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March 12, 2010
House Drug Safety Hearing Highlights FDA Focus on Product Safety and Supply Chain Obligation
On March 10, 2010, Dr. Joshua M. Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration (FDA), presented testimony at the House of Representatives’ Committee on Energy and Commerce, Subcommittee on Health hearing on drug safety. The hearing addressed the Food and Drug Administration Amendments Act of 2007, imported drug safety, and FDA’s Sentinel, Drug Safety, and Regulatory Science Initiatives. Drug manufacturers can expect further FDA focus on supplier qualification and audit measures.
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- Food, Drug and Medical Device Regulatory
- Food, Drug and Medical Device Compliance and Enforcement
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March 11, 2010
New Rules Ease U.S. Sanctions for Agricultural Exports and Free Speech
The U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) promulgated two final rules this week that ease sanctions against Cuba, Iran and Sudan with respect to key areas of authorized trade. OFAC’s new rules will make it easier for exporters to supply agricultural commodities to Cuba, as well as to support Internet-based personal communications in Cuba, Iran and Sudan. Companies in the agricultural and communications industries should consider whether OFAC’s new rules create additional opportunities for them in these markets.
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- International Trade/Arbitration
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March 8, 2010
Federal Reserve Proposes Limits on Credit Card Penalty Fees and Required Review of Rate Increases
In order to implement the final provisions of the Credit CARD Act of 2009, the Federal Reserve has issued proposed regulations that would significantly limit card issuers’ ability to charge penalty fees, and would require issuers to review regularly the interest rates on all accounts for which the rate was previously raised. A final rule will be effective on August 22, 2010.
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- Financial Institutions Regulatory
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March 8, 2010
SEC Adopts Amendments to Investment Company Act Rules Relating to Money Market Funds
On February 23, 2010, the SEC issued a release describing final rule amendments to the regulatory framework for money market funds. These rule amendments are designed to address primarily the difficulties faced by money market funds and money market fund investors during the recent market events.
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- Investment Funds, Advisers and Derivatives
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March 5, 2010
FDA Letter to Congress Signals More Individual Prosecutions in Connection With Corporate Cases
In the wake of a Government Accountability Office report on the Food and Drug Administration’s (FDA) oversight of its Office of Criminal Investigations (OCI), Commissioner Margaret Hamburg, M.D., sent a letter to Sen. Charles Grassley on March 4, 2010, setting forth the steps that FDA was taking both to exert more control over OCI and to increase communication between OCI and the regulatory components of FDA, its Centers and the Office of Regulatory Affairs.
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- Food, Drug and Medical Device Compliance and Enforcement
- Food, Drug and Medical Device Regulatory
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March 4, 2010
New Information-Posting Requirements for Issuers, Sponsors and Underwriters of Rated Structured Finance Securities
Rules adopted in November 2009 by the Securities and Exchange Commission (the “SEC”) under the Credit Rating Agency Reform Act of 2006 will require issuers, sponsors or underwriters (referred to as “arrangers”) of structured finance securities to post on a password-protected internet website, the information provided by arrangers to credit rating agencies hired by an arranger to rate or monitor the credit ratings of the securities. The new rules will require the arranger to provide access to the website to other credit rating agencies that provide the arranger with a required certification. The deadline for compliance with these new rules is June 2, 2010.
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- Asset-Backed Securitization
- Structured Finance and Securitization
- Risk Transfer and Insurance Securitization
- Mortgage-Backed Securitization
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March 4, 2010
Notable E-Discovery Cases and Events
This Month’s case notes features a decision by Magistrate Judge Facciola discussing the standards under Fed. R. Evid. 502 governing the reasonableness of efforts to prevent inadvertent disclosure of privileged material. It also includes cases addressing the production of ESI in native format as well as decisions that award sanctions of over $4.1 million for discovery violations and that appoint a third party expert to assess a party’s compliance with its preservation and production obligations.
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- Complex Commercial Litigation
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March 3, 2010
BAE Systems plc Agrees to Pay Substantial Fines in the U.S. and UK to Resolve Bribery Charges
2010 is on pace to be a record-setting year for enforcement of the Foreign Corrupt Practices Act, as evidenced by the recent announcement of another major enforcement action. On February 5, 2010, the British defense company BAE Systems plc announced that it had entered into plea agreements with both the U.S. Department of Justice and the UK Serious Fraud Office to resolve allegations that it made or authorized improper payments to secure lucrative defense contracts.
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- Corporate Governance and Compliance
- International Trade/Arbitration
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March 2, 2010
Bill Introduced in Iowa Senate based on NCOIL Model
A bill has recently been introduced in the Iowa Senate proposing to regulate the sale of Credit Default Insurance in Iowa. The Iowa bill is substantially similar to the Credit Default Insurance Model Legislation adopted last fall by the National Conference of Insurance Legislators (NCOIL). If adopted, the bill will impact the ability of Iowa entities to utilize credit default swaps to mitigate or replicate credit risk and could also have unintended consequences with respect to certain bank participation, syndication and letter of credit arrangements.
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March 2, 2010
California Legislature Proposes to Require Placement Agents Who Solicit California Public Retirement Systems to Register as Lobbyists
The California legislature recently introduced a bill that would require persons who solicit investments by CA public retirement systems (primarily, CalPERS) to register as lobbyists and be subject to strict limitations on their fees and their provision of gifts.
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- Securities and Futures Regulatory
- Investment Funds, Advisers and Derivatives
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March 2, 2010
IRS Provides Relief from FBAR Reporting for Pre-2010 Interests in Hedge Funds and Private Equity Funds; FinCEN Issues Proposed FBAR Regulations
On February 26, 2010, the IRS released Announcement 2010-16 and Notice 2010-23, both relating to the reporting obligations on Form TD F 90-22.1, the Report of Foreign Bank and Financial Accounts (FBAR). Also on February 26, 2010, the Financial Crimes Enforcement Network, a bureau of the Treasury Department, issued proposed FBAR regulations.
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- Financial Institutions Regulatory
- Investment Funds, Advisers and Derivatives
- Private Equity and Venture Capital Funds
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March 2, 2010
The Customs Union between Russia, Kazakhstan and Belarus: How Will It Affect Your Business?
Russia, Kazakhstan and Belarus currently operate a Customs Union (CU). Since 1 January 2010, these countries apply a Common Customs Tariff. But the CU is still transitional. It will not become fully operational until 1 July 2010, when a Common Customs Code with harmonized procedures takes effect and even than there will be a transitional period for some issues.
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- International Trade/Arbitration
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March 1, 2010
Highlights from "SEC Speaks in 2010”
The SEC held its annual "SEC Speaks" conference in Washington, D.C. on February 5, 2010. Due to weather conditions, Day Two of the conference was canceled and has been rescheduled for March 26, 2010. This Sidley Update summarizes the highlights of the conference.
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- Corporate Governance and Compliance
- Investment Funds, Advisers and Derivatives
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February 25, 2010
EU Data Protection Challenges for the Insurance Industry
Recent fines against UK insurance companies for failing to comply with data protection and other regulatory requirements in relation to protection of personal and customer data have highlighted the need for insurers and others in the insurance industry to examine their use of customer data and put in place appropriate measures to protect such data.
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- Financial Institutions Regulatory
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February 25, 2010
SEC Announces Adoption of New Short Sale Price Test
The Securities and Exchange Commission (SEC) voted to adopt a new short sale price test. More specifically, in the event that certain stocks experienced an intra-day price drop of 10% or more from the prior day’s closing price, all short sales in those stocks would be prohibited at a price at or below the National Best Bid, for the remainder of the day and the following day. The SEC has not yet issued the Adopting Release for the new price test, and so this Client Update is based on statements by the Commissioners and SEC Staff at the Open Meeting held yesterday.
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- Securities and Futures Regulatory
- Investment Funds, Advisers and Derivatives
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February 24, 2010
Senate Jobs Bill May Impose Withholding Tax on Payments to Non-U.S. Insurance Companies
The Senate passed a jobs bill today that would subject payments to certain foreign financial institutions to a 30% withholding tax. Congress has indicated that it is considering the extent to which this withholding tax is applicable to non-U.S. insurance companies.
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February 24, 2010
Senate Passes Foreign Account Tax Legislation
The Senate passed a jobs bill today that would, in addition to providing for certain job creation incentives, impose a 30% withholding tax on payments to foreign financial institutions that fail to disclose financial accounts owned by U.S. persons to the IRS.
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- Private Equity and Venture Capital Funds
- Tax Aspects of Derivative Products
- Tax Aspects of Mergers and Acquisitions
- Tax Aspects of Securitization
- Tax Aspects of Capital Markets Transactions
- Private Equity and Joint Ventures
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February 23, 2010
Time Sensitive Developments on Data Security from Massachusetts, the FTC and the Director of National Intelligence
This Privacy, Data Security and Information Law Update is intended to provide clients with brief updates regarding a number of highly current and time-sensitive matters. We recommend that companies consider how these issues may affect their organizations and, in particular, whether any revisions to existing privacy and data security policies should be considered. Please contact Sidley’s Privacy, Data Security and Information Law group if you would like more information or assistance regarding these developments.
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- Privacy, Data Security and Information Law
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February 18, 2010
States Use Insurance Regulations to Target Companies Doing Business in Iran
Insurance companies licensed to do business in U.S. states have become the latest target of state efforts to encourage divestment from non-U.S. companies that do business in Iran. On February 10, 2010, the California Department of Insurance announced that as of March 31, 2010 insurers will no longer be able to count their investments in certain companies doing business in Iran toward their capitalization and surplus requirements. The California Department of Insurance is also asking insurers to refrain from making future investments in these companies. It is unclear whether these measures, if challenged in court, would be determined to be constitutional.
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- International Trade/Arbitration
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February 16, 2010
SFDA’s Working Plan for the Year of Tiger
On January 19, 2010, officials from the State Food and Drug Administration (SFDA) and its local counterparts gathered together in Beijing to attend the 2010 National Conference on the Food and Drug Administration. This annual conference, convened to develop implementation plans for 2010, serves as an early indicator of SFDA’s policy focus this year.
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- Food, Drug and Medical Device Regulatory
- Food, Drug and Medical Device Compliance and Enforcement
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February 15, 2010
EPA Takes Two Actions Under its New Source Review Programs
On February 11, 2010, the Environmental Protection Agency (EPA) took two actions under its New Source Review (NSR) programs. First, EPA proposed to accelerate the end of its policy of allowing an applicant for a Prevention of Significant Deterioration permit to use PM10 as a surrogate for PM2.5 in their air quality modeling and analysis of best available control technology. 75 Fed. Reg. 6,827 (Feb. 11, 2010). Second, EPA proposed to stay indefinitely the December 2008 “Fugitive Emissions Rule,” leaving uncertain whether all sources must consider fugitives when making NSR determinations. 75 Fed. Reg. 6,823 (Feb. 11, 2010). Public comments are due on each proposal by March 15, 2010.
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February 10, 2010
IRS Releases Audit Guidelines on Equity Swaps
On January 14, 2010, the IRS alerted its field offices that non-U.S. persons may be using abusive total return swaps to avoid U.S. withholding tax on dividends. The IRS identified four common fact patterns and provided guidance on when equity swaps should be recharacterized as contracts that may give rise to payments subject to withholding.
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- Investment Funds, Advisers and Derivatives
- Private Equity and Venture Capital Funds
- Tax Aspects of Derivative Products
- Tax Aspects of Securitization
- Tax Aspects of Capital Markets Transactions
- Private Equity and Joint Ventures
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February 9, 2010
Marketing of Funds Under the Proposed EU Directive on Alternative Investment Fund Managers – Spanish Presidency Draft of 1 February, 2010
A new draft of the proposed EU Directive on Alternative Investment Fund Managers has been published by the Spanish Presidency. Under the new draft a non-EU fund can be marketed by a non-EU manager to EU investors only if such non-EU manager provides detailed reports to the regulator in, it would appear, each EU Member State the non-EU fund is marketed into.
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- Investment Funds, Advisers and Derivatives
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February 9, 2010
Second Circuit Distinguishes Twombly and Dagher in Vacating Dismissal of Antitrust Challenge to Joint Ventures’ Conduct
In vacating dismissal of a complaint (see Starr v. Sony BMG Music Entertainment), the United States Court of Appeals for the Second Circuit recently issued an opinion analyzing two key issues under antitrust law: (1) the standard for alleging an antitrust conspiracy claim under Bell Atlantic Corp. v. Twombly and (2) the circumstances in which a joint venture’s conduct can be exempt from Section 1 of the Sherman Act under Texaco Inc. v. Dagher.
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- Complex Commercial Litigation
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February 8, 2010
SEC Interpretive Release on Climate Change Disclosure
On February 2, 2010, a divided Securities and Exchange Commission published a release stating its views regarding disclosure of climate change under its existing rules under the Securities Act of 1933 and the Securities Exchange Act of 1934. According to the SEC, its existing disclosure requirements are applicable to climate change matters.
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February 3, 2010
Center for Biological Diversity Petitions EPA to Develop Water Quality Criteria for Endocrine Disrupters
On January 11, 2010, the Center for Biological Diversity (CBD) petitioned EPA to publish water quality criteria for over 60 pharmaceuticals and personal care products, pesticides, plasticizers and other chemicals alleged to disrupt the endocrine system. Endocrine disrupting chemicals (EDCs) potentially interfere with hormones in humans and animals causing adverse developmental, reproductive, neurological or immunological effects. CBD’s petition claims that new scientific research shows that its long list of common chemicals are EDCs and “that infinitesimally small levels of exposure, in fact any level of exposure at all – may cause endocrine or reproductive abnormalities.”
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- Food, Drug and Medical Device Compliance and Enforcement
- Food, Drug and Medical Device Regulatory
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February 2, 2010
January Edition of Notable Cases and Events in E-Discovery
The January Case Notes highlight an important new decision by Judge Shira Scheindlin, the author of the various Zubulake opinions, discussing the current state of the law and setting forth a framework for analyzing a party’s compliance with its obligations to preserve and produce electronic and paper documents in discovery.
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- Complex Commercial Litigation
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February 1, 2010
SEC Proposes VWAP Exception and Other Amendments to Issuer Repurchase Safe Harbor
The Securities and Exchange Commission recently proposed amendments to Rule 10b-18 under the Securities Exchange Act of 1934, which provides issuers and their affiliated purchasers with a limited safe harbor from manipulation liability if their repurchases of the issuer’s common equity securities are made in accordance with the rule’s manner, time, price and volume conditions. One of the most noteworthy proposals is a proposed exception from the safe harbor’s price condition for VWAP purchases that satisfy certain criteria.
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- Securities and Futures Regulatory
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Winter 2010
Winter 2010 Reinsurance Law Report
For more than fifteen years, the Sidley Reinsurance Law Report has been a useful tool for cedents, reinsurers, retrocessionaires, intermediaries, arbitrators, and others transacting business in the insurance and reinsurance industry.
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- Insurance/Reinsurance Disputes
- Insurance and Reinsurance Litigation
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January 29, 2010
New PRC Tort Law Offers Clarification on Medical Product Liability, Remains Silent on Top Industry Concerns
After eight years of deliberation and four rounds of revisions, the Tort Law of the People’s Republic of China was adopted by the Standing Committee of the National People’s Congress on December 26, 2009 and will become effective on July 1, 2010. Consisting of 12 chapters with 92 clauses, the Tort Law sets forth general principles in defining tort liabilities, and addresses liabilities for specific tortious conduct.
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- Food, Drug and Medical Device Regulatory
- Food, Drug and Medical Device Compliance and Enforcement
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January 29, 2010
TransCanada Alaska Company Files Binding Open Season Plan for Alaska Natural Gas Pipeline Project
TransCanada Alaska Company LLC (TC Alaska) filed today at the Federal Energy Regulatory Commission a proposed plan to conduct a binding open season for an Alaska natural gas pipeline project beginning on April 30, 2010, and ending on July 30, 2010. The open season will solicit binding precedent agreements for interstate natural gas transportation service and optional gas treatment service provided by the Alaska Pipeline Project (APP or Project). The APP is being advanced on behalf of TC Alaska by affiliates of TransCanada and ExxonMobil.
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- Project Finance and Infrastructure
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January 28, 2010
Recent Developments in the Enforcement of the Prohibition On Off-Label Promotion
In recent weeks, there have been two important judicial decisions and an important government filing in cases involving “off-label promotion” by drug and medical device manufacturers. Taken together, these developments reflect that the promotion of drugs for off-label uses remains a significant enforcement area for drug and medical device manufacturers.
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January 27, 2010
IRS Proposes Disclosure of Uncertain Positions on Tax Returns
The IRS has announced a proposal to require business taxpayers with more than $10 million in assets to disclose uncertain tax positions on their tax returns. The proposal, would, if implemented, generally require taxpayers to disclose any tax position for which a reserve has been established on its financial statements and would require taxpayers to disclose the maximum amount of potential U.S. federal income tax liability for each uncertain tax position.
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- Investment Funds, Advisers and Derivatives
- Tax Aspects of Bankruptcy
- Tax Aspects of Derivative Products
- Tax Aspects of Mergers and Acquisitions
- Tax Aspects of Securitization
- Private Equity and Venture Capital Funds
- Foundations and Other Exempt Organizations
- Private Equity and Joint Ventures
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January 26, 2010
ITC vs. Internet: Winning the Fight to Protect IP Rights Against Online Sales of Infringing Imports
In the fight to protect intellectual property rights against online sales of infringing imports, the U.S. International Trade Commission has emerged as a forum of choice. The ITC has unique tools available to provide cost-effective relief against this seemingly intractable problem.
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- Intellectual Property Litigation
- International Trade/Arbitration
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January 22, 2010
Department of Justice and FBI Conduct Largest Sting Operation in FCPA History
U.S. government officials arrested 22 executives on Tuesday, January 19th, on charges of violating the Foreign Corrupt Practices Act (FCPA) following the largest undercover operation in the history of FCPA enforcement. As we reported just last week, 2009 set a record for the number of individuals indicted on FCPA violations—20 in all. Now, only three weeks into the new year, the Department of Justice (DOJ) not only has broken the previous year’s record but has done so in one fell swoop.
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- Corporate Governance and Compliance
- International Trade/Arbitration
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January 22, 2010
FTC Announces Reductions in HSR Premerger Notification and Clayton Act § 8 Thresholds
The Federal Trade Commission has announced the most recent annual adjustments to the Hart-Scott-Rodino Act premerger notification thresholds and the thresholds that apply to interlocking directorates under Section 8 of the Clayton Act. The changes take effect February 22, 2010. For the first time, the thresholds are being lowered.
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- Antitrust Legislative and Regulatory Representation
- Investment Funds, Advisers and Derivatives
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January 15, 2010
Health Care Reform Legislation Would Significantly Expand Fraud and Abuse Enforcement
As the House and Senate work to reconcile their respective health care reform bills, much attention has been paid to how the legislation would affect the scope of coverage and how expanded coverage would be funded. Significantly, the bills contain a variety of provisions that would substantially expand the government’s enforcement authority concerning, and the penalties for, fraud and abuse in the health care sector. This alert provides an overview of key fraud and abuse provisions in the pending bills.
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January 15, 2010
Record Prosecutions for FCPA Violations in 2009
In 2009, the government continued to aggressively pursue enforcement of the Foreign Corrupt Practices Act (FCPA). The year saw the second-highest FCPA sanction of all time came. It also was noteworthy because more individuals were indicted and tried for FCPA violations than ever before. FCPA cases generally are rare, but in 2009, the government took three cases to trial. In addition, the government has promised more focused enforcement of the Act and is concentrating on “high-risk” industries, such as the pharmaceutical industry, for greater scrutiny under the FCPA. It also has indicated that it will pursue enforcement of the FCPA in conjunction with other regulatory areas.
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- International Trade/Arbitration
- Food, Drug and Medical Device Compliance and Enforcement
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January 15, 2010
Supreme Court Upholds Mobile-Sierra Presumption for Noncontracting Parties
In a decision of major importance for all energy industry participants, the U.S. Supreme Court has ruled that the Mobile-Sierra doctrine – which requires the Federal Energy Regulatory Commission (FERC) to presume that an electricity or gas rate set by a freely negotiated wholesale contract meets the Federal Power Act’s and Natural Gas Act’s “just and reasonable” standards, which presumption may not be overcome unless the FERC concludes that the contract rate harms, or is against, the public interest – also applies to non-contracting parties (that is, third parties who did not enter into the contract at issue) who seek to challenge such rates. While prior to the Supreme Court’s ruling it was well settled that the Mobile-Sierra doctrine applied to the FERC and to parties to contracts who sought to challenge the contract rates, the Supreme Court’s ruling clarifies that even non-parties to the contracts must overcome the Mobile-Sierra doctrine’s presumption that such rates are just and reasonable and meet the more stringent public interest test to successfully challenge a freely negotiated contract rate.
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January 14, 2010
Basel II and CRD Changes to the Securitisation Framework – a Discussion of the Implications
This Update considers the impact on securitisation transactions of significant changes to Basel II and the EU Capital Requirements Directive (CRD) that will take effect from 1 January, 2011. The changes impose new requirements in respect of originator risk retention, additional disclosure, investor due diligence and risk weights for resecuritisation.
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- Structured Finance and Securitization
- Financial Institutions Regulatory
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January 14, 2010
EPA Issues Effluent Guidelines Program Plan
On December 28, 2009, EPA published in the Federal Register its preliminary 2010 effluent guidelines Program Plan, which outlines the status of the Agency’s ongoing review of its effluent guidelines and its plan for additional studies of and potential modifications to the guidelines. Of particular interest, the Plan emphasizes actions affecting discharges from four industrial categories: Steam Electric Power Generating facilities, hospitals and other healthcare facilities disposing of unused pharmaceuticals, coalbed methane extraction activities, and ore mining and dressing activities. EPA is accepting comments on its preliminary plan through February 26, 2010.
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January 13, 2010
China Publishes Medical Device GMP Regulations and Proposes New Draft Drug GMP
On December 16, 2009, the State Food and Drug Administration of China (SFDA) published a package of medical device GMP regulations, which will become effective on January 1, 2011. Device manufacturers in China will need to re-examine carefully the GMP compliance status of their operations. In addition, on December 7, 2009, SFDA published yet another draft of drug GMP for public comment. A few, but significant, changes are noted.
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- Food, Drug and Medical Device Compliance and Enforcement
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January 8, 2010
December Notable E-Discovery Cases and Events
The December 2009 Case Notes includes a report on an Idaho federal court decision finding that emails sent between an attorney and client through the client’s work email system are not privileged. The Case Notes also discuss a Florida federal court ruling imposing sanctions on defendants and their internal general counsel for failing to issue a litigation hold and thereby allowing the destruction of evidence, as well as a discussion of two other cases of interest.
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- Complex Commercial Litigation
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January 6, 2010
Federal Reserve and Federal Trade Commission Issue Risk-Based Pricing Notice Rule
The Board of Governors of the Federal Reserve System and the Federal Trade Commission jointly issued a final rule on December 22, 2009 to implement the requirements of Section 615(h) of the federal Fair Credit Reporting Act (FCRA). Section 615(h) of the FCRA was added by the FACT Act, and provides for so-called “risk-based pricing” notices. The effective date of the Rule is January 1, 2011.
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- Financial Institutions Regulatory
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January 5, 2010
EPA Revises RCRA Rules For International Shipments of Hazardous Wastes to Comport with OECD Standards
The U.S. Environmental Protection Agency announced, on December 28, 2009, revisions to its regulations regarding international shipment of hazardous waste for recovery. The final rule is designed to make international shipment regulations under the Resource Conservation and Recovery Act more consistent with those of the Organization for Economic Cooperation and Development, a consortium of 30 countries including the United States.
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January 5, 2010
Health and Human Services Semi-Annual Regulatory Agenda and Annual Regulatory Plan
In the Federal Register of December 7, 2009, the Department of Health and Human Services published its semi-annual regulatory agenda identifying the Obama Administration’s intended regulatory actions throughout the Department. In the same edition of the Federal Register, the Regulatory Information Service Center within the General Services Administration also published its annual regulatory plan, reflecting the contributions of all federal cabinet-level departments and administrative agencies. Together, these documents reveal FDA’s current regulatory priorities, including, among others, tobacco regulation and the streamlining of drug and medical device requirements.
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- Food, Drug, Device and Cosmetic Law
- Food, Drug and Medical Device Regulatory
- Food, Drug and Medical Device Compliance and Enforcement
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January 5, 2010
Seventh Circuit Defines “Substantial Burden” Under RLUIPA
A recent Seventh Circuit opinion may provide significant guidance to religious institutions who claim that they face a “substantial burden” under the Religious Land Use and Institutionalized Persons Act of 2000.
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December 30, 2009
EPA Objects to Title V Permits for New Electric Generating Units
On December 15, 2009, the U.S. Environmental Protection Agency (EPA) objected, in part, to two Clean Air Act (the Act) Title V permits for new electricity generating capacity. EPA found each state agency had not adequately considered alternatives to the proposed source during the Best Available Control Technology analysis required by the Prevention of Significant Deterioration program under the Act.
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December 23, 2009
China Releases New Draft Environmental Tort Provisions
Recently the National People’s Congress issued for public comment a third draft of the Tort Liability Law of the People’s Republic of China. The proposed law establishes both fault and no-fault tort liabilities arising from environmental pollution, and further provides for such liabilities even absent violation of any pollution control laws.
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December 23, 2009
Omnibus Appropriations Act May Increase U.S. Exports to Cuba of Ag-Med Products
The recently signed omnibus appropriations act may increase sales to Cuba of agricultural commodities, medicine and medical products by reversing a 2005 interpretation of “cash in advance” as used in the Trade Sanctions Reform Act of 2000. On December 16, 2009, the President signed into law H.R. 3288, which provides fiscal year 2010 appropriations for several departments in the U.S. government. Section 619 of this act reverses a 2005 rule by the Treasury Department’s Office of Foreign Assets Control defining “cash in advance” to require that U.S. suppliers receive payment before goods are loaded onto a carrier for export to Cuba, thereby making trade with Cuba more difficult.
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- International Trade/Arbitration
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December 22, 2009
COBRA Premium Subsidy Extension
On December 19, 2009, President Obama signed the Department of Defense Appropriations Act, 2010 (H.R. 3326), which extends (i) the last day of the eligibility period for the federal COBRA premium subsidy from December 31, 2009 to February 28, 2010 and (ii) the maximum period for the subsidy from nine months to 15 months. Individuals who allowed their COBRA coverage to lapse because their maximum nine-month subsidy period had expired can retroactively reinstate their COBRA coverage if they pay their reduced portion (35%) of the COBRA premium for the retroactive coverage period.
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- Labor, Employment and Immigration
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December 22, 2009
New EU Cosmetics Regulation Published
A new EU law on cosmetic products, the Cosmetics Regulation, was published in the EU’s Official Journal today. The Regulation introduces a number of important changes to the way cosmetic products are regulated in the EU. As such, it will likely affect all companies that manufacture or import cosmetic products in the EU.
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- Food, Drug and Medical Device Regulatory
- Food, Drug, Device and Cosmetic Law
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