Leech Tishman’s multi-disciplinary Life Sciences team has extensive experience navigating the unique issues that businesses in this industry face, including regulatory compliance, intellectual property, corporate/transactional, and litigation matters.
The life sciences industry continues to be at the forefront of innovation. To properly navigate this rapidly evolving, highly competitive industry, it is essential that life sciences lawyers possess a strong technical understanding and sophisticated knowledge of the business and legal challenges inherent to the industry.
Our lawyers understand the life sciences product cycle and are directly involved in leading clients from product inception to bringing a product to market, helping them navigate complex legal issues to ensure a successful product launch.
Many of our lawyers possess technical degrees and practical experience in the fields of biology, cardiovascular physiology, immunology, molecular biology, neuroanatomy, neurobiology, genetics, chemistry, biochemistry, chemical engineering, and more.
- FDA & FTC compliance counseling
- Product classification, labeling, and promotion
- Filings, including IND, IDE, BLA, NDA, ANDA, PMA, and 510(k)
- Clinical trial compliance (GCP, GMP)
- Regulatory strategy, including combination products, digital health, AI-enabled technology, and consumer wellness
- Investment due diligence and risk assessment
- Patents
- Trademarks and brand protection
- Copyrights
- Trade secrets
- Licensing and development agreements
- Enforcement of IP
- IP portfolio management
- Organizational structuring
- Mergers & acquisitions
- Contracts, including vendor and supplier agreements
- Corporate formation
- Corporate governance
- Commercial transactions
- Bankruptcy and pre-bankruptcy planning
- Confirmation of plans of reorganization and liquidation
- Claims administration and distribution
- Representation of creditors’ committees
- Representation of secured creditors
- Obtaining cash collateral and debtor-in-possession financing
- Liquidation of assets by auction and private sale
- Negotiating, restructuring, and documenting of defaulted loans outside of bankruptcy representing both lenders and debtors
- Public and private financing
- Startup funding / venture capital
- Loans (securitized, syndicated, convertible, mezzanine & hybrid loans)
- Compliance Counseling
- Audits & risk assessment
- Privacy program & program development
- Awareness & training
- Incident response planning
- Strategic counseling on Medicare, Medicaid, and commercial payor coverage
- Coding and payment strategy
- Assistance with CMS coverage determination
- Analysis of reimbursement implications
- Value-based arrangements and innovative payment models
- Guidance on fraud and abuse (Anti-Kickback Statute, Stark Law, and False Claims Act)
- Compliance with federal, state, and local employment regulations
- Agreements
- Confidentiality and Non-Disclosure
- Founder and Key Employee, including Assignment
- Employment, including Restrictive Covenants
- Service/Independent Contractor
- Separation
- Hiring and termination issues including offers, classifications, discipline, and reductions in force
- Workplace Safety issues including OSHA compliance and reporting
- Advice and counsel including wage and hour, leave, discrimination and harassment, and performance
- Handbook and policy drafting
- ERISA, employee benefits and executive compensation
- Collective bargaining/labor matters
- COVID-19 related matters including compliance, policies, consent/waiver, and screening/testing
- Market authorization of products
- Regulatory compliance
- Competition matters
- Navigating clinical trials
- Cross-border regulatory guidance
- Temporary/professional work visas (H1-B, TN, O-1, E-1, E-2, O-1, B-1)
- International student/researcher issues (J-1, F-1, STEM specific issues, NIW petitions, Schedule A/B applications)
- Permanent residence (i.e., EB1, EB2, Labor certifications/PERM)
- Citizenship/naturalization
- I-9, Employment Eligibility Verification
- Insurance policy review
- Assist in documenting/evidencing and quantifying claim
- Prepare notice of claim, loss, and/or circumstances to insurer(s) with supporting materials
- Assist in preparing proof of loss and related documentation, as necessary
- Correspond and negotiate with insurer(s)
- Representation in mediation, arbitration, or other alternative dispute resolution proceeding
- Prepare complaint and represent client in insurance-coverage litigation through settlement or judgment
- IP Infringement
- Contract disputes
- Employment-related actions
- Alternative dispute resolution
- Commercial and mixed-use developments
- Development and financing
- Purchase and sale of property
- Zoning and land use matters
- Compliance with environmental regulations
- Business and personal income tax planning
- Formation of captive insurance companies
- Transactional income tax analysis
- Tax planning for mergers and acquisitions
- IRS audits and appeals
- State tax disputes
- International taxation issues
- U.S. taxation for foreign companies and individuals
- Tax exempt formation and operation & tax analysis for non-profit organizations/private foundations
