Document(s) published by this organization: 477
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|FDA Takes Steps to Streamline Individual Patient Expanded Access|
Edgar Asebey, Maureen Bennett, Christian B. Fulda, Colleen M. Heisey, Cristiana Spontoni; Jones Day;
August 3, 2016, previously published on July 2016On June 2, 2016, FDA announced the availability of three final guidance documents aimed at simplifying and clarifying expanded access for investigational drugs and assisting health care professionals, patients, and industry in navigating the expanded access process. In the FDA blog, FDA Voice, Dr....
|Italian Competition Authority Closes Sector Inquiry on Vaccines Competition|
Francesco Liberatore, Cristiana Spontoni, Mario Todino; Jones Day;
August 3, 2016, previously published on July 2016Over the last few years the pharmaceutical industry in Italy has attracted increasingly intensive antitrust scrutiny. Last month the Italian Competitive Conspiracy (ICA) concluded an important sector inquiry on vaccines for human use, just after the conclusion of two other high profile antitrust...
|The Trans-Pacific Partnership's Dramatic Impact on International Aviation|
John D. Goetz, Sarah L. Thompson; Jones Day;
August 3, 2016, previously published on July 2016On February 4, 2016, the world witnessed Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, and Vietnam—nations that comprise 40 percent of the world's GDP—sign the Trans-Pacific Partnership ("TPP" or...
|SEC Publishes Final Rules Amending the Rules of Practice for Administrative Proceedings|
Daniel Vincent Bradley, Harold K. Gordon, Henry Klehm, Joan E. McKown, David Ronald Woodcock; Jones Day;
August 3, 2016, previously published on July 2016On July 13, 2016, the Securities and Exchange Commission ("SEC" or "Commission") voted to adopt amendments to the rules of practice that govern its Administrative Proceedings ("APs"). In a press release accompanying publication of the amended rules, SEC Chair Mary...
|SEC Adopts Final Resource Extraction Disclosure Rules|
Bradley C. (Brad) Brasser, Rory T. Hood, Robert (Bob) Joseph, Joel T. May, Michael J. (Mike) Solecki; Jones Day;
August 3, 2016, previously published on July 2016On June 27, 2016, the Securities and Exchange Commission ("SEC") adopted final rules requiring disclosure by resource extraction issuers of payments made to governments for the commercial development of oil, natural gas, or minerals. Specifically, issuers must disclose payments of...
|Australia's First Criminal Prosecution of Price Fixing|
Prudence Smith, Nick Taylor; Jones Day;
August 3, 2016, previously published on July 2016A Japanese shipping company has pled guilty in the first criminal price fixing prosecution by the Australian Competition and Consumer Commission (ACCC). Other companies still are under investigation in the same case. This first criminal prosecution will mark a new trend in competition law...
|The EU-U.S. Privacy Shield Approved|
Jonathon Little, Giuseppe Mezzapesa, Mauricio F. Paez, Elizabeth A. (Liz) Robertson, Undine von Diemar; Jones Day;
August 3, 2016, previously published on July 2016After months of criticism from various EU bodies and institutions, the much-anticipated EU-U.S. Privacy Shield finally has been approved by the European Commission, paving the way for self-certifying U.S. organizations to transfer legally EU personal data across the Atlantic. The adoption of this...
|Financial Reporting: 2016 Mid-Year Update|
Shawn Cleveland, Laura Jane Durfee, Steven G. Gersten, Anand Varadarajan, David Ronald Woodcock; Jones Day;
August 3, 2016, previously published on July 2016We are pleased to offer our clients and friends this mid-year update on financial reporting and issuer disclosure enforcement activity in 2016. The level of attention regulators are paying to financial reporting and disclosure remains quite high. That has meant not just a large number of...
|New York Reins In "Common Interest" Doctrine|
William J. (Bill) Hine, Sevan Ogulluk; Jones Day;
August 3, 2016, previously published on July 2016In June 2016, New York's highest court reversed an important 2014 decision by an intermediate appellate court that had expanded the application of the common interest doctrine to commercial transactions, such as mergers, where litigation was neither pending nor anticipated. In Ambac Assurance...
|U.S. DOJ Obtains Record Fine Against Activist Investor for Failing to Make HSR Premerger Filing|
Michael H. (Mike) Knight, Bevin M.B. Newman; Jones Day;
August 3, 2016, previously published on July 2016This week the Department of Justice obtained a record $11 million fine for an investor's failure to comply with the premerger notification and waiting period requirements of the Hart-Scott-Rodino (HSR) Act. DOJ challenged hedge fund ValueAct's reliance on the "investment-only" exemption...