Connected With Latham

Stakeholders from across the healthcare industry, including members of Congress, the US Food and Drug Administration, and the Center for Medicare and Medicaid Services, recently convened in Washington D.C. for the Medical Device Manufacturers Association (MDMA) Annual Meeting. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Nate Beaton, and Bill McConagha, and associate Danny Machado share their key takeaways from the meeting, including compliance hot topics and what the industry can expect in terms of regulatory enforcement in 2025.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The “Lowering Drug Prices by Once Again Putting Americans First” Executive Order addresses various FDA matters, such as importation from Canada and accelerated approval of generics and biosimilars. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Ben Haas, and Bill McConagha analyze these FDA implications, and explore how the EO overlaps with five drug pricing bills championed by Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa). Also check out Chris's interview with Life Sciences IP Review about industry impacts of the Grassley bills. And yes, it's back: Read our bi-weekly Drug Pricing Digest on the website or subscribe to receive future editions in your inbox.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Founded in 2015, Shield AI uses technology and intelligence systems to protect service members and civilians. The venture-backed unicorn's flagship autonomy software, Hivemind, powers aircraft, drones, and other platforms to reliably support complex missions in contested environments. Latham represented Shield AI on its US$240 million strategic funding round, raising the company's valuation to US$5.3 billion, in March 2025. In this episode of Connected with Latham, Haim Zaltzman, Global Vice Chair of Latham's Emerging Companies & Growth Practice, engages in a dynamic conversation with Shield AI's Chief Financial Officer Kingsley Afemikhe and Chief Legal and Information Officer Jim Carlson. They discuss Shield AI's historic Series F1 fundraising, the macro trends in defense and AI shaping the future, and the company's strategic positioning to navigate these developments.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The initial months of the Trump administration have been marked by a flurry of executive orders and significant activity by the Department of Government Efficiency (DOGE). The US Food and Drug Administration is a key target of these efforts. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Ben Haas and associate Danny Machado explore how FDA may be affected, particularly as it relates to novel tobacco and nicotine products, which can be a bellwether for approval and enforcement trends more generally.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Stakeholders from across the healthcare and biopharmaceutical industry recently convened in San Francisco for the annual J.P. Morgan Healthcare Conference. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Jason B. Caron and associate Danny Machado share key takeaways from the conference, including a renewed optimism from the dealmaking world and the healthcare policy outlook under the new Trump administration.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The deadline for the EU's Digital Operational Resilience Act (DORA) has arrived. This regulation applies to most financial entities operating in the EU market and impacts a broad range of third-party providers of technology-related services. In this episode of Connected with Latham, Christian McDermott and Alain Traill explore the key changes introduced by DORA, its broad territorial scope, the types of entities that will be impacted, and what compliance is likely to involve for each of them.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

In this episode of Connected with Latham, the final of three episodes complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025” report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss the key cross-sector trends for financial services firms in 2025. They provide their thoughts on what firms need to be thinking about in relation to the use of AI, and the continuing importance of ESG.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

In this episode of Connected with Latham, the second of three episodes complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025” report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss the upcoming reform agenda for retail markets in 2025. They break down the difficult challenge of balancing risk-taking and growth with consumer protection, what is next for the Consumer Duty, and the progress on reforms to the consumer credit and consumer investment regimes.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

In this episode of Connected with Latham, the first of three episodes complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025” report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss what will likely appear on the reform agenda for wholesale markets in 2025. They examine capital markets reforms, changes to the remuneration rules and SMCR, and ongoing work on repealing and restating MiFID II.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

In this episode of Connected With Latham, Haim Zaltzman, Global Vice Chair of Latham's Emerging Companies & Growth Practice, sits down with BridgeBio's Co-Founder and Chief Executive Officer Neil Kumar and Chief Financial Officer Brian Stephenson. Since 2015, BridgeBio, a commercial-stage biopharmaceutical, has maintained a mission to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. Latham has been involved with BridgeBio since its inception, representing BridgeBio on multiple fronts, including recently the company's US$1.25 billion cross-border capital financing, one of the largest private capital financings in life sciences in the last five years and one of the largest combined senior debt and royalty transactions in the last decade. In a wide-ranging conversation, Haim, Neil, and Brian discuss BridgeBio's novel rise from startup to unicorn, how the company's portfolio has increasingly diversified and adjusted, and why BridgeBio represents the right approach to establishing enterprise and patient value in the genetics — and broader biotech — space. They also reflect on balancing patient impact with value creation, their anticipation of faster approval timelines in a new presidential administration, and the lessons learned from the evolution of BridgeBio's legal structure, as well as which fast food is near and dear to their stomachs, and who was the biggest nerd in grad school.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

FDA enforcement activities range from administrative actions like conducting establishment inspections and issuing warning letters to judicial enforcement through the Department of Justice, which can take the shape of civil or criminal actions. While we can expect the agency's core activities to continue, its priorities may shift under the incoming Trump Administration. One point of emphasis might be increasing inspections at ex-US manufacturing sites, both to help ensure the quality of products sold into the United States from abroad, and to encourage US-based manufacturing. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Jennifer Bragg, and Bill McConagha discuss important FDA enforcement trends, including the impact of First Amendment jurisprudence on the regulation of promotional statements, increasing reliance on tools like import alerts and warning letters to address alleged misconduct, and oversight of manufacturing facilities outside of the US — all in the context of how the incoming presidential administration may shape the FDA enforcement landscape. They also examine how the recent overturning of the Chevron doctrine may impact FDA's regulatory and guidance activities.    Latham's related webcast — "FDA Life Sciences Enforcement Updates: Recent Trends and a Look Ahead" — is available on-demand here.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The Centers for Medicare & Medicaid Services (CMS) recently published its final rule to implement the Medicaid Services Investment and Accountability Act of 2019 (MSIAA). The final rule significantly deviates from the agency's 2023 proposal, with CMS backing off from “follow the pill” best price stacking, subjecting certain vaccines to Medicaid rebates, and creating a “shame list” of high-cost Medicaid drugs, among other proposals. But the final rule still imposes new burdens on manufacturers, such as by expanding which type of utilization triggers a Medicaid rebate, and imposing aggressive compliance deadlines in connection with misclassifications. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and associate Danny Machado break down what CMS included — and omitted — from its final rule. They also speculate about the impact the Supreme Court's overturning of the Chevron doctrine might have had on CMS' regulatory decision-making, as well as why the final rule's effective date is 60 days before the next presidential inauguration.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Manufacturers, government officials, and other stakeholders recently convened in Chicago for the annual Medicaid Drug Rebate Program Summit. In this episode of Connected with Latham, Washington, D.C. associate Danny Machado interviews partner Chris Schott about takeaways from the conference, including thoughts on the new Medicaid regulation that CMS released just days before the conference.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies interpret ambiguous statutes when regulating the pharmaceutical industry. And in Securities & Exchange Commission v. Jarkesy, the Court established a right to a jury trial for defendants facing civil monetary penalties in agency enforcement actions, which may affect how industry stakeholders respond to enforcement actions. In addition to these cases, which are not specifically focused on the pharmaceutical industry, ongoing manufacturer challenges to the Inflation Reduction Act's negotiation provisions and to state 340B contract pharmacy laws will likely have a significant impact on the pharmaceutical industry. In this episode of Connected with Latham, Washington, D.C. partner Chris Schott and associate Danny Machado review recent and ongoing cases and explore how they could affect the pharmaceutical industry. Also tune in to the Latham webcast “The Demise of Chevron Deference and Its Impact on the Healthcare and Life Sciences Industries” for a deep dive into Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce.    This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

In this episode of Connected with Latham, we explore the remarkable story of Shabir Kabiri, an Afghan refugee who secured asylum in the United States with the help of a Latham pro bono team. Shabir shares his harrowing journey, his time as a cadet at West Point, and the dangers he faced upon returning home. When Kabul fell to the Taliban in 2021, Shabir experienced the chaos and fear firsthand, as his former West Point roommate and a group of West Point classmates worked to orchestrate Shabir's evacuation. New York partner Michèle Penzer and Director of Global Pro Bono Laura Atkinson-Hope discuss with Shabir the legal intricacies of his asylum case and the coordinated efforts of the Latham team to ensure his family's safety.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The US healthcare landscape is undergoing significant changes as the Centers for Medicare & Medicaid Services (CMS) continues to implement the Inflation Reduction Act (IRA). One key stakeholder group affected by the IRA drug price negotiations and Medicare Part D redesign are health insurance companies. In this episode of Connected with Latham, we delve into how these payers are responding to the IRA, including the new ability for Part D beneficiaries to spread their cost-sharing equally across the plan year. Amanda Forys from Magnolia Market Access joins Washington, D.C. partner Chris Schott and associate Danny Machado to discuss the findings of a recent survey on payer trends. Beyond discussing the broader effects of the IRA on the healthcare industry, the conversation also touches on possible Part D premium increases and how payers might be shifting new IRA obligations onto manufacturers.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Current developments grabbed much of the spotlight when key industry stakeholders met in New Orleans for the Pricing and Contracting USA Conference. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and associates Danny Machado and Elisabeth Crusey share their observations from the conference, concluding with four calls to action for pharmaceutical manufacturers.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The Centers for Medicare and Medicaid Services (CMS) recently updated its portal for Average Sales Price (ASP) reporting under Medicare Part B. Data collection portals are also essential for manufacturer compliance with the Inflation Reduction Act and for price reporting under the Medicaid Drug Rebate Program. The 340B program operates yet another online data portal. In addition to these federal programs, states are also implementing data collection interfaces. For example, the Texas Vendor Drug Program recently launched its electronic certification of information (eCOI) portal. Despite the significance of these portals, only a small number of users have access and can directly evaluate compliance obligations. In this episode of Connected with Latham, Washington, D.C. partner Chris Schott and associate Danny Machado discuss the details of the various data collection portals with Lynn Buhl and Sophie Sam of Riparian, a pharmaceutical consulting company that helps manufacturers navigate government pricing regulations, reporting, strategies, and program operations. Drawing on Lynn and Sophie's direct experience with the various reporting portals, the podcast explores the challenges posed by the various certification requirements, explains why CMS' update to the ASP Data Collection Module marks a good time for manufacturers to review their reasonable assumptions, and explores how implementation of the Inflation Reduction Act will further transform the price reporting landscape.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

As the energy tech sector continues to mature, venture capital offers an increasingly a viable path to growth as emerging energy tech companies seek to disrupt the energy space, often following a fundraising and growth trajectory similar to software and AI. Energy tech provides opportunities for financial institutions and strategic partners to invest early in the company and also at the project level, addressing the capital-intensive needs of emerging companies through innovative funding structures. Additionally, energy tech companies and their investors face unique challenges, including heightened regulatory hurdles, permitting requirements, and environmental risks, which place additional importance on setting precedent with an initial project's finance and design. In this episode of Connected With Latham, partners Scott Craig, Josh Bledsoe, and Spencer Ricks break down how the energy tech sector has set itself apart from other emerging companies. They also discuss the latest trends in energy tech funding, the risks that entrepreneurs face in raising capital, and how emerging companies and their investors can best navigate the complexities of project development.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Latham's recently released 2023 Pro Bono Annual Review highlights our public service initiatives around the world, including our ongoing relationship with Trees for Life. This conservation charity is dedicated to rewilding the Scottish Highlands through the restoration of the Caledonian Forest, which supports wildlife found nowhere else in Britain. In this episode of Connected with Latham, introduced by Lauren Meyer, Latham's Pro Bono Managing Attorney — EMEA, London partner Huw Thomas sits down with Steve Micklewright, chief executive of Trees for Life. They discuss how Trees for Life relies on natural capital investment, works with local communities, and, ultimately, creates more resilient ecosystems. Latham is proud to provide free legal services in support one of the largest rewilding projects in the UK.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Following an array of ESG-focused regulation and escalating concerns of greenwashing risks in 2023, the year ahead looks to deliver significant industry developments at a rapid pace. In the UK, the FCA's Sustainability Disclosure Requirements (SDR), investment labelling regime, and anti-greenwashing rule will take effect during 2024. The FCA also plans to consult this year on incorporating standards set by the International Sustainability Standards Board into disclosure requirements for listed companies, and the FCA and the PRA are consulting on broader proposals relating to diversity and inclusion disclosures for larger authorised financial services firms. Meanwhile, firms attempting to minimise greenwashing risk must continue to navigate fluid standards and market practices. In this episode of Connected with Latham, the final episode in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partners Rob Moulton and Nicola Higgs and associate Ella McGinn discuss how firms should prepare for the plethora of ESG-related regulation, as well as how firms can mitigate greenwashing risk. They also explore whether new FCA rules will align market practice and set clear regulatory expectations, and highlight some of the global regulatory developments relating to ESG.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

In 2023, the FCA brought more charges for fraud offences against individuals than any other year in the regulator's history, and secured several convictions related to fraudulent investment schemes. Yet while the FCA has signaled that economic crime is on its radar, recent years have been defined by relative inactivity, as the higher burden of proof for criminal convictions has resulted in fewer opened enforcement cases and extended investigations. Still, with new leadership appointments to the market oversight team and a Memorandum of Understanding (MoU) with the UK Serious Fraud Office, individuals will look for the coming year to reveal if the FCA has become a more assertive regulator. In this episode of Connected with Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partners Rob Moulton and Pamela Reddy discuss why the FCA seems poised to act more collaboratively – and assertively – on enforcement against individuals going forward. They examine the regulator's recent activity in criminal enforcement, why past investigations have been difficult to close, the potential impact of new leadership, and possible collaborations with other enforcement agencies.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The UK's announcement of the Edinburgh Reforms in 2022 made clear the government's intention to chart its own course in rulemaking for the UK financial services sector, and no longer prioritise equivalence with EU legislation. The UK is currently in the process of repealing and restating all retained EU legislation, which will result in divergence from the EU in several areas. Priority areas of reform have already seen significant progress, particularly those reflecting areas in which the government is keen to boost the UK's attractiveness as a place to do business, including the UK listing and prospectus regimes, MiFID II, the Securitisation Regulation, Solvency II, PRIIPs, and the Money Market Funds Regulation. In this episode of Connected with Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partners Rob Moulton and Nicola Higgs and Frankfurt partner Markus Krüger discuss the pace and focus of UK/EU regulatory divergence seen to date and what firms can expect in 2024. They also explore areas of potential regulatory convergence between the EU and the UK, including in relation to retail market investor protection, ESG reforms, and implementation of the Basel III Endgame international capital standard.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Two new Joint Executive Directors of Enforcement and Market Oversight appointed by the FCA in 2023 will settle into their roles over the year ahead. Following a period of enforcement defined by increased investigations and a willingness to push the envelope of legal interpretation, firms will look toward the coming year to resolve which areas of focus the FCA will prioritise. Recent activity suggests that the FCA aims to align its enforcement with its broader strategy, expedite the resolution of legacy cases, and improve its data and monitoring capabilities, while also addressing non-financial misconduct and maintaining a focus on retail conduct and market abuse. While the PRA has historically been less active in enforcement, PRA-authorised firms will look to see whether the regulator's new early account scheme makes a difference to the enforcement process. In this episode of Connected with Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partners Rob Moulton and Andrea Monks address the key issues expected to emerge on the radars of the FCA's joint heads of enforcement, and the potential impact of the PRA's changes to its enforcement process. They also discuss the regulators' data strategy and potential “quality over quantity” approach to investigations.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

With the UK financial services regulators due to publish Policy Statements to their consultations on diversity and inclusion (D&I) this year, conduct and culture remain high on the regulators' agenda and connect closely to their other regulatory priorities. The regulators have proposed new D&I reporting and disclosure requirements for larger financial services firms, and the FCA is consulting on new guidance on non-financial misconduct. Although final rules are not expected until the second half of this year, firms should consider now how to meet regulatory expectations. In this episode of Connected With Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partners Rob Moulton and Nell Perks highlight the steps firms can take to improve their culture ahead of upcoming regulatory changes. They also discuss the impact of the regulators' proposals on establishing D&I strategies and targets, as well as how firms should approach the FCA's proposed guidance on non-financial misconduct.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The coming year looks poised to act as a pivotal junction for the UK financial services regulators in deciding how to approach the regulation of artificial intelligence (AI), as the financial services industry sees the continued expansion of AI-related capabilities and use cases. To avoid stifling innovation, the UK government plans to take an “agile and iterative” approach, focusing on regulating harmful uses of AI rather than regulating AI systems as a whole. Yet this stance stands in contrast with more prescriptive approaches taken by the EU and US, requiring firms to carefully consider their use and management of AI. In this episode of Connected With Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partners Rob Moulton and Fiona Maclean speak about the expected regulatory developments addressing artificial intelligence. They discuss the potentially busy year ahead for financial services regulators, the risks firms should consider, and how to navigate differing international approaches to AI.    This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Since the announcement of the Edinburgh Reforms in 2022, the UK government has made progress on an assortment of measures spanning financial services regulation, with more developments expected in 2024. Though tabled initially as an ambitious suite of reforms, many of the proposals have not been particularly radical in reality. A recent Treasury Committee report found that completed work has had little economic impact, and that many of the workstreams are not true reforms. In this episode of Connected with Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partner Rob Moulton and Knowledge Management Counsel Charlotte Collins discuss anticipated developments under the Edinburgh Reforms in 2024. They also explore whether the Treasury Committee report represents a fair assessment, which changes qualify as truly ambitious, and the potential impact of the general election on further regulatory reforms.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 statutes seeking to regulate the federal 340B program. Manufacturers have responded with greater willingness to challenge overreach in court, a trend that is likely to continue in 2024. In this episode of Connected with Latham, Washington, D.C. partner Chris Schott and associate Danny Machado examine some of the challenges that lie ahead for drug manufacturers.   Also refer to a recent Bloomberg Law article authored by Chris on the same topic.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 rule changes by midyear, firms accustomed to the MiFID II rules will need to adapt to the added flexibility regarding how they pay for investment research. In this episode of Connected with Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, partner Rob Moulton talks with Giulia Pecce, Head of MiFID Policy, Research and Wholesale Investor Protection for the Association of Financial Markets in Europe (AFME), about the 2024 outlook for investment research. They discuss whether rule changes will likely be readily workable operationally, how quickly market practice might change, and the impact of EU reforms and US regulation on the UK's ultimate approach to unbundling.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 PRIIPs regime. In this episode of Connected With Latham, the latest in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, partner Rob Moulton and counsel Becky Critchley discuss the FCA's recent work in relation to the Consumer Duty, including what is expected of boards, the proposed new UK Consumer Composite Investment regime, and work to modernise the UK consumer credit framework.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 guidance would add price as one such factor. In this episode of Connected with Latham, partners Chris Schott and Reba Rabenstein and associate Danny Machado discuss the implications of using drug pricing as a factor in exercising march-in rights, the feasibility of the examples featured in the draft guidance, and what the draft guidance means in light of the 2024 election cycle.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 episode of Connected With Latham, Huw Thomas, Co-Chair of Latham's London Corporate Department, speaks to fellow London partner James Lloyd about the unique challenges PE firms now face.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 commercial entities at the point of entry and no longer mandating shareholder votes for a variety of transaction types. The goal of these reforms is to re-establish London as an attractive choice among global listing jurisdictions. In this episode of Connected With Latham, the first in a 10-part series complementing Latham's “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2024” report, London partners Rob Moulton and Mark Austin discuss how regulatory reform of the UK's primary markets became a central priority, why the introduction of more risk will increase the markets' appeal, and what further changes investors can expect in the coming year.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200 Quick LinksGet Embed PlayerShare on SocialDownload Audio File

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 considerations, a critique sometimes referred to as “greenbashing” or the “ESG backlash”. In major markets, politicians and stakeholders have expressed concerns that ideological considerations are illegitimately impacting investment and business decisions. In this episode of Connected With Latham, London private equity partner David Walker speaks with Betty Huber, corporate partner and Global Co-Chair of Latham's ESG practice, about how PE firms should approach their ESG strategies and messaging in the current political environment.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200 Quick LinksGet Embed PlayerShare on SocialDownload Audio File  

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 holding businesses accountable for their environmental practices and claims. Companies implementing or reporting on sustainability practices must develop consistent approaches to navigating an increasingly uncertain landscape. In this episode of Connected With Latham, partners Sophie Lamb and Robin Hulshizer and associate Aleksandra Dulska discuss the risks, enforcement actions, and litigation shaping the trend of greenwashing, as well as the strategies that businesses can deploy to minimize scrutiny.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 enforcement on no-poach agreements, while the UK government plans to limit the length of non-compete clauses in employment contracts. In this episode of Connected With Latham, London M&A partner Beatrice Lo speaks to Chicago partner Nineveh Alkhas and London associate Karima Salway about why deal teams and corporates should match regulators' focus on their use of restrictive covenants, and how to mitigate the risk of existing and proposed laws targeting the use of non-compete and no-poach clauses.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Following a number of challenges to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released new draft guidance document addressing truthful and non-misleading communications for product uses not approved or cleared by the FDA. Notably, the document updates standard for using scientific or medical journal reprints and creates a new category for firm-generated presentations. These changes suggest a potential expansion of the safe harbor for manufacturers' communication of scientific information. In this episode of Connected With Latham, Ben Haas, Global Vice Chair of Latham's Healthcare & Life Sciences Practice Group, speaks with counsel Monica Groat and associate Nate Beaton. They discuss the implications of the FDA's draft guidance document, including the “scientifically sound and clinically relevant” criteria for reprints, the scope of the “firm-generated presentation” definition, and the parts of the document that may be challenged by industry.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 Therapeutics. They discuss how the OIG's compliance framework is relevant to drug manufacturers, how past enforcement actions can inform implementation of a compliance program, and how an effective compliance program can be beneficial in the enforcement context.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 enforcement action in the merger control context. In this episode of Connected With Latham, London private equity partner David Walker speaks to London counsel Ludmilla Le Grand about the CMA's key tests for initiating review of a roll-up transaction, as well as the impact of a CMA investigation on acquirers and how private equity firms should approach merger control risk.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 Act (ADA) claim seeking monetary damages because he had not exhausted his Individuals with Disabilities Education Act (IDEA) remedies. A unanimous US Supreme Court held that a plaintiff need not exhaust the IDEA's administrative processes when seeking remedies under other statutes that the IDEA does not authorize — in this case, monetary damages under the ADA. In this episode of Connected With Latham, Roman Martinez, a partner in the firm's Supreme Court & Appellate Practice, sits down with associate Nick Rosellini and Disability Rights Michigan's Mitch Sickon to discuss Perez's journey to the US Supreme Court, the strategies that shaped Latham's brief, and the experience of arguing before the highest court in the land.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 Brussels counsel Philipp Studt about the increasing volume of regulations and laws regarding the Foreign Direct Investment – in particular, what we are seeing in this space, and what are the business implications.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 activity, including the publication of the first group of drugs selected for negotiation under the IRA and the release of a proposed Medicaid regulation earlier this summer.  Representatives from the Federal Trade Commission emphasized the agency's interest in pharmacy benefit managers, while the Office of the Inspector General explained that the IRA will be a key focus in the coming year. In this episode of Connected with Latham, partner Chris Schott and associate Danny Machado recap their biggest takeaways from the Summit, and discuss how the IRA will continue to shape the pharmaceutical sector.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 suffering from “buyer's remorse” have options. In this episode of Connected With Latham, London M&A partner Beatrice Lo speaks to fellow London partner Nell Perks and associate Leah Adeniran about how to address — and avoid — buyer's remorse in M&A deals.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 insurtech startups should navigate the nuances of an FCA authorization, including evolving regulations and investor inquiries, in order to maintain their startup ethos and develop a strong compliance culture, positioning their business for growth.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 Connected with Latham, partner Chris Schott and associate Danny Machado explain how CMS's proposed rule on best price stacking differs from past interpretations, and discuss possible ways CMS could implement the Inflation Reduction Act's statutory change to the best price definition.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 careful consideration to the structure of their financing instruments. On this episode of Connected With Latham, Dubai partner and global coordinator of Latham's Sustainable Finance Practice, Ed Kempson, speaks with London associate Chidi Onyeche and New York associate Giulia Franzoso about the role sustainable finance can play — and the potential it can unlock — in financing the energy transition.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 Medicare & Medicaid Services (CMS) final guidance for the negotiation provisions of the Inflation Reduction Act. In this episode of Connected With Latham, partner Chris Schott and associate Danny Machado discuss the emerging policy signals for assessing value across therapeutic classes, rather than for individual products.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 intended to avoid subjecting Part B drugs to the process sooner than the statute provides. In this episode of Connected With Latham, partner Chris Schott and associate Danny Machado of the firm's DC office explain how CMS structures its final guidance and what questions remain for drug manufacturers.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 Latham, London private equity partner David Walker speaks to London counsel Becky Critchley about the impact of forthcoming regimes, and how PE firms can meet a higher standard of compliance set by these financial services reforms.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 more carefully at green claims. Although regulatory authorities increasingly seek to hold regulated firms to account for exaggerated credentials and misstated investment policies, several options exist for private equity to go beyond general compliance and mitigate greenwashing risks. In this episode of Connected With Latham, London private equity partner David Walker speaks to fellow London partner Nell Perks, and London associate Anne Mainwaring, about the implications of rising scrutiny of greenwashing, and how private equity firms should respond.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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 US expectations. In this episode of Connected With Latham, London M&A partner Beatrice Lo speaks to associate Jennifer Cadet about the core expectations of UK sellers and US buyers. They discuss which preferences will emerge as the new norm in coming deals, and the implications that dealmakers should consider.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200