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Practice Tip: FDA Issues Draft Guidance for REMS Image

Practice Tip: FDA Issues Draft Guidance for REMS

Alan G. Minsk & Lanchi Nguyen

On Sept. 30, 2009, the FDA issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics.

Features

Ticketmaster Lead Counsel on Live Nation Merger Issues Image

Ticketmaster Lead Counsel on Live Nation Merger Issues

Amanda Bronstad

The proposed merger between Ticketmaster Entertainment Inc. and Live Nation Inc. won Justice Department approval in January 2010, following a year of negotiations. Steven Sletten of Gibson, Dunn & Crutcher counseled Ticketmaster. In an interview, Sletten stated that he prepared his client to face a tough audience, both at the Justice Department and in the court of public opinion.

Features

Five Steps to Managing Social Media Risks Image

Five Steps to Managing Social Media Risks

Douglas J. Wood

On the one hand, companies want to capture the attention of potential customers roaming the social media space. On the other hand, conversations in the blogosphere are largely uncontrollable, and raise a myriad of risks. Social media can cause serious losses if not handled correctly.

Features

Third Circuit Tackles Teen 'Sexting' As Child Pornography Image

Third Circuit Tackles Teen 'Sexting' As Child Pornography

Shannon P. Duffy

As the nation's first case involving criminal prosecutions of teenagers for "sexting" made its way to a federal appeals court in Philadelphia, all three judges seemed skeptical of the prosecutor's claim that child pornography laws are violated when a teen transmits a nude image of herself.

Features

Registering Marks As Top-Level Domain Names Image

Registering Marks As Top-Level Domain Names

Robert B.G. (Red) Horowitz

The Internet Corporation for Assigned Names and Numbers ("ICANN") plans to issue generic top-level domain names ("gTLDs") beyond the current 21 top-level domain names ("TLDs") such as .com and .net. For the first time, trademark owners may use their marks as gTLDs; for example, .nike. The application process is complex, and trademark owners have no guarantee that they will secure gTLDs for their marks. e-Commerce providers, however, can use trademark-law strategy to gain advantages during the application process.

Features

Worker Misclassification to Receive Heightened Scrutiny Image

Worker Misclassification to Receive Heightened Scrutiny

Joel W. Rice & Brian K. LaFratta

Over the past year, federal and state governmental agencies have signaled their intent to more seriously investigate the misclassification of employees as independent contractors. Penalties for misclassification are severe and can put a company out of business.

Features

COBRA Subsidy Extended; Further Extensions Likely Image

COBRA Subsidy Extended; Further Extensions Likely

Stuart Sirkin

In the midst of the ongoing health care reform debate, Congress was able to unanimously agree on retroactively extending the Federal 65% COBRA health care premium subsidy for workers involuntarily separated.

Features

Money Laundering: A Changing Paradigm Image

Money Laundering: A Changing Paradigm

Michael Zeldin & Miriam Ratkovicova

Over the past several months there has been a slew of public pronouncements that should put financial institutions on edge. Enhanced enforcement of the Foreign Corrupt Practices Act (FCPA) is now migrating into the financial sector and linking up with anti-money laundering (AML) and Office of Foreign Assets Control (OFAC) compliance requirements.

Features

<b><i>BREAKING NEWS:</i></b> Gay Marriage Falls in New Jersey Senate Image

<b><i>BREAKING NEWS:</i></b> Gay Marriage Falls in New Jersey Senate

ALM Staff & Law Journal Newsletters

The New Jersey state senate has voted down the gay marriage bill 20-14, according to the Associated Press and <i>The Huffington Post</i>.

Features

Interpreting FTC's New Endorsement Guidelines Image

Interpreting FTC's New Endorsement Guidelines

Alan L. Friel

This series examines changes to the Federal Trade Commission guidelines for product endorsements and testimonials. The revised new guidelines took effect Dec. 1, 2009.

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    “Baseball arbitration” refers to the process used in Major League Baseball in which if an eligible player's representative and the club ownership cannot reach a compensation agreement through negotiation, each party enters a final submission and during a formal hearing each side — player and management — presents its case and then the designated panel of arbitrators chooses one of the salary bids with no other result being allowed. This method has become increasingly popular even beyond the sport of baseball.
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    Insiders (and others) in the private equity business are accustomed to seeing a good deal of discussion ' academic and trade ' on the question of the appropriate methods of valuing private equity positions and securities which are otherwise illiquid. An interesting recent decision in the Southern District has been brought to our attention. The case is <i>In Re Allied Capital Corp.</i>, CCH Fed. SEC L. Rep. 92411 (US DC, S.D.N.Y., Apr. 25, 2003). Judge Lynch's decision is well written, the Judge reviewing a motion to dismiss by a business development company, Allied Capital, against a strike suit claiming that Allied's method of valuing its portfolio failed adequately to account for i) conditions at the companies themselves and ii) market conditions. The complaint appears to be, as is often the case, slap dash, content to point out that Allied revalued some of its positions, marking them down for a variety of reasons, and the stock price went down - all this, in the view of plaintiff's counsel, amounting to violations of Rule 10b-5.
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