In an era when the life science industry is experiencing rapid growth, the multidisciplinary Life Sciences group of Polsinelli Shughart PC is on the forefront of providing the entire spectrum of the legal needs for life science businesses, entrepreneurs, investors, institutes and scientists. Our team of life sciences attorneys provide tailored and focused representation to early stage, emerging and mature life sciences businesses in the areas of intellectual property and technology transfer, health care, corporate finance, regulatory and real estate development, and nonprofit organizations, among others. Our clients cover the entire field of the life sciences industry, including those involved with human health, animal health, plant science, alternative energy and biosecurity.
Our attorneys take leading roles on issues affecting the industry, including economic development, legislation and ethics. By working closely with leaders in research, politics and business, we are able to provide our clients with knowledgeable counsel, industry insight and strategic contacts.
We utilize our experience and broad contacts in the life science industry nationwide to assist our clients by providing guiding strategic advice grounded in real industry experience. The Life Sciences group brings together legal leaders from the following disciplines to serve your needs on a strategic and fully integrated basis:
Corporate Finance
Our attorneys handle deals of all types and sizes of public and private finance transactions representing a diverse range of clients from small businesses and venture capitalists to some of the country’s hottest new companies. We have played a vital role in helping clients achieve successful results through angel and venture capital investments, securities offerings, tender offers and secured and mezzanine finance transactions, to name a few.
Mergers & Acquisitions
With decades of significant experience in sophisticated merger and acquisition and strategic transactional assignments, our attorneys have led efforts for our clients in negotiating, documents and closing numerous complex transactions, with values in the multiple billions of dollars and across a wide variety of industries. In addition to the team’s work in mergers, acquisitions and divestitures, our attorneys also have structured numerous strategic alliances and joint ventures, licensing and technology transfers, sale of control interests, leveraged buyouts and recapitalizations and spin-offs with extensive experience in cross-border transactions.
Energy
Polsinelli Shughart is a leader in assisting clients across the country in the development and construction of the full scope of renewable power and alternative energy projects from biofuels to wind power. Our attorneys have extensive knowledge serving intellectual property and government contracting clients involved in renewable energy development, project finance and public utility services. Our attorneys’ vast experience in real estate, environmental, construction, land use, zoning, finance, regulatory, general business and litigation is an invaluable resource for meeting our client’s objectives.
Executive Compensation/Labor & Employment/Immigration
We have wide-ranging experience with numerous types of employee benefits and executive compensation arrangements for life science organizations, both for profit and nonprofit. Our practice covers the tax, securities law and ERISA aspects of a variety of arrangements, including maintaining compliance with Internal Revenue Code Section 409A, for a variety of employment agreements, severance arrangements, “golden parachutes”, stock options, phantom stock, excess benefit plans, supplemental executive retirement plans, and other incentive compensation arrangements. On the labor and employment front, employers face an ever-growing web of workplace regulations and potential entanglements with employees. Our attorneys understand the complexity and sensitivity of employee relations and workplace issues. We also coordinate the needs of our clients in attracting the best scientists, technicians and other executives from both inside and outside the United States, and qualifying those experts to work in the United States under H-1B Visas, “green cards” and other legal immigration provisions.
FDA Regulatory/Clinical Trials
Polsinelli Shughart’s life sciences lawyers assist our clients in developing their human health and animal health products and in facilitating and accelerating their market introduction. We are involved in this process from proof-of-concept stage through commercialization, working with our clients to:
- Successfully navigate the complex regulatory processes that apply to human and animal health products, including FDA, SSDA, EPA, FTC and DOJ regulations; clinical trial strategies and regulations; assisting in IND, NDA, ANDA, PMA and other regulatory filings and submissions; CLIA, GMP, GLP and GCP regulations; and import/export and international trade laws
- Integrating the complex health care regulatory scheme into our client’s strategic product development plan, including HIPAA and Stark compliance; informed patient consent requirements; insurance and other payer requirements; and IRB regulations
- Documenting the relationships among the various parties in the complex human drug and medical device and animal drug and product development process, including clinical trial documentation, contract research agreements and marketing and distribution agreements
- Assistance in product launch planning and execution, including product labeling, off-label promotion restrictions, product warranties, Web site review and antitrust issues
- Risk management and litigation, including preparation for FDA investigations, risk mitigation policies and procedures, white-collar crime consulting and defense and insurance coverage issues.
Government Contracts
We assist clients in structuring, negotiating and executing on complex governmental contracts, including compliance with the detailed provisions of the Federal Acquisition Regulations, the United State Post Office procurement regulations and the myriad of Department of Defense regulations, among others.
Health Care
Our firm has vast national resources and strong Washington, D.C. connections in the health care industry that allow Polsinelli Shughart to deliver unique insight and results for our life science clients whose products have human health implications. With highly trained, regulatory-experienced attorneys practicing health care law in offices across the country, we are familiar with the full range of lifecycle and business issues confronting health care and life science organizations today. For example, we work with our life science clients from the beginning of their product development process to ensure that their professional arrangements with hospitals and physicians are proper under STARK and other legal requirements, that the informed consents and information technology procedures comply with the HIPPA regulations and that their clinical trials and product marketing materials are structured to maximize the potential that the cost of these products can be reimbursed by insurance companies and other payers, if that is a part of our client’s strategic plan.
Intellectual Property Litigation
We have a national presence in intellectual property enforcement and litigation in virtually every industry that has a need to protect innovation and intellectual property. We handle patent prosecution, licensing and technology transfer, mergers and acquisitions and “due diligence” projects, and related litigation in the fields of human and animal health sciences, software and information technology, biosciences, medical devices, electrical and mechanical devices and methods of doing business. Our representations include public and private companies in patent, trademark, copyright, false advertising, trade dress, trade secrets and unfair competition matters throughout the United States.
Intellectual Property
Polsinelli Shughart protects creativity and encourages the growth of knowledge in the science and technology industries by prosecuting patents, copyrights, trademarks, drafting license agreements and protecting other intellectual property assets. The Science and Technology Law group brings considerable resources and experience to entrepreneurial work by focusing on the special needs of biotechnology, chemical, food science, pharmaceutical, bioinformatic, medical device, computer hardware, software, electronic commerce and new media companies. Staffed with experienced lawyers and scientists with advanced degrees in engineering, biology, microbiology and chemistry, to name a few, our attorneys handle the most complex and cutting edge issues facing technology, high-tech, bioscience, consumer food products, animal science, medical device and agriculture industries. We assist our clients in developing intellectural property strategies, launching websties, raising capital, acquiring and selling technologies and companies and developing strategic partnerships. In addtion, we prepare and review a wide range of technologies, vendor and licensing agreements. We also protect our clients' intellectual property assets through trademarks, copyrighrts, patents, licencing agreements, employment agreements, privacy policies, litigation, technology development, trade secret protection and research and development issues.
International Transactions & Trade
The globalization of life science business has resulted in a need for experienced international tax advice. With the labyrinth of United States and foreign tax laws and international tax treaties, you need guides with substantive experience who can point out international tax issues and configure your international operations to maximize your business. Polsinelli Shughart international tax attorneys have developed that experience by assisting both United States and foreign-based multinational corporations and individuals in the design and implementation of tax efficient global finance, intellectual property, and trading/distribution structures and U.S. tax audits and controversies.
Litigation
Resolving disputes and lawsuits is an essential part of what we do at Polsinelli Shughart. In every case, we work to understand not only the legal issues involved, but also the client’s business goals. Only this kind of in-depth analysis can truly meet a client’s legal challenges today. Our experience includes all aspects of dispute resolution including arbitration and mediation. We have tried and won cases and appeals involving some of the largest companies and against some of the most acclaimed law firms in the nation, in courts from Puerto Rico to Alaska, and Maine to California. We also try cases in federal and state courts all over the country. We have protected our clients’ interests in simple breach of contract matters as well as complex antitrust and RICO actions.
Nonprofit Tax
Polsinelli Shughart is one of the nation’s leading providers of legal services to nonprofit organizations such as universities, scientific institutes, hospitals and foundations. Our attorneys have made significant contributions to nonprofit organizations through innovative approaches to legal and organizational issues. The Polsinelli Shughart team literally “wrote the book” on tax-exempt and nonprofit law. Between them, team members have published more than 25 books in this area reflecting their extensive practical experience in strategically and proactively serving the needs of nonprofit clients.
Product Liability
Polsinelli Shughart’s products liability litigators have more than 50 years’ experience in defending companies from complex products liability claims in courts across the nation. Our life science group works closely with our expert litigators to develop strategies to protect from liability claims, develop document retention policies and procedures and aggressively respond to claims if and when filed. Working closely with our intellectual property and regulatory lawyers, our trial lawyers both manager industry-wide litigation and try individual lawsuits, no matter how simple or complex, including successfully defending “bet the company” products liability claims.
Public Policy Legislation & Lobbying
Our public policy experts advise clients on critical legislative initiative issues impacting the life science industry, on both the federal and state levels. These services range from advising clients on possible future legislative, administrative and policy trends, to lobbying on a client’s behalf to advance the enactment of a law or a congressional or agency decision.
Real Estate Development and Incentives
Our life sciences clients have specialized real estate needs, ranging from clean rooms and CLIA qualified facilities, to large production plants with complex environmental and engineering requirements. Polsinelli Shughart’s real estate development and incentive lawyers assist clients in all phases of the development process for their facilities and in maximizing the public incentives that may be available to enhance the viability of our client’s development processes. Our Construction Litigation group assists in documenting the complex relationships among the parties to a life science real estate development process and in resolving the disputes that may arise in that process.
Real Estate Transactions
Considered by the industry to be deal makers, not deal breakers, Polsinelli Shughart has vast experience in simple and complex real estate transactions. In addition, our real estate transactions attorneys team with other practice groups within the Polsinelli Shughart family to meet our clients' needs concerning environmental issues, taxation (including 1031 exchanges), tax credits, tax increment financing and other development incentives, zoning and other land use issues, design and construction, entity choice and formation, securitization and other general securities needs.
Taxation
We provide creative solutions and legal guidance on international, federal, state and local tax laws in executing transactions for our life sciences clients. Our attorneys partner with our clients to develop business solutions for both short-term and long-term planning. Our attorneys pride themselves on innovative thinking and expertise in structuring business formation, combinations, reorganizations, mergers and acquisitions, and liquidations in the most tax-advantageous manner. If needed, we have litigation experience that spans all judicial forums including the U.S. Tax Court, federal courts, state courts and administrative tribunals throughout the country.