News & Analysis as of

Modification

CBP Provides The Trade Community with An Opportunity to Identify Regulatory Burdens for Possible Elimination or Modification

• On September 12, 2017, U.S. Customs and Border Protection issued a Federal Register notice, “Reducing Regulation and Controlling Regulatory Costs,” to request comments from interested parties on CBP regulations, paperwork...more

Commercial landlords beware! Time to modify your lease form allowing encumbrance of tenant’s interest?

by Thompson Coburn LLP on

The California Court of Appeal recently held that a lender that took possession of a defaulting tenant’s premises and then transferred its interest to a third party was not liable to the landlord for future rent. In BRE DDR...more

DC Circuit Vacates FERC Order on PJM's Capacity Market

by Stinson Leonard Street on

Decision limits FERC's ability to modify rate proposals - In an opinion issued on July 7, 2017, the U.S. Court of Appeals for the District of Columbia Circuit held that Section 205 of the Federal Power Act "does not allow...more

The Paris Agreement: Where We Were, Where We Are, Where We Are Going

On June 1, 2017, President Donald Trump announced that the United States would withdraw from the Paris Agreement (the “Agreement”), describing it as “disadvantaging the United States” and indicating that the United States...more

Plotting the Course for Maritime and Infrastructure Federal Action

by Cozen O'Connor on

This edition of the Cozen O’Connor Maritime and Infrastructure Federal Update attempts to navigate the mixed messages of recent government actions including (i) Customs and Border Protection’s letter ruling modification...more

FASB Clarifies Accounting for Modifications of Equity Awards

The Financial Accounting Standards Board has issued an Accounting Standards Update (ASU 2017-09; Topic 718) to clarify the accounting for modifications to outstanding share-based payment awards such as stock options and...more

April Showers Bring Mass Mods: New GSA Schedule Refresh and Mass Modification

by Bass, Berry & Sims PLC on

Later this month, the GSA will issue a refresh to all GSA Multiple Award Schedules (MAS) to incorporate new provisions and clause updates. Even if you are already a GSA Schedule holder, keep reading – a bilateral modification...more

Modifying Unmodifiable Agreements

by Fox Rothschild LLP on

A standard provision in most written agreements establishes that no modification of the agreement shall occur unless the parties do so in writing (and usually notarized to avoid fraud). Recently, however, I confronted the...more

What to do when the winner of a sweepstakes or contest wants a different prize

by Thompson Coburn LLP on

What if you offer a sweepstakes and the winner wants to receive only a portion of the prize? Recently, a winner won a vacation for her and a travel companion. However, she did not want anyone to travel with her even though it...more

House Held In Trust Lost Marital Asset Status

by Bryan Cave on

In the afterglow of a wedding, the spouses probably don’t immediately start thinking how the bliss they feel may end spectacularly and expensively. Chances are they may even start estate planning, thinking how they can...more

A Possible New Year’s Hangover for Multistate Employers With California Employees

by Foley & Lardner LLP on

Multistate employers with headquarters located outside California may wake up to a rude surprise on January 1, 2017, as a result of a new California Labor Code law affecting their employment agreements with California...more

California Restricts Choice of Law and Venue Selection Clauses in Employment Agreements

by White & Case LLP on

On September 25, 2016, Governor Jerry Brown signed Senate Bill 1241 into law, adding Section 925 to the California Labor Code. This new California law prohibits an employer from requiring California employees to agree to...more

Preparing for a new year: Take time now for a quick estate plan review

Year end is the time to make certain estate planning provisions to protect the interests of heirs and minimize potential estate tax liability. It’s also a good time to conduct a quick review of your estate plan. This article...more

If it’s broken, fix it! Trusts that no longer achieve their objective can be repaired

What with changing life circumstances and new tax laws, not to mention potential mistakes made when an estate plan was first drafted, the trusts used in the plan may now be “broken.” This article details why trusts break and...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

by Mintz Levin on

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

by Morgan Lewis on

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

Wealth Management Update - October 2016

by Proskauer Rose LLP on

October Interest Rates for GRATs, Sales to Defective Grantor Trusts, Intra-Family Loans and Split Interest Charitable Trusts - The October Section 7520 rate for use with estate planning techniques such as CRTs, CLTs,...more

Redefining U.S. Export Controls: Takeaways from Key Changes Effective September 1st

On September 1, 2016 new rules previously published by the U.S. Department of Commerce, Bureau of Industry and Security (BIS)1 and the U.S. Department of State, Directorate of Defense Trade Controls (DDTC)2 will become...more

Volte face as hardship becomes part of French law

by Reed Smith on

We sent out a client alert in April on the approaching entry into force of the new French civil code. We highlighted four innovations arising out of this major legal reform. This alert focuses on the introduction of the...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

by Reed Smith on

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

When Is a Software Change Really a Change that Requires FDA Review?: When to Submit a 510(k) for a Software Change to an Existing...

by Arnall Golden Gregory LLP on

On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more

Insurer Can Breach Duty by Refusing to a Modification of a Release

Insurer Can Breach Duty by Refusing to a Modification of a Release Woodland hills personal injury lawyer Barry P. Goldberg analyzes insurance company obligations particularly involving ‘Releases.” Mr. Goldberg recently...more

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

When It’s Time to Change, You’ve Got to Rearrange: FDA Issues Draft Guidance on When Changes to an Existing Medical Device...

by Arnall Golden Gregory LLP on

Many of us remember the classic 1972 Brady Bunch song, “Time to Change,” when Peter Brady sings (as his voice cracks), “When It’s Time to Change, You’ve Got to Rearrange,” channeling its inner Brady, the Food and Drug...more

FDA Issues Proposed Guidance for Changes to Medical Device Software

by Knobbe Martens on

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software...more

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