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January 10, 2012
NDA Approval Under FDCA Section 505(B)(1) Based On Effectiveness Data From One Clinical Trial
Social Science Research Network
For new drug approval, the Food and Drug Administration (FDA) generally requires two or more clinical trials that demonstrate effectiveness. Notwithstanding, the Federal Food, Drug, and Cosmetic Act (FDCA) expressly authorizes FDA to approve drugs based on one trial with “confirmatory” evidence, and the Agency has issued guidance describing when only one trial is sufficient. To evaluate the frequency with which FDA approves new drugs based on only one trial, we researched the relevant statutory background and FDA guidance, and also reviewed new drug and biological product approvals since 1997. Out of 394 products approved from 1998 to 2011, we identified 30 products that were approved based on effectiveness data from one trial.
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January 6, 2012
Consumer Financial Protection Bureau Proposes Two-page Credit Card Agreement
International Law Office
On December 7, 2011 the Consumer Financial Protection Bureau announced a new Know Before You Owe project. The stated goal of the project is to simplify credit card agreements to enhance consumer understanding of the prices, risks and terms of credit cards.
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January 2012
FAQs: New Listing Rules in Respect of Debt Securities Offered to Professional Investors
Hong Kong Lawyer
This article discusses the most frequently asked questions about what the new regime entails for the listing of debt securities issued to professional investors and the impact it will have on issuers in the Hong Kong debt market.
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January-March 2012
A Move to Self-Assessment in Mergers
MLex Magazine
It may be hard for some to believe now, but when the European Commission was first given jurisdiction over large mergers in the 1989 Merger Control Regulation (which came into force in late 1990) it was enacted in the face of substantial opposition and scepticism. Many commentators expressed reservations that the commission was bound to fail in its task. Some of the objections turned on substantive issues but even more of them were essentially procedural. In particular, how could an organisation which routinely took two or three years to review a simple notification of a commercial practice be expected to handle potentially complex mergers in large numbers and in a fraction of that time? References to “old dogs” and “new tricks” abounded. There was widespread concern that the tight deadlines which were imposed as part of the bargain for being given these powers would prove impossible to respect, and there was much discussion of the consequences of those fixed time limits expiring without a decision.
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January 2012
Antitrust Concerns From Partial Ownership Interest Acquisitions: New Developments in the European Union and United States
Competition Policy International
This article will focus on recent developments in the European Union and the United States relating to antitrust issues arising from the acquisition of partial ownership interests in an entity. An important distinction exists in the treatment of partial ownership acquisitions between the European Union and the United States. While the European Commission (the “EC”) does not (currently at least) have competence under its merger control rules to review partial ownership acquisitions that do not confer control on the purchaser, the U.S. authorities (and certain EU Member States) have broader jurisdiction.
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December 16, 2011
FinCEN Releases FAQs on Pre-paid Access Rule
International Law Office
On November 2 2011 the Treasury Department's Financial Crimes Enforcement Network (FinCEN) released a set of frequently asked questions (FAQs) to assist providers and sellers of pre-paid access in understanding certain aspects of the final pre-paid access rule that FinCEN issued on July 29 2011. FinCEN makes clear that the FAQs are intended to provide interpretive guidance only, and do not supersede or replace any aspect of the pre-paid access rule. This article discusses certain aspects of the guidance that the FAQs provide with respect to the pre-paid access rule.
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December 9, 2011
First Look: Leaked Draft of New EU Data Protection Regulation Suggests Significant Impacts for Global Businesses
BNA's Privacy and Security Law Report
A draft of a new EU Regulation on Data Protection to replace the existing EU Data Protection Directive was released un-officially earlier this week. The draft Regulation once adopted will have a significant impact on virtually all businesses established in the EU, or who carry on business with the EU, introducing significant internal compliance requirements and fines that range up to 5% of worldwide turnover.
In an article published by the Bureau of National Affairs, John Casanova and William Long of the London office of Sidley Austin and Alan Raul and Ed McNicholas of the Sidley Washington office provide their initial analysis of this significant new EU development.
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November/December 2011
China’s New Drug GMP: Higher Standard, New Compliance Philosophy
The Food and Drug Law Institute
China’s major new drug Good Manufacturing Practices regulations (GMP 2010) took effect on March 1, 2011. Multinational companies can no longer rely solely upon compliance with U.S. or EU GMP regulations, and will need to review current procedures in China.
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November 11, 2011
OFAC Eases Rules for Food Exports to Iran and Sudan
International Law Office
On October 12, 2011, the Office of Foreign Assets Control (OFAC) issued a final rule authorizing the export and re-export of food to Iran and Sudan. These changes come in the form of two new general licenses under the Iranian Transactions Regulations and the Sudanese Sanctions Regulations. These licenses replace a 2009 interim final rule that required agricultural and other commodity exporters to apply for specific licenses on an annual basis.
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October 28, 2011
A Transatlantic Initiative to Prevent a Digital Trade War in the Cloud
The Washington Times
Just about the last thing the world economy needs right now is a trumped up, digital trade war about electronic data stored and processed on servers located virtually anywhere. However, unless the governments of United States and Europe, and multinational tech companies, start talking soon about reconciling and simplifying international data protection rules, some ominous storm clouds could threaten transatlantic eCommerce.
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October 18, 2011
Financial Advisors and the Attorney-Client Privilege
Bloomberg Law Reports - Corporate and M&A Law
Investment bankers and other business advisors frequently are key participants in corporate transactions. This makes it important for counsel to understand the application of the attorney-client privilege with respect to such advisors and to carefully consider the circumstances under which such advisors are considered third parties whose review of or participation in confidential communications may waive the privilege.
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October 2011
Futures-Based Exchange-Traded Funds - What are They, How are They Structured and Who Regulates Them?
Futures & Derivatives Law Report
The popularity of exchange traded funds (“ETFs”) has led to almost constant innovation in this relatively young market. Many newer ETF offerings are more tailored in their investment objectives, creating greater diversity within the ETF space. This evolution includes the introduction in 2006 of the first futures-based ETFs (“Futures-Based ETFs”). This subset of the ETF industry differs from its predecessors principally because of the type of investments it makes (e.g., futures contracts), its fund structure, and the cocktail of futures regulations and securities and broker-dealer regulations that apply. As the title indicates, this outline focuses on Futures-Based ETFs and attempts to shed some light on a segment of the market that has amassed substantial assets under management in a relatively short time.
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September 14, 2011
Must FDA Engage in Rulemaking to Regulate Laboratory-Developed Tests?
FDLI's Food and Drug Policy Forum
For more than a year, the Food and Drug Administration (FDA) has been signaling plans to develop a risk-based framework for laboratory-developed tests (LDTs), which largely have been outside of the agency’s regulatory purview. In July 2010 FDA held a public meeting at which officials unveiled plans to regulate clinical laboratories that develop and perform LDTs as “manufacturers” of medical devices and to subject the LDTs to certain of FDA’s medical device requirements, including establishment registration and device listing. More recently, in the context of discussions regarding the reauthorization of the Medical Device User Fee Amendments, FDA confirmed that the agency plans to regulate clinical laboratories and LDTs using a risk-based approach.
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September 9, 2011
A New Battleground in Class Actions: Rule 23(a)(2)’s Commonality Requirement
BNA's Class Action Litigation Report
The U.S. Supreme Court’s landmark decision in Wal-Mart v. Dukes has thrust the commonality requirement of Fed. R. Civ. P. 23(a)(2) on to center stage for class litigation, says attorney Jeffrey E. Crane in this BNA Insight. This author summarizes Rule 23(a)(2) standards prior to Wal-Mart, and ponders how future class actions will adapt to Wal-Mart’s standard for Rule 23(a)(2) commonality and for complying generally with Rule 23.
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September 2, 2011
United States Tightens Sanctions Against Syria
International Law Office
On August 18, 2011 President Obama imposed further sanctions on Syria. The new sanctions block all property interests of the government of Syria and prohibit many trade transactions by US persons with Syria. These sanctions represent the strongest US financial action taken against the regime of Syrian President Bashar al-Assad since the start of popular protests in Damascus earlier this year.
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September 2011
The New Arbitration Legislation in Hong Kong and France: A Comparative Study
Mealey's International Arbitration Report
Hong Kong and France are both strong promoters of arbitration as a means of alternative dispute resolution. They both have legal systems that are well developed and arbitration friendly. And coincidentally, both have recently enacted new arbitration legislation. Hong Kong’s new Arbitration Ordinance came into force on 1 June 2011, and France’s new arbitration law, Decree 2011-48 of 13 January 2011 came into force on 1 May 2011. The writer does not profess to be an expert on French law. Nevertheless, the differences between the two new regimes are so striking that it hardly matters. This article highlights some of them.
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2011 Edition
Participation of Third Parties in International Arbitration: Thinking Outside of the Box
The International Comparative Legal Guide to: International Arbitration 2011
Large multinational firms frequently involve more than one corporate entity in the performance of cross-border contracts. It is likewise common for a number of parties to participate in a single economic transaction through multiple contracts, or for contracts to continue in force following the sale or other disposition of a business. These scenarios can generate complex disputes which involve the conduct of multiple parties, some not signatories to an arbitration agreement, or at least not to the same arbitration agreement. In these circumstances, the involvement of third parties in an arbitration may be essential to the twin goals of efficiency and justice, and can even lead to the early resolution of a dispute. Joining such third parties to an arbitration, however, can be procedurally complex, particularly when they are unwilling participants.
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September 2011
Gates, A Primer
Bloomberg Law Reports - Securities Law
Redemption gates have been applied more than ever before in the past few years. This article discusses various aspects of gates that should be considered by managers and investors, including different types of gates and their various features, drawbacks and benefits within the overall context of liquidity issues confronting hedge funds. As such, it provides a framework for discussion related to the establishment of a gate and negotiation between a hedge fund and its investors with respect to the gate’s attributes. Gates which apply on a fund-wide basis and gates that apply on an investor by investor basis are addressed.
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September 2011
Privacy and Mobile Apps
This paper first provides a background discussion of the rapidly developing mobile app industry. It discusses the market for apps, the key players in the industry, and focuses on the privacy and security implications of mobile apps. The paper next examines the roles of key United States regulators of app privacy, as well as current relevant legislation and litigation. We next explore non-U.S. legal frameworks for app privacy. Lastly, we analyze new directions for app privacy propounded by privacy advocates and NGOs.
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Reports
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September 2011
The Raj Rajaratnam Conviction: What Does It Really Indicate?
Financial Fraud Law Report
As has been well publicized, a New York jury has convicted Raj Rajaratnam, founder and principal of the Galleon Group, of all 14 counts charged against him in a criminal indictment. The case is widely and correctly perceived as a seminal case in the prosecution and defense of insider trading. Many commentators have proclaimed that this will encourage aggressive prosecutions in the future, signals the end of the mosaic defense, and is a significant victory for the prosecutors. On a closer look, however, this verdict was neither the easy result the prosecutors might have expected nor the end of sound defenses in insider trading cases. In many ways, this verdict stems from unique facts not present in many insider trading prosecutions. While the full implications of the case will have to await the outcome on appeal, two lessons are immediately apparent.
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September 2011
OCC Moves to Implement Dodd-Frank Act Preemption Provisions
The Banking Law Journal
The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) amended the National Bank Act to specifically address the preemption of state law. The Office of the Comptroller of the Currency (“OCC”), the regulator of national banks, recently issued two releases — a letter and a proposed regulation — regarding the implementation of the Dodd-Frank Act. These releases have provided important and long-awaited guidance into the OCC’s interpretation of the Dodd-Frank Act preemption provisions and the continuing applicability of the preemption regulations adopted by the OCC in 2004 (“OCC Preemption Regulations”). The authors review the Dodd-Frank preemption provisions and new regulatory developments with respect to preemption.
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August 2011
Wisconsin Courts Reject Heightened Scrutiny in Mergers and Acquisitions Litigation
Bloomberg Law Reports - Corporate and M&A Law
Other than Delaware, very few states have well-developed jurisprudence concerning the law to be applied in shareholder lawsuits challenging merger and acquisition transactions. Over the last few years, the Wisconsin courts have had the opportunity to develop law in this area, applying the business judgment rule to evaluate the validity of merger transactions and rejecting Delaware-style heightened scrutiny. Absent specific allegations of a breach of the duty of loyalty or bad faith, the Wisconsin courts are not likely to interfere with a board’s decision to enter into a merger transaction. The Wisconsin courts have also suggested that the same analytical framework may apply to the judicial review of proxy materials.
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July 26, 2011
Real Harmony in Cloud Computing Between U.S., EU Closer Than You Think
BNA's Daily Report for Executives
Laws in the European Union and the United States regarding government access to personal information in the cloud are more harmonious than many in the EU believe. Those governments specifically authorize derogations from individual privacy rights in the interest of protecting national security, combating terrorism, and investigating serious crime, writes Alan Charles Raul, partner in Sidley Austin LLP's Washington, D.C., office. The United States is not an outlier because Europe recognizes the same imperatives to balance data protection and privacy against security and law enforcement needs, the author says. Raul contends that concerns of an EU parliamentarian from the Netherlands—that U.S.-based cloud-computing providers are more exposed to government intrusion than EU providers—do not acknowledge parallels between U.S. and EU law.
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July 21, 2011
Dodd-Frank Act Has its First Birthday, But Derivatives End Users Have Little Cause to Celebrate
Harvard Business Law Review
A year has passed since the enactment of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”). Title VII of the Dodd-Frank Act, entitled the Wall Street Transparency and Accountability Act of 2010 (“Title VII”) created a new transparent exchange-type trading marketplace for over-the-counter swaps subject to regulation by the Commodity Futures Trading Commission and security-based swaps subject to regulation by the Securities and Exchange Commission (collectively, “OTC derivatives” or “swaps”). This article will discuss the significant impact Title VII has, and will continue to have, on the end user, or “buy” side, of the derivatives markets.
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June 24, 2011
Evolving Use of Experts in Class Certification Proceedings
BNA's Class Action Litigation Report
Prior to the Seventh Circuit’s landmark 2010 decision in American Honda Motor Co. v. Allen, federal courts applied varying standards to the admissibility of expert reports at the class certification stage, say attorneys Joel S. Feldman, Christopher M. Assise, and Laura Bayard in this BNA Insight. In addition to examining the disparate ways courts assessed expert testimony in certification proceedings before American Honda, the authors analyze the seminal ruling, and place it in the context of ‘‘a growing movement among federal courts to apply more exacting evidentiary and burden of proof standards to plaintiffs’ requests for class certification.’’
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June 2011
Delegation Dilemma: Can HHS Require Medicare ACOs To Undergo Pre-Clearance by the Antitrust Agencies?
BNA's Health Law Reporter
One of the most anticipated aspects of last year’s health reform legislation, the Patient Protection and Affordable Care Act (PPACA), is the Medicare Shared Savings Program. That program seeks to cut Medicare costs and promote quality care through the use of accountable care organizations (ACOs). This article addresses the question of whether or not HHS can require Medicare ACOs to undergo pre-clearance by the antitrust agencies and concludes that the proposed ACO regulations, to the extent they make the antitrust agencies the final arbiters of whether certain proposed ACOs qualify to participate in the Medicare Shared Savings Program, likely exceed HHS’s statutory authority.
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July 2011
New Rules in China Tighten ADR Reporting Environment
Regulatory Affairs Pharma
This article discusses the new reporting rules on adverse drug reactions.
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April - June 2011
A Bosman Moment for Online Content Delivery?
MLex Magazine
This article analyses the EU’s task of creating a comprehensive framework for territorial licensing of broadcasting and digital rights, and the wider ramifications of AG Kokott’s Opinion in Murphy and QC Leisure.
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June 2011
Proposed Changes to ISDA Section 2(a)(iii) and the "Flawed Asset" Approach
Bloomberg Law Reports - Derivatives Law
One of the cornerstones of the ISDA Master Agreement is Section 2(a)(iii), which provides in relevant part that "Each obligation of each party under Section 2(a)(i) [that is, each obligation of that party to make a payment or delivery] is subject to (1) the condition precedent that no Event of Default or Potential Event of Default with respect to the other party has occurred and is continuing . . . ."
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June 1, 2011
Position Limits for Commodity Derivatives Under Dodd-Frank
Business Law Currents
This article discusses the recently proposed position limits for derivatives. All of the rules discussed in this article are currently in proposal and comment phase and the final effective rule may be different.
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May 6, 2011
Treasury Issues Guidance on Economic Sanctions Against Sudan and Libya
International Law Office
Reflecting the changing geopolitical landscape, the U.S. Treasury Department’s Office of Foreign Assets Control recently issued guidance concerning U.S. economic sanctions against Sudan and Libya. This guidance is intended to assist companies and non-profit organizations with ties to these countries to maximize available opportunities while still complying with U.S. law.
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May 6, 2011
Frequently Asked Questions and Answers on Overdraft Payment Programmes
International Law Office
The Federal Deposit Insurance Corporation (FDIC) recently issued frequently asked questions (FAQs) and answers in response to questions from FDIC-supervised institutions and third-party vendors about the FDIC's Overdraft Payment Supervisory Guidance issued in November 2010. The FAQs provide further explanation of the FDIC's supervisory expectations regarding overdraft payment programmes. The FAQs state that the FDIC expects institutions to have internally approved and "responsive" compliance and risk management action plans, policies and procedures for overdraft programmes in place by July 1, 2011.
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May 2011
The Use of Non-pecuniary Remedies in WTO Dispute Settlement: Lessons for Arbitral Practitioners
ASA Performance as a Remedy, JurisNet, LLC
In recent years, arbitral practitioners have looked with increasing frequency to the World Trade Organization (WTO) for guidance. Arbitral tribunals constituted under the auspices of the International Centre for the Settlement of Investment Disputes (ICSID) have cited and discussed WTO principles and jurisprudence in their awards. In addition, commentators have debated the relevance of WTO rules, such as nondiscrimination and most favored nation treatment, to investor-state arbitration.
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May 2011
Solvency II: Globalisation of Insurance Regulation
Reactions
It is a time of interesting changes in both the European and US insurance regulatory frameworks. As is well known, in Europe, Solvency II promises a fundamental review of solvency and risk management standards across the European insurance and reinsurance industry, replacing 14 existing EU insurance directives which make up the ‘Solvency I’ regime with a single one, aimed at achieving a high degree of regulatory convergence across Europe. At the same time, similar changes are afoot in the United States. This article provides a short summary of some of the potential effects of these changes.
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May 2011
Top Ten Trends for Latin Investment Funds
Latin American Law & Business Report
A February article in The Economist proclaimed Brazil “this year’s hot market for private-equity firms and hedge fund managers”. Brazil emerged relatively unscathed by the global financial crisis, and in terms of market size and political risk is proving attractive to investors such as Carlyle Group that had typically not focused on the country or the region in the past. Nor is Brazil alone. Legal reforms and GDP growth in Colombia and Peru, among others, have brought these markets to the attention of new investors seeking to form private equity, credit, hedge, infrastructure and real estate funds to capitalize on the expected growth of investment opportunities in the region. According to the Latin American Venture Capital Association, private equity funds raised a record high of $8.1 billion for Latin America in 2010, a 122%increase over 2009. At the same time, private equity investments quintupled on a year-over year basis to $17.2 billion. Assets under management by hedge funds also increased. For example, assets under management of Brazilian hedge funds increased 23% over the same period, to reach a total of $243 billion in that country alone. But no matter how experienced an investor may be in other markets, both forming a fund for making investments into Latin America and structuring such investments have unique challenges, as set forth in this article.
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April 2011
Enforcement of Arbitral Awards: the Taiwanese Perspective
Asian Dispute Review
This article discusses the enforcement of Convention awards in Taiwan and of Taiwanese awards in New York Convention jurisdictions and the statutory provisions governing enforcement in Taiwan and in several Convention jurisdictions.
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2011
Recent Bankruptcy Developments: Meet the Investors in Chapter 11 – Should Motives Matter?
LSTA 2011 Loan Market Chronicle
Recent bankruptcy cases have highlighted a renewed focus on both the identity and motives of creditors actively participating in bankruptcy cases. Taken together, these cases reflect a growing trend to restrict the available strategies for some creditors, and in certain instances, require extensive disclosures bases on their identity and perceived motives.
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April 2011
Recent Regulatory Developments Affecting Private Fund Managers
Futures & Derivatives Law Report
The Commodity Futures Trading Commission and the Securities and Exchange Commission have recently proposed new rules implementing sweeping changes passed as part of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”). If adopted these proposed rules will have a significant impact on many investment funds and their managers. This article focuses on certain of these proposed rules as well as related provisions of Dodd-Frank.
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March 31, 2011
Nanotechnology Manufacturers’ Duty to Warn and Potential Affirmative Defenses
BNA's Toxics Law Reporter
Companies commercializing nanotechnology should evaluate ways to safeguard against a potential tide of future ‘‘nanotorts.’’ The authors assess a manufacturer’s duty to warn of potential dangers posed by nanomaterials, and discuss several ‘‘potentially powerful’’ defenses against failure-to-warn claims that could aid nanomaterial defendants facing failure to warn claims.
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March 28, 2011
Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection
Social Science Research Network
When the Food and Drug Administration (FDA) authorizes the marketing of a new drug or medical device, the license reflects the FDA’s review of data and information relating to uses specified by the manufacturer and set forth in agency-approved labeling. Authorized products are often used “off-label,” i.e., for purposes other than those for which they are labeled. However, such uses are legal. Indeed, “off-label” use can be standard medical practice. Despite this undisputed fact, in most instances the FDA prohibits manufacturers from promoting such off-label uses, even to members of the medical profession. In short, the FDA prohibits the speech, even though the activity promoted is perfectly legal and the speech is neither false nor misleading.
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March 18, 2011
New Economic Sanctions Imposed Against Libya
International Law Office
In response to the growing violence in Libya, the United States imposed economic sanctions against Libya on February 25, 2011. Entities with business ties to Libya should ensure that their compliance programmes adequately address these new measures.
Effective at 8:00pm Eastern Standard Time on February 25, the United States blocked all property interests of the Libyan government, certain senior officials and others implicated in human rights abuses. Any such property interests that are in the United States or within the possession or control of a US person may not be transferred, paid, exported, withdrawn or otherwise dealt in. US persons holding such blocked property were given a 10 business-day period in which to report it to the US Treasury Department's Office of Foreign Assets Control.
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March 14, 2011
European Shift to Concrete Cost Analysis of Data Protection
BNA's Privacy & Security Law Report
Following meetings held Feb. 24-25, the Council of the European Union released its ‘‘Conclusions’’ in response to the EU Commission’s Nov. 4, 2010 ‘‘Communication’’ proposing ‘‘a comprehensive approach on personal data protection in the European Union.’’ The Council is the main decision-making body of the European Union, comprising the ministers of the Member States. Depending on the issue on the agenda, each country is represented by the minister responsible for that subject (foreign affairs, finance, social affairs, transport, agriculture, etc.).
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March 11, 2011
MMTA Trade and Lobby Committee's Newsletter: Issue XV
Minor Metals Trade Association
Topic discussed in this issue of the MMTA Trade and Lobby Committee's Newsletter – Trade Law Update
- Changes in the European decision-making procedures in anti-dumping procedures
- Changes in the EU’s General System of Preferences (GSP)
- EU Pursues Free Trade Agreements
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March 10, 2011
MMTA Trade and Lobby Committee's Newsletter: Issue XIV
Minor Metals Trade Association
Topic discussed in this issue of the MMTA Trade and Lobby Committee's Newsletter – Countries and Entities added to the List of EU Economic and Financial Sanctions.
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March 9, 2011
The New E.U. Directive On Alternative Investment Fund Managers
BNA's Alternative Investment Law Report
On November 11, 2010, the European Parliament voted to adopt the E.U. Directive on Alternative Investment Fund Managers (the ‘‘Directive’’). The Directive has been the subject of intense industry and media scrutiny since the original draft was published by the European Commission on April 30, 2009.
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March 2011
Getting the Deal Through - Vertical Agreements 2011
Sidley lawyers wrote four of the chapters in this year's edition of "Getting the Deal Through — Vertical Agreements," a book recently published by Global Competition Review. The book is intended for in-house counsel and provides an overview of antitrust regulation of distribution arrangements in 39 jurisdictions worldwide.
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Reports
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February 28, 2011
Cybersecurity–It’s Not Just About ‘‘National Security’’ Anymore: ‘‘Directors Desk’’ and Other Incidents Sound Wake-Up Call for the Executive Suite and Board Room
BNA's Privacy & Security Law Report
Media attention on the recent security incident disclosed by NASDAQ in connection with its ‘‘Directors Desk’’ application has focused attention on the potential for organized cybercriminals to access sensitive corporate documents, such as communications related to board of director meetings. But while the media, the government and the techie crowd may be up to speed on cybersecurity threats to trade secrets and other commercially sensitive information, corporate executives and directors may benefit from some information on the subject.
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February 15, 2011
World Trade Organization “Doha Round” Negotiations
North American Free Trade & Investment Report
Frequently written off, the long-running “Doha Round” of international trade negotiations at the World Trade Organization (WTO) is now approaching an endgame. While hopes have been dashed on previous occasions, timing factors and geopolitical considerations may this time work to the Round’s advantage. Its conclusion in 2011 is now a distinct possibility.
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February 14, 2011
The Survival Guide to Regulatory Examinations
BNA's Securities Regulation & Law Report
The following is intended to serve as a guide to handling regulatory examinations for registered investment advisers or broker-dealers. The purpose of this document is to highlight legal and regulatory issues, as well as practical issues, that firms should consider and be ready to address during a regulatory examination.
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February 14, 2011
Alternative Fees are not the Enemy
The National Law Journal
The billable hour, over time, has served both clients and law firms alike, and in a great many diverse matters will continue to do so. Billing by the hour is transparent, and firms interested in maintaining or establishing a long-term relationship will not overcharge their clients. Nevertheless, a growing number of corporate counsel and lawyers in private practice argue that the billable hour may reward inefficiency, fail to provide adequate incentive for outside counsel to work cost-effectively and represent a poor method for rationally predicting future costs. Current economic pressures and challenges — and the need for reduced costs for legal services — have increased the demand for alternative fee arrangements that begin to address these perceived shortcomings.
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February 11, 2011
New Food Safety Bill Has Consequences For Importers
International Law Office
On January 4, 2011, President Obama signed into law H.R. 2751, the much-anticipated FDA Food Safety Modernization Act (the Act), bringing about the biggest reform of U.S. food safety regulation in decades. The new law has significant consequences for importers of food items, who should prepare for increased federal government oversight of food imports.
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February 9, 2011
Obama Review of Regulatory Burden to Be Weighed in Cost-Benefit Analysis
BNA's Daily Report for Executives
Former Office of Management and Budget General Counsel Alan Charles Raul sees President Obama’s executive order subjecting new regulations to cost-benefit analysis and reviewing existing regulations as potentially aligning him (and OMB) more closely with those who want to see federal regulations strictly justified to preserve free enterprise and innovation. Moreover, Raul says the application of the president’s regulatory review principles to independent agencies is potentially very important if those agencies comply with the president’s wishes (or if Congress mandates that they do so). The 120-day retrospective review of existing significant regulations should empower businesses to communicate where they see opportunities to rationalize existing rules.
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