Life Sciences and
Health Care

Skadden advises life sciences and health care clients on their most complex legal andregulatory issues across multiple disciplines, including Food and Drug Administration(FDA) regulatory counseling and enforcement defense; government and internalinvestigations; compliance program design and implementation; litigation and disputeresolution; complex corporate transactions; and the acquisition, enforcement andcommercialization of intellectual property and technology assets. Companies andinvestors across the industry rely on the sector-specific insights of our life sciences
and health care attorneys, who work as an integrated team and collaborate to help
clients realize scientific innovations as they navigate an ever-evolving landscape.

Skadden is consistently ranked as a leading firm for Healthcare inChambers USA and for Life Sciences by The Legal 500 U.S. We havebeen recognized among the top firms for Health Care and FDA Law
by Best Lawyers Best Law Firms. In 2024, Skadden was named
M&A Firm of the Year and received two Impact Deal of the Yearawards from LMG Life Sciences, which recognized “the most innovative and challenging life sciences work of the past year.” We also
received the Healthcare, Pharma & Biotech Deal of the Year (LargeCap) award from The Deal in 2021.

Life Sciences Compliance Counseling and Enforcement
Defense
Skadden frequently advises on complex FDA matters, internal andgovernment investigations, compliance program design and implementation, litigation and other high-profile disputes. Our lawyers’
knowledge across these areas allows them to help clients anticipate
complexities and develop well-rounded strategies to address theirmost pressing issues.
FDA
Skadden advises established life sciences companies and startups
seeking to leverage new technologies relating to medical products and food on critical FDA regulatory and compliance issues,
including product promotion and advertising; labeling requirements;
recalls and risk management strategies; warning letter and 483
responses; GxP and Quality System Regulation (QSR) compliance;
Hazard Analysis and Risk-Based Preventive Controls (HARPC)

obligations; medical affairs and drug safety; clinical trials; premarket approval pathways and submissions, including Orphan designations, accelerated approval and other review pathways; digital healthand Software as a Medical Device (SaMD) policies; combination
products; and affirmative advocacy, including citizen petitions. Our
experience serving at and working with the FDA helps us develop
creative solutions to address our clients’ mission-critical challenges.
Government and Internal Investigations
We handle investigations by various federal and state law enforcement agencies, including U.S. Attorneys’ Offices, the Criminal
and Civil Divisions of the DOJ, and state attorneys general. We
have successfully defended numerous life sciences and health carecompanies and their boards, laboratories, nursing homes and healthplans in criminal and civil government investigations into alleged
violations under the Federal Food, Drug and Cosmetic Act (FDCA);
the Anti-Kickback Statute and state law analogs; the Stark Law; andstate and federal False Claims Acts. We have experience handlingcomplex multidistrict and multiagency government investigations,including managing parallel investigations by federal and state
government entities. We routinely undertake internal investigations implicating the FDCA and fraud and abuse laws on behalf ofcompanies and their boards and audit committees. We have counseled clients in numerous matters involving voluntary disclosures
to the U.S. Department of Health and Human Services, Office ofInspector General (HHS OIG), DOJ and other federal agencies.

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False Claims Act

Litigation

Our attorneys defend clients against False Claims Act (FCA) cases
pursued by federal and state governments and qui tam relators
following government declination. Our team represents companies,
their boards and management, and individuals in all aspects of FCA
matters, including internal investigations; transactional due diligence; the implementation of remedial measures and complianceprograms; and the defense of government investigations, enforcement actions, and criminal and civil proceedings. We have handled
numerous FCA matters in the life sciences and health care industries
arising from investigations by United States Attorneys’ Offices,
the Offices of Inspector General and state attorneys general, often
in response to a whistleblower report or lawsuit, as well as fromaudits by the General Services Administration (GSA), the Defense
Contract Audit Agency and the Defense Contract ManagementAgency.

Our attorneys — many of whom have held senior positions ingovernment — provide comprehensive litigation and dispute resolution services, including representing life science and health careclients in product liability defense; commercial, intellectual property
and licensing disputes in litigation and arbitration (domestic andinternational); internal investigations and government investigations
and enforcement (civil and criminal); antitrust matters; and securities litigation. We have handled numerous state and federal individual and class action cases, as well as related multidistrict litigationproceedings.

Compliance Programs
We have extensive experience developing, implementing and assessing corporate compliance programs in line with the U.S. Sentencing Commission and DOJ and HHS OIG guidelines. Skadden has
negotiated numerous corporate integrity agreements with HHS OIG
and advised clients regarding their implementation. We regularly
advise management and boards of life sciences and health carecompanies on compliance and corporate governance practices anddevelopments specific to the industries. Our attorneys also provide
strategic guidance on the fraud and abuse implications of productsupport programs and other client initiatives, and have represented
life sciences and health care industry clients seeking HHS OIG
advisory opinions.
HIPAA and Privacy
Our attorneys counsel and defend clients on privacy-related matters,
including compliance with the Health Insurance Portability andAccountability Act (HIPAA). Our work in this area includes advising on HIPAA-related aspects of complex digital health deals andcounseling life sciences companies on HIPAA privacy standards andBusiness Associate Agreement compliance. We also are experienced
in guiding clients through HIPAA data breaches, other privacy challenges and attendant enforcement and litigation risks.

Our team regularly manages controversies for life sciences companies. We have successfully defended numerous federal and state
securities class actions against pharmaceutical, biotechnology
and medical device clients. Our attorneys have extensive experience managing mass tort litigation for a variety of FDA-regulatedcompanies. We also handle various commercial disputes involving
life sciences companies in litigation and arbitration in the U.S. andinternationally, including disputes arising out of collaborations
among large and small life sciences companies and contract manufacturing organizations, involving complex licensing arrangements,
and relating to substantial corporate and commercial transactions inthe industry.
Our team also has represented clients in connection with civil andcriminal allegations involving Medicaid and Medicare fraud, including alleged violations of the Anti-Kickback Statute, the Stark Law
and federal and state FCAs, as well as commercial insurance fraud.
The team regularly helps clients navigate Foreign Corrupt Practices Act
investigations conducted by the DOJ and the SEC and FDCA investigations, as well as judicial challenges to agency decision-making.

Corporate Transactions
We represent life sciences and health care clients in merger transactions and significant acquisitions, leveraging our understanding ofregulatory and business trends. Our team also advises on takeover
preparedness and shareholder activism. We represent establishedpharmaceutical, biotechnology and medical device companies; foodand dietary supplement companies; genomic and clinical laboratories; digital health companies; consumer product companies;
tobacco companies; hospital and health care systems and service
providers; long-term care facilities; nursing homes; and managed
care companies in merger transactions and significant acquisitions,investments and collaborations; development and early commercial-stage companies in sale or partnering transactions with larger

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industry participants; and private equity, venture capital and otherfinancial clients with portfolios focused in this sector across therange of their investment structures. Our industry experience also
includes capital markets, spin-off and restructuring transactions.
We understand the unique legal, regulatory, tax and commercial
issues that transactions in this industry present, and we offer extensive experience in transactions involving the design of contingent
value rights or earnout structures to bridge valuation gaps. Our
regulatory and intellectual property experience enable us to target
issues affecting critical assets. Our executive compensation attorneys
are fluent in the structures for retaining and incentivizing key talent
in this sector throughout pivotal transactions. Our global tax practiceassists with optimizing efficiency of a transaction itself and any
subsequent integration.
In addition, we represent financial sponsors with a focus on M&A
and financings in these sectors. We provide innovative solutions toindustry participants in distressed situations, including in-court andout-of-court restructurings. We have advised on some of the largest
health insurance and government program managed care mergers,
bringing to bear our insurance M&A and reinsurance know-how.
Our attorneys also represent health care-related REITs in numerous
mergers, acquisitions, joint ventures and spin-offs of REITs andtheir subsidiaries, as well as in IPOs and offerings of debt, equity,
hybrid and synthetic securities in both private and public transactions.

Intellectual Property
Our intellectual property attorneys, many of whom have scientifictraining and in-house experience at life sciences companies, perform“deep-dive” intellectual property diligence relating to acquisitions,joint ventures, divestitures, financings and investments, and effecttransactions in the pharmaceutical, biotechnology and related life
sciences areas. We help structure clinical studies, product andtechnology licenses, and royalty interest sales and securitizations.
Lawyers on our team are registered to practice before the U.S. Patentand Trademark Office, are experienced in handling matters before
the Patent Trial and Appeal Board, and regularly handle IP enforcement and disputes in litigation and arbitration involving pharmaceuticals, biologics, medical devices and other technologies employedin the life sciences arena.

Artificial Intelligence
Artificial intelligence (AI) is quickly altering the life sciences industry, and with innovation, legal challenges arise. Key areas we areseeing impacted include drug discovery and development; clinical
trial recruitment and management; use and disclosure of clinicaland genomic data; and related regulatory compliance, intellectual
property, data protection and ethical considerations. Skadden’s life
sciences team regularly works with our global AI attorneys, whooffer years of experience with complex AI legal matters. Together,
we offer clients an understanding of key AI technology issues,
business drivers and the evolving global regulatory landscape ascompanies navigate the impact of this complex and cutting-edge
technology.

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