News & Analysis as of

Good Faith Pharmaceutical Industry

Cadwalader, Wickersham & Taft LLP

Third Circuit Dismisses J&J Affiliate LTL’s Talc Liability Chapter 11 Filing; “Good Faith” Under 1112(b) Requires Financial...

Executive Summary: On January 30, 2023, the U.S. Court of Appeals for the Third Circuit (the “Court”) issued an opinion in In re LTL Management, LLC, No. 22-2003, 2023 WL 1098189, at *1 (3d Cir. Jan. 30, 2023) (“LTL...more

McDermott Will & Emery

Prescription Drug Data Reporting's “Good Faith Compliance” Extension

We recently reported on an FAQ issued December 23, 2022 (FAQ About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56) by the US Departments of Labor, Health and Human Services and the...more

Verrill

A Last-Minute Gift – Prescription Drug Reporting Grace Period and Good Faith Relief

Verrill on

In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more

Fish & Richardson

What to Know About the USPTO’s Duty of Candor Guidance Regarding FDA Submissions

Fish & Richardson on

​​​​​​​By now you have seen multiple reports discussing the PTO’s Notice of July 29, 2022, relating to the duties of candor and good faith. Federal Register, Vol. 87, No. 145, July 29, 2022....more

Bass, Berry & Sims PLC

Health Care Investors Conference: 2021 Recap

Bass, Berry & Sims PLC on

Bass, Berry & Sims and Deloitte presented the 2021 Health Care Investors Conference virtually on November 16... Here are some of the most significant takeaways for healthcare investors from the stimulating discussions and...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

Farrell Fritz, P.C.

Cooperation And Collaboration In E-Discovery Is Still The TARget

Farrell Fritz, P.C. on

My February 17th blog, “Judges Make the Case for TAR” discussed the widespread acceptance by federal courts of technology assisted review (“TAR”), which is acknowledged as cost effective, efficient, and likely superior to the...more

The Volkov Law Group

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

The Volkov Law Group on

On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more

K&L Gates LLP

K&L Gates Triage: 340B Program: A Conversation with Chris Hatwig, Apexus President Part 2

K&L Gates LLP on

This is the second episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor under the 340B Program, including by providing technical...more

Knobbe Martens

Janssen and Celltrion: Remicade Biosimilar Patent Dance

Knobbe Martens on

Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more

Mintz - Health Care Viewpoints

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

Bilzin Sumberg

Caveat Emptor: Non-compliance with a Non-Binding Term Sheet Results in $195 Million Judgment

Bilzin Sumberg on

On December 23, 2015, the Delaware Supreme Court affirmed the Delaware Chancery Court’s award of $195 million to PharmAthene, Inc. (“PharmAthene”) as compensation for lost profits (a/k/a expectation damages) on account of the...more

K&L Gates LLP

Delaware Supreme Court Holds That Expectation Damages Involving the Breach of an Obligation to Negotiate in Good Faith a License...

K&L Gates LLP on

On December 23, 2015, the Delaware Supreme Court sitting en banc issued its second opinion in Siga Technologies Inc. v. PharmAthene, Inc. In its first decision, the Court reaffirmed its recent decision in Titan “that where...more

K&L Gates LLP

The Delaware Chancery Court Awards Lump-Sum Expectation Damages, Including Interest and Attorneys Fees, in the Amount of...

K&L Gates LLP on

This Legal Insight updates our Legal Insight dated June 25, 2013, regarding the Delaware Chancery Court case captioned PharmAthene, Inc. v. SIGA Technologies, Inc., Civ. Action No. 2627-VCP, in which K&L Gates LLP serves as...more

McDermott Will & Emery

Inside M&A - Summer 2014

McDermott Will & Emery on

“Commercially Reasonable Efforts” Diligence Obligations in Life Science M&A" - More than 80 percent of all deals in the pharmaceutical, medical device and biotech industries include an earnout structure that provides...more

McDermott Will & Emery

IP Update, Vol. 16, No. 7, July 2013

McDermott Will & Emery on

“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more

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