Life Sciences

Day Pitney provides a broad range of services to our life sciences clients, including counsel in the following related practice areas:

Corporate and Transactional Matters

Our attorneys have participated in numerous venture capital investments and other forms of equity and debt financings, mergers and acquisitions, and other strategic transactions. We have structured complex licensing, distribution, development and manufacturing agreements to allow our clients to meet their current and future business needs. Examples include:

• Formation, sale and dissolution of corporations, partnerships, and limited liability companies, including drafting and negotiating stockholders’ and partners’ agreements
• Counseling on strategic alliances, partnering relationships and commercial contracts, including technology-driven agreements; research, development and clinical trial agreements; cross-border licensing; and manufacturing, consulting and vendor agreements
• Advice, preparation, and negotiation of software licensing and systems agreements, leases, and purchase agreements
• Advice on and advocacy of commercial and asset-based lending, equipment leasing, acquisition financings, sale leaseback investment, and bank and other forms of debt and tax-exempt financing
• Tax counseling with respect to federal, state and local tax issues involving choice of entity, structures for transactions, taxable and nontaxable reorganizations, and specialized tax incentives, credits and deferrals

Litigation

In the complex and competitive life sciences industry, Day Pitney's team of litigators counsel and assist our clients in identifying, assessing, and avoiding litigation risks inherent in their business and, where necessary, pursuing and defending claims to protect their business. Whether the litigation involves products liability and mass torts, fraud, securities, or commercial disputes, Day Pitney's decades of experience in complex litigation matters bring invaluable resources to help resolve trial, appellate and administrative matters. Examples include:

• Unfair competition
• Insurance
• Antitrust
• White collar criminal defense
• Foreign Corrupt Practices Act
• Fiduciary liability
• ERISA, reimbursement and insurance coverage
• Government investigations and regulation
• Contract disputes
• Environmental law
• Creditors’ rights
• Appeals
• Administrative
• Collection and general commercial litigation
• Alternative means of dispute resolution, including those related to intellectual property rights and trade secrets
• Construction, banking and securities
• Consumer finance
• Insurance coverage
• Real estate and environmental
• Franchising and distributing

Intellectual Property

Day Pitney's team of intellectual property attorneys provides strategically focused advice regarding the complex issues that arise in patents and trademarks, websites and e-commerce, advertising and promotions, technology transfer and licensing, outsourcing, and other intellectual property matters, including strategic planning and protection programs. Examples include the following:

• Advising a leading global life sciences company on a series of development, patent license and research collaboration agreements in the fields of drug discovery, genomics and biochip analysis
• Represented a major pharmaceutical company in an action to correct inventorship of several patents issued to a former employee, involving off-label usage of a branded drug
• Representing a global leader of  innovative detection, imaging, informatics and service capabilities in patent litigation
• Representing a global leader of  innovative detection, imaging, informatics and service capabilities in trademark counseling and prosecution

Regulatory and Corporate Compliance

We understand the complex federal, state and international regulatory demands that life sciences companies face every day in the development of their products, operations and business relationships. Our regulatory counsel regularly advise our clients on Medicare/Medicaid reimbursement, Current Good Manufacturing Practices (cGMP), product advertising, sale of research and products (including FDA, FTC and BIS regulation), FDA drug and device approval, fraud and abuse, federal and state anti-kickback, HIPAA, HITECH and corporate compliance, government inspections and investigations, and privacy laws. Examples include:

• Representing a pharmaceutical company in all phases of planning, developing and executing drug product launch, including acting as a legal representative on the Advertising Review Committee and advising on marketing regulations, physician grants and physician advisory panels
• Ensuring compliance with governing board and corporate compliance programs

Labor and Employment

We provide complete labor, executive compensation, employment and benefits counseling, and litigation services to meet all of your operational needs. Examples include:

• Management matters before the National Labor Relations Board and in collective bargaining negotiations, labor arbitrations  and related litigation
• Preventive labor relations, including preventing and responding to union organization efforts
• Employment discrimination suits and wrongful discharge suits based on public policy, employee handbooks, or employer manuals and policies, as well as whistleblower claims and various employment tort claims
• Covenants not to compete and to protect proprietary information
• Management employment law issues, such as employee rights in the workplace and developing and implementing detailed personnel policies and procedures
• Compliance with evolving workplace safety and health requirements of the Occupational Safety and Health Administration (OSHA) and with management matters in occupational disease and injury litigation
• Employee benefit plans, retirement plans, and executive compensation agreements and ERISA compliance
• Anti-harassment and anti-discrimination training seminars
• Alternative dispute resolution (ADR) procedures
• Corporate immigration matters, including business, professional and investor visas