U.S. Supreme Court Upholds State Law Rights of Trademark Licensees and Other Non-Debtor Contract Parties in Bankruptcy
On May 20, 2019, the U.S. Supreme Court issued an 8-1 ruling in the case of Mission Product Holdings, Inc. v. Tempnology, LLC ...
CMS Announces Request for Applications: BPCI Advanced Model Year 3
On April 24, 2019, the Centers for Medicare and Medicaid (“CMS”) released a Request for Applications (“RFA”) for the Bundled Payments ...
UK’s ICO invites enquiries from organisations considering developing a GDPR certification scheme
The UK Information Commissioner’s Office (“ICO”) is welcoming enquiries from organisations that are considering developing a General Data Protection Regulation (&ldquo ...
China Proposes Major Changes to Pharmaceutical Regulations
On April 20, 2019, the Chinese government submitted a second draft of the Drug Administration Law of the People's Republic of China (Second Draft ...
Robare v. SEC: The D.C. Circuit “May” Have Punted on Key Disclosure Question, but Takes Clear Stand on “Willful” Conduct
On April 30, 2019, the U.S. Court of Appeals for the D.C. Circuit issued a long-awaited decision in Robare Group, LTD. v ...
For the First Time CFTC Publishes Enforcement Manual
On May 8, 2019, the Commodity Futures Trading Commission’s (“CFTC”) Division of Enforcement (“DOE”) issued its Enforcement Manual (&ldquo ...
Federal Circuit Holds that ITC’s Trademark Decisions Are Not Binding on District Courts, Creating a Potential Circuit Split
The U.S. International Trade Commission, a quasi-judicial independent agency based in Washington, D.C., is a common forum for patent, trademark, and trade ...
Practical advice for directors of distressed companies
In normal circumstances, a director’s primary duty (owed to the company, not the company’s shareholders or the corporate group) is to ...
Sales of businesses in distress
When a company enters a period of financial distress, directors must consider the interests of the company’s creditors and, depending on the extent ...
Converting Traditional Open-End Funds into ETFs
The Securities and Exchange Commission (the “SEC”) recently published a notice relating to an application for exemptive relief filed by Precidian ETFs Trust ...
Guidance on Tax Incentives for Investments in Qualified Opportunity Zones
On April 17, 2019, the Treasury Department and the Internal Revenue Service (“IRS”) issued a second set of proposed regulations (the “Proposed ...
What to Know About the CMS Primary Cares Initiative
On April 22, 2019, the U.S. Department of Health and Human Services and its Centers for Medicare & Medicaid Services (CMS) announced the &ldquo ...
New FDA Draft Guidance on Voluntary Recalls Asks: Are You Prepared?
On April 24, 2019, the Food and Drug Administration (“FDA”) released a draft guidance, entitled “Initiation of Voluntary Recalls Under 21 CFR ...
Federal Circuit Affirms ITC’s Non-Institution Decision, Offering Guidance for Future FDCA-Related Section 337 Claims
In its long-awaited decision in Amarin Pharma. v. ITC, the Federal Circuit provided guidance on the U.S. International Trade Commission’s discretion ...
New DOJ Guidance Reflects an Evolution in the Evaluation of Corporate Compliance Programs
On April 30, 2019, the DOJ's Criminal Division published an updated Evaluation of Corporate Compliance Programs Guidance Document (“the Guidance”) for prosecutors ...
Concerns About Pay-to-Play Violations Amplify As 2020 Giving Ramps Up
I. Concerns About Pay-to-Play Violations Amplify As 2020 Giving Ramps Up As the 2020 Democratic presidential primary election field develops and new candidates ...
FDA’s Draft Guidances on Medical Device Inspection Transparency: Anything New Here?
Two recent FDA draft guidances respond to directives from Congress to improve transparency with medical device firms regarding inspections, including the process for requesting nonbinding ...
SEC Publishes Framework for Investment Contract Analysis of Digital Assets and Issues First No-Action Letter for a Token Sale
On April 3, 2019, the SEC’s Strategic Hub for Innovation and Financial Technology (“FinHub”)1 published a framework for analyzing whether ...
Bankruptcy “Safe Harbor” Fraudulent Transfer Defense Reaffirmed in Tribune LBO Litigation
On April 23, 2019, Ropes & Gray, representing a large group of shareholder defendants, won a decision in the U.S. District Court for the ...
Congressional Review Act: OMB Memo Would Make SEC, CFTC and Other Independent Agency’s “Major Rule” Analyses Subject to Executive Branch Review
The Congressional Review Act (the “CRA”) is an oversight tool that Congress may use to overturn a rule issued by a federal department ...
Federal Reserve Board Proposes Changes in Control Analysis
On April 23, 2019, the Federal Reserve Board (the “Board”) released for public comment proposed changes to its longstanding positions on the exercise ...
FCA 2019/20 Business plan released highlighting conduct supervision and financial crime as key focus
The Financial Conduct Authority (“FCA”) has released its business plan for 2019/20, in which it sets out its areas of focus for ...
Justices Could Trigger Sea Change For Tender Offer Suits
This article by partners Martin Crisp, Douglas Hallward-Driemeier, David Hennes, and Gregg Weiner, with contributions from associates Jordan Harvey and Logan Pettigrew ...
Delaware Supreme Court Reaffirms Importance of Deal Price in Appraisal Litigation
In Verition Partners Master Fund Ltd. v. Aruba Networks, Inc.,1 the Delaware Supreme Court again endorsed deal-price-minus-synergies as a foundational ...
India Finalizes Rules Regarding Compensation for Subjects Injured in Clinical Trials and Post-Trial Access to Study Drugs
I. Background Since 2013, India’s clinical trials regulatory framework has undergone continuous, significant changes to bolster protections for clinical trial participants. In an ...