After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
Another natural disaster has devastated a community. By now, all are aware of the tragedy the tornado inflicted on residents of Moore, Oklahoma, destroying lives and property. We join in offering our condolences to those affected by the storm. Although there is no way to replace lost lives, as with other catastrophes, there are likely to be a myriad of financial issues that will need to be addressed to rebuild and replace property. Maximizing insurance recoveries is one component ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
Important Considerations In Drafting An Arbitration Provision: With the continuing increase in cross-border investments, it bears reminding that companies must plan for the eventuality that parties may not see eye-to-eye in the future – something known but not always implemented ...
In the last legislative session (2011–12), bills that would have imposed severe restrictions or even an outright moratorium on hydraulic fracturing (HF) were narrowly defeated in the California legislature. Earlier this year, we issued an alert regarding draft regulations that had been issued by the Division of Oil, Gas, and Geothermal Resources ...
As anticipated, on May 29, 2013, the Consumer Financial Protection Bureau delivered the final version of amendments to its January 2013 Ability-to-Repay/Qualified Mortgage rules (the bureau released an early draft of the amendments when the original rule was published). For more information about the Ability-to-Pay/Qualified Mortgage rules, see our prior alerts.1 The rules, as well as the amendments, take effect on January 10, 2014 ...
In Louisiana Generating LLC v. Illinois Union Ins. Co., No. 12-30651 (5th Cir. May 15, 2013), the United States Court of Appeals for the Fifth Circuit held that a lawsuit brought by the Environmental Protection Agency ("EPA") alleging violations of the Clean Air Act ("CAA") obligated an insurer to defend its insured ...
On May 30, 2013, as had long been expected, the staff in the Division of Corporation Finance of the Securities and Exchange Commission released Frequently Asked Questions concerning the SEC’s conflict minerals rules.1 The FAQs do not address some of the thorniest interpretive issues under the conflict minerals rules, but they do reinforce a number of developing practices and provide helpful guidance on a number of topics for SEC reporting companies.2 We summarize some of the key FAQs below ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
On June 13, 2013, the Securities and Exchange Commission brought a settled administrative proceeding against Revlon, Inc., for disclosure violations relating to a 2009 exchange offer subject to the going-private rules under Rule 13e-3 of the Securities Exchange Act of 1934.1 As described below, the SEC alleges that Revlon engaged in various acts described as "ring fencing" in an effort to conceal negative information about the transaction from minority stockholders ...
After a prolonged internal debate, the Securities and Exchange Commission has unanimously proposed new rules for the regulation of money market mutual funds, also known as money market funds or money funds. If adopted, these rules would fundamentally change the basic characteristics of most money funds ...
On June 25, 2013, the Consumer Financial Protection Bureau (CFPB or Bureau) issued CFPB Bulletin 2013-06 to announce its "Responsible Business Conduct" policies. The bulletin lays out, in very general terms, suggestions for how companies might curry favor with the Bureau’s Office of Enforcement by engaging in voluntary self-policing, self-reporting, remediation, and cooperation activities. The bulletin is available at [link to http://files.consumerfinance ...
The US Court of Appeals for the Second Circuit recently held that excess insurance policies are triggered when the payment of losses exceed the attachment point rather than when the policyholder’s loss obligations exceed the attachment point. Ali v. Fed. Ins. Co., No. 11-5000-cv, 2013 WL 2396046 (2d Cir. June 4, 2013). The decision is another reminder that outcomes in insurance disputes may depend on subtle differences in the wording of insurance policies ...
At the end of May, the U.S. District Court for the Southern District of Florida sentenced a Florida import company president to 22 months in federal prison for violating consumer product safety and other laws. His wife, an executive of a related company, was sentenced to a year of probation. The case is significant because it involves a criminal prosecution of importers of unsafe children’s products ...
The United States Court of Appeals for the Second Circuit (the "Second Circuit") recently affirmed a broad reading of the safe harbor of United States Bankruptcy Code (the "Bankruptcy Code") section 546(e), which protects from avoidance both "margin payments" and "settlement payments" as well as transfers made in connection with a "securities contract ...
In Vance, the Supreme Court announced a narrow standard for determining which employees constitute "supervisors" for purposes of establishing vicarious liability under Title VII. In a 5-4 decision, the Court decided that a supervisor is a person authorized to take "tangible employment actions," such as hiring, firing, promoting, demoting or reassigning employees to significantly different responsibilities ...
The Environmental Protection Agency (EPA) recently announced that it will extend its current set of six National Enforcement Initiatives through fiscal years 2014–2016. EPA’s current list of top priorities includes reducing air emissions from major industrial and utility sources, reducing contamination from mineral processing operations and ensuring that energy extraction activity complies with environmental regulations ...
Insurers often have a duty to settle underlying claims against their insureds. While that duty generally requires insurers to accept reasonable settlement offers, insurers and insureds alike face many other issues regarding settlement of the underlying case ...
