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HTMLWhat is War? Understanding Aviation War Risk Coverage
John E. Iole; Jones Day;
Legal Alert/Article
July 31, 2014, previously published on July 23, 2014
In the world of insurance, words frequently have a defined or accepted meaning that is different from the popular or intuitive understanding of the term. “War” and, in particular, war in the context of aviation insurance, is one of these.

 

HTMLEuropean Court of Justice Upholds European Commission’s First Withdrawal of Immunity for Cartel Whistleblower but Finds General Court Failed to Timely Adjudicate
Bernard E. Amory, Cecelia Kye; Jones Day;
Legal Alert/Article
July 31, 2014, previously published on July 2014
The European Court of Justice has upheld a €30 million fine against cartel whistleblower Deltafina, which was imposed following the withdrawal of Deltafina's conditional immunity as a result of the breach of its duty to cooperate under the European Commission's leniency program. This ruling...

 

HTMLGerman Renewable Energy Act—Changes in 2014
Thomas Berg; Jones Day;
Legal Alert/Article
July 29, 2014, previously published on July 2014
The amended German Renewable Energy Act ("REA") takes effect on August 1, 2014 and will cause significant changes to Germany's renewable energy landscape, including increased electric generation production targets from renewable energy sources, increased plant capacity, replacement of...

 

HTMLIn re: Kellogg Brown & Root, Inc., et al.: D.C. Circuit Grants Petition for Mandamus and Protects Attorney-Client Privilege of Internal Investigation in False Claims Act Case
J. Andrew Jackson, Lindsey Lonergan, Rebekah N. Plowman, Stephen G. Sozio; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
In March 2014, we issued an Alert summarizing a decision issued by the U.S. District Court for the District of Columbia in United States ex rel. Barko v. Halliburton Co., et al. The District Court granted a relator's motion to compel and ordered defendants to produce documents reflecting the...

 

HTMLNew Tax Treaty Between Mexico and United Arab Emirates Enters into Force
Rodrigo Gómez, Karl L. Kellar, Andrés Lieja, Luis Ignacio Martel, Luis Rodrigo Salinas; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
The Mexico-United Arab Emirates tax treaty, signed on May 20, 2012 (the "Treaty"), entered into force on July 9, 2014 after its publication in the Mexican Official Gazette. Pursuant to Article 28, the Treaty will be applicable on January 1, 2015. The Treaty results from Mexico's...

 

HTMLRecent Decision in Lance Armstrong False Claims Act Case Raises New Timeliness Arguments
Peter F. Garvin, Meghan E. Greenfield, J. Andrew Jackson, Grant H. Willis, Alexander M. Yabroff; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
For several years now, litigants have wrestled with three questions: (i) does the Wartime Suspension of Limitations Act ("WLSA") apply to civil False Claims Act ("FCA") actions, (ii) do the 2009 Fraud Enforcement and Recovery Act ("FERA") amendments to the FCA apply to...

 

HTMLFDA Continues to Bolster Regulation of Compounding Pharmacies
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of...

 

HTMLPayers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...

 

HTMLFDA Contemplates Further Revisions to "Off-Label" Drug Marketing Rules and Guidance
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
According to recent reports, FDA is reevaluating longstanding policies regarding the marketing of pharmaceutical products for "off-label" uses, such as when a manufacturer promotes an otherwise approved product for an indication, age group, or dosage that has not been approved. As...

 

HTMLRussia Adopts Restrictive Changes to its Data Privacy Law Data Location Requirement Will Adversely Affect Data Flows
Veronica Fridman, Anita Leung, Mauricio F. Paez, Sergei Volfson, Undine von Diemar; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
During the first week of July 2014, the State Duma (lower chamber of the Russian Parliament) adopted a set of amendments to the Federal Law "On Information, Information Technologies, and Information Protection" ("Information Law") and to the Federal Law "On Personal...

 


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