News & Analysis as of

Safe Harbors

New Partnership Audit Regulations Released as Permitting Push-Out Election Through Tiered Partnerships

by Ropes & Gray LLP on

In a trilogy of releases in the last six weeks, the Department of Treasury (“Treasury”) provided much-needed guidance on the implementation of the partnership audit rules in the Bipartisan Budget Act of 2015 (the “BBA...more

A Federal Court Gets Opportunity to Weigh In on Prop 65 With a Little Help from Some Friends

Much of the recent discussion regarding Prop 65 has been focused on the regulatory changes going into effect in August of 2018. And that makes sense since there will be significant changes to the warnings, responsibility, and...more

DOL Revives Slate of FLSA Opinion Letters From 2009

Continuing the pro-business activities many expected from the agency, the U.S. Department of Labor has revived 17 Fair Labor Standards Act opinion letters that were published in the waning days of the Bush Administration in...more

Court Punishes Company For Statement Of Belief

by Allen Matkins on

Thomas Carlyle famously called economics, the "dismal science". Sometimes, the law can be equally disheartening. Imagine trying to explain to a client that a statement that the company is "on track" to meet its projections...more

OIG Invites Anti-kickback Safe Harbor, Fraud Alert Recommendations

by Reed Smith on

The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for new or revised anti-kickback statute safe harbors and new Special Fraud Alerts. The OIG states that in considering any...more

2018: Predictions From Socially Aware’s Editors and Contributors

Happy 2018 to our readers! It has become a Socially Aware tradition to start the New Year with some predictions from our editors and contributors. With smart contracts on the horizon, the Internet of Things and...more

OIG Requests Public Input on Anti-Kickback Statute Safe Harbors

by King & Spalding on

In a notification published last week, OIG began soliciting proposals and recommendations for modifying existing and developing new safe harbor provisions under the Federal Anti-Kickback Statute (AKS). Public comments must...more

Reminder: Re-Register Your DMCA Agent Designations Before End of Year or Risk Losing Safe Harbor Protections!

by Bracewell LLP on

U.S. Copyright Office Goes Paperless for DMCA registered agents; All paper registrations invalid as of December 31, 2017. As you’re making your end of year lists and checking them twice, better make sure you’ve registered...more

Year in Review: Top Five Legal Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

DMCA Safe Harbors Will Discontinue for Websites and Internet Service Providers that Fail to Electronically Register their...

by Ladas & Parry LLP on

Proprietors of websites that host user generated content and online search engines and directories have long benefitted from the safe harbors available to them under the Digital Millennium Copyright Act (DMCA). These safe...more

Social Links: Twitter’s tougher anti-hate-speech policy; tech-industry-friendlier version of bill to narrow the §230 safe harbor;...

In an effort to deter hate groups from tweeting sanitized versions of their messages, Twitter has began considering account holders’ off platform behavior when the platform evaluates whether potentially harmful tweets should...more

A Deeper Dive Into Oregon’s Landmark Pay Equity Law

by Fisher Phillips on

Six months ago, the Oregon legislature passed the most sweeping statewide equal pay law in the nation. It was a confusing move for some. After all, Oregon has had an equal pay law on the books since the early 1980s, while the...more

Australia: phoenixing reform rising beyond the safe harbour

by DLA Piper on

Australian insolvency law reform is gaining momentum. In September 2017, we saw the Treasury Laws Amendment (2017 Enterprise Incentives No. 2) Bill 2017 receive royal assent, introducing a new safe harbour for directors who...more

Worldwide Bolar-type Provisions*

Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more

Navigating the Safe Harbour – To Disclose or not to Disclose?

by K&L Gates LLP on

The Safe Harbour reforms that became law on 19 September 2017 aim to create a better environment for the effective corporate rescue of distressed companies. By removing the perceived fear of insolvent trading from directors...more

California Clarifies Requirements for Consumer Product Warnings When Marketing Over the Internet or in Catalogs

by Reed Smith on

The California Office of Environmental Health Hazard Assessment (OEHHA) recently clarified its regulations on when a warning needs to be given when marketing consumer products via the Internet or catalogs. The regulations...more

Bolar Exemption in Europe and Asia

Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...more

Bolar Exemptions in North America

Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more

Newly Proposed Partnership Audit Rules Allow for Multiple-Tier “Push-Out” Election

by Dechert LLP on

The U.S. Department of the Treasury (the “Treasury”) and the U.S. Internal Revenue Service (the “IRS”) have issued a new installment of proposed regulations under the centralized partnership audit regime included in the...more

California Approves New Amendments to Proposition 65 Safe-Harbor Regulations

by Beveridge & Diamond PC on

The California Office of Environmental Health Hazard Assessment (OEHHA) announced on December 6, 2017 that the state had approved new amendments (Final Amendments) to the Proposition 65 Clear and Reasonable Warning...more

Global Patent Prosecution Newsletter - December 2017

Worldwide Bolar Exemptions - Many countries have exemptions for patent infringement for a product and/or process that is not being used for direct commercialization and profit. For biopharmaceuticals, this exemption,...more

Department of Defense Publishes Amends and Adds Further Guidance on Military Lending Act Regulations

by Morrison & Foerster LLP on

On December 14, 2017, the Department of Defense (“DOD”) published final interpretive rules (the “2017 Interpretive Rule”) amending previously issued interpretive rules on the Military Lending Act (“MLA”). The 2017...more

The Digital Millennium Copyright Act (DMCA) Registration is due by December 31st, 2017

by Ervin Cohen & Jessup LLP on

The Digital Millennium Copyright Act (DMCA) is a safe harbor from copyright infringement liability for “online service providers.” An “online service providers” is a website that falls into one of the four following...more

Plans should get rid of those forfeitures

by Ary Rosenbaum on

Forfeitures that occur when people terminate service from retirement plans is usually a problem when the plan sponsor and their providers forget about them. Whether forfeitures are used to pay expenses, reduce employer...more

Examining the Limits of the Forward Contract Safe Harbor

by Dechert LLP on

As discussed in a recent Dechert OnPoint, section 365(e)(1) of the U.S. Bankruptcy Code provides that an executory contract of a debtor may not be terminated solely because of a provision in such contract that is conditioned...more

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