Life Sciences

Morgan Lewis is a cross-border, full-service law firm that handles a broad range of matters for clients in the life sciences sector—from innovation and emerging-business issues through research, development and regulatory approval; marketing and distribution; product reimbursement; fraud, abuse, product liability, and intellectual property litigation; licensing and collaborations, mergers, acquisitions, and other corporate transactions; and outsourcing.

Our comprehensive cross-practice life sciences team is made up of more than 250 global partners and counsel, including more than 60 professionals with advanced scientific degrees. Our team members work from offices across the United States, Asia, Europe, and the Middle East, with a network of additional resources in Latin America and Africa. No matter the location, we have the capability to advise life sciences companies on the wide array of transactional and regulatory matters they face throughout the world.

Morgan Lewis’s commitment to the life sciences industry is reflected in our participation in premier life sciences organizations such as BIO, including regional chapters MassBio, BioNJ, and Life Sciences Pennsylvania. Our lawyers are thought leaders in the field, publishing client alerts and articles on timely topics affecting the industry and presenting at industry professional conferences around the world on trending life sciences subjects.

Morgan Lewis has handled some of the most complex and far-reaching licensing and collaboration transactions ever accomplished for life sciences companies around the globe. Our clients include more than 1,000 life sciences businesses, ranging from large and mid-sized pharmaceutical and biotechnology companies, healthcare providers, insurers, and product manufacturers to emerging biopharma, medical device, and digital health companies. We also advise companies in the immunology, virology, pharmaceutical chemistry, molecular biology, and bioinformatics industries.

In addition to global pharmaceutical companies, biotechs, and medical device companies, we count among our clients:

• Investment banks
• Private equity firms
• Venture capital firms
• Precision medicine companies
• HealthTech companies
• Biopharmaceutical companies
• Pharmacy benefit managers
• Wholesale and distribution companies
• Contract research organizations
• Contract manufacturing organizations
• Institutional lenders
• Royalty monetization firms
• Independent director committees
• Management groups

• Biogen Inc. in its collaboration, valued up to $55 million, with TheraPanacea that focuses on multiple therapeutic areas in neuroscience
• Regeneron in its license and collaboration agreement with Nykode Therapeutics for the discovery, development, and commercialization of potential new vaccines for cancer and infectious diseases
• GlaxoSmithKline GSK in its exclusive license with Arrowhead Pharmaceuticals to develop and commercialize ARO-HSD, Arrowhead’s investigational RNA interference therapeutic that is being developed as a treatment for patients with NASH
• Takeda Pharmaceutical Company in its sale of two clinical-stage compounds for cancer treatment to Calithera Biosciences Inc. for $45 million with potential payments from Calithera related to clinical development, regulatory, and sales milestones, as well as tiered royalties
• Takeda Pharmaceutical Company in its agreement with Moderna and the Government of Japan’s Ministry of Health, Labour, and Welfare to import and distribute an additional 50 million doses of Moderna’s mRNA COVID-19 vaccine in Japan
• Adira in its license agreement with Intellia to combine Intellia’s CRISPR/Cas9 allogeneic platform with GEMoaB’s switchable, universal CAR T-cell platforms and its co-development and co-funding agreement to develop an allogeneic universal CAR T-cell product for an immuno-oncology indication
• Strand Therapeutics in its licensing agreement valued up to $277 million with BeiGene aimed at developing and commercializing Strand’s innovative, multifunctional mRNA treatments for solid tumors
• CRISPR Therapeutics in its strategic partnership with Nkarta Inc. to research, develop, and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer
• Zai Lab in its cross-border strategic collaboration with Cullinan Management Inc. for the development, manufacturing, and commercialization of CLN-081, a next-generation irreversible EGFR inhibitor for the treatment of non-small cell lung cancer
• Merck in its development and commercialization agreement with Gilead Sciences that combine medicines from each company into a two-drug regimen with the potential to provide new, meaningful treatment options for people living with HIV
• 23andMe in its $400 million acquisition of Lemonaid Health Inc.
• uniQure NV in its $59.6 million acquisition of Corlieve Therapeutics
• Advanz Pharma in its agreement with Eisai Co. Ltd to acquire rights for the antiseizure drug Zonegran in the European Union, Middle East, Russia, and Australia
• 23andMe in its merger with VG Acquisition Corp.
• Oncoceutics in its sale up to $450 million to Chimerix
• NBE-Therapeutics in its $1.4 billion sale to Boehringer Ingelheim
• Third Point Ventures in the $88 million Series D financing of Cambridge Epigenetix
• Borealis Ventures in the $45 million Series B financing of Ankyra
• Mirae Asset Global Investments in the $265 million Series B financing of Sonoma Biotherapeutics
• Reify Health Inc. in its $220 million Series C financing led by Coatue
• Heru Inc. in its $30 million Series A financing led by D1 Capital Partners

Serving life sciences companies from offices in Greater China, Singapore, and Tokyo, we are strategically positioned to provide essential legal, business, regulatory, and governmental advice across the Asia-Pacific region. Our local knowledge and global reach allow us to help clients achieve their diverse and ambitious business objectives in the region’s dynamic life sciences arena.

Our lawyers understand the critical connection between the law, business, and science. We regularly help life sciences companies—as well as entities that invest in them—with inbound and outbound business in China, Japan, Korea, Australia, and Southeast Asia, including Singapore, Indonesia, Malaysia, the Philippines, Thailand, Vietnam, and Myanmar.

We work throughout the region to efficiently and strategically solve the myriad business, transactional, regulatory, intellectual property, litigation, and related issues our clients face throughout the product life cycle. Our command of local laws and regulations is particularly important to our advice on the US Foreign Corrupt Practices Act, antitrust and competition issues, and labor and employment matters.

Our multinational lawyers in Singapore, Beijing, Hong Kong, Shanghai, and Tokyo advise clients doing business in the full spectrum of life sciences industry sectors. Across the region, our team represents clients on matters related to capital markets; mergers and acquisitions; licensing and collaborations; private equity; finance and restructuring; intellectual property; white collar, government, and internal investigations; labor and employment; and international tax planning. In addition to global pharmaceutical, biotech, and medtech companies, we serve other entities involved in the sector, including investment banks; private equity, venture capital, and royalty monetization firms; precision medicine and digital health companies; contract research and contract manufacturing organizations; institutional lenders; independent director committees; and management groups.

• US Federal Trade Commission, including Hatch-Waxman, settlements and investigations
• US Department of Justice, European Commission, and other non-US competition authority investigations
• Sham citizen petitions claims
• Patent infringement counterclaims
• Multidistrict horizontal conspiracy class actions
• Robinson-Patman Act price-fixing claims
• Exclusive dealing claims

• Initial public offerings
• Stock exchange listings
• Corporate governance issues
• Public issuer reporting
• Board of directors, board committee, and executive representations

• Research platform deals
• Development and commercialization collaborations
• Co-promotion arrangements
• Manufacturing and other operational agreements
• Financings with venture capital funds, private equity firms, investment and commercial banks, institutional lenders, and other investors
• Alternative financing transactions with royalty monetization firms and collaborative development and funding partners
• Multinational drug development, manufacturing, licensing, and related transactions
• Product acquisitions and divestitures
• Negotiated business combinations by both public and private companies
• Mergers and acquisitions
• Joint ventures and service agreements
• Tender offers (friendly and unsolicited)
• Proxy contests
• Bankruptcy and restructurings
• Leveraged buyouts
• Senior secured credit facilities
• Acquisition financing and refinancing

• Medicare, Medicaid, and other US healthcare program matters
• Audits and investigations into alleged billing and coding practice irregularities
• Medicare Appeals Council, US and state court, and administrative law judge appeals
• Provider Reimbursement Review Board representations

• Qualified and non-qualified retirement plans
• Health and welfare plans
• Employment agreements
• Severance and retention arrangements
• Employee Retirement Income Security Act (ERISA) fiduciary issues
• Deferred compensation and profit sharing plans
• Internal Revenue Code Sections 280G and 162(m) matters
• Executive compensation agreements
• Equity incentive plans

• US Food and Drug Administration (FDA) Compliance matters
• Pathway strategies
• Clinical trial design
• Orphan drug submissions
• Investigational new drug, new drug, and biologics license applications
• Biosimilar and Hatch-Waxman strategies
• FDA advisory committee matters and dispute resolution
• Government sales and contracting disputes
• Reimbursement strategies
• Available market exclusivity assessments
• Promotional, reimbursement, marketing, distribution, and pricing strategies
• Labeling and advertising matters
• Manufacturing processes
• Recall, correction, removal, and supply chain issues
• Comparative effectiveness research
• Export and import matters
• Investigational device submissions
• Humanitarian-use device exemptions
• 510(k) and premarket approval applications
• Product modifications
• Medical device reporting
• Quality System Regulation issues
• Medicare and Medicaid coverage and reimbursement
• Sunshine, state distribution, and related device-compliance matters
• 483 observations and warning letters

• US Patent and Trademark Office matters
• Patent procurement strategies
• Patent applications
• Reexamination, reissue, and interference matters
• Third-party rights infringement avoidance
• Patent rights enforcement
• Patent infringement claims
• Patent and technology licensing agreements
• IP audits and due diligence investigations
• Patentability, infringement, and validity opinions

• Employee Retirement Income Security Act (ERISA) and Fair Labor Standards Act issues
• Systemic employment discrimination claims
• Union campaigns
• Corporate campaigns
• Multiemployer bargaining group representations
• Complex labor-management matters
• US Department of Labor compliance
• Wage and hour issues
• Leave law compliance
• Occupational Safety and Health Administration (OSHA) compliance
• Equal Employment Opportunity Commission (EEOC) matters
• I-9 immigration compliance
• Executive transfer visa programs
• Global visas
• Immigration strategic planning
• Layoffs, restructurings, spin-offs, and acquisition-related matters

• Criminal and civil healthcare fraud litigation
• US federal and state grand jury subpoenas
• US government civil investigative demands and administrative subpoenas
• Settlement discussions
• Corporate Integrity Agreement (CIA) negotiations
• Anti-Kickback Statute litigation
• Healthcare Fraud Statute litigation
• Civil Monetary Penalties Law litigation
• Responsible Corporate Officer Doctrine disputes
• US and state false claims acts disputes
• Suspensions and debarments
• Deferred prosecution agreements
• Consent decrees
• Payment disputes
• Development, production, sale, and distribution disputes
• US False Claims Act litigation, including qui tam matters
• Anti-Kickback and Physician-Self Referral (Stark) Law investigations and litigation
• Trade secret and non-compete litigation
• Supplier/purchaser and post-acquisition disputes
• Consumer class actions and other consumer-related litigation
• FDA Form 483 and Warning Letter responses
• Foreign Corrupt Practices Act, UK Bribery Act, and other anticorruption matters
• US state bureaus of Consumer Protection actions
• Insurance recovery

• Information technology
• Business processes
• Clinical trials and development
• Manufacturing and supply
• Sales and marketing
• FDA documentation and submissions

• US Health Insurance Portability and Accountability Act (HIPAA) matters
• Gramm-Leach-Bliley Act issues
• US Health Information Technology for Economic and Clinical Health (HITECH) Act matters
• US state security breach notification law compliance
• Medical privacy law matters
• US Federal Trade Commission privacy and security compliance
• Red Flags Rule and other global privacy rule compliance
• Security breach responses
• Data transmissions to government agencies
• Information disclosure and compliance training for employees

• Acquisitions, including for patient care facilities, senior housing, medical office buildings, research and development facilities, clean rooms, laboratories, and vivariums
• Financing, workouts, and restructurings,
• Land assemblage and development
• Sale-leasebacks
• Leasing and taxation
• Real estate investment trusts (REITs)
• Global entity investments

• Internal Revenue Service disputes
• US Department of the Treasury disputes
• Global transactional tax planning
• Mergers and acquisition
• Reorganizations
• Spin-offs, joint ventures, and strategic alliances
• Equity and debt securities offerings