Pre-commercial life sciences companies turn to Sidley in the U.S., Europe, and Asia to help them navigate the complex legal issues that arise as they conduct their research and development activities and prepare to bring their products to market. Our transactional work spans formation and early-stage capital-raising through IPO and beyond, licensing and collaboration deals, operational agreements, and buy- and sell-side M&A transactions. Our healthcare and FDA regulatory teams counsel clients on issues related to conducting clinical trials, engaging with regulatory agencies for approval or marketing clearance, developing pricing, reimbursement, and market access/payer contracting strategies, and establishing quality systems and right-sized compliance programs. Our life sciences transactional, litigation and regulatory lawyers coordinate to leverage and protect a company’s intellectual property through an integrated patent and regulatory strategy and to reduce future enforcement risk.
Pre-Commercial Life Sciences Companies
We bring particular value to pre-commercial life sciences companies in the following areas:
- Corporate/Venture Capital: We advise emerging companies in the biotechnology, pharmaceuticals, diagnostics, and medical devices sectors — and their VC and corporate investors — in their most important transactions, including public and private capital-raising and M&A. Clients choose Sidley because of our depth and breadth of experience navigating the business life cycle. Our clients benefit from our efficient staffing models tailored to early-stage companies, our access to deal flow, and introductions through our extensive network, including connections to VC and corporate investors, as well as incubators and accelerators.
- Licensing and Collaborations: We help pre-commercial life sciences companies identify and address their key business needs in undertaking their partnering transactions. Our licensing lawyers structure, negotiate, and draft complex collaborations, partnerships, in-licenses, out-licenses, sponsored research agreements, clinical trial agreements and a host of different business arrangements, and advise on royalty-based and/or revenue interest-based financing and monetization unique to life sciences companies. Our licensing lawyers regularly team with our regulatory colleagues to anticipate and address issues associated with the regulatory development and approval process, market access, and pricing and reimbursement, including in the context of complex combination therapies, regional licenses, and co-commercialization arrangements.
- Capital Markets/IPOs: Our capital markets lawyers possess deep experience across the entire capital structure and work in financial centers across the U.S., Asia Pacific, and Europe. We are well-versed in pre-IPO financings, IPOs, follow-on equity offerings, PIPEs, SPACs/deSPACs and debt offerings. We help pre-commercial life sciences companies successfully execute their financing transactions with key market participants, including private equity and venture capital investors and industry-leading investment bankers.
- SEC Compliance: We advise and defend public life sciences companies in a wide range of securities-related matters. Our lawyers provide insight into leading developments at the SEC based on an understanding of the informal interpretations, practices, and positions of the SEC staff. Our lawyers understand that for life sciences companies, a coordinated approach to disclosure that considers the views of the SEC and the FDA, alongside the strategic goals of the company, is critical. We maintain strong working relationships with regulators in the U.S., as well as with sovereign regulators in Europe and Asia. We have guided public companies through a broad spectrum of regulatory challenges over the last 15 years and counseled clients on prospective compliance issues, risk-mitigation measures, and regulatory disclosures.