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]
FDA Publishes Proposed Rule Asserting Medical-Device Jurisdiction over Laboratory-Developed Tests
On September 29, 2023, the U.S. Food and Drug Administration (FDA) released its highly anticipated proposed rule on laboratory-developed tests (LDTs) (“LDT Proposed Rule”), which was officially published in the Federal Register on Tuesday, October 3, 2023.[1] In the LDT Proposed Rule, FDA announced plans to formally classify LDTs as medical devices under its regulations, subjecting these tests to extensive premarket review and postmarket compliance requirements. If finalized, the LDT Proposed Rule would result in a significant impact to the growing laboratory testing industry.
FDA Draft Guidance Sheds Light on Agency’s Evaluation of Prescription Drug Use-Related Software
The U.S. Food and Drug Administration (FDA) recently published a draft guidance document proposing to regulate end-user output of prescription drug use-related software (PDURS) as labeling.[1] The draft guidance sets forth review pathways that could benefit prescription drug application sponsors, including by allowing sponsors to incorporate information about PDURS in the FDA-approved labeling and to seek premarket review for certain PDURS functions that meet the definition of a medical device. But by proposing to regulate PDURS-related information as labeling, the draft guidance poses potential enforcement risks for sponsors under the Federal Food, Drug, and Cosmetic Act (FDCA), the False Claims Act (FCA), and other laws, including through possible off-label promotion claims. Interested parties should consider submitting comments to FDA on the draft guidance. FDA has invited comments through December 18, 2023.
Webcast: Recent Developments – ATM Programs and Rights Offerings
In the current equity capital markets environment, offerings that avoid significant dilution can be advantageous. ATM offering programs provide public companies an efficient means of raising capital over time by allowing them to tap into the existing trading market for their shares on an as-needed basis. Rights offerings allow public companies to raise capital while offering all current shareholders the opportunity to participate equally, thereby allowing shareholders to avoid dilution when trading prices are relatively low.
Webcast: Raising Capital in the Current Environment V: ATM Programs and Rights Offerings
In the current equity capital markets environment, innovative offerings that avoid massive dilution can be advantageous. ATM offering programs provide public companies an efficient means of raising capital over time by allowing a company to tap into the existing trading market for its shares on an as-and-when-needed basis. Rights offerings allow public companies to raise capital while offering all current shareholders the opportunity to participate equally, thereby allowing each shareholder to avoid objectionable dilution when trading prices are relatively low.