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HTMLDepartment of Commerce Mandatory Foreign Direct Investment Survey BE-13: Information Collection Related to Direct or Indirect Foreign Investment in the United States
Giovanna M. Cinelli, Chad O. Dorr, Kenneth J. Nunnenkamp; Jones Day;
Legal Alert/Article
January 19, 2015, previously published on December 2014
On November 26, 2014, the Department of Commerce, Bureau of Economic Analysis ("BEA" or "the Bureau") published a notice on the BEA website reinstating BE-13 Form: "Survey of New Foreign Direct Investment in the United States," after a false start in August 2014. This...

 

HTMLP5+1 and Iran Nuclear Negotiations and Joint Plan of Action Extended Up To an Additional Seven Months
Renato Antonini, Sean Thomas Boyce, Michael P. Gurdak, Fahad A. Habib, Paul C. Hines; Jones Day;
Legal Alert/Article
December 22, 2014, previously published on November 2014
On November 24, 2014, the P5+1 (or, alternatively, E3+3) countries (the United States, United Kingdom, France, Germany, China, and Russia) announced that ongoing negotiations with Iran regarding its nuclear enrichment and development activities, along with sanctions relief agreed to by the United...

 

HTMLLuxembourg Leaks: Potential Risks to Companies Whose Luxembourg Tax Rulings Have Been Released to the Public
Lodewijk P.W. Berger, Thomas Jestaedt, Scott M. Levine, Howard M. Liebman, Raymond J. Wiacek; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
This week, the so-called "International Consortium of Investigative Journalists" ("ICIJ"), on its website, leaked a total of 548 tax rulings that multinational companies obtained in Luxembourg in the period from 2002 to 2010.

 

HTMLFDA Voices Privacy Concerns and Promotes Medical Device Cybersecurity with New Guidance, Collaborative Information-Sharing
Laurie A. Clarke, Alexis Slagle Gilroy, Colleen Heisey, Kevin D. Lyles, Mauricio F. Paez; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
Cybersecurity of medical devices poses unique challenges for industry and regulators, because of potential risks in device malfunction, disruption of medical care, and compromised patient data, as well as the challenge of balancing countervailing needs, such as patient safety and ensuring that...

 

HTMLAdministrator v. Pirker: NTSB Holds that Existing Regulations Can Apply to Unmanned Aerial Systems (Drones)
Jeffrey J. Immel, Rebecca MacPherson, Jameson C. Rohrer, Devin A. Winklosky; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on December 2014
On November 18, 2014, the National Transportation Safety Board ("NTSB") issued its long-awaited decision in Administrator v. Pirker. The NTSB reversed the holding of the Administrative Law Judge ("ALJ") and found that 14 C.F.R. § 91.13(a), which forbids careless or reckless...

 

HTMLCFPB Permits Online Posting of Annual Privacy Notices
Michael R. Butowsky, Lisa M. Ledbetter, Todd S. McClelland, Stephen J. Obie, Mauricio F. Paez; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
The Consumer Financial Protection Bureau ("CFPB") recently adopted a final rule that under certain conditions provides financial institutions it regulates with the option of posting annual consumer privacy notices online rather than mailing paper copies to customers (the "Privacy...

 

HTMLJury Finds for Drug Manufacturers in First Post-Actavis "Reverse Payment" Trial
Jonathan Berman, Benjamin H. Cheng, Aimee E. DeFilippo, Kevin D. McDonald; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on December 2014
In the first "reverse payment" trial since the U.S. Supreme Court’s Actavis decision held that "reverse payment" settlements potentially could be found anticompetitive under a rule of reason analysis, a federal jury in Massachusetts has returned a verdict in favor of the...

 

HTML2015 HHS OIG Work Plan Focuses on Payment Accuracy, Privacy Concerns, and Insurance Marketplaces
Laura F. Laemmle-Weidenfeld, Heather M. O'Shea, Rebekah N. Plowman, Stephen G. Sozio, Heidi Ann Wendel; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
On October 31, 2014, the Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") published its Work Plan for Fiscal Year 2015 ("2015 Work Plan") to provide an annual summary of new and ongoing OIG audit activities related to HHS programs....

 

Adobe PDFAmendment to Drugs and Medical Devices Law in Japan Takes Effect
Laurie A. Clarke, Colleen Heisey, Scott T. Jones, Mark Mansour, Mitsutaka Okano; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on December 2014
A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented. The amendment mainly covers (i) establishing a fast-track authorization process for regenerative medicine products (described below), (ii) restructuring medical device regulations, and (iii)...

 

HTMLDOJ Brings "Gun Jumping" Enforcement Action and Requires Disgorgement
Kathryn M. Fenton, J. Bruce McDonald, Thomas D. York; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
The U.S. Department of Justice has announced the settlement of an enforcement action challenging illegal "gun jumping," which is the coordination of the business activities of companies that are planning a merger but where the government has not completed its pre-closing review of the...

 


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