Connected With Latham

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. After analyzing these FDA implications, Washington, D.C. partners Chris Schott, Ben Haas, and Bill McConagha 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