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Analysis The AI Act
The AI Act: first-ever comprehensive
legal framework on AI worldwide


 
SPACs
SEC is adopting rules to enhance investor protections


 
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„ Securities Act 1933. Final climate-
related disclosure rules adopted

Mohamed Rungu

 
„ Compliance required? Federal
court finds CTA unconstitutional
„ US Department of Labor releases
final rule on contractor classification




 
„ US government reminds non-US
companies to comply with sanctions

Andrew Vogel

finma News >

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DOL releases final rule on
contractor classification

ANITA YORCK AND
JOHN LI - BOSTON

The US Department of Labor (DOL) published its final rule defining independent contractors under the Fair Labor Standards Act (FLSA).

The final rule materially tracks the DOL’s October 2022 proposed rule. It is anticipated that this new rule will have far-reaching implications for employers across all industries. Employers are encouraged to review their current service provider classifications while monitoring legal challenges to the new rule.

The DOL’s final rule makes it easier to classify workers as employees.
Among the factors to be considered are (1) opportunity for profit or loss depending on managerial skill, (2) investments by the worker and the potential employer, (3) degree of permanence of the work relationship, (4) nature and degree of control over the working relationship, (5) extent to which the work performed is an integral part of the potential employer’s business, and (6) whether the worker uses specialized skills to perform the work and whether those skills contribute to business-like initiative. According to the rule, additional factors may be considered if such factors are relevant to the overall question of economic dependence.

With its final rule, the DOL has nearly unfettered discretion to challenge the propriety of virtually any independent contractor relationship. Indeed, the application of the totality-of-the-circumstances test likely will create immediate challenges for many employers utilizing independent contractors, as some workers could be classified as employees – and would, in that case, be entitled to minimum wage and overtime protections, along with a wide range of employer-provided benefits.
It is expected that the DOL will initially target industries which are heavily reliant on subcontracting and/or services agreements, such as the hospitality, media, transportation, and manufacturing industries.
If and when the final rule takes effect, employers are also likely to face an increased risk of private misclassification claims, including as raised in collective actions, and the potential liabilities that accompany such claims, such as backpay, liquidated damages, and attorneys fees.
Importantly, this new test is applicable only to the federal FLSA and does not impact state-specific independent contractor tests applicable to state wage and hour claims.

Employers should consider auditing their independent contractor relationships, including contracts and services agreements, to determine the ongoing propriety of such relationships in view of the final rule. For any relationships that no longer meet the applicable standards, employers should consider the pros and cons of reclassifying such workers.

   John Li
    Employment

   
  john.li@mdg-lawyers.com
Registration Statements

SEC Adopts Final Climate-Related Disclosure Rules


MOHAMED RUNGU
JUDY DEWITT - NEW YORK

The Securities and Exchange Commission (SEC) is adopting amendments to its rules under the Securities Act of 1933 and Securities Exchange Act of 1934 that will require registrants to provide certain climate-related information in their registration statements and annual reports.

The final rules will require information about a registrant’s climate-related risks that have materially impacted, or are reasonably likely to have a material impact on, its business strategy, results of operations, or financial condition. In addition, under the final rules, certain disclosures related to severe weather events and other natural conditions will be required in a registrant’s audited financial statements.
The SEC adopted final rules requiring registrants to disclose certain climate-related information in registration statements and annual reports. The final rules represent a historic expansion of US securities disclosure regulation, and will likely significantly increase the complexity of public company reporting for many US registrants in the future.

In summary, the final rules will require disclosure regarding:

Registrants will need to disclose any oversight by the board of directors of climate-related risks and any role by management in assessing and managing the registrant’s material climate-related risks.
Registrants will need to disclose any climate-related risks identified by the registrant that have had or are reasonably likely to have a material impact on the registrant, including on its strategy, results of operations, or financial condition in the short and long term. Registrants will also need to disclose the actual and potential material impacts of any identified climate-related risks on the registrant’s strategy, business model, and outlook, including, as applicable, any material impacts on a non-exclusive list of items enumerated in the rules.
If a registrant is a large accelerated filer or an accelerated filer that is not otherwise exempted, and its emissions metrics are material, that registrant will be required to disclose those GHG emissions and produce an attestation report in respect of those emissions subject to phased-in compliance dates. With respect to registrants who are not otherwise required to disclose their GHG emissions or produce a GHG emissions attestation report, those registrants will be required to disclose certain information under the rules if they voluntarily disclose their GHG emissions in an SEC filing and voluntarily subject those disclosures to third-party assurance.
If, as part of its strategy, a registrant has undertaken activities to mitigate or adapt to a material climate-related risk, the registrant will need to disclose a quantitative and qualitative description of material expenditures incurred and material impacts on financial estimates and assumptions that, in management’s assessment, directly result from such mitigation or adaptation activities.
Registrants will be required to disclose the capitalized costs, expenditures expensed, charges, and losses incurred as a result of severe weather events and other natural conditions, such as hurricanes, tornadoes, flooding, drought, wildfires, extreme temperatures, and sea level rise, subject to applicable 1% and de minimis disclosure thresholds, and will also be required to disclose the capitalized costs, expenditures expensed, and losses related to carbon offsets and renewable energy credits or certificates (RECs) if used as a material component of a registrant’s plans to achieve its disclosed climate-related targets or goals.
If a registrant has set a climate-related target or goal that has materially affected or is reasonably likely to materially affect the registrant’s business, results of operations, or financial condition, the registrant will have to make certain disclosures about such target or goal, including disclosures regarding material expenditures and material impacts on financial estimates and assumptions as a direct result of the target or goal or actions taken to make progress toward meeting such target or goal.
If a registrant uses scenario analysis and, in doing so, determines that a climate-related risk is reasonably likely to have a material impact on its business, results of operations, or financial condition, the rules require certain disclosures regarding such use of scenario analysis. In addition, if a registrant’s use of an internal carbon price is material to how it evaluates and manages a material climate-related risk, that registrant will be required to make certain disclosures about the internal carbon price.
In addition, while the release for the proposed rules discussed the possibility of allowing foreign private issuers or other companies to provide information based on non-US standards in place of SEC requirements, the final rules provide no such accommodation. The final rules also provide that information relating to transition plans, scenario analysis, the use of an internal carbon price, and targets and goals, except for historical facts, is considered a forward-looking statement for the purposes of the Private Securities Litigation Reform Act and the federal securities laws.
The final rules generally require that registrants (both domestic and foreign private issuers) file the climate-related disclosures in their registration statements and Exchange Act annual reports.

   Judy DeWitt
    Capital Markets

   
judy.dewitt@mdg-lawyers.com
SPACs

SEC Adopts Rules and Guidance on SPACs


Special Purpose
Acquisition and
Shell Companies

TAYLOR CRIDDLE - NEW YORK

The SEC is adopting rules intended to enhance investor protections in initial public offerings by special purpose acquisition companies (commonly known as SPACs) and in subsequent business combination transactions between SPACs and private operating companies.

Further, the SEC is adopting a rule that would deem any business combination transaction involving a reporting shell company, including a SPAC, to be a sale of securities to the reporting shell and amendments to a number of financial statement requirements applicable to transactions involving shell companies.

In addition, SEC is providing guidance on the status of potential underwriters in de-SPAC transactions and adopting updates to the guidance regarding the use of projections in Commission filings as well as requiring additional disclosure regarding projections when used in connection with business combination transactions involving SPACs.
Here are the
highlights of
the new rules
and guidance
 SEC accepts disclosure requirements with respect to, among other things, compensation paid to sponsors, conflicts of interest, dilution, and the determination, if any, of the board of directors (or similar governing body) of a SPAC regarding whether a de-SPAC transaction is advisable and in the best interests of the SPAC and its shareholders. Furthermore rules that require a minimum dissemination period for the distribution of security holder communication materials in connection with de-SPAC transactions.
The safe harbor in the Private Securities Litigation Reform Act of 1995 for projections and other forward-looking statements will be unavailable for filings by SPACs and other blank check companies, with the intention of placing this type of disclosure in de-SPAC transactions on an equal footing with comparable disclosure in traditional IPOs.

OpCo will be required to be a co-registrant when a SPAC files a registration statement on Form S-4 or Form F-4 for a de-SPAC transaction. This is already the case with certain de-SPAC transaction structures, but the change means that all registered de-SPAC transactions will subject OpCo, and its officers and directors, to Sections liability.
Because they have little revenue, many SPACs qualify as SRCs prior to the de-SPAC transaction and are able to take advantage of disclosure accommodations afforded to SRCs. Under existing rules that test SRC status only once per year, some SPACs have been able to stay in SRC status for several months after the de-SPAC.
Under the new rules, a post-de-SPAC public company will be required to re-determine its status as an SRC within four business days following the consummation of the de-SPAC transaction and reflect that re-determined status in any filing made 45 days after consummation of the de-SPAC, which may include an amendment to the super 8-K. However, there is no re-determination with respect to qualification as a large accelerated or an accelerated filer, an emerging growth company, or a foreign private issuer.

A domestic SPAC that is the registrant in a de-SPAC transaction with an FPI OpCo must file on Form S-4 (not F-4), and the financial statements of the FPI OpCo must be presented in US GAAP. The combined company will be deemed to be a domestic company in that circumstance. Use of a Form F-4 would be permitted if the SPAC registrant qualifies as an FPI as of a date within 30 days of filing the de-SPAC transaction, OpCo is an FPI, and the combined company is expected to be an FPI at the time of consummation of the de-SPAC.

OpCo financial statements will need to be audited under PCAOB standards;
two years (not three years) of OpCo financial statements will be required if both SPAC and OpCo qualify as EGCs, regardless of whether SPAC has filed an annual report;
the requirements for financial statement staleness will be the same as if OpCo were filing an initial Securities Act registration statement (and in the case of an SRC, would be based on whether OpCo would qualify as an SRC in its own right).

New requirements governing projections include: Projections based on historical financial results or operational history must give equal or greater prominence to the historical measures or operational history. Presentation of projections that include a non-GAAP financial measure should include a clear definition or explanation of the measure, a description of the GAAP financial measure to which it is most directly comparable, and an explanation why the non-GAAP financial measure was used instead of a GAAP measure.
Status of SPACs under the Investment Company Act of 1940 (Company Act). The SEC withdrew proposed Company Act Rule 3a-10, which would have provided a safe harbor from the definition of investment company under the Company Act. Instead, the SEC provided its views on facts and circumstances that are relevant to whether a SPAC meets the definition of an investment company. For example, a SPAC that holds its assets in US Government securities, money market funds, and cash items prior to a de-SPAC transaction, and that does not propose to hold “investment securities,” will likely not be deemed to be an investment company.
   Taylor Criddle
    Capital Markets

   
  t.criddle@mdg-lawyers.com
US government reminds
to comply with US sanctions
Andrew Vogel
Markets Insight

T

  he US Departments of Commerce, Treasury, and Justice jointly issued a Tri-Seal Compliance Note putting non-US companies on notice that US sanctions and export controls may apply to them and that they must comply with applicable US sanctions and export controls or face severe penalties.
Transactions that have
a US nexus are subject
to US sanctions
jurisdiction
 The Tri-Seal Compliance Note provides background on how non-US parties become subject to US sanctions and export control laws, highlights recent civil and criminal enforcement actions against non-US parties, and advises on appropriate compliance controls to reduce the risk of a violation.

There are several circumstances in which the operations of a non-US party may be subject to US sanctions, US export controls, or both.
US sanctions assert jurisdiction over US persons wherever in the world located. However, in practice, US sanctions can be applied more broadly to certain conduct by non-US persons. For example, OFAC may assert jurisdiction over non-US persons to enforce US sanctions in the following circumstances:

  Foreign subsidiaries of US companies also may be subject to restrictions under certain US sanctions programs, including US sanctions on Iran, Cuba, and North Korea. In addition, parent companies that exert control over the activities of their foreign subsidiary may themselves become subject to US sanctions because of the actions of the foreign subsidiary with sanctioned countries or persons.

  Even where there is no US nexus, a non-US person also risks being designated as a Specially Designated National (SDN) if they are determined to have materially assisted, sponsored, or provided financial, material, technological or other support for sanctioned persons or sanctionable activities.
The US applies its export control laws to goods subject to US export controls regardless of where they are in the world and how many times they have been exported, not just to direct exports from the US.

Violations of US sanctions and export controls are subject to strict liability – which means a company or individual may face penalties even if the violation was unintentional or unknown at the time.

  Civil penalties can include fines ranging up to roughly $370,000 per violation or twice the amount of the transaction that is the basis of the violation, whichever is greater.

  Criminal penalties for intentional violations can be up to $1 million per violation and imprisonment for up to 20 years.

The Tri-Seal Compliance Note reinforces the US focus and commitment to compliance with sanctions and export controls broadly, and we understand from recent US government actions that the focus for enforcement continues to be related to Russia’s invasion of Ukraine, the embargo on Iran, and the export controls on critical technology to China.

Among the examples cited was a $300 million settlement with a US data storage company and its affiliate in Singapore for shipping millions of hard disk drives to Huawei (a Chinese entity restricted under US export controls) – the largest BIS standalone administrative settlement in its history.

A non-US person that
causes a US person to
violate sanctions may
itself become subject
to sanctions

 OFAC settled for $6.1 million with an Australian freight forwarding and logistics company for violating US sanctions on Russia. The company originated or received payments through the US financial system related to shipments involving Iran, North Korea, and Syria, countries subject to comprehensive US sanctions prohibitions.
The company was liable under US sanctions because it caused U.S. financial institutions to transact with blocked persons and export financial services to sanctioned jurisdictions.

Additionally, although not specifically covered in the Tri-Seal Compliance Note, other recent, key OFAC resolutions further highlight the focus on non-US companies, including one involving a tobacco and cigarette manufacturer headquartered in London, which agreed to pay over $508.6 million to settle its potential civil liability for apparent violations of sanctions targeting North Korea and weapons of mass destruction proliferators.
The apparent violations arose from the export of tobacco and related products to North Korea and receipt of payment for those exports through the US financial system and from the use of US financial institutions to receive or otherwise process US dollar-denominated payments for the sale of cigarettes. In doing so, the company caused US financial institutions to process wire transfers that contained the blocked property interests of sanctioned North Korean banks and to export financial services and facilitate the exportation of tobacco to North Korea.
CTA unconstitutional.
Is compliance still required?

BARBARA CLINTON AND
BILL FARY - CHICAGO

Congress passed the Corporate Transparency Act (CTA) as an anti-money-laundering initiative in 2021.

In National Small Business United v. Yellen, No. 5:22-cv-01448 (N.D. Ala.), the National Small Business Association (NSBA) and one of its members brought a suit in the US District Court of the Northern District of Alabama challenging the CTA.
On March 1, 2024, the District Court ruled for the plaintiffs, holding that the CTA is unconstitutional because it exceeds the Constitution’s limits on the legislative branch.

While the District Court held that the CTA is unconstitutional, its injunction against enforcement applies to only the plaintiffs in this matter, including the NSBA.

The District Court rejected the US government’s arguments that Congress had the power to enact the CTA under its
(1) plenary power to conduct foreign affairs,
(2) its Commerce Clause authority, and
(3) its taxing power, or under its authority to pass laws “necessary and proper” to carrying out those enumerated powers.

The US government is expected to appeal this decision to the US Court of Appeals for the Eleventh Circuit. The government may also seek a stay of the District Court’s ruling pending the appeals process. If a request for a stay is granted, FinCEN would be permitted to continue to enforce the CTA against the plaintiffs, including the NSBA members, during the appeal process.

Similar litigation in other courts is also anticipated; however, it is not clear how other federal district judges will rule on this issue.
This decision comes as many states have started to introduce and implement disclosure laws similar to the CTA, such as the New York LLC Transparency Act. While the District Court’s decision in National Small Business United strikes down the CTA on federal constitutional grounds, it does not affect reporting requirements under state statutes.
In response to the ruling, FinCEN published a statement acknowledging that it will comply with the ruling for as long as it remains in effect and, as a result, will not enforce the CTA with respect to the plaintiffs in the action.

New entities that are not exempt should plan to comply with the CTA and its reporting requirements by filing their initial BOI reports within the 90-day timeframe.

Existing entities that are not exempt should continue planning for compliance by the January 1, 2025 deadline while monitoring for legal updates.

   Bill Fary
    Litigation

   
  bill.fary@mdg-lawyers.com
EU Pharmaceutical Policy
Parliament supports reform

ANDREAS MEIER - MUNICH

MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.

The EU Environment, Public Health and Food Safety Committee adopted its position on the new directive and regulation covering medicinal products for human use.

To reward innovation, MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a marketing authorisation.
Pharmaceutical companies would be eligible for additional periods of data protection if the particular product addresses an unmet medical need (+12 months), if comparative clinical trials are conducted for the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a cap on the combined data protection period of eight and half years.

A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains a marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.
European Parliament underlines the need to boost the research and development of novel antimicrobials, notably through market entry rewards and milestone reward payment schemes (e.g. early-stage financial support upon achieving certain R&D objectives prior to market approval). These would be complemented by a subscription model-based voluntary joint procurement scheme, to encourage investment in antimicrobials.
Among the new measures to promote the prudent use of antimicrobials, European Parliament want stricter requirements, such as restricting the prescriptions and dispensation to the amount required for the treatment and limiting the duration for which they are prescribed.

These new rules would require companies to submit an environmental risk assessment (ERA) when requesting a marketing authorisation. To ensure adequate evaluation of ERAs, European Parliament wants the creation, within the European Medicines Agency, of a new ad-hoc environmental risk assessment working party. MEPs insist that the risk mitigation measures (taken to avoid and limit emissions to air, water and soil) should address the entire life cycle of medicines.

   Andreas Meier
    Healthcare & Sciences

   
 a.meier@mdg-lawyers.com
AI Act

The AI Act is the first-ever legal framework


Act addresses the risks
and positions Europe to
play a leading role

ROBERTA DIAZ - LONDON

The AI Act aims to provide AI developers and deployers with clear requirements and obligations regarding specific uses of AI. At the same time, the regulation seeks to reduce administrative and financial burdens for business, in particular small and medium-sized enterprises.

The AI Act is part of a wider package of policy measures to support the development of trustworthy AI, which also includes the AI Innovation Package and the Coordinated Plan on AI. Together, these measures will guarantee the safety and fundamental rights of people and businesses when it comes to AI.
They will also strengthen uptake, investment and innovation in AI across the EU. The AI Act is the first-ever comprehensive legal framework on AI worldwide.
The aim of the new rules is to foster trustworthy AI in Europe and beyond, by ensuring that AI systems respect fundamental rights, safety, and ethical principles and by addressing risks of very powerful and impactful AI models.
The AI Act ensures
that Europeans can
trust what AI has
to offer
 For example, it is often not possible to find out why an AI system has made a decision or prediction and taken a particular action. So, it may become difficult to assess whether someone has been unfairly disadvantaged, such as in a hiring decision or in an application for a public benefit scheme. The proposed rules will:

 address risks specifically created by AI applications;
 prohibit AI practices that pose unacceptable risks;
 determine a list of high-risk applications;
 set clear requirements for AI systems for high-risk applications;
 define specific obligations deployers and providers of high-risk AI applications;
 require a conformity assessment before a given AI system is put into service or placed on the market;
 put enforcement in place after a given AI system is placed into the market;
 establish a governance structure at European and national level.

The Regulatory Framework defines 4 levels of risk for AI systems: All AI systems considered a clear threat to the safety, livelihoods and rights of people will be banned, from social scoring by governments to toys using voice assistance that encourages dangerous behaviour.

AI systems identified as high-risk include AI technology used in:

 critical infrastructures (e.g. transport), that could put the life and health of citizens at risk;
 educational or vocational training, that may determine the access to education and professional course of someone’s life (e.g. scoring of exams);
 safety components of products (e.g. AI application in robot-assisted surgery);
 employment, management of workers and access to self-employment (e.g. CV-sorting software for recruitment procedures);
 essential private and public services (e.g. credit scoring denying citizens opportunity to obtain a loan);
 law enforcement that may interfere with people’s fundamental rights (e.g. evaluation of the reliability of evidence);
 migration, asylum and border control management (e.g. automated examination of visa applications);
 administration of justice and democratic processes (e.g. AI solutions to search for court rulings).

All remote biometric identification systems are considered high-risk and subject to strict requirements. The use of remote biometric identification in publicly accessible spaces for law enforcement purposes is, in principle, prohibited.
Narrow exceptions are strictly defined and regulated, such as when necessary to search for a missing child, to prevent a specific and imminent terrorist threat or to detect, locate, identify or prosecute a perpetrator or suspect of a serious criminal offence.
Those usages is subject to authorisation by a judicial or other independent body and to appropriate limits in time, geographic reach and the data bases searched.

Limited risk refers to the risks associated with lack of transparency in AI usage. The AI Act introduces specific transparency obligations to ensure that humans are informed when necessary, fostering trust. For instance, when using AI systems such as chatbots, humans should be made aware that they are interacting with a machine so they can take an informed decision to continue or step back. Providers will also have to ensure that AI-generated content is identifiable. Besides, AI-generated text published with the purpose to inform the public on matters of public interest must be labelled as artificially generated. This also applies to audio and video content constituting deep fakes.

The AI Act allows the free use of minimal-risk AI. This includes applications such as AI-enabled video games or spam filters. The vast majority of AI systems currently used in the EU fall into this category.
   Roberta Diaz
    Technology

   
   r.diaz@mdg-lawyers.com