Overview

We work closely with our leading M&A, capital markets, and IP transactions practices to deliver seamless regulatory due diligence, advise on innovative deal structures and their regulatory implications, and draft key contractual provisions in highly complex life sciences transactions, licensing deals, and collaborations, including some of the most significant deals in the industry. This distinctive combination of transactional and regulatory capabilities allows us to translate diligence findings directly into effective deal negotiations and contract terms.

How We Help

We advise on the following types of transactions and related matters:

Mergers, Acquisitions, and Securities Offerings

Representing life sciences companies, private equity firms, and financial institutions in transactions involving drug, biologic, device, cosmetic, and consumer products companies, including mergers, acquisitions, and public and private securities offerings.
Performing FDA regulatory diligence, advising on remediation strategies for issues identified during diligence, and negotiating transaction terms for acquisitions and investments in FDA-regulated companies on behalf of both private equity firms and strategic buyers.
Advising boards, management teams, and investors on regulatory risk assessment and disclosure obligations in connection with securities offerings and public company reporting.

Asset Purchases and Carve-Outs

Advising on regulatory aspects of product acquisitions, divestitures, and carve-out transactions, including FDA registration transfer requirements and manufacturing site qualifications.
Counseling on strategies for maintaining regulatory continuity during ownership transitions, including New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), and device registration transfers.

Licensing and Collaboration Agreements

Structuring and negotiating FDA-related provisions in licensing, co-development, and co-promotion agreements for pharmaceutical, biotechnology, and medical device products.
Advising on regulatory milestone provisions, including approval triggers, labeling commitments, and post-marketing obligations in partnership agreements.
Drafting and negotiating regulatory provisions in research collaboration and joint venture agreements, including allocation of regulatory responsibilities and data rights.

Supply and Distribution Agreements

Contacts

View All Attorneys

Gregory H. Levine

Partner

Washington, D.C.+1 202 508 4831

[email protected]

See Bio

Joshua Oyster

Partner

Washington, D.C.+1 202 508 4616

[email protected]

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Sarah Blankstein

Counsel

Boston+1 617 951 7512

[email protected]

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Rebecca H. Williams

Associate

Washington, D.C.+1 202 508 4726

[email protected]

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Ropes & Gray has exceptional FDA attorneys. They are our go-to resource and very strong in a number of areas, including commercial awareness, value for money, service levels, responsiveness, and ability to handle complex and sophisticated matters.

Chambers USA

Overview

Mergers, Acquisitions, and Securities Offerings

Asset Purchases and Carve-Outs

Licensing and Collaboration Agreements

Supply and Distribution Agreements

Contacts

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