Biotechnology
Succeeding in today’s biotechnology industry demands equal parts strategy and execution and research and development. With the breakneck pace of technology growth and expansion, biotechnology companies must be able to efficiently navigate and respond to this dynamic space.
Kendall PC’s biotechnology practice delivers insightful, practical guidance and sophisticated representation to biotechnology entities. Contact us today online or at (484) 414-4093. We proudly serve small, mid-sized, and emerging businesses throughout the United States and across the globe.
Our biotechnology team offers assistance across a wide-ranging spectrum of services to assist with an array of issues, including:
- Innovation
- Research and development
- Regulatory approval
- Commercialization and post-market enforcement
- Product liability
- Mass tort litigation
- Commercial contracting
- Data privacy
We understand that each client’s circumstances are unique and commit ourselves to help find the distinct strategic paths to foster growth and minimize risk based upon our clients’ needs. Kendall PC regularly advises manufacturers as well as distributors and other companies of all sizes and stages in the product life cycle.
Pharmaceutical, Biotechnology, and Medical Device Commercialization
The seasoned pharmaceutical, biotechnology, and medical device commercialization team of attorneys at Kendall PC have an expansive view of the commercial, scientific, regulatory, and political trends shaping the biotechnology markets in which our clients operate. We know how traditional regulatory pathways work and provide tailored strategies for pre – and post – approval commercialization challenges. We routinely counsel clients on:
- Regulatory filings and communications
- Promotional review committees (medical, legal & regulatory review committee)
- Development, manufacturing, and supply agreements
- Sales and distribution contracting: PBM, wholesaler, and 3PL contracting
- Manufacturing, distribution, and wholesale licensure
- Open Payments (Sunshine Act) compliance
Litigation
When disputes arise, Kendall PC’s litigation
team works to preserve our manufacturer, designer, and distributor clients’ interests, assets, and reputations quickly and efficiently. Our multidisciplinary team provides comprehensive counsel in the most complex and high-stakes biotechnology technology disputes, including:
- Healthcare litigation
- Settlement discussions
- Anti-Kickback Statute litigation
- Healthcare Fraud Statute litigation
- Responsible Corporate Officer Doctrine disputes
- US False Claims Act litigation
- Physician Self-Referral (Stark) Law litigation
- Consumer class action and other consumer-related litigation
- Development, production, sale, and distribution disputes
Ethical and Constitutional Issues
Biotech law focuses on young and emerging technologies. This means that biotechnology lawyers may work on ethical and constitutional issues that could be related to the development of ideas, as well as the application of budding technologies.
Mass Tort and Toxic Tort Defense
The mass tort and toxic tort defense team of attorneys at Kendall PC is comprised of experienced litigators who have defended cases on every level. We have served as national coordinating counsel in state and federal courts throughout the country. Kendall PC has demonstrated past performance including successful exclusions of general causation experts via Daubert hearings and trials, defending petitions to create Multidistrict Litigation (MDL) in nationwide products liability actions, conducting expert discovery, and mapping strategies to obtain important early substantive motion victories for our clients.
Healthcare and Clinical Compliance
The healthcare and clinical compliance team of attorneys at Kendall PC advises on a wide range of compliance topics to guide our biotechnology companies through the evolving legal compliance requirements and governmental oversight employed by the U.S. Food and Drug Administration (FDA), U.S. Federal Trade Commission (FTC), U.S. Health and Human Services (HHS), and Department of Justice (DOJ). We work with our clients to implement effective and cost-efficient compliance strategies tailored to protect our clients’ interests.
Within these areas, our work typically encompasses:
- Policy development and implementation
- Compliance training
- Risk assessments, audits, and gap analysis
- Day-to-day “help desk” compliance support
- Industry benchmarking
- Due diligence and monitoring processes
Regulatory Counsel
Kendall PC’s regulatory practice has deep U.S. and global experience providing regulatory counseling and advice on all areas of biotechnology product regulation. Our regulatory team excels at providing advisory services to support the biotechnology sector in today’s changing, technology-driven economy. We have extensive experience providing assistance to clients on matters relating to:
- US Food and Drug Administration (FDA) compliance matters
- Regulatory approval pathway strategies
- Clinical trial design
- Biologics license applications
- Biosimilar strategies
- FDA advisory committee matters and dispute resolution
- Government sales and contracting disputes
- Reimbursement strategies
- Availability 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
- Product modifications
- Quality system regulation issues
- Medicare, Medicaid, and other federal Healthcare program coverage and reimbursement
- Sunshine compliance
- State distribution compliance matters
- State license registration matters
- State price reporting matters
- 483 Observations and Warning Letters
Government Investigations
Kendall PC handles investigations across a range of law enforcement agencies, including the U.S. attorney’s offices, the DOJ, and state attorneys general. We have extensive experience in defending biotechnology companies in government investigations into alleged violations under the Federal Food, Drug and Cosmetic Act, the Anti-Kickback Statute, and state and federal False Claims Acts, among others. Our government investigations team handles complex multiagency government investigations, including managing parallel investigations by federal and state government entities and settlement and corporate integrity agreement (CIA) discussions and negotiations.
Our government investigations team of attorneys counsel clients on the following government investigation matters:
- Suspensions and debarments
- Anti-Kickback Statute
- FDA Form 483 and Warning Letter Responses
- Foreign Corrupt Practices Act, UK Bribery Act, and other fraud and corruption matters investigations
- False Claims Act investigations
- Deferred prosecution agreements
- US federal and state government civil investigative demands and administrative subpoenas
- Corporate Integrity Agreement (CIA) negotiations
- Billing and coding practices
- Biologics price reporting practices, including discounting and rebate practices
- Medicare, Medicaid, and other US healthcare program matters
Internal Investigations
The seasoned pharmaceutical, biotechnology, and medical device commercialization team of attorneys at Kendall PC have an expansive view of the commercial, scientific, regulatory, and political trends shaping the biotechnology markets in which our clients operate. We know how traditional regulatory pathways work and provide tailored strategies for pre – and post – approval commercialization challenges. We routinely counsel clients on:
Our internal investigations team has experience in investigations concerning:
- Audit committee inquiries into illegal or improper conduct
- Corporate governance, risk management practices, and compliance programs
- Diligence in connection with M&A transactions
- Export compliance
- The False Claims Act, qui tam actions, and government contract billing
- The Foreign Corrupt Practices Act
- Restatements
- Section 10A
- Shareholder and other derivative demands
- Special litigation committees
- Whistleblower and other investigations under Sarbanes-Oxley
- Healthcare fraud
- FDA violations
Commercial Contracting
Kendall PC’s commercial contracting combines legal knowledge with deep sector experience to cover the full spectrum of commercial and business law issues. Companies must address a myriad of relationships and contracts that bind them to their suppliers, customers, licensors, distributors, and other strategic partners. These complexities are intensified by the regulatory obligations that impact every facet of operations within the biotechnology sector. Our team of attorneys has decades of experience advising biotechnology companies on business-critical commercial transactions, among them:
- Manufacturing and supply
- Product development
- Sales and distribution
- Logistics and warehousing
- Master service
- Software as a service (SaaS)
- Commercial lease
- Intellectual property agreements
Data Protection and Privacy
The data protection and privacy team at Kendall PC focuses on the evolving business technological and legal issues relating to the security and privacy of networks and data. We represent biologics clients in counseling, transactions, investigations, government relations, and responses to data breach and security incidents. We have extensive experience with data protection and privacy matters pertinent to manufacturers, distributors, and other entities including the application of:
- EU General Data Protection Regulation (GDPR)
- California Consumer Privacy Act (CCPA) / California Privacy Rights Act (CRPA)
- Health Insurance Portability and Accountability Act (HIPAA)
- Health Information Technology for Economic and Clinical Health (HITECH) Act
- Federal Trade Commission (FTC) Act
- Children’s Online Privacy Protection Act (COPPAA)
- CAN-SPAM Act
- US state security breach notification law compliance
- Medical privacy law matters
- Information disclosure and compliance training
Business Startup, Formation, and Corporate Governance
We conduct due diligence reviews for biotechnology companies engaging in acquisitions, mergers, licensing deals, and investments. Our business, startup, formation, and corporate governance team works with our attorneys in the regulatory, data protection and privacy, and litigation teams to identify and evaluate the myriad of issues that may affect the proposed transactions.
Contact Kendall PC Today
To learn more about how our team of experienced and knowledgeable attorneys can help your biotechnology company, contact Kendall PC today online or at (484) 414-4093. We help companies of all sizes and stages of development throughout the United States and across the globe.
