Whether we are counseling on the buy side or sell side, assisting a life sciences company in merging with a competitor, or helping a private equity firm’s portfolio company with a raft of physician practice roll-ups, our clients benefit from high-quality deal counsel grounded in the deep industry understanding that comes from a half century of health care and life sciences counseling.
We regularly assist clients with:
Private equity investments
As one of the largest and fastest-growing segments of the private equity market, the health care and life sciences industry is ripe with opportunity for funds able to navigate the complex regulatory issues involved with these types of investments.
We bring together market-leading private equity and subject-matter life sciences and health care teams to assist our private equity clients and their portfolio companies with their most strategic transactions around the world. We offer decades of experience handling the corporate, financial, and regulatory aspects of these types of transactions, including the critical regulatory due diligence necessary to identify and mediate transactional risk.
We have served as deal or regulatory counsel on hundreds of private equity transactions across nearly every subsector of the health care and life sciences space, including investments in hospital systems and ambulatory care facilities, medical device and medical equipment manufacturers, hospice and long-term health centers, urgent care and retail clients, physician practice management platforms, optical and dental practices, payor services, clinical trial sites, pharmacies, and the veterinary and animal health space. With our proven track record across diverse health care and life sciences subsectors, we are able to help our private equity clients achieve successful outcomes in even the most complex transactional environments.
To learn more about our practice, please visit our Private Equity page.
Mergers, acquisitions, and divestitures
We combine our sophisticated M&A capabilities with our internationally recognized life sciences and health care experience to provide exceptional support to buyers and sellers of public and private companies and non-profit organizations. From helping life sciences companies acquire a promising new product, to assisting MedTech companies in divesting product lines that no longer align with company strategy, to advising hospitals on everything from the acquisition of physician practices to mergers into regional academic centers, we have the deal and regulatory experience to help you achieve your goals.
Our deep industry focus and understanding differentiate our M&A service offering. Our counsel understand the unique challenges and opportunities that health care and life sciences companies face, such as regulatory and compliance issues, pricing pressures, market competition, technological advancements, supply chain disruptions, economic and geopolitical risks, and more.
To learn more about our practice, please visit our Mergers & Acquisitions page.
Joint ventures
We help health care entities form joint ventures in a variety of contexts – from hospital joint ventures to nursing home/pharmacy joint ventures and hospital joint ventures that operate outpatient facilities (such as ambulatory surgical centers). We also structure joint hospital/physician research programs and secure rights to intellectual property resulting from such programs. Additionally, we assist parties in structuring and operating joint ventures to minimize risks under fraud and abuse laws, as well as advising on other compliance considerations.
Financing, lending, and restructuring
In addition to counseling companies investing in life sciences and health care companies, we advise lenders to the industry. This often takes the form of providing regulatory due diligence on life sciences or health start-ups pursuing “venture debt,” but can also take the form of advising on loans to more mature businesses. For example, we provide specialized regulatory due diligence to lenders entering agreements with management services organizations (MSOs), focused on ensuring the agreements the MSOs in turn have with their revenue-generating health care providers sufficiently protect the MSOs interest so that the lender’s interest is protected by extension. Additionally, we advise lenders on appropriate representations and warranties to protect their collateral and on accounts receivable financing involving Medicare and Medicaid receivables.
We also have broad experience in assisting with bankruptcies and workouts for health care industry clients. In addition to representing lending institutions, we have represented hospitals, physician practices, and other types of health care providers in restructuring their debt obligations. Often, these representations involve the need to deal with novel regulatory and reimbursement issues unique to the health care industry, as well as compliance and licensure challenges inherent in distressed assets. The depth of our health care law practice often plays an important role in finding solutions for our clients.
Emerging companies and venture capital
Whether it’s a company’s first raise, a strategic partnership, or a major liquidity event, we provide the legal and strategic support needed to help early-stage companies grow, scale, and lead. Our experience spans from pre-seed start-ups to high-growth unicorns and public companies, helping clients scale with confidence. We provide strategic legal counsel that evolves alongside our clients – from formation to fundraising, expansion, and exit. Our team is deeply embedded in the venture ecosystem, with a particular focus on the life sciences, MedTech, and health care sectors, including artificial intelligence, digital health, SaaS, enterprise software, and beyond. We understand the fast-moving nature of these industries and offer strategic, real-time guidance to help our clients navigate critical growth milestones.
We also have extensive experience advising corporate venture capital (CVC) investors on structuring strategic investments, navigating governance complexities, and maximizing portfolio synergies. Whether working with Fortune 500 companies launching strategic investment arms or established CVCs deploying capital in early- to growth-stage companies, we help clients manage risk, structure investments for long-term value, and anticipate regulatory challenges that are unique to corporate-backed deals.
To learn more about our practice, please visit our Emerging Companies & Venture Capital page.
Industry-informed specialty diligence and assessments
Savvy health care and life sciences companies pursuing strategic growth through acquisitions or investments know quality deal counsel is only part of the equation. True valuation of a target’s assets – and its liabilities – requires understanding its intellectual property; its adherence to regulatory, privacy, and security requirements; and its litigation and enforcement risk. We offer IP, FDA, EU, broader health regulatory, privacy, cybersecurity, and product liability diligence assessments that inform target valuation; regulatory approvals and closing timelines; necessary indemnification and escrow provisions; integration priorities, and more.
We are particularly well known and respected for our regulatory due diligence skills, and regularly partner with our corporate colleagues to provide these services as part of seamless, full-service support for our clients’ most important acquisitions and investments. More than that, however, numerous clients opt to hire us for certain specialized diligence services even when using another firm as deal counsel – and our competitors often bring us onto deals they are handling for assistance with specialized diligence. Our strength in this area is informed by our deep operational regulatory experience from acting as day-to-day lawyers to numerous industry clients, as discussed on our health care services and life sciences manufacturer regulatory, compliance, and operations counseling pages.
For example, in the United States, our regulatory teams advising on health care-related transactions help secure certificates of need, evaluate and validate licensure, and assess reimbursement policies. They also review arrangements to ensure compliance with relevant federal laws and regulations, including the Anti-Kickback Statute, the Physician Self-Referral (Stark) Law, and the Eliminating Kickbacks in Recovery Act, as well as related state laws, to ensure our clients are not opening themselves up to allegations and investigations under the False Claims Act or similar state laws. We also advise clients on state corporate practice of medicine laws and fee-splitting laws. And we help clients with both change of ownership strategy and actual transfer notifications, as well as other regulatory submissions for targets’ state and federal permits and authorizations, ensuring there is no disruption to the target’s business – and therefore its value to the buyer – during an acquisition or investment. We also handle state transaction notification and approval processes, including in more challenging jurisdictions such as California and Oregon.
In the life sciences space, our FDA regulatory teams review clinical trial authorizations, marketing authorizations, advertising and promotion, Form 483s, Warning and Untitled Letters, and more. We also help smooth transactions by negotiating transitional agreements, such as pharmaceutical transitional services agreements.
In the EU, our team provides similar services in order to identify and resolve regulatory risks that affect valuation, deal certainty, timing, and post-closing operations. We perform targeted regulatory due diligence to verify status, scope, and conditions of marketing authorizations and CE marking; the robustness of the quality system (working closely with the QA/RA teams); and the target’s inspection, audit, and enforcement history. We distill diligence into clear, commercially-focused red flag reports that prioritize issues by impact and remediation complexity (pre- and post-closing). We draft and negotiate regulatory representations and warranties calibrated to the diligence findings and the buyer’s risk appetite. Where appropriate, we coordinate with the European Medicines Agency, notified bodies, and national competent authorities to clarify transfer requirements, obtain scientific or procedural advice, and align change of ownership notifications and variations with closing.
