Contract Terms, Pharmaceutical Industry, Food and Drug Administration (FDA)

Exclusive Licensing May Offer Biotechs a Financial Lifeline

Troutman Pepper Locke on 7/14/2025

With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

FDA Approves BLA for Novavax’s COVID-19 Vaccine

Goodwin on 5/27/2025

On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Husch Blackwell LLP on 3/17/2025

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

The Delaware Court of Chancery Rejects Termination of Merger Agreement Based on Material Adverse Effect

Cadwalader, Wickersham & Taft LLP on 1/8/2020

In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more

Securities and Corporate Governance Update – October 2019

BCLP on 10/24/2019

This newsletter discusses noteworthy updates, key regulatory decisions and upcoming compliance reminders. In this edition, we review: ...SEC Changes Approach to Shareholder Proposal No-Action Requests ...SEC Issues...more

Akorn v. Fresenius: Important Practical Lessons from First-Ever Material Adverse Effect

Fenwick & West LLP on 10/25/2018

On October 1, in Akorn v. Fresenius Kabi, the Delaware Court of Chancery for the first time found that a material adverse effect — or MAE — had occurred in a merger transaction, which, combined with other breaches of the...more

MAE is MIA No Longer: Delaware Court Upholds Use of “Material Adverse Event” Clause for the First Time

Dorsey & Whitney LLP on 10/15/2018

In Akorn, Inc. v. Fresenius Kabi AG, the Delaware Chancery Court held that Fresenius, a German pharmaceutical company, was justified in invoking a “material adverse event” (MAE) clause to terminate its $4.8 billion merger...more

Delaware Judge Finds Elusive MAC—Does It Change Anything?

Bennett Jones LLP on 10/10/2018

Purchasers of businesses often want an "escape hatch" prior to closing if the target business suffers a "material adverse change" (or a "material adverse effect"). Historically, based on court decisions primarily out of the...more

Delaware Court Of Chancery Rules For The First Time That MAE Justifies Termination Of Deal

A&O Shearman on 10/9/2018

In a first-of-its-kind ruling, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery ruled post-trial that Fresenius SE & Co. KGaA (“Fresenius”) properly terminated its $4.3 billion agreement to acquire Akorn,...more

Delaware Court of Chancery Finds a Material Adverse Effect and Permits Termination of Merger Agreement

Wilson Sonsini Goodrich & Rosati on 10/5/2018

In a 246-page post-trial decision issued this week, the Delaware Court of Chancery ruled that a buyer could terminate a $4.75 billion public company acquisition because of material adverse effects that had occurred at the...more

Contract Terms › Pharmaceutical Industry › Food and Drug Administration (FDA)

"My best business intelligence, in one easy email…"