Life sciences clients operate in a heavily regulated and constantly changing environment. Pepper understands this environment and we help clients navigate all of the issues they may encounter — from escalating business, financing and pricing pressures to government investigations, to commercial, patent and mass tort products liability litigation.
We employ a holistic approach, providing comprehensive counseling at every stage of a company’s development or a product’s life cycle, including discovery, development, manufacturing, marketing and sales.
MAJOR AREAS OF PRACTICE
We represent general partners and venture investors in fund formation, domestic and foreign tax planning, fund investments in portfolio companies and the public and private sale of portfolio company investments. We also represent entrepreneurs and venture and later-stage businesses seeking access to private equity investors. Through our experience, we have deep relationships with leading venture and private equity funds focused on the life sciences sector.
As businesses grow, they frequently require advice on corporate governance issues, debt and equity financing transactions, and compliance with securities laws and regulations. We counsel life sciences businesses on numerous capital markets transactions, including IPOs and follow-on public offerings, PIPE transactions; and structuring, negotiating and documenting other sophisticated equity and debt financing transactions. We also counsel growing life sciences companies on compliance with federal and state securities laws and regulations, stock exchange listing rules and other governance requirements. We advise clients on governance practices, and we are experienced at defending against securities and shareholder litigation.
Licensing, Collaboration and Partnering Arrangements
We assist clients in long-term collaborations, life-of-patent licensing arrangements and other transactions common in the life sciences industry, as well as the sophisticated issues that often arise in such transactions, including:
In addition, we counsel on the structuring and implementation of the following:
The most valuable assets of most life sciences companies are their proprietary technologies, products and market identity. Pepper’s Life Sciences Group includes patent lawyers and patent agents experienced in securing patent protection for pharmaceuticals, nutraceuticals, medical devices and other medical and life science-related products and methods. Many of our lawyers are scientists with advanced degrees who have had hands-on experience in the life sciences. We offer full service IP counseling - patent prosecution, trademark and trade secret protection, maximizing the value of IP portfolios, due diligence of IP-related aspects of corporate transactions, the interplay between FDA regulations and patent law, and patent and other IP litigation, both offensive and defensive.
Product Acquisition and Disposition
Acquisition and disposition of products are essential components of the cycle for most life sciences companies. We assist clients in all aspects of these transactions, including:
Company Exit Transactions
When investing in the life sciences industry, it is not only important to find a good investment, an investor must also implement an exit strategy to realize the investment’s original value proposition. A successful exit strategy may involve a number of things, ranging from pre-disposition acquisitions in order to enhance a liquidity event platform to refinancing or leveraging the portfolio company’s assets to a public offering.
We understand the full spectrum of exit transactions, and we work with our clients to choose the best strategies for their individual needs. We assist funds and their portfolio companies in asset sales, stock sales, recapitalizations, refinancings, mergers and consolidations, IPOs and other liquidity events, and we utilize cross-practice teams to ensure we address all tax and compensation concerns. Our lawyers also assist our clients’ investment bankers with sell-side auctions, and we counsel portfolio companies on public and private offerings of debt and equity securities.
As part of our “molecule to marketing” services, we provide comprehensive advice to life sciences clients on the regulation of drugs and medical devices — from development to clinical trials to marketing. Then, once a product is on the market, we help our clients navigate the Medicare and Medical payment systems, as well as anti-kickback, fraud and abuse and other regulatory issues.
Litigation and Government Investigations
Pepper Hamilton offers clients one of the largest and strongest teams in the country devoted to representing pharmaceutical, biotechnology and medical device companies in complex litigation and investigations matters. We have more than 60 years of experience in defending pharmaceutical, medical device and other life sciences businesses against all types of litigation and government investigations and enforcement actions.