Connected With Latham

The pressure and uncertainty of 2023 will likely continue for drug manufacturers in 2024, with the election cycle bringing added scrutiny. At the federal level, continuing implementation of the Inflation Reduction Act, including publication of the so-called negotiated prices, may be disruptive. The states, meanwhile, will likely move forward with their own drug pricing initiatives, including statu...

The UK's decision to scrap compulsory research unbundling, following the final recommendations of the Investment Research Review, marked one of the most striking developments for financial services firms in 2023. Permitting rebundling across the board with no market capitalisation threshold comes as part of a wider approach to reinvigorate UK capital markets. With the FCA expected to finalise its...

As part of the FCA's continued focus on retail markets, updates to several key regimes are due to progress over the next year. In addition to further implementation of the FCA's Consumer Duty, the government plans to present detailed proposals on modernising the consumer credit regime, develop proposals to address the "advice gap", and bring in a new UK retail disclosure framework to replace the P...

The National Institute of Standards and Technology (NIST) recently published a draft guidance framework for considering the exercise of march-in rights. Under the Bayh-Dole Act, government agencies can "march in" on patents resulting from government-funded research if the patent licensee is not sufficiently developing the patented invention, based on the consideration of various factors. The guida...

Cyberattacks targeting well-resourced businesses, especially those with institutional backing, financial support, and deep insurance coverage, have become increasingly prevalent. PE portfolio companies in particular find themselves in the crosshairs of sophisticated attackers — a heightened risk that underscores the need for boards to devote attention to cyber-incident preparations. In this episod...

For the last three years, UK regulatory authorities have commissioned an array of reviews and consultations to address friction points in the UK's primary markets, culminating in reforms to the listing regime scheduled to take place in 2024. In addition to simplifying listing segments, these reforms signal a shift to a more disclosure-based regime, by relaxing eligibility requirements for commerci...

Regulatory drivers and stakeholder demands have put environmental, social, and governance (ESG) considerations at the forefront of their agendas, with PE firms adopting ESG strategies across funds, investments, due diligence, and portfolio company management. This strong focus has prompted certain stakeholders to argue that ESG factors are receiving undue attention at the expense of financial cons...

As companies feel heightened pressure from stakeholders to adopt environmental, social, and governance (ESG) measures, greenwashing allegations continue to rise in tandem. Complex regulatory environments in the US and across Europe increase the likelihood of enforcement actions and demands for leadership teams to validate their public statements and disclosures. Lawsuits have become a tool for hol...

Regulators in the US, EU, and UK have increasingly scrutinized non-compete and no-poach clauses in employment agreements and M&A deals. The US Federal Trade Commission proposed a rule to ban non-competes in most situations, while several US states seek to implement complete or partial non-compete bans. In Europe, the European Commission and the UK's Competition and Markets Authority are enhancing...

Following a number of challenges to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released a new draft guidance document addressing truthful and non-misleading communications regarding product uses not approved or cleared by the FDA. Notably, the document updates the standard for using scientific or medical journal reprints and creates a new category...

In November, the Department of Health and Human Services' Office of the Inspector General (OIG) issued new compliance program guidance that affirms OIG's long-standing focus on the seven elements of an effective compliance program, first published in 2003 . In this episode of Connected With Latham , partner Chris Schott and associate Danny Machado are joined by guest Lynn Robson of United Therapeu...

The UK's Competition and Markets Authority (CMA) has increasingly asserted its jurisdiction to review private equity buy-and-build transactions, including completed deals, citing competition concerns and protection against perceived threats to consumers. With regulators in the US and elsewhere voicing similar concerns, PE firms and portfolio companies must now consider the heightened risk of enfor...

On March 21, 2023, the US Supreme Court ruled for Miguel Luna Perez, a Latham pro bono client, in Perez v. Sturgis . Perez, who is deaf, was repeatedly denied reasonable accommodations, including a qualified sign-language interpreter, by Sturgis Public Schools and the Sturgis Public Schools Board of Education. Lower courts had held that Perez could not proceed with an Americans with Disabilities A...

As security interests have become increasingly important in Europe and globally, comprehensive investment control reviews are now an unavoidable element of any cross-border acquisition – with complex legal standards that vary greatly from country to country. In this episode of Connected With Latham, London private equity partner Tom Evans speaks to Hamburg counsel Jana Dammann de Chapto and Brusse...

Not surprisingly, the Inflation Reduction Act (IRA) and its impact on the pharmaceutical industry was a key topic when manufacturers, government officials, and other stakeholders convened in Chicago for the annual Medicaid Drug Rebate Program Summit. The conference's wide-ranging agenda spotlighted key questions and trends emerging from the Centers for Medicare and Medicaid Services' recent activi...

The buoyant market of 2021 and early 2022 resulted in compressed deal timelines and frenzied competition, causing many deals to be signed with fewer buyer protections and less information about target businesses. The aftermath of this M&A surge has seen a rise in post-closing discoveries of target company issues, compounded by ongoing macroeconomic and geopolitical challenges. Yet acquirers suffer...

Startups in the insurtech sector have found increasing success in obtaining authorization from the Financial Conduct Authority (FCA). Yet the requirements to achieve such success can complicate a startup's operations, from early pressure on resources and staffing to regulatory obligations. In this episode of Connected With Latham , partner Shing Lo and associate Gabriel Lakeman discuss how insurte...

In a proposed rule issued earlier this summer, the Centers for Medicare & Medicaid Services (CMS) suggested expanding the scope of combining, or stacking, discounts when determining best price. Meanwhile, the Inflation Reduction Act amended the statutory best price definition to include maximum fair prices negotiated under CMS's new Medicare price negotiation authority. In this episode of Connecte...

As more energy and infrastructure companies commit to sustainability targets amidst the energy transition, sustainable finance options, such as green bonds, increasingly offer a viable alternative to traditional financing for projects across the globe. Still, with enhanced regulatory scrutiny, concerns of greenwashing, and ESG-related litigation, companies considering sustainable finance must pay...

The policy conversation related to reimbursement rates for drugs has recently turned toward pricing for entire therapeutic classes, rather than assessing the value of an individual drug. Two recent developments emphasize a growing call for establishing a single payment rate for therapeutic classes: the Medicare Payment Advisory Commission's (MedPAC) June report to Congress, and the Centers for Med...

The Centers for Medicare & Medicaid Services (CMS) recently published its final guidance to implement the drug price negotiation provisions of the Inflation Reduction Act. While retaining the active moiety/active ingredient approach to identifying drugs subject to negotiation, CMS now will only include those products with historic or likely Part D utilization in negotiations in 2026. This is inten...

Consumer-facing companies face an increasingly complex UK regulatory landscape as multiple regulators place the spotlight on consumer rights and protections. A raft of new legislation focused on "good consumer outcomes" is set to impact businesses and PE sponsors, heightening enforcement and censure risks including fines, public sanctions, and consumer redress. In this episode of Connected With La...

Amid concerns of exaggerated or misleading sustainability claims, the UK Financial Conduct Authority's (FCA) proposal for new labelling and disclosure rules for sustainability claims has put a spotlight on a growing range of greenwashing risks. Private equity firms should evaluate the latest wave of new rules and requirements being enacted and contemplated as regulators across jurisdictions look m...

Global M&A deal volumes have dipped at the start of Q1 2023, yet UK-bound M&A activity is expected to be one of the year's highlights as overseas buyers seek out attractively priced British public and private targets. Within this activity, US buyers' deal term preferences are likely to impact private UK M&A. So transatlantic dealmakers will find it increasingly important to understand both UK and...

As interest rates soar to the highest rates in a decade, European real estate buyers and sellers are struggling to makes economic deals — transaction volumes in Europe fell by 44% in the last year. Despite a comparatively down year in fundraising for real estate funds, some €80 billion has already been raised for real estate acquisitions, in contrast to the situation in the 2008 global financial c...