This update provides key takeaways on the new draft guidance and Diversity Action Plan requirements, including when the new requirements will go into effect, the types of clinical studies that require submission of a Diversity Action Plan, whether FDA intends to issue waivers for the requirements, and the consequences of failure to submit a Diversity Action Plan.
Delaware Court of Chancery Opines on Meaning of ‘Commercially Reasonable Efforts’ in Pharmaceutical Earn-Out Provision
Ryan Murr, Karen Spindler, Todd Trattner, Marina Szteinbok and Artin Au-Yeung are the authors of “Delaware Court of Chancery Opines on Meaning of ‘Commercially Reasonable Efforts’ in Pharmaceutical Earn-Out Provision” [PDF] published by the Deal Lawyers in its May-June 2024 issue.
Delaware Court of Chancery Opines on the Meaning of “Commercially Reasonable Efforts” in a Pharmaceutical Earn-Out Provision
Observations and drafting suggestions for CRE terms in merger agreements, licenses, and royalty purchase agreements.
On April 30, 2024, the Delaware Court of Chancery held that the buyer in a life sciences merger and its successor had not breached their contractual obligations under an earn-out provision to use commercially reasonable efforts (“CRE”) to achieve regulatory approvals for a pharmaceutical product. In Himawan, et al. v. Cephalon, Inc., et al., Vice Chancellor Glasscock found that the merger agreement’s definition of CRE for purposes of the earn-out provision, which referred to the efforts of a company with substantially the same resources and expertise as the buyer, required the Court to analyze whether a reasonable actor faced with the circumstances would continue to pursue the development of a drug that had failed to meet one of its co-primary endpoints in an earlier clinical trial.[1]
Webcast: Preparing for Stronger Markets: Considerations for IPO Readiness
As more private companies begin to explore IPOs again after a difficult period in the markets, strong pre-IPO readiness can position companies to more swiftly access IPO market windows when they open. This presentation explores preliminary IPO planning considerations and key issues for private companies thinking about an IPO.
Behind The ‘CVR Spin’ Method Of Unlocking Assets In M&A
San Francisco partner Ryan Murr, Washington, D.C. partner Stephen Glover and San Francisco partner Branden Berns are the authors of “Behind The ‘CVR Spin’ Method Of Unlocking Assets In M&A” [PDF] published by Law360 on March 11, 2024.
Life Sciences Review and Outlook – 2024
This update provides a recap of 2023 highlights for capital markets, M&A activity, royalty finance transactions and clinical funding arrangements, along with expectations for 2024.
The past five years have been particularly tumultuous in the biopharma sector. Strong capital markets and M&A activity into early 2020 were whipsawed during the pandemic, with equity valuations climbing significantly through early 2021 before dropping dramatically through the fourth quarter of 2023.
OpEd: How to Get Value for Non-Core Assets With CVR Spinoffs
Ryan Murr, Stephen Glover and Branden Berns are the authors of “OpEd: How to Get Value for Non-Core Assets With CVR Spinoffs” published by The Deal on March 7, 2024.
How Biotech Cos. Can Utilize Synthetic Royalty Financing
San Francisco of counsel Todd Trattner and partner Ryan Murr are the authors of “How Biotech Cos. Can Utilize Synthetic Royalty Financing” [PDF] published by Law360 on February 1, 2024.
Webcast: M&A Insights – How to Use CVRs to Bridge Valuation Gaps, DOJ Self-Disclosure Guidelines for M&A, and Shareholder Activism Update
Join us for a 30-minute briefing covering several M&A practice topics. The program is the fourth in a series of quarterly webcasts designed to provide quick insights into emerging issues and practical advice on how to manage common M&A problems. Stephen Glover, co-chair of the firm’s Global Mergers and Acquisitions Practice, acts as moderator.
False Claims Act Risks for Cyber Device Manufacturers Arising under New Requirements Subject to FDA Enforcement Beginning October 1, 2023
The False Claims Act (FCA) is one of the government’s chief tools to address false claims involving government funds, imposing liability on “any person who… knowingly presents, or causes to be presented, a false or fraudulent claim for payment” to the federal government or who “knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.”[1] Through its qui tam provisions, the FCA also allows private citizens to file suit on behalf of the government for statutory violations.[2]