adds a 24-hour reporting requirement for incidents posing an “imminent risk of death or serious physical injury.” The RAISE Act’s 72-hour baseline is significantly shorter than the TFAIA’s, which provides a longer baseline window of 15 days for critical safety incident reports. However, the TFAIA also requires 24-hour disclosure for incidents posing imminent risk of death or serious physical injury.

New large frontier developer disclosure requirement

The amended RAISE Act adds a “large frontier developer disclosure” provision with no parallel in the TFAIA. Under the RAISE Act, large frontier developers may not develop, deploy or operate a frontier model in New York without filing a current disclosure statement with the regulator and paying a required assessment. Disclosure statements must be renewed at least every two years and identify the developer’s corporate names, New York addresses, certain beneficial owners, and designated points of contact. Large frontier developers will also be required to pay a fee to defray the regulator’s operating expenses. The regulator is required to publish a list of developers who file disclosure statements.

New effective date

The amended RAISE Act takes effect on January 1, 2027, which is one year after the TFAIA’s effective date of January 1, 2026. This gives frontier developers additional time to prepare for compliance in New York, though companies already subject to the TFAIA will have had a year of experience with substantially similar requirements.

Oversight shift and rulemaking authority

The amended RAISE Act shifts regulatory oversight from the New York Division of Homeland Security and Emergency Services to a new office within the New York Department of Financial Services (DFS Office). The DFS Office will receive disclosures, incident reports and catastrophic risk assessment summaries, with authority to share reports with other governmental entities, including the New York attorney general. The amended law also grants the DFS Office broad rulemaking authority to implement the law, including the power to consider “additional reporting or publication requirements.” DFS already oversees a range of cybersecurity matters, including experience with cyber incident reporting for covered entities, and is an active regulator. The TFAIA does not have a similar grant of rulemaking authority to the administrating agency.

Territorial scope

The RAISE Act is explicitly limited to frontier models “developed, deployed, or operating in whole or in part in New York state.” The TFAIA contains no express territorial limitation. California courts generally apply a presumption against extraterritoriality of state law.

Academic exemptions

The RAISE Act exempts accredited colleges and universities in New York engaged in academic research, as well as the Empire AI consortium, a public-private AI research partnership. The TFAIA contains no comparable exemptions for academic institutions.

Key takeaways

The amended RAISE Act signals a meaningful convergence with California on how to regulate frontier AI, aligning two of the country’s largest and most influential state economies in the absence of federal legislation. Companies developing or deploying frontier models may consider several practical implications.

First, the substantial alignment between the RAISE Act and the TFAIA suggests that a harmonized compliance approach is feasible, but developers must account for key differences. In particular, the RAISE Act includes shorter incident reporting timelines, higher penalty ceilings for repeat violations, and new ownership disclosure requirements, and the DFS Office’s rulemaking authority may introduce further distinctions.
Second, while the RAISE Act primarily targets developers, companies that fine-tune, retrain or otherwise materially modify frontier models should assess whether those activities bring them within the law’s scope.
Finally, with the White House urging AI legislation to preempt state laws, companies should maintain compliance with existing state laws while closely monitoring developments in Washington that could reshape the regulatory landscape.

Cooley Shortlisted for Seven Awards at ALB China Law Awards 2026

Wed, 01 Apr 2026 15:06:00 Z

Beijing, Hong Kong and Shanghai – Cooley was shortlisted by Asian Legal Business (ALB) in its annual China Law Awards series, which honors the exceptional achievements of private practitioners and in-house teams across China. ALB recognized the firm’s work in seven award categories – four for the entire firm, two for deal work and one for individual lawyers.

Cooley was shortlisted for International Law Firm of the Year, International Deal Firm of the Year, Capital Markets Law Firm of the Year – Overseas, and Private Equity Law Firm of the Year – International.

The firm was shortlisted for Equity Market Deal of the Year – Midsize for its representation of Butong Group on its HK$781 million initial public offering (IPO), in addition to being shortlisted for Equity Market Deal of the Year – Premium for its representation of the underwriters of Seres Group on its HK$14.28 billion IPO.

In addition, Cooley partner Yiming Liu was shortlisted for Dealmaker of the Year – International.

Read the full shortlist

The awards will be presented in April during the annual awards ceremony in Beijing.

Cooley’s Beijing, Hong Kong and Shanghai offices represent a growing number of China’s most innovative and dynamic tech and life sciences companies, advising them from formation through financing and exit. The teams’ in-depth subject matter knowledge and transactional prowess enable the firm to handle a raft of corporate, finance, M&A and capital markets work for international and China-based high-tech and life sciences entities engaged in inbound and outbound endeavors.

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

Wed, 01 Apr 2026 07:00:00 Z

New York – April 1, 2026 – Cooley’s global mergers and acquisitions and private equity practices were again recognized for top ranking positions in Q1 league tables from Bloomberg*. Despite the unpredictable market, Cooley continues to dominate in public and private deals around the world.

Cooley’s 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
#2 for US mid-market M&A
#3 for global mid-market M&A
#2 for US and global private equity deals

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

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 M&A and PE groups include 180+ practitioners in major business and technology centers worldwide, representing all categories of participants in transactions.

Investors Are Suing Over Proxy Proposals – Here’s What to Know

Tue, 31 Mar 2026 15:18:37 Z

Cooley special counsel Michael Mencher was quoted in an FT Agenda article about the US Securities and Exchange Commission’s (SEC) withdrawal from Rule14a-8 no action process and how companies should approach the change.

Read the article (subscription required)

Pro Football Focus Sale of Enterprise Business to Teamworks

Tue, 31 Mar 2026 12:29:02 Z

Cooley advised Pro Football Focus (PFF) on the sale of its enterprise business, including its proprietary game event data and analytics platform that NFL teams and collegiate football programs rely on daily, to Teamworks, the Operating System for Sports™ powering more than 7,000 elite sports organizations globally.

The transaction was announced publicly here: Teamworks Acquires PFF's Enterprise Business, Cementing Position as the Leading AI Platform in American Football

Lead Team: Bram Couvreur, Bobby Ghajar, Raphael Davidian, Todd Gluth, Chris Chynoweth, Ellie Seber, Ross Eberly, Ryan Montgomery, Megan Browdie, and Michael Egan led the Cooley team advising Pro Football Focus.

Supporting Team: Galen Pham, Daniel Moses, Michael Gladstone, Patrick Sharma, Tony Guan, Jennifer Ok, Allison Nostdahl, and Bryan Berman provided invaluable support.

Geron Corporation Secures Dismissal of Federal Securities Class Action

Mon, 30 Mar 2026 20:17:00 Z

San Diego – March 30, 2026 – Cooley secured a dismissal without prejudice for Geron Corporation and its officers in a securities fraud class action arising from the company’s commercialization of its first-in-class blood cancer drug RYTELO. The lawsuit alleged that Geron made material misstatements and false or misleading statements about the company’s preparedness for launch and success commercializing RYTELO.

On March 30, 2026, Judge Vince Chhabria of the US District Court for the Northern District of California granted the motion to dismiss without prejudice, holding that the plaintiffs failed to adequately allege a plausible inference that Geron intended to defraud investors about its commercial launch progress. The court further held that many of “plaintiffs’ claims do not even come close to surviving dismissal” and noted that the court is “skeptical that the plaintiffs will be able to state a claim” with respect to the vast majority of statements that the plaintiffs alleged were false or misleading.

Read the order

Partners Ryan Blair and Brett De Jarnette led the Cooley team representing Geron Corporation, along with associates Caitlin Munley, Nicholas Orr and Vivienne Goldschlag.

The case is In re Geron Corporation Securities Litigation before the Northern District of California.

Kezar Life Sciences Acquired by Aurinia Pharmaceuticals

Mon, 30 Mar 2026 19:25:56 Z

Cooley advised Kezar Life Sciences, a biotechnology company focusing on small-molecule therapeutics to treat unmet needs in autoimmunity and cancer, on its agreement to be acquired by Aurinia Pharmaceuticals, a biopharmaceutical company focused on developing therapies to people living with autoimmune diseases with high unmet medical needs, for $6.955 in cash per share of Kezar common stock, plus one non-transferable contingent value right.

The transaction was announced publicly in the Aurinia Pharmaceuticals' press release, which can be viewed here: Aurinia Pharmaceuticals to Acquire Kezar Life Sciences for $6.955 in Cash per Share Plus a Contingent Value Right

Lead Team: Bill Roegge, Rita Sobral, Laura Berezin, Jaime Chase, and Parth Bhatt led the Cooley team advising Kezar Life Sciences.

Cooley previously advised Kezar Life Sciences on its $50 million Series B financing (2017), $75 million IPO (2018), and response to an unsolicited takeover proposal from Tang Capital Management, including its adoption of a shareholder rights plan.

Navigating Life Sciences Deals Amid Heightened Scrutiny

Mon, 30 Mar 2026 16:18:49 Z

Cooley partners Sarah Hogan, Jenna Ventorino, Stephen Abreu and Stephanie Hales co-authored an article for Law360 about how most favored nation and drug pricing initiatives, the Biosecure Act and broader market uncertainty affect life sciences transactions.

Read the article

Textron Aviation Secures Summary Judgment

Mon, 30 Mar 2026 14:41:00 Z

San Francisco – March 30, 2026Cooley secured a summary judgment for Textron Aviation, a subsidiary of Textron, in a significant fleetwide dispute concerning the Cessna TTx aircraft.

Textron, a New York Stock Exchange-listed American industrial conglomerate based in Providence, Rhode Island, has revenues exceeding $13 billion. Since 1992, it has owned Cessna, one of the most recognizable names in general aviation manufacturing.

A group of more than 400 individual plaintiffs, owners of Textron’s flagship high-performance aircraft known as the Cessna TTx, sued Textron due to their aircraft exhibiting cosmetic cracking around the windows. The suit alleged that when Textron’s subsidiary Cessna purchased airplane manufacturer Columbia Aircraft Company out of bankruptcy in 2007, Cessna promised to fix all cosmetic cracking in the TTx line regardless of warranty status or whether the owner purchased their aircraft direct from the manufacturer or from a previous owner. The plaintiffs advanced breaches of express and implied warranties, strict products liability, negligence, fraudulent/negligent misrepresentation, and unfair trade practices claims against Textron. The parties selected nine bellwether plaintiffs for a trial that was scheduled for May 11, 2026.

After nearly seven years of litigation, on March 30, District Judge Daniel D. Crabtree granted the defendant’s motion for summary judgment, disposing all remaining claims against it.

Read the order >

The Cooley team advising Textron is led by partner William O’Connor, with special counsel Joshua Siegel, and associates Matthew Martinez, Rachael Heller and Mike Tetreault.

The case is Zone Five, LLC et al. v. Textron Aviation, Inc. before the US District Court for the District of Kansas.

The Legal 500 + Chambers Recognize Cooley in Europe

Fri, 27 Mar 2026 20:39:08 Z

Brussels and London – March 27, 2026 – This week, The Legal 500 guide covering Europe, the Middle East and Africa (EMEA) and Chambers Europe 2026 recognized Cooley in multiple practice areas across the European Union and United Kingdom.

The Legal 500 EMEA honored lawyers from Cooley’s Brussels office based on their work representing technology and media companies in EU regulatory law regarding privacy and data protection, information technology and financial services. The firm was also recognized in competition law in the EU and globally.

Cooley’s leading practice rankings include:

EU regulatory: Information technology
EU regulatory: Privacy and data protection +
EU regulatory: Financial services +
Media and entertainment
Competition: EU and global

Indicates Tier 1 ranking
+ Indicates improved ranking

Partner Patrick Van Eecke was honored as a leading individual for privacy and data protection, as well as information technology; special counsel Enrique Gallego Capdevila was praised for privacy and data protection as well as information technology; and associate Bartholomäus Regenhardt was recognized for information technology.

Additionally, Chambers Europe 2026 recognized Cooley with four practice rankings and eight individual lawyer rankings in their respective fields. Cooley lawyers in Brussels and London were noted for their work representing leading technology and media clients in EU regulatory law, competition law, data protection and information technology, corporate/M&A and tax.

Cooley’s leading practice rankings include:

Competition: EU – Belgium
Technology, Media and Telecommunications (TMT) – Belgium
Corporate/M&A: Mid-Market – UK
Tax – UK

Chambers Europe honored Cooley with eight individual lawyer rankings in their respective fields. Van Eecke was recognized for TMT: Data Protection, and both he and Gallego Capdevila were ranked for TMT: Information Technology. Brussels-based Jonas Koponen and London-based Mark Simpson and Caroline Hobson were each honored for competition law. Additionally, London-based Ben Shribman received a corporate/ M&A recognition, John Clark was ranked for leveraged finance, and David Wilson was recognized for tax law.

Supreme Court Confirms Limits on Contributory Liability for Copyright Infringement

Fri, 27 Mar 2026 18:59:00 Z

On March 25, 2026, in a unanimous decision, the US Supreme Court held that an internet service provider (ISP) was not contributorily liable for copyright infringement committed by its subscribers. Under the Supreme Court’s ruling, the intent required for contributory liability can be shown only if the service provider induced the infringement, or the provided service is tailored to that infringement. Justice Clarence Thomas penned the majority opinion in Cox Communications, Inc., et al., v. Sony Music Entertainment et al., 607 US ___ (2026). Justice Sonia Sotomayor filed the concurrence, which Justice Ketanji Brown Jackson joined.

Background of the dispute

Cox Communications is an ISP that serves millions of subscribers. In 2018, Sony and other copyright owners brought suit against Cox and its subsidiary for copyright infringement on the theory that ISPs are secondarily liable – including under theories of both contributory and vicarious infringement – for internet users using an ISP’s internet services to illegally reproduce and download copyrighted works.

Over a two-year period, Cox received notice of 163,148 incidents of infringement and implemented its 13-warning plan for each, but ultimately terminated only 32 subscribers’ accounts. Sony argued that this showed Cox was contributorily liable because it continued to provide internet services to subscribers it knew were infringing. Sony also contended that Cox was vicariously liable for the infringement because the ISP had a right and ability to supervise the infringers, and it financially benefitted from the acts of infringement.

Cox countered that the knowledge an ISP has about its users and their individual activities is limited. This is because, although ISPs assign an Internet Protocol (IP) address to each user’s account, a single IP address may cover a house, coffee shop, university or geographic region. It is therefore difficult to ascribe an activity to a particular user of an IP address, even if the ISP is aware of the IP address where infringement is occurring. Cox also argued that its users contractually agreed to not use its services for infringement purposes, and that it merely provided a service for which a substantial number of uses are non-infringing. There was no evidence that Cox had advertised the ability to infringe via its services.

After a trial in the US District Court for the Eastern District of Virginia, the jury found in favor of Sony on both contributory and vicarious liability. It also found that Cox’s infringement was willful and awarded Sony $1 billion in statutory damages. The district court denied Cox’s post-trial motion for judgment as a matter of law.

Cox appealed to the US Court of Appeals for the Fourth Circuit, where the court affirmed the ruling in part, finding Cox was contributorily liable for continuing to provide internet to known infringers. The Fourth Circuit reversed the vicarious liability finding because Cox did not financially benefit directly from the infringement, vacated the damages award and remanded for the jury to reassess damages based on contributory liability alone.

Both sides petitioned the Supreme Court for review. The Supreme Court granted Cox’s petition concerning contributory liability but denied Sony’s petition concerning vicarious liability.

Earlier cases on contributory liability

Unlike the Patent Act, the Copyright Act does not include a provision for contributory infringement (i.e., liability for infringement committed by another). Nevertheless, the Supreme Court has recognized the doctrine of contributory liability in the copyright context on multiple occasions.

In Sony Corp. of America v. Universal City Studios, Inc., 464 US 417 (1984), the Supreme Court found Sony was not contributorily liable for selling Betamax videotape recorders, which many consumers were using to create infringing copies of copyrighted works. The Supreme Court held that the sale of copying equipment, like the sale of other articles of commerce, does not constitute contributory infringement if the product is widely used for legitimate, unobjectionable purposes. The Betamax machines were capable of substantial non-infringing uses, and the sale of such equipment to the general public therefore did not constitute contributory infringement of the respondents’ copyrights.

More recently, in MGM Studios, Inc. v. Grokster, Ltd., 545 US 913 (2005), the Supreme Court found that peer-to-peer file sharing companies could be contributorily liable for inducing copyright infringers in the context of distribution of a device with the object of promoting its use to infringe copyright, as shown by clear expression or other affirmative steps taken to foster infringement.

In the wake of these Supreme Court decisions, some courts went a step further. For example, the US Court of Appeals for the Ninth Circuit held that, in the online context, a “computer system operator” is liable under a “material contribution theory of infringement ‘if it has actual knowledge that specific infringing material is available using its system, and can take simple measures to prevent further damage to copyrighted works, yet continues to provide access to infringing works’” (Perfect 10, Inc. v. Giganews, Inc., 847 F.3d 657, 671 (9th Cir. 2017)).

The Cox decision

The Supreme Court sided with Cox, holding that a service provider is contributorily liable for a service user’s infringement only if it induced the infringement or provided a service tailored to the infringement. Citing Grokster, the Supreme Court clarified that a service is tailored to infringement if it is not capable of “substantial” or “commercially significant” non-infringing uses. In doing so, the Supreme Court reinforced its long-standing precedent that service providers cannot be held liable for copyright infringement merely because they have knowledge that some users will exploit their service for that purpose. Here, the Supreme Court observed, Cox did not induce or encourage its subscribers to infringe, and in fact it repeatedly discouraged copyright infringement by users. While the case will be remanded, the Supreme Court has effectively put an end to Sony’s bid to revive its $1 billion award.

In reversing the Fourth Circuit’s ruling on contributory liability and remanding, the Supreme Court also confirmed that the Digital Millennium Copyright Act (DMCA) does not create liability for ISPs that continue to provide services to known infringers; rather, terminating repeat infringers to qualify for the DMCA safe harbor merely gives rise to a defense on which service providers can rely. Failure to comply with the DMCA safe harbor provisions does not itself create a basis for liability.

In the concurrence, Justice Sotomayor criticized the majority’s decision for limiting common law doctrines that she would have left open as possible theories of liability, like aiding and abetting. However, Justice Sotomayor concurred in the decision because Sony could not prove that Cox had the requisite intent to be liable on a common law aiding-and-abetting theory under the facts of this case.

Significance

This case is a significant win for ISPs and other service providers that may face copyright claims relating to the actions of their users. The Supreme Court’s decision confirms limits on contributory liability in the copyright context. To the extent that other theories of contributory liability had begun to emerge in the lower courts, whether under a “material contribution” theory or other common law theories, the Cox decision rejects such expansion of the doctrine of contributory infringement. However, service providers should continue to manage risk by maintaining reasonable policies and avoiding the paths to contributory liability left open by the Supreme Court’s decision.

Fifth Circuit Holds FTC Adjudication of Deceptive Advertising Claims Is Unconstitutional

Fri, 27 Mar 2026 07:00:00 Z

On March 20, 2026, the US Court of Appeals for the Fifth Circuit delivered a major decision in Intuit, Inc. v. FTC, holding that the Federal Trade Commission’s internal administrative adjudication of deceptive advertising claims violates the constitutional separation of powers. By vacating a 20-year cease-and-desist order against Intuit over its TurboTax “Free Edition” marketing, the Fifth Circuit has fundamentally disrupted the FTC’s enforcement playbook in that circuit.

This decision has important implications for the agency’s ability to obtain monetary relief and signals a potential shift in how the FTC will undertake its enforcement mission.

Background: The shadow of AMG

For decades, the FTC routinely used Section 13(b) of the FTC Act to go directly to federal court to obtain equitable monetary relief (like restitution and disgorgement). The US Supreme Court’s 2021 decision in AMG Capital Management, LLC v. FTC definitively stripped the FTC of this power, ruling that Section 13(b) only allows for injunctions, not monetary awards.

Post-AMG, the FTC was forced to rely on an arduous workaround to obtain money in most scenarios: Section 19 of the FTC Act. This required a two-step process. First, the FTC had to successfully sue a company in its own in-house administrative court to obtain a final cease-and-desist order. Then, the agency had to take that administrative order to federal court and prove the conduct was of a kind that a reasonable person would have known under the circumstances was dishonest or fraudulent, in order to secure monetary redress.

The holding

In Intuit, the Fifth Circuit essentially dismantled step one of that Section 19 workaround for deceptive advertising claims. Relying heavily on the Supreme Court’s recent decision in SEC v. Jarkesy, which held that the Securities and Exchange Commission’s use of administrative tribunals for fraud claims violated the Seventh Amendment right to a jury trial, the Fifth Circuit applied the same logic to the FTC. The court concluded that deceptive advertising claims under Section 5 of the FTC Act closely mirror the common law torts of fraud and deceit. Because these claims implicate traditional “private rights” rather than “public rights,” the Constitution requires them to be adjudicated in an Article III federal court, not by an in-house administrative law judge (ALJ).¹

Narrowing the path to monetary relief

This ruling is a major development because it effectively forecloses the FTC’s primary pathway to obtaining monetary relief in the Fifth Circuit for deceptive advertising practices in cases where:

No specific statute or trade regulation rule independently authorizes monetary remedies.
The company lacked actual knowledge that its conduct was unfair or deceptive (precluding civil penalties under Section 5(m)(1)(B)).
The FTC must therefore rely on the Section 19 administrative-order-first process to reach monetary redress.

If the FTC cannot constitutionally adjudicate deceptive advertising claims in its own administrative courts, it cannot secure the foundational administrative cease-and-desist order required to trigger Section 19. Without that order, the FTC cannot go to federal court for monetary redress in these cases in the Fifth Circuit.

The FTC’s remaining options

Because the administrative route to create new orders is now constitutionally suspect – at least in the Fifth Circuit – for deceptive advertising, the FTC will likely lean into alternative avenues to maintain its ability to obtain money through enforcement. We anticipate the agency will explore several strategic workarounds:

Aggressive enforcement of specific statutes and rules

The FTC will likely double down on enforcing specific federal statutes and their implementing regulations, such as the Children’s Online Privacy Protection Act (COPPA), the Restore Online Shoppers’ Confidence Act (ROSCA) and trade regulation rules. Violations of these statutes and rules allow the agency to seek civil penalties and consumer redress directly in federal district court, circumventing the administrative adjudication process entirely.

A surge in ‘Notices of Penalty Offenses’

Under Section 5(m)(1)(B), the FTC can seek civil penalties directly in federal court if a company engages in conduct it knows has been condemned in prior FTC administrative orders. By sending out “Notices of Penalty Offenses” – which attach older, finalized administrative decisions to hundreds of companies – the FTC can attempt to establish the requisite “actual knowledge” to seek monetary penalties. The FTC has used this mechanism in the past to enhance its ability to obtain monetary penalties for specific types of deceptive practices, such as unsubstantiated “Made in the USA” labeling claims, deceptive claims about money-making opportunities, unsupported claims about job placement rates for graduates of for-profit universities, deceptive endorsements and testimonials, and unfair practices related to commercial surveillance and data security. Expect the FTC to consider expanding its use of this tool.

A narrow reading of ‘advertising’

The Fifth Circuit specifically addressed “deceptive advertising,” but the FTC regulates an array of deceptive conduct. The decision leaves open whether general misrepresentations – for example, in a company's privacy policy – constitute “advertising" subject to the ruling. Where such a statement is designed to induce a consumer to use a service, it closely resembles common law fraud and likely falls into the Jarkesy “private rights” bucket, barring administrative adjudication. However, expect the FTC to argue that misstatements in privacy or data security disclosures are not advertising and distinct from common law deceit.

Pivoting to ‘unfairness’ claims

Section 5 prohibits both “deceptive” and “unfair” acts. While the court found deception has a common law analogue in fraud, “unfairness” (defined as practices causing substantial, unavoidable consumer injury not outweighed by benefits) is arguably a modern regulatory construct without a direct common law twin. The FTC may attempt to pivot to unfairness claims, arguing these implicate “public rights” and therefore survive the Jarkesy framework.

Coordination with state regulators

State attorneys general wield broad authority under state-level “little FTC Acts” – unfair or deceptive acts or practices (UDAP laws) – to seek monetary relief, including restitution and civil penalties, directly in state or federal court. With its own administrative avenues for monetary relief restricted in the Fifth Circuit, the FTC could increase its collaboration with state attorneys general, resulting in more joint enforcement actions or direct referrals to state authorities to ensure financial consequences for deceptive conduct.

The FTC retains its authority under Section 13(b) to go directly to federal court to seek preliminary and permanent injunctions. However, this power is statutorily limited. Section 13(b) only applies when the agency has reason to believe a company “is violating, or is about to violate” the law. The FTC can use this direct-to-court avenue to halt ongoing or imminent harm, but it cannot use it to pursue companies for purely past conduct that has already ceased, nor can it use this avenue to extract monetary settlements.

Echoes of AMG and looming circuit splits

The genesis of this decision strongly mirrors how the AMG decision came about. For nearly 40 years, appellate courts universally accepted the FTC’s Section 13(b) monetary authority – until the Seventh Circuit broke from that consensus, creating a circuit split that the Supreme Court ultimately resolved against the agency.

We are likely to witness a similar trajectory regarding the FTC’s administrative adjudication. Companies currently facing FTC administrative proceedings (whether for data privacy, dark patterns or false advertising) will quickly assert this Article III defense. As these cases are appealed to the DC, Ninth or other circuits, the potential for a circuit split is high, making this an issue ripe for Supreme Court review.

The concurrence: A roadmap for constitutional attack

Going further than the majority, the concurrence broadly questioned the fundamental constitutionality of the FTC itself. Specifically, Judge James Ho questioned whether the combination of legislative (rulemaking), executive (enforcement) and judicial (adjudication) powers in a single agency is consistent with the separation of powers principles embedded in the Constitution. His opinion serves as an open invitation for future litigants to mount existential structural challenges against the agency.

What you need to know now

The Intuit decision is a major strategic victory for targets of FTC investigations. Companies facing FTC scrutiny should reassess their litigation leverage, as the agency’s threat of a grueling, yearslong administrative proceeding just lost significant credibility – at least in the Fifth Circuit. However, companies should also brace for FTC counter-maneuvers, including a heavier reliance on rulemaking, unfairness claims, characterization of deceptive practices as violations of rules or statutes, Notices of Penalty Offenses and more coordinated enforcement with state partners.

If you have questions about how this decision impacts your business or your interactions with the FTC, please reach out to the Cooley lawyers listed below.

Note

While the FTC’s Rules of Practice technically permit the FTC itself, or individual commissioners, to preside over adjudicative hearings instead of an ALJ (16 CFR § 3.42), using this mechanism would almost certainly face the exact same constitutional defect. The Fifth Circuit’s ruling is rooted in the requirement for an Article III court and a jury trial for “private rights” claims; keeping the adjudication within the executive branch, regardless of who presides, fails to cure this violation.

Lessons From the Skies for Executive Compensation Programs

Fri, 27 Mar 2026 07:00:00 Z

As seasoned pilots know, a downward spiral often starts gradually, almost imperceptibly, unless you heed the early warning signs. If those signs are missed or ignored, trouble compounds. It’s often tough to know whether you’re really in a spiral until it starts to tighten, and at some point – sometimes seemingly suddenly – breaking free may no longer be possible.

So, you’re thinking, what does that have to do with the design and administration of executive compensation programs? Although the nexus is perhaps not immediately obvious, the hard lessons from the sky have something to teach us.

Unfortunately, unlike pilots with instruments tailored to reveal an incipient spiral, those responsible for making decisions about executive compensation programs don’t have specialized tools that can reliably identify external factors that could cause the program to misfire and fail to achieve its intended purpose. Most commonly those external factors relate to the broader macroeconomic climate – for instance, the 2008 financial crisis or, more recently, the COVID-19 pandemic. The volatility caused by financial or geopolitical shocks can easily disrupt compensation programs, leading them to a spiral toward dysfunction – for example, because of unanticipated swings in equity value or the depletion of cash reserves.

So is a spiral for compensation programs tightening? No one knows of course. The only thing that’s certain is that something will happen, even if that something is simply not much of anything. That realization will cause its own reckoning.

The lesson for executive compensation programs is to be prepared for the uncertainty and whatever may (or may not) come out of it. The playbook for that preparation is becoming well-worn, but it’s worth reviewing, particularly with the incentive award season in full swing.

As a refresher, some levers to keep at the ready are briefly described below along with some related considerations brought to the fore by volatility and its attendant uncertainty. Which levers to pull, if any, is a balancing act because compensation decision-makers (be that the board, compensation committee or a manager) must always remain focused on providing properly calibrated incentives with appropriate performance metrics and a reasonable assessment of performance against those metrics after taking volatility impacts into account among all other relevant factors. In a similar vein, compensation decision-makers need to be sensitive to how hard they pull on the levers to avoid overcorrection and ensure that the action is narrowly and otherwise appropriately tailored to the circumstances.

1. Consider the availability of company discretion to determine whether corporate or individual performance targets are met.

Companies may need to rely on, or build in more, discretion within their bonus plans or performance-based equity awards to provide flexibility to address volatility. Treatment of currently active compensation programs will differ from planning for programs that have not yet been established, because existing programs may have been established with limited flexibility in that regard. In any event, any actual use of discretion can risk adverse stockholder or proxy advisory firm reaction, particularly if the rationale for its use is not well articulated to stakeholders. It’s worth bearing in mind that when to exercise discretion – during a performance period or upon its completion – can sometimes be just as important as how it’s exercised.

2. Consider using stock price averages to determine the number of shares subject to incentive equity awards.

The impact of stock price fluctuations and market volatility can be reduced by using a trailing average stock price when determining the number of shares subject to an equity incentive award. For public companies, because the value shown for an award in the executive compensation table pursuant to Securities and Exchange Commission rules may differ from the award value communicated to executives based on the trailing average price, expectations may need to be managed. Stock price fluctuations can create especially acute problems when periodic share grants are denominated by a share number rather than dollar value, as is sometimes the case with director compensation programs – though of course a converse issue is that stock price declines can exhaust share reserves more quickly than anticipated where a target value is delivered.

3. Assess adequacy of share reserves.

Companies should confirm the number of shares available under their equity incentive compensation plans, including employee stock purchase plans (ESPPs), if applicable, to ensure that sufficient shares remain available, particularly if there has been a steep drop in price since the share pool was last assessed (or, in the case of an ESPP, since the commencement of the current offering period). Similarly, any individual or aggregate award limits under a plan based on share number may need to be revisited.

4. Preserve company cash if appropriate.

Uncertainty can often strain a company’s cash resources or at least require prudent cash flow management. Companies should consider whether they have the flexibility to settle awards in equity rather than cash, being mindful that doing so can trigger significant securities law, accounting and disclosure consequences. In addition, companies can explore the feasibility of limiting net settlement for exercise price payment or tax withholding purposes, with public companies perhaps providing it only to individuals subject to Section 16 reporting requirements.

5. Consider whether recent events have impacted the company’s 409A valuation.

Private companies should consider whether they may still rely on an Internal Revenue Code Section 409A valuation issued within the past 12 months. If a company’s situation is rapidly changing, it may make sense for the company to briefly pause new stock option grants and obtain a new 409A valuation once there’s more clarity around future developments.

6. Avoid or address underwater stock options.

If a company is concerned about a falling stock price, granting full value awards (e.g., restricted stock units) instead of stock options will avoid underwater options (i.e., options with exercise prices above the current market value). Stock option repricing and exchange programs can be powerful tools in the context of a prolonged market downturn, but they should be carefully considered before implementation.

7. Keep track of vesting and changes in employment status.

Companies anticipating workforce reductions should ensure that records of vested and unvested equity awards at the time of termination are current and accurate. It is also important to keep track of applicable provisions in equity awards that may be implicated when an award holder takes a leave of absence, transitions from full-time to part-time employment status or ceases employment entirely.

8. Reduced services now may have a lasting impact.

Section 409A generally measures a “separation from service” by reference to the average level of services performed by an employee or other service provider over the 36-month period immediately preceding the purported termination of employment or services. Companies maintaining any deferred compensation arrangements subject to Section 409A (which commonly include equity awards granted in the form of restricted stock units) should keep detailed records of any reduced service levels to avoid future disputes or IRS challenges.

* * *

Sometimes the only thing scarier than what’s in the rearview mirror is what you don’t yet know about the road up ahead. Being prepared for whatever you might run into is key to a smoothly and appropriately functioning executive compensation program. Cooley’s compensation and benefits group is ready to help you navigate that road ahead – and safely help pull you out of any spiral along the way.

Global Alliances: Structuring Successful Cross-Border Life Sciences Partnerships

Fri, 27 Mar 2026 00:23:06 Z

Cross-border life sciences partnerships have become one of the most powerful and complex routes to innovation. As deal activity involving Chinese biotech assets accelerates, companies are facing faster timelines, more sophisticated structures, new sources of pricing and regulatory uncertainty – reshaping how these transactions are crafted and executed.

While innovation remains the catalyst, success increasingly depends on execution. Successful companies are adapting quickly: rethinking the way deals are sourced, negotiated and structured to keep up with the evolving realities of the related marketing.

Life sciences leaders pursuing cross-border partnerships in this increasingly complex landscape should keep in mind the below themes when approaching the table:

Cross-border deal activity is accelerating.

There has been a significant improvement in the quality and maturity of assets emerging from China over the past decade, particularly in oncology and biologics. Faster generation of human clinical data and strong scientific execution have made Chinese biotech a compelling source of global partnering opportunities.

Deal timelines are compressing.

Competition for differentiated assets has led to increasingly compressed deal timelines. Parties often move quickly from initial evaluation to exclusivity, with negotiations that once took many months now closing in weeks. While speed can preserve momentum, it puts pressure on diligence and documentation.

Innovation is increasing structural complexity.

Advances in biologics are adding complexity to deal structures. Agreements must now address sophisticated development paths, manufacturing considerations and governance mechanisms tailored to these modalities.

MFN-related uncertainty is reshaping negotiations.

Emerging most-favored-nation (MFN)-style concerns related to pricing and policy have injected new uncertainty into dealmaking. Parties are increasingly negotiating trigger-based adjustments, conditional shifts in control, and financial consequences tied to future regulatory or pricing developments.

Cross‑border life sciences partnerships are no longer the exception – they are a core strategy for accessing innovation. The challenge is building them for resilience: balancing speed with structure, competition with collaboration and short‑term deal pressure with long‑term operational reality.

Preparing for a global alliance and ready to learn more about Cooley’s services? Get in touch with us.

Steno Secures $49 Million Series C

Thu, 26 Mar 2026 16:00:00 Z

Santa Monica – March 26, 2026Cooley advised Steno, the leader in tech-enabled court reporting and litigation support services, on its $49 million Series C funding. The round was led by Savano Capital Partners, with continued participation from First Round Capital, The LegalTech Fund and other strategic investors.

Lawyers Dave Young, Sean O'Neill, Zack Allen, Leila Kazerouni, Scott McCall, Stephanie Gentile and Ryan Vann led the Cooley team advising Steno.

Cooley has advised Steno since 2020, leading the company on all rounds since its Seed financing.

FCC Moves to Prevent New Foreign Routers

Thu, 26 Mar 2026 15:26:45 Z

On March 23, 2026, the FCC’s Public Safety and Homeland Security Bureau took the sweeping step of adding all “routers produced in a foreign country” to the FCC’s Covered List. This action follows a national security determination that these devices –specifically those intended for residential or “small office/home office” use – pose an unacceptable risk to US infrastructure. This action takes effect immediately.

The determination explicitly links foreign-produced routers to recent high-profile cyber campaigns, including Volt Typhoon and Salt Typhoon, which targeted American energy and water systems. By placing these products on the Covered List, the FCC is effectively preventing any new foreign-produced router models from being authorized for sale or marketing in the US.

Products that are on the Covered List cannot receive FCC authorizations; therefore, any routers that were previously approved can continue to be sold in the US, but no new foreign-produced routers can be marketed or sold in the US without a waiver. Companies that produce routers outside the US can seek conditional waivers from the Department of War or Department of Homeland Security (DHS). The FCC also announced an additional waiver that permits previously authorized routers to receive basic software and firmware updates to maintain usability until March 1, 2027. Finally, the FCC released an FAQ with more information about the effect of its action to add foreign-produced routers to the Covered List.

The FCC defined “routers” to mean consumer-grade networking devices that are primarily intended for residential use and can be installed by the customer. Routers forward data packets, most commonly Internet Protocol packets, between networked systems. The FCC also defined “production” broadly to include any significant stage of the process by which the device is made, including manufacturing, assembly, design and development.

This latest action follows several other recent FCC efforts to mitigate perceived undue risks raised by foreign actors. For example, the FCC recently banned drones manufactured outside the US, withdrew recognition from several test labs and implemented stringent disclosure requirements for entities with ties to foreign adversaries.

Practical actions for affected companies

If your company manufactures, distributes or integrates these products, you should consider the following immediate steps:

Audit your roadmap and supply chain

Identify country of origin: Determine exactly where your current router inventory and future pipeline are manufactured. Under the new rule, even “American” brands may be affected if their physical production occurs in a foreign country.
Assess “foreign-produced” models: If only minor assembly of a product happens abroad, you may be able to demonstrate that it should not be on the Covered List.
Identify “previously authorized” models: Confirm which of your foreign-produced models already have an approved FCC ID. These can still be imported and sold.
Pipeline review: Any new models (e.g., upcoming Wi-Fi 7 releases) currently in development abroad will likely be blocked from the U.S. market unless you pivot your manufacturing strategy.

Apply for ‘conditional approval’

The FCC has provided a pathway for exemptions through the Department of War and DHS. To succeed, applicants should be prepared to provide:

A detailed bill of materials and country of origin for all components.
A US manufacturing and onshoring plan that is time-bound and overseen by a dedicated officer.
Quarterly updates on the progress of bringing production to US soil.

Secure your legacy fleet

Take advantage of the FCC Office of Engineering and Technology waiver. This allows previously authorized routers to receive software and firmware updates to mitigate security harms. This waiver is currently set to expire on March 1, 2027. Ensure you have a plan to push security updates to existing foreign-made routers before the waiver window potentially narrows or expires.

Update certifications

Going forward, all applicants for FCC equipment authorization who have a product on the “covered list” will need to self-certify, in good faith, that their device is not “covered equipment.” False certifications could lead to significant legal exposure and the revocation of existing authorizations.

How we can help

The landscape for telecommunications equipment is shifting toward a “buy American” or “produce American” mandate. If you have questions about the conditional approval application process, need assistance analyzing how this action impacts your current inventory or would like to explore legal challenges, please reach out to the Cooley lawyers listed below.